The Supreme question

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.

Continue reading below

---

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."

Post a comment

Name:

Email Address:

URL:

Remember personal info?

Comments: (you may use HTML tags for style)

Please only click "Post" once. It may take a few moments to process.