Medtronic Inc., the Minnesota based medical device company, has been in the hot seat on a regular basis. Its
Sprint Fidelis defibrillator recall in October 2007 prompted various shareholder and patient lawsuits. Now a Senate panel wants additional information on the recall and the U.S. Justice Department is investigating whether Medtronic made illegal payments to doctors.
Senate probe
The Senate Finance Committee recently requested additional information from Medtronic about the recall of their Sprint Fidelis defibrillator lead. The lead, a small wire that connects an implanted defibrillator device to the heart, was recalled in October 2007 after some leads began to fracture. When a lead fractures, it can cause the device to shock the heart unnecessarily or fail to shock the heart when needed.
At least five deaths have been linked to the Fidelis leads and the recall affects approximately 235,000 patients worldwide – 172,000 of those are in the U.S alone. Analysts allege that Medtronic knew about the fractureswell before the recall and the Senate’s probe into what the company knew and when it may shed some light on how the recall was handled.
U.S. Justice Department investigation
In addition to the Senate probe, the U.S. Justice Department is investigating whether Medtronic made illegal payments to foreign doctors in Greece, Poland and Germany in violation of the Corrupt Foreign Practices Act. The Department is also investigating whether the company enticed doctors or groups to purchase equipment by way of payments or gifts. This is the second investigation about alleged kickbacks against the company in the past few months. Senator Charles Grassley began an investigation earlier this year, but the results of his probe have not been published.
U.S. Supreme Court ruling
In addition to the investigations, Medtronic argued a pre-emption case in front of the U.S. Supreme Court on December 4, 2007 regarding whether patients are pre-empted from suing medical device manufacturers in state court where remedies are often greater. The case stemmed from a patient whose Medtronic-made catheter broke while he was having angioplasty surgery. He was severely injured and sued the company.
Ruling for Medtronic, two lower courts barred his suit saying that he could not bring a state claim as the Food and Drug Administration (FDA) – a federal agency – is ultimately responsible approving these products. Consumer groups say that this leaves patients without due recourse and are watching the case closely. If the court rules for Medtronic, it will essentially bar patient lawsuits from certain FDA approved products. Many legal experts doubt that the conservative high court will overturn the lower courts’ rulings. The court’s decision is expected before July 2008.
