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Appellate ruling favors drug firms in lawsuits

A federal appeals panel in Philadelphia backed the pharmaceutical industry's arguments today that it should be insulated from certain lawsuits.

A federal appeals panel in Philadelphia backed the pharmaceutical industry's arguments today that it should be insulated from certain lawsuits.

The 2-1 opinion said drugmakers could not be blamed for the suicides of two people on antidepressants whose families claimed that the drug's warning labels were not strong enough.

While narrowly written, the decision was a clear victory for drugmakers and Bush administration officials, who want scientists at the Food and Drug Administration, not lay juries, deciding what drug labels should say.

Lawyers for the plaintiffs countered that the FDA was outgunned and poorly funded at best and that lawsuits represented an important check on the system and a last attempt for injured victims to get redress.

The issue could come to a head in October, when the U.S. Supreme Court is scheduled to hear Wyeth v. Levine, another dispute over the adequacy of a drug label. Several lawyers said that case could determine the scope of future pharmaceutical litigation unless Congress intervened. A defining opinion could come in early 2009.

The ramifications will be felt in Philadelphia, a pharmaceutical hub that is host to major operations of GlaxoSmithKline P.L.C., Merck & Co. Inc., AstraZeneca P.L.C. and Wyeth, along with dozens of biotech firms, makers of generic drugs, marketing firms, and companies that conduct clinical trials. The area also is home to an estimated 2,000 lawyers involved in attacking or defending drug companies.

The opinion drew a passionate response today from Sol H. Weiss, a Philadelphia lawyer who represented one of the plaintiffs.

"The drug companies get a free ride here," Weiss said. "They interpret data in a way that's not scientifically valid. The FDA may not ever know that, and so the drug companies get away with it for six, seven or eight years. People get injured and die because of it. You should have the right at least to expose this stuff to sunshine."

Rob Weiner, a senior partner in the Washington law firm Arnold & Porter L.L.P., took an opposing tack.

"Pharmaceutical companies are caught in this situation where they need to follow FDA's instructions," said Weiner, who wrote an acmicus brief in the case for PhRMA, a lobbying organization for the drug industry. "They also need to worry about state courts' telling them to do something else."

The conflicting sources could cause the drugs to be underused and confuse doctors over the meaning of warnings, Weiner said.

The cases decided today involved two plaintiffs. In early October 2003, Lois Colacicco, 55, of New York state, began taking a generic version of Paxil, an antidepressant marketed by GlaxoSmithKline. Apotex Inc. made the generic, and both drugs shared similar FDA-approved warning labels.

Colacicco was a psychotherapist who used to counsel patients that suicide was not the answer, said her Conshohocken lawyer, Derek T. Braslow. She also was a breast-cancer patient who was undergoing chemotherapy when she committed suicide in her bathtub on Oct. 28, 2003.

Theodore DeAngelis, 64, of Atlantic County, N.J., was prescribed Pfizer's Zoloft, also an antidepressant, on Jan. 22, 2003. A psychiatrist increased his dose six days later, and he committed suicide two days after that.

In their 41-page opinion, Circuit Judges Dolores K. Sloviter and Jane A. Restani noted that the FDA had filed papers in the case asserting that it had rejected stronger label warnings that plaintiffs' lawyers said would have protected their clients.

The judges pointedly declined to decide whether the class of antidepressants, known as SSRIs, contributed to suicidal thoughts and behavior in adults.

"We are not scientists, and we do not purport to have any expertise on that issue," they wrote. "That is within the FDA's authority. This decision is based on the record before us."

In dissent, Judge Thomas L. Ambro argued that for 75 years, the FDA has viewed state suits "as complementary to its warning regulations. Only for the last two years has it claimed otherwise."

"I believe courts should fear to tread where Congress has not given us a clear statement," he wrote.

Ambro was appointed by President Bill Clinton. Sloviter was named by President Jimmy Carter, and Restani was appointed by President Bush.

Andrea Parry, a GlaxoSmithKline assistant general counsel in Philadelphia, said the case was limited to a specific set of facts and represented "an extremely narrow decision."

But Braslow, who represents the Colacicco family, doubted the drugmakers would stick to a narrow interpretation and said he would ask the entire Third Circuit to rehear oral arguments.

"The drug companies are going to try to expand this ruling so that it applies to all drugs" and possibly to other areas where federal agencies hold sway, Braslow said. "What we're doing here is we're throwing out the laws of every state in this country and applying this federal law run by agencies that aren't even elected," he said. "There's no accountability."