We have seen many large False Claims and Anti Kickback settlements with pharmaceutical companies and the prescriptions they manufacture. Now, a medical device company has gotten into difficulty for many of the same types of violative activities. This article provides an overview of the allegations and the settlement.
In early January 2017, the United States Department of Justice (“DOJ”) announced the largest False Claims Act recovery by the United States in a kickback case involving a medical device company.40 The $350 million agreement with Shire Pharmaceuticals LLC (and other subsidiaries of Shire plc) settles federal and state False Claims Act allegations that Shire and Advanced BioHealing (a company acquired by Shire in 2011 that has since been divested) employed kickbacks and other unlawful methods to induce clinics and physicians to use – or overuse – “Dermagraft,” an FDA-approved bioengineered human skin substitute used in treating diabetic skin ulcers.