Stroligo v. Mentor Worldwide Llc et al

MOTION for Summary Judgment

M.D. Ga.July 25, 2016

IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION MDL No. 2004 Master Case No. 4:08-md-2004-CDL Individual Case No. 4:13-cv-00462 (Stroligo) DEFENDANT MENTOR WORLDWIDE LLC’S MOTION FOR SUMMARY JUDGMENT AGAINST PLAINTIFF SUSAN STROLIGO Pursuant to Rule 56 of the Federal Rules of Civil Procedure and Local Rule 56, Defendant Mentor Worldwide LLC (“Mentor”) respectfully moves the Court for summary judgment on all of Plaintiff’s claims. Plaintiff has failed to put forth expert testimony necessary to sustain her burden of proof on her strict liability and negligence claims. Plaintiff’s strict liability claim is also barred by Pennsylvania’s adoption of comment k to the Restatement (Second) of Torts § 402(A). The grounds for this Motion are set forth in more detail in the accompanying memorandum in support. Dated: July 25, 2016 Respectfully submitted, s/ John Q. Lewis John Q. Lewis TUCKER ELLIS LLP 950 Main Avenue, Suite 1100 Cleveland, OH 44113-7213 Telephone: 216.592.5000 Facsimile: 216.592.5009 john.lewis@tuckerellis.com Designated Lead Counsel for Defendant Mentor Worldwide LLC Case 4:13-cv-00462-CDL Document 36 Filed 07/25/16 Page 1 of 2 2 012813\002061\2759937.1 IN RE: MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION MDL NO. 2004 CERTIFICATE OF SERVICE A copy of the foregoing was served via ECF and email on the following counsel this 25th day of July 2016: Peyton P. Murphy peyton@murphylawfirm.com Counsel for Plaintiff Susan Stroligo s/ John Q. Lewis John Q. Lewis Designated Lead Counsel for Defendant Mentor Worldwide LLC Case 4:13-cv-00462-CDL Document 36 Filed 07/25/16 Page 2 of 2 1 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. 4:13-cv-00462 (Stroligo) DEFENDANT MENTOR WORLDWIDE LLC’S MEMORANDUM IN SUPPORT OF ITS MOTION FOR SUMMARY JUDGMENT AGAINST PLAINTIFF SUSAN STROLIGO Plaintiff’s claims for strict liability and negligence both fail, regardless of whether Pennsylvania or Florida law applies, for lack of medical causation because Plaintiff has failed to put forth any expert testimony that could establish that her ObTape was defective or that a defect in her ObTape caused her injuries. Moreover, under Pennsylvania law, comment k to the Restatement (Second) of Torts § 402(A) bars strict liability product defect claims against medical device manufacturers. Plaintiff’s Complaint thus fails in its entirety, and Mentor respectfully requests that this Court enter summary judgment in its favor on all of Plaintiff’s claims. UNDISPUTED FACTS RELEVANT TO THIS MOTION This Court previously described general facts related to ObTape (e.g., Apr. 22, 2010, Order, Doc. 241 at 4-5); Mentor will not restate them here because this Motion is premised on undisputed facts unique to Plaintiff Susan Stroligo (“Plaintiff”). On March 2, 2004, in Dunedin, Florida, Dr. Cesar Abreu implanted Plaintiff with ObTape to treat her stress urinary incontinence (“SUI”). (Separate Statement of Material Facts (“SSMF”) ¶ 1.) Dr. Abreu testified that he was not aware of any defects in Case 4:13-cv-00462-CDL Document 36-1 Filed 07/25/16 Page 1 of 9 2 the ObTape he implanted in Plaintiff and that he could not substantiate any complications Plaintiff experienced with her ObTape. (Id. ¶ 2.) In 2012, one of Plaintiff’s friends saw attorney advertising regarding mesh litigation and recommended that Plaintiff talk to a lawyer because of her renewed incontinence. (SSMF ¶ 3.) Within a couple of months, Plaintiff contacted attorneys regarding her ObTape. (Id. ¶ 4.) In May 2013, at the suggestion of her attorneys, Plaintiff sought treatment from Dr. Alina Wang regarding recurrent urinary leakage. (Id. ¶ 5.) This was the first time Plaintiff sought medical treatment regarding any potential sling complication. (Id. ¶ 6.) Dr. Wang referred Plaintiff to Dr. Vanessa Elliott, a urologist at Hershey Medical Center in Pennsylvania. (Id. ¶ 7.) On March 24, 2014, Plaintiff presented to Dr. Elliott regarding recurrent urinary incontinence, urinary urgency, and pain with intercourse. (SSMF ¶ 8.) Dr. Elliott performed a vaginal exam and noted vaginal atrophy, cystocele, and obturator tenderness. (Id. ¶ 9.) On June 2, 2014, Dr. Elliott performed urodynamic testing on Plaintiff, which demonstrated no urinary leakage, no bladder spasms, and no obstructed voiding. (Id. ¶ 10.) Plaintiff was adamant that she wanted Dr. Elliott to remove her ObTape completely because her attorneys told her that it was a bad product that caused problems and was not FDA approved. (Id. ¶ 11.) Dr. Elliott was not convinced that Plaintiff’s symptoms were caused by her ObTape and believed they could have been caused by Plaintiff’s other medical issues. (Id. ¶ 12.) Despite Plaintiff’s insistence that her ObTape be removed, Dr. Elliott refused to do so because, in her independent medical judgment, she did not believe that sling removal was justified. (Id. ¶ 13.) Even after Plaintiff “explained to [Dr. Elliott] what [she] learned from the attorneys handling [her case], that [her ObTape] would likely need to come out or, you Case 4:13-cv-00462-CDL Document 36-1 Filed 07/25/16 Page 2 of 9 3 know, be removed,” Dr. Elliott refused to remove the ObTape, so Plaintiff discontinued care with her. (SSMF ¶ 14.) After Dr. Elliott refused to remove Plaintiff’s sling, a paralegal at Plaintiff’s attorneys’ office provided her a “long list” of doctors who would remove her ObTape, including Dr. Renee Bassaly in Florida. (Id. ¶ 15.) In January 2015, Plaintiff presented to Dr. Bassaly, adamantly requesting sling removal because she believed it was causing renewed urinary leakage, urgency, and pain with intercourse, and because her lawyers told her that her sling was not FDA-approved. (SSMF ¶ 16.) On exam, Dr. Bassaly noted that Plaintiff’s sling was non-tender and not exposed. (Id. ¶ 17.) Dr. Bassaly testified that Plaintiff’s reported symptoms could have been caused by pelvic floor dysfunction, which can occur absent a vaginal sling. (Id. ¶ 18.) Dr. Bassaly recommended conservative treatment before removing Plaintiff’s ObTape, but Plaintiff insisted on sling removal. (Id. ¶ 19.) During an April 2015 pre- operative visit, Plaintiff told her doctors that her sling “must come out” because it “is a non-FDA-approved sling.” (Id. ¶ 20.) Dr. Bassaly could not confirm whether Plaintiff’s symptoms were caused by her ObTape, but agreed to remove the sling because Plaintiff insisted on having it removed. (Id. ¶ 21.) On May 4, 2015, Dr. Bassaly removed Plaintiff’s ObTape. (Id. ¶ 22.) Dr. Bassaly never diagnosed Plaintiff with a sling erosion or infection. (Id. ¶ 23.) Dr. Bassaly testified that even if Plaintiff’s ObTape ultimately contributed to her symptoms, this did not mean that the sling was defective or that a defect in the sling caused Plaintiff’s symptoms because such symptoms could result from a non-defective sling. (Id. ¶ 24.) Per this Court’s Direct Filing Order (Doc. 446), Plaintiff filed her Complaint with this Court on October 10, 2013, bringing claims for strict liability and negligence. (SSMF ¶ 25.) Plaintiff was a Florida resident at the time her ObTape was implanted in Case 4:13-cv-00462-CDL Document 36-1 Filed 07/25/16 Page 3 of 9 4 Florida, a Pennsylvania resident at the time she filed her Complaint, a Pennsylvania resident at the time Dr. Bassaly removed her ObTape in Florida, and is currently a Florida resident. (Id. ¶ 26.) LAW AND ARGUMENT Summary judgment should be granted where “there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed R. Civ. P. 56(a). Indeed, Rule 56 “mandates the entry of summary judgment, after adequate time for discovery and upon motion, against a party who fails to make a showing sufficient to establish the existence of an element essential to that party’s case, and on which that party will bear the burden of proof at trial.” Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). Facts are “material” only if they could affect the outcome of the suit under the governing substantive law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). On a motion for summary judgment, “facts must be viewed in the light most favorable to the nonmoving party only if there is a ‘genuine’ dispute as to those facts.” Scott v. Harris, 550 U.S. 372, 380 (2007). A. Regardless of Whether This Court Applies Pennsylvania or Florida Law, Plaintiff’s Claims Fail. Plaintiff direct-filed her case per this Court’s Direct Filing Order. (SSMF ¶ 25; see also Direct Filing Order, Doc. 446 in Case No. 4:08-md-2004.) In direct-filed cases, the “Court will apply the choice of law rules of the state where the plaintiff resides at the time of the filing of the complaint.” (Direct Filing Order § II(E)). Here, Pennsylvania choice-of-law rules apply because Plaintiff was a resident of Pennsylvania when she filed her Complaint. (SSMF ¶ 26.) The first step of Pennsylvania’s choice-of-law analysis is to “determine whether a real conflict exists, that is, whether these states would actually treat the relevant issues Case 4:13-cv-00462-CDL Document 36-1 Filed 07/25/16 Page 4 of 9 5 any differently.” Kallman v. Aronchick, 981 F. Supp. 2d 372, 378 (E.D. Pa. 2013) (citing Hammersmith v. TIG Ins. Co., 480 F.3d 220, 229-30 (3d Cir. 2007)). If no substantive difference exists, there is no conflict and the forum law—Pennsylvania—applies. Id. Here, two states’ laws may apply: Florida, where Plaintiff resided at the time of her implant and where her implant and removal procedures occurred; or Pennsylvania, where Plaintiff resided when she filed her Complaint, when she had her ObTape removed, and where she treated with Dr. Elliott. Because Plaintiff’s claims fail under both states’ laws for lack of expert testimony that establishes a product defect or that a product defect caused her injuries, there is no real conflict between the laws of Pennsylvania and Florida, so the forum law applies. B. Plaintiff’s Claims Fail Under Pennsylvania Law. 1. Plaintiff’s Strict Liability Claim Is Barred by Comment k. Pennsylvania has adopted the Restatement (Second) of Torts § 402(A), comment k, in prescription drug cases, making manufacturers of prescription drugs “effectively immune from strict liability suit in Pennsylvania.” Soufflas v. Zimmer, Inc., 474 F. Supp. 2d 737, 749 (E.D. Pa. 2007); see also Runner v. C.R. Bard, 108 F. Supp. 3d 261, 265-66 (E.D. Pa. 2015); Hahn v. Richter, 543 Pa. 558, 673 A.2d 888, 889-91 (1996). Although the Pennsylvania Supreme Court has not ruled on comment k’s application to prescription medical devices, the Pennsylvania Superior Court has held that there is “no reason why the same rational[e] applicable to prescription drugs may not be applied to medical devices.” Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. Ct. 2006). And federal district courts in Pennsylvania routinely apply comment k to bar strict liability claims in medical device cases. See Runner, 108 F. Supp. 3d at 265-66 (dismissing strict liability design defect, manufacturing defect, Case 4:13-cv-00462-CDL Document 36-1 Filed 07/25/16 Page 5 of 9 6 and failure to warn claims); Geesey v. Stryker Corp., No. 09-2988, 2010 WL 3069630, at *4-5 (E.D. Pa. Aug. 4, 2010) (citing cases) (attached as Ex. F to Decl. of John Q. Lewis (“Lewis Decl.”)); Soufflas, 474 F. Supp. 2d at 749-51 (citing cases). Accordingly, Plaintiff’s strict liability claim fails under Pennsylvania law. 2. Plaintiff’s Negligence Claim Fails Because She Failed to Put Forth Expert Testimony Sufficient to Survive Summary Judgment. Plaintiff’s negligence claim fails under Pennsylvania law because Plaintiff has failed to put forth expert testimony establishing the necessary elements of her claim. To survive summary judgment on a negligence-based products liability claim, a plaintiff must establish: (1) the manufacturer owed a duty to the plaintiff, (2) the duty was breached, and (3) such a breach was the proximate cause of plaintiff’s injuries. Soufflas, 474 F. Supp. 2d at 753. In cases involving complex issues of causation not readily apparent to the finder of fact, the plaintiff must present admissible expert testimony to carry her burden. See Soldo v. Sandoz Pharms. Corp., 244 F. Supp. 2d 434, 525 (W.D. Pa. 2003) (citing Heller v. Shaw Indus., Inc., 167 F.3d 146, 153 (3d Cir. 1999) (stating expert testimony was required to establish alleged respiratory ailments were caused by carpet fumes)); see also Kline v. Zimmer Holdings, Inc., No. 13-513, 2015 WL 4077495, at *1, *23-24 (W.D. Pa. July 6, 2015) (appeal filed Aug. 4, 2015); Soufflas, 474 F. Supp. 2d at 751 (“Generally, the adequacy of a warning in prescription medical device cases must be proven by expert testimony.” (citing Demmler v. SmithKline Beecham Corp., 448 Pa. Super. 425, 671 A.2d 1151, 1154 (1996))) (granting summary judgment for Case 4:13-cv-00462-CDL Document 36-1 Filed 07/25/16 Page 6 of 9 7 defendant based on plaintiff’s failure to present expert testimony on failure to warn claim).1 Plaintiff has put forth no expert testimony that Mentor breached its duty of care or that such a breach was the proximate cause of her symptoms. Indeed, Plaintiff identified only one, non-retained expert—Dr. Bassaly—and Plaintiff’s expert disclosure does not state that Dr. Bassaly will provide any testimony suggesting a product defect, a basis for establishing a product defect, or that a defect caused Plaintiff’s symptoms. (See Plaintiff’s Designation and Disclosure of Non-Retained Expert Renee Bassaly, D.O., attached as Ex. G to Lewis Decl.) Dr. Bassaly testified that even if Plaintiff’s ObTape ultimately caused her symptoms, that did not mean that the sling was defective or that a defect in the sling caused Plaintiff’s symptoms because such symptoms could result from a non-defective sling. (SSMF ¶ 24.) Therefore, Plaintiff’s negligence claim fails under Pennsylvania law. C. Plaintiff’s Claims Also Fail Under Florida Law for Lack of Expert Testimony on Product Defect and Causation. To prevail in a product liability action under Florida law, whether in strict liability or negligence, a plaintiff must establish that the product was defective and unreasonably dangerous. Payne v. C.R. Bard, Inc., No. 6:11-CV-1582-ORL-37, 2014 WL 1887297, at *2 (M.D. Fla. May 12, 2014), aff’d, 606 F. App’x 940 (11th Cir. 2015) (citing Bailey v. Janssen Pharmaceutica, Inc., 288 F. App’x 597, 606 (11th Cir. 2008) (quoting 1 Although medical device cases are not subject to strict liability, the same requirement for expert testimony applies to strict liability claims under Pennsylvania law. French v. Commonwealth Associates, Inc., 2009 PA Super 152, ¶ 16, 980 A.2d 623, 634 (“Expert testimony is often necessary in products liability and breach of warranty cases.”); Dion v. Graduate Hosp. of Univ. of Penn., 360 Pa. Super. 416, 422-24, 520 A.2d 876, 879-80 (1987) (holding in pre-comment k case that expert testimony was required in complex products liability case to determine whether drug manufacturer’s warning to medical community was adequate). Case 4:13-cv-00462-CDL Document 36-1 Filed 07/25/16 Page 7 of 9 8 West v. Caterpillar Tractor Co., 336 So. 2d 80, 86-87 (Fla. 1976))) (attached as Ex. H to Lewis Decl.). Expert testimony is generally required to prove that a medical device is defective. See Worsham v. A.H. Robins Co., 734 F.2d 676, 685 n.8 (11th Cir. 1984) (“[E]xpert testimony is often necessary to establish defective design of a product.”); Savage v. Danek Med., Inc., 31 F. Supp. 2d 980, 983 (M.D. Fla. 1999) (“A defect must be proven by expert testimony”); Alexander v. Danek Med., Inc., 37 F. Supp. 2d 1346, 1349 (M.D. Fla. 1999) (same); Wilson v. Danek Med., Inc., No. 96-2460-CIV-T-17B, 1999 WL 1062129, at *5 (M.D. Fla. Mar. 29, 1999) (“To establish liability for negligence or strict liability under a product defect theory, Plaintiff must present expert testimony that the product was defective.”) (attached as Ex. I to Lewis Decl.). A plaintiff must also establish through expert testimony that the defect caused Plaintiff’s injuries. Payne, 2014 WL 1887297, at *2 (citing Edgar v. Danek Med., Inc., No. 96-cv-2451-T24A, 1999 WL 1054864, at *2, *4-5 (M.D. Fla. Mar. 31, 1999) (“Even if Plaintiffs were able to point to a genuine issue of material fact as to defect, they would still be forced to come forward with evidence from which a trier of fact could conclude that the defect caused [plaintiff’s] subsequent back pain.”)). In Payne, the Florida District Court granted the defendant’s summary judgment motion on the plaintiff’s negligence and strict products liability claims because the plaintiff did not offer any admissible expert testimony on product defect. 2014 WL 1887297, at *3 (citing Sumner v. Biomet, Inc., 434 F. App’x 834, 843-44 (11th Cir. 2011) (holding district court “properly granted summary judgment” to defendant on medical device product liability and negligence claims after excluding testimony of plaintiff’s expert witness); Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1302-03 (11th Cir. 2011) (affirming summary judgment for defendant in medical Case 4:13-cv-00462-CDL Document 36-1 Filed 07/25/16 Page 8 of 9 9 012813\002061\2759189.1 device product liability action)). The same result is warranted here. As explained above, Plaintiff has put forth no expert testimony suggesting that her ObTape contained a product defect or that such a defect caused Plaintiff’s symptoms. (See Plaintiff’s Designation and Disclosure of Non-Retained Expert Renee Bassaly; SSMF ¶ 24.) Therefore, Plaintiff’s strict liability and negligence claims fail under Florida law. CONCLUSION Regardless of whether Pennsylvania or Florida law applies to Plaintiff’s claims, her Complaint fails in its entirety. Plaintiff has failed to put forth expert testimony necessary to establish the prima facie elements of her strict liability and negligence claims. Moreover, the strict liability claim is not viable under Pennsylvania’s adoption of comment k. For these reasons, Mentor is entitled to summary judgment on all of Plaintiff’s claims. Dated: July 25, 2016 Respectfully submitted, s/ John Q. Lewis John Q. Lewis TUCKER ELLIS LLP 950 Main Avenue, Suite 1100 Cleveland, OH 44113-7213 Telephone: 216.592.5000 Facsimile: 216.592.5009 john.lewis@tuckerellis.com Designated Lead Counsel for Defendant Mentor Worldwide LLC Case 4:13-cv-00462-CDL Document 36-1 Filed 07/25/16 Page 9 of 9 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION MDL No. 2004 Master Case No. 4:08-md-2004-CDL Individual Case No. 4:13-cv-00462 (Stroligo) DEFENDANT MENTOR WORLDWIDE LLC’S SEPARATE STATEMENT OF MATERIAL FACTS IN SUPPORT OF ITS MOTION FOR SUMMARY JUDGMENT AGAINST PLAINTIFF SUSAN STROLIGO Pursuant to Rule 56 of the Federal Rules of Civil Procedure and Local Rule 56, Defendant Mentor Worldwide LLC (“Mentor”) submits this Separate Statement of Material Facts in support of its Motion for Summary Judgment on all counts asserted in Plaintiff Susan Stroligo’s Complaint. A. Plaintiff’s ObTape Implant. 1. On March 2, 2004, in Dunedin, Florida, Dr. Cesar Abreu implanted Plaintiff Susan Stroligo (“Plaintiff”) with ObTape to treat her stress urinary incontinence (“SUI”). (Dep. of Cesar Abreu, M.D., (“Dr. Abreu Dep.”) 39:7-19, 49:18-21, attached as Ex. A to Decl. of John Q. Lewis (“Lewis Decl.”); Supp. Pl. Fact Sheet §§ II.2-4 (Apr. 4, 2016), attached as Ex. B. to Lewis Decl.; Compl., Doc. 1, ¶ 18.) 2. Dr. Abreu testified that he was not aware of any defects in the ObTape he implanted in Plaintiff and that he could not substantiate any complications Plaintiff experienced with her ObTape. (Dr. Abreu Dep. 48:18-21, 51:11-16.) B. Plaintiff’s Post-Implant History. 3. In 2012, one of Plaintiff’s friends saw attorney advertising regarding mesh litigation and recommended that Plaintiff talk to a lawyer because of her renewed Case 4:13-cv-00462-CDL Document 36-2 Filed 07/25/16 Page 1 of 5 2 incontinence. (Deposition of Susan E. Stroligo (“Pl. Dep.”) 163:5-165:15, attached as Ex. C. to Lewis Decl.) 4. Within a couple of months, Plaintiff contacted attorneys regarding her ObTape. (Pl. Dep. 164:4-168:17.) 5. In May 2013, at the suggestion of her attorneys, Plaintiff sought treatment from Dr. Alina Wang regarding recurrent urinary leakage. (Pl. Dep. 161:7-163:1, 172:14- 173:19.) 6. This was the first time Plaintiff sought medical treatment regarding any potential sling complication. (Pl. Dep. 162:22-163:1, 172:14-173:19.) 7. Dr. Wang referred Plaintiff to Dr. Vanessa Elliott, a urologist at Hershey Medical Center in Pennsylvania. (Pl. Dep. 173:20-174:9.) 8. On March 24, 2014, Plaintiff presented to Dr. Elliott regarding recurrent urinary incontinence, urinary urgency, and pain with intercourse. (Dep. of Vanessa Elliott, M.D., (“Dr. Elliott Dep.”) 31:10-25, 32:5-33:3, attached as Ex. D. to Lewis Decl.) 9. Dr. Elliott performed a vaginal exam and noted vaginal atrophy, cystocele, and obturator tenderness. (Dr. Vanessa Dep. 34:4-35:1.) 10. On June 2, 2014, Dr. Elliott performed urodynamic testing on Plaintiff, which demonstrated no urinary leakage, no bladder spasms, and no obstructed voiding. (Dr. Elliott Dep. 44:8-49:18.) 11. Plaintiff was adamant that she wanted Dr. Elliott to remove her ObTape completely because her attorneys told her that it was a bad product that caused problems and was not FDA approved. (Dr. Elliott Dep. 43:13-20, 49:23-50:17, 52:4- 53:13; Pl. Dep. 130:17-131:4, 201:19-204:10.) Case 4:13-cv-00462-CDL Document 36-2 Filed 07/25/16 Page 2 of 5 3 12. Dr. Elliott was not convinced that Plaintiff’s symptoms were caused by her ObTape and believed they could have been caused by Plaintiff’s other medical issues. (Dr. Elliott Dep. 38:19-39:6, 43:9-12, 44:25-45:13, 46:13-15, 54:15-55:10, 58:8-15; Pl. Dep. 196:21-197:25, 199:1-13, 200:4-25.) 13. Despite Plaintiff’s insistence that her ObTape be removed, Dr. Elliott refused to do so because, in her independent medical judgment, she did not believe that sling removal was justified. (Dr. Elliott Dep. 49:23-50:17, 52:24-53:13; Pl. Dep. 196:1-5, 201:19-204:16.) 14. Even after Plaintiff “explained to [Dr. Elliott] what [she] learned from the attorneys handling [her case], that [her ObTape] would likely need to come out or, you know, be removed,” Dr. Elliott refused to remove the ObTape, so Plaintiff discontinued care with her. (Pl. Dep. 130:17-131:4, 131:14-16, 201:19-204:16.) 15. After Dr. Elliott refused to remove Plaintiff’s sling, a paralegal at Plaintiff’s attorneys’ office provided her a “long list” of doctors who would remove her ObTape, including Dr. Renee Bassaly in Florida. (Pl. Dep. 131:14-132:18, 204:5-205:13, 206:9- 206:15.) 16. In January 2015, Plaintiff presented to Dr. Bassaly, adamantly requesting sling removal because she believed it was causing renewed urinary leakage, urgency, and pain with intercourse, and because her lawyers told her that her sling was not FDA- approved. (Dep. of Renee Bassaly, M.D., (“Dr. Bassaly Dep.”) 9:3-12, 11:6-13:11, attached as Ex. E to Lewis Decl.; Pl. Dep. 207:12-16, 213:9-214:5.) 17. On exam, Dr. Bassaly noted that Plaintiff’s sling was non-tender and not exposed. (Dr. Bassaly Dep. 15:2-15, 18:9-19:9.) Case 4:13-cv-00462-CDL Document 36-2 Filed 07/25/16 Page 3 of 5 4 18. Dr. Bassaly testified that Plaintiff’s reported symptoms could have been caused by pelvic floor dysfunction, which can occur absent a vaginal sling. (Dr. Bassaly Dep. 18:9-23:2.) 19. Dr. Bassaly recommended conservative treatment before removing Plaintiff’s ObTape, but Plaintiff insisted on sling removal. (Dr. Bassaly Dep. 26:14-21, 27:8-29:4; Pl. Dep. 210:13-211:11.) 20. During an April 2015 pre-operative visit, Plaintiff told her doctors that her sling “must come out” because it “is a non-FDA-approved sling.” (Dr. Bassaly Dep. 30:7-31:12.) 21. Dr. Bassaly could not confirm whether Plaintiff’s symptoms were caused by her ObTape, but agreed to remove the sling because Plaintiff insisted on having it removed. (Dr. Bassaly Dep. 31:23-32:20, 38:13-17.) 22. On May 4, 2015, Dr. Bassaly removed Plaintiff’s ObTape. (Dr. Bassaly Dep. 38:13-17; Pl. Dep. 211:12-15, 215:21-216:10.) 23. Dr. Bassaly never diagnosed Plaintiff with a sling erosion or infection. (Dr. Bassaly Dep. 33:15-34:1, 34:22-35:8, 37:7-13.) 24. Dr. Bassaly testified that even if Plaintiff’s ObTape ultimately contributed to her symptoms, that did not mean that the sling was defective or that a defect in the sling caused Plaintiff’s symptoms because such symptoms could result from a non- defective sling. (Dr. Bassaly Dep. 32:15-20, 40:12-24.) C. Plaintiff’s Lawsuit. 25. Per this Court’s Direct Filing Order (Doc. 446), Plaintiff filed her Complaint with this Court on October 10, 2013, asserting claims for strict liability and negligence. (Compl. ¶¶ 1-2, 21, 31.) Case 4:13-cv-00462-CDL Document 36-2 Filed 07/25/16 Page 4 of 5 5 012813\002061\2759185.1 26. Plaintiff was a Florida resident at the time her ObTape was implanted in Florida, a Pennsylvania resident at the time she filed her Complaint, a Pennsylvania resident at the time Dr. Bassaly removed her ObTape in Florida, and is currently a Florida resident. (Compl. ¶ 4; Supp. Pl. Fact Sheet §§ II.3-7, III.4; Pl. Dep. 48:16-24, 130:16-132:21.) Dated: July 25, 2016 Respectfully submitted, s/ John Q. Lewis John Q. Lewis TUCKER ELLIS LLP 950 Main Avenue, Suite 1100 Cleveland, OH 44113-7213 Telephone: 216.592.5000 Facsimile: 216.592.5009 john.lewis@tuckerellis.com Designated Lead Counsel for Defendant Mentor Worldwide LLC Case 4:13-cv-00462-CDL Document 36-2 Filed 07/25/16 Page 5 of 5 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION MDL No. 2004 Master Case No. 4:08-md-2004-CDL Individual Case No. 4:13-cv-00462 (Stroligo) DECLARATION OF JOHN Q. LEWIS IN SUPPORT OF DEFENDANT MENTOR WORLDWIDE LLC’S MOTION FOR SUMMARY JUDGMENT AGAINST PLAINTIFF SUSAN STROLIGO I, JOHN Q. LEWIS, declare as follows: 1. I am an attorney admitted to practice law in the State of Ohio and admitted pro hac vice in this action. I am a partner at the law firm of Tucker Ellis LLP and counsel of record for Defendant Mentor Worldwide LLC (“Mentor”) in this action. I have personal knowledge of the matters stated herein, and, if called upon, I could and would competently testify to the matters contained in this Declaration. 2. Attached as Exhibit A are true and correct copies of excerpts from the Deposition of Cesar Abreu, M.D., dated June 24, 2016. 3. Attached as Exhibit B is a true and correct, partially redacted, copy of Susan Stroligo’s Supplemental Plaintiff Fact Sheet, executed April 4, 2016. 4. Attached as Exhibit C are true and correct copies of excerpts from the Deposition of Plaintiff Susan E. Stroligo, dated May 25, 2016. 5. Attached as Exhibit D are true and correct copies of excerpts from the Deposition of Vanessa Elliott, M.D., dated June 21, 2016. 6. Attached as Exhibit E are true and correct copies of excerpts from the Deposition of Renee Bassaly, M.D., dated June 24, 2016. Case 4:13-cv-00462-CDL Document 36-3 Filed 07/25/16 Page 1 of 2 2 012813\002061\2759931.1 7. Attached as Exhibit F is a true and correct copy of an unreported case, Geesey v. Stryker Corp., No. 09-2988, 2010 WL 3069630 (E.D. Pa. Aug. 4, 2010). 8. Plaintiff disclosed only one expert witness for specific causation purposes, Plaintiff’s treating physician, Dr. Renee Bassaly. 9. Attached as Exhibit G is a true and correct copy of Plaintiff’s Designation and Disclosure of Rule 26(a)(2)(c) Expert Report of Non-Retained Expert Renee Bassaly, D.O., dated June 27, 2016. 10. Attached as Exhibit H is a true and correct copy of an unreported case, Payne v. C.R. Bard, Inc., No. 6:11-CV-1582-ORL-37, 2014 WL 1887297 (M.D. Fla. May 12, 2014). 11. Attached as Exhibit I is a true and correct copy of an unreported case, Wilson v. Danek Medical, Inc., No. 96-2460-CIV-T-17B, 1999 WL 1062129 (M.D. Fla. Mar. 29, 1999). I declare under penalty of perjury under the laws of the United States that the foregoing is true and correct. Executed this 25th day of July 2016 in Cleveland, Ohio. s/John Q. Lewis John Q. Lewis Case 4:13-cv-00462-CDL Document 36-3 Filed 07/25/16 Page 2 of 2 Exhibit A Case 4:13-cv-00462-CDL Document 36-4 Filed 07/25/16 Page 1 of 14 1 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA 2 COLUMBUS DIVISION 3 4 IN RE MENTOR CORP. OBTAPE MDL CASE NO. 5 TRANSOBTURATOR SLING PRODUCTS 4:08-MD-2004 (CDL) LIABILITY LITIGATION Individual Case No. 6 4:13-cv-00462 (Stroligo) 7 _ _ _ _ _ _ _ _ _ _ / 8 VIDEOTAPED 9 DEPOSITION OF: CESAR ABREU, M.D. 10 DATE: June 24, 2016 11 12 TIME: 9:19 a.m. to 10:50 a.m. 13 PLACE: CLEARWATER BEACH MARRIOTT 14 1201 Gulf Boulevard Clearwater Beach, Florida 15 16 PURSUANT TO: Notice by counsel for Defendant for purposes of discovery, use 17 at trial or such other purposes as are permitted under the 18 Federal Rules of Civil Procedure 19 20 BEFORE: DAWN M. DANTSCHISCH, RMR, CRR Notary Public, State of 21 Florida at Large 22 23 24 25 Job No. CS2318903 Page 1 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-4 Filed 07/25/16 Page 2 of 14 1 APPEARANCES: 2 NATALIE KOBETZ, ESQUIRE (Via Telephone) PEYTON P. MURPHY, ESQUIRE (Via Telephone) 3 Murphy Law Firm 7035 Jefferson Highway 4 Baton Rouge, Louisiana 70806 (225) 317-9907 5 Attorneys for Plaintiff Susan Stroligo 6 ANDREA GLINKA PRZYBYSZ, ESQUIRE Tucker Ellis, LLP 7 233 South Wacker Drive, Suite 6950 Chicago, Illinois 60606 8 (312) 624-6317 Attorney for Defendant Mentor Worldwide, LLC 9 ALSO PRESENT: 10 BRIAN D. AGLIANO, ESQUIRE 11 Josepher & Batteese 500 North Westshore Boulevard, Suite 630 12 Tampa, Florida 33609 (813) 228-7755 13 Attorney for Deponent 14 Jeff Mecham, Videographer 15 INDEX 16 PAGE 17 DIRECT EXAMINATION BY MS. PRZYBYSZ 4 18 CROSS-EXAMINATION BY MR. MURPHY 48 19 CERTIFICATE OF OATH 52 20 REPORTER'S CERTIFICATE 53 21 ERRATA SHEET 54 22 23 24 25 Page 2 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-4 Filed 07/25/16 Page 3 of 14 1 EXHIBITS 2 ID'd MARKED 3 1 - Deposition Notice 10 10 4 2 - Outpatient Note dated 5/3/13 13 13 5 3 - Outpatient Note dated 6/2/14 14 14 6 4 - Consultation Report dated 1/14/15 16 16 7 5 - Complaint 17 17 8 6 - Informed Consent dated 2/13/14 28 28 9 7 - Consent for Procedure 10 dated 2/28/04 28 28 11 8 - Outpatient Morton Plant Health Care Form dated 3/1/04 33 33 12 9 - Operative Report and Discharge 13 Instructions dated 3/2/04 36 36 14 15 16 17 18 19 20 21 22 23 24 25 Page 3 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-4 Filed 07/25/16 Page 4 of 14 1 THE VIDEOGRAPHER: We're on the record. The 2 time is 9:19 on June 24th, 2016. We're located at 3 1201 Gulf Boulevard, Clearwater, Florida, to take 4 the deposition of Dr. Cesar Abreu In Re: Mentor 5 Corp. ObTape Transobturator Sling Products 6 Liability Litigation. 7 I'm Jeff Mecham, the videographer, and the 8 court reporter is Dawn Dantschisch. 9 Will counsel please introduce themselves for 10 the record. 11 MS. PRZYBYSZ: Andrea Przybysz from Tucker 12 Ellis on behalf of Mentor Corporation. 13 MR. AGLIANO: Was that Natalie? Natalie, do 14 you want to put your appearance on the record? 15 MS. KOBETZ: I'm sorry. Yes. Natalie Kobetz, 16 Murphy Law Firm. 17 MR. AGLIANO: And Brian Agliano for Dr. Abreu. 18 THE VIDEOGRAPHER: Will the court reporter 19 please swear in the witness. 20 CESAR ABREU, M.D., 21 the witness herein, being first duly sworn on oath, was 22 examined and deposed as follows: 23 THE WITNESS: Yes, I do. 24 DIRECT EXAMINATION 25 BY MS. PRZYBYSZ: Page 4 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-4 Filed 07/25/16 Page 5 of 14 1 the balloon of the catheter that you've got in the -- 2 in the bladder and the opening of the urethra that you 3 are visualizing. Once you have those two needles in 4 place, then you attach the needle -- you attach the 5 sling to the needles, and then you bring the needles 6 out, bringing the sling in place underneath the 7 urethra. 8 And we used a Hegar dilator to make sure that 9 the sling was not too tight, was not too loose. And 10 usually the Hegar dilator -- we used about an eight 11 Hegar, which is a specific size, and usually that gives 12 you the correct spacing between the sling and the 13 urethra so it's neither too loose or too tight. 14 Once we have the sling correctly in position, 15 then we irrigate all that area with antibiotic 16 solution. We irrigate internally up to the endopelvic 17 fascia on either side, and then we trim the excess 18 sling that comes out of the two incisions. We trim it 19 right underneath the skin level. 20 We irrigate again. We use a lot of antibiotic 21 irrigation during these procedures, or any kind of 22 implantables, to prevent infections. And then after 23 the sling is placed correctly and we're satisfied and 24 there's no bleeding, then we close the mucosa of the 25 vaginal incision with sutures. And I usually use Page 38 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-4 Filed 07/25/16 Page 6 of 14 1 two-oh Vicryl -- I'm sorry, two-oh chromic, which is an 2 absorbable suture, so we don't have to go back in and 3 remove that suture. 4 Q. And, Doctor, that is captured in Exhibit 5 No. 9, correct? 6 A. Yes, correct. 7 Q. Doctor, you did not have any complications 8 with respect to Ms. Stroligo's surgery on March 2nd, 9 2004? 10 A. No. 11 Q. You would have noted that in the note had you 12 have, correct? 13 A. That is correct. 14 Q. Doctor, after reviewing kind of the medical 15 record up to Ms. Stroligo's implant on March 2nd, 2004, 16 would you agree that it was your medical judgment as of 17 the date of implant that the benefits of surgery 18 outweighed the risks of surgery? 19 A. Yes. 20 Q. Otherwise, you wouldn't have performed the 21 procedure -- 22 A. That is correct. 23 Q. -- correct? 24 Doctor, going to your discharge instructions 25 on March 2nd, 2004, the next page in Exhibit No 9, Page 39 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-4 Filed 07/25/16 Page 7 of 14 1 what do you typically tell -- sorry. Again, is this 2 Ms. Helene Eld's handwriting, if you know? 3 A. Oh. Yeah. No, this is my handwriting. 4 Q. This is your handwriting. Okay. 5 A. Correct. 6 Q. So, in terms of your discharge orders, would 7 you sit down and write these out and go over them with 8 the patient, or would you write them out and give them 9 to someone to give to the patient? How does that work? 10 A. These are orders that I write either 11 immediately after the surgery, if the patient's having 12 the surgery as an outpatient, or that I write on the 13 following day before the patient goes home. And all of 14 these orders are explained to the patient by myself. 15 Q. And which orders specifically did you give 16 Ms. Stroligo? 17 A. Well, the orders that I would give 18 Ms. Stroligo myself is that, one, I would want to see 19 her in the office in a couple of weeks. That she can 20 return to normal activities in 14 days. She could be 21 up as tolerated; although, I did not want her to do any 22 bending, crunching, bending over, lifting for six 23 weeks. And diet was normal. 24 Q. Doctor, why do you recommend the patient come 25 back to you for follow-up in two weeks? Page 40 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-4 Filed 07/25/16 Page 8 of 14 1 any surgery. And if I would find anything that was not 2 appropriate or was not correct, I would correct it 3 right then and there. 4 Q. And, Doctor, in terms of dictating your 5 records, did you dictate contemporaneously with 6 treatment of your patient or after a visit? 7 A. Usually with the patient in the room. 8 Q. And, Doctor, you agree that you also tried to 9 keep accurate information, correct? 10 A. That I also what? 11 Q. That you tried to keep accurate information in 12 your medical records. 13 A. Oh, yes. Absolutely. 14 Q. And that would be evidenced by the fact that 15 you would often review your records and change anything 16 that looked improper, correct? 17 A. Correct. 18 MS. PRZYBYSZ: Doctor, those are all my 19 questions for right now. 20 THE WITNESS: Okay. 21 MS. PRZYBYSZ: Thank you so much. 22 THE WITNESS: Thank you. 23 MS. PRZYBYSZ: All set. 24 MS. KOBETZ: All right. If it's okay, I'm 25 going to take a five-minute break and grab Page 47 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-4 Filed 07/25/16 Page 9 of 14 1 Mr. Murphy. 2 MS. PRZYBYSZ: Sure. 3 MS. KOBETZ: Okay. 4 THE VIDEOGRAPHER: The time is 10:42. We're 5 going off the record. 6 (Brief recess was taken.) 7 (Mr. Murphy joined the deposition via 8 telephone.) 9 THE VIDEOGRAPHER: The time is 10:45. We're 10 back on the record. 11 CROSS-EXAMINATION 12 BY MR. MURPHY: 13 Q. Hey, Dr. Abreu. This is Peyton Murphy, and I 14 represent the plaintiff in this matter. 15 A. Hi. How are you? 16 Q. I'm doing fine. Thank you. I just have a few 17 questions for you. It will be very brief. 18 Do you know of any defects in the product that 19 you put in this -- in this patient? 20 MS. PRZYBYSZ: Form. 21 THE WITNESS: Not that I know of. 22 BY MR. MURPHY: 23 Q. When's the last time you saw her, Doctor? 24 A. I have no recollection, since I don't have any 25 records on this patient. So, the only thing I can say Page 48 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-4 Filed 07/25/16 Page 10 of 14 1 is that the last time I know I saw her was on March 2nd 2 or March 3rd when -- before she went home. 3 Q. What problems was she having on that date? 4 A. On that particular day? 5 Q. Yes, sir. 6 A. None that I can recollect. Otherwise, I would 7 not -- she would not have been discharged. 8 Q. She was discharged on that date? 9 A. Again, I don't have a recollection and I don't 10 have a record as to exactly when her discharge was. 11 Usually, most of these patients are done on an 12 outpatient basis and they go home the same day with 13 some home health care. But, occasionally, if the 14 patient was too old or didn't have anybody to stay with 15 them at home post-operatively, then we usually keep 16 those patients overnight, and then they go home the 17 next day with home health care. 18 Q. Okay. What was the date of the -- of the 19 implant? 20 A. The date of the implant, it's stated here, 21 date of the procedure was March 2nd, 2004. 22 Q. Was that -- was that the last time you saw 23 her? 24 A. I don't have recollection of that, because I 25 don't have any records. Normally, I see the patients, Page 49 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-4 Filed 07/25/16 Page 11 of 14 1 my post-operative patients, two weeks after a 2 procedure, unless they have a problem and then we see 3 them as soon as they call in that they're having a 4 problem. And usually I will see them two or three 5 times within the first three months after a surgical 6 procedure. Thereafter, if everything is okay, then I 7 see them six months afterwards. 8 That's my usual protocol for post-op patients 9 in the office. But, again, I don't have any records 10 pertaining to this particular patient, so I cannot tell 11 you when she was seen or if she was or wasn't seen. 12 Q. So, you can't testify today or in front of a 13 jury as to what complications she may have experienced 14 after the implant -- 15 MS. PRZYBYSZ: Form. 16 BY MR. MURPHY: 17 Q. -- was -- after the surgery? 18 MS. PRZYBYSZ: Form. 19 THE WITNESS: Again, I do not have any 20 records. The only thing I can state is that per 21 some of the records that have been submitted to me 22 when she was seen in Hershey, she said she had no 23 problems for eight years after the -- the sling 24 was implanted. That's the only thing I can say. 25 And, again, that's not even me saying it, it's Page 50 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-4 Filed 07/25/16 Page 12 of 14 1 somebody else saying it. 2 BY MR. MURPHY: 3 Q. Are you aware that she's -- she's had a 4 revision or removal of the product? 5 MS. PRZYBYSZ: Form. 6 THE WITNESS: I was just handed that. No. 7 Yes, I was aware of it from prior communications. 8 What I was handed was just a visit with 9 Dr. Bassaly at USF. 10 BY MR. MURPHY: 11 Q. So, when we go to trial, you're not going to 12 be able to testify as to what complications this 13 patient was experiencing? 14 MS. PRZYBYSZ: Form. 15 THE WITNESS: No. I don't have any -- 16 anything to substantiate any complications. 17 MR. MURPHY: That's all the questions I have. 18 Thank you. 19 THE WITNESS: Okay. 20 MS. PRZYBYSZ: All set here. 21 THE VIDEOGRAPHER: If there are no further 22 questions, this concludes the deposition. We're 23 going off the record at 10:50. 24 (Deposition concluded at 10:50 a.m.) 25 Page 51 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-4 Filed 07/25/16 Page 13 of 14 1 CERTIFICATE OF OATH 2 3 4 STATE OF FLORIDA 5 COUNTY OF HILLSBOROUGH 6 7 8 I, Dawn M. Dantschisch, RMR, CRR, Notary 9 Public, State of Florida, certify that CESAR ABREU, 10 M.D. personally appeared before me on the 24th day of 11 June, 2016, and was duly sworn. 12 13 14 Witness my hand and official seal this _____ 15 of June, 2016. 16 17 ______________________________ 18 Dawn M. Dantschisch, RMR, CRR 19 Notary Public - State of Florida 20 My Commission Expires: 11/4/19 21 Commission No. FF926341 22 23 24 25 Page 52 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-4 Filed 07/25/16 Page 14 of 14 Exhibit B Case 4:13-cv-00462-CDL Document 36-5 Filed 07/25/16 Page 1 of 22 Case 4:13-cv-00462-CDL Document 36-5 Filed 07/25/16 Page 2 of 22 Case 4:13-cv-00462-CDL Document 36-5 Filed 07/25/16 Page 3 of 22 Case 4:13-cv-00462-CDL Document 36-5 Filed 07/25/16 Page 4 of 22 Case 4:13-cv-00462-CDL Document 36-5 Filed 07/25/16 Page 5 of 22 Case 4:13-cv-00462-CDL Document 36-5 Filed 07/25/16 Page 6 of 22 Case 4:13-cv-00462-CDL Document 36-5 Filed 07/25/16 Page 7 of 22 Case 4:13-cv-00462-CDL Document 36-5 Filed 07/25/16 Page 8 of 22 Case 4:13-cv-00462-CDL Document 36-5 Filed 07/25/16 Page 9 of 22 Case 4:13-cv-00462-CDL Document 36-5 Filed 07/25/16 Page 10 of 22 Case 4:13-cv-00462-CDL Document 36-5 Filed 07/25/16 Page 11 of 22 Case 4:13-cv-00462-CDL Document 36-5 Filed 07/25/16 Page 12 of 22 Case 4:13-cv-00462-CDL Document 36-5 Filed 07/25/16 Page 13 of 22 Case 4:13-cv-00462-CDL Document 36-5 Filed 07/25/16 Page 14 of 22 Case 4:13-cv-00462-CDL Document 36-5 Filed 07/25/16 Page 15 of 22 Case 4:13-cv-00462-CDL Document 36-5 Filed 07/25/16 Page 16 of 22 Case 4:13-cv-00462-CDL Document 36-5 Filed 07/25/16 Page 17 of 22 Case 4:13-cv-00462-CDL Document 36-5 Filed 07/25/16 Page 18 of 22 Case 4:13-cv-00462-CDL Document 36-5 Filed 07/25/16 Page 19 of 22 Case 4:13-cv-00462-CDL Document 36-5 Filed 07/25/16 Page 20 of 22 Case 4:13-cv-00462-CDL Document 36-5 Filed 07/25/16 Page 21 of 22 Case 4:13-cv-00462-CDL Document 36-5 Filed 07/25/16 Page 22 of 22 Exhibit C Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 1 of 61 1 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA 2 COLUMBUS DIVISION 3 IN RE MENTOR CORP. OBTAPE MDL CASE NO. 4 TRANSOBTURATOR SLING 4:08-MD-2004 (CDL) PRODUCTS LIABILITY 5 LITIGATION Individual Case No. 4:13-CV-00462 (Stroligo) 6 _ _ _ _ _ _ _ _ _ _ _ _ _ / 7 8 VIDEOTAPED 9 DEPOSITION OF: SUSAN E. STROLIGO 10 DATE: May 25, 2016 11 12 TIME: 9:37 a.m. to 1:52 p.m. 13 PLACE: MICHAEL MUSETTA & ASSOCIATES, 14 Palais Royale Building 146 Second Street North 15 Suite 310 St. Petersburg, Florida 16 17 PURSUANT TO: Notice by counsel for Defendant for purposes of 18 discovery, use at trial or such other purposes 19 as are permitted under the Federal Rules 20 of Civil Procedure 21 22 BEFORE: COURTNEY N. LANGHOFF, RMR, CRR Notary Public, State of 23 Florida at Large 24 Volume 1 25 Pages 1 to 157 Page 1 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 2 of 61 1 APPEARANCES: 2 3 DENISE A. VINET, ESQUIRE 4 Murphy Law Firm, LLC 7035 Jefferson Highway 5 Baton Rouge, Louisiana 70806 (225) 928-8800 6 Attorney for Plaintiff Susan E. Stroligo 7 8 EDWARD E. TABER, ESQUIRE 9 Tucker Ellis, LLP 950 Main Avenue, Suite 1100 10 Cleveland, Ohio 44113 (216) 592-5000 11 Attorney for Defendant Mentor Worldwide, LLC 12 13 ALSO PRESENT: 14 15 Mick Bowman, Videographer 16 17 * * * * * 18 19 20 21 22 23 24 25 Page 2 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 3 of 61 1 INDEX PAGE 2 PROCEEDINGS 4 3 DIRECT EXAMINATION BY MR. TABER 5 4 CERTIFICATE OF OATH 156 5 REPORTER'S CERTIFICATE 157 6 7 EXHIBITS ID'd MARKED 8 1 Key Medical Records binder containing 9 Susan Stroligo's records that are 10 pertinent to the lawsuit 109 4 11 2 Second Amended Notice of Taking 12 Videotaped Deposition of Susan Stroligo 8 8 13 3 Plaintiff Fact Sheet for Susan Stroligo 14 In Re Mentor Corp. ObTape Transobturator 15 Sling Products Liability Litigation 16 filled out in 2013 29 46 17 4 Plaintiff Fact Sheet for Susan Stroligo 18 In Re Mentor Corp. ObTape Transobturator 19 Sling Products Liability Litigation 20 filled out in April of 2016 46 98 21 22 23 24 25 Page 3 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 4 of 61 1 P R O C E E D I N G S 2 (Exhibit No. 1 was marked for identification.) 3 THE VIDEOGRAPHER: This is the videotaped 4 deposition of Sue -- excuse me. Pardon me -- 5 Susan "Straligo" (sic) -- 6 THE WITNESS: Stroligo. 7 THE VIDEOGRAPHER: Thank you. 8 -- taken in the matter of In Re Mentor Corporation 9 held in St. Pete, Florida, on May the 25th, 2016, at 10 approximately 9:37 a.m. 11 Will counsel please introduce themselves, beginning 12 with the plaintiff? 13 MS. VINET: Denise Vinet here on behalf of 14 Susan Stroligo. 15 MR. TABER: This is Ed Taber from Tucker Ellis on 16 behalf of Mentor. 17 THE VIDEOGRAPHER: Thank you very much. 18 Would the court reporter please swear the witness? 19 THE COURT REPORTER: Would you please raise your 20 right hand? 21 SUSAN E. STROLIGO, 22 the witness herein, being first duly sworn on oath, was 23 examined and deposed as follows: 24 THE WITNESS: Yes. 25 THE COURT REPORTER: Thank you. Page 4 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 5 of 61 1 DIRECT EXAMINATION 2 BY MR. TABER: 3 Q. Ms. Stroligo, again, my name is Ed Taber, and I 4 wanted to first of all thank you very much for giving us some 5 time today to talk about the lawsuit that you and your 6 counsel have filed. 7 Please be at ease. This is sort of an informal 8 proceeding. We're here in a conference room in 9 St. Petersburg, and the first thing I want you to be is as 10 entirely comfortable as you can be. 11 So there are a number of rules for the deposition. 12 The first one is, if you would like to take a break, if you 13 would like to make a phone call, whatever you need, at any 14 point in time, as long as there's not a question pending, 15 we're happy to accommodate that. Just ask for a break, and 16 the answer will be "yes." Okay? 17 A. Okay. 18 Q. Thank you. 19 A. Let me turn my phone off. 20 Q. Yes, please. Go right ahead. I'll do the same, in 21 that case. Just like we're at the movie theater, right? 22 A. Yes. 23 MS. VINET: Yes. No talking. 24 THE WITNESS: Okay. Cell phone's off. 25 BY MR. TABER: Page 5 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 6 of 61 1 Exhibit 3, it's not dated but it looks like it was filled out 2 sometime in 2013. Does that sound about right to you? 3 A. It was filed in 2011. 4 Q. Yes. That was -- 5 A. What's that? 6 Q. That's not the filled-out portion. 7 A. No, it wouldn't have been '11. Okay. 8 Q. That's just when the blank form was filed in court. 9 Thank you. You are trained as a -- you worked in a law firm. 10 A. Golly. 11 Q. I think if you look through Exhibit 3, you'll see, 12 for example, that this occurred -- there's a reference that 13 you're coming up on a March 24th of 2014 visit, which is 14 when, I think, you went in for some urology issues after not 15 having received any treatment for that for a long time. 16 So it looked to me on that basis that it was late 17 2013, maybe very early '14. Does that help you at all for 18 when you would have filled out Exhibit 3? 19 A. No. There's -- I obviously did it. I don't know 20 that. I don't remember the time frame. 21 Q. Okay. Is there any way we can tell when you would 22 have first filled out this Plaintiff Fact Sheet questionnaire 23 that we've marked as Exhibit 3? 24 MR. TABER: And, Denise, if you know -- 25 THE WITNESS: Probably, you know -- Page 47 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 7 of 61 1 MS. VINET: I looked through. I didn't see a 2 signature page or date or anything on it. 3 MR. TABER: Right. That's why I couldn't -- 4 MS. VINET: So I was trying to find that, too, at 5 the beginning. 6 THE WITNESS: I mean, initially all the 7 information, when I first contacted Denise, but -- 8 BY MR. TABER: 9 Q. Uh-huh. (Indicates affirmatively.) If it -- maybe 10 look at the -- if you would, please, look at the third to 11 last page, which is listed as the "Plaintiff Fact Sheet 12 Additional Information," and you'll see -- oh, good. You're 13 there -- you'll see your address at that time was the 14 Middletown, Pennsylvania, one still. 15 A. Yes. 16 Q. And maybe that could help us. When did you move 17 from Middletown, Pennsylvania, back to the Tampa, St. Pete 18 area? 19 A. It was October of '15. 20 Q. Oh, okay. Well, that doesn't help too much then. 21 A. So it was within the time period that I was living 22 in Middletown that I would have provided this information. 23 Q. Somewhere between '12 and '15 then? 24 A. Yes. 25 Q. Okay. Let me -- Page 48 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 8 of 61 1 A. Well, actually, maybe '13. 2 Q. '13. That would make sense. Is there anything 3 else on that third to last page which starts out, "Plaintiff 4 Fact Sheet Additional Information" that would help you figure 5 out when you completed this Plaintiff Fact Sheet, the first 6 one, the old one? 7 A. No. Like I said, it would have been '13 or '14. 8 Probably the year of 2013 or '14. I can't pinpoint. 9 Q. Uh-huh. (Indicates affirmatively.) Okay. I think 10 maybe I can help you a little bit further. There's a 11 reference -- let me get you a page -- sorry. I should be 12 able to turn to this more quickly. 13 Okay. Page 3, please. Sorry. At the bottom of 14 page 3, there's a Question Number 11. Let me know when 15 you're there. 16 A. Yes. 17 Q. Actually, it's page 3, Question Numbers 10 and 11. 18 Again, this is Exhibit 3. The question is, "Has any doctor 19 told you that portions of the ObTape still in your body need 20 to be removed?" 21 You've checked, "Yes," and then you say, 22 "Appointment is scheduled for March 24 of '14," which tells 23 me that this was completed before March 24 of '14. But it 24 sounds like you already had the appointment, which suggests 25 to me that it was fairly close in time before that date. Page 49 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 9 of 61 1 years after your ObTape sling was placed in March of '04? 2 A. I began leaking again, but other than that, no. 3 Q. Okay. And there are some records about when the 4 leaking began. Let's talk for the first month or two after 5 surgery first. In the first couple months after your ObTape 6 surgery in March of '04, did you have any complications? 7 A. I don't believe so. 8 Q. So, for example, did your incision heal up quickly? 9 A. Right. I heal -- I heal well. 10 Q. Okay. And do you recall that you had three 11 incisions? You had one on either side in the groin crease 12 where your legs meet your pelvis, and then you had one 13 incision within the anterior wall of the vagina? 14 A. I don't remember. 15 Q. So you had no problems healing up after your March 16 of '04 surgery, best of your memory? 17 A. No, I did not have any problems. 18 Q. Did you go back to see Dr. Abreu after the 19 March '04 surgery, best of your memory? 20 A. Just for the follow-up. 21 Q. Just one time then? 22 A. I believe so. 23 Q. Yes. I'm a little -- 24 A. Yes. He probably -- more than likely, you know, I 25 probably maybe had followed up with Dr. Marks after that, Page 129 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 10 of 61 1 maybe. 2 Q. Okay. Do you remember either way? Because I'm 3 missing some of the records. 4 A. Except for this two-week follow-up, I don't 5 remember. 6 Q. Okay. Let's take a real quick break. 7 A. I do -- I mean, I go by their instructions. 8 Q. Sure. 9 A. If there was another six-week or something like 10 that, I would have followed up on that. 11 MR. TABER: Okay. Let's take a quick break now. 12 THE VIDEOGRAPHER: Off the record at 12:40 p.m. 13 (Brief recess held.) 14 THE VIDEOGRAPHER: We're back on the record at 15 12:45 p.m. 16 BY MR. TABER: 17 Q. Ms. Stroligo, thanks for coming back from the 18 break. I understand that there was something you wanted to 19 add in, and please feel free to do it about the question I 20 had about criticism of the doctors. 21 A. Right. Dr. Elliott at Penn State Hershey did 22 not -- she just kept putting it off, would not treat me any 23 further. She only wanted me to do the Kegel or take this 24 medication. 25 She didn't want to treat me in any other way, and I Page 130 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 11 of 61 1 explained to her what I learned from the attorneys handling 2 this, that it would likely need to come out or, you know, be 3 removed or some more treatment than that. And she refused 4 and -- 5 Q. And this all happened about when? 6 A. That was in Pennsylvania, the records that I have 7 for Vanessa Elliott. 8 Q. Let me help you with that then. 9 A. That would be 2013, I guess. 10 Q. '13, yes. 11 A. '13 or '14. 12 Q. Much more recent, yes? 13 A. Yes, yes. 14 Q. Okay. Is that why you then switched to 15 Dr. Bassaly? 16 A. Yes. 17 Q. And you happened to be moving at the same time back 18 to Florida, too? 19 A. I wasn't really planning on that at that time. I 20 had been -- when I learned that she would not do this -- 21 Q. Uh-huh. (Indicates affirmatively.) 22 A. -- talking with Courtney, she told me that there 23 was a list of surgeons that have learned a new procedure to 24 do this sort of thing without complications or with the least 25 amount of complications, more trained to remove the mesh Page 131 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 12 of 61 1 and -- 2 Q. And who's Courtney? 3 A. Courtney Diaz, the paralegal. 4 MS. VINET: She's a paralegal at the law firm. 5 BY MR. TABER: 6 Q. Oh, okay. At the law firm -- 7 MS. VINET: Yes. 8 THE WITNESS: Right. 9 BY MR. TABER: 10 Q. -- that Denise is with? 11 A. Right. 12 MS. VINET: Yes. 13 THE WITNESS: And she gave me a list of surgeons 14 that were capable of doing that, and one was at -- or 15 that's who Dr. Bassaly is at USF Medicine. 16 And my plan at that time was to come here and do 17 that and stay with my mother and go back to 18 Pennsylvania, but it just turned out that I moved here. 19 BY MR. TABER: 20 Q. Got a job, and it turned out okay, right? 21 A. Got a job, and everything's good today. 22 Q. Okay. Excellent. I appreciate you volunteering 23 that and correcting that. 24 So if there's anything else that I have asked 25 poorly or that you want to correct, just let us know. We're Page 132 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 13 of 61 1 happy to -- I do want to hear everything you have to say 2 today. So thank you. 3 A. Okay. 4 Q. Okay. I'm going to take you back in time a little 5 bit to that month after your ObTape in March of '04. So I'm 6 doing this to you now, taking you back a decade from where 7 you were. 8 I know this has been a long time. When you had -- 9 that ObTape was 12 years ago, it was implanted, right? 10 A. Right. 11 Q. So you were telling us that, for the first month or 12 so, from what you could see, you didn't have any 13 complications from the ObTape surgery; is that fair? 14 A. Right. Yes. 15 Q. Did the ObTape surgery in the beginning cure your 16 leakage problem? 17 A. Yes. 18 Q. Can you tell me how quickly? You say you had a 19 catheter removed the next day after your surgery. 20 A. Right. 21 Q. And how quickly did you feel that cure from the 22 ObTape, in terms of the leakage problem? 23 A. Oh, probably a couple of weeks into it, as my body 24 readjusted and recovered. Maybe a month, I should say. 25 Just, you know, everything's getting put back in there and Page 133 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 14 of 61 1 It's your choice, but I would prefer not to. But, 2 again, you're the star of the show, Ms. Stroligo. If 3 you want to take a break and eat, that's fine with me. 4 THE WITNESS: I do need to. 5 MR. TABER: Okay. Off the record. We'll take a 6 break. 7 THE VIDEOGRAPHER: Off the record at 1:17 p.m. 8 (Lunch break was had from 1:17 p.m. to 1:52 p.m.) 9 (Conclusion of Volume 1.) 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 155 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 15 of 61 Page 156 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 16 of 61 Page 157 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 17 of 61 1 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA 2 COLUMBUS DIVISION 3 IN RE MENTOR CORP. OBTAPE MDL CASE NO. 4 TRANSOBTURATOR SLING 4:08-MD-2004 (CDL) PRODUCTS LIABILITY 5 LITIGATION Individual Case No. 4:13-CV-00462 (Stroligo) 6 _ _ _ _ _ _ _ _ _ _ _ _ _ / 7 8 VIDEOTAPED 9 DEPOSITION OF: SUSAN E. STROLIGO 10 DATE: May 25, 2016 11 12 TIME: 1:52 p.m. to 3:30 p.m. 13 PLACE: MICHAEL MUSETTA & ASSOCIATES, 14 Palais Royale Building 146 Second Street North 15 Suite 310 St. Petersburg, Florida 16 17 PURSUANT TO: Notice by counsel for Defendant for purposes of 18 discovery, use at trial or such other purposes 19 as are permitted under the Federal Rules 20 of Civil Procedure 21 22 BEFORE: COURTNEY N. LANGHOFF, RMR, CRR Notary Public, State of 23 Florida at Large 24 Volume 2 25 Pages 158 to 240 Page 158 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 18 of 61 1 APPEARANCES: 2 DENISE A. VINET, ESQUIRE 3 Murphy Law Firm, LLC 7035 Jefferson Highway 4 Baton Rouge, Louisiana 70806 (225) 928-8800 5 Attorney for Plaintiff Susan E. Stroligo 6 EDWARD E. TABER, ESQUIRE 7 Tucker Ellis, LLP 950 Main Avenue, Suite 1100 8 Cleveland, Ohio 44113 (216) 592-5000 9 Attorney for Defendant Mentor Worldwide, LLC 10 ALSO PRESENT: 11 12 Mick Bowman, Videographer 13 14 * * * * * 15 16 INDEX PAGE 17 PROCEEDINGS 160 18 DIRECT EXAMINATION BY MR. TABER CONT'd 160 19 CERTIFICATE OF OATH 239 20 REPORTER'S CERTIFICATE 240 21 22 EXHIBITS ID'd MARKED 23 (All were marked and identified in Volume 1.) 24 25 Page 159 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 19 of 61 1 P R O C E E D I N G S 2 THE VIDEOGRAPHER: We're back on the record at 3 1:52. 4 BY MR. TABER: 5 Q. Ms. Stroligo, thanks for coming back from 6 lunch, and we'll wrap this up as soon as we can now. 7 Probably less than another hour for you -- okay? -- so 8 you can plan. 9 We were speaking in time chronologically. At 10 the very end of that nine-year period of time after the 11 ObTape -- so you have an ObTape in March of '04. And 12 during the next nine years, I don't have any medical 13 records of urology treatment all the way up until May 14 of '13, and we've talked about how you were feeling 15 during that intervening time. 16 To get us -- do you recall where we were at 17 that point then? 18 A. Yes. 19 Q. Okay. When you began having recurrent leakage 20 around 2007-ish, was your best estimate -- 21 A. Yeah. Between 2006, 2007. 22 Q. Yes -- was this something that occurred to you 23 as being something you knew could happen or was this a 24 complete shock to you and you were, you know, upset and 25 disappointed, that sort of thing, or -- Page 160 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 20 of 61 1 A. I was -- it was totally unexpected. 2 Q. So, for example, nobody who had provided you 3 with informed consent discussions before the ObTape, to 4 your memory, had told you, "Hey, this might work for a 5 while and then stop working"? 6 A. Correct. I was not informed of that. 7 Q. When you first started having that recurrent 8 leakage, did you, in your mind, feel that something had 9 gone wrong with the ObTape or did you think it was 10 something else? 11 A. I thought it was something else. I didn't 12 connect it with the ObTape. 13 Q. Okay. What else did you suspect it may be, 14 when your leakage came back in '06, '07, and going 15 forward? 16 A. I wasn't sure what to think. It just -- 17 you know, maybe I -- I realized there might be something 18 with the ObTape not working, but I didn't expect it to 19 or look at that as the issue that I've found since, 20 you know, with the tape. 21 Q. Okay. Would you explain what you mean there? 22 A. What was the first question? 23 Q. Oh, sure. I asked you what you thought was 24 going on in '06, '07, when your leakage came back? 25 A. Okay, okay. I just thought it wasn't working, Page 161 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 21 of 61 1 or I didn't have any explanation. I didn't know what to 2 think about it. 3 Q. Okay. And the first time you talked to a 4 doctor about it, it looks like it was May of '13 at 5 Hershey, when you saw Dr. Wang. 6 A. Right. 7 Q. Now, Dr. Wang is primary care, right? 8 A. I thought Dr. Wang was an OB/GYN. 9 Q. Oh, okay. That may be true. I know he 10 referred you to Dr. Elliott. 11 A. Oh, that's Dr. Dang. Dr. Dang and Alina Wang 12 are two different people. 13 Q. Right. 14 A. Dr. Dang is my primary care here in St. Pete -- 15 Q. Gotcha. 16 A. -- and Dr. Wang was up in Hershey. 17 Q. Okay. I understood that. Dr. Wang referred 18 you to Dr. Elliott, the urologist -- 19 A. Yes. 20 Q. -- with whom you were not terribly satisfied? 21 A. Yes. 22 Q. That's what I meant to say. So the first 23 doctor that you talked to about the problems you were 24 having with your ObTape, it looks like it was 25 Dr. Alina Wang in about May of '13; is that correct? Page 162 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 22 of 61 1 A. Yes. 2 Q. Now, this was already after you had seen a 3 lawyer for a mesh lawsuit; is that correct? That was -- 4 A. What was that? That was after or before? 5 Q. Well, that's my question. Let me ask you a 6 better question, though. What prompted you to go to a 7 lawyer about your mesh? 8 A. A friend of mine. She had been seeing 9 commercials, and we were talking about it, and she 10 encouraged me to check it out. As I learned more and 11 more, I started connecting. 12 And then when I went to the attorney's office, 13 they -- you know, they answered that and confirmed some 14 of my concerns, but it was really not -- you know, not 15 any of my doing to see what's wrong with this product or 16 something. 17 Q. I understand. 18 A. It was -- it was out of the concern of a 19 friend. 20 Q. Your lawsuit was filed October 10th of '13. 21 By that point in time, you'd already been, you know, 22 presumably working with the lawyers for a while and 23 giving them proof of, you know, the fact that you had 24 the product and signed authorizations to get medical 25 records and all that sort of thing? Page 163 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 23 of 61 1 A. It was only within that year. 2 Q. Right. 3 A. I think it was 2012. 4 Q. So that's my question for you. When did you 5 have this conversation with your friend that recommended 6 you pursue -- go to a lawyer for a mesh lawsuit, 7 possibly? 8 A. Sometime before that. You know, we laughed 9 about my incontinence and just -- you know, we never 10 really thought of anything, why it would be, and then 11 she brought my attention to the commercials. 12 Q. Okay. What's your best estimate for when that 13 took place? 14 A. It would have been probably late 2012. 15 Q. What's the friend's name? 16 A. Janet Vastine Kirchner. 17 Q. Could you spell it for Courtney, please? 18 A. Middle, Vastine, V-a-s-t-i-n-e; Kirchner, 19 K-i-r-c-h-n-e-r. 20 Q. And without digging into her much, does she 21 also have a mesh lawsuit -- 22 A. No. 23 Q. -- or she just saw the commercial? 24 A. Right. 25 Q. And you had confided in her some of your Page 164 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 24 of 61 1 problems with incontinence? 2 A. Yes. 3 Q. She connected the two and said, "Hey, go check 4 out these lawyers," or, "this lawsuit," or something? 5 A. Well, she didn't really, you know, get into the 6 lawsuit. She just wanted to see what the product was 7 about, you know, to see, "Is this product connected to 8 what they're talking about?" 9 Q. Okay. Did she do some research then and share 10 it with you, or -- 11 A. No. 12 Q. So did you have ongoing discussions with Janet, 13 or after the first discussion you went ahead and found 14 yourself some attorney, or -- 15 A. Yes. 16 Q. Okay. Tell me about that, please. Don't tell 17 me what the attorneys told you; just tell me how you 18 went about pursuing your claim after speaking with 19 Janet, please. 20 A. Well, gosh, I probably just went to a site, 21 you know, that -- there's all these advertisements of 22 attorneys handling it, and I just picked one. 23 Q. A website, you mean? 24 A. Yeah. Well, they would -- why I went to that, 25 you know, is based off of the commercials; it's not like Page 165 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 25 of 61 1 I was doing research on my own. Just I was prompted by 2 that to find an attorney to tell me whether I was -- if 3 that, my problem, was connected to the mesh. 4 Q. Okay. Did you actually see the commercials 5 yourself, or you just did the Internet research 6 yourself? 7 A. I saw them. And I saw them for a while, and I 8 just dismissed them. 9 Q. The commercials? 10 A. Yeah, yeah. 11 Q. Okay. Do you know how far back you started 12 seeing commercials, about what year; if it was before or 13 after, perhaps, your conversation with Janet Kirchner in 14 late 2012? 15 A. Probably -- I don't. I don't know when they 16 started. 17 Q. And do you remember what you used as search 18 terms to look for the websites? 19 A. No, I don't. 20 Q. Did you look at any actual Mentor websites, or 21 were you only looking for attorneys? 22 A. I was only looking for attorneys. And on -- 23 you know, like I had just -- that was all. I don't know 24 how I -- I stumbled, really. 25 I just stumble on anything on the Internet. I Page 166 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 26 of 61 1 don't really know where to go. So I just stumbled on 2 this firm and -- 3 Q. Okay. And is Denise's firm the first one that 4 you contacted? 5 A. Yes. 6 Q. Do you know when you first contacted Denise's 7 firm, without telling me what was said? 8 A. Well, in between those times when I -- when I 9 had the conversation with my girlfriend. 10 Q. So the conversation with your girlfriend was 11 late 2012, we said, right? 12 A. Right. 13 Q. So was it within a month or two that you then 14 contacted Denise's firm? 15 A. Yes. 16 Q. Okay. And that was -- knowing -- that's kind 17 of how we got on this tangent then. So knowing that you 18 had this conversation with Denise (sic) in late 2012, 19 knowing that you spoke with someone at Denise's firm a 20 couple months -- 21 MS. VINET: No. Excuse me. A conversation 22 with her friend. 23 MR. TABER: Let me start over. 24 MS. VINET: Yes. 25 BY MR. TABER: Page 167 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 27 of 61 1 Q. So what I'm trying to do is piece together the 2 events. So we've established the conversation with your 3 friend was in late 2012, correct? 4 A. Uh-huh. Uh-huh. (Indicates affirmatively.) 5 Q. And then you just told me a moment ago that you 6 then went ahead and contacted a law firm within a couple 7 of months, correct? 8 A. Correct. 9 Q. And then the visit with Dr. Wang, which appears 10 to be the first discussion of problems with your sling, 11 is at least six months later, in May of '13? 12 A. Right. 13 Q. Therefore, we can now establish that the visit 14 with Dr. Wang, which is page 67 in your binder, would 15 have been at least six months after you had already gone 16 to a law firm to pursue your mesh lawsuit, correct? 17 A. Yes. 18 Q. Okay. Please turn to page 67, if you haven't 19 already done so. So the chief complaint there is listed 20 as "bladder leakage" and "frequency." Do you see that? 21 A. Yes. 22 Q. Looking at these notes, I see no mention of any 23 pain associated with your pelvic region at all. 24 In fact, this is the note where it says "denies 25 dyspareunia. (However, not sexually active currently.)" Page 168 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 28 of 61 1 Do you know if you told Dr. Wang in May of '13, 2 after this nine-year period of no treatment for your 3 sling, if you were actually having pain at that time? 4 A. I probably did. Because they were all the 5 symptoms that I was, you know, trying to get to. And 6 maybe with this -- this was the -- if this was the first 7 visit -- 8 Q. Yes, it was, as far as I can tell you. 9 A. -- I was really mainly concerned about the 10 leakage. I just -- you know, and all these -- all these 11 symptoms I just had. They just kind of built as I began 12 thinking about where my pain is, just connecting it. 13 I didn't know it was associated. 14 Q. Uh-huh. (Indicates affirmatively.) 15 A. So I thought, "Well, maybe it's the 16 fibromyalgia." You know, it's -- 17 Q. Okay. So even in your mind, you thought 18 perhaps the pain you were having in your pelvis might be 19 related to the pain you've had with fibromyalgia all 20 over your body? 21 A. I can't say for sure. I can't say why I didn't 22 mention the pain. 23 Q. Now, it appears that, if you look at page 3 of 24 Dr. Wang's record, where she's talking about the 25 "Plan" -- Page 169 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 29 of 61 1 MS. VINET: That's on, what, 69? 2 MR. TABER: Yes. That's -- exactly, Denise. 3 Thank you. 4 MS. VINET: Okay. 5 BY MR. TABER: 6 Q. It says here, "Differential diagnosis: UTI," 7 which is obviously a urinary tract -- a urinary tract 8 infection, "Urge versus Stress versus Mixed versus 9 Overflow Incontinence, Medication effect," and then it 10 says, "(prazosin)," and then it says, "Diabetes." 11 First of all, with that background, do you 12 remember Dr. Wang telling you that the leakage problem 13 you may be having could be caused by one of your 14 medications, perhaps the "prazosin"? 15 A. No, I don't remember that. 16 Q. If you look even farther down, under "Plan," 17 Dr. Wang writes, "May be associated with medication side 18 effect - Prazosin for PTSD." Do you see that? 19 A. No. Oh, "may be associated." Okay. 20 Q. Do you recall any discussion about some of the 21 medication you were taking, per Dr. Wang, maybe being 22 the cause of your leakage problem? 23 A. I don't remember specifically, no. 24 Q. Did you stop taking prazosin? 25 A. No. Page 170 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 30 of 61 1 Q. Dr. Wang also says, under differential 2 diagnosis, "diabetes." Do you recall any discussion 3 with her about whether you may have an early form of 4 diabetes that could be causing some of your urinary 5 problems? 6 A. I don't remember that. 7 Q. Have you ever been diagnosed with diabetes? 8 A. No. 9 Q. You have been diagnosed with a blood sugar 10 intolerance condition? 11 A. Yes. 12 Q. How -- 13 A. Pre, prediabetes. 14 Q. Prediabetes. When did that start? 15 A. I just got that diagnosis last year. It must 16 have been -- 17 Q. 2015? 18 A. Yes. 19 Q. Have you ever -- so who diagnosed you with 20 prediabetes? 21 A. Dr. Dang. 22 Q. Okay. And what -- is that a he or a she, first 23 of all? 24 A. A he. 25 Q. What did Dr. Dang tell you to do about it? Page 171 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 31 of 61 1 A. Change my diet. 2 Q. Diet? 3 A. And I have extremely. I've most often -- I 4 haven't had another blood test, but the symptoms I was 5 aware of at that time are gone. 6 Q. Okay. At any other time in your past medical 7 history, have you ever had blood sugar problems before, 8 you know, a year or two ago? 9 A. No. 10 Q. Anybody else diabetic -- 11 A. No. 12 Q. -- in your bloodline? 13 A. No. 14 Q. Do you remember talking to Dr. Wang in May 15 of 2013 about the recurrent leakage problem? 16 A. Do I remember talking to her? 17 Q. Yes. 18 A. Yes. 19 Q. Okay. And I understand that she's the one that 20 referred you then to Dr. Elliott? 21 A. Yes. 22 Q. Given that Dr. Wang was six months or so after 23 you had gone to see counsel, was -- let me back up. 24 By the time you went to see your counsel in 25 late 2012, you had not been treated for any problems Page 172 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 32 of 61 1 with your sling for nine years; is that true? 2 A. Correct. 3 Q. And then six months after you'd gone to see 4 counsel, you're back to Dr. -- to a doctor after a 5 nine-year period of time, for the first time in nine 6 years complaining to a doctor about problems potentially 7 with your sling; is that fair? 8 A. Yes. 9 Q. Okay. Was the fact that you went to Dr. Wang, 10 in part, suggested by your attorneys? 11 A. Yes. 12 Q. Tell me how that happened. 13 A. Well, as I just even learned about a possible 14 complication, I think it was just suggested that I see a 15 urologist and a -- and connect it, if there was a 16 connection. 17 Q. Okay. So the referral to Dr. Wang was the 18 recommendation of your counsel, true? 19 A. Yes. 20 Q. And then when Dr. Wang got you over to 21 Dr. Elliott, the urology specialist at Penn, was that 22 also upon the recommendation of your attorneys or only 23 indirectly because your attorneys said, "Go back to see 24 the doctor," you went to Dr. Wang, and then Dr. Wang 25 said to go to Elliott? Page 173 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 33 of 61 1 A. Right. I was following my doctor's 2 recommendation at that point. 3 Q. So you got to Dr. Wang from the attorney 4 recommendation, and then Dr. Wang forwarded you, after 5 that attorney recommendation, to Dr. Elliott? 6 A. Right. 7 Q. At the same facility, the 8 Hershey Medical Center? 9 A. Yes. 10 Q. Okay. And it would seem that almost a year 11 passed between the two. So I have the first visit to 12 Dr. Wang in May of '13, and then it doesn't look like 13 you actually went to see Dr. Elliott's practice until 14 March of '14. Does that sound about right to you? 15 A. I don't know. Other than just documents with 16 the dates on them. 17 Q. Okay. Well, Dr. Wang had a couple 18 recommendations at the end of her note. If you look 19 back on page 69 in Exhibit 1, her "plan" is to give you 20 a prescription for "oxybutynin" -- 21 A. Uh-huh. (Indicates affirmatively.) 22 Q. -- and it says she, "recommended Kegel 23 exercises and keeping a voiding diary," and then the 24 other thing she did was -- it says, "Urology consult 25 placed." Page 174 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 34 of 61 1 So it looks like she wanted you to see a 2 urologist. Do you see that? 3 A. Yes. 4 Q. Did you start this "oxybutynin" that Dr. Wang 5 recommended? 6 A. Yes, I did. 7 Q. Did it help? 8 A. No. I -- excuse me. I stopped taking it a few 9 days in. It was -- I had horrible side effects. 10 Q. Oh, which ones? 11 A. I was dizzy and just nauseous. And I don't 12 know. It didn't feel right. 13 Q. Okay. Did you also follow Dr. Wang's 14 recommendations made in May of '13 to do Kegel 15 exercises? 16 A. Yes. 17 Q. Was this the first time you'd ever done Kegels? 18 A. No. 19 Q. You had done them before, upon recommendation 20 of -- all the way back with Dr. Abreu or Marks? 21 A. No. Just over the years. Like what we were 22 talking earlier about, just something that women should 23 do as just general health care. 24 Q. Okay. Did you keep a voiding diary as Dr. Wang 25 suggested? Page 175 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 35 of 61 1 that it," meaning the sling, "had helped her symptoms 2 for approximately two years, and over the next three to 3 four years, the leakage had restarted." 4 A. Yes. 5 Q. Is that true? 6 A. Yes. 7 Q. That would place your problems with recurrence 8 in about 2006? 9 A. Yes. 10 Q. Okay. That's consistent with your memory? 11 A. Yes. And we covered that. 12 Q. Excuse me. And it says, "She denies the need 13 for pads," is that correct, at that time with the 14 leaking? 15 A. Only because I was always at home. If I -- 16 you know, I would use a pad if I was out, but I was 17 rarely out; I stayed home. 18 Q. Okay. The next page, it, again, says, "Not 19 currently sexually active." That was true at that time? 20 A. Yes. 21 Q. It also says, "Denies recreational drug use." 22 That's not entirely correct, true? 23 A. Over the years, I've not -- I don't consider 24 marijuana use a "recreational drug"; I think of the 25 other harmful drugs. Page 195 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 36 of 61 1 Q. Okay. So now that we've looked through the 2 note from Dr. Elliott, the takeaway from Dr. Elliott was 3 that she didn't think you needed to have the sling 4 removed, correct? 5 A. Right. 6 Q. In fact, she probably warned you, "If you take 7 the sling out, the leakage might get worse"? 8 A. I don't remember her saying that. 9 Q. Okay. Would it make sense, in your mind, that 10 if the sling is there to prevent leakage, if you take it 11 out, it might even get worse? 12 A. I would think -- I mean, just in my thinking 13 you would replace it with something that worked or found 14 another resolution. 15 Q. How many times did you go see Dr. Elliott? 16 I just -- 17 A. Probably only two or three times. 18 Q. I have one more visit. If you turn to the next 19 page, it's 67. 20 A. Yeah. It was so hard to get into her office. 21 Q. Yes. So we have the March 24th visit, and then 22 if you turn to page 67, we have one more visit with her 23 June of '14. Do you see that? 24 A. Yes. I remember it. I don't remember -- what 25 page is it? Page 196 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 37 of 61 1 MS. VINET: 67. 2 BY MR. TABER: 3 Q. Sorry. 67. 4 A. I don't have that page here. 5 MS. VINET: It's in the back. 6 BY MR. TABER: 7 Q. It should be dated June 2nd of '14. 8 A. Nothing's in order. Here it is. 67? 9 MS. VINET: Yes. 10 BY MR. TABER: 11 Q. Yes. Let me back up one second. 12 At the end of the first visit with Dr. Elliott, 13 she had a plan for you. Do you recall that? 14 A. The Kegels? 15 Q. She was going to look into your bladder with a 16 cystoscopy -- 17 A. Right, right. 18 Q. -- and look to see if your mesh was eroded or 19 extruded, meaning sticking through the skin. 20 A. Uh-huh. (Indicates affirmatively.) 21 Q. Do you remember that? 22 A. Yes. 23 Q. And she did then look and found nothing wrong 24 with your mesh; is that true? 25 A. Right. Page 197 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 38 of 61 1 Q. She performed a cystoscopy, where she looked in 2 your bladder and actually looked in your vagina to see 3 if the mesh was through the skin anywhere, correct? 4 A. Right. 5 Q. And you recall that she found no problems 6 whatsoever with your mesh when she saw you between March 7 and June of '14, correct? 8 A. Right. She was only looking for erosion. 9 Q. Yes. Yes, erosion and extrusion. Right. And 10 then she wanted you, as part of her plan, to have 11 bladder function studies. They call that 12 "cystometrogram." Do you remember that -- 13 A. Yes. 14 Q. -- where they fill the bladder with liquid, see 15 if you're leaking? 16 A. Yes. 17 Q. And you had that testing done prior to or on 18 June 2nd of '14, right, through Dr. -- 19 A. Right. 20 Q. This is, again, through Dr. Elliott's practice, 21 correct? 22 A. Right. 23 Q. And the records of that testing begin on 24 pages 67 and 68, correct? 25 A. Yes. Page 198 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 39 of 61 1 Q. And do you recall that Dr. Elliott found that 2 your bladder function, based on the testing, was 3 completely normal; no leakage? 4 A. I don't understand that. 5 Q. If you would turn to page 68 -- 6 A. Right. But -- 7 Q. Well, let me back up. Look on page 67 first, 8 at the bottom where it says, "Assessment." 9 A. Well, you know, this is where the problem began 10 with her. 11 Q. Uh-huh. (Indicates affirmatively.) 12 A. She was -- she negated everything that I said I 13 came in for. 14 Q. Okay. Well, I'm asking you about the testing 15 just for the moment -- 16 A. Right. 17 Q. -- the bladder testing. 18 A. Right. 19 Q. Do you remember that bladder testing? 20 A. Yes. 21 Q. And do you remember that you did not leak 22 during that testing? 23 A. I don't remember, no. 24 Q. Okay. At the bottom of page 67, under, 25 "Assessment," it lists all the six things that one looks Page 199 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 40 of 61 1 for for this bladder function testing, and they all 2 turned out normal. 3 A. Okay. 4 Q. And then at the top of page 68, Dr. Elliott 5 says, quote, "We had a discussion with Mrs. Stroligo 6 today about the findings. Essentially this is a normal 7 exam today with no evidence of incontinence, no evidence 8 of detrusor instability, and no evidence of obstruction 9 from a sling procedure," unquote. 10 Did I read that correctly? 11 A. Yes. 12 Q. Do you remember her saying all those things to 13 you -- 14 A. No. 15 Q. -- that they -- 16 A. No, she didn't say I didn't have incontinence. 17 Q. Do you remember her saying that the results of 18 the bladder function testing, the cystometrogram, were 19 normal? 20 A. I don't remember. 21 Q. Do you remember her telling you that the 22 results of her physical examination looking for mesh 23 problems were normal based on the examination in your 24 pelvis? 25 A. I think I do, yeah. Page 200 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 41 of 61 1 Q. Okay. And do you remember her palpating your 2 abdomen, feeling your pelvis to see if it caused pain? 3 A. Externally, yeah. 4 Q. Do you remember if you told her, "Ouch, that 5 hurts," or anything like that? 6 A. I probably did, yes. 7 Q. Do you have a specific memory of that? 8 A. No, I don't. 9 Q. Now, at the end of that June visit with 10 Dr. Elliott, she says, in terms of a plan, "We are going 11 to prescribe Toviaz," and then it says, "She is going to 12 be headed out to California for the summer. So we have 13 some bladder with a prescription for 90 days of Toviaz, 14 and when she gets back in town in ten weeks, we'll 15 reassess her symptoms on this medication. She was happy 16 with that plan," unquote. Is that what happened? 17 A. I did go out of town. I don't remember what 18 Toviaz is for. 19 Q. Do you remember if you tried a medication with 20 Dr. Elliott after June of '14? 21 A. I may have tried it. 22 Q. You never went back to her, though -- 23 A. Right. 24 Q. -- because you moved? 25 A. Well, no, I didn't. Well, I didn't go back to Page 201 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 42 of 61 1 her because she wouldn't remove it, and what she's 2 saying about, "There's no obstruction" -- or I don't 3 know what she's trying to say when there was no pain. 4 There was another doctor that examined me, and he hit 5 right in there where the pain was. 6 Q. Well, tell me about the discussion with 7 Dr. Elliott whereby she didn't think your sling needed 8 to come out. 9 A. That was -- it was a real short -- it was -- 10 she didn't discuss it. She just was not going to do the 11 surgery. 12 Q. Well, did you ask her, "Why not?" 13 A. She said it wouldn't -- probably wouldn't help 14 the situation, I think. 15 Q. Did she say anything to you about what may be 16 causing the dyspareunia that you had mentioned? 17 A. No. 18 Q. Do you remember when she placed a speculum to 19 do her exam of the vagina, if that hurt? 20 A. More than likely. 21 Q. Do you remember, one way or another? 22 A. I don't remember sitting here right now, no. 23 Q. Okay. Did you have -- did you ask her? Did 24 you tell her that you wanted the sling removed? 25 A. Yes. Page 202 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 43 of 61 1 Q. This is Dr. Elliott in March and June of '14. 2 A. Yes, I did. 3 Q. Okay. Why did you say that? 4 A. Because I learned about what the product was, 5 and I didn't want it in my body. 6 Q. And what was your source of this information? 7 A. My attorney. 8 Q. Okay. There's a mention a little later in your 9 records, something about, "It wasn't" -- something about 10 "FDA approval." Is that something that you would have 11 said to Dr. Elliott? 12 A. I probably did. I remember that. You know, we 13 were talking about that earlier, and I remember now the 14 visit. I was just really upset, and I was just trying 15 to make it clear to her why I wanted it removed. 16 Q. Why did you want the sling removed as of June 17 or March of -- and June of '14? 18 A. Because it was a bad product. I learned that 19 it was a bad product, and it caused problems, and it 20 could cause more problems the longer it stayed in there. 21 Okay. That date, it wasn't -- there was no 22 erosion. I don't know from that date and to -- to 23 forward when the -- when the erosion would begin. It 24 didn't say that it would not erode. 25 Q. Did you share these concerns with Dr. Elliott? Page 203 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 44 of 61 1 A. Yes. 2 Q. Okay. And did she at least listen to you when 3 you shared them? 4 A. No. 5 Q. She told you her judgment was that the sling 6 was not causing your pain on that day and that taking it 7 out would not improve anything; is that fair? 8 A. I don't remember if she said that wasn't 9 causing my pain, but she just refused to remove the 10 mesh. 11 Q. Okay. Did she give you any more explanation 12 for why she did not think the mesh should be removed? 13 A. No. 14 Q. And that's why you stopped going to 15 Dr. Elliott? 16 A. Yes. 17 Q. Let's -- so that was June of '14. Now I think 18 we can speed up the rest of this. 19 After June of '14, you went back to your 20 lawyers and said, "I need a doctor who will take this 21 out," and they referred you to Dr. Bassaly down in 22 Florida, true? 23 A. They gave me a list of several surgeons -- 24 Q. Gave you a list. 25 A. -- and I chose that one because it was nearby. Page 204 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 45 of 61 1 Q. Nearby your mother's home? 2 A. Right. 3 Q. You were in Pennsylvania at the time? 4 A. Right. 5 Q. So you actually went to Florida, where you had 6 lived before, but your mother -- you could stay with 7 your mother then, and your plan was to have the surgery, 8 the removal surgery, in Florida; stay at your Mom's 9 house while that was done? 10 A. Right. 11 Q. That's why you came back to Florida in 2000 -- 12 I guess the end of 2014? 13 A. Right. 14 Q. Do you remember exactly when you came back to 15 Florida? 16 A. Oh, it was just a couple of weeks before the 17 end of October. 18 Q. Of '14? 19 A. It may not -- yeah. Maybe the last week of 20 October. You know, within that last two weeks of 21 October. 22 Q. Okay. And then you -- St. Anthony's 23 Primary Care, this is Dr. Dang. 24 A. Yes. 25 Q. While you were down in Florida, I guess you had Page 205 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 46 of 61 1 to wait for a while to see Dr. Bassaly? 2 A. Yes. 3 Q. Okay. In the meantime, you needed medications 4 refilled, I assume. So that's why you saw Dr. Dang? 5 A. Yes. 6 Q. And he's with St. Anthony's Primary Care here 7 in St. Petersburg? 8 A. Yes. 9 Q. And I don't think we need to go off his note, 10 but -- so the way you got to Dr. Bassaly then was from 11 your lawyers, true, from their list? 12 A. Yes. 13 Q. Do you know who else was on the list? Was it a 14 long list or just -- 15 A. It was a long list. 16 Q. And what were they -- what was your 17 understanding of -- what was that list of? Doctors who 18 would remove it upon request, or -- 19 A. They were -- my understanding, it was that they 20 were specialized. They specialized -- it was a more 21 specialized procedure to remove this mesh and any 22 complications, and they were more qualified to do that. 23 Q. Okay. Let's -- thank you. Let's turn to 24 page 315. It's just a couple more pages, which is 25 Dr. Bassaly. We're almost to the end. Page 206 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 47 of 61 1 MS. VINET: 315? 2 MR. TABER: Yes, please. It's 3 dated January 14th of '15. 4 THE WITNESS: 351 (sic)? 5 MS. VINET: 351 (sic)? 6 MR. TABER: 315. It's right after -- 7 THE WITNESS: I gotcha. 8 MS. VINET: Oh, here we go. 9 MR. TABER: Yes, Dr. Dang's note. 10 MS. VINET: Yes. 11 MR. TABER: USF? There we go. 12 BY MR. TABER: 13 Q. So it would appear the first time you saw 14 Dr. Bassaly then, after the referral from counsel, was 15 January of '15? 16 A. Yes. 17 Q. All right. And under "HPI," History of 18 Present Illness, it says, quote, "She complains of a 19 sling placed 2004 for urinary incontinence. She felt 20 that immediately after she had pain with intercourse but 21 hasn't been sexually active for several years," unquote. 22 What does that mean? 23 A. I don't know. 24 Q. Did you have pain with intercourse immediately 25 after the sling was placed in '04? Page 207 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 48 of 61 1 A. No. Because I didn't have intercourse. 2 I was -- I think I had talked about it in 2006, and I 3 had pain. 4 Q. Uh-huh. (Indicates affirmatively.) 5 A. So yeah, that would be immediate. Probably 6 like the -- it was a couple of years before I even had 7 it, had intercourse. So that's immediate. I mean, the 8 next time I had intercourse, that's what my experience 9 was. 10 Q. Okay. Now, it says, "She admits to going to 11 Hershey Pennsylvania with Dr. Elliott and having a sling 12 release by cystoscopy in 2013, which helped urgency 13 somewhat." Do you know what that refers to, that 14 "release"? 15 A. When she did one of those diagnostic tests -- 16 Q. Yes. 17 A. I think it was a cystoscopy. 18 Q. Yes. 19 A. -- she mentioned that she -- I don't know how 20 she loosened it, but she loosened it. She mentioned she 21 had done that. 22 Q. Oh. And did that, in fact, help? 23 A. It seemed to. You know, it was so hard to 24 define all that, you know. 25 Q. Yes. And then at the bottom of that page, it Page 208 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 49 of 61 1 says, "She is not sexually active." That's true right 2 there, right? 3 A. Right. 4 Q. And the third page, it mentions that you're on 5 "Estrace" by that time. That's consistent with your 6 memory? 7 A. Yes. 8 Q. Okay. Could you please turn to the fourth page 9 of her note, page 318? She's talking about her exam of 10 you, and there's no mention of any pain either vaginally 11 or in the pelvic region at all; is that true, you just 12 weren't feeling any pain that day, or is she making 13 errors in her records? 14 A. I don't know if pain was discussed. 15 Q. Well, she's talking about, for example, "No 16 abdominal wall trigger points noted." I assume that's 17 part of her abdomen exam looking for pain. 18 And then she says, "Bimanual Exam," where she's 19 actually pushing right on your pelvis from two sides, 20 "Nontender urethra and bladder, without masses, 21 midurethral sling nontender." Do you remember her 22 actually doing your pelvic exam that day and you feeling 23 no pain? 24 A. Yes. But I can tell you she wasn't -- I mean, 25 this was the exam, touching. It wasn't, you know, Page 209 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 50 of 61 1 pushing into -- you know, where the pain is, it's not on 2 the surface. You know, it just wasn't that intense of 3 a -- by her saying that, I don't feel like it was really 4 finding those points. I don't know how to say it, 5 but -- 6 Q. Do you know what a "bimanual exam" is? 7 A. No. 8 Q. Do you know when one hand is in the vagina, one 9 hand is on the top of the abdomen, and they're pressing 10 together to feel what's between them? Do you remember 11 that she did that? 12 A. I don't remember, no. 13 Q. All right. I understand. It was a while ago. 14 In any event, at the end of Dr. -- your first 15 visit with Dr. Bassaly, she wasn't convinced that the 16 sling should come out immediately either. She wanted to 17 try some other stuff first; isn't that fair? 18 A. Yes. 19 Q. And one of the things she wanted to try was 20 "Estrace therapy," cream? 21 A. Yes. 22 Q. And she wanted to try some medications? It 23 says, quote, "She may try antimuscarinics or if cannot 24 tolerate again Myrbetriq prior to making any decision to 25 remove sling since nontender," unquote. Does that jog Page 210 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 51 of 61 1 your memory about your discussions after first seeing 2 Dr. Bassaly? 3 A. It doesn't. 4 Q. Do you remember she wanted to do some things 5 before taking out the sling? 6 A. She did. And what it was, it was repeating. 7 From what I remember, it was repeating the 8 other diagnostic tests that Dr. Elliott did, and that's 9 when I told them, "That's already been done." It's only 10 been, you know, maybe less than a year, and I just 11 didn't feel it was necessary to do that. 12 Q. Okay. And so to fast-forward to -- add then 13 three months or four months later, you did have 14 Dr. Bassaly remove the sling, correct? 15 A. Yes. 16 Q. And before Dr. Bassaly operated to remove the 17 sling, do you recall that there was an informed consent 18 discussion with you about the complications that could 19 happen? 20 A. Yes. 21 Q. And what do you remember about them warning you 22 of complications of removing the sling? 23 A. Nothing out of the ordinary. It's, like I said 24 before, about a surgery. She hadn't indicated, I think, 25 any of these. Since they didn't mention that there was Page 211 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 52 of 61 1 erosion, I don't -- I just don't think that there was 2 any great warning of anything that could go wrong. 3 Q. Well, did she warn you that if you take the 4 sling out, your leakage might get worse? 5 A. She may have. 6 Q. Okay. Did you understand that -- 7 A. Yes, yes. 8 Q. -- when you went into that 2015 removal? 9 A. Yes. 10 Q. You were willing to assume that risk? 11 A. Yes. I wanted it out. 12 Q. And did she say if your -- "After we get this 13 sling out, there may be some other things down the road 14 we can do, if you have recurrent leakage"? 15 A. Yes. 16 Q. What sort of things did she tell you about? 17 A. Probably the exercises. All I remember is the 18 Kegel and physical therapy. I don't remember what we 19 talked about, other than that. 20 Q. Did she say, "Well, there are other slings that 21 we could put in afterwards"? 22 A. I don't remember if she did. 23 Q. Okay. Do you remember if she talked about 24 possible biological slings, living tissue slings, that 25 could be put in if you have -- if your incontinence got Page 212 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 53 of 61 1 worse after removal of the ObTape? 2 A. She may have. I honestly don't remember. 3 My focus was on getting this thing removed. 4 Q. You just wanted to get it out -- 5 A. Yeah. 6 Q. -- and weren't really concerned about after 7 that? 8 A. No. That was -- you know, that was secondary. 9 Q. Okay. The last visit I have before your sling 10 removal is April 30th of '15. It's page 240, if you 11 could please skip forward a few pages to page 240. 12 That's probably six or seven pages deeper. 13 It looks like this, "Tampa General Hospital." 14 Yes, I think you're there. Under -- this is a "History 15 & Physical" done. It's multi pages by, again, 16 Dr. Bassaly, and I think it starts on page 235. It's 17 dated April 30th of '15, "History & Physical." 18 And on page 240 -- again, this is Exhibit 1 -- 19 it says, "Susan E. Stroligo is a 57-year-old female who 20 was evaluated by Dr. Bassaly. She is here for sling 21 that she states is a non-FDA approved sling. She 22 believes that it must come out. Procedure described in 23 detail to patient using pictures." 24 Did I read that correctly? 25 A. Yes. Page 213 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 54 of 61 1 Q. So where did you get the idea that the ObTape 2 was not FDA approved? 3 A. I learned this through this whole research with 4 the attorneys. And they gave me that information, that 5 this product was not. 6 Q. Did anyone tell you that that's not, in fact, 7 true; that the ObTape was, in fact, cleared through the 8 FDA for safety and efficacy before it was ever sold in 9 the U.S.? 10 A. No. And, you know -- no. I've not been -- no. 11 I'm tired. 12 Q. Okay. Did you have any source for that comment 13 that ObTape was not FDA approved, other than your 14 attorneys? 15 A. I don't -- I don't know. 16 Q. Okay. We're almost done. 17 A. And I may have misunderstood. I just knew that 18 it was proven to be a product that caused a lot of 19 complications. So I may have used the wrong term to say 20 "non-FDA." 21 Q. In any event, when it's saying, "She states is 22 a non-FDA approved sling," that "she" is referring to 23 you and not Dr. Bassaly, right? 24 A. Right. 25 Q. And where it says, "She believes that it must Page 214 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 55 of 61 1 come out" -- again, that's page 240 -- that "she" was 2 you? 3 A. Yes. 4 Q. Okay. And if you could, please turn to 5 page 212. You signed a consent form for the mesh 6 removal, and that's your signature on page 213, correct? 7 It's a two-page consent form. 8 MS. VINET: Just go a little bit further. 9 MR. TABER: Yes. Sorry. 10 THE WITNESS: 213? 11 BY MR. TABER: 12 Q. Yes. It's a two-page form at 212 and 213. 13 A. Yes. 14 Q. And one of the risks that was specifically 15 disclosed to you in this written form that you signed 16 was the risk on page 1 of, "Acute voiding dysfunction," 17 meaning that your leakage might get even worse. 18 A. Yes. 19 Q. You understood that? 20 A. Yes. 21 Q. And I understand that you -- when that sling 22 was removed on May 4th of '15 by Dr. Bassaly, you had 23 asked that it be preserved by the hospital if it was 24 removed? 25 A. Yes. Page 215 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 56 of 61 1 Q. Okay. That was your request? 2 A. Yes. 3 Q. How did the removal surgery go, from your 4 perspective? 5 A. Very well. 6 Q. Did you go home the same day? Was that a 7 one-day surgery? 8 A. Yes. 9 Q. And it was May 4th of '15, correct? 10 A. Right. 11 Q. Did you have any complications from the removal 12 surgery? 13 A. Not one. 14 Q. And given that that was just a little over a 15 year ago, how have you done since the mesh removal 16 surgery on May 4th of '15? 17 A. Everything's great. I've had no problems at 18 all. I immediately felt better. No bladder leakage; no 19 pain. 20 Q. Fabulous. How long did it take to recover from 21 the removal surgery? 22 A. I was able to get back to work probably within 23 that six weeks. 24 Q. Okay. Had you already secured -- I think you 25 said you started work December of '15 -- Page 216 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 57 of 61 1 A. Right. 2 Q. -- at the museum. 3 A. Right. 4 Q. Between May of '15 and December, you found a 5 different job? 6 A. No. Between where? 7 Q. Oh, sorry. So I think you told me you started 8 at the museum December of '15. The ObTape was taken out 9 six months before that -- or five months before that in 10 May of '15. 11 A. No. 12 Q. Did I get my dates off, or did -- 13 A. I've been there a year. This is 2016. So it 14 was 2014. 15 Q. Oh, okay. So you started at the museum -- 16 A. 2014. 17 Q. -- even before your explant surgery? 18 A. Yes. 19 Q. Okay. So then you were back to work at the 20 museum within six weeks of your explant? 21 A. Yes. 22 Q. And then tell me all the ways that your health 23 improved after the removal of the explant in May of '15. 24 A. I felt immediately better. I mean, I felt -- 25 I had feeling. I was no longer numb. I felt like -- Page 217 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 58 of 61 1 thank you enough. I know this has been difficult 2 for you, but you did a great job. Thank you so 3 much for your time. It was a pleasure talking with 4 you today, and those are all the questions I have 5 for now. 6 THE WITNESS: Thank you. 7 MR. TABER: For the record, as we normally do 8 in these because we're getting records even as we 9 speak, we do routinely and I will in this case, 10 again, reserve our rights to possibly redepose, if 11 there were some things that we don't have that we 12 should have had. 13 But that's merely a routine reservation for the 14 record at this point. That's all I can think of to 15 ask you today. Thank you so much. 16 THE WITNESS: You're welcome. 17 MS. VINET: Thank you. I don't have any 18 questions. 19 THE VIDEOGRAPHER: Off the record at 3:30 p.m. 20 (Deposition concluded at 3:30 p.m.) 21 22 23 24 25 Page 238 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 59 of 61 1 CERTIFICATE OF OATH 2 STATE OF FLORIDA 3 COUNTY OF HILLSBOROUGH 4 5 I, the undersigned authority, certify that 6 SUSAN E. STROLIGO personally appeared before me on 7 May 25, 2016, and was duly sworn. 8 9 10 WITNESS my hand and official seal this 2nd day 11 of June, 2016. 12 13 14 <%Signature%> 15 Notary Public - State of Florida 16 My Commission Expires: 3/5/17 17 Commission No. EE 881047 18 Michael Musetta & Associates 19 20 21 22 23 24 25 Page 239 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 60 of 61 1 REPORTER'S CERTIFICATE 2 3 STATE OF FLORIDA 4 COUNTY OF HILLSBOROUGH 5 I, Courtney N. Langhoff, Registered Merit 6 Reporter and Certified Realtime Reporter, certify that I was authorized to and did stenographically report the 7 deposition of SUSAN E. STROLIGO; that a review of the transcript was not requested; and that the transcript is 8 a true and complete record of my stenographic notes. 9 I further certify that I am not a relative, 10 employee, attorney, or counsel of any of the parties, nor am I a relative or employee of any of the parties' 11 attorney or counsel connected with the action, nor am I financially interested in the action. 12 13 Dated this 2nd day of June, 2016. 14 15 16 <%Signature%> 17 18 19 20 21 22 23 24 25 Page 240 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-6 Filed 07/25/16 Page 61 of 61 Exhibit D Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 1 of 37 1 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA 2 COLUMBUS DIVISION 3 Susan Stroligo, : Plaintiff : Case Number 4 : 4:13-cv-00462 V : 5 Mentor Worldwide, LLC, : Defendant : 6 7 VIDEOTAPED 8 DEPOSITION OF: Vanessa Elliott, MD 9 TAKEN BY: Defendant 10 DATE: June 21, 2016, 3:01 p.m. 11 BEFORE: Ramona Devlin, Reporter Notary Public 12 PLACE: 100 Corporate Center Drive 13 Camp Hill, Pennsylvania 14 APPEARANCES: 15 For - Plaintiff 16 Denise Vinet, Esquire Murphy Law Firm 17 7035 Jefferson Highway Baton Rouge, LA 70807 18 For - Defendant 19 Jeffrey Sindelar, Esquire Tucker Ellis, LLP 20 950 Main Avenue, Suite 1100 Cleveland, OH 44113 21 For - Dr. Elliott 22 Carolyn Smith, Esquire McQuaide Blasko 23 1249 Cocoa Avenue, Suite 210 Hershey, PA 17033 24 25 Job No. CS2321852 Page 1 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 2 of 37 1 INDEX 2 WITNESSES 3 NAME DIRECT CROSS REDIRECT RECROSS 4 Vanessa Elliott, MD 4 58 66 -- 5 6 7 EXHIBITS 8 NO. DESCRIPTION PAGE 9 1. Subpoena 10 2. Curriculum Vitae 11 10 3. Records 13 4. Records 30 11 5. Records 44 6. Records 55 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 2 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 3 of 37 1 THE VIDEOGRAPHER: We are now on the 2 record. My name is Ken Haase, representing Veritext. 3 The date today is June 21, 2016, and the time is 4 approximately 3:01 p.m. 5 This deposition is being held at Urology 6 of Central Pennsylvania, located at 100 Corporate 7 Center Drive, Camp Hill, Pennsylvania and is being 8 taken by counsel for the defense. 9 The caption of this case is Susan 10 Stroligo versus Mentor Worldwide, LLC. This case is 11 being held in the United States District Court for the 12 Middle District of Georgia, case number 4:13-CV-00462. 13 The name of the witness is Dr. Vanessa Elliott. 14 At this time, will the attorneys present 15 please identify themselves and the parties they 16 represent. 17 MR. SINDELAR: Jeff Sindelar from Tucker 18 Ellis, LLP, out of Cleveland, Ohio, here on behalf of 19 the defendant, Mentor Worldwide, LLC. 20 MS. VINET: And this is Denise Vinet here 21 on behalf of the plaintiff, Susan Stroligo. 22 MS. SMITH: My name is Carolyn Smith. 23 I'm here from McQuaide Blasko Law Offices on behalf of 24 Milton S. Hershey Medical Center and Dr. Elliott. 25 THE VIDEOGRAPHER: Our court reporter, Page 3 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 4 of 37 1 Mona Devlin, representing Veritext, will swear in the 2 witness and we can proceed. 3 VANESSA ELLIOTT, MD, called as a witness, 4 having been duly sworn, testified as follows: 5 THE VIDEOGRAPHER: Please begin. 6 DIRECT EXAMINATION 7 BY MR. SINDELAR: 8 Q. Good afternoon, Dr. Elliott. Can you 9 please state your full name for the record? 10 A. Sure. Vanessa Lee Elliott. 11 Q. And, Doctor, what is the name of your 12 practice and the address? 13 A. Currently, my practice is Urology of 14 Central PA, which is at 100 Corporate Center Drive, 15 Camp Hill, Pennsylvania. 16 Q. Thank you, Doctor. My name is Jeff 17 Sindelar, and I represent Mentor Worldwide, LLC, in a 18 lawsuit brought against it by one of your former 19 patients, Susan Stroligo, related to complications she 20 alleges from an ObTape suburethral sling that she 21 received in March of 2004 from a Dr. Abreu in Florida. 22 Do you understand that you are here today 23 to give testimony in that lawsuit? 24 A. Yes. 25 Q. And you understand that neither party has Page 4 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 5 of 37 1 A. Yes. 2 Q. And if you perform a surgery, for 3 instance, or a procedure on a patient, how long do you 4 typically wait before you dictate that operative report 5 or note? 6 A. Usually within 24 hours. 7 Q. I want to look now at the records from 8 the visits that Ms. Stroligo had with you, and I think 9 I just see two different encounter dates. 10 And I have gone ahead and separated those 11 into two sets of records we can use as exhibits. I'll 12 mark and hand you a copy as well, and you can either 13 refer to the version I hand you or the version you have 14 with you. 15 A. Okay. 16 (Exhibit No 4 was marked.) 17 BY MR. SINDELAR: 18 Q. I believe we are on Exhibit 4 now; is 19 that correct? 20 A. Uh-huh. 21 Q. So I'm going to mark as Exhibit 4, and 22 hand you a copy of a set of records I believe are 23 related to your care and treatment of Ms. Stroligo from 24 March 24, 2014. 25 And if you look at the bottom right-hand Page 30 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 6 of 37 1 corner, there is a set of what attorneys call Bates 2 labeling. It is just a way for us to keep track and a 3 way of referring to documents to make sure we are all 4 looking at the same page. 5 This one looks like it starts PLF 6 Stroligo S 00117. I believe it runs consecutively 7 through Number 136, so I may refer to one of those 8 numbers at times just to make sure we are all oriented 9 on the same document. 10 First of all, Doctor, does what I have 11 handed you as Exhibit 4 look like an accurate copy of a 12 record that you would have took a part in creating for 13 a visit with Ms. Stroligo on March 24, 2014? 14 A. Yes. 15 Q. And can you -- I don't need you to walk 16 through the whole record verbatim, but can you just 17 explain to us why Ms. Stroligo came in to see you that 18 day, and what your care and treatment of her entailed? 19 A. Sure. Basically, she came to see me with 20 a history of urinary incontinence; and basically, the 21 history entailed that she had had a sling in the past; 22 and in short, had done well for a period of time, then 23 began to have some recurrence of leakage and some other 24 symptoms also associated with the leakage, and so that 25 is why she was seeking care in the office that day. Page 31 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 7 of 37 1 Q. Okay. And it notes in the record that, 2 at the time of the interview, you did not have any 3 outside documentation. 4 A. That is correct. 5 Q. Okay. So is the information regarding 6 the patient's medical history -- what was the source of 7 that? 8 A. So at the time of this note, it would 9 have just been from the patient telling me what she had 10 had completed. So this was just her verbally telling 11 me what she had had done. 12 Q. Okay. And can you -- it looks like the 13 patient, after this section of the note, it says the 14 patient -- it says, she states that it had helped her 15 with her symptoms for approximately two years, and then 16 goes on. 17 Can you just walk us through what she 18 reported to you? 19 A. Sure. She tells me that she did well for 20 two years; and then over the next three to four years 21 following that, she began to have some urinary leakage 22 that was recurring with increasing amounts of urgency 23 and urge incontinence. 24 She also mentioned that she was having 25 some leakage with intercourse, as well as some pain Page 32 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 8 of 37 1 with intercourse in addition; and though she was having 2 intercourse, it looks like she told me that she wasn't 3 requiring any pads because of the incontinence. 4 Q. And, Doctor, you note that she reported 5 increasing amounts of urgency and urge incontinence. I 6 don't think we have discussed it yet; but again, 7 something for the benefit of the jury, can you explain 8 the difference between urge and stress incontinence and 9 how they will present in female patients? 10 A. Stress incontinence is basically 11 incontinence that women experience upon exertion, so 12 they usually complain of leakage with an activity or 13 with coughing or laughing or sneezing. 14 Urge incontinence is instead when they 15 have a loss of urinary control because of a bladder 16 spasm, and so they usually have a sense of urgency, 17 can't get to the bathroom on time and then experience 18 leakage. 19 Q. And are those two sets of symptoms 20 related or do they appear -- do they appear always 21 together or separate? 22 A. No, they don't always appear together, 23 but they can. 24 Q. Okay. And then under past medical 25 history, it lists several significant medical events in Page 33 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 9 of 37 1 the patient's life. Is that information that the 2 patient reported to you? 3 A. Correct. 4 Q. Okay. If we turn over to the next page, 5 which is Number 118, it looks like you performed a 6 physical examination during this March 2014 encounter. 7 Can you walk us through what you did on 8 that examination and what you were able to diagnose or 9 tell from the examination? 10 A. So I think pertinent is just her 11 genitourinary exam. So I did a vaginal exam on the 12 patient, which would have been with a speculum in the 13 office. 14 And what I saw on the exam was that she 15 had some mild atrophy of her tissues. I had her strain 16 during the exam, and I couldn't appreciate that she had 17 any leakage. She had a very small cystocele. I said a 18 one, grade one cystocele or a plus one cystocele. 19 And the other thing I did that day was I 20 catheterized the patient for a post void residual or 21 amount of urine that was left over after she would have 22 voided at one point, which was 250cc. 23 And to end the procedure, I basically did 24 a palpation exam and identified that the patient had 25 significant obturator tenderness on exam, with right Page 34 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 10 of 37 1 sided greater than left-sided tenderness. 2 Q. And, Doctor, just to kind of break out a 3 few of the items and to go a little more into detail, 4 you note that the exam revealed mildly atrophic vaginal 5 mucosa. Can you explain what that means in laymen's 6 terms? 7 A. So as women age, their estrogen levels 8 decline and the tissue in the vaginal area thins, and I 9 just noticed that she had some mild thinning of the 10 tissue. 11 Q. And what type of symptoms or what kind of 12 patient experience due to an atrophic vaginal mucosa? 13 A. Sometimes nothing, or sometimes they will 14 experience pain with intercourse or vaginal dryness. 15 In this patient's case, the reason I mention it is 16 because, if they have enough thinning, sometimes they 17 will have a mesh issue, and I did not see that when I 18 examined her. 19 Q. And then you also note no leakage 20 appreciated with Valsalva maneuvers. Again, can you 21 explain in laymen's terms what kind of testing you are 22 doing and what you are looking for there? 23 A. Sure. So I always have the patient 24 strain. I tell them to bear down like they are having 25 a baby; and they typically cough as well for me during Page 35 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 11 of 37 1 the exam, and I'm just looking to see if they have 2 leakage. 3 Q. Okay. And the patient here did not 4 demonstrate any leakage with the straining procedure? 5 A. Correct. 6 Q. And you mentioned she has a one plus 7 cystocele. Can you explain what a cystocele is and the 8 degree of a cystocele being demonstrated here? 9 A. So a cystocele is basically descent of 10 the bladder. It's basically a small hernia, or can be 11 large, a hernia into the vaginal area. 12 In her case, a grade 1 cystocele is -- 13 there is many ways to classify a cystocele; but 14 probably the easiest in laymen's terms, a grade one 15 would be the smallest cystocele with a grade four being 16 a very large cystocele, so I felt that she had a fairly 17 minor cystocele when I had examined her. 18 Q. And is a cystocele something that can be 19 connected to a midurethral sling to treat stress 20 incontinence? 21 A. No. It's a separate entity. 22 Q. Then you note post void residual of 23 approximately 250 milliliters. Can you explain what a 24 post void residual is? 25 A. A post void residual is when a patient Page 36 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 12 of 37 1 urinates and then we, by some means, check to see how 2 much is in the bladder afterwards. In her case -- 3 typically, 100 or less is considered to be normal. In 4 her case, it was elevated that day. 5 Q. Okay. And were you able to determine a 6 cause for her having an elevated level of retention of 7 urine? 8 A. No. And with it being so long ago, I 9 don't know how long it was between the patient voiding 10 and me checking that volume; but based on this exam, I 11 didn't see a reason for it that day. 12 Q. Okay. And you note a bimanual exam 13 revealed bilateral obturator tenderness, right greater 14 than left. Can you explain what a bimanual exam is and 15 what you were looking for with that procedure? 16 A. Sure. I mean, a bimanual exam can be for 17 many things; but in this case, what I was doing was 18 just using a finger instead of a speculum to palpate or 19 feel the muscles in her pelvic area. 20 And so when I examined them, I always 21 examine the obturators and the levators, and in her 22 case, I stated that the obturators were tender. 23 Q. Can you explain where the obturators are 24 -- where -- not atomically, anatomically. Let me start 25 over and rephrase. Can you explain where anatomically Page 37 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 13 of 37 1 you were able to -- or the patient reported tenderness 2 to you? 3 A. So it is usually -- there is an obturator 4 muscle on the left and the right side of the bladder, 5 and they connect from the pelvic area into the upper 6 leg basically; and so just by putting a finger in and 7 feeling behind the bones of the pelvis, you can palpate 8 the obturator muscles. 9 Q. Okay. And how is it you are able to 10 determine the patient is experiencing tenderness? 11 A. Just by -- most patients don't feel any 12 pain when you are pushing on those areas, and in her 13 case, when I was just gently touching the area, she 14 vocalized to me. I asked her if she was having any 15 pain, and she said that she was. 16 Q. Okay. So that is information that the 17 patient would report to you? 18 A. Correct. 19 Q. And then do you have an understanding of 20 what causes of the type of pain that the patient 21 reported to you could be? 22 A. There is many causes for obturator and 23 pelvic floor muscle pain. Do you want to know in her 24 case specifically or just in general? 25 Q. Well, both in general, and whether you Page 38 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 14 of 37 1 were able to identify any specific cause in her case. 2 A. I mean, in her case, by the exam, all I 3 could identify was that she had the pain. I'm not sure 4 what caused it or how long it was present, but I mean, 5 it can come from pelvic floor dysfunction. It can be a 6 result of a sling at times. 7 It can come from having children, or in 8 her case, she had had an assault at one point early in 9 her life that could have been a contributing factor. 10 Q. And then can you -- strike that. What 11 was your assessment and plan going forward for Ms. 12 Stroligo after this examination on March 24, 2015 -- or 13 2014, I'm sorry? 14 A. From my notes, I recommended that she 15 have a cystoscopy to make sure that she didn't have any 16 mesh erosion to her urethra, and I also felt that, 17 because she was complaining of incontinence, that she 18 should have a urodynamics procedure completed to 19 evaluate her incontinence. 20 Q. And can you explain what a cystoscopy and 21 what a urodynamics evaluation is? 22 A. A cystoscopy is when we place a small 23 scope into the urethra and the bladder to identify any 24 abnormalities. 25 And a urodynamics procedure is basically Page 39 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 15 of 37 1 a study of the bladder and how it functions, both in 2 filling and in emptying, and it is commonly used as -- 3 a tool we use to assess the degree of incontinence and 4 why maybe someone is having incontinence. 5 Q. Okay. And I think if we turn to the 6 third page of this set of records, which is Number 119, 7 we can see that you electronically signed this record 8 March 27, 2014; is that correct? 9 A. Correct. 10 Q. Okay. And then we have more pages in 11 this record. I don't think they are going to take that 12 long to go through, but I just want to go through them 13 quickly. 14 First of all, page 122, looks like 15 there is a Penn State Hershey, Division of Urology 16 patient medical history, adult female. 17 Then there is -- looks like there is 18 three, maybe four, pages of handwriting in here, 19 filling out of a form. 20 Is this the form that the patient fills 21 out? 22 A. Correct. 23 Q. Okay. And do you recall reviewing this 24 form as a part of your care and treatment -- 25 A. Uh-huh. Page 40 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 16 of 37 1 Q. -- of Ms. Stroligo in March of 2014? 2 A. I mean, I don't recall that day reviewing 3 it, but yes, I would have reviewed it. I review them 4 on all the new patients who have this paper. 5 Q. And if you could review those pages. Is 6 there anything that stands out to you as being 7 significant for a patient you are seeing complaining of 8 pelvic pain and stress or urinary incontinence? 9 A. Well, I mean, definitely the fact that 10 she had reported that she had had a bladder sling 11 completed with those complaints. And she also -- let's 12 see here. 13 She has a lot of other pain issues as 14 well, like, joint pain, neck pain, back pain, in 15 general. 16 I just noticed that she had a lot of pain 17 symptoms that she had filled out in her review of 18 systems. And then also as well, she had had two 19 pregnancies and one vaginal delivery. 20 So those -- it's something I always look 21 at. And then, of course, the last page is her 22 urogenital distress inventory and incontinence impact 23 questionnaire, and that is where I pretty much get all 24 of my subjective evidence about the patient, how they 25 feel about their incontinence and pain, and those types Page 41 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 17 of 37 1 of symptoms. 2 Q. Okay. And it looks like it's on Page 3 125; is that correct? 4 A. Uh-huh. 5 Q. And this is an area where the patient 6 ranks their subjective feelings about the symptoms they 7 have? 8 A. Correct. 9 Q. Okay. And then going forward, starting 10 on 126, it looks like there is an outpatient visit 11 summary. 12 A. Uh-huh. 13 Q. And going forward a little more, there is 14 a lab interpretation that looks like it might be a 15 urinalysis. 16 Are the results of a urinalysis test on 17 Page 131, is there anything significant in the 18 urinalysis test from March of 2014? 19 A. I mean, she had trace intact blood, but 20 what wouldn't be shown, and it wasn't seen as what my 21 -- I would have looked at her urine under the 22 microscope to confirm whether or not there was truly 23 blood present. 24 However, I don't really see that listed 25 here; but otherwise, it is a negative urinalysis. Page 42 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 18 of 37 1 Q. And it looks like there is a pain 2 assessment on the last page, which is Page 136. Do you 3 know what that pain assessment was connected to? 4 A. So when the patients are taken into the 5 room by the nurses, this would have been the nurse 6 asking the patient on a scale of 1 to 10 how much pain 7 she was having that day, and she would have reported a 8 zero. 9 Q. Okay. During your vaginal examination of 10 Ms. Stroligo on March 24, 2014, were you able to 11 diagnose her with any erosion of her mesh? 12 A. No. 13 Q. Then you mentioned at the beginning of 14 the deposition that you do recall Ms. Stroligo wanting 15 you to remove her ObTape mesh; is that correct? 16 A. Yes. I don't have that in the record, 17 but that is my recollection of the visit. 18 Q. Okay. And was that at this first -- this 19 March 2014 visit she asked you about that? 20 A. Yes. 21 Q. Okay. Do you recall why she said she 22 wanted her mesh removed? 23 A. I think -- I do recall. I mean, and if 24 you look at her reports, it was very emotionally 25 bothersome to her that -- in addition to the complaints Page 43 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 19 of 37 1 already that she stated, having that mesh in there was 2 emotionally devastating for the patient. 3 And it was occupying a lot of her time 4 just thinking about the mesh being in there, 5 potentially causing these problems that she was having. 6 (Exhibit No 5 was marked.) 7 BY MR. SINDELAR: 8 Q. Okay. We can set Exhibit 4 to the side. 9 Looks like you saw her again on June 2, 2014. And I 10 will mark a set of records from that encounter as 11 Exhibit 2. I don't know why I said 2, Exhibit 5. I 12 remarked the exhibit correctly as Exhibit 5, and handed 13 it back to you now. 14 This set of records also has Bates 15 numbering at the bottom right-hand corner. It looks 16 like these run roughly from PLF Stroligo S 00067 17 through 97, but it doesn't appear that they are 18 consecutively all in there. There are some page 19 numbers that are skipped over. 20 First of all, Doctor, do you agree that 21 Exhibit 5 appears to be copies of a set of medical 22 records created regarding your care and treatment of 23 Ms. Stroligo on June 2, 2014? 24 A. Yes. 25 Q. And can you, again, walk us through -- we Page 44 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 20 of 37 1 start with an outpatient note. Can you walk us through 2 your encounter with Ms. Stroligo on June 2, 2014? 3 A. Yeah. So this note would have been a 4 summary note of the testing basically that I had 5 completed that day, and a review of the fact that she 6 had had a cystoscopy completed between her first visit 7 and this study. 8 I basically said that her cystoscopy was 9 within normal limits, that there was no evidence of any 10 issues with the mesh on that cystoscopy; and then this 11 note just outlines basically the bladder testing that I 12 had completed that day, after I had completed the 13 testing and reviewed the results of it. 14 Do you want me to go into details about 15 what the -- 16 Q. Yeah. If you could go into some more 17 details of your examination -- 18 A. So basically, when the patients come in 19 the room, I ask them to void. We complete what we call 20 a Uroflow, which is a void basically for us to see the 21 velocity of which they void. 22 And it looked as though -- I said that 23 she had a good flow and she voided a large volume. 24 She, again, had a post void residual that was a little 25 bit elevated today, or during this visit of 150. Page 45 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 21 of 37 1 After we did that, we went through the 2 standard operations of putting in the bladder and 3 rectal catheters for the study, calibrating the 4 machine, and having her hooked up and ready. 5 Then we filled the patient with fluid. 6 And during that filling process, I asked her questions 7 about what she sensed and when she felt like she needed 8 to void, and when she felt like when she was at a full 9 capacity. 10 And when she was at that full capacity, I 11 had her void, and I observed her voiding to make sure 12 that she had a normal voiding pattern. 13 Q. And then during the cystoscopy, were you 14 able to diagnose any mesh erosion in Ms. Stroligo? 15 A. No. 16 Q. Okay. And then from her -- the 17 urodynamic study you just discussed, where you fill the 18 bladder with fluid and then ask her to drain the fluid 19 out of the bladder, did you notice any abnormalities or 20 was there anything significant from that testing? 21 A. No. I said that, on this testing, that 22 she had a fairly normal capacity. She had no evidence 23 of any leakage when I did the study, no evidence of 24 any, what we call detrusor instability, which is 25 bladder spasms during the study. Page 46 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 22 of 37 1 And I said that she voided with an 2 unobstructed flow. And at the end of the study, she 3 emptied her bladder within 10cc of what I had put in, 4 which is normal. 5 Q. And then it notes, in addition to no 6 detrusor instability, it says no episodes of urge 7 incontinence. Is urge incontinence something that you 8 were looking for in this testing? 9 A. So usually, if patients have detrusor 10 instability, sometimes they will leak urine at that 11 time, and in her case, she didn't have that happen. 12 Q. And then were you able to demonstrate any 13 stress incontinence symptoms during this urological 14 testing? 15 A. No. 16 Q. And then under the assessment section of 17 the note, you have unobstructed flow rate. Can you 18 explain what that means? 19 A. Sure. Sometimes when women have a sling 20 placed, they can -- the sling can be a little snug and 21 they will have a slow flow, essentially. 22 And in her case, she voided with a 23 completely normal velocity to her flow, so that is why 24 I said that she was unobstructed, meaning nothing was 25 blocked. Page 47 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 23 of 37 1 Q. And then you also note impaired emptying 2 prior to the cystometrogram, but on this exam, she 3 emptied almost her entire bladder. Can you explain in 4 laymen's terms what that is describing? 5 A. Sure. I just noticed in the encounter 6 when I had seen her before, as well as at the initial 7 part of the test, that she had some extra urine in her 8 bladder at the end of voiding; but when I did the 9 actual study with her, she was able to empty within 10 normal limits. 11 Q. Okay. And then over on the next page, 12 which is Number 68, in the bottom right-hand corner, 13 looks like the note continues, and then you recount the 14 discussion of the findings with Ms. Stroligo. 15 Can you walk us through that discussion 16 that you had with Ms. Stroligo on June 2, 2014? 17 A. So basically, I told her that day that, 18 essentially, she had a normal study and I couldn't find 19 any evidence that she was obstructed from her sling or 20 blocked from the sling. 21 I told her that, at times, she may be 22 having detrusor instability or bladder spasms at home 23 and that she might be having leakage, but that I was 24 unable to demonstrate that that day in the office. 25 And so, because of her history, I Page 48 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 24 of 37 1 recommended trying her on a medication for the urge 2 incontinence, since that was her major complaint and 3 trialing that for a few weeks. 4 It looks like she was getting ready to 5 travel, so I was going to trial her that for an 6 extended period of time while she was traveling. 7 Q. And then did you have any plan regarding 8 any treatment for stress incontinence symptoms? 9 A. I didn't just at that point, because in 10 the first note, she really wasn't complaining much of 11 stress incontinence unless she was having intercourse; 12 so at this point, I felt that her main complaint was 13 urge incontinence and that we should deal with that 14 first. 15 Q. Based on the urodynamic study, though, 16 were you able to demonstrate either stress or 17 incontinence? 18 A. No. 19 Q. Okay. And do you recall the patient's 20 reaction to the assessment? 21 A. I don't recall this visit -- I don't 22 recall her reaction to this visit actually. 23 Q. I think that this visit is the last visit 24 that I have records for. Do you know if you saw her 25 again? Page 49 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 25 of 37 1 A. I did see her after this. I don't have 2 records of that visit either. I recall that -- I can't 3 recall if the medicine helped her or not. 4 You know, I would have probably also had 5 the discussion with her, and, as we read -- as you look 6 at the records, residents work with me on all of these 7 cases as well; and so, you know, sometimes the exact 8 details of what is in here are -- they are summarized 9 to some ability, but I also would have had the 10 discussion with her of going to physical therapy as 11 well. 12 As far as my recall from our last visit, 13 she just really wanted the sling in its entirety 14 removed, and I felt that she hadn't really tried 15 conservative measures, and I felt that that was a 16 drastic procedure for her to undergo, and I told her 17 that I would not do that. 18 Q. Okay. And just -- so you mention that 19 the residents are involved in your treatment. It says, 20 at one point, Dr. Elliott was present for the 21 evaluation. 22 A. Sure. 23 Q. And agrees with the assessment and the 24 plan above. Is the Penn State Hershey, is that a 25 teaching hospital? Page 50 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 26 of 37 1 A. It is. 2 Q. Okay. And at a teaching hospital, can 3 you explain what that means to the people in the jury? 4 A. So it means that the residents are 5 learning while we are seeing patients. They are 6 assisting in their care. But at least in my setting, I 7 was always present. 8 Well, they would typically take the 9 history from the patient. I would then review the 10 history that they collected with the patient to confirm 11 that that is exactly what the patient said. 12 I was always present for the physical 13 exam on the patient as well. And I was always present 14 for all of the bladder testing on all of the patients. 15 So they were part of it, but I was there 16 for 85 percent of their encounter with the patient. 17 Q. Okay. So even though a resident may be 18 involved in the care and treatment of a patient, that 19 you, as the attending physician, would be the 20 supervising physician? 21 A. Correct. 22 Q. Okay. And then you mentioned that you 23 saw Ms. Stroligo. Do you know if you saw her multiple 24 times after this June visit or just once? 25 A. I can't recall. Page 51 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 27 of 37 1 Q. Okay. To the extent you can recall, you 2 know you saw her at least one more time after this? 3 A. Correct. 4 Q. Okay. And Ms. Stroligo told you that she 5 -- she was adamant about wanting her sling removed? 6 A. She was. 7 Q. Okay. Did she give an explanation as to 8 why she wanted her sling removed? 9 A. She just did not like the idea that it 10 was in her body. She felt that, if there were -- I 11 remember her saying that, if there were all these 12 commercials on television, all these bad things about 13 the sling, she did not want it left inside of her, 14 basically. 15 Q. Okay. And were those the attorneys 16 advertising with mesh lawsuits that you are talking 17 about? 18 A. Correct. 19 Q. Okay. And did she tell you that that was 20 the reason she wanted the sling taken out? 21 A. That, and she felt that, by taking the 22 sling out, that this urgency and all these other 23 symptoms that she complained of would improve. 24 Q. Okay. And in your medical judgment, 25 during the time that you saw and treated Ms. Stroligo, Page 52 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 28 of 37 1 did you believe that removing her mesh was medically 2 justified at that time? 3 A. No. 4 Q. Okay. And as a doctor, do you have an 5 independent responsibility to act in the -- act in what 6 you think is the best interest of the patient, even if 7 they demand something contrary to that? 8 A. Yes. 9 Q. So despite the fact that Ms. Stroligo 10 wanted you to take her sling out, you as a medical 11 professional, refused to do so because you didn't think 12 it was medically justified? 13 A. Correct. 14 Q. And then there are, again, a few more 15 pages, might be 30 pages more in this record. I just 16 want to breeze through those quickly to see if there is 17 anything significant. 18 The first thing I notice, it looks like 19 there is another urinalysis study, which is page 78. 20 Is there anything significant in that urinalysis? 21 A. Other than she has, again, trace intact 22 urine, but it would have been looked at under the 23 microscope, and would have presume -- I would presume 24 it was negative microscopically. 25 Q. And then it looks like there is a Page 53 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 29 of 37 1 urodynamic report, and then there is a series of charts 2 and graphs. 3 Is there anything from those charts and 4 graphs that is significant or adds to anything we 5 discussed earlier regarding that report? 6 A. No. Everything on Page 1 would have been 7 summ -- basically been a summary of all these tables 8 and graphs. 9 Q. And do you know the last time that you 10 saw Ms. Stroligo? 11 A. I don't know the last time I saw her. 12 Q. Do you know if you have seen her within 13 the past year? 14 A. No. 15 Q. And during the time that you treated Ms. 16 Stroligo, did you diagnose her with any symptoms or 17 complications that you attributed to her mesh? 18 A. It was unclear to me. Some of the 19 symptoms that she had could have come from mesh, but I 20 clearly wasn't convinced enough of it that I would tell 21 her to remove the mesh. I felt that it could have 22 stemmed from other issues as well. 23 Q. Okay. And with regard to the issues that 24 she reported, which of those issues could have 25 potentially been related to mesh? Page 54 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 30 of 37 1 A. So the urgency and the frequency and the 2 urge incontinence could have come from a mesh sling; 3 however, typically, patients have those issues fairly 4 shortly after having had the sling, and she didn't have 5 those problems for a few years, she had told me; so I 6 wasn't as convinced that the connection existed, but it 7 could. 8 And then the dyspareunia as well could 9 result from a mesh, but it could also result from other 10 issues as well. 11 (Exhibit No 6 was marked.) 12 BY MR. SINDELAR: 13 Q. Okay. And then I just want to look at a 14 record from later on when Ms. Stroligo went to see 15 another doctor in Florida, only because it restates 16 your care and treatment of Ms. Stroligo. 17 I just want to confirm whether that 18 information is accurate or not based on your own review 19 of your records. 20 I want to mark those as Exhibit 6 and 21 hand you a copy. It looks like this is from Tampa 22 General Hospital. And it looks like, on the back, it 23 was signed by a Dr. Renee Bassaly on 5/4/2015. 24 If you want to review those records 25 briefly, you can. Let me know after you had time to Page 55 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 31 of 37 1 review the records in order to discuss them. 2 A. Okay. 3 Q. First of all, have you ever seen this 4 record or this set of records before? 5 A. Huh-uh. 6 Q. Okay. The first page, which is PLF 7 Stroligo S 00235, under the referred-here section, 8 looks like this visit was from January 14, 2015. 9 A. Uh-huh. 10 Q. The record states, Susan Stroligo was 11 referred here by Dr. Dang and lawyers. When Ms. 12 Stroligo was coming to see you, did she mention whether 13 she had been referred to you by lawyers to have 14 treatment for her mesh? 15 A. I don't know that she told me she was 16 referred by lawyers, but I knew that she was involved 17 in some sort of -- pursuing a lawsuit. I did know 18 that. 19 Q. Okay. And then on the second page, there 20 is a mention in the history and physical section, looks 21 like it's the top portion of Page 236, looks like it is 22 the third to last sentence says, she admits to going to 23 Hershey, PA with Dr. Elliott and having a sling release 24 by a cystoscopy in 2013, which helped urgency somewhat. 25 I don't recall seeing anything about a Page 56 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 32 of 37 1 sling release that you did. Did you ever perform a 2 sling release on Ms. Stroligo? 3 A. Not that I recall. I mean, I don't have 4 my operative report here, if I did, but I know I 5 performed a cystoscopy. 6 But the way it is worded, a sling release 7 by cystoscopy, I would have never done a sling release 8 in that fashion. 9 And I don't recall doing a sling release 10 on the patient. I recall doing a cystoscopy on the 11 patient. 12 Q. Okay. So based on what you do have in 13 your records and your own memory, do you have any 14 recollection of ever performing a sling release on Ms. 15 Stroligo? 16 A. No. And this says in 2013. I never even 17 met the patient until 2014, so no. 18 Q. And based on your records and your 19 memory, is that statement regarding sling release by 20 cystoscopy in 2013 accurate? 21 A. No. 22 MR. SINDELAR: I think I might be done. 23 Why don't we take a quick break and go off the record? 24 And I just will review my notes and outline and see if 25 I have anything else to ask; and if not, I'll turn you Page 57 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 33 of 37 1 over to plaintiff's counsel if there is any further 2 questions. 3 THE VIDEOGRAPHER: Off camera time is 4 4:05:06. 5 (Break.) 6 THE VIDEOGRAPHER: On camera time is 7 4:06:13. 8 BY MR. SINDELAR: 9 Q. Dr. Elliott, one more question, really. 10 We talked about whether you diagnosed the patient with 11 any complications related to the ObTape mesh. And I 12 want to follow up with one thing in particular. 13 Did you ever diagnose Ms. Stroligo with 14 any erosion of her mesh material? 15 A. No. 16 MR. SINDELAR: Okay. I have no further 17 questioning. If plaintiff's counsel has any questions, 18 she can ask those at this time. 19 MS. VINET: Okay. Thank you. Just a 20 few. 21 CROSS-EXAMINATION 22 BY MS. VINET: 23 Q. So if I understand you, you never used 24 the Mentor ObTape product? 25 A. Correct. Page 58 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 34 of 37 1 Q. Is there any reason why? 2 A. No, just a preference. I just was 3 trained on a different company's, and I'm happy with 4 that. 5 Q. Okay. Do you know of any FDA warnings 6 concerning mesh implants? 7 A. Mesh implants, yes, not midurethral 8 slings. 9 Q. Have you heard of any FDA warnings 10 concerning any mesh implants? 11 A. Yes. 12 Q. And what have you heard? 13 MR. SINDELAR: Object to form. 14 MS. SMITH: I am going to object to limit 15 the answer to the time period in question, back in 16 2014, when she would have been treating the patient. 17 BY MS. VINET: 18 Q. Have you -- in 2014, have you heard of 19 any FDA warnings concerning mesh implants? 20 A. Yes. 21 Q. Okay. And what did you hear? 22 A. There was an FDA warning regarding the 23 use of vaginal mesh for the repair of pelvic organ 24 prolapse; modifying it to an increased classification, 25 requiring more FDA studies -- requiring more studies by Page 59 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 35 of 37 1 deposition. Time on the monitor is 4:18:28. 2 MR. SINDELAR: I need a rough and regular 3 turnaround for final. Denise, we need your 4 information. 5 MS. VINET: I can do that right now. My 6 name is Denise Vinet, and the address actually -- the 7 deposition, I'm taking the deposition, I have my own 8 law firm, Vinet & Day, but the law firm that is going 9 to be responsible for paying and receiving the 10 deposition is named Murphy Law Firm. 11 We like only e-mail. The physical 12 address is 7035 Jefferson Highway, and that is Baton 13 Rouge, Louisiana 70807. 14 MS. SMITH: I don't need a copy and waive 15 reading and signing. 16 (The deposition concluded at 4:16 p.m.) 17 18 19 20 21 22 23 24 25 Page 68 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 36 of 37 1 CERTIFICATE OF REPORTER 2 STATE OF Pennsylvania ) ) ss 3 COUNTY OF Cumberland ) 4 I, Ramona Devlin, Reporter and Notary Public 5 within and for the State of Pennsylvania, do hereby 6 certify that the witness whose testimony appears in the 7 foregoing deposition was duly sworn by me; that the 8 testimony of said witness was taken by me to the best 9 of my ability and thereafter reduced to typewriting 10 under my direction; that I am neither counsel for, 11 related to, nor employed by any of the parties to the 12 action in which this deposition was taken, and further 13 that I am not a relative or employee of any attorney or 14 counsel employed by the parties thereto, nor 15 financially or otherwise interested in the outcome of 16 the action. 17 18 _________________________ Ramona Devlin, Notary Public in and 19 for the State of Pennsylvania 20 My Commission expires January 7, 2020 21 22 23 24 25 Page 69 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-7 Filed 07/25/16 Page 37 of 37 Exhibit E Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 1 of 40 1 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA 2 COLUMBUS DIVISION 3 IN RE MENTOR CORP. OBTAPE MDL CASE NO: 4 TRANSOBTURATOR SLING PRODUCTS 4:08-MD-2004(CDL) LIABILITY LITIGATION 5 _______________________________/ 6 SUSAN STROLIGO, Individual Case No. 4:13-cv-00462 7 Plaintiff, (Stroligo) v. 8 MENTOR WORLDWIDE, LLC, 9 Defendant. 10 _ _ _ _ _ _ _ _ _ _ _ _ _ / 11 12 VIDEOTAPED DEPOSITION OF: RENEE BASSALY, M.D. 13 DATE: June 24, 2016 14 TIME: 8:06 a.m. to 8:47 a.m. 15 PLACE: One Tampa City Center 16 Suite 3400 Tampa, Florida 17 PURSUANT TO: Notice by counsel for 18 Defendant for purposes of discovery, use at trial 19 or such other purposes as are permitted under 20 the Florida Rules of Civil Procedure 21 BEFORE: PAMELA KINGSBURY, RPR 22 Notary Public, State of Florida at Large 23 24 Pages 1 to 43 25 Job No. CS2325688 Page 1 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 2 of 40 1 APPEARANCES: 2 DENISE VINET, ESQUIRE Murphy Law Firm 3 7035 Jefferson Highway Baton Rouge, Louisiana 70806 4 (225) 928-8800 Attorney for Plaintiff 5 SETH LINNICK, ESQUIRE 6 Tucker Ellis, LLP 950 Main Avenue 7 Suite 1100 Cleveland, Ohio 44113 8 (216) 696-4976 Attorney for Defendant 9 ALSO PRESENT: ERIC WYMAN, VIDEOGRAPHER 10 11 INDEX PAGE 12 DIRECT EXAMINATION BY MR. LINNICK 3 13 CROSS-EXAMINATION BY MS. VINET 38 14 REDIRECT EXAMINATION BY MR. LINNICK 40 15 CERTIFICATE OF OATH 42 16 REPORTER'S CERTIFICATE 43 17 18 19 EXHIBITS ID'd MARKED 20 1 - Notice of Deposition 7 7 21 2 - 1/14/15 Consultation Note 11 11 22 3 - Preadmission Testing 27 27 23 4 - History and Physical Form 30 30 24 5 - 5/4/15 Note 32 32 25 6 - Pathology Report 36 36 Page 2 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 3 of 40 1 THE VIDEOGRAPHER: Today is Friday, the 24th 2 day of June, 2016. The time is 8:05 a.m. We are 3 at 201 North Franklin Street, Tampa, Florida, for 4 the purpose of taking the video deposition of 5 Renee Bassaly taken by the defendant in re: Mentor 6 Corporation, Obtape -- Obtape Transobturator Sling 7 Products Liability Litigation in Case Number 8 4:13-cv-00462, Case Susan Stroligo versus Mentor 9 Worldwide, LLC, which is filed in the U.S. District 10 Court for the Middle District of Georgia. 11 The court reporter is Pamela Kingsbury of 12 Michael Musetta & Associates. The videographer is 13 Eric Wyman of Veritext. Would all counsel please 14 state their appearance for the record and the 15 witness sworn. 16 MS. VINET: My name is Denise Vinet. I 17 represent Ms. Susan Stroligo. 18 MR. LINNICK: Seth Linnick for Defendant 19 Mentor Worldwide, LLC. 20 RENEE BASSALY, M.D., 21 the witness herein, being first duly sworn on oath, was 22 examined and deposed as follows: 23 THE WITNESS: I do. 24 DIRECT EXAMINATION 25 BY MR. LINNICK: Page 3 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 4 of 40 1 produced; is that correct? 2 A. I don't know what you have -- 3 Q. Okay. 4 A. -- so I can't compare. 5 Q. When you were reviewing the notes for this 6 patient prior to this deposition, could you ballpark 7 the number of visits you think that you had with her? 8 A. Four, perhaps, four or five visits in the 9 office. 10 Q. It sounds to me, then, like we probably have 11 everything. If, when we go through that today, you're 12 aware of things that we don't have, will you just let 13 me know? 14 A. Yes. Absolutely. 15 Q. Okay. Dr. Bassaly, sitting here today, do you 16 have any independent recollection of this patient? 17 A. Yes. 18 Q. Okay. What do you remember about 19 Ms. Stroligo? 20 A. I remember the most recent visit in January 21 and that she had improvement from her surgical removal 22 of the sling. I remember very briefly the encounter 23 with the operative time period with the fellows' 24 discussion about some of her views of the actual, you 25 know, preadmission state. But that's it. That's all I Page 8 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 5 of 40 1 remember. I don't actually remember physically the 2 surgery. 3 Q. Okay. When you say her views about her 4 preadmission state, what are you referencing? 5 A. Just -- I remember our discussion about that 6 the patient, she was really adamant about the fact that 7 she has had this sling for several years. And at this 8 point, not only did she feel that she wanted to have it 9 removed because of her symptoms, but also because she 10 felt that with her lawyers and talking to them, that 11 she had some knowledge that she felt that the Obtape 12 sling was not FDA approved. 13 Q. Okay. Do you have any knowledge of the 14 background of the Obtape product or any exposure to it? 15 A. I have never used the Obtape other than at the 16 time of removal. 17 Q. Okay. And have you removed any other Obtape 18 slings besides Ms. Bassaly's [sic]? 19 A. Off the top of my head, I couldn't tell you. 20 Q. Okay. Have you done any other surgeries in 21 which you have treated mesh complications besides 22 Ms. Bassaly, assuming she had a mesh complication? 23 A. Have I removed other mesh? 24 Q. Yes. 25 A. Yes. Page 9 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 6 of 40 1 Q. Okay. Have you removed other synthetic 2 slings? 3 A. Yes. 4 Q. Okay. And have you removed all different 5 brands of slings? 6 A. Absolutely, yes. 7 Q. Okay. And Doctor, sitting here today, you're 8 aware that there are certain complications that are 9 inherent with suburethral slings, correct? 10 A. Yes. 11 Q. Those would include infection, correct? 12 A. Yes. 13 Q. Erosion? 14 A. Yes. 15 Q. Pain? 16 A. Yes. 17 Q. Recurrent incontinence? 18 A. Yes. 19 Q. What other complications have you seen from 20 suburethral slings that you've treated? 21 A. Urinary incontinence. I've seen -- well, 22 we've already talked about infections. Erosions 23 including not just erosions into the urethra and the 24 bladder but exposures through the vaginal epithelium. 25 Q. And Doctor, those are risks of all slings, Page 10 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 7 of 40 1 correct? 2 A. Yes. 3 Q. Okay. All right, Doctor. Let's go ahead and 4 jump ahead to your treatment of Ms. Stroligo. I 5 brought the records here. I'll show them to you. 6 According to the records that were produced to 7 us, it looks like the first time you saw Ms. Stroligo 8 was January of 2015. Does that sound about right to 9 you? 10 A. Yes. 11 Q. Okay. I'm going to hand you what I'm marking 12 as Exhibit 2. 13 (Defendant's Exhibit No. 2 was marked for 14 identification.) 15 BY MR. LINNICK: 16 Q. Doctor, please take a minute to look at this, 17 and let me know if you recognize it. 18 A. Yes, I recognize this document. 19 Q. Okay. This would be a record memorializing a 20 visit that you had with Ms. Stroligo on January 14th of 21 2015; is that correct? 22 A. Yes. 23 Q. Doctor, take as much time as you need to look 24 it over before we start talking about it. But if you 25 are ready to talk about it, could you orient the jury Page 11 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 8 of 40 1 as to what this patient presented to you with and what 2 she was complaining of. 3 A. This is my first encounter with the patient on 4 her initial visit. She came complaining about mesh 5 complications in the sense of that since she had the 6 sling placed, she had had pain with intercourse. And 7 because of that pain, she's never attempted intercourse 8 since then. She also stated, shortly after the sling, 9 she started to have urinary leakage again, mainly 10 urgency and frequency leakage associated with that. 11 She had seen other physicians prior to the 12 time that she saw me, so she was seeking a second 13 opinion. She stated she had seen a physician in 14 Hershey, PA. 15 At that time, I did not have any of her 16 medical records, but she did state that she tried one 17 medication for the treatment of urgency incontinence 18 and -- which caused her to have some nausea. She said 19 that she did have some type of sling revision or 20 release by cystoscopy -- 21 THE REPORTER: I'm sorry? 22 THE WITNESS: She stated she had some type of 23 sling release by cystoscopy in 2013 with the prior 24 physician, but she was very unclear about that 25 specific treatment and really did not really Page 12 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 9 of 40 1 understand at all at that time. 2 BY MR. LINNICK: 3 Q. Okay. So she came to you -- I just want to 4 make sure I have this. She was complaining of pain, 5 recurrent incontinence -- 6 A. Uh-huh. (Indicates affirmatively). 7 Q. -- and she claimed she had dyspareunia, but 8 she was not sexually active, correct? 9 A. Right. She said after the sling, she had pain 10 with intercourse. And because of that pain, she is not 11 sexually active. 12 Q. Okay. And this record says that she was 13 referred to you by a Dr. Dang. Do you know who 14 Dr. Dang is? 15 A. I do not know who that is personally. 16 Q. Okay. I believe this came up in 17 Ms. Stroligo's deposition, that she was actually given 18 a list of physicians by her attorneys, and you were on 19 that list. Have you ever had any contact with any 20 attorneys about seeing patients related to litigation? 21 A. No. 22 Q. Okay. So you were unaware that that had 23 occurred? 24 A. That's correct. 25 Q. Okay. Page 13 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 10 of 40 1 A. Yeah. 2 Q. All right. So this woman is 56 years old 3 according to this note, correct? 4 A. Yes, correct. 5 Q. If we look on the second page, we can see that 6 she had had an oophorectomy. She had had both her 7 ovaries removed, correct? 8 A. Yes. 9 Q. So she would be in a post-menopausal state, 10 correct? 11 A. That's correct. 12 Q. Do you recall from looking at this record or 13 reviewing your own records that she was estrogen 14 deficient? 15 A. Yes, she was estrogen deficient. 16 Q. A woman in her 50s who is post-menopausal who 17 has estrogen deficiency, is it uncommon for a woman in 18 that situation to experience pain during intercourse? 19 A. Is it uncommon? 20 Q. Yes. 21 A. No. They may have pain with intercourse. 22 Q. Okay. Is there a correlation between being 23 post-menopausal and having dyspareunia? 24 A. Yes. 25 Q. Okay. What's that correlation? Page 14 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 11 of 40 1 A. From vaginal dryness. 2 Q. Okay. And Ms. Stroligo presented to you 3 saying that she had mesh complications, correct? That 4 was not your initial diagnosis? 5 A. That is correct. 6 Q. Okay. Did you ever make a diagnosis of 7 Ms. Stroligo that she had any mesh complications? 8 A. She did not have any mesh complications from 9 mesh exposure. Her sling was nontender on examination, 10 but she did have urinary urgency and frequency and 11 urgency incontinence de novo of the sling as well as 12 new onset of pain with intercourse. 13 Q. Okay. And the pain with intercourse, 14 obviously something that she has to tell you? 15 A. That is correct. 16 Q. Okay. From your examination -- and we'll get 17 to your physical examination in a minute -- you didn't 18 diagnose her with any complication from the sling, 19 correct? 20 A. So complications from slings can be pain with 21 intercourse and urgency frequency and new onset of 22 urgency incontinence, and she did have those diagnoses. 23 Q. Okay. Do you know -- let's talk about the 24 urgency for a second. First of all, sort of, at a high 25 level, slings don't treat urge incontinence, correct? Page 15 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 12 of 40 1 A. That is correct. 2 Q. Okay. You treat urge incontinence with 3 medication, right? 4 A. And other things, yes. 5 Q. Okay. But there can be instances with all 6 slings where someone can have a sling to treat stress 7 incontinence, and it can create what's called de novo 8 urge incontinence, correct? 9 A. That is absolutely correct. 10 Q. Okay. Do you know and are you able to 11 determine from looking at these records how long 12 Ms. Stroligo had had urge incontinence? 13 A. At the time of her initial visit, no. But she 14 stated -- let me make sure -- she was dry for about two 15 years, so two years after the time of her sling 16 placement. 17 Q. Okay. And you didn't have any records to -- 18 A. That is correct. 19 Q. -- verify that, correct? 20 A. That is correct. 21 Q. Okay. So can you walk me through what you did 22 during this visit. 23 A. Yes. So we took an initial history and the 24 physical examination. In looking at her physical 25 examination, we look at any type of incomplete bladder Page 16 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 13 of 40 1 emptying with post-void residuals; and I think it was 2 1-something, 173 by a bladder scan, so abnormal but not 3 extremely abnormal over 150. We obviously look at her 4 overall medical health. 5 In looking at her vaginal examination, she did 6 have evidence of atrophic vaginitis, which would be 7 from vaginal dryness and lack of estrogen. She also 8 had a palpable sling but nontender on examination, but 9 she had significant pelvic floor tenderness from 10 trigger points in the musculoskeletal levator ani 11 muscles but no evidence of pelvic organ prolapse. 12 Q. Okay. So let me try to unpack that a little 13 bit. 14 A. Yes. 15 Q. First of all, can you explain to the jury what 16 atrophic vaginitis is. 17 A. Yes. So atrophic vaginitis is appearance of 18 the vaginal mucosa where it starts to thin, and that 19 appearance looks like there's redness. There's 20 petechiae. Sometimes there's hypopigmentation of the 21 tissue and then usually some type of discharge that can 22 be associated with it. 23 Q. Okay. And I believe -- I'm not sure if it's 24 in this note or a later note. You did find some 25 discharge, correct? Page 17 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 14 of 40 1 A. That's correct, yes. 2 Q. Okay. And atrophic vaginitis is something 3 that can occur naturally with aging, correct? 4 A. Yes. 5 Q. One of the effects of atrophic vaginitis is 6 that if a woman is sexually active and has atrophic 7 vaginitis, it may be uncomfortable, correct? 8 A. Yes. 9 Q. Okay. Now let's talk about your physical 10 examination. First of all, can you describe to the 11 jury what you would have done to Ms. Stroligo to 12 determine whether she had tenderness that could have 13 been related to the sling? 14 A. So on the examination, we look at the sling 15 overall to make sure that there is no exposures noted 16 on the vaginal side, which we did; and it was not 17 present in her specific situation. We feel the sling 18 at the time. You can feel slings on most patients, not 19 all patients. And if they're tender, we look for that 20 to see if they're tender just upon palpation. And then 21 we feel the musculoskeletal muscles of the pelvic area 22 as well to see if they are tender, specifically in the 23 insertion sites as well to see if they hurt as well. 24 Q. Okay. Now, when you examined Ms. Stroligo, 25 you could feel where the sling was, correct? Page 18 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 15 of 40 1 A. Yes. 2 Q. And that's not uncommon, correct? 3 A. No, that's not uncommon. 4 Q. That's not indicative of any migration or 5 erosion of the sling, correct? 6 A. Yes, that's correct. 7 Q. And when you examined her along the sling, 8 there was no tenderness, correct? 9 A. That's correct. 10 Q. Now, you mentioned that there was some 11 tenderness when you did a musculoskeletal examination. 12 Can you describe to the jury what you mean by that? 13 A. So if you take a look on page 4 of 5 under 14 "Myofascial Screen," we individually try to isolate the 15 puborectalis, iliococcygeus, the obturator internus; 16 and the arcus is kind of part of that obturator 17 internus site. And on a scale -- we ask the patient on 18 a scale from zero to 10, 10 being the worst pain ever, 19 zero being zero pain, when we just gently palpate and 20 put pressure on the muscle, are they having any pain in 21 this site. And so you can see -- we look bilaterally. 22 We palpate bilaterally each muscle group. And if she 23 has any pain, she gives us a number. 24 Q. Okay. So she told you she was experiencing 25 pain when you did that, correct? Page 19 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 16 of 40 1 A. Right. Those were the numbers. 2 Q. And what is that pain indicative of, or what 3 can it be indicative of? 4 A. Pelvic floor dysfunction. 5 Q. Okay. And can you explain to the jury what 6 you mean by pelvic floor dysfunction. 7 A. So pelvic floor dysfunction comes from 8 multiple reasons. But in this situation when we're 9 palpating the muscles, what we're looking for, are they 10 basically tight. So if there are pain sites, trigger 11 point areas where the muscles are tight, what happens 12 in those situations is that the muscle can't properly 13 work -- work. 14 So in the pelvic area, when we think about the 15 muscles in the pelvis, we think of it as a hammock. 16 Those muscles need to function for continence of 17 urination, continence of defecation, as well as support 18 of the pelvic organs, along with allowing for 19 stretching for sexual function. So when the muscles 20 get tight, you can have a multitude of symptoms. 21 Those symptoms can include issues with 22 urination, not completely emptying, worsening of 23 urinary incontinence for whatever reasons, stress or 24 urgency frequency, urgency incontinence, incomplete 25 emptying of bowel symptoms, feeling a pelvic pressure, Page 20 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 17 of 40 1 feeling like things are falling out. If you look at 2 her pelvic floor dysfunction index, if you look at the 3 symptoms that she's having, she actually admits to most 4 of those symptoms. 5 Q. You're looking at the page that's labeled 6 00317, page 3 of 5, correct? 7 A. 3 of 5 in the PFDI scores, yes. 8 Q. Okay. So she's got all those symptoms. She's 9 got abdominal pelvic pressure, abdominal pelvic 10 heaviness, splinting to defecate, incomplete emptying, 11 straining stool, incomplete bowel emptying, solid fecal 12 incontinence, fecal urgency, rectal prolapse, urinary 13 frequency. She's got all those things, correct? 14 A. According -- yes, according to this document. 15 Q. Okay. Now, what are some of the things that 16 can cause those symptoms to occur? 17 A. So you want me to do a differential diagnosis 18 on all those different symptoms or just pelvic floor 19 dysfunction? 20 Q. Pelvic floor dysfunction. I mean, I guess 21 let's cut to the chase. 22 A. Yeah. 23 Q. If you see that -- 24 A. Yes. 25 Q. -- do you automatically associate that as a Page 21 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 18 of 40 1 sling complication? 2 A. No. 3 Q. Okay. What would you associate it with? 4 A. Well, if you look at -- let's just talk about 5 musculoskeletal trigger points. Those can occur in any 6 patients that present to us for multiple reasons. 7 One -- any musculoskeletal issue can occur from 8 multiple reasons, from anxiety, pain sources, overuse, 9 unfortunately etiology unknown. We don't know why it 10 happens. 11 We know that there are a high prevalence of 12 patients who have painful bladder syndrome like 13 interstitial cystitis. Chronic pain patients can have 14 these symptoms as well. You know, so pain from 15 multiple infections, endometriosis, sexual abuse, car 16 accidents, I mean, the list can go on and on and on. 17 Q. Okay. And you've certainly seen these 18 symptoms in women who didn't have slings, correct? 19 A. That is correct. 20 Q. You've seen these symptoms in women who had 21 retropubic slings, correct? 22 A. That is correct. 23 Q. This is certainly not something that you would 24 associate strictly with transobturator slings, correct? 25 A. I would not associate strictly with Page 22 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 19 of 40 1 transobturator slings but can be aggravated by, like 2 you said, slings. 3 Q. Okay. When you say it can be aggravated by a 4 sling, what do you mean by that? 5 A. So obturator slings, the inherent way they're 6 placed is through these muscles, the obturator internus 7 muscle specifically. So if you think of the way that 8 they're placed and the nature of the actual product, 9 those meshes sometimes can contract and pull on them. 10 Not just -- it doesn't mean that it has to be a nerve 11 injury, per se. But as things contract, you certainly 12 can get pulling and aggravation of any type of pelvic 13 floor dysfunction that may already be present or can be 14 triggered by the slings. 15 Q. And Doctor, is that something that you know 16 from your education, training, and experience can 17 occur? 18 A. Yes. 19 Q. Okay. And you said that you still use slings, 20 correct? 21 A. That is correct. 22 Q. Knowing that that can occur, why would you 23 still use slings? 24 A. Because it's a small amount of patients that 25 this can occur in, and I typically don't actually Page 23 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 20 of 40 1 perform transobturator tape slings. 2 Q. Okay. So when you -- first of all, in this 3 particular case, there was no way for you to know if 4 the sling played any role in any of these symptoms; is 5 that fair to say? 6 A. It's fair to say that I think that in this 7 particular -- in any patient who has slings, that this 8 could be a complication of the slings. 9 Q. Okay. 10 A. Can I 100 percent guarantee that it's from the 11 sling? Absolutely not. 12 Q. Okay. And when you see that, you don't view 13 that as a failure of the sling, correct? 14 A. That is correct. 15 Q. That's just something that can occur with any 16 sling even if there is nothing wrong with the sling, 17 correct? 18 A. That is correct. 19 Q. Okay. So if we look at your assessment, your 20 assessment is that the patient is diagnosed with mixed 21 urinary incontinence, urgency, predominant voiding 22 dysfunction, frequency, dyspareunia, myofascial pain, 23 atrophic vaginitis, vaginal discharge, prior 24 midurethral sling. Then it looks like you discussed a 25 range of therapies with Ms. Stroligo to address her Page 24 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 21 of 40 1 complaint. Can you walk the jury through the options 2 that you gave her for treatment. 3 A. Yes. In all my patients who present with 4 symptoms after slings or anything in general, we always 5 try to do things conservatively. So the first thing we 6 wanted to do was definitely rule out she didn't have 7 any type of vaginal infections, which is why it becomes 8 very complicated in patients who are post-menopausal, 9 as you've already noted. They do get dryness, and they 10 do get discharge. So it becomes complicated to see, is 11 it really a yeast infection, bacterial vaginosis. So 12 we usually sit down and affirm to confirm that. 13 And then because of the atrophy, we want to 14 start them on estrogen therapy to kind of help with 15 that vaginal dryness. On top of that, any patient who 16 presents with pelvic floor dysfunction, I always 17 strongly recommend physical therapy because that is the 18 main standard of care to fix musculoskeletal symptoms. 19 So we start off very conservatively with physical 20 therapy, also treating the vaginal atrophy with the 21 estrogen. 22 And then on top of that, for her urgency 23 incontinence, physical therapy is definitely the first 24 line for someone who has pelvic floor dysfunction as 25 well because that is a big component of fixing the Page 25 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 22 of 40 1 urgency of frequency, along with medications, which at 2 that time I was unaware of which ones she had tried. 3 She had only stated she had tried one, and so she 4 already failed, somewhat, one; but I didn't know how 5 long she had taken it, if she had side effects for it. 6 So that was definitely something I felt could 7 be a benefit for her as well, as well as making sure we 8 got her records. Did she have a cystoscopy? If she 9 already had a cystoscopy, we also would do it -- make 10 sure that it looked -- she didn't have anything in her 11 bladder. And if she hadn't had a cystoscopy, we wanted 12 to look inside her bladder and make sure there was no 13 foreign body there. 14 Q. Okay. So after this initial visit, after 15 conducting the examination of her, your first reaction 16 wasn't, We need to remove the sling, correct? 17 A. That is correct. 18 Q. You wanted to look at some other things first? 19 A. I always approach the patient that the options 20 are, let's start off with conservative therapy prior to 21 removing any type of material. 22 Q. Do you recall what Ms. Stroligo's reaction to 23 your proposals were? 24 A. I don't recall off the top of my head. I -- 25 no. Page 26 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 23 of 40 1 Q. Okay. Doctor, I'm going to hand you what I'm 2 marking as Exhibit 3. To be honest with you, I'm not 3 exactly sure what this is. But it has your name on it, 4 I think, so let's take a look. 5 (Defendant's Exhibit No. 3 was marked for 6 identification.) 7 BY MR. LINNICK: 8 Q. Can you tell me what we're looking at in 9 Exhibit 3? 10 A. This looks like preadmission testing. 11 Q. It says "Amb Encounter Report" at the top. Do 12 you see that? 13 A. Ambulatory encounter. 14 Q. Okay. So can you explain what this record is 15 showing? 16 A. This is preadmission testing, I think, for 17 Tampa General Hospital, where she was going to have her 18 procedure performed at, where they assessed the 19 patient. 20 Q. Okay. So is this pre -- is this testing 21 because she had already determined or you had already 22 determined at that point that she was going to have an 23 explant, or is this before that? 24 A. This would be that she already had determined 25 that she wanted to proceed with removal of the sling -- Page 27 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 24 of 40 1 Q. Okay. 2 A. -- or that she was proceeding with some type 3 of procedure. 4 Q. Okay. So I didn't see in my review any 5 additional visits between you and Ms. Stroligo from the 6 January visit. So do you recall, sitting here today, 7 how she arrived at the decision to proceed with sling 8 removal -- 9 A. Yes. 10 Q. -- based on the advice you gave her in 11 January? 12 A. I do not recall off the -- I do not personally 13 recall off the top of my head. I do recall the day of 14 the surgery the fellows stating that she was very 15 persistent that she wanted to have the sling removed. 16 That's all I can remember. I can only assume that at 17 that point -- at some point between the office visit 18 and the day of the surgery that she had called or we 19 had talked that she did not want to proceed with the 20 conservative therapy and wanted to have the sling 21 removed. 22 Q. Okay. So in your medical opinion, the best 23 course of action, based on the symptoms that she 24 presented to you with, was to try conservative therapy, 25 correct? Page 28 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 25 of 40 1 A. That's correct. 2 Q. Okay. And she didn't do that, so we don't 3 know if that would have worked; fair to say? 4 A. Fair to say. 5 Q. Okay. Did she tell you at any time during the 6 course of your treatment of her that she had a pending 7 lawsuit against the sling manufacturer? 8 A. I don't think so until the day of -- as far as 9 I remember off the top of my head, until -- like I 10 said, I only remember the conversation of the morning 11 of the operative report. I don't remember before that. 12 Q. Okay. Let's jump through this, and then we'll 13 get to that. 14 A. Yeah. 15 Q. So if we look at her problem list, there are a 16 host of problems on here. Myofascial pain is noted. 17 I'm looking on the page that is page 2 of this record. 18 A. Uh-huh. (Indicates affirmatively). 19 Q. And she also has fibromyalgia, correct, 20 according to this? 21 A. Yeah, according to this. 22 Q. Okay. So this testing was performed. And 23 then on -- it looks like the next record that we have 24 is April 30th, which is a history and physical. So I'm 25 going to hand you that and mark it as Exhibit 4. Page 29 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 26 of 40 1 (Defendant's Exhibit No. 4 was marked for 2 identification.) 3 MS. VINET: Thank you. 4 MR. LINNICK: I think I gave you two copies. 5 Thanks. 6 BY MR. LINNICK: 7 Q. So Exhibit 4 is a history and physical form 8 dated April 30th of 2015; do you see that? 9 A. Yes. 10 Q. It says, "Pre-op for surgery on 5/4/2015 sling 11 revision/removal, cystoscopy." And then if we look to 12 the referring -- the referral section here, it says, 13 "Susan Stroligo was referred by Dr. Dang and lawyers." 14 A. Uh-huh. (Indicates affirmatively). 15 Q. Were you aware that she had been referred to 16 you by lawyers at this time? 17 A. Again, this history and physical was taken by 18 our fellows in the office prior to the surgery. So no, 19 prior to this time, I was not aware. 20 Q. Okay. 21 A. This was an intake by our fellows who sees our 22 patients preoperatively. 23 Q. Okay. If we go to the very last page of this 24 record, there is an assessment and plan in the middle 25 of that page. Page 30 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 27 of 40 1 A. Uh-huh. (Indicates affirmatively). 2 Q. It says, "Susan E. Stroligo is a 57-year-old 3 female who was evaluated by Dr. Bassaly. She is here 4 for a sling that she states is a non-FDA-approved 5 sling. She believes that it must come out." 6 Did you ever have a conversation with her 7 about the regulatory approval of the sling that she 8 had? 9 A. So this was a conversation she had with our 10 fellow who had that conversation with her. This was 11 not a conversation I had with her personally until the 12 day of the surgery. 13 Q. Okay. What was your conversation with her on 14 the day of the surgery? 15 A. That all slings have complications, and this 16 is a complication of a sling and that she should not 17 think of it as a non-FDA-approved type of sling, that 18 we're removing it because of the symptoms that she 19 presented for, not because her lawyers, not because 20 it's a whatever type of sling she feels it is -- 21 Q. Okay. And to be fair -- 22 A. -- so she had that understanding. 23 Q. Okay. And to be fair, you weren't sure that 24 it was a sling complication. You just couldn't rule it 25 out; is that fair to say? Page 31 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 28 of 40 1 A. So the symptoms, as I discussed, are 2 complications of slings. We talked about urgency, 3 frequency. So most likely it could have been, which is 4 why we're proceeding with it; but I could not guarantee 5 it. 6 Q. Okay. So I just want to be clear on this. 7 You were not sure at the time that you removed the 8 sling that any of her symptoms were caused by the fact 9 that she had a sling, correct? 10 A. That's correct. 11 Q. Okay. But because she wanted it out and you 12 couldn't rule out that the sling may be playing some 13 role, you decided to proceed with the removal, correct? 14 A. That is correct. 15 Q. Okay. And Doctor, is it fair to say, in your 16 medical opinion that even if the sling was playing a 17 role in some of the symptoms that she was encountering, 18 that would not necessarily be because there was a 19 problem with the sling, correct? 20 A. Correct. 21 Q. Let's go ahead and move to your operative 22 note. Doctor, I'm handing you what I'm marking as 23 Exhibit 5. 24 (Defendant's Exhibit No. 5 was marked for 25 identification.) Page 32 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 29 of 40 1 BY MR. LINNICK: 2 Q. This is a note dated May 4th of 2015. Do you 3 recognize it? 4 A. I recognize seeing this document. 5 Q. Okay. Other than what you've told me, do you 6 recall any other discussions that you had with 7 Ms. Stroligo on the day of her surgery? 8 A. No. 9 Q. Okay. If we look at the description of 10 findings, it says, "Vaginal mesh palpable in the 11 midurethra." That's at the bottom of the first page. 12 Again, you explained to me earlier that's not an 13 abnormality, correct? 14 A. Yes, that's not an abnormality. 15 Q. Okay. You also note on the top of the second 16 page that you did a cystoscopy, and the bladder was 17 intact, and there was no indication of any mesh in the 18 bladder, correct? 19 A. Correct. 20 Q. Okay. So during the entirety of your 21 treatment of Ms. Stroligo, you saw no evidence that she 22 ever had an erosion, correct? 23 A. Correct. 24 Q. You saw no evidence that she ever had an 25 infection, correct? Page 33 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 30 of 40 1 A. Correct. 2 Q. Can you walk the jury through the procedure 3 that you performed based on your operative note here. 4 A. Uh-huh. (Indicates affirmatively). Based on 5 the operative report, it was a typical finding that we 6 were easily able to palpate the mesh. When we do that, 7 we typically make a midline incision where that mesh 8 is, and we take the vaginal mucosa off the anterior 9 surface of the mesh. 10 Then we dissect it in the midline very 11 carefully until we get through the whole mesh so that 12 we're not making any incisions into the urethra. And 13 then very carefully, we take it off the urethra as far 14 into the groin behind the inferior pubic rami as we can 15 go safely as possible, and then we excise it at that 16 point. 17 Q. So in laymen's terms, you cut down the middle, 18 correct? 19 A. Uh-huh. (Indicates affirmatively). 20 Q. And then you take out each side, right? 21 A. That's correct. 22 Q. And in this particular surgery, you couldn't 23 just pull the mesh out. You actually had to dissect 24 the mesh out, correct? 25 A. That is correct. Page 34 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 31 of 40 1 Q. The way a sling is supposed to work is that 2 it's supposed to be implanted into the body and 3 incorporated with the surrounding tissues, correct? 4 A. Correct. 5 Q. Based on the fact that you had to dissect the 6 mesh out in this case, is it your understanding that 7 that's what happened with the sling in Ms. Stroligo? 8 A. Yes. 9 Q. Okay. If there was no tissue incorporation, 10 you would have expected that the sling would just pull 11 right out, correct? 12 A. That's correct. 13 Q. Okay. Were there any surprises or 14 abnormalities that you discovered during the course of 15 this excision surgery? 16 A. No. 17 Q. Okay. After you finished your surgery, you 18 took the excised mesh, and you sent it to pathology, 19 correct? 20 A. Correct. 21 Q. Okay. Can you describe what was the duration 22 of Ms. Stroligo's hospital stay for a surgery like 23 this? 24 A. I don't recall hers in particular, but 25 typically it's an outpatient procedure. They go home Page 35 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 32 of 40 1 that day. 2 Q. Okay. The last thing that I want to show you, 3 that I'll mark as Exhibit 6, is the path report. 4 (Defendant's Exhibit No. 6 was marked for 5 identification.) 6 BY MR. LINNICK: 7 Q. After you perform a surgery like this, do you 8 ever look at the path reports? 9 A. Yes. 10 Q. Why do you look at the path report? 11 A. To ensure that they document that there's 12 foreign body and no signs of infection. 13 Q. All right. So you would have reviewed this 14 record in May of 2015, correct? 15 A. That's correct. 16 Q. All right. Can you walk us through this 17 pathology report that we have marked as Exhibit 6 and 18 tell me what you're seeing. 19 A. So looking at the specimen received, it says, 20 "Vaginal foreign body." And the pathology -- final 21 pathological diagnosis says, "Fragment of fibrous 22 connective tissue with abundant foreign body material 23 and fibrosis associated grossly with mesh foreign body 24 material." 25 Q. Okay. Let's -- can you put that in lay terms Page 36 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 33 of 40 1 for our jury? 2 A. Yes. That the foreign body was present and 3 had tissue incorporated around it. 4 Q. Okay. And that's what you would hope to see, 5 correct? 6 A. That is correct. 7 Q. Okay. There's no suggestion in this pathology 8 report that there was any infection going on in 9 Ms. Stroligo, correct? 10 A. That's correct. 11 Q. What there is evidence of is that the mesh was 12 incorporated with the surrounding tissue, correct? 13 A. That is correct. 14 Q. Okay. I'm just going to take one minute to 15 look over my notes, but I think I'm almost done. 16 A. Okay. 17 Q. Doctor, I just have one more question for you. 18 If Ms. Stroligo had come to you and had not herself 19 asked for the mesh to be removed, based on your 20 examination of her, would you have elected to remove 21 it? 22 A. So based on any patient who comes to me with a 23 sling with those symptoms, I would have done exactly 24 the same thing I did: Recommend conservative therapy 25 first. And if that did not work or they were adamant Page 37 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 34 of 40 1 about trying to get the sling removed, I would have 2 done the exact same thing. 3 Q. Okay. So there's really no way of knowing 4 with Ms. Stroligo because she never attempted any of 5 the conservative measures that you recommended, 6 correct? 7 A. Well, there is a note in the operative 8 report -- and again, I don't remember, per se, that she 9 did attempt maybe some physical therapy and estrogen 10 with minimal improvement; but I'm not really certain. 11 That was from a fellow's note, so I don't know the 12 answer to that. 13 Q. Okay. Fair to say that the removal that 14 occurred on May 4th of 2015, occurred because she was 15 pushing to have the sling taken out, correct? 16 A. Correct, I guess, yes. She wanted the sling 17 out. 18 MR. LINNICK: Okay. I think those are all my 19 questions for now. Thank you. 20 CROSS-EXAMINATION 21 BY MS. VINET: 22 Q. Doctor, after -- my name is Denise Vinet. I 23 represent Ms. Stroligo in this case. 24 After taking the sling out, did you have any 25 conversations with Ms. Stroligo to see if the symptoms Page 38 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 35 of 40 1 she had had before had improved? 2 A. Yes. 3 Q. And what was her answer to you? 4 A. She had much improvement. 5 Q. What does that tell you? 6 A. That most likely, it was causing some of her 7 symptoms. 8 Q. When you do take the sling out, as in this 9 particular case, did you do anything to prop up the 10 bladder or any of the muscles when you did the removal? 11 A. No. 12 Q. So the -- because she improved, how would that 13 make it improved? 14 A. So with any complication of slings that cause 15 these symptoms, again, my differential diagnosis is 16 that it aggravated, probably, her pelvic floor 17 dysfunction; or it caused pelvic floor dysfunction. 18 And with removal and taking the tension away from 19 pulling on those muscles, I could only hypothesize that 20 that's what improved her symptoms. 21 Q. Doctor, are you aware that the FDA has 22 recently -- well, within the next -- the last 9 to 23 12 months stated that slings are considered a higher 24 risk than as they had warned previously to 2015? 25 MR. LINNICK: Objection. Lack of foundation. Page 39 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 36 of 40 1 Go ahead. Sorry. 2 THE WITNESS: No. 3 BY MS. VINET: 4 Q. And it's your testimony that you have never 5 used this type of sling in any of your patients? 6 A. That is correct. 7 MS. VINET: Thank you. That's all I have. 8 REDIRECT EXAMINATION 9 BY MR. LINNICK: 10 Q. One more question, Doctor. 11 A. Yes. 12 Q. You said that based on Ms. Stroligo's own 13 statements that her symptoms improved after the sling 14 removal, your logical conclusion would be that the 15 sling was playing a role in those complications, 16 correct? 17 A. That's correct. 18 Q. That doesn't suggest to you that any defect in 19 the sling is what caused those complications, correct? 20 A. That is correct. 21 Q. You have seen many slings that you would 22 consider to be nondefective that caused the exact same 23 issues, correct? 24 A. That's correct. 25 MR. LINNICK: Okay. Those are all my Page 40 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 37 of 40 1 questions. Thank you. 2 MS. VINET: Thanks, Doctor. 3 THE VIDEOGRAPHER: This concludes the 4 deposition of Renee Bassaly. The time is 8:47. 5 We are now off the record. 6 (Concluded at 8:47 a.m.) 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 41 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 38 of 40 1 CERTIFICATE OF OATH 2 3 STATE OF FLORIDA 4 5 COUNTY OF HILLSBOROUGH 6 7 I, the undersigned authority, certify that 8 RENEE BASSALY, M.D., personally appeared before me and 9 was duly sworn on June 24, 2016. 10 11 WITNESS my hand and official seal this 8th day 12 of July, 2016. 13 14 15 16 ______________________________ 17 Pamela Kingsbury, RPR 18 Notary Public - State of Florida 19 My Commission Expires: 7/18/18 20 Commission No. FF 132048 21 22 23 24 25 Page 42 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 39 of 40 Page 43 Case 4:13-cv-00462-CDL Document 36-8 Filed 07/25/16 Page 40 of 40 Exhibit F Case 4:13-cv-00462-CDL Document 36-9 Filed 07/25/16 Page 1 of 7 Geesey v. Stryker Corp., Not Reported in F.Supp.2d (2010) 2010 WL 3069630, Prod.Liab.Rep. (CCH) P 18,464 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 1 2010 WL 3069630 This decision was reviewed by West editorial staff and not assigned editorial enhancements. United States District Court, E.D. Pennsylvania. Nathan GEESEY, Plaintiff, v. STRYKER CORPORATION, et al., Defendants. Civil Action No. 09–2988. | Aug. 4, 2010. Attorneys and Law Firms Daniel N. Gallucci, Dianne M. Nast, Joanne E. Matusko, Joseph F. Roda, Roda & Nast PC, Lancaster, PA, for Plaintiff. Kim M. Catullo, Gibbons P.C., New York, NY, Madeline M. Sherry, Gibbons, Del Deo, Dolan, Griffinger & Vecchione, P.C., Philadelphia, PA, for Defendant. ORDER JOEL H. SLOMSKY, District Judge. *1 AND NOW, this 3rd day of August 2010, upon consideration of Defendants' Motion to Dismiss Plaintiff's First Amended Complaint Pursuant to Federal Rule of Civil Procedure 12(b)(6) (Doc. No. 11), Plaintiff's Response in Opposition to the Motion (Doc. No. 17), Defendants' Reply in Support of the Motion (Doc. No. 18), argument made at the hearing held on May 26, 2010, and after a complete and independent review of Plaintiff's First Amended Complaint (Doc. No. 2) and Second Amended Complaint (Doc. No. 25), and for the reasons set forth in the Court's August 3, 2010 Opinion, it is ORDERED that Defendants' Motion to Dismiss (Doc. No. 11) is GRANTED IN PART and DENIED IN PART as follows: 1. Defendants' Motion to Dismiss Plaintiff's strict liability claim is GRANTED. 2. Defendants' Motion to Dismiss Plaintiff's fraud and fraudulent concealment claims is DENIED. 3. The Court will schedule a pre-trial conference pursuant to Fed.R.Civ.P. 16 with Plaintiff and Defendants as to the remaining counts. OPINION Before the Court is Defendants Stryker Corporation, Stryker Instruments, and Stryker Sales Corporation's Motion to Dismiss several Counts of Plaintiff's First Amended Complaint pursuant to Federal Rule of Civil Procedure 12(b) (6) (Doc. No. 11). 1 On February 15, 2010, Plaintiff filed a Response in Opposition to Defendants' Motion (Doc. No. 17). On February 24, 2010, Defendants filed a Reply in Support of the Motion to Dismiss (Doc. No. 18), and on May 26, 2010, the Court held a hearing on the Motion. On June 7, 2010, Plaintiff filed a Second Amended Complaint (Doc. No. 25.) 2 For the following reasons, the Court will grant Defendants' Motion to Dismiss in part and will deny in part. 1 Also before this Court are two related cases, Frank Gore v. Stryker Corp., et al., Civil Action No. 09–2987, and Timothy Lehr v. Stryker Corp., et al., Civil Action No. 09– 2989, involving similar claims. The parties are represented by the same counsel in all three cases. The Court has contemporaneously issued three separate opinions covering the Motion to Dismiss filed in each case. In addition, the three cases were part of an attempt to centralize numerous cases under multidistrict litigation rules. On May 5, 2010, the Judicial Panel on Multidistrict Litigation denied a motion to include the three cases before this Court in centralized litigation. (Doc. No. 19.) 2 As explained in more detail below, several claims in Plaintiff's First Amended Complaint have been either withdrawn or are not subject to this Motion. I. BACKGROUND Case 4:13-cv-00462-CDL Document 36-9 Filed 07/25/16 Page 2 of 7 Geesey v. Stryker Corp., Not Reported in F.Supp.2d (2010) 2010 WL 3069630, Prod.Liab.Rep. (CCH) P 18,464 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 2 Plaintiff Nathan Geesey is a resident of Lancaster, Pennsylvania. (Compl.¶ 1.) In his Complaint, Plaintiff alleges that he had shoulder surgery and that after surgery a pain pump manufactured by Defendants was inserted into his shoulder joint. A pain pump is a “medical device designed to deliver continuous doses of pain relief medication directly into the shoulder joint space via catheter.” (Compl.¶ 11.) Plaintiff maintains that anesthetic medication released by the pain pump caused him to develop in his shoulder arthritis and/ or chondroylsis, which is a complete, or nearly complete loss of all cartilage. (Compl.¶ 12.) Due to the allegedly faulty device, Plaintiff has undergone additional shoulder surgery. To obtain full relief, Plaintiff asserts that he needs a complete shoulder replacement. (Compl.¶ 14.) Defendants designed, manufactured, marketed and sold the pain pump inserted into Plaintiff's shoulder. (Compl.¶ 5.) Defendants are corporations organized under the laws of Michigan and have principal places of business in Michigan. (Compl.¶ 4.) This case is brought in federal court under diversity of citizenship jurisdiction pursuant to 28 U.S.C. § 1332. In the First Amended Complaint (Doc. No. 2), Plaintiff made the following claims: Count I (Fraudulent Concealment); Count II (Strict Liability); Count III (Breach of Implied Warranty of Merchantability); Count IV (Breach of Implied Warranty of Fitness For a Particular Purpose); Count V (Negligent Failure to Warn); Count VI (Negligence); Count VII (Negligent Misrepresentation); Count VIII (Breach of Express Warranty); and Count IX (Fraud). *2 In the Motion presently before the Court, Defendants move to dismiss Counts I, II, III, IV, VIII, and IX. Defendants do not move to dismiss Plaintiff's claims rooted in negligence (Counts V, VI, and VII). In Plaintiff's Response in Opposition to the Motion to Dismiss (Doc. No. 17), Plaintiff voluntarily withdrew his warranty claims, contained in Counts III, IV, and VIII. (Pl.Resp.7.) 3 Consequently, the only causes of action covered by the Motion to Dismiss are Plaintiff's fraudulent concealment and fraud claims (Counts I and IX) and the strict liability claim (Count II). For the reasons stated below, the Court will grant Defendants' Motion to Dismiss the strict liability claim and will deny Defendants' Motion to Dismiss the fraud and fraudulent concealment claims. 3 Additionally, Plaintiff filed a Second Amended Complaint (Doc. No. 25), amending the causes of action as follows: Count I (Fraud/Fraudulent Concealment); Count II (Strict Liability); Count III (Negligent Failure to Warn); Count IV (Negligence); Count V (Negligent Misrepresentation). II. STANDARD OF REVIEW The Court has jurisdiction over this case pursuant to diversity of citizenship jurisdiction under 28 U.S.C. § 1332. Here, Defendants have moved to dismiss certain counts for failure to state a claim upon which relief can be granted under Fed.R.Civ.P. 12(b) (6). The Motion to Dismiss standard has undergone recent transformation, culminating with the Supreme Court's Opinion in Ashcroft v. Iqbal, ––– U.S. ––––, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). After Iqbal it is clear that “threadbare recitals of the elements of a cause of action, supported by mere conclusory statements do not suffice” in defeating a Motion to Dismiss. Id. at 1949; see also Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). Applying the principles of Iqbal, the Third Circuit in Fowler v. UPMC Shadyside, 578 F.3d 203 (3d Cir.2009), articulated a two-part analysis that district courts in this Circuit must conduct in evaluating whether allegations in a complaint survive a Motion to Dismiss. First, the factual and legal elements of a claim should be separated, meaning “a District Court must accept all of the complaint's well-pleaded facts as true, but may disregard any legal conclusions.” Id. at 210–11. Second, the Court must determine whether the facts alleged in the complaint demonstrate that the plaintiff has a “plausible claim for relief.” Id. at 211. In other words, a complaint must do more than allege a plaintiff's entitlement to relief, it must “show” such an entitlement with its facts. Id. (citing Phillips v. County of Allegheny, 515 F.3d 224, 234– Case 4:13-cv-00462-CDL Document 36-9 Filed 07/25/16 Page 3 of 7 Geesey v. Stryker Corp., Not Reported in F.Supp.2d (2010) 2010 WL 3069630, Prod.Liab.Rep. (CCH) P 18,464 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 3 35 (3d Cir.2008)). “Where the well-pleaded facts do not permit the court to infer more than the mere possibility of misconduct, the complaint has alleged—but it has not ‘shown’—‘that the pleader is entitled to relief.’ “ Iqbal, 129 S.Ct. at 1950. This “plausibility” determination under step two of the analysis is a “context-specific task that requires the reviewing court to draw on its judicial experience and common sense.” Id. III. DISCUSSION A. Count II: Strict Liability The Pennsylvania Supreme Court has adopted § 402A of the Restatement (Second) of Torts as setting forth the law of strict product liability in Pennsylvania. Webb v. Zern, 422 Pa. 424, 220 A.2d 853, 854 (1966); Mazur v. Merck & Co., 964 F.2d 1348, 1353 (3d Cir.1992). Section 402A provides in relevant part: *3 § 402A. Special Liability of Seller of Product for Physical Harm to User or Consumer. (1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer ... is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if (a) the seller is engaged in the business of selling such a product, and (b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold ... Defendants move to dismiss Count II of Plaintiff's First Amended Complaint on the grounds that strict liability claims involving “unavoidably unsafe products” are barred by comment k to § 402A. Comment k provides in relevant part: There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use ... Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true for many other drugs, vaccines, and the like, many of which for this very reason cannot be legally sold except to physicians, or under the prescription of the physician ... The seller of such products ... with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known and apparently reasonable risk. Restatement (Second) of Torts § 402A comment k. In Hahn v. Richter, the Pennsylvania Supreme Court recognized that comment k specifically applied to prescription drugs. 543 Pa. 558, 673, 673 A.2d 888 (Pa.1996) (“Comment k ... denies application of strict liability to products such as prescription drugs, which although dangerous in that they are not without medical risks, are not deemed defective and unreasonably dangerous when marketed with proper warnings.”). In this case, Defendants argue that comment k applies equally to cases involving prescription medical devices. Plaintiff, however, contends that the strict liability claim should not be dismissed because the Pennsylvania Supreme Court has not yet extended comment k to cover prescription medical devices. (Pl.'s Brief in Opp'n to Mot. to Dismiss 3.) In a diversity case, this Court must apply the substantive law of Pennsylvania. Erie R.R. Co. v. Tompkins, 304 U.S. 64, 78–79, 58 S.Ct. 817, 82 L.Ed. 1188 (1938); State Auto Prop. & Cas. Ins. Co. v. Pro Design, P.C., 566 F.3d 86, 89 (3d Case 4:13-cv-00462-CDL Document 36-9 Filed 07/25/16 Page 4 of 7 Geesey v. Stryker Corp., Not Reported in F.Supp.2d (2010) 2010 WL 3069630, Prod.Liab.Rep. (CCH) P 18,464 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 4 Cir.2009). Ideally, the Court would simply apply Pennsylvania Supreme Court precedent that is on point. However, the Pennsylvania Supreme Court has not yet determined whether comment k applies to cases involving medical devices. Consequently, this Court must predict how the Supreme Court would rule on the issue. Berrier v. Simplicity Mfg., Inc., 563 F.3d 38, 45–46 (3d Cir.2009) (“In the absence of a controlling decision by the Pennsylvania Supreme Court, a federal court applying that state's substantive law must predict how Pennsylvania's highest court would decide this case.”). In doing so, this Court “must look to decisions of state intermediate appellate courts, of federal courts interpreting the state's law, and of other state supreme courts that have addressed the issue,” as well as “dicta, scholarly works, and any other reliable data tending convincingly to show how the highest court in the state would decide the issue at hand.” Norfolk Southern Ry. Co. v. Basell USA, Inc., 512 F.3d 86, 92 (3d Cir.2008) (quoting Koppers Co., Inc. v. Aetna Cas. and Sur. Co., 98 F.3d 1440, 1445 (3d Cir.1996)); see also Jewelcor, Inc. v. Karfunkel, 517 F.3d 672, 676 (3d Cir.2008) (“In diversity cases, ‘where the applicable rule of decision is the state law, it is the duty of the federal court to ascertain and apply that law, even though it has not been expounded by the highest court of the state.’ ”) (internal quotations omitted). *4 While the Pennsylvania Supreme Court has not yet applied comment k to prescription medical devices, the Pennsylvania Superior Court and numerous district courts applying Pennsylvania law have predicted that the Pennsylvania Supreme Court will extend comment k to medical devices. For example, in Taylor v. Danek Medical, Inc., a district court predicted that the Pennsylvania Supreme Court would, pursuant to its reasoning in Hahn, find that prescription medical devices are excluded from strict liability because they present the same “unique set of risks and benefits” as prescription drugs in that “what may be harmful to one patient may be beneficial to another.” No. 95– 7232, 1998 WL 962062, *7 (E.D.Pa. Dec.29, 1998) (internal citations omitted). Similarly, in Murray v. Synthes (U.S.A.) Inc., another district court explained, “The Supreme Court of Pennsylvania recognizes that prescription drugs present a unique set of risks and benefits ... This Court finds that prescription medical devices presents [sic] the same or very similar risks and benefits.” No. 95–7796, 1999 WL 672937, *7 (E.D.Pa. Aug.23, 1999). Likewise, the district court in Davenport v. Meditronic, Inc. found, “Numerous courts in the Eastern District of Pennsylvania have predicted that the Pennsylvania Supreme Court will follow its reasoning in Hahn and hold that prescription medical devices are not covered by Section 402A ... This Court agrees with the reasoning in these cases.” 302 F.Supp.2d 419, 442 (E.D.Pa.2004); see also Soufflas v. Zimmer, Inc., 474 F.Supp.2d 737, 750 (E.D.Pa.2007) (following several district courts in predicting that the Pennsylvania Supreme Court would extend § 402A's comment k to exclude prescription medical devices from strict liability); Burton v. Danek Medical, Inc., No. 95–5565, 1999 WL 118020, *7 (E.D.Pa. Mar.1, 1999) (finding that plaintiffs' strict liability claims must fail because prescription medical devices are not covered by § 402A). Furthermore, in Parkinson v. Guidant Corp., a district court found that the direct language of comment k implied application to medical devices, because it lists “other drugs, vaccines, and the like, many of which ... cannot be legally sold except to physicians, or under the prescription of a physician” as unavoidably unsafe products. 315 F.Supp.2d 741, 747 (W.D.Pa.2004) (emphasis in original). Parkinson also noted the drafters of the Restatement (Third) of Torts combined prescription drugs and prescription medical devices into one section dealing with liability for harm caused by defective products. Restatement (Third) Torts, § 6. Although that section has “yet to be adopted by the Pennsylvania Supreme Court, it does bolster the already formidable rationale for treating prescription drugs and prescription devices alike.” Parkinson, 315 F.Supp.2d at 747. Finally, in Creazzo v. Medtronic, Inc., the Pennsylvania Superior Court affirmed the trial court's holding that plaintiffs' strict liability claim was barred by comment k. In that case, the medical device at issue “was designed to alleviate chronic pain by passing an electrical stimulus through nerve Case 4:13-cv-00462-CDL Document 36-9 Filed 07/25/16 Page 5 of 7 Geesey v. Stryker Corp., Not Reported in F.Supp.2d (2010) 2010 WL 3069630, Prod.Liab.Rep. (CCH) P 18,464 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 5 structures in the dorsal aspect of the patient's spinal cord by way of a stimulation lead.” In concluding that strict liability could not be the basis for liability in that case, the Superior Court found “no reason why the same rational [sic] applicable to prescription drugs may not be applied to medical devices.” 903 A.2d 24, 31 (Pa.Super.Ct.2006) *5 In the alternative, Plaintiff argues that even if the Court agrees with Defendants that comment k applies in this case, the Court should withhold dismissal of the strict liability claim until the summary judgment stage of litigation. (Transcript of Hearing, May 27, 2010 [“Tr.”] at 43:4–12.) In support, Plaintiff submits that nearly every federal court (and the Pennsylvania Superior Court in Creazzo ) which found that comment k applies to medical device cases did so on a motion for summary judgment. The Court is not persuaded by Plaintiff's argument. Recently, two district courts confronted the same argument in a medical device, strict liability case and predicted, as a matter of law, that the Pennsylvania Supreme Court would apply comment k to medical devices and granted motions to dismiss the strict liability claims. See Delaney v. Stryker Orthopaedics, No. 08–03210, 2009 WL 564243, *6 (D.N.J. Mar.5, 2009); Kester v. Zimmer Holdings, No. 10–00523, 2010 WL 2696467, *9 (W.D. Pa. June 16, 2010). The Court agrees with the above cases that comment k applies to medical devices. Consequently, Plaintiff has failed to state a cognizable strict product liability claim under Pennsylvania law and Defendants' Motion to Dismiss Count II of the First Amended Complaint will be granted. B. Counts I & IX: Fraudulent Concealment & Fraud Next, Defendants argue that Plaintiff has failed to plead his claims of fraud and fraudulent concealment with sufficient particularity. Under Fed.R.Civ.P. 9(b), a party must state with particularity the circumstances constituting fraud. A court, therefore, must decide if plaintiff has pled with particularity the “circumstances” of the alleged fraud “in order to place defendants on notice of the precise misconduct with which they are charged, and to safeguard against spurious charges of immoral and fraudulent behavior.” Seville Indus. Mach. Corp. v. Southmost Mach. Corp., 742 F.2d 786, 791 (3d Cir.1984). In order to satisfy this exacting standard, a plaintiff must “plead (1) a specific false representation of material fact; (2) knowledge by the person who made it of its falsity; (3) ignorance of its falsity by the person to whom it was made; (4) the intention that it should be acted upon; and (5) that the plaintiff acted upon it to his damage.” Birchall v. Countrywide Home Loans, Inc., 2009 U.S. Dist. LEXIS 106813, *23 (E.D.Pa. Nov. 16, 2009) (quoting Shapiro v. UJB Fin. Corp., 964 F.2d 272, 284 (3d Cir.1982)); see also Lum v. Bank of America, 361 F.3d 217, 223–24 (3d Cir.2004) (requiring some means of precision when pleading fraudulent circumstances, such as date, place, or time of fraud). As noted above, after the Court held a hearing on this Motion, Plaintiff filed a Second Amended Complaint (Doc. No. 25). In that filing, Plaintiff added facts about the circumstances surrounding his shoulder surgeries at Lancaster General Hospital in Lancaster, PA, such as the dates on which Plaintiff underwent surgery. (Second Amended Complaint, ¶ 8). Moreover, Plaintiff has more specifically pled the fraud claims by alleging facts regarding the Food and Drug Administration's warnings between 1998 and 2001 on the use of a pain pump in orthopedic joint surgery. (Id. at ¶¶ 28–31.) *6 Accordingly, the Court is satisfied that Plaintiff's Second Amended Complaint cures any pleading deficiencies that may have existed in the First Amended Complaint. Consequently, Defendants' Motion to Dismiss Plaintiff's claims of fraudulent concealment and fraud (Counts I and IX) for failure to plead them with particularity will be denied. IV. CONCLUSION Case 4:13-cv-00462-CDL Document 36-9 Filed 07/25/16 Page 6 of 7 Geesey v. Stryker Corp., Not Reported in F.Supp.2d (2010) 2010 WL 3069630, Prod.Liab.Rep. (CCH) P 18,464 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 6 For the reasons noted above, the Court predicts that the Pennsylvania Supreme Court will apply comment k of § 402A (excluding manufacturers of unavoidably unsafe products from strict liability) to manufacturers of prescription medical devices. Consequently, the Court finds that strict liability is not a sustainable cause of action in this case and will grant Defendants' Motion to Dismiss Plaintiff's strict liability claim in Count II. Because Plaintiff's strict liability claim fails as a matter of law, an amendment to the complaint would be futile. See Fed. R. Civ. P 15(a); Murray, 1999 WL 672937, at *8 (“[F]utility is a ground to refuse an amendment to a complaint.”) (citing Lorenz v. CSX Corp., 1 F.3d 1406, 1413 (3d Cir.1993)). As to the fraudulent concealment and fraud claims, alleged in Counts I and IX, Plaintiff's Second Amended Complaint satisfies the pleading requirements under Fed.R.Civ.P. 9(b). Accordingly, the fraud and fraudulent concealment claims will not be dismissed. An appropriate Order follows. All Citations Not Reported in F.Supp.2d, 2010 WL 3069630, Prod.Liab.Rep. (CCH) P 18,464 End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:13-cv-00462-CDL Document 36-9 Filed 07/25/16 Page 7 of 7 Exhibit G Case 4:13-cv-00462-CDL Document 36-10 Filed 07/25/16 Page 1 of 5 Case 4:13-cv-00462-CDL Document 36-10 Filed 07/25/16 Page 2 of 5 Case 4:13-cv-00462-CDL Document 36-10 Filed 07/25/16 Page 3 of 5 Case 4:13-cv-00462-CDL Document 36-10 Filed 07/25/16 Page 4 of 5 Case 4:13-cv-00462-CDL Document 36-10 Filed 07/25/16 Page 5 of 5 Exhibit H Case 4:13-cv-00462-CDL Document 36-11 Filed 07/25/16 Page 1 of 4 Payne v. C.R. Bard, Inc., Not Reported in F.Supp.3d (2014) 2014 WL 1887297 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 1 2014 WL 1887297 Only the Westlaw citation is currently available. United States District Court, M.D. Florida, Orlando Division. Anthony PAYNE; and Johnita Payne, Plaintiffs, v. C.R. BARD, INC.; and Bard Peripheral Vascular, Inc., Defendants. No. 6:11–cv–1582–Orl–37GJK. | Signed May 12, 2014. Attorneys and Law Firms Cyrus S. Niakan, Julie H. Littky-Rubin, Nancy La Vista, Clark, Fountain, La Vista, Prather, Keen, Littky-Rubin, LLP, West Palm Beach, FL, Lorenzo Williams, Gary, Williams, Parenti, Watson & Gary, PL, Stuart, FL, for Plaintiffs. David E. Cannella, Carlton Fields Jorden Burt, PA, Orlando, FL, Elizabeth C. Helm, Matthew B. Lerner, Richard B. North, Jr., Taylor Tapley Daly, Nelson, Mullins, Riley & Scarborough, LLP, Atlanta, GA, James F. Rogers, Nelson, Mullins, Riley & Scarborough, LLP, Columbia, SC. Jane Davis, Nelson, Mullins, Riley & Scarborough, LLP, Charleston, SC, John A. Camp, Carlton Fields Jorden Burt, PA, Miami, FL, for Defendants. ORDER ROY B. DALTON JR., District Judge. *1 This matter comes before the Court on the following: 1. Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.'s Motion for Summary Judgment (Doc. 76), filed December 31, 2013; 2. Plaintiffs' Redacted Response in Opposition of Defendants, C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.'s Motion for Summary Judgment (Doc. 114), filed February 14, 2014; 3. Plaintiffs' Sealed Response in Opposition to Defendants, C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.'s Motion for Summary Judgment (Doc. 120), filed February 18, 2014; 4. Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.'s Reply Brief in Further Support of Defendants' Motion for Summary Judgment (Doc. 126), filed February 28, 2014; 5. Plaintiffs' Notice of Compliance with the Court's Order Dated April 28, 2014 (Doc. 154) and Notice of Disclosure of Rebuttal Fact and Expert Witness Murray Asch, M.D. Pursuant to Rule 26(a)(2)(C) (Doc. 155), filed April 30, 2014); and 6. Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.'s Objection to Plaintiffs' Disclosure of Rebuttal Fact and Expert Witness Murray Asch, M.D. pursuant to Rule 26(a)(2)(C) (Doc. 156), filed May 7, 2014. BACKGROUND This is a medical device product liability action against Defendants C.R. Bard, Inc. (“Bard”) and Bard Peripheral Vascular, Inc. (“Bard PV”) concerning a Bard G2 inferior vena cava filter, which was surgically implanted in Plaintiff Anthony Payne (“Payne”) by Dr. Robert Schultz, at Florida Hospital Orlando in Orlando, Florida, on September 28, 2007. In their second amended complaint, Payne and his spouse Johnita Payne (“Plaintiffs”) assert claims for: (1) strict liability- defective design (Count I); (2) strict liability- defective manufacturing (Count II); 1 (3) negligence (Count III); and (4) loss of consortium (Count IV). Defendants request summary judgment concerning all of the Plaintiffs' claims. (Doc. 76.) Defendants also moved to exclude the opinions of Plaintiffs' two expert witnesses-Dr. Frederick Hetzel, Ph.D (Doc. 74), and Dr. Timothy Harward, M.D. (Doc. 75). Case 4:13-cv-00462-CDL Document 36-11 Filed 07/25/16 Page 2 of 4 Payne v. C.R. Bard, Inc., Not Reported in F.Supp.3d (2014) 2014 WL 1887297 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 2 1 In response to Defendants' motions to exclude expert testimony, Plaintiffs withdrew their expert opinions “with respect to ... the existence of a manufacturing defect.” (Doc. 95, p. 2.) Apparently conceding that their defective manufacturing claims fail absent such evidence, Plaintiffs asked the Court “not to consider” the aspects of Defendants' summary judgment motion that dealt with Plaintiffs' manufacturing defect claims. (See Doc. 120, pp. 2–3; see also Doc. 126, p. 2) Plaintiffs opposed Defendants motions. (Doc. 93, 95, 97, 114, 120.) After a hearing (Doc. 133), the Court granted the Defendants' motion to exclude the opinions of Dr. Hetzel. (Doc. 136.) Because the exclusion of Dr. Hetzel's testimony was fatal to Plaintiffs' claims, the Court gave Plaintiffs an opportunity to file a motion to reopen the deadline to disclose an expert witness on causation and defect issues. (Id. at 17–18.) Plaintiffs then filed a motion to reopen (Docs.138, 139), which the Court granted in part over the Defendants' objections. (See Docs. 154, 143.) Specifically, the Court ordered that Plaintiffs could, on or before April 30, 2014, notify the Court whether they had retained Dr. Murray Asch as an expert witness in Plaintiffs' case- in-chief. (Doc. 14, p. 4.) On April 30, 2014, Plaintiffs notified the Court that Dr. Asch would not “serve as an expert in Plaintiffs' case-in-chief.” (Doc. 155, p. 1.) With the deadline for discovery and disclosure of expert witnesses long past (Docs.37, 44, 65), Plaintiff is left with no expert witness on the issues of product defect and causation for its case-in-chief. STANDARDS I. Strict Liability and Negligence *2 “Florida courts apply the basic elements of a strict liability claim with equal force to medical device ... manufacturers....” Bailey v. Janssen Pharmaceutica, Inc., 288 F. App'x 597, 607 (11th Cir.2008). To hold a manufacturer liable on a theory of “ ‘strict liability in tort, the [plaintiff] must establish the manufacturer's relationship to the product in question, the defect and unreasonably dangerous condition of the product, and the existence of the proximate causal connection between such condition and the [plaintiff's] injuries or damages.’ ” See id. at 606 (quoting West v. Caterpillar Tractor Co., 336 So.2d 80, 86–87 (Fla.1976)). To hold a manufacturer liable on a negligence theory, the plaintiff must establish that: (1) the defendant owed a duty to plaintiff; (2) the defendant breached that duty; (3) the breach proximately caused injury to plaintiff; and (4) “the product was defective or unreasonably dangerous.” See Cooper v. Old Williamsburg Candle Corp., 653 F.Supp.2d 1220, 1223, 1226 (M.D.Fla.2009). “[A] product may be defective by virtue of a design defect, a manufacturing defect, or an inadequate warning.” Jennings v. BIC Corp., 181 F.3d 1250, 1255 (11th Cir.1999) (quotation omitted). Expert testimony is generally necessary to prove that a complex product like a medical device is defective. See Worsham v. A.H. Robins Co., 734 F.2d 676, 685 n. 8 (11th Cir.1984) ( “[E]xpert testimony is often necessary to establish defective design of a product.”); see also Cooper, 653 F.Supp.2d at 1225; Savage v. Danek Med., Inc., 31 F.Supp.2d 980, 983 (M.D.Fla.1999) (“A defect must be proven by expert testimony”); Alexander v. Danek Med., Inc., 37 F.Supp.2d 1346, 1349 (M.D.Fla.1999) (same); Wilson v. Danek Med., Inc., No. 96–2460–CIV–T– 17B, 1999 WL 1062129, at *5 (M.D.Fla. Mar.29, 1999) (“To establish liability for negligence or strict liability under a product defect theory, Plaintiff must present expert testimony that the product was defective.”). Causation in medical device product liability cases also often requires expert evidence. See Edgar v. Danek Med., Inc., No. 96–cv–2451– T24A, 1999 WL 1054864, at *2, *4–*5 (M.D.Fla. Mar.31, 1999). II. Summary Judgment Summary judgment is appropriate only “if the movant shows that there is no genuine dispute as to any material fact and that the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(a). “ ‘No genuine issue of material fact exists if a party has failed to make a showing sufficient to establish the existence of an element ... on which that party will bear the burden of proof at trial.” Williams v. Mast Biosurgery USA, Inc., 644 F.3d 1312, 1318 (11th Cir.2011) (quotations omitted). The Court draws “all inferences and reviews all evidence in the Case 4:13-cv-00462-CDL Document 36-11 Filed 07/25/16 Page 3 of 4 Payne v. C.R. Bard, Inc., Not Reported in F.Supp.3d (2014) 2014 WL 1887297 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 3 light most favorable to the non-moving party.” See also Hughes v. Stryker Corp., 423 F. App'x 878, 879 (11th Cir.2011) (citation omitted). DISCUSSION *3 Defendants argue that Plaintiffs' lack of expert opinion evidence concerning causation and defect is fatal to Plaintiffs' claims. (See Doc. 76, pp. 19– 21; Doc. 126, p. 8.) This argument was contingent on Defendants' prevailing on their Daubert motion concerning Plaintiffs' witness, Dr. Hetzel. Indeed, at the hearing concerning the Daubert motions, Plaintiffs conceded that summary judgment was likely warranted if the Court excluded Dr. Hetzel's testimony. (Doc. 133.) Defendants prevailed on their Daubert motion (Doc. 136), and Plaintiffs have notified the Court that Dr. Asch cannot testify as an expert witness in Plaintiffs' case-inchief. (Doc. 155.) Thus, Plaintiffs can point to no expert testimony to establish either product defect or causation. Absent such evidence, Defendants' motion for summary judgment is due to be granted. See Sumner v. Biomet, Inc., 434 F. App'x 834, 843–44 (11th Cir.2011) (holding that district court “properly granted summary judgment” to defendant on medical device product liability and negligence claims after excluding testimony of plaintiff's expert witness); Wolicki– Gables v. Arrow Int'l, Inc., 634 F.3d 1296, 1302– 03 (11th Cir.2011) (affirming summary judgment for defendant in medical device product liability action); Rink v. Cheminova, Inc., 400 F.3d 1286, 1297 (11th Cir.2005) (granting summary judgment based on exclusion of expert testimony); see also Hughes v. Stryker Corp., 423 F. App'x 878, 882 (11th Cir.2011) (rejecting plaintiff's argument that she could establish her medical device product liability and negligence claims absent expert opinion testimony); Allison v. McGhan Med. Corp., 184 F.3d 1300, 1320–22 (11th Cir.1999) (holding summary judgment was proper because “essential” causation testimony was “inadmissible”). CONCLUSION Accordingly, it is hereby ORDERED AND ADJUDGED: 1. Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.'s Motion for Summary Judgment (Doc. 76) is GRANTED. 2. The Clerk is DIRECTED to enter judgment in favor of Defendants, terminate all pending motions, and CLOSE this case. DONE AND ORDERED. All Citations Not Reported in F.Supp.3d, 2014 WL 1887297 End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:13-cv-00462-CDL Document 36-11 Filed 07/25/16 Page 4 of 4 Exhibit I Case 4:13-cv-00462-CDL Document 36-12 Filed 07/25/16 Page 1 of 8 Wilson v. Danek Medical, Inc., Not Reported in F.Supp.2d (1999) 1999 WL 1062129 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 1 1999 WL 1062129 Only the Westlaw citation is currently available. United States District Court, M.D. Florida. Jesse WILSON, Plaintiff, v. DANEK MEDICAL, INC. a Tennessee corporation, Defendant. No. 96–2460–CIV–T–17B. | March 29, 1999. ORDER ON DEFENDANT'S MOTION FOR SUMMARY JUDGMENT AND PLAINTIFF'S MOTION TO REINSTATE CLAIM KOVACHEVICH, Chief District J. *1 This cause comes before the Court on the following: 1. Defendant DANEK MEDICAL, INC.'s motion for summary judgment and supporting memorandum (Docket Nos. 24–25), filed July 30, 1998; Plaintiff JESSE WILSON's response (Docket No. S–1), filed in camera October 16, 1998; and Defendant's reply (Docket No. 34), filed December 16, 1998; and 2. Plaintiff's motion to reinstate a fraud-on- the-FDA claim and supporting memorandum (Docket Nos. 42 and 44), filed February 22, 1999, and March 5, 1999; and Defendant's response (Docket No. 46), filed March 11, 1999. STANDARD OF REVIEW Summary judgment is proper if “the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” Fed.R.Civ.P. 56(c). The moving party bears the burden of proving that no genuine issue of material fact exists. See Celotex Corp. v. Catrett, 477 U.S. 317, 322–24, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). A material fact is one which “might affect the outcome of the suit under the governing law .” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). “Where the record taken as a whole could not lead a rational trier of fact to find for the nonmoving party, there is no ‘genuine issue for trial.” ’ Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986). The evidence presented must be construed in favor of the non-moving party, and that party must receive the benefit of all favorable inferences that can be drawn from that party's evidence. United States v. Diebold, Inc., 369 U.S. 654, 655, 82 S.Ct. 993, 8 L.Ed.2d 176 (1962); Evans v. Meadow Steel Products, Inc., 579 F.Supp. 1391, 1394 (N.D.Ga.1984). The Court's function is not to weigh the evidence and determine the truth of the matter, but to determine whether there is a genuine issue for trial. See Liberty Lobby, Inc., 477 U.S. at 249. If the non-moving party fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which the party will bear the burden of proof at trial, summary judgment should be granted. See Jones v. Gerwens, 874 F.2d 1534, 1538 (11th Cir.1989) (citing Celotex, 477 U.S. at 324–25). BACKGROUND This case is one of approximately two thousand products liability actions against this Defendant and other manufacturers of orthpedic bone screws. These actions arise out of the surgical implantation of plate-and-screw devices in the pedicles of the spine. The bone screw devices are used in conjunction with spinal fusion surgery on patients with a number of severe back problems. They are intended to stabilize the spine to allow spinal fusion to take place. The case was transferred to the United States District Court for the Eastern District of Pennsylvania by the Judicial Panel on Multidistrict Litigation and placed on the docket of MDL 1014, In re Orthopedic Bone Screw Products Liability Case 4:13-cv-00462-CDL Document 36-12 Filed 07/25/16 Page 2 of 8 Wilson v. Danek Medical, Inc., Not Reported in F.Supp.2d (1999) 1999 WL 1062129 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 2 Litigation, before the Honorable Louis C. Bechtle. Following pretrial proceedings and discovery, the case was remanded to this Court for disposition. *2 The facts regarding Defendant's alleged misrepresentations to the FDA and the medical community are set out in detail in several published opinions, including Baker v. Danek Medical, 1998 WL 672696 (N.D.Fla. August 5, 1998) and Cali v. Danek, 24 F.Supp.2d 941 (W.D.Wis.1998). This Court will therefore discuss that aspect of Plaintiff's case only briefly. Taken in the light most favorable to Plaintiff, the evidence shows that Defendant marketed bone screw devices for use in the pedicles of the spine without FDA approval. Marketing the bone screw devices for this purpose was in direct contravention of FDA orders that they were to be marketed for use only in the sacrum of the spine until further investigation of their use in the pedicles had taken place. Plaintiff further alleges that Defendant misled the medical community regarding the FDA status of the device and the safety and efficacy of its use in the pedicles of the spine. The evidence regarding Plaintiff's injuries show that he injured his back at work several times, dating back to the 1970's. Most recently, in August 1991, he bent to lift crates of milk from a pallet and experienced severe pain in his back and legs. He was diagnosed as having a bulging disk and two herniated disks. Over the next two years, he saw several physicians and underwent a number of treatments for this back injury, including medication, physical therapy, and percutaneous discectomy surgery. None of these alleviated his disabling back pain for any significant length of time. In June 1993, Plaintiff consulted Dr. Scott Cutler, a neurosurgeon. Plaintiff's pain had been diagnosed as being consistent with nerve root compression in one of the vertebrae. He elected to have surgical decompression. Dr. Cutler and Dr. Richard Goldberger, an orthopedic surgeon, performed the surgery in July 1993. The doctors removed bone and tissue to relieve the pressure on the spinal nerves, then performed spinal fusion using a bone graft from Plaintiff's hip. They used one of Defendant's bone screw devices to stabilize Plaintiff's spine and promote spinal fusion. Plaintiff's condition initially improved following the surgery, but within months he began experiencing back pain again, even though X-rays showed that fusion had been achieved in his spine. In February 1994, Plaintiff had surgery to remove the bone screw device from his spine. Dr. Cutler found that the fusion was intact and strong. Plaintiff's back pain was not relieved by the removal of the bone screw device, but remained exactly the same. He continues to suffer from back pain, for which he takes several prescription pain relievers. ANALYSIS I. Counts I and II Product Defect and Failure to Warn Count I is a claim for negligence under both a product defect theory and a failure to warn theory. Count II is a claim for strict liability under the same theories. Defendant makes the following arguments with respect to both counts: (1) Plaintiff's product defect claims must fail because Plaintiff offers no evidence that the bone screw device was defective; (2) Plaintiff's failure to warn claims must fail under the learned intermediary doctrine; and (3) Plaintiff's claims based on either theory must fail because there is no admissible evidence of causation. *3 There have been a large number of published bone screw cases discussing the same and similar arguments. To the knowledge of this Court, three courts have applied Florida law in bone screw cases, with two granting motions for summary judgment, and one denying a motion for summary judgment. Because these cases involved similar facts as the instant case, addressed essentially the same arguments as this Court is faced with, and reached differing conclusions, the Court will discuss these cases in detail. The first of these was Baker v. Danek Medical,— F. Supp.2d—, 1998 WL 968329 (N.D.Fla.1998). In Baker, Senior District Judge Paul stated that a claim for strict liability requires a plaintiff to “prove Case 4:13-cv-00462-CDL Document 36-12 Filed 07/25/16 Page 3 of 8 Wilson v. Danek Medical, Inc., Not Reported in F.Supp.2d (1999) 1999 WL 1062129 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 3 two essential elements: first, that the product was defective and unreasonably dangerous; and second, that the unreasonably dangerous defect was the proximate cause of the injuries.” Id. at *3. The court held that mere “temporal connection” between implantation and symptoms is not sufficient to prove causation. See id. “Conclusory speculation that the mere fact of pedicle screw use somehow proves a connection to subsequent pain ... in not sufficient medical causation testimony to defeat a summary judgment challenge.” Id. at *4 (quoting Cali v. Danek, No. 95–C–7583–S, at 22 (W.D. Wis. filed May 18, 1998)). The only evidence of causation the plaintiff in Baker provided other than “temporal connection” between the implantation of the bone screw device and his symptoms was the assertion by the plaintiff's expert, Dr. Yarus, that “the medical literature supports the conclusion that ‘increased back pain is often caused by the implantation of spinal fixation devices such as the [Danek device].” ’ Id. at *4. The Baker court called Dr. Yarus's conclusion “problematic” for two reasons. First, Dr. Yarus did not “include any analysis of the literature and application to the facts in the instant case in his conclusory report.” Id. at *4. Second, “the view that pedicle screw fixation devices are unreasonably dangerous is hardly generally accepted in the scientific community and the literature relied on by the plaintiffs is very general and speculative.” Id. The court held that the plaintiff had not met the minimum standard in the Eleventh Circuit of showing the soundness of the “basic methodologies” the plaintiff's expert used to reach the conclusion that the bone screw device caused the plaintiff's injuries. Id. Alternatively, the Baker court held that the Plaintiff's failure to warn claims failed under the “learned intermediary doctrine.” See id. at *5. The court stated: Under this doctrine, manufacturers of prescription medical products have a duty only to warn physicians, rather than patients, of the risks associated with the use of a product. As spinal fixation devices are available only upon prescription of a duly licensed physician, the warning required is not to the general public or to the patient, but to the prescribing doctor. This is so because the prescribing physician, acting as a “learned intermediary” between the manufacturer and the consumer, weighs the potential benefits against the dangers in deciding whether to recommend the product to meet the patient's needs. Thus, when adequate information is provided to the physician, the manufacturer will not be held liable despite the physician's failure to give notice to the patient. Such information may be provided to the physician through the manufacturer's package insert. *4 Even if the manufacturer provides inadequate information, however, the manufacturer will not be liable if the plaintiff's physician independently knew of the risks and failed to advise the plaintiff. Hence, a plaintiff must not only show that a manufacturer's warning was inadequate, but that such inadequacy affected the prescribing physician's use of the product and thereby injured the plaintiff. Id. at *5 (citations omitted). Because the plaintiff's doctors were “fully aware of all the risks and benefits” of the bone screw device, the “learned intermediary” doctrine barred his failure to warn claims. Id. at *5. In Savage v. Danek Medical, Inc., 31 F.Supp.2d 980 (M.D.Fla.1999), Judge Lazzara granted summary judgment on negligence and strict liability claims based on the plaintiff's failure to offer expert testimony that the bone screw device was defective. The Savage court noted that under Florida law, “a defect must be proven by expert testimony.” Id. at 983. Judge Lazzara held that Dr. Yarus' statement that, in his opinion, the bone screw device had contributed to Savage's symptoms, without any testimony that the product was defective, was not sufficient to withstand summary judgment. See id. at 983–84. Judge Lazzara also held that the “learned intermediary” doctrine barred the plaintiff's claim for failure to warn, because the plaintiffs had “not produced any evidence tending to show that the warnings were not accurate, clear, and unambiguous.” Id. at 984. Case 4:13-cv-00462-CDL Document 36-12 Filed 07/25/16 Page 4 of 8 Wilson v. Danek Medical, Inc., Not Reported in F.Supp.2d (1999) 1999 WL 1062129 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 4 The court in Bellofatto v. Danek Medical, Inc., Case No. 95–8643–CIV–Hurley (S.D.Fla. November 16, 1998), reached the opposite result from the courts in Savage and Baker. Judge Hurley stated that the Plaintiff had adduced evidence showing that the bone screw device was defective, referring to the expert testimony contained in the reports by Drs. Franklin, Kimmel, Strom, Welford, and Alexander. See id. at 10 & n. 6. The court likewise found that the plaintiff had produced sufficient evidence of causation to survive summary judgment, based on an expert's affidavit stating that the plaintiff's symptoms had been caused or worsened by implantation of the bone screw device. See id. at 14. With regard to the failure to warn claim, the Bellofatto court also found that the plaintiff in that case had “raised triable issues with regard to the adequacy of the warning on the product,” because the device did not come with the warning that it was not to be pedicularly applied, as the FDA required. Id. at 10. The court refused to apply the “learned intermediary” doctrine. It held that because the manufacturer had withheld information about the risk of its product, and the physician had relied on information from the manufacturer in forming his opinion about the risks of using the bone screw device, the standard to show that the physician was a “learned intermediary” was higher. See id. at 11. Plaintiff urges this Court to reach the result in Bellofluto, but does not provide any evidence that the factors present in that case are present here. In all material ways, the facts of this case are nearly identical to the facts of the Baker and Savage cases. Moreover, the reasoning and analysis of Judge Lazzara and Judge Paul were both convincing and congruent with Florida and Eleventh Circuit precedent. *5 Like the plaintiff in Baker, Plaintiff relies on Dr. Yarus' report to show causation. Defendant raises valid concerns regarding Dr. Yarus' qualifications as an expert on this question and the soundness of the methods he used in reaching his conclusions. Dr. Yarus lacks both experience and expertise in the use of spinal fixation devices. He formed the opinions set forth in his report without ever examining Plaintiff, using only the portions of Plaintiff's medical records Plaintiff's counsel sent him. This Court need not decide the question of whether Dr. Yarus offers admissible opinion testimony, however. Assuming for the sake of argument that Dr. Yarus' report is admissible, it is not sufficient to demonstrate causation. The report is nearly a word-for-word repetition of the report held in Baker to be inadequate to show causation. It relies entirely on temporal connection and a conclusory and unsupported statement regarding the medical literature to show causation. Even drawing all inferences in favor of Plaintiff, this simply is not enough to satisfy the causation requirement. Additionally, even if there were evidence of causation, neither claim could survive. To establish liability for negligence or strict liability under a product defect theory, Plaintiff must present expert testimony that the product was defective. See Savage, 31 F.Supp.2d at 983. Plaintiff provides numerous expert opinions regarding bone screw devices. However, not one of the expert opinions states that Defendant's bone screw device is defective. The strongest support for Plaintiff's position is contained in the Alexander report, which states that “pedicle screw based spinal fixation devices are not proved safe and effective and pose a substantial risk to treated patients. Until these devices are adequately tested for pedicular fixation, it must be assumed that they are unreasonably dangerous and should not be in general use.” Alexander report, at 7 (emphasis added). Assumptions of this sort are not sufficient to show that a product is defective. The other expert opinions provided by Plaintiff fall into three categories: (1) use of the bone screw device entails certain risks, see Esterhai report, Peyster report, (2) the studies showing favorable results from the implantation of bone screw devices are flawed for various reasons, see Franklin report, Kimmel report, Kimmel and Strom report, Larson report, Merz report, and (3) the marketing of the bone screw device for use in spinal fixation violated the law, see Welford report. This Court must agree with Judge Lazzara that these reports do not create a Case 4:13-cv-00462-CDL Document 36-12 Filed 07/25/16 Page 5 of 8 Wilson v. Danek Medical, Inc., Not Reported in F.Supp.2d (1999) 1999 WL 1062129 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 5 jury question as to whether the bone screw device is defective. Likewise, Plaintiff's claims under a failure to warn theory must fail as well. The issue here is not whether the warnings Defendant provided Plaintiff's physicians were adequate, but whether Plaintiff's physicians were aware of the risks of using Defendant's product. “[A] plaintiff must not only show that a manufacturer's warning was inadequate, but that such inadequacy affected the prescribing physician's use of the product and thereby injured the plaintiff.” Baker, 1998 WL 968329 at *5. There is abundant unrebutted evidence that Dr. Cutler and Dr. Goldberger were well aware of the risks and dangers inherent in use of the bone screw device. The exception to the “learned intermediary” doctrine relied on by the Bellofatto court does not apply here, because, in this case, Plaintiff's physicians both testified that they did not rely on materials from the manufacturer in forming their opinions about the bone screw device. Negligence Per Se *6 Although it was not pled in Plaintiff's complaint, Plaintiff argues in his response to Defendant's motion for summary judgment that his negligence claim can survive summary judgment under a negligence per se theory, based on Defendant's alleged violation of the Medical Device Amendments [MDA] to the Food, Drug, and Cosmetic Act [FDCA], 21 U.S.C. § 360. Putting aside the question of whether the response to a motion for summary judgment is the proper time to raise a new theory of liability, Plaintiff's claim under this theory does not survive summary judgment for two reasons. First, under Florida law, whether there is civil liability for violation of a statute depends on legislative intent. See Murthy v.. N. Sinha Corp., 644 So.2d 983, 985–86 (Fla.1984). In the absence of evidence “of a legislative intent to create a private cause of action,” violation of a statute creates no civil liability. Id. at 985. The FDCA expressly prohibits private claims for violations of that statute, 21 U.S.C. § 337(a), strongly evidencing a legislative intent not to create a private cause of action. Under Florida law, therefore, Plaintiff cannot use a negligence per se claim to create a private cause of action for Defendant's alleged violations of the FDCA. Second, even under a negligence per se theory, a plaintiff must prove causation. See Groh v. Hasencamp, 407 So.2d 949, 953 (Fla. 3d DCA 1981). As is discussed above, Plaintiff has not satisfied this requirement, because he has not shown that the use of the bone screw device was the cause of his injury. Further, Plaintiff has not produced any evidence that the alleged misrepresentations as to the FDA status of the devices caused his physician to select that device. With respect to a negligence per se claim, the Baker court found it significant that: [T]he uncontroverted testimony of plaintiff's physician ... was that FDA approval status of pedicle bone screws was not material to his decision whether or not to use them. He testified that doctors frequently use products off- label if the doctors, exercising independent judgment, regard the products as the best possible treatment for their patients. 1998 WL at *1. Likewise, Plaintiff has failed to produce any evidence to contradict his physician's testimony that the physician's decision to use Defendant's product was based on his independent medical judgment. In sum, whether the claims are brought under a product defect, failure to warn, or negligence per se theory, Plaintiff's failure to produce any evidence that use of the bone screw device caused his injuries is fatal to those claims. Plaintiff has further failed to establish his claim under a product defect theory, because he has provided no expert testimony that Defendant's product is defective. The “learned intermediary” doctrine would also bar a claim under a failure to warn theory. Plaintiff cannot salvage the negligence claim under a negligence per se theory, because Florida law does not allow such Case 4:13-cv-00462-CDL Document 36-12 Filed 07/25/16 Page 6 of 8 Wilson v. Danek Medical, Inc., Not Reported in F.Supp.2d (1999) 1999 WL 1062129 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 6 a claim in the absence of legislative intent to create a private cause of action. For the above reasons, summary judgment will be granted as to Counts I and II. II. Counts III and IV *7 Count III is a claim for breach of the implied warranty of merchantability. Count IV is a claim for breach of the implied warranty of fitness for a particular purpose. Defendant's argument that these claims must fail under Florida law is well-taken. With the adoption of the doctrine strict liability, Florida “abolished the no-privity, breach of implied warranty cause of action for personal injury.” Kramer v. Piper Aircraft Corp., 520 So.2d 37, 39 (Fla.1988); see also, Baker, 1998 WL 968329, at *2. Defendant points out that Plaintiff's doctors and not Plaintiff selected the bone screw device used on Plaintiff, and that no warranties, or indeed communication of any kind, existed between Plaintiff and Defendant. Plaintiff makes no response to Defendant's argument on this point. The Court finds Defendant's argument on this point convincing, and summary judgment will therefore be granted as to counts III and IV. III. Count V Count V is a claim for fraud, based on Defendant's alleged fraudulent misrepresentations as to the safety of the bone screw device, the benefits from its use, and its status before the FDA. Under Florida law, the elements of a claim for fraudulent misrepresentation are as follows: (1) a false statement of fact; (2) known by the defendant to be false at the time that it was made; (3) made for the purpose of inducing the plaintiff to act in reliance thereon; (4) action by the plaintiff in reliance on the correctness of the representation; and (5) resulting damage or injury. Mosley v. American Medical Int'l, Inc., 712 So.2d 1149, 1151 (Fla. 4th DCA 1998) see also, Crown Eurocars, Inc. v. Schropp, 636 So.2d 30, 35 n. 8 (Fla. 2d DCA 1993); S.H. Inv. & Dev. Corp. v.. Kincaid, 495 So.2d 768, 770 (Fla. 5th DCA 1986); Taylor v. Kenco Chem. & Mfg. Corp., 465 So.2d 581, (Fla. 1st DCA 1985); Standard Jury Instructions— Civil Cases (1.0, 6.1d, MI8), 613 So.2d 1316, 1317– 1318 (Fla.1993). Under Florida law, Plaintiff has not set forth sufficient evidence to survive summary judgment. Plaintiff has offered no evidence that he relied on any of the alleged misrepresentations. It was his physician who determined that use of a spinal fixation device was appropriate and selected the device manufactured by Defendant. Further, as discussed above, Plaintiff has provided no evidence that the implantation of the bone screw device was the cause of his injuries. Therefore, summary judgment will be granted as to Count V of Plaintiff's complaint. IV. Motion to Reinstate Fraud–on–the–FDA Claim Plaintiff moves to add a fraud-on-the-FDA claim, that is, a claim that Defendant misrepresented to the FDA that the bone screw device would not be marketed for use in the pedicles. Although this motion is characterized as a motion to reinstate, no such claim was pled in Plaintiff's complaint. It will therefore be treated as a motion to amend the complaint. Leave to amend should be “freely given when justice so requires.” Fed.R.Civ.P. 15(a). *8 Judge Bechtle dismissed all fraud-on-the- FDA claims on the ground that they are pre- empted under the Medical Device Amendments [MDA] to the Food, Drug, and Cosmetic Act [FDCA], 21 U.S.C. § 360. After this case had been transferred back to this Court, the Third Circuit Court of Appeals reversed Judge Bechtle's dismissal of a fraud-on-the-FDA claim against another defendant. See In re Orthopedic Bone Screw Products Liability Litigation, 159 F.3d 817 (3d Cir.1998). The Third Circuit stated that “dismissal of all ‘fraud on the FDA’ claims was appropriate only if federal law forecloses resort to state claims or if the allegations comprising those claims do not state a claim on which relief can be granted under any of the potentially applicable state laws.” Id. at 822. Case 4:13-cv-00462-CDL Document 36-12 Filed 07/25/16 Page 7 of 8 Wilson v. Danek Medical, Inc., Not Reported in F.Supp.2d (1999) 1999 WL 1062129 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 7 The Third Circuit's analysis of whether a fraud- on-the-FDA claim is pre-empted under the MDA was based on the United States Supreme Court's opinion in Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). In that case, the Supreme Court held that the FDCA preempts only state law claims that impose requirements on manufacturers that are different or greater than the requirements imposed under federal law. See id. at 492–97. Based on Lohr, the Third Circuit held in the Orthopedic Bone Screw Litigation that: there is no federal “requirement” “applicable to the device at issue here; nor is there a state “requirement” “with respect” to that device. Moreover, the state common law relied upon does not impose any obligation on [the manufacturer] inconsistent with federal law. As plaintiffs stress, 18 U.S.C. § 1001 makes it a crime to make a fraudulent statement to a federal agency and 21 C.F.R. § 807.87(j) requires every pre-market notification to contain a statement that the information contained therein is believed to be truthful. 159 F.3d at 823. Next, the Third Circuit considered whether a fraud- on-the-FDA claim could ever be made under state law. Even though the misrepresentations were alleged to have been made to the FDA and not to the plaintiffs or their physicians, the court rejected the proposition that a fraud-on-the-FDA claim could not stand under the law of any state. It pointed out that under Restatement (Second) of Torts Section 310, a person who makes a misrepresentation may in some circumstances be liable for damages that misrepresentation causes third parties. 159 F.3d at 826–27. The court emphasized that its holding was a “narrow one,” and that it was not holding that “any of the plaintiffs have stated a claim under state law upon which relief should be granted.” Id. at 829. Under Florida law, Plaintiff's “fraud-on-the-FDA” claim is precluded. Florida has not adopted Restatement (Second) of Torts Section 310, and it does not allow claims based on fraudulent statements made to someone other than the plaintiff or the plaintiff's agents. As is clear from the elements of a fraud claim under Florida law, stated above in Section III, “a plaintiff must have relied on a defendant's misrepresentations and must have been deceived by them in order to maintain a Florida fraud cause of action.” Williams Elec. Co., Inc. v. Honeywell, Inc., 772 F.Supp. 1225, 1239 (N.D.Fla.1991). Thus, Plaintiff cannot state a fraud claim based on misrepresentations of which the plaintiff was unaware. The ends of justice would not be served by allowing Plaintiff to amend his complaint to add a claim that is not recognized under Florida law. Accordingly, it is *9 ORDERED that Defendant DANEK MEDICAL, INC.'s motion for summary judgment (Docket Nos. 24) be GRANTED; Plaintiff JESSE WILSON's motion to reinstate a fraud-on-the- FDA claim (Docket No. 44) be DENIED; and the Clerk of the Court shall enter judgment in favor of Defendant. All Citations Not Reported in F.Supp.2d, 1999 WL 1062129 End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:13-cv-00462-CDL Document 36-12 Filed 07/25/16 Page 8 of 8