Bloomberg.comPfizer Faces First Trial on Neurontin Suicide Claim (Update1)By Margaret Cronin Fisk, Jef Feeley and Cary O'Reilly
July 24 (Bloomberg) -- Pfizer Inc., the world's biggest drugmaker, goes to trial next week on claims its epilepsy medication Neurontin increases the risk of suicide, in a case the judge called "very tough" for the plaintiffs to win.
The July 27 trial will be the first of what plaintiffs' lawyers say are about 1,200 cases. It will show each side the other's strategy and may help point the way to settlements. The lead attorney for the family of Susan Bulger, 39, who took the drug before hanging herself in 2004, is Mark Lanier, winner of the biggest verdict over Merck & Co.'s painkiller Vioxx.
Pfizer says Bulger's suicide was unrelated to its medicine and points to what it calls a history of mental disorders and abusing drugs including cocaine. Her past might make it hard for the family to win, said Robert Rabin, a law professor at Stanford University in Palo Alto, California.
"If she was taking other drugs, there's a question if this particular drug contributed to the suicide," Rabin said in a phone interview.
U.S. District Judge Patti B. Saris in Boston made a similar point at a July 20 pretrial hearing. It's "a very tough case because of her personal history," she said.
Pfizer hasn't taken a reserve to deal with litigation expenses tied to the suits, said Christopher Loder, a company spokesman. Neurontin's 2008 sales of $387 million represented 0.8 percent of its total revenue, which included $12 billion for the cholesterol pill Lipitor, the world's biggest-selling drug.
Pfizer rose 19 cents, or 1.2 percent, to $16.34 in New York Stock Exchange composite trading at 11:39 a.m. The drugmaker's shares have fallen 7.7 percent this year.
Bulger's LifeThe company says Bulger's life was "fraught with psycho-social stressors, including physical and mental abuse, long-term substance abuse and addiction to cocaine, heroin, Methadone and Oxycontin."
"Mrs. Bulger attempted suicide multiple times before ever ingesting Neurontin," Pfizer said in court papers. "Six months before her suicide, Mrs. Bulger was caught buying cocaine on the street," it said.
Saris told lawyers she hadn't decided how much of the information will be admissible in the trial.
Lanier, a Houston lawyer representing the family and about 600 other Neurontin plaintiffs, counters that the drug helped push a "fragile lady" over the edge. He is asking for $250,000 in compensation plus punitive damages.
Lanier was among attorneys who negotiated a $4.85 billion settlement with Merck & Co. in 2007 to resolve the majority of cases over its painkiller Vioxx. He won a $253 million jury award in 2005 in the first Vioxx trial. The verdict was cut to about $26 million, then thrown out on appeal. The case is still on appeal in the Texas courts.
Lanier on PfizerThe lawyer vowed in an interview to expose Pfizer's "seedy" handling of Neurontin during the three-week trial. Pfizer hid the drug's health risks to pump up profits, he said.
Lanier also will rely on a December decision by the U.S. Food and Drug Administration to order all makers of epilepsy drugs to add a suicide-risk warning to their labels.
The agency's reviewers found an 80 percent rise in suicidal thoughts and behavior in data from 199 studies of 11 drugs. Pfizer opposed the warning, saying Neurontin was safe and it was unfair to combine data for medicines that work differently.
The government-required suicide warning may tip the scales against Pfizer in subsequent trials, said Rabin, the law professor. "Plaintiffs would have a better chance in other cases," he said.
"If this person wins, it opens the door for more litigation," said Les Funtleyder, an analyst with Miller Tabak & Co. in New York. "It could become an issue for Wall Street if the verdicts and settlements are large enough."
Testimony on CauseThe judge refused to dismiss the Bulger case and others on alleged failure to warn of Neurontin's side effects. She rejected Pfizer's bid to block expert testimony the drug increases the risk of suicide.
Their "general causation testimony is reliable," and plaintiffs showed that a relationship between the medicine and increased suicide risk is "biologically plausible," she said.
"What you have here is a standard case of individual trials that are going to produce early readings from a host of jurisdictions," said Professor Anthony Sebok of Benjamin N. Cardozo School of Law in New York. "The manufacturers will have to litigate five to 10 cases as they did in Vioxx to get a clear picture of what juries will do."
After several verdicts, "each side begins to see what its expected returns will be," Sebok said. "That'll impact on the price of settlement."
Suit in 2007Bulger's family, of Peabody, Massachusetts, sued New York-based Pfizer and its Warner Lambert unit in August 2007, more than three years after Bulger's husband and 4-year-old daughter found her body in their basement. Ronald Bulger said he gave his wife four Neurontin pills an hour before she killed herself.
She took the drug, approved to treat epilepsy, for mood swings and arthritis pain, her family's lawyers said. Pfizer's marketing of the drug for so-called off-label uses played a role in her decision to take it, the family says in the lawsuit.
Companies are forbidden to market medications for off-label use. Doctors may prescribe a medicine for any condition. Drugs developed and approved as safe and effective for one condition sometimes are found to help with others.
Warner-Lambert paid $430 million in 2004 to resolve off- label marketing allegations involving Neurontin by the U.S. Justice Department. The family's lawyers can introduce evidence about that settlement, Saris said July 20.
'Appropriate' Label"Pfizer believes that the reliable scientific evidence does not demonstrate a causal association between Neurontin treatment and suicidal behavior," said Loder, the spokesman.
"The Neurontin label prior to Mrs. Bulger's death was adequate and appropriate based on the reliable scientific data concerning the medicine, and all pertinent safety information was provided to the FDA," Loder said.
The trial is to start as Pfizer pushes to complete its $64 billion purchase of rival drugmaker Wyeth. Investors in Madison, New Jersey-based Wyeth voted to approve the cash-and- stock buyout earlier this week.
The acquisition will give Pfizer the pneumonia vaccine Prevnar and the antidepressant Effexor to offset some of the $12 billion in sales it will begin losing in 2011 when Lipitor faces generic competition.
Saris is overseeing all federal-court litigation over Neurontin, which includes product-liability claims like the Bulger family's and suits by insurance companies and consumers seeking to recoup money spent on the drug.
No Whitey Bulger TiesPfizer hired William Ohlemeyer, a former associate general counsel for cigarette maker Altria Group Inc., to defend it in the case, Lanier said. Loder, the company spokesman, declined to comment on who will be the company's lead defense lawyer, or to say exactly how many Neurontin claims Pfizer faces.
Ohlemeyer, from the New York office of Boies, Schiller & Flexner LLP, along with Mark Cheffo, a mass-tort defense specialist from New York's Skadden, Arps, Slate, Meagher & Flom LLP, are listed as lawyers for the drugmaker on Pfizer's court filings.
Saris told lawyers for both sides she will instruct jurors there are no family ties between the plaintiffs and James "Whitey" Bulger, a Boston crime boss and FBI informant who has been a fugitive since 1994, Lanier said.
Whitey Bulger, one of the FBI's 10 most-wanted men, has been indicted on 18 counts of murder, conspiracy, extortion and narcotics trafficking over his actions as the head of Boston's Winter Hill Gang. The FBI is offering $2 million for information leading to the fugitive's arrest.
The case is Bulger v. Pfizer Inc., 1:07-cv-11426, U.S. District Court, District of Massachusetts (Boston). The suit is part of In Re Neurontin Marketing, Sales Practices and Products Liability Litigation, MDL 1629.
To contact the reporters on this story: Margaret Cronin Fisk in Southfield, Michigan, at
[email protected]; Cary O'Reilly in Washington at
[email protected].
Last Updated: July 24, 2009 11:45 EDT©2009 BLOOMBERG.COM L.P. ALL RIGHTS RESERVED.
