OtisMed—More than $80 million
In December 2014, OtisMed Corporation agreed to pay more than $80 million after acknowledging that the company and its ex-CEO knowingly sold surgical cutting guides for knee replacements even though FDA had denied regulatory approval. According to the DOJ, OtisMed pled guilty to violating the Food, Drug, and Cosmetic Act. The penalty included a $34.4 million criminal fine and a $5.16 million criminal forfeiture, according to the release. The company also agreed to pay a $40 million plus interest fine to settle the civil allegation.
The DOJ release notes that OtisMed made about $27 million from sales of the cutting guides between May 2006 and September 2009, despite only filing for FDA clearance in October 2008 and later being denied approval. OtisMed was acquired by Stryker Corp. in November 2009 and Stryker was not aware of the shipments that followed FDA's rejection, according to the release.
The case was examined by numerous government agencies, including FDA, HHS Office of Inspector General, the National Association of Medicaid Fraud Control Units, and others.
OtisMed Corp. fine: More than $80 million
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