A District Court in New Jersey recently dismissed a products liability action against Boston Scientific Corp., Guidant Corp., and two related medical device companies, finding that the Medical Device Amendments (“MDA”) to the Federal Food, Drug, and Cosmetic Act (“FDCA”) preempted the state law claims alleged against the companies. See Chester v. Boston Scientific Corp., No. 16-cv-2421 (D. N.J.).
The Plaintiff in Chester filed suit over alleged flaws in her late husband’s defibrillator that had been implanted to address his cardiac issues. The Plaintiff claimed that the Defendants’ defibrillator contained defective “leads” or wires, and was unfit for the purpose for which it was sold– the treatment of heart failure. The Plaintiff also claimed that the device caused Plaintiff’s husband serious physical harm and lead to his death.
The original Complaint contained eight causes of action and named Defendants, as well as hospitals, healthcare providers and fictitious entities. Defendants moved to Dismiss on MDA preemption as well as other grounds, and Plaintiff cross-moved for leave to amend the original Complaint to cure the defective pleadings. Shortly thereafter, Plaintiff’s claims against the medical provider defendants were dismissed via stipulation, resulting in diversity of citizenship among the parties. The remaining Defendants then removed the case to federal court, prior to the state court’s determination of the motion to dismiss and cross-motion to amend.
After granting Plaintiff’s motion for leave to file an amended complaint, Plaintiff asserted five claims arising from the alleged design, manufacturing, and labeling defects of the Defendants’ defibrillator. These claims included a strict liability failure to warn claim under the New Jersey Products Liability Act (“PLA”), common law and consumer fraud, deceit, and fraudulent concealment.
Under the PLA, a product liability action is defined as any action brought by a claimant for harm caused by a product, regardless of the theory underlying the claim, except actions for harm caused by breach of an express warranty. N.J.S.A. 2A:58C-1(b)(3). The District Court found that all five causes of action were subsumed by the PLA, and the only properly plead claim was for strict product liability for failure to adequately warn. This claim, the Court found, was preempted by the federal MDA.
As the Court explained in the decision, the FDCA requires FDA approval for introduction of new drugs and medical devices into the market, though it does not govern all medical devices. The defibrillator and its components are governed, however, as Class-III medical devices requiring pre-market approval from the FDA, conditioned upon continued compliance with FDA regulations. The FDA grants pre-market approval where it finds there is a reasonable assurance of the device’s safety and effectiveness, and must weigh any probable benefit to health from the use of the device against any probable risk of injury or illness from such use. Consequently, the FDA can approve devices that may present risks if they nonetheless offer greater benefits in light of available alternatives.
The Court concluded that under the PLA, a manufacturer is liable for failure to warn only if the Plaintiff can prove that the device was defective, i.e., not safe for its intended purpose, absent the desired warning, and that the warning was not actually provided. The Court determined that these state requirements impose different and additional obligations on the Defendants than the federal obligations of the pre-market approval process, and in granting the defibrillator pre-market approval, the FDA already evaluated the safety and effectiveness of the device and determined that the labeling was not false or misleading. “To find that the device is unsafe and defective because of the omission of a warning from an FDA-approved label,” the Court held, “would therefore overturn the FDA’s determination and impose a stricter state standard.” Thus, the Court found that Plaintiff’s claim was preempted.
This decision illustrates the important role the FDA pre-market approval process plays in the assertion of a preemption defense. We will continue to monitor litigation in the area of preemption here at the Monitor.