Bottom-line: Medtronic pays doctors to recommend defective devices. Once those defective devices hurt the patient that patient cannot sue the manufacturer.
Medtronic Inc. agreed to pay the United States $23.5 million to resolve allegations that it violated the False Claim Act by 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 Justice Department announced yesterday (December 12, 2011). (See DOJ Press Release Here)
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.
Kickbacks + Unnecessary Device Implants = Injury & Death
A few months ago, I reported on a study published in January 2011’s issue of the Journal of the American Medical Association where researchers scrutinized the use of implantable cardioverter-defibrillators (ICD) in 111,000 ICD recipients to determine whether or not they met the appropriate criteria for placement of one of these devices. The study was conducted by researchers affiliated with Duke University who analyzed the cases and determined that 25,145 (or 22.5%) were unnecessarily implanted with ICD devices.
Despite the number of patients who underwent unnecessary surgery, the real issue lies in the risk of injury. The rate of complications (including death) was drastically increased in patients who did not need the devices in the first place. Also tack on a lengthier hospital stay (usually three times longer) and the risk for major complications and you have a recipe for disaster.
What About The People Who Are Injured Or Killed By These Medical Devices? Tough Luck
Donna Riegel filed suit against Medtronic after a Medtronic catheter burst inside the artery of her husband Charles causing him to undergo emergency bypass surgery in 1996. Although Charles Riegel survived the surgery, he passed since, and Donna carried the fight all the way to the Supreme Court.
On February 20, 2008, in an 8-1 decision, the Supreme Court ruled against the estate of Riegel stating that you cannot sue for injuries resulting from a medical device that undergoes “PMA” testing.
What Is A Medical Device That Undergoes PMA Testing?
Federal law requires that a company must submit an application to the U.S. Food and Drug Administration (FDA) before a medical device can be sold. Medical devices are classified as Class I, II, or III. Generally speaking, Class III devices pose the most danger to the public. The FDA can approve a Class III medical device when a manufacturer shows that the device is either substantially equivalent to a device already on the market through the 510K process or that the device is safe through the pre-market approval process (PMA).
The catheter that caused Charles Riegel injuries was approved by the FDA through pre-market approval (PMA). PMA is the most stringent type of review required by the FDA.
The main difference between 510K and PMA is that 510K focuses on substantial equivalency to a product already approved to go to market whereas PMA focuses on the safety of a previously unapproved product.
ICDs and other heart devices undergo PMA testing. So if you were injured by an ICD or any other heart device, you are not able to sue for your injuries.