Wednesday, March 04, 2009

Supreme Court Shoots Down Wyeth Pre-Emption Argument

After more than a year of anxiety, the U.S. Supreme Court this morning voted 6-to-3 to allow product-liability lawsuits to proceed against drugmakers in state courts (here is the ruling). At issue was the notion of preemption, which says that FDA approval of a drug supercedes state law claims challenging safety, efficacy or labeling.

The decision upheld a ruling by the Vermont Supreme Court that sided with Diana Levine, 63, a musician who lost part of her arm after a hospital administered a Wyeth drug improperly. She developed gangrene, sued Wyeth and was awarded $6 million after arguing the drugmaker wasn't prevented from adding or strengthening the warning on the label, even though the FDA rejected a proposed change.

"Oh, my God. I'm so, so happy. I can't believe this phone call," she tells the Associated Press. "I've been waiting for so long, and I had no idea of what the chances were. I'm just ecstatic. I'm going to have to sit down."

The ruling is a victory for consumers and many others - including 47 state attorneys general; former FDA commissioners; AARP; editors of the New England Journal of Medicine and the Journal of the American Medical Association, as well as various unions and tort law professors - who filed briefs last summer in support of Levine. They insisted that preemption would harm patients, making it more difficult, if not impossible, to seek legal recourse when they are allegedly harmed by a prescription drug.

Once a drug is marketed to thousands of people, we learn of things that we never knew in the clinical trials for that drug - problems that arise over the year as doctors prescribe and patients take the drug day in and day out," says Brian Wolfman, the director of the Public Citizen Litigation Group, who is also one of Levine's attorneys. "For all these reasons, legal immunity for drug manufacturers - as called for by the drug companies and the Bush administration - would have been a huge mistake."

The decision is a blow to the pharmaceutical industry. Drugmakers and their supporters maintained that FDA approval of a drug supercedes state law claims challenging safety, efficacy or labeling. Drugmakers and the FDA - with the backing of the Bush administration and various business groups - had insisted that preemption existed by maintaining the agency's action are the final word on safety and effectiveness.

But the Supremes disagreed. "Wyeth's argument that requiring it to comply with a state-law duty to provide a stronger warning would interfere with Congress' purpose of entrusting an agency with drug-labeling decisions is meritless, because it relis on an untenable interpretation of congressional intent and an overbroad view of an agency's power to preempt state law," the majority ruled.

In advancing the argument that the FDA must be presumed to have established a specific labeling standard that leaves no room for different state-law judgments, Wyeth relies not on any statement by Congress but on the preamble to a 2006 FDA regulation declaring that state law failure-to-warn claims threaten the FDA’s statutorily prescribed role.

Although an agency regulation with the force of law can preempt conflicting state requirements, this case involves no such regulation but merely an agency’s assertion that state law is an obstacle to achieving its statutory objectives. Where, as here, Congress has not authorized a federal agency to pre-empt state law directly, the weight this Court accords the agency’s explanation of state law’s impact on the federal scheme depends on its thoroughness, consistency,and persuasiveness.

Under this standard, the FDA’s 2006 preamble does not merit deference: It is inherently suspect in light of the FDA’s failure to offer interested parties notice or opportunity for comment on the preemption question; it is at odds with the available evidence of Congress’ purposes; and it reverses the FDA’s own longstanding position that state law is a complementary form of drug regulation without providing a reasoned explanation."

For its part, Wyeth was unbowed. "We believed that Federal law prohibited the company from revising its product label as the Vermont court required, and we regret that the Supreme Court disagreed. The medical and scientific experts at FDA are in the best position to weigh the risks and benefits of a medicine and to assess how those risks and benefits should be described in the product's label," the drugmaker's outside attorney, Burt Rein, said in a statement.

Justice Clarence Thomas agreed with the outcome, but didn't join the majority opinion written by Justice John Paul Stevens. Justice Samuel Alito wrote a dissent that was joined by Chief Justice John Roberts and Justice Antonin Scalia. "This case illustrates that tragic facts make bad law," Alito wrote. "The court holds that a state tort jury, rather than the Food and Drug Administration, is ultimately responsible for regulating warning labels for prescription drugs."

Check our coverage in The Pink Sheet Daily for still more info.

image from flickr user dbking used under a creative commons license.

1 comment:

Anonymous said...

So, the next thing Wyeth should do is declare unilateral control of all decisions regarding labeling for their products. FDA can provide advisory language if it wishes, but it is no longer controlling. If any ambitious tort lawyer in America can shop for cases & a gullible lay-jury to hold Wyeth accountable for the content of these labels, and FDA oversight provides no safe harbor, then the Fiduciary duty to shareholders, coupled with this expanded view of duty to inform patients of potential harms, places the onus squarely on Wyeth Management. If FDA does not like the idea of Rx firms seizing editorial control of their labels, then they should go to Congress or the courts to resolve the paradox this has created for Rx industry managers.