Biology

A settlement has been reached in a whistleblower class action lawsuit brought against Medtronic Inc who is accused of using physician payments related to post-market studies and device registries as kickbacks to induce doctors to implant the company’s pacemakers and defibrillators.

The settlement resolves allegations contained in two whistleblower lawsuits. The whistleblowers will receive payments totaling more than $3.96 million from the federal share of the recovery.

The United States alleged that Medtronic caused false claims to be submitted to Medicare and Medicaid by using two post-market studies and two device registries as vehicles to pay participating physicians illegal kickbacks to induce them to implant Medtronic pacemakers and defibrillators. Although Medtronic collected data and information from participating physicians, each of the studies and registries required a new or previous implant of a Medtronic device in each patient, and in each case Medtronic paid participating physicians a fee ranging from approximately $1,000 to $2,000 per patient. The United States contends that Medtronic solicited physicians for the studies and registries in order to convert their business from a competitor’s product and/or persuade the physicians to continue using Medtronic products.

A settlement has been reached in a whistleblower class action lawsuit brought against St. Jude Medical Inc of St. Paul, MN who is accused of paying kickbacks to induce physicians to implant the company’s pacemakers and defibrillators.

The whistleblower will recover a $2.64 million share of the government's settlement.

Originally filed in July 2006, the United States allged 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 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. The United States alleged that St. Jude solicited physicians for the studies in order to retain their business and/or convert their business from a competitor’s product.

A settlement was reached to resolve False Claims Act allegations against Serono Laboratories Inc., EMD Serono Inc., Merck Serono S.A, and Ares Trading S.A. They are accused of paying health care providers to promote or prescribe Rebif, a recombinant interferon injectable that is used to treat relapsing forms of multiple sclerosis. 

Under the terms of the agreemen, the proceeds from the settlement will be split between the federal government and various states, with the United States receiving $34.6 million to resolve the federal claims and the states receiving $9.7 million to settle their respective claims under Medicaid.

Serono is alleged to have made payments to providers for hundreds of speaker training meetings and programs, as well as payments for attending consultant, marketing and advisory board meetings, all at upscale resorts and other locations. Serono’s actions allegedly resulted in the submission of false claims to federal health care programs including Medicare and Medicaid for the payment of Rebif, i.e., claims that were tainted by kickbacks.