Determining whether your company is subject to liability for a defect in the chemical composition of a drug, or for a failure to adequately warn of dangers associated with the drug, can be a frustrating task. Earlier this month, a federal judge in Georgia gave clarity to pharmaceutical companies facing this issue. The following provides an overview of the federal court guidance taken from the opinion in Brazil v. Janssen Research & Dev. LLC, 2016 U.S. Dist. LEXIS 93528 (N.D. Ga. 2016).
With regards to design defects (a problem with the chemical composition of a drug), drug manufacturers cannot be sued for failing to change the formulation of a prescription drug because that type of claim is preempted by federal law. Specifically, FDA regulation 506A requires FDA approval prior to redesigning a drug. Therefore, the remedial action required to avoid liability is prohibited by federal law.
The analysis for determining whether your company is protected by federal law for alleged inadequate warnings turns on who holds the approved Application for the New Drug (NDA). The District Court made clear that only the company that filed the NDA can be subject to suit for a failure to warn. “When a company does not have the NDA, it has ‘no more power to change the label’ of a drug than a generic manufacturer.” Brazil, 2016 U.S. Dist. LEXIS 93528, citing In re Darvocet, Darvon, & Propoxyphene Products Liab. Litig., 756 F.3d 917, 940 (6th Cir. 2014). Thus, if your company was involved in the development, design, marketing, or distribution of a drug, then you may have a federal preemption defense to claims for inadequate warnings. Generic manufacturers, likewise, are protected by federal preemption from a failure to warn lawsuit.
There are a number of procedural defenses that can serve to minimize or extinguish your company’s exposure to liability. Be sure to consult with counsel as soon as a complaint is made about a drug that your company developed, designed, manufactured, marketed, or distributed. It could save your company tremendous time, money, and stress.