Supreme Court answers pre-emption question
March 4, 2009 – 4:07 pm by Steven Niles
The pre-emption question has been answered. But it wasn’t what Wyeth or the rest of the pharma industry wanted to hear.
As part of our Agenda 2009 report in January, we reported on the U.S. Supreme Court case Wyeth v. Levine, which asked the judges to decide whether federal regulations governing product liability litigation can preempt state law. In the case, a patient who developed gangrene and had her arm amputated due to an improper administration of the Wyeth sedative and nausea drug Phenergan won a ruling from a Vermont jury that found that Wyeth should have changed the drug’s labeling. Levine argues the label did not warn against the risks of I.V. push method of administration. This labeling, Wyeth argues, was approved by FDA and mandated by federal law, exempting the company from any such liability.
Well, the Supreme Court has made its decision. In a rejection of the Bush administration’s position on the matter, the court ruled in a 6-3 decision that federal law does not block a lawsuit in state court. The Court’s decision upholds the Vermont Supreme Court verdict awarding more than $6 million to Diana Levine, who sued Wyeth after receiving a financial settlement from the Vermont clinic that was treating her for migraine headaches.
“Wyeth has not persuaded us that failure-to-warn claims like Levine’s obstruct the federal regulation of drug labeling,” wrote Justice John Paul Stevens, writing for five of the justices in the majority. “Congress has repeatedly declined to pre-empt state law, and the FDA’s recently adopted position that state tort suits interfere with its statutory mandate is entitled to no weight.”
Wyeth, needless to say, is disappointed. The company’s position is that patients are best served by a national standard for the labeling of prescription medications, set by FDA. Company executives believe that when lay juries are permitted to second-guess the experts at FDA on the benefits and risks of particular medicines, the result is uncertainty for patients and doctors alike about how and when to use prescription drugs.
“Wyeth’s labeling of Phenergan provided clear instructions and warnings about its use, including clear warnings about the very risk at issue in this case,” says Bert Rein, an attorney from Wiley Rein, a Washington D.C. law firm representing Wyeth in this matter. “The medical and scientific experts at FDA are in the best position to weigh the benefits and risks of a medicine and to assess how those benefits and risks should be described in the product’s label.”
In the dissenting opinion, Justice Alito stated, “This case illustrates that tragic facts make bad law. 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 … To be sure, state tort suits can peacefully coexist with the FDA’s labeling regime, and they have done so for decades. But this case is far from peaceful coexistence. The FDA told Wyeth that Phenergan’s label renders its use “safe.” But the State of Vermont, through its tort law, said: “Not so.’”
Tags: law, Phenergan, Supreme Court, Wyeth
