Yesterday, the Supreme Court issued a ruling in the case of Wyeth v. Levine, a case where a drug manufacturer argued that the act of FDA approval and a label – as an act of a federal agency – pre-empted any state law that allowed a lawsuit against the manufacturer of the product by anyone who uses the product.
The court itself describes the case the best:
After a clinician injected respondent Levine with Phenergan by the “IV-push” method, whereby a drug is injected directly into a patient’s vein, the drug entered Levine’s artery, she developed gangrene, and doctors amputated her forearm. Levine brought a state-law damages action, alleging, inter alia, that Wyeth had failed to provide an adequate warning about the significant risks of administering Phenergan by the IV-push method. The Vermont jury determined that Le-vine’s injury would not have occurred if Phenergan’s label included an adequate warning, and it awarded damages for her pain and suffering, substantial medical expenses, and loss of her livelihood as a professional musician. Declining to overturn the verdict, the trial court rejected Wyeth’s argument that Levine’s failure-to-warn claims were pre-empted by federal law because Phenergan’s labeling hadbeen approved by the federal Food and Drug Administration (FDA). The Vermont Supreme Court affirmed.
Inter alia, by the way, means "among other things".
I have avoided writing about the issue of pre-emption. The reason – it just did not, in my opinion, stack up. The Supremes didn't think so either.
Here is part of what the Court reasoned:
Wyeth’s argument that requiring it to comply with a state-law duty to provide a stronger warning would interfere with Congress’ purpose of entrusting an expert agency with drug labeling decisions is meritless because it relies on an untenable interpretation of congressional intent and an overbroad view of an agency’s power to pre-empt state law.
Think about it. The notion of pre-emption implies that a manufacturer's duties to maintain protection of the public health by updating the public and prescribers about evolving understanding of the product are non-existent because a federal label provided a label and states cannot require greater diligence on the part of manufacturers.
Not only from a legal point of view does the argument sound off – but from a public policy point of view as well. It is not until a drug has a label and is out in the market that a greater experience informs a more developed point of view about the product. That is why there are always updates given to the public via various means.
The notion that a label is somehow shielding from liability is kind of like saying – well my state gave me a driver's license, therefore, the state has endorsed my driving skills. You can't sue me because the state has endorsed me. It isn't that simple of course, but you get the idea.
Case over. Let's move on.