Osborn v. Boston Scientific CorporationMOTIONS.D.W. Va.December 28, 20171 648726 v2 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: Betty Ann Osborn, Plaintiff, v. BOSTON SCIENTIFIC CORP., Defendant. 2:17-CV-00318 BOSTON SCIENTIFIC CORPORATION’S MOTION FOR SUMMARY JUDGMENT AND MEMORANDUM IN SUPPORT AGAINST PLAINTIFF BETTY ANN OSBORN INTRODUCTION Plaintiff Betty Ann Osborn brings this product liability action against Boston Scientific Corporation (“Boston Scientific”) alleging that Boston Scientific’s implantable pelvic mesh device–the Solyx Single-Incision Sling System–was defective and caused her personal injury. Plaintiff asserts causes of action for negligence, strict liability (design defect, manufacturing defect, and failure to warn), breach of express warranty, breach of implied warranty, fraudulent concealment,1 and punitive damages. 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. See Kilgore v. Boston Sci. Corp., No. 2:13-CV-09171, 2015 WL 5838513, at *6 (S.D.W. Va. Oct. 5, 2015). Case 2:17-cv-00318 Document 20 Filed 12/28/17 Page 1 of 16 PageID #: 91 2 648726 v2 Over the course of discovery, it has become clear that certain of Plaintiff’s legal theories are without evidentiary or legal support and are subject to dismissal as a matter of law: Plaintiff’s manufacturing defect claims for lack of evidence. Plaintiff’s failure to warn claims are barred by the learned intermediary doctrine. Plaintiff’s breach of warranty claims fail as a result of the learned intermediary doctrine and 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 Plaintiff’s claims. STATEMENT OF MATERIAL FACTS 1. Ms. Osborn is citizen and resident of Texas. Short Form Complaint (SFC)2 at ¶ 4. 2. In August 2010, Ms. Osborn visited Dr. Natver Jariwala with complaints of severe pelvic pain and back pain during menstrual periods and stress urinary incontinence. Ms. Osborn’s stress incontinence occurred with laughing, coughing, sneezing, lifting, and sexual intercourse and was accompanied by frequency and urge incontinence. Betty Ann Osborn Deposition (“Osborn Dep.”)3 at 39:4-20; 40:20-41:14; Natver Jariwala, M.D. Medical Records (“Jariwala Records”)4 at 15. Dr. Jariwala diagnosed uterine fibroids and stress urinary incontinence and recommended laparoscopic assisted vaginal hysterectomy and placement of a mid-urethral sling. Jariwala Records at 15. 3. On August 23, 2010, Ms. Osborn underwent a hysterectomy and placement of the Solyx device by Dr. Jariwala to treat multiple conditions including pelvic pain, 2 A true and correct copy of Plaintiff’s SFC is attached as Exhibit A. 3 True and correct copies of the relevant portions of Betty Ann Osborn’s deposition are attached as Exhibit B. 4 True and correct copies of the relevant portions of Dr. Natver Jariwala’s medical records are attached as Exhibit C. Case 2:17-cv-00318 Document 20 Filed 12/28/17 Page 2 of 16 PageID #: 92 3 648726 v2 excessive uterine bleeding, and stress urinary incontinence. Permian Regional Medical Center Records (“Permian Records”)5 at 113. 4. Dr. Jariwala used transvaginal mesh products to treat urinary incontinence for 20 years prior to his retirement in 2013 and performed 450 such procedures prior to Ms. Osborn’s surgery. Deposition of Dr. Natver Jariwala (“Jariwala Dep.”)6 at 22:15-23; 44:22-45:15. He was aware of the risks associated with such procedures, including the Solyx procedure, prior to his implant procedure for Ms. Osborn through his medical training, the medical literature, and the directions for use. Id. at 33:10-34:20. 5. Dr. Jariwala was aware of the 2008 and 2011 Food and Drug Administration notifications regarding use of synthetic slings and continued to use the Solyx. Id. at 37:14-38:7; 40:15-24. 6. Dr. Jariwala was adequately trained and possessed the requisite skills to perform the Solyx procedure on Ms. Osborn. Id. at 45:11-18. He used his own medical judgment and knowledge and determined that Ms. Osborn was an appropriate candidate for the Solyx for treatment of stress urinary incontinence. Id. at 155:22- 156:2. 7. Dr. Jariwala believes that synthetic slings like the Solyx have a proven safety record and they are the gold standard for treatment of SUI. Id. at 45:5-9; 47:9-24. 8. Prior to her surgical procedure, Dr. Jariwala informed Ms. Osborn of the risks associated with the Solyx procedure including injury to bladder, erosion, recurrent 5 True and correct copies of the relevant portions of medical records from Permian Regional Medical Center are attached as Exhibit D. 6 True and correct copies of the relevant portions of Dr. Navter Jariwala deposition are attached as Exhibit E. Case 2:17-cv-00318 Document 20 Filed 12/28/17 Page 3 of 16 PageID #: 93 4 648726 v2 incontinence, pain, exposure, and infection. Jariwala Records at 15; Jariwala Dep. at 27:22-32:13; 54:9-16; 55:13-56:1. 9. The Solyx Directions for Use (“DFU”)7 lists the following as potential complications, among others: bleeding, dyspareunia, erosion/exposure, extrusion, incontinence, infection, inflammation, irritation, pain, urinary retention, urinary tract obstruction, vaginal discharge, and sexual dysfunction. 10. Ms. Osborn saw Dr. Jariwala for follow up after her surgical procedure on August 31, 2010. Jariwala Records at 17; Jariwala Dep. at 63:2-18. She did not complain of any pain, bleeding, discharge, or stress incontinence at that time. Id. She followed up with Dr. Jariwala again on September 21, 2010. Jariwala Records at 18; Jariwala Dep. at 63:19-64:16. Again, she had no complaints. Id. 11. Ms. Osborn saw Dr. Jariwala about three years later on July 10, 2013 with complaints of rectal bleeding, reflux and dysphagia. Jariwala Records at 19; Jariwala Dep. at 64:17-65:24. She did not report any problems related to her Solyx device and no vaginal exam was performed at that time. Id. 12. The Solyx is a medical device, implanted during surgery by a physician, and is available by prescription only. 13. As a result of the implantation of the Solyx, Ms. Osborn attributes complaints of repeated infections, urinary incontinence, and painful intercourse. Plaintiff Fact Sheet (“PFS”)8 at 6; Osborn Dep. at 15:16-16:3; 17:4-8; 18:4-12; 19:5-10. 7 A true and correct copy of the applicable Boston Scientific Solyx DFU is attached as Exhibit F. 8 A true and correct copy of Betty Ann Osborn’s Plaintiff Fact Sheet is attached as Exhibit G. Case 2:17-cv-00318 Document 20 Filed 12/28/17 Page 4 of 16 PageID #: 94 5 648726 v2 APPLICABLE LAW For implantable medical device cases that originate elsewhere, this Court applies the choice-of-law rules of the state in which the plaintiff was implanted with the product. See Sanchez v. Boston Scientific Corp., No. 2:12-cv-05762, at *1-5 (S.D. W. Va. Jan. 17, 2014) (ECF No. 55); In re Yasmin & Yaz (Drospirenone) Mktg., Sales Practices & Prods. Liab. Litig., 2011 WL 1375011, at *6 (“[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.”); In re Avandia Mktg, Sales Practices & Prods. Liab. Litig., MDL No. 1871, 2012 WL 3205620, at *2 (E.D. Pa. Aug. 7, 2010) (“The Court has concluded, as have other MDL courts, that such cases should be governed by the law of the states where Plaintiff received treatment and prescriptions for Avandia. This ruling will promote uniform treatment between those Plaintiffs whose cases were transferred into the MDL from their home states and those Plaintiffs who filed directly into the MDL.”). Plaintiff’s surgery with the Solyx was in Texas. Plaintiff is a resident of Texas. Plaintiff received all medical care and treatment in Texas. As a result, this Court should apply Texas’s choice-of-law rules. Texas applies the “most-significant-relationship” test as set forth in the Restatement (Second) of Conflict of Laws. Torrington Co. v. Stutzman, 46 S.W.3d 829, 848 (Tex. 2000), Hughes Wood Products, Inc. v. Wagner, 18 S.W.3d 202, 205 (Tex. 2000). Under the “most significant-relationship” analysis, the Court considers the place where the injury occurred, the place where the conduct causing the injury occurred, the domicile, residence, nationality, place of incorporation, and place of business of the parties, and the place where the relationship, if any, between the parties is centered. Sico N. Am., Inc. v. Willis, 2009 WL 3365856, *3 (Tex. App.— Case 2:17-cv-00318 Document 20 Filed 12/28/17 Page 5 of 16 PageID #: 95 6 648726 v2 Houston [14th Dist.] 2009, no pet.). Here, Ms. Osborn’s alleged injuries occurred in Texas, she is a citizen and resident of Texas, and all relevant medical care and treatment took place in Texas. Ex. A, SFC at ¶ 4, 11. Therefore, Texas has the most significant interest in having its substantive law applied to Plaintiff’s compensatory damages claims in this case and, thus, Texas law should apply. SUMMARY JUDGMENT STANDARD To prevail on a motion for summary judgment, the moving party must show that there are no genuine issues of material fact and that it is entitled to summary judgment as a matter of law. Fed. R. Civ. P. 56(c). “Unsupported speculation is not sufficient to defeat a summary judgment motion.” Felty v. Graves-Humphreys Co., 818 F.2d 1126, 1128 (4th Cir. 1987). If the evidence favoring the non-moving party is “merely colorable or is not significantly probative, summary judgment may be granted.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249-50 (1986) (citations omitted). Likewise, if the Court finds that the non-moving party has failed to make a showing sufficient to establish the existence of an element essential to its case, and on which it will bear the burden of proof at trial, the Court must grant summary judgment against that party. Lujan v. Nat’l Wildlife Fed’n, 497 U.S. 871, 884 (1990). ARGUMENT I. PLAINTIFF’S STRICT LIABILITY AND NEGLIGENT MANUFACTURING DEFECT CLAIMS FAIL FOR LACK OF EVIDENCE To prevail on a strict liability manufacturing defect claim, Plaintiff must prove that 1) the Solyx device implanted into Ms. Osborn deviated from the specifications or planned output; 2) at the time they left the hands of Boston Scientific; 3) in a way that rendered the products unreasonably dangerous; and 4) the defect was a producing cause of her injuries. See Ford Motor Co. v. Ledesma, 242 S.W.3d 32, 41-42 (Tex. 2007). Moreover, Plaintiff must provide expert Case 2:17-cv-00318 Document 20 Filed 12/28/17 Page 6 of 16 PageID #: 96 7 648726 v2 testimony because these elements are not within the experience of the layman. FFE Transp. Services, Inc. v. Fulgham, 154 S.W.3d 84, 90 (Tex. 2004) (citations omitted). Expert testimony is generally required to establish causation in manufacturing defect cases. See Bic Pen Corp. v. Carter, 346 S.W.3d 533, 542 (Tex. 2011). Here, Plaintiff lacks evidence on each of these elements. Plaintiff has no evidence – expert or otherwise – to support that the Solyx device in question deviated from its ―specifications or planned output its intended design or that any alleged manufacturing deviation in the Solyx device caused Plaintiff‘s alleged injuries. To recover under their negligent manufacturing defect claim, Plaintiff ―must prove 1) a legal duty owed to the plaintiff by the defendant, 2) breach of that duty, and 3) damages to the plaintiff proximately caused by the breach of the duty. Dewayne Rogers Logging, Inc. v. Propac Industries, Ltd., 299 S.W.3d 374, 385 (Tex. App.—Tyler 2009, pet. denied). Plaintiff must also prove that the product was defective, i.e., unreasonably dangerous—even for a negligence claim—as a result of the manufacturing process. See Ford Motor Co. v. Miles, 141 S.W.3d 309, 315 (Tex. App.—Dallas 2004, pet. denied). As with Plaintiff’s strict liability manufacturing defect claim, Plaintiff’s Complaint reveals that Plaintiff has pleaded a negligent ―manufacturingǁ defect claim in name only. It is clear that all of Plaintiff’s negligence allegations relate only to purported design or marketing defects. See Master Long Form Complaint generally. Plaintiff does not have evidence of any of the four essential elements of a negligent manufacturing defect claim. In particular, Plaintiff will not be able to present any competent evidence concerning a defect arising from the manufacturing of the Solyx device, nor will Plaintiff be able to present any evidence that an alleged manufacturing defect in the Solyx device caused Plaintiff‘s alleged personal injuries. Case 2:17-cv-00318 Document 20 Filed 12/28/17 Page 7 of 16 PageID #: 97 8 648726 v2 Moreover, this Court has dismissed identical manufacturing defect claims under Texas law in prior cases in this MDL litigation. See, e.g., Flores-Banda v. Boston Scientific Corp., No. 2:13-CV-04434, 2016 WL 2343895, at *4 (S.D.W. Va. May 3, 2016) (applying Texas law and granting motion for summary judgment on plaintiff’s claims of strict liability and negligent manufacturing defect on the grounds that plaintiff has failed to proffer any evidence to support its manufacturing defect claims). As such, the Court should grant summary judgment for Boston Scientific as to Plaintiff‘s strict liability and negligent manufacturing defect claims. II. PLAINTIFF’S FAILURE TO WARN CLAIMS FAIL UNDER THE LEARNED INTERMEDIARY DOCTRINE Whether sounding in strict liability, negligence or breach of express or implied warranties, the gravamen of Plaintiff’s Complaint is that Boston Scientific failed to warn about the Boston Scientific Solyx’s risks. The learned intermediary doctrine thus extends to and bars all of Plaintiff’s claims. The learned intermediary doctrine applies in the context of prescription products available to a consumer through a prescriber, i.e., a learned intermediary. Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 153-54 (Tex. 2012) (“[W]e hold that a prescription drug manufacturer fulfills its duty to warn end users of its product’s risks by providing adequate warnings to the intermediaries who prescribe the drug and, once fulfilled, it has no further duty to warn the end users directly.”); see also Guzman v. Synthes (USA), 20 S.W.3d 717, 720 n.2 (Tex. App.—San Antonio 1999, pet. denied) (“[W]here, as here, the product is meant only for administration by a physician, the physician is integrally involved in deciding what type of medical device to use on the patient, and the physician is in a better position than the patient to understand the dangers and propensities of the possible devices, the supplier satisfies its duty by warning and instructing the treating physician.”). In addition, a corollary of the Learned Intermediary Doctrine is that where the warning specifically mentions the circumstances Case 2:17-cv-00318 Document 20 Filed 12/28/17 Page 8 of 16 PageID #: 98 9 648726 v2 complained of, the warning is adequate as a matter of law. Brumley v. Pfizer, 149 F.Supp. 2d 305, 310 (S.D. Texas 2001). The Learned Intermediary Doctrine and the rationale behind the doctrine applies equally to medical device cases. See, Wyeth-Ayerst Labs. Co. v. Medrano, 28 S.W.3d 87, 94 (Tex. App. 2000) (Norplant (contraception device) case finding that “under the learned intermediary doctrine, [the manufacturer] sustains its duty by warning the learned intermediary of the risks associated with its product.”); Smith v. Johnson & Johnson, Inc., 483 Fed. Appx. 909, 913-14 (5th Cir. 2012) (“The learned intermediary doctrine applies to medical devices as well as prescription drugs.”). Thus, a prescription medical device manufacturer may be held liable only if the “warning to the prescribing physician is inadequate or misleading.” Centocor, 372 S.W.3d at 153-54 (emphasis added). In order to recover for failure to warn under the learned intermediary doctrine, Plaintiff must prove: 1) defendant failed to warn the physician of a risk associated with the use of the product not otherwise known to the physician; and 2) the failure to warn the physician was both a cause in fact and proximate cause of the plaintiff’s injury. See Centocor, 372 S.W.3d at 170. Here, Boston Scientific adequately warned Dr. Jariwala of the risks associated with the device, including the very injuries now claimed by Plaintiff. As a result of the implantation of the Solyx, Ms. Osborn attributes complaints of repeated infections, urinary incontinence, and painful intercourse. PFS at 6; Osborn Dep. at 15:16-16:3; 17:4-8; 18:4-12; 19:5-10. The DFU that accompanied the Boston Scientific Solyx warned her implanting physician of the risks attributable to the Solyx. See DFU. Because Boston Scientific provided accurate, clear and unambiguous warnings concerning the potential risks and complications of the Boston Scientific Case 2:17-cv-00318 Document 20 Filed 12/28/17 Page 9 of 16 PageID #: 99 10 648726 v2 Solyx, including the exact complications for which Plaintiff seeks recovery, Boston Scientific discharged its duty to warn under the learned intermediary doctrine Moreover, Plaintiff cannot establish proximate causation. Plaintiff must prove the alleged inadequate warning was the producing cause of her injuries. Centocor, 372 S.W.3d at 170 (citing Technical Chem. Co. v. Jacobs, 480 S.W. 2d 602, 605-06 (Tex. 1972). Texas courts have established that to prove proximate causation, Plaintiff must show that a different warning to her doctor would have changed the treatment decisions. Centocor, 372 S.W.3d at 170; see also Skotak v. Tenneco Resins, Inc. 953 F.2d 909, 911, 917 (5th Cir. 1992) (affirming summary judgment granted under Texas law because plaintiffs did not meet their burden of establishing a different warning would have changed the actions of the physician). This is because when a “prescribing physician is aware of the product’s risks and decides to use it anyway, any inadequacy of the product’s warning, as a matter of law, is not the producing cause of the patient’s injuries.” Id. at 170 (emphasis added); see also Smith v. Johnson & Johnson, 483 Fed. Appx. 909, 913-14 (5th Cir. 2012) (“If . . . the physician was aware of the possible risks involved in the use of the product but decided to use it anyway, the adequacy of the warning is not a producing cause of the injury and the plaintiff's recovery must be denied.”). This Court has granted summary judgment on failure to warn claims under Texas law under similar facts in the past and should do likewise here. In Cantrell, this Court held that “the plaintiff must show ‘that but for the inadequate warning, the treating physician would have not used or prescribed the product.’ If a physician, as the learned intermediary, does not testify that he or she would not have used or prescribed the product, the causal chain is broken, the plaintiff cannot show causation, and the failure to warn claim fails.” Cantrell v. Boston Sci. Corp., No. 2:13-CV-02340, 2016 WL 2343894, at *5 (S.D.W. Va. May 3, 2016) (quoting Dyer v. Danek Case 2:17-cv-00318 Document 20 Filed 12/28/17 Page 10 of 16 PageID #: 100 11 648726 v2 Med. Inc., 115 F. Supp. 2d 732, 741 (N.D. Tex. 2000). The Court then dismissed Plaintiff’s failure to warn claims on the grounds that the record “does not include any evidence that [implanter] would not have used or prescribed the product if the warnings were different.” Id. The Court further rejected as insufficient testimony by implanter that “he had not been aware of the MSDS and that he would have passed that information, and other relevant risk information, to patients if he had known it.” Id. The same is true here—Plaintiff can present no evidence that Dr. Jariwala was inadequately warned of or otherwise unaware of the risks associated with the Solyx. Dr. Jariwala used transvaginal mesh products to treat urinary incontinence for 20 years prior to his retirement in 2013 and performed 450 such procedures prior to Ms. Osborn’s surgery. Jariwala Dep. at 22:15-23; 44:22-45:15. He was aware of and discussed the potential risks involved with the procedure with Ms. Osborn including injury to bladder, erosion, recurrent incontinence, pain, exposure, and infection. Jariwala Records at 15; Jariwala Dep. at 27:22-32:13; 54:9-16; 55:13- 56:1. He was aware of those risks prior to his implant procedure for Ms. Osborn through his medical training, the medical literature, and the directions for use. Id. at 33:10-34:20. Dr. Jariwala was adequately trained and possessed the requisite skills to perform the Solyx procedure on Ms. Osborn. Jariwala Dep. at 45:11-18. He used his own medical judgment and knowledge and determined that Ms. Osborn was an appropriate candidate for the Solyx for treatment of stress urinary incontinence. Id. at 155:22-156:2. Plaintiff cannot establish that any alleged inadequacy in Boston Scientific’s warnings regarding the device caused her alleged injuries because no different warning would have changed his treatment decision. He relied on his own knowledge, education, skill and judgment in deciding to implant the devices. He had independent medical knowledge of the risks Case 2:17-cv-00318 Document 20 Filed 12/28/17 Page 11 of 16 PageID #: 101 12 648726 v2 associated with the device, which did not alter his decision to use the device. He was aware of those risks through his medical training, the medical literature, and the directions for use. Dr. Jariwala still believes that synthetic slings like the Solyx have a proven safety record and they are the gold standard for treatment of SUI. Id. at 45:5-9; 47:9-24. He was aware of the 2008 and 2011 Food and Drug Administration notifications regarding use of synthetic slings and continued to use the Solyx. Id. at 37:14-38:7; 40:15-24. Although Dr. Jariwala is now retired, if he were still practicing he would still recommend synthetic slings to treat SUI today. Id. at 48:3-7. Moreover, he testified that he had adequate information on the Solyx at the time of Ms. Osborn’s surgery to properly evaluate the risks and benefits of the product and nothing presented to him by plaintiff’s counsel changed that opinion. Id. at 153:24-155:19. Because Plaintiff is unable to establish that 1) Dr. Jariwala was inadequately warned of, or was otherwise unaware of, the risks; and 2) a different warning would have changed his treatment decision, Plaintiff cannot meet her burden of proof on her failure to warn claims. Accordingly, summary judgment should be granted on all of Plaintiff’s claims premised on failure to warn under the learned intermediary rule. III. PLAINTIFF’S BREACH OF WARRANTY CLAIMS FAIL As a threshold matter, like the negligent and strict liability failure to warn claims, Plaintiff’s warranty claims are barred by the learned intermediary doctrine. Courts across the country have applied the learned intermediary doctrine to warranty and misrepresentation claims. See Talley v. Danek Med., Inc., 179 F.3d 154, 162-64 (4th Cir. 1999) (applying the learned intermediary doctrine to fraud and warranty claims under Virginia law); In re Norplant Contraceptive Prods. Liab. Litig., 955 F. Supp. 700, 709 (E.D. Tex. 1997), aff’d, 165 F.3d 374 (5th Cir. 1999) (applying the doctrine to fraud, Deceptive Trade Practices Act, and other claims Case 2:17-cv-00318 Document 20 Filed 12/28/17 Page 12 of 16 PageID #: 102 13 648726 v2 under Texas law); In re Diet Drugs Prods. Liab. Litig., 220 F. Supp. 2d 414, 422-25 (E.D. Pa. 2002) (applying learned intermediary doctrine to claims for breach of warranty and other causes of action based on alleged harm from diet drugs). Accordingly, Boston Scientific is entitled to summary judgment on those grounds. a. Missing Elements of Breach of Express Warranty Claim. To recover under her breach of express warranty claim, Plaintiff must prove 1) that Boston Scientific sold the Solyx to Plaintiff; 2) there was an “affirmation of fact or promise” made by Boston Scientific to Plaintiff relating to the Solyx that became “part of the basis of the bargain,” i.e. reliance 3) the Solyx did not comply with the representations 4) Plaintiff notified Boston Scientific of the breach, and 5) Plaintiff suffered injury as a result of that breach. Tex. Bus. & Com. Code Ann. § 2.313; see American Tobacco Co. v. Grinnell, 951 S.W.2d 420, 436 (Tex. 1997); Morris v. Adolph Coors Co., 735 S.W.2d 578, 587 (Tex. App.— Fort Worth 1987, writ ref’d n.r.e.). Here, Plaintiff has not presented any evidence of any of the above elements of an express warranty claim. In particular, Plaintiff has not presented any evidence that 1) the Boston Scientific Solyx device failed to comply with any representations; 2) Plaintiff notified Boston Scientific of the breach; or 3) Plaintiff suffered injury as a result of that breach. The Court should rule as it has in past cases in this MDL and dismiss Plaintiff’s breach of warranty claims under Texas law for lack of evidence. See, e.g., Adams v. Boston Scientific Corp., 2:12-cv- 00932, *10 (Doc. 110) (S.D. W. Va. Apr. 1, 2016) (applying Texas law and granting motion for summary judgment for defendant on plaintiff’s express or implied warranty claims for lack of evidence of pre-suit notice). Case 2:17-cv-00318 Document 20 Filed 12/28/17 Page 13 of 16 PageID #: 103 14 648726 v2 b. Missing Elements of Breach of Implied Warranty Claim. To recover under her breach of implied warranty claim pertaining to a purported design defect, Plaintiff must prove that the Solyx was defective in that it was “unfit for the ordinary purposes for which it is used because of a lack of something necessary for adequacy.” See Hyundai Motor Co. v. Rodriguez ex rel. Rodriguez, 995 S.W.2d 661, 664-65 (Tex. 1999). Plaintiff must also prove that the breach proximately caused her injury. Id.; see also Polaris Indus. v. McDonald, 119 S.W.3d 331, 336 (Tex. App.—Tyler 2003, no pet.) (explaining that plaintiff must prove that the product was unmerchantable; plaintiff notified the defendant of the breach; and plaintiff suffered injury as a result of that breach) (citing TEX. BUS. & COM. CODE ANN. §§ 2.314, 2.314 cmt. 13, 2.607(c)(1), 2.714, 2.715)); see also Equistar Chems., L.P. v. Dresser-Rand Co., 240 S.W.3d 864, 867 (Tex. 2007) (citing Polaris favorably). Furthermore, with a warranty claim arising from a purported design defect, Plaintiff must prove a safer alternative design. And, finally, Plaintiff must prove notice. McKay v. Novartis Pharms. Corp., 934 F.Supp.2d 898, 913-14 (W.D. Tex. 2013) (holding that the required notice to pursue a breach of warranty claim notice “must” alert the manufacturer “to a particular buyer/end user” who was claiming a breach of warranty and that “commencement of litigation did not satisfy the pre-suit notice requirement under Texas law”). Plaintiff has not presented any evidence of any of the above elements of an implied warranty claim. In particular, Plaintiff has not presented any evidence that 1) the Boston Scientific Solyx device was defective, unmerchantable, and unfit for ordinary purposes; 2) Plaintiff notified Boston Scientific of the breach; or 3) Plaintiff suffered injury as a result of that breach. Again, the Court should rule as it has in past cases in this MDL and dismiss plaintiff’s breach of warranty claims. Adams, 2:12-cv-00932 (Doc. 110) at *10. Case 2:17-cv-00318 Document 20 Filed 12/28/17 Page 14 of 16 PageID #: 104 15 648726 v2 CONCLUSION For all of the foregoing reasons, Boston Scientific respectfully requests this Court grant its Motion for Summary Judgment and dismiss, with prejudice, Plaintiff’s claims against Boston Scientific. Dated: December 28, 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-00318 Document 20 Filed 12/28/17 Page 15 of 16 PageID #: 105 16 648726 v2 CERTIFICATE OF SERVICE I hereby certify that on December 28, 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-00318 Document 20 Filed 12/28/17 Page 16 of 16 PageID #: 106