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The Food and Drug Administration (FDA) is cracking down on makers of medical devices that fall in the most risky category of products approved by the FDA, ordering the companies to provide tougher evidence of their products’ safety and effectiveness or pay for extensive clinical trials for their products currently on the market, according to the Wall Street Journal.
U.S. District Judge Richard Kyle dismissed thousands of lawsuits against Medtronic Inc., manufacturer of the faulty Sprint Fidelis defibrillators that have allegedly injured and killed several people. Attorneys serving the patients, however, may seek to have the judge disqualified from the case because he never disclosed that his son works for the law firm representing Medtronic.
A group of FDA scientists recently sent a six-page letter to Barack Obama’s transition team venting consternation over their agency’s corruption and mismanagement. It’s not the first time FDA scientists have sought the help of Washington, pleading for a shakeup, but the number of complaints and the overall tone of the latest letter indicate agency insiders are eager to grab some of the new President’s much promised change.
Medtronic, Inc. has acknowledged that they are the subject of multiple federal investigations regarding their marketing practices and the recent Sprint Fidelis defibrillator lead recall. The Senate Finance Committee and the Justice Department have both asked the company for information as part of investigations of wrongdoing. They also face thousands of potential lawsuits from individuals who received one of the defective wires, which are used to connect implantable defibrillators to the heart.
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