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Certain State Law Medical Device Claims Partially Preempted


A man received a drug-eluting arterial stent to treat coronary artery disease. Five months later, a blood clot formed near the site of the stent and he suffered a subacute stent thrombosis. Eleven days later, he died.

 

Three years and nine months later, his widow filed suit in New Jersey seeking damages for the injuries suffered by her husband and his estate. The defendant filed a motion to dismiss all the claims which the trial court granted. The court of appeals affirmed in part, reversed in part and remanded.

 

The Supreme Court of New Jersey affirmed the court of appeals. First, the court held that no conflict of laws existed between New Jersey and Kentucky statutes of limitations so as to preclude the application of the Kentucky statute of limitations, even though the New Jersey statute permitted two years after the accrual of the action to file a claim and the Kentucky statute permitted only one year, where the discovery rule applied to claims under the laws of both states and the difference in time limits did not implicate a fundamental public policy of New Jersey. The court concluded that the complaint was time-barred.

 

Additionally, the court held that most of the plaintiff’s state statutory and common law claims were preempted by federal law. To the extent that they do impose additional requirements or burdens on the manufacturer, state law claims are preempted. Two claims survived in part: the failure to warn claim and the breach of express warranty claim.

 

The failure to warn claim based on the defendant manufacturer's concealment and misrepresentations concerning risks of the approved use of its stent was partially preempted under the federal statute governing state law claims related to devices approved by the FDA. The claim was preempted to the extent that it related to approved and off-label uses of the stent. It was not preempted to the extent that it was based on allegations of deliberate non-disclosure or fraudulent representations of known adverse information apart from the manufacturer's failure to comply with FDA disclosure requirements or promotion of off-label uses outside of the statutory safe harbor.

 

The breach of express warranty claim based on misstatements of the risks of the stent while marketing and selling it was partially preempted under the federal statute governing state law claims related to devices approved by the FDA. The claim was preempted to the extent that it was based on information contained in product labels and packaging that were approved by the FDA. The claim was not preempted to the extent that it was based on voluntary statements by the manufacturer to third parties beyond and different from information on the approved label or packaging.

 

See: Cornett v. Johnson & Johnson, 2012 WL 3210943 (N.J., August 9, 2012) (not designated for publication).

 

 

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