Supreme Court shields device makers

Medical device makers got some supreme protection yesterday. The highest court raised a partial shield against lawsuits, saying that devices that passed the FDA's most stringent premarketing review are exempt from consumer lawsuits [1]. Essentially, the justices ruled that federal law--i.e., FDA regulation--preempts liability under state law for these devices.

Can drugmakers anticipate their own celebration when the Supreme Court decides a couple of other preemption cases that involve meds instead of a device? Don't buy the champagne yet, some legal experts say. In ruling for Medtronic yesterday, the Court relied on a federal law specific to medical devices, not drugs. The Medical Device Amendments of 1976 set up detailed requirements for FDA testing of devices, wrote Justice Antonin Scalia in the majority opinion, and prohibited states from imposing different requirements.

The ruling will affect numerous outstanding lawsuits, but some pending cases will still be allowed to go forward; the ruling doesn't keep consumers from suing if a device was made improperly, contrary to FDA specifications.

The Court will hear one drug-related case Monday and will consider another in October. Ironically, the justices are considering these rules just as big questions have been raised about the FDA's ability to effectively regulate drugs and devices. Several recent reports have castigated the agency for scientific shortcomings, outdated technology, and mismanagement. Experts say the agency is way underfunded and understaffed. If the courts want FDA as our final authority, then shouldn't it be good at its job?

- read the story [2] in the Washington Post
- see this New York Times article [3]
- check out the NYT's take [4] on preemption under an inadequate FDA
- find this Q&A [5] with a consumer in a preemption case at Pharmalot

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Proposed FDA rule riles lawyers. Report [7]
Bush: FDA's word shields against lawsuits. Report [8]
Supremes to mull block on drug suits. Report [1]