Grigg v. Mentor Corporation et alMOTION for Summary JudgmentM.D. Ga.July 25, 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. 4:13-cv-393 (Grigg) DEFENDANT MENTOR WORLDWIDE LLC’S MOTION FOR SUMMARY JUDGMENT AGAINST PLAINTIFF TERESA GRIGG 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 claims asserted by Plaintiff Teresa Grigg. Mentor is entitled to summary judgment because Plaintiff’s claims are time-barred under North Carolina’s statute of repose and because she has presented no expert testimony that her alleged injuries are causally related to her ObTape. The grounds for this Motion are more fully set forth in the attached memorandum in support. Dated: July 25, 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 4:13-cv-00393-CDL Document 33 Filed 07/25/16 Page 1 of 2 2 2735135.1 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 25th day of July, 2016: Thomas W. Pirtle tomp@LPM-triallaw.com Buffy K. Martines buffym@LPM-triallaw.com Attorneys for Plaintiff Teresa Grigg s/ John Q. Lewis John Q. Lewis Designated Lead Counsel for Defendant Mentor Worldwide LLC Case 4:13-cv-00393-CDL Document 33 Filed 07/25/16 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. 4:13-cv-393 (Grigg) DEFENDANT MENTOR WORLDWIDE LLC’S MEMORANDUM IN SUPPORT OF ITS MOTION FOR SUMMARY JUDGMENT AGAINST PLAINTIFF TERESA GRIGG Plaintiff Teresa Grigg brought this product liability action against Mentor for injuries she allegedly experienced following her ObTape implant surgery. All of her claims, however, are time-barred under North Carolina’s six-year statute of repose because she filed suit more than six years after the date of the product’s purchase. As this Court has determined on three prior occasions, her claims should thus be dismissed as a matter of law. All of Plaintiff’s claims also fail because no expert has opined that her alleged injuries were causally related to her ObTape. UNDISPUTED FACTS RELEVANT TO THIS MOTION This Court previously described general facts related to ObTape (e.g., Apr. 22, 2010 Order, Doc. No. 241 at 4-5); Mentor will not restate them here because this motion is premised on undisputed facts unique to Plaintiff Teresa Grigg. In 2004, Plaintiff developed stress urinary incontinence. (See Separate Statement of Material Facts (“SSMF”) ¶ 1.) After consulting with Dr. David Barker, Plaintiff decided to proceed with an ObTape implant to treat her symptoms. (Id. ¶ 2.) On March 18, 2004, Dr. Barker and Dr. Michael Keeley performed Plaintiff’s ObTape implant surgery. (Id. ¶ 3.) Plaintiff’s ObTape resolved her incontinence for two years. (Id. ¶ 4.) In 2006, Plaintiff began experiencing painful bladder spasms, dyspareunia, Case 4:13-cv-00393-CDL Document 33-1 Filed 07/25/16 Page 1 of 7 2 and recurrent incontinence. (Id. ¶ 5.) She has also experienced one to two urinary tract infections per year since 2006. (Id. ¶ 6.) Plaintiff attributes her bladder spasms, dyspareunia, recurrent incontinence, and urinary tract infections to her ObTape. (Id. ¶ 7.) Plaintiff is a North Carolina resident, and all of her ObTape-related medical treatment occurred in North Carolina. (Id. ¶ 8.) Plaintiff direct-filed her suit alleging injury related to her ObTape implant on August 29, 2013. (Id. ¶ 9.) She asserts two causes of action against Mentor: (I) Strict Liability and (II) Negligence. (Id. ¶ 10.) LAW AND ARGUMENT “The court shall grant summary judgment 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). “Rule 56(c) 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). 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. North Carolina Law Applies to Plaintiff’s Claims. Plaintiff direct-filed her suit against Mentor in this Court on August 29, 2013. (Doc. 1; see also SSMF ¶ 11.) There is no choice-of-law issue in this case; North Carolina law applies to Plaintiff’s claims because she is a North Carolina resident and all of her ObTape-related medical care occurred in North Carolina. (SSMF ¶ 10.) Case 4:13-cv-00393-CDL Document 33-1 Filed 07/25/16 Page 2 of 7 3 B. Summary Judgment Is Warranted as a Matter of Law Because Plaintiff’s Claims Are Time-Barred Under North Carolina’s Statute of Repose. Under North Carolina law, the statute of repose bars product liability claims filed more than six years after the date of a product’s purchase: “No action for the recovery of damages for personal injury . . . based upon or arising out of any alleged defect or any failure in relation to a product shall be brought more than six years after the date of initial purchase for use or consumption.” N.C. Gen. Stat. § 1-50(a)(6).1 “Statutes such as N.C.G.S. § 1-50(6) [predecessor to § 1-46.1(1)] have been denominated statutes of repose because they set a fixed limit after the time of the product’s manufacture, sale, or delivery beyond which a plaintiff’s claim will not be recognized.” Boudreau v. Baughman, 368 S.E.2d 849, 856-57 (N.C. 1988). North Carolina’s statute of repose jurisprudence is well-established. “Whether a statute of repose has expired is a question of law.” Chicopee, Inc. v. Sims Metal Works, Inc., 391 S.E.2d 211, 213 (N.C. Ct. App. 1990). “A statute of repose is a substantive limitation, and is a condition precedent to a party’s right to maintain a lawsuit.” Tipton & Young Constr. Co., Inc. v. Blue Ridge Structure Co., 446 S.E.2d 603, 605 (N.C. Ct. App. 1994), aff’d per curiam, 456 S.E.2d 308 (N.C. 1995). “It is well established North Carolina law . . . that a plaintiff has the burden of proving that the statute of repose does not bar his or her claim.” Robinson v. Bridgestone/Firestone N. Am. Tire, L.L.C., 703 S.E.2d 883, 889 (N.C. Ct. App. 2011). 1 This statute of repose was amended in 2009 (see N.C. Gen. Stat. § 1-46.1(1)), but that amendment only applies to causes of action that accrued on or after October 1, 2009. The amended statute of repose does not apply in this case because Plaintiff’s ObTape was purchased more than five years before its effective date. Case 4:13-cv-00393-CDL Document 33-1 Filed 07/25/16 Page 3 of 7 4 The statute of repose cannot be tolled for delayed discovery; the date of purchase starts the clock under all circumstances: Unlike an ordinary statute of limitations which begins running upon accrual of the claim . . . the period contained in the statute of repose begins when a specific event occurs, regardless of whether a cause of action has accrued or whether any injury has resulted. Thus, the repose serves as an unyielding and absolute barrier that prevents a plaintiff’s right of action even before his cause of action may accrue. . . . Black v. Littlejohn, 325 S.E.2d 469, 474-75 (N.C. 1985); see also Lackey v. DePuy Orthopaedics, Inc., No. 5:10-cv-00030, 2011 WL 2791264 (W.D.N.C., July 14, 2011) (holding § 1-50(a)(6) barred plaintiff’s claims relating to hip implant purchased in January 1998) (attached as Ex. C to Decl. of John Q. Lewis (“Lewis Decl.”)). Under North Carolina’s statute of repose, “the date of initial purchase for use or consumption” triggers the repose period. N.C. Gen. Stat. § 1-50(a)(6). Here, Plaintiff’s ObTape was implanted on March 18, 2004 (SSMF ¶ 3), and that is the latest possible date that can be considered “the date of initial purchase for use or consumption.” Plaintiff filed her Complaint on August 29, 2013 – 9 years and five months after her ObTape implant. (Id. ¶ 11.) Plaintiff’s action is therefore time-barred as a matter of law under N.C. Gen. Stat. § 1–50(a)(6). See Bryant v. Don Galloway Homes, Inc., 556 S.E.2d 597, 600 (N.C. Ct. App. 2001) (“Summary judgment is proper if the pleadings or proof show without contradiction that the statute of repose has expired.”). This Court recently found, under nearly identical circumstances, that North Carolina’s statute of repose barred a plaintiff’s claims when her ObTape was purchased no later than March 24, 2005 (the date of her implant surgery) and she delayed filing her Complaint until December 13, 2012 – over seven years later. See Wallace v. Mentor Case 4:13-cv-00393-CDL Document 33-1 Filed 07/25/16 Page 4 of 7 5 Worldwide LLC, No. 4:12-cv-335, Order Granting Mentor’s Mot. for Summ. J. (M.D. Ga. March 4, 2016) (attached as Ex. D to Lewis Decl.).2 Here, it is undisputed that Plaintiff’s ObTape was purchased more than nine years before she filed her Complaint. Further, Plaintiff’s alleged injuries – pain, infection, and recurrent incontinence – are not diseases excepted from the statute of repose under Wilder v. Amatex Corp., 336 S.E.2d 66 (N.C. 1985) and its progeny. As explained by this Court in Wallace, the “disease exception” applies to injuries that “develop over long periods of time after multiple exposures to offending substances which are thought to be causative agents where it is impossible to identify any exposure as the ‘first injury.’” Ex. D to Lewis Decl. at 5-6 (citing, among others, Hyer v. Pittsburgh Corning Corp., 790 F.2d 30, 33 (4th Cir. 1986) and Wilder, 336 S.E.2d at 73). As this Court recognized in Wallace, a claim for injuries allegedly sustained as a result of ObTape “is not a claim arising from disease that developed over many years after multiple exposures to a toxic substance; it is a claim arising from complications [the plaintiff] contends were caused by a medical device that was implanted in her body.” Id. at 6; see also Lackey, 2011 WL 2791264 at *1 (finding “disease exception” inapplicable to plaintiff who suffered pain following hip replacement surgery). Here, Plaintiff did not develop a disease as a result of her ObTape; rather, she experienced pain, infection, and recurrent incontinence. SSMF ¶¶ 5-6. Thus, the “disease exception” does not apply and Plaintiff’s claims, filed more than nine years after her ObTape was purchased, are barred by North Carolina’s statute of repose. 2 This court previously reached similar conclusions in Duarte v. Mentor Worldwide LLC, No. 4:13-cv-267, Order Granting Mentor’s Mot. for Summ. J. (M.D. Ga. Dec. 23, 2015) (attached as Ex. E to Lewis Decl.), and Broome v. Mentor Worldwide LLC, No. 4:11-cv-5078, Order Granting Mentor’s Mot. for Summ. J. (M.D. Ga. Feb. 11, 2013) (attached as Ex. F to Lewis Decl.). Case 4:13-cv-00393-CDL Document 33-1 Filed 07/25/16 Page 5 of 7 6 C. Plaintiff’s Claims Also Fail for Lack of Causation. All of Plaintiff’s claims require proof of causation. Martishius v. Carolco Studios, Inc., 562 S.E.2d 887, 892 (N.C. 2002) (negligence); Ward v. Am. Med. Sys., Inc., 170 F. Supp. 594, 599 (W.D.N.C. 2001) (product liability). “In cases involving ‘complicated medical questions far removed from the ordinary experience and knowledge of laymen, only an expert can give competent opinion evidence as to the cause of the injury.’” Holley v. ACTS, Inc., 581 S.E.2d 750, 753 (N.C. 2003) (quoting Click v. Pilot Freight Carriers, Inc., 265 S.E.2d 389, 391 (N.C. 1980)); see also Dunn v. Sandoz Pharm. Corp., 275 F. Supp. 2d 672, 684 (M.D.N.C. 2003) (granting summary judgment after exclusion of causation expert). Because Plaintiff’s claims involve “complicated medical questions far removed from the ordinary experience and knowledge of laymen,” she was required to produce expert testimony regarding the causal nature of her injuries by the Court-ordered deadline of June 27, 2016. See Doc. 930 at 4 (setting June 27, 2016 as deadline for service of Plaintiff’s Expert Disclosures for Phase IV-6.) To date, Plaintiff has served no expert disclosures. (Lewis Decl. ¶ 8.) Because she has failed to submit expert disclosures, she cannot establish an essential element of her claims and Mentor is entitled to summary judgment. CONCLUSION Mentor is entitled to summary judgment on all of Plaintiff’s claims because they are time-barred under the applicable statute of repose and because she has failed to present expert testimony as to causation. Mentor is thus entitled to summary judgment on all of Plaintiff’s claims. Case 4:13-cv-00393-CDL Document 33-1 Filed 07/25/16 Page 6 of 7 7 2734366.1 Dated: July 25, 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 4:13-cv-00393-CDL Document 33-1 Filed 07/25/16 Page 7 of 7 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. 4:13-cv-393 (Grigg) DEFENDANT MENTOR WORLDWIDE LLC’S SEPARATE STATEMENT OF MATERIAL FACTS IN SUPPORT OF ITS MOTION FOR SUMMARY JUDGMENT AGAINST PLAINTIFF TERESA GRIGG 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 Teresa Grigg. 1. In 2004, Plaintiff developed stress urinary incontinence. (Dep. of Teresa Grigg (“Grigg Dep.”) 52:4-6, attached as Ex. A to Decl. of John Q. Lewis (“Lewis Decl.”).) 2. After consulting with Dr. David Barker, Plaintiff decided to proceed with an ObTape implant to treat her symptoms. (Grigg Dep. 54:11-13, 55:1-11; 59:16-21.) 3. On March 18, 2004, Dr. Barker and Dr. Michael Keeley performed Plaintiff’s ObTape implant surgery. (Pl.’s Fact Sheet (“PFS”) p. 1, attached as Ex. B to Lewis Decl.) 4. Plaintiff’s ObTape resolved her incontinence for two years. (Grigg Dep. 18:19-24.) 5. In 2006, Plaintiff began experiencing painful bladder spasms, dyspareunia, and recurrent incontinence. (Grigg Dep. 16:2-24.) Case 4:13-cv-00393-CDL Document 33-2 Filed 07/25/16 Page 1 of 2 2 2734463.1 6. Plaintiff has also experienced one to two urinary tract infections per year since 2006. (Id. 18:2-8.) 7. Plaintiff attributes her bladder spasms, dyspareunia, recurrent incontinence, and urinary tract infections to her ObTape. (Grigg Dep. 14:9-15.) 8. Plaintiff is a North Carolina resident, and all of her ObTape-related medical treatment occurred in North Carolina. (Grigg Dep. 9:1-2; PFS p. 4.) 9. Plaintiff direct-filed her suit alleging injury related to her ObTape implant on August 29, 2013. (Pl.’s Compl., Doc. 1.) 10. She asserts two causes of action against Mentor: (I) Strict Liability and (II) Negligence. (Id. ¶¶ 20-39.) Dated: July 25, 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 4:13-cv-00393-CDL Document 33-2 Filed 07/25/16 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. 4:13-cv-393 (Grigg) DECLARATION OF JOHN Q. LEWIS IN SUPPORT OF DEFENDANT MENTOR WORLDWIDE LLC’S MOTION FOR SUMMARY JUDGMENT AGAINST PLAINTIFF TERESA GRIGG 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 Teresa Grigg, dated April 19, 2016. 3. Attached as Exhibit B is a true and correct copy of Plaintiff Teresa Grigg’s Plaintiff Fact Sheet. 4. Attached as Exhibit C is a true and correct copy of an unreported case, Lackey v. DePuy Orthopaedics, Inc., No. 5:10-cv-30, 2011 WL 2791264 (W.D.N.C. July 14, 2011). 5. Attached as Exhibit D is a true and correct copy of this Court’s Order in Wallace v. Mentor Worldwide LLC, No. 4:12-cv-335, Order Granting Mentor’s Mot. for Summ. J. (Doc. 39) (M.D. Ga. March 4, 2016). Case 4:13-cv-00393-CDL Document 33-3 Filed 07/25/16 Page 1 of 2 2 2734483.1 6. Attached as Exhibit E is a true and correct copy of this Court’s Order in Duarte v. Mentor Worldwide LLC, No. 4:13-cv-267, Order Granting Mentor’s Mot. for Summ. J. (Doc. 41) (M.D. Ga. Dec. 23, 2015). 7. Attached as Exhibit F is a true and correct copy of this Court’s Order in Broome v. Mentor Worldwide LLC, No. 4:11-cv-5078, Order Granting Mentor’s Mot. for Summ. J. (Doc. 47) (M.D. Ga Feb. 11, 2013). 8. Plaintiff has served no expert disclosures in this case. I declare under penalty of perjury under the laws of the United States that the foregoing is true and correct. Executed this 25th day of July, 2016, in Cleveland, Ohio. s/ John Q. Lewis John Q. Lewis Case 4:13-cv-00393-CDL Document 33-3 Filed 07/25/16 Page 2 of 2 EXHIBIT A Case 4:13-cv-00393-CDL Document 33-4 Filed 07/25/16 Page 1 of 12 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 1 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION IN RE: MENTOR CORP. OBTAPE TRANSOBTURATOR SLING MDL Case No. PRODUCTS LIABILITY 4:08-MD-2004 (CDL) LITIGATION Individual Case No. 4:13-cv-00393 Video Deposition of Teresa Grigg April 19, 2016 At 9:05 a.m. Taken at: Regus Business Center 525 North Tryon Street Suite 1600 Charlotte, North Carolina Reported by LeShaunda Cass-Byrd, CSR, RPR Job No. CS2280736 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00393-CDL Document 33-4 Filed 07/25/16 Page 2 of 12 1 2 3 4 5 6 7 8 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 2 APPEARANCES OF COUNSEL: On behalf of Witness: SUSAN EARNEST, Esq. Laminack Pirtle & Martines LLP 5020 Montrose Boulevard 9th Floor Houston, Texas 77006 713.292.2750 Susane@lpm-traillaw.com On behalf of Defendant: ERNEST W. AUCIELLO, Esq. Tucker Ellis LLP 950 Main Avenue Suite 1100 Cleveland, Ohio 44113 216.696.4780 Ernest.auciello@tuckerellis.com 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00393-CDL Document 33-4 Filed 07/25/16 Page 3 of 12 1 2 3 4 5 6 7 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 9 Q. Okay. What is your current address? A. 3605 Grigg Road, Shelby, North Carolina 28150. Q. And how far out of Shelby from here in Charlotte? A. It's about an hour and a half. Q. Okay. It's farther than I thought. Thank you for coming in. A. Something like that, yes, sir. Q. Now, are there -- a lot of these are standard questions, too. Are you under the influence of any drugs or narcotics or alcohol or anything that would prevent you from being able to answer questions truthfully today? A. No, sir. Q. Are you under -- on any pain medication today? A. No, sir. Q. Have you done any research to get ready for this deposition? A. No, sir. Q. By research, I mean going on the internet and Googling things or looking up medical terms? A. No, sir. 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00393-CDL Document 33-4 Filed 07/25/16 Page 4 of 12 1 2 3 4 5 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 14 talking about? A. Yes, sir. Q. And when you -- let's talk about in 2012 when you saw that commercial. You had worsening incontinence. Is that true? A. It was getting -- it was getting -- it was getting worse, but not to the point where I was having to wear -- I was wearing just pads at the time. Q. Okay. Did you have any other problems going on that you attributed to the sling? A. Yes, sir. Q. What problems was that, or that? A. Sexual discomfort and pain. Urinary tract infections, bladder spasms, incontinence, and worrying about the future and what is going to happen to me. Q. Okay. You said sexual discomfort, pain, urinary tract infections. What else? A. Bladder spasms, incontinence, and worrying about what is going to happen to me. The stress from all of that. Q. I will start with the sexual discomfort. And I apologize in advance, because some of the questions that I have to ask are kind of personal. A. Yes, sir. Q. It's something you wouldn't ordinarily talk 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00393-CDL Document 33-4 Filed 07/25/16 Page 5 of 12 1 2 3 4 5 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 16 A. 2006. Q. Was there anything in particular in 2006 that led to its starting? A. 2004, I had the first mesh put in. I was doing fine for a couple of years. And then in 2006, I started bleeding. I went to my gynecologist first because I still had my uterus and ovaries and everything. I didn't know what was going on. Q. Okay. Is that when the sexual discomfort started? A. That started, too. Q. At the same time that you were bleeding? A. Yes, sir. Q. Okay. We will get to it in detail about that. I'm just trying to look backwards. Now, other than the sexual discomfort, you said pain. What kind of pain were you talking about? A. I'm not sure how to describe it. I just know that whenever -- it causes my bladder to go into spasms, for one thing. Q. When did your bladder spasms start? A. 2013, that is when it started. But when we have sex, it will act up, and that has been like since 2006. And see now, my bladder spasms just do it on their own. It doesn't matter when I'm doing anything, 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00393-CDL Document 33-4 Filed 07/25/16 Page 6 of 12 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 18 It doesn't just -- Q. Okay. And you said you had urinary tract infections? A. Yes, sir. Q. Do you know how many? A. One -- maybe one or two a year. I just recently got over one. It was so severe, I was bleeding. Q. Now, you have treated with your doctor for all of those urinary -- A. Yes, sir, so far. Q. And now you mentioned incontinence. I take it you were in -- you had some problem with incontinence before you had the sling placed, or else you wouldn't have had the sling placed? A. Correct. When that started, that is when I went to my doctor, because I knew that that wasn't right. Q. All right. Did the sling ever alleviate your incontinence, the 2004 implant? A. For a couple of years it did. Q. When did your incontinence worsen or return? A. 2006. Q. Was there any precipitating event or 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00393-CDL Document 33-4 Filed 07/25/16 Page 7 of 12 1 2 3 4 5 6 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 52 forever, and I have gone to him for a lot of female things. Whenever I have problems female wise, I would go to him. Q. Now, do you remember when you first started having a problem with urinary incontinence? A. I believe it was in 2004. Q. The earliest record I get is December of 2003, and you mentioned it to Dr. Rabrindrum. Would that be consistent with what you remember? MS. EARNEST: Object to form. Asked and answered. But subject to the objection, go ahead and answer it if you can. THE WITNESS: I just remember going to Dr. Keeley about this. BY MR. AUCIELLO: Q. Okay. And do you remember if anything -- was there anything that started -- that caused you to start to having a problem? I mean, anything in your life that changed that you can say that is when I started having urinary incontinence? MS. EARNEST: Object to form. THE WITNESS: In 2004, I remember -- I don't know why it is plain to me, but I was having incontinence problems, but I was 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00393-CDL Document 33-4 Filed 07/25/16 Page 8 of 12 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 54 have to be hospitalized? A. Yes, sir. Q. Did that affect your incontinence? A. I do not know. I was so sick, I don't know what happened. I think -- I think they had the urinary tube up in me. That is all I know. Q. Okay. Do you remember discussions about Dr. Barker about what to do about your stress urinary incontinence? A. About what to do with my Q. Did he talk to you about how to address your incontinence? A. Yes, sir. Q. What did he tell you? A. He -- he prescribed pills at first, believe, and then they run tests on me. And I remember having to take some type of medication to actually turn my urine orange and anything else it touched, but that was supposed to help, once it got cleared up. And when it -- when it didn't, that is when we started talking about different bladder procedures to help it because it had fallen or something. Q. Okay. What procedures did he talk about? A. I'm trying to remember. He talked about 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00393-CDL Document 33-4 Filed 07/25/16 Page 9 of 12 1 2 3 4 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 55 the sling. I think it was mostly the sling he talked to me about. He may have mentioned another one or two, but the sling is the one that really sticks in my mind. Q. Okay. His note he says he discussed the indications, risks and benefits for a pelvic sling, and suggested that we use Mentor sling. Do you remember him talking to you about a Mentor sling? A. I don't remember the name of the sling. I just know he is talking about the sling and what it would do and how it would help me. Q. How did -- what was your understanding of how it would help you? A. That once my sling was, that the sling would actually pick my bladder up, and it would be tacked to the inside of me, and that once it was picked up, then I could get better control of my bladder. Q. Okay. Did he explain how he would put it in? A. I think he did, but I just -- I don't remember what all he said. Q. Did he tell you about any risks involved in having a sling put in? A. The only risk that I can remember that he 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00393-CDL Document 33-4 Filed 07/25/16 Page 10 of 12 Page 59 A. To a point they do. All of them do. Q. But you talk to him, you know, and gained an understanding yourself of what you wanted to have done, right? A. Yes, sir. Q. Okay. And at the time, maybe you don't remember, do you believe you understood the risk that he explained to you? A. Yes, sir. Q. And if you didn't understand the risk, you wouldn't have gone forward, right? MS. EARNEST: Object to form. THE WITNESS: What did you say? You are talking low. BY MR. AUCIELLO: Q. Do you feel you understood the risk and procedure that Dr. Barker was going to do for you? A. For the most part, I believe I did understand what he was talking about and what he said. But he reassured me, too, that he was selecting the procedure that would work with me. Q. Okay. But did he tell you anything about why he was using a Mentor sling as opposed to other slings? A. No, sir. Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00393-CDL Document 33-4 Filed 07/25/16 Page 11 of 12 1 REPORTER'S CERTIFICATE 2 I, LESHAUNDA CASS-BYRD, CSR No. B-2291, RPR, 3 Registered Professional Reporter, certify that the 4 foregoing proceedings were taken before me at the time 5 and place therein set forth, at which time the witness 6 was put under oath by me; 7 That the testimony of the witness, the questions 8 propounded, and all objections and statements made at 9 the time of the examination were recorded 10 stenographically by me and were thereafter 11 transcribed; 12 That the foregoing is a true and correct 13 transcript of my shorthand notes to taken. 14 I further certify that I am not a relative or employee 15 of any attorney or the parties, nor financially 16 interested in the action. 17 I declare under penalty of perjury under the laws 18 of North Carolina that the foregoing is true and 19 correct. 20 Dated this April 29, 2016. 21 22 23 LESHAUNDA CASS-BYRD, CCR-B-2291V RPR 24 25 Page 94 Case 4:13-cv-00393-CDL Document 33-4 Filed 07/25/16 Page 12 of 12 EXHIBIT B Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 1 of 25 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 Ind. Case No. 4:13-cv00393 PLAINTIFF FACT SHEET Please provide the following information for each individual on whose behalf a claim is being made. Whether you are completing this Plaintiff Fact Sheet for yourself or for someone else, please assume that "You" means the person who had the ObTape implanted. In filling out this form please use the following definition: "healthcare provider" means any hospital, clinic, center, physician's office, infirmary, medical or diagnostic laboratory, or other facility that provides medical care or advice, and any pharmacy, x-ray depaitinent, radiology department, laboratory, physical therapist or physical therapy department, rehabilitation specialist, or other persons or entities involved in the diagnosis, care and/or treatment of you. In filling out any section or sub-section of this form, please submit additional sheets as necessary to provide complete information. In addition, if you learn that any of your responses are incomplete or incorrect at any time, please supplement your responses to provide that information as soon as you become aware of this information. In completing this Plaintiff Fact Sheet, you are under oath and must provide information that is true and correct to the best of your knowledge, information and belief. Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 2 of 25 I. CASE INFORMATION 1. Name of person completing this form: Teresa R. Grigg 2. Name of person on whose behalf a claim is being made: Teresa R. Grigg THE REST OF THIS PLAINTIFF FACT SHEET REQUESTS INFORMATION ABOUT THE PERSON WHO WAS IMPLANTED WITH THE OBTAPE II. CORE INFORMATION 1. Lot No. for the ObTape (please attach a copy of the stickers shown on the operative report): 030926E 2. Date of Implantation: 03/18/04 3. Name and Address of Implanting Surgeon(s): Dr. Michael Keeley Dr. David Barker 335 West College Avenue 1001 N Washington Street Shelby, NC 28152 Shelby, NC 28150 4. Name and Address of Hospital, Clinic, or Doctor's Office where implantation surgery was performed: Cleveland Regional Medical Center 201 E Grover Street, Shelby, NC 28150 5. If the ObTape has been removed, provide the date on which it was removed: 08/21/14 6. Name and Address of Surgeon(s) who removed the ObTape: Dr. Robert Gossett 1001 N Washington Street Shelby, NC 28150 2 Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 3 of 25 7. Name and Address of Hospital, Clinic, or Doctor's Office where surgery(ies) performed: Cleveland Regional Medical Center (Surgical Pavilion) 201 E Grover Street, Shelby, NC 28150 8. Name of the Manufacturer and Type of the replacement sling, if any: Unknown 9. Were any potions of the ObTape surgically removed? Yes X No a. If Yes, what is the present location of the removed portions of the ObTape? Unknown 10. Has any doctor ever told you that there are portions of the ObTape still in your body? Yes X No If Yes, please provide name and address of each such doctor: Dr. Robert Gossett 1001 N Washington Street Shelby, NC 28150 11. Has any doctor told you that those portions of the ObTape still in your body need to be removed? Yes X No If Yes, please provide name and address of each such doctor: Dr. Robert Gossett 1001 N Washington Street Shelby, NC 28150 Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 4 of 25 III. PERSONAL INFORMATION 1. Name (first, middle name or initial, last): Teresa R. Grigg 2. Maiden or other names used and dates you used those names: Ramsay 06/07/57 - November 1977 3. Current address and date when you began living at this address: 11111111111111 Shelby, NC 28150 June 2009 4. Identify each address at which you resided for the period from ten years before your ObTape surgery up to the present and the dates you resided at each one. Address Dates of Residence 3605-1 Grigg Road, Shelby, NC 28150 1977 — June 2009 5. Social Security Number: 6. Date and place of birth: 1111111 Shelby, NC 7. Current marital status: Married 8. If married, please provide the following information: Date of marriage: 11/15/77 Name of spouse: Daniel Grigg Date and place of birth of spouse AM Shelby, NC 9. Name(s) of former spouse(s), date(s) of marriage(s) and dates the marriage(s) were terminated, and the nature of the termination (i.e., death, divorce): Not applicable 10. If you have children, list each child's name and date of birth and whether they were delivered vaginally or by Caesarian. Joshua Burgin Grigg Darcie Ann Grigg Andrew Clarence Grigg Lindsay Elizabeth Grigg Vaginally Vaginally Caesarian Vaginally 4 Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 5 of 25 11. Identify all schools you attended, starting with high school: Name of School Address Dates of Attendance Degree Awarded Major or Primary Field R-S Central High School 641 US Hwy 221 N Rutherfordton, NC 28139 1973-1976 Diploma N/A Western Carolina University 1 University Way Cullowhee, NC 28723 1976-1978 N/A Nursing Cleveland Community College 137 S Post Road Shelby, NC 28152 2007-2008 N/A Art 12. Are you currently employed? Yes No X If yes, please identify your current employer with name, address and telephone number and your position there: Not applicable If not, did you leave your last job for a medical reason? Yes X No If Yes, describe why you left: Repeated back surgeries left me unable to lift items, as the position required. 13. For the period of time from ten years before you had your ObTape surgery, until the present, please identify all of your employers, with name, address and telephone number, your employment dates, your position there, and your reason for leaving: Name of Employer Address and Dates of Describe Your Reason for Telephone Employment and Position or Duties Leaving Number Wage/Salary Cleveland County 1440 Union 1992 — January Food Disability School System Church Road 2002 Services/Cafeteria (Union Shelby, NC Elementary) 28150 (704) 481-8001 Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 6 of 25 14. If you have Medicare, please state your HICN number: 15. For the period from ten years before your ObTape surgery to the present, have you been on or applied for workers' compensation, social security, and/or state or federal disability benefits? Yes X No If Yes, then as to each application, separately state the following and attach any documents you have which relate to the application and/or award of benefits: (a) Date (or year) of application: 2004 (b) Type of benefits: Disability (c) Nature of claimed injury/disability: Back injury (d) Period of disability: 2001 - present (e) Amount awarded: $682/month (f) Basis of your claim: Medical records showing back injuries (g) Was claim denied? Yes No X (h) To what agency or company did you submit your application: Social Security (i) Claim/docket number, if applicable: Cannot recall 16. Have you ever filed a lawsuit or made a claim (other than this suit)? Yes No X If Yes, please provide the following information and attach copies of all pleadings, releases or settlement agreements and deposition transcripts you have: Party You Sued/Made Claim Against Court in Which Suit Filed/Claim Made Case/Claim Number Attorney Who Represented You Nature of Claim and Injury Not applicable 6 Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 7 of 25 17. Have you ever been convicted of, or pled guilty to, a felony or a crime of dishonesty within the past ten years? Yes No X If Yes, please state the charge to which you plead guilty or which you were convicted of, as well as the court where the action was pending and the date of such conviction or plea: Not applicable 18. Have you or your spouse ever declared bankruptcy since the date of your initial ObTape surgery? Yes No X If Yes, please state when and in what court you filed your bankruptcy petition, including the docket number of the petition and the orders of discharge: Not applicable 19. Have you or your spouse (if he/she is pursuing a loss of consortium claim) received any money from a third party in exchange for an assignment of any portion of your claim or recovery in this lawsuit, so that the payer or assignee has decision making authority over the terms of any settlement or other resolution of your claim or has lien rights (excluding liens by healthcare providers) against any funds generated by the resolution of your claim? Yes No X If Yes, please state: The name and address of the third party with whom you have entered into such a contract. Not applicable Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 8 of 25 IV. HEALTHCARE PROVIDERS 1. Identify each doctor, healthcare provider, hospital, clinic, surgery center, healthcare facility, physical therapy or rehabilitation centers (including but not limited to family/primary care physicians, surgeons, urologists, gynecologists, infectious disease specialists, physical therapists, practitioners of the healing arts) whom you have seen for medical care and treatment for the period ten years before your ObTape surgery to the present. Name (Specialty) Address and Telephone Number Approx Dates/Years of Visits Reason/Procedure Performed Dr. Aimee Pearson, Shelby Family Practice 1124 North Washington Street, Shelby, NC 28150 (704) 980-1148 Cannot recall — multiple years Primary care physician Dr. Robert Gossett, Carolina Urology Partners PLLC 1001 North Washington Street, Shelby, NC 28150 (704) 482-2011 Cannot recall — multiple years Incontinence Dr. Michael Keeley, Boiling Springs Women's Care 335 West College Avenue, Shelby, NC 28152 (704) 434-0990 Cannot recall — multiple years Pelvic Pain Dr. David Barker, Cleveland Urologic Surgery 1001 North Washington Street, Shelby, NC 28150 (704) 482-2011 Cannot recall — multiple years Incontinence Dr. Evelyn Rabindran, Shelby Medical Associates 711 N Dekalb Street Shelby, NC 28150 (704) 482-1482 Cannot recall — multiple years Primary care physician Cleveland Regional Hospital 201 E Grover Street, Shelby, NC 28150 (980) 487-3816 2001 May 2004 July/Aug 2004 August 2006 December 2006 May 2008 June 2010 August 2012 Two foot surgeries Sling surgery Uterine scalding Right shoulder surgery Hysterectomy Hemorrhoidectomy Frontal lobe sinus surgery Sling revision 8 Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 9 of 25 Charlotte Presbyterian 200 Hawthorne Ln October 1997 Spinal surgery Hospital Charlotte, NC 28204 (704) 384-4000 2000 Spinal/neck surgery March 2005 Right hand carpal tunnel surgery May 2005 Left hand carpal tunnel surgery July 2005 Thumb surgery Gaston Hospital 2525 Court Drive May 2012 Foot surgery Gastonia, NC 28054 (704) 834-2000 Charlotte Pain Clinics Cannot recall 1999-2002 Various pain treatments 2. Identify each pharmacy, drugstore or any other facility or supplier (including but not limited to mail order pharmacies) where you ever received any prescription medication for the period ten years before your ObTape surgery to the present. Name of Pharmacy/Supplier Address and Telephone Number of Pharmacy/Supplier Approx Dates/Years You Used Pharmacy/Supplier CVS 1830 W Dixon Blvd Shelby, NC 28150 (704) 482-0336 1977 - present Medical Arts 108 E Grover Street Shelby, NC 28150 (704) 487-0557 Cannot recall Eckerds Cannot recall Cannot recall 9 Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 10 of 25 V. MEDICAL BACKGROUND 1. Current Height: 5' 2" 2. Please state your weight at the following times: (a) Current: 200 (b) Time of implant: 175 (c) Time of explant/excision surgery (if any): 200 3. Smoking History (a) Have you ever smoked cigarettes? Yes No X State amount smoked: N/A packs per day for N/A years, during the years N/A to N/A 4. Other Conditions (a) To the best of your knowledge, have you ever experienced or been diagnosed with any of the following conditions from the time beginning ten years before your ObTape surgery to the present? Please select Yes or No for each condition. For each condition for which you answer Yes, please provide the additional information requested in the table following this chart: Condition Experienced or Diagnosed Yes No Don't Know 1. Abnormal pap smear X 2. Autoimmune disease X 3. Bacterial vaginosis X 4. Cervical cancer X 5. Cystocele X 6. Diabetes X 7. Endometriosis X 8. Gestational diabetes X 9. Hormone deficiency X 10. Hypertension/high blood pressure X 11. Interstitial cystitis X 12. Obesity X 13. Ovarian cancer X 14. Pelvic inflammatory disease X 15. Polycystic ovary disease X 10 Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 11 of 25 Condition Experienced or Diagnosed Yes No Don't Know 16. Rectocele X 17. Stress urinary incontinence X 18. Thyroid disorder X 19. Toxic shock syndrome . X 20. Urethral erosion X 21. Urinary tract infection X 22. Urge incontinence X 23. Uterine cancer X 24. Vaginal erosion X 25. Vaginal infection X 26. Venereal disease X 27. Yeast infection X (b) For each condition for which you answered Yes in the previous chart, please provide the information requested below: Condition You Experienced Approximate Date of Onset Name, Address and Telephone Number of Treating Physician (if any) Treatment Received Gestational diabetes 1982 Dr. Michel Keeley 335 West College Avenue Shelby, NC 28152 (704) 434-0990 Diet High blood pressure January 2014 Dr. Aimee Pearson 1124 N Washington Street Shelby, NC 28150 (704) 980-1148 Losartan Potassium Obesity 2007 Dr. Michael Keeley 335 West College Avenue Shelby, NC 28152 (704) 434-0990 Diet Polycystic ovary disease 1981 Cannot recall Cannot recall Stress urinary incontinence 2004 Dr. David Barker 1001 N Washington Street Shelby, NC 28150 (704) 482-2011 Dr. Michael Keeley 335 West College Avenue Shelby, NC 28152 (704) 434-0990 Dr. Robert Gossett 1001 N Washington Street Shelby, NC 28150 (704) 482-2011 Bladder sling 11 Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 12 of 25 Urinary tract infection Cannot recall Cannot recall Cannot recall Urge incontinence 2004 Dr. David Barker 1001 N Washington Street Shelby, NC 28150 (704) 482-2011 Dr. Michael Keeley 335 West College Avenue Shelby, NC 28152 (704) 434-0990 Dr. Robert Gossett 1001 N Washington Street Shelby, NC 28150 (704) 482-2011 Bladder sling Vaginal infection Cannot recall Cannot recall Cannot recall Yeast infection 1977 Dr. Robert Gossett 1001 N Washington Street Shelby, NC 28150 (704) 482-2011 Monistat 12 Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 13 of 25 VI. MEDICATIONS 1. List all of the medications (prescription and over the counter) you currently take. Medication Dose/ Frequency/Dates of Use Physician Ordering Pharmacy Dispensing Purpose Gummy vitamins 1/twice daily/cannot recall OTC N/A General Health Vitamin B12 3000mg/twice daily/cannot recall OTC N/A Energy Nexium 40mg/once daily/cannot recall Dr. Aimee Pearson CVS Acid reflux Losartan Potassium 50mg/once daily/cannot recall Dr. Aimee Pearson CVS High blood pressure Lipitor Once daily/cannot recall Dr. Aimee Pearson CVS Lowering cholesterol Mirapex Once daily/cannot recall Dr. DeArment CVS Restless leg syndrome Hydrocodone 5/325mg/once daily/cannot recall Dr. Aimee Pearson CVS Pain Clonazepam As needed/cannot recall Dr. Aimee Pearson CVS Anxiety Potassium gluconate 595mg/once daily/cannot recall Dr. Aimee Pearson CVS Low potassium Meclizine 25mg/once daily/cannot recall Dr. Aimee Pearson CVS Vertigo Aspirin BC 325mg/once daily/cannot recall Dr. Gabriel Rocha CVS Stroke prevention 2. To the best of your recollection, are there any prescription medications other than those identified that you have taken on a regular basis for any duration of more than two months for the period ten years before your ObTape surgery to the present? Yes X No 13 Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 14 of 25 If Yes, please identify the medication(s), the doctor(s) who prescribed it, the approximate dates/years you have taken this medication, and why it was given to you: Medication Dose/ Frequency/Dates of Use Physician Ordering Pharmacy Dispensing Purpose Various pain medications Cannot recall Cannot recall Cannot recall Pain Various stomach medications Cannot recall Cannot recall Cannot recall Gastrointestinal issues 14 Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 15 of 25 VII. IMPLANT AND EXCISION/REMOVAL 1. Describe the condition for which the ObTape was implanted: Stress urinary incontinence 2. Before the implantation of the ObTape, did you receive non-surgical treatment for your stress urinary incontinence? Yes No X (a) State the period during which you received non-surgical treatment: Not applicable (b) State the nature of the non-surgical treatment (e.g., physical therapy, medication, injections): Not applicable (c) State the name and address of all doctors or health care providers involved in your non-surgical treatment: Not applicable 3. Did you see, read or rely upon any documents or other information from Mentor in making your decision to have the ObTape implanted? Yes X No (a) If Yes, identify each document/source of information. Pamphlet of information about the bladder sling (b) When did you read the document/receive the information? Prior to the implantation surgery, while meeting with Dr. Keeley at his office (c) How did you obtain the document or information? It was given to me by Dr. Keeley at his office. 15 Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 16 of 25 (d) Do you have the document or written information in your possession? If so, please produce a copy of it together with your answers to the Plaintiff Fact Sheet. Yes No I don't know X 4. Have you had any communications with any present or former employee of Mentor or concerning ObTape or matters in any way related to this lawsuit? Yes No X If Yes, for each, please state: Date of Communication Name of Person with Whom You Communicated Mode of Communication Do you have a writing or recording? (IF SO, PLEASE ATTACH)(In Person, By Phone, By Email, By Mail) Not applicable If the communication was by phone or in-person, please tell us what was said: Not applicable 16 Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 17 of 25 VIII. INJURIES & DAMAGES 1. Are you claiming any physical injuries or illness as a result of the ObTape? Yes X No If Yes, please describe in detail the following: (a) The physical injuries or illness claimed and when the symptoms began: Vaginal bleeding 2004 Vaginal infections 2004 Chronic vaginal drainage 2012 Pain during urination and intercourse 2004 Localized pelvic pain 2004 Recurrence of urinary incontinence 2012 (b) Are those injuries or illnesses continuing? Yes X No (c) Provide the name and address of each health care provider that you have seen for these problems: Condition You Experienced Name, Address and Telephone Number of Health Care Provider (if any) Pelvic pain, vaginal infections Dr. Michael Keeley 335 West College Avenue, Shelby, NC 28152 (704) 434-0990 Incontinence Dr. David Barker Dr. Robert Gossett 1001 North Washington Street, Shelby, NC 28150 (704) 482-2011 17 Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 18 of 25 2. Have you ever been hospitalized as a result of any of these conditions? Yes X No If Yes, please provide the following information: (i) Approximate date(s) of hospital admission: Dec 2006, Aug 2014 (ii) Approximate date(s) of discharge: Dec 2006, Aug 2014 (iii)Hospital names(s) and address(es): Cleveland Regional Hospital 201 E Grover Street, Shelby, NC 28150 3. Do you claim any psychological or psychiatric injury (other than garden variety emotional distress) as a consequence of having the ObTape? Yes No X If Yes, please state the following as it pertains to your treatment for any psychiatric and/or psychological condition(s): Condition Name and Address of Mental Healthcare Provider (if any) Approx. Dates/Years of Treatment/Visits (if any) Not applicable 4. Are you making a claim for lost wages or lost earning capacity? Yes No X (a) If Yes, describe your claim and attach your W-2 forms for the relevant years. Your description should include the total amount of time (and amount of income) which you have lost or will lose from work as a result of any condition which you claim or believe was caused by the ObTape, and an explanation of how those amounts were calculated: Not applicable 18 Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 19 of 25 (b) If you claim a loss of earnings, state your earned income from work for the following years: YEAR INCOME 2012 $ Not applicable 2011 $ Not applicable 2010 $ Not applicable 2009 $ Not applicable 2008 $ Not applicable 2007 $ Not applicable 2006 $ Not applicable 2005 $ Not applicable 2004 $ Not applicable 2003 $ Not applicable 5. Is your spouse claiming loss of consortium? Yes No X 6. Is your spouse claiming physical injury from the ObTape? Yes No X If Yes, please describe in detail the following: (a) The physical injuries claimed and the approximate date of treatment for each injury, and identify the name and address of each health care provider that your spouse has seen for these problems: Condition Spouse Experienced Approximate Date of Treatment Name, Address and Telephone Number of Health Care Provider (if any) Not applicable 19 Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 20 of 25 IX. MEDICAL AND OUT-OF-POCKET EXPENSES 1. State the amount of medical expenses, by provider,, which you have incurred, including amounts billed to insurers and other third party payors, which are related to any condition which you claim or believe was caused by the ObTape for which you seek recovery in this action: Name and Address of Provider Dates of Treatment Description of Treatment Amount of Medical Expenses Not calculated at this time — plaintiff will supplement as more information is gathered $ $ For any expenses claimed above, have they been reimbursed by any third party? Yes No *Unknown at this time If Yes, identify which expenses, the amount reimbursed and the date reimbursed. Unknown at this time 20 Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 21 of 25 X. FACT WITNESSES Please identify all persons whom you believe possess information concerning you injury(ies) and current medical conditions, other than your healthcare providers, and please state their name, address, and relationship to you: Name: Daniel Grigg Address: 3605 Grigg Road, Shelby, NC 28150 Relationship to you: Husband Name: Lindsay Grigg Address: 3605 Grigg Road, Shelby, NC 28150 Relationship to you: Daughter Name: Andrew Grigg Address: Unknown Relationship to you: Son 21 Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 22 of 25 XI. DOCUMENT DEMANDS These document requests are not intended to seek attorney client communications, or attorney work product materials. In addition, these requests do not encompass or seek information about expert witnesses or communications with and/or from experts or proposed trial exhibits or trial materials which may be subject to disclosure at a later date in accordance with subsequent Court Order or rule. Thus, if you have any of the following in your possession which is not protected as set forth above, please provide a copy of it with this Plaintiff Fact Sheet. REQUEST NO. 1: All medical records (including, but no limited to, all charts, hospital records, consent forms, treating. physician records, photographs, videotapes/DVDs, drawings, X- rays, ultrasounds, MRIs, CT scans, radiographs, angiograms, blood tests, laboratory reports, prescriptions, spirometry tests, electrocardiograms, urine tests, blood gases tests, psychometric tests, neuropsychological tests, stress tests, notes, telephone messages) from any physician, hospital, clinic, health care provider, pharmacy, psychiatrist, psychologist, counselor or therapist created since 1990 reflecting, referring or relating to Plaintiff. REQUEST NO. 2: All medical bills for which plaintiff seeks recovery in this lawsuit, as well as all documents relating to third-party payments of medical bills. REQUEST NO. 3: All records of any other expenses (including, but not limited to, nursing services, outpatient care, home health care, lost wages, etc.) allegedly incurred as a result of the injuries alleged in the complaint. REQUEST NO. 4: All photographs and videos of plaintiff's surgery and all photographs and videos of plaintiff which show plaintiffs condition since the date of the original implantation. REQUEST NO. 5: Any documents including but not limited to literature, warnings or informed consent forms received by you from surgeons, physicians, or other health care professionals who have treated you for any condition related to ObTape. 22 Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 23 of 25 XII. AUTHORIZATIONS Complete and sign the Authorization attached as Exhibit A. Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 24 of 25 XIII. VERIFICATION I declare under penalty of perjury that all of the information provided in this Plaintiff Fact Sheet is true and correct to the best of my knowledge upon information and belief, that I have supplied all the documents requested in part XI of this declaration, to the extent that such documents are in my possession, custody, or control, or in the possession, custody, or control of my lawyers, and that I have supplied the authorization attached to this declaration. Date: Z-D, 7-Da, .eiteAtiti 5z.) ignatu 24 Case 4:13-cv-00393-CDL Document 33-5 Filed 07/25/16 Page 25 of 25 EXHIBIT C Case 4:13-cv-00393-CDL Document 33-6 Filed 07/25/16 Page 1 of 5 Lackey v. DePuy Orthopaedics, Inc., Not Reported in F.Supp.2d (2011) 2011 WL 2791264 2011 WL 2791264 Only the Westlaw citation is currently available. United States District Court, W.D. North Carolina, Statesville Division. Randy D. LACKEY, Plaintiff, v. DePUY ORTHOPAEDICS, INC., Defendant. No. 5:10—cv-00030—RLV—DSC. July 14, 2011. Attorneys and Law Firms Angela Newell Gray, Gray Newell, LLP, Greensboro, NC, for Plaintiff. John E. Grupp, Parker Poe Adams & Bernstein L.L.P., Charlotte, NC, for Defendant. ORDER RICHARD L. VOORHESS, District Judge. *1 THIS MATTER is before the Court on Defendant DePuy Orthopaedics, Inc.'s Motion to Dismiss (Doc. # 2) and accompanying Memorandum in Support (Doc. # 3), filed March 16, 2010; Plaintiffs Memorandum in opposition to Defendant DePuy's Motion to Dismiss (Doc. # 7), filed April 4, 2010; and Defendant's Reply Memorandum in Support of its Motion to Dismiss (Doc. # 8), filed April 14, 2010. This matter is now ripe for disposition. I. Background Plaintiff Randy D. Lackey ("Lackey") is a citizen of the state of North Carolina. 1 Compl. ¶ 1. Defendant DePuy Orthopaedics, Inc. ("DePuy") is a corporation engaged in the business of manufacturing, designing, assembling, inspecting, and distributing prosthetic hip components. Id ¶ 5. On January 19, 1998, Lackey underwent hip replacement surgery. Id. ¶ 2. During this surgery, Lackey received a hip prosthetic manufactured and distributed by DePuy. 2 Subsequent to the hip replacement surgery, in approximately January 2009, the Plaintiff experienced a painful abrupt popping sensation in his left hip. Plaintiff began having discomfort and constant and severe pain in his left hip. Id. ¶ 7. In June 2009, Plaintiff underwent a left total hip revision, allegedly to address the damage caused by the defective hip prosthetic. Id. ¶ 9. Plaintiff contends that the design of the prosthetic device, the selection of the materials from which it was fabricated, the manufacturing procedures by which it was made, and the inspection procedures attendant on the manufacturer Defendant, were solely within the control of the Defendant and were the cause of the failure of the device which resulted in Plaintiffs injuries. Id. ¶ 10. Plaintiffs Complaint asserts claims for: (1) negligent infliction of injury, (2) breach of express warranty, and (3) breach of implied warranty. II. Standard of Review When deciding a motion to dismiss, the plaintiff must allege facts in the Complaint that "raise a right to relief above the speculative level." Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007). A complaint will not survive a Motion to Dismiss where it contains "naked assertion[s] devoid of further factual enhancement." Id. at 557. Instead, a complaint "must contain sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face.' " Ashcroft v. Iqbal, 129 S.Ct. 1937, 1949 (2009) (citations omitted). A "claim has facial plausibility when the plaintiff pleads sufficient factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id at 1949. When ruling on a motion to dismiss, "a judge must accept as true all of the factual allegations contained in the complaint." Erickson v. Pardus, 551 U.S. 89, 94 (2007) (per curiam). However, a court "need not accept as true unwarranted inferences, unreasonable conclusions, or arguments." Eastern Shore Mkt.'s Inc. v. J.D. Assoc.'s LLP, 213 F.3d 175, 180 (4th Cir.2000). III. Discussion A. Plaintiffs Claims for Negligence and Breach of Warranty Sound in Product Liability *2 As a threshold issue, this Court must determine the nature of the Plaintiffs claims. Plaintiffs Complaint asserts the following claims: (1) negligent infliction of VOESTLA' •• © 2016 Thomson Reuters. No claim to original U.S. Government Works. 1 Case 4:13-cv-00393-CDL Document 33-6 Filed 07/25/16 Page 2 of 5 Lackey v. DePuy Orthopaedics, Inc., Not Reported in F.Supp.2d (2011) 2011 WL 2791264 injury; (2) breach of implied warranty; and (3) breach of express warranty. Defendant contends that Plaintiffs claims are multiple ways of asserting a product liability action. A " Ip]roduct liability action' includes any action brought for or on account of personal injury, death or property damage caused by or resulting from the manufacture, construction, design, formulation, development of standards, preparation, processing, assembly, testing, listing, certifying, warning, instructing, marketing, selling, advertising, packaging, or labeling of any product." Couick v. Wyeth, Inc., 691 F.Supp.2d 643, 645 (W.D . N.C.2010) (citing N.C. Gen.Stat. § 99B-1(3)). A thorough review of Plaintiffs Complaint reveals that Plaintiffs claims all stem from the purchase of an allegedly defective hip prosthetic designed and manufactured by DePuy. Plaintiff alleges personal injury and damages caused by the purportedly defective hip prosthetic. Artful pleading does not allow Plaintiff to transform product liability claims into claims sounding in negligence and breach of warranty. See Couick v. Wyeth, Inc., No. 3:09—cv-00210—RJC—DSC, 2010 WL 785952, at *2 (W.D.N. C. March 8, 2010) (holding that each of Plaintiffs 11 claims for relief, ranging from negligence to unfair and deceptive trade practices, was grounded in the injuries Plaintiff allegedly suffered from the inadequate warnings associated with defendants' drug and, therefore, constituted a single product liability action). Plaintiffs claims clearly fall within North Carolina's definition of a product liability action. B. Plaintiffs Claims are Barred by the Statute of Repose Defendant contends that this Court should dismiss Plaintiffs claims because they are barred by the product liability statute of repose. Plaintiff argues that the applicable statute of repose is N .C. Gen.Stat. § 1-46.1, which would provide Plaintiff with twelve years from the initial purchase date to bring a claim for an injury resulting from the defective prosthetic hip. Defendant argues that the applicable statute of repose is N.C. Gen.Stat. § 1-50(a) (6), which was in effect at the time Plaintiff purchased the allegedly defective product. This Court agrees with Defendant. All product liability claims, regardless of their nature, are subject to a statute of repose. Nat'l Property Investors, VIII v. Shell Oil Co., 950 F.Supp. 710, 713 (E.D.N.C.1996); Colony Hill Condominium I Ass'n v. Colony Co., 320 S.E.2d 273 (N.C.Ct.App.1984), review denied, 325 S.E.2d 485 (1985) (noting that the North Carolina legislature intended that the product liability statute of repose cover "the multiplicity of claims that can arise out of a defective product"). Compliance with the statute of repose is a condition precedent to a product liability action. See Winslow v. Dedmon, 615 S.E.2d 41, 44 (N.C.Ct.App.2005) (noting that unlike a statute of limitations which affects a plaintiffs remedy and not his right to recover, the statute of repose establishes a time period in which suit must be brought in order for the cause of action to be recognized). "If the action is not brought within the specified time period, the plaintiff literally has no cause of action." Id at 615 S.E.2d at 44 (emphasis in original). A statute of repose bars a right of action even before injury has occurred, in instances when the injury occurs outside of the prescribed time period. Bollick v. Am. Barmag Corp ., 293 S.E.2d 415, 418 (N.C.1982). The purpose of the statute of repose is to "limit the manufacturer's liability at some definite point in time." Chicopee, Inc. v. Sims Metal Works, Inc. 391 S.E .2d 211, 214 (N.C.Ct.App.1990) (emphasis in original). *3 Plaintiff purchased the allegedly defective hip in January 1998. The applicable statute of repose for a product liability claim for the period of October 1, 1979, through October 1, 2009, was N.C. Gen.Stat. § 1-50(a)(6), which provides that: No action for the recovery of damages for personal injury, death or damage to property based upon or arising out of any alleged defect or any failure in relation to a product shall be brought more than six years after the date of initial purchase for use or consumption. N.C. Gen.Stat. § 1-50(a)(6). This statute functions as an "unyielding and absolute barrier" to claims brought more than six years after the product at issue was purchased. Nat'l Property Investors, VIII v. Shell Oil, 950 F.Supp. 710, 713 (1996). The statute "is intended to be a substantive definition of rights which sets a fixed limit after the time of the product's manufacture beyond which the seller will not be held liable." Id (quoting Bryant v. Adams, 448 S.E.2d 832, 836 (N.C.Ct.App.1994), review denied, 454 S.E.2d 647 (1995). "This statute gives the defendant a 'vested right not to be sued' if the plaintiff fails to file within the six-year period." Id As such, in order for Plaintiff to :UAW CO 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:13-cv-00393-CDL Document 33-6 Filed 07/25/16 Page 3 of 5 Lackey v. DePuy Orthopaedics, Inc., Not Reported in F.Supp.2d (2011) 2011 WL 2791264 have a cognizable product liability claim against DePuy, Plaintiff must have asserted the claim within six years of the initial purchase of the allegedly defective prosthetic hip device. Plaintiff failed to bring any claim against Defendant within the time period established by the statute of repose. Put another way, Plaintiffs claims were barred and extinguished by the statute of repose on January 19, 2004. It is undisputed that Plaintiff filed this action approximately 12 years after Plaintiffs initial use and consumption of the subject prosthetic hip device. Accordingly, the statute of repose is an insurmountable bar to any recovery by Plaintiff. C.N.C. Gen. Stat. § 1-46.1 Does Not Apply to This Case Plaintiff argues that the applicable statute of repose in the instant case is N.C. Gen.Stat. § 1-46.1, 3 which provides that: No action for the recovery of damages for personal injury, death, or damage to property based upon or arising out of any alleged defect or any failure in relation to a product shall be brought more than 12 years after the date of initial purchase for use or consumption. N.C. Gen.Stat. § 1-46.1. Plaintiff argues that because Plaintiff purchased the prosthetic hip device on January 19, 1998 and then filed the present action on January 14, 2010, it is apparent from the face of the Complaint that Plaintiff did bring this action within the time limit established by N.C. Gen.Stat. § 1-46.1. Plaintiffs argument is misplaced. The thrust of Plaintiffs argument is that when the North Carolina General Assembly modified the statute of repose for product liability claims in 2009 it revived Plaintiffs claim. Plaintiffs argument misses the mark and has been specifically rejected by the North Carolina Supreme Court and the North Carolina Court of Appeals. McCarter v. Stone & Webster Eng'g Corp., 104 S.E.2d 858 (N.C.1958); Colony Hill Condominium I Ass'n v. Colony Co., 320 S.E.2d 273 (N.C.Ct.App.1984), review denied, 325 S.E.2d 485 (1985). In Colony Hill, the North Carolina Court of Appeals held that the real property statute of repose in effect at the time the plaintiff purchased a condominium applied despite the fact that a subsequently-enacted law extended the statute of repose. Colony Hill, 320 S.E.2d at 275-76. The Court of Appeals went on to reject the plaintiffs argument that the subsequently-enacted statute of repose revived Plaintiffs claims. Id Similarly, in McCarter, the North Carolina Supreme Court held that a subsequent statute extending the time for filing a claim after a worker's compensation accident did not revive the plaintiffs claim. Plaintiff fails to present any argument addressing why the newly-enacted statute of repose in the instant case would revive a previously extinguished claim. The precedent set forth in McCarter and Colony Hill provides further support for the dismissal of Plaintiffs claims under N.C. Gen.Stat. § 1-50(a)(6). *4 The analysis articulated in McCarter and Colony Hill is also consistent with the legislative intent and purpose behind the statute of repose. As the North Carolina Supreme Court has explained, statutes of repose are distinguishable from ordinary statutes of limitation in that they begin to run "at a time unrelated to the traditional accrual of the cause of action." Bollick v. Am. Barmag Corp., 293 S.E.2d 415, 418 (N.C.1982). Unlike statutes of limitation which are procedural in nature, statutes of repose are substantive, deriving their substantive quality from the fact that they will bar a right of action even before injury has occurred if the injury occurs subsequent to the prescribed time period. Id. The intent of the legislature in enacting the statute of repose was "to limit the manufacturer's liability at some definite point in time." Chicopee, Inc. v. Sims Metal Works, Inc., 391 S.E.2d 211, 214 (1990) (emphasis in original) (citing Tetterton v. Long Mfg. Co., 332 S.E.2d 67, 74 (1985)). The legislature wanted to avoid subjecting manufacturers to "open-ended liability created by allowing claims for an indefinite period of time after the product was first sold and distributed." Id (emphasis in original). Because the statute of repose is a condition precedent, it establishes a time period in which suit must be brought for a cause of action to be recognized —if the condition precedent is not met, the court does not acquire jurisdiction. Nello L. Teer Co. v. N. C. Dep't of Transp., 625 S.E.2d 135, 137 (N.C.Ct.App.2006). In sum, N.C. Gen.Stat. § 1-50(a)(6) set the fixed time limit at six years from the time of the product's sale or delivery beyond which DePuy cannot be liable for a product sold in 1998. A statute enacted after expiration of that six-year period, such as N.C. Gen.Stat. § 1-46.1, cannot change that outcome. Accordingly, Plaintiffs Complaint must be dismissed. IV. CONCLUSION THEREFORE, IT IS HEREBY ORDERED that: WEST © 2016 Thomson Reuters. No claim to original U.S. Government Works. 3 Case 4:13-cv-00393-CDL Document 33-6 Filed 07/25/16 Page 4 of 5 Lackey v. DePuy Orthopaedics, Inc., Not Reported in F.Supp.2d (2011) 2011 WL 2791264 (1) Defendant's Motion to Dismiss (Doc. # 2) is GRANTED. All of Plaintiffs claims are therefore dismissed and the case is closed. All Citations Not Reported in F.Supp.2d, 2011 WL 2791264 Footnotes 1 All facts are presented in the light most favorable to Plaintiff, the party opposing the Motion to Dismiss. 2 Lackey originally filed this suit in the North Carolina General Court of Justice, Superior Court Division, against Depuy and Biomet 3i, LLC. Lackey subsequently dismissed Biomet 3i, LLC without amending his Complaint. The Court assumes that Plaintiffs allegations in the Complaint originally designated as the responsibility of both Defendants can apply solely to Defendant DePuy. 3 In 2009, N.C. Gen.Stat. § 1-50(a)(6) was repealed by Session Law 2009-420, effective October 1, 2009. Session Law 2009-420 applies only to causes of action that accrue on or after October 1, 2009. See Act of Aug. 5, 2009, S.L.2009-420 § 3 (2009) (clarifying and reforming the statutes of limitation and repose in product liability actions). Even when viewing the facts in the light most favorable to Plaintiff, Plaintiffs cause of action accrued on or about January 2009. As a result, N.C. Gen.Stat. § 1-46.1., by its terms, does not apply to the instant case. End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works. liVESTLAW © 2016 Thomson Reuters. No claim to original U.S. Government Works. 4 Case 4:13-cv-00393-CDL Document 33-6 Filed 07/25/16 Page 5 of 5 EXHIBIT D Case 4:13-cv-00393-CDL Document 33-7 Filed 07/25/16 Page 1 of 8 Case 4:12-cv-00335-CDL Document 46 Filed 03/04/16 Page 1 of 7 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION IN RE MENTOR CORP. OBTAPE MDL Docket No. 2004 4:08-MD-2004 (CDL) TRANSOBTURATOR SLING PRODUCTS Case Nos. LIABILITY LITIGATION 4:12-cv-335 (Wallace) ORDER Defendant Mentor Worldwide LLC developed a suburethral sling product called ObTape Transobturator Tape, which was used to treat women with stress urinary incontinence. Plaintiff Gale Wallace was implanted with ObTape and asserts that she suffered injuries caused by ObTape. Mrs. Wallace brought a product liability action against Mentor, contending that ObTape had design and/or manufacturing defects that proximately caused her injuries. Mrs. Wallace also contends that Mentor did not adequately warn her physicians about the risks associated with ObTape. Mrs. Wallace's husband asserts a loss of consortium claim. Mentor seeks summary judgment on the Wallaces' claims, contending that they are barred under North Carolina's statute of repose. The Court agrees, and Mentor's summary judgment motion (ECF No. 39 in 4:12-cv-335) 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 Case 4:13-cv-00393-CDL Document 33-7 Filed 07/25/16 Page 2 of 8 Case 4:12-cv-00335-CDL Document 46 Filed 03/04/16 Page 2 of 7 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 Dr. Thomas Barefoot implanted Mrs. Wallace with ObTape on March 24, 2005 to treat her stress urinary incontinence. Within three or four months of the surgery, Mrs. Wallace began experiencing dyspareunia, which she attributed to ObTape. She contends that she continues to suffer ObTape complications. The Wallaces are North Carolina residents, and all of Mrs. Wallace's ObTape-related treatment took place in North Carolina. The Wallaces filed their action in this Court pursuant to the Court's direct filing order on December 13, 2012, asserting claims for negligence, strict liability - design defect, strict liability - manufacturing defect, strict liability - failure to warn, breach of implied warranties, breach of express warranties, fraudulent misrepresentation, fraudulent 2 Case 4:13-cv-00393-CDL Document 33-7 Filed 07/25/16 Page 3 of 8 Case 4:12-cv-00335-CDL Document 46 Filed 03/04/16 Page 3 of 7 concealment, and negligent misrepresentation. Mr. Wallace asserts a loss of consortium claim. DISCUSSION The Wallaces filed their action in this Court under the Court's direct filing order. The parties agreed that for direct-filed cases, the "Court will apply the choice of law rules of the state where the plaintiff resides at the time of the filing of the complaint." Order Regarding Direct Filing § II(E), ECF No. 446 in 4:08-md-2004. The Wallaces are North Carolina residents, and Mrs. Wallace's ObTape-related treatment took place in North Carolina. The parties agree that North Carolina law applies to the Wallace's claims. Mentor contends that the Mrs. Wallace's claims are barred by North Carolina's statute of repose and that Mr. Wallace's loss of consortium claim fails because Mrs. Wallace's claim fails. Until 2009, North Carolina law provided that no personal injury claims "based upon or arising out of any alleged defect or any failure in relation to a product shall be brought more than six years after the date of initial purchase for use or consumption." N.C. Gen. Stat. § 1-50(a)(6) (1995). On October 1, 2009, a new statute of repose for product liability claims became effective: no personal injury claims "based upon or arising out of any alleged defect or any failure in relation to a product shall be brought more than 12 years after the date of 3 Case 4:13-cv-00393-CDL Document 33-7 Filed 07/25/16 Page 4 of 8 Case 4:12-cv-00335-CDL Document 46 Filed 03/04/16 Page 4 of 7 initial purchase for use or consumption." N.C. Gen. Stat. § 1- 46.1(1). The new rule became effective on October 1, 2009 and applies only "to causes of action that accrue on or after that date." 2009 N.C. Sess. Laws 2009-420 § 3. North Carolina courts apply the statute of repose in effect at the time of the initial product sale or delivery. Robinson v. Bridgestone/Firestone N. Am. Tire, LLC, 703 S.E.2d 883, 886- 87 (N.C. Ct. App. 2011 (applying statute of repose in effect when the allegedly defective tires were initially purchased in 1995 or 1996 and declining to apply N.C. Gen. Stat. § 1-46.1(1) (2009)); see Lackey v. DePuy Orthopaedics, Inc., No. 5:10-CV- 00030-RLV, 2011 WL 2791264, at *3 (W.D.N.C. July 14, 2011) (applying statute of repose in effect when allegedly defective replacement hip was purchased in 1998); see also Colony Hill Condo. I Ass'n v. Colony Co., 320 S.E.2d 273, 276 (N.C. Ct. App. 1984) (applying real property statute of repose in effect when the plaintiff purchased his condominium); McCrater v. Stone Webster Eng'g Corp., 104 S.E.2d 858, 860 (N.C. 1958) (applying worker's compensation statute of limitations in effect on the date of the plaintiff's accident); cf. Black v. Littlejohn, 325 S.E.2d 469, 474-75 (N.C. 1985) ("Unlike an ordinary statute of limitations which begins running upon accrual of the.claim, the period contained in the statute of repose begins when a specific event occurs, regardless of whether a cause of action has Case 4:13-cv-00393-CDL Document 33-7 Filed 07/25/16 Page 5 of 8 Case 4:12-cv-00335-CDL Document 46 Filed 03/04/16 Page 5 of 7 accrued or whether any injury has resulted.") (citations omitted). Therefore, the 1995 statute of repose applies here. Mrs. Wallace nonetheless argues that § 1-50(a)(6) does not apply to her claims, citing Wilder v. Amatex Corp., 336 S.E.2d 66 (N.C. 1985). In Wilder, the North Carolina Supreme Court considered N.C. Gen. Stat. § 1-15(b), which was North Carolina's statute of limitations for certain claims until it was repealed in 1979. The statute contained a ten-year statute of repose "from the last act of the defendant giving rise to the claim for relief." Id. at 69 (quoting N.C. Gen. Stat. § 1-15(b) (Interim Supp. 1976) (repealed 1979)). The Wilder court found that § 1- 15(b) did not apply to the plaintiff's personal injury claim related to the disease of asbestosis and that a different statute of limitations (without a statute of repose) applied to the plaintiff's claims. Id. at 73. And the Wilder court found that the plaintiff's claims did not accrue until he was diagnosed with asbestosis. Id. Based on Wilder, the Fourth Circuit predicted that the North Carolina Supreme Court would hold that § 1-50(6) did not apply to "claims arising from disease." Hyer v. Pittsburgh Corning Corp., 790 F.2d 30, 33-34 (4th Cir. 1986). But the Fourth Circuit suggested that its rationale was limited to diseases that "develop over long periods of time after multiple exposures to offending substances which are thought to be causative agents," where it "is Case 4:13-cv-00393-CDL Document 33-7 Filed 07/25/16 Page 6 of 8 Case 4:12-cv-00335-CDL Document 46 Filed 03/04/16 Page 6 of 7 impossible to identify any particular exposure as the 'first injury.'" Id. at 33. Mrs. Wallace's claim is not a claim arising from disease that developed over many years after multiple exposures to a toxic substance; it is a claim arising from complications 'she contends were caused by a medical device that was implanted in her body. Wilder simply does not apply. Under § 1-50(a)(6), the 1995 statute of repose, no personal injury claims "based upon or arising out of any alleged defect or any failure in relation to a product shall be brought more than six years after the date of initial purchase for use or consumption." N.C. Gen. Stat. § 1-50(a)(6) (1995). Therefore, a personal injury cause of action based on a product defect must be brought within six years of the date when the product was initially purchased for use or consumption. Robinson, 703 S.E.2d at 887 (finding that to bring a claim related to an allegedly defective tire, the plaintiffs had to prove that the "tire was initially purchased within six years of the filing of the complaint"); see also Bryant v. Don Galloway Homes, Inc., 556 S.E.2d 597, 600 (N.C. Ct. App. 2001) (noting that a statute of repose begins to run when the statutory triggering event occurs, "regardless of whether or not there has been an injury"); cf. Black, 325 S.E.2d at 475 (noting that "the repose serves as an unyielding and absolute barrier that prevents a plaintiff's right of action even before his cause of action may Case 4:13-cv-00393-CDL Document 33-7 Filed 07/25/16 Page 7 of 8 Case 4:12-cv-00335-CDL Document 46 Filed 03/04/16 Page 7 of 7 accrue"). Here, it is undisputed that Mrs. Wallace's ObTape was initially purchased for use on March 24, 2005 at the latest, when the ObTape was implanted into her body. Mrs. Wallace did not file her Complaint until more than seven years later, on December 13, 2012. Her claims are barred by the North Carolina statute of repose, and Mentor is entitled to summary judgment on all of her claims. Mr. Wallace's derivative loss of consortium claim is likewise barred. See King v. Cape Fear Mem'l Hosp., Inc., 385 S.E.2d 812, 814 (N.C. Ct. App. 1989) (affirming motion to dismiss loss of consortium claim where underlying claim was time-barred). CONCLUSION As discussed above, Mentor's summary judgment motion (ECF No. 39 in 4:12-cv-335) is granted. IT IS SO ORDERED, this 4th day of March, 2016. s/Clay D. Land CLAY D. LAND CHIEF U.S. DISTRICT COURT JUDGE MIDDLE DISTRICT OF GEORGIA 7 Case 4:13-cv-00393-CDL Document 33-7 Filed 07/25/16 Page 8 of 8 EXHIBIT E Case 4:13-cv-00393-CDL Document 33-8 Filed 07/25/16 Page 1 of 7 Case 4:13-cv-00267-CDL Document 41 Filed 12/23/15 Page 1 of 6 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION IN RE MENTOR CORP. OBTAPE MDL Docket No. 2004 4:08-MD-2004 (CDL) TRANSOBTURATOR SLING PRODUCTS Case No. LIABILITY LITIGATION 4:13-cv-267 (Duarte) ORDER Defendant Mentor Worldwide LLC developed a suburethral sling product called ObTape Transobturator Tape, which was used to treat women with stress urinary incontinence. Plaintiff Matilde Duarte was implanted with ObTape and asserts that she suffered injuries caused by ObTape. Duarte brought a product liability action against Mentor, contending that ObTape had design and/or manufacturing defects that proximately caused her injuries. Duarte also asserts that Mentor did not adequately warn her physicians about the risks associated with ObTape. Duarte brought her claims under several theories. Mentor seeks summary judgment on all of her claims. For the reasons set forth below, Mentor's summary judgment motion (ECF No. 35 in 4:13-cv-67) 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. Case 4:13-cv-00393-CDL Document 33-8 Filed 07/25/16 Page 2 of 7 Case 4:13-cv-00267-CDL Document 41 Filed 12/23/15 Page 2 of 6 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 Plaintiff Matilde Duarte consulted Dr. Ansley Lowder Hilton and Dr. Marcia Harris-Owens regarding her incontinence symptoms. Drs. Hilton and Harris-Owens implanted Duarte with ObTape on August 12, 2005. Duarte contends that she suffered complications due to ObTape. She also asserts that Dr. Felice James removed a portion of Duarte's ObTape in 2011 and told her that it was causing her problems. Duarte Dep. 7:10-9:16, ECF No. 37-3 in 4:13-cv-267. Duarte is a North Carolina resident whose ObTape-related treatment took place in North Carolina. Duarte filed her Complaint on July 11, 2013. She asserts claims for personal injury under the following theories: negligence, strict liability design defect, strict liability manufacturing defect, strict liability failure to warn, breach of implied warranties, 2 Case 4:13-cv-00393-CDL Document 33-8 Filed 07/25/16 Page 3 of 7 Case 4:13-cv-00267-CDL Document 41 Filed 12/23/15 Page 3 of 6 breach of express warranties, fraudulent misrepresentation, fraudulent concealment, and negligent misrepresentation. DISCUSSION Duarte filed her action in this Court under the Court's direct filing order. The parties agreed that for direct-filed cases, the "Court will apply the choice of law rules of the state where the plaintiff resides at the time of the filing of the complaint." Order Regarding Direct Filing § II(E), ECF No. 446 in 4:08-md-2004. Duarte is a North Carolina resident whose ObTape-related treatment took place in North Carolina, and the parties agree that North Carolina law applies to her claims. Mentor contends that Duarte's claims are barred under North Carolina's statute of repose. Until 2009, North Carolina law provided that no personal injury claims "based upon or arising out of any alleged defect or any failure in relation to a product shall be brought more than six years after the date of initial purchase for use or consumption." N.C. Gen. Stat. § 1- 50(a)(6) (1995). On October 1, 2009, a new statute of repose for product liability claims became effective: no personal injury claims "based upon or arising out of any alleged defect or any failure in relation to a product shall be brought more than 12 years after the date of initial purchase for use or consumption." N.C. Gen. Stat. § 1-46.1(1). The new rule became effective on October 1, 2009 and applies only "to causes of 3 Case 4:13-cv-00393-CDL Document 33-8 Filed 07/25/16 Page 4 of 7 Case 4:13-cv-00267-CDL Document 41 Filed 12/23/15 Page 4 of 6 action that accrue on or after that date." 2009 N.C. Sess. Laws 2009-420 § 3. North Carolina courts apply the statute of repose in effect at the time of the initial product sale or delivery. Robinson v. Bridgestone/Firestone N. Am. Tire, LLC, 703 S.E.2d 883, 886- 87 (N.C. Ct. App. 2011 (applying statute of repose in effect when the allegedly defective tires were initially purchased in 1995 or 1996 and declining to apply N.C. Gen. Stat. § 1-46.1(1) (2009)); see also Lackey v. DePuy Orthopaedics, Inc., No. 5:10- CV-00030-RLV, 2011 WL 2791264, at *3 (W.D.N.C. July 14, 2011) (applying statute of repose in effect when allegedly defective replacement hip was purchased in 1998); see also Colony Hill Condo. I Ass'n v. Colony Co., 320 S.E.2d 273, 276 (N.C. Ct. App. 1984) (applying real property statute of repose in effect when the plaintiff purchased his condominium); McCrater v. Stone & Webster Eng'g Corp., 104 S.E.2d 858, 860 (N.C. 1958) (applying worker's compensation statute of limitations in effect on the date of the plaintiff's accident); cf. Black v. Littlejohn, 325 S.E.2d 469, 474-75 (N.C. 1985) ("Unlike an ordinary statute of limitations which begins running upon accrual of the claim, the period contained in the statute of repose begins when a specific event occurs, regardless of whether a cause of action has accrued or whether any injury has resulted.") (citations omitted). Therefore, the 1995 statute of repose applies here. 4 Case 4:13-cv-00393-CDL Document 33-8 Filed 07/25/16 Page 5 of 7 Case 4:13-cv-00267-CDL Document 41 Filed 12/23/15 Page 5 of 6 Under the 1995 statute of repose, no personal injury claims "based upon or arising out of any alleged defect or any failure in relation to a product shall be brought more than six years after the date of initial purchase for use or consumption." N.C. Gen. Stat. § 1-50(a)(6) (1995). Therefore, a personal injury cause of action based on a product defect must be brought within six years of the date when the product was initially purchased for use or consumption. Robinson, 703 S.E.2d at 887 (finding that to bring a claim related to an allegedly defective tire, the plaintiffs had to prove that the "tire was initially purchased within six years of the filing of the complaint"); see also Bryant v. Don Galloway Homes, Inc., 556 S.E.2d 597, 600 (N.C. Ct. App. 2001) (noting that a statute of repose begins to run when the statutory triggering event occurs, "regardless of whether or not there has been an injury"). Here, it is undisputed that Duarte's ObTape was initially purchased for use on August 12, 2005 at the latest, when the ObTape was implanted into Duarte's body. Duarte did not file her Complaint until nearly eight years later, on July 11, 2013. Duarte argues, however, that the statute of repose is tolled by fraudulent concealment. In support of this argument, Duarte cited Minnesota law on fraudulent concealment. But North Carolina law applies here, and Duarte cited no authority that fraudulent concealment applies to toll the North Carolina Case 4:13-cv-00393-CDL Document 33-8 Filed 07/25/16 Page 6 of 7 Case 4:13-cv-00267-CDL Document 41 Filed 12/23/15 Page 6 of 6 statute of repose. North Carolina precedent establishes that "the repose serves as an unyielding and absolute barrier that prevents a plaintiff's right of action even before his cause of action may accrue." Black, 325 S.E.2d at 475. For all of these reasons, Duarte's claims are barred by the North Carolina statute of repose, and Mentor is entitled to summary judgment on all of her claims. CONCLUSION For the reasons set forth above, Mentor's summary judgment motions (ECF No. 35 in 4:13-cv-267) is granted. IT IS SO ORDERED, this 23rd day of December, 2015. s/Clay D. Land CLAY D. LAND CHIEF U.S. DISTRICT COURT JUDGE MIDDLE DISTRICT OF GEORGIA Case 4:13-cv-00393-CDL Document 33-8 Filed 07/25/16 Page 7 of 7 EXHIBIT F Case 4:13-cv-00393-CDL Document 33-9 Filed 07/25/16 Page 1 of 9 Case 4:11-cv-05078-CDL Document 47 Filed 02/11/13 Page 1 of 8 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS. DIVISION IN RE MENTOR CORP. OBTAPE MDL Docket No. 2004 4:08-MD-2004 (CDL) TRANSOBTURATOR SLING PRODUCTS Case No. LIABILITY LITIGATION 4:11-cv-5078 (T. Broome) ORDER Defendant Mentor Worldwide LLC ("Mentor") developed a suburethral sling product called ObTape Transobturator Tape ("ObTape"), which was used to treat women with stress urinary incontinence. Plaintiff Teresa Broome ("Broome") was implanted with ObTape, and she asserts that she suffered injuries caused by ObTape. Broome brought this product liability action against Mentor, contending that ObTape had design and/or manufacturing defects that proximately caused her injuries. Broome also asserts that Mentor did not adequately warn her physicians about the risks associated with ObTape. Mentor contends that Broome's claims are barred by North Carolina's statute of repose. As discussed below, the Court agrees, and Mentor's Motion for Summary Judgment (ECF No. 37 in 4:11-cv-5078) 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. Case 4:13-cv-00393-CDL Document 33-9 Filed 07/25/16 Page 2 of 9 Case 4:11-cv-05078-CDL Document 47 Filed 02/11/13 Page 2 of 8 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 Broome, the record reveals the following. Unless otherwise noted, the facts are undisputed for purposes of Mentor's summary judgment motion. Broome is a resident of North Carolina, and all medical treatment related to her claims occurred in North Carolina. In 2004, Broome visited her physician, Dr. Carl Fisher, because she was experiencing incontinence and other problems. After discussing her options with. Dr. Fisher, Broome decided to undergo a transobturator sling procedure. Dr. Fisher implanted ObTape in Broome on November 17, 2004 and also performed several other surgical procedures. Shortly after the surgery, Broome was unable to void her bladder and had to be catheterized. Dr. Fisher told Broome that this problem occurred because the sling was too tight. In the 2 Case 4:13-cv-00393-CDL Document 33-9 Filed 07/25/16 Page 3 of 9 Case 4:11-cv-05078-CDL Document 47 Filed 02/11/13 Page 3 of 8 spring and summer of 2005, Broome began experiencing bleeding and vaginal discharge. Dr. Fisher examined Broome and found an erosion of the ObTape. On May 27, 2005, Dr. Fisher performed a procedure to release the ObTape and to remove some scar tissue. Broome continued to experience discharge, and Dr. Fisher referred Broome to Dr. G. Bernard Taylor. After examining Broome, Dr. Taylor performed surgery to excise a portion of Broome's ObTape on August 19, 2005. Following the excision surgery, Broome's incontinence returned, but she had no other symptoms that she attributed to ObTape. In 2006, about a year after the excision surgery, Broome did some internet research to determine if other women had similar complications following sling surgery. She also contacted an attorney to investigate a potential product liability action, and she called Dr. Fisher's office to find out what company manufactured her sling. Broome asserts that she did not suspect that ObTape might be defective until she saw a television ad regarding ObTape complications in 2011. Broome filed her Complaint in the United States District Court for the District of Rhode Island on October 20, 2011. See generally Compl., ECF No. 1 in 4:11-cv-5078. Broome brought claims for strict liability, negligence, breach of warranty, and failure to warn. 3 Case 4:13-cv-00393-CDL Document 33-9 Filed 07/25/16 Page 4 of 9 Case 4:11-cv-05078-CDL Document 47 Filed 02/11/13 Page 4 of 8 DISCUSSION The Judicial Panel on Multidistrict Litigation transferred Broome's diversity action from the United States District Court for the District of Rhode Island to this Court for pretrial proceedings. Therefore, the Court must apply the choice-of-law rules of Rhode Island, the transferor forum, to determine which state law controls. See In re Volkswagen & Audi Warranty Extension Litig., 692 F.3d 4, 17 (1st Cir. 2012) ("Where a suit is consolidated and transferred under [28 U.S.C.] § 1407, courts typically apply the choice of law rules of each of the transferor courts."); Toll Bros., Inc. v. Dryvit Sys., Inc., 432 F.3d 564, 568 n.4 (4th Cir. 2005) (noting that law of transferor court must be applied in multidistrict litigation case). In this action, Broome and Mentor agree that North Carolina law, including North Carolina's statute of repose, applies to Broome's claims. See Harodite Indus., Inc. v. Warren Elec. Corp., 24 A.3d 514, 534 (R.I. 2011) (noting that factors to be considered in choice of law analysis regarding applicable statute of limitations include the place where the injury occurred, the place where the conduct causing the injury occurred, and the residence of the parties). Broome lives in North Carolina, all relevant medical treatment occurred in North Carolina, and there is no evidence that Rhode Island has significant contacts to this action. Neither side has suggested Case 4:13-cv-00393-CDL Document 33-9 Filed 07/25/16 Page 5 of 9 Case 4:11-cv-05078-CDL Document 47 Filed 02/11/13 Page 5 of 8 that another state's law applies, and the Court will therefore analyze Broome's claims under North Carolina law. Until 2009, North Carolina law provided that no personal injury claims "based upon or arising out of any alleged defect or any failure in relation to a product shall be brought more than six years after the date of initial purchase for use or consumption." N.C. Gen. Stat. § 1-50(a) (6) (1995). On October 1, 2009, a new statute of repose for product liability claims became effective: no personal injury claims "based upon or arising out of any alleged defect or any failure in relation to a product shall be brought more than 12 years after the date of initial purchase for use or consumption." N.C. Gen. Stat. § 1- 46.1(1) The new rule became effective on October 1, 2009 and applies only "to causes of action that accrue on or after that date." 2009 N.C. Sess. Laws 2009-420 § 3; see also Robinson v. Bridgestone/Firestone N. Am. Tire, L.L.C., 703 S.E.2d 883, 886- 87 (N.C. Ct. App. 2011) (finding that § 1-46.1(1) does not apply to actions that accrued prior to October 1, 2009). The relevant question, therefore, is when Broome's cause of action accrued. For purposes of North Carolina's statute of limitations, a personal injury cause of action accrues when "bodily harm to the claimant . . becomes apparent or ought reasonably to have become apparent to the claimant, whichever event first occurs." N.C. Gen. Stat. § 1-52(16). In Soderlund v. Kuch, the primary 5 Case 4:13-cv-00393-CDL Document 33-9 Filed 07/25/16 Page 6 of 9 Case 4:11-cv-05078-CDL Document 47 Filed 02/11/13 Page 6 of 8 case on which Broome relies, the North Carolina Court of Appeals explained that a discovery statute, such as N.C. Gen. Stat. § 1- 52(16), "allows a statute of limitations to not begin to run until plaintiff discovers, or in the exercise of reasonable care, should have discovered, that he was injured as a result of defendant's wrongdoing." Soderland, 546 S.E.2d 632, 638 (N.C. Ct. App. 2001) (internal quotation marks omitted). "[A]s soon as the injury becomes apparent to the claimant or should reasonably become apparent, the cause of action is complete and the limitation period begins to run." Id. at 638 (alteration in original); cf. Pinczkowski v. Norfolk S. Ry. Co., 571 S.E.2d 4, 6 (N.C. Ct. App. 2002) ("[O]nce a plaintiff concludes he has an injury and believes the injury may have been caused by his employment, he is under an affirmative duty to investigate the potential cause of the injury."). In Soderland, the North Carolina Court of Appeals found that the plaintiff's emotional distress claims were time-barred because the plaintiff's claims accrued when he realized, at the time of the defendants' wrongful conduct, that the defendants' wrongful conduct caused his distress. Soderland, 546 S.E.2d at 639, 641. Here, it is undisputed that Broome was told in 2005 that she had suffered an erosion of the ObTape, and Broome cannot seriously dispute that she realized at that time that certain symptoms, including discharge, were caused by the ObTape. At 6 Case 4:13-cv-00393-CDL Document 33-9 Filed 07/25/16 Page 7 of 9 Case 4:11-cv-05078-CDL Document 47 Filed 02/11/13 Page 7 of 8 that time, Broome had sufficient notice that her injuries were related to ObTape so that she could begin an investigation to determine whether those injuries were caused by a problem with ObTape, a problem with the implantation surgery, or some other problem. Broome nonetheless argues that she did not suspect that ObTape might be defective until she saw a television ad regarding ObTape complications in 2011. This argument is disingenuous; it is undisputed that Broome conducted research and consulted a lawyer in 2006 based on her suspicion that her symptoms were related to the ObTape. Based on these undisputed facts, Broome's injury became apparent or should reasonably have been apparent to her by 2006 at the latest, so that is when her cause of action accrued.1 Accordingly, North Carolina's 1995 statute of repose, not the 2009 statute of repose, applies. Under the 1995 statute of repose, no personal injury claims "based upon or arising out of any alleged defect or any failure in relation to a product shall be brought more than six years after the date of initial purchase for use or consumption." N.C. Gen. Stat. § 1-50(a)(6) (1995). Therefore, a personal injury cause of action based on a product defect must be brought To the extent that this holding may appear to be inconsistent with the Court's previous holding under Georgia law in In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, 711 F. Supp. 2d 1348 (M.D. Ga. 2010), the Court finds that North Carolina law has not been as broadly interpreted as the Eleventh Circuit seemed to interpret Georgia law in Welch v. Celotex Corp., 951 F.2d 1235 (11th Cir. 1992). 7 Case 4:13-cv-00393-CDL Document 33-9 Filed 07/25/16 Page 8 of 9 Case 4:11-cv-05078-CDL Document 47 Filed 02/11/13 Page 8 of 8 within six years of the date when the product was initially purchased for use or consumption. Robinson, 703 S.E.2d at 887 (finding that to bring a claim related to an allegedly defective tire, the plaintiffs had to prove that the "tire was initially purchased within six years of the filing of the complaint"); see also Bryant v. Don Galloway Homes, Inc., 556 S.E.2d 597, 600 (N.C. Ct. App. 2001) (noting that a statute of repose begins to run when the statutory triggering event occurs, "regardless of whether or not there has been an injury"). Here, it is undisputed that Broome's ObTape was initially purchased for use on November 17, 2004 at the latest, when the ObTape was implanted into Broome's body. Broome did not file her Complaint until more than six years later, on October 20, 2011. Accordingly, her claims are barred by the statute of repose, and Mentor is entitled to summary judgment. CONCLUSION For the reasons set forth above, Mentor's Motion for Summary Judgment (ECF No. 37 in 4:11-cv-5078) is granted. IT IS SO ORDERED, this llth day of February, 2013. S/Clay D. Land CLAY D. LAND UNITED STATES DISTRICT JUDGE 8 Case 4:13-cv-00393-CDL Document 33-9 Filed 07/25/16 Page 9 of 9