FDA rule may aid drug firms in liability suits

WASHINGTON -- A new rule issued by the Food and Drug Administration yesterday to make cryptic drug labels easier to read also preempts state laws that conflict with the agency's stance on drug warnings, aiding manufacturers in some liability lawsuits.

The new 275-page rule, which takes effect June 30, represents the FDA's first overhaul in 25 years of the onionskin label that accompanies prescription drugs. Current and former FDA officials said one aim is to simplify labels that had become complex legal disclaimers.

''It expresses our concern that, over time, the labels became cluttered with a lot of information that wasn't necessarily directly pertinent to the patient and the physician," said Dr. Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs. ''These labels need to be reclaimed for patients and physicians."

But manufacturers worried that highlighting some warnings instead of printing an exhaustive list might open them to lawsuits for failing to warn patients about specific, known risks.

''FDA said we can't have that. We want highlights to be short and sweet, and we want to be able to decide what goes in it," said Daniel Troy, former FDA chief counsel.

Troy, who left the FDA in 2004 and now represents drug companies as a partner at the law firm Sidley Austin, also filed a series of legal briefs arguing that federal rules preempt certain liability claims in state courts.

The FDA included language preempting certain state laws in the preamble of the new rule, saying an FDA-approved label ''whether it be in the old or new format, preempts conflicting or contrary state law, regulations, or decisions of a court of law for purposes of product liability litigation." The stance also applies to print drug advertising that reprints warning information from drug labels.

That drew fire from US Senator Edward M. Kennedy, Democrat of Massachusetts.

''It's a typical abuse by the Bush administration take a regulation to improve the information that doctors and patients receive about prescription drugs and turn it into a protection against liability for the drug industry," Kennedy said in a statement.

US Representative Maurice Hinchey also criticized the regulators' actions.

''It runs contrary to everything the FDA was set up for," said the New York Democrat. ''And it creates a situation where the drug companies are not going to be held responsible, in the way they should be, for the items that they put on the market."

''This has a tremendous impact on people's ability to hold these companies accountable," said Chris Mather, a spokeswoman for the Association of Trial Lawyers of America.

But Victor Schwartz, general counsel for the American Tort Reform Association, said the change is less sweeping than opponents fear. It simply immunizes drug companies from claims alleging they failed in their ''duty to warn" and will not reduce the thousands of lawsuits, for example, already filed against Merck, he said. Nor will it stop juries from awarding millions in punitive damages to injured Americans.

Such damage awards require proof of conscious, flagrant actions by the company and indifference to patient safety, Schwartz said.

''To get over that line, you've go to show very severe, wrongful behavior, not merely that a warning wasn't long enough," he said.

Merck, in a statement, called the FDA's stance ''consistent with what we have always said about the primacy of the FDA in determining what information should be conveyed to physicians in the labeling." Spokeswoman Casey Stavropoulos declined to describe its potential effect on Vioxx lawsuits pending against Merck.

The National Conference of State Legislatures, in a Jan. 13 letter sent to Health and Human Services Secretary Mike Leavitt, sought to eliminate the final rule's language and called it ''a thinly veiled attempt on the part of FDA to confer upon itself authority it does not have."

Diedtra Henderson can be reached at dhenderson@globe.com.

THE NEW RULES FOR DRUG LABELS

Read the FDA documents relating to the new drug label rules at boston.com/business.