Rep. Frank Pallone says the Supreme Court's decision in Medtronic's case gave device makers blanket immunity for the life of a product.
Democrats in Congress introduced a bill in late June that would change the law that allowed Medtronic to prevail in a product liability case decided by the Supreme Court. If it becomes law, it could make premarket approval (PMA) holders face more lawsuits.
The Medical Device Safety Act of 2008 would overturn the federal preemption clause contained in the Medical Device Amendments of 1976. The high court cited language in that law in its 8–1 decision in favor of Medtronic. It interpreted the law to mean that makers of PMA products cannot be sued in state courts if the products did not violate federal regulations (that is, if they are not adulterated or misbranded). The wording established FDA as the sole arbiter of safety and effectiveness of PMA products.
This preemption of lawsuits in state courts does not apply to 510(k) products, nor to PMA products that are found to be adulterated or misbranded. (The Medtronic product in question, a catheter, was neither, the court found.)
The bill was introduced in the House by Representatives Frank Pallone (D–NJ) and Henry Waxman (D–CA), and in the Senate by Senators Ted Kennedy (D–MA) and Patrick Leahy (D–VT).
“This bill reverses an unfortunate Supreme Court decision that denied victims any legal recourse and gave device makers blanket immunity for the life of a product,” said Pallone. “Congress should pass this legislation so that we can protect patients from dangerous and defective medical devices.”
Waxman said that the 1976 law had never been interpreted as preemptive of state-court cases until the Bush administration was in place.
Click here for more of Ubl's take on The Medical Device Safety Act of 2008.
As soon as the legislation was introduced, AdvaMed released a strongly worded statement against it. The organization charged that allowing such cases to proceed in state courts could allow states to set their own standards for safety and effectiveness of PMA products. This would be chaotic and could restrict patient access to innovative medical products, it said.
“A patchwork approach to medical device approvals where state courts effectively review and regulate medical devices would result in a dizzying array of conflicting labeling and indications for use, and ultimately may result in technologies not being available for patients,” said AdvaMed president Stephen Ubl.