Weaver v. Eli Lilly And Company

MOTION for Summary Judgment and Brief in Support

E.D. Tex.October 31, 2016

DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 1 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS SHERMAN DIVISION GENE WEAVER, Individually, and as Personal Representative of the ESTATE OF JO DEAN WEAVER, deceased, and on behalf of ALL PERSONS ENTITLED TO RECOVER FOR THE WRONGFUL DEATH OF JO DEAN WEAVER, Plaintiff, vs. ELI LILLY AND COMPANY, Defendant. § § § § § § § § § § § § § § CIVIL ACTION NO. 4:14-CV-00665-RAS DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT Pursuant to Federal Rule of Civil Procedure 56, Defendant Eli Lilly and Company ("Lilly") files this Motion for Summary Judgment on Plaintiff's Claims and Brief in Support on grounds that Plaintiff's causes of action for negligence, strict products liability, breach of express and implied warranty, and gross negligence fail as a matter of law and due to Plaintiff's lack of supporting evidence. In support of this Motion, Lilly respectfully shows the Court the following: I. INTRODUCTION AND BACKGROUND Plaintiff Gene Weaver, Individually, and as Personal Representative of the Estate of Jo Dean Weaver, deceased, and on behalf of all persons entitled to recover for the wrongful death of Jo Dean Weaver ("Plaintiff") brings this product liability action against Lilly in pursuit of recovery for the medical injuries and death of decedent Jo Dean Weaver following her use of Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 1 of 25 PageID #: 174 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 2 Effient, an FDA-approved prescription drug.1 Plaintiff asserts product-liability causes of action against Lilly related to Effient including: negligence; strict liability for defective design, manufacture, and marketing; breach of express and implied warranties; and gross negligence.2 Plaintiff filed this action on September 2, 2014, more than two years ago.3 This case was initially set for trial on May 3, 2016.4 On April 20, 2016, the Court entered an Order requiring the parties to file their Joint Final Pretrial Order by April 28th or face dismissal for want of prosecution or sanctions.5 To accommodate Plaintiff's counsel's treatment for an unanticipated medical condition and to explore the potential for informal resolution, Lilly did not oppose Plaintiff's Unopposed Motion for Continuance and Entry of Amended Scheduling Order.6 The Court granted Plaintiff's Motion for Continuance and issued an amended scheduling order resetting this case for trial on January 3, 2017.7 In the two plus years this case has been pending, Plaintiff has not conducted any form of discovery. The deadlines for fact discovery and expert disclosures under the amended scheduling order have passed.8 Most notably, Plaintiff's deadline to disclose expert testimony pursuant to Fed. R. Civ. P. 26(a)(2) and Local Rule CV-26(b) expired on September 2, 2016, and Plaintiff did not designate any expert witnesses, move for relief from the amended scheduling 1 Exhibit A: Pl.'s Pet., Doc. No. 4. 2 Id. 3 Id. 4 Exhibit B: Scheduling Order, Doc. No. 15. 5 Exhibit C: Order, Doc. No. 16. 6 Exhibit D: Pl.'s Unopp. Mot. for Cont., Doc. No. 17. 7 Exhibit E: Ct. Order on Pl.'s Unopp. Mot. for Cont., Doc. No. 18. 8 Id. Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 2 of 25 PageID #: 175 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 3 order, or otherwise contact Lilly to request an extension.9 Plaintiff therefore has no expert testimony to support his allegations with regard to his negligence, strict liability manufacturing, marketing and design defect claims, warranty claims, and gross negligence claims, nor does Plaintiff have expert testimony on medical causation. Texas law requires expert testimony to support each of these allegations, and therefore, Plaintiff has no legal basis to continue to pursue this scientifically complex pharmaceutical product liability case. Additionally, Plaintiff's failure-to-warn claims are barred by the presumptions of non- liability under Section 82.007 of the Texas Civil Practice and Remedies Code and by the Learned Intermediary Doctrine, and Plaintiff's strict liability design defect and negligent design claims are barred by comment k, Section 402 of the Restatement (Second) of Torts. Further, Plaintiff's did not provide the required statutory pre-suit notice of his breach of warranty claims, nor has Plaintiff established the essential elements of his breach of warranty and gross negligence claims. Because Plaintiff cannot succeed in proving any theory of liability, and because Plaintiff cannot meet his burden of proof on any of Plaintiff's claims without expert medical causation testimony, Lilly respectfully requests that the Court to grant its Motion in its entirety. II. SUMMARY JUDGMENT GROUNDS Lilly seeks summary judgment on all of Plaintiff's claims on the following grounds: 1. All of Plaintiff's causes of action against Lilly (negligence, strict product liability manufacturing, marketing and design defect claims, breach of express and implied warranty, and gross negligence) must be dismissed given Plaintiff's lack of expert testimony because Plaintiff lacks evidence to support a finding on medical causation, an essential element to all of Plaintiff's claims. 9 Id. Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 3 of 25 PageID #: 176 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 4 2. All of Plaintiff's causes of action against Lilly (negligence, strict product liability manufacturing, marketing and design defect claims, breach of express and implied warranty, and gross negligence) must be dismissed given Plaintiff's lack of expert testimony, or other evidence, in support of the essential elements of each of Plaintiff's asserted causes of action. 3. Plaintiff's claims premised on Lilly's alleged failure to warn of dangers associated with Effient (negligence, strict liability marketing and design defect claims, and breach of express and implied warranties) must be dismissed pursuant to the presumption against liability under Tex. Civ. Prac. & Rem. § 82.007. 4. The Learned Intermediary Doctrine requires dismissal of Plaintiff's failure to warn claims against Lilly (negligence, strict liability marketing, and breach of express and implied warranties). 5. Plaintiff's strict liability design defect and negligent design claims are barred by comment k, Section 402 of the Restatement (Second) of Torts, which prohibits the assertion of design defect claims for prescription drugs. 6. Plaintiff's breach of warranty claims fail for lack of evidence and because Plaintiff did not comply with Texas' statutory notice requirements. 7. Plaintiff's gross negligence claim fails for lack of evidence and because Plaintiff has no basis to recovery exemplary damages. III. STATEMENT OF UNDISPUTED MATERIAL FACTS In support of its Motion for Summary Judgment, Lilly offers the following undisputed facts: Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 4 of 25 PageID #: 177 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 5 1. Effient was first approved as safe and effective by the FDA on July 10, 2009 (NDA 22- 307), and it is presently on the market.10 2. Effient is a prescription antiplatelet drug indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) for patients with unstable angina or non-ST-elevation myocardial infarction, or patients with ST-elevation myocardial infarction when managed with either primary or delayed PCI.11 3. Eli Lilly and Company holds the New Drug Application (NDA) for Effient.12 4. The use of Effient requires a doctor's prescription.13 5. Plaintiff alleges that decedent Jo Dean Weaver had a cardiovascular stent implanted in her body on or about October 15, 2011, and received Effient at the time of surgery, and thereafter by prescription, for its indicated purposes to prevent blood clots. According to Plaintiff, approximately five months later, she was diagnosed with multiple malignant tumors and subsequently died the following September 2012.14 6. Plaintiff has conducted no fact or expert discovery in this case. Further, Plaintiff has not designated any expert witnesses in this case to opine on medical causation, or any aspect or element of Plaintiff's claims against Lilly. IV. ARGUMENTS AND AUTHORITIES A. Summary Judgment Standard 10 Exhibit F: New Drug Application Approval Letter (NDA 22-307) for Effient from FDA. 11 Id. 12 Id. 13 Id. 14 See Exhibit A, ¶¶ 4.1-4.3. Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 5 of 25 PageID #: 178 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 6 Summary judgment shall be granted when the record shows that there is no genuine dispute as to any material fact and that the moving party is entitled to judgment as a matter of law. FED R. CIV. P. 56(a). The moving party has the initial burden of showing the lack of genuine issue, but it may do so by pointing out the absence of evidence to support one or more essential elements of the non-moving party’s claim. Celotex Corp. v. Catrett, 477 U.S. 317, 323- 25 (1986). Once the moving party meets the initial burden of showing there is no genuine dispute of material fact, the burden shifts to the non-moving party to come forward with specific facts and sufficient evidence demonstrating the existence of a genuine issue for trial. Fordoche, Inc. v. Texaco, Inc., 463 F.3d 388, 392 (5th Cir. 2006). A dispute regarding a material fact is "genuine" if the evidence is such that a reasonable jury could return a verdict in favor of the non-moving party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). "[W]hen the record taken as a whole could not lead a rational trier of fact to find for the nonmoving party, there is no 'genuine [dispute] for trial.'" Matsushita Elec. Indus. Co. v. Zenith Radio, 475 U.S. 574, 587 (1986). A court should view all disputed facts and inferences in favor of the non-moving party when ruling on a motion for summary judgment. Boudreaux v. Swift Transp. Co., Inc., 402 F.3d 536, 540 (5th Cir. 2005). However, "the court should not, in the absence of any proof, assume that the nonmoving party could or would prove the necessary facts." Painter Family Investments, LTD., L.L.P. v. Underwriters at Lloyds, 836 F. Supp. 2d 484, 489 (S.D. Tex. 2011). Further, the nonmoving party's burden “is not satisfied simply by creating some metaphysical doubt as to the material facts or by providing only conclusory allegations, unsubstantiated assertions or merely a scintilla of evidence.” Id. (citations omitted); Easton v. Thaler, 73 F.3d 1322, 1325 (5th Cir. 1996) (holding mere conclusory allegations are not competent summary judgment evidence, and thus are insufficient to defeat a motion for summary judgment); Forsyth v. Barr, 18 F.3d 1527, 1533 (5th Cir. 1994) (finding unsubstantiated assertions, improbably inferences, and unsupported Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 6 of 25 PageID #: 179 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 7 speculation are not competent summary judgment evidence). Instead, the Court should resolve factual controversies in favor of the nonmoving party “only when there is an actual controversy, that is, when both parties have submitted evidence of contradictory facts." Id. (citations omitted). If the non-moving party fails 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 should grant summary judgment. Celotex, 477 U.S. at 322-23. Here Plaintiff has not, and cannot, demonstrate the existence of genuine disputes on the material facts on his claims. Therefore, the Court is entitled to grant summary judgment in Lilly's favor. B. Plaintiff's Lack of Expert Testimony on Medical Causation is Fatal to All His Claims The entirety of Plaintiff's causes of action against Lilly in this case arise from Plaintiff's basic allegation that defects in Effient caused decedent Jo Dean Weaver to suffer medical injury in the form of multiple malignant tumors, which ultimately metastasized and caused her death.15 Causation is a required element of proof for each of Plaintiff's causes of action against Lilly in this case. See Horak v. Pullman, Inc., 764 F.2d 1092, 1095 (5th Cir. 1985) (concluding that Texas law requires proof of causation for product liability claims based on negligent and strict liability theories); Hyundai Motor Co. v. Rodriguez, 995, S.W.2d 661, 667 (Tex. 1999) ("Liability for breach of warranty requires a showing of proximate cause."); Wise v. SR Dallas, LLC, 436 S.W.3d 402, 409 (Tex. App.—Dallas 2014, no pet.) (explaining that fraud by affirmative misrepresentation or nondisclosure requires that an injury was caused by the affirmative misrepresentation or non-disclosure). Thus, in order to recover for any and all of his claims against Lilly, Plaintiff must prove that a defect in the prescription medication was a producing cause of the injury for which he 15 Exhibit A: Pl.'s Pet., Doc. No. 4 ¶ 4.1. Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 7 of 25 PageID #: 180 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 8 seeks recovery. Timpte Indus., Inc. v. Gish, 286 S.W.3d 306, 311 (Tex. 2009). To do so, Plaintiff must present expert testimony on the issue of medical causation. See Nissan Motor Co. v. Armstrong, 145 S.W.3d 131, 137 (Tex. 2004) (stating that the Texas Supreme Court has consistently required competent expert testimony and objective proof that a defect caused the condition complained of); Mack Trucks v. Tamez, 206 S.W.3d 572, 583 (Tex. 2006) (stating that proof other than expert testimony will constitute some evidence of causation only when a layperson’s general experience and common understanding would enable the layperson to determine from the evidence, with reasonable probability, the causal relationship between the event and the condition);16 Anderson v. Siemens Corp., 335 F.3d 466, 474 (5th Cir. 2003) (holding "ordinarily, expert testimony is needed to satisfy the reasonable medical probability standard for establishing a causal link."). Texas courts have also held that "highly technical matters of design and engineering require scientific, technical, and/or specialized knowledge.” Kallassy v. Cirrus Design Corp., 2006 WL 1489248, at *3 (N.D. Tex. May 30, 2006), aff’d, 265 F. App’x 165, 2008 WL 341581 (5th Cir. 2008). This requirement of expert testimony holds true regardless of the nature of Plaintiff’s claims. See, e.g., Ethicon Endo-Surgery, Inc. v. Gillies, 343 S.W.3d 205, 211 (Tex. App.—Dallas 2011, pet. denied) (stating that expert testimony is required in negligent marketing cases); FFE Transp. Services, Inc. v. Fulgham, 154 S.W.3d 84, 90 (Tex. 2004) (indicating that expert testimony is required in strict liability cases); Rangel v. Lapin, 177 S.W.3d 17, 22-23 (Tex. App.—Houston [1st Dist.] 2005, no pet.) (stating that expert testimony is required to prove elements of design and manufacturing defect claims); Champion v. Great Dane Ltd. P’hip, 286 S.W.3d 533, 538 (Tex. App.—Houston [14th Dist.] 2009, no pet.) (“Generally, the requirements 16 For example, Texas courts have held that expert medical testimony is required to establish medical causation in cases involving frostbite, fibromyalgia, and bronchiolitis obliterans organizing pneumonia. Hamburger v. State Farm Mut. Auto. Ins. Co., 361 F.3d 875, 885 (5th Cir. 2004) (citations omitted). Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 8 of 25 PageID #: 181 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 9 to prove a design defect necessitate competent expert testimony and objective proof that a defect caused the injury.”) (emphasis added). Despite these clear requirements under Texas law for expert testimony on the element of medical causation, Plaintiff did not designate an expert witness to present testimony critical to his claims. In fact, Plaintiff has done nothing to establish medical causation. This is fatal to all of Plaintiff's claims against Lilly. Moreover, it is well settled that, if “there are other plausible causes of the injury or condition that could be negated, the plaintiff must offer evidence excluding those causes with reasonable certainty.” Merrell Dow Pharms., Inc. v. Havner, 953 S.W.2d 706, 720 (Tex. 1997) (emphasis added). Here, of course, without the designation of any experts in this case, Plaintiff will be unable to offer any evidence that Effient caused Jo Dean Weaver's cancer and subsequent death, let alone any evidence excluding other plausible causes of such injuries and death. Plaintiff's claims undoubtedly require the jury to consider complex injuries and highly- technical details regarding the design and functionality of the drug Effient, decedent's physiological processes, and the circumstances surrounding her medical history and treatment, and the effect of these variables on decedent's medical prognoses and her ultimate cause of death. The purported causal link between Jo Dean Weaver's ingestion of Effient and her lung cancer diagnosis five months later, and subsequent death one year later, is beyond the jury's common understanding and experience. It is imperative that the common knowledge of the lay juror be supplemented with reliable expert testimony. Without expert testimony, Plaintiff lacks proof of the casual link between Plaintiff's purported injuries and the culpable conduct Plaintiff alleges against Lilly in this case, and Plaintiff has no legal basis to recover from Lilly under any of the causes of action asserted against Lilly. Therefore, summary judgment on the entirety of Plaintiff's claims is appropriate. Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 9 of 25 PageID #: 182 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 10 C. Plaintiff's Manufacturing Defect Claims Under Strict Liability and Negligence Theories Fail for Lack of Evidence To recover under a strict liability manufacturing defect claim, Plaintiff must prove that: (1) the product deviated from the specifications or planned output; (2) at the time it left the hands of Defendant; (3) in a way that rendered the product unreasonably dangerous; and (4) the defect was a producing cause of their injuries. See Ford Motor Co. v. Ledesma, 242 S.W.3d 32, 41-42 (Tex. 2007). Under a negligence theory, Plaintiff's manufacturing defect claim requires Plaintiff to prove: "(1) a legal duty owed to the plaintiff by the defendant, (2) a breach of that duty, and (3) damages to the plaintiff [that are] (4) 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). Further, Plaintiff must prove that the product was defective as a result of the manufacturing process. See Ford Motor Co. v. Miles, S.W.3d 309, 315 (Tex. App.–Dallas 2004, pet. denied). Plaintiff must provide expert testimony to support both his strict liability and negligent manufacturing claims against Lilly because the required elements of these claims are not "within the experience of the layman." Fulgham, 154 S.W.3d at 90 (finding expert testimony is required to prove manufacturing defect claims). Yet, Plaintiff lacks evidence of every element required to sustain his negligence and strict-liability manufacturing defect claims. Plaintiff has not designated any expert witnesses or put forth any expert testimony or reports on this case. Thus, Plaintiff has no evidence – expert or otherwise – to support the notion that the Effient that the decedent Jo Dean Weaver consumed deviated from Lilly's manufacturing "specifications or planned output," that any such manufacturing defect caused the Effient that decedent Jo Dean Weaver consumed to be unreasonably dangerous, or that any alleged manufacturing deviation constituted a breach of legal duty which proximately caused Plaintiff's alleged injuries. Given Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 10 of 25 PageID #: 183 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 11 this lack of evidence, Plaintiff cannot succeed on his manufacturing defect claims against Lilly under the theories of strict liability or negligence. Therefore, summary judgment is appropriate. D. Plaintiff's Marketing Defect Claims Under Strict Liability and Negligence Theories Fail for Lack of Evidence To recover under his strict liability marketing defect claim against Defendant, Plaintiff must prove that: (1) a risk of harm is inherent in the product or may arise from the intended or reasonably-anticipated use of the product; (2) Defendant actually knew or reasonably foresaw the risk of harm at the time they marketed the product; (3) the product possessed a marketing defect; (4) the absence of the warning or instructions rendered the product unreasonably dangerous to the user or consumer of the product; and (5) the failure to warn caused injury to the user of the product. See Olympic Arms, Inc. v. Green, 176 S.W.3d 567, 578 (Tex. App.—Houston [1st Dist.], 2004, no pet.). Moreover, expert testimony is necessary to prove strict liability marketing defect claims. See Ethicon Endo-Surgery, Inc. v. Gillies, 343 S.W.3d 205, 211 (Tex. App.— Dallas 2011, pet. denied). With regard to a negligent marketing defect, Plaintiff must prove the following elements: "(1) a duty by [Defendant] to act according to an applicable standard of care; (2) a breach of the applicable standard of care; (3) an injury; and (4) a causal connection between the breach of care and the injuries. Id. at 211. Plaintiff must also prove that the product was unreasonably dangerous or "defective." Id. at 211-12. Expert testimony is also required in negligent marketing cases. Id. at 212. In this case, Plaintiff has no factual evidence to support any of the essential elements of Plaintiff's strict liability marketing defect and negligent marketing or warning claims. Plaintiff is also unable to provide any expert evidence on these matters given that the deadline to do so has passed. As such, Plaintiff cannot succeed on these claims as a matter of law and summary judgment is appropriate. Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 11 of 25 PageID #: 184 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 12 E. Plaintiff's Design Defect Claims Under Strict Liability and Negligence Fail for Lack of Evidence To recover under a strict liability design defect claim, Plaintiff must prove that: (1) the product was defectively designed so as to render it unreasonably dangerous; (2) a safer alternative design existed; and (3) the defect was a producing cause of the injury for which Plaintiff seeks recovery. Timple Indus., Inc. v. Gish, 286 S.W.3d 306,311 (Tex. 2009). Moreover, Plaintiff must provide expert testimony in support of these elements because they are not "within the experience of a layman." Fulgham, 154 S.W.3d at 90 (internal citations omitted); see also Rangel v. Lapin, 177 S.W.3d 17, 22-23 (Tex. App. Houston [1st Dist.] 2005, no pet.) (stating that expert testimony is required to prove design and manufacturing defect claims; Honda of America Mfg. v. Norman, 104 S.W.3d 600, 608 (Tex. App.—Houston [1st Dist.] 2003, pet. denied) (reversing judgment because plaintiff presented no expert testimony of a safer alternative design for the product at issue). Moreover, to establish a safer alternative design, Plaintiff must establish at least three things: 1) that the purported alternative design was feasible at the time she was taking the product; 2) that the alternative design would have been prescribed by her doctor and would have been effective in treating her symptoms; and 3) that the alternative design would have somehow prevented her cancer. Plaintiff has no competent evidence of a safer alternative design. See Gerber v. Hoffmann-La Roche Inc., 392 F. Supp. 2d 907, 922 (S.D. Tex. 2005) (summary judgment in prescription drug case where plaintiff offered no evidence of a safer alternative design). In order to maintain a negligent design defect claim, Plaintiff must prove: (1) defendant owed Plaintiff a legal duty; (2) Defendant breached that duty; and (3) Plaintiff suffered damages; (4) proximately caused by the breach of the duty. Dewayne Rogers Logging, 299 S.W.3d at 385. Further, Plaintiff must also prove that the product at issue was defective. See Ford Motor Co. v. Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 12 of 25 PageID #: 185 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 13 Miles, 141 S.W.3d 309, 315 (Tex. App.—Dallas 2004, pet. denied). Expert testimony is required for Plaintiff to prove each of these elements. Fulgham, S.W.3d at 90 (internal citations omitted). Lilly is entitled to summary judgment because Plaintiff lacks expert testimony, or any other form of evidence, to support each necessary element of Plaintiff's strict liability and negligent design defect claims. F. Plaintiff's Breach of Express and Implied Warranty Claims Fail for Lack of Evidence and Because Plaintiff Did Not Comply with Texas' Statutory Notice Requirements To recover under a breach of express warranty claim, Plaintiff must prove (1) that Lilly sold Effient to Plaintiff; (2) there was an “affirmation of fact or promise” made by Lilly to Plaintiff relating to Effient that became “part of the basis of the bargain,” i.e. reliance (3) Effient did not comply with the representations (4) Plaintiff notified Lilly 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 identified or proven any affirmative representation made by Lilly or presented any evidence that Effient failed to comply with any representations; that Plaintiff notified Lilly of the breach; and Plaintiff suffered injury as a result of that breach. To recover under a breach of implied warranty claim, Plaintiff must prove that Effient 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 them injury. Id.; see also Polaris Indus. v. McDonald, 119 S.W.3d 331, 336 (Tex. App.—Tyler 2003, no pet.) (explaining that plaintiffs must prove that the product was Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 13 of 25 PageID #: 186 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 14 unmerchantable; plaintiffs notified the defendant of the breach; and plaintiffs 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 Effient was defective, unmerchantable, and unfit for ordinary purposes; Plaintiff notified Lilly of the breach; and Plaintiff suffered injury as a result of that breach. In further respect to notice requirements, in Texas, "the buyer must within a reasonable time after he discovers or should have discovered any breach notify the seller of breach or be barred from any remedy." Tex. Bus. & Com. Code § 2.607(c)(1). The burden of "alleging and proving proper notice" is on the buyer, and "[f]ailure to notify the seller of the breach, thereby allowing the seller an opportunity to cure, bars recovery on the basis of breach of warranty." Lochinvar Corp. v. Meyers, 930 S.W.2d 182, 189 (Tex. App. – Dallas 1996, no writ). Commencement of litigation does not satisfy the notice requirement. U.S. Tire-Tech, Inc. v. Boeran, B.V., 110 S.W.3d 194, 201-02 (Tex. App. – Houston [1st Dist.] 2003, writ ref'd n.r.e.). Because Plaintiff did not notify Lilly before suing for breach of warranty, Lilly is entitled to summary judgment on Plaintiff's breach of express and implied warranty claims. See McKay v. Novartis Pharmaceutical Corp., 751 F.3d 694, 707 (5th Cir. 2014). Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 14 of 25 PageID #: 187 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 15 G. Plaintiff's Failure to Warn Claims are Barred by the Presumption of Non-Liability Pursuant to Section 82.007 of the Texas Civil Practice and Remedies Code Plaintiff's claims of negligence, strict products liability and breach of warranties are precluded by the Texas Civil Practice and Remedies Code § 82.007, which established as a rebuttable presumption that pharmaceutical companies are not liable for failure to warn cases where the Federal Drug Administration ("FDA") approved the warnings accompanying the product. TEX. CIV. PRAC. & REM. CODE § 82.007(a)(1); Ebel v. Eli Lilly & Co., 536 F. Supp. 2d 767,774 (S.D. Tex. 2008), aff'd, 321 F. App'x 350 (5th Cir. 2009). Section 82.007 provides, in relevant part: (a) In a products liability action alleging that an injury was caused by a failure to provide adequate warnings or information with regard to a pharmaceutical product, there is a rebuttable presumption that the defendant or defendants, including a health care provider, manufacturer, distributor, and prescriber, are not liable with respect to the allegations involving failure to provide adequate warnings or information if: (1) the warnings or information that accompanied the product in its distribution were those approved by the United States Food and Drug Administration for a product approved under the Federal Food, Drug, and Cosmetic Act ... The Fifth Circuit has confirmed that the Texas Act "presumptively insulates from liability, for failure to warn, defendants who made, prescribe, or sell drugs in accord with FDA standards." Lofton v. McNeil Consumer & Specialty Pharm., 672 F.3d 372, 379 (5th Cir. 2012); see also Phares v. Actavis- Elizabeth LLC, 892 F. Supp. 2d 835, 846 (S.D. Tex. 2012) (holding "[b]ased on the applicable products liability statute and relevant case law," plaintiff could not prevail on any of her claims against defendant). Where claims fall within the ambit of the Texas Act and are not subject to an exception, they are barred as a matter of law. See Del Valle v. Pliva, Inc., 2012 WL 4747259, at *8 (S.D. Tex. Sept. 12, 2012) ("Even if the brand name defendants owed [plaintiff] a duty to warn, Texas statutes afford a presumption that any Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 15 of 25 PageID #: 188 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 16 warnings were adequate and lead to the inescapable conclusion that [plaintiff]'s claims should be dismissed."); Anderson v. Abbott Labs., 2012 WL 4512484, at *5-7 (N.D. Tex. Sept. 30, 2012) (dismissing with prejudice plaintiffs' product liability claims alleging injuries from the prescription medicine Humira under § 82.007(a) of the Texas Act). Here, the Texas Act applies to Plaintiff's claims in this action, which is a "products liability action alleging that an injury was caused by a failure to provide adequate warnings or information with regard to a pharmaceutical product." Tex. Civ. Prac. & Rem. Code § 82.007(a). In particular, Plaintiff alleges that Lilly "failed to include … proper warnings regarding the significant dangers and risks of death and serious injury" and "misrepresent[ed] and conceal[ed] the risks and dangers involving … Effient."17 It is undisputed that the FDA has approved Effient.18 The fact that Plaintiff has pled multiple causes of action does not remove any part of Plaintiff's action from the scope of Section 82.007. The presumption against liability broadly applies to all product liability actions, whether the plaintiff's asserted causes of action are "based in strict tort liability, strict products liability, negligence, misrepresentation, breach of express or implied warranty, or any other theory or combination of theories." TEX. CIV. PRAC. & REM. CODE § 82.001(2). In short, "if a claim is based upon [a product's] labeling, its omissions, or inaccuracies, it falls under the purview of the . . . Texas Civil Practices and Remedies Code provision[]." Del Valle v. Qualitest Pharms., Inc., No. B-11-113, 2012 WL 2899406, at *2 (S.D. Tex. June 22, 2012) (recognizing that "Texas law groups all inadequate warning causes of action together regardless of how they are pleaded"). Thus, the presumption encompasses all of Plaintiff's causes of action, regardless of their labels or legal theories, including negligence, strict 17 See e.g., Exhibit A: Pl.'s Pet., Doc. No. 4 ¶¶ 4.4, 5.3, 8.1-8.6. 18 Exhibit F: New Drug Application Approval Letter (NDA 22-307) for Effient from FDA; Exhibit D: Pl.'s Unopp. Mot. for Cont., Doc. No. 17, ¶ 1. Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 16 of 25 PageID #: 189 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 17 liability marketing, and breach of warranties, because they are all premised on Lilly's alleged failure to provide adequate warnings with regard to the alleged risks of Effient. See, e.g., Jackson v. Wyeth LLC, 2015 WL 363513, at * 1 (S.D. Tex. Tan. 27, 2015) ("[The Texas Act] applies, regardless of the theory of liability that Plaintiff pleads.").19 Plaintiff's allegations of negligent and strict liability design defect are also subject to the Texas Act, in addition to being independently preempted by federal law,20 since Texas law provides that a design defect claim with regard to a prescription medication requires proof of a failure to warn. See Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1274-75 (5th Cir. 1974).21 Plaintiff has not pled or proved, nor can he, the applicability of any exception to Section 82.007. Section 82.007 provides that the presumption against liability can be rebutted in only five narrow circumstances by establishing that: (1) the manufacturer withheld from or misrepresented to the FDA required information that was material and relevant to the 19 A Plaintiff's failure to warn claims, although labeled as negligence, strict liability and breach of warranty, are nonetheless subject to the statutory presumption of non-liability found in Section 82.007 and the learned intermediary doctrine. See Del Valle v. Qualitest Pharms. Inc., 2012 WL 2899406, *2 (S.D. Tex. June 22, 2012), appeal dismissed in part, No. 12-41148, 2012 WL 4747259 (5th Cir. Feb. 5, 2012) (finding that "presumption of no liability applies regardless of how the cause of action is framed"); see also Murthy, 847 F. Supp.2d at 958, 977 (S.D. Tex. 2012) (holding that because plaintiff's "strict liability and breach of warranty claims are premised on failure to warn, they must be dismissed pursuant to § 82.007(a)"). 20 The Supreme Court recently recognized in Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), that "[o]nce a drug—whether generic or brand name—is approved, the manufacturer is prohibited from making any major changes to the 'qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application."' Id. at 2471 (quoting 21 C.F.R. § 314.70(b)(2)(i)). Accordingly, state-law design defect claims that would require a brand name manufacturer to alter the chemical composition of the medication necessarily conflict with federal law and are preempted under Bartlett. See Yates v. Ortho-McNeil Pharm., Inc., 2015 WL 66423, at *5-7 (N.D. Ohio Jan. 5, 2015); Booker v. Johnson &Johnson, 2014 WL 5113305, at *4-5 (N.D. Ohio Oct. 10, 2014); Amos v. Biogen Idec Inc., 28 F. Supp. 3d 164, 169 (W.D.N.Y. 2014). 21 As Reyes makes clear, Texas has adopted comment k to Section 402A of the Restatement (Second) of Torts, which provides that "an unavoidably unsafe product is neither defective nor unreasonably dangerous if such a product is properly prepared, and is accompanied by proper directions and warning." Reyes, 498 F.2d at 1274 (internal quotation marks omitted). "Under Texas law, all FDA-approved prescription drugs are unavoidably unsafe as a matter of law." Carter v. Tap Pharm., Inc., 2004 WL 2550593, at *2 (W.D. Tex. Nov. 2, 2004). Thus, a plaintiff in Texas cannot prevail on a design defect claim against the manufacturer of a prescription medication unless he proves a failure to warn. See, e.g., Gerber v. Hoffmann-La Roche Inc., 392 F. Supp. 2d 9Q7, 922 (S.D. Tex. 2005); McKay v. Novartis Pharm. Corp., 934 F.Supp.2d 898 (W.D. Tex. Mar. 28, 2013), aff'd, 751 F.3d 694, 707 (5th Cir. 2014). Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 17 of 25 PageID #: 190 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 18 performance and causally related to the claimant's injury;22 or (2) the medication was sold or prescribed after the FDA ordered a withdrawal or withdrew the medication's application; (3) the manufacturer recommended, promoted, or advertised the medication for an off-label use, it was prescribed for that off-label use, and the claimant's injury was causally related to the off-label prescription; (4) a defendant physician prescribed the medication for an off-label use, it was prescribed for that off-label use, and the claimant's injury was causally related to the off-label prescription; or (5) the manufacturer made an illegal payment to an FDA official or employee that caused the warning to be inadequate. Tex. Civ. Prac. & Rem. Code § 82.007(b)(1)-(5). The second, third, fourth and fifth bases for presumption are easily rejected here. It is undisputed that the FDA has never revoked Effient's approval or ordered it to be withdrawn from the market. (See § 82.007(b)(2)). Plaintiff's own Petition confirms that Jo Dean Weaver was prescribed Effient by her physician for an indicated use, i.e., to prevent blood clots following a cardiovascular stent implantation.23 (See § 82.007(b)(3)). Lilly is not a physician defendant. (See § 82.007(b)(4)). And, Plaintiff does not allege or provide any evidence that Lilly paid an FDA employee to gain approval for Effient. (See § 82.007(b)(5)). Moreover, Plaintiff has not pled, nor can he establish the "fraud-on-the-FDA exception" exception under § 82.007(b)(1). Under the U.S. Supreme Court's decision in Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001), a claim that a manufacturer committed fraud on the FDA is impliedly preempted by the federal Food, Drug, and Cosmetic Act. See id. at 350-53. In Lofton, the Fifth Circuit applied this holding to the Texas Act, ruling that "because § 82.007(b)(1) requires a Texas plaintiff to prove fraud-on-the-FDA to recover for failure to warn, this requirement invokes federal law supremacy according to Buckman." Lofton, 672 F.3d at 379. Thus, under the 22 See Loftin v. McNeil Consumer and Specialty Pharms., 672 F.3d 372, 380 (5th Cir. 2012) (holding that TEX. CIV. PRAC. & REM. § 82.007(b)(1) is preempted by federal law "unless the FDA itself has found fraud."). 23 Exhibit A: Pl.'s Pet., Doc. No. 4, ¶¶ 4.1-4.3. See also Pl.'s Pet., ¶ 7.3 ("Jo Dean Weaver used the antiplatelet drug Effient for its intended and foreseeable purpose."). Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 18 of 25 PageID #: 191 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 19 Texas Act, a plaintiff can satisfy the fraud-on-the-FDA exception only if "the FDA itself finds fraud." Lofton, 672 F.3d at 381 (emphasis added); see also Lashley v. Pfizer, Inc., 750 F.3d 470, 478 (5th Cir. 2014) ("[T]he FDA has not made such a finding [of fraud] and, therefore, that avenue for overturning the brand defendants' presumption of non-liability is foreclosed to [plaintiff]."); Jackson v. Wyeth LLC, 2015 WL 363513, at *2 (S.D. Tex. Jan. 27, 2015) ("[I]t is now well-established that, to prove such fraud-on-the-FDA, the Plaintiff must show that the FDA, itself, has pursued Defendants and prevailed on such claims ...."). Here, Plaintiff does not allege, nor can he, that Lilly fraudulently obtained FDA approval for Effient, much less that the FDA has ever made a determination of fraud regarding Effient. As a result, Plaintiff cannot establish the fraud-on-the-FDA exception to the presumption of the Texas Act. Therefore all of Plaintiff's claims based on Lilly's alleged failure to warn of Effient's dangerous side effects must be dismissed. This includes Plaintiff's claims for negligence, strict liability, and breach of warranty. H. Plaintiff's Design Defect Claims are Not Viable Pursuant to § 402A, Comment k of the Restatement (Second) of Torts Plaintiff's design defect claims are be barred as a matter of law pursuant to Comment k to § 402A, of the Restatement (Second) of Torts. Under Texas law, prescription drugs cannot be defective or unreasonably dangerous based on its design. Generally, a product is defectively designed under Section 402A if it is unreasonably dangerous taking into consideration its utility and the risks involved in its use. Am. Tobacco Co., Inc. v. Grinnell, 951 S.W.2d 420, 432 (Tex. 1997). However, prescription drugs present a unique issue. By their nature, such medications may cause adverse events; yet, they can also bring significant benefits when properly used. For this reason, they are only available by prescription by a licensed healthcare provider: Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can take into account the Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 19 of 25 PageID #: 192 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 20 propensities of the drug, as well as the susceptibilities of the patient. His is the task of weighing the benefits of any medication against its potential dangers. Wyeth-Ayerst Labs. Co. v. Medrano, 28 S.W.3d 87, 91 (Tex. App.—Texarkana 2000, no pet.) (quoting Reyes v. Wyeth Labs., 498 F.2d 1264, 1276 (5th Cir. 1974)). Comment k to Section 402A recognizes that "[t]here are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use" on a risk-free basis. RESTATEMENT (SECOND) OF TORTS § 402A cmt. k (1965).24 As the well-known “comment k” explains, an unavoidably unsafe product that is “properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.” Id.25 “Texas courts apply comment k to product liability claims,” and, thus far, have applied it specifically to design defect “prescription drug claims.” Hackett v. G.D. Searle & Co., 246 F.Supp.2d 591, 595 (W.D. Tex. 2002) (citing Reyes v. Wyeth Labs., 498 F.2d 1264, 1273–75 (5th Cir. 1974)). Moreover, the Texas Supreme Court has recognized and approved comment k. See Crocker v. Winthrop Labs., Division of Sterling Drug, Inc., 514 S.W.2d 429, 432-33 (Tex. 1974) (citing comment k with approval); see also Hackett, 246 F.Supp.2d at 595; Holland v. Hoffman-La Roche, Inc., No. 3-06-CV-1298-RD, 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007). 24 Comment k specifically states: k. Unavoidably unsafe products. 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. These are especially common in the field of drugs. . . . Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician . . . . The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be 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 but apparently reasonable risk. RESTATEMENT (SECOND) OF TORTS § 402A cmt. k (1965) (emphasis in original). 25 Note that Plaintiff cannot rebut the presumptions of non-liability for adequacy of warnings under Section 82.007. TEX. CIV. PRAC. & REM. CODE § 82.007(a)(1) Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 20 of 25 PageID #: 193 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 21 The policy behind barring design defect claims against prescription products is that allowing such suits would “provide a disincentive to companies to develop” new products and would allow juries to “second-guess” FDA. Hackett, 246 F.Supp.2d at 595; see also Holland, 2007 WL 4042757, at *3 (“Prescription drugs are not susceptible to a design defect claim where, as here, the drug is ‘accompanied by proper directions and warning.’”) (citing Hackett, 246 F.Supp.2d at 595). This reasoning powerfully applies here. For these reasons, Lilly maintains that the only potentially viable claims against a prescription drug maker are for a manufacturing defect (i.e., contamination or mis-formulation) or a marketing defect (i.e., failure to warn or inadequate warning), neither of which are viable here for the reasons outlined in this Motion. See Hackett v. G.D. Searle &Co., 246 F. Supp.2d 591, 595 (W.D. Tex. 2002). Plaintiff does not dispute that Effient is a prescription drug. Therefore, Plaintiff's negligent design and design defect claims are not viable under Section 402A, comment k of the Restatement (Second), and summary judgment is appropriate. I. Plaintiff's Failure to Warn Claims Fail Under the Learned Intermediary Doctrine Each of Plaintiff's causes of action premised on failure to warn allegations, whether sounding in negligence, strict liability, or breach of express or implied warranty, fail under the learned intermediary doctrine.26 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, 153-154 (Tex. 2012) (“[W]e hold that a 26 Like the negligent and strict liability failure to warn/marketing 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 under Texas law). Accordingly, Lilly is entitled to summary judgment on those grounds. See also Lofton v. McNeil Consumer & Specialty Pharm., 682 F.Supp.2d 662, 675-76 (N.D. Tex. 2010), aff'd 672 F.3d 372 (5th Cir. 2012); Ebel v. Eli Lilly & Co., 536 F. Supp.2d 767, 773 (S.D. Tex. 2008) (refusing to allow plaintiff to plead around learned intermediary doctrine by recasting failure to warn claims as claims for marketing defect, breach of warranty and negligence and finding that "[w]here the crux of the suit is based on a failure to adequately warn, the learned intermediary doctrine may apply to strict liability, negligence, misrepresentation, and breach of warranty claims). Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 21 of 25 PageID #: 194 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 22 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). When, as is the case here, a "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." Guzman, 20 S.W.3d at 720 n.2. Thus, a manufacturer may be 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 decedent's physician of a risk associated with the use of the product not otherwise known to him or her; and (2) that the alleged failure to warn the physician was both a cause in fact and a proximate cause of decedent's injuries. Id. at 170. 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. Id.; 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.” Centacor, 372 S.W.3d. at 170 (emphasis added); see also Smith v. Johnson & Johnson, 483 Fed. Appx. 909, 913-14 (5th Cir. 2012). Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 22 of 25 PageID #: 195 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 23 Plaintiff is unable to establish that Jo Dean Weaver's prescribing physicians were inadequately warned of, or was otherwise unaware of, the risks associated with Effient; that the prescribing physicians actually relied on warnings from Lilly; that any proposed revised Effient warning would have informed the physicians of risks that were otherwise unknown to them; that a different Effient warning would have caused her prescribing physicians not to prescribe Effient to her. In short, Plaintiff has not put forth any evidence indicating that any change in Lilly's conduct would have altered the course of decedent's medical treatment or avoided her fatal medical condition. Without some evidence demonstrating the causal link between Plaintiff's injuries and Lilly's alleged culpability, summary judgment should be granted in Lilly's favor. J. Plaintiff's Gross Negligence Claim Fails for Lack of Evidence and Plaintiff Has No Basis to Recovery Exemplary Damages Plaintiff bases his entitlement to recover exemplary damages solely on his allegation that Lilly's conduct "constitutes gross negligence, which was a proximate cause of Jo Dean Weaver's death and Plaintiff's damages."27 Texas law provides that an award for exemplary damages is justified only upon proving fraud, malice, or gross negligence by clear and convincing evidence. TEX. CIV. PRAC. & REM. CODE ANN. § 41.003. The term "clear and convincing" means "the measure or degree of proof that will produce in the mind of the trier of fact a firm belief or conviction as to the truth of the allegations sought to be established." TEX. CIV. PRAC. & REM. CODE ANN. § 41.001(2). This burden of proof may not be shifted to Defendant and is not satisfied by evidence of ordinary negligence. TEX. CIV. PRAC. & REM. CODE ANN. § 41.003(b). A plaintiff can recover exemplary damages for harm that results from gross negligence only by showing (1) the act or omission, when viewed objectively from defendant’s standpoint at the time it occurred, involved an extreme degree of risk, considering the probability and 27 Exhibit A: Pl.'s Pet., Doc. No. 4 ¶¶ 11.1, 14.1. Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 23 of 25 PageID #: 196 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 24 magnitude of the potential harm to others, and (2) the defendant had actual, subjective awareness of the risk, but still proceeded with a conscious indifference to the rights, safety, or welfare of others. TEX. CIV. PRAC. & REM. CODE §41.001(11); Coastal Transp. Co. v. Crown Cent. Pet. Corp., 136 S.W.3d 227, 231 (Tex. 2004). Plaintiff cannot present any evidence – let alone that which satisfies the heightened clear and convincing standard – that Lilly acted with gross negligence to support a recovery of exemplary damages. To the contrary, it is uncontroverted that Lilly adhered to all FDA requirements and obtained FDA approval for Effient with full knowledge of the potential benefits and risks.28 Therefore, there is no evidence to support gross negligence or an award of exemplary damages and summary judgment is warranted on the issue of gross negligence and punitive damages as a matter of law. V. CONCLUSION For the foregoing reasons, Lilly respectfully requests the Court to grant its Motion for Summary Judgment and dismiss, with prejudice, each of Plaintiff's claims and causes of action against Lilly. 28 See Exhibit F. Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 24 of 25 PageID #: 197 DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT AND BRIEF IN SUPPORT PAGE 25 Respectfully submitted, /s/ Dawn Shawger McCord WAYNE B. MASON State Bar No. 13158950 wayne.mason@sedgwicklaw.com DAWN SHAWGER MCCORD State Bar No. 24002934 dawn.mccord@sedgwicklaw.com SEDGWICK LLP 1717 Main Street, Suite 5400 Dallas, TX 75201 (469) 227-8200 (telephone) (469) 227-8004 (facsimile) ATTORNEYS FOR DEFENDANT ELI LILLY AND COMPANY CERTIFICATE OF SERVICE I hereby certify that a true and correct copy of the above and foregoing document has been electronically filed with the Clerk of the Court using the Court's ECF system and has served on counsel of record via the Court’s ECF filing system on this the 31st day of October, 2016. /s/ Dawn Shawger McCord Dawn Shawger McCord Case 4:14-cv-00665-KPJ Document 21 Filed 10/31/16 Page 25 of 25 PageID #: 198 Case 4:14-cv-00665-RAS Document 4 Filed 10/17/14 Page 1 of 11 PageID #: 56 Filed: 9/2/2014 7:15:09 PM AndreaS. Thompson District Clerk CAUSE NO. 416-03365-2014 Collin County, Texas By Pam English Deputy Envelope ID: 2354582 GENE WEAVER, § IN THE DISTRICT COURT Individually, and as Personal § Representative of the ESTATE OF § JO DEAN WEAVER, deceased, and on § behalf of ALL PERSONS ENTITLED § TO RECOVER FOR THE WRONGFUL § DEATH OF JO DEAN WEAVER § § JUDICIAL DISTRICT Plaintiffs, § § vs. § § ELI LILLY AND COMPANY; § Defendant § COLLIN COUNTY, TEXAS PLAINTIFF'S ORIGINAL PETITION AND REQUESTS FOR DISCLOSURES TO THE HONORABLE COURT: Plaintiff, GENE WEAVER, individually, and as Personal Representative ofthe Estate of JO DEAN WEAVER, and on behalf of all those entitled to recover for the wrongful death of Jo Dean Weaver, hereby files his original petition and complains ofDefendant Eli Lilly and Company. I. Discovery Level 1.1 Plaintiff requests that the Court assign this case a Level 3 discovery control plan. II. Parties 2.1 Plaintiff Gene Weaver is an individual residing in Collin County, Texas, and is a surviving spouse and Personal Representative of the Estate of Jo Dean Weaver. He brings suit Page 1 of 11 Case 4:14-cv-00665-KPJ Document 21-1 Filed 10/31/16 Page 1 of 11 PageID #: 199 Case 4:14-cv-00665-RAS Document 4 Filed 10/17/14 Page 2 of 11 PageID #: 57 individually for the wrongful death damages he suffered as a result of his wife's wrongful death. As personal representative of Jo Dean Weaver's Estate, he is bringing the Estate survival claims. Gene Weaver also brings suit for and on behalf of all those entitled to recover for Jo Dean Weaver's death, under the Texas and Wrongful Death Act. 2.2 At the time of death, Jo Dean Weaver resided in Frisco, Collin County, Texas. 2.3 Defendant Eli Lilly Company is a corporation organized under the laws of the State of Indiana with its headquarters in Indianapolis, Indiana. Eli Lilly and Company is a global pharmaceutical company with market leading positions in pharmaceuticals, including medications in oncology, cardiovascular, diabetes, critical care, neuroscience, men's health and musculoskeletal fields This company is engaged in business of designing, manufacturing, marketing, distributing, selling and otherwise placing into the stream of commerce the cardiovascular/antiplatelet drug Prasugrel, known by its trade name "Effient" throughout the United States, including Texas. Accordingly, this party will be referred to as "Defendant." Eli Lilly and Company does routine and substantial business in the State of Texas, and derives substantial revenues from its business activities in Texas, but does not maintain a registered agent for service of process. Under Texas Civil Practice and Remedies Code§ 17.044, the Texas Secretary of State is the agent for service of process on Eli Lilly and Company because it is a foreign corporation that engages in business in Texas but does not maintain a regular place of business in Texas, or a designated agent for service of process, and this proceeding arises out of business done in Texas to which this Defendant is a party; and, also, because this defendant is required by statute to designate or maintain an agent for service of process and engages in business in Texas but has not maintained or designated a registered agent for service of process. III. Page 2 of 11 Case 4:14-cv-00665-KPJ Document 21-1 Filed 10/31/16 Page 2 of 11 PageID #: 200 Case 4:14-cv-00665-RAS Document 4 Filed 10/17/14 Page 3 of 11 PageID #: 58 Venue and Jurisdiction 3.1 Venue is proper in Collin County under Texas Civil Practice & Remedies Code § 15.033 because this is a suit for breach of warranty against a manufacturer of consumer goods (anti platelet therapy drug Prasugrel, known by its trade name "Effient" intended for personal use and which Jo Dean Weaver purchased and took for personal use). Venue is also proper as to Plaintiffs claims against Defendant under Texas Civil Practice & Remedies Code§ 15.005 because all of Plaintiff's claims arise from the same occurrence or transaction or series of occurrences or transactions, the injuries to and death of Jo Dean Weaver. 3.2 This Court has subject matter jurisdiction over this civil action because Plaintiff seeks damages far exceeding the minimal jurisdictional limits of the Court. 3.3 The Court has specific and general personal jurisdiction over Defendant because they purposely availed themselves of the privilege of conducting activities within Texas; they have substantial and continuous contacts with the State of Texas, generally and with respect to this action, to satisfy both general and specific minimum contacts; and exercising jurisdiction over them does not offend the traditional notions of fair play and substantial justice. 3.4 Plaintiff seeks damages far exceeding $75,000, and jurisdiction is proper. IV. Background Facts 4.1 On September 3, 2012, Jo Dean Weaver died from multiple metastasis of malignant tumors caused by the defective drug "Effient" designed, manufactured, marketed, distributed, sold and otherwise placed in the stream of commerce by Defendant Eli Lilly and Company. 4.2 On or about October 15, 2011, Jo Dean Weaver underwent cardiovascular stent implantation and received the drug "Effient" at the time of surgery, and subsequently by Page 3 of 11 Case 4:14-cv-00665-KPJ Document 21-1 Filed 10/31/16 Page 3 of 11 PageID #: 201 Case 4:14-cv-00665-RAS Document 4 Filed 10/17/14 Page 4 of 11 PageID #: 59 prescription, to prevent blood clots from forming. She took the drug "Effient" pursuant to all instructions of the Defendant, Eli Lilly and Company. 4.3 After approximately five months on the "Effient" drug therapy, she was diagnosed with multiple malignant tumors, and died as a result of those multiple tumors and their metastases the following September of2012. 4.4 Defendant knew or had reason to know, prior to Jo Dean Weaver's death, of the significant danger or risk of its drug "Effient" which had been proven to cause tumor growth and/or enhanced metastasis of malignant tumors. Nevertheless, Defendant took no steps or took insufficient steps to reduce those dangers and failed to advise consumers such as Gene and Jo Dean Weaver of the significant risks involved. CAUSES OF ACTION AGAINT ELI LILLY AND COMPANY V. Negligence 5.1 Defendant committed acts of omission and commission, which collectively and severally constituted negligence, which was a proximate cause of the death of Jo Dean Weaver and Plaintiffs damages. 5.2 Defendant owed J o Dean Weaver the duty to exercise reasonable care in the designing, manufacturing, marketing, testing, labeling, distributing, selling and placing into the stream of commerce the drug "Effient". Defendant further owed the duty to exercise ordinary care to prevent users such as Jo Dean Weaver from suffering malignant tumor growth and metastasis when taking "Effient" as directed for its intended purpose. Defendant breached these duties and proximately caused Jo Dean Weaver's death and Plaintiffs damages. 5.3 Defendant's conduct constituting negligence included without limitation: Page 4 of 11 Case 4:14-cv-00665-KPJ Document 21-1 Filed 10/31/16 Page 4 of 11 PageID #: 202 Case 4:14-cv-00665-RAS Document 4 Filed 10/17/14 Page 5 of 11 PageID #: 60 a. failing to remove its anti platelet drug "Effient" from the market when it knew or should have known of the likelihood of serious injury and death to its users; b. continuing to market and sell its anti platelet drug "Effient" when it knew or should have known of the likelihood of death and serious injury to its users and without providing sufficient post-sale warnings; c. failing to use ordinary care in the designing, manufacturing, marketing, testing, labeling, selling, distributing, and placing into the stream of commerce the anti platelet drug "Effient" so as to prevent and minimize the likelihood of death and serious injury to its users; d. failing to include with its anti platelet drug "Effient" proper warnings regarding the significant dangers and risks of death and serious injury; e. failing to adequately monitor and respond to reports of malignant tumors associated with the use of "Effient"; f. negligently misrepresenting and concealing the risks and dangers involving Defendant's antiplatelet drug "Effient", on which Jo Dean Weaver and relied to her detriment. VI. Strict Labeling: Design Defect 6.1 At all pertinent times, Defendant was engaged in the business of designing, manufacturing, marketing, testing, labeling, selling, distributing, and placing the anti platelet drug "Effient" into the stream of commerce. Page 5 of 11 Case 4:14-cv-00665-KPJ Document 21-1 Filed 10/31/16 Page 5 of 11 PageID #: 203 Case 4:14-cv-00665-RAS Document 4 Filed 10/17/14 Page 6 of 11 PageID #: 61 6.2 When it left the control of the Defendant, the design and formulation of the antiplatelet drug "Effient" rendered it defective and unreasonably dangerous in that it was prone to cause tumor growth or metastasis. 6.3 The antiplatelet drug "Effient" reached Jo Dean Weaver in the condition expected and intended by the Defendant. 6.4 Jo Dean Weaver used the drug "Effient" for its intended and foreseeable purpose. 6.5 There were safer alternative designs and formulations other than the one used, which were economically and technological feasible and would have prevented or significantly reduced the risk of injury in question. 6.6 The defective design of Defendant's antiplatelet drug "Effient" directly and proximately caused Jo Dean Weaver's death and Plaintiffs damages. VI. Strict Liability: Manufacturing Defect 7.1 At all pertinent times, Defendant was engaged in the business of designing, manufacturing, marketing, testing, labeling, selling, distributing, and placing the anti platelet drug "Effient" into the stream of commerce, including the drug consumed by Jo Dean Weaver. 7.2 When it left the control of the Defendant, defects in the manufacture of the antiplatelet drug "Effient" rendered it defective and unreasonably dangerous in that is was prone to cause tumor growth and/or metastasis. 7.3 Jo Dean Weaver used the antiplatelet drug "Effient" for its intended and foreseeable purpose. 7.4 The defective manufacture of Defendant's antiplatelet drug "Effient" directly and proximately caused Jo Dean Weaver's death and Plaintiffs damages. VII. Page 6 of 11 Case 4:14-cv-00665-KPJ Document 21-1 Filed 10/31/16 Page 6 of 11 PageID #: 204 Case 4:14-cv-00665-RAS Document 4 Filed 10/17/14 Page 7 of 11 PageID #: 62 Strict Liability: Marketing Defect 8.1 At all pertinent times, Defendant was engaged in the business of designing, manufacturing, marketing, testing, labeling, selling, distributing, and placing the anti platelet drug "Effient" into the stream of commerce, including the drug "Effient" that caused Jo Dean Weaver's cancer and death. 8.2 When it left the control of Defendant, the drug "Effient" was defective and unreasonably dangerous because it contained warnings insufficient to alert users such as Jo Dean Weaver and her care givers of the dangers and risks associated with its use, including, but not limited to the risk of malignant tumor growth, metastasis and death. 8.3 Defendant failed to give adequate warnings of such risks, which were known or by the application of reasonably developed human skill and foresight should have been known. Defendant further failed to give adequate instructions to avoid such dangers, which failure rendered the product unreasonably dangerous as marketed. 8.4 Defendant's failure to provide adequate warnings and instruction rendered its antiplatelet drug "Effient" dangerous to an extent beyond which that would be contemplated by an ordinary user with an ordinary knowledge common to the community as to the product's characteristics. 8.5 Jo Dean Weaver used the antiplatelet drug "Effient" for its intended and foreseeable purpose. 8.6 The defective marketing of Defendant's antiplatelet drug "Effient" directly and proximately caused Jo Dean Weaver's death and Plaintiffs damages. IX. Breach of Express Warranty Page 7 of 11 Case 4:14-cv-00665-KPJ Document 21-1 Filed 10/31/16 Page 7 of 11 PageID #: 205 Case 4:14-cv-00665-RAS Document 4 Filed 10/17/14 Page 8 of 11 PageID #: 63 9.1 Defendant expressly warranted to Jo Dean Weaver and her care givers by and through statements made by this Defendant or their authorized agents or sales representatives, orally and in publications, package inserts and other written materials intended for physicians, medical patients, and the general public that their anti platelet drug ''Effient" was safe, effective, fit and proper for their intended use. 9.2 Defendant's breach of these express warranties proximately caused Jo Dean Weaver's death and Plaintiffs damages. X. Breach of Implied Warranty 10.1 At the time Defendant designed, developed, manufactured, marketed, sold, supplied and/or distributed their antiplatelet drug "Effient," they knew of the use for which such drugs were intended and implicitly warranted the drugs to be of merchantable quality and safe and fit for its intended use. 10.2 Jo Dean Weaver and her care givers reasonably relied upon the skill and judgment of Defendant as to whether its drug "Effient" was of merchantable quality and safe and fit for their intended, reasonably foreseeable and/or ordinary use. 10.3 In breach of the implied warranties given by Defendant, the drug "Effient" was neither or merchantable quality nor safe or fit for their intended, reasonably foreseeable and/or ordinary use because it was and is unreasonably dangerous and unfit for the intended, reasonably foreseeable and/or ordinary purpose for which it was to be used due to the defects described above. 10.4 Defendant's breach of implied warranty proximately caused Plaintiffs injuries and damages. XI. Page 8 of 11 Case 4:14-cv-00665-KPJ Document 21-1 Filed 10/31/16 Page 8 of 11 PageID #: 206 Case 4:14-cv-00665-RAS Document 4 Filed 10/17/14 Page 9 of 11 PageID #: 64 Gross Negligence 11.1 Defendant's conduct constitutes gross negligence, which was a proximate cause of Jo Dean Weaver's death and Plaintiffs damages, for which Plaintiff is entitled to recover punitive damages. Defendant knew of the risks and dangers associated with the formulation, manufacture, and marketing of its drug "Effient". Nevertheless, Defendant concealed these risks and dangers and sold its drug "Effient" for use by unsuspecting persons such as Jo Dean Weaver. DAMAGES XII. Actual Damages 12.1 As a result of the injuries to and death of Jo Dean Weaver, her estate sustained survival damages including without limitation conscious physical pain and mental anguish suffered by her prior to her death as well as reasonable medical and funeral expenses. 12.2 As a result of the injuries to and death of Jo Dean Weaver, her husband Gene Weaver has suffered wrongful death damages including without limitation past and future pecuniary loss, loss of companionship and society, mental anguish, and loss of inheritance. 12.3 Gene Weaver further pleads, on behalf of all of persons entitled to recover for the wrongful death of Jo Dean Weaver, if any, for all wrongful death damages recoverable under the Texas Wrongful Death Act. XIII. Pre-Judgment and Post-Judgment Interest 13.1 Plaintiff seeks pre-judgment and post-judgment interest at the maximum legal rate. XIV. Exemplary Damages Page 9 of 11 Case 4:14-cv-00665-KPJ Document 21-1 Filed 10/31/16 Page 9 of 11 PageID #: 207 Case 4:14-cv-00665-RAS Document 4 Filed 10/17/14 Page 10 of 11 PageID #: 65 14.1 Because Defendant is guilty of gross negligence, it should have punitive damages assessed against it and awarded to Plaintiff in an amount deemed appropriate by the jury. XV. Jury Demand 15.1 Plaintiff requests a jury trial and have paid the jury fee. XVI. Conditions Precedent 16.1 Pursuant to Rule 54 of the Texas Rules of Civil Procedure, all conditions precedent to Plaintiffs rights to recover herein and to Defendant's liability have been performed or have occurred. XVII. Request for Disclosures 17.1 Pursuant to Rule 194 of the Texas Rules of Civil Procedure, Plaintiff requests that Defendant disclose, within 50 days of service of their request, the information and material described in Rule 194.2(a) through (1). XVIII. Prayer 18.1 WHEREAS, PREMISES CONSIDERED, Plaintiff prays that Defendant be cited to appear and answer herein, that this cause be set for trial before a jury, and that Plaintiff recover judgment of and from Defendant for actual and exemplary damages in such an amount as the evidence may show and the jury may determine to be proper, together with all interest, costs of suit, and such other and further relief to which Plaintiff may show himself to be justly entitled, whether at law or in equity. Page 10 of 11 Case 4:14-cv-00665-KPJ Document 21-1 Filed 10/31/16 Page 10 of 11 PageID #: 208 Case 4:14-cv-00665-RAS Document 4 Filed 10/17/14 Page 11 of 11 PageID #: 66 Respectfully submitted, SHELLY COOK HOUGHTON By: jsj Shelly Cook Houghton Shelly Cook Houghton Texas State Bar No. 04747250 4100 Stanhope Avenue, Suite No.1 Dallas, Texas 75205 Phone: (214) 649-3307 Fax: (214) 956-0211 shellylcook@aol. com ATTORNEY FOR PLAINTIFF Page 11 of 11 Case 4:14-cv-00665-KPJ Document 21-1 Filed 10/31/16 Page 11 of 11 PageID #: 209 UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS SHERMAN DIVISION GENE WEAVER § § Plaintiff, § § VS. § CASE NO. 4:14CV665 § ELI LILLY AND COMPANY § § Defendant. § SCHEDULING ORDER After reviewing the report from the parties required by Fed. R. Civ. P. 26(f) and after consulting with the parties by mail or a scheduling conference, the Court hereby enters the following Scheduling Order pursuant to this Court’s Local Rule CV-16 and Fed. R. Civ. P. 16: (1) Other parties shall be joined pursuant to Fed. R. Civ. P. 19 and 20 by February 9, 2015. A motion for leave to add parties is not necessary provided parties are added by this date, otherwise leave of court is required. (2) Amended pleadings shall be filed by the parties by February 9, 2015. A motion for leave to amend is not necessary. (3) All motions to transfer, motions to remand, motions to dismiss, motions for summary judgment, or other dispositive motions, shall be filed by February 19, 2016. Unless leave of court is first obtained, a party may file no more than one motion for summary judgment. (4) Disclosure of expert testimony pursuant to Fed. R. Civ. P. 26(a)(2) and Local Rule CV-26(b) shall be made by the plaintiff by January 6, 2016, and by the defendant by February 5, 2016. Thereafter, each party shall have until March 4, 2016 to object to any other party’s expert witnesses. Such objections shall be made by a motion to strike or limit expert testimony and shall be accompanied by a copy of the expert’s report in order to provide the Court with all of the information necessary to make a ruling on any objection. 1 Case 4:14-cv-00665-DDB Document 15 Filed 01/27/15 Page 1 of 2 PageID #: 139Case 4:14-cv-00665-KPJ Document 2 -2 Filed 10/31/16 Page 1 of 2 PageID #: 210 (5) Pretrial disclosure pursuant to Fed. R. Civ. P. 26(a)(3) shall be made by the plaintiff by March 11, 2016 and by the defendant by April 11, 2016. (6) All fact discovery shall be commenced in time to be completed by February 19, 2016. In the event a discovery dispute arises, the Court encourages the parties to contact the undersigned telephonically or, if it is an appropriate matter for the Discovery Hotline, to use the Discovery Hotline before filing a discovery motion to immediately obtain a ruling on discovery disputes. See LOCAL RULE CV-26(e). (7) This Court does not require mediation. (8) A copy of the Joint Final Pretrial Order prepared in accordance with Local Rule CV- 16(b) and Joint Proposed Jury Instructions and Verdict Form (or proposed Findings of Fact and Conclusions of Law in nonjury cases) shall be delivered by the plaintiff to the Court by April 11, 2016. In order to enable the plaintiff to prepare and deliver the Joint Final Pretrial Order and Joint Proposed Jury Instructions and Verdict Form (or proposed Findings of Fact and Conclusions of Law in nonjury cases) to the Court, and to enable the defendant and any third parties to participate in the preparation of such documents, the plaintiff shall provide the plaintiff’s share of the necessary information to all other parties by March 21, 2016. Thereafter, all defendants and third parties shall provide their share of the information to plaintiff by April 4, 2016. (9) Any motions in limine shall be filed by April 8, 2016. Responses to motions in limine shall be filed within the time provided by Local Rule CV-7. (10) This case is set for a Final Pretrial Conference and Trial Scheduling on May 3, 2016 at 2:00 p.m. SO ORDERED. 2 Case 4:14-cv-00665-DDB Document 15 Filed 01/27/15 Page 2 of 2 PageID #: 140Case 4:14-cv-00665-KPJ Document 2 -2 Filed 10/31/16 Page 2 of 2 PageID #: 211 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS SHERMAN DIVISION GENE WEAVER § Plaintiff § § vs. § Case No. 4:14cv665 § ELI LILLY AND COMPANY § Defendant § ORDER The Final Pretrial Conference in this matter is scheduled for May 3, 2016 (see Dkt. 15). The parties did not file their Joint Final Pretrial Order and Joint Proposed Jury Instructions and Verdict Form by the Court’s April 11, 2016 deadline. If the parties do not file these materials by April 28, 2016, the Court will dismiss the case for want of prosecution or issue sanctions as is appropriate. SO ORDERED. Case 4:14-cv-00665-DDB Document 16 Filed 04/20/16 Page 1 of 1 PageID #: 141Case 4:14-cv-00665-KPJ Document 2 -3 Filed 10/31/16 Page 1 of 1 PageID #: 212 83211934v1 PLAINTIFF'S UNOPPOSED MOTION FOR CONTINUANCE PAGE 1 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS SHERMAN DIVISION GENE WEAVER, Plaintiff, vs. ELI LILLY AND COMPANY, Defendant. § § § § § § § § § § CIVIL ACTION NO. 4:14-CV-00665-RAS PLAINTIFF'S UNOPPOSED MOTION FOR CONTINUANCE AND ENTRY OF AMENDED SCHEDULING ORDER Plaintiff Gene Weaver (“Plaintiff”) submits his Unopposed Motion for Continuance of Final Pretrial Conference and Trial Setting and Entry of Amended Scheduling Order and in support thereof would respectfully show the Court the following: 1. This is a products liability lawsuit involving the FDA-approved pharmaceutical drug, Effient. Plaintiff asserts that decedent Jo Dean Weaver developed malignant tumors and subsequently died after using Effient that was manufactured and distributed by Defendant Lilly. Plaintiff claims strict liability for design, manufacturing and marketing defects, negligence, breach of express and implied warranties, and gross negligence. 2. Plaintiff filed suit against Defendant Eli Lilly and Company in the District Court of Collin County, Texas on September 2, 2014. Defendant timely removed this matter to the United States District Court for the Eastern District of Texas, Sherman Division on October 17, 2014. 3. The parties submitted their Joint Report of Scheduling Conference and Contents of Scheduling Order pursuant to this Court’s Order of October 27, 2014 and Rule 26(f) of the Case 4:14-cv-00665-DDB Document 17 Filed 04/28/16 Page 1 of 5 PageID #: 142Case 4:14-cv-00665-KPJ Document 2 -4 Filed 10/31/16 Page 1 of 7 PageID #: 213 83211934v1 PLAINTIFF'S UNOPPOSED MOTION FOR CONTINUANCE PAGE 2 Federal Rules of Civil Procedure on January 15, 2015. The Court thereafter entered a Scheduling Order on January 27, 2015. 4. Pursuant to this Court’s Scheduling Order, this matter is set for a Final Pretrial Conference and Trial Scheduling on May 3, 2016 at 2:00 p.m. 5. During the early pendency of this matter, Plaintiff's counsel and Defendant's counsel had several discussions regarding the potential for early, informal resolution conferences prior to engaging in extensive and costly discovery. 6. Before the parties were able to arrange a mutually agreeable time and place for potential resolution or settlement discussions, Plaintiff's counsel was unfortunately diagnosed with breast cancer in October 2015. Counsel for Plaintiff subsequently underwent pre-adjuvant chemotherapy (which failed), a bilateral mastectomy, and is currently in another chemotherapy program, prior to radiation. As a result of Plaintiff's counsel's cancer diagnosis, subsequent surgery and ongoing radiation treatments, the early resolution discussions and the work-up of this case have been unavoidably delayed. Almost no discovery has been completed in this matter to date. 7. Defendant has been respectful and accommodating of Plaintiff counsel's condition and physical inability to pursue this matter under the current Scheduling Order. 8. The parties are in the process of exchanging available dates in May and June 2016 after Plaintiff's counsel's final radiation treatment or Plaintiff is able to substitute in as counsel, on a pro se basis for an informal meeting and resolution discussions. The foregoing illustrates the parties’ good faith efforts to resolve their dispute without unnecessary expense. The parties are optimistic that the issues in this matter can be resolved during their forthcoming meeting. However, should the parties fail to reach a resolution, the parties will need additional time to Case 4:14-cv-00665-DDB Document 17 Filed 04/28/16 Page 2 of 5 PageID #: 143Case 4:14-cv-00665-KPJ Document 2 -4 Filed 10/31/16 Page 2 of 7 PageID #: 214 83211934v1 PLAINTIFF'S UNOPPOSED MOTION FOR CONTINUANCE PAGE 3 engage in discovery, take depositions, file dispositive motions, and prepare for trial. Should the parties reach a settlement during their forthcoming meeting, the parties will notify the court. 9. Prior to the instant motion, no parties have sought a continuance in this matter. 10. Continuing final pretrial conference and trial setting date and extending the scheduling deadlines as proposed in the Motion will not prejudice any party and will conserve judicial economy as the matter is not ready to be tried. The requested relief is not sought for purposes of delay, but so that the parties may have the opportunity to engage in good faith negotiations and resolution discussions and so that justice may be done. 11. In light of the foregoing circumstances, Plaintiff seeks a continuance of the Final Pretrial Conference and Trial Setting to January 9, 2017, or on a date in close proximity thereto, and an extension of all corresponding deadlines as set forth in the parties’ proposed Amended Scheduling Order attached hereto as Exhibit "A," including a continuance of the deadline to file their Joint Final Pretrial Order and Joint Proposed Jury Instructions and Verdict Form as set forth in the Court's April 20, 2015 Order. 12. Plaintiff requests that this matter be heard on an expedited basis due to the fast- approaching deadlines. WHEREFORE, Plaintiff Gene Weaver respectfully requests that this Court continue the Final Pretrial Conference and Trial Setting to January 9, 2017, or on a date in close proximity thereto, and an extension of all corresponding deadlines as set forth in the proposed Amended Scheduling Order attached hereto as Exhibit "A," including a continuance of the deadline to file their Joint Final Pretrial Order and Joint Proposed Jury Instructions and Verdict Form as set for in the Court's April 20, 2015 Order. Case 4:14-cv-00665-DDB Document 17 Filed 04/28/16 Page 3 of 5 PageID #: 144Case 4:14-cv-00665-KPJ Document 2 -4 Filed 10/31/16 Page 3 of 7 PageID #: 215 83211934v1 PLAINTIFF'S UNOPPOSED MOTION FOR CONTINUANCE PAGE 4 Respectfully Submitted, /s/ Shelly Cook Houghton Shelly Cook Houghton State Bar No. 04747250 4100 Stanhope Avenue, Suite No. 1 Dallas, Texas 75205 (214) 649-3307 (telephone) (214) 956-0211 (facsimile) shellylcook@aol.com ATTORNEY FOR PLAINTIFF GENE WEAVER Case 4:14-cv-00665-DDB Document 17 Filed 04/28/16 Page 4 of 5 PageID #: 145Case 4:14-cv-00665-KPJ Document 2 -4 Filed 10/31/16 Page 4 of 7 PageID #: 216 83211934v1 PLAINTIFF'S UNOPPOSED MOTION FOR CONTINUANCE PAGE 5 CERTIFICATE OF CONFERENCE I hereby certify that a conference on the above motion for continuance and proposed amended scheduling order was held between counsel for Plaintiff, Shelly Cook Houghton, and counsel for Defendant, Dawn Shawger McCord, and Defendant is not opposed to the requested relief. /s/ Shelly Cook Houghton Shelly Cook Houghton CERTIFICATE OF SERVICE I hereby certify that a true and correct copy of the above and foregoing has been served on counsel of record via the Court’s ECF filing system on this the 28th day of April, 2016. /s/ Shelly Cook Houghton Shelly Cook Hougton Case 4:14-cv-00665-DDB Document 17 Filed 04/28/16 Page 5 of 5 PageID #: 146Case 4:14-cv-00665-KPJ Document 2 -4 Filed 10/31/16 Page 5 of 7 PageID #: 217 AMENDED SCHEDULING ORDER Page 1 83211938v1 UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS SHERMAN DIVISION GENE WEAVER, Plaintiff, v. ELI LILLY AND COMPANY, Defendant. § § § § § § § § § CASE NO.: 4:14CV665 ORDER ON UNOPPOSED MOTION FOR CONTINUANCE AND AMENDED SCHEDULING ORDER This Court has received and considered Plaintiff's Unopposed Motion for Continuance and proposed Amended Scheduling Order. Because good cause has been shown: IT IS THEREFORE ORDERED that this case is set for a Final Pretrial Conference and Trial Scheduling on January 9, 2017 at ___:00 a.m./p.m. IT IS FURTHER ORDERED, and the Court hereby enters the following Amended Scheduling Order pursuant to Fed. R. Civ. P. 16: (1) All motions to transfer, motions to remand, motions to dismiss, motions for summary judgment, or other dispositive motions, shall be filed by October 31, 2016. Unless leave of court is first obtained, a party may file no more than one motion for summary judgment. (2) Disclosure of expert testimony pursuant to Fed. R. Civ. P. 26(a)(2) and Local Rule CV-26(b) shall be made by the plaintiff by September 2, 2016, and by the defendant by October 3, 2016. Thereafter, each party shall have until November 3, 2016 to object to any other party’s expert witnesses. Such objections shall be made by a motion to strike or limit expert testimony and shall be accompanied by a copy of the expert’s report in order to provide the Court with all of the information necessary to make a ruling on any objection. (3) Pretrial disclosure pursuant to Fed. R. Civ. P. 26(a)(3) shall be made by the plaintiff by November 14, 2016 and by the defendant by December 14, 2016. Case 4:14-cv-00665-DDB Document 17-1 Filed 04/28/16 Page 1 of 2 PageID #: 147 : - - -KPJ t 21-4 il 10/31/ 6 f 7 I : 218 AMENDED SCHEDULING ORDER Page 2 83211938v1 (4) All fact discovery shall be commenced in time to be completed by October 31, 2016. In the event a discovery dispute arises, the Court encourages the parties to contact the undersigned telephonically or, if it is an appropriate matter for the Discovery Hotline, to use the Discovery Hotline before filing a discovery motion to immediately obtain a ruling on discovery disputes. See LOCAL RULE CV- 26(e). (5) This Court does not require mediation. (6) A copy of the Joint Final Pretrial Order prepared in accordance with Local Rule CV-16(b) and Joint Proposed Jury Instructions and Verdict Form (or proposed Findings of Fact and Conclusions of Law in nonjury cases) shall be delivered by the plaintiff to the Court by December 14, 2016. In order to enable the plaintiff to prepare and deliver the Joint Final Pretrial Order and Joint Proposed Jury Instructions and Verdict Form (or proposed Findings of Fact and Conclusions of Law in nonjury cases) to the Court, and to enable the defendant and any third parties to participate in the preparation of such documents, the plaintiff shall provide the plaintiff’s share of the necessary information to all other parties by November 21, 2016. Thereafter, all defendants and third parties shall provide their share of the information to plaintiff by November 30, 2016. (7) Any motions in limine shall be filed by December 19, 2016. Responses to motions in limine shall be filed within the time provided by Local Rule CV-7. SO ORDERED. Case 4:14-cv-00665-DDB Document 17-1 Filed 04/28/16 Page 2 of 2 PageID #: 148 : - - -KPJ t 21-4 il 10/31/ 7 f 7 I : 219 AMENDED SCHEDULING ORDER Page 1 83211938v1 UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS SHERMAN DIVISION GENE WEAVER, Plaintiff, v. ELI LILLY AND COMPANY, Defendant. § § § § § § § § § CASE NO.: 4:14CV665 ORDER ON UNOPPOSED MOTION FOR CONTINUANCE AND AMENDED SCHEDULING ORDER This Court has received and considered Plaintiff's Unopposed Motion for Continuance and proposed Amended Scheduling Order (Dkt. 17). Because good cause has been shown: IT IS THEREFORE ORDERED that this case is reset for a Final Pretrial Conference and Trial Scheduling on January 3, 2017 at 2:00 p.m. IT IS FURTHER ORDERED, and the Court hereby enters the following Amended Scheduling Order pursuant to Fed. R. Civ. P. 16: (1) All motions to transfer, motions to remand, motions to dismiss, motions for summary judgment, or other dispositive motions, shall be filed by October 31, 2016. Unless leave of court is first obtained, a party may file no more than one motion for summary judgment. (2) Disclosure of expert testimony pursuant to Fed. R. Civ. P. 26(a)(2) and Local Rule CV-26(b) shall be made by the plaintiff by September 2, 2016, and by the defendant by October 3, 2016. Thereafter, each party shall have until November 3, 2016 to object to any other party’s expert witnesses. Such objections shall be made by a motion to strike or limit expert testimony and shall be accompanied by a copy of the expert’s report in order to provide the Court with all of the information necessary to make a ruling on any objection. (3) Pretrial disclosure pursuant to Fed. R. Civ. P. 26(a)(3) shall be made by the plaintiff by November 14, 2016 and by the defendant by December 14, 2016. Case 4:14-cv-00665-DDB Document 18 Filed 05/02/16 Page 1 of 2 PageID #: 149Case 4:14-cv-00665-KPJ Document 2 -5 Filed 10/31/16 Page 1 of 2 PageID #: 220 AMENDED SCHEDULING ORDER Page 2 83211938v1 (4) All fact discovery shall be commenced in time to be completed by October 31, 2016. In the event a discovery dispute arises, the Court encourages the parties to contact the undersigned telephonically or, if it is an appropriate matter for the Discovery Hotline, to use the Discovery Hotline before filing a discovery motion to immediately obtain a ruling on discovery disputes. See LOCAL RULE CV- 26(e). (5) This Court does not require mediation. (6) A copy of the Joint Final Pretrial Order prepared in accordance with Local Rule CV-16(b) and Joint Proposed Jury Instructions and Verdict Form (or proposed Findings of Fact and Conclusions of Law in nonjury cases) shall be delivered by the plaintiff to the Court by December 14, 2016. In order to enable the plaintiff to prepare and deliver the Joint Final Pretrial Order and Joint Proposed Jury Instructions and Verdict Form (or proposed Findings of Fact and Conclusions of Law in nonjury cases) to the Court, and to enable the defendant and any third parties to participate in the preparation of such documents, the plaintiff shall provide the plaintiff’s share of the necessary information to all other parties by November 21, 2016. Thereafter, all defendants and third parties shall provide their share of the information to plaintiff by November 30, 2016. (7) Any motions in limine shall be filed by December 19, 2016. Responses to motions in limine shall be filed within the time provided by Local Rule CV-7. SO ORDERED. Case 4:14-cv-00665-DDB Document 18 Filed 05/02/16 Page 2 of 2 PageID #: 150Case 4:14-cv-00665-KPJ Document 2 -5 Filed 10/31/16 Page 2 of 2 PageID #: 221 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 22-307 APPROVAL LETTER Case 4:14-cv-00665-KPJ Document 21-6 Filed 10/31/16 Page 1 of 10 PageID #: 222 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 22-307 NDA APPROVAL Eli Lilly and Company Attention: Elizabeth C. Bearby, Pharm.D. Director, U.S. Regulatory Affairs Lilly Corporate Center Indianapolis, IN 46285 Dear Dr. Bearby: Please refer to your new drug application (NDA) dated December 26, 2007, submitted under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act for Effient (prasugrel) 5 and 10 mg Tablets. We acknowledge receipt of your submissions dated January 9, 15, 25, 28 and 30, February 4, 6, 19, 25 and 28, March 20 (two), 21, 24, 25 and 28, April 2, 7 (two), 14, 15, 17, 22 (two), 24 (two), 25, 28 and 30 (three), May 6, 9 (two), 10, 12 (two), 14, and 16, June 11 (two), 17, 20 (two) and 25 (two), July 22 and 30, August 8, 14, 19, 25 and 28, September 4, 11, 18, 22, 24 and 26, October 3 (two), 10 (two) and 23, November 4, 12, 13, 17 and 21, December 3, 5, 11, 12, 18 (two) and 23, 2008, and January 1, 5, 7, 15, 19, 20, 27 (two) and 29, February 6, 12, 13, 19 and 23, March 5, 10 (two), 11, 12, 13 and 23, April 24, May 4, 21 and 22, June 4, 10, 12, 13, and 25, July 8 (two), 9 (three), 2009. This new drug application provides for the use of Effient (prasugrel) 5 and 10 mg Tablets for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows: • Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI) • Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI We have completed our review of this application, as amended. It is approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling text. CONTENT OF LABELING As soon as possible, but no later than 14 days from the date of this letter, please submit the content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format as described at http://www.fda.gov/oc/datacouncil/spl.html that is identical to enclosed labeling (text for the package insert, and Medication Guide). Upon receipt, we will transmit that version to the Case 4:14-cv-00665-KPJ Document 21-6 Filed 10/31/16 Page 2 of 10 PageID #: 223 NDA 22-307 Page 2 National Library of Medicine for public dissemination. For administrative purposes, please designate this submission “SPL for approved NDA 22-307.” CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and container labels that are identical to the submitted carton and immediate container labels as soon as they are available, but no more than 30 days after they are printed. Please submit these labels electronically according to the guidance for industry titled Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (October 2005). Alternatively, you may submit 12 paper copies, with 6 of the copies individually mounted on heavy-weight paper or similar material. For administrative purposes, designate this submission “Final Printed Carton and Container Labels for approved NDA 22-307.” Approval of this submission by FDA is not required before the labeling is used. Marketing the product(s) with FPL that is not identical to the approved labeling text may render the product misbranded and an unapproved new drug. PROPRIETARY NAME The Division of Medication Error Prevention and Analysis (DMEPA) and the Division of Cardiovascular and Renal Products do not object to the use of the proprietary name Effient for this product. PEDIATRIC RESEARCH EQUITY ACT (PREA) Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication in pediatric patients unless this requirement is waived, deferred, or inapplicable. We are waiving the pediatric study requirement for this application. The studies needed to assess the value of Effient in acute coronary syndrome in children would be impossible to conduct because the disease does not exist in children. POSTMARKETING REQUIREMENTS UNDER 505(o) Section 505(o) of the FDCA authorizes FDA to require holders of approved drug and biological product applications to conduct post-marketing studies and clinical trials for certain purposes, if FDA makes certain findings required by the statute (section 505(o)(3)(A)). We have determined that an analysis of spontaneous post-marketing adverse events reported under subsection 505(k)(1) of the FDCA will not be sufficient to assess a known serious risk of major bleeding and a signal of a serious risk of increased incidence of malignancies. Case 4:14-cv-00665-KPJ Document 21-6 Filed 10/31/16 Page 3 of 10 PageID #: 224 NDA 22-307 Page 3 Furthermore, the new pharmacovigilance system that FDA is required to establish under section 505(k)(3) of the FDCA has not yet been established and is not sufficient to assess this serious risk. Finally, we have determined that only a clinical trial (rather than a non-clinical or observational study) will be sufficient to assess this known risk of bleeding and signal of risk of increased malignancies. Therefore, based on appropriate scientific data, FDA has determined that you are required to conduct the following: 1. An open-label trial of ex vivo reversal of platelet inhibition by exogenous platelets as a function of time and plasma level of prasugrel active metabolite in 28 normal volunteers administered a single 60-mg loading dose of prasugrel plus aspirin 325 mg. The methods should be similar to those described by Vilahur et. al., 2007. J. Thromb Haemost 5:82. Descriptive statistics should be reported. The timetable you submitted on July 8, 2009 states that you will conduct this trial according to the following timetable: Final Protocol Submission: 09/2009 Trial Completion Date: 08/2011 Final Report Submission: 09/2011 2. You will gather baseline cancer history and cancer adverse event data from the ongoing trial TRILOGY, a 10,300-subject trial being conducted in patients with acute coronary syndrome who are being managed medically (without coronary revascularization). The final report on cancers in this trial is to be submitted to IND 63,449. The timetable you submitted on July 8, 2009 states that you will conduct this trial according to the following timetable: Protocol Submission: 06/2008 Trial Completion Date: 12/2012 Final Report Submission: 01/2013 Submit the protocols to your IND, with a cross-reference letter to this NDA. Submit all final reports to your NDA. Prominently identify the submission with the following wording in bold capital letters at the top of the first page of the submission, as appropriate: • REQUIRED POSTMARKETING PROTOCOL UNDER 505(o) • REQUIRED POSTMARKETING FINAL REPORT UNDER 505(o) • REQUIRED POSTMARKETING CORRESPONDENCE UNDER 505(o) Section 505(o)(3)(E)(ii) of the FDCA requires you to report periodically on the status of any study or clinical trial required under this section. This section also requires you to periodically report to FDA on the status of any study or clinical trial otherwise undertaken to investigate a Case 4:14-cv-00665-KPJ Document 21-6 Filed 10/31/16 Page 4 of 10 PageID #: 225 (b) (4) (b) (4) (b) (4) NDA 22-307 Page 4 safety issue. Section 506B of the FDCA, as well as 21 CFR 314.81(b)(2)(vii) requires you to report annually on the status of any post-marketing commitments or required studies or clinical trials. FDA will consider the submission of your annual report under section 506B and 21 CFR 314.81(b)(2)(vii) to satisfy the periodic reporting requirement under section 505(o)(3)(E)(ii) provided that you include the elements listed in 505(o) and 21 CFR 314.81(b)(2)(vii). We remind you that to comply with 505(o), your annual report must also include a report on the status of any study or clinical trial otherwise undertaken to investigate a safety issue. Failure to submit an annual report for studies or clinical trials required under 505(o) on the date required will be considered a violation of FDCA section 505(o)(3)(E)(ii) and could result in enforcement action. POSTMARKETING COMMITMENTS We remind you of your post-marketing commitments in your submission dated July 10, 2009. These commitments are listed below: 3. You commit to develop a new formulation of the Effient (prasugrel) drug product that . You commit to submit the data to support this new formulation as a supplemental new drug application (sNDA). The submission will provide information on the development, manufacture, control, and stability of the new formulation. In addition, you commit to develop a robust and sensitive method to quantify very low level in the reformulated product, and submit this information to the sNDA. sNDA Submission Date: 4. You commit to performing a clinical trial in the fasting and fed state, to compare the pharmacokinetics of single 60-mg doses of the marketed and new prasugrel formulations with respect to concentrations of the prasugrel active metabolite and effects on platelet inhibition. We understand that the protocols for these trials have been submitted. Trial Completion Date: 08/2009 Final Report Submission: 12/2009 5. You commit to performing, in the presence and absence of a proton pump inhibitor, a clinical trial to compare the pharmacodynamics of single 60-mg doses of the marketed and new prasugrel formulations with respect to concentrations of the prasugrel active metabolite and effects on platelet inhibition. Case 4:14-cv-00665-KPJ Document 21-6 Filed 10/31/16 Page 5 of 10 PageID #: 226 NDA 22-307 Page 5 We understand that the protocols for these trials have been submitted and the trial has been completed. Final Report Submission: 12/2009 6. You commit to the collection of samples at baseline for genotyping CYP450 enzymes in TRILOGY subjects, to allow a comparison of effectiveness and bleeding in prasugrel and clopidogrel subgroups by metabolizer status. These data will be submitted with the final study report of TRILOGY. The periodic reports will include the fraction of subjects who consented to genetic testing. We understand that the protocols for these trials have been submitted. Trial Completion Date: 12/2012 Final Report Submission: 01/2013 Submit clinical protocols to your IND for this product. Submit nonclinical and chemistry, manufacturing, and controls protocols and all study final reports to this NDA. In addition, under 21 CFR 314.81(b)(2)(vii) and 314.81(b)(2)(viii), you should include a status summary of each commitment in your annual report to this NDA. The status summary should include expected summary completion and final report submission dates, any changes in plans since the last annual report, and, for clinical studies, number of patients entered into each study. All submissions, including supplements, relating to these post-marketing study commitments should be prominently labeled “Post-marketing Study Commitment Protocol,” “Post-marketing Study Commitment Final Report,” or “Post-marketing Study Commitment Correspondence.” RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS Section 505-1 of the Federal Food, Drug, and Cosmetic Act (FDCA) authorizes FDA to require the submission of a Risk Evaluation and Mitigation Strategy (REMS) if FDA determines that such a strategy is necessary to ensure that the benefits of the drug outweigh the risks (section 505-1(a)). Your proposed REMS, submitted on July 10, 2009, and appended to this letter, is approved. The REMS consists of a Medication Guide, a communication plan, an implementation system, and a timetable for submission of assessments of the REMS. The information needed for assessment (REMS Assessment Plan) should include the following data: • Patients’ understanding of the serious risks of Effient (prasugrel) • Patients’ understanding, via a patient survey, of the Medication Guides Case 4:14-cv-00665-KPJ Document 21-6 Filed 10/31/16 Page 6 of 10 PageID #: 227 NDA 22-307 Page 6 • A report on periodic assessments of the distribution and dispensing of the Introductory Letter and Prescriber Brochure. • A report on periodic assessments of the distribution and dispensing of the Medication Guide in accordance with 21 CFR 208.24. • A report on failures to adhere to distribution and dispensing requirements, and corrective actions taken to address non-compliance. • Prescribers’ understanding, via a prescriber’s survey, of the safety messages and adherence to the boxed warning. • A description of specific measures that would be taken to increase awareness if surveys of healthcare prescribers indicate that prescriber awareness is not adequate. You are expected to submit a detailed description of methodology and the instruments used in the prescriber and patient surveys. A complete description of survey protocols is to be submitted to FDA 90 days prior to conducting surveys. The survey protocol submission should include: • The sample size and confidence interval associated with that sample size • How the sample will be determined (selection criteria) • The expected number of prescribers/patients surveyed • How the participants will be recruited • How and how often the surveys will be administered • An explanation of controls used to minimize bias • An explanation of controls used to compensate for the limitations associated with their methodology • An explanation of what will be done with the resulting data from the surveys • The survey instruments (questionnaires and/or moderator's guide). • Any background information on testing survey questions and the correlation to the messages in the Medication Guide. The requirements for assessments of an approved REMS also include, in section 505-1(g)(3)(B) and (C), information on the status of any post-approval study or clinical trial required under section 505(o) or otherwise undertaken to investigate a safety issue. You can satisfy these requirements in your REMS assessments by referring to relevant information included in the most recent annual report required under section 506B and 21 CFR 314.81(b)(2)(vii) and including any updates to the status information since the annual report was prepared. Failure to comply with the REMS assessments provisions in 505-1(g) could result in enforcement action. We remind you that in addition to the assessments submitted according to the timetable included in the approved REMS, you must submit a REMS assessment and may propose a modification to the approved REMS when you submit a supplemental application for a new indication for use as described in Section 505-1(g)(2)(A) of FDCA. Prominently identify the submission containing the REMS assessments or proposed modifications with the following wording in bold capital letters at the top of the first page of the submission: Case 4:14-cv-00665-KPJ Document 21-6 Filed 10/31/16 Page 7 of 10 PageID #: 228 NDA 22-307 Page 7 NDA 22-307 REMS ASSESSMENT NEW SUPPLEMENT FOR NDA 22-307 PROPOSED REMS MODIFICATION REMS ASSESSMENT NEW SUPPLEMENT (NEW INDICATION FOR USE) FOR NDA 22-307 REMS ASSESSMENT PROPOSED REMS MODIFICATION (if included) If you do not submit electronically, please send 5 copies of REMS-related submissions. We request that the revised labeling approved today be available on your website within 10 days of receipt of this letter. PRODUCT EXPIRATION An expiration dating period of 18 month is granted for Effient tablets, 5 and 10 mg stored in bottles at 25oC (USP Controlled Room Temperature). Effient 10 mg tablets stored in blisters will have an expiration dating period of 12 months. PROMOTIONAL MATERIALS You may request advisory comments on proposed introductory advertising and promotional labeling. To do so, submit, in triplicate, a letter requesting advisory comments, the proposed materials in draft or mock-up form with annotated references, and the package inserts to: Food and Drug Administration Center for Drug Evaluation and Research Division of Drug Marketing, Advertising, and Communications 5901-B Ammendale Road Beltsville, MD 20705-1266 As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the package insert(s), at the time of initial dissemination or publication, accompanied by a Form FDA 2253. For instruction on completing the Form FDA 2253, see page 2 of the Form. For more information about submission of promotional materials to the Division of Drug Marketing, Advertising, and Communications (DDMAC), see www.fda.gov/cder/ddmac. Please submit one market package of the drug product when it is available. Case 4:14-cv-00665-KPJ Document 21-6 Filed 10/31/16 Page 8 of 10 PageID #: 229 NDA 22-307 Page 8 LETTERS TO HEALTH CARE PROFESSIONALS If you issue a letter communicating important safety related information about this drug product (i.e., a “Dear Health Care Professional” letter), we request that you submit an electronic copy of the letter to both this NDA and to the following address: MedWatch Food and Drug Administration Suite 12B05 5600 Fishers Lane Rockville, MD 20857 REPORTING REQUIREMENTS We remind you that you must comply with reporting requirements for an approved NDA (21 CFR 314.80 and 314.81). MEDWATCH-TO-MANUFACTURER PROGRAM The MedWatch-to-Manufacturer Program provides manufacturers with copies of serious adverse event reports that are received directly by the FDA. New molecular entities and important new biologics qualify for inclusion for three years after approval. Your firm is eligible to receive copies of reports for this product. To participate in the program, please see the enrollment instructions and program description details at www.fda.gov/medwatch/report/mmp.htm. If you have any questions, please call: Meg Pease-Fye, M.S., R.A.C. Regulatory Project Manager (301) 796 - 1130 Sincerely, {See appended electronic signature page} Robert Temple, M.D. Director Office of Drug Evaluation I Center for Drug Evaluation and Research Enclosure: Final Product Labeling REMS Medication Guide Introductory Letter Prescriber’s Brochure Case 4:14-cv-00665-KPJ Document 21-6 Filed 10/31/16 Page 9 of 10 PageID #: 230 --------------------------------------------------------------------------------------------------------------------- --------------------------------------------------------------------------------------------------------------------- --------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. /s/ Robert Temple 7/10/2009 02:33:24 PM Case 4:14-cv-00665-KPJ Document 21-6 Filed 10/31/16 Page 10 of 10 PageID #: 231 PROPOSED ORDER GRANTING ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT PAGE 1 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS SHERMAN DIVISION GENE WEAVER, Individually, and as Personal Representative of the ESTATE OF JO DEAN WEAVER, deceased, and on behalf of ALL PERSONS ENTITLED TO RECOVER FOR THE WRONGFUL DEATH OF JO DEAN WEAVER, Plaintiff, vs. ELI LILLY AND COMPANY, Defendant. § § § § § § § § § § § § § § CIVIL ACTION NO. 4:14-CV-00665-RAS PROPOSED ORDER GRANTING DEFENDANT ELI LILLY AND COMPANY'S MOTION FOR SUMMARY JUDGMENT ON THIS DAY, the Court considered Defendant Eli Lilly and Company's Motion for Summary Judgment. Having considered the Motion and exhibits attached thereto, Plaintiff's response, and the pleadings and evidence on file, the Court is of the opinion that Defendant's Motion should in all things be GRANTED. IT IS THEREFORE ORDERED ADJUDGED AND DECREED that Defendant's Motion for Summary Judgment is hereby GRANTED in its entirety and each of Plaintiff Gene Weaver, Individually, and as Personal Representative of the Estate of Jo Dean Weaver's claims and causes of action against Defendant in the above-styled and numbered cause are hereby DISMISSED, WITH PREJUDICE to the refiling of same. SIGNED ___________________, 2016. ____________________________________ PRESIDING JUDGE Case 4:14-cv-00665-KPJ Document 21-7 Filed 10/31/16 Page 1 of 1 PageID #: 232