Shiflet v. Boston Scientific CorporationMOTIONS.D.W. Va.December 27, 20171 8528559 v1 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA CHARLESTON DIVISION IN RE: BOSTON SCIENTIFIC CORP., PELVIC REPAIR SYSTEM PRODUCTS LIABILITY LITIGATION MDL No. 2326 THIS DOCUMENT RELATES TO THE FOLLOWING CASE: BRENDA SHIFLET, Plaintiff, v. BOSTON SCIENTIFIC CORP., Defendant. 2:17-cv-01845 BOSTON SCIENTIFIC CORPORATION’S MOTION FOR SUMMARY JUDGMENT AND MEMORANDUM IN SUPPORT AGAINST PLAINTIFF BRENDA SHIFLET INTRODUCTION Plaintiff Brenda Shiflet brings this product liability action against Boston Scientific Corporation (“Boston Scientific”) alleging that Boston Scientific’s implantable pelvic mesh device–the Advantage Transvaginal Mid-Urethral Sling System–was defective and caused her personal injury. Plaintiff asserts causes of action for strict liability (design defect, manufacturing defect, and failure to warn), negligence, breach of express warranty, breach of implied warranty, fraudulent concealment,1 and punitive damages. Boston Scientific moves for summary judgment, because (1) the Tennessee one-year statute of limitations bars Plaintiff’s claims; (2) the learned 1 Here, Plaintiff’s fraudulent concealment claim relates solely to tolling the statute of limitations. See Master Long Form Complaint. It is not a standalone claim, and should therefore be dismissed. SeeKilgore v. BostonSci. Corp., No. 2:13-CV-09171, 2015 WL 5838513, at *6 (S.D.W. Va. Oct. 5, 2015). As it relates to tolling, and as set forth infra, Plaintiff’s own testimony admits her complaint is time-barred. Case 2:17-cv-01845 Document 20 Filed 12/27/17 Page 1 of 16 PageID #: 101 2 8528559 v1 intermediary doctrine bars Plaintiff’s failure to warn claim, (3) Plaintiff’s manufacturing defect claim fails for lack of evidence, and 4) Plaintiff’s express and implied warranty of fitness claims fail for lack of evidence. For the reasons discussed in the incorporated Memorandum, Boston Scientific respectfully moves the Court for an order granting summary judgment on all of Plaintiff’s claims. STATEMENT OF MATERIAL FACT 1. Plaintiff is a citizen and resident of Tennessee. Short Form Complaint (“SFC”) (ECF Doc. No. 1) at ¶ 4. 2. Boston Scientific manufactures the Advantage Transvaginal Mid-Urethral Sling System (“Advantage”), a polypropylene mesh midurethral sling designed to treat female stress urinary incontinence (SUI). SeeBSC Advantage Sling FDA 510k Clearance Letter.2 3. The Food and Drug Administration cleared the Advantage device for marketing in April 2002. Seeid. 4. The American Urogynecologic Society (AUGS) has stated that “[t]he polypropylene mesh midurethral sling is the recognized worldwide standard of care for the surgical treatment of stress urinary incontinence. The procedure is safe, effective, and has improved the quality of life for millions of women.” SeeAUGS Position Statement on Mesh Midurethral Slings for Stress Urinary Incontinence.3 5. AUGS has also stated that “[f]ull-length midurethral slings, both retropubic and transobturator, have been extensively studied, are safe and effective relative to other treatment options and remain the leading treatment options and current gold standard of care for stress 2 A true and correct copy of the BSC Advantage Sling FDA 510k Clearance Letter is attached as Exhibit A. 3 A true and correct copy of AUGS Position Statement on Mesh Midurethral Slings for Stress Urinary Incontinence is attached as Exhibit B. Case 2:17-cv-01845 Document 20 Filed 12/27/17 Page 2 of 16 PageID #: 102 3 8528559 v1 incontinence surgery.” SeeAUGS Position Statement on Restriction of Surgical Options for Pelvic Floor Disorders.4 6. The American Urological Association (AUA) has stated that “[e]xtensive data exist to support the use of synthetic polypropylene mesh suburethral slings for the treatment of female SUI, with minimal morbidity compared with alternative surgeries . . . . It is the AUA’s opinion that any restriction of the use of synthetic polypropylene mesh suburethral slings would be a disservice to women who choose surgical correction of SUI.” SeeAUA Position Statement on the Use of Vaginal Mesh for the Surgical Treatment of Stress Urinary Incontinence.5 7. Boston Scientific’s Advantage sling is a medical device implanted during surgery by a physician and is available by prescription only. SeeAdvantage Directions for Use (DFU) at p. 2.6 8. The Advantage DFU warns of numerous risks, including pelvic and vaginal pain, dyspareunia, inflammation, irritation, infection, device migration, recurrent urinary incontinence, mesh erosion, and failure of the procedure. Id. at p. 4. 9. The Advantage DFU states the “physician is advised to consult the medical literature regarding techniques, complications and hazards associated with the intended procedures.” Id. at p. 2. 10. On March 11, 2011, Ms. Shiflet underwent a transvaginal procedure in which the Advantage device was placed to treat her stress urinary incontinence. See SHIFLETB_CARTER_000073-75.7 4 A true and correct copy of AUGS Position Statement on Restriction of Surgical Options for Pelvic Floor Disorders is attached as Exhibit C. 5 A true and correct copy of AUA Position Statement on the Use of Vaginal Mesh for the Surgical Treatment of Stress Urinary Incontinence is attached as Exhibit D. 6 A true and correct copy of the Advantage Directions for Use is attached as Exhibit E. 7 A true and correct copy of SHIFLETB_CARTER_000073-75 is attached as Exhibit F. Case 2:17-cv-01845 Document 20 Filed 12/27/17 Page 3 of 16 PageID #: 103 4 8528559 v1 11. The surgery was performed by Dr. Jason Carter at Laughlin Memorial Hospital in Greeneville, Tennessee. Id. SeealsoSFC at ¶¶ 11-12. 12. Dr. Carter has been in practice for over 14 years. SeeDr. Jason Carter Deposition (“Carter Dep.”) at 82:5-16.8 He has been a board certified urologist since 2005. Id. at 82:24-83:4. 13. Dr. Carter believes that the Advantage is a safe and effective option for treating his patients. Id. at 38:7-9; 39:8-12. 14. Dr. Carter still uses the Advantage today. Id. at 20:21-22. 15. Dr. Carter first became aware of the risks of placing a synthetic sling in 2001-2002 and he believes that the risks have always been understood from the very beginning. Id. at 27:14- 21. 16. Dr. Carter learned about the risks and benefits of the Advantage sling primarily through his own clinical experience, as well as attending continuing medical education and conferences. Id. at 77:18-78:15, 78:24-79:5. 17. Dr. Carter knew of the risks listed in the Advantage DFU at the time of Plaintiff’s surgery, including the potential for infection, pain, dyspareunia, retention, and recurrent stress incontinence. Id. at 34:20-35:22, 83:14-23. 18. Dr. Carter was specifically aware that a risk of chronic or permanent dyspareunia exists for the Advantage and he would have communicated that to Ms. Shiflet. Id. at 86:17-87:13. 19. Dr. Carter believes he had adequate information on the use of the Advantage and to properly evaluate the risks and benefits of the procedure. Id. at 85:9-15. 20. Before her surgery, Dr. Carter informed Ms. Shiflet of possible risks potentially associated with midurethral slings, like the Advantage. Id. at 30:20-31:4, 36:6-10, 70:22-71:1. 8 A true and correct copy of the relevant excerpts of Dr. Carter’s deposition is attached as Exhibit G. Case 2:17-cv-01845 Document 20 Filed 12/27/17 Page 4 of 16 PageID #: 104 5 8528559 v1 21. Dr. Carter has not changed his practice related to implanting slings since Ms. Shiflet’s surgery. Id. at 39:13-16. 22. Dr. Carter believes Ms. Shiflet was an appropriate candidate for the Advantage surgery. Id. at 87:14-17. 23. Ms. Shiflet relied on Dr. Carter to evaluate the risks of the Advantage surgery on her behalf. SeeBrenda Shiflet Deposition (“Shiflet Dep.”) at 85:11-13.9 24. Ms. Shiflet trusted Dr. Carter’s medical judgment and opinion that the Advantage was an appropriate treatment option. Id. at 85:14-18. 25. Ms. Shiflet does not recall receiving a Boston Scientific specific brochure prior to her surgery. Id. at 80:1-3. She has no documents from Boston Scientific or documents evidencing any contact with a representative or employee of Boston Scientific. Id. at 13:24-14:6. 26. Ms. Shiflet alleges that her Advantage implant caused the inability to have sex, recurrent incontinence, pelvic pain, and urgency. Id. at 33:10-15. 27. Ms. Shiflet reported that her inability to have sexual intercourse started in 2011 and she became completely abstinent in 2012-2013. Id. at 24:1-10. 28. Ms. Shiflet testified that she experienced leaking immediately after the March 3, 2011 Advantage surgery within the first two to three months. Id. at 82:7-9, 92:7-10. 29. The first time Ms. Shiflet experienced pain she attributes to her Advantage was in the next two or three months after surgery. Id. at 92:11-13. 30. Ms. Shiflet visited Dr. Carter on November 3, 2014 with complaints that the Advantage sling was not working. Id. at 136:22-137:7. See also 9 A true and correct copy of the relevant excerpts of Ms. Shiflet’s Deposition are attached as Exhibit H. Case 2:17-cv-01845 Document 20 Filed 12/27/17 Page 5 of 16 PageID #: 105 6 8528559 v1 SHIFLETB_AUSTIN_MEDICAL_000057-6110 (“She complains with bladder incontinence and had a stimulator and mesh placed a year ago by Dr. Carter but states not working and has even ‘wet the bed.’). 31. Plaintiff filed this action against Boston Scientific on March 13, 2017. SeeSFC. 32. Plaintiff asserts claims for negligence, strict liability (design defect, manufacturing defect, and failure to warn), breach of express warranty, breach of implied warranty, fraudulent concealment, and punitive damages. SeeSFC ¶ 13. APPLICABLE LAW For implantable medical device cases that originate elsewhere and are directly filed in the MDL, this Court applies the choice-of-law rules of the state in which the plaintiff was implanted with the device. SeeSanchezv. BostonScientificCorp., 2:12-CV-05762, 2014 WL 202787, *4 (S.D.W. Va. Jan. 17, 2014); seealsoInreYasmin& Yaz(Drospirenone)Mktg., SalesPractices & Prods. Liab. Litig., MDL No. 2100, 2011 WL 1375011, *6 (S.D. Ill. Apr. 12, 2011) (“[T]he better approach is to treat foreign direct filed cases as if they were transferred from a judicial district sitting in the state where the case originated,” which is “the state where the plaintiff purchased and was prescribed the subject drug.”). Absent direct filing, the proper venue for this case is identified as U.S. District Court for the Eastern District of Tennessee as Plaintiff’s surgery with the Advantage was in Tennessee. SFC ¶ 11-12. As a result, this Court should apply Tennessee’s choice-of-law rules. Tennessee applies the “most significant relationship” choice-of- law approach. H atawayv. McKinley, 830 S.W.2d 53, 59 (Tenn. 1992). This approach “provides that the law of the state where the injury occurred will be applied unless some other state has a more significant relationship to the litigation.” Id. Plaintiff is a citizen of Tennessee and all 10 A true and correct copy of SHIFLETB_AUSTIN_MEDICAL_000057-61 is attached as Exhibit I. Case 2:17-cv-01845 Document 20 Filed 12/27/17 Page 6 of 16 PageID #: 106 7 8528559 v1 relevant medical care and treatment took place in Tennessee. SFC ¶¶ 4, 11; SHIFLETB_CARTER_000073-75. Plaintiff’s alleged injuries likewise occurred in Tennessee. Therefore, Tennessee has the most significant interest in having its substantive law applied to Plaintiff’s compensatory damages claims in this case. SUMMARY JUDGMENT STANDARD Summary judgment is proper when “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; CelotexCorp. v. Catrett, 477 U.S. 317, 322-23 (1986). Summary judgment “is properly regarded not as a disfavored procedural shortcut, but rather as an integral part of the Federal Rules as a whole, which are designed to ‘secure the just, speedy and inexpensive determination of every action.’” Celotex, 477 U.S. at 327 (citations omitted). Once the moving party has satisfied its burden of proof, the burden then shifts to the nonmoving party to set forth specific facts showing that there is a genuine issue for trial. See Fed. R. Civ. P. 56(e). Not every factual dispute between the parties will prevent summary judgment, however. SeeAndersonv. LibertyLobby,Inc., 477 U.S. 242, 248-49 (1986). Although the Court must review the evidence in the light most favorable to the non-moving party, the non- moving party is required to do more than show some “metaphysical doubt as to the material facts.” MatsushitaElec. Indus. Co., Ltd. v. ZenithRadioCorp., 475 U.S. 574, 586 (1986). Conclusory allegations or unsupported speculation is insufficient to preclude the granting of a summary judgment motion. SeeFeltyv. Graves-H umphreysCo., 818 F.2d 1126, 1128 (4th Cir. 1987); Rossv. Commc’nsSatelliteCorp., 759 F.2d 355, 365 (4th Cir. 1985), abrogatedonother groundsby490 U.S. 228 (1989). Case 2:17-cv-01845 Document 20 Filed 12/27/17 Page 7 of 16 PageID #: 107 8 8528559 v1 ARGUMENT I. THE STATUTE OF LIMITATIONS UNDER THE TENNESSEE PRODUCTS LIABILITY ACT BARS PLAINTIFF’S CLAIMS. The Tennessee Product Liability Act (“TPLA”) governs all “actions brought for or on account of personal injury . . . caused by or resulting from the manufacture, construction, design, formula, preparation, assembly, testing, service, warning, instruction, marketing, packaging or labeling of any product.” Tenn. Code Ann. § 29-28-102(6). Thus, for purposes of Tennessee law, Plaintiff’s product liability claims sound as a single action and are governed by a one-year statute of limitation. Tenn. Code Ann. § 28-3-104 (one-year limitations period for “. . .actions for injury to the person”). SeealsoTenn. Code Ann. § 29-28-103 (“Any action against a manufacturer or seller of a product for injury to person or property caused by its defective or unreasonably dangerous condition must be brought within the period fixed by § 28-3-104 ….”). Thus, the one- year statute of limitation applies to all of Plaintiffs’ claims filed on March 13, 2017. Under Tennessee law, a “personal injury cause of action accrues when the plaintiff knows, or in the exercise of reasonable care and diligence should know, that an injury has been sustained.” Wyattv. A-Best, Co., Inc., 910 S.W.2d 851, 854 (Tenn. 1995) (citing McCroskeyv. BryantAirConditioningCo., 524 S.W.2d 487, 491 (Tenn. 1975)) (emphasis added). Plaintiff has a “duty to investigate and discover pertinent facts” rather than sit back and “plead ignorance . . . effectively extend[ing] the statute of limitations, by way of the discovery rule[.]” Willisv. Wal- MartStores, Inc., 819 F. Supp. 2d 700, 704 (M.D. Tenn. 2011) (internal citations omitted). Although Tennessee recognizes a “discovery rule,” it “has been carefully narrowed by the Tennessee courts to ensure that the exception ‘does not swallow the rule.’” Id. at 703. The discovery rule applies “to plaintiffs' knowledge of their injuries.” Willis, 819 F. Supp. 2d at 703. “[T]he statute [of limitations] is tolled only during the period when the plaintiff had no knowledge Case 2:17-cv-01845 Document 20 Filed 12/27/17 Page 8 of 16 PageID #: 108 9 8528559 v1 at all that the wrong had occurred and, as a reasonable person, was not put on inquiry.” Wyatt, 910 S.W.2d at 855. The discovery rule, however, does not require that the “plaintiff actually knows that he or she has a cause of action.” Leonardv. Leo'sExterminatingServs., Inc., No. E200901398COAR3CV, 2010 WL 2134145, at *13 (Tenn. Ct. App. May 27, 2010). The tolling ceases and the statute of limitations begins to run “when Plaintiffs discover[] their injury[.]” Willis, 819 F. Supp. 2d at 704. In Smothersv. BostonScientificCorp., this Court granted Boston Scientific’s motion for summary judgment based on statute of limitations. No. 2:12-cv-08016 (S.D.W. Va. July 11, 2014) (ECF Doc. No. 102).11 In that case, Ms. Smothers was implanted with Boston Scientific’s Obtryx sling on May 11, 2009. Id. at *6. Ms. Smothers filed suit in the District of Massachusetts on July 10, 2012.12 Id. at *7. However, Ms. Smothers testified that she first attributed her symptoms to the Obtryx sling “about two or three weeks after I had it put in.” Id. at *6. Applying Massachusetts’ three-year statute of limitations,13 this Court determined that Ms. Smothers was “on notice that she had been harmed, and that her harm was attributable to the Obtryx sling as early as three weeks after implantation. . . . No reasonable jury could infer otherwise.” Id. at *6-7. Because Ms. Smothers failed to file her lawsuit within the three-year limitations period, her claims were time-barred and dismissed with prejudice. Id. at *7. Here, Plaintiff was implanted with the Advantage on March 11, 2011. See SHIFLETB_CARTER_000073-75. Plaintiff admitted she was experiencing dyspareunia, pelvic pain, and recurrent incontinence by the end of 2011. Shiflet Dep. at 24:1-10; 82:7-9; 92:7-13. By 11 SeealsoNo. 2:12-cv-4078 (S.D. W. Va. July 11, 2014) (ECF Doc. No. 29). 12 Plaintiff later filed a duplicative action directly in the MDL on November 20, 2012. Id. at *7. 13 The Order does not settle the dispute as to whether Massachusetts’ or Tennessee’s statute of limitations properly applied to the plaintiff’s claims. The Court assumed, “for the sake of argument,” that Massachusetts law applied. Id. at *5. Case 2:17-cv-01845 Document 20 Filed 12/27/17 Page 9 of 16 PageID #: 109 10 8528559 v1 her own admission, Plaintiff knew the mesh was not working on or before November 3, 2014 when she visited Dr. Carter. Id. at 136:22-137:7; SHIFLETB_AUSTIN_MEDICAL000057-61. Plaintiff’s own testimony shows that she was “on notice that she had been harmed, and that her harm was attributable to the [] sling by November 3, 2014. The statute of limitations thus began to run and expired on November 3, 2015. However, Plaintiff waited nearly three years— until March 13, 2017—to file her complaint in this action. Because Plaintiff discovered her injuries as early as 2011 and no later than November 3, 2014, the one-year statute of limitations bars all of Plaintiff’s claims. II. PLAINTIFF’S FAILURE TO WARN CLAIM FAILS UNDER THE LEARNED INTERMEDIARY DOCTRINE. Summary judgment is warranted on Plaintiff’s failure to warn claim pursuant to the learned intermediary doctrine. Tennessee’s adoption of the learned intermediary doctrine in cases involving prescription medical products allows medical device manufacturers to “reasonably rely on intermediaries to transmit their warnings and instructions.” Pittmanv.UpjohnCo., 890 S.W.2d 425, 429 (Tenn. 1994). In adopting the learned intermediary doctrine, the Tennessee Supreme Court recognized “the pivotal role [physicians] play in the unique system used to distribute prescription drugs.” Id. at 426. In order to recover for failure to warn under the learned intermediary doctrine, Plaintiff must prove: “(1) that the defendant failed to warn the physician of a risk associated with the use of the product not otherwise known to the physician; and (2) that the failure to warn the physician was both a cause in fact and proximate cause of the plaintiff’s injury.” H ardenv. Danek Med., Inc., 985 S.W.2d 449, 451-52 (Tenn. Ct. App. 1998) (citing 63A Am. Jur. 2d Products Liability § 1200 (1984)). Plaintiff’s failure to warn claim fails for lack of evidence showing that 1) Boston Scientific did not warn Dr. Carter about a risk that was not otherwise known to him and 2) that any inadequate warning was the proximate cause of Plaintiff’s alleged injuries. Case 2:17-cv-01845 Document 20 Filed 12/27/17 Page 10 of 16 PageID #: 110 11 8528559 v1 First, it is undisputed that Boston Scientific included with the Advantage adequate and specific warnings of the risks associated with the product, including the very injuries now claimed by Plaintiff. SeeAdvantage DFU. Dr. Carter testified that he knew of and understood the risks of implanting the Advantage sling as early as 2001-2002 (almost ten years before Plaintiff’s surgery), including the potential for infection, pain, retention, dyspareunia and recurrent stress incontinence. Carter Dep. at 35:20-22, 27:14-21. He was even aware that there was a potential risk of chronic or permanent dyspareunia and would have communicated it to Ms. Shiflet. Id. at 86:17-87:13. There is a complete absence of evidence that Dr. Carter would have wanted to know of a certain risk for which he was not already aware. Therefore, Plaintiff’s failure to warn claim is without merit. Even assuming arguendothat Plaintiff could prove that Boston Scientific failed to warn Dr. Carter about a risk that was not otherwise known to him, she still must “establish proximate causation between the failure to warn and her injury.” Paynev. NovartisPharm. Corp., 1:12-CV- 77, 2013 WL 4779571, at *4 (E.D. Tenn. Sept. 6, 2013) (citing H urtv. CoyneCylinderCo., 956 F.2d 1319, 1329 (6th Cir.1992)). To prove proximate causation in Tennessee, Plaintiff must show that a different warning to her doctor would have changed the doctor’s treatment decisions: [Plaintiffs] have failed to establish that the defendants’ alleged failure to warn was the proximate cause of their injuries. Both of the plaintiffs’ implanting physicians were well experienced in the use of internal fixation devices utilizing pedicle screws. Both testified that they relied upon their own knowledge and judgment in deciding to implant the devices into the plaintiffs. The plaintiffs have not shown that these decisions were influenced by any representation which the defendants made or failed to make. Thus, the plaintiffs’ claims in this regard fail because they have failed to establish that, had additional warnings been given, the plaintiffs would not have sustained their injuries. Case 2:17-cv-01845 Document 20 Filed 12/27/17 Page 11 of 16 PageID #: 111 12 8528559 v1 Kingv. DanekMedical, Inc., 37 S.W.3d 429, 453 (Tenn. Ct. App. 2000) (emphasis added); H arden, 985 S.W.2d at 453 (finding no causation when the doctor “relied entirely upon his own expertise and experience in deciding whether and how to use the defendant’s product.”). Here, Plaintiff cannot prove that Dr. Carter relied on Boston Scientific to make his treatment decision or that a different warning from Boston Scientific would have altered his decision to use the Advantage in Ms. Shiflet’s surgery. Dr. Carter is a board certified urologist with 14 years of clinical experience. Carter Dep. at 82:5-16, 82:24-83:4. He does not rely on device manufacturers like Boston Scientific when making medical decisions about the safety of devices, rather he relies primarily on his own clinical experience, as well as attending continuing medical education conferences. Id. at 77:18-78:15; 78:24-79:5; seeWoodv. DanekMed., Inc., 96C-1022, 1998 WL 665774 (Tenn. Cir. Ct. June 17, 1998) (granting summary judgment where physician relied on his own experience and judgment in prescribing device, concluding any inadequate warning was not the cause of plaintiff’s injuries). Dr. Carter believes the Advantage is a safe and effective treatment for stress incontinence. Carter Dep. at 38:7-9, 39:8-12. Dr. Carter testified that he has not changed is practice related to implanting slings since Ms. Shiflet’s surgery, and he maintains that she was an appropriate candidate for the Advantage sling procedure. Id. at 39:13-16, 87:14-17. He believes he had adequate information on the use of the Advantage and to properly evaluate the risks and benefits of the procedure. Id. at 85:9-15. Plaintiff therefore cannot meet her burden of proof on the proximate cause element of her failure to warn claims, and Boston Scientific is entitled to summary judgment. See, e.g., H arden, 985 S.W.2d at 451-52; Payne, 2013 WL 4779571, at *9 (granting summary judgment where plaintiff could not prove a different warning would have altered physician’s decision). Case 2:17-cv-01845 Document 20 Filed 12/27/17 Page 12 of 16 PageID #: 112 13 8528559 v1 III. THERE IS NO EVIDENCE TO SUPPORT A MANUFACTURING DEFECT CLAIM. A manufacturing defect is generally shown by proving the product in question departed from its intended design. SeeRestatement (Third) of Torts: Prod. Liab. § 2(a) (1998). Here, there is no evidence in the record, and Plaintiff can produce no evidence, showing that the Advantage sling implanted in Shiflet was in any way departed from its intended design. In fact, just as in the Eghnayem Pinnacle consolidated cases, where this Court granted Boston Scientific’s summary judgment motion on the plaintiffs’ manufacturing defect claims, even considering the “allegations in the Master Long Form Complaint, no material fact exists suggesting that the [Advantage] had manufacturing defects.” SeeEghnayem v. BostonScientificCorp., 2:13-cv-07965, Mem. Op. & Order (Oct. 27, 2014) (J. Goodwin) (ECF Doc. No. 243) (“Eghnayem Order”) (applying Florida law and granting Boston Scientific’s summary judgment motion on the plaintiffs’ negligent and strict liability manufacturing defect claims for lack of evidence).14 Therefore, because Plaintiff has provided no evidence of a manufacturing defect, just like in the Eghnayem Pinnacle consolidated cases, the Court should grant Boston Scientific’s motion for summary judgment on Plaintiff’s manufacturing defect claims. Seeid. Seealso, InreC.R. Bard, Inc., No 2:11-CV-00114, 2013 WL 5591948, at *4 (S.D. W. Va. June 4, 2013) (granting defendant’s motion for summary judgment on manufacturing defect claim because plaintiff provided no evidence the product implanted in her deviated in some way “from the manufacturer’s specifications or from otherwise identical units manufactured to the same manufacturing specifications”); Savagev. DanekMed., 31 F. Supp. 2d 980, 983-84 (M.D. Fla. Jan. 14, 1999) (granting summary judgment for defendant medical device manufacturer on plaintiff’s theories of negligence and strict liability in the design, manufacture, distribution, promotion and sale of 14 A true and correct copy of this Court’s October 27, 2014 Order is attached to the Motion as Exhibit J. Case 2:17-cv-01845 Document 20 Filed 12/27/17 Page 13 of 16 PageID #: 113 14 8528559 v1 surgical screws and noting that, as in this case, “[t]here is simply no evidence” of a manufacturing defect). IV. PLAINTIFF’S WARRANTY CLAIMS FAIL AS A MATTER OF LAW Plaintiff’s express and implied warranty claims are deficient under Tennessee law for lack of evidence of reliance. A claim of breach of express warranty under Tennessee law requires the plaintiff to prove that: (1) the seller made an affirmation of fact intending to induce the plaintiff buyer to purchase the goods; (2) the buyer was in fact induced by the seller’s acts; and (3) the affirmation of fact was false regardless of the seller’s knowledge of the falsity or intention to create a warranty. Coffeyv. DowleyManuf., Inc., 187 F. Supp. 2d 958, 969 (M.D. Tenn. 2002) (emphasis added). To bring a claim for implied warranty of fitness, plaintiff must prove that: (1) the seller at the time of contracting has reason to know any particular purpose for which the goods are required; (2) the seller has reason to know that the buyer is relying on the seller’s skill or judgment to select or furnish suitable goods; and (3) the good is not fit for the particular purpose for which it was bought. Tenn. Code Ann. § 47-2-315;AlumaxAluminum Corp. v. ArmstrongCeilingSys., Inc., 744 S.W.2d 907 (Tenn. Ct. App. 1987). Actual reliance by the buyer on the seller’s skill and judgment is required. Tenn. Code Ann. § 47-2-315, cmt. 1 (“The buyer, of course must actually be relying on the seller.”)(emphasis added); TravelersIndem. Co. v. Indus. Paper& Packaging Corp., No. 3:02-CV-491, 2006 WL 3864857, at *10 (E.D. Tenn. Dec. 18, 2006). Plaintiff has no evidence that Plaintiff or Dr. Carter relied on any warranty, express or implied, from Boston Scientific. Plaintiff does not recall receiving a Boston Scientific specific brochure prior to her surgery. Shiflet Dep. at 80:1-3. She has no documents from Boston Scientific or documents evidencing any contact with a representative or employee of Boston Scientific. Id. Case 2:17-cv-01845 Document 20 Filed 12/27/17 Page 14 of 16 PageID #: 114 15 8528559 v1 at 13:24-14:6. Further, Dr. Carter relied on his own clinical practice to learn about the risks and benefits of the Advantage product. Id. at 77:18-78:15, 78:24-79:5. There is no evidence that Plaintiff or Dr. Carter relied on any warranty from Boston Scientific to support Plaintiff’s claims for express or implied warranty. Accordingly, summary judgment should be granted on plaintiff’s express and implied warranty claims. See, e.g., Bakerv. PromarkProds. West, Inc., 692 S.W.2d 844, 849 (Tenn. Ct. App. 1985) (summary judgment properly granted where plaintiff did not rely on defendant’s skill or judgment to furnish suitable goods); Kellyv. Nordyne, Inc., No. 107-CV- 235, 2008 WL 11342578, at *5 (E.D. Tenn. Sept. 8, 2008) (granting summary judgment on plaintiffs’ express warranty claims where plaintiffs did not establish that they actually relied on defendant’s warranties). CONCLUSION For the foregoing reasons, Boston Scientific respectfully requests that the Court grant summary judgment in its favor with respect to all of Plaintiff’s claims. Dated: December 27, 2017 Respectfully submitted, By: /s/ Jon A. Strongman Jon A. Strongman SHOOK, HARDY & BACON L.L.P. 2555 Grand Boulevard Kansas City, Missouri 64108 Telephone: 816.474.6550 Facsimile: 816.421.5547 jstrongman@shb.com COUNSEL FOR DEFENDANT BOSTON SCIENTIFIC CORP. Case 2:17-cv-01845 Document 20 Filed 12/27/17 Page 15 of 16 PageID #: 115 16 8528559 v1 CERTIFICATE OF SERVICE I hereby certify that on December 27, 2017, I caused the foregoing document to be electronically filed with the Clerk of the Court using the CM/ECF system, which will send notification of such filing to the CM/ECF participants registered to receive service in this MDL. By: /s/ Jon A. Strongman Jon A. Strongman SHOOK, HARDY & BACON L.L.P. 2555 Grand Boulevard Kansas City, Missouri 64108 Telephone: 816.474.6550 Facsimile: 816.421.5547 jstrongman@shb.com COUNSEL FOR DEFENDANT BOSTON SCIENTIFIC CORP. Case 2:17-cv-01845 Document 20 Filed 12/27/17 Page 16 of 16 PageID #: 116
