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Attorney warns of more regulations on medical device-makers following J&J complaint case

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The state Supreme Court's decision not to dismiss a complaint against a Johnson & Johnson subsidiary's coronary stent could lead to more litigation and legal costs for medical device manufacturers, an attorney said.

"Any medical device manufacturer worries about state courts whittling away at federal pre-emption," said Michael Hinckle, an attorney with K&L Gates LLP who specializes in federal Food and Drug Administration regulatory cases. "Under the Food, Drug and Cosmetic Act, they already have to go through a lot of time and money to get approvals for their devices and warning labels. The wording of the labels is so worked through with the FDA that to have juries in 50 states and the District of Columbia second-guess them, and to face liability for it, is a definitely concern."

Though Hinckle said federal pre-emption directly applies to FDA-approved medical devices like Johnson & Johnson's coronary stent, he noted there's a "willingness of state courts to find limits to it, and permit plaintiffs to go forward with a complaint."

In its ruling on Vonnie Cornett v. Johnson & Johnson and Cordis Corp., the court said if the plaintiff — the executor of the estate of Billie Cornett, who died from complications related to an implanted coronary stent — had solely argued that the stent's warning label did not comply with FDA standards, then federal law would trump state law, and the court could dismiss the case. But the court noted the plaintiff also made allegations about the label outside of the scope of FDA compliance issues, which is not pre-empted by federal law and, thus, is open to state action.

"The court said if the plaintiff claims a wrongdoing outside of FDA approval, then the case can move to the fact-finding phase, as it could in this one," Hinckle said. "A device manufacturer wants to make the federal pre-emption argument up front to get the claim thrown out quickly, but that didn't work in this case."

Hinckle said if state courts continue rejecting medical device manufacturers' pre-emptive arguments, "the only end all, be all for this type of case is the U.S. Supreme Court," and he noted getting to that level is expensive and time consuming for companies.

"The takeaway for this case is the potential further chipping away of federal pre-emption for medical devices," he said. "It will be a lot harder for manufacturers to get cases dismissed at an earlier stage now … and it's leaving them open to more litigation."

Write to the Editorial Department at editorial@njbiz.com

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