by Ben Vernia | January 20th, 2011
On January 20, the Department of Justice announced that St. Paul-based St. Jude Medical, Inc., has entered into a $16 million settlement to resolve allegations first raised by a whistleblower that the company used post-market studies and a patient registry to pay kickbacks to participating physicians. According to DOJ’s press release:
St. Jude Medical Inc. of St. Paul, Minn., has agreed to pay the United States $16 million to resolve allegations that the company used post-market studies and a registry to pay kickbacks to induce physicians to implant the company’s pacemakers and defibrillators, the Justice Department announced today.
Post-market studies are intended to assess the clinical performance of a medical device or drug after that device or drug has been approved by the Food and Drug Administration. Registries are collections of data maintained by a device manufacturer concerning its products that have been sold and implanted in patients.
The United States contends that St. Jude used three post-market studies and a device registry as vehicles to pay participating physicians kickbacks to induce them to implant St. Jude pacemakers and defibrillators. Although St. Jude collected data and information from participating physicians, it is alleged that the company knowingly and intentionally used the studies and registry as a means of increasing its device sales by paying certain physicians to select St. Jude pacemakers and I mplantable cardioverter defibrillator for their patients. In each case, St. Jude paid each participating physician a fee that ranged up to $2,000 per patient. The United States alleges that St. Jude solicited physicians for the studies in order to retain their business and/or convert their business from a competitor’s product.
The government announced that the relator will receive $2.64 million (a 16.5% relator’s share).