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Microsoft word - pl_wyeth_v_levine_decision_alertmar09.docMarch 2009
Product Liability Alert
U.S. Supreme Court rules no federal preemption for prescription drug labels
In a long-awaited decision, on March 4, 2009, in Wyeth v. Levine, the United States Supreme Court found by a
6 to 3 vote, that the Food and Drug Administration’s approval of a warning label on a prescription drug did
not preempt state law tort claims. This case is the follow up to Riegel v. Medtronic, decided on February 20,
2008, in which the Court held that state lawsuits alleging that a medical device is defective were preempted
because of FDA approval of the medical device. One of the key differences between medical devices and
prescription drugs that the Supreme Court found is that Congress specifically stated that state law claims
against medical devices were preempted by the FDA regulations. In contrast, the Court found that the FDA
itself has no power to state that there is federal preemption over an area, although it will consider the agency’s
position in its review of all the pertinent facts of the case.
In Wyeth v. Levine, the plaintiff’s arm was amputated following her receipt of an IV push injection of
Phenergan which was manufactured by Wyeth. The Vermont trial court found that Wyeth did not provide
adequate warnings about the dangers of gangrene resulting from injection of Phenergan by an IV push. The
FDA approved the label for Phenergan in 1955 after reviewing the new drug application for the drug. The
FDA subsequently approved changes to the label as proposed by Wyeth between 1955 and 1998. The trial
court awarded the plaintiff $7.4 million, which was later reduced to offset the settlement by the health center
and the physician’s assistant who injected the Phenergan. The Vermont Supreme Court affirmed. This appeal
to the US Supreme Court followed.
Wyeth argued that the Vermont Courts’ decisions should be reversed as they could not comply with the
Vermont duty to modify the label without violating federal law. Wyeth claimed that Congress intended to
preempt state law in this area. In deciding this issue, the Court examined the Riegel case. There, the Court
found that in 1976, Congress specifically enacted an express preemption for medical devices. At that time,
and at any time subsequent, Congress could also have chosen to state that any state law claims alleging
inadequate warnings for prescription drugs were preempted by federal law. Congress failed to do so.
One point which the Court focused on was the FDA’s “changes being effected” (CBE) regulation. Generally,
a manufacturer can only change a product label after the FDA approves the supplemental application. The
CBE, however, allows a manufacturer to make certain changes to a label before getting FDA approval. One of
these changes is strengthening a label warning in certain prescribed manners. Wyeth’s argument that the CBE
does not apply in this case because it only applies to new information discovered about the drug was rejected
by the Court. The Court said that a CBE is not restricted to new information, but also applies to a new
analysis of information previously submitted to the FDA. The Court also found that it was unlikely that the
FDA would prosecute a manufacturer for strengthening its warnings and providing additional information to
the consumer. Wyeth was unable to present any such cases to the Court. The Court found that under the CBE
regulations, Wyeth could have revised the warning before getting FDA approval. There was no evidence
submitted that the FDA would not have approved a change to the label. The Supreme Court found that Wyeth
did not prove that it was impossible for it to comply with both federal and state requirements in this case. The
Supreme Court ruled that the manufacturer, not the FDA, is ultimately responsible for the warning labels and instructions provided with the product. For more information, please contact Lorraine E.J. GallaghMaynard M. Kirpalani 2009 Wilson Elser Moskowitz Edelman & Dicker LLP. All Rights Reserved.
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