No immunity for FDA approved products
Everyone should take a moment and watch a few of these video testimonials. The FDA is not responsible for testing the safety of medical devices, but rather, they rely on the manufacturer’s testing data when issuing an approval. If medical device manufacturers can’t be held accountable in a court of law, they have no incentive to produce a reliable product or to be forthright with the FDA about the device’s safety.
Here is a press release from the Campaign to Stop Corporate Immunity
The House Energy and Commerce Subcommittee on Health will hold a hearing on the Medical Device Safety Act, a bill that would reinstate the rights of patients to hold device manufacturers accountable. Testimony will be heard from physicians representing the New England Journal of Medicine, the Medical Device Safety Institute, a patient harmed by a defective device, and noted legal scholar David Vladeck.
This hearing will set the stage for a vote on critical legislation which is pending in Congress called the Medical Device Safety Act. HR 1346 would restore the rights of thousands of Americans who have suffered or even died because of defective medical devices, like heart defibrillators, artificial valves, and prosthetic knees and hips, to seek justice through the civil justice system. The legislation’s lead sponsors are Health, Education, Labor and Pensions Committee Chairman Ted Kennedy in the Senate and Health Subcommittee Chairman Frank Pallone in the House.
The medical device industry opposes this bill. They claim that the Medical Device Safety Act would prevent them from developing new medical technologies even though they had no problems with innovation prior to the Riegel decision when they could be held accountable for faulty devices.
“Medical devices are some of the most dangerous products on the market, causing devastating injuries to millions of people, yet currently manufacturers of these devices are completely immune from liability,” said Joanne Doroshow, Executive Director of the Center for Justice and Democracy. “It is gratifying to know that steps are being taken in Congress to fix the law.”
“People with disabilities deserve and expect that the medical devices they depend upon will be safe and reliable. When they're not, they should have a right to hold the manufacturer of faulty equipment accountable,” said Paul Tobin, President and Chief Executive Officer of the United Spinal Association. “The Medical Device Safety Act will hold manufacturers accountable for the quality and durability of the critical equipment that they market.”
Now is the time for Congress to act and pass the Medical Device Safety Act; it is not the time to allow special favors for corporate America.
Please let Congress know you support this.
