Stryker Medical Implant Maker Offers $33 Million to End Probe

Marketing non-approved medical devices in the United States is a crime, as Stryker and every device manufacturer know. In a public announcement in May, 2012, Stryker told shareholders it was taking a $33 million charge which reflected the minimum amount they may eventually pay the Department of Justice to settle allegations about its OtisKnee device. The details of the federal subpoena and specific allegations are not known at this time. Medical device manufacturers can get approval through a full blown "pre-market approval" process, or a "510k" fast-track process. The latter requires that the device is similar to another already on the market. What is defined as "similar" can be quite stretched, and many 510k products, such as the DePuy ASR metal-on-metal hip implant and various Medtronic defibrillators have been pulled from the market. A recent Supreme Court decision allows suits against 510k devices but pre-empts, also known as barring, lawsuits if the product got premarket approval. PMA device makers are always certain they won't be sued, even if their approval was allegedly done fraudulently.