Medical device company St. Jude Medical Inc. paid the United States $16 million to resolve allegations raised by the whistleblower that the company violated the False Claims Act when it used post-market studies and a registry to pay kickbacks to induce physicians to implant the company’s pacemakers and defibrillators.
The whistleblower alleged that while St. Jude collected data and information from participating physicians through three post-market studies and a device registry, the company knowingly and intentionally used those studies and registry as a means of increasing its device sales by paying certain physicians to select St. Jude pacemakers and implantable cardioverter defibrillator for their patients. In each case, St. Jude paid each participating physician a fee that ranged up to $2,000 per patient. St. Jude solicited physicians for the studies in order to retain their business and/or convert their business from a competitor’s product.
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. St. Jude subverted the valid purposes of the post-market studies and the device registry
Attorneys Thomas and Durrell were co-counsel in this case with attorneys Ken Nolan and Marcella Auerbach.