Trial lawyers turning to FDA experts

WASHINGTON -- A former Food and Drug Administration staffer who specialized in antidepressant drugs is expected to take the stand this week as a defense witness in a double-murder case that the youth's attorneys blame on Zoloft.

The testimony reflects a trend: the increased use of FDA expertise by trial lawyers.

Dr. Richard Kapit said he expected to testify about the impact Zoloft would have on the brain of someone as young as Christopher Pittman. A gangly 15-year-old now, Pittman was 12 when he shot his grandparents, Joe and Joy Pittman. He had begun taking the antidepressant a few weeks before the Nov. 28, 2001, shooting.

The testimony by Kapit -- the FDA staffer who approved Prozac, the only FDA-endorsed antidepressant for children -- will play out on computer and television screens throughout the nation as Court TV provides live coverage of the high-profile case.

"That's very powerful evidence, particularly more powerful when you have an FDA insider that's now not with the agency anymore who can testify freely," said Andy Vickery, one of four defense attorneys in the Pittman case.

Vickery and Kapit were interviewed by the Globe before the court last week imposed a gag order on participants in the case.

More often, FDA expertise often finds its way into courtrooms through documents. In the wake of the high-profile market withdrawal of Vioxx and whistle-blower David Graham's estimate that the drug caused as many as 140,000 extra cases of serious heart disease, plaintiffs' attorneys are seeking FDA paper trails to try to make their cases in lawsuits against drug makers.

Florida trial attorney Mike Papantonio is already promising a rush of internal documents will flood the court as he and other lawyers file hundreds of lawsuits this year alleging heart problems caused by Celebrex, a painkiller that works similarly to Vioxx.

While Graham and FDA drug reviewers who preceded him have complained that some of their drug safety cautions fell on deaf ears within the agency, attorneys hoping to sway juries have snagged those internal memos and reports.

When it comes to written documents, the type that trial attorneys covet has the clarity of a memo written by former FDA reviewer Leo Lutwak, as he seethed with outrage that the FDA had been "hustled," Papantonio said.

On Sept. 15, 1997, the FDA said it had asked Wyeth-Ayerst Laboratories to remove fen-phen, a combination treatment for obesity, from the market, due to damage to heart valves. Serious side effects linked to fen-phen and the drugs' marginal benefits "should be brought out," Lutwak had e-mailed a colleague about a year earlier.

"If this hurts the sales, so be it. The company has gotten away with much manipulation these past 3 years, of the public, of the press, of the FDA," Lutwak wrote on Sept. 24, 1996.

"I started getting upset about this drug in '93 or '94 and was running into a lot of blocks from the FDA and from the drug company," Lutwak said in an e-mail that distills three years of frustration.

This week, Wyeth took a $14.5 billion charge for costs related to the fen-phen recall. About $3.1 billion remains of the $16.6 billion the firm set aside to cover legal liabilities from the recalled drug.

Lutwak has heard from numerous attorneys filing Freedom of Information Act requests to get internal FDA documents who are following the fen-phen case filings like legal road maps as they pursue product liability actions against the manufacturers of such drugs as Baycol, Celebrex, Meridia, Rezulin, and Vioxx.

Lutwak expects the list of troubled drugs to grow.

"The whole problem has reached the critical level in the last 10 years. There have been a tremendous number of medications that have been introduced that were either unnecessary or unsafe, but they were blockbuster," said Lutwak, who is retired. "We're dependent on what the drug company tells us: the patients, the physicians, the FDA. If the drug company doesn't pass on the information, and doesn't act -- and there are no laws that allow the FDA to force the drug company to do it -- they can sit on this information for years."

Vickery's Zoloft-made-me-do-it defense leans on unpublished Pfizer Inc. documents linking the antidepressant to violent acts and on expert witnesses that include the former FDA drug reviewer.

The weight that juries assign to material bearing the FDA's stamp depends on whom you ask.

Pfizer spokesman Bryant Haskins said he is unfamiliar with Kapit and uncertain how jurors would react to testimony from a former FDA reviewer. In 12 of 13 criminal trials the company is aware of, jurors rejected the Zoloft defense argument in favor of the drug's safety record over 13 years and 250 million prescriptions.

"There's a huge amount of clinical data and patient experience about the drug. There is no scientific evidence to establish that Zoloft contributes to violent behavior in either adults or children," Haskins said. "While these murders were obviously a tragic situation for the family, they are in no way connected to Zoloft."

An attorney representing Whitehouse Station, N.J.-based Merck & Co., which faces up to $18 billion in legal liability following withdrawal of Vioxx, said juries would be inclined to discount Graham's estimates of harm from the painkiller, published last month in the medical journal Lancet. "There are issues" with the FDA's scientist's methodology, said Ted Mayer, a partner at Hughes, Hubbard & Reed, in New York.

"If something is a speculative report, if it's not good science, I think that there are evidentiary means to deal with that," Mayer said. "If it does come before the jury, one would hope the jury would see it for what it is and keep their eye on the ball here, which is the individual facts of the case" and that Merck did "the right thing, every step of the way."

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