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The proposed Medical Device Safety Act of 2008 would hold manufacturers liable for their devices by allowing victims to sue for their injuries in state court. If passed, it would essentially reverse the U.S. Supreme Court’s decision earlier this year that prohibited lawsuits against manufacturers in situations where the U.S. Food and Drug Administration (FDA) was ultimately responsible for a medical device’s approval before being released into the marketplace.

What the Act provides

The Medical Device Safety Act of 2008, also known as HR (House of Representatives) Number 6831, is sponsored by Representatives Harry Waxman (D-CA) and Frank Pallone (D-NJ). According to a Congressional press release, http://www.house.gov/waxman/pdfs/pressrelease_MDSA_2008.pdf, the legislation would clarify that state product liability lawsuits are preserved.

It would also reverse a very controversial, and very recent, U.S. Supreme Court ruling. According to Pallone, the Act would reverse, “an unfortunate Supreme Court decision that denied victims any legal recourse and gave medical device makers blanket immunity for the life of a product. Congress should pass this legislation so that we can protect patients from dangerous and defective medical devices."

In that case, Riegel v. Medtronic, Riegel was severely injured when a balloon catheter made by Medtronic burst during angioplasty surgery. His wife sued Medtronic, but the company claimed that preemption barred the lawsuit. The U.S. Supreme Court agreed. It ruled 8–1 that the express preemption provision of the federal Food, Drug and Cosmetic Act does preempt state-law claims seeking damages for injuries caused by devices with pre-market approval.

The Senate is allegedly drafting a similar bill which is being sponsored by Senators Edward Kennedy (D-MA) and Patrick Leahy (D-VT).

How it may affect other lawsuits

If either the House of Representative’s or Senate’s bill – or a combination of the two – becomes law, it may affect other lawsuits in which manufacturers claim preemption. In fact, a U.S. Supreme Court case that many are watching is Wyeth vs. Levine.

That case addresses the same issue, but in respect to pharmaceutical companies. Levin was a musician who lost her arm after receiving an anti-nausea drug via an off-label injection method. She sought recovery from Wyeth Pharmaceuticals under Vermont state law, but similar to the Riegel case, the manufacturer claimed that Levin was preempted from bringing a lawsuit because the FDA was ultimately responsible for the drug’s pre market approval. That case will be decided by the U.S. Supreme Court this fall.