Drug maker Wyeth must pay nearly $6.8 million to a Vermont woman whose arm had to be amputated after she was injected with one of its medications, the Vermont Supreme Court ruled, upholding a lower court’s ruling.
In a case hailed as a victory by a national consumers’ group, the court cited a U.S. Food and Drug Administration rule saying drug companies can issue sterner warnings than required by regulators if they think it’s necessary.
The case, which was originally decided by a Washington County Superior Court jury, centered on Diana Levine, who went to the Health Center in Plainfield in April 2000 complaining of nausea stemming from migraine headaches. She was given an injection of Phenergan.
She returned later and received more of the drug by intravenous injection in a technique called “IV push,” according to court documents.
“The second injection resulted in an inadvertent injection of Phenergan into an artery,” wrote Associate Justice Denise Johnson for the court’s 4-1 majority. “As a result, the artery was severely damaged, causing gangrene. After several weeks of deterioration, (Levine’s) hand and forearm were amputated.”
The drug’s label cited such a danger, and a company spokesman said it had sought to strengthen the warnings on the label — a move rejected by the FDA.
Levine’s suit against the Health Center was settled out of court for an undisclosed sum. Wyeth opted to go to trial, arguing that a suit under state law was pre-empted by the FDA’s approval of the warning label the company issued with the drug.
In a dissenting opinion, Chief Justice Paul Reiber agreed with Wyeth. The FDA approves a drug and its label “in the context of public health and the associated risk-benefit analysis,” he wrote.
But a jury “views the safety of the drug through the lens of a single patient who has already been catastrophically injured,” Reiber wrote. “Such an approach is virtually guaranteed to provide different conclusions in different courts about what is ‘reasonably safe’ than the balancing approach taken by the FDA.”
Johnson wrote for the majority that federal labeling requirements “create a floor, not a ceiling” for state regulation, noting that FDA regulations allow drug companies to go beyond required warnings.
“When further warnings become necessary, the manufacturer is at least partially responsible for taking additional action, and if it fails to do so, it cannot rely on the FDA’s continued approval of its labels as a shield against state tort liability,” Johnson wrote.
A message left for Levine’s lawyer, Richard Rubin of Barre, was not immediately returned.
Christopher Garland, a spokesman for Wyeth, said the company’s lawyers were still reviewing the decision and would have no comment on it. He said when the company recommended a label change to the FDA, the agency told Wyeth to keep the existing language.
“And we followed the instructions of the FDA,” he said.
Peter Lurie, deputy director of the health research group at Washington-based Public Citizen, said the case appeared to mark a push-back against efforts by the industry, the Bush administration and the FDA to pre-empt state regulation of prescription drugs.
Companies have the opportunity, and sometimes the responsibility, to offer stronger warning labels than are required by the FDA, Lurie argued. “If you have a wide enough berth that you can strengthen the label, you can’t use the FDA-approved label as an automatic protection against lawsuits.”
Scott Lassman, lawyer for the Pharmaceutical Research and Manufacturers of America, said the wasn’t unusual.
He said the industry group agrees with the FDA that its labels “ought to be both a ceiling and a floor, and ought to pre-empt state product liability laws.”
He said the FDA puts drugs through rigorous trials. “When you have the federal regulatory agency that’s the expert in this area approving drug products and getting second-guessed by state courts … that can add a lot of confusion to the label.”
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