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Federal Appeals Court Affirms Imposition of Civil Money Penalties against Device Manufacturer and Individual Corporate Officer for Failure to File Medical Device Reports
by Daniel A. Kracov
Arnold & Porter LLP - Washington Office
Arthur N. Levine
Arnold & Porter LLP - Washington Office
Jennifer Newberger
Arnold & Porter LLP - Washington Office
Vernessa T. Pollard
Arnold & Porter LLP - Washington Office
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November 5, 2009
Previously published on November 2009
In TMJ Implants, Inc. v. United States Department of Health & Human Services, the United States Court of Appeals for the Tenth Circuit addressed the standards for liability for civil monetary penalties (CMPs) for the failure to file medical device reports (MDRs), and affirmed the US Food and Drug Administration's (FDA) interpretation of the MDR regulations, which require medical device manufacturers, importers, and user facilities to submit device-related adverse event reports to FDA. The court held, in relevant part, that: (1) manufacturers need not confirm or believe that their device actually caused the adverse event to be required to submit an MDR; and (2) the responsible corporate officer liability standards of United States v. Park apply to the imposition of CMPs against individuals for violations of the Federal Food, Drug, and Cosmetic Act (FDCA). The favorable ruling may signal a renewed focus on MDR requirements by FDA as well as increased use of CMPs as an enforcement tool. www.arnoldporter.com
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