U. S. Democrats on Thursday moved a legislation to overturn a 2008 ruling that protected medical device companies from being sued by patients over harm from their products that were approved by the Food and Drug Administration.
This move followed close on the heels of the Supreme Court on Wednesday deciding in favor of a Vermont woman whose arm had to be amputated after she was improperly injected with Phenegran, a nausea medication and the ruling upheld a $6.7 million award against the drug maker Wyeth. The court found claims were pre-empted by a clause in a 1976 federal device law.
The bill reintroduced by the Democrats would allow similar lawsuits against companies that make heart devices, catheters, hip replacements and other devices. The Supreme Court last year in a case involving a patient injured by a catheter from Medtronic agreed with the pre-emption policy that the patient could not sue. That case turned on a provision of federal law which prohibited states from imposing their own requirements on the devices. There's no similar provision for drugs.
Subsequently citing the Supreme Court's decision thousands of lawsuits against Medtronic and other device companies have been dismissed by lower courts.
"Yesterday the Supreme Court rightfully upheld a patient's right to legal recourse after sustaining an injury from a pharmaceutical product," said Rep. Frank Pallone, D-N. J. "Today, we introduce legislation that gives patients that same right when injured by a medical device."
Pallone, who chairs the House of Representatives Energy and Commerce subcommittee on health said, the legislation "puts safety first and eliminates the blanket immunity that medical device companies currently enjoy thanks to an unfortunate Supreme Court decision last year."
He added that Congress needed to move quickly on the measure to restore patients' right to sue over devices. A similar bill is pending in the Senate. Advanced Medical Technology Association (AdvaMed) said the FDA should assess a products risks rather than state courts.
AdvaMed President Stephen Ubl said, "This bill does not in any way improve patient safety. It will, however, restrict patient access to essential medical technologies, produce a chilling effect on medical innovation, create more lawsuits and ultimately result in higher health-care costs for all Americans."












