Merck, Genentech Sold Unapproved Drugs, FCA Suit Says

By Kurt Orzeck (May 11, 2016, 8:41 PM EDT) -- Merck Serono S.A., Genentech and other drug manufacturers are facing qui tam claims that they illegally received reimbursements from the government for unapproved vaccines and other biologic drugs, according to a False Claims Act suit unsealed Wednesday in New York federal court.

The complaint alleges that Merck Serono S.A., Genentech Inc., Amgen Inc., Bayer Schering Pharma AG, Bristol-Myers Squibb and a host of other companies put patients at risk by conspiring with pharmacies and drug-packaging companies to repackage drugs with excess product in violation of approved labeling.

Relator John F. Underwood, a former sales representative for Merck and Genentech, said the...

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