Products Liability Law Daily Failure to warn claims can proceed against Prozac® maker in birth defect case
Monday, August 27, 2018

Failure to warn claims can proceed against Prozac® maker in birth defect case

By Kathleen Bianco, J.D.

Failure to warn claims brought against drug manufacturer Eli Lilly & Company by the father of a minor child who was born with cardiac birth defects allegedly caused by his mother’s ingestion of Prozac® during her pregnancy were allowed to proceed, while various other product liability-related claims were dismissed by a federal district court in Kentucky (Robinson v. Eli Lilly and Co., August 23, 2018, Caldwell, K.).

The minor child’s mother had been prescribed and took Prozac during the first trimester of her pregnancy. She subsequently gave birth to a child who was born with cardiac birth defects, which required corrective surgery when the child was nine years old. The child’s father filed suit on behalf of his minor child against Eli Lilly, the manufacturer of Prozac, asserting claims for design defect, manufacturing defect, failure to warn (arising in both strict liability and negligence), breach of warranties, fraudulent concealment, and negligent misrepresentation.

In his suit, the father claimed that at the time of his wife’s pregnancy, the manufacturer knew through testing, studies, and other sources, that its drug was associated with a significant risk of cardiac defects in babies whose mothers ingested Prozac during pregnancy, and that despite this knowledge, the manufacturer continued to aggressively and actively promote its drug as safe for pregnant woman, and failed to inform health care professionals of the serious risks. The manufacturer filed a motion to dismiss the suit in its entirety, asserting that the claims were preempted by federal law, failed to meet pleading requirements, or were invalid under Kentucky law.

Failure to warn. Kentucky law follows the learned intermediary doctrine. As such, a failure to warn claim must allege that the manufacturer failed to provide a prescribing physician with adequate warnings about the risks related to its product’s use and that the failure to provide an adequate warning resulted in the patient’s injuries. Based on the evidence presented, the court determined that the father had sufficiently alleged that the warnings provided by the manufacturer were inadequate and were relevant to the injuries sustained. Accordingly, the father’s failure to warn claims, both under strict liability and negligence, were not subject to dismissal. The manufacturer’s claim of preemption due to the impossibility doctrine was unavailing as to the failure to warn claims because there are procedures in place to allow a manufacturer to change a warning label before receiving the approval of the Food and Drug Administration (FDA). Therefore, it was not impossible for the manufacturer to satisfy both state and federal requirements.

Design defect. Unlike the failure to warn claims, the father’s design defect claims were preempted by federal law and the impossibility doctrine. Under FDA rules, a manufacturer cannot unilaterally change a drug formulation without FDA approval. As such, it would be impossible for the manufacturer to satisfy a state requirement that called for the change to a drug’s makeup without prior approval from the FDA. Consequently, the design defect claim was preempted by federal law.

Manufacturing defect. The manufacturing defect claim was dismissed because the father neglected to identify how the manufacturer had breached a duty of care in the manufacturing process or deviated from the drug’s intended design. Under Kentucky law, a manufacturing defect exists when a product leaves the hands of the manufacturer in a defective condition because it was not manufactured or assembled in accordance with its specifications. The father’s failure to identify such a defect doomed his manufacturing defect claim.

Other claims. The remaining claims for breach of warranty, fraudulent concealment, and negligent misrepresentation were dismissed for various reasons. The breaches of warranty claims were rejected due to a lack of privity, which is required under Kentucky law. The fraudulent concealment and negligent misrepresentation claims both failed to meet the applicable pleading standards because the father failed to provide specific instances of omissions, misinformation, or misrepresentations. In order to have adequately asserted these claims, the father needed to have identified the specific fraudulent statements, identified the speaker, indicated when and where the information was provided, and explained how the statement was fraudulent. His failure to do so resulted in the dismissal of those claims.

The case is No. 5:17-CV-338-KKC.

Attorneys: Alex C. Davis (Jones Ward PLC) for Timothy Robinson. Andrew E. Kantra (Pepper Hamilton LLP) and Carol Dan Browning (Stites & Harbison, PLLC) for Eli Lilly and Co.

Companies: Eli Lilly and Co.

MainStory: TopStory WarningsNews DrugsNews DesignManufacturingNews KentuckyNews

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