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News, Events & Seminars
Jury Runs Roughshod over FDA Regulations
by Kevin M. Cox.
For more information, contact Robert E. Scott
Preemption (pree-emp-Shen), n. The principle (derived from the Supremacy Clause)
that a federal law can supersede or supplant any inconsistent state law or
regulation.
In a very recent 6-3 decision, turning on federal preemption of state law, the
Supreme Court held in Wyeth v. Levine that state law consumer safety tort claims
are not preempted by the Federal Drug Administration's approval of a warning
label for the drug and regulations prohibiting changing the label to conform
with state law.
http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf.
In Wyeth, a Vermont jury found that the petitioner, Wyeth, the manufacturer of
the drug Phenergan, had failed to provide an adequate warning of the risk
injecting the drug via "I.V.-push method" and awarded damages to Diana Levine to
compensate her for the infection, and subsequent amputation of her arm. The jury
determined that Levine's injury would not have occurred if Phenergan's label
included an adequate warning. Notably, the label clearly warned practitioners to
use "extreme care" when injecting the drug and explaining that resultant
gangrene requiring amputation are likely" to occur with the IV-push method.
Wyeth's attorney's argued that Levine's failure-to-warn
claims were preempted by federal law. Phenergan's labeling had been approved
by the FDA. The Supreme Court rejected Wyeth's arguments, holding that the
agency's "changes being effected" (CBE) regulation permits certain
pre-approval labeling changes that add or strengthen a warning to improve
drug safety, and there was no evidence to suggest the FDA would have denied
Wyeth's request to include a stronger warning label. The Court also held
that requiring Wyeth to comply with a state-law duty to provide a stronger
warning does not interfere with Congress' purpose of entrusting an expert
agency with drug labeling decisions because the history of the FDCA shows
that Congress did not intend to preempt state law failure-to-warn actions.
In his dissent, Justice Alito noted, "This case
illustrates that tragic facts make bad law." The jury was presented with the
injury to the Plaintiff and not the benefits to the untold numbers of
individuals helped by the drug. According to Justice Alito, "the real issue
is whether a state tort jury can countermand the FDA's considered judgment
that Phenergan's FDA-mandated warning label renders its intravenous (IV) use
‘safe.'" Justice Alito's dissent urged that this case represents, at most, a
medical-malpractice claim, and should not be a "'frontal assault' on the
FDA's regulatory regime for drug labeling" upsetting "the well-settled
meaning of the Supremacy Clause and conflict pre-emption jurisprudence."
Some see this case as representing a potential increase
in products liability cases against drug manufacturers. Whereas previously
manufacturers could sell a drug with FDA approval under the assumption that
the approval provided them some liability protection, this case has the
effect of nullifying this protection. Others see this case as a "strategic
loss" for the drug companies.
http://www.forbes.com/2009/03/04/supreme-court-drug-safety-fda-business-washington_wyeth_levine.html.
However, a ruling by the Supreme Court giving drug
companies federal immunity from suits under state laws could have provoked a
drastic, and worse, response from the Democrat-controlled Congress.
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