01/29/2010 When the U.S. Supreme Court ruled in Riegel v. Medtronic that many
state tort claims against manufacturers of PMA-approved medical devices are preempted by federal law, it didn’t give
clear guidance on which types of cases may still proceed in litigation. As a result, lower federal courts are struggling with
the issue and have reached varying conclusions, according to an analysis by attorneys Steven Ellison, Peter Goss, and Joe Wearmouth (all Faegre and Benson).
The
attorneys say that in theory, Riegel provided that state-law claims may proceed so long as they don’t interfere
with federal regulation. But the courts have had difficulty determining which cases are parallel and don’t interfere
with federal requirements.
A decision in Hofts v. Howmedica took a broad view, finding that the Medical
Device Amendments don’t prevent a state from providing a damages remedy for claims premised on violation of the Federal
Food, Drug, and Cosmetic Act (FDCA). The court’s reasoning was that a medical device manufacturer could be liable under
state tort law for any departure from its approved PMA. Read the full report on FDA Webview
(www.fdaweb.com)
This report provided by FDA Webview (www.fdaweb.com) -- the Internet's leading online daily FDA regulatory and compliance news site.
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