Claims Regarding Post-FDA Approval Problems Not Preempted
While Medical Device Amendments of 1976, 21 U.S.C. § 360k(a) provides protection to manufacturers for medical devices approved by the FDA, certain post-FDA approval activities may still give rise to claims. In this recent case, the defendant St. Jude Medical, Inc. moved to dismiss the complaints against it for injuries allegedly resulting from St. Jude Riata leads on implantable cardiac defibrillators where the insulation failed and caused unnecessary shocks in the body. The product was removed from the market in 2010, a warning letter was sent to doctors in 2011, and the FDA eventually recalled the product. St. Jude argued that the plaintiffs’ product liability claims in five separate cases were preempted because the medical device was approved by the FDA. On January 9, 2014, the court held that plaintiffs’ claims were not preempted in an opinion that can be found here.
The court started its preemption analysis by stating that plaintiffs’ design defect claims were preempted as acknowledged by the parties, and thus, only the manufacturing defect and failure-to-warn claims remained. The court found that the Federal Food, Drug and Cosmetic Act imposes certain post- FDA approval requirements upon manufacturers, such as reporting product defects to the FDA within defined time periods. The court noted that an inquiry into whether or not the manufacturer met these obligations was fact specific and relied largely upon “who knew what when” regarding the problems with leads and efforts to report and correct those issues. The court found that plaintiffs had sufficiently pled that the manufacturer had post-approval knowledge of manufacturing issues such that they could meet the pleading requirement for a negligent failure-to-warn claim. The court found that because the state law negligent failure-to-warn claims paralleled federal post-approval requirements, those claims were not preempted.
This case highlights the importance of why a medical device manufacturer needs to continue to monitor its devices and activities even after the FDA issued its approval. These post-approval obligations include: (1) the requirement that manufacturers submit reports of individual adverse events no later than 30 calendar days after the day they become aware of a reportable death, serious injury or malfunction pursuant to 21 C.F.R. 803.10(c); (2) the obligation to report corrections or removals of the device initiated by the manufacturers if the correction or removal is initiated to reduce a risk to health posed by the device pursuant to 21 C.F.R. 806.10(a)(1); (3) removal of device from the market and corrections due to design defects as well as manufacturing defects; and (4) an obligation to establish and maintain procedures for implementing corrective and preventative actions in order to identify existing and potential causes of nonconforming products pursuant to 21 C.F.R. 820.100(a)(1). A device manufacturer’s failure to have a proactive strategy developed and executed will, at least according to this recent case, expose the company to possible liability for failure to act. This is why it is important for a device manufacturer to act early with the assistance of regulatory counsel to minimize this type of potential exposure.