FDA

Justices Add Legal Complications to Debate on F.D.A.’s Competence

The Supreme Court’s ruling on Wednesday limiting lawsuits by patients over medical devices comes just as independent groups have raised questions about the Food and Drug Administration’s ability to ensure the safety of these products.

The Institute of Medicine, the Government Accountability Office and the F.D.A.’s own science board have all issued reports concluding that poor management and scientific inadequacies have made the agency incapable of protecting the country against unsafe drugs, medical devices and food.

A result, said David Vladeck, a professor at Georgetown University Law Center, is that the public is facing the worst of both worlds: a government health agency that cannot protect them and rules that block them from winning compensation when injured.

Randall Lutter, the F.D.A.’s deputy commissioner for policy, said that the agency was responding to reports of its deficiencies and improving. And advocates for the administration’s position say that regardless of the recent reports, the F.D.A. is a far better judge of product safety than the courts.

“Anyone who is in favor of a strong F.D.A. cannot also be in favor of unlearned, unscientific state juries second-guessing F.D.A.’s science-based decisions,” said Daniel Troy, a former F.D.A. general counsel who helped push the new policy.

Before President Bush took office, F.D.A. officials said that courts provided patients additional protection. In a 1997 brief, the agency’s chief lawyer wrote that “even the most thorough regulation of a product such as a critical medical device may fail to identify potential problems.”

But the administration argues that the courts interfere with rather than bolster agency oversight and it has undertaken a concerted effort to protect drug and device makers from lawsuits by filing briefs in the Supreme Court and other courts and changing rules to limit companies’ liability.

With Wednesday’s ruling, those efforts proved successful for device makers. Two more cases, one to be argued Monday and the other in October, will determine whether drug makers will benefit as well. In his majority opinion, Justice Antonin Scalia wrote that the F.D.A.’s interpretation of its rules deserves “substantial deference.” Since the administration now interprets those rules to provide similar liability protection to drug makers, Justice Scalia’s opinion suggests that the court may soon provide a liability shield to pharmaceutical companies, too.

The politics of these cases are bewildering, said Susan P. Frederick, federal affairs counsel for the National Conference of State Legislatures. Republican administrations generally advocate limited regulation and deference to state oversight, Ms. Frederick said. But in what she said was its push to reduce court damage awards, the administration has written a blizzard of rules that do just the opposite.

“This is shocking to us because usually Republicans align quite nicely with our federalism policy,” she said.

The administration has undertaken similar efforts in other regulatory areas, including highway and consumer safety, contending that strengthened federal regulations trump, or pre-empt, the decisions of state courts.

Diana Levine’s suit, which will be argued in October, illustrates the debate.

In April 2000, Ms. Levine, a professional guitarist in Vermont, suffered a disabling migraine and went to a health clinic for a shot of Phenergan, an anti-nausea medicine. The drug was inadvertently injected into her artery, where it caused an arterial spasm that led to gangrene. After slowly turning black, Ms. Levine’s hand and forearm were amputated.

Ms. Levine sued Wyeth, arguing that the drug’s label should have forcefully warned of this known risk. She won a $6.8 million judgment. Wyeth appealed, contending that federal drug regulators did not call for such a forceful warning and instead approved a label that simply stated a preference for a less risky method of administering the drug.

The question is who controlled the drug’s label, the lengthy listing of the drug’s uses, dosages and risks.

F.D.A. rules had long allowed companies, which know their products better than the government and usually learn of new or worsening risks first, to change labels without federal approval. Indeed, the labels initially approved by regulators were seen as setting minimum safety standards that companies could then bolster.

But in January, the agency issued a proposed rule to limit when companies can list new warnings without federal approval, which Mr. Lutter said “improves and strengthens our control of the label.”

The administration argues that a product’s approved label represents not only the least but the most that the drug agency allows in warnings, “both a floor and a ceiling for labeling,” its brief in the Levine case states.

“If you put too much junk in the label, people don’t understand it in the right way,” Mr. Lutter said. “There is a risk of overreaction and ignoring it.”

For the administration, an unstated warning is a deliberate decision by the F.D.A. to protect against undue alarm, and companies cannot be held liable for such nonwarnings. Citing this argument, Wyeth contends that Ms. Levine’s suit punishes the company for failing to issue a warning that the F.D.A. implicitly rejected.

Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, said that the F.D.A. oversees drug safety and labeling because its “expert staff is the most qualified to make such highly scientific and technical judgments.”

Andy Vickery, a plaintiffs’ lawyer in Houston, said that without the threat of litigation, companies would be less careful and patients would suffer.

“Many of the problems with drugs have been found out only because of vigorous litigation,” Mr. Vickery said. Phenergan’s label now includes a lengthy warning about the dangers of intravenous injections.

(Published by BBC News, February 21, 2008)