Ertz et al v. Mentor Worldwide Llc

MOTION for Partial Summary Judgment

M.D. Ga.January 23, 2017

IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION MDL No. 2004 Master Case No. 4:08-md-2004-CDL Individual Case No. 4:14-cv-190 (Ertz) DEFENDANT MENTOR WORLDWIDE LLC’S MOTION FOR PARTIAL SUMMARY JUDGMENT AGAINST TERRI AND PAUL ERTZ 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 partial summary judgment on Counts IV, V, VI, and X of Plaintiffs Terri and Paul Ertz’s Complaint. To the extent Ms. Ertz asserts that Mentor had a continuing, post-implant duty to warn of ObTape’s risks, such a claim fails for lack of evidence that the lack of post-implant warnings affected her treatment. The express and implied warranty claims fail as a matter of law or, alternatively, are time-barred. And the derivative consortium claim fails because Mr. Ertz died before the filing of the Complaint, and Ms. Ertz concedes that there no longer is a consortium claim. The grounds for this Motion are set forth in more detail in the accompanying memorandum in support. Dated: January 23, 2017 Respectfully submitted, s/ John Q. Lewis John Q. Lewis TUCKER ELLIS LLP 950 Main Avenue, Suite 1100 Cleveland, OH 44113-7213 Telephone: 216.592.5000 Facsimile: 216.592.5009 john.lewis@tuckerellis.com Designated Lead Counsel for Defendant Mentor Worldwide LLC Case 4:14-cv-00190-CDL Document 33 Filed 01/23/17 Page 1 of 2 012813\003022\3008536.2 IN RE: MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION MDL NO. 2004 CERTIFICATE OF SERVICE A copy of the foregoing filing was served via ECF and by electronic mail on the following counsel this 23rd day of January, 2017: J. Steven Mostyn jmostyn@mostynlaw.com Jason A. Itkin jitkin@arnolditkin.com Kurt B. Arnold karnold@arnolditkin.com Noah M. Wexler nwexler@arnolditkin.com Emily Hilliard ehilliard@arnolditkin.com John Benjamin Bireley bbireley@arnolditkin.com Ryan S. Macleod rmacleod@arnolditkin.com Attorneys for Plaintiffs Terri and Paul Ertz s/ John Q. Lewis Attorney for Defendant Mentor Worldwide LLC Case 4:14-cv-00190-CDL Document 33 Filed 01/23/17 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 Case No. 2004 Master Case No. 4:08-md-2004-CDL Individual Case No. 4:14-cv-190 (Ertz) DEFENDANT MENTOR WORLDWIDE LLC’S MEMORANDUM IN SUPPORT OF ITS MOTION FOR PARTIAL SUMMARY JUDGMENT AGAINST TERRI AND PAUL ERTZ Defendant Mentor Worldwide LLC (“Mentor”) is entitled to partial summary judgment on Plaintiffs’ claims for the following reasons:  The failure to warn claim (Count IV) fails to the extent Ms. Ertz pleads a continuing duty to warn because she cannot demonstrate how her post- implant care would have changed in light of further warnings, or that the lack of a different course of treatment based on further warnings caused her claimed injuries.  The breach of warranty claims (Counts V and VI) fail because Wisconsin does not recognize them for tort-based products liability claims, and even if it did, they are time-barred by Wisconsin’s six-year statute of limitations because Plaintiffs filed suit more than six years after Ms. Ertz’s implant.  The loss of consortium claim (Count X) fails because Mr. Ertz died before Ms. Ertz filed the Complaint, and she now concedes that there is no viable consortium claim. UNDISPUTED FACTS RELEVANT TO THIS MOTION This Court previously described general facts related to ObTape (e.g., Apr. 22, 2010 Order, Doc. 241, at 4-5); Mentor will not restate them here because this motion is premised on undisputed facts unique to Plaintiffs Terri and Paul Ertz. Terri Ertz consulted with Dr. Siddharth Jain in 2005 regarding her stress urinary incontinence (SUI) and, after conservative treatments failed to resolve the problem, Dr. Jain recommended implanting ObTape. (Separate Statement of Material Facts (SSMF) Case 4:14-cv-00190-CDL Document 33-1 Filed 01/23/17 Page 1 of 6 2 ¶ 1.) With Ms. Ertz’s consent, Dr. Jain surgically implanted her with ObTape on December 22, 2005. (Id. ¶ 2.) Nearly five years passed before Ms. Ertz reported recurrent incontinence in November 2010. (Id. ¶ 3.) When conservative treatments, including Kegel exercises and pessaries, failed to resolve the problem, Ms. Ertz’s doctor recommended a second sling implant. (Id. ¶ 4.) Ms. Ertz was surgically implanted with a different sling product in November of 2013. (Id. ¶ 5.) The operative report from the November 2013 sling procedure does not indicate that the ObTape was removed. (Id. ¶ 6.) Ms. Ertz was never diagnosed with an erosion or infection of her ObTape. (SSMF ¶ 7.) Mr. Ertz passed away in September 2013. (Id. ¶ 8.) Ms. Ertz direct-filed a Complaint against Mentor on July 15, 2014. (Doc. 1, Compl.) She asserts nine products liability claims: (1) negligence, (2) strict liability design defect, (3) strict liability manufacturing defect, (4) strict liability failure to warn, (5) implied warranty, (6) express warranty, (7) fraudulent misrepresentation, (8) fraudulent concealment, and (9) negligent misrepresentation. (Id. Cts. I-IX.) The Complaint also asserts a loss of consortium claim on behalf of her late husband. (Id. Ct. X.) Ms. Ertz concedes that there no longer is a loss of consortium claim. (SSMF ¶ 12.) Plaintiffs were Wisconsin citizens at all relevant times, and all of Ms. Ertz’s medical treatment relating to ObTape occurred in Wisconsin. (Id. ¶ 13.) LEGAL ARGUMENT Summary judgment should be granted where “there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed R. Civ. P. 56(a). Indeed, Rule 56 “mandates the entry of summary judgment, after adequate time for discovery and upon motion, against a party who fails to make a showing Case 4:14-cv-00190-CDL Document 33-1 Filed 01/23/17 Page 2 of 6 3 sufficient to establish the existence of an element essential to that party’s case, and on which that party will bear the burden of proof at trial.” Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). Facts are “material” only if they could affect the outcome of the suit under the governing substantive law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). On a motion for summary judgment, “facts must be viewed in the light most favorable to the nonmoving party only if there is a ‘genuine’ dispute as to those facts.” Scott v. Harris, 550 U.S. 372, 380 (2007). A. Wisconsin Law Applies. Per this Court’s Direct-Filing Order, Wisconsin choice-of-law rules apply because Ms. Ertz was a Wisconsin resident when she filed the Complaint. There is no choice of law issue here, because Plaintiffs were Wisconsin residents at all relevant times, and all of Ms. Ertz’s ObTape-related treatment occurred there. Wisconsin law thus applies. B. Any “Continuing Duty” Failure-to-Warn Claim (Count IV) Fails for Lack of Evidence that Additional Warnings Would Have Affected Ms. Ertz’s Post-Implant Treatment. To the extent Ms. Ertz intends to argue1 that, post-implant, Mentor failed to warn her physicians of additional product risks, her claim fails. Wisconsin recognizes the sophisticated user doctrine, so the duty to warn of risks associated with a product runs to the sophisticated user of the product, and there is no duty if the professional or industry using the product knows or should know of its risks. Haase v. Badger Mining Corp., 669 N.W.2d 737, 743-44 (Wis. Ct. App. 2003); see also Lukaszewicz v. Ortho Pharm. Corp., 510 F. Supp. 961, 963 (E.D. Wis. 1981) (recognizing “general rule” that “proper warnings to a physician will satisfy the manufacturer’s duty to warn” of the risks 1 It is Mentor’s position that Ms. Ertz has not alleged a continuing-duty failure-to-warn claim in her Complaint. Case 4:14-cv-00190-CDL Document 33-1 Filed 01/23/17 Page 3 of 6 4 of medical products “since the patient cannot obtain the drug except through the physician.”). In states recognizing a continuing-duty failure-to-warn claim, a patient receiving an implanted medical device must establish that the neglected warning affected her post-implant medical treatment, so as to have caused an injury. See In re Guidant Corp. Implantable Defibrillators Prods. Liab. Litig., MDL No. 05-1708, 2007 U.S. Dist. LEXIS 50303, at *11 (D. Minn. July 6, 2007) (applying California law and granting summary judgment for manufacturer on post-implant warning claim because plaintiff could not establish a causal link between the failure to give any post-implant warnings and the plaintiff’s claimed injuries) (Ex. D to Lewis Decl.). In other words, if warned of additional risks after an implant, a plaintiff must show that the warnings would have prompted her physician to take additional or different treatment measures. Without such a burden, plaintiffs bringing failure-to-warn claims could assert a never-ending duty to warn resulting in limitless liability. See Kozlowski v. John E. Smith’s Sons Co., 275 N.W.2d 915, 901 (Wis. 1979) (rejecting the notion of an “absolute continuing duty, year after year, for all manufacturers to warn”). Ms. Ertz has presented no evidence that her post-implant treatment would have been different if Mentor had provided additional warnings. As an initial matter, Ms. Ertz has not indicated what additional warning Mentor should have given with respect to ObTape. Ms. Ertz was never diagnosed with an erosion or infection of her ObTape, and she underwent a second sling procedure only due to recurrent SUI. (SSMF ¶¶ 3-7.) There is no testimony from any of her treating physicians that they would have changed their course of treatment had Mentor provided additional ObTape warnings between her 2005 implant and her 2013 surgery to implant a different sling device. Without this Case 4:14-cv-00190-CDL Document 33-1 Filed 01/23/17 Page 4 of 6 5 requisite evidence, Ms. Ertz cannot sustain a failure-to-warn claim premised on a continuing duty to warn. C. The Breach of Warranty Claims Fail Because Wisconsin Does Not Recognize Them for Tort-Based Products Liability Claims, and Even If It Did, They Are Time- Barred. Because Ms. Ertz alleges injuries caused by design, manufacturing, and warning defects with ObTape, her products liability claims sound in tort, and thus cannot support warranty claims as a matter of law. Austin v. Ford Motor Co., 273 N.W.2d 233, 240 (Wis. 1979) (“We conclude that, in view of this court’s development of the jurisprudence of products liability, it is inappropriate to bring an action for breach of warranty where a tort remedy is sought.”); accord Liberty Mut. Fire Ins. Co. v. LG Elecs. USA, Inc., No. 10-C-520, 2012 WL 5497852, at *5 (E.D. Wis. Nov. 13, 2012), attached as Ex. E to Lewis Decl. Her warranty claims thus fail. But even if Wisconsin law permitted such claims, they are time-barred. Wisconsin imposes a six-year limitations period on claims arising under the Uniform Commercial Code, including breach of warranty claims. Wis. Stat. § 402.725. Moreover, the statute is explicit as to when breach of warranty claims accrue: “[a] breach of warranty occurs when tender of delivery is made.” Id. § 402.725(2).2 No discovery rule applies. See id. (“A cause of action accrues when the breach occurs, regardless of the aggrieved party’s lack of knowledge of the breach.”). Here, Ms. 2 The only exception to the accrual-on-tender rule is “where a warranty explicitly extends to future performance of the goods,” in which case “the cause of action accrues when the breach is or should have been discovered.” Wis. Stat. § 402.725(2). Wisconsin’s Supreme Court has narrowly construed this exception to require a specific reference to a future time in the warranty. Selzer v. Brunsell Bros., 652 N.W.2d 806, 824-27 (Wis. 2002). Here, Plaintiff never alleged-much less presented evidence of- any specific reference to future performance. Case 4:14-cv-00190-CDL Document 33-1 Filed 01/23/17 Page 5 of 6 6 012813\003022\3008535.3 Ertz’s ObTape was “delivered,” and the warranty claims accrued, no later than the date it was implanted: December 22, 2005. (SSMF ¶ 2.) Accordingly, any breach of warranty claims had to be filed by December 22, 2011. Because they were not, they are time-barred. D. The Loss of Consortium Fails Because Mr. Ertz Died Before the Complaint Was Filed, and Ms. Ertz Concedes That There Is No Viable Consortium Claim. Loss of consortium, as a distinct form of damages, is “personal to the claiming spouse and apart from the claim of the injured spouse.” Zentgraf v. Hanover Ins. Co., 640 N.W.2d 171, 175 (Wis. Ct. App. 2001) (quoting Kottka v. PPG Indus., Inc., 388 N.W.2d 160 (Wis. 1986)). Mr. Ertz died in September of 2013 before the Complaint was filed (SSMF ¶ 8), and Ms. Ertz offers no evidence in support of his consortium claim. Indeed, she admits there no longer is a consortium claim. (Id. ¶ 12.) Accordingly, Mentor is entitled to summary judgment on this claim, too. CONCLUSION For these reasons, Plaintiffs’ warranty, fraud, and consortium claims fail as a matter of law. Mentor respectfully requests that this Court grant partial summary judgment for Mentor on Counts IV, V, VI, and X of Plaintiffs’ Complaint. Dated: January 23, 2017 Respectfully submitted, s/ John Q. Lewis John Q. Lewis TUCKER ELLIS LLP 950 Main Avenue, Suite 1100 Cleveland, OH 44113-7213 Telephone: 216.592.5000 Facsimile: 216.592.5009 john.lewis@tuckerellis.com Designated Lead Counsel for Defendant Mentor Worldwide LLC Case 4:14-cv-00190-CDL Document 33-1 Filed 01/23/17 Page 6 of 6 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION MDL No. 2004 Master Case No. 4:08-md-2004-CDL Individual Case No. 4:14-cv-190 (Ertz) DEFENDANT MENTOR WORLDWIDE LLC’S SEPARATE STATEMENT OF MATERIAL FACTS IN SUPPORT OF ITS MOTION FOR PARTIAL SUMMARY JUDGMENT AGAINST TERRI AND PAUL ERTZ Pursuant to Rule 56 of the Federal Rules of Civil Procedure and Local Rule 56, Defendant Mentor Worldwide LLC submits this Separate Statement of Material Facts in support of its Motion for Partial Summary Judgment against Plaintiffs Terri and Paul Ertz. A. Plaintiff’s ObTape Implant. 1. Terri Ertz consulted with Dr. Siddharth Jain in 2005 regarding her stress urinary incontinence (SUI) and, after conservative treatments failed to resolve the problem, Dr. Jain recommended implanting ObTape. (Dep. of Terri Ertz 66:9-67:9, 71:11-73:12, 77:8-14, attached as Ex. A to Decl. of John Q. Lewis (“Lewis Decl.”).) 2. With Ms. Ertz’s consent, Dr. Jain surgically implanted her with ObTape on December 22, 2005. (Id. 82:10-83:24; see also Am. Pl. Fact Sheet (PFS) § II, ¶ 2, attached as Ex. B to Lewis Decl.) 3. Nearly five years passed before Ms. Ertz reported recurrent incontinence in November 2010. (Ertz Dep. 100:9-14.) Case 4:14-cv-00190-CDL Document 33-2 Filed 01/23/17 Page 1 of 3 2 4. When conservative treatments, including Kegel exercises and pessaries, failed to resolve the problem, Ms. Ertz’s doctor recommended a second sling implant. (See id. 101:20-102:7, 104:11-106:8, 139:4-14.) 5. Ms. Ertz was surgically implanted with a different sling product in November of 2013. (Id. at 120:13-18; PFS § II, ¶¶ 5, 8.) 6. The operative report from the November 2013 sling procedure does not indicate that the ObTape was removed. (See 11/15/13 Operative Report at 1-2, attached as Exhibit C to Lewis Decl.) 7. Ms. Ertz was never diagnosed with an erosion or infection of her ObTape. (See PFS § V, ¶ 4.) 8. Mr. Ertz passed away in September 2013. (Ertz Dep. 29:4-9.) B. Procedural History. 9. Ms. Ertz direct-filed a Complaint against Mentor on July 15, 2014. (Doc. 1, Compl.) 10. Ms. Ertz asserts nine products liability claims: (1) negligence, (2) strict liability design defect, (3) strict liability manufacturing defect, (4) strict liability failure to warn, (5) implied warranty, (6) express warranty, (7) fraudulent misrepresentation, (8) fraudulent concealment, and (9) negligent misrepresentation. (Compl. ¶¶ 19-102.) 11. The Complaint also asserts a loss of consortium claim on behalf of her late husband. (Id. ¶¶ 103-05.) 12. Ms. Ertz concedes that there no longer is a loss of consortium claim. (PFS § 8, ¶ 5.) Case 4:14-cv-00190-CDL Document 33-2 Filed 01/23/17 Page 2 of 3 3 012813\003022\3008538.2 13. Plaintiffs were Wisconsin citizens at all relevant times, and all of Ms. Ertz’s ObTape-related medical treatment occurred in Wisconsin. (PFS § II, ¶¶ 3-7, § III ¶¶ 3-4, § IV.) Dated: January 23, 2017 Respectfully submitted, s/ John Q. Lewis John Q. Lewis TUCKER ELLIS LLP 950 Main Avenue, Suite 1100 Cleveland, OH 44113-7213 Telephone: 216.592.5000 Facsimile: 216.592.5009 john.lewis@tuckerellis.com Designated Lead Counsel for Defendant Mentor Worldwide LLC Case 4:14-cv-00190-CDL Document 33-2 Filed 01/23/17 Page 3 of 3 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION MDL No. 2004 Master Case No. 4:08-md-2004-CDL Individual Case No. 4:14-cv-190 (Ertz) DECLARATION OF JOHN Q. LEWIS IN SUPPORT OF DEFENDANT MENTOR WORLDWIDE LLC’S MOTION FOR PARTIAL SUMMARY JUDGMENT AGAINST TERRI AND PAUL ERTZ 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 Plaintiff Terri Ertz’s October 21, 2016 deposition. 3. Attached as Exhibit B is a true and correct copy of Plaintiff’s First Amended Fact Sheet. 4. Attached as Exhibit C is a true and correct copy of Ms. Ertz’s November 15, 2013 Operative Report. 5. Attached as Exhibit D is a true and correct copy of the unpublished decision, In re Guidant Corp. Implantable Defibrillators Prods. Liab. Litig., MDL No. 05-1708, 2007 U.S. Dist. LEXIS 50303 (D. Minn. July 6, 2007). Case 4:14-cv-00190-CDL Document 33-3 Filed 01/23/17 Page 1 of 2 2 012813\003022\3008537.2 6. Attached as Exhibit E is a true and correct copy of the unpublished decision, Liberty Mut. Fire Ins. Co. v. LG Elecs. USA, Inc., No. 10-C-520, 2012 WL 5497852 (E.D. Wis. Nov. 13, 2012). I declare under penalty of perjury under the laws of the United States that the foregoing is true and correct. Executed this 23rd day of January, 2017, in Cleveland, Ohio. s/John Q. Lewis John Q. Lewis Case 4:14-cv-00190-CDL Document 33-3 Filed 01/23/17 Page 2 of 2 Exhibit A Case 4:14-cv-00190-CDL Document 33-4 Filed 01/23/17 Page 1 of 14 800-567-8658 973-410-4040 Veritext Legal Solutions 1 1 IN THE UNTIED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA 2 COLUMBUS DIVISION 3 4 IN RE MENTOR CORP. OBTAPE ) MDL CASE NO. TRANSOBTURATOR SLING ) 4:08-MD-2004(CDL) 5 PRODUCTS LIABILITY LITIGATION ) Individual Case No. ______________________________) 4:14-cv-00190(Ertz) 6 7 8 The video deposition of TERRI L. ERTZ, a witness in 9 the above-entitled matter, taken at the instance of the 10 Defendant, pursuant to Section 804.05 of the Wisconsin 11 Statutes, before and reported by Maridee J. Olson, a 12 Registered Merit Reporter and Notary Public for the State 13 of Wisconsin, at 303 Main Street, Eau Claire, Wisconsin on 14 the 21st day of October, 2016, commencing at 8:58 a.m. 15 16 A P P E A R A N C E S 17 BEN BIRELEY, of the Law Firm of Arnold & Itkin, LLP, 18 6009 Memorial Drive, Houston, Texas 77007, appearing on 19 behalf of the Plaintiff. 20 ZACHARY ADAMS, of the Law Firm of Tucker Ellis, LLP, 950 21 Main Avenue, Suite 1100, Cleveland, Ohio 44113-7213, 22 appearing on behalf of the Defendant. 23 24 (ORIGINAL TRANSCRIPT FILED WITH ATTORNEY ADAMS.) 25 Case 4:14-cv-00190-CDL Document 33-4 Filed 01/23/17 Page 2 of 14 800-567-8658 973-410-4040 Veritext Legal Solutions 2 (Pages 2 to 5) 2 1 I N D E X PAGE 2 WITNESS TERRI L. ERTZ 3 Examination by Mr. Adams 4 - 135 4 Examination by Mr. Bireley 135 - 140 5 Certificate of the Court Reporter 141 6 7 EXHIBITS 8 Exhibit 1 - Plaintiff's First Amended 23 Fact Sheet 9 Exhibit 2 - 7-19-05 Marshfield Clinic 56 10 Record of Dr. Jain 11 Exhibit 3 - 12-14-05 Marshfield Clinic 71 Record of Dr. Jain 12 Exhibit 4 - 12-22-05 Operative Report 81 13 14 (Original Exhibits 1 - 4 sealed with transcript.) 15 16 17 18 19 20 21 22 23 24 25 3 1 October 21, 2016. 8:58 a.m. 2 P R O C E E D I N G S 3 THE VIDEOGRAPHER: We are on the video record. 4 My name is Theresa VanLieshout, the certified 5 videographer for today's deposition. The date today is 6 Friday, October 21st, 2016, and the time is 8:58 Central 7 Standard Time. This deposition is being held at Q & A 8 Reporters, 303 Main Street, Eau Claire, Wisconsin, and 9 it's being taken by the counsel for the Defendants. 10 The caption of this case is regarding Mentor 11 Corporation ObTape Transobturator Sling Products 12 Liability Litigation. This case is being held in the 13 United States District Court for the Middle District of 14 Georgia, Columbus Division. The name of the witness is 15 Terri Ertz. At this time the attorneys present in the 16 room will identify themselves and the parties they 17 represent. 18 MR. BIRELEY: Ben Bireley, Arnold & Itkin, on 19 behalf of the Plaintiff. 20 MR. ADAMS: Zach Adams, Tucker Ellis, on behalf 21 of the Defendant. 22 THE VIDEOGRAPHER: Our court reporter is Maridee 23 Olson and she will swear in the witness and we can 24 proceed. 25 4 1 (TERRI L. ERTZ, having been first duly sworn 2 under oath, was examined and testified as follows:) 3 TERRI L. ERTZ: Yes. 4 * * * * * * * * * * * * * * * * 5 EXAMINATION BY MR. ADAMS: 6 Q Can you please state your full name and date of birth? 7 A Terri Lynn Ertz 8 Q Okay. And your current address? 9 A 10 Q Ms. Ertz, my name is Zach Adams, and I represent Mentor 11 Worldwide, LLC in a lawsuit you've brought against 12 Mentor regarding the ObTape sling that was implanted on 13 you -- or in you on December 22nd, 2005. Do you 14 understand that you are here today to give testimony 15 about that case? 16 A Yes. 17 Q Have you ever been deposed before? 18 A No. 19 Q I just want to go over some basic ground rules. The way 20 this will work is I'll ask questions and you'll answer 21 and the court reporter will document our entire 22 conversation. And you understand that you're testifying 23 under oath today the same way you would be testifying 24 under oath in court, correct? 25 A Yes. 5 1 Q And you promise to give me true and complete answers to 2 all of my questions to the best of your ability? 3 A Yes. 4 Q And if at any time you remember something that would 5 complete an answer to an earlier question, just let me 6 know, okay? 7 A Okay. 8 Q Are you currently taking any medications that might 9 impair your ability to understand or answer my questions 10 today? 11 A No. 12 Q Are you aware of anything else that would impair your 13 ability to comprehend or testify here today? 14 A No. 15 Q And just so you know, whenever I ask a question, you 16 have to answer verbally, so the court reporter can't 17 document us, you know, doing this and this so -- 18 A Right. 19 Q Okay. And we'll also try and take our time so we don't 20 talk over each other, so I'll always let you finish your 21 answer and I would just ask that you let me finish my 22 question, okay? 23 A Okay. 24 Q Thank you. And if I ask you a question that's not 25 clear, just ask me to repeat it or to clarify it because Case 4:14-cv-00190-CDL Document 33-4 Filed 01/23/17 Page 3 of 14 800-567-8658 973-410-4040 Veritext Legal Solutions 8 (Pages 26 to 29) 26 1 Q Okay. 2 A Hang on. I can look this up for you. She's at 2720 3 West Folsom Street, F-O-L-S-O-M, Eau Claire, and I'm not 4 exactly sure what the zip code is over there. I don't 5 know if it's 01 or 03. 6 Q Well, with the marvels of Google, I'm sure we can figure 7 it out, right? 8 A Okay. 9 Q Thank you, though. 10 A I -- I hope so. 11 Q I'm sure. 12 A I'm -- I'm sure the post office would know too so -- 13 Q Okay. So other than those changes, are there any other 14 changes that need to be made to Exhibit 1? 15 A Not that I'm aware. I'm just -- oh, yeah, they have her 16 name right here. That was just the other one. Hm. 17 Okay. Oh, here we go, Page 8, Dr. London is actually 18 Dr. England. 19 Q Okay. 20 A Oh, yeah. See, it says Dr. England up here and then 21 Dr. London down below. 22 Q And just so we're clear, any time that you're 23 referencing Dr. London on Exhibit 1, you mean 24 Dr. England, correct? 25 A Yes. 27 1 Q Okay. Thank you. 2 A Yeah. So everything else looks pretty good. 3 Q Okay. And if you could flip to the last page of 4 Exhibit 1. 5 A Oh, same thing on Page 14. 6 Q Okay. 7 A Did you say which page? 8 Q The very last page. I just want to clarify. The name 9 below the signature line, that's your name, correct? 10 A Yes. 11 Q And is that your signature? 12 A Yes. 13 Q Okay. Thank you. Now I'd like to talk a little bit 14 about your background, get some personal information. 15 So in talking about your high school -- sorry. Talking 16 about your education, where'd you go to high school? 17 A Marshall High School. 18 Q And when did you graduate? 19 A 1987. 20 Q And did you go to college? 21 A Yes. 22 Q Where at? 23 A University of Wisconsin-Eau Claire. 24 Q And did you graduate? 25 A Yes, I did. 28 1 Q When was that? 2 A 2012 -- 3 Q Okay. 4 A -- December. 5 Q And what did you study there? 6 A I have a degree in sociology and a minor in women's 7 studies. 8 Q It must have been hard going there with five kids, so 9 congratulations. That's awesome. 10 A It was hard going there with five kids and have a GPA of 11 over 3.3 so -- 12 Q It's better than some of my friends' GPAs. Yeah, it is 13 very impressive. 14 A Yeah, and a sick -- well, and don't forget about the 15 sick husband too, so that was not -- I really had to 16 pressure myself to get through that one. 17 Q Well, it sounds like you did a great job, so congrats. 18 Have you ever had any type of medical training? 19 A No. I didn't go into the medical field. 20 Q And have you ever worked in a hospital? 21 A No. 22 Q And you've never had any medical-field job experience? 23 A No. 24 Q Let's talk now about your family. How many times have 25 you been married? 29 1 A Once. 2 Q And to who? 3 A Paul Ertz. 4 Q Okay. And are you still married to Paul? 5 A He passed away. 6 Q Sorry to hear that. When was that? 7 A September of 2013. 8 Q And were you guys still married when he passed away? 9 A Yes. 10 Q Okay. At any time were you guys separated? 11 A There's no such a thing as legal separation in the state 12 of Wisconsin. 13 Q Sure. I'm -- I'm saying at any time were you guys not 14 living together, not -- 15 A Yes. 16 Q Okay. And when was that? 17 A I don't know, a couple times, I believe. I can't -- I 18 couldn't tell you the year but -- 19 Q Okay. Just a couple times you guys had a brief 20 separation? 21 A Yeah. 22 Q And then I'm guessing you would reconcile. 23 A Yes. 24 Q Okay. And now let's talk about your children. How many 25 kids do you have? Case 4:14-cv-00190-CDL Document 33-4 Filed 01/23/17 Page 4 of 14 800-567-8658 973-410-4040 Veritext Legal Solutions 18 (Pages 66 to 69) 66 1 A -- you know, resolve whatever problem this is. 2 Q And so, you know, obviously, your incontinence is 3 impacting all of these parts of your life -- 4 A Um-hm. 5 Q -- and Dr. Jain's offering the sling, and so you're 6 hopeful the sling's going to work, and you want to have 7 the surgery done, correct? 8 A Yes. 9 Q Okay. And then you come back and see Dr. Jain in 10 September of 2005, and you're still not seeing any 11 results with your Kegel exercises. Is that consistent 12 with your recollection? 13 A Yes. 14 Q And then it states here that Dr. Jain discussed surgical 15 intervention for stress urinary incontinence. This was 16 the first time he's kinda telling you here's the 17 alternative, I can do surgery and put the sling in. Is 18 that consistent with your recollection? 19 A Yes. 20 Q Okay. He says, "Both options are discussed in detail 21 including risks and benefits. Patient is tired of doing 22 Kegels. They are not helping." Is that consistent with 23 your recollection? 24 A Yes. 25 Q So you remember having the discussion about risks and 67 1 benefits? 2 A Yes. 3 Q Okay. And you remember talking about how the Kegels 4 weren't helping, correct? 5 A Yes. 6 Q Okay. And it says that you want the surgical 7 correction, but you're in school right now and would 8 like to have the surgery over the Christmas holiday. 9 A Yes. 10 Q Is that consistent with your recollection? 11 A Yes. 12 Q Okay. And so I'm guessing you didn't want to have the 13 surgery at this point because you were focused on school 14 and you thought the Christmas holiday between semesters 15 would be a better time to have it? 16 A Yes. 17 Q Okay. 18 A You know, life is still going on regardless of whether 19 you have the surgery. 20 Q Right, and so you were trying to schedule it at maybe 21 the most opportune time, correct? 22 A Correct. 23 Q Okay. And then you start seeing a physical therapist, 24 Beth Smith. 25 A Yes. 68 1 Q Do you remember her? 2 A Yes. 3 Q Okay. And she states all the stuff we've been over 4 about your incontinence, about the Kegels, things like 5 that, and she states that you're not able to exercise 6 because of your incontinence. Do you remember that? 7 A Yes. 8 Q And so can you kind of explain what you meant by that? 9 A That there -- you know, if I tried to do a lot of 10 physical stuff, it would make the incontinence worse. 11 Q Okay. 12 A So, you know, can you imagine going to the gym and then 13 coming back with a big wet spot? 14 Q Of course. 15 A It's embarrassing and it's disgusting, and you're like, 16 no, I think I'm just gonna stay home. 17 Q Okay. 18 A You know, I mean, you had to be really careful about 19 where you went and what you did. 20 Q Yeah. 21 A And that's not -- you know, that's something that you 22 need to take seriously about your life because it's your 23 life. It's like, well, there's certain things you don't 24 advertise and that would happen to be one of them. 25 Q Okay. And it says she gives you a bladder diary to fill 69 1 out and return along with a pelvic floor instruction 2 book. Do you remember being given the diary and the 3 book? 4 A Yes. 5 Q And then your next visit it states that you didn't fill 6 out the diary but that you did read the book, is that 7 consistent with your recollection? 8 A Right. 9 Q And so why didn't you fill out the diary? 10 A I don't know, probably busy with school and kids, and I 11 think I made more of a, you know, mental note of it and 12 then sort of reviewed it with her. I don't know if I 13 actually physically -- I don't think I physically filled 14 it out, but it was more like, you know, do you know what 15 you were doing and what things would make this worse 16 and, you know -- you know, if -- when would you have the 17 most problems? Did you drink this? Did you eat this? 18 Did you -- what were you doing? Were you exercising? 19 Were you, you know, standing up? Were you sitting down? 20 Were you -- just like things like that. They -- they -- 21 she wanted to know what -- what was triggering things. 22 Were -- were there any particular triggers that are 23 making anything worse? 24 Q Okay. And it says at the end of this record that you 25 were convinced you needed the surgery and nothing else Case 4:14-cv-00190-CDL Document 33-4 Filed 01/23/17 Page 5 of 14 800-567-8658 973-410-4040 Veritext Legal Solutions 19 (Pages 70 to 73) 70 1 will help. Does that kind of sum up how you were 2 feeling at this time? 3 A Yeah. It was looking pretty hopeless. 4 Q Okay. Then you see Dr. Jain a week before you have the 5 surgery done. This is December of 2005, and it's 6 everything we've been discussing. Nothing's helping. 7 You've tried therapy at this point, you've tried Kegels, 8 and you're planning on having the surgery scheduled for 9 the next week. Is that consistent with your 10 recollection? 11 A Yes. 12 Q Okay. And it says, again, here that Dr. Jain discussed 13 the procedure with you, discussed the risks, discussed 14 the risk of erosion and discussed issues with your 15 urethra or vaginal mucosa, which I'm guessing he means 16 future problems with your vagina. Do you remember that 17 discussion? 18 A Not -- not specifically that -- what did the -- what 19 did -- 20 Q How about we bring in the record? Maybe that would be 21 easier. 22 A Okay. 23 Q Let's do that because I'm thinking maybe the notes 24 aren't consistent with what Dr. Jain intended. So I'm 25 introducing the record from Dr. Jain from December 14th, 71 1 2005. 2 (Deposition Exhibit 3 marked for 3 identification.) 4 THE WITNESS: Oh, okay. 5 Q So, Ms. Ertz, we're going to do the same thing before. 6 I'll read and follow and you follow, and then I'll ask 7 you some questions. How's that sound? 8 A Okay. 9 Q So "Patient," we've got "Mrs. Terri L. Ertz," correct? 10 A Correct. 11 Q "Service: 12/14/2005," correct? 12 A Yes. 13 Q "History of Present Illness," we're going to go down to 14 the fourth sentence and it's going to say, "Her stress 15 urinary incontinence is not any better at all. She has 16 leakage with coughing, sneezing, lifting, bending, any 17 activity. She has tried physical therapy with 18 biofeedback. That has not helped. She has done Kegels 19 for a number of years and that did not help her. She 20 wants to have the surgery which we have tentatively 21 scheduled for next week." Does that sound consistent 22 with your recollection? 23 A Yes. 24 Q Okay. And then if you flip to the back -- well, 25 actually, it starts on the front, and under "Plan" it 72 1 states, "Surgery for stress urinary incontinence was 2 discussed. We discussed about different materials used 3 including rectus fascia, cadaver fascia and synthetic 4 fascia. The procedure of transobturator tape for stress 5 incontinence was discussed. The risks of infection, 6 bleeding, urinary retention, injury to the urethra, 7 bladder, et cetera, were discussed. The risk of erosion 8 of sling material through the urethra or vaginal mucosa 9 was discussed. The risk from anesthetics were 10 discussed. All options were discussed. The patient 11 wants to proceed with the surgery. This is scheduled 12 for next week and we will go ahead with this." Did I 13 read that correctly? 14 A Yes. 15 Q And is that consistent with your recollection? 16 A Yes. 17 Q And so this sounds kind of like the same discussion you 18 had with Dr. Jain previously about your alternatives, 19 correct? 20 A Right. 21 MR. BIRELEY: Objection, form. 22 Q And so did you understand the risks? 23 A Pretty much. 24 Q Did you ask Dr. Jain any questions about the risks? 25 A I probably did. I'm -- I'm not certain. I'm honestly 73 1 not certain if I did or if I didn't. I was more -- you 2 know, I was going by his, you know, statements of I've 3 done this procedure, it has helped, I can help you -- 4 Q Okay. 5 A -- and at that point I was pretty hopeless about things, 6 how they had been going, so it was, you know, a little 7 light-at-the-end-of-a-tunnel kind of a deal. 8 Q Sure. And so after this discussion you still wanted to 9 have the ObTape surgery, right? 10 A Yeah. 11 Q Because you thought it would help? 12 A Yeah -- 13 Q Okay. 14 A -- because I thought it would help. That's all I 15 wanted, just make this stop. 16 Q And so prior to seeing the doctor did you do any 17 research on your own concerning your stress urinary 18 incontinence? 19 A No. 20 Q Google searches? 21 A No. 22 Q Okay. Do you know anyone with stress urinary 23 incontinence? 24 A Yeah, a couple people, I guess. It would be more like, 25 I think, my mom had it, my sister. Case 4:14-cv-00190-CDL Document 33-4 Filed 01/23/17 Page 6 of 14 800-567-8658 973-410-4040 Veritext Legal Solutions 20 (Pages 74 to 77) 74 1 Q Did you ever discuss it with them? 2 A Not at length or anything. I -- I -- I think I knew 3 about it. I think it was more of like -- I don't know 4 if this is like a genetic tendency, you know, things 5 that run in the family -- 6 Q Sure. 7 A -- I mean, doctors ask you about things like is there a 8 history of cancer in your family, is there a history of 9 heart disease, is there a history of high blood 10 pressure? And since I know that, you know, I believe, 11 my mom had this from time to time, my sister's had it, 12 you know, I was more curious -- curious if it -- if this 13 is something that runs in families like -- 14 Q Okay. 15 A -- you know, we have a long history of women in our 16 family who have had -- 17 Q So -- so you discussed it to the extent that they had 18 it, but I'm guessing this wasn't a discussion of tell me 19 all about your symptoms or tell me about -- 20 A Right. 21 Q -- you know, how bad your leakage is. 22 A Right. No. 23 Q Okay. 24 A It was more of a passing thing than a -- 25 Q Not dinner conversation? 75 1 A No. 2 Q Okay. Did you know anyone that actually had surgery to 3 correct their stress urinary incontinence? 4 A I'm -- I'm not even certain. I'm not -- I'm not even 5 certain if my mom had it or my sister had it. It was 6 just, you know -- well, there was -- there was a point 7 in time when my sister was, you know, caring for my mom, 8 and I know she'd go to -- she would go to the store and 9 pick up pads so -- 10 Q Got it. 11 A -- you kinda knew what was going on. You just -- it 12 wasn't a conversation. It was more like I'm aware that 13 there's probably this problem and that's -- it wasn't 14 some big, huge discussion. It was just I'm aware of it, 15 okay. Now, I never got into any -- with anybody whether 16 they had surgery about it or whether they -- you know, 17 what they did or if their problem was ever a hundred 18 percent resolved. I don't know. 19 Q Okay. And so just to clarify and I probably should have 20 gone over this before, but you were self-referred to 21 Dr. Jain, correct? Like you sought out a urologist 22 consult, right? 23 A Right. 24 Q Okay. Just wanted to make sure. And this, again, is 25 because you were experiencing such severe stress urinary 76 1 incontinence, right? 2 A Right. 3 Q Okay. Do you recall Dr. Jain doing any testing on your 4 bladder before your surgery? Sometimes they have women 5 cough or things like that to see if there's any leakage. 6 A I remember more the one with Dr. England, but I think 7 that there might have been something with Dr. Jain as 8 well. I don't recall -- I don't recall specifics -- 9 Q Okay. 10 A -- 'cause we're talking, you know -- 11 Q So you're just not sure? 12 A I'm -- I'm -- yeah, I'm not certain so -- 13 Q Did Dr. Jain ever discuss with you if the surgery was 14 common or not? 15 A He -- he said he'd performed many. 16 Q Do you -- did he give like a specific number or did he 17 just say I've performed a lot of these? 18 A No, it was I performed -- 19 Q Okay. 20 A -- you know, quite a few of these or many of these so -- 21 Q Okay. And did your insurance pay for the surgery? 22 A Yes. 23 Q Okay. And was there any difficulty in getting them to 24 pay for the surgery? 25 A No. 77 1 Q Did Dr. Jain ever show you different types of vaginal 2 slings like, you know, physically show you slings? 3 A No. 4 Q Did Dr. Jain ever discuss FDA clearance about the sling 5 or regarding the sling, whether it was cleared or not by 6 the FDA? 7 A No. 8 Q So who ultimately made the decision to use the 9 specifically ObTape sling? Was it your decision or 10 Dr. Jain's decision? 11 A Dr. Jain's. 12 Q All right. And did he say why he was choosing the 13 ObTape sling specifically to you? 14 A No. 15 Q No. Okay. Did Dr. Jain ever discuss the odds of the 16 procedure being successful with you? 17 A All I recall is he performed the surgery successfully 18 many times. That was it. 19 Q But did he ever give you like it's, you know, guaranteed 20 this percentage to be successful? 21 MR. BIRELEY: Objection, form. You can answer. 22 THE WITNESS: No. 23 Q Okay. What rate of success would have been acceptable 24 to you? 25 MR. BIRELEY: Objection, form. You can answer. Case 4:14-cv-00190-CDL Document 33-4 Filed 01/23/17 Page 7 of 14 800-567-8658 973-410-4040 Veritext Legal Solutions 21 (Pages 78 to 81) 78 1 THE WITNESS: Well, I would like a hundred 2 percent, but, you know -- optimally, but, I mean, even 3 if -- even if it got, you know, 70 percent better, 4 60 percent better, you know, that -- that would have 5 been better. If you're starting at zero, it really 6 doesn't -- any -- anything past zero is really, really 7 good, you know. I'd prefer not it to be one or two, you 8 know. Like I said, you're hoping for a hundred and if 9 you come up short of that, you know, but you're hoping 10 over 50 at least. 11 Q Okay. And we kind of already touched on this, but did 12 Dr. Jain leave any of your questions about the surgery 13 unanswered? 14 A I don't know. Maybe I didn't ask enough questions or 15 the right questions, and that's not uncommon with 16 patients, I guess. They trust their doctor and, you 17 know, when you have a doctor who actually takes your 18 symptoms seriously, isn't telling you, you know, like, 19 well, you shouldn't be having these problems instead of 20 like, here, I can help you, I can try and fix this, I 21 can -- I can make your problems better, and that, in 22 itself, is like, wow. 23 Q And so you trusted Dr. Jain, correct? 24 A Yes, I trusted Dr. Jain. I -- you know, I -- I did. I 25 was like because this was the first doctor who, you 79 1 know, wasn't telling me that I shouldn't have a problem 2 that I already have. 3 Q Right. 4 A Well, gee, genius, I -- I know I already have the 5 problem. That's why I come here to see you, but at 6 least they were taking it seriously enough to say, okay, 7 now that you're coming to me with the problem, I have -- 8 I have several things to try to make it better. 9 Q Okay. 10 A I'm not gonna tell you you shouldn't have a problem that 11 you have, and I'm not gonna, you know, give you one pat 12 answer of like, here, Kegel for the next six years and 13 see if that helps and, when it doesn't, they're not 14 leaving you with a lot of options. 15 Q Sure. 16 A So I -- I probably trusted him more than anybody else 17 because he -- he said I -- I have several things for you 18 to try, and, you know, when you are given more than one 19 option, you say, awesome, I'm -- I'm on board. 20 Q Right. Do you feel sitting here today that Dr. Jain 21 adequately warned you of the risks associated with the 22 ObTape surgery? 23 MR. BIRELEY: Objection, form. You can answer. 24 THE WITNESS: I guess I don't really understand 25 the question. Do you mean that -- or, okay. Can you 80 1 repeat that? Sorry. 2 MR. ADAMS: Can you repeat that, please? 3 THE COURT REPORTER: Sure. 4 (Last question read back by the court reporter.) 5 MR. BIRELEY: Same objection. You can answer. 6 THE WITNESS: I'm not certain. I -- I was -- I 7 was more thinking on the optimistic side. I mean, I -- 8 he -- yes, he went through things like, you know, there 9 is a -- 10 MR. ADAMS: Things we covered in the exhibits. 11 THE WITNESS: -- there is a possibility of this 12 and that and the other thing -- 13 MR. ADAMS: Okay. 14 THE WITNESS: -- but when you have a doctor who 15 is a urologist who specializes in this and says I have 16 already completed, you know, many successful surgeries, 17 you're thinking that, you know, okay, well, since 18 nothing else has actually worked, I -- I'm going for 19 broke and, you know, trusting that, yeah, they can help. 20 Q So are there any risks associated with the ObTape 21 procedure that you wish Dr. Jain would have told you 22 about before the surgery? 23 MR. BIRELEY: Objection, form. You can answer. 24 THE WITNESS: Oh, he -- you know, he -- he did 25 warn me about things like, well, it -- it might -- 81 1 things might erode, and I guess I should have asked more 2 questions perhaps. Well, what exactly do you mean by 3 "erode"? Do you mean by disintegrate inside your body 4 or are you talking about it intruding and poking through 5 things and having to -- you know, I mean, there's -- 6 there's a difference between it disintegrating and it 7 puncturing. 8 Q Sure. 9 A Do you know what I mean? 10 Q Yeah. 11 A So maybe that was my fault for not asking the right 12 questions. I don't know, so -- and, like he said, all 13 surgeries do have some amount of risk and they even tell 14 you, well, you know, it's common to have like 15 infection -- you know, and you're thinking more of 16 commonplace things like, you know, infection just from 17 being opened up and getting some sort of, you know, 18 staph or who knows? I don't know but -- 19 Q Okay. And so what I'm going to introduce now is your 20 operation report with your implant procedure. 21 A Okay. 22 MR. ADAMS: That's going to be Exhibit Number 3. 23 THE COURT REPORTER: It'll be 4. 24 MR. ADAMS: Four. Sorry. 25 (Exhibit 4 marked for identification.) Case 4:14-cv-00190-CDL Document 33-4 Filed 01/23/17 Page 8 of 14 800-567-8658 973-410-4040 Veritext Legal Solutions 22 (Pages 82 to 85) 82 1 Q And, Ms. Ertz, we're going to do the same thing we've 2 been doing where I read and you make sure I'm reading it 3 correctly, okay? 4 A All right. 5 Q So at the top we've got, "Name: Ertz, Terri L.," 6 correct? 7 A Yes. 8 Q "Surgeon: S. Jain, M.D.," correct? 9 A Yes. 10 Q "Date of Procedure: 12/22/05," correct? 11 A Yes. 12 Q And down here we've go the "Operative Procedure" is 13 "Transobturator vaginal sling surgery," correct? 14 A Yes. 15 Q Okay. And then under "History" we've got, "This is a 16 36-year-old female with stress urinary incontinence not 17 responding to Kegels or pelvic floor strengthening 18 exercises. Options were discussed with the patient. We 19 decided to proceed with the transobturator vaginal sling 20 surgery. Other options were discussed using autologous 21 fascia versus cadaveric fascia versus synthetic fascia. 22 Risk and benefits were discussed. All options were 23 discussed. Informed consent was obtained. Risks of 24 infection, bleeding, urinary retention and injury to the 25 urethra or bladder were all discussed. Possibility of 83 1 indwelling catheter if she goes into retention was 2 discussed. Success rate, which is about 85 percent, was 3 discussed." Did I read that correctly? 4 A Yes. 5 Q And if you could flip to the back, under the signature 6 line that's "S. Jain, M.D.," correct? 7 A Are you talking about the signature? 8 Q Yes, under the signature line. 9 A Oh, "S. Jain" -- under the signature line like his name 10 typed? 11 Q Yes. It's "S. Jain, M.D.," correct? 12 A Yeah. 13 Q And there's a signature on the line, right? 14 A If that's what you want to call a signature, yeah. 15 Q There's something on the line. 16 A There's something on the line. 17 Q Okay. And so what I'm wondering about is whenever you 18 sign the -- did you sign the consent form before the 19 surgery? 20 A Yes. 21 Q Okay. And did you read that consent form? 22 A Yes. 23 Q Okay. And did you understand it? 24 A Yes. 25 Q Okay. And was there anyone else around whenever you 84 1 signed the consent form besides the doctor? 2 A No. 3 Q And then you had the surgery, right? 4 A Yes. 5 Q And, of course, you don't remember anything about the 6 actual surgery because you were unconscious, presumably? 7 A Yes. 8 Q Okay. 9 A I don't remember a thing about it. 10 Q Okay. And so were you getting any other procedures 11 whenever you had the sling implanted? 12 A Not as far as I knew. 13 Q Okay. And before the surgery did you know what company 14 manufactured the vaginal sling used in your surgery? 15 A No. I had no clue. 16 Q And do you know now? 17 A Apparently, just from the medical records. 18 Q Okay. And what company is that? 19 A ObTape Mentor Worldwide, I'm assuming. 20 Q Okay. And so right before the surgery -- and this is, 21 again, whenever you're checked in, so you're, you know, 22 getting ready for surgery, you're being prepped, that 23 kind of stuff -- was there anything unusual going on? 24 Were you experiencing any random symptoms or anything 25 like that? 85 1 A Not as far as I know. 2 Q Okay. And who was with you? 3 A I think it was just me. 4 Q Okay. And you talked to Dr. Jain before the surgery, 5 right? 6 A I don't recall specifically. I know they -- I -- I 7 think they prep you and then they give you like 8 something to, here, this will help you relax. 9 Q Right. 10 A So after getting that it's sort of like -- 11 Q So you didn't see Dr. Jain before you received that? 12 I'm just wondering if you even saw him before the 13 surgery. 14 A I'm -- I don't recall. 15 Q You don't recall. Okay. 16 A I'm not sure. 17 Q And so after the surgery you, obviously, stayed in the 18 hospital for a little bit, right, at least a couple 19 hours -- 20 A Yeah. 21 Q -- I would assume. But did you stay overnight? 22 A No. 23 Q Okay. And did you have to do any rehab or physical 24 therapy before you left? 25 A No. Case 4:14-cv-00190-CDL Document 33-4 Filed 01/23/17 Page 9 of 14 800-567-8658 973-410-4040 Veritext Legal Solutions 26 (Pages 98 to 101) 98 1 your recollection? 2 A No. She gave me the pamphlet and, you know, went over 3 like dietary stuff and, you know, eat more fruits, eat 4 more vegetables, drink more water, you know, that kind 5 of thing, and, no, it wasn't that I was uninterested. 6 Just she said reduce your caloric intake, you know, so I 7 pretty much did. 8 Q So you followed her guidelines? 9 A By reducing caloric intake, yeah, I did. Maybe not to 10 the extent that she wanted or -- I don't know. I'm not 11 sure so -- 12 Q Okay. And did it help with your weight, following her 13 recommendations? 14 A It -- did it help? Are you asking did I lose weight or 15 are you asking -- what are you asking? 16 Q I guess what I'm asking is: You were diagnosed with 17 obesity, and, presumably, that's why you're seeing 18 Ms. Getten, correct? 19 A Yes. 20 Q And so did following her recommendations help you in 21 dealing with your obesity through weight loss or any 22 other method? 23 A Not to the -- not to the results that I'd like, if 24 that's what you're asking -- 25 Q Okay. Sure. 99 1 A -- but it wasn't -- it wasn't hurting because I wasn't 2 gaining, you know what I mean? 3 Q Okay. So you were staying the same? 4 A Yeah. There was no gain, but there was no significant 5 loss, put it that way. 6 Q Okay. And at any point did any doctor tell you that 7 obesity can cause the ObTape procedure to fail? 8 A No. 9 Q Okay. Were you worried that obesity could cause your 10 ObTape procedure to fail? 11 A Not really. I was kind of obese when I had it done in 12 the first place and it worked so -- 13 Q Okay. And then you see -- you go to the Urgent Care 14 Clinic in August of 2009 for lower back pain that you 15 had been having for two or three days. It says that you 16 woke up with extreme pain in your lower back -- 17 A Um-hm. 18 Q -- and it was hard for you to stand or walk. Do you 19 remember experiencing that pain? 20 A What year? 21 Q 2009. 22 A Yes. 23 Q And can you kind of describe what that pain felt like? 24 Was it stabbing, aching, burning? 25 A Oh, it was -- it was stabbing and it was painful, yeah. 100 1 Q Okay. And do you know what caused that pain? 2 A No. 3 Q Okay. Did you ever ask a doctor what caused that pain? 4 A No. 5 Q And did you receive any treatment for it? 6 A I probably did. I -- I know at some point in time I 7 was -- I don't know if it was that specific time, but I 8 know at some point in time I got muscle relaxers. 9 Q Okay. And then in November of 2010, this is your first 10 complaint after ObTape, your ObTape procedure, in which 11 you're at a doctor discussing incontinence. 12 A Um-hm. 13 Q Is that consistent with your recollection? 14 A Yes. 15 Q Okay. And so you're seeing a Dr. Holley. Do you 16 remember Dr. Holley? 17 A Actually, no. 18 Q Okay. 19 A That must have been a -- what was she? Was she an OB or 20 was she -- 21 Q Well, it says it's a urology consultation, so I presume 22 she's a urologist. 23 A Hm. I wonder if she's still there. 24 Q And this was at the Marshfield Clinic, and it states 25 that over the past month you had been experiencing 101 1 incontinence requiring you to wear pads, and you also 2 need to change your clothes multiple times a day, and 3 you're experiencing urinary frequency every three to 4 four hours during the day with nocturia every two hours 5 at night. Is that consistent with your recollection? 6 A Yeah. 7 Q So by November of 2010, it seems like things have gotten 8 pretty bad? 9 A Um-hm. 10 Q Okay. And it says that you're reporting urinary 11 urgency, urge incontinence. You report leakage of urine 12 with cough, sneeze or activity, and you're reporting 13 stress urinary incontinence more often and more 14 bothersome than your urge incontinence. Is that 15 consistent with your recollection? 16 A Yes. 17 Q And so at this point what did you think was causing your 18 incontinence? 19 A I had no idea. 20 Q Okay. And whenever you went to see Dr. Holley, what did 21 she think was causing your stress urinary incontinence? 22 A I don't recall her saying. 23 Q Okay. And did you ask? 24 A No. 25 Q Okay. And it says that you should begin performing Case 4:14-cv-00190-CDL Document 33-4 Filed 01/23/17 Page 10 of 14 800-567-8658 973-410-4040 Veritext Legal Solutions 27 (Pages 102 to 105) 102 1 routine Kegel exercises. Do you remember being told to 2 do Kegel exercises? 3 A I remember being told that a lot. 4 Q And did you? 5 A Um-hm. 6 Q Okay. And did it help? 7 A No. 8 Q No. Okay. 9 A It didn't help before either so -- 10 Q Right. And then you go back to see Dr. Holley about a 11 month later at the Marshfield Clinic. 12 A Um-hm. 13 Q And after receiving an informed consent she does a 14 cystoscopy. Do you remember that? 15 A I'm not sure exactly what that is. 16 Q It's where they insert a catheter to take a look inside 17 your urethra and bladder. 18 A Oh. 19 Q Do you remember that procedure? 20 A I think I've had that done more than once, so I'm not -- 21 you know, like I said, I'm not sure of the time line or 22 who did it but -- 23 Q So you're not saying that it didn't happen, you're just 24 saying you're not sure? 25 A Right. 103 1 Q Okay. And do you remember going over the results of 2 that cystoscopy or do you not remember that either? 3 A I don't remember. 4 Q Okay. And so then about a month later you come to the 5 Urgent Care Clinic and you're complaining of pain with 6 urination and lower abdomen pain for the past two days. 7 Do you remember experiencing those symptoms? 8 A Not specifically that incident, but -- 9 Q Okay. 10 A -- I'm sure if it says I did, I probably did. 11 Q Okay. And it says that you had previously received a 12 bladder suspension surgery several years ago and that 13 you just began having problems once again now. So it 14 seems like we've at least pinpointed that in late 2010 15 is whenever you were for sure experiencing incontinence 16 again, correct? 17 A Um-hm. 18 Q Okay. And at this point you mentioned previously that 19 you didn't ask Dr. Holley what was causing it, correct? 20 A Right. 21 Q What did you think was causing your incontinence? 22 Because we're -- we're three years after your pregnancy, 23 and so I'm just trying to get kind of an idea of where 24 your head's at at this point. 25 A I probably -- I wasn't sure. I mean, that's -- that's 104 1 why you go to the doctor, so that they can -- they can 2 figure it out. It wasn't -- 3 Q Right. 4 A I don't usually -- I'm not in the medical field, so 5 it's -- you know. 6 Q And did you ask any doctor at this point what they 7 thought was causing the return of your incontinence? 8 A No. I just assumed that they had -- whatever it was 9 that was causing it, that they would figure out how to 10 make that stop. 11 Q Okay. And then it looks like around February of 2011 12 you get a pessary put in. 13 A Yes. 14 Q Okay. And we don't have the record as far as the 15 consult or when that's first given to you, so do you 16 remember around when that was? 17 A Honestly, I -- I don't. 18 Q Okay. And whenever you were given a pessary, what did 19 they say that it would help with? 20 A The -- the SUI symptoms. 21 Q Okay. And which doctor gave you the pessary? 22 A I believe it was Dr. -- I believe it was Dr. Emmerich or 23 it could have been Dr. Lysy. I saw them both at about 24 the same time so it's kinda hard to remember which one, 25 but it was -- it was one of the two. 105 1 Q And did you know that the pessary would be used to treat 2 the same symptoms that your ObTape sling was supposed to 3 be treating? 4 A All I was told is that that's -- it created some pelvic- 5 floor support. I -- I don't believe -- I don't know 6 if -- I -- I -- I don't know. 7 Q And at this point did you think anything was wrong with 8 your ObTape sling? 9 A I -- I wasn't sure, you know. Yes, I already had a 10 baby, but, you know, like I said, it was -- like they 11 told me before, babies cause your pelvic floor to weaken 12 so -- and that you can, you know, get stress 13 incontinence from pelvic-floor weakening through 14 pregnancy or, you know, other things, so I assume that's 15 maybe what it -- that for some reason it was weaker. I 16 don't know. 17 Q Okay. 18 A I wasn't sure what was going on so -- 19 Q So you weren't sure what was causing the return of your 20 stress urinary incontinence? 21 A No. 22 Q And did any part of you even consider that it could be 23 failure of your ObTape sling? 24 A Not really. 25 Q Okay. And then in July of 2011 you get fitted for a Case 4:14-cv-00190-CDL Document 33-4 Filed 01/23/17 Page 11 of 14 800-567-8658 973-410-4040 Veritext Legal Solutions 28 (Pages 106 to 109) 106 1 different pessary. It looks like it's a bigger one. Is 2 that consistent with your recollection? 3 A It was -- it was just a different -- yeah, it was 4 bigger, and it had -- yeah, it was bigger, and it had 5 like a knob and it was supposed to be like stronger. 6 Q Okay. And how did that pessary ring -- what results did 7 you have with that pessary ring? 8 A Not a lot of difference. 9 Q But was it helping at all with your stress urinary 10 incontinence? 11 A Not -- not a lot. 12 Q Not a lot? 13 A No, not a lot of difference. 14 Q So then in January of 2012 I have a record here from 15 your meeting with a physical therapist, Katie Stearns, 16 and you're complaining of low back pain, and it says 17 that you were diagnosed with -- diagnosed with some 18 degeneration of the discs in your lumbar spine. Is that 19 consistent with your recollection? 20 A Yeah. 21 Q Okay. And in 2012, is this the first time you're ever 22 hearing of disc degeneration or had you previously been 23 diagnosed with that? 24 A No. That was about the first time I was hearing about 25 it. 107 1 Q And it looks like you wanted to get a joint injection, 2 correct? 3 A Yeah. 4 Q And then you did get the joint injection about, 5 actually, the next day. 6 A Yeah. 7 Q Is that consistent with your recollection? 8 A A Cortisone injection, I believe, yeah. 9 Q And so, presumably, that injection was in your back, 10 correct? 11 A Yes. 12 Q Okay. And did you have any problems with that, any 13 complications? 14 A No. 15 Q Okay. And did it work? 16 A Not really. 17 Q Okay. Did you receive any follow-up injections? 18 A No. 19 Q Did you receive any follow-up treatment? 20 A Yeah. I started seeing a chiropractor. 21 Q Okay. And that was the chiropractor we discussed 22 earlier, correct? 23 A Yeah. He -- actually, he -- I'd been seeing the same 24 chiropractor until he sold his business, and now I'm 25 seeing the guy who bought his business. 108 1 Q Okay. And it says here later that month, in January of 2 2012, you were also diagnosed with a bulging disc -- 3 A Um-hm. 4 Q -- to go with your degenerative disc -- degenerative 5 disc disease, correct? 6 A Right. 7 Q And are you still receiving treatment for both of those 8 disc issues? 9 A Yeah. That's why I gotta see a chiropractor pretty 10 regularly. 11 Q And then at the end of January you see Dr. Emmerich, and 12 it says that, "The patient is doing well with the ring 13 pessary with knob for pelvic organ prolapse and 14 incontinence." Were you doing well at this point? 15 A Not -- I'm doing well. I wouldn't say I was a hundred 16 percent, but, you know, it might have helped with some 17 of the symptoms, but I don't think that they completely, 18 obviously, didn't go away a hundred percent. 19 Q So do you think that Dr. Emmerich misrepresented how you 20 were feeling at this point? 21 A She might have or she might have -- you know -- 22 Q Sure. 23 A -- there might have been some -- like I said, there 24 might have been some relief but not to the degree of it 25 not being a problem anymore. 109 1 Q So you, certainly, weren't doing well? 2 A Well, no. I don't know. 3 Q Okay. 4 A "Doing well" is a relative term, isn't it? 5 Q I suppose so. You see Dr. Tana about a month later, and 6 you're seeing him for worsening urinary incontinence, 7 and that's consistent with your recollection, correct? 8 A Yeah. 9 Q And then you see Dr. Emmerich in May, and it looks like 10 it's just an annual exam, but Dr. Emmerich talks about, 11 you know, regarding your obesity, "She struggles with 12 chronic low back pain and recurrent problems with some 13 urinary incontinence and cystocele with some relief with 14 the pessary but reports that it's still not perfect." 15 Is that consistent with your recollection? 16 A Yes. 17 Q Okay. And Dr. Emmerich goes on to say, "I let her know 18 what she really needs to do is lose weight and stop 19 smoking. She requests evaluation for possible bariatric 20 surgery. I did give that referral." Is that consistent 21 with your recollection? 22 A Yes. 23 Q So Dr. Emmerich at least implied that weight loss and 24 ceasing to smoke would help with your incontinence, 25 correct? Case 4:14-cv-00190-CDL Document 33-4 Filed 01/23/17 Page 12 of 14 800-567-8658 973-410-4040 Veritext Legal Solutions 31 (Pages 118 to 121) 118 1 Q Okay. So you didn't receive any treatment for them? 2 A I don't recall what it would be. 3 Q Okay. 4 A I -- I might have been given an antibiotic. I'm not 5 sure. 6 Q And do you know how long they lasted for? 7 A I don't recall. 8 Q Okay. More than a week? 9 A Possibly. 10 Q More than a month? 11 A I don't recall specifically, no. 12 Q Okay. And did you ever ask a doctor what would be 13 causing the sebaceous cysts? 14 A No. 15 Q Okay. And did a doctor ever tell you what would be the 16 cause of the sebaceous cysts? 17 A No. 18 Q Okay. And then here in October of 2013 you start seeing 19 Nancy Peloquin, and it looks like this is for counseling 20 for depression. 21 A Um-hm. 22 Q Is that consistent with your recollection? 23 A Yeah. 24 Q And it says here that your spouse just passed away and, 25 you know, obviously, that was having a detrimental 119 1 effect on your mental health. Is that consistent with 2 your recollection? 3 A Yeah. 4 Q And so at this point were you suffering from depression? 5 A Probably. 6 Q And what was causing that depression? 7 MR. BIRELEY: Objection, form. You can answer. 8 THE WITNESS: Spouse passing away, I imagine, 9 life in general. I don't know. Take your pick. 10 Q And it says here that you're willing to proceed with 11 counseling every two weeks -- 12 A Yeah. 13 Q -- is that consistent with your recollection? Okay. 14 And then you go back to see Dr. England in October of 15 2013. 16 A Um-hm. 17 Q And there's a discussion about -- so you're discussing 18 having another sling implanted, okay? 19 A Um-hm. 20 Q And it says that, "The risks were discussed. Patient 21 acknowledges no guarantees have been made to her 22 concerning the results of the procedure. Mesh risks 23 were explained," and that Dr. England goes on to say, "I 24 have discussed with the patient that her success rate 25 with suburethral sling is substantially hampered by her 120 1 weight and smoking. She has requested to have this done 2 even though she has a high risk of failure, as she 3 doesn't think she will be able to exercise and, thus, 4 lose weight if she doesn't have this done." Is that 5 consistent with your recollection? 6 A If it's -- I -- I recall having a conversation about 7 risks. I don't remember specifics, but if that's what 8 it said, then, yeah. 9 Q Okay. And, again, you're not saying it's not accurate? 10 A Correct. 11 Q You just don't remember it, right? 12 A Right. 13 Q Okay. And so we don't actually have any records of you 14 having a second sling procedure. So did you have one 15 done? 16 A Absolutely. 17 Q Okay. And when was it? 18 A I believe it was November of 2013. 19 Q Okay. And at that point -- and who did the surgery? 20 A Dr. England. 21 Q Okay. And at that point was your ObTape sling removed? 22 A According to the discovery information that I got, yes, 23 it was. From the previous surgery in 2005, yes. 24 Q And so whenever you say discovery information you got, 25 what do you mean? 121 1 A I mean I was mailed a packet of information that was 2 previously given to the Court, I imagine. 3 Q But you filled out that information, correct? 4 A Yes. 5 Q Okay. 6 A Some -- some of it. 7 Q Okay. So did you fill out the part about your ObTape 8 sling being removed? 9 A I believe that was part of the medical records that were 10 submitted. I did not personally get a copy of my 11 medical records. They were just literally mailed out, 12 so I don't -- 13 MR. ADAMS: And, counsel, to the extent that you 14 have the medical records of the second sling, we'd just 15 request those. 16 MR. BIRELEY: Yes. 17 MR. ADAMS: Thanks. 18 Q Because, again, we're not trying to cast any doubt. We 19 just haven't seen them, that's all. And so do you know 20 what type of new sling was implanted? 21 A No. 22 Q Okay. 23 MR. BIRELEY: I'll just add to the extent we 24 have them 'cause I don't -- I'm not sure that we do. 25 MR. ADAMS: Sure. Okay. Right, and -- and just Case 4:14-cv-00190-CDL Document 33-4 Filed 01/23/17 Page 13 of 14 800-567-8658 973-410-4040 Veritext Legal Solutions 36 (Pages 138 to 141) 138 1 around 2005? The -- the initial implantation of the 2 ObTape sling was -- 3 A Yes. Yes. 4 Q And then the incontinence went away for a little bit? 5 A Yes. 6 Q And then the incontinence resumed? 7 A Yes. 8 Q And after the incontinence resumed did you go see 9 physicians to address a recurrence of stress urinary 10 incontinence? 11 A Yes. 12 Q Did any physician ever tell you that the recurrence was 13 the result of your sling not working? 14 A No. 15 Q Would you have expected your physician to tell you that 16 your sling's not working if that was, in fact, the cause 17 of the return of your urinary incontinence? 18 A Yeah, I would expect that if they knew something, that 19 they would tell me. 20 Q And did your physicians -- physicians recommend that you 21 pursue alternative treatments like physical therapy, 22 Kegel exercises and the pessary? 23 A Absolutely. 24 Q And did you think that -- strike that. And did you 25 think that there was something wrong with you that was 139 1 causing the SUI to recur as opposed to something wrong 2 with the sling? 3 A Yes. 4 Q And then did you see Dr. Emmerich in late 2012? 5 A Yes. 6 Q And did Dr. Emmerich refer you to Dr. England? 7 A Yes. 8 Q And did Dr. England recommend that you undergo an 9 additional procedure to have a different sling 10 implanted? 11 A Yes. 12 Q And did that sling address your urinary incontinence 13 symptoms? 14 A Yes. 15 Q And at what point did you realize that the sling that 16 had been implanted in you by Dr. Jain in 2005 was 17 defective or didn't address your symptoms? 18 A I guess it would be after I had the -- the second 19 surgery and it worked so darn well, so, you know, like 20 I -- I was afraid at some point it was like, well, maybe 21 it was my weight, maybe it was, you know, something I 22 ate, something I drank that was exacerbating the 23 problem, pregnancy after the surgery, that that didn't 24 help, and then after I had the surgery and it 100 25 percent took care of the problem, I was like, oh, maybe 140 1 it wasn't me. 2 Q And then do you remember whether or not you contacted 3 attorneys before or after the second procedure that you 4 underwent with Dr. England? 5 A I -- I did. 6 Q Do you recall if it was before or after that procedure? 7 A Oh, after. 8 MR. BIRELEY: I have no further questions. 9 MR. ADAMS: Good from me. 10 THE WITNESS: Okay. 11 THE VIDEOGRAPHER: Okay. This concludes the 12 deposition. The time is 12:30. We are off the record. 13 (Conclusion of record at 12:30 p.m.) 14 15 16 17 18 19 20 21 22 23 24 25 141 1 STATE OF WISCONSIN) SS. 2 EAU CLAIRE COUNTY ) 3 4 I, MARIDEE J. OLSON, Registered Merit Reporter and 5 Notary Public, State of Wisconsin, certify that the foregoing 6 is a true record of the video deposition of TERRI L. ERTZ, 7 who was duly sworn by me; having been taken on the 21st day 8 of October, 2016, at Eau Claire, Wisconsin, in my presence 9 and reduced to writing in accordance with my stenographic 10 notes made at said time and place. 11 I further certify that I am not a relative or employee 12 or attorney or counsel of any of the parties, or a relative 13 or employee of such attorney or counsel, or financially 14 interested in said action. 15 In witness whereof, I have hereunto set my hand and 16 affixed my seal of office at Eau Claire, Wisconsin, this 31st 17 day of October, 2016. 18 19 20 _______________________________ 21 Registered Merit Reporter Notary Public, State of Wisconsin 22 My commission expires November 11, 2017. 23 24 25 Case 4:14-cv-00190-CDL Document 33-4 Filed 01/23/17 Page 14 of 14 Exhibit B Case 4:14-cv-00190-CDL Document 33-5 Filed 01/23/17 Page 1 of 21 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION IN RE: MENTOR CORP. OBTAPE TRANSOBTURATION SLING PRODUCTS LIABILITY LITIGATION MDL NO. 2004 HON. CLAY D. LAND U.S. DISTRICT JUDGE THIS DOCUMENT RELATES TO: Terri Ertz v. Mentor Worldwide, LLC Case No. 4:14-cv-00190-CDL PLAINTIFF’S FIRST AMENDED 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 department, 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 4:14-cv-00190-CDL Document 33-5 Filed 01/23/17 Page 2 of 21 2 I. CASE INFORMATION 1. Name of person completing this form: Terri Ertz 2. Name of person on whose behalf a claim is being made: Terri Ertz 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): 5614100-026 2. Date of Implantation: 12/22/2005 3. Name and Address of Implanting Surgeon(s): Dr. Siddharth Jain Marshfield Clinic 1000 N. Oak Avenue Marshfield, WI 54449 4. Name and Address of Hospital, Clinic, or Doctor’s Office where implantation surgery was performed: Sacred Heart Hospital 900 W. Clairemont Avenue Eau Claire, WI 54701 5. If the ObTape has been removed, provide the date on which it was removed: 11/15/2013 6. Name and Address of Surgeon(s) who removed the ObTape: Dr. Rebecca England 1411 N. Taylor Drive Sheboygan, WI 53081 7. Name and Address of Hospital, Clinic, or Doctor’s Office where surgery(ies) performed: Case 4:14-cv-00190-CDL Document 33-5 Filed 01/23/17 Page 3 of 21 3 8. Name of the Manufacturer and Type of the replacement sling, if any: 11/15/2013 Unidentified synthetic retropubic sling per MD records 9. Were any portions of the ObTape surgically removed? Yes 5 No a) If yes, what is the present location of the removed portions of the ObTape? Unknown - hospital pathology 10. Has any doctor ever told you that there are portions of the ObTape still in your body? Yes No 5 If yes, please provide name and address of each such doctor: 11. Has any doctor told you that those portions of the ObTape still in your body need to be removed? Yes No 5 If yes, please provide name and address of each such doctor: III. PERSONAL INFORMATION 1. Name (first, middle name or initial, last): Terri Lynn Ertz 2. Maiden or other names used and dates you used those names: Terri Lynn Morrow Birth thru 1990 3. Current address and date when you began living at this address: 3/27/2015 Eau Claire, WI 54701 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 Eau Claire, WI 54701 3/27/2015 thru Present Altoona, WI 9/2014 thru 3/2015 Eau Claire, WI 54703 8/2009 thru 9/2014 Case 4:14-cv-00190-CDL Document 33-5 Filed 01/23/17 Page 4 of 21 4 Address Dates of Residence Eau Claire, WI 54703 10/2007 thru 5/2009 Eau Claire, WI 4/2006 thru 10/2007 Elk Mound, WI 4/2003 thru 4/2006 Hixton, WI 2002 thru 4/2003 Altoona, WI 2001 thru 2002 Marshall, WI 2000 thru 2001 Marsfield, WI 1999 thru 2000 Colby, WI 1997 thru 1999 Withee, WI 1999 Loyal, WI 1995 thru 1997 5. Social Security Number: 6. Date and place of birth: Place of Birth: Madison, WI 7. Current marital status: Widow 8. If married, please provide the following information: N/A 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): Paul Ertz 7/14/1990 thru 9/2013 Reason for Termination: Deceased 10. If you have children, list each child’s name and date of birth and whether they were delivered vaginally or by Caesarian. Alexander Ert 12/20/1990 Delivered Vaginal Nicholas Ertz Delivered Vaginal Zoe Delivered Vaginal Case 4:14-cv-00190-CDL Document 33-5 Filed 01/23/17 Page 5 of 21 5 Vivian Ertz Delivered Vaginal Katherine Ert 27 Delivered Caesarian 11. Identify all schools you attended, starting with high school: Name of School Address Dates of Attendance Degree Awarded Major or Primary Field University of Wisconsin, Eau Claire Eau Claire, WI 8/2007 thru 12/2012 Diploma Sociology Chippewa Valley Technical College Clairemont Avenue Eau Claire, WI 2005 thru 2007; 1999 thru 2000 CDL Training Madison Area Technical College Madison, WI 1990 thru 1993 College transfer courses Marshall High School Marshall, WI 1984 thru 1987 Diploma General studies 12. Are you currently employed? Yes 5 No If yes, please identify your current employer with name, address and telephone number and your position there: Lutheran Social Services 1320 W. Clairemont Avenue, Suite 200 Eau Claire, WI 54701 877/967-5577 Position: Community Living Support Agent Grace Lutheran Church 202 W. Grand Avenue Eau Claire, WI 54701 715/832-9713 Position: Housekeeper/Kitchen Manager If not, did you leave your last job for a medical reason? Yes No 5 If yes, describe why you left: N/A Case 4:14-cv-00190-CDL Document 33-5 Filed 01/23/17 Page 6 of 21 6 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 Telephone Number Dates of Employment and Wage/Salary Describe Your Position or Duties Reason for Leaving University of Wisconsin Eau Claire, WI 2011 thru 2012 $7.25/hour Student researcher (Sociology) Work study job during college All A’s Driving School Seymour Road Eau Claire, WI 2006 thru 2010 $10.0/hour Driving instructor $10.00/hour Business sold Goodwill Menomonie, WI Donation attendant Lorman Eau Claire, WI Audio editor Laid off Wiza Trucking Hixton, WI 2002 thru 2003 $.28/mile Driver Personal leave - house fire 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 5 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: 2005 (b) Type of benefits: SSI Disability (c) Nature of claimed injury/disability: Chronic Depression (d) Period of disability: 2005 thru Present (e) Amount awarded: $920.00/month (f) Basis of your claim: Chronic Depression (g) Was claim denied? Yes No 5 Case 4:14-cv-00190-CDL Document 33-5 Filed 01/23/17 Page 7 of 21 7 (h) To what agency or company did you submit your application: Social Security Administration (i) Claim/docket number, if applicable: Unknown 16. Have you ever filed a lawsuit or made a claim (other than this suit)? Yes  No  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 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  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: 18. Have you or your spouse ever declared bankruptcy since the date of your initial ObTape surgery? Yes  No  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: 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  If yes, please state the name and address of the third party with whom you have entered into such a contract. Case 4:14-cv-00190-CDL Document 33-5 Filed 01/23/17 Page 8 of 21 8 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. To the best of Plaintiff’s memory and knowledge, Plaintiff states: Name (Specialty) Address and Telephone Number Approx Dates/Years of Visits Reason/Procedure Performed Dr. Siddharth Jain, Marsfield Clinic (no longer there) (Urologist) 1000 N. Oak Avenue Marshfield, WI 54449 715/389-0700 2005 thru 2007 Mentor ObTape mesh implant Sacred Heart Hospital 900 W. Clairemont Avenue Eau Claire, WI 54701 715/717-4121 12/22/2005 Mentor ObTape mesh implant Dr. Rebecca England (OB/GYN) 1411 N. Taylor Drive Sheboygan, WI 53081 888/477-3832 11/15/2013 Mentor ObTape mesh explant Dr. Daniel Bowman, Eau Claire Anesthesiologists (Anesthesiologist) 1101 W. Clairemont Avenue Eau Claire, WI 54701 Marshfield Clinic 2116 Craig Road Eau Claire, WI 54701 715/858-4500 Dr. Amy Lysy (OB/GYN) 2116 Craig Road Eau Claire, WI 54703 715/858-4700 2006 thru 2007 Dr. Melissa Emmerich (OB/GYN) 2116 Craig Road Eau Claire, WI 54703 715/858-4700 2007 thru Present Dr. London (OB/GYN) Craig Road Eau Claire, WI 54703 2012 Dr. Tana (General Practice) Craig Road Eau Claire, WI 54703 2007 thru Present Primary care Dr. Somsak Tanawattanacharoen (Nephrologist) 2116 Craig Road Eau Claire, WI 54701 715/858-4500 Obesity Plaintiff reserves the right to supplement as she continues to be treated for injuries sustained as a result of the implant/explant of her mesh sling. Case 4:14-cv-00190-CDL Document 33-5 Filed 01/23/17 Page 9 of 21 9 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. Plaintiff reserves the right to supplement as she continues to be treated for injuries sustained as a result of the implant/explant of her mesh sling. Name of Pharmacy/Supplier Address and Telephone Number of Pharmacy/Supplier Approx. Dates/Years You Used Pharmacy/Supplier Marshfield Clinic Pharmacy 2116 Craig Road Eau Claire, WI 54701 715/858-4500 2002 thru Present Walgreens S. Hastings Way Eau Claire, WI 2002 thru Present Marshfield Clinic Pharmacy 1000 N. Oak Avenue Marshfield, WI 54449 1995 thru 2001 UW Hospital and Clinic Pharmacy Madison, WI 2001 thru 2002 V. MEDICAL BACKGROUND 1. Current Height: 5’6” 2. Please state your weight at the following times: (a) Current: 315 lbs. (b) Time of implant: 285 lbs. (c) Time of explant/excision surgery (if any): Unknown 3. Smoking History (a) Have you ever smoked cigarettes? Yes  No  State amount smoked: 1 pack per day for 30 years, during the years 1986 thru Present. Case 4:14-cv-00190-CDL Document 33-5 Filed 01/23/17 Page 10 of 21 10 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: To the best of Plaintiff’s memory and knowledge, Plaintiff states: Condition Experienced or Diagnosed Yes No Don’t Know 1. Abnormal pap smear  2. Autoimmune disease  3. Bacterial vaginosis  4. Cervical cancer  5. Cystocele  6. Diabetes  7. Endometriosis  8. Gestational diabetes  9. Hormone deficiency  10. Hypertension/high blood pressure  11. Interstitial cystitis  12. Obesity  13. Ovarian cancer  14. Pelvic inflammatory disease  15. Polycystic ovary disease  16. Rectocele  17. Stress urinary incontinence  18. Thyroid disorder  19. Toxic shock syndrome  20. Urethral erosion  21. Urinary tract infection  22. Urge incontinence  23. Uterine cancer  24. Vaginal erosion  25. Vaginal infection  26. Venereal disease  27. Yeast infection  Case 4:14-cv-00190-CDL Document 33-5 Filed 01/23/17 Page 11 of 21 11 (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 Stress Urinary Incontinence and Urge Incontinence 1998 Dr. Siddharth Jain 1000 N. Oak Avenue Marshfield, WI 54449 Dr. London Craig Road Eau Claire, WI 54703 Mesh implant and revision/explant; medication Obesity 1990 Dr. Somsak Tanawattanacharoen 2116 Craig Road Eau Claire, WI 54701 715/858-4500 Urinary Tract Infections Various Medication Yeast Infections Various Medication, powders VI. MEDICATIONS 1. List all of the medications (prescription and over the counter) you currently take. To the best of Plaintiff’s memory and knowledge, Plaintiff states: Medication Dose/Frequency/ Dates of Use Physician Ordering Pharmacy Dispensing Purpose Vesicare Marshfield Clinic Pharmacy Bladder spasms Oxybutynin Chloride 5 mg daily Marshfield Clinic Pharmacy Bladder spasms Simvastatin 20 mg daily Marshfield Clinic Pharmacy Cholesetrol Albuterol Sulfate 90 mcg twice daily as needed Marshfield Clinic Pharmacy Breathing Meloxicam 15 mg daily as needed Marshfield Clinic Pharmacy Arthritis in knees Case 4:14-cv-00190-CDL Document 33-5 Filed 01/23/17 Page 12 of 21 12 Medication Dose/Frequency/ Dates of Use Physician Ordering Pharmacy Dispensing Purpose Nystatin Topical Powder 4 times daily as needed Marshfield Clinic Pharmacy Skin problems Ibuprofen 200 mg, 3 tablets 3 times daily as needed Marshfield Clinic Pharmacy Pain Chlorhexidine Gluconate Mouthwash .12% twice daily Marshfield Clinic Pharmacy Teeth and gums 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  No  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 VII. IMPLANT AND EXCISION/REMOVAL 1. Describe the condition for which the ObTape was implanted: Stress Urinary Incontinence (SUI) 2. Before the implantation of the ObTape, did you receive non-surgical treatment for your stress urinary incontinence? Yes  No  (a) State the period during which you received non-surgical treatment: 1998 thru 2005; 2006 thru 2013 (b) State the nature of the non-surgical treatment (e.g., physical therapy, medication, injections): Medication, Kegels, Pessary device, physical therapy, Kegel exercises, electro-stimulation of pelvic floor Case 4:14-cv-00190-CDL Document 33-5 Filed 01/23/17 Page 13 of 21 13 (c) State the name and address of all doctors or health care providers involved in your non-surgical treatment: 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  No  (a) If yes, identify each document/source of information. (b) When did you read the document/receive the information? (c) How did you obtain the document or information? (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  Don’t Know  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  If yes, for each, please state: Date of Communication Name of Person with Whom You Communicated Mode of Communication (In Person, By Phone, By Email, By Mail) Do you have a writing or recording? (IF SO, PLEASE ATTACH) If the communication was by phone or in-person, please tell us what was said: VIII. INJURIES & DAMAGES 1. Are you claiming any physical injuries or illness as a result of the ObTape? Yes  No  If yes, please describe in detail the following: (a) The physical injuries or illness claimed and when the symptoms began: Following Plaintiff’s ObTape implant, she sustained injuries and has suffered from numerous complaints including, but not limited to, recurrent pain, infection, urinary problems, extrusion, erosion and bleeding. In addition, these issues have caused mental anguish, pain and suffering. (b) Are those injuries or illnesses continuing? Yes  No  Case 4:14-cv-00190-CDL Document 33-5 Filed 01/23/17 Page 14 of 21 14 (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) All problems Dr. Siddharth Jain, Marsfield Clinic (until he left in 2007) All problems Dr. Amy Lysy 2116 Craig Road Eau Claire, WI 54703 715/858-4700 All problems Dr. Melissa Emmerich Craig Road Eau Claire, WI 54703 715/858-4700 All problems Dr. London Craig Road Eau Claire, WI 54703 2. Have you ever been hospitalized as a result of any of these conditions? Yes  No  If yes, please provide the following information: (a) Approximate date(s) of hospital admission: (b) Approximate date(s) of discharge: (c) Hospital names(s) and address(es): 3. Do you claim any psychological or psychiatric injury (other than garden variety emotional distress) as a consequence of having the ObTape? Yes  No  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) Anxiety and Depression Marshfield Clinic Behavioral Health Eau Claire, WI Case 4:14-cv-00190-CDL Document 33-5 Filed 01/23/17 Page 15 of 21 15 Condition Name and Address of Mental Healthcare Provider (if any) Approx. Dates/Years of Treatment/Visits (if any) Marshfield Clinic 1000 N. Oak Avenue Marshfield, WI 54449 4. Are you making a claim for lost wages or lost earning capacity? Yes  No  1. 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: N/A 2. If you claim a loss of earnings, state your earned income from work for the following years: N/A YEAR INCOME 2012 $ 2011 $ 2010 $ 2009 $ 2008 $ 2007 $ 2006 $ 2005 $ 2004 $ 2003 $ 5. Is your spouse claiming loss of consortium? Yes  No  6. Is your spouse claiming physical injury from the ObTape? Yes  No  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) Case 4:14-cv-00190-CDL Document 33-5 Filed 01/23/17 Page 16 of 21 16 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: Plaintiff does not have exact calculation regarding economic damages or out of pocket expenses at this time and reserves the right to supplement concurrent with ongoing treatment. Name and Address of Provider Dates of Treatment Description of Treatment Amount of Medical Expenses $ $ For any expenses claimed above, have they been reimbursed by any third party? Yes No 5 Don’t Know If yes, identify which expenses, the amount reimbursed and the date reimbursed. 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: Kelly Bonner Eau Claire, WI 54703 Relationship to you: Sister Case 4:14-cv-00190-CDL Document 33-5 Filed 01/23/17 Page 17 of 21 17 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, Xrays, 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. See medical and pharmacy records produced to date. Plaintiff reserves the right to supplement as she continues to be treated for injuries sustained as a result of the implant/explant of her mesh sling. 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. See billing records produced to date. Plaintiff reserves the right to supplement as she continues to be treated for injuries sustained as a result of the implant/explant of her mesh sling. 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. See billing records produced to date. Plaintiff reserves the right to supplement as she continues to be treated for injuries sustained as a result of the implant/explant of her mesh sling. REQUEST NO. 4: All photographs and videos of plaintiff’s surgery and all photographs and videos of plaintiff which show plaintiff’s condition since the date of the original implantation. Plaintiff has no responsive documents currently in her possession. Case 4:14-cv-00190-CDL Document 33-5 Filed 01/23/17 Page 18 of 21 18 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. Plaintiff has no responsive documents currently in her possession. XII. AUTHORIZATIONS Complete and sign the Authorization attached as Exhibit A. See attached medical authorization. Case 4:14-cv-00190-CDL Document 33-5 Filed 01/23/17 Page 19 of 21 Case 4:14-cv-00190-CDL Document 33-5 Filed 01/23/17 Page 20 of 21 9/15/2016 Case 4:14-cv-00190-CDL Document 33-5 Filed 01/23/17 Page 21 of 21 Exhibit C Case 4:14-cv-00190-CDL Document 33-6 Filed 01/23/17 Page 1 of 5 Case 4:14-cv-00190-CDL Document 33-6 Filed 01/23/17 Page 2 of 5 r aqe 2 zmz, TERR! L Tlie bladder was then drained. The guide was placed in the catheter and the bladder was diverted fo the contralateral side. The trocar was placed through the left incision into the space of Retzius and into the vagina using the surgeon's hand as a guide. The bladder was then diverted to contralateral side, and the trocar was placed at the right incision. Once both trocars were placed and the sling material was brought up through incision, the Foley catheter was removed and cystoscopy was performed. Cystoscopy revealed intact bladder mucosa throughout with no evidence of iatrogenic bladder injury. Both ureters were seen to be peristalsing normally. The cystoscopy was then discontinued at this point. The bladder was drained and the catheter was placed to support the urethra, using a 6-inch Kelly clamp to aid in tensioning of the urethra. Once this was completed, the plastic around the mesh was removed, the excess mesh was excised. The vaginal incision was closed with a running suture of 0 Vicryl and the skin incisions were closed with Dermabond. The patient was then awoken and taken to the recovery room in stable condition. Ail sponge, instrument, and needle counts were correct x3. the the Signed by R. L. England, M.D. 11/18/2013 03:55 P Dictated by: R. L. England. M.D. RLE/ams DD: 11/15/2013/DT: 11/15/2013 12:17 P Job #: 998332/Doc #: 1985517 R. L. England, M.D. cc: R# 1115-02 06 Cfi.-JAl 1V h Hif'JKl OBT ERTZ T 01195 Case 4:14-cv-00190-CDL Document 33-6 Filed 01/23/17 Page 3 of 5 Case 4:14-cv-00190-CDL Document 33-6 Filed 01/23/17 Page 4 of 5 Case 4:14-cv-00190-CDL Document 33-6 Filed 01/23/17 Page 5 of 5 Exhibit D Case 4:14-cv-00190-CDL Document 33-7 Filed 01/23/17 Page 1 of 6 FOCUS - 34 of 68 DOCUMENTS In re: GUIDANT CORP. IMPLANTABLE DEFIBRILLATORS PRODUCTS LIABILITY LITIGATION; This Document Relates to: Leopoldo Duron, Jr., Plaintiff, v. Civil No. 06-25 (DWF/AJB), Guidant Corporation, Guidant Sales Corporation, Boston Scientific Corp., and Cardiac Pacemakers, Inc., Defendants. MDL No. 05-1708 (DWF/AJB) UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MINNESOTA 2007 U.S. Dist. LEXIS 50303 July 6, 2007, Decided July 6, 2007, Filed SUBSEQUENT HISTORY: Subsequent appeal at Gaydos v. Guidant Corp. (In re Guidant Corp. Implantable Defibrillators Prods. Liab. Litig.), 496 F.3d 863, 2007 U.S. App. LEXIS 18238 (8th Cir. Minn., Aug. 1, 2007) PRIOR HISTORY: In re Guidant Corp. Implantable Defibrillators Prods. Liab. Litig., 2007 U.S. Dist. LEXIS 50302 (D. Minn., July 6, 2007) COUNSEL: [*1] For Plaintiffs' Lead Counsel, Plaintiff: Charles S Zimmerman, LEAD ATTORNEY, Zimmerman Reed, PLLP, Mpls, MN; Elizabeth J Cabraser, LEAD ATTORNEY, Lieff Cabraser Heimann & Bernstein, San Francisco, CA; Gale D Pearson, LEAD ATTORNEY, Pearson, Randall & Schumacher, PA, Mpls, MN; Richard J Arsenault, LEAD ATTORNEY, Neblett, Beard & Arsenault, Alexandria, LA; Seth R Lesser, LEAD ATTORNEY, Locks Law Firm, PLLC, New York, NY. For Plantiffs' Liaison Counsel, Plaintiff: Charles S Zimmerman, LEAD ATTORNEY, Ronald S Goldser, LEAD ATTORNEY, Zimmerman Reed, PLLP, Mpls, MN; Elizabeth J Cabraser, Lieff Cabraser Heimann & Bernstein, San Francisco, CA. For Leta Joyner, Plaintiff: Michael K Johnson, LEAD ATTORNEY, Goldenberg & Johnson, PLLC, Mpls, MN. For Defendants' Lead Counsel, Defendant: Timothy A Pratt, LEAD ATTORNEY, Shook Hardy & Bacon LLP, Kansas City, MO. For Defendants' Liaison Counsel, Defendant: Joseph M Price, LEAD ATTORNEY, Faegre & Benson LLP, Minneapolis, MN. For St. Anthony's Medical Center, Defendant: V Scott Williams, LEAD ATTORNEY, Hazelwood & Weber, LLC, St Charles, MO. For Dr. Leland B. Housman, Defendant: David P Burke, Neil, Dymott, Frank, Harrison & McFall, APLC, San Diego, CA. For [*2] Bloomberg L.P., Intervenor: Paul R Hannah, LEAD ATTORNEY, Kelly & Berens, PA, Minneapolis, MN. For Anthem Health Plans of Kentucky, Inc., Intervenor: Gene F Price, LEAD ATTORNEY, Frost Brown Todd LLC, Louisville, KY. JUDGES: DONOVAN W. FRANK , Judge of United Page 1 Case 4:14-cv-00190-CDL Document 33-7 Filed 01/23/17 Page 2 of 6 States District Court. OPINION BY: DONOVAN W. FRANK OPINION MEMORANDUM OPINION AND ORDER This matter came before the Court pursuant to a Motion for Summary Judgment on Plaintiff Leopoldo Duron, Jr.'s Failure-to-Warn Claims Based on the Learned Intermediary Doctrine brought by Guidant Corporation, Guidant Sales Corporation, Boston Scientific Corp., and Cardiac Pacemakers, Inc. (collectively, "Guidant"). For the reasons set forth below, the Court grants in part and denies in part the motion. BACKGROUND The factual background and procedural history of this case are fully set forth in the Court's May 22, 2007 and June 12, 2007 Orders. Briefly, in March 2002, Dr. Steven Higgins, an electrophysiologist, 1 surgically implanted an implantable cardioverter defibrillator ("ICD"), the VENTAK PRIZM 2 DR, Model 1861 (the "Prizm 2"), in Duron after an electrophysiology study showed that he needed an ICD. Guidant manufactured the Prizm 2. Prior to the surgery, Guidant provided [*3] Dr. Higgins with a copy of the Prizm 2's Physician Technical Manual and System Guide. In that manual and/or guide, Guidant warned that Prizm 2 devices were "subject to random component failure" and that "[s]uch failure could cause inappropriate shocks, induction of arrhythmias or inability to sense arrhythmias, and could lead to the patient's death." 2 1 An electrophysiologist is a cardiologist who has had additional education and training in the diagnosis and treatment of abnormal heart rhythms. Although the parties did not provide any actual numbers, the Court notes there is a relatively small number (1,000-2,000 range) of electrophysiologists in the United States. 2 Guidant did not provide the Court with a copy of the manual; instead, these quotes are taken from Dr. Higgins' Affidavit. (Guidant's Summ. J. Mem., Ex. I.) Duron does contest the accuracy of the quotations. In June 2005, Guidant recalled Prizm 2 devices, including Duron's device, which were manufactured prior to April 2002. Shortly thereafter, the Food and Drug Administration classified Guidant's recall as a Class I recall. A Class I recall is reserved for devices that create a reasonable probability of serious adverse health [*4] consequence or death. On August 19, 2005, Dr. Sardul Singh explanted Duron's Prizm 2 and replaced it with a different Guidant-manufactured ICD. Subsequently, Duron commenced an action against Guidant based on alleged injuries he suffered as a result of the Prizm 2. ARGUMENT I. Motion for Summary Judgment Summary judgment is proper if there are no disputed issues of material fact and the moving party is entitled to judgment as a matter of law. Fed. R. Civ. P. 56(c). The Court must view the evidence and the inferences, which may be reasonably drawn from the evidence, in the light most favorable to the nonmoving party. Enter. Bank v. Magna Bank of Mo., 92 F.3d 743, 747 (8th Cir. 1996). As the United States Supreme Court has stated, "[s]ummary judgment procedure is properly regarded not as a disfavored procedural shortcut, but rather as an integral part of the Federal Rules as a whole, which are designed 'to secure the just, speedy, and inexpensive determination of every action.'" Celotex Corp. v. Catrett, 477 U.S. 317, 327, 106 S. Ct. 2548, 91 L. Ed. 2d 265 (1986) (quoting Fed. R. Civ. P. 1). The moving party bears the burden of showing that there is no genuine issue of material fact and that it is entitled to judgment as [*5] a matter of law. Enter. Bank, 92 F. 3d at 747. The nonmoving party must demonstrate the existence of specific facts in the record that create a genuine issue for trial. Krenik v. County of Le Sueur, 47 F.3d 953, 957 (8th Cir. 1995). A party opposing a properly supported motion for summary judgment may not rest upon mere allegations or denials of his pleading, but must set forth specific facts showing that there is a genuine issue for trial. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 256, 106 S. Ct. 2505, 91 L. Ed. 2d 202 (1986). Guidant moves for summary judgment on Duron's failure-to-warn claims based on the learned intermediary doctrine. The parties agree that the learned intermediary doctrine applies to Duron's failure-to-warn claims and on the standard used for failure-to-warn claims under California law. They disagree about the impact of that Page 2 2007 U.S. Dist. LEXIS 50303, *2 Case 4:14-cv-00190-CDL Document 33-7 Filed 01/23/17 Page 3 of 6 doctrine and standard on Duron's claims. 3 3 It is unclear which exact counts in Duron's Amended Complaint-by-Adoption the parties classify as the "failure-to-warn" claims. Guidant classifies the claims "as strict liability warning and negligent failure to warn, [and]. . . the consumer protection claims to the extent they are based on a failure to warn theory." (6/19/07 Tr. [*6] at 58.) Duron classifies his failure-to-warn claims as those claims that "sound in fraud or something akin to fraud or negligence." (Id. at 63.) Given this, Counts I, III, VI, and VIII are likely implicated. The standards for such claims are quite different. See Carlin v. Superior Court, 13 Cal. 4th 1104, 1112-13, 56 Cal. Rptr. 2d 162, 920 P.2d 1347 (Cal. 1996) (discussing differences between negligent failure-to-warn claims and strict liability failure-to-warn claims). Because the focus of the parties' briefing is on the "known or knowable" aspect of failure to warn, which is derived from strict liability cases, the focus of this Order is on that standard. Under California law, it is well-settled that a manufacturer of medical devices or prescription drugs owes to the medical profession the duty of providing adequate warnings if it knows, or has reason to know, of any dangerous side effects of its devices or drugs. See Carlin, 13 Cal. 4th at 1112-13. California follows the learned intermediary doctrine, which provides that the duty to warn "runs to the physician, not to the patient." Id. at 1116. Thus, a manufacturer discharges its duty to warn if it provides adequate warnings to the physician about any known or reasonably [*7] knowable dangerous side effects, regardless of whether the warning reaches the patient. The adequacy of a warning is controlled by comment k of the Restatement (Second) of Torts, § 402A, and it requires that a manufacturer's device be accompanied with warnings of a device's "dangerous propensities that were either known or reasonably scientifically knowable at the time of distribution." Brown v. Superior Court, 44 Cal. 3d 1049, 1061, 245 Cal. Rptr. 412, 751 P.2d 470 (Cal. 1988). The Court assumes, and the parties appear to agree, that under California law, a plaintiff asserting failure-to-warn claims must prove not only that no warning was provided or the warning was inadequate, but also that the inadequacy or absence of the warning caused the plaintiff's injury. Motus v. Pfizer, Inc., 196 F. Supp. 2d 984, 993 (CD. Cal. 2001) (applying California law and concluding that California courts would likely not apply a reputable presumption for causation in failure-to-warn claims). Using these standards, Guidant asserts that it is entitled to summary judgment on Duron's failure-to-warn claims for three primary reasons. The Court will discuss each in turn. A. Pre-Implant Warning Dr. Higgins implanted the Prizm 2 in Duron on March [*8] 9, 2002. Prior to that time, Guidant had received one report on February 1, 2002, involving arcing in the header of a Prizm 2. Guidant received that device on February 12, 2002, and its engineers analyzed the device and determined that the incident was caused by a short circuit within the header. The parties dispute the result of those findings and whether, at that time or before, Guidant knew or should have known that there was a potentially systematic problem in the Prizm 2s, whether that problem is with polyimide or with the placement of the DF- feed through wire. Guidant asserts that it had no duty to warn Duron's doctor of the February 1, 2002 incident because, at that time, it did not know the cause of the problem; therefore, it contends that it could not have given an accurate warning. And, Guidant argues that its warning about "random component failure" covers the February 1, 2002 incident. Guidant also asserts that over-warning doctors carries with it a risk that the warnings will go unheeded. In addition, Guidant contends that, at that time, the FDA precluded it from giving a warning because there was no significant medical evidence to suggest there was a possible health hazard [*9] to Prizm 2 patients. Finally, Guidant characterizes Duron's failure-to-warn claims as a back-door way to get to design defect claims, which are unavailable to him under California law. Duron responds that Guidant did have a duty to warn of the February 1, 2002 incident because it knew or should have known that the device defect at issue was a systematic, as opposed to a random, defect that could lead to death or serious injury. He points out that Guidant's own Independent Panel concluded that reports of single events should be communicated to doctors if (a) there is a risk of death or serious injury; (b) there is a suspected or defined basis for the malfunction or failure; and (c) the failure is likely to be systematic and to occur in other patients. (Duron's Ex. 66. at 19.) Moreover, even Page 3 2007 U.S. Dist. LEXIS 50303, *5 Case 4:14-cv-00190-CDL Document 33-7 Filed 01/23/17 Page 4 of 6 if Guidant did not know the "root cause" of the February incident, Duron points to several scientific authorities published years before Duron's implant surgery to show that Guidant should have known of the problems created by polyimide when it is placed in contact with bodily fluids. The Court agrees with Duron. It is true that medical device manufacturers may not have a duty to warn after receiving [*10] every single incident report, depending on the circumstances underlying the incident report and the cause of that report. Here, however, there are genuine issues of material fact with respect to what Guidant knew or should have known after receiving the February 1, 2002 report and what Guidant knew or should have known about polyimide prior to Duron's implant. The FDA's actions or inactions may be admissible to show whether these risks were known or reasonably scientifically knowable. 4 Carlin, 13 Cal. 4th at 1111. These genuine issues of material fact need to be resolved before determining whether Guidant should have issued specific warnings that the Prizm 2 may malfunction as a result of polyimide degradation. Guidant's boilerplate warnings of random failures or potential mortality due to failure to defibrillate do not cover failures caused by specific, known or knowable, causes and do not insulate Guidant from potential liability. For these reasons, the Court denies Guidant's motion with respect to whether its warnings were adequate prior to Duron's implant surgery. See id. at 1116-17. 4 The June 29, 2007 Daubert Order [*11] addresses the evidentiary implications of the FDA actions or inactions. B. Post-Implant Warning The parties agree that California law imposes a continuous post-sale duty to warn so long as the device remains in use. See Valentine v. Baxter Healthcare Corp., 68 Cal. App. 4th 1467, 81 Cal. Rptr. 2d 252, 262 (Cal. Ct. App. 1999). Guidant moves for summary judgment on any claims involving post-implant warnings because it asserts that Duron cannot show that any post-implant warnings caused his injuries. Duron's alleged injuries stem from the June 2005 recall and his subsequent explant surgery in August 2005. Duron does not specifically respond to this argument; instead he focuses on what Guidant knew or should have known post-implant surgery. The Court agrees with Guidant that Duron's post-implant warning claims must fail because there is no causal link between those warnings and his alleged injuries. Accordingly, the Court grants Guidant's motion with respect to this aspect of Duron's failure-to-warn claims. C. Causation As stated earlier, the Court assumes, and the parties appear to agree, that under California law, a plaintiff must show that the inadequacy or lack of warning caused the plaintiff's injury. Motus, 196 F. Supp. 2d at 995. [*12] In connection with its summary judgment motion, Guidant submitted Dr. Higgins' affidavit, in which he avers that his decision to implant the Prizm 2 in Duron would not have changed had Guidant warned him of the February 1, 2002 incident. Dr. Higgins further states that prior to Duron's implant surgery, he was aware that "electrical arcing and short circuiting in ICDs may occur." (Guidant's Summ. J. Mem. Ex. I, P 10.) Dr. Higgins does not state if he knew why the arcing and short circuiting might occur, but he does state that "these risks have been generally known in the medical community for over twenty years." (Id. at P 11.) He further explains that he would not want or expect to be notified every time an ICD fails. Dr. Higgins does not discuss polyimide degradation. Based on Dr. Higgins' affidavit, Guidant asserts that it is entitled to summary judgment because Duron cannot establish causation, given that Dr. Higgins would have implanted Duron's Prizm 2 even if he had the warnings Duron says Guidant should have given. Both before and after Duron's implant, Dr. Higgins had a long-standing relationship with Guidant. Not surprisingly, the parties characterize the Dr. Higgins-Guidant [*13] relationship differently. Guidant asserts that Dr. Higgins was simply reasonably compensated for consulting work that he performed for Guidant and for his service as a member of Guidant's Medical Advisory Board. It contends that Dr. Higgins merely "thinks Guidant is a great company because Guidant makes great devices that save people's lives." (6/19/07 Tr. at 52.) Guidant further asserts that Dr. Higgins has no bias for Guidant because many other electrophysiologists in the United States have relationships with medical device companies similar to Dr. Higgins' relationship with Guidant. According to Guidant, Dr. Higgins' "admiration for Guidant is entirely understandable and pretty typical of the vast majority of [electrophysiologists]." (Id. at 54.) Page 4 2007 U.S. Dist. LEXIS 50303, *9 Case 4:14-cv-00190-CDL Document 33-7 Filed 01/23/17 Page 5 of 6 In response, Duron points out that, among other things, Guidant paid for Dr. Higgins, Guidant's Cardiac Rhythm Management Division President Fred McCoy, and other top Guidant executives to travel to Ireland for a golf trip to celebrate Dr. Higgins' birthday. He also points out that top Guidant executives regularly visited Dr. Higgins at his home and went on golfing trips in the United States. He notes that in e-mails to Guidant, Dr. Higgins [*14] described himself as Guidant's "alter ego" and as a "hit man." (Id. at 73-74.) In addition, Duron states that on-going, past-due discovery will show that Guidant paid Dr. Higgins very large sums of money for his various consulting and study activities. Finally, Duron points to other doctors' testimony to demonstrate that other doctors would not have implanted the Prizm 2 in their patients had they been properly warned of the risks of arcing and polyimide degredation. Guidant's causation argument is that there is no way for Duron to succeed on his failure-to-warn claims because his implanting doctor, despite his relationship with Guidant, averred that he would have implanted the Prizm 2 in Duron independent of any additional or different warnings. Guidant also argues that other doctors' opinions are irrelevant. But the law does not turn a blind eye to an implanting doctor's bias or interest. Rather, Dr. Higgins' statements must be viewed in conjunction with his ties and/or relationship to Guidant. See, e.g., Stevens v. Parke, Davis, & Co., 9 Cal. 3d 51, 66-67, 107 Cal. Rptr. 45, 507 P.2d 653 (Cal. 1973) (explaining that the evidence supported the jury's inference that the doctor was induced to prescribe a drug based [*15] on defendant's overpromotion); see also Motus, 196 F. Supp. 2d at 997 (explaining that summary judgment would not be warranted if plaintiff had presented evidence putting the physician's credibility in question). Contrary to Guidant's assertions, the Court doubts that Guidant provides European-birthday-golfing-trips to most electrophysiologists in the United States, that top Guidant executives frequently visit electrophysiologists' homes, and that Guidant or other ICD manufacturers pay electrophysiologists the sums Guidant paid Dr. Higgins. If this is true, at a minimum, it creates an appearance of bias and interest that the jury is entitled to consider and that certainly deserves an explanation. Given this, summary judgment is inappropriate because, as discussed above, genuine issues of material fact exist concerning Dr. Higgins' credibility and whether Duron can establish causation. Therefore, the Court denies Guidant's motion with respect to causation. CONCLUSION Based on the foregoing, it is HEREBY ORDERED that: 1. Guidant's Motion for Summary Judgment on Plaintiff Leopoldo Duron, Jr.'s Failure-to-Warn Claims Based on the Learned Intermediary Doctrine (MDL No. 05-1708 (DWF/AJB), Doc. [*16] No. 1458; Civ. No. 06-25 (DWF/AJB), Doc. No. 25) is GRANTED IN PART AND DENIED IN PART as follows: a. Guidant's Motion for Summary Judgment with respect to Post-Implant Warnings is GRANTED. b. Guidant's Motion for Summary Judgment with respect to Pre-Implant Warnings and Causation is DENIED. Dated: July 6, 2007 s/ Donovan W. Frank Judge of United States District Court Page 5 2007 U.S. Dist. LEXIS 50303, *13 Case 4:14-cv-00190-CDL Document 33-7 Filed 01/23/17 Page 6 of 6 Exhibit E Case 4:14-cv-00190-CDL Document 33-8 Filed 01/23/17 Page 1 of 5 Liberty Mut. Fire Ins. Co. v. LG Electronics USA, Inc., Not Reported in F.Supp.2d (2012) 2012 WL 5497852 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 1 2012 WL 5497852 Only the Westlaw citation is currently available. United States District Court, E.D. Wisconsin. LIBERTY MUTUAL FIRE INSURANCE COMPANY et al., Plaintiffs, v. LG ELECTRONICS USA, INC., Defendant. No. 10-C-520. | Nov. 13, 2012. Attorneys and Law Firms Michael A. Emer, Law Offices of Thomas P. Stilp, Milwaukee, WI, for Plaintiffs. John W. Halpin, Nathan J. Bayer, Patrick W. Brennan, Crivello Carlson SC, Milwaukee, WI, for Defendant. DECISION AND ORDER DENYING DEFENDANT'S MOTION IN LIMINE AND GRANTING, IN PART, DEFENDANT'S MOTION FOR SUMMARY JUDGMENT AARON E. GOODSTEIN, United States Magistrate Judge. I. PROCEDURAL HISTORY *1 On June 12, 2007, Susan Borth discovered the dehumidifier in the basement of her home ablaze. (Docket No. 45, ¶ 1.) This fire led to damage to her home and personal property, and her insurer, Liberty Mutual Fire Insurance Company (“Liberty Mutual”), compensated her for the loss. (Docket No. 45, ¶ 2.) On May 14, 2010, Liberty Mutual filed suit against the manufacturer of the dehumidifier, LG Electronics USA, Inc. (“LG”), in Waukesha County Circuit Court alleging negligence, strict product liability, and breach of the implied warranty of merchantability. (Docket No. 1.) LG removed the matter to this federal court on June 22, 2012 due to the diversity of the parties, (Docket No. 1), and the matter was reassigned to this court upon all parties consenting to the full jurisdiction of a magistrate judge, (Docket Nos. 6, 19, 20, 21, 22). Currently before the court is the defendant's motion in limine to limit the testimony of one of the plaintiffs' experts, Paul Hansen (“Hansen”), (Docket No. 40), and the defendant's motion for summary judgment, (Docket No. 43). The plaintiffs responded to these motions, (Docket No. 47), the defendant replied, (Docket No. 54), and with leave of the court, the plaintiffs submitted a sur-reply, (Docket No. 59). The pleadings on these motions are closed and the matters are ready for resolution. II. MOTION IN LIMINE TO LIMIT TESTIMONY OF PAUL HANSEN Paul Hansen is an electrical engineer retained by the plaintiffs as an expert to offer an opinion as to whether a design defect in the dehumidifier led to the fire. Hansen examined the remains of the unit, compared it to a new unit of the same model, and concluded that the fire started in the dehumidifier as a result of a failure of the insulation in the dehumidifier's wiring, possibly caused by the lack of a grommet at the point where wires enter the control enclosure of the unit. (Docket No. 48-5 at 9.) LG contends that Hansen lacks the training and experience to make this conclusion, and in any event, this opinion is not adequately supported. Therefore, LG seeks to exclude Hansen from offering his opinion at trial. Expert testimony is governed by Federal Rule of Evidence 702, which states: A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if: (a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the expert has reliably applied the principles and methods to the facts of the case. Thus, “Rule 702 requires that expert testimony be relevant, reliable, and have a factual basis-requirements that must be met before the jury is allowed to hear and perhaps be persuaded by the expert testimony.”Lapsley v. Xtek, Inc., 689 F.3d 802, 809 (7th Cir.2012). Under this Rule, the court plays the role of gatekeeper and “must ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable.”Daubert v. Merrell Dow Pharms., 509 U.S. Case 4:14-cv-00190-CDL Document 33-8 Filed 01/23/17 Page 2 of 5 Liberty Mut. Fire Ins. Co. v. LG Electronics USA, Inc., Not Reported in F.Supp.2d (2012) 2012 WL 5497852 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 2 579, 589, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993); Lapsley, 689 F.3d at 809. “The purpose of the Daubert inquiry is to scrutinize proposed expert witness testimony to determine if it has ‘the same level of intellectual rigor that characterizes the practice of an expert in the relevant field’ so as to be deemed reliable enough to present to a jury.”Lapsley, 689 F.3d at 805 (quoting Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999)). *2 The court does not decide whether the witness is credible or the evidence accurate; those are matters that remain reserved for the jury. Id. Rather, the court's inquiry is limited to the question of whether the expert's opinion has cleared the threshold of reliability. This “inquiry is fact-dependent and flexible.” Id. at 810.“The non-exclusive list of Daubert reliability factors for scientific evidence includes whether or not the theory or technique has been (1) tested, (2) subjected to peer review and publication, (3) analyzed for known or potential error rate, and/or is (4) generally accepted within the specific scientific field.”Id. If an expert's conclusion is based upon a disputed fact, the court cannot resolve that factual dispute as part of its analysis of whether the evidence is reliable. Rather, “[t]he soundness of the factual underpinnings of the expert's analysis and the correctness of the expert's conclusions based on that analysis are factual matters to be determined by the trier of fact, or, where appropriate, on summary judgment.”Smith v. Ford Motor Co., 215 F.3d 713, 718 (7th Cir.2000). The defendant contends that Hansen's conclusion that a design defect led to the fire is inadequately supported and thus unreliable because, although he based his conclusions upon the standards of Underwriters Laboratory (“UL”), UL inspected this model of dehumidifier and approved its design. (Docket No. 41 at 8-11.)Specifically, UL stated in a report that the wiring within the dehumidifier is “positively routed in such a manner that it is not subject to mechanical damage due to contact with sharp edges, abrasive surfaces, vibrating or moving parts.”(Docket No. 41 at 10.)Hansen noted that the absence of a grommet left only the rolled metal edges to protect the wiring as it entered the control enclosure and opined that this may have resulted in damage to the insulation on the wiring. (Docket No. 48-5 at 8.) Even if the court was to assume that UL's standards are the benchmark of safe design, a UL approval is certainly not dispositive of the issue. It is entirely possible that the UL misapplied its own guidelines in its review of this dehumidifier design. Or a design in conformity with the UL standards may nonetheless be defective. Ultimately, these are clearly issues for the finder of fact akin to the court being presented with dueling experts, one saying a design was safe, the other saying it was defective. The defendant next contends that Hansen should be excluded from offering testimony as to a design defect because he was barred from offering such testimony in a prior case. (Docket No. 41 at 11-12 (citing Auto-Owners Ins. Co. v. Uniden Am. Corp., 503 F.Supp.2d 1087 (E.D.Wis.2007)).) In that prior case, the court concluded that although Hansen could point to various scenarios under which the phone at the center of the case might have caused the fire, he did not point to any design defect that might have led to one of these scenarios. The court permitted Hansen to testify that the phone caused the fire, but concluded he lacked a sufficient basis to go the next step and opine that a design or manufacturing defect led to the phone igniting. Id. at 1096. *3 The court in that prior case never said that Hansen was unqualified to opine as to the existence of a design defect; it simply concluded that there was a lack of evidence that any design defect led to the fire in the five-year-old phone. But more importantly, even if the court had rejected Hansen's report altogether, it would not be dispositive in this matter. It is not as if some variety of collateral estoppel acts to bar an expert from ever testifying again simply because a judge once found his opinion inadequate. Here, in contrast to Uniden, Hansen points to a specific aspect of the dehumidifier's design that he alleges was defective-the absence of a grommet at the point where the wiring entered the control unit. Moreover, Hansen's conclusion that the lack of a grommet was defective is not simply his opinion. He relies upon UL's guidelines, which even the defendant seems to concede are industry benchmarks. While the UL report indicates that all wires were “positively routed in such a manner that it is not subject to mechanical damage due to contact with sharp edges, abrasive surfaces, vibrating or moving parts,” (Docket No. 41 at 10), a statement that articulates the UL standard, (Docket No. 59 at 3), Hansen says they were not. It is not the court's role at this stage to resolve this factual dispute; rather, this is a question for the finder of fact at trial. In reply, the defendant states, “Liberty Mutual's response to LG Electronics [sic] motions failed completely to address the primary legal issue raised by LG: that plaintiffs' electrical engineer, Paul Hansen, does not have the requisite Case 4:14-cv-00190-CDL Document 33-8 Filed 01/23/17 Page 3 of 5 Liberty Mut. Fire Ins. Co. v. LG Electronics USA, Inc., Not Reported in F.Supp.2d (2012) 2012 WL 5497852 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 3 scientific foundation, or the knowledge, skill, training, experience, on which to offer an opinion on the design of a dehumidifier.”(Docket No. 54 at 1.) The plaintiffs certainly cannot be faulted for having missed the argument. The court, rereading the defendant's brief even aided by the defendant's strenuous assurances that this was the “primary legal issue” had difficulty locating it. The only reference to this argument that the court could identify in the defendant's brief in support of its motion in limine is a single isolated sentence stating, “Further, there is no basis to suggest that Hansen is even qualified to weigh in on design issues.”(Docket No. 41 at 12.)This conclusory contention is hardly the sort of discussion one would expect for a party's “primary legal issue.” In any event, the court rejects this argument. While Hansen is an electrical engineer by training, he has ample and adequate experience related to relevant matters of industrial design. (SeeDocket No. 57-3.)Although there is no indication that Hansen possesses the training or experience to opine on all matters of product design, the issue here is specifically related to product design vis-à-vis electrical systems, and thus within Hansen's training and experience. Hansen has worked as a forensic electrical engineer since 1984. (Docket No. 48-4 at 3.) He is professional engineer, registered in both Wisconsin and Illinois. (Docket No. 55- 1.)He is a member of the International Association of Arson Investigators, the National Fire Protection Association, the National Society of Professional Engineers, the International Association of Electrical Inspectors, and the Wisconsin Arson Insurance Council. (Docket No. 55-1.)He has attended and taught various seminars related to arson, electrical fires, and fire generally, and he has participated in numerous cases as an expert. (Docket No. 55-1);see, e.g., CIC Partners v. Sunbeam Prods., 2012 U.S. Dist. LEXIS 5047, 2012 WL 124982 (D.Minn. Jan. 17, 2012); Mich. Millers Mut. Ins. Co. v. Hamilton Beach/Proctor-Silex, Inc., 2007 U.S. Dist. LEXIS 5615 (E.D.Wis. Jan. 25, 2007); Westfield Ins. Co. v. J.C. Penney Corp., 466 F.Supp.2d 1086 (W.D.Wis.2006); Mich. Millers Mut. Ins. Co. v. Hamilton Beach / Proctor Silex, Inc., 2006 U.S. Dist. LEXIS 18634, 2006 WL 897790 (E.D.Wis. Apr. 6, 2006); Allstate Ins. Co. v. Electrolux Home Prods., 2005 U.S. Dist. LEXIS 47897, 2005 WL 6746594 (E.D.Wis. Oct. 31, 2005). Thus, the court concludes that Hansen possesses the requisite knowledge, skill, experience, training, or education to testify as an expert in this matter. *4 As for Hansen's methodology, the defendant characterizes the method by which Hansen arrived at his conclusion as having “essentially threw up his hands,” (Docket No. 41 at 2). Hansen's method can be more accurately described as process of elimination, which is an accepted scientific technique. Uniden, 503 F.Supp.2d at 1093 (citing cases). Moreover, Hansen indicated that his investigation followed National Fire Protection Association (“NFPA”) 921, which is well-established as a standard in fire investigations and is generally accepted within the field. See, e.g., Electrolux, 2005 U.S. Dist. LEXIS 47897, *5, 2005 WL 6746594 (describing NFPA 921 as “the industry guide for fire inspections”); Abu-Hashish v. Scottsdale Ins. Co., 88 F.Supp.2d 906, 908 (N.D.Ill.2000) (describing NFPA 921 as “a recognized guide for use by fire investigators in the fire investigation process”). The court concludes that Hansen's scientific, technical, or other specialized knowledge will help the trier of fact understand the evidence or determine a fact in issue. Based upon the report and deposition excerpts presented, Hansen's testimony is based upon sufficient facts or data, is the product of reliable principles and methods, and Hansen has reliably applied these principles and methods to the facts of the case. Accordingly, the court concludes that Hansen's testimony is admissible under Fed.R.Evid. 701 and Daubert, and therefore the defendant's motion in limine, (Docket No. 40), shall be denied. III. MOTION FOR SUMMARY JUDGMENT The court's denial of the defendant's motion in limine to limit the testimony of Hansen moots much the defendant's motion for summary judgment. Hansen's opinion that the absence of a grommet was a design defect and this led to the fire is sufficient to create a dispute of material fact as to the claims presented in the complaint. However, one question remains to be resolved. The defendant contends that “[a]s a matter of law, in Wisconsin, a breach of implied warranty claim cannot be pursued alongside the first two causes of action [in the plaintiff's complaint] and must be dismissed.”(Docket No. 44 at 1.) The plaintiffs do not address this argument in their response or sur-reply. The complaint alleges three causes of action against the defendant: (1) negligence; (2) strict product liability; and (3) breach of the implied warranty of merchantability. (Docket No. 1.) This case comes before the court on diversity jurisdiction pursuant to 28 U.S.C. § 1332, and thus this court is required to apply state substantive law. Lexington Ins. Co. v. Rugg & Knopp, Inc., 165 F.3d 1087 (7th Cir.1999). Both sides cite Wisconsin substantive law and thus in the absence of Case 4:14-cv-00190-CDL Document 33-8 Filed 01/23/17 Page 4 of 5 Liberty Mut. Fire Ins. Co. v. LG Electronics USA, Inc., Not Reported in F.Supp.2d (2012) 2012 WL 5497852 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 4 any dispute, this court applies Wisconsin law. Massachusetts Bay Ins. Co. v. Vic Koenig Leasing, 136 F.3d 1116, 1120 (7th Cir.1998) (quoting Wood v. Mid-Valley, Inc., 942 F.2d 425, 426-27 (7th Cir.1991)) (“the operative rule is that when neither party raises a conflict of law issue in a diversity case, the federal court simply applies the law of the state in which the federal court sits.... Courts do not worry about conflict of laws unless the parties disagree on which state's law applies.”); see also Grundstad v. Ritt, 166 F.3d 867, 870 (7th Cir.1999) (same). *5 In Austin v. Ford Motor Co., 86 Wis.2d 628, 273 N.W.2d 233 (1979), the Wisconsin Supreme Court stated “it is inappropriate to bring an action for breach of warranty where a tort remedy is sought....[W]here the action is one in tort, the only appropriate action is that of strict liability in tort....”Id . at 644-45, 273 N.W.2d at 240. This court has not been presented with any argument as to why the rationale of Austin should not apply to this case. In the absence of any objection to the defendant's motion for summary judgment on this point, the motion shall be granted in part. Accordingly, the plaintiffs' claim for breach of the implied warranty of merchantability shall be dismissed. IT IS THEREFORE ORDERED that the defendant's motion in limine, (Docket No. 40), is denied. IT IS FURTHER ORDERED that the defendant's motion for summary judgment (Docket No. 43), is granted with respect to the plaintiff's claim for breach of the implied warranty of merchantability, and accordingly count three of the complaint is hereby dismissed. The defendant's motion for summary judgment is denied as to all other grounds. IT IS FURTHER ORDERED that the court shall conduct a telephonic scheduling conference on Friday, November 30, 2012 at 9:00 A.M. to discuss scheduling this matter for trial. The parties shall advise the court as to which attorneys will participate, together with their direct telephone numbers, and the court shall initiate the call. All Citations Not Reported in F.Supp.2d, 2012 WL 5497852 End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:14-cv-00190-CDL Document 33-8 Filed 01/23/17 Page 5 of 5