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Not a week goes by without a headline reporting on yet another settlement between a multi-national pharmaceutical company and state or federal prosecutors. Medical device manufacturers are often also frequently subject to similar prosecutions.  While it is laudable that governmental authorities are finally taking action against chronic wrongdoers, the frequency […]

On September 8 and 9, 2011, the Food & Drug Administration will convene a panel of experts to provide advice to the Agency with regard its regulation of gynecological medical devices.  The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will focus on evaluating the safety and […]

The recent news about the Food & Drug Administration’s (FDA) actions in connection with hip implant manufacturers demands the question: why wasn’t the action being ordered required before the hip implants were placed on the market? The answer is that the FDA’s order to 20 device makers to study the […]

Bloomberg has an interesting article today discussing medical device approval and where the fault lies for bad devices being approved for use. The Food & Drug Administration (FDA) “approves” medical devices and often (some say too often) grants review and approval under Section 510(k) of the Food, Drug & Cosmetic […]

The Depuy hip replacement device, the Articular Surface Replacement, manufactured by Johnson & Johnson has been recalled. But, wasn’t it approved by the Food & Drug Administration? Yes, it was approved based on representations by the manufacturer of its safety. The discussion with the FDA about new devices often goes […]

In 2006, Stanford University took a tough and unpopular stand with its medical school professors. They banned what might be characterized as “payola”. Stanford put a stop to free lunches, trinkets with drug company names inscribed and have now barred professors from giving paid promotional speeches for pharmaceutical companies. This […]

Suppose that when a product malfunctions it was acceptable for the manufacturer to pay “experts”, recognized and notable professionals; to write articles, opinion letters, and studies, that spoke of the product’s safety. Articles that dispelled any notion that the product was really what was causing the problem. Suppose that each […]

It is old hat in the medical device and drug industry; do not ask for permission—simply deal with the fall out of asking for forgiveness. The US Attorney’s Office announced indictments against a number of Stryker executives for lying to the Food & Drug Administration. Apparently, Stryker was given permission […]