Design defect and failure to warn claims can proceed against antiplatelet drug’s manufacturer


February 13, 2017

The scope of a lawsuit alleging numerous causes of action, including products liability claims, against pharmaceutical giant Eli Lilly and Co. on behalf of a patient who died from a brain bleed after having taken the prescription antiplatelet medication, Effient®, was narrowed by a federal district court in Kentucky, which tossed claims for manufacturing defect, negligent manufacturing, breach of warranty, state consumer protection violations, and loss of consortium because the claims failed to meet pleadings specificity standards. However, causes of action for strict liability design defect and failure to warn were adequately supported and could move forward, the court ruled (Estate of DeMoss v. Eli Lilly and Co., February 10, 2017, McKinley, J.).

After the patient suffered a massive cerebral hemorrhage and died 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—his widow and estate (collectively, the estate) filed suit against the drug’s manufacturer, Eli Lilly and Company, alleging that the company designed, manufactured, and promoted a drug it knew to be highly dangerous based on clinical trials it had funded; promoted the medication as "better" than safer, competitor drugs; and failed to adequately warn users of the unreasonably significant risk of intracranial hemorrhage without any opportunity for reversal.

The estate asserted claims for negligence, strict products liability, breach of implied warranty, negligent misrepresentation, violation of state consumer protection law, and loss of consortium. The drug maker moved for dismissal of all of the claims, asserting that they failed to meet the pleadings standards set forth in relevant case precedent and/or federal procedural rules.

Design defect. The estate alleged that the benefits of Effient did not outweigh its risks given the clinical trials conducted by the manufacturer and that the company failed to adequately warn end-users of the risks associated with the medication. The pharmaceutical company countered that it was not subject to design defect liability in Kentucky, given the state’s adoption of comment k to section 402A of the Restatement (Second) of Torts (under which a prescription drug manufacturer is not subject to strict liability for design defects). Effient falls within the ambit of this provision, the manufacturer contended.

Because the estate’s allegations had to be accepted as true at the pleadings stage and because the analysis under comment k is highly fact-dependent, the strict liability design defect claim was not subject to dismissal. Furthermore, the allegations in the estate’s complaint stated a plausible claim for relief for a strict liability design defect in that they alleged that Effient was defective because it created an unreasonably high bleeding risk without any reversal agent available to account/compensate for the increased bleeding risk and alleged that the patient died as a result of that injury. Accordingly, the drug maker’s motion to dismiss the strict liability design defect claim was denied.

Failure to warn. Also adequately pleaded was the failure to warn claim, given the estate’s specific allegation that the pharmaceutical company made, distributed, marketed, and sold Effient without adequate warning to the patient or his prescribing physicians; and that the medication 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®.

In addition, the estate contended that the manufacturer’s failure to test adequately and to study the life-threatening bleeding risk further rendered the warnings for Effient inadequate. Consequently, the patient suffered death as a result of the massive cerebral hemorrhage caused by the medication. Contrary to the manufacturer’s argument, those statements were not conclusory, and they complied with the specificity standard established by relevant case precedent. As such, the drug maker’s motion to dismiss the failure to warn claim also was denied.

Manufacturing defect. The estate failed to allege specific facts to support their manufacturing defect claim, however. Although they alleged that "Effient … manufactured … by [d]efendants was manufactured defectively in that Effient was in a defective condition and was unreasonably dangerous to its intended users," the complaint did not contain any specific manufacturing defect or failure that occurred with the medication, nor did it allege how the product deviated from the drug maker’s specifications. Therefore, due to the lack of factual allegations, the manufacturing defect claim was dismissed without prejudice.

Negligence. Inasmuch as the drug maker argued that the estate’s causes of action for negligence were redundant and duplicative of their strict liability claims, applicable case law supported their ability to assert multiple theories of liability. However, because the negligent design, negligent manufacture, and negligent failure to warn claims essentially were premised on the same allegations as the strict liability-based claims, the same analyses undertaken for the latter were equally applicable to the former.

Thus, the negligent design and failure to warn claims complied with the applicable pleadings specificity standards, but the negligent manufacture claim did not, given the complaint’s lack of factual allegations as to how the company breached the duty of care in manufacturing Effient or how the medication deviated from its intended design. Accordingly, the estate’s negligent design and failure to warn claims survived the drug maker’s dismissal motion, but the negligent manufacture claim was dismissed without prejudice.

Other claims. Given the estate’s lack of facts supporting the requisite privity of contract necessary to support both a breach of implied warranty and a state consumer protection law cause of action, those claims were dismissed. Also dismissed was the negligent misrepresentation claim, which was not properly stated. Finally, the widow’s loss of consortium claim was not appropriate given the portions of the complaint that survived the drug maker’s motion to dismiss.

The case is No. 4:16CV-00103-JHM.

Attorneys: Abigale R. Green (Grossman & Moore, PLLC) for Estate of Jerry DeMoss. Brittney D. Johnson (Sedgwick, LLP) and Carol D. Browning (Stites & Harbison, PLLC) for Eli Lilly and Co.

Companies: Eli Lilly and Co.

MainStory: TopStory CourtDecisions DesignManufacturingNews WarningsNews DrugsNews KentuckyNews

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