ESTATE OF JERRY DEMOSS, by and through CYNTHIA DEMOSS as Administratrix, and CYNTHIA DEMOSS Individually v. ELI LILLY AND COMPANY
CIVIL ACTION NO. 4:16CV-00103-JHM
UNITED STATES DISTRICT COURT WESTERN DISTRICT OF KENTUCKY OWENSBORO DIVISION
February 10, 2017
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
I. STANDARD OF REVIEW
Upon a motion to dismiss for failure to state a claim pursuant to
II. BACKGROUND
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.
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.
III. DISCUSSION
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
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
Here, Plaintiffs allege that the benefits of Effient did not outweigh its risks given the clinical trials Defendant conducted, and that Defendant failed to adequately warn end-users of the risks associated with Effient. Further, Plaintiff contends that Defendant sought and had FDA panelist Dr. Sanjay Kaul removed from the advisory panel because of his reservations regarding the safety of Effient. Because the Court must accept as true Plaintiffs’ allegations at this stage of the proceeding and because the analysis under comment k is highly fact dependent, see Weiss, 2006 WL 3533072, at *4, the Court declines at this stage to dismiss Plaintiffs’ strict liability design defect claim based on comment k. See House v. Bristol-Myers Squibb Co., 2017 WL 55876, *3 (W.D. Ky. Jan. 4, 2017)(denying motion to dismiss because the analysis under comment K is fact dependent and because the cases relied upon by defendants were addressing comment k in the context of motions for summary judgment).
Defendant also argues that Plaintiffs’ strict liability defective design allegations are deficient. According to Defendant, Plaintiffs have not identified what aspect of the drug‘s design
The Court disagrees. The allegations in the complaint state a plausible claim for relief for a strict liability design defect claim. Plaintiffs sufficiently allege that Effient posed a significantly higher bleeding risk as compared to other competing drugs, like Plavix, and that no antidote exists for Effient, making it more dangerous than other drugs used for similar purposes. (Complaint ¶¶ 25, 26, 34.) Further, Plaintiffs allege that DeMoss died of a massive cerebral hemorrhage caused by Effient. (Id. at ¶40.) Essentially, Plaintiffs allege that Effient was defective because it created an unreasonably high bleeding risk without any reversal agent available to account or compensate for the increased bleeding risk and that DeMoss died as a result of that injury. Accordingly, the Court denies Defendant‘s motion to dismiss the strict liability design defect claim.
2. Strict Liability Manufacturing Defect
Defendant argues that Plaintiffs’ strict liability manufacturing defect claim is insufficiently pleaded. Under Kentucky law, a plaintiff alleging a manufacturing defect must show that the product was “in a defective condition because it was not manufactured or assembled in accordance with its specifications” and that the condition caused the alleged injuries. See Greene v. B.F. Goodrich Avionics Sys., Inc., 409 F.3d 784, 788 (6th Cir. 2005) (applying Kentucky law); Bosch v. Bayer Healthcare Pharm., Inc., 13 F. Supp. 3d 730, 743–44
In this case, Defendant argues that Plaintiffs have failed to allege facts to support a manufacturing defect claim, instead offering only a formulaic recitation of the claim‘s elements. Although Plaintiffs allege that “Effient . . . manufactured . . . by Defendants was manufactured defectively in that Effient was in a defective condition and was unreasonably dangerous to its intended users” (complaint at ¶ 67), Plaintiffs fail to allege specific facts to support their manufacturing defect claim. They do not allege any specific manufacturing defect or failure that occurred with the Effient product. They similarly do not allege how Effient deviated from Defendant‘s specifications. Due to the lack of factual allegations, the Court holds that Plaintiffs have failed to properly state a manufacturing defect claim. Plaintiffs’ manufacturing defect
3. Strict Liability Failure to Warn Claim
To plead a failure to warn claim in a prescription drug case, a plaintiff must allege facts for the Court to infer that (1) the manufacturer failed to provide his prescribing physician with adequate warnings about risks of which it knew or should have known and (2) the inadequate warnings proximately caused his injuries. Prather, 960 F. Supp. 2d at 708-09. Here, Plaintiffs adequately allege how the warnings provided were defective and how they caused his injury. Specifically, Plaintiffs allege that Defendant made, distributed, marketed, and sold Effient without adequate warning to Plaintiff‘s prescribing physicians or DeMoss that Effient was associated with and/or could cause life-threatening bleeding and presented a risk of life-threatening bleeding in patients who used it, especially as compared to similar antiplatelet drugs, such as Plavix. Additionally, Plaintiffs contend that Defendant‘s failure to adequately test and study the life-threatening bleeding risk further rendered the warnings for this medication inadequate. (Complaint at ¶¶36-40, 71-73.) As a result, DeMoss suffered death as a result of the massive cerebral hemorrhage caused by Effient. Contrary to Defendant‘s argument, these statements are not conclusory and comply with the Iqbal and Twombly standard.
For these reasons, the Court denies Defendant‘s motion to dismiss Plaintiffs’ claims for strict liability design defect and failure to warn. Plaintiffs’ strict liability manufacturing defect claim is dismissed without prejudice.
B. Negligence Claims
Plaintiffs allege that the Defendant negligently designed, manufactured, promoted, marketed, sold, and distributed Effient in an unreasonably dangerous condition. (Complaint ¶¶ 42-54.) Under Kentucky law, to succeed on a negligence claim, Plaintiff must establish that: (1) Defendant owed a duty of care to DeMoss; (2) Defendant breached its duty; and (3) the breach
With respect to the negligent manufacture claim, the Court finds that Plaintiffs have not included any factual allegations as to how Defendant breached the duty of care as to manufacturing of Effient or how Effient deviated from the Defendant‘s intended design. See Bosch, 13 F. Supp. 3d at 741–42 (dismissing negligent manufacture claim because plaintiffs failed to “allege how their specific [intrauterine contraceptive] devices were defective due to manufacturing” and otherwise failed to assert “any facts to support” their conclusory allegations); see also Guidry v. Janssen Pharmaceuticals, Inc., 2016 WL 633673, *4 (E.D. La. Feb. 17, 2016) (dismissing manufacturing defect claim where plaintiff failed to allege any facts as how the Invokana she ingested deviated from the intended design). Therefore, Plaintiffs’ negligent manufacture claim is dismissed without prejudice.
Furthermore, in as much as Defendant argues that Plaintiffs’ cause of action for negligence is redundant and duplicative of Plaintiffs’ strict liability claims, the case law supports Plaintiffs ability to assert multiple theories of liability. “‘Under Kentucky law, a plaintiff can advance both a strict-liability claim and a negligence claim against the manufacturer of a product for injury suffered by that product.‘” Stanley v. Bayer Healthcare Pharm. Inc., 2015 WL 4511973, *2 (W.D. Ky. July 24, 2015)(quoting Waltenburg v. St. Jude Medical, Inc., 33 F. Supp. 3d 818, 836 (W.D. Ky. 2014)). “Strict liability typically focuses on the condition of the product while a negligence inquiry examines whether the [defendant] exercised the proper degree of care
Finally, in response to the motion to dismiss, Plaintiffs note that they do not assert a separate and independent claim for “failure to test,” but simply allege that Defendant‘s failure to adequately test its products supports Plaintiffs’ products liability claims. Kentucky courts have treated failure to properly test pharmaceutical drugs as subsumed by a failure to warn claim. See Baird v. Bayer Healthcare Pharmaceuticals, Inc., 2013 WL 5890253, *2 (E.D. Ky. Oct. 31, 2013); Bosch, 13 F. Supp. 3d at 747.
For these reasons, the Court denies Defendant‘s motion to dismiss Plaintiffs’ claims for negligent design defect and failure to warn. Plaintiffs’ claim for negligent manufacturing defect is dismissed without prejudice.
C. Breach of Implied Warranty
Defendant argues that Plaintiffs’ claim for breach of implied warranty (Complaint ¶¶ 79-89) must be dismissed because there is no privity of contract between the parties. Under Kentucky law, privity of contract is an essential element of a claim for breach of an implied warranty. Baird, 2013 WL 5890253, at *3; Brown Sprinkler Corp. v. Plumbers Supply Co., 265
Plaintiffs have alleged no facts to support the conclusion that privity existed. Plaintiffs allege that the drug is a prescription drug that was prescribed to DeMoss by his doctor. (Compl. ¶ 8.) Plaintiffs do not allege facts indicating that DeMoss purchased Effient from Defendant. Because the Complaint fails to show that DeMoss and Defendant were in a buyer-seller relationship, DeMoss was not in privity with Defendant. See Bosch, 13 F. Supp. 3d at 749. See also House v. Bristol-Myers Squibb Co., 2017 WL 55876, at *2–7 (W.D. Ky. Jan. 4, 2017). Furthermore, Plaintiffs’ reliance on Naiser v. Unilever U.S., Inc., 975 F. Supp. 2d 727 (W.D. Ky. 2013) is misplaced. Naiser involved a breach of express warranty claim which Plaintiffs have not asserted in this case. “The Court‘s ruling in Naiser had no impact on the privity of contract requirement with respect to implied warranty causes of action.” Bosch v. Bayer Healthcare Pharmaceuticals, Inc., 13 F. Supp. 3d 730, 749 (W.D. Ky. 2014). Accordingly, Plaintiffs’ breach of implied warranty claim is dismissed without prejudice.
D. Negligent Misrepresentation
Defendant argues that Plaintiffs’ claim for negligent misrepresentation (Complaint ¶¶ 90-
Initially, with respect to Defendant‘s reliance upon Bland and similar cases, more recent precedent reflects that the Restatement (Third) of Torts § 9 now governs. In Morris Aviation, LLC v. Diamond Aircraft Indus., Inc., the Sixth Circuit pointed to the Kentucky Supreme Court‘s acknowledgement in Giddings & Lewis v. Industrial Risk Insurers of Section 9 of the Restatement (Third) of Torts: Products Liability, which provides:
One engaged in the business of selling or otherwise distributing products who, in connection with the sale of a product, makes a fraudulent, negligent, or innocent misrepresentation of material fact concerning the product is subject to liability for harm to persons or property caused by the misrepresentation.
Morris Aviation, LLC v. Diamond Aircraft Indus., Inc., 536 Fed. Appx. 558, 567-68 (6th Cir. 2013) (quoting Giddings & Lewis v. Industrial Risk Insurers, 348 S.W.3d 729, 746 n. 11 (Ky. 2011)). See also Stanley v. Bayer Healthcare Pharm. Inc., 2015 WL 4511973, at *3–4 (W.D. Ky. July 24, 2015). Accordingly, with the adoption of the Restatement (Third) of Torts § 9, Kentucky law provides for negligent misrepresentation claims associated with the sale of a product, and the Bland reasoning does not compel its dismissal.
Notwithstanding, Plaintiffs’ allegations do not state a claim for negligent misrepresentation. Under Kentucky law, a plaintiff must identify the false or misleading information provided by the specific defendant. See Gaunce, 2015 WL 893569, at *2–3;
Here, Plaintiffs contend they have sufficiently advised Defendant of the basis of their claims and identified to whom the misrepresentations were made (Mr. DeMoss and his healthcare professionals), by whom they were made (Defendant who marketed and promoted Effient), where and when they were made (in the promotional materials provided to DeMoss and his healthcare providers), and why those representations were fraudulent (because the materials failed to identify the risks of Effient as compared to safe alternative drugs.). (Complaint ¶¶ 22, 23, 45(o), 93). Specifically, Plaintiffs allege that “Defendants negligently misrepresented Effient‘s high risk of unreasonable, dangerous side effects,” “[concealed] information from Mr. DeMoss and Plaintiffs in knowing that Effient was unsafe, dangerous, and/or non-conforming with FDA regulations,” and that “Defendants’ promotional materials fail to highlight the increased risk of bleeding that cannot be reversed and can lead to death, as it did for Mr. DeMoss.” (Id. at ¶¶ 93, 45(o), 23).
The Supreme Court of Kentucky in Giddings & Lewis, Inc. v. Indus. Risk Insurers, 348 S.W.3d 729 (Ky. 2011) has emphasized that the tort of negligent misrepresentation “requires an affirmative false statement; a mere omission will not do.” Id. at 746 (quoting Republic Bank & Trust Co. v. Bear, Stearns & Co., Inc., 707 F. Supp. 2d 702, 714 (W.D. Ky. 2010)). See also
E. Violation of KCPA
Count V of the complaint alleges a claim for violation of the Kentucky Consumer Protection Act (“KCPA“). (Complaint at ¶¶ 98-108.) The KCPA declares unlawful “[u]nfair, false, misleading, or deceptive acts or practices in the conduct of any trade or commerce.”
The KCPA provides a private right of action for “[a]ny person who purchases or leases goods or services primarily for personal, family or household purposes and thereby suffers any ascertainable loss of money or property, real or personal” as a result of a violation of
In [Skilcraft Sheetmetal, Inc.], Kentucky‘s Court of Appeals analyzed whether
K.R.S. § 367.220 allows an action by a person who has not purchased or leased goods from the person he claims to have violated the KCPA. The Court held that a subsequent purchaser could not “maintain an action against a seller with whom he did not deal or who made no warranty for the benefit of the subsequent purchaser.” The Court went on to explain that while privity is generally required to assert a cause of action under the KCPA, it found certain situations “distinguishable . . . such as that presented in Ford Motor Co. v. Mayes, Ky. App., 575 S.W.2d 480 (1978), where the defendant (Ford Motor Company) provides warranties to the ultimate purchaser to repair the item purchased.”
Naiser, 975 F. Supp. 2d at 743 (internal citations omitted). The plaintiffs in Naiser relied on this language in Skilcraft Sheetmetal, Inc. to argue that they should be allowed to maintain a KCPA cause of action since they alleged that the manufacturer made valid express warranties for the benefit of consumers. The Court agreed. See id. (representations that the product‘s “effects would last no longer than 30 days,” when it “could be expected to last for months,” and that “the product contained no formaldehyde,” when it actually “contained a chemical known to release formaldehyde upon its use“). According to the Court in Naiser, since the plaintiffs had sufficiently alleged that the manufacturer made valid express warranties for plaintiffs’ benefit, the exception outlined in Skilcraft Sheetmetal, Inc. was applicable. The plaintiffs were permitted to maintain a KCPA claim despite the absence of a direct buyer-seller relationship. See Bosch v. Bayer Healthcare Pharm., Inc., 13 F. Supp. 3d 730, 750–51 (W.D. Ky. 2014)
F. Loss of Consortium
Dismissal of Mrs. DeMoss‘s claim for loss of consortium is not appropriate given portions of the complaint survive the motion to dismiss.
G. Leave to Amend Complaint
Finally, in response to the motion to dismiss, Plaintiffs request in the alternative that, if the Court finds the complaint defective in any way, they be granted leave to amend the complaint. The Court does not consider this request an appropriate motion to amend. If Plaintiffs want the Court to consider such a request, they should submit a properly supported motion, with a copy of the amended complaint attached, no later than twenty-one (21) days from the entry of this Memorandum Opinion and Order. Thereafter, Defendant may file its response, and the Court will address the merits of Plaintiffs’ motion.
For the reasons set forth above, IT IS HEREBY ORDERED that the motion by Defendant, Eli Lilly and Company, to dismiss the complaint pursuant to
Joseph H. McKinley, Jr., Chief Judge
United States District Court
February 10, 2017
cc: counsel of record