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Estate of Demoss v. Eli Lilly And Co.

United States District Court, W.D. Kentucky, Owensboro Division

February 10, 2017

ESTATE OF JERRY DEMOSS, by and through CYNTHIA DEMOSS as Administratrix, and CYNTHIA DEMOSS Individually PLAINTIFFS


          Joseph H. McKinley, Jr., Chief Judge

         This matter is before the Court on a motion by Defendant, Eli Lilly and Company, to dismiss the complaint pursuant to Fed.R.Civ.P. 8(a), 9(b), and 12(b)(6) [DN 13]. Fully briefed, this matter is ripe for decision.


         Upon a motion to dismiss for failure to state a claim pursuant to Federal Rule of Civil Procedure 12(b)(6), a court “must construe the complaint in the light most favorable to plaintiff[], ” League of United Latin American Citizens v. Bredesen, 500 F.3d 523, 527 (6th Cir. 2007), “accept all well-pled factual allegations as true, ” id., and determine whether the “complaint . . . states a plausible claim for relief, ” Ashcroft v. Iqbal, 556 U.S. 662, 679 (2009). Under this standard, the plaintiff must provide the grounds for his or her entitlement to relief, which “requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). A plaintiff satisfies this standard only when he or she “pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678. A complaint falls short if it pleads facts “‘merely consistent with' a defendant's liability, ” id. at 678 (quoting Twombly, 550 U.S. at 557), or if the alleged facts do not “permit the court to infer more than the mere possibility of misconduct, ” id. at 679. Instead, the allegations must “‘show[ ] that the pleader is entitled to relief.'” Id. at 679 (quoting Fed.R.Civ.P. 8(a)(2)). It is against this standard that the Court reviews the following facts.


         This case arises from the death of Jerry DeMoss following his use of Effient, a prescription medication approved by the Food and Drug Administration (“FDA”) for the treatment of patients with acute coronary syndrome (“ACS”) to reduce the risk of thrombotic cardiovascular events, including heart attack, stroke, or blood clot. In July 2009, Effient was approved by the FDA for use in patients with ACS with unstable angina or non-ST-elevation myocardial infarction, or patients with ST-elevation myocardial infarction. Approval of Effient was based on a series of clinical trials derived from the TRITON-TIMI 38 trial, a 13, 608 patient, multicenter, international, randomized, double-blind, parallel-group study comparing Effient (prasugrel) and Plavix (clopidogrel). (Complaint at ¶ 22.) The TRITON-TIMI 38 trial indicated that Effient was superior to Plavix for preventing ischemic events, but “that Effient (prasugrel) was associated with significantly increased risk of bleeding, including fatal bleeding, as compared to Plavix (clopidogrel).” (Id. at ¶ 22.) Plaintiffs allege that the TRITON-TIMI 38 trial made clear that the benefits of Effient should be balanced with its increased associated risk for bleeding events. Plaintiffs further contend while Defendant marketed Effient as a new antiplatelet treatment alternative to Plavix, its promotional materials failed to highlight the increased risk of bleeding, to disclose to patients and members of the medical community that there is no drug, agent, or means to reverse the effects of Effient, and to disclose that the use of Effient, as opposed Plavix, placed patients at greater risk for bleeding events. Additionally, Plaintiffs allege that Defendant sought and had FDA panelist Dr. Sanjay Kaul removed from the advisory panel because of his reservations regarding the safety of Effient.

         Including June 2015, a total of 12, 281 Effient-associated adverse reports had been filed with the FDA, including 171 hemorrhages and 153 deaths. (Id. at ¶ 30.) Plaintiffs allege that, despite the reported adverse events, the Defendant failed to perform further investigation and studies into the safety of Effient; failed to disclose its knowledge that Effient was associated with or could cause life-threatening bleeding; and failed to provide adequate warnings and instructions. (Id. at ¶¶ 31-39.)

         DeMoss began taking Effient on or about April 2014 (id. at ¶8) and subsequently suffered a massive cerebral hemorrhage and died on July 19, 2014. (Id. at ¶10.) Plaintiffs filed this action in Hopkins Circuit Court on July 19, 2016. Defendant removed this action on August 24, 2016. Plaintiffs contend that Defendant designed, manufactured, and promoted a drug it knew to be highly dangerous based on clinical trials funded by Defendant; promoted it as “better” than Effient's safer, competitor drugs, such as Plavix; and failed to adequately warn users of the unreasonably significant risk of intracranial hemorrhage without any opportunity for reversal. Plaintiffs assert claims for negligence (design defect, manufacturing defect, and failure to warn); strict products liability (design defect, manufacturing defect, and failure to warn); breach of implied warranties; negligent misrepresentation; violation of the Kentucky Consumer Protection Act; and loss of consortium.

         Defendant moves the Court to dismiss Plaintiffs' claims arguing that the causes of action are unsustainable as a matter of Kentucky law and fail to meet the pleading standards articulated by the Supreme Court in Iqbal and Twombly.


         A. Strict Liability Claims

         Plaintiffs have asserted strict liability claims based on the theory that Effient was defective in its design and manufacture and because the Defendant failed to warn of the risk of injury caused by the medication. (Complaint at ¶¶ 55-78.)

         1. Strict Liability Design Defect Claim

         Under Kentucky law, to prevail in a strict products liability action, a plaintiff must establish: “(1) that there is a product, which is (2) in a defective condition unreasonably dangerous to the user or consumer or his property, and (3) which reaches the user or consumer without substantial change in the condition in which it is sold; (4) that the product is sold by one who is engaged in the business of selling such a product which (5) results in physical harm to the ultimate user or consumer or his property.” Bosch v. Bayer Healthcare Pharms., Inc., 13 F.Supp.3d 730, 740 (W.D. Ky. 2014) (citations omitted). A plaintiff also must establish that there was “an alternative, safer design that is practicable under the circumstances.” Id. Defendant contends that Effient falls within the ambit of comment k to section 402A of the Restatement (Second) of Torts because the FDA's approval of Effient for the treatment of acute coronary syndrome conclusively demonstrates that the benefits of Effient exceed the potential risks. Thus, Defendant argues it is not subject to design defect liability, and the Court should dismiss this claim.

         Kentucky follows the Restatement (Second) of Torts, including comment k to section 402A. Prather v. Abbott Labs., 960 F.Supp.2d 700, 706 (W.D. Ky. 2013) (citing McMichael v. American Red Cross, 532 S.W.2d 7, 9-11 (Ky. 1975)). Comment k “provides an exception to the general rule of strict liability for ‘apparently useful and desirable product[s], attended with a known but apparently reasonable risk.'” Id. (quoting Restatement (Second) of Torts § 402A cmt. k). Where comment k applies, a prescription drug manufacturer “is not subject to strict liability for design defects. Instead, the manufacturer's liability is limited to manufacturing defects, for those cases in which the [drug] given had been improperly prepared, and warning defects, where a manufacturer's failure to market a drug . . . without adequate warnings of its dangers renders the product defective.” Snawder v. Cohen, 749 F.Supp. 1473, 1476 (W.D. Ky. 1990); see Foister v. Purdue Pharma, L.P., 295 F.Supp.2d 693, 705 (E.D. Ky. 2003). In Kentucky, the scope of comment k is determined on a case-by-case basis. Prather, 960 F.Supp.2d at 707; see Weiss v. Fujisawa Pharm. Co., 2006 WL 3533072, *1, *3-4 (E.D. Ky. Dec. 7, 2006)(extends “comment k protection when the apparent benefits of the drug exceed the apparent risks, given the scientific knowledge available when the drug was marketed”). Courts consider such factors as “(1) the drug's overall ...

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