Some product liability claims involving an allegedly defective coronary stent made by Johnson & Johnson’s (NYSE:JNJ) Cordis Corp. are preempted by federal law, but state law applies to other claims, according to a ruling by the Superior Court for New Jersey’s Appellate Division.
Although the court affirmed the dismissal of some of the claims in lawsuits against Cordis over its Cypher sirolimus-eluting stent, it reversed the dismissal of other claims and remanded the cases back to lower courts.
The lead case, Vonnie Cornett, individually and on behalf of the estate of Billie Cornett vs. Johnson & Johnson and Cordis Corp., began when Vonnie Cornett and another couple sued over alleged defects in the Cypher stent. The plaintiffs claimed negligence and product liability for defects in the design and manufacture of the stent and for Cordis’ alleged failure to warn of the alleged defects. The two cases and 46 others were consolidated into a single action, which was dismissed by a lower court in Kentucky on statute of limitation and preemption grounds.
Billie Cornett, a diabetic, had a Cypher stent implanted in December 2004. In May 2005 doctors discovered a partial blockage in the artery with the stent; Cornett died June 1, 2005, "purportedly from subacute stent thrombosis arising from the device’s implantation," according to court documents.
Writing for the court, Judge Anthony Parillo ruled that Kentucky’s statute of limitations expired in the Cornett case, upholding its dismissal. As for the rest of the cases, Parillo wrote, "we conclude that some of plaintiffs’ claims were properly dismissed as preempted, but that others should not have been rejected on a motion to dismiss,” according to court documents.
Specifically, Parillo wrote, the defendants’ claims of manufacturing defect were not preempted because Cordis "decided that laboratory test results of ‘[o]ut-[o]f-[s]pecification’ for some lots were invalid" and released lots without "’adequate data or justification’ for Cordis’ conclusion that the nonconformity posed a minimal safety risk."
The New Jersey law governing manufacturing defects is not preempted by federal law because "it incorporates the federal requirements of having to maintain fidelity to the manufacturer’s own design and performance standards without allowing an alternative measure of the manufacturer’s duty. The additional requirement that this state claim imposed on plaintiffs, proving that the deviations actually rendered the device unsafe or unsuitable for the intended uses, was acceptable because it narrowed the circumstances in which manufacturers could be liable compared to the federal scheme, instead of enlarging them," according to court documents.
The court also ruled that claims of Cordis’ failure to warn were not preempted because the company allegedly concealed data from clinical trials "about the adverse events that the studies reported, and they withheld other relevant treatment information they had about off-label uses," according to court documents.