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Interstate Commerce › Department of Justice (DOJ) › Medical Devices

Knobbe Martens

Affordable Healthcare Solutions Pleads Guilty to Dealing in Non-FDA Approved Devices

Knobbe Martens on

The United States Department of Justice announced that Affordable Healthcare Solutions, LLC has pleaded guilty and was sentenced to Receiving Adulterated Devices in Interstate Commerce and Delivery for Pay with Intent to...more

Skadden, Arps, Slate, Meagher & Flom LLP

Failure to Report Adverse Events Results in Criminal Misbranding Settlement and Individual Liability

Skadden, Arps, Slate, Meagher & Flom LLP on

On December 10, 2018, Olympus Medical Systems Corporation and a former quality manager at the company pleaded guilty to introducing misbranded medical devices into interstate commerce in violation of the Federal Food, Drug...more

Wilson Sonsini Goodrich & Rosati

DOJ Acknowledges in Proposed Jury Instructions That Dissemination of Truthful and Non-Misleading Off-Label Use Information Is Not...

Wilson Sonsini Goodrich & Rosati on

For years, the U.S. Food and Drug Administration (FDA) has taken the position that a medical device (or drug) manufacturer that promotes an FDA-approved device (or drug) for an unapproved use violates the Federal Food, Drug,...more

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