Supreme Court Refuses to Shield Drug Manufacturers From Liability

Supreme Court Refuses to Shield Drug Manufacturers From Liability

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.

Wyeth’s cramped reading of the CBE regulation and its broad assertion that unilaterally changing the Phenergan label would have violated federal law governing unauthorized distribution and misbranding of drugs are based on the fundamental misunderstanding that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling. It is a central premise of the Food, Drug, and Cosmetic Act (FDCA) and the FDA’s regulations that the manufacturer bears responsibility for the content of its label at all times. 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 preempt state law.

The history of the FDCA shows that Congress did not intend to preempt state-law failure-to-warn actions. In advancing the argument that the FDA must be presumed to have established a specific labeling standard that leaves no room for different state-law judgments, Wyeth relies not on any statement by Congress but on the preamble to a 2006 FDA regulation declaring that state-law failure-to-warn claims threaten the FDA’s statutorily prescribed role. Although an agency regulation with the force of law can preempt conflicting state requirements, this case involves no such regulation but merely an agency’s assertion that state law is an obstacle to achieving its statutory objectives. Where, as here, Congress has not authorized a federal agency to preempt state law directly, the weight this Court accords the agency’s explanation of state law’s impact on the federal scheme depends on its thoroughness, consistency, and persuasiveness.

Under this standard, the FDA’s 2006 preamble does not merit deference: It is inherently suspect in light of the FDA’s failure to offer interested parties notice or opportunity for comment on the preemption question; it is at odds with the available evidence of Congress’ purposes; and it reverses the FDA’s own longstanding position that state law is a complementary form of drug regulation without providing a reasoned explanation. The importance of this ruling cannot be exaggerated. Had Wyeth’s arguments been upheld, the acts of the drug companies that kill and harm countless numbers would have been more insulated from justice.

They would have just said, “Well the FDA said it was ok and that means you can’t sue us.” Until we have real reform at the FDA and until we start sending these drug company executives to jail who falsify documents to increase sales, even at the cost of killing thousands, we must have the right to punish these gangsters with large injury verdicts. The Supreme Court has gotten this one right.

At Novus Medical Detox Center, we regularly have people come to us who are the victims of the immoral actions of the drug companies. If you know someone that wants to safely and more comfortably withdraw from OxyContin, methadone, heroin, Percocet, Vicodin, Xanax, anti-depressants and other prescription drugs please let them know about Novus. We are here to help.

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