Amputees’ Case Asks If FDA Label Immunizes Drug Firms from Liability

When Diana Levine turned 63 recently, her daughter made her 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,” the Marshfield, Vermont resident said this week as she was awaiting a hearing 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 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 nauseous, 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 recalls first seeing what remained of her arm after surgery. “I was horrified and shocked and about as sad as I ever have been in my life,” she said.

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 like 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.

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.

The court could effectively “eliminate all pharmaceutical company liability in this one case,” he said.

Bert Rein, a lawyer for Wyeth, said that concern was overblown. “Some of the hysteria being whipped up is really unjustified,” he said. “We believe the court will rule on the specific facts of the case,” rather than so broadly as to affect most liability claims.

That was not what Wyeth argued when urging the Supreme Court to take the case. In its appeal to the court, Wyeth said the justices should act to prevent erroneous rulings in “tens of thousands of individual claims and potentially millions of class action claims” that are pending in state and federal courts.

While the legal war continues, Levine wages a more personal struggle. Sometimes it’s just to roll her left sleeve up or down, file papers, wash dishes or mow the lawn.

“If you were to put your hand in your pocket for a day and not use it, you would pretty much come to the conclusion that there’s nothing that’s a one-handed activity,” she said.

Mostly, the struggle is to continue a life in which songwriting was her gift and the guitar and piano were the tools of her trade.

“My identity was seriously damaged. Not just the musical one, but the physical. I mean, I had lost my glow, the glow was gone,” Levine said, recalling her recent performance with a group of women singers. “That’s what it’s about, it’s about getting my glow back.”

Levine has had more than a little help from her friends.

“She’s determined not to let this setback destroy her music,” said singer-songwriter Jon Gailmor, who had collaborated with Levine and her late husband in performances and on recordings. “It’s probably given her some new material, made her stronger even. She’s an amazing person.”

Quoting a musician friend, Levine calls the right hand the “joyous hand” _ the one that gets to strum or pick the guitar, finding the rhythm, while the left searches the neck for the right note or chord. On keyboards, the right hand most often finds the improvisational riffs while the left lays down the underlying rhythm and chord changes.

Levine has no joyous hand now.

A piano and guitar player since childhood, she studied chemistry and psychology at the University of Vermont. Levine, who performed under the name Diana Winn, married a blues guitarist David “Crow” Levine, playing bass alongside of him in the Re-Bops, a band that gained a regional following in the 1980s.

Her husband died in 1993, leaving Levine and the couple’s daughter, Jessamine, now 25.

Now, she’s less concerned with the legal arguments than with making music and sharing it, especially with children.

She pays the bills using her monthly disability check from Social Security, Re-Bob Records sales _ though she says she’s unable to keep up the business as well as she used to _ and assistance from her family. “I have help from home. Nobody’s going to let me be out in the cold.”

Levine sat one recent afternoon at her piano, accompanied by Jessamine on guitar, working out a new tune she hoped to send to actor Dennis Quaid, who is waging a drug labeling fight of his own after his infant twins were given a dose of the blood-thinner Heparin _ 1,000 times what was called for.

The twins’ birthday is in November, and Levine was writing a song for them.

Plunking out chords with her left hand, Levine asked Jessamine, “What do we go to there? Do you like G? Or should it be D-minor?”

And then she sang a song fragment:

“It’s the twinses’ birthday, celebrate times two. It’s the twinses’ birthday, if you only knew. There’s been some hard times they’ve both been through …”