Okay, first things first -- here's the link to the actual US Supreme Court slip opinion, issued today in Cause No. 06-1249, styled Wyeth v. Levine, certiorari to the Supreme Court of Vermont.
It's a pre-emption case. 6-3 decision.
The high court has ruled that federal law does not pre-empt the claims made by the plaintiff, Diana Levine, that the defendant, Wyeth Laboratories, did not provide adequate warnings concerning the use of the IV-push method of administering its drug Pherangan. In other words, FDA approval doesn't shield the drug manufacturer from responsibility for monetary damages as defined by state personal injury law.
As a result, Wyeth is facing paying big money liability under Vermont state law for the improper administration to Levine of its drug, which entered her artery and not her vein as it should have, causing immediate gangrene and the ultimate amputation of her arm. (In her initial trial, the Vermont jury awarded Diana Levine $6.7 million - and I don't know what she's going to get now, what with all that interest covering all these years.)
Her job? Professional musician (pianist and guitarist). Did I mention big money yet?
Today, there's lot of coverage (like this article in USA TODAY and this one in USNews & World Report) about the US Supreme Court's decision.
As well there should be.
First, the high court could have written this opinion narrowly. It didn't. If you take the time to read it, it's quite broad. Don't think this wasn't intentional.
Second, there are lots of personal injury attorneys out there who know the costs involved in pursuing these type of drug injury cases, and today's decision sure does give them a comfortable level when they're analyzing risk in taking future drug injury cases to trial in state court.
FDA approval, schmoval. You can just hear the plaintiffs' bar tee-heeing with glee.
Third, and best from my perspective, people who have been injured or killed by a lot of sloppy FDA decisions aren't going to have to worry about that FDA pre-emption issue now. Who really trusts FDA approval now, like say folk did in 1980?
There have been too many recalls -- and those "oops" were in a big way. Kids and pets and all sort of innocent folk got hurt and killed by products that initially got the FDA okey-dokey.
My vote? Levine v. Wyeth was a good decision, even if you can already hear the cries of "lawsuit abuse" in the wings.