Medical Device Litigation: Suprement Court 8-1 Decision

[Slackwater]

My understanding is FDA approval means the device maker can not be sued. It's not the last word yet. The Supreme Court's decision relates to the 01/30/08(?) Reed Abelson, New York Times ProDisc article, "Financial Ties Are Cited as Issue in Spine Study".

I saw "Supreme Court" and "Medical Devices" on the front page of the New York Times when I got coffee this morning. Figured this relates to ADRSupport.org's discussion.

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February 20, 2008
Supreme Court Embraces Medical Device Preemption

The Supreme Court today decided Riegel v. Medtronic, an important case concerning federal preemption of state law product liability claims. Justice Scalia wrote for the 8-1 majority in favor of preemption, reasoning that experts at the FDA are better positioned than jurors to evaluate the risks and benefits of medical devices. Justice Ginsburg dissented. Here's a copy of the opinion on Findlaw. And here's an excerpt from David Stout's story in the New York Times, Justices Make It Tougher to Sue Medical Device Makers:

<UL TYPE=SQUARE>In a case with huge implications for the health care-technology industry, the Supreme Court ruled on Wednesday that the manufacturer of a federally approved medical device cannot be sued under state law if the device causes an injury.

The 8-to-1 ruling in favor of Medtronic, the Minneapolis-based maker of cardiovascular devices, made it much more difficult for patients and their families to sue makers of medical devices that have been granted federal approval. ...

The Supreme Court upheld the lower federal courts on Wednesday, with Justice Antonin Scalia writing for the majority that Medtronic and other manufacturers were protected under the Medical Device Amendments of 1976, which in its section on pre-emption bars states from imposing on medical devices “any requirement which is different from, or in addition to, any requirement applicable under this chapter.”

But the justices’ ruling was hardly the last word on when F.D.A. approval bars patients from suing. They are already considering at least three cases involving drugs and drug-labeling.[/list]=========================
ref:
NYTimes
MoneyCentral
Washington Post
Mass Tort Litigation

Slackwater

[annapurna]

My first reaction is to question what effect this will have on off-label use of medications and devices. If the FDA has been blessed as the ultimate arbiter of what's safe, then will any off-label use automatically be declared unsafe?