Manufacturer Responsibility for Defective Medical Devices is Getting Closer

Todd Slaughter — Wed, 05 Aug 2009 12:21:21 GMT

Tuesday, 8/4/09, patients and doctors testified before the Senate Health, Education, Labor and Pensions Committee in support of the Medical Device Safety Act of 2009 which will restore manufacturer responsibility for defective medical devices. This law will overturn the holding in the U.S. Supreme Court case of Reigel v. Medtronic decided two years ago. Background on that case can be found at the author's website.

Though the opposition claims that this law will give unsophisticated juries more authority than the FDA experts, the FDA has conceded for years that it does not have the wherewithall to monitor and control the medical product performances in the field. The FDA has relied on state court actions brought by injured consumers as a "complimentary review" of the medical devices it authorizes into the marketplace.

Following the Reigel decision, the FDA has had to rely on manufacturers to correct defects in their products, something that manufacturers are naturally reluctant to do. Contrary to the opposition's view, profit most often motivates the actions of the manufacturers. The "initiative" and "inventiveness" that the opposition claims will be stifled by the law seldom overrules the profit motive in favor of safety innovations. This is particularly true when the manufacturer is made completely immune from responsibility to those hurt by its defective products.

We commend Congress for its work to correct the "black hole" that the Supreme Court created, and to return responsibility to those that place defective medical products into the medical marketplace and our bodies.

Originally posted at InjuryBoard by Todd Slaughter

Science Was Made Criminal at FDA

Todd Slaughter — Thu, 29 Jan 2009 17:18:13 GMT

The continuing revelations about the ordeals that FDA scientists endured when they voiced scientific concern about the Bush approval process for medical devices, engenders not only alarm but horror.

The New York Times reported today that the nine scientists of the Food and Drug Administration who complained to Congress about the inadequacies of the approval process of medical devices during the Bush years, were made the targets of criminal investigations for their perceived acts of defiance. As we previously wrote, these scientists had been critical of the efforts of the Bush appointed management to continually decrease the requirements of testing and scientific evaluation before approval. The Bush team put commercial expedience at the head of the class, and science in the back row. Now to learn that the agency's management sought retaliation through the initiation of an internal criminal investigation against these scientist is, in the scientists' apt words, "an outrage."

The positive side of the report of this embroilment is, hopefully, that science again will lead the way, rather than be shuffled aside for profit. With these recent revelations, it feels as if the last eight years took us to the brink of a return to the Dark Ages. Science and technology must be fostered and nutured for it to flourish. Did we learn nothing from the Inquisition?

Originally posted at InjuryBoard by Todd Slaughter

Redding Personal Injury Lawyer - Medical Devices & Implants

Manufacturer Responsibility for Defective Medical Devices is Getting Closer

Science Was Made Criminal at FDA