Friday, March 06, 2009


"Wow," an interjection defined as "an exclamation of surprise, wonder, pleasure, or the like."

So yeah, wow, indeed.

Jonathan Turley lets us know that the Supreme Court
has ruled 6-3 in favor of [Diana] Levine, a musician from Vermont, who lost her right arm after being given a anti-nausea drug [made] by Wyeth.
Levine was administered the drug, Phenergan, by intravenous injection even though that created a danger of gangrene by inadvertent contact with arterial blood. As I noted when I wrote about the case in November, Wyeth and the FDA both knew of the risk but the warning label merely advised against intravenous injection rather than banning it. Levine sued on the grounds that the warning was clearly inadequate and was awarded $6.7 million.

Wyeth appealed to the Vermont Supreme Court and lost again. So it turned to the feds.
The issue[, Turley goes on,] was federal preemption and whether Congress effectively barred lawsuit once a drug was approved by the Food and Drug Administration. The Bush Administration entered the case on behalf of Wyeth and against Levine to try to block patients from being able to seek recovery against drug manufacturers.
More specifically, the issue was implied preemption. In February 2008, SCOTUS ruled in Riegel v. Medtronic
that manufacturers of FDA-approved medical devices were immune from common-law suits based on state law principles because federal law expressly preempted them - that is, the law said that no interpretation of liability could be stricter than that established by the feds.
In Wyeth v. Levine, the corporate giant, supported by the Department of Justice, tried to expand on that argument, claiming in effect that because FDA considers itself to be the final authority on safety issues, suits based on state laws are preempted - even though federal law regarding warning labels on drugs contains no preemption clause. In other words,
[t]he lowest common denominator consumer protection established by the FDA, Wyeth and the DOJ are saying, is not a minimum the company must meet but a maximum anyone is able to enforce.
And the Shrub gang and Wyeth lost. At the Supreme Court. The almost shamelessly pro-corporate Supreme Court. The supreme Court that ruled against Lily Ledbetter. Damn.

Surprisingly, Clarence Thomas was part of the majority. Unsurprisingly, the dissenters were Justices John Roberts, Antonin Scalia, and Samuel Alito, the latter of who called the ruling “a frontal assault on the FDA’s regulatory regime for drug labeling.”

Alito is just a little confused; of course he meant the pharmaceutical industry's regime for drug labeling. An easy mistake to make, as the two are so similar.

Footnote: When I wrote about this in November, I predicted that the case would go as other corporate issues have of late at SCOTUS: That Wyeth would win on some technicality that would allow for implied preemption without swinging the door open wide. One of the nice things about being cynical is that you can be happy to be wrong.

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