Do FDA approvals trump state law in drug-injury cases?

November 2, 2008 at 12:00a.m.

MARSHFIELD, Vt. (AP) — When Diana Levine turned 63 recently, her daughter made her a birthday card, drawing on Greek mythology with an illustration of Diana the Huntress, her bow string drawn taut, an arrow ready to fly.

But the arm pulling at the bowstring was amputated below the elbow — just like Diana Levine’s — and the target was labeled the “Wyeth monster.”

That’s Wyeth as in Wyeth Pharmaceuticals, the company Levine blames for a botched injection of the Wyeth-made 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. “It’s about getting my glow back,” she said recently as she was awaiting a hearing Monday before the U.S. Supreme Court, where Wyeth is appealing a $6.7 million verdict in her favor.

The outcome of Levine’s case could have major ramifications for drug makers and consumers. 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 said the drug makers “are using my case ... to get through this doctrine that will say that if it is FDA-approved, then we are not accountable, because FDA said it’s OK. ... Mr. Pharmaceutical Company is not responsible and is not liable and doesn’t have to help the person who just lost her arm, or her life.”

Levine, who suffered from migraine headaches, had a particularly bad episode in the spring of 2000. A friend drove her from her dirt road farmhouse-turned-music 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 that she still felt nauseated, the clinic suggested an “IV-push” of Phenergan. This delivered a high volume of the drug 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 to set in. After several weeks of deterioration, her arm was amputated.

Levine reached an out-of-court settlement with the clinic and sued Wyeth, contending that the label on the Phenergan she was given 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. With two other methods for injecting Phenergan, “there’s no earthly reason for this third option [IV-push] to even be made available,” she said.

Wyeth and the FDA say when a drug such as Phenergan has a federally approved label, its manufacturer is immune from lawsuits in state court. Wyeth maintains its label clearly describes the risks of Phenergan, and that it was not only approved but mandated by the FDA. “Wyeth could not change Phenergan’s labeling to comply with Vermont law without violating federal law,” it said in court papers.