Pfizer Inc., whose Wyeth unit reserved more than $21 billion to settle lawsuits over the fen-phen diet drugs, lost its bid to have claims that the pills caused a fatal disease years after users stopped taking them thrown out.
U.S. District Judge Harvey Bartle III in Philadelphia today rejected Pfizer’s arguments that there was no reliable evidence that fen-phen could cause an often-fatal lung disease to arise years after a user stopped taking the pills.
Experts hired by plaintiffs to review their cases can “properly rely on” studies and case reports showing primary pulmonary hypertension, known as PPH, can be caused by diet-drug combination more than 10 years after the last use of the appetite suppressant, Bartle said in a 22-page ruling.
Pfizer’s challenge to plaintiffs’ PPH latency argument was an attempt to wipe out the last significant litigation tied to the diet-drug combination’s 1997 recall, Alex MacDonald, a Boston-based plaintiffs’ lawyer who has litigated cases over the pills for more than a decade, said this month.
“Today’s decision is a total victory for plaintiffs, who only sought to keep the courthouse doors open so they could have juries hear how their loved ones died of a horrible disease because they took prescription diet drugs years ago,” MacDonald said in a telephone interview today.
Chris Loder, a Pfizer spokesman, said in an e-mailed statement today that the company was disappointed with Bartle’s ruling and was “weighing its legal options.”
Pfizer, the world’s largest drugmaker, acquired Wyeth in a $68 billion buyout in 2009. It also acquired a $21.1 billion liability for the fen-phen cases, many of which had been consolidated in federal court in Philadelphia.
More than 6 million prescriptions were written for the diet combination before it was withdrawn. Consumers took Wyeth’s Pondimin or Redux drugs as well as the generic Phentermine to help suppress their appetites.
Wyeth once faced more than 175,000 claims over the diet combination. Former users accused the drugmaker of hiding its health risks to generate billions in profits.
Wyeth officials sought to resolve the litigation by setting up a $3.75 billion national settlement program for former users in 2000. Costs of settlements forced the drugmaker to add $1.3 billion to the fund in 2004. Wyeth eventually boosted reserves to more than $21 billion.
While the number of PPH cases Wyeth has faced has been relatively small, claims over the fatal lung disease have generated verdicts and settlements for tens of millions of dollars.
A state-court jury in Beaumont, Texas, ordered Wyeth in April 2004 to pay more than $1 billion to the family of a former fen-phen user who died from PPH. The panel awarded Cynthia Cappel-Coffey’s family $113 million in compensatory damages and $900 million in punitive damages over the company’s mishandling of the combination.
The drugmaker’s lawyers filed their PPH latency challenge this year as two new cases were set for trial in the federal and state courts in Philadelphia.
Wyeth’s attorneys argued Jamie Cheek and Valarie Farmer couldn’t prove their PPH cases were caused by their diet-drug use in the 1990s. Cheek’s symptoms didn’t appear for nine years after her last use of the drug, and Farmer’s became evident 11 years after she stopped taking it.
Cheek’s case is filed in federal court in Philadelphia and among the cases consolidated before Bartle while Farmer’s suit is pending in state court in the same city.
The women’s lawyers countered there are a wealth of studies and case reports to back up the idea that PPH can have a latency period of a decade or more and that respected medical researchers have linked the disease to diet-drug use.
While Bartle found that plaintiffs’ experts properly relied on those studies and case reports to argue that their diet-drug use caused them to develop PPH, it will be up to a jury to make the final determination of that issue.
The ruling expressed “no view on whether Ms. Cheek’s ingestion of diet drugs caused her PPH when her symptoms did not appear until eleven years after she stopped taking those drugs,” Bartle wrote. “That is a matter for the jury to decide after hearing from the experts on both sides and considering all other relevant evidence.”
The cases are In re Diet Drugs Products Liability Litigation, MDL No. 1203, and Brown v. American Home Products Corp., 99-cv-20593, U.S. District Court, Eastern District of Pennsylvania (Philadelphia).