Young Avery Degroh was the victim of a defective medical device, and because of bad laws, Medtronic, the maker of the device, faces no legal responsibility for selling a medical device that caused a severe personal injury to a child.As a result, Avery’s family must bear enormous medical costs, while Medtronic gets the profits. And it is against the law for Avery to sue Medtronics for selling a defectively designed medical device.
Avery was born with a heart defect, and had a defibrillator implanted in her chest when she was very young.
When she was 3, her mother heard Avery screaming in pain and terror. Mom picked up her child and felt electricity running through the girl’s body. The wire on Avery’s defibrillator had malfunctioned, and it was shocking her from within. She received a total of 9 shocks within 30 minutes. The child thought that monsters were attacking her.
Avery and her family have no right to sue Medtronic, and no one injured by any defective medical device can bring legal action against the manufacturer because of provisions in the Medical Device Amendments of 1976. That legislation provides that once a medical device receives FDA approval, anyone who suffers a personal injury from a defective medical device cannot bring legal action against the manufacturer. The obvious result is that Avery and all the other Americans who suffer injuries from defective medical devices must suffer in silence and bear the financial and personal burdens alone.
The legislation that shields medical device manufacturers from responsibility has two serious flaws.
First, the FDA has total authority over medical devices. As that agency has proven, it lacks the skill and the will to protect American citizens from the dangers posed by foods and drugs. It also does a inadequate job of reviewing and testing medical devices.
The second serious problem is that even if the FDA were perfect, its approval of a medical device should not give a manufacturer the right to sell defective versions of a product or to make changes and refinements in the product without re-testing before releasing to the public.
Manufacturers of medical devices have lived without being accountable since 1976, but help may finally be on the way. If Congress will pass it, the Medical Device Safety Act of 2009 will hold manufacturers such as Medtronic responsible when they sell defective medical devices that cause personal injury or wrongful death.
This bill is an act of fairness, but it has many opponents. One is the highly influential United States Chamber of Commerce, which argues that the bill would stifle innovation and ultimately harm consumers. That’s a deceptive way to say the law would make organization’s members behave responsibly, and might harm their bottom lines slightly in the interest of safety and human health.
It’s probably no surprise that in addition to Medtronic, two of the companies listed on the US Chamber’s letter are Eli Lilly and Bayer. Both of those companies have extensive histories of knowingly selling dangerous drugs and engaging in illegal marketing practices, so it’s easy to understand why they oppose this bill.
Americans of all ages utilize medical devices. Whether it’s a child with a defibrillator or an adult with a hip replacement, everyone has a right to expect that the device will work as intended and that it will do no harm.
The Medical Device Safety Act of 2009 is important consumer protection legislation, and the action that Congress takes on this bill will be a clear indication of whether our legislators are working for the people who elected them or for the corporations that make the biggest campaign donations.
Every American citizen can help in the fight for safe medical devices by sending this petition to your representative in Congress. Please make your voice heard for the good of us all.
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Richard Alexander
