OR WAIT null SECS
On November 3, the US Supreme Court heard arguments in the case of Wyeth v Levine; the ultimate decision of the Court on this case may set a precedent on the issue of pre-emption, a tenet that FDA actions regarding drug approvals and medication safety supersede state laws.
On November 3, the U.S. Supreme Court heard arguments in the case of Wyeth v Levine. The Court’s ultimate decision on this case may set a precedent on the issue of pre-emption, a tenet that FDA actions regarding drug approvals and medication safety supersede state laws.
In 2000, Diana Levine was treated with Wyeth’s promethazine (Phenergan) for nausea resulting from a migraine headache. Levine received 2 administrations of the drug at a Vermont clinic. The first was given by intramuscular injection; the second by direct intravenous (IV) injection into the arm (“IV push”). This second administration was inadvertently injected into an artery, which led to arterial damage and then to gangrene. Levine’s hand and forearm had to be amputated.
Levine sued Wyeth in Vermont, citing negligence and failure-to-warn product liability, and a jury found in favor of Levine. The Vermont Supreme Court upheld this finding when Wyeth appealed the original ruling. In response to Wyeth’s assertion that federal law should supersede state law, the court stated, “We hold that there is no conflict between state and federal law that requires pre-emption of plaintiff’s [Levine’s] claim,” adding, “We hold that the jury’s verdict against defendant [Wyeth] did not conflict with the FDA’s labeling requirements for Phenergan because defendant could have warned against IV-push administration without prior FDA approval, and because federal labeling requirements create a floor, not a ceiling, for state regulation.” Wyeth appealed this decision, and the case was sent to the U.S. Supreme Court.
The oral arguments presented on November 3 centered around several key issues: whether FDA had considered the risks of IV push versus IV administration via infusion, whether Wyeth had new information or new analyses of old information regarding these potential risks, and whether the product labeling approved by FDA sufficiently outlined the risks associated with IV push administration.
Wyeth’s attorney, Seth Waxman, argued that FDA was aware of the risks associated with IV push administration and that the agency did not think it necessary to revise the product labeling. He stated that FDA “provided ample, lavish warnings about the risk of intra-arterial injection and exposure of an irritant drug like Phenergan to arterial blood. It provided in the labeling to the physicians a cascading hierarchy of methods of administration.” He added, “All that information was available to physicians and the FDA has to understand and does understand that in labeling to allow medical professionals to make their judgments, taking options away from physicians is not always better.”
Levine’s attorney David Frederick asserted that “FDA never considered any comparative risks of IV push versus IV drip,” pointing to a lack of correspondence between the agency and Wyeth on the subject as evidence. He added that “because the catastrophic risks of IV push are so dramatic, no reasonable person could have made a safety determination to allow this drug with its risks when there are corresponding benefits that create exactly the same kind of treatment of care for the patient.” He stated that his case is “dependent on a finding that the manufacturer had a duty of due care and it didn’t live up to that.”
The full Supreme Court transcript can be accessed at: http://www.supremecourtus.gov/oral_arguments/argument_transcripts/06-1249.pdf.