Before the Supreme Court agreed in January to hear Wyeth v. Levine, Diana Levine says, "I thought the case had to do with me."
More precisely, she thought it was about how to compensate her for losing her right arm to gangrene after a Wyeth company drug was administered improperly to her in 2000. The error "leveled my career" as a Vermont guitarist and songwriter, she said in an interview last week.
But soon, Levine learned that her case, set for argument today, is about something quite different, at once bigger and yet less tangible: federal pre-emption. It's a concept she knew nothing about but, partly because of her case, it has become a major political flash point that could be influenced as much by the presidential election on Tuesday as by the Supreme Court argument today.
As it affects Levine, the issue is this: whether the drug-labeling requirements imposed on Wyeth and other drug companies by the Food and Drug Administration pre-empt -- that is, wipe out -- her state law tort action in Vermont that resulted in a $6.7 million verdict against Wyeth. Her suit against Wyeth was based on its inadequate label warnings for Phenergan, the nausea medication she received.
But here's the bigger picture: whether a range of companies, aided by the Bush administration and the Supreme Court, should be able to use the pre-emption card to free themselves of the noisome product liability litigation they've been unable to contain through legislation and punitive damages challenges. A victory for Wyeth would be the broadest victory yet on pre-emption, which the National Chamber Litigation Center's Robin Conrad describes as "the hot-button issue" for businesses now.
And then there is the political overlay. Since the potency of pre-emption -- whether and to what extent federal laws and regs trump states -- is largely a statutory issue, a Democrat in the White House and a Democratic Congress could erase whatever pre-emption protection companies have won in the last eight years. Bills are already before Congress to do just that.
"If the Supreme Court gives Wyeth a big win, the trial lawyers have a big war chest and they can go to Congress and get rid of this pre-emption language," says Victor Schwartz, a Shook Hardy & Bacon partner and longtime tort reform strategist. "If Obama comes in, it will be history."
A COORDINATED EFFORT
Just last week -- the timing was not accidental -- two new reports added fuel to the growing political fire. One, entitled "Get Out of Jail Free," was from the American Association for Justice, the trial lawyers' group Schwartz had in mind. Citing documents obtained under the Freedom of Information Act, the association alleged that Bush officials mounted a "stealth campaign" to insert pre-emption claims into numerous regulations for the benefit of corporations seeking immunity from state suits and regulation. "This was a hugely coordinated effort," says the association's Cecelia Prewett. "It was all tied up in a neat little bow."
The House Committee on Government Oversight and Reform issued the other report, offering evidence specific to the FDA that career officials unsuccessfully objected to political efforts to reverse the agency's stance against federal pre-emption. "The agency's actions have undoubtedly helped shield drug manufacturers from liability," the report concludes. The Bush administration will be arguing on the side of Wyeth in the Levine case.
"When we heard the solicitor general came out in support of Wyeth, my daughter Jessamine burst into tears," says Levine. Jessamine, also a musician, promptly wrote a song with a message, according to her mother, that is something like this: "Mr. Solicitor General, let's talk. This is my mom."
Levine, 62, tells anecdotes like that as her way of dealing with her grievous injury. "When I try to make sense of it, I try to make it go down to the personal -- like, would the president want his daughter to have the drug administered the way it was to me?"
Levine's encounter with Phenergan occurred when she went to a clinic near Marshfield, Vt., in April 2000 with a severe migraine headache. When a traditional intramuscular injection of the drug failed to relieve her pain, she returned to the clinic and a physician's assistant gave her another dose via a "push IV" -- injecting the medicine from a syringe into the tubing of an IV set connected to what she thought was a vein. It was a way of delivering the medicine more quickly.
The FDA-approved warning label for the drug said IV administration into a vein was "not without some hazard," but it was not prohibited. The label did state that if injected into an artery instead, it could cause gangrene in the affected limb. In Levine's case the IV was accidentally connected to an artery, causing irreversible gangrene. First her hand, then her forearm, were amputated.
Levine, the clinic, and the medical personnel worked out a settlement amounting to $700,000 paid to her, but she also sued Wyeth under state law, claiming that the label should have prohibited IV administration outright. The failure to do so amounted to a failure to warn and a product defect, she charged. Wyeth, for its part, claimed then and in a recent statement that "Diana Levine's tragic injury was the result of an improper administration of Wyeth's product," and not the fault of Wyeth itself.
Former Solicitor General Seth Waxman, who will argue the case for Wyeth, says Phenergan has been "the subject of more or less regular scrutiny by the FDA" since it was first licensed in 1955. As a result, he says, the labeling represents the agency's expert balancing of the risks and benefits of the drug overall -- not just through the lens of one case. "We can't have a world in which individual drug companies or individual states, or certainly individual juries viewing it from the perspective of a single injured victim" require labelling that contradicts what the FDA approved.
David Frederick of Kellogg, Huber, Hansen, Todd, Evans & Figel, a veteran advocate who has developed a niche practice of representing consumers in pre-emption cases, argues that Wyeth could have updated its label without FDA approval, especially when, in his view, the FDA and Wyeth never specifically balanced the risks and benefits of push-IV administration of the drug. Without that analysis, Frederick says, "pre-emption simply provides a windfall for the drug maker."
Frederick also highlights the FDA's "about-face" on the issue of pre-emption. Until 2002, he says, the FDA viewed state tort litigation as a complement to federal oversight "by bringing to light drug risks unknown or underappreciated by FDA."
The House report issued Oct. 29 asserts that change in policy -- and new restrictions on when drug makers could change their labeling -- came over the objection of career FDA staffers. A recent ABA Journal article reports that then-FDA counsel Daniel Troy invited pharmaceutical lawyers to seek FDA support for pre-emption arguments at a meeting in New York's Plaza Hotel in 2003. Troy, now general counsel of GlaxoSmithKline, told the magazine that "very few cases" resulted.
Shook Hardy's Schwartz dismisses suggestions that the pre-emption push was a secret conspiracy. "Did we all meet in a coven at OMB and try to do silent tort reform? No," Schwartz says. But he does acknowledge there may have been "unconscious parallelism" with several agencies adopting pre-emption policies on their own.
At the personal level, Diana Levine finds it hardest to believe that Wyeth would hide behind the FDA and assert that it could not do the right thing and change the label for Phenergan even though it knew IV administration was dangerous. An Oct. 17 Wyeth statement says "the FDA-approved labeling for Phenergan was mandated by federal law" and changing it would have violated federal law.
Even though her case has gotten caught up in the abstraction of pre-emption, Levine still hopes that eight years after her amputation, "justice delayed won't be justice denied."
She says, "I only have one index finger left. But I have no qualms about pointing it at Wyeth."
Editor's note: For more information on this topic, see 'Preemptive Strike' by Tamara Loomis of The American Lawyer.