Hendrix v. Mentor Corporation et al

MOTION for Summary Judgment

M.D. Ga.October 24, 2016

IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION MDL No. 2004 Master Case No. 4:08-md-2004-CDL Individual Case No. 4:14-cv-00105 (Hendrix) DEFENDANT MENTOR WORLDWIDE LLC’S MOTION FOR SUMMARY JUDGMENT AGAINST PLAINTIFF DIANE HENDRIX Pursuant to Rule 56 of the Federal Rules of Civil Procedure and Local Rule 56, Defendant Mentor Worldwide LLC (“Mentor”) respectfully moves the Court for summary judgment on all of Plaintiff’s claims because they are time-barred as a matter of law under the applicable Minnesota statutes of limitations. The grounds for this Motion are set forth in more detail in the accompanying memorandum in support. Dated: October 24, 2016 Respectfully submitted, s/ John Q. Lewis John Q. Lewis TUCKER ELLIS LLP 950 Main Avenue, Suite 1100 Cleveland, OH 44113-7213 Telephone: 216.592.5000 Facsimile: 216.592.5009 john.lewis@tuckerellis.com Designated Lead Counsel for Defendant Mentor Worldwide LLC Case 4:14-cv-00105-CDL Document 32 Filed 10/24/16 Page 1 of 2 2 012813\002767\2873673 IN RE: MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION MDL NO. 2004 CERTIFICATE OF SERVICE A copy of the foregoing was served via ECF and email on the following counsel this 24th day of October 2016: Daniel J. Thornburgh dthornburgh@awkolaw.com Douglass A. Kreis dkreis@awkolaw.com Counsel for Plaintiff Diane Hendrix s/ John Q. Lewis John Q. Lewis Designated Lead Counsel for Defendant Mentor Worldwide LLC Case 4:14-cv-00105-CDL Document 32 Filed 10/24/16 Page 2 of 2 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION MDL No. 2004 Master Case No. 4:08-md-2004-CDL Individual Case No. 4:14-cv-00105 (Hendrix) DEFENDANT MENTOR WORLDWIDE LLC’S MEMORANDUM IN SUPPORT OF ITS MOTION FOR SUMMARY JUDGMENT AGAINST PLAINTIFF DIANE HENDRIX Plaintiff’s claims fail for the following reasons:  The negligence claims (Counts II and VII) and common-law fraud, constructive fraud, and misrepresentation claims (Counts V-VII) are time- barred by the applicable Minnesota statutes of limitations because Plaintiff initiated her lawsuit more than six years after these claims accrued.  The strict liability claim (Count I) and breach of warranty claims (Counts III and IV) are time-barred by the applicable Minnesota statutes of limitations because Plaintiff initiated her lawsuit more than four years after these claims accrued. For these reasons, Mentor respectfully requests that this Court enter summary judgment in its favor on all of Plaintiff’s claims. UNDISPUTED FACTS RELEVANT TO THIS MOTION This Court previously described general facts related to ObTape (e.g., Apr. 22, 2010, Order, Doc. 241 at 4-5); Mentor will not restate them here because this motion is premised on undisputed facts unique to Plaintiff Diane Hendrix (“Plaintiff”). In July 2005, Plaintiff presented to Dr. Jitendra Shah with stress urinary incontinence, and Dr. Shah recommended a sling implant. (Separate Statement of Material Facts (“SSMF”) ¶ 1.) On August 29, 2005, Dr. Shah implanted Plaintiff with Case 4:14-cv-00105-CDL Document 32-1 Filed 10/24/16 Page 1 of 12 2 ObTape. (Id. ¶ 2.) At two 2005 follow-up visits with Dr. Shah, Plaintiff reported no complaints and was continent. (Id. ¶ 3.) On March 16, 2007, Plaintiff returned to see Dr. Shah, reporting recurrent vaginal infections that did not resolve after several rounds of antibiotics. (SSMF ¶ 4.) Dr. Shah performed a vaginal examination and saw that Plaintiff’s ObTape had eroded into her vagina. (Id. ¶ 5.) Dr. Shah told Plaintiff that her ObTape had eroded and that he would have to remove the eroded portion of her ObTape. (Id. ¶ 6.) Plaintiff testified that Dr. Shah told her that “he had to clip the band” he had implanted in her. (Id. ¶ 7.) That same day, Dr. Shah excised the eroded portion of Plaintiff’s ObTape. (Id. ¶ 8.) On August 2, 2007, Plaintiff returned to see Dr. Shah because she was experiencing vaginal discharge and was concerned that her ObTape had eroded again. (SSMF ¶ 9.) Dr. Shah performed a vaginal examination and did not find an erosion. (Id. ¶ 10.) On April 9, 2014, Plaintiff served Mentor with a Complaint captioned in Hennepin County District Court of the State of Minnesota, stating claims for strict liability (Count I), negligence (Count II), breach of express warranty (Count III), breach of implied warranty (Count IV), common law fraud (Count V), constructive fraud (Count VI), and negligent and intentional misrepresentation (Count VII). (SSMF ¶ 11.) Mentor promptly removed this case to the U.S. District Court for the District of Minnesota, and the case was transferred to this Court for coordinated proceedings. (Id. ¶ 12.) At all relevant times, Plaintiff was a resident of Missouri, and she received all ObTape-related medical treatment in Missouri. (Id. ¶ 13.) Case 4:14-cv-00105-CDL Document 32-1 Filed 10/24/16 Page 2 of 12 3 LAW AND ARGUMENT Summary judgment should be granted where “there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed R. Civ. P. 56(a). Indeed, Rule 56 “mandates the entry of summary judgment, after adequate time for discovery and upon motion, against a party who fails to make a showing sufficient to establish the existence of an element essential to that party’s case, and on which that party will bear the burden of proof at trial.” Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). Facts are “material” only if they could affect the outcome of the suit under the governing substantive law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). On a motion for summary judgment, “facts must be viewed in the light most favorable to the nonmoving party only if there is a ‘genuine’ dispute as to those facts.” Scott v. Harris, 550 U.S. 372, 380 (2007). A. A Conflict Exists Between Minnesota and Missouri Law, But Minnesota Law Will Apply. Because Plaintiff brought her case in Minnesota, Minnesota’s choice-of-law rules apply. See In re Gen. Am. Life Ins. Co. Sales Practices Litig., 391 F.3d 907, 911 (8th Cir. 2004); accord Murphy v. Fed. Deposit Ins. Corp., 208 F.3d 959, 965 (11th Cir. 2000). Here, the two states’ laws that may apply are Minnesota (where the suit was initiated) and Missouri (where Plaintiff lived at all relevant times and received all of her ObTape- related medical care). Under Minnesota’s choice of law rules, this Court must determine whether there is an actual conflict between Minnesota and Missouri law before proceeding to a choice- of-law analysis. Glover v. Merck & Co., Inc., 345 F. Supp. 2d 994, 997 (D. Minn. 2004) (citing Jepson v. Gen. Cas. Co. of Wisc., 513 N.W.2d 467, 469 (Minn. 1994)). A conflict Case 4:14-cv-00105-CDL Document 32-1 Filed 10/24/16 Page 3 of 12 4 exists if the rule of one state or the other is outcome-determinative. Id. If there is no actual conflict, or if the law at issue is procedural, then this Court should apply Minnesota law. See, e.g., Christian v. Birch, 763 N.W.2d 50, 58 (Minn. Ct. App. 2009). Here, no conflict exists between Minnesota and Missouri law on Plaintiff’s breach of express warranty claims since both states apply the U.C.C.’s four-year limitations period and accrual-on-tender rule.1 See Minn. Stat. § 336.2-725; Mo. Rev. Stat. § 400.2- 725(1)-(2).2 There are, however, conflicts between the Minnesota and Missouri statutes of limitations for negligence, strict liability, breach of implied warranty, and fraud and misrepresentation. Compare, Minn. Stat. § 541.05(1), (5) (6-year limitations period for negligence claims), Minn. Stat. § 541.05(2) (4-year limitations period for strict liability claims), Minn. Stat. § 336.2-725 (4-year limitations period for warranty claims), and Minn. Stat. § 541.05(1), (6) (6-year limitations period for fraud and misrepresentation claims), with Mo. Rev. Stat. § 516.120(4), Buttice v. G.D. Searle & Co., 938 F. Supp. 561, 566, 568 (E.D. Mo. 1996) (5-year limitations period for personal injury claims based on negligence, strict liability, and breach of implied warranty), Mo. Rev. Stat. § 516.120(5), and Buttice, 938 F. Supp. at 568 (5-year limitations period for fraud-based claims). But the fact that Minnesota courts “have consistently held that statutes of limitations are 1 Missouri treats implied warranty claims in products liability actions as arising in tort and subject to Mo. Rev. Stat. § 516.120(4)’s five-year limitations period. See Witherspoon v. Gen. Motors Corp., 535 F. Supp. 432, 434 (W.D. Mo. 1982) (citing Matulunas v. Baker, 569 S.W.2d 791, 794 (Mo. App. 1978)). 2 The only exception to the accrual-on-delivery rule under Missouri law is when a warranty explicitly extends to future performance. Mo. Rev. Stat. § 400.2–725(2). Because Plaintiff has not alleged—and cannot point to—any warranty extending to future performance, this exception does not apply. Buttice v. G.D. Searle & Co., 938 F. Supp. 561, 568 (E.D. Mo. 1996). Case 4:14-cv-00105-CDL Document 32-1 Filed 10/24/16 Page 4 of 12 5 procedural” is dispositive of the choice-of-law issue.3 Christian, 763 N.W.2d at 57 (collecting cases); see id. (“[T]he second and third steps in the choice-of-law analysis apply only if the conflicting rules of law are substantive rather than procedural.” (citing Danielson v. Nat’l Supply Co., 670 N.W.2d 1, 4 (Minn. Ct. App. 2003))). Because Minnesota courts treat statutes of limitations as procedural, there is no need to engage in a substantive choice-of-law analysis, and Minnesota’s statutes of limitations govern.4 B. Plaintiff’s Negligence Claims Are Time-Barred Because She Brought Them More Than Six Years After They Accrued. Minnesota applies a six-year limitations period to negligence-based claims: Except where the Uniform Commercial Code otherwise prescribes, the following actions shall be commenced within six years: * * * (5) for criminal conversation, or for any other injury to the person or rights of another, not arising on contract, and not hereinafter enumerated. Minn. Stat. § 541.05(1), (5) (emphasis added). The limitations period begins to run “when the plaintiff has suffered some damage as a result of the alleged negligence.” 3 Minnesota courts recognize a narrow exception in which a limitations period is treated as substantive “when it applies to a right created by statute, as opposed to a right recognized at common law.” Birch, 763 N.W.2d at 58 (citing Danielson v. Nat’l Supply Co., 670 N.W.2d 1, 6 n.2 (Minn. Ct. App. 2003)). Because Plaintiff brings only common law claims, this exception does not apply. See id. 4 Applying Minnesota’s statutes of limitations here is consistent with this Court’s Order in Morey and Cline. There, the Court determined that, because Minnesota substantive law applies in the face of a conflict of law, the Minnesota statute of limitations applies under the borrowing statute. Minn. Stat. § 541.31(b); In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., MDL Docket No. 2004, Nos. 4:10-cv-05060 (Cline), 4:11-cv-5065 (Morey), 2013 WL 286276, at *8 n.1 (M.D. Ga. Jan. 24, 2013) (attached as Ex. D to Decl. of John Q. Lewis (“Lewis Decl.”)). Under either analysis, the Minnesota statutes of limitations govern. Case 4:14-cv-00105-CDL Document 32-1 Filed 10/24/16 Page 5 of 12 6 Klempka v. G.D. Searle and Co., 963 F.2d 168, 170 (8th Cir. 1992) (emphasis added) (citing Dalton v. Dow Chem. Co., 158 N.W.2d 580, 584 (Minn. 1968)). Specifically, the Eighth Circuit has held that a claim involving personal injuries allegedly caused by a defective product accrues when two independent elements are both present: “(1) a cognizable physical manifestation of the disease or injury, and (2) evidence of a causal connection between the injury or disease and the defendant’s product, act, or omission.” Hildebrandt v. Allied Corp., 839 F.2d 396, 398 (8th Cir. 1987); see Edwards v. Wyeth, Inc., No. 07-3921, 2008 WL 1908907, at *3 (D. Minn. Apr. 25, 2008) (attached as Ex. E to Lewis Decl.). And courts have elaborated that an injury is “cognizable” when it is “capable of being perceived or known.” Narum v. Eli Lilly & Co., 914 F. Supp. 317, 320- 21 (D. Minn. 1996). Relying on Klempka, this Court has previously concluded that a cause of action accrues when a plaintiff has knowledge “that she suffered some injuries caused by ObTape.” See In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., MDL No. 2004, Nos. 4:13-cv-93, 101, 151, 153, 241, 346, 377, 426, 483, 503, 4:14-cv-61, 63 (Jackson, Rupert, Charles, Klum, Leon, Urbieta, Lovell, Suen, Uriegas, Degroot, Hall, Chambers, collectively “Jackson et al.”), 2015 WL 9307267, at *6-7 (M.D. Ga. Dec. 21, 2015) (concluding that cause of action accrues when a plaintiff learns that she has an erosion of her ObTape) (attached as Ex. F to Lewis Decl.).5 5 See also In re Mentor Corp., MDL No. 2004, Nos. 4:12-cv-301, 303, 311, 4:13-cv-011, 092 (Downey, Cavazos, Latta, Hirshfield, Greenman, collectively “Downey et al.”), 2016 WL 877773, at *4-5 (M.D. Ga. Mar. 2, 2016) (attached as Ex. G to Lewis Decl.); In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., MDL No. 2004, Nos. 4:12-cv-307, 308, 319, 323, 4:13-cv-10, 48 (Rogers, Mosier, Kearse, Shirey, Weikel, Shaffer, collectively “Rogers et al.”), 2015 WL 8578364, at *3-4 (M.D. Ga. Dec. 9, 2015) (attached as Ex. H to Lewis Decl.). Case 4:14-cv-00105-CDL Document 32-1 Filed 10/24/16 Page 6 of 12 7 Plaintiff’s negligence claims accrued in March 2007. At that time, she returned to see Dr. Shah with recurrent vaginal infections, Dr. Shah told her that her ObTape had eroded into her vagina, and he removed the eroded portion of her ObTape. (SSMF ¶¶ 4- 6, 8.) Plaintiff testified that before the March 2007 excision surgery, Dr. Shah told her that “he had to clip the band” he had implanted in her. (Id. ¶ 7.) And in August 2007, Plaintiff returned to see Dr. Shah because she was experiencing vaginal discharge and was concerned that her ObTape had eroded again. (SSMF ¶ 9.) It is beyond dispute that Plaintiff understood in 2007 that she had experienced an injury that was causally connected to her ObTape. Because Plaintiff did not serve Mentor with her Complaint until April 2014, her negligence claims are untimely under Minnesota’s six-year statute of limitations. Jackson et al., 2015 WL 9307267, at *6-10 (concluding that plaintiffs’ negligence and negligent misrepresentation claims were time-barred under Minn. Stat. § 541.05 subd. 1(5) because plaintiffs knew of injuries connected to their ObTape more than six years before filing suit). Mentor anticipates that Plaintiff will argue that she is only pursuing claims related to injuries she experienced in 2010, and that therefore her March 2007 erosion and removal surgery should not trigger the running of the statute of limitations. But this Court has recognized that a negligence claim accrues under Minnesota law when the plaintiff first learns that she has experienced an injury caused by the defendant’s product. See Downey et al., 2016 WL 877773, at *4; see also Klempka, 963 F.2d at 170- 71 (holding that claims accrued upon initial manifestation of injuries and that later manifestation of injuries did not delay accrual date); Narum, 914 F. Supp. at 320 (relying on Klempka to hold that a plaintiff’s injury was cognizable at the time she was Case 4:14-cv-00105-CDL Document 32-1 Filed 10/24/16 Page 7 of 12 8 diagnosed with an earlier, less severe injury, notwithstanding that she was later diagnosed with a more severe injury). Mentor also anticipates that Plaintiff will argue that she needed to know of a specific product defect for her claim to accrue, which she did not learn about until she saw a television commercial sometime shortly before she initiated her lawsuit. This Court expressly rejected this exact argument in Jackson et al., Rogers et al., and In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, MDL No. 2004, No. 4:13-cv-195 (Cole), 2015 WL 6126829 (M.D. Ga. Oct. 16, 2015) (attached as Ex. I to Lewis Decl.). This Court has stated: Plaintiffs contend that it is not enough that they made a connection between ObTape and some of their injuries. Rather, they appear to argue that they must have been on notice that a defect in ObTape caused their injuries. Plaintiffs did not point to any Minnesota authority holding that a plaintiff must be on actual notice that her specific injuries were caused by a product defect. Rather, the precedent establishes that a claim accrues when the plaintiff becomes aware of an injury and a causal connection between the injury and the defendant’s product. * * * [H]ere, each Plaintiff suffered injuries that were connected to an erosion of the ObTape, and each Plaintiff knew of, strongly suspected, or had enough information to know of a connection between ObTape and at least some of her injuries by the time of her excision procedure. Rogers et al., 2015 WL 8578364, at *5; accord Jackson et al., 2015 WL 9307267, at *8- 9; Cole, 2015 WL 6126829, at *2-3. See also Rogers et al., 2015 WL 8578364, at *4 (rejecting argument that plaintiffs first learned of connection between ObTape and their injuries from television commercials aired in 2011 and 2012); Jackson et al., 2015 WL 9307267, at *7 (same). Case 4:14-cv-00105-CDL Document 32-1 Filed 10/24/16 Page 8 of 12 9 So too here. Because Plaintiff was informed in March 2007 that her ObTape had eroded and needed to be removed, Minnesota law required her to file her negligence and negligent misrepresentation claims no later than March 2013. Because she did not bring her lawsuit until April 2014, her claims are time-barred.6 C. Plaintiff’s Strict Liability Claim Is Time-Barred Because She Brought It More Than Four Years After It Accrued. Minnesota applies a four-year limitations period to strict liability claims: Unless otherwise provided by law, any action based on the strict liability of the defendant and arising from the manufacture, sale, use or consumption of a product shall be commenced within four years. Minn. Stat. § 541.05, subd. 2. As with negligence claims, strict liability claims accrue when there is both a cognizable physical manifestation of an injury and evidence of a causal connection between the injury and the defendant’s product. Hildebrandt, 839 F.2d at 398 & n.1. As shown above, Plaintiff’s strict liability claim accrued in March 2007. Because she did not initiate her lawsuit until April 2014, her strict liability claim is time-barred by Minnesota’s four-year statute of limitations. 6 To the extent Plaintiff argues that she could not have reasonably discovered the cause of her injuries until recently (see Compl. ¶ 18), that allegation is insufficient to establish fraudulent concealment to toll the statutes of limitations. That is because: (1) Plaintiff has not alleged that Mentor concealed the existence of the very facts that caused her cause of action to accrue; and (2) “[f]raudulent concealment . . . requires an act of affirmative misrepresentation over and above the acts creating the alleged cause of action,” which is not alleged here. Evans v. Rudy-Luther Toyota, Inc., 39 F. Supp. 2d 1177, 1184 (D. Minn. 1999) (emphasis added) (quoting Ripplinger v. Amoco Oil Co., 916 F.2d 441, 442 (8th Cir. 1990)). This Court’s decisions in Jackson et al., Rogers et al., and Cole rejected similar, unsubstantiated fraudulent concealment arguments. Jackson et al., 2015 WL 9307267, at *9; Rogers et al., 2015 WL 8578364, at *6; Cole, 2015 WL 6126829, at *3. Case 4:14-cv-00105-CDL Document 32-1 Filed 10/24/16 Page 9 of 12 10 D. Plaintiff’s Breach Of Warranty Claims Are Time-Barred Because She Brought Them More Than Four Years After They Accrued. Minnesota applies a four-year limitations period on claims arising under the Uniform Commercial Code, including claims for breach of warranty. Minn. Stat. § 336.2-725. Moreover, the statute is explicit as to when breach of warranty claims accrue: “[a] breach of warranty occurs when tender of delivery is made.” Here, Plaintiff’s ObTape was “delivered,” and her warranty claims accrued, no later than when it was implanted—August 29, 2005. Therefore, Plaintiff’s breach of warranty claims had to be brought by August, 29, 2009. Because they were not, they are time-barred. E. Plaintiff’s Fraud, Constructive Fraud, And Misrepresentation Claims Are Time-Barred Because Plaintiff Brought Them More Than Six Years After They Accrued. Under Minn. Stat. § 541.05 subd. 1(6), the statute of limitations for fraud and misrepresentation claims is six years, with the claim “not . . . deemed to have accrued until the discovery by the aggrieved party of the facts constituting the fraud.” As this Court recognized in Jackson et al., “the facts constituting fraud are deemed to have been discovered when, with reasonable diligence, they could and ought to have been discovered,” and “[t]he failure to actually discover the fraud does not toll the statute of limitations if it is inconsistent with reasonable diligence.” Jackson et al., 2015 WL 9307267, at *10 (quoting Veldhuizen v. A.O. Smith Corp., 839 F. Supp. 669, 674 (D. Minn. 1993)). Plaintiff bears the burden of proving reasonable diligence. Id. Case 4:14-cv-00105-CDL Document 32-1 Filed 10/24/16 Page 10 of 12 11 In Jackson et al., this Court held that the plaintiffs’ fraud and intentional misrepresentation claims were time-barred because: each Plaintiff knew of, strongly suspected, or had enough information to know of a connection between ObTape and at least some of her injuries by the time of her excision procedure, if not before. A reasonable person in that situation would take some action to follow up on the cause of her injuries and try to find out whether the injuries were caused by a problem with ObTape, a problem with the implant surgery, or some other problem. Jackson et al., 2015 WL 9307267, at *10. See also Downey et al., 2016 WL 877773, at *6-7. Construing the constructive fraud claim as a claim for “fraudulent misrepresentation based on the concealment of a material fact,” the Court applied the same analysis in disposing of that claim as well. Jackson, et al., 2015 WL 9307267, at *10 n.5. The same conclusion applies here. Plaintiff knew by March 2007 that her ObTape had eroded and required removal. At that time, she was aware of sufficient facts to put her on notice of a potential fraud claim, triggering a duty to investigate. She identifies no facts that Mentor concealed that prevented her from learning of her alleged injuries or their relation to ObTape. Like her negligence and strict liability claims, Plaintiff’s fraud, constructive fraud, and intentional misrepresentation claims accrued in March 2007, rendering her April 2014 Complaint untimely. CONCLUSION Plaintiff had a cognizable injury that she understood was causally connected to her ObTape in March 2007. Because Plaintiff did not bring her lawsuit until April 2014—more than seven years after her claims accrued—all of her claims are time-barred under Minnesota law. Plaintiff’s Complaint therefore fails in its entirety, and Mentor Case 4:14-cv-00105-CDL Document 32-1 Filed 10/24/16 Page 11 of 12 12 012813\002767\2873214.1 respectfully requests that the Court enter summary judgment in its favor on all of Plaintiff’s claims. Dated: October 24, 2016 Respectfully submitted, s/ John Q. Lewis John Q. Lewis TUCKER ELLIS LLP 950 Main Avenue, Suite 1100 Cleveland, OH 44113-7213 Telephone: 216.592.5000 Facsimile: 216.592.5009 john.lewis@tuckerellis.com Designated Lead Counsel for Defendant Mentor Worldwide LLC Case 4:14-cv-00105-CDL Document 32-1 Filed 10/24/16 Page 12 of 12 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION MDL No. 2004 Master Case No. 4:08-md-2004-CDL Individual Case No. 4:14-cv-00105 (Hendrix) DEFENDANT MENTOR WORLDWIDE LLC’S SEPARATE STATEMENT OF MATERIAL FACTS IN SUPPORT OF ITS MOTION FOR SUMMARY JUDGMENT AGAINST PLAINTIFF DIANE HENDRIX Pursuant to Rule 56 of the Federal Rules of Civil Procedure and Local Rule 56, Defendant Mentor Worldwide LLC (“Mentor”) submits this Separate Statement of Material Facts in support of its Motion for Summary Judgment against Plaintiff Diane Hendrix. A. Plaintiff’s ObTape Implant. 1. In July 2005, Plaintiff presented to Dr. Jitendra Shah with stress urinary incontinence, and Dr. Shah recommended a sling implant. (Dep. of Jitendra P. Shah, M.D., (“Dr. Shah Dep.”) 49:18-50:1, 52:1-13, 53:12-54:19, attached as Ex. A to Decl. of John Q. Lewis (“Lewis Decl.”); Dep. of Diane Hendrix (“Pl. Dep.”) 119:2-7, attached as Ex. B to Lewis Decl.) 2. On August 29, 2005, Dr. Shah implanted Plaintiff with ObTape. (Dr. Shah Dep. 61:24-62:3.) B. Plaintiff’s Post-Implant History. 3. At two 2005 follow-up visits with Dr. Shah, Plaintiff reported no complaints and was continent. (Dr. Shah Dep. 67:23-69:17.) Case 4:14-cv-00105-CDL Document 32-2 Filed 10/24/16 Page 1 of 3 2 4. On March 16, 2007, Plaintiff returned to see Dr. Shah, reporting recurrent vaginal infections that did not resolve after several rounds of antibiotics. (Dr. Shah Dep. 70:4-15.) 5. Dr. Shah performed a vaginal examination and saw that Plaintiff’s ObTape had eroded into her vagina. (Dr. Shah Dep. 70:16-23.) 6. Dr. Shah told Plaintiff that her ObTape had eroded and that he would have to remove the eroded portion of her ObTape. (Dr. Shah Dep. 70:24-71:10.) 7. Plaintiff testified that Dr. Shah told her that “he had to clip the band” he had implanted in her. (Pl. Dep. 41:21-42:12, 58:25-60:1, 144:22-145:11.) 8. That same day, Dr. Shah excised the eroded portion of Plaintiff’s ObTape. (Dr. Shah Dep. 71:11-18, 74:3-76:22.) 9. On August 2, 2007, Plaintiff returned to see Dr. Shah because she was experiencing vaginal discharge and was concerned that her ObTape had eroded again. (Dr. Shah Dep. 78:17-79:12.) 10. Dr. Shah performed a vaginal examination and did not find an erosion. (Dr. Shah Dep. 79:13-19.) C. Plaintiff’s Lawsuit. 11. On April 9, 2014, Plaintiff served Mentor with a Complaint captioned in Hennepin County District Court of the State of Minnesota, stating claims for strict liability (Count I), negligence (Count II), breach of express warranty (Count III), breach of implied warranty (Count IV), common law fraud (Count V), constructive fraud (Count VI), and negligent and intentional misrepresentation (Count VII). (Notice of Removal ¶ 1, Doc. 1; Compl. ¶¶ 20, 30, 40, 52, 62, 91, 99, Doc. 1-1.) Case 4:14-cv-00105-CDL Document 32-2 Filed 10/24/16 Page 2 of 3 3 012813\002767\2872109.1 12. Mentor removed this case to the U.S. District Court for the District of Minnesota (Notice of Removal, Doc. 1), and the case was transferred to this Court for coordinated proceedings (CTO-104, Doc. 4). 13. At all relevant times, Plaintiff was a resident of Missouri, and she received all ObTape-related medical treatment in Missouri. (Pl. Dep. 44:3-11, 60:10-17; Compl. ¶ 1; Am. Pl. Fact Sheet §§ II.3-7, attached as Exhibit C to Lewis Decl.) Dated: October 24, 2016 Respectfully submitted, s/ John Q. Lewis John Q. Lewis TUCKER ELLIS LLP 950 Main Avenue, Suite 1100 Cleveland, OH 44113-7213 Telephone: 216.592.5000 Facsimile: 216.592.5009 john.lewis@tuckerellis.com Designated Lead Counsel for Defendant Mentor Worldwide LLC Case 4:14-cv-00105-CDL Document 32-2 Filed 10/24/16 Page 3 of 3 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION MDL Case No. 2004 Master Case No. 4:08-md-2004-CDL Individual Case No. 4:14-cv-00105 (Hendrix) DECLARATION OF JOHN Q. LEWIS IN SUPPORT OF DEFENDANT MENTOR WORLDWIDE LLC’S MOTION FOR SUMMARY JUDGMENT AGAINST PLAINTIFF DIANE HENDRIX I, JOHN Q. LEWIS, declare as follows: 1. I am an attorney admitted to practice law in the State of Ohio and admitted pro hac vice in this action. I am a partner at the law firm of Tucker Ellis LLP, and counsel of record for Defendant Mentor Worldwide LLC (“Mentor”) in this action. I have personal knowledge of the matters stated herein and, if called upon, I could and would competently testify to the matters contained in this Declaration. 2. Attached as Exhibit A are true and correct copies of excerpts from the Deposition of Jitendra P. Shah, M.D., dated September 23, 2016. 3. Attached as Exhibit B are true and correct copies of excerpts from the Deposition of Diane Hendrix, dated August 23, 2016. 4. Attached as Exhibit C is a true and correct, partially redacted, copy of Plaintiff Diane Hendrix’s Amended Plaintiff Fact Sheet, executed August 17, 2016. 5. Attached as Exhibit D is a true and correct copy of this Court’s unreported decision in In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, MDL Docket No. 2004, Nos. 4:10-cv-05060 (Cline), 4:11-cv-5065 (Morey), 2013 WL 286276 (M.D. Ga. Jan. 24, 2013). Case 4:14-cv-00105-CDL Document 32-3 Filed 10/24/16 Page 1 of 2 2 6. Attached as Exhibit E is a true and correct copy of an unreported case, Edwards v. Wyeth, Inc., No. 07-3921, 2008 WL 1908907 (D. Minn. Apr. 25, 2008). 7. Attached as Exhibit F is a true and correct copy of this Court’s unreported decision in In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, MDL No. 2004, Nos. 4:13-cv-93, 101, 151, 153, 241, 346, 377, 426, 483, 503, 4:14-cv-61, 63 (Jackson, Rupert, Charles, Klum, Leon, Urbieta, Lovell, Suen, Uriegas, Degroot, Hall, Chambers), 2015 WL 9307267 (M.D. Ga. Dec. 21, 2015). 8. Attached as Exhibit G is a true and correct copy of this Court’s unreported decision in In re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation, MDL No. 2004, Nos. 4:12-cv-301, 311, 4:13-cv-011, 092 (Downey, Latta, Hirschfield, Greenman), 2016 WL 877773 (M.D. Ga. Mar. 2, 2016). 9. Attached as Exhibit H is a true and correct copy of this Court’s unreported decision in In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, MDL No. 2004, Nos. 4:12-cv-307, 308, 319, 323, 4:13-cv-10, 048 (Rogers, Mosier, Kearse, Shirey, Weikel, Shaffer), 2015 WL 8578364 (M.D. Ga. Dec. 9, 2015). 10. Attached as Exhibit I is a true and correct copy of this Court’s decision in In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, MDL No. 2004, No. 4:13-cv-195 (Cole), 2015 WL 6126829 (M.D. Ga. Oct. 16, 2015). I declare under penalty of perjury under the laws of the United States that the foregoing is true and correct. Executed this 24th day October 2016 in Cleveland, Ohio. s/ John Q. Lewis John Q. Lewis Case 4:14-cv-00105-CDL Document 32-3 Filed 10/24/16 Page 2 of 2 Exhibit A Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 1 of 39 1 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA 2 COLUMBUS DIVISION 3 4 5 IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS 6 LIABILITY LITIGATION, 7 MDL CASE NO. 2004 8 CASE NO. 4:14-cv-000105 9 10 DEPOSITION OF JITENDRA P. SHAH, M.D. 11 TAKEN ON BEHALF OF THE DEFENDANT SEPTEMBER 23, 2016 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Job No. CS2380899 Page 1 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 2 of 39 1 INDEX 2 EXAMINATION PAGE 3 4 QUESTIONS BY MR. SINDELAR 5 5 QUESTIONS BY MR. THORNBURGH 84 6 7 EXHIBITS 8 DEPOSITION EXHIBIT 1 40 9 DEPOSITION EXHIBIT 2 44 10 DEPOSITION EXHIBIT 3 49 11 DEPOSITION EXHIBIT 4 57 12 DEPOSITION EXHIBIT 5 59 13 DEPOSITION EXHIBIT 6 71 14 DEPOSITION EXHIBIT 7 83 15 DEPOSITION EXHIBIT 8 109 16 DEPOSITION EXHIBIT 9 125 17 DEPOSITION EXHIBIT 10 134 18 19 20 21 22 (Exhibits attached to original transcript.) 23 24 25 Page 2 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 3 of 39 1 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA 2 COLUMBUS DIVISION 3 IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS 4 LIABILITY LITIGATION, 5 MDL CASE NO. 2004 No. 4:14-cv-00105 6 7 8 Deposition of JITENDRA P. SHAH, M.D., produced, sworn, and examined on the 23rd day of September, 9 2016, between the hours of 2:27 o'clock in the afternoon and 5:34 o'clock in the afternoon, at the 10 offices of Brinker & Doyen, L.L.P., 34 North Meramec Avenue, 5th Floor , in Clayton, Missouri, before 11 Pamela K. Needham, CCR, CSR (MO, IL), in a certain cause now pending IN THE UNITED STATES DISTRICT 12 COURT, FOR THE MIDDLE DISTRICT OF GEORGIA, COLUMBUS DIVISION. 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 3 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 4 of 39 1 APPEARANCES: 2 FOR THE PLAINTIFF: 3 Mr. Daniel Thornburgh 4 Aylstock, Witkins, Kreis & Overholtz 17 East Main Street, Suite 200 5 Pensacola FL 32502 (850) 776-7788 6 dthornburgh@awkolaw.com 7 FOR THE DEFENDANT MENTOR WORLDWIDE, LLC: 8 Mr. Jeffrey C. Sindelar, Jr. 9 Tucker Ellis, LLP 950 Main Avenue, Suite 1100 10 Cleveland, OH 44113 (216) 696-3697 11 jeffrey.sindelar@tuckerellis.com 12 FOR THE DEPONENT: 13 Mr. Jeffrey Brinker 14 Brinker Doyen, LLP 34 North Meramec Avenue, 5th Floor 15 Clayton, MO 63105 (314) 863-6311 16 jbrinker@brinkerdoyen.com 17 THE VIDEOGRAPHER: 18 Mr. Robert Pedroli, III Veritext 19 100 South 4th Street, Suite 550 St. Louis, MO 63102 20 21 The Court Reporter: 22 Pamela K. Needham, IL CSR, MO CCR 23 Veritext 100 South 4th Street, Suite 550 24 St. Louis, MO 63102 25 Page 4 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 5 of 39 1 IT IS HEREBY STIPULATED AND AGREED, by and between 2 counsel for the Plaintiffs and counsel for the 3 Defendants, that the deposition of DR. JITENDRA P. 4 SHAH, M.D., may be taken in shorthand by Pamela K. 5 Needham, Certified Court Reporter (IL 084-002247 and 6 MO 505), and afterwards transcribed into 7 typewriting; and the signature of the witness is 8 reserved. 9 * * * * * 10 (On the record at 2:27 p.m.) 11 THE VIDEOGRAPHER: We are now on the 12 record. Please note that the microphones are 13 sensitive and may pick up whispering and private 14 conversations. Please turn off all cell phones and 15 place them away from the micro -- microphones, as 16 they can interfere with the deposition audio. 17 Recording the continue until all parties agree to go 18 off the record. 19 My name is Robert Pedroli, III, I 20 represent Veritext as a videographer. Today is 21 September 23rd, 2016, at approximately 2:27 p.m. 22 We're holding the deposition at Brinker and Doyen 23 located at 34 North Meramec, and it is being taken 24 by counsel of Brinker & Doyen, Jeffrey Brinker, and 25 of Tucker Ellis, Jeffrey -- Page 5 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 6 of 39 1 MR. BRINKER: No. 2 THE VIDEOGRAPHER: -- Sindelar -- 3 MR. BRINKER: I'm sorry, I just 4 represent, I just represent the doctor. 5 THE VIDEOGRAPHER: Oh, sorry. 6 MR. BRINKER: I represent the witness, 7 that's okay. 8 THE VIDEOGRAPHER: Oh, sorry. 9 Mr. Brinker represents the doctor here today, and 10 Dr. Shah is the witness. 11 And the caption of the case is In Re: 12 Mentor Corp. ObTape Trans-Obturator Sling Products 13 Liability Litigation. The case is being held in the 14 Middle District of Georgia, Case Number 4:14-CV-105, 15 the name of the witness is... Jinetra Shah? 16 THE WITNESS: Jitendra Shah. 17 THE VIDEOGRAPHER: Jitendra Shah. And 18 at this time the attorneys present in the room and 19 everyone attending remotely will identify 20 themselves, and our court reporter -- you guys want 21 to identify yourselves? 22 MR. BRINKER: Sure. Jeff, I'm Jeff 23 Brinker here for Dr. Shah. 24 MR. THORNBURGH: I'm Daniel Thornburgh 25 with Aylstock, Witkins, Kreis and Overholtz, and I Page 6 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 7 of 39 1 represent the Plaintiff, Diane Hendrix. 2 MR. SINDELAR: Jeff Sindelar with Tucker 3 Ellis, LLP, here on behalf of the Defendant, behalf 4 of the Defendant Mentor Worldwide, LLC. 5 THE VIDEOGRAPHER: Our court reporter 6 will now swear the witness, and we can proceed. 7 THE REPORTER: Doctor, will you raise 8 your right hand, please? 9 JITENDRA P. SHAH, M.D., 10 of lawful age, produced, sworn, and examined on 11 behalf of the Defendant deposes and says: 12 EXAMINATION 13 QUESTIONS BY MR. SINDELAR 14 Q. Good afternoon, Dr. Shah, could you 15 please state your full name for the record? 16 A. Jitendra P. Shah. 17 Q. And could you please provide your 18 address of the place that you have your medical 19 practice? 20 A. 10004 Kennerly, K-E-N-N-E-R-L-Y, 21 Kennerly Road, St. Louis, Missouri, 63128. 22 Q. And what is the name of your medical 23 practice? 24 A. St. Louis Hills Urological Associates. 25 Q. Okay. Thank you. Doctor, my name is Page 7 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 8 of 39 1 the record that your office sent me a -- 2 MR. SINDELAR: Look -- 3 MR. THORNBURGH: I'm -- I'm going to put 4 it on the record. 5 MR. SINDELAR: This, this is coming out 6 of your time for your deposition -- 7 MR. THORNBURGH: You're -- 8 MR. SINDELAR: -- you keep 9 interrupting -- 10 MR. THORNBURGH: -- causing -- 11 MR. SINDELAR: -- and getting in the 12 way -- 13 MR. THORNBURGH: Your office -- 14 MR. SINDELAR: -- of my questioning. 15 MR. THORNBURGH: Your office sent me a 16 stack of records that you intended to use with the 17 doctor, with Dr. Shah, that you forwarded -- that 18 you sent to Dr. Shah, which you represented to me 19 was his complete medical file regarding my client. 20 And so this was not given to us at that time either. 21 MR. SINDELAR: I'll make a motion to 22 strike that colloquy. We're going to continue on 23 with the deposition. Can you mark this as our next 24 record? Next exhibit, please? 25 (Deposition Exhibit Number 3 marked for Page 48 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 9 of 39 1 identification.) 2 Q (By Mr. Sindelar) Doctor, you've been 3 handed a copy of what I believe has been marked as 4 Exhibit 3, is that correct? 5 THE WITNESS: Mm-hmm. Yes. 6 Q. And Doctor, does Exhibit 3 appear to be 7 a set of your office notes from your care and 8 treatment of Ms. Hendrix? 9 A. Yes. 10 Q. Okay. And it's a two-sided document, 11 and if you look at it I believe it indicates that 12 your first visit with Ms. Hendrix was July 25th, 13 2005. 14 A. Yes. 15 Q. And your last visit was May 6 of 2008, 16 is that correct? 17 A. Yes. 18 Q. And Doctor, I want to just start with 19 your first visit with Ms. Hendrix which occurred 20 July 25th, 2005. Can you just walk us through why 21 Ms. Hendrix came in to see you, and any examinations 22 or recommendations you made on that day? 23 A. She came to see me because of stress and 24 urgent incontinence, and she has had it for a while, 25 but it was gradually getting worse, and she had to Page 49 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 10 of 39 1 wear pads to keep dry. 2 Q. And you note in the record: "No CVA 3 tenderness." What does that mean? 4 A. There's no tenderness in the kidney 5 area. 6 Q. And, and why would you check for 7 tenderness in the kidney area? 8 A. That is just part of the general 9 urological examination. 10 Q. Okay. And you note in the record that: 11 "The bladder was descended and came down further on 12 coughing." What does that mean, Doctor? 13 A. That the bladder had dropped. And see, 14 most of the time when a lady has stress 15 incontinence, it is, most of the time it is because 16 of the bladder coming down. And most of the time it 17 is due to childbirth. And the bladder had come down 18 in this lady, and that is when we, we ask them to 19 cough, and it came down further when she coughed, 20 and that is why it is called stress incontinence, 21 when that, the bladder is subjected to the stress 22 from the abdominal cavity, and that is why it leaks, 23 so that is why it is called stress incontinence. 24 Q. And based on this visit with Ms. Hendrix 25 in July of 2005, you were able to see anatomically Page 50 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 11 of 39 1 why she had stress incontinence? 2 A. Yes. 3 Q. Okay. And then you, you go through, 4 describes the Neosporin being instilled and the 5 urethra dilated. Can you walk us through what you 6 did and what you were able to -- 7 A. Well, that is just part of the 8 procedure, it is nothing peculiar for this lady 9 which we, I do, you know, in all the patients when 10 they come to, just to get a general idea as to how 11 much urine they had in the bladder, and sometimes we 12 do instill Neosporin, because I've instilled a 13 catheter, which is a foreign body, so I just, a 14 local antibiotic to prevent any infection. 15 Q. And you note: "Urethra dilated to 24F 16 Van Buren sounds." Can you explain for the jury 17 what that means? 18 A. Van Buren is a, the name of the person 19 who devised the sound, and a lot of these women do 20 not empty completely, so I just stretch it, and at 21 24 is the, the size of the particular sound. 22 Q. And could you, could you explain what a 23 sound is? 24 A. Sound is a metal instrument that 25 stretches the urethra. Page 51 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 12 of 39 1 Q. And at the end of this 7-25-05 visit, 2 could you explain what you told Ms. Hendrix? 3 A. I told her that because she's having 4 urinary incontinence, we have to do some tests to 5 find out what would be the best treatment, and I 6 told her that she would have to come for the 7 evaluation, and that is what we told her. 8 Q. Okay. And it looks like she did come in 9 for that evaluation -- 10 A. Yes. 11 Q. -- a few days later on July 28th, 2005, 12 is that correct? 13 A. Right. 14 Q. And can you walk us through that visit 15 on July -- 16 A. I looked into -- 17 Q. -- 28? 18 A. I looked into her bladder and I did not 19 find anything unusual, I didn't find any tumor or 20 stone, and I found that the urethra orifices were 21 within normal limits and there was nothing else 22 abnormal. 23 Q. It says she "came in for cysto." Can 24 you explain what that means? 25 A. Cysto is when you look into the bladder. Page 52 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 13 of 39 1 Q. Okay. And it says that: "This was done 2 with a dilation which revealed cystourethrocele." 3 Can you explain what cystourethrocele is? 4 A. Cystourethrocele is when the bladder 5 drops, when part of the bladder and the urethra has 6 dropped from its normal anatomical position. That 7 is what it is. 8 Q. Okay. And is that cystourethrocele one 9 of the anatomical causes of stress urinary 10 incontinence? 11 A. Yes. 12 Q. Okay. And then your plan after this 13 7-28-05 visit was for her to come back in for 14 another test, is that correct? 15 A. Yes. 16 Q. And it looks like she did come in on 17 August the 1st, 2005, is that correct? 18 A. Yes. 19 Q. And can you walk us through that August 20 1st, 2005, visit? 21 A. She came in for what is called a 22 cystometrogram, that is when we run water in the 23 bladder and see what, how the body, her body reacts 24 to the normal installation of water in the bladder 25 in that it sort of mimics what happens in real life Page 53 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 14 of 39 1 when the body, when the bladder gets filled up with 2 urine from natural causes, and so that is how we run 3 water in the bladder, and then we try to find out as 4 to when she first felt that she needed to go to the 5 bathroom. And when she, you know, needed to be told 6 that I really cannot hold it anymore, and then we 7 would ask them to urinate, and that would generate 8 pressure, and that would tell us whether the, the 9 motor -- whether the strength of the bladder muscle 10 is normal or not, whether there is any neurological 11 deficit in the bladder. 12 Q. And based on the results of that 13 cystometrogram, did you believe that Ms. Hendrix was 14 a good candidate for a TOT procedure? 15 A. Yes. 16 Q. Okay. Now did you tell Ms. Hendrix 17 during this August 1st, 2005, visit that you wanted 18 to perform a TOT procedure on her? 19 A. Yes. 20 Q. And Doctor, do you have a discussion 21 with your patients prior to performing a procedure 22 on them about the risks and benefits of the 23 procedure? 24 A. Well, I do not discuss the risks and 25 benefit of cystometrogram. Page 54 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 15 of 39 1 Q. But with respect to the TOT procedure. 2 A. Yes. 3 Q. Okay. So would this August 1st, 2005, 4 visit have been when you had a discussion with Ms. 5 Hendrix about the TOT procedure and the risks and 6 benefits? 7 A. I, I don't think I would have done it on 8 the 15th of September, I would have done it, you 9 know -- before we scheduled the surgery I would do 10 it. 11 Q. Okay. And the TOT ObTape -- 12 A. Was done on the August, the 29th. 13 Q. So at some point before the August 29th, 14 2005, ObTape implant -- 15 A. Yes. 16 Q. -- you would have had a discussion with 17 Ms. Hendrix -- 18 A. I would have done it at that time. 19 Q. Okay. And do you believe that would 20 have been on, on the August 1st, 2005 -- 21 A. Yes. 22 Q. -- visit? 23 A. Yes. 24 Q. Okay. And during that discussion, we 25 talked earlier about what you would commonly discuss Page 55 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 16 of 39 1 by page with you. The first one appears to be your 2 operative note from the ObTape implant, is that 3 correct? 4 A. Yes. 5 Q. Okay. And Doctor, can you please just 6 walk us through the implant note? 7 A. I -- can you ask me, ask me the question 8 again? 9 Q. I can, I just want you to walk us 10 through the procedure that you performed on Ms. 11 Hendrix. 12 A. You want me to tell you what I did. 13 Q. Yeah, and I mean you don't need to go 14 through the entire record word for word, but can you 15 just explain the procedure that you performed on Ms. 16 Hendrix on -- 17 A. Well -- 18 Q. -- August 29th, 2005? 19 A. You know, that is, I did what is called 20 the TOT, I did the TOT procedure, and that is what 21 it has been described, I, you know, I... you know, 22 you make a small incision on the groin, and through 23 that groin incision, you put a bigger needle, and 24 you bring the needle out to another small incision 25 in the vagina, and you thread the, the needle with Page 60 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 17 of 39 1 the tape, and you bring the tape out from the groin 2 incision, so one end of the tape is in the groin and 3 the other end of the tape is in the vagina, and the 4 same thing you do on the other side, and that way 5 you pull the tape out from the other groin incision; 6 so what happens is that, that the sling stays under 7 the bladder like a hammock. 8 Q. Okay. And Doctor, if you could just 9 turn over to the next page with me really quickly, 10 it's on the, on the back side, if you look kind of 11 towards the bottom where there's like a lined sheet, 12 there's a -- it's a copy, so you don't see that it's 13 a sticker, but there's a copy of the ObTape 14 product -- 15 A. Yes, Mentor. 16 Q. Okay. And Doctor, if you had wanted to 17 at any point determine what the name of the product 18 was that you'd implanted on the plaintiff -- in the 19 plaintiff on August 29th, 2005, you could have 20 turned to this record to determine what that product 21 was, is that correct? 22 A. Yes. 23 MR. THORNBURGH: Objection. 24 Q (By Mr. Sindelar) Doctor, looking at your 25 operative report and the ObTape product, that D Page 61 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 18 of 39 1 sticker, does that confirm to you that you implanted 2 Ms. Hendrix with ObTape on August 29th, 2005? 3 A. Yes. 4 Q. And Doctor, were there any complications 5 during the implant procedure on August 29th, 2005? 6 A. No. 7 Q. And it looks like Dr. Brennan was also 8 performing surgery on Ms. Hendrix on that day, is 9 that correct? 10 A. Yes. 11 Q. Okay. And do you know what, what Dr. 12 Brennan was doing during the procedure? 13 A. Dr. Brennan did -- 14 MR. THORNBURGH: Objection. 15 THE WITNESS: -- vaginal hysterectomy, 16 and A&P repair. 17 Q (By Mr. Sindelar) Okay. And do you, do 18 you know what order those different procedures took 19 place in the operating room? 20 A. Generally speaking I don't. 21 Q. Okay. 22 A. Because I mean, you know, the way it 23 happens, I do my procedure, then I leave. 24 Q. Okay. 25 A. Then he does his work. Page 62 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 19 of 39 1 Q. Okay. Do you know if he did his 2 procedures first or you did yours first? 3 A. I -- generally speaking the way it 4 works, that I did my procedure first. 5 Q. Okay. I think if you look at the second 6 sentence it says: The patient initially had surgery 7 by Dr. Robert J -- Robert Brennan, Jr., and after he 8 was done with his part he -- 9 A. Okay, so in this case Dr. Brennan did it 10 first. 11 Q. Okay. And you also indicate that you 12 did, it looks like you did two separate 13 cystoscopies, is that correct? 14 A. Yeah, that is a normal thing, because 15 when you are putting the tape, you just want to be 16 sure that you have not entered the bladder. 17 Q. Okay. 18 A. And that is why you do the cystoscopy, 19 every time you put the... when I put the needle on 20 one side, and after that look into the bladder to be 21 sure that the needle is not in the bladder. So 22 since you are putting the needle in twice, once from 23 the left side and once from the right side, so that 24 is how you do it. 25 Q. Okay. And then based on those Page 63 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 20 of 39 1 cystoscopies, you were able to confirm that there 2 was no injury to the bladder during Ms. Hendrix's -- 3 A. Yes. 4 Q. -- procedure. 5 A. Yes. 6 Q. And then you also note in your operative 7 report that: "The curved Mayo scissor could be 8 passed very easily between the tape and the urethra. 9 At this time it was felt that this was adequate 10 tension." Can you explain why you do that 11 tensioning test? 12 A. One of the reason -- the main -- one of 13 the big complications of the TOT is that if you put 14 too much tension on the tape, then the patient 15 cannot urinate, and if you don't put enough tension, 16 then the operation is not a success. So the... 17 the... you just have to put the amount of tension 18 which is just right, enough to produce relief of 19 symptoms, but not that bad to cause retention. 20 Q. And then it notes, it notes that you 21 did -- strike that. 22 The record notes that: "Redundant tape 23 was cut off at the thigh wounds on both sides, and 24 the thigh wounds were closed with 4-0 chromic 25 subcuticular stitch." Can you explain what that Page 64 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 21 of 39 1 means? 2 A. Well, you know, when we put the tape, 3 there is a lot of tape remaining, and so we cut off 4 the redundant tape and through small incisions we 5 just close. 6 Q. And then it notes: At this juncture the 7 undersigned scrubbed out and Dr. Robert Brennan, 8 Jr., scrubbed back in to do his part of the 9 operation again? 10 A. Yes, so, you know, he did, initially did 11 part, then I did, and then again he came. 12 Q. And then would Dr. Brennan have been the 13 one who stitched up the vaginal incision? 14 A. Yes. 15 Q. Okay. And then did you make a separate 16 vaginal incision insert? 17 A. Most of the time it is the same 18 incision. 19 Q. Okay, so, so you would have used the 20 incision, the vaginal incision that had been made by 21 Dr. Brennan -- 22 A. Right. 23 Q. -- to insert the ObTape, okay. If we 24 could turn over two pages, Doctor, to the page with 25 PLF Hendrix D119 in the bottom right-hand corner, it Page 65 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 22 of 39 1 indicates 8-30-2005, so the day after the surgery, 2 and I believe it says: "Foley out, voiding?" 3 MR. BRINKER: Can I show him what page 4 you are looking at? 5 MR. SINDELAR: Oh, certainly. 6 MR. BRINKER: I think it's a page before 7 where you are. 8 THE WITNESS: Okay. 9 Q (By Mr. Sindelar) And they're double 10 sided, so I'm sorry -- 11 THE WITNESS: Yeah. 12 Q. -- if I got a little confusing. And 13 Doctor, that's a notation from the day after the 14 surgery -- 15 A. Yes. 16 Q. -- August 30th, is that correct? 17 A. Right. 18 Q. Okay, and does that say -- what does the 19 note say on the record? 20 A. The Foley, you know, that is a Foley 21 catheter that we usually put on the patient after 22 surgery, and then we take it out the next day, so 23 that is what it mentioned, that the Foley catheter 24 was taken out, and the patient was voiding. I mean 25 that is the, the important thing, to be sure that Page 66 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 23 of 39 1 the patient is urinating okay. 2 Q. Okay. And I believe we have some 3 records related to Dr. Brennan's surgeries on the 4 plaintiff on that day. Did you review Dr. Brennan's 5 notes -- 6 A. (Shakes head no.) 7 Q. -- around that time? No, okay. Well, 8 we can skip over those, then. You can set Exhibit 5 9 to the side. 10 And if we could turn back to what I 11 believe is Exhibit 3, which is the set of your 12 office notes, it looks like there's documentation of 13 your next visit with Ms. Hendrix? 14 A. Yes. 15 Q. Okay. Notes that you saw Ms. Hendrix 16 again on September 15th, 2005, is that correct? 17 A. Yes. 18 Q. Can you explain why she came in to see 19 you? 20 A. Well, because I had operated on her, 21 this is normal, I follow up on the patients who have 22 had surgery. 23 Q. Okay, and when she came in to see you on 24 September 15th, 2005, she, she was doing well? 25 A. Yes. Page 67 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 24 of 39 1 Q. And she was feeling well? 2 A. Yes. 3 Q. And she reported she had no complaints 4 to you. 5 A. Right. 6 Q. Okay. You note: "She's healing well, 7 and her bladder is working very well," is that 8 correct? 9 A. Yes. 10 Q. And then based on this follow-up visit 11 that Ms. Hendrix had with you two weeks out from her 12 ObTape implant, at this point did she appear to be 13 recovering from the surgery well? 14 A. Yes. 15 Q. And the fact that you note that her 16 bladder is working very well, does that indicate to 17 you that her, her incontinence was under control at 18 this point? 19 A. I had mentioned it. 20 Q. Okay. 21 A. That she is continent. 22 Q. Okay. 23 A. And has had good results with the 24 surgery. 25 Q. Okay. Oh, you know, I think that might Page 68 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 25 of 39 1 be down in the 10-20 note actually. 2 A. Yeah. 3 Q. Okay, I'm sorry, I just want to talk 4 about the 9-15 note now. 5 A. Okay. 6 Q. And then we'll, we'll go to the 10-05 7 one next. 8 A. Yeah. 9 Q. And it looks like she did come back to 10 see you -- 11 A. Yes. 12 Q. -- a little over a month later on 13 October the 20th of 2005, is that correct? 14 A. Mm-hmm. 15 Q. And at this point you note that she's 16 continent and has good results from her surgery? 17 A. Yes. 18 Q. And then it notes: "I told her I would 19 see her on a p.r.n. basis?" 20 A. Yeah. 21 Q. Ask you explain for the jury what that 22 means? 23 A. P.r.n. basis means as and when 24 necessary. 25 Q. Okay. So, so you told Ms. Hendrix at Page 69 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 26 of 39 1 this point to come back and see you if she needed 2 you for anything? 3 A. Yes. 4 Q. Okay, it looks like you next saw Ms. 5 Hendrix on March 16th, 2007, which is over on the 6 back side? 7 A. Yes. 8 Q. Of Exhibit Number 3? Can you explain 9 why Ms. Hendrix came in to see you on March 16th, 10 2007? 11 A. Because she said that she's have, was 12 having vaginal infections, and she said that she has 13 had those vaginal infections since the surgery, and 14 she had been on numerous antibiotics and those had 15 not helped. 16 Q. Okay, now did you perform a vaginal 17 examination? 18 A. I did the vaginal examination, I could 19 see that the tape had eroded on the one side. 20 Q. Okay. And, and the tape you're 21 referring to, that was the tape that you implanted 22 back in August of 2005? 23 A. Yes. 24 Q. And would you have told Ms. Hendrix 25 during this March 16th, 2007, visit, that her tape Page 70 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 27 of 39 1 had eroded? 2 A. Yes. 3 Q. Okay. And then what -- 4 A. I... I have mentioned that I told her 5 that the -- I told her I shall have to remove this 6 tape. 7 Q. So, so you also told her on this March 8 16th, 2007, visit, that you had to remove her tape 9 because it had eroded? 10 A. Yes. 11 Q. Okay, and then it looks like you 12 scheduled her for a surgery to remove the tape that 13 same day, is that correct? 14 A. Yes. 15 Q. Okay, then it looks like you actually 16 did that very same day, March 16th, 2007, do an 17 excision of the eroded ObTape? 18 A. Yes. 19 Q. And I have the records for that, as 20 well. 21 (Deposition Exhibit Number 6 marked for 22 identification.) 23 Q (By Mr. Sindelar) Doctor, you've been 24 handed a copy of what has been marked as Exhibit 6? 25 THE WITNESS: Yes. Page 71 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 28 of 39 1 Q. Which is a set of records from St. 2 Anthony's Medical Center from when you removed Ms. 3 Hendrix's eroded tape? 4 A. Yes. 5 Q. The same as the last time, I'm going to 6 go through these records, I don't think we're going 7 to touch on every single page, but I'll just go in 8 the order that they are in Exhibit 6. 9 The first page is the History and 10 Physical, is that correct? 11 A. Yes. 12 Q. And it indicates that Ms. Hendrix was 13 being, was being taken to the hospital for her tape 14 erosion? 15 A. Yes. 16 Q. Okay. If you would turn a few pages in 17 to the one with the Bates number at the bottom that 18 says OBT Hendrix D769? 19 A. 769, yes. 20 Q. Okay, again, can you explain what this 21 form is, Doctor? 22 A. This is the form that I sent to the 23 hospital, and that is the form that tells them what, 24 the consent for what kind of surgery is going to be 25 done, so that, you know, it says over there: "Have Page 72 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 29 of 39 1 the consent signed for excision of vaginal tape." 2 Q. Okay. If we turn a few more pages in to 3 the one marked 774 on the bottom? 4 A. Okay. 5 Q. And this indicates: "Post invasive 6 procedure/surgery note," is that correct? 7 A. Yes. 8 Q. And can you explain what this note is? 9 A. You know, they said that if you -- 10 whatever procedure you do, you have to write a note. 11 Q. Okay. And is this your note to the 12 hospital saying that you performed excision vaginal 13 tape done -- 14 A. Yeah. 15 Q. -- under anesthesia? 16 A. Yes. 17 Q. Okay. And then if we turn over to the 18 it next page, it's a two-part letter. And is this 19 the Informed Consent Form that you had -- 20 A. Yes. 21 Q. -- requested? Okay. And is this a 22 consent form for excision: Vaginal tape? 23 A. Yes. 24 Q. Okay. And would you go, would you go 25 over this form with the patient, or would someone at Page 73 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 30 of 39 1 the hospital do that? 2 A. Usually somebody at the hospital. 3 Q. Okay. And then we can actually skip 4 ahead a number of pages now, I want to go to your 5 operative note from that day. And that is on OBT 6 Hendrix 802. 7 A. Okay. 8 Q. And this is your Operative Report from 9 your excision and removal of eroded tape on March 10 16th, 2007, is that correct? 11 A. Mm-hmm. 12 Q. And Doctor, can you please just walk us 13 through the operation you performed on Ms. Hendrix 14 on March 16th, 2007? 15 A. You, you put a vaginal speculum so you 16 can see where the tape erosion has occurred, and 17 then you try to hook it with an instrument so you 18 can see the, both ends where it had come, and you 19 just excise it. 20 Q. Okay. And do you know what side Ms. 21 Hendrix's tape erosion was on? 22 A. I think it was on the left side, if I 23 remember. 24 Q. Okay, you indicate traction -- well, 25 first of all, let me -- let me start over again. Page 74 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 31 of 39 1 When you're examining a patient under 2 anesthesia with a speculum, are you able to get a 3 better visualization of the vagina? 4 A. Yes. 5 Q. Okay. And you were able to confirm 6 during this operation that her tape had, in fact, 7 eroded? 8 A. No -- 9 MR. THORNBURGH: Objection. 10 THE WITNESS: -- the tape had eroded. 11 MR. THORNBURGH: He testified he saw it 12 in the office on her pel -- pelvic exam, it 13 wasn't -- 14 MR. SINDELAR: I'm sorry, you can 15 object, but I don't want you giving a speaking 16 objection. 17 MR. THORNBURGH: Well, you're 18 mischaracterizing -- 19 MR. SINDELAR: That is improper. 20 MR. THORNBURGH: You're 21 mischaracterizing the testimony. 22 MR. SINDELAR: I'd appreciate it if you 23 stuck to your objections and quit testifying. 24 Q (By Mr. Sindelar) Doctor, I'm sorry, let 25 me, let me just say that again. When you examined Page 75 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 32 of 39 1 the patient under anesthesia, you were able to 2 confirm that there was a tape erosion -- 3 THE WITNESS: Yes. 4 Q. -- as you had seen in the office. Okay. 5 And then you paced -- placed traction on the tape. 6 Can you explain what that means? 7 A. Well, you just pull on it so you can see 8 the, both the ends properly. 9 Q. Okay. And when you pulled on the tape, 10 it didn't come sliding out of her body, correct? 11 A. No. 12 Q. Okay. And does that indicate to you 13 that the tape had, had been ingrown into her 14 tissues? 15 MR. THORNBURGH: Objection. 16 THE WITNESS: I don't know what to say, 17 I'm sure it has ingrown into the tissue, because 18 this has been a few months after the procedure. 19 Q (By Mr. Sindelar) And then you indicate 20 you cut the point where the tape was exposed on both 21 sides of the eroded piece? 22 A. Yes. 23 Q. Okay. And is there a reason you don't 24 at this point go in and try to remove the entire 25 tape? Page 76 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 33 of 39 1 A. That is not what is, is supposed to do. 2 Q. Okay. And where do you get that 3 information as to what you're supposed to do? 4 A. That is what the, the... all the people, 5 you know, when we go to the meetings and all that, 6 they say. 7 Q. From going to your professional 8 meetings -- 9 A. Yes. 10 Q. -- with other urologists? 11 A. Yes. 12 Q. Okay, so that the standard of care is 13 to -- 14 A. Yes. 15 Q. -- is to cut the eroded portion. 16 A. Yes. 17 MR. THORNBURGH: Objection. 18 Q (By Mr. Sindelar) The standard of care is 19 not to go in and remove the entire tape. 20 THE WITNESS: No. 21 MR. THORNBURGH: Objection. 22 Q (By Mr. Sindelar) And Doctor, is there a 23 reason why you wouldn't go in and try to take the 24 whole tape out when a patient has an erosion? 25 THE WITNESS: No. Page 77 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 34 of 39 1 Q. Is there a particular reason why you 2 wouldn't do that? 3 A. I mean I don't see why you would want to 4 take the thing, there was only one part that was, 5 had eroded, so you just remove that part. 6 Q. And is that still your practice to this 7 day, that you would only remove the portion that was 8 eroded? 9 A. Well, that is what, you know, I would do 10 if I had to. 11 Q. Okay, now if we could turn, it's 12 actually the last printed page here, it's 810. Can 13 you explain what the note on Page 810 is, please? 14 A. This is the, you know, the, the note 15 that the nurses discuss with the patient before they 16 are going home. 17 Q. Okay, we can set Exhibit 6 to the side. 18 And it looks like Ms. Hendrix was next in to see you 19 on August 2, 2007, that's back on Exhibit 3, which 20 is the set of your office notes? 21 A. August 2nd, yes. 22 Q. Okay. And why did Ms. Hendrix come in 23 to see you on August 2nd? 24 A. For a follow-up of the -- because, you 25 know, that the patient says over here that she felt Page 78 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 35 of 39 1 there was a discharge, and she wanted to be sure 2 that everything was okay. 3 Q. Mm-hmm. 4 A. Because when the first, it had excised, 5 when it had eroded, that is when she was having 6 discharge also, so she just wanted to be sure 7 everything was okay. 8 Q. Okay. So she came back to you because 9 she had some discharge and wanted to make sure -- 10 A. Yes. 11 Q. -- there wasn't another erosion? 12 A. Yes. 13 Q. Okay. And then did you do a vaginal 14 exam that day? 15 A. Yes. 16 Q. And were you able to determine whether 17 she had an erosion? 18 A. I, I did not -- I was unable to feel any 19 erosion. 20 Q. Okay. And then it, you also note here: 21 "The patient is not having any stress incontinence," 22 is that correct? 23 A. Yes. 24 Q. So even though you had removed a portion 25 of her ObTape, she was still continent? Page 79 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 36 of 39 1 A. Yes. 2 Q. Okay. It looks like the next and I 3 believe the last time that you saw Ms. Hendrix was 4 on May the 6th, 2008, is that correct? 5 A. Yes. 6 Q. Okay, and why did she come in to see you 7 that day? 8 A. She said that her husband told her that 9 he felt something when she had intercourse. 10 Q. Okay. And did she express to you she 11 wanted to be sure that the tape was not coming out? 12 A. Yes. 13 Q. And did you do an exam on Ms. Hendrix on 14 May 6, 2008? 15 A. Yes, but I was not un -- able to feel 16 anything abnormal. 17 Q. Okay. And have you seen Ms. Hendrix 18 since May 6, 2008? 19 A. No. 20 Q. And do you have any information 21 regarding her subsequent medical history? 22 A. No. 23 Q. Okay, Doctor, I just want to close out 24 in a few areas. 25 Doctor, do you have any training or Page 80 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 37 of 39 1 deposition so I can do a redirect examination. Is 2 that accurate? 3 MR. THORNBURGH: Yeah. 4 THE VIDEOGRAPHER: And we are off the 5 record at 5:34 p.m. 6 (Signature reserved.) 7 (Deposition recessed at 5:34 p.m.) 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 158 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 38 of 39 1 CERTIFICATE OF REPORTER 2 I, Pamela K. Needham, Certified Court Reporter 3 within and for the State of Missouri, do certify 4 that the witness whose testimony appears in the 5 foregoing deposition was duly sworn by me; the 6 testimony of said witness was taken by me to the 7 best of my ability and thereafter reduced to 8 typewriting under my direction; that I am neither 9 counsel for, related to, nor employed by any of the 10 parties to the action in which this deposition was 11 taken, and further, that I am not a relative or 12 employee of any attorney or counsel employed by the 13 parties thereto, nor financially or otherwise 14 interested in the outcome of the action. 15 16 <%Signature%> 17 Pamela K. Needham, CSR, CCR Illinois CSR No. 084-002247 18 Missouri CCR No. 505 19 20 21 22 23 24 25 Page 159 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-4 Filed 10/24/16 Page 39 of 39 Exhibit B Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 1 of 29 1 UNITED STATES DISTRICT COURT 2 FOR THE MIDDLE DISTRICT OF GEORGIA 3 COLUMBUS DIVISION 4 --o0o-- 5 In re: Mentor Corp. Obtape )MDL Case No. Transobturator Sling Products )2004 6 Liability Litigation ) )Individual Case No: 7 )4:14-CV-00105 )(Hendrix) 8 _____________________________ ) 9 10 VIDEO-RECORDED DEPOSITION OF 11 DIANE HENDRIX ________________________________ 12 August 23, 2016 13 14 15 (Beginning at 9:08 a.m.) 16 17 18 19 20 21 22 23 24 25 Job No. CS2361005 Page 1 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 2 of 29 1 INDEX 2 PAGE 3 4 EXAMINATION BY MR. SINDELAR .....................9 5 EXAMINATION BY MR. DALY .......................216 6 EXHIBITS 7 Exhibit 1 Notice of deposition 36 8 Exhibit 2 Summons and complaint 37 9 Exhibit 3 Plaintiff fact sheet from May 5, 38 10 2014 11 Exhibit 4 Plaintiff fact sheet from June 57 12 14, 2016 13 Exhibit 5 Plaintiff fact sheet from August 66 14 17, 2016 15 Exhibit 6 Plaintiff's responses to 69 16 defendant Mentor Worldwide LLC's 17 first requests for admissions 18 directed to plaintiff Diane 19 Hendrix 20 Exhibit 7 Plaintiff's responses to 72 21 defendant Mentor Worldwide LLC's 22 first set of interrogatories to 23 plaintiff Diane Hendrix 24 Exhibit 8 Responses and objections to 75 25 defendant's first set of requests Page 2 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 3 of 29 1 for production to plaintiff Diane 2 Hendrix 3 Exhibit 9 Set of records from Dr. Brennan's 89 4 office from visits that start in 5 July of 2005 6 Exhibit 10 Set of office notes from Dr. Shah 98 7 Exhibit 11 set Of records from care and 106 8 treatment with Dr. Brennan 9 Exhibit 12 Set of records starting with OBT 109 10 HENDRIX D 59 11 Exhibit 13 Set of records starting with OBT 109 12 HENDRIX D 54 13 Exhibit 14 Set of records starting with PLF 109 14 HENDRIX D 55 15 Exhibit 15 Set of hospital records related 147 16 to when Dr. Shah removed a 17 portion of ObTape in March 2007 18 Exhibit 16 Set of records from Dr. Brennan 155 19 Exhibit 17 Set of records from an ER visit 159 20 from December 7th, 2008 21 Exhibit 18 Set of records reflecting visit 161 22 with Dr. Naseer 23 Exhibit 19 Records reflecting St. Anthony 165 24 Medical Center urgent care visit 25 Exhibit 20 Set of records from Dr. Brennan 166 Page 3 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 4 of 29 1 beginning with OBT HENDRIX D 11 2 Exhibit 21 Record reflecting visit with Dr. 175 3 Khan on November 10, 2010 4 Exhibit 22 Set of medical records related to 182 5 hospital stay that started on 6 November 11th, 2010 7 Exhibit 23 Set of records from infectious 184 8 disease doctor 9 Exhibit 24 Records from a follow-up visit 190 10 with Dr. Khan from April 27th, 11 2011 12 Exhibit 25 Records from visit with Dr. Desai 194 13 Exhibit 26 Records from a visit with Julie 196 14 Stewart, DPM, dated July 11th, 15 2016 16 17 (The original exhibits were retained by the court 18 reporter and will be copied and attached to copies 19 of the transcript.) 20 21 22 23 24 25 Page 4 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 5 of 29 1 UNITED STATES DISTRICT COURT 2 FOR THE MIDDLE DISTRICT OF GEORGIA 3 COLUMBUS DIVISION 4 --o0o-- 5 In re: Mentor Corp. Obtape )MDL Case No. Transobturator Sling Products )2004 6 Liability Litigation ) )Individual Case No: 7 )4:14-CV-00105 )(Hendrix) 8 _____________________________ ) 9 --oOo-- 10 VIDEO-RECORDED DEPOSITION OF DIANE 11 HENDRIX, produced, sworn, and examined on Tuesday, 12 August 23, 2016, taken on behalf of the Defendants, 13 at the offices of Midwest Litigation Services, 711 14 North 11th Street, in the City of St. Louis, State 15 of Missouri, before RENÉE C. QUINBY, a Certified 16 Court Reporter (MO), Certified Shorthand Reporter 17 (CA), Registered Merit Reporter, Certified Realtime 18 Reporter, and a Notary Public within and for the 19 State of Missouri. 20 21 22 23 24 25 Page 5 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 6 of 29 1 A P P E A R A N C E S 2 3 FOR THE PLAINTIFF: 4 Michael Daly, Esq. Pogust, Braslow & Millrood 5 8 Tower Bridge, Suite 940 161 Washington Street 6 Conshohocken, PA 19428 (610)941-4204 7 mdaly@pbmattorneys.com 8 9 10 FOR THE DEFENDANT: 11 Jeffrey C. Sindelar, Jr. Tucker Ellis, LLP 12 950 Main Avenue, Suite 1100 Cleveland, OH 44113 13 (216)696-2678 jeffrey.sindelar@tuckerellis.com 14 15 16 17 18 19 THE VIDEOGRAPHER: 20 John Niehaus 21 22 COURT REPORTER: 23 RENÉE COMBS QUINBY, RMR, CRR Realtime Systems Administrator 24 CSR (CA) #11867 CCR (MO) #1291 25 Page 6 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 7 of 29 1 --oOo-- 2 IT IS HEREBY STIPULATED AND AGREED by and 3 between counsel for the Plaintiff and counsel for 4 the Defendant, that this deposition may be taken in 5 machine shorthand by RENÉE C. QUINBY, a Certified 6 Court Reporter and Notary Public, and afterwards 7 transcribed into typewriting, and the signature not 8 waived by agreement of Counsel and consent of the 9 Witness. 10 --o0o-- 11 P R O C E E D I N G S 9:08 a.m. 12 --o0o-- 13 THE VIDEOGRAPHER: We're on the record. 14 Please note that the microphones are sensitive and 15 may pick up whispering and private conversations. 16 Please turn off all cell phones or place them away 17 from the microphones as they can interfere with the 18 deposition audio. Recording will continue until all 19 parties agree to go off the record. 20 My name is John Niehaus representing 21 Veritext. The date today is August 23rd, 2016, and 22 the time is approximately 9:07 a.m. 23 This deposition is being held at 24 Midwest Litigation Services, located at 711 North 25 11th Street, St. Louis, Missouri 63101 and is being Page 7 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 8 of 29 1 taken by counsel for the defendant. The caption of 2 this case is In Re: Mentor Corporation ObTape 3 Transobturator Sling Products Liability litigation. 4 This case is filed in the United States District 5 Court for the Middle District of Georgia, Columbus 6 Division, case number 411 -- excuse me -- 7 14-CV-00105. The name of the witness is Diane 8 Hendrix. 9 At this time the attorneys present in 10 the room and attending remotely will identify 11 themselves and the parties they represent. 12 MR. SINDELAR: This is Jeff Sindelar 13 with Tucker Ellis LLP here on behalf of the 14 defendant, Mentor Worldwide LLC. 15 MR. DALY: Mike Daly from the law firm 16 of Pogust Braslow & Millrood on behalf of the 17 plaintiff, Diane Hendrix. 18 THE VIDEOGRAPHER: We're going off the 19 record at approximately 9:08 a.m. 20 (Discussion off the record.) 21 THE VIDEOGRAPHER: Our court reporter, 22 Renée Quinby, representing Veritext will swear in 23 the witness and we can proceed. 24 DIANE HENDRIX, 25 of lawful age, having been first duly sworn to Page 8 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 9 of 29 1 true and correct to the best of your knowledge? 2 A. Yes. 3 Q. Okay. I want to go through -- I don't 4 want to go through every single item in here. There 5 are just a few elements I had questions about. 6 First of all, on the second page -- and 7 it's double-sided, so it's the back of the first 8 page -- it asks about the date of implantation for 9 the ObTape. And that's indicated as August 29th, 10 2005. Do you see that? 11 A. Yes, I do. 12 Q. Okay. And you understand today that 13 your ObTape was implanted on August 29th, 2005? 14 A. Yes. 15 Q. Okay. And I want to ask a little bit 16 about the ObTape and your understanding of it. 17 First of all, do you know when you learned that the 18 name of the product implanted on -- in you in August 19 of 2005 was called ObTape? 20 A. I was -- I was never told that that's 21 what it was called until later on. 22 Q. Okay. Do you know when you learned 23 that it was called ObTape? 24 MR. DALY: I'm just going to again 25 remind the deponent not to reveal the substance of Page 40 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 10 of 29 1 any conversations that she's had with me or anybody 2 from my office or any of her attorneys in this case. 3 THE WITNESS: I learned about it 4 through my -- my lawyer when she said that's what it 5 was called. 6 BY MR. DALY: 7 Q. Okay. So you -- you learned the name 8 of the product was ObTape after you already 9 contacted the lawyer about bringing a lawsuit? 10 A. Yes, because I was told it was called a 11 band. 12 Q. Okay. Do you know when -- and that's 13 helpful. I know sometimes people are told it's 14 called a tape or a band or a sling; so it's helpful 15 to know what you were told and how you talked about 16 it with your doctors. 17 Do you know who told you it was called 18 a band? 19 A. Dr. Shah, the one that did the -- I 20 mean, the bladder raise. 21 Q. And was that before Dr. Shah implanted 22 you with what you now know is the ObTape, he was 23 referred to as a band? 24 A. It was later, like in 2007, when I had 25 to go back in. And he said he had to clip the band. Page 41 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 11 of 29 1 Q. Okay. And then if we turn over to the 2 next page of Exhibit Number 3, question 5 asks: "If 3 the ObTape has been removed, provide the date on 4 which it was removed." And you indicated that on 5 3/16/2007 and 11/10/2010 portions of the ObTape were 6 removed; is that correct? 7 A. That I know of. 8 Q. Okay. And the -- you mentioned that in 9 2007, Dr. Shah had to -- had to clip the band. Is 10 that 3/16/2007 date in reference to that time he had 11 to clip the band? 12 A. Yes. 13 Q. Sitting here today do you know what the 14 name of the company that made the ObTape product is? 15 A. No. 16 Q. And then if we could turn to page -- 17 page 3 of 21, it says on the bottom -- I think 18 sometimes these forms get retyped and the numbering 19 doesn't quite match up, but it's the page that says 20 3 of 21; do you see that? 21 A. Yes, I do. 22 Q. Okay. And I just want to ask about, 23 question 10 asks: "Has any doctor ever told you 24 that there are portions of the ObTape still in your 25 body?" And you answered "no"; is that correct? Page 42 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 12 of 29 1 A. Yes. 2 Q. Okay. And is that still correct today 3 that no -- can you just state whether a doctor has 4 told you that or not? 5 A. No doctor has ever told me if it was 6 still inside me or not. 7 Q. Okay. Okay. And do you mean no doctor 8 has told you either way? 9 A. No. 10 Q. I just want to ask because I'm worried 11 the answer didn't come out clear in the record. So 12 let me just ask the question as it is -- let me just 13 ask it this way: Is your answer to number 10 in 14 Exhibit 3 that we're looking at on page 3 still 15 correct as of today? 16 A. Yes. 17 Q. Okay. And you were married on 18 June 22nd of 1974; is that correct? 19 A. Yes. 20 Q. And you're still married to that same 21 man? 22 A. Yes, I am. 23 Q. Congratulations. 24 A. Thank you. 25 Q. And that's the only time you've ever Page 43 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 13 of 29 1 been married? 2 A. Yes. 3 Q. Okay. And you have lived in the 4 St. Louis, Missouri, area your entire life? 5 A. Yes. 6 Q. Okay. And you've lived at the same 7 address since 1978? 8 A. Yes. 9 Q. Okay. And that is -- that house is in 10 St. Louis? 11 A. Yes, it is. 12 Q. Okay. And you have two children born 13 in 1974 and 1978? 14 A. Yes. 15 Q. And they were both delivered vaginally? 16 A. Yes. 17 Q. Now, I want to talk about question 11 18 on page 5 talks about your education starting with 19 high school. And it looks like there are two -- two 20 separate high schools and different graduation dates 21 here. And I just wanted to clarify that. Can you 22 explain why -- it looks like you went to Humboldt 23 Academy of Higher Learning from 1961 to 1966. 24 A. Yes. 25 Q. And then Shepherd High School from 1967 Page 44 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 14 of 29 1 to 1969. Did you get a diploma from either of those 2 schools? 3 A. No, I did not. 4 Q. Okay. And then how old were you when 5 you left high school? 6 A. 16. 7 Q. 16, okay. 8 And the next questions talk about your 9 employment. And your -- your employer listed on 10 this form, which is from May of 2014, lists you as a 11 scanner at GL Group in St. Louis, Missouri; is that 12 correct? 13 A. Yes. 14 Q. Okay. And are you still working in 15 that same job? 16 A. Yes. 17 Q. Okay. 18 A. I'm not a scanner anymore though. 19 Q. Okay. What time did your job title or 20 job function change? 21 A. Last year. 22 Q. At some point in 2015? 23 A. Yes. 24 Q. Do you recall what month that was? 25 A. I'm going to say October I believe it Page 45 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 15 of 29 1 answer still correct? 2 A. Yes. 3 Q. And question 4 over on the next page 4 asks: "Are you making a claim for lost wages or 5 earning capacity?" And you indicate no. Is that 6 answer still correct? 7 A. Yes. 8 Q. Okay. Number 5: "Is your spouse 9 claiming loss of consortium?" You indicated no. Is 10 that answer still correct? 11 A. Yes. 12 Q. And your spouse is not claiming any 13 physical injury from the ObTape; is that correct? 14 A. Yes. 15 Q. Okay. And I think that's all I have 16 for Exhibit Number 3. We can set that one to the 17 side. 18 I want to look now at the next version 19 you received. It looks like it was a June 14th, 20 2016, you've provided an updated plaintiff fact 21 sheet, which I'm going to mark as Exhibit 4. I'll 22 hand you a copy of that. 23 (Exhibit 4 was marked for 24 identification.) 25 BY MR. SINDELAR: Page 57 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 16 of 29 1 Q. Does Exhibit 4 look familiar to you? 2 A. Yes. 3 Q. And if we just turn to the back page 4 again, which I think will be the second to last 5 page, it's that same verification form. And it 6 looks like you -- you signed this verification on 7 June 14th, 2016; is that correct? 8 A. Yes. 9 Q. And when you were signing this 10 verification, were you declaring that you believed 11 all the information contained in this plaintiff fact 12 sheet to be true and correct to the best of your 13 knowledge? 14 A. Yes. 15 Q. I think there are just a couple of 16 areas where your answers may have changed a little 17 bit. And I just wanted to clarify a couple of 18 those. The first is on page 2. Actually number 5 19 the question asks: "If the ObTape has been removed, 20 provide the date on which it was removed." And it 21 states: "Plaintiff underwent an excision and 22 removal of eroded ObTape on March 16, 2007." Did I 23 read that correctly? 24 A. Yes. 25 Q. And is March 16th, 2007, is that the Page 58 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 17 of 29 1 time where Dr. Shah clipped the portion of what you 2 called the band? 3 A. I believe so, to my knowledge. 4 Q. Okay. Okay. Did Dr. Shah tell you 5 what he was going to do before -- before he was 6 clipping the band? 7 A. No. 8 Q. Did -- afterwards did he explain to you 9 that he had removed a part of the band he'd 10 implanted in you a couple years ago? 11 A. No. 12 Q. What did he explain to you? 13 A. He just -- when I went in to him, I 14 told him about I felt like I was having a problem 15 down there because me and my husband had sex and he 16 noticed something was rubbing; so that's why I went 17 in to him. And he said it was lowered down, that he 18 would have to clip it. That's all he told me. 19 Q. Okay. And when you're saying "clip," 20 he was referring to the -- the band he had put in 21 you? 22 A. I'm assuming, yes. 23 Q. Okay. And he told you that back in 24 2007 before he operated on you? 25 A. Yes. And then I went in to Page 59 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 18 of 29 1 St. Anthony's hospital the same day. 2 Q. Okay. And you were talking about you 3 and your husband having sex and him feeling it, your 4 husband felt something while you guys were having 5 sex? 6 A. Yes. He felt something rubbing on him. 7 Q. Okay. And then you went to see 8 Dr. Shah after that happened? 9 A. Yes. 10 Q. Okay. And you saw Dr. Shah, that was 11 at St. -- St. Louis Hills Urology Associates here in 12 St. Louis? 13 A. Yes. 14 Q. Okay. And he performed the removal at 15 St. Anthony's Medical Center which is also located 16 in St. Louis, Missouri? 17 A. Yes. Right next door. 18 Q. Okay. And question 10 over on page 3 19 asks: "Has any doctor ever told you that there are 20 portions of ObTape still in your body?" And you 21 indicate yes on this form. The last one we looked 22 at, you indicated no. Do you know why that answer 23 changed? 24 A. I can't remember. 25 Q. Okay. Do you know what doctor told you Page 60 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 19 of 29 1 that there are still portions of the ObTape in your 2 body? 3 A. No, I don't. 4 Q. Did the doctor tell you that between 5 2014 when you provided the first plaintiff fact 6 sheet and 2016 when we got this updated version? 7 A. No. 8 Q. Do you -- do you have any memory as to 9 why the answer would have changed from the first 10 plaintiff fact sheet to this one? 11 MR. DALY: Objection. Asked and 12 answered. 13 BY MR. SINDELAR: 14 Q. You can answer. 15 A. I'm not for sure on why I changed it. 16 I mean, I can't remember. 17 Q. Do you -- do you know the name of any 18 doctor who has told you that the ObTape is still in 19 your body? 20 A. No. 21 Q. And then question 11 asks: "Has any 22 doctor told you that those portions of the ObTape 23 still in your body need to be removed?" And you 24 indicated no in Exhibit 4; is that correct? 25 A. Yes. Page 61 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 20 of 29 1 understand that that bladder repair that Dr. Shah 2 performed on August 8th, 2009 -- 2005 -- strike 3 that. Let me start over. 4 You understand sitting here today that 5 the surgery that Dr. Shah performed on you on 6 August 29th, 2005, involved the implantation of the 7 ObTape product? 8 MR. DALY: I'm just going to object to 9 the form of the question. Foundation or lack 10 thereof. 11 BY MR. SINDELAR: 12 Q. Go ahead. 13 A. I didn't know -- I didn't know what it 14 was. That they was putting -- I don't remember, you 15 know, them calling it a tape, mesh, band. 16 Q. Okay. So sitting here today though, 17 you understand that they put that ObTape in -- 18 A. Yes. 19 Q. -- back in 2000 -- sitting here today, 20 you understand that that's what they did in 2005? 21 A. Yes. They raised my bladder. 22 That's -- 23 Q. Okay. And in 2005 they didn't -- they 24 didn't say, "We're going to use something called an 25 ObTape"? Page 118 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 21 of 29 1 A. No. 2 Q. Okay. So back at that time, not 3 sitting here today, back in 2005 right before 4 Dr. Shah implanted you with the ObTape, do you 5 understand that he'd be -- he'd be putting something 6 inside of your body to hold your bladder up? 7 A. Yes. 8 Q. Okay. And then if you look a couple 9 lines down in the operative note, it says "general 10 anesthetic was administered"; do you see that? 11 A. Yes. 12 Q. Okay. So is it fair to say you were 13 unconscious when they were operating on you? 14 A. Oh, yes. 15 Q. Okay. And because you were 16 unconscious, you don't remember anything about them 17 actually performing the surgery? 18 A. No. 19 Q. Okay. You can set -- actually do you 20 know what? One more thing on this one. Page 57, 21 the very last one. It looks like it's a discharge 22 summary it says on the bottom. Do you see that kind 23 of towards the bottom left-hand corner? 24 A. Okay. 25 Q. And then, so it looks like date of Page 119 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 22 of 29 1 discharge was 8/31/2005. So you did the operation 2 on the 29th and then you stayed overnight that night 3 and the night of the 30th and went home the 31st of 4 August. Does that sound right to you? 5 A. Yes. 6 Q. Okay. And then it looks like there's 7 some information provided here about your follow-up 8 care. 9 A. Yes. 10 Q. So it says that you'd underwent a 11 vaginal hysterectomy, A & P repair, and TOT 12 procedure by Dr. Shah. Patient did well in the 13 postoperative period. And you were going to see 14 Dr. Brennan back in approximately one week. Do you 15 see that part of the record? 16 A. Yes. 17 Q. Okay. So do you recall Dr. Brennan or 18 one of the nurses having a discussion with you 19 before you left the hospital? 20 A. No, no. 21 Q. Okay. And is that just, again, because 22 that was almost 11 years ago; you don't have a 23 memory of it? 24 A. I don't remember, but I don't remember 25 talking to him. If I -- If I did talk to him, I Page 120 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 23 of 29 1 Q. Same practice? Okay. Do you recall 2 that you went to see Dr. Shah the same day as you 3 had the appointment with Dr. Brennan? 4 A. I can't remember. 5 Q. So it states here: "3/16/2007: 6 Patient is here because she keeps on having vaginal 7 infections. She has had this ever since she has had 8 surgery." Do you recall -- do you recall the first 9 time you came back to see Dr. Shah in 2007? 10 A. No. 11 Q. Okay. The statement in this record 12 from 3/16/2007 that you kept on having vaginal 13 infections, was that an accurate statement? 14 MR. DALY: Objection to form. 15 You can answer. 16 THE WITNESS: That would be what they 17 were saying, yes, that I was having them kind of 18 infections, yes. 19 BY MR. SINDELAR: 20 Q. Okay. Do you have any reason to doubt 21 the accuracy of what they were saying that you had 22 repeated vaginal infections? 23 A. No. 24 Q. And then it says that you -- you stated 25 that you had a discharge and a foul odor. Do you Page 143 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 24 of 29 1 see that part of the record? 2 A. Yes. 3 Q. Is that consistent with your -- your 4 own memory of the symptoms that you were having back 5 in 2006 and 2007? 6 A. Somewhat. If I was having a discharge, 7 I was having that odor. I mean, that and -- all 8 that was coming out at the same time, I mean ... 9 Q. And that's -- and that's -- those 10 symptoms are something that you've been experiencing 11 for at least a year at this point? 12 A. Yes. Yes. 13 Q. And then it says: "On vaginal 14 examination I could see that the tape had eroded 15 from one side and it was at the vaginal mucosa. I 16 told her we shall remove this tape." Do you see 17 that part of the record? 18 A. Yes. 19 Q. And did you -- have you ever seen this 20 record prior to today? 21 A. No. 22 Q. Okay. Do you recall visiting with 23 Dr. Shah in March of 2007 and him telling you that 24 the tape had eroded in your vagina? 25 A. No. Page 144 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 25 of 29 1 Q. Do you have any reason to doubt the 2 accuracy of his record? 3 A. No, I do not. 4 Q. Do you recall him telling you that he 5 was going to have to remove a portion of the tape 6 from your vagina? 7 A. I remember him saying he's going to 8 clip a piece of the band. 9 Q. Okay. That's right. You did tell me 10 that earlier. 11 A. Yes. 12 Q. Okay. So you do remember in March of 13 2007 -- 14 A. That's when I went because it was 15 rubbing on my husband. 16 Q. Okay. 17 A. I don't know what date -- 18 Q. Okay. 19 A. -- that that all happened. But I did 20 go back for that. 21 Q. Okay. So based on this record, does it 22 make you think -- does this sound like this was that 23 visit with him that you referred to earlier? 24 A. A little bit. 25 Q. And so let's talk a little bit more Page 145 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 26 of 29 1 about your husband feeling something rubbing on him. 2 So can you explain what happened and what -- what 3 your husband said to you? 4 A. Well, I didn't really want to have sex 5 in the first place because I was smelly and -- and 6 it was a mind game with me I guess you could say. 7 And I was kind of like pushing my husband away 8 because I felt like I was dirty or -- I don't know 9 how to explain it, but I just felt uncomfortable. 10 But we had sex and he said -- he 11 stopped a little bit after that and said something 12 was bothering him down there that was rubbing on 13 him. 14 Q. Okay. 15 A. And that I should maybe call the doctor 16 the next day. 17 Q. Okay. 18 A. And I did. 19 Q. Okay. And then so you went into -- 20 A. Then I went in, but what day I don't 21 know. 22 Q. Okay. And then it states in this 23 record, it says: "We shall schedule her for 24 surgery." Do you see that? 25 A. Yes. Page 146 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 27 of 29 1 that you could get a serious thigh abscess from the 2 mesh procedure, would you have maybe reconsidered 3 having the mesh procedure at all? 4 MR. SINDELAR: Object to form. 5 THE WITNESS: Yes. 6 BY MR. DALY: 7 Q. And is that because of all the pain 8 that came along with your abscess when it eventually 9 happened in 2010? 10 A. Correct. 11 MR. DALY: That's all the questions I 12 have for now. 13 MR. SINDELAR: I have no other 14 questions. 15 MR. DALY: Huh? 16 MR. SINDELAR: I don't have any 17 questions. 18 MR. DALY: We beat 4:00 o'clock. 19 THE VIDEOGRAPHER: We're going off the 20 record at approximately 3:52 p.m. 21 (Whereupon, signature was not 22 waived and the witness was 23 excused at 3:52 p.m.) 24 --oOo-- 25 Page 236 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 28 of 29 Page 237 Case 4:14-cv-00105-CDL Document 32-5 Filed 10/24/16 Page 29 of 29 Exhibit C Case 4:14-cv-00105-CDL Document 32-6 Filed 10/24/16 Page 1 of 19 Case 4:14-cv-00105-CDL Document 32-6 Filed 10/24/16 Page 2 of 19 Case 4:14-cv-00105-CDL Document 32-6 Filed 10/24/16 Page 3 of 19 Case 4:14-cv-00105-CDL Document 32-6 Filed 10/24/16 Page 4 of 19 Case 4:14-cv-00105-CDL Document 32-6 Filed 10/24/16 Page 5 of 19 Case 4:14-cv-00105-CDL Document 32-6 Filed 10/24/16 Page 6 of 19 Case 4:14-cv-00105-CDL Document 32-6 Filed 10/24/16 Page 7 of 19 Case 4:14-cv-00105-CDL Document 32-6 Filed 10/24/16 Page 8 of 19 Case 4:14-cv-00105-CDL Document 32-6 Filed 10/24/16 Page 9 of 19 Case 4:14-cv-00105-CDL Document 32-6 Filed 10/24/16 Page 10 of 19 Case 4:14-cv-00105-CDL Document 32-6 Filed 10/24/16 Page 11 of 19 Case 4:14-cv-00105-CDL Document 32-6 Filed 10/24/16 Page 12 of 19 Case 4:14-cv-00105-CDL Document 32-6 Filed 10/24/16 Page 13 of 19 Case 4:14-cv-00105-CDL Document 32-6 Filed 10/24/16 Page 14 of 19 Case 4:14-cv-00105-CDL Document 32-6 Filed 10/24/16 Page 15 of 19 Case 4:14-cv-00105-CDL Document 32-6 Filed 10/24/16 Page 16 of 19 Case 4:14-cv-00105-CDL Document 32-6 Filed 10/24/16 Page 17 of 19 Case 4:14-cv-00105-CDL Document 32-6 Filed 10/24/16 Page 18 of 19 Case 4:14-cv-00105-CDL Document 32-6 Filed 10/24/16 Page 19 of 19 Exhibit D Case 4:14-cv-00105-CDL Document 32-7 Filed 10/24/16 Page 1 of 7 In re Mentor Corp. ObTape Transobturator Sling Products..., Not Reported in... 2013 WL 286276 © 2015 Thomson Reuters. No claim to original U.S. Government Works. 1 2013 WL 286276 Only the Westlaw citation is currently available. United States District Court, M.D. Georgia, Columbus Division. In re MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION. MDL Docket No. 2004. | Nos. 4:08– MD–2004 (CDL), 4:10–cv–5060 (C. Cline), 4:11–cv–5065 (I.Morey). | Jan. 24, 2013. ORDER CLAY D. LAND, District Judge. *1 The summary judgment motions of Defendant Mentor Worldwide LLC (“Mentor”) as to the actions filed by Plaintiffs Carol Cline (“Cline”) and Irene Morey (“Morey”) (collectively, “Plaintiffs”) present choice of law issues that are dispositive of the pending motions. Both of these product liability actions were originally filed in the United States District Court for the District of Minnesota before being transferred to this Court for pretrial proceedings by the Judicial Panel on Multidistrict Litigation. In both cases, Plaintiffs, who were surgically implanted with Mentor's suburetheral stress urinary incontinence sling product, ObTape Transobturator Tape (“ObTape”), allege that ObTape was defectively designed and/or manufactured, that it proximately caused their injuries, and that Mentor did not adequately warn their physicians about the risks associated with ObTape. Plaintiffs contend that Mentor has a strong connection to Minnesota and that Minnesota law applies to their claims. Mentor seeks summary judgment on the issue of which state's law is applicable to each Plaintiff's claims. Mentor argues that Ohio substantive law governs Cline's claims because she is an Ohio resident who was implanted with ObTape and had all relevant medical treatment in Ohio. Mentor contends that if the Court grants Mentor's summary judgment motion on the choice of law issue, then Cline's action should be dismissed without prejudice because she failed to reference the Ohio Product Liability Act in her Complaint. Mentor maintains that Washington law applies to Morey's claims because that is where she was implanted with ObTape and where she received treatments related to the alleged failure of the product. Mentor contends that if the Court applies Washington substantive law to Morey's claims, then it must also apply Washington's statute of limitations, which would bar Morey's claims. For the reasons set forth below, the Court finds that Minnesota law applies to the claims of Cline and Morey. Therefore, Mentor's Motion for Summary Judgment against Cline (ECF No. 58 in 4:10–cv–5060) is denied, as is Mentor's Motion for Summary Judgment against Morey (ECF No. 51 in 4:11–cv– 5065). In addition, Morey's Motion to Amend (ECF No. 36 in 4:11–cv–5065) is granted. SUMMARY JUDGMENT STANDARD Summary judgment may be granted only “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.”Fed.R.Civ.P. 56(a). In determining whether a genuine dispute of material fact exists to defeat a motion for summary judgment, the evidence is viewed in the light most favorable to the party opposing summary judgment, drawing all justifiable inferences in the opposing party's favor.Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986). A fact is material if it is relevant or necessary to the outcome of the suit. Id. at 248.A factual dispute is genuine if the evidence would allow a reasonable jury to return a verdict for the nonmoving party. Id. DISCUSSION *2 The Judicial Panel on Multidistrict Litigation transferred Plaintiffs' diversity actions from the United States District Court for the District of Minnesota to this Court for pretrial proceedings. Therefore, the Court must apply the choice-of- law rules of Minnesota, the transferor forum, to determine which state law controls. In re Gen. Am. Life Ins. Co. Sales Practices Litig., 391 F.3d 907, 911 (8th Cir.2004); accord Murphy v. Fed. Deposit Ins. Corp., 208 F.3d 959, 965 (11th Cir.2000) (“Our system contemplates differences between different states' laws; thus a multidistrict judge asked to apply divergent state positions on a point of law would face a coherent, if sometimes difficult, task.”) (internal quotation marks omitted). Case 4:14-cv-00105-CDL Document 32-7 Filed 10/24/16 Page 2 of 7 In re Mentor Corp. ObTape Transobturator Sling Products..., Not Reported in... 2013 WL 286276 © 2015 Thomson Reuters. No claim to original U.S. Government Works. 2 Under Minnesota law, the Court must first determine whether there is an actual conflict “between the laws of [the] two forums.”Nodak Mut. Ins. Co. v. Am. Family Mut. Ins. Co., 604 N.W.2d 91, 93–94 (Minn.2000). If there is no actual conflict regarding substantive law or if the law at issue is procedural, then the Court may apply Minnesota law. Christian v. Birch, 763 N.W.2d 50, 58 (Minn.Ct.App.2009). If there is an actual conflict, then the Court must determine “whether the law of both states can be constitutionally applied.”Jepson v. Gen. Cas. Co. of Wis., 513 N.W.2d 467, 469–70 (Minn.1994). Finally, if there is an actual conflict but no constitutional impediment exists for the application of either state's law, the Court must apply the “significant contacts test,” which consists of five “choice-influencing factors .” Nodak Mut. Ins. Co., 604 N.W.2d at 94. At this stage of the proceedings, the facts are viewed in the light most favorable to the Plaintiffs. I. Mentor's Connection to Minnesota Mentor distributed ObTape in the United States between 2003 and 2006. Pl.' Cline's Statement of Additional Facts Relevant to Mentor's Mot. for Summ. J. Attach. 8, Wyatt Decl. ¶ 41, ECF No. 59–8 in 4:10–cv–5060. It is undisputed that “Mentor Corporation” was incorporated in Minnesota from 1969 to 2009. It is also undisputed that, “for regulatory purposes, Mentor Minnesota was the designated manufacturer and distributor of ObTape and ObTape introducer needles.”Def.'s Resp. to Pl. Morey's Statement of Additional Facts Relevant to Mentor's Mot. for Summ. J. ¶ 17, ECF No. 59–2 in 4:11–cv–5065. Mentor's 2003 510(k) Premarket Notification submission to the Food and Drug Administration lists “Mentor Minneapolis” as the “Manufacturer” of ObTape with an address in Minneapolis, Minnesota. Pl. Cline's Statement of Additional Facts Relevant to Mentor's Mot. for Summ. J. Attach. 7, 510(k) Premarket Notification at MENTOR/ OBTAPE CONFIDENTIAL—058373, ECF No. 59–7 in 4:10–cv–5060. The 510(k) also lists Analytic Biosurgical Solutions (ABISS) in France as the “Contract Manufacturer.” Id. It is undisputed that Mentor's Minnesota employees were responsible for assuring that ObTape conformed to specifications. Specifically, a quality inspection manager at “Mentor Minnesota” reviewed certificates of conformity provided by the contract manufacturer and made sure that “[n]o ObTape was shipped unless [it] was accompanied by a certificate of conformity. Wyatt Decl. ¶¶ 17–19. It is further undisputed that Mentor's product evaluation department was in Minnesota and was responsible for investigating complaints associated with ObTape, making adverse consequences reports to the United States Food and Drug Administration (“FDA”), and training sales representatives regarding adverse events. Mentor's 510(k) for ObTape states that any complications from the use of ObTape should be reported to Mentor's quality assurance department in Minneapolis, Minnesota and that Mentor would analyze any explanted devices. 510(k) Premarket Notification at MENTOR/OBTAPE CONFIDENTIAL_058409 to 058410. Mentor admits that complications associated with ObTape that were known to Mentor were subject to internal investigations at Mentor's facilities in Minnesota. Mentor contends that investigation of issues related to ObTape was not limited to Mentor's Minnesota location, but Mentor did not point to any evidence in support of this contention. *3 Mentor asserts that “Mentor Corporation” merged into “Mentor Worldwide LLC” in 2009 and is now a citizen of New Jersey. Def.'s Resp. to Pl. Cline's Statement of Additional Facts Relevant to Def.'s Mot. for Summ. J. ¶ 1, ECF No. 63–3. II. Cline's Action Cline is a resident of the State of Ohio. All medical treatment related to Cline's claims occurred in Ohio. Cline experienced symptoms of urinary incontinence and was referred to a urologist in 2004. The urologist implanted Cline with ObTape in November 2004. In April 2006, Cline returned to the urologist because she was experiencing pain, bleeding, and discharge. The urologist conducted an examination and found an erosion of the ObTape. He removed the exposed portion of ObTape and sent it to pathology. Cline filed her action in the United States District Court for the District of Minnesota on September 24, 2010. Cline asserts claims for strict liability, negligence, breach of warranty, failure to warn, and punitive damages. Cline contends that Mentor “was negligent in designing, manufacturing, marketing, labeling, packaging, and selling the Ob[ ]Tape and in failing to warn [Cline] of the defective nature of its product.”Cline Compl. ¶ 15, ECF No. 1 in 4:10– cv–5060. III. Morey's Action Morey is a resident of the State of Washington. All medical treatment related to Morey's claims occurred in Washington. In 2003, Morey consulted her urologist, Dr. Kathleen Kobashi, regarding bladder prolapse, urge incontinence, Case 4:14-cv-00105-CDL Document 32-7 Filed 10/24/16 Page 3 of 7 In re Mentor Corp. ObTape Transobturator Sling Products..., Not Reported in... 2013 WL 286276 © 2015 Thomson Reuters. No claim to original U.S. Government Works. 3 and stress urinary incontinence. Dr. Kobashi implanted Morey with ObTape on December 29, 2004. Following the surgery, Morey suffered from several complications, including discharge, vaginitis, and extrusion of the ObTape. On June 14, 2005, Morey was examined by Dr. Fred Govier, who told Morey that she had an erosion and that he needed to remove as much of the ObTape as possible. Dr. Govier told Morey that the problems she had experienced were because of her sling. Dr. Govier also told Morey that he and Dr. Kobashi had stopped using ObTape by that point. Neither Dr. Govier nor Dr. Kobashi specifically told Morey that they believed ObTape was defective. Morey contends that she first learned that her sling might be defective in 2011, when her son-in-law saw something on television regarding sling products. Morey Decl. ¶ 8, ECF No. 55 in 4:11–cv–5065. Morey filed her action in the United States District Court for the District of Minnesota on May 11, 2011. Morey's Complaint asserts a claim for negligence. She contends that Mentor “failed to exercise ordinary and reasonable care in designing, manufacturing, testing, marketing, labeling, packaging, selling and/or distributing the Mentor ObTape vaginal sling [and] negligently failed to provide adequate warnings and instructions to [Morey] and to her physicians regarding the Mentor ObTape vaginal sling.”Morey Compl. ¶ 23, ECF No. 1 in 4:11–cv–5065. Morey also contends that Mentor was negligent “by failing to promptly and adequately notify [Morey, her] doctors, the medical community, and the public at the earliest possible date of known defects in the Mentor ObTape vaginal sling.”Id. ¶ 24.Morey also seeks to add a claim for punitive damages. See Pl. Morey's Mot. to Amend, ECF No. 36 in 4:11–cv–5065. IV. Application of Minnesota Choice of Law Principles A. Is There an Actual Conflict Between Minnesota Law and the Law of Ohio and Washington? *4 An actual conflict of law “exists if the choice of one forum's law over the other will determine the outcome of the case.”Nodak Mut. Ins. Co., 604 N.W.2d at 94. Regarding Cline's claims, it is undisputed that Minnesota permits common law product liability claims, while product liability claims in Ohio are governed by the Ohio Product Liability Act (“OPLA”), Ohio Rev.Code Ann. §§ 2307.71–2307.80. The OPLA was “intended to abrogate all common law product liability claims or causes of action.”Ohio Rev.Code Ann. § 2307.71(B). Although Cline and Mentor appear to agree that an actual conflict exists between Ohio law and Minnesota law, the Court is skeptical as to whether this difference is outcome determinative as contemplated by Minnesota's choice of law rules. It is undisputed that Minnesota permits common law product liability claims couched in terms of strict liability and negligence, while Ohio has abrogated such claims, replacing them with a statutory cause of action for product liability. It is unclear, however, that the differences in these types of causes of action would make any difference in the outcome of this lawsuit. Neither party pointed to any outcome determinative differences between the product liability law in Minnesota and Ohio. As the Court understands Minnesota choice of law principles, mere differences in the law are not sufficient to authorize the application of the law from the non- forum state. Those differences must affect the outcome. The present record does not demonstrate how Cline's proof and Mentor's defenses would be different, as a practical matter, if Cline's claims are pursued under Minnesota's common law product liability principles instead of under Ohio's product liability statute. Although the Court doubts that any practical outcome determinative difference has been demonstrated by the present record, the Court nevertheless assumes for purposes of the remainder of this Order that such a difference does exist given the fact that Cline has made no effort to contest that assumption. Regarding Morey's action, product liability claims in Washington are governed by the Washington Product Liability Act (“WPLA”), Wash. Rev.Code § 7.72.010, et seq. Like Ohio's product liability statute, the WPLA preempts common law product liability remedies. Washington Water Power Co. v. Graybar Elec. Co., 774 P.2d 1199, 1207 (Wash.1989) (“[T]he WPLA creates a single cause of action for product-related harms that supplants previously existing common law remedies.”). A WPLA “product liability claim” includes any claim previously based on negligence. Wash. Rev.Code § 7.72.010(4). If a plaintiff brings product liability claims under both the WPLA and a common law negligence theory, the “the negligence theory is subsumed under the WPLA product liability claim .”Macias v. Saberhagen Holdings, Inc., 282 P.3d 1069, 1074 (Wash.2012). Although differences certainly exist between Minnesota and Washington law, the parties, like the parties in Cline, failed to demonstrate how those differences will affect the outcome based on the facts presented by the present record. Accordingly, the Court is skeptical that an outcome determinative difference exists. Nevertheless, given that Morey did not challenge Mentor's argument that an Case 4:14-cv-00105-CDL Document 32-7 Filed 10/24/16 Page 4 of 7 In re Mentor Corp. ObTape Transobturator Sling Products..., Not Reported in... 2013 WL 286276 © 2015 Thomson Reuters. No claim to original U.S. Government Works. 4 outcome determinative difference exists, the Court assumes that such a difference does exist for purposes of this Order and moves to the next step of the choice of law analysis. B. Can Minnesota Law Be Constitutionally Applied? *5 The next question is whether the law of each state can be constitutionally applied. It is undisputed that the law of Ohio can be constitutionally applied to Cline's claim and that the law of Washington can be constitutionally applied to Morey's claim. Mentor contends, however, that Minnesota law cannot be constitutionally applied. For Minnesota's law to be selected in a constitutionally permissible manner, Minnesota “must have a significant contact or significant aggregation of contacts, creating state interests, such that choice of its law is neither arbitrary nor fundamentally unfair .”Jepson, 513 N.W.2d at 469. In support of its argument that Minnesota law cannot be constitutionally applied here, Mentor cites an unreported federal district court case, Newman v. Stryker Sales Corp., Civ. No. 09–2866 (JRT/JJK), 2010 WL 3926200 (D.Minn. Sept. 30, 2010). In Newman, the plaintiff was an Ohio resident who was implanted with the defendant's product in Ohio. Id. at *1. The defendant was a Michigan corporation whose only contact with Minnesota was that it conducted business unrelated to the plaintiff there. Id. When the defendant argued that it would be arbitrary and fundamentally unfair to apply Minnesota law under these circumstances, the plaintiff did not oppose that assertion. Id. at *10.Therefore, the court found that Minnesota law could not be constitutionally applied. Id. Newman is readily distinguishable from the facts in this action. Here, Mentor's significant contacts with Minnesota at the time of the events giving rise to both Cline's and Morey's actions are sufficient to render application of Minnesota law constitutionally permissible. It is undisputed that “Mentor Corporation” was incorporated in Minnesota until 2009. As discussed above, it is also undisputed that Mentor completed several key manufacturing tasks in Minnesota, including ObTape quality control, and that Mentor represented to the FDA that ObTape was manufactured by Mentor in Minnesota. It is further undisputed that Mentor's Minnesota employees were responsible for evaluating any complaints regarding ObTape and for making adverse consequences reports to the FDA. Mentor's Minnesota employees were also responsible for training sales representatives regarding adverse events. Finally, it is undisputed that any explanted ObTape was to be sent to Mentor in Minnesota for analysis and that complications associated with ObTape were subject to investigation at Mentor's Minnesota facilities. Thus, when Mentor marketed ObTape to Plaintiffs' physicians and provided warnings about the product, Mentor was a Minnesota company. When ObTape was manufactured, quality controlled, distributed, and implanted into Plaintiffs' bodies, Mentor was a Minnesota company. And when Plaintiffs experienced complications with ObTape and the ObTape had to be explanted, Mentor was a Minnesota company. Accordingly, it is constitutionally permissible for Minnesota law to be applied to Plaintiffs' claims. See Jepson, 513 N.W.2d at 470 (finding that Minnesota law could constitutionally be applied to dispute regarding application of a North Dakota insurance policy to a car accident that occurred in Arizona because of the plaintiff's sufficient contacts with Minnesota). C. iChoice–Influencing Factors *6 Having assumed for purposes of this Order that there is an actual conflict between Minnesota law and the law of Ohio and Washington and having found no constitutional impediment to the application of the law of any of these states to the respective claims, the Court next evaluates the five choice influencing factors employed by the Minnesota courts: “(1) predictability of result; (2) maintenance of interstate and international order; (3) simplification of the judicial task; (4) advancement of the forum's governmental interest; and (5) application of the better rule of law.”Id. 1. Predictability of Result “This factor addresses whether the choice of law was predictable before the time of the transaction or event giving rise to the cause of action.”Schumacher v. Schumacher, 676 N.W.2d 685, 690 (Minn.Ct.App.2004). This factor is not usually considered in tort cases because many tort cases, such as car accident cases, result from accidental encounters and not consensual transactions. Nodak Mut. Ins. Co., 604 N.W.2d at 94. Neither Plaintiff's action resulted from an accidental encounter; Plaintiffs (or their surgeons) intentionally selected Mentor's product to treat their symptoms. “Applying Minnesota law to product- liability cases involving a Minnesota manufacturer enables the manufacturer ... to know the rules that will govern [its] transactions.”Kolberg–Pioneer, Inc. v. Belgrade Steel Tank, 823 N.W.2d 669, 673 (Minn.Ct.App.2012) (finding that predictability of results favored application of Minnesota law in an action by a seller against a Minnesota manufacturer for indemnity related to a product failure that occurred in Montana). Mentor cannot seriously dispute that it was Case 4:14-cv-00105-CDL Document 32-7 Filed 10/24/16 Page 5 of 7 In re Mentor Corp. ObTape Transobturator Sling Products..., Not Reported in... 2013 WL 286276 © 2015 Thomson Reuters. No claim to original U.S. Government Works. 5 reasonably aware that its connection to Minnesota at the time Cline and Morey were implanted with its product would authorize the application of Minnesota substantive law to a claim brought in the state of Minnesota. The Court finds that the first factor weighs in favor of applying Minnesota law. 2. Maintenance of Interstate and International Order In evaluating this factor, the courts “are primarily concerned with whether the application of Minnesota law would manifest disrespect for [another state]' s sovereignty or impede the interstate movement of people and goods. Jepson, 513 N.W.2d at 471. “An aspect of this concern is to maintain a coherent legal system in which the courts of different states strive to sustain, rather than subvert, each other's interests in areas where their own interests are less strong.”Id. Here, both Cline and Morey's claims have genuine contacts with Minnesota because their ObTape was manufactured and sold by Mentor while Mentor was a Minnesota corporation. Even though they received ObTape in their home states and allegedly suffered injury there, the Court cannot find that application of the law of the state where the product was manufactured in an action filed in that state would thwart the legitimate interest of any other state in having its law applied to such an action, particularly when the plaintiff voluntarily files her claim in Minnesota and rejects any protections that may be available to her under the law of her home state. Therefore, the Court concludes that this second factor does not weigh in favor of applying Ohio law to Cline's claim or Washington law to Morey's claim. 3. Simplification of the Judicial Task *7 The Court finds that the judicial task is not complicated by the application of either state's law. This third factor is neutral. 4. Advancement of the Forum's Governmental Interest “The fourth choice influencing factor is which choice of law most advances a significant interest of the forum.”Jepson, 513 N.W.2d at 472. “This factor is designed to ensure that Minnesota courts do not have to apply rules of law that are inconsistent with Minnesota's concept of fairness and equity.”Schumacher, 676 N.W.2d at 691(internal quotation marks omitted).“In considering which law will advance the governmental interest of Minnesota,” the Court must consider “the public policy of both forums.”Id. Minnesota has “weighty interest in compensating tort victims” and also “a clearly expressed public policy in holding a product's maker responsible for the costs of a defective product.”Kolberg–Pioneer, Inc., 823 N.W.2d at 675. In enacting their product liability statutes, both Ohio and Washington, like Minnesota, expressed an interest in vindicating the rights of those who have been legitimately harmed by a defective product. Even though Ohio and Washington may take a different approach than Minnesota, the Court cannot find based on the present record that Minnesota law is in conflict with the public policy underlying the Ohio and Washington product liability statutes. The Court finds that the fourth factor favors application of the law of the forum in which the actions were filedMinnesota. 5. Application of the Better Rule of Law The fifth and final choice influencing factor “is whether, in an objective sense, [Ohio/Washington] or Minnesota has the better rule of law.”Jepson, 513 N.W.2d at 472. In general, “this factor is addressed only when the other four factors are not dispositive as to which state's law should be applied.”Schumacher, 676 N.W.2d at 691–92. Mentor appears to misunderstand this factor and argues that the better rule of law is applying the law of Plaintiffs' home states to their claims. The factor, however, is intended to inquire into which state's substantive law provides the better rule. Jepson, 513 N.W.2d at 473. Here, the relevant question is whether it is better to have remedies available only within the framework of a product liability statute or to permit common law claims in product liability cases. Neither party offers a compelling explanation of which approach is the better rule. “Sometimes different laws are neither better nor worse in an objective way, just different.”Id. For these reasons, the Court concludes that the final factor is neutral. 6. Summary of Choice Influencing Factors The Court finds that an evaluation of the influencing factors establishes that Cline's claim, Morey's claim, and Mentor's activities have sufficiently significant contacts with the forum state to support the application of Minnesota law. Accordingly, Mentor's summary judgment motion against Cline (ECF No. 58 in 4:10–cv–5060) is denied, and Cline's claims are not subject to dismissal. Similarly, Mentor's summary judgment motion against Morey (ECF No. 51 in 4:11–cv–5065) is denied. V. Morey's Motion to Amend Case 4:14-cv-00105-CDL Document 32-7 Filed 10/24/16 Page 6 of 7 In re Mentor Corp. ObTape Transobturator Sling Products..., Not Reported in... 2013 WL 286276 © 2015 Thomson Reuters. No claim to original U.S. Government Works. 6 *8 As the Court previously noted, Morey seeks to add a claim for punitive damages. Mentor's only argument in opposition to Morey's proposed amendment is that Morey's claim is time-barred under Washington law. 1 The Court has concluded that Minnesota law, not Washington law, applies. Mentor did not argue that Morey's proposed punitive damages claim is time-barred under Minnesota law, and Mentor did not advance any other argument in opposition to Morey's proposed amendment. Therefore, the Court grants Morey's Motion to Amend (ECF No. 36 in 4:11–cv–5065). Morey shall file her amendment to her complaint within 7 days of today's order. 1 Under Minnesota's borrowing statute, Washington's three-year statute of limitations applies to claims based on Washington substantive law. Minn.Stat. § 541.31 subdiv. 1(a)(1); Wash. Rev.Code. § 7.72.060(3). But here, the Court has concluded that Minnesota substantive law applies to Morey's claims, so Minnesota's six-year statute of limitations applies. Minn.Stat. § 541.31 subdiv. 1(b); id. § 541.05 subdiv. 1(5). Morey's claims are timely under Minnesota law. CONCLUSION As discussed above, the Court finds that Minnesota law should be applied to the claims of Cline and Morey. The Court therefore denies Mentor's Motion for Summary Judgment against Cline (ECF No. 58 in 4:10–cv–5060) and Mentor's Motion for Summary Judgment against Morey (ECF No. 51 in 4:11–cv–5065). The Court grants Morey's Motion to Amend (ECF No. 36 in 4:11–cv–5065). IT IS SO ORDERED. All Citations Not Reported in F.Supp.2d, 2013 WL 286276 End of Document © 2015 Thomson Reuters. No claim to original U.S. Government Works. Case 4:14-cv-00105-CDL Document 32-7 Filed 10/24/16 Page 7 of 7 Exhibit E Case 4:14-cv-00105-CDL Document 32-8 Filed 10/24/16 Page 1 of 7 Edwards v. Wyeth, Inc., Not Reported in F.Supp.2d (2008) © 2016 Thomson Reuters. No claim to original U.S. Government Works. 1 2008 WL 1908907 Only the Westlaw citation is currently available. United States District Court, D. Minnesota. Clifford E. EDWARDS and Marilyn Edwards, individually and as husband and wife, Plaintiffs, v. WYETH, INC. (d/b/a Wyeth), formerly known as American Home Products Corporation, individually and as successor in interest to A .H. Robins, Inc.; Alpharma, Inc., d/b/a Alpharma Pharmaceuticals; Purepac Pharmaceutical Company; Actavis Elizabeth LLC; and the following fictitious party defendants (whether singular or plural, individual or corporate): No. 1, that entity which originally obtained permission from the U.S. Food and Drug Administration to market the drug branded Reglan; No. 2, that entity which obtained permission from the FDA to market the Reglan, metoclopramide and/or metoclopramide HCI ingested by Clifford Edwards; No. 3, that entity which originally manufactured and sold any Reglan which was ultimately ingested by Clifford Edwards: No. 4, that entity which originally manufactured And sold any Reglan, metoclopramide and/or Metoclopramide HCI which was ultimately ingested by Clifford Edwards; No. 5, that entity which marketed Reglan, metoclopramide and/or metoclopramide HCI., Defendants. Civil No. 07–3921 (DWF/SRN). | April 25, 2008. Attorneys and Law Firms Daniel J. McGlynn, Esq., and Patty F. Trantham, Esq., McGlynn, Glisson & Koch, APLC; and Lucia J.W. McLaren, Esq. and Michael K. Johnson, Esq., Goldenberg & Johnson, PLLC, for Plaintiffs. Bridget M. Ahmann, Esq., and Erin M. Verneris, Esq., Faegre & Benson LLP; and Jeffrey R. Pilkington, Esq., and Tom Wagner, Esq., Davis, Graham & Stubbs, LLP, for Defendant Wyeth, Inc. Bradley J. Linderman, Esq., and Michael D. Hutchens, Esq., Meagher & Geer, PLLP; and Richard A. Dean, Esq., Tucker Ellis & West, for Defendants Alpharma, Inc., Purepac Pharmaceutical Co., and Actavis Elizabeth LLC. MEMORANDUM OPINION AND ORDER DONOVAN W. FRANK, District Judge. INTRODUCTION *1 This matter is before the Court on a Motion to Dismiss Pursuant to Fed.R.Civ.P. 12(b)(6) or, in the Alternative to Transfer Venue Pursuant to 28 U.S.C. § 1404(a), brought by Defendants Wyeth, Inc. (“Wyeth”), and Schwarz Pharma, Inc. (“Schwarz”); a Joint Motion to Dismiss Pursuant to Federal Rule of Civil Procedure 12(c), brought by Defendants Actavis Elizabeth LLC (“Actavis”), Alpharma, Inc. (“Alpharma”), and Purepac Pharmaceutical Co. (“Purepac”); a Motion to Dismiss, or in the Alternative, Notice of Joinder in Wyeth and Schwarz Pharma, Inc.'s Motion to Transfer Venue Pursuant to 28 U .S.C. § 1404(a), brought by PLIVA, Inc. (“PLIVA”); and a Motion for Leave to File an Amended Complaint, brought by Plaintiffs Clifford E. and Marilyn Edwards. 1 1 Subsequent to the hearing on the motions to dismiss, all claims against Defendants Schwarz, PLIVA, and Teva Pharmaceuticals USA, Inc ., have been dismissed. Therefore, any motion brought by one of these Defendants is now moot. BACKGROUND Plaintiffs claim that Mr. Edwards developed Tardive Dyskinesia, a neurological disorder, as a result of his ingestion of metoclopramide. Metoclopramide, which is available in brand (Reglan®) or generic form, is used to treat certain gastrointestinal disorders. Plaintiffs allege in their Complaint that beginning in May 2000, and continuing until approximately 2001, Mr. Edwards was treated for gastroesophageal reflux disease (Compl.¶ 24); that Mr. Edwards was prescribed and ingested Reglan®/metoclopramide (Id. ¶¶ 27, 28); that Defendants warned that exposure to Reglan®/ metoclopramide can lead to Tardive Dyskinesia (Id. ¶ 431); and that Case 4:14-cv-00105-CDL Document 32-8 Filed 10/24/16 Page 2 of 7 Edwards v. Wyeth, Inc., Not Reported in F.Supp.2d (2008) © 2016 Thomson Reuters. No claim to original U.S. Government Works. 2 Reglan®/metoclopramide caused Mr. Edwards' injuries (Id. ¶ 29). Plaintiffs' causes of action include strict products liability, breach of express warranty (against Wyeth), negligence, misrepresentation by omission, negligence (against Wyeth), negligent misrepresentation, negligent misrepresentation (against Wyeth), fraud by concealment, violation of the Minnesota Consumer Protection Act (“MCPA”), fraud by concealment (against Wyeth), breach of implied warranties, strict joint and several liability, constructive fraud, intentional infliction of emotional distress, negligent infliction of emotional distress, and loss of consortium. Defendants Wyeth, Actavis, Alpharma, and Purepac move in two separate motions to dismiss Plaintiffs' action for failing to file the action within the applicable statutes of limitation. Wyeth also brings an alternative motion to transfer. Finally, Plaintiffs bring a Motion for Leave to File an Amended Complaint. DISCUSSION I. Motions to Dismiss A. Standard of Review In deciding a motion to dismiss, a court assumes all facts in the complaint to be true and construes all reasonable inferences from those facts in the light most favorable to the complainant. Morton v. Becker, 793 F.2d 185, 187 (8th Cir.1986). In doing so, however, a court need not accept as true wholly conclusory allegations, Hanten v. Sch. Dist. of Riverview Gardens, 183 F.3d 799, 805 (8th Cir.1999), or legal conclusions drawn by the pleader from the facts alleged. Westcott v. City of Omaha, 901 F.2d 1486, 1488 (8th Cir.1990). A court may consider the complaint, matters of public record, orders, materials embraced by the complaint, and exhibits attached to the complaint in deciding a motion to dismiss under Rule 12(b)(6) of the Federal Rules of Civil Procedure. Porous Media Corp. v. Pall Corp., 186 F.3d 1077, 1079 (8th Cir.1999). *2 To survive a motion to dismiss, a complaint must contain “enough facts to state a claim to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 127 S.Ct. 1955, 1974 (2007). Although a complaint need not contain “detailed factual allegations,” it must contain facts with enough specificity “to raise a right to relief above the speculative level.” Id. at 1964–65. This standard “calls for enough fact[s] to raise a reasonable expectation that discovery will reveal evidence of [the claim].” Id. at 1965. The Court evaluates a motion brought under Rule 12(c) under the same standard as a motion brought under Rule 12(b)(6). Fed.R.Civ.P. 12(c) and (h)(2). A motion to dismiss may be granted when a claim is barred under the statute of limitations. Fed.R.Civ.P. 12; Varner v. Peterson Farms, 371 F.3d 1011, 1016 (8th Cir.2004). The parties ask the Court to assume, for the purposes of this motion, that Minnesota's statutes of limitation apply to Plaintiffs' claims. 2 Under Minnesota law, the following limitations periods apply to the Plaintiffs' causes of action: two years for intentional infliction of emotional distress, Minn.Stat. Ann. § 541.07(1); four years for breach of warranty and strict liability, Minn.Stat. Ann. § 336.2–725; § 541.05, subd. 2; and six years for negligence, misrepresentation, fraud, and statutory claims, Minn.Stat. Ann. § 541.05, subd. 1. Also under Minnesota law, a civil action is commenced against a defendant for statute of limitations purposes by service of the summons upon the defendant, by acknowledgement of service if served by mail, or by delivery of the summons to the sheriff. Minn. R. Civ. P. 3.01; see also MW Ag, Inc. v. New Hampshire Ins. Co., 107 F.3d 644, 646 (8th Cir.1997). 3 2 Plaintiffs acknowledge that they filed this case in Minnesota because the statute of limitations had run in Plaintiffs' home forum. 3 Minnesota's commencement rules also apply. See Larsen v. Mayo Med. Ctr., 218 F.3d 863, 867 (8th Cir.2000). B. Wyeth's Motion to Dismiss Wyeth seeks dismissal of Plaintiffs' complaint on the grounds that the claims asserted against it are barred by the applicable statutes of limitation. Plaintiffs served Wyeth on October 19, 2007. Therefore, October 19, 2007, is the date on which this action was commenced against Wyeth. 1. Warranty claims Plaintiffs' warranty claims are subject to a four-year statute of limitations. Minn.Stat. § 336.2–725. In addition, Case 4:14-cv-00105-CDL Document 32-8 Filed 10/24/16 Page 3 of 7 Edwards v. Wyeth, Inc., Not Reported in F.Supp.2d (2008) © 2016 Thomson Reuters. No claim to original U.S. Government Works. 3 Plaintiffs' warranty claims accrued when the breach of warranty occurred, which is “when tender of delivery is made.” Id. Wyeth asserts that this claim is time- barred. Plaintiffs do not offer any arguments disputing this assertion. Plaintiffs have alleged that Mr. Edwards' injury was caused by the ingestion of Reglan® and/or metoclopramide. Plaintiffs further allege that Mr. Edwards' injury was diagnosed on or about September 17, 2001. Therefore, tender of delivery of the Reglan® and/ or metoclopramide must have occurred sometime prior to September 17, 2001. Accordingly, more than four years have passed since the statute began to run, and Plaintiffs' warranty claims are time-barred. 2. Minnesota Consumer Protection Act *3 Plaintiffs' MCPA claim is subject to a six-year statute of limitations. Minn.Stat. Ann. § 541.05, subd. 1(2). Wyeth asserts that this claim is time-barred. Plaintiffs do not offer any arguments in opposition. Plaintiffs' MCPA claims began to accrue on the date of sale when each alleged statutory violation occurred. Klehr v. A.O. Smith Corp., 875 F.Supp. 1342, 1352–53 (D.Minn.1995). Again, Plaintiffs have alleged that Mr. Edwards' injury was caused by the ingestion of Reglan® and/or metoclopramide and that his injury occurred on or about September 17, 2001. Therefore, the Reglan® and/ or metoclopramide that allegedly caused Mr. Edwards' injury must have been purchased prior to September 17, 2001. Accordingly, more than six years have passed since the statute began to run, and Plaintiffs' MCPA claim is time-barred. 3. Remaining claims The statutes of limitation on Plaintiffs' remaining claims began to run on the date that Mr. Edwards was aware of some damage resulting from Defendants' alleged conduct. See Offerdahl v. Univ. of Minn. Hosps. and Clinics, 426 N.W.2d 425, 429 (Minn.1988) (citing Dalton v. Dow Chem. Co., 158 N.W.2d 580, 583–84 (Minn.1968)); see also Herrmann v. McMenomy & Severson, 590 N.W.2d 641, 643 & n. 17 (Minn.1999). “Some damage” exists when a cognizable physical manifestation of the disease is present and there is evidence of a causal connection between the disease and the defendant's product, act, or omission. Klepmka v. G.D. Searle & Co., 963 F.2d 168, 170 (8th Cir.1992). The parties dispute when the statutes of limitation on Plaintiffs' remaining causes of action began to run. Wyeth asserts that Plaintiffs' causes of action accrued on or before September 17, 2001, the date on which Plaintiff has alleged “[Mr. Edwards] was diagnosed with Tardive Dyskinesia.” (Compl.¶ 25.) Plaintiffs, on the other hand, argue that their causes of action did not actually accrue until January 17, 2002, the date they claim Mr. Edwards was definitively diagnosed with Tardive Dyskinesia. Plaintiffs have since moved for leave to amend their Complaint to allege that the actual date of Mr. Edwards' diagnosis was January 17, 2002. The Court denies Plaintiffs' motion for leave to amend, as discussed below, and therefore looks only to the allegations of the original Complaint in considering the motions to dismiss. 4 4 For purposes of opposing the present motions to dismiss, Plaintiffs rely on extrinsic exhibits. The Court need not consider those exhibits as they are not “necessarily embraced by the pleadings.” Porous Media Corp., 186 F.3d at 1079. However, even if the Court did, the extrinsic evidence supports the finding that Plaintiffs' causes of action accrued on September 17, 2001. Based on the Plaintiffs' own allegations in Paragraph 25 of the Complaint, wherein Plaintiffs specifically allege that Mr. Edwards was diagnosed with Tardive Dyskinesia on September 17, 2001, it is appropriate to conclude that Mr. Edwards suffered some damage on or before September 17, 2001. In addition, the allegations in Plaintiffs' Complaint indicate that Plaintiffs were aware that Mr. Edwards' ingestion of Reglan® and/or metoclopramide likely caused his claimed injury. In particular, Plaintiffs allege that Defendants warned that Reglan® and/or metoclopramide could cause Tardive Dyskinesia. Thus, Plaintiffs allege both knowledge of Mr. Edwards' injury and of a causal connection between the injury and his ingestion of Reglan® and/or metoclopramide on or about September 17, 2001. Accordingly, Plaintiffs' remaining claims accrued, and the statutes of limitation began to run, on September 17, 2001. a. Intentional Infliction of Emotional Distress (“IIED”) Case 4:14-cv-00105-CDL Document 32-8 Filed 10/24/16 Page 4 of 7 Edwards v. Wyeth, Inc., Not Reported in F.Supp.2d (2008) © 2016 Thomson Reuters. No claim to original U.S. Government Works. 4 *4 Plaintiffs' IIED claim is subject to a two-year statute of limitations. Minn.Stat. Ann. § 541.07(1). As explained above, Plaintiffs' IIED claim accrued on September 17, 2001. Plaintiffs did not commence this action against Wyeth until October 19, 2007, more than two years later. Accordingly, Plaintiffs' IIED claim is barred by the statute of limitations. Even if the Court accepted Plaintiffs' alleged date-of-injury, January 17, 2002, more than two years passed before Plaintiffs commenced this action and their claims would still be time-barred. b. Strict Liability Plaintiffs' strict liability claim is subject to a four-year statute of limitations. Minn.Stat. Ann. § 541.05, subd. 2. As explained above, Plaintiffs' strict liability claim accrued on September 17, 2001. Plaintiffs did not commence this action against Wyeth until October 19, 2007, more than four years later. Accordingly, Plaintiffs' strict liability claim is time-barred. Even accepting Plaintiffs' alleged date-of-injury, January 17, 2002, more than four years passed before Plaintiffs commenced this action and their claims would still be time-barred. c. Negligence, Misrepresentation, and Fraud claims Plaintiffs' negligence, misrepresentation, and fraud claims are subject to a six-year statute of limitations. Minn.Stat. Ann. § 541.05, subd. 1. After Plaintiffs' claims accrued on September 17, 2001, more than six years passed before Plaintiffs served Wyeth on October 19, 2007. Accordingly, these claims are time-barred. 4. Fraudulent Concealment Plaintiffs argue that the doctrine of equitable estoppel prevents Defendants from relying on the statute of limitations defense because of Plaintiffs' allegedly fraudulent conduct. Specifically, Plaintiffs assert that Defendants concealed material facts about the risk of contracting Tardive Dyskinesia, that Plaintiffs and the treating physicians were unaware of the risks, and that Plaintiffs relied on the Defendants to their detriment. Plaintiffs actually seek to toll the statute of limitations pursuant to the “fraudulent concealment” exception. Fraudulent concealment tolls the statute of limitations until the plaintiff discovers or has a reasonable opportunity to discover the concealed facts. Hydra–Mac, Inc. v. Onan Corp., 450 N.W.2d 913, 918 (Minn.1990). The very existence of the facts which establish the cause of action must be fraudulently concealed in order to toll the statute of limitations. Id. “Merely establishing that a defendant had intentionally concealed the alleged defects is insufficient; the claimant must establish that it was actually unaware that the defect existed before a finding of fraudulent concealment can be sustained.” Id. The allegations contained in Plaintiffs' Complaint fail to support the tolling of the statute of limitations due to fraudulent concealment. First, Plaintiffs do not allege that Defendants affirmatively tried to conceal the presence of a cause of action from Plaintiffs. In addition, Plaintiffs allege that Defendants disclosed Tardive Dyskinesia as a possible risk of taking Reglan® and/or metoclopramide. (Compl.¶¶ 431.) Therefore, Plaintiffs cannot claim that Defendants concealed the basis for a cause of action or that Plaintiffs were unaware of any basis for a cause of action. C. Actavis Elizabeth, Alpharma, and Purepac's Motion to Dismiss *5 Plaintiffs assert various claims against Actavis Elizabeth, Alpharma, and Purepac. These claims include strict products liability, negligence, misrepresentation by omission, negligent misrepresentation, fraud by concealment, violation of the MCPA, breach of implied warranties, strict and joint liability, constructive fraud, IIED, negligent infliction of emotional distress, and loss of consortium. Alpharma and Actavis Elizabeth were served on October 19, 2007 and October 25, 2007, respectively. (Aff. of John R. Duff ¶¶ 3, 4.) Purepac has not been served. (Id. ¶ 6.) As explained above, the longest statute of limitations for any of Plaintiffs' claims against Actavis, Alpharma, and Purepac is six years. Plaintiffs' various causes of action accrued no later than September 17, 2001. Plaintiffs, however, did not commence this action against Actavis, Alpharma, or Purepac until more than six years had passed. In addition, as explained above, the allegations contained in Plaintiffs' Complaint fail to support the tolling of the statute of limitations due to fraudulent concealment. Accordingly, all claims asserted against these defendants are time-barred. II. Plaintiffs' Motion For Leave to File an Amended Complaint Case 4:14-cv-00105-CDL Document 32-8 Filed 10/24/16 Page 5 of 7 Edwards v. Wyeth, Inc., Not Reported in F.Supp.2d (2008) © 2016 Thomson Reuters. No claim to original U.S. Government Works. 5 Plaintiffs filed their original Complaint on September 7, 2007. In that Complaint, Plaintiffs allege that Mr. Edwards was diagnosed with Tardive Dyskinesia on or about September 17, 2001. As discussed above, Plaintiffs' claims are time-barred using September 17, 2001, as the day that Mr. Edwards' causes of action accrued. Shortly before the hearing on Defendants' motions to dismiss, Plaintiffs filed a motion for leave to amend their Complaint. The Court heard oral arguments on the motions to dismiss and received further briefing on Plaintiffs' motion for leave to amend. “[A] party may amend its pleading ... with the opposing party's written consent or the court's leave.” Fed.R.Civ.P. 15(a)(2). Leave to amend should be freely given “when justice so requires.” Id. However, leave should not be given when the proposed amendments are futile. See DeRoche v. All Am. Bottling Corp., 38 F.Supp.2d 1102, 1005 (D.Minn.1998). The Court finds that justice does not require the granting of Plaintiffs' motion for leave to amend. Indeed, it would be contrary to the interests of justice to allow an amendment, as Plaintiffs essentially ask the Court to engage in a fiction. Plaintiffs represent that they made a “clerical error” in pleading September 21, 2007, as the date of Mr. Edwards' diagnosis. Plaintiffs purport to correct the error in their proposed Amended Complaint by omitting any reference to the September 17, 2001, date and instead asserting that the alleged correct date of Mr. Edwards' diagnosis as January 17, 2002. Even accepting Plaintiffs' newly alleged date of diagnosis, the Court notes that this date is not necessarily the same date on which Mr. Edwards sustained “some damage” for the purpose commencing the statute of limitations. Instead, “some damage” existed when Mr. Edwards' experienced a cognizable physical manifestation of his disease and there was evidence of a causal connection between his disease and Reglan® and/or metoclopramide. Klepmka, 963 F.2d at 170. Plaintiffs' original Complaint plainly alleges that Mr. Edwards was diagnosed with Tardive Dyskinesia on or about September 17, 2001. Even if not the date of diagnosis, it is evident that Mr. Edwards was suffering symptoms at that time and knew the likely cause of his symptoms was his ingestion of Reglan® and/or metoclopramide. Although Plaintiffs now claim that they made a “clerical error” in alleging the September 2001 date, they do not claim that the facts underlying their original assertion of the September 2001 date to, likewise, be erroneous. In fact, Plaintiffs have put before the Court extrinsic evidence that substantiates the significance of the September 17, 2001, date. The evidence submitted by Plaintiffs demonstrates that Mr. Edwards saw a neurologist on September 17, 2001, and that the neurologist informed Mr. Edwards that his neurological symptoms were likely caused by Reglan®. Indeed, Plaintiffs readily acknowledge these facts. 5 The Court will not allow Plaintiffs to amend their original Complaint to assert directly contradictory factual allegations when it is evident that they are omitting key facts that, if included, would render the amendment futile. 5 In their memorandum in opposition to Defendants' motions to dismiss, Plaintiffs acknowledge that Mr. Edwards saw a neurologist on September 17, 2001, presenting with a “shuffling gait and masked face,” and that the doctor recommended cessation of Reglan®. (Plfs.' Mem. in Supp. of Her Resp. to Wyeth and Schwarz Pharma's Mot. to Dismiss at 2 (citing Dep. of David Weidman, M.D.).) *6 In addition, the allegations contained in Plaintiffs' proposed Amended Complaint fail to support the tolling of the statute of limitations due to fraudulent concealment. In particular, the allegations do not demonstrate that Defendants affirmatively attempted to conceal from Plaintiffs the presence of a cause of action. Nor can Plaintiffs demonstrate that they were unaware of any basis for a cause of action against Defendants. Accordingly, the Court denies Plaintiffs' motion for leave to amend. CONCLUSION Accordingly, based on the files, records, and proceedings herein, and for the reasons set forth above, IT IS ORDERED that: 1. Wyeth's Motion to Dismiss Pursuant to Fed.R.Civ.P. 12(b)(6) or, in the Alternative, to Transfer Venue Pursuant to 28 U.S.C. § 1404(a) (Doc. No. 26) is GRANTED. 2. Actavis, Alpharma, and Purepac's Joint Motion to Dismiss Pursuant to Federal Rule of Civil Procedure 12(c) (Doc. No. 45) is GRANTED. Case 4:14-cv-00105-CDL Document 32-8 Filed 10/24/16 Page 6 of 7 Edwards v. Wyeth, Inc., Not Reported in F.Supp.2d (2008) © 2016 Thomson Reuters. No claim to original U.S. Government Works. 6 3. PLIVA's Motion to Dismiss, or in the Alternative, Notice of Joinder in Wyeth and Schwarz Pharma, Inc.'s Motion to Transfer Venue Pursuant to 28 U.S.C. § 1404(a) (Doc. No. 51), is DENIED AS MOOT; and 4. Plaintiffs' Motion for Leave to File and Amended Complaint (Doc. No. 77) is DENIED. 5. Plaintiffs' Complaint (Doc. No. 1) is DISMISSED. LET JUDGMENT BE ENTERED ACCORDINGLY. All Citations Not Reported in F.Supp.2d, 2008 WL 1908907 End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:14-cv-00105-CDL Document 32-8 Filed 10/24/16 Page 7 of 7 Exhibit F Case 4:14-cv-00105-CDL Document 32-9 Filed 10/24/16 Page 1 of 10 In re Mentor Corp. Obtape Transobturator Sling Products Liability..., Slip Copy (2015) © 2016 Thomson Reuters. No claim to original U.S. Government Works. 1 KeyCite Blue Flag – Appeal Notification Appeal Filed by LIBBY HALL v. MENTOR CORPORATION, ET AL, 11th Cir., January 26, 2016 2015 WL 9307267 Only the Westlaw citation is currently available. United States District Court, M.D. Georgia, Columbus Division. In re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation. MDL Docket No. 2004 4:08-MD-2004 (CDL) | Case Nos. 4:13-cv-93 (Jackson), 4:13-cv-101 (Rupert), 4:13-cv-151 (Charles), 4:13-cv-153 (Klum), 4:13-cv-241 (Leon), 4:13-cv-346 (Urbieta), 4:13-cv-377 (Lovell), 4:13-cv-426 (Suen), 4:13- cv-483 (Uriegas), 4:13-cv-503 (Degroot), 4:14-cv-61 (Hall), 4:14-cv-63 (Chambers) | Signed 12/21/2015 ORDER CLAY D. LAND, CHIEF U.S. DISTRICT COURT JUDGE *1 Defendant Mentor Worldwide LLC developed a suburethral sling product called ObTape Transobturator Tape, which was used to treat women with stress urinary incontinence. Plaintiffs Michele Jackson, Andrea Rupert, Wendy Charles, Carrie Klum, Olga Leon, Graciela Urbieta, Sharon Lovell, Arleen Suen, Sylvia Uriegas, Debra Degroot, Libby Hall, and Sherry Lynn Chambers were implanted with ObTape and assert that they suffered injuries caused by ObTape. Each Plaintiff brought a product liability action against Mentor, contending that ObTape had design and/or manufacturing defects that proximately caused her injuries. Plaintiffs also assert that Mentor did not adequately warn their physicians about the risks associated with ObTape. Plaintiffs brought their claims under several theories. Mentor seeks summary judgment on all of their claims. For the reasons set forth below, the Mentor's summary judgment motions are granted. SUMMARY JUDGMENT STANDARD Summary judgment may be granted only “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). In determining whether a genuine dispute of material fact exists to defeat a motion for summary judgment, the evidence is viewed in the light most favorable to the party opposing summary judgment, drawing all justifiable inferences in the opposing party's favor. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986). A fact is material if it is relevant or necessary to the outcome of the suit. Id. at 248. A factual dispute is genuine if the evidence would allow a reasonable jury to return a verdict for the nonmoving party. Id. FACTUAL BACKGROUND I. Plaintiff Michele Jackson (ECF No. 37 in 4:13-cv-93) Michele Jackson sought treatment for stress urinary incontinence from Dr. Glen Diacon. Dr. Diacon recommended ObTape, and he implanted Jackson with ObTape on March 26, 2004. In October 2004, Jackson visited Dr. Diacon's assistant and complained of pain near the ObTape incision site, as well as suprapubic discomfort and dyspareunia. The assistant felt some exposed graft material. Jackson sought a second opinion from Dr. Daniel Barnes. Dr. Barnes diagnosed Jackson with an erosion of the ObTape. He recommended that Jackson have the exposed portion of the ObTape removed, and he told Jackson that the revision surgery “would most likely take away her pain.” Barnes Dep. 16:6-13, ECF No. 37-7 in 4:13-cv-93. Dr. Barnes removed portions of Jackson's ObTape in November 2004. Jackson is an Oklahoma resident whose ObTape-related treatment took place in Oklahoma. On March 27, 2013, Jackson served Mentor with a copy of her Complaint captioned in Hennepin County District Court of the State of Minnesota. Jackson brought claims for strict liability, negligence, breach of express warranty, breach of implied warranty, common law fraud, constructive fraud, and negligent and intentional misrepresentation. II. Plaintiff Andrea Rupert (ECF No. 41 in 4:13-cv-101) *2 Dr. Murphy Townsend diagnosed Andrea Rupert with incontinence, and he implanted Rupert with ObTape on May 3, 2004. After the surgery, Rupert's incontinence improved. In June 2005, Rupert went to the emergency room with extreme pain in her right groin, vaginal discharge and bleeding, and ase 4:14-cv-00105-CDL Document 32-9 Filed 10/24/16 Page 2 of 10 In re Mentor Corp. Obtape Transobturator Sling Products Liability..., Slip Copy (2015) © 2016 Thomson Reuters. No claim to original U.S. Government Works. 2 a foul odor. The emergency room doctor attributed Rupert's symptoms to a urinary tract infection. Rupert went to Dr. Townsend for follow-up on her emergency room visit. According to Rupert, Dr. Townsend told her that she had an infection and that “perhaps [her] body was not adapting well to the” ObTape. Rupert Dep. 47:8-15, ECF No. 43-3 in 4:13-cv-101. Dr. Townsend recommended that Rupert's ObTape be removed. On June 22, 2005, Dr. Townsend removed part of Rupert's ObTape and drained an abscess he discovered during the explant surgery. At some point, Dr. Townsend came to believe that ObTape was defective. Townsend Dep. 19:15-18, ECF No. 43-3 in 4:13-cv-101. He encouraged Rupert to contact Mentor to tell Mentor about her complications with ObTape, and Rupert did so. Id. at 18:18-19:10. In August 2005, Rupert visited Dr. Thomas Fassuliotis with recurrent incontinence. Dr. Fassuliotis noted that Rupert was concerned that half of her ObTape was still in her body and that it may become infected. Def.'s Mot. for Summ. J. Ex. E, History & Physical Examination (Aug. 2, 2005), ECF No. 41-8 in 4:13-cv-101. Dr. Fassuliotis also noted that Rupert stated that “this may be a litigious issue with the manufacturer of the Mentor Ob Tape.” Id. 1 Rupert is a Georgia resident whose ObTape-related treatment took place in Georgia. On April 1, 2013, Rupert served Mentor with a copy of her Complaint captioned in Hennepin County District Court of the State of Minnesota. Rupert brought claims for strict liability, negligence, breach of express warranty, breach of implied warranty, common law fraud, constructive fraud, and negligent and intentional misrepresentation. III. Plaintiff Wendy Charles (ECF No. 34 in 4:13- cv-151) 2 Wendy Charles sought treatment from Dr. Mitesh Parekh for stress urinary incontinence. On February 9, 2004, Dr. Parekh implanted Charles with ObTape. In April 2004 and again in January 2005, Charles reported to Dr. Parekh with groin pain. And in May 2005, Charles sent Dr. Parekh a medical journal article entitled “Groin Pain After a Tension-Free Vaginal Tape or Similar Suburethral Sling: Management Strategies” and expressed concern that ObTape was causing her groin pain. After Charles and Dr. Parekh discussed the pros and cons of removing Charles's ObTape, Charles decided to have the ObTape removed because she believed it was causing her groin pain. Dr. Parekh removed Charles's ObTape on March 27, 2006. At her follow-up visit, Charles reported that she was happy with the revision surgery and that her groin pain symptoms were gone. *3 Charles is a Pennsylvania resident whose ObTape- related treatment took place in Pennsylvania. On May 7, 2013, Charles served Mentor with a copy of her Complaint captioned in Hennepin County District Court of the State of Minnesota. Charles brought claims for strict liability, negligence, breach of express warranty, breach of implied warranty, common law fraud, constructive fraud, and negligent and intentional misrepresentation. IV. Plaintiff Carrie Klum (ECF No. 34 in 4:13-cv-153) Carrie Klum visited Dr. Sakina Khalidi for treatment of stress urinary incontinence. Dr. Khalidi implanted Klum with ObTape on June 3, 2004. In February 2005, Klum visited Dr. Khalidi because she had been experiencing pressure in the lower abdomen and an occasional bleed for about three weeks. Dr. Khalidi examined Klum and saw some exposed ObTape. Dr. Khalidi told Klum that the ObTape was infected and that the bleeding was caused by the ObTape. Dr. Khalidi prescribed an antibiotic and advised that the exposed portion of ObTape may need to be removed. The next week, Dr. Khalidi removed a small segment of Klum's ObTape. In February 2006, Klum returned to Dr. Khalidi complaining of blood in her urine and vaginal bleeding. Klum understood from Dr. Khalidi that her body was rejecting the ObTape and that is why she had an infection. Dr. Khalidi advised Klum that the entire ObTape needed to be removed, but when Dr. Khalidi performed the revision surgery the entire ObTape could not be removed. Klum is a Florida resident whose ObTape-related treatment took place in Florida. On April 29, 2013, Klum served Mentor with a copy of her Complaint captioned in Hennepin County District Court of the State of Minnesota. Klum brought claims for strict liability, negligence, breach of express warranty, breach of implied warranty, common law fraud, constructive fraud, and negligent and intentional misrepresentation. Her husband Anthony brought a loss of consortium claim. V. Plaintiff Olga Leon (ECF No. 40 in 4:13-cv-241) Dr. Bernard Morris implanted Olga Leon with ObTape on August 19, 2004. In January 2005, Leon returned to Dr. Morris with complaints of pain and irritation. Dr. Morris examined Leon, diagnosed an erosion of the ObTape, and told Leon that there was a problem with her ObTape and he would ase 4:14-cv-00105-CDL Document 32-9 Filed 10/24/16 Page 3 of 10 In re Mentor Corp. Obtape Transobturator Sling Products Liability..., Slip Copy (2015) © 2016 Thomson Reuters. No claim to original U.S. Government Works. 3 have to perform a revision surgery. Leon Dep. 162:7-15, ECF No. 42-3 in 4:13-cv-241. Dr. Morris removed Leon's eroded ObTape on January 11, 2005. Leon testified that she started thinking about bringing a lawsuit regarding ObTape “after the second surgery.” Id. at 197:2-199:25. It is not clear from the present record whether Leon meant the revision surgery she had in January 2005 or a later surgery performed by a different doctor in 2006. Leon is a California resident whose ObTape-related treatment took place in California. On June 10, 2013, Leon served Mentor with a copy of her Complaint captioned in Hennepin County District Court of the State of Minnesota. Leon brought claims for strict liability, negligence, breach of express warranty, breach of implied warranty, common law fraud, constructive fraud, and negligent and intentional misrepresentation. VI. Plaintiff Graciela Urbieta (ECF No. 31 in 4:13- cv-346) Graciela Urbieta visited Dr. Charles Feinstein complaining of urinary incontinence, and Dr. Feinstein recommended ObTape. Dr. Feinstein implanted Urbieta with ObTape on March 8, 2005. In January 2006, Urbieta went to the emergency room complaining of a painful rash, leg pain, and vaginal odor. She was admitted to the hospital and treated for necrotizing fasciitis. Later that year, she was treated for abscesses by Dr. Marie Crandall. Dr. Crandall became concerned that Urbieta's ObTape was chronically infected; Dr. Crandall told Urbieta of this concern and referred her to Dr. Stephanie Kielb for further evaluation. Crandall Dep. 54:8-21, ECF No. 31-8 in 4:13-cv-346. Dr. Crandall also told Urbieta that her ObTape might need to be removed. Urbieta Dep. 6:1-2, 59:3-13, ECF No. 31-5 in 4:13-cv-346. Dr. Kielb examined Urbieta, found an erosion of the ObTape, and told Urbieta that the ObTape would have to be removed because it was causing discharge and other problems. Id. at 59:24-60:4; Kielb Dep. 42:13-44:4, ECF No. 31-9 in 4:13-cv-346. After Dr. Kielb performed the excision surgery in December 2006, Urbieta's symptoms improved, and she no longer had pus. Urbieta Dep. 60:6-13. *4 Urbieta is an Illinois resident whose ObTape-related treatment took place in Illinois. On July 11, 2013, Urbieta served Mentor with a copy of her Complaint captioned in Hennepin County District Court of the State of Minnesota. Urbieta brought claims for strict liability, negligence, breach of express warranty, breach of implied warranty, common law fraud, constructive fraud, and negligent and intentional misrepresentation. Her husband Mateo brought a loss of consortium claim. VII. Plaintiff Sharon Lovell (ECF No. 31 in 4:13-cv-377) Sharon Lovell sought treatment for stress urinary incontinence from Dr. Bechara Tabet. Dr. Tabet implanted Lovell with ObTape on December 27, 2004. In May 2006, Lovell was hospitalized with a left thigh abscess and vaginal discharge, and her doctors suspected that the infection was related to Lovell's ObTape. Dr. Tabet examined Lovell, discovered that the ObTape had eroded, and removed the entire sling. After the excision procedure, Dr. Tabet explained to Lovell that the ObTape “had eroded and snapped and embedded in [her] leg and caused the abscess.” Lovell Dep. 130:5-14, ECF No. 31-5 in 4:13-cv-377. Lovell is an Ohio resident whose ObTape-related treatment took place in Ohio. On July 16, 2013, Lovell served Mentor with a copy of her Complaint captioned in Hennepin County District Court of the State of Minnesota. Lovell brought claims for strict liability, negligence, breach of express warranty, breach of implied warranty, common law fraud, constructive fraud, and negligent and intentional misrepresentation. VIII. Plaintiff Arleen Suen (ECF No. 32 in 4:13-cv-426) Arleen Suen visited Dr. Laurence Orbuch for treatment of incontinence. Dr. Orbuch diagnosed Suen with stress urinary incontinence and recommended that she undergo an ObTape implant. Dr. Orbuch implanted Suen with ObTape on December 2, 2004. After the surgery, Suen had abnormal vaginal discharge and several follow-up operative procedures and sought treatment from Dr. William McCormack, who referred Suen to Dr. Victor Nitti. Suen visited Dr. Nitti in December 2005, and he told her that the ObTape was infected and that it would be best to remove it. At the time, Dr. Nitti understood that it was “well-established that ObTapes had a higher rate of infection than other tapes.” Nitti Dep. 45:17-46:10, ECF No. 32-6 in 4:13-cv-426. Dr. Nitti removed Suen's ObTape in December 2005. When Dr. McCormack followed up with Suen in May of 2006, Suen reported that her “ongoing problems with bleeding, yeast and vaginal infections and numbness in [her] left leg [had] all disappeared.” Suen Dep. 103:5-8, ECF No. 32-4 in in 4:13- cv-426. Suen also reported that Dr. Nitti had told her that “the mesh used to act as a sling has had a history of creating infections therefore he removed all traces of the mesh.” Id. at 103:8-11. ase 4:14-cv-00105-CDL Document 32-9 Filed 10/24/16 Page 4 of 10 In re Mentor Corp. Obtape Transobturator Sling Products Liability..., Slip Copy (2015) © 2016 Thomson Reuters. No claim to original U.S. Government Works. 4 Suen is a New York resident whose ObTape-related treatment took place in New York. On August 8, 2013, Suen served Mentor with a copy of her Complaint captioned in Hennepin County District Court of the State of Minnesota. Suen brought claims for strict liability, negligence, breach of express warranty, breach of implied warranty, common law fraud, constructive fraud, and negligent and intentional misrepresentation. IX. Plaintiff Sylvia Uriegas (ECF No. 29 in 4:13-cv-483) Sylvia Uriegas visited Dr. Leopoldo Tecuanhuey complaining of incontinence and other symptoms. Dr. Tecuanhuey implanted Uriegas with ObTape on October 25, 2004. After her ObTape implant, Uriegas experienced vaginal infections, bleeding, malodorous discharge, incontinence, painful urination, urinary tract infections, and pain during intercourse. In October and November of 2006, Dr. Tecuanhuey removed portions of Uriegas's ObTape. And in December of 2006, Dr. Tecuanhuey told Uriegas that he had removed her ObTape and that he suspected that the ObTape had caused her problems. Tecuanhuey Dep. 197:4-198:12, ECF No. 29-5 in 4:13-cv-483. *5 Uriegas is a Texas resident whose ObTape-related treatment took place in Texas. On September 27, 2013, Uriegas served Mentor with a copy of her Complaint captioned in Hennepin County District Court of the State of Minnesota. Uriegas brought claims for strict liability, negligence, breach of express warranty, breach of implied warranty, common law fraud, constructive fraud, and negligent and intentional misrepresentation. X. Plaintiff Debra Degroot (ECF No. 30 in 4:13-cv-503) Dr. David Grapey implanted Debra Degroot with ObTape on September 29, 2004. In November 2005, Degroot returned to Dr. Grapey complaining of chronic malodorous vaginal discharge, and she reported that she had seen a portion of her ObTape protruding from her vagina. Dr. Grapey examined Degroot and found an erosion of the ObTape. He removed the eroded portion of ObTape. Degroot returned to Dr. Grapey again in April 2007 complaining of chronic malodorous vaginal discharge. Dr. Grapey became concerned that Degroot's ObTape was chronically infected, and he referred her to Dr. Scott MacDiarmid for further treatment. Dr. MacDiarmid told Degroot that at least some of her remaining ObTape was infected, and he recommended surgery to remove more of her ObTape. Dr. Grapey and Dr. MacDiarmid performed an excision surgery in May of 2007 to remove additional ObTape. When she filed her Complaint, Degroot was a North Carolina resident, and all of her ObTape-related treatment took place in North Carolina. On October 11, 2013, Degroot served Mentor with a copy of her Complaint captioned in Hennepin County District Court of the State of Minnesota. Degroot brought claims for strict liability, negligence, breach of express warranty, breach of implied warranty, common law fraud, constructive fraud, and negligent and intentional misrepresentation. XI. Plaintiff Libby Hall (ECF No. 25 in 4:14-cv-61) Libby Hall sought treatment for incontinence from Dr. Stephen Farmer. Dr. Farmer diagnosed Hall with stress urinary incontinence and recommended that Hall undergo an ObTape implant procedure. Dr. Farmer implanted Hall with ObTape on January 10, 2005. Hall returned to Dr. Farmer in July 2005 with complaints of continued incontinence and dyspareunia. Dr. Farmer examined Hall and told her that the ObTape, which was just under the vaginal mucosa, was likely the source of her pain. Dr. Farmer also told Hall that removing the ObTape should improve her symptoms, and he removed Hall's ObTape on July 11, 2005. Hall is a Mississippi resident whose ObTape-related treatment took place in Mississippi. On January 23, 2014, Hall served Mentor with a copy of her Complaint captioned in Hennepin County District Court of the State of Minnesota. Hall brought claims for strict liability, negligence, breach of express warranty, breach of implied warranty, common law fraud, constructive fraud, and negligent and intentional misrepresentation. XII. Plaintiff Sherry Lynn Chambers (ECF No. 26 in 4:14-cv-63) Dr. Luis Sanz diagnosed Sherry Lynn Chambers with stress urinary incontinence and recommended that she undergo a transobturator tape procedure. Dr. Sanz implanted Chambers with ObTape on April 1, 2004. In September 2004, Chambers complained to Dr. Sanz of some vaginal bleeding, and Dr. Sanz recommended a revision surgery to try and stop the bleeding. Chambers Dep. 91:1-92:10, ECF No. 26-4 in 4:14- cv-63. After the September 2004 revision surgery, Chambers continued to experience problems with bleeding, and she had two additional revision surgeries during June and October of ase 4:14-cv-00105-CDL Document 32-9 Filed 10/24/16 Page 5 of 10 In re Mentor Corp. Obtape Transobturator Sling Products Liability..., Slip Copy (2015) © 2016 Thomson Reuters. No claim to original U.S. Government Works. 5 2005. At some point after the October 2005 surgery, the sling scratched Chambers's husband during intercourse. *6 In 2006, Chambers was still experiencing bleeding, so she consulted with Dr. Briana Walton in August or September of 2006. Dr. Walton observed an erosion of the ObTape, and she showed the erosion to Chambers's husband. Dr. Walton told the Chamberses, “This is what scratched you. This is the erosion of the sling. This is what's making you bleed.” Id. at 138:9-15. After that, Chambers was referred to Dr. George Webster, who recommended a complete removal of the ObTape. Chambers is a Maryland resident whose ObTape-related treatment took place in Washington, D.C., Virginia, and North Carolina. On February 7, 2014, Chambers served Mentor with a copy of her Complaint captioned in Hennepin County District Court of the State of Minnesota. Chambers brought claims for strict liability, negligence, breach of express warranty, breach of implied warranty, common law fraud, constructive fraud, and negligent and intentional misrepresentation. DISCUSSION Each Plaintiff filed her action in Minnesota state court, and Mentor removed each Plaintiff's action to the United States District Court for the District of Minnesota. The cases were later transferred to this Court as part of a multidistrict litigation proceeding regarding ObTape. The parties agree for purposes of summary judgment that Minnesota law applies to Plaintiffs' claims. See In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., No. 4:08-md-2004, 2013 WL 286276, at *7 (concluding that Minnesota law applied to claims of non-Minnesota ObTape plaintiffs who brought their actions in Minnesota). I. Strict Liability and Negligence Claims Mentor contends that Plaintiffs' strict liability and negligence claims are time-barred under Minnesota law. 3 The statute of limitations for a strict liability claim is four years. Minn. Stat. § 541.05 subd. 2 (“[A]ny action based on the strict liability of the defendant and arising from the manufacture, sale, use or consumption of a product shall be commenced within four years.”). The statute of limitations for a negligence claim is six years. Minn. Stat. § 541.05 subd. 1(5) (establishing six- year limitation period for personal injury claims not arising in contract or strict liability). Under Minnesota law, “a claim involving personal injuries allegedly caused by a defective product accrues when two elements are present: ‘(1) a cognizable physical manifestation of the disease or injury, and (2) evidence of a causal connection between the injury or disease and the defendant's product, act, or omission.’ ” Klempka v. G.D. Searle & Co., 963 F.2d 168, 170 (8th Cir. 1992) (quoting Hildebrandt v. Allied Corp., 839 F.2d 396, 398 (8th Cir. 1987)) (applying Minnesota law). “A plaintiff who is aware of both her injury and the likely cause of her injury is not permitted to circumvent the statute of limitations by waiting for a more serious injury to develop from the same cause.” Id. For example, in Klempka, the plaintiff suffered injuries and was diagnosed with chronic pelvic inflammatory disease, which her doctor said was caused by the plaintiff's intrauterine device. Id. at 169. Several years later, the plaintiff was told that she was infertile and that the intrauterine device caused her infertility. Id. Applying Minnesota law, the Eighth Circuit concluded that the plaintiff's cause of action accrued when she first learned that she had an injury (chronic pelvic inflammatory disease) that was caused by the intrauterine device. Id. at 170. *7 Here, each Plaintiff contends that she did not learn of a connection between ObTape and her injuries until 2011 or later – either based on a television commercial regarding mesh complications or a consultation with a new doctor. But each Plaintiff knew that she suffered some injuries caused by ObTape well before then. Michele Jackson. In October 2004, Jackson visited her doctor because she was experiencing pain, and her doctor found an erosion of the ObTape. Her doctor recommended removal of the exposed portion of the ObTape, and he told Jackson that the revision surgery “would most likely take away her pain.” Barnes Dep. 16:6-13. Therefore, Jackson knew by October 2004 that there was a likely connection between ObTape and some of her injuries. She did not file her complaint until more than eight years later, in March 2013. Andrea Rupert. After Rupert reported to the emergency room complaining of extreme pain and vaginal bleeding in June 2005, Rupert was diagnosed with an infection and her doctor recommended that her ObTape be removed. When Rupert's doctor removed the ObTape, he discovered an abscess. Rupert's doctor encouraged Rupert to contact Mentor about ase 4:14-cv-00105-CDL Document 32-9 Filed 10/24/16 Page 6 of 10 In re Mentor Corp. Obtape Transobturator Sling Products Liability..., Slip Copy (2015) © 2016 Thomson Reuters. No claim to original U.S. Government Works. 6 her problems with ObTape, which she did. And in August 2005, Rupert visited another doctor, who noted that Rupert was concerned that half of her ObTape was still in her body and that it may become infected. Thus, by August 2005, Rupert connected her injuries to ObTape. She did not file her complaint until nearly eight years later, on April 1, 2013. Wendy Charles. Charles began experiencing severe groin pain several months after her ObTape implant. Based on her independent research, Charles became convinced by May 2005 that there was a connection between her pain and the ObTape. Charles persuaded her doctor to remove her ObTape in March 2006; after the ObTape removal, Charles did not experience more groin pain symptoms. Therefore, Charles was aware of a connection between ObTape and her injuries by March 2006 at the latest. She did not file her complaint until more than seven years later, on May 7, 2013. Carrie Klum. Klum visited her doctor complaining of pressure in the lower abdomen and bleeding. She was diagnosed with an infection and erosion of her ObTape in 2005. At the time, Klum's doctor told her that her pain and bleeding were caused by the ObTape. And in February 2006, when Klum experienced similar symptoms, her doctor told her that the entire ObTape needed to be removed. Thus, by February 2006 at the latest, Klum knew that her injuries were connected to ObTape. She did not file her complaint until more than seven years later, on April 29, 2013. Olga Leon. Leon was diagnosed with an erosion of her ObTape in January 2005 after she complained to her doctor of pain and irritation. The doctor told Leon that there was a problem with her ObTape and he would have to perform a revision surgery. Therefore, Leon knew by January 2005 that some of her injuries were connected to ObTape. Furthermore, in 2005 or 2006, Leon started thinking about bringing a lawsuit regarding ObTape. But Leon did not bring her lawsuit until June 10, 2013. Graciela Urbieta. After her ObTape implant, Urbieta experienced a variety of problems; her doctor became concerned that Urbieta's ObTape was chronically infected, and she referred Urbieta to a specialist. The specialist diagnosed Urbieta with an erosion of ObTape in late 2006 and told Urbieta that the ObTape would have to be removed because it was causing discharge and other problems. After Urbieta's excision surgery in December 2006, Urbieta's symptoms improved. Therefore, Urbieta knew by December 2006 that there was likely a connection between ObTape and at least some of her injuries. She did not file her complaint until more than six years later, on July 11, 2013. *8 Sharon Lovell. In May 2006, Lovell was hospitalized with a left thigh abscess and vaginal discharge, and her doctors suspected that the infection was related to Lovell's ObTape. After an examination, Lovell's doctor confirmed that the ObTape had eroded, and he removed the entire sling. At the time, Lovell's doctor explained to her that the ObTape had eroded and caused the abscess. Therefore, Lovell knew by May 2006 that there was a connection between her ObTape and her injuries. She did not file her complaint until more than seven years later, on July 16, 2013. Arleen Suen. Suen experienced abnormal vaginal discharge and had to have several follow-up operative procedures after her ObTape implant. When she was referred to another doctor for treatment, that doctor told Suen that the ObTape was infected and that it would be best to remove it. Suen's doctor told her that ObTape had a history of creating infections. After her ObTape was explanted in December 2005, Suen's adverse symptoms disappeared. Thus, Suen knew by December 2005 that there was a connection between ObTape and her injuries. She did not file her complaint until more than seven years later, on August 8, 2013. Sylvia Uriegas. Uriegas had multiple adverse symptoms after her ObTape implant and sought additional treatment from her doctor. The doctor removed portions of Uriegas's ObTape and told her in December of 2006 that he suspected that the ObTape had caused her problems. Therefore, Uriegas knew by December 2006 that there was a possible connection between ObTape and her adverse symptoms. She did not file her complaint until nearly seven years later, on September 27, 2013. Debra Degroot. After her ObTape implant, Degroot experienced chronic malodorous vaginal discharge and saw a portion of her ObTape protruding from her vagina. In November 2005, Degroot's doctor diagnosed Degroot with an erosion of the ObTape and removed the eroded portion. Degroot continued to experience malodorous discharge. In April 2007, Degroot's doctor told her that her remaining ObTape was infected and needed to be removed, so Degroot had another excision procedure in May 2007. Therefore, Degroot knew by April 2007 at the latest that there was a connection between ObTape and at least some of her injuries. She did not file her complaint until more than six years later, on October 11, 2013. ase 4:14-cv-00105-CDL Document 32-9 Filed 10/24/16 Page 7 of 10 In re Mentor Corp. Obtape Transobturator Sling Products Liability..., Slip Copy (2015) © 2016 Thomson Reuters. No claim to original U.S. Government Works. 7 Libby Hall. Hall had problems with dyspareunia after her ObTape implant. In July 2005, Hall's doctor told her that the ObTape was likely the source of her pain. The doctor also told Hall that her symptoms should improve if the ObTape was removed. Therefore, Hall knew in July 2005 that there was a likely connection between ObTape and some of her injuries. She did not file her complaint until more than eight years later, on January 23, 2014. Sherry Lynn Chambers. After her ObTape implant, Chambers experienced vaginal bleeding and had at least three revision surgeries by October 2005. In 2006, Chambers was still experiencing vaginal bleeding, so she visited a different doctor, who found an erosion of the ObTape and told Chambers that the erosion was causing her bleeding and had scratched Chambers's husband during intercourse. Therefore, Chambers knew by 2006 at the latest that her symptoms were connected to ObTape. She did not file her complaint until more than seven years later, on February 7, 2014. In summary, each Plaintiff connected at least some of her injuries to ObTape more than six years before she filed suit. Accordingly, their strict liability and negligence claims are time-barred under Minnesota law. Plaintiffs contend that it is not enough that they made a connection between ObTape and some of their injuries. Rather, they appear to argue that they must have been on notice that a defect in ObTape caused their injuries. Plaintiffs did not point to any Minnesota authority holding that a plaintiff must be on actual notice that her specific injuries were caused by a product defect. Rather, the precedent establishes that a claim accrues when the plaintiff becomes aware of an injury and a causal connection between the injury and the defendant's product. Klempka, 963 F.2d at 170. *9 Plaintiffs nonetheless contend that two Eighth Circuit cases and one Minnesota District Court case support denial of summary judgment on their negligence and strict liability claims. The Court disagrees. First, they point to Hildebrandt v. Allied Corp., 839 F.2d 396 (8th Cir. 1987), where the plaintiffs alleged that they suffered lung damage due to their exposure to a toxic chemical at their workplace. But there, unlike here, the plaintiffs' doctors initially told the plaintiffs that there was no correlation between their symptoms and the chemical. Id. at 399. The Eighth Circuit thus concluded that the plaintiffs' claims did not accrue until the cause of the plaintiffs' injuries was rationally identified. Second, Plaintiffs point to Tuttle v. Lorillard Tobacco Co., 377 F.3d 917 (8th Cir. 2004). In Tuttle, the district court found that the decedent's smokeless tobacco product liability action accrued when the decedent discovered a lump in his cheek. The Eighth Circuit reversed because the decedent's doctor initially told the decedent that the lump was caused by an oral infection and was treatable with antibiotics—not that it was oral cancer caused by the tobacco. Id. at 922. Third, Plaintiffs point to Huggins v. Stryker Corp., 932 F. Supp. 2d 972 (D. Minn. 2013). In Huggins, the plaintiff asserted that the defendant's pain pump caused a condition that resulted in degeneration of his cartilage. The plaintiff's doctor discovered the loss of cartilage in 2002, but he did not connect the condition to the pain pump or tell the plaintiff that there was such a connection. The district court noted that the “first article recognizing a potential causal link between pain pumps” and the plaintiff's condition was not published until 2007. Id. Hildebrandt, Tuttle, and Huggins are all distinguishable from Plaintiffs' cases. In Hildebrandt, Tuttle, and Huggins, the plaintiffs suffered injuries that could have been caused by the defendant's product OR could have been caused by something else, and the courts concluded that the cause of action did not accrue until the plaintiffs had some objective information suggesting a causal link between the product and the injury. In contrast, here, each Plaintiff suffered injuries that were connected to an erosion or infection of the ObTape, and each Plaintiff knew of, strongly suspected, or had enough information to know of a connection between ObTape and at least some of her injuries by the time of her excision procedure, if not before. Plaintiffs argue that even if Minnesota's discovery rule does not save their strict liability and negligence claims, the statute of limitations should be tolled by fraudulent concealment. “Fraudulent concealment, if it occurs, will toll the running of the statute of limitations until discovery or reasonable opportunity for discovery of the cause of action by the exercise of due diligence.” Holstad v. Sw. Porcelain, Inc., 421 N.W.2d 371, 374 (Minn. Ct. App. 1988); accord Hydra- Mac, Inc. v. Onan Corp., 450 N.W.2d 913, 918 (Minn. 1990). “The party claiming fraudulent concealment has the burden of showing that the concealment could not have been discovered sooner by reasonable diligence on his part and was not the result of his own negligence.” Wild v. Rarig, 234 N.W.2d 775, 795 (Minn. 1975). As discussed above, each Plaintiff knew of, strongly suspected, or had enough information to know of a connection between ObTape and at least some of her injuries by the time ase 4:14-cv-00105-CDL Document 32-9 Filed 10/24/16 Page 8 of 10 In re Mentor Corp. Obtape Transobturator Sling Products Liability..., Slip Copy (2015) © 2016 Thomson Reuters. No claim to original U.S. Government Works. 8 of her excision procedure, if not before. A reasonable person in that situation would take some action to follow up on the cause of her injuries and try to find out whether the injuries were caused by a problem with ObTape, a problem with the implant surgery, or some other problem. But Plaintiffs pointed to no evidence that they took any action to investigate their potential claims even though they knew (or had enough information to know) there was a connection between their injuries and the ObTape. 4 Under these circumstances, the Court concludes that fraudulent concealment does not toll the statute of limitations. *10 None of the Plaintiffs filed their complaints within six years after their claims accrued. Their strict liability and negligence claims (including their negligent misrepresentation claims) are therefore time-barred. The loss of consortium claims of Anthony Klum and Mateo Urbieta fail because their wives' claims fail. Kohler v. Fletcher, 442 N.W.2d 169, 173 (Minn. Ct. App. 1989). (“As a husband's claim for loss of consortium is derivative only, if his wife's underlying tort claim fails, his claim for loss of consortium also fails.”). II. Fraud and Intentional Misrepresentation Claims Mentor also seeks summary judgment on Plaintiffs' fraud and intentional misrepresentation claims. 5 The statute of limitations for fraud claims is six years. Minn. Stat. § 541.05 subd. 1(6). A fraud cause of action “shall not be deemed to have accrued until the discovery by the aggrieved party of the facts constituting the fraud.” Id. But “the facts constituting fraud are deemed to have been discovered when, with reasonable diligence, they could and ought to have been discovered.” Veldhuizen v. A.O. Smith Corp., 839 F. Supp. 669, 674 (D. Minn. 1993) (quoting Bustad v. Bustad, 116 N.W.2d 552, 555 (Minn. 1962)). “The failure to actually discover the fraud does not toll the statute of limitations if it is inconsistent with reasonable diligence.” Id.; accord Blegen v. Monarch Life Ins. Co., 365 N.W.2d 356, 357-58 (Minn. Ct. App. 1985). Plaintiffs “carry the burden of proving that they did not discover the facts constituting fraud within six years before commencement of the action.” Veldhuizen, 839 F. Supp. 674. “They must also show that they could not have discovered the fraud through the exercise of reasonable diligence.” Id. Again, each Plaintiff knew of, strongly suspected, or had enough information to know of a connection between ObTape and at least some of her injuries by the time of her excision procedure, if not before. A reasonable person in that situation would take some action to follow up on the cause of her injuries and try to find out whether the injuries were caused by a problem with ObTape, a problem with the implant surgery, or some other problem. But Plaintiffs pointed to no evidence that they exercised reasonable diligence to investigate their potential claims even though they knew (or had enough information to know) there was a connection between their injuries and the ObTape. They also did not point to evidence that they could not have discovered enough facts to support their fraud and intentional misrepresentation claims had they started investigating the connection they made (or had enough information to make) between ObTape and their injuries within a reasonable time after they discovered the connection. For these reasons, the Court finds that Plaintiffs' fraud and intentional misrepresentation claims are time-barred. CONCLUSION *11 For the reasons set forth above, Mentor's summary judgment motions are granted as to Jackson (ECF No. 37 in 4:13-cv-93), Rupert (ECF No. 41 in 4:13-cv-101), Charles (ECF No. 34 in 4:13-cv-151), Klum (ECF No. 34 in 4:13- cv-153), Leon (ECF No. 40 in 4:13-cv-241), Urbieta (ECF No. 31 in 4:13-cv-346), Lovell (ECF No. 31 in 4:13-cv-377), Suen (ECF No. 32 in 4:13-cv-426), Uriegas (ECF No. 29 in 4:13-cv-483), Degroot (ECF No. 30 in 4:13-cv-503), Hall (ECF No. 25 in 4:14-cv-61), and Chambers (ECF No. 26 in 4:14-cv-63). IT IS SO ORDERED, this 21st day of December, 2015. All Citations Slip Copy, 2015 WL 9307267 Footnotes 1 Rupert objects to the medical record because it has not been authenticated since scheduling conflicts prevented the parties from taking Dr. Fassuliotis's deposition before the dispositive motion deadline. Rupert does not appear to dispute that the document is her medical record from Dr. Fassuliotis's office, which she produced to Mentor during discovery. ase 4:14-cv-00105-CDL Document 32-9 Filed 10/24/16 Page 9 of 10 In re Mentor Corp. Obtape Transobturator Sling Products Liability..., Slip Copy (2015) © 2016 Thomson Reuters. No claim to original U.S. Government Works. 9 The Court thus finds that this document could be reduced to admissible evidence at trial and thus may be considered at summary judgment. 2 Charles did not respond to Mentor's summary judgment motion or statement of material facts. Therefore, under the Court's local rules, Mentor's material facts are deemed admitted. M.D. Ga. R. 56. The Court has reviewed Mentor's citations to the record and determined that no genuine fact dispute exists. 3 Mentor also argues that Plaintiffs' warranty claims are time-barred. Jackson, Rupert, Klum, Leon, Urbieta, Lovell, Suen, Degroot, Hall, and Chambers do not contest summary judgment as to their warranty claims, so Mentor is entitled to summary judgment on those claims. Charles did not respond to Mentor's summary judgment motion on this point and does not dispute that her warranty claims accrued when she was implanted with ObTape on February 9, 2004. See Minn. Stat. § 336.2-725(2) (“A breach of warranty occurs when tender of delivery is made[.]”). She also does not dispute that she did not file her action within four years after her warranty claims accrued. See Minn. Stat. § 336.2-725(1) (establishing four- year limitations period for warranty claims). Accordingly, Mentor is entitled to summary judgment on Charles's warranty claims. Uriegas also did not file her complaint within four years after her ObTape implant. Uriegas contends that the statute of limitations for her warranty claims is tolled due to fraudulent concealment. As discussed in more detail below, fraudulent concealment does not apply to Uriegas's claims, and Mentor is entitled to summary judgment on her warranty claims. 4 There is evidence that two plaintiffs attempted an investigation regarding their problems with ObTape. First, Charles researched the issue and even had her doctor remove the ObTape because she was convinced it was causing her pain, but she did nothing to pursue her claims until years later. Second, Urbieta suspected that her implanting doctor had placed the sling incorrectly. About a year after her excision procedure, Urbieta asked the physician who excised her ObTape to make a statement to that effect. Urbieta Dep. 65:20-66:1. The physician refused and also told Urbieta that leg infections had been reported with mesh slings. Kielb Dep. 31:23-32:1. Urbieta offered no explanation for why she waited a year before asking questions of her physicians; such a delay does not demonstrate reasonable diligence. 5 In addition to their common law fraud and intentional misrepresentation claims, Plaintiffs assert “constructive fraud” claims. The Court construes those claims as claims for fraudulent misrepresentation based on the concealment of a material fact. See Flynn v. Am. Home Prods. Corp., 627 N.W.2d 342, 350 (Minn. Ct. App. 2001) (“Under Minnesota law, fraudulent misrepresentation based on the concealment of a material fact occurs when one party knowingly conceals a material fact that is ‘peculiarly within his own knowledge,’ and the other party relies on the presumption that the fact does not exist.”) (quoting Richfield Bank & Trust Co. v. Sjogren, 309 Minn. 362, 364, 244 N.W.2d 648, 650 (1976)). End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works. ase 4:14-cv-00105-CDL Document 32-9 Filed 10/24/16 Page 10 of 10 Exhibit G Case 4:14-cv-00105-CDL Document 32-10 Filed 10/24/16 Page 1 of 7 In re Mentor Corp. Obtape Transobturator Sling Products Liability..., Slip Copy (2016) 2016 WL 877773 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 1 KeyCite Blue Flag – Appeal Notification Appeal Filed by CHRISTINA LATTA v. MENTOR CORPORATION, ET AL, 11th Cir., April 4, 2016 2016 WL 877773 Only the Westlaw citation is currently available. United States District Court, M.D. Georgia, Columbus Division. In re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation. MDL Docket No. 2004 4:08-MD-2004 (CDL) | Case Nos. 4:12-cv-301 (Downey), 4:12- cv-303 (Cavazos), 4:12-cv-311 (Latta), 4:13- cv-011 (Hirshfield), 4:13-cv-092 (Greenman) | Signed 03/02/2016 ORDER CLAY D. LAND, CHIEF U.S. DISTRICT COURT JUDGE *1 Defendant Mentor Worldwide LLC developed a suburethral sling product called ObTape Transobturator Tape, which was used to treat women with stress urinary incontinence. Plaintiffs Lisa Marie Downey, Dorales Cavazos, Christina Latta, Deborah Hirshfield, and Margie Greenman were implanted with ObTape and assert that they suffered injuries caused by ObTape. Each Plaintiff brought a product liability action against Mentor, contending that ObTape had design and/or manufacturing defects that proximately caused her injuries. Plaintiffs also assert that Mentor did not adequately warn their physicians about the risks associated with ObTape. Plaintiffs brought their claims under several theories. Mentor argues that all of their claims are time-barred. For the reasons set forth below, Mentor's summary judgment motions are granted as to all of Plaintiffs' claims except Cavazos's negligence and fraudulent concealment claims. Summary judgment is denied as to Cavazos's negligence and fraudulent concealment claims. SUMMARY JUDGMENT STANDARD Summary judgment may be granted only “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). In determining whether a genuine dispute of material fact exists to defeat a motion for summary judgment, the evidence is viewed in the light most favorable to the party opposing summary judgment, drawing all justifiable inferences in the opposing party's favor. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986). A fact is material if it is relevant or necessary to the outcome of the suit. Id. at 248. A factual dispute is genuine if the evidence would allow a reasonable jury to return a verdict for the nonmoving party. Id. FACTUAL BACKGROUND I. Plaintiff Lisa Marie Downey (ECF No. 48 in 4:12-cv-301) Lisa Downey was diagnosed with stress urinary incontinence and referred to Dr. David Pollifrone for a sling implant surgery. Dr. Pollifrone implanted Downey with ObTape on December 8, 2003. In August 2004, Downey went to Dr. Kathryn Garner complaining of vaginal bleeding. Dr. Garner told Downey that she thought the tape was eroding and that Downey should see Dr. Pollifrone for further treatment. Dr. Pollifrone confirmed that Downey's ObTape had eroded. He told Downey that he thought her bleeding was caused by the erosion and that he needed to remove the eroded ObTape. Dr. Pollifrone removed the entire tape on August 25, 2004. Downey is an Indiana resident whose ObTape-related treatment took place in Indiana. On September 26, 2012, Downey served Mentor with a copy of her Complaint captioned in Hennepin County District Court of the State of Minnesota. Downey brought claims for strict liability, negligence, and fraudulent concealment. II. Plaintiff Dorales Cavazos (ECF No. 48 in 4:12-cv-303) Dr. Joan Meaney implanted Dorales Cavazos with ObTape on July 22, 2004 to treat Cavazos's stress urinary incontinence. At some point after the implant surgery, Cavazos began experiencing sharp pain, and she became aware that a hard object was coming out of her vagina. ase 4:14-cv-00105-CDL Document 32-10 Filed 10/24/16 Page 2 of 7 In re Mentor Corp. Obtape Transobturator Sling Products Liability..., Slip Copy (2016) 2016 WL 877773 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 2 Cavazos began carrying a glove with her so that she could push the hard object back into her vagina. When she did that, the glove would fill with pus and blood, and the “the smell was just horrible.” Cavazos Dep. 59:10-17, ECF No. 48-5 in 4:12-cv-303. Cavazos testified that she believed that her implanting physician had left something inside of her. Id. at 127:8-9. It is not clear from the present record when Cavazos began experiencing these complications. *2 In October 2006, Cavazos visited Dr. Denise Woody- Gross for an annual exam. Dr. Woody-Gross told Cavazos she had “something” in her vagina but that she had “no idea” what. Id. at 126:7-8. Dr. Woody-Gross asked Cavazos if she had “something put in.” Id. at 127:6-7. Cavazos told Dr. Woody-Gross that she “had a mesh put in.” Id. at 127:7. In her office notes, Dr. Woody- Gross wrote that there was a ridge palpable where the sling was, although Cavazos denies that Dr. Woody-Gross told her that the “something” was the mesh. Cavazos asked Dr. Woody-Gross to take out “whatever it [was she had] in there.” Id. at 126:16-17. Dr. Woody-Gross replied that she did not perform surgeries, and she suggested that Cavazos see a urogynecologist. In her file, Dr. Woody-Gross noted that she suggested that Cavazos see a urogynecologist about the ridge and the sling. Cavazos went to see Dr. James Lovell in September 2007. He told Cavazos that her mesh had become exposed through her vagina. Id. at 130:7-10. According to Cavazos, Dr. Lovell “wanted to snip” the mesh. Id. at 61:15. Cavazos “wanted it all taken out and he ... said he wouldn't work that way.” Id. at 61:15-16. Cavazos thought that Dr. Lovell was rude to her because he refused to remove the entire mesh, so she sought treatment from Dr. Stephen Kraus in November 2007. Cavazos told Dr. Kraus that her mesh was coming out of her vagina. Kraus Dep. 25:17-26:9, ECF No. 48-6. Dr. Kraus noted that Cavazos told him that she had experienced erosions for more than three years. Cavazos Dep. 137:21-138:9. Dr. Kraus confirmed the erosion and told Cavazos that her mesh needed to be removed. Dr. Kraus and another doctor removed Cavazos's ObTape on February 19, 2008. Cavazos is a Texas resident whose ObTape-related treatment took place in Texas. On September 28, 2012, Cavazos served Mentor with a copy of her Complaint captioned in Hennepin County District Court of the State of Minnesota. Cavazos brought claims for strict liability, negligence, and fraudulent concealment. III. Plaintiff Christina Latta (ECF No. 50 in 4:12-cv-311) Christina Latta visited Dr. Gill Anderson for treatment of stress urinary incontinence, and Dr. Anderson recommended an ObTape implant procedure. Dr. Anderson implanted Latta with ObTape on March 25, 2004. In July 2004, Latta went back to see Dr. Anderson, complaining of malodorous vaginal discharge. Dr. Anderson told Latta that a portion of her ObTape had eroded through her vaginal wall and that he needed to cut out a piece of it. Dr. Anderson performed the revision surgery on July 15, 2004. Between October 2004 and September 2005, Dr. Anderson performed three other revision surgeries. Latta believed that her body was rejecting the ObTape. Latta is a Washington resident whose ObTape-related treatment took place in Washington. On October 2, 2012, Latta served Mentor with a copy of her Complaint captioned in Hennepin County District Court of the State of Minnesota. Latta brought claims for strict liability, negligence, and fraudulent concealment. IV. Plaintiff Deborah Hirshfield (ECF No. 50 in 4:13-cv-11) Deborah Hirshfield saw Dr. Natalie Sohn for treatment of stress urinary incontinence. On July 1, 2004, Dr. Sohn implanted Hirshfield with ObTape. In December 2005, Hirshfield developed discharge, abdominal pain, and several other symptoms. She went to Dr. Sohn for treatment of these symptoms. Dr. Sohn told Hirshfield that her ObTape had eroded, was infected, and needed to be removed. Hirshfield understood that Dr. Sohn planned to remove the ObTape to resolve her symptoms. Dr. Sohn performed a partial removal procedure on January 5, 2006. Hirshfield continued to experience discharge and began experiencing leg pain, so she returned to Dr. Sohn in February 2006. Dr. Sohn removed the rest of Hirshfield's ObTape. Most of Hirshfield's symptoms, including the leg pain, were resolved after the second excision procedure. *3 Hirshfield is a Florida resident whose ObTape-related treatment took place in Florida. On December 12, 2012, Hirshfield served Mentor with a copy of her Complaint captioned in Hennepin County District Court of the State ase 4:14-cv-00105-CDL Document 32-10 Filed 10/24/16 Page 3 of 7 In re Mentor Corp. Obtape Transobturator Sling Products Liability..., Slip Copy (2016) 2016 WL 877773 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 3 of Minnesota. Hirshfield brought claims for strict liability, negligence, and fraudulent concealment. V. Plaintiff Margie Greenman (ECF No. 41 in 4:13-cv-92) In 2003, Margie Greenman visited Dr. Jonathan Vukovich for treatment of a renal cyst. Dr. Vukovich diagnosed Greenman with stress urinary incontinence. Dr. Vukovich began treating Greenman's incontinence with medication, but he later recommended that Greenman undergo a sling implant. Dr. Vukovich implanted Greenman with ObTape on January 21, 2004. Greenman began experiencing bleeding in November 2004. During her annual physical, Greenman's nurse practitioner identified a “puncture” and told Greenman to go back to Dr. Vukovich and “tell him to pay special attention to the area at 3 o'clock.” Greenman Dep. 101:16-102:16, ECF No. 41-5. Greenman visited Dr. Vukovich on November 18, 2004. He diagnosed Greenman with a vaginal erosion and told her that he needed to excise the exposed portion of ObTape. Dr. Vukovich performed an excision procedure on December 2, 2004. Many of Grenman's symptoms resolved after that procedure. Greenman returned to Dr. Vukovich in August 2005 because she was experiencing spotting and was concerned that she had another erosion. Dr. Vukovich did not find an erosion, and Greenman's spotting symptoms stopped by December 2005. Greenman did have a second erosion in 2010, and Dr. Vukovich performed another revision surgery. Greenman is a Florida resident whose ObTape-related treatment took place in Alabama. On April 1, 2013, Greenman served Mentor with a copy of her Complaint captioned in Hennepin County District Court of the State of Minnesota. Greenman brought claims for strict liability, negligence, breach of express warranty, breach of implied warranty, common law fraud, constructive fraud, and negligent and intentional misrepresentation. Greenman does not contest Mentor's summary judgment motion on her warranty claims, and summary judgment is therefore granted as to those claims. DISCUSSION Each Plaintiff filed her action in Minnesota state court, and Mentor removed each Plaintiff's action to the United States District Court for the District of Minnesota. The cases were later transferred to this Court as part of a multidistrict litigation proceeding regarding ObTape. The parties agree for purposes of summary judgment that Minnesota law applies to Plaintiffs' claims. See In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., No. 4:08-md-2004, 2013 WL 286276, at *7 (concluding that Minnesota law applied to claims of non- Minnesota ObTape plaintiffs who brought their actions in Minnesota). I. Strict Liability and Negligence Claims Mentor contends that Plaintiffs' strict liability and negligence claims are time-barred under Minnesota law. The statute of limitations for a strict liability claim is four years. Minn. Stat. § 541.05 subd. 2 (“[A]ny action based on the strict liability of the defendant and arising from the manufacture, sale, use or consumption of a product shall be commenced within four years.”). The statute of limitations for a negligence claim is six years. Minn. Stat. § 541.05 subd. 1(5) (establishing six-year limitation period for personal injury claims not arising in contract or strict liability). *4 Under Minnesota law, “a claim involving personal injuries allegedly caused by a defective product accrues when two elements are present: '(1) a cognizable physical manifestation of the disease or injury, and (2) evidence of a causal connection between the injury or disease and the defendant's product, act, or omission.”' Klempka v. G.D. Searle & Co., 963 F.2d 168, 170 (8th Cir. 1992) (quoting Hildebrandt v. Allied Corp., 839 F.2d 396, 398 (8th Cir. 1987)) (applying Minnesota law). “A plaintiff who is aware of both her injury and the likely cause of her injury is not permitted to circumvent the statute of limitations by waiting for a more serious injury to develop from the same cause.” Id. For example, in Klempka, the plaintiff suffered injuries and was diagnosed with chronic pelvic inflammatory disease, which her doctor said was caused by the plaintiff's intrauterine device. Id. at 169. Several years later, the plaintiff was told that she was infertile and that the intrauterine device caused her infertility. Id. Applying Minnesota law, the Eighth Circuit concluded that the plaintiff's cause of action accrued when she first learned that she had an injury (chronic pelvic inflammatory disease) that was caused by the intrauterine device. Id. at 170. ase 4:14-cv-00105-CDL Document 32-10 Filed 10/24/16 Page 4 of 7 In re Mentor Corp. Obtape Transobturator Sling Products Liability..., Slip Copy (2016) 2016 WL 877773 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 4 Here, each Plaintiff contends that she did not learn of a connection between ObTape and her injuries until 2009 or later – either based on a television commercial regarding mesh complications or a consultation with a doctor. But each Plaintiff knew that she suffered some injuries caused by ObTape well before then. Lisa Marie Downey. In August 2004, Downey went to her doctor because she was experiencing vaginal bleeding. The doctor found an erosion of the ObTape and told Downey that her bleeding was likely caused by the erosion. He also told Downey that he needed to remove the eroded ObTape, and he did so on August 25, 2004. Therefore, Downey knew by August 2004 that there was a likely connection between ObTape and some of her injuries. She did not file her complaint until more than eight years later, in September 2012. Dorales Cavazos. After her ObTape implant, Cavazos began experiencing sharp pain, and she became aware that a hard object was coming out of her vagina. It is not clear from the present record when Cavazos began experiencing these symptoms. Mentor argues that Cavazos became aware in 2004 that she had suffered an erosion because she told Dr. Kraus in 2007 that she had experienced erosions for more than three years. But Mentor did not point the Court to any evidence that Cavazos knew she had suffered an erosion in 2004 (or that she had actually suffered an erosion in 2004). Rather, the evidence Mentor pointed to establishes that Cavazos knew by the time she saw Dr. Kraus in 2007—after seeking treatment from two other doctors—that she had suffered an erosion. Mentor also did not point to any evidence that Cavazos knew the hard object she felt in her vagina was ObTape until at least October 5, 2006, when Dr. Woody-Gross told Cavazos she needed to see a urogynecologist about the palpable ridge in the area of her sling. 1 Mentor argues, however, that Cavazos should have known of a connection between ObTape and her injuries before October 2006 because a reasonable person in her situation would have investigated her symptoms by visiting a doctor. But it is not clear from the present record when Cavazos began experiencing these symptoms or how soon she was able to see a doctor after she started having them. Thus, based on the present record, there is a genuine fact dispute as to when Cavazos's claims accrued, and a reasonable factfinder could conclude that her claims did not accrue until October 5, 2006. Cavazos filed her action within six years of that date, so her negligence claim is timely. But she did not file her action within four years of that date or within four years of September 2007, when she asked Dr. Lovell to remove her entire ObTape. 1 Cavazos denies making a connection between ObTape and her injuries as a result of her consultation with Dr. Woody-Gross. Although Cavazos denies that Dr. Woody-Gross told her that the hard object in her vagina was ObTape, Dr. Woody-Gross did conclude that there was an issue with the ObTape and presumably would have shared this conclusion with Cavazos had she asked. *5 Christina Latta. In July 2004, Latta went to her doctor complaining of malodorous vaginal discharge. Latta's doctor told her that a portion of her ObTape had eroded through her vaginal wall and that he needed to cut out a piece of it. He did so in July 2004. At the time, Latta believed that her body was rejecting the ObTape. Therefore, Latta knew in July 2004 that there was a likely connection between ObTape and some of her injuries. She did not file her complaint until more than eight years later, in October 2012. Deborah Hirshfield. In December 2005, Hirshfield went to her doctor for treatment of discharge, abdominal pain, and several other symptoms. The doctor told Hirshfield that her ObTape had eroded, was infected, and needed to be removed. The first excision procedure did not resolve all of Hirshfield's symptoms, so Hirshfield had a second excision procedure in February 2006. After that procedure, most of Hirshfield's symptoms were resolved. Therefore, Hirshfield knew by February 2006 that there was a likely connection between ObTape and some of her injuries. She did not file her complaint until more than six years later, in December 2012. Margie Greenman. Greenman began experiencing bleeding in November 2004, and her nurse practitioner found a puncture in Greenman's vaginal wall. Greenman's doctor diagnosed her with a vaginal erosion and told her that he needed to excise the exposed portion of ObTape. After the excision surgery, many of Greenman's symptoms resolved. Therefore, Greenman knew by November 2004 that there was a likely connection between ObTape and some of her injuries. She did not file her complaint until more than eight years later, in April 2013. ase 4:14-cv-00105-CDL Document 32-10 Filed 10/24/16 Page 5 of 7 In re Mentor Corp. Obtape Transobturator Sling Products Liability..., Slip Copy (2016) 2016 WL 877773 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 5 In summary, with the exception of Cavazos, each Plaintiff connected at least some of her injuries to ObTape more than six years before she filed suit. Accordingly, their strict liability and negligence claims are time-barred under Minnesota law. And Cavazos connected her injuries to ObTape more than four years before she filed suit, so her strict liability claims are time-barred. Plaintiffs contend that it is not enough that they made a connection between ObTape and some of their injuries. Rather, they appear to argue that they must have been on notice that a defect in ObTape caused their injuries. Plaintiffs did not point to any Minnesota authority holding that a plaintiff must be on actual notice that her specific injuries were caused by a product defect. Rather, the precedent establishes that a claim accrues when the plaintiff becomes aware of an injury and a causal connection between the injury and the defendant's product. Klempka, 963 F.2d at 170. Plaintiffs nonetheless contend that two Eighth Circuit cases and one Minnesota District Court case support denial of summary judgment on their negligence and strict liability claims. The Court disagrees. First, they point to Hildebrandt v. Allied Corp., 839 F.2d 396 (8th Cir. 1987), where the plaintiffs alleged that they suffered lung damage due to their exposure to a toxic chemical at their workplace. But there, unlike here, the plaintiffs' doctors initially told the plaintiffs that there was no correlation between their symptoms and the chemical. Id. at 399. The Eighth Circuit thus concluded that the plaintiffs' claims did not accrue until the cause of the plaintiffs' injuries was rationally identified. Second, Plaintiffs point to Tuttle v. Lorillard Tobacco Co., 377 F.3d 917 (8th Cir. 2004). In Tuttle, the district court found that the decedent's smokeless tobacco product liability action accrued when the decedent discovered a lump in his cheek. The Eighth Circuit reversed because the decedent's doctor initially told the decedent that the lump was caused by an oral infection and was treatable with antibiotics—not that it was oral cancer caused by the tobacco. Id. at 922. Third, Plaintiffs point to Huggins v. Stryker Corp., 932 F. Supp. 2d 972 (D. Minn. 2013). In Huggins, the plaintiff asserted that the defendant's pain pump caused a condition that resulted in degeneration of his cartilage. The plaintiff's doctor discovered the loss of cartilage in 2002, but he did not connect the condition to the pain pump or tell the plaintiff that there was such a connection. The district court noted that the “first article recognizing a potential causal link between pain pumps” and the plaintiff's condition was not published until 2007. Id. *6 Hildebrandt, Tuttle, and Huggins are all distinguishable from Plaintiffs' cases. In Hildebrandt, Tuttle, and Huggins, the plaintiffs suffered injuries that could have been caused by the defendant's product OR could have been caused by something else, and the courts concluded that the cause of action did not accrue until the plaintiffs had some objective information suggesting a causal link between the product and the injury. In contrast, here, each Plaintiff suffered injuries that were connected to an erosion or infection of the ObTape, and each Plaintiff knew of, strongly suspected, or had enough information to know of a connection between ObTape and at least some of her injuries by the time of her excision procedure, if not before. Plaintiffs argue that even if Minnesota's discovery rule does not save their strict liability and negligence claims, fraudulent concealment should toll the statute of limitations. “Fraudulent concealment, if it occurs, will toll the running of the statute of limitations until discovery or reasonable opportunity for discovery of the cause of action by the exercise of due diligence.” Holstad v. Sw. Porcelain, Inc., 421 N.W.2d 371, 374 (Minn. Ct. App. 1988); accord Hydra-Mac, Inc. v. Onan Corp., 450 N.W.2d 913, 918 (Minn. 1990). “The party claiming fraudulent concealment has the burden of showing that the concealment could not have been discovered sooner by reasonable diligence on his part and was not the result of his own negligence.” Wild v. Rarig, 234 N.W.2d 775, 795 (Minn. 1975). As discussed above, each Plaintiff knew of, strongly suspected, or had enough information to know of a connection between ObTape and at least some of her injuries by the time of her excision procedure, if not before. A reasonable person in that situation would take some action to follow up on the cause of her injuries and try to find out whether the injuries were caused by a problem with ObTape, a problem with the implant surgery, or some other problem. But Plaintiffs pointed to no evidence that they took any action to investigate their potential claims even though they knew (or had enough information to know) there was a connection between their injuries and the ObTape. Under these circumstances, the Court concludes that fraudulent concealment does not toll the statute of limitations. ase 4:14-cv-00105-CDL Document 32-10 Filed 10/24/16 Page 6 of 7 In re Mentor Corp. Obtape Transobturator Sling Products Liability..., Slip Copy (2016) 2016 WL 877773 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 6 Downey, Latta, Hirshfield, and Greenman did not file their complaints within six years after their claims accrued. Their strict liability and negligence claims (including their negligent misrepresentation claims) are therefore time- barred. Cavazos filed her complaint within six years after her claims accrued, so her negligence claim is not time- barred. But Cavazos did not file her complaint within four years after her claims accrued, so her strict liability claim is time-barred. II. Fraud and Intentional Misrepresentation Claims Mentor also seeks summary judgment on Plaintiffs' fraud, fraudulent concealment, and intentional misrepresentation claims. The statute of limitations for fraud claims is six years. Minn. Stat. § 541.05 subd. 1(6). A fraud cause of action “shall not be deemed to have accrued until the discovery by the aggrieved party of the facts constituting the fraud.” Id. But “the facts constituting fraud are deemed to have been discovered when, with reasonable diligence, they could and ought to have been discovered.” Veldhuizen v. A.O. Smith Corp., 839 F. Supp. 669, 674 (D. Minn. 1993) (quoting Bustad v. Bustad, 116 N.W.2d 552, 555 (Minn. 1962)). “The failure to actually discover the fraud does not toll the statute of limitations if it is inconsistent with reasonable diligence.” Id.; accord Blegen v. Monarch Life Ins. Co., 365 N.W.2d 356, 357-58 (Minn. Ct. App. 1985). Plaintiffs “carry the burden of proving that they did not discover the facts constituting fraud within six years before commencement of the action.” Veldhuizen, 839 F. Supp. 674. “They must also show that they could not have discovered the fraud through the exercise of reasonable diligence.” Id. *7 As discussed above, Cavazos filed her complaint within six years after learning of a connection between ObTape and her injuries, so her fraudulent concealment claim is not time-barred. But Downey, Latta, Hirshfield, and Greenman did not file their complaints within six years after learning of a connection between ObTape and their injuries. They knew of, strongly suspected, or had enough information to know of a connection between ObTape and at least some of their injuries by the time of their excision procedures, if not before. A reasonable person in that situation would take some action to follow up on the cause of her injuries and try to find out whether the injuries were caused by a problem with ObTape, a problem with the implant surgery, or some other problem. But Plaintiffs pointed to no evidence that they exercised reasonable diligence to investigate their potential claims even though they knew (or had enough information to know) there was a connection between their injuries and the ObTape. They also did not point to evidence that they could not have discovered enough facts to support their fraud and intentional misrepresentation claims had they started investigating the connection they made (or had enough information to make) between ObTape and their injuries within a reasonable time after they discovered the connection. For these reasons, the Court finds that the fraud and intentional misrepresentation claims of Downey, Latta, Hirshfield, and Greenman are time- barred. CONCLUSION For the reasons set forth above, Mentor's summary judgment motions are granted as to Downey (ECF No. 48 in 4:12-cv-301), Latta (ECF No. 50 in 4:12-cv-311), Hirshfield (ECF No. 50 in 4:13-cv-11), and Greenman (ECF No. 41 in 4:13-cv-92). Summary judgment is also granted as to Cavazos's strict liability claims (ECF No. 48 in 4:12-cv-303) but denied as to her negligence and fraudulent concealment claims. Within seven days of the date of this Order, the parties shall notify the Court whether they agree to a Lexecon waiver for Cavazos's action. IT IS SO ORDERED, this 2nd day of March, 2016. All Citations Slip Copy, 2016 WL 877773 End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works. ase 4:14-cv-00105-CDL Document 32-10 Filed 10/24/16 Page 7 of 7 Exhibit H Case 4:14-cv-00105-CDL Document 32-11 Filed 10/24/16 Page 1 of 6 In re Mentor Corp., Not Reported in F.Supp.3d (2015) 2015 WL 8578364 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 1 2015 WL 8578364 Only the Westlaw citation is currently available. United States District Court, M.D. Georgia, Columbus Division. In re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation MDL Docket No. 2004 | 4:08-MD-2004 (CDL) | Case Nos. 4:12-cv-307 (Rogers), 4:12-cv-308 (Mosier), 4:12-cv-319 (Kearse), 4:12-cv-323 (Shirey), 4:13-cv-10 (Weikel), 4:13-cv-48 (Shaffer) | Signed 12/09/2015 ORDER CLAY D. LAND, Chief Judge *1 Defendant Mentor Worldwide LLC developed a suburethral sling product called ObTape Transobturator Tape, which was used to treat women with stress urinary incontinence. Plaintiffs Deborah Rogers, Verna Mosier, Victoria Kearse, Samantha Shirey, Michelle Weikel, and Betty Lou Shaffer were implanted with ObTape and assert that they suffered injuries caused by ObTape. Each Plaintiff brought a product liability action against Mentor, contending that ObTape had design and/or manufacturing defects that proximately caused her injuries. Plaintiffs also assert that Mentor did not adequately warn their physicians about the risks associated with ObTape. Plaintiffs brought their claims under negligence and strict liability theories. Mentor contends that their claims are all time-barred. For the reasons set forth below, the Court agrees, and Mentor's summary judgment motions are granted. SUMMARY JUDGMENT STANDARD Summary judgment may be granted only “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). In determining whether a genuine dispute of material fact exists to defeat a motion for summary judgment, the evidence is viewed in the light most favorable to the party opposing summary judgment, drawing all justifiable inferences in the opposing party's favor. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986). A fact is material if it is relevant or necessary to the outcome of the suit. Id. at 248. A factual dispute is genuine if the evidence would allow a reasonable jury to return a verdict for the nonmoving party. Id. FACTUAL BACKGROUND I. Plaintiff Deborah Rogers (ECF No. 42 in 4:12-cv-307) Deborah Rogers visited Dr. Jonathan Kalish in 2005 for treatment of stress urinary incontinence. Dr. Kalish implanted Rogers with ObTape on September 26, 2005. In July 2006, Rogers went to Dr. Newt Harrison because she had a foreign body hanging from her vaginal area. Dr. Harrison reviewed Rogers's medical records and discovered that the foreign body must be the ObTape that had been implanted in 2005. Dr. Harrison called Dr. Kevin Bond, a urologist, to remove the exposed ObTape. As Dr. Bond excised the eroded portion of Rogers's ObTape, the entire sling “slid right out.” Bond Dep. 19:17-20:10, ECF No. 42-8 in 4:12-cv-307. Though Dr. Bond did not recall exactly what he told Rogers, he is sure that he discussed his operative findings with Rogers or a family member. Id. at 34:12-16. Rogers acknowledges that her doctors probably communicated to her regarding the reason for the excision surgery and that her medical records reflect that her ObTape was removed in July 2006. Rogers Dep. 58:12-60:11, ECF No. 44-3. Rogers is a Mississippi resident whose ObTape-related treatment took place in Mississippi. On October 11, 2012, Rogers served Mentor with a copy of her Complaint captioned in Hennepin County District Court of the State of Minnesota. Rogers brought claims for strict liability and negligence. II. Plaintiff Verna Mosier (ECF No. 45 in 4:12-cv-308) *2 Verna Mosier visited Dr. Helen Kinsey for treatment of stress urinary incontinence, and Dr. Kinsey implanted Mosier with ObTape on June 29, 2004. In February 2005, Mosier was diagnosed with a left groin abscess. Dr. Kinsey told Mosier that she suspected a connection between the abscess and Mosier's ObTape, and she referred Mosier to ase 4:14-cv-00105-CDL Document 32-11 Filed 10/24/16 Page 2 of 6 In re Mentor Corp., Not Reported in F.Supp.3d (2015) 2015 WL 8578364 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 2 Dr. Jyot Saini for further evaluation. Dr. Saini diagnosed Mosier with a vaginal erosion of the ObTape and told Mosier that there was a high likelihood that the ObTape was related to her abscess. Dr. Saini removed Mosier's ObTape in March 2005. Mosier was an Indiana resident whose ObTape-related treatment took place in Indiana. On September 26, 2012, Mosier filed a Complaint in Hennepin County District Court of the State of Minnesota. Mosier died in 2014, and her husband Abraham Mosier is pursuing Mosier's claims for strict liability and negligence on behalf of Mosier's estate. He also asserts a claim for loss of consortium. III. Plaintiff Victoria Kearse (ECF No. 44 in 4:12-cv-319) Dr. Christopher Pieczonka implanted Victoria Kearse with ObTape on November 5, 2004. In January 2005, Kearse presented to Dr. Pieczonka complaining of vaginal discharge. Dr. Pieczonka observed that a portion of Kearse's ObTape was exposed through the incision site, and he attempted to close the incision. Later that month, Kearse returned to Dr. Pieczonka complaining of vaginal discharge. Again, Dr. Pieczonka saw exposed ObTape, and he surgically removed a portion of it. In September 2005, Dr. Pieczonka diagnosed an erosion of Kearse's ObTape and performed another excision procedure. At the time, Kearse knew that Dr. Pieczonka had to remove portions of her ObTape, and she believed that her body was rejecting the mesh. Kearse is a New York resident whose ObTape-related treatment took place in New York. On October 19, 2012, Kearse served Mentor with a copy of her Complaint captioned in Hennepin County District Court of the State of Minnesota. Kearse brought claims for strict liability and negligence. IV. Plaintiff Samantha Shirey (ECF No. 49 in 4:12-cv-323) Dr. Brian Chadwick diagnosed Samantha Shirey with stress urinary incontinence and recommended that she undergo an ObTape implant surgery. Dr. Chadwick implanted Shirey with ObTape on December 15, 2004. In 2006, Shirey began experiencing complications, including vaginal discharge and thigh pain, and Shirey's husband encouraged her to see a doctor after he felt something protruding from her vagina during sex. On June 24, 2006, Shirey went to the hospital and was told that the object in her vagina was an exposed piece of mesh. Shirey was ultimately referred to Dr. Connor Smith. Dr. Smith examined Shirey and told her that he needed to remove the exposed ObTape. He also told her that the ObTape was causing her discharge and thigh pain and that he thought removing the exposed portion of the mesh would alleviate these symptoms. Shirey Dep. 73:7-74:3. On July 11, 2006, Dr. Smith removed the exposed portion of the mesh, but Shirey continued to experience pain in her thigh. Dr. Smith told Shirey that the pain was caused by her ObTape, and he recommended removing as much of the remaining mesh as possible. Dr. Smith performed a second excision procedure on July 19, 2006. Shirey is a Georgia resident whose ObTape-related treatment took place in Georgia. On October 19, 2012, Shirey served Mentor with a copy of her Complaint captioned in Hennepin County District Court of the State of Minnesota. Shirey brought claims for strict liability and negligence, and her husband Brian brought a loss of consortium claim. V. Plaintiff Michelle Weikel (ECF No. 40 in 4:13-cv-10) *3 Dr. Deborah Poplawsky implanted Michelle Weikel with ObTape on April 2, 2004 to treat Weikel's stress urinary incontinence. In April 2005, Weikel returned to Dr. Poplawsky complaining of vaginal discharge, burning, and itching. Weikel knew that something was wrong because she had pain and noticed a foul odor. Dr. Poplawsky examined Weikel and found an erosion of Weikel's ObTape. Dr. Poplawsky told Weikel that a portion of her ObTape had eroded and would need to be removed. Dr. Poplawsky removed the exposed piece of ObTape on May 3, 2005. Although Dr. Poplawsky told Weikel that she did not think that the ObTape caused Weikel's external itching, Weikel believes that ObTape caused her itching and other symptoms, such as pain and discharge. And Weikel knew that she had to have a second surgical procedure because of the erosion. Since the revision surgery in 2005, Weikel has wanted to have the remainder of her ObTape removed because of the problems she believes it causes. Weikel is a Pennsylvania resident whose ObTape-related treatment took place in Pennsylvania. On December 12, 2012, Weikel served Mentor with a copy of her Complaint captioned in Hennepin County District Court of the State ase 4:14-cv-00105-CDL Document 32-11 Filed 10/24/16 Page 3 of 6 In re Mentor Corp., Not Reported in F.Supp.3d (2015) 2015 WL 8578364 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 3 of Minnesota. Weikel brought claims for strict liability and negligence. VI. Plaintiff Betty Lou Shaffer (ECF No. 41 in 4:13-cv-48) Dr. Subodh Patel implanted Betty Lou Shaffer with ObTape on November 17, 2003. In late 2003 or early 2004, Shaffer returned to Dr. Patel complaining of pain and a sandpaper-like sensation inside her vagina. Dr. Patel diagnosed Shaffer with an erosion of the ObTape and told Shaffer that he would have to remove the ObTape. After Dr. Patel performed the revision surgery, the sandpaper pain feeling went away. Shaffer is a Pennsylvania resident whose ObTape-related treatment took place in Pennsylvania. On January 31, 3013, Shaffer served Mentor with a copy of her Complaint captioned in Hennepin County District Court of the State of Minnesota. Shaffer brought claims for strict liability and negligence. DISCUSSION Each Plaintiff filed her action in Minnesota state court, and Mentor removed each Plaintiff's action to the United States District Court for the District of Minnesota. The cases were later transferred to this Court as part of a multidistrict litigation proceeding regarding ObTape. The parties agree for purposes of summary judgment that Minnesota law applies to Plaintiffs' claims. See In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., No. 4:08-md-2004, 2013 WL 286276, at *7 (concluding that Minnesota law applied to claims of non- Minnesota ObTape plaintiffs who brought their actions in Minnesota). Mentor contends that Plaintiffs' claims are time-barred under Minnesota law. The statute of limitations for a strict liability claim is four years. Minn. Stat. § 541.05 subd. 2 (“[A]ny action based on the strict liability of the defendant and arising from the manufacture, sale, use or consumption of a product shall be commenced within four years.”). The statute of limitations for a negligence claim is six years. Minn. Stat. § 541.05 subd. 1(5) (establishing six-year limitation period for personal injury claims not arising in contract or strict liability). Under Minnesota law, “a claim involving personal injuries allegedly caused by a defective product accrues when two elements are present: '(1) a cognizable physical manifestation of the disease or injury, and (2) evidence of a causal connection between the injury or disease and the defendant's product, act, or omission.”' Klempka v. G.D. Searle & Co., 963 F.2d 168, 170 (8th Cir. 1992) (quoting Hildebrandt v. Allied Corp., 839 F.2d 396, 398 (8th Cir. 1987)) (applying Minnesota law). “A plaintiff who is aware of both her injury and the likely cause of her injury is not permitted to circumvent the statute of limitations by waiting for a more serious injury to develop from the same cause.” Id. For example, in Klempka, the plaintiff suffered injuries and was diagnosed with chronic pelvic inflammatory disease, which her doctor said was caused by the plaintiff's intrauterine device. Id. at 169. Several years later, the plaintiff was told that she was infertile and that the intrauterine device caused her infertility. Id. Applying Minnesota law, the Eighth Circuit concluded that the plaintiff's cause of action accrued when she first learned that she had an injury (chronic pelvic inflammatory disease) that was caused by the intrauterine device. Id. at 170. *4 Here, each Plaintiff contends that she did not learn of a connection between ObTape and her injuries until she saw a television commercial regarding mesh complications during 2011 or 2012. But each Plaintiff knew that she suffered some injuries caused by ObTape well before then. Deborah Rogers. Rogers knew in July 2006 that she had a foreign body hanging from her vaginal area and that she had to have it surgically removed. Rogers's doctors discussed their operative findings with her or a family member. Rogers acknowledges that her medical records reflect that her ObTape was removed in July 2006, and she also acknowledges that her doctors probably told her the reason for the excision surgery at that time. Therefore, Rogers knew in July 2006 (or could have known, through the exercise of reasonable diligence) of a connection between ObTape and at least some of her injuries. She did not file her complaint until more than six years later, in October 2012. Verna Mosier. Mosier suffered an abscess in February 2005, and her doctor told her at the time that she suspected a connection between the abscess and Mosier's ObTape. Shortly thereafter, another doctor diagnosed Mosier with a vaginal erosion of the ObTape and told Mosier that there ase 4:14-cv-00105-CDL Document 32-11 Filed 10/24/16 Page 4 of 6 In re Mentor Corp., Not Reported in F.Supp.3d (2015) 2015 WL 8578364 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 4 was a high likelihood that the ObTape was related to her abscess. Therefore, Mosier knew by March 2005 that there was a likely connection between ObTape and some of her injuries. She did not file her complaint until more than seven years later, in September 2012. Victoria Kearse. Kearse began to experience vaginal discharge shortly after her implant surgery, and her doctor diagnosed an erosion of ObTape. Several months later, in September 2005, Kearse's doctor diagnosed another erosion and performed another excision procedure. At the time, Kearse knew that the doctor had to remove portions of her ObTape, and she believed that her body was rejecting the mesh. Therefore, Kearse knew by September 2005 that there was a connection between ObTape and some of her injuries. She did not file her complaint until more than seven years later, in October 2012. Samantha Shirey. In 2006, Shirey began experiencing adverse symptoms, including vaginal discharge, thigh pain, and the feeling that she had a foreign object in her vagina. In June 2006, Shirey was told that the object in her vagina was an exposed piece of mesh. Shirey's doctor told her that he needed to remove the ObTape, that the ObTape was causing her discharge and thigh pain, and that he thought removing the exposed portion of the mesh would alleviate these symptoms. After the doctor removed a portion of the mesh, Shirey continued to experience pain. Shirey's doctor told her that the pain was caused by her ObTape. He recommended removing as much of the remaining mesh as possible and performed a second excision surgery in July 2006. Therefore, Shirey knew by July 2006 that there was a connection between ObTape and some of her injuries. She did not file her complaint until more than six years later, in October 2012. Michelle Weikel. In April 2005, Weikel went to her doctor complaining of vaginal discharge, a foul odor, burning, and itching. Weikel's doctor told her that a portion of her ObTape had eroded and would need to be removed. Weikel's doctor removed the exposed piece of ObTape on May 3, 2005. Although the doctor told Weikel that she did not think that the ObTape caused Weikel's external itching, Weikel believes that ObTape caused her itching and other symptoms, such as pain and discharge. And Weikel knew that she had to have a surgical procedure to remove the exposed ObTape. Since the revision surgery in 2005, Weikel has wanted to have the remainder of her ObTape removed because of the problems she believes it causes. Therefore, by May 2005, Weikel strongly suspected a connection between ObTape and some of her injuries. She did not file her complaint until more than seven years later, in December 2012. *5 Betty Lou Shaffer. In late 2003 or early 2004, Shaffer went to her doctor complaining of pain and a sandpaper-like sensation inside her vagina. Shaffer's doctor diagnosed her with an erosion of her ObTape and told Shaffer that he would have to remove the ObTape. After Shaffer's doctor performed the revision surgery, the sandpaper pain feeling went away. Therefore, by January 2004, Shaffer knew of a connection between ObTape and some of her injuries. She did not file her complaint until approximately nine years later, in January 2013. Plaintiffs contend that it is not enough that they made a connection between ObTape and some of their injuries. Rather, they appear to argue that they must have been on notice that a defect in ObTape caused their injuries. Plaintiffs did not point to any Minnesota authority holding that a plaintiff must be on actual notice that her specific injuries were caused by a product defect. Rather, the precedent establishes that a claim accrues when the plaintiff becomes aware of an injury and a causal connection between the injury and the defendant's product. Klempka, 963 F.2d at 170. Plaintiffs nonetheless contend that two Eighth Circuit cases and one Minnesota District Court case support denial of summary judgment. The Court disagrees. First, they point to Hildebrandt v. Allied Corp., 839 F.2d 396 (8th Cir. 1987), where the plaintiffs alleged that they suffered lung damage due to their exposure to a toxic chemical at their workplace. But there, unlike here, the plaintiffs' doctors initially told the plaintiffs that there was no correlation between their symptoms and the chemical. Id. at 399. The Eighth Circuit thus concluded that the plaintiffs' claims did not accrue until the cause of the plaintiffs' injuries was rationally identified. Second, Plaintiffs point to Tuttle v. Lorillard Tobacco Co., 377 F.3d 917 (8th Cir. 2004). In Tuttle, the district court found that the decedent's smokeless tobacco product liability action accrued when the decedent discovered a lump in his cheek. The Eighth Circuit reversed because the decedent's doctor initially told the decedent that the lump was caused by an oral infection and was treatable with antibiotics— not that it was oral cancer caused by the tobacco. Id. at 922. Third, Plaintiffs point to Huggins v. Stryker Corp., ase 4:14-cv-00105-CDL Document 32-11 Filed 10/24/16 Page 5 of 6 In re Mentor Corp., Not Reported in F.Supp.3d (2015) 2015 WL 8578364 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 5 932 F. Supp. 2d 972 (D. Minn. 2013). In Huggins, the plaintiff asserted that the defendant's pain pump caused a condition that resulted in degeneration of his cartilage. The plaintiff's doctor discovered the loss of cartilage in 2002, but he did not connect the condition to the pain pump or tell the plaintiff that there was such a connection. The district court noted that the “first article recognizing a potential causal link between pain pumps” and the plaintiff's condition was not published until 2007. Id. Hildebrandt, Tuttle, and Huggins are all distinguishable from Plaintiffs' cases. In Hildebrandt, Tuttle, and Huggins, the plaintiffs suffered injuries that could have been caused by the defendant's product OR could have been caused by something else, and the courts concluded that the cause of action did not accrue until the plaintiffs had some objective information suggesting a causal link between the product and the injury. In contrast, here, each Plaintiff suffered injuries that were connected to an erosion of the ObTape, and each Plaintiff knew of, strongly suspected, or had enough information to know of a connection between ObTape and at least some of her injuries by the time of her excision procedure. *6 Plaintiffs argue that even if Minnesota's discovery rule does not save their strict liability claims, the statute of limitations should be tolled by fraudulent concealment. “Fraudulent concealment, if it occurs, will toll the running of the statute of limitations until discovery or reasonable opportunity for discovery of the cause of action by the exercise of due diligence.” Holstad v. Sw. Porcelain, Inc., 421 N.W.2d 371, 374 (Minn. Ct. App. 1988); accord Hydra-Mac, Inc. v. Onan Corp., 450 N.W.2d 913, 918 (Minn. 1990). “The party claiming fraudulent concealment has the burden of showing that the concealment could not have been discovered sooner by reasonable diligence on his part and was not the result of his own negligence.” Wild v. Rarig, 234 N.W.2d 775, 795 (Minn. 1975). As discussed above, each Plaintiff knew of, strongly suspected, or had enough information to know of a connection between ObTape and at least some of her injuries by the time of her excision procedure. A reasonable person in that situation would take some action to follow up on the cause of her injuries and try to find out whether the injuries were caused by a problem with ObTape, a problem with the implant surgery, or some other problem. But Plaintiffs pointed to no evidence that they took any action to investigate their potential claims even though they knew (or had enough information to know) there was a connection between their injuries and the ObTape. Under these circumstances, the Court concludes that fraudulent concealment does not toll the statute of limitations. None of the Plaintiffs filed their complaints within six years after their claims accrued. Their strict liability and negligence claims are therefore time-barred. The loss of consortium claims of Abraham Mosier and Brian Shirey fail because their wives' claims fail. Kohler v. Fletcher, 442 N.W.2d 169, 173 (Minn. Ct. App. 1989). (“As a husband's claim for loss of consortium is derivative only, if his wife's underlying tort claim fails, his claim for loss of consortium also fails.”). CONCLUSION For the reasons set forth above, Mentor's summary judgment motions (ECF No. 42 in 4:12-cv-307; ECF No. 45 in 4:12-cv-308; ECF No. 44 in 4:12-cv-319; ECF No. 49 in 4:12-cv-323; ECF No. 40 in 4:13-cv-10; ECF No. 41 in 4:13-cv-48) are granted. IT IS SO ORDERED, this 9th day of December, 2015. All Citations Not Reported in F.Supp.3d, 2015 WL 8578364 End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works. ase 4:14-cv-00105-CDL Document 32-11 Filed 10/24/16 Page 6 of 6 Exhibit I Case 4:14-cv-00105-CDL Document 32-12 Filed 10/24/16 Page 1 of 4 IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR..., Not Reported in... 2015 WL 6126829 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 1 2015 WL 6126829 Only the Westlaw citation is currently available. United States District Court, M.D. Georgia, Columbus Division. In re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation MDL Docket No. 2004 | 4:08-MD-2004 (CDL) | Case No. 4:13-cv-195 (M. COLE) | Signed 10/16/2015 ORDER CLAY D. LAND, CHIEF U.S. DISTRICT COURT JUDGE MIDDLE DISTRICT OF GEORGIA *1 Defendant Mentor Worldwide LLC developed a suburethral sling product called ObTape Transobturator Tape, which was used to treat women with stress urinary incontinence. Plaintiff Melanie Grubbs Cole was implanted with ObTape and asserts that she suffered injuries caused by ObTape. Cole brought this product liability action against Mentor, contending that ObTape had design defects that proximately caused her injuries. 1 Cole also asserts that Mentor did not adequately warn her physicians about the risks associated with ObTape. Mentor contends that several of Cole's claims are barred by the applicable statute of limitations. For the reasons set forth below, the Court agrees, and Mentor's Motion for Partial Summary Judgment (ECF No. 30 in 4:13-cv-195) is granted. 1 Mentor argues that to the extent Cole pursues a claim under a manufacturing defect theory, summary judgment is warranted on that claim. Cole did not respond to Mentor's motion on this issue, so the Court finds that she abandoned any manufacturing defect claim she previously asserted. See Trnka v. Biotel, Inc., Civ. No. 07-1206 (RHK/JSM), 2008 WL 108995, at *3 n.4 (D. Minn. Jan. 9, 2008) (finding that plaintiff abandoned claims she did not address in her opposition to summary judgment). SUMMARY JUDGMENT STANDARD Summary judgment may be granted only “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). In determining whether a genuine dispute of material fact exists to defeat a motion for summary judgment, the evidence is viewed in the light most favorable to the party opposing summary judgment, drawing all justifiable inferences in the opposing party's favor. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986). A fact is material if it is relevant or necessary to the outcome of the suit. Id. at 248. A factual dispute is genuine if the evidence would allow a reasonable jury to return a verdict for the nonmoving party. Id. FACTUAL BACKGROUND Viewed in the light most favorable to Cole, the record reveals the following. Cole is a resident of North Carolina. She sought treatment from Dr. C. Frederic Reid for stress urinary incontinence. After several years of treatment, Cole decided to undergo a mesh sling implant, and Dr. Reid implanted Cole with ObTape on October 14, 2004. Three weeks later, Cole visited Dr. Reid complaining that the sling was not working properly and that her incontinence was worse than it was before the surgery. Cole Dep. 120:2-121:11, ECF 30-5. She attributed her problems to the mesh surgery. Id. Cole continued to have problems with incontinence, and she also experienced urinary tract infections and pain that she associated with ObTape. Cole visited Dr. Bradley Jacobs in 2007, and he diagnosed an erosion of the ObTape. Dr. Jacobs removed the eroded ObTape. In 2008, Cole visited Dr. John Smith because she believed that Dr. Jacobs had not removed all of the ObTape and she wanted it removed. Dr. Smith spoke with Cole about her scar tissue and the mesh, and he believes he told her that some of her pain came from inflammation caused by the ObTape and if the ObTape could be removed, then most of the pain should go away. Dr. Smith removed more ObTape in January 2009. *2 Cole filed her Complaint on June 5, 2013. She brought claims under the following theories: strict liability design Case 4:14-cv-00105-CDL Document 32-12 Filed 10/24/16 Page 2 of 4 IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR..., Not Reported in... 2015 WL 6126829 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 2 defect, negligence, breach of warranty, and strict liability failure to warn. DISCUSSION Cole filed this action in the United States District Court for the District of Minnesota. See generally Compl., ECF No. 1 in 4:13–cv–195. The action was later transferred to this Court as part of a multidistrict litigation proceeding regarding ObTape. The parties agree that Minnesota law applies to Cole's claims. See In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., No. 4:08-md-2004, 2013 WL 286276, at *7 (concluding that Minnesota law applied to claims of non- Minnesota ObTape plaintiffs who brought their actions in Minnesota). Mentor argues that all of Cole's claims except her negligence claim are time-barred. I. Breach of Warranty Claim The statute of limitations for Cole's breach of warranty claim is four years. Minn. Stat. § 336.2-725(1). “A cause of action accrues when the breach occurs, regardless of the aggrieved party's lack of knowledge of the breach.” Minn. Stat. § 336.2-725(2). “A breach of warranty occurs when tender of delivery is made, except that where a warranty explicitly extends to future performance of the goods and discovery of the breach must await the time of such performance the cause of action accrues when the breach is or should have been discovered.” Minn. Stat. § 336.2-725(1). Cole did not point to any evidence that any warranty made by Mentor explicitly extended to future performance, so her breach of warranty claim accrued in 2004, when her ObTape was implanted. Cole did not bring her claim within four years, so her breach of warranty claim is time-barred. II. Design Defect and Failure to Warn Claims Cole brought design defect and failure to warn claims under a strict liability theory. Under Minnesota law, “any action based on the strict liability of the defendant and arising from the manufacture, sale, use or consumption of a product shall be commenced within four years.” Minn. Stat. § 541.05 subd. 2. Under Minnesota law, “a claim involving personal injuries allegedly caused by a defective product accrues when two elements are present: '(1) a cognizable physical manifestation of the disease or injury, and (2) evidence of a causal connection between the injury or disease and the defendant's product, act, or omission.”' Klempka v. G.D. Searle & Co., 963 F.2d 168, 170 (8th Cir. 1992) (quoting Hildebrandt v. Allied Corp., 839 F.2d 396, 398 (8th Cir. 1987)) (applying Minnesota law). “A plaintiff who is aware of both her injury and the likely cause of her injury is not permitted to circumvent the statute of limitations by waiting for a more serious injury to develop from the same cause.” Id. For example, in Klempka, the plaintiff suffered injuries and was diagnosed with chronic pelvic inflammatory disease, which her doctor said was caused by the plaintiff's intrauterine device. Id. at 169. Several years later, the plaintiff was told that she was infertile and that the intrauterine device caused her infertility. Id. Applying Minnesota law, the Eighth Circuit concluded that the plaintiff's cause of action accrued when she first learned that she had an injury (chronic pelvic inflammatory disease) that was caused by the intrauterine device. Id. at 170. Here, Cole does not deny that she knew by 2008 at the latest that her injuries—worsened incontinence, pain, and infections—were caused by ObTape. Cole argues, however, that her claims did not accrue until she knew that her injuries were caused by a defect in ObTape. Cole did not point to any Minnesota authority holding that a plaintiff must be on notice that her injuries were caused by a defect. Rather, the precedent states that the plaintiff must be aware of an injury and a causal connection between the injury and the defendant's product. Id. *3 Cole nonetheless contends that two Eighth Circuit cases support denial of summary judgment in this case. The Court disagrees. First, Cole points to Hildebrandt v. Allied Corp., 839 F.2d 396 (8th Cir. 1987), where the plaintiffs alleged that they suffered lung damage due to their exposure to a toxic chemical at their workplace. But there, unlike here, the plaintiffs' doctors initially told the plaintiffs that there was no correlation between their symptoms and the chemical. Id. at 399. The Eighth Circuit thus concluded that the plaintiffs' claims did not accrue until the cause of the plaintiffs' injuries was rationally identified. Second, Cole points to Tuttle v. Lorillard Tobacco Co., 377 F.3d 917 (8th Cir. 2004). In Tuttle, the district court found that the decedent's smokeless tobacco product liability action accrued when the decedent discovered a lump in his cheek. 377 F.3d at 922. The Eighth Circuit reversed because the decedent's doctor initially told the decedent that the lump was caused by an oral infection and was treatable with antibiotics Case 4:14-cv-00105-CDL Document 32-12 Filed 10/24/16 Page 3 of 4 IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR..., Not Reported in... 2015 WL 6126829 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 3 —not that it was oral cancer caused by the tobacco. Id. Hildebrandt and Tuttle are both distinguishable from Cole's case. Here, unlike Hildebrandt and Tuttle, there is no question that Cole and her doctors connected her injuries to ObTape as early as 2004 and by 2008 at the latest. Cole argues that even if Minnesota's discovery rule does not save her strict liability claims, the statute of limitations should be tolled by fraudulent concealment. “Fraudulent concealment, if it occurs, will toll the running of the statute of limitations until discovery or reasonable opportunity for discovery of the cause of action by the exercise of due diligence.” Holstad v. Sw. Porcelain, Inc., 421 N.W.2d 371, 374 (Minn. Ct. App. 1988); accord Hydra-Mac, Inc. v. Onan Corp., 450 N.W.2d 913, 918 (Minn. 1990). “The party claiming fraudulent concealment has the burden of showing that the concealment could not have been discovered sooner by reasonable diligence on his part and was not the result of his own negligence.” Wild v. Rarig, 234 N.W.2d 775, 795 (Minn. 1975). As discussed above, Cole suspected in 2004 that she had injuries caused by ObTape. She knew by 2007 that portions of the ObTape had to be removed because of an erosion. And by 2008, Cole wanted all of the ObTape removed because of her problems with it. A reasonable person in those circumstances would take some action to follow up on the cause of her injuries. But Cole pointed to no evidence that she took any action to investigate her potential claims even though she knew there was a connection between her injuries and the ObTape. Under these circumstances, the Court concludes that fraudulent concealment does not toll the statute of limitations. Cole's strict liability claims are therefore barred. CONCLUSION As discussed above, Mentor's Motion for Partial Summary Judgment (ECF No. 30 in 4:13-cv-195) is granted. Only Cole's negligence claim remains pending for trial. Within seven days of the date of this Order, the parties shall notify the Court whether the parties agree to a Lexecon waiver. IT IS SO ORDERED. All Citations Not Reported in F.Supp.3d, 2015 WL 6126829 End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:14-cv-00105-CDL Document 32-12 Filed 10/24/16 Page 4 of 4