When Diana Levine turned 63 recently, her daughter made a birthday card, drawing on Greek mythology with an illustration of Diana the Huntress, an arrow ready to fly.
The arm at the bowstring was amputated below the elbow – just like Diana Levine's – and the target was the “Wyeth monster.”
That's as in Wyeth Pharmaceuticals, the company Levine blames for a botched injection of the drug Phenergan that led doctors to amputate her right arm in 2000.
Levine, once a professional guitar player and pianist, now plays with one hand and sings. Wyeth is appealing a $6.7 million verdict in her favor in a hearing before the U.S. Supreme Court today.
The court is expected to decide whether people can sue under state law – or are pre-empted from doing so – for harm caused by a drug approved by the federal Food and Drug Administration.
Levine had a particularly bad migraine headache in spring of 2000. A friend drove her from her dirt-road farmhouse-turned- studio in Marshfield, Vt., to a clinic in neighboring Plainfield.
She was given drugs for the pain and, to combat nausea, an intramuscular injection of Phenergan, a drug that has been around for 50 years.
When Levine complained she still felt nauseated, the clinic suggested an “IV-push.” This delivered a high volume of Phenergan very quickly to her right arm, not the slow flow that could have been delivered by an IV drip.
The second injection accidentally punctured an artery, prompting gangrene. After weeks of deterioration, her arm was amputated.
Levine reached an out-of-court settlement with the clinic and sued Wyeth, saying the Phenergan label should have more clearly warned about the danger of giving the drug IV-push.
Combatting an upset stomach with a method that can end up causing limb loss is “an unfathomable benefit-risk ratio,” Levine said.
Wyeth and the FDA say when a drug like Phenergan has a federally approved label, its manufacturer is immune from lawsuits in state court. Wyeth maintains its label clearly describes the risks, and was not only approved but mandated by the FDA.
Consumer groups are mounting a vigorous campaign against that position, saying federal regulation should represent the floor, not the ceiling, of a drug company's responsibility.
“What a trial lawyer reasonably could fear in this case is that in one fell swoop, the U.S. Supreme Court would eliminate the right of an injured person to recover from a drug company in the case of a dangerous drug that caused their injury,” said Fordham University law professor Benjamin Zipursky, a product liability expert.
Bert Rein, a lawyer for Wyeth, said that concern was overblown. “We believe the court will rule on the specific facts of the case,” rather than so broadly as to affect most liability claims.