On March 4, 2009, the United States Supreme Court released their decision entitled Wyeth v. Levine. In our August 19, 2008 newsletter we described the issues at stake in this case.
Briefly, Levine was a musician who was administered the anti-nausea drug Phenergan directly into her vein using an IV. The drug entered Levine's artery and she developed gangrene, forcing her doctors to amputate her forearm. Levine brought a state-law damages action against Wyeth, alleging that Wyeth had failed to provide an adequate warning about the significant risks of administering Phenergan via an IV.
The Vermont jury determined that Levine'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. The trial court rejected Wyeth's argument that Levine's failure-to-warn claims were pre-empted by federal law because Phenergan's labeling had been approved by the federal Food and Drug Administration (FDA). The Vermont Supreme Court affirmed.
When a claim is said to be pre-empted, this means that Congress has decided that the right to rule on the claim is not with the state courts but with the federal courts.
In essence, what Wyeth was arguing was that even though there may have been serious damages caused by their failure to provide adequate warnings, the fact that the FDA approved their labels insulates them from any liability from a victim of their failure to provide adequate warning. This is a particularly insulting argument when you know:
- The drug labels are accepted by the FDA long before a drug has been used by the general public;
- It is generally after use by the general public that problems with the drug and its label become known;
- There are many cases where the FDA has taken years to require a label change even when the evidence of risk was overwhelming;
- Many times the drug labels are changed not in response to pressure from the FDA but because of lawsuits filed by people like Ms. Levine.
The Supreme Court did not fall for Wyeth's specious arguments. In a 6-3 decision, the Court ruled:
- Federal law does not preempt Levine's claim that Phenergan's label did not contain an adequate warning about the IV method of administration.
- Although a manufacturer generally may change a drug label only after the FDA approves a supplemental application, the agency's "changes being effected" (CBE) regulation permits certain preapproval labeling changes that add or strengthen a warning to improve drug safety. Pursuant to the CBE regulation, Wyeth could have unilaterally added a stronger warning about IV administration, and there is no evidence that the FDA would ultimately have rejected such a labeling change.
To read on, click here.
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