As the nation negotiates its transition from Bush to Obama, the U.S. Supreme Court is weighing a case that could test the new administration on matters far beyond the immediate question of the Food and Drug Administration's regulatory authority.
The court heard arguments Nov. 3 in Wyeth v. Levine. The background: Vermont musician Diana Levine visited a local health clinic in 2000 with a migraine headache. The clinic used a technique called IV push to inject Wyeth nausea drug Phenergan and botched it. Her arm turned gangrenous and had to be amputated. She sued Wyeth, and a Vermont jury awarded her more than $6 million. She also won a settlement from the clinic.
In punishing Wyeth, the jury found the drug company should have included a stronger warning about using IV push to administer the drug, even though the FDA's label -- the guidelines for physicians that accompany each approved drug -- rules the day. The Phenergan label warned against using the technique but did not ban it entirely, allowing that it produces relief faster than other methods.
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Counsel for Wyeth and the Bush administration pushed back in the
hearing, arguing that FDA approval pre-empts the right to sue in a
state court. After all, they said, drug oversight can't be sewn
together in a 50-state patchwork, with citizen juries free to trump FDA
expertise. To be clear, safe and consistent, FDA rules must take
precedent.
In February, the court ruled in favor of national FDA pre-emption in
Riegel v. Metronic, in which the product in question was a catheter
made by Medtronic Inc. But Wyeth -- and drugs -- are a different
matter, as Chief Justice John Roberts immediately pointed out to Wyeth
counsel Seth Waxman, who was U.S. solicitor general from 1997 to 2001
and is now partner at Wilmer Cutler Pickering Hale and Dorr LLP.
"In the medical device area, of course, you have an express
pre-emption clause, while here in contrast you don't," Roberts said.
"And one reason perhaps that it didn't is that when the Drug Act was
passed, you had an established background of state actions; when the
Medical Device Act was passed, you didn't."
So why not sue the FDA, Justice Antonin Scalia asked. Levine's counsel, David Frederick of Kellogg, Huber, Hansen, Todd, Evans & Figel PLLC,
argued that because labels can change based on new evidence, the
drugmaker bears the burden of bringing the new data to light. Justice
Ruth Bader Ginsburg said the FDA can't possibly monitor and be
proactive about potential changes for thousands of marketed drugs.
Especially in its drastically underfunded state. Wyeth should have
moved years ago to ban IV push for Phenergan, as Pfizer Inc.
did in the 1970s with its drug Vistrol, Frederick said. With prompting
from Scalia, U.S. Deputy Solicitor General Edwin Kneedler acknowledged
that a company that doesn't bring new data to light is open to tort
remedy.
Ginsburg said the FDA traditionally believed "tort suits were a
helpful adjunct to the FDA's own efforts to protect consumers." But as
the American Association for Justice -- formerly the Trial Lawyers
Association -- pointed out in a recent report, the FDA's position
shifted as part of a wider Bush administration effort to shield
corporations from product liability by rewriting agency regulations.
The court isn't expected to rule until next year. If it upholds the
pre-emption shield, an Obama presidency and strong Democratic Congress
could knock it down through legislation. Tort lawyers and consumer
advocates will help make that push.
Wyeth v. Levine could ripple beyond the drug industry into other
federally regulated industries -- such as pollution emissions -- and
prompted political maneuvering from all sides in the run-up to the
hearing. Rep. Henry Waxman, D-Calif., already positioning himself for a
more senior role in the next Congress, released e-mails a few days
before arguments from a few FDA officials who opposed the pre-emption
defense.
And with FDA overhaul on the California congressman's agenda, the
hearings revealed currents of the larger debate about how much risk the
FDA should tolerate when evaluating drug safety. Even if their ruling
doesn't specifically address the FDA's labeling practices, several
justices sounded like drug-safety advocates as they peppered counsel
with questions. For example, Justice Samuel Alito Jr. asked Seth
Waxman, "How could the FDA conclude that IV push was safe and effective
when on the benefit side of this, you don't have a life-saving drug,
you have a drug that relieves nausea, and on the risk side you have the
risk of gangrene?"
With so many issues packed into one case, it could be the ruling of
the year. Diana Levine, now fitted with a prosthetic arm, can be
forgiven for feeling like a bit player. She told the Legal Times, "I
thought this case had to do with me."
