Pfizer Inc., whose Wyeth unit set aside more than $21 billion to settle lawsuits over the fen-phen diet drug, asked a judge to throw out claims that the pills caused a fatal disease years after users stopped taking them.
Pfizer’s lawyers asked a federal judge in Philadelphia today to bar cases from going to trial that allege former fen-phen users developed primary pulmonary hypertension, also known as PPH, nine or more years after they last used the appetite suppressant. Wyeth withdrew the diet-drug combination from the market in 1997 after it was linked to heart problems and PPH, an often-fatal lung ailment.
The drugmaker contends in court filings there’s “no reliable scientific evidence” to back up claims that using fen-phen can cause PPH years later. Plaintiffs’ lawyers say studies show the diet aid has a so-called latency period that can cause the disease to arise 15 years after its use.
“It is crucial that the court exercise its gatekeeper function to stop these PPH suits now,” New York-based Pfizer told U.S. District Judge Harvey Bartle III in court filings. Bartle is overseeing some of the remaining 30 PPH cases pending against the drugmaker. The company is making the same arguments to bar cases in a state court in Philadelphia.
If Pfizer’s challenge to the PPH latency argument is successful, it will wipe out the last significant litigation tied to the drug’s recall, said Alex MacDonald, a Boston-based plaintiffs’ lawyer who has litigated cases over the diet aid for more than a decade.
“This is a scientifically baseless effort to slam shut the courthouse doors to scores of dying women afflicted with a lethal disease caused solely by these diet pills,” MacDonald said this week in a telephone interview.
Pfizer, the world’s largest drugmaker, acquired Wyeth in a $68 billion buyout in 2009. It also acquired a more than $21 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More than 6 million prescriptions were written for the diet combination before it was withdrawn.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 the company’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.
The skyrocketing costs of the settlements and litigation ultimately forced the drugmaker to boost 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.
Testimony showed that Cappel-Coffey, an X-ray technician, took Pondimin for five months in 1997 and was diagnosed with PPH in February 2002. She died the following year at age 41. Cappel-Coffey’s case later was settled for an undisclosed sum, according to her lawyers.
Wyeth officials also agreed to pay at least $10 million in 2000 to settle claims brought by the family of a Massachusetts woman who used the fen-phen combination for less than a month before developing PPH and dying.
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 contend that Jamie Cheek and Valarie Farmer can’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.
If the drugmaker wins, its lawyers plan to use the rulings in those two cases to keep the remaining PPH cases around the country from going to trial.
PPH cases were excluded from the national settlement. Wyeth officials specifically defined what constituted a proper PPH case to be litigated outside the accord, Raymond Williams and Heidi Levine, two of Pfizer’s lawyers, said in a July 7 filing.
The definition requires plaintiffs to present evidence ruling out alternative causes for their PPH other than diet-drug use, Pfizer’s attorneys said in the filing.
“PPH is not a signature disease that is necessarily associated with diet-drug use,” according to the filing. “It has many non-diet-drug causes.”
Anand Agneshwar, a Pfizer lawyer, told Bartle at today’s hearing that the settlement requires plaintiffs’ doctors to do an exhaustive review of the possible causes of the former fen-phen user’s PPH.
The physician “must rule out other conditions” that could have caused the ailment, such as sleep apnea, Agneshwar said.
The company also contends the risks of developing PPH tied to diet-drug use drop a year after the last use of the pills, according to the filing.
Plaintiffs with cases pending “ingested diet drugs nearly a decade or more before the onset of their symptoms and there is no reliable evidence of risk today,” Chris Loder, a company spokesman, said in an e-mailed statement.
Plaintiffs still file PPH cases against the drugmaker, forcing it to spend money to evaluate claims that are sometimes as much as 11 years old, Pfizer’s lawyers said in the filing.
“Part of the essential bargain of the National Settlement Agreement was an end to settled diet-drug claims, including claims for pulmonary hypertension when the plaintiff could not rule out other causes of the disease,” Pfizer’s lawyers argued.
“Nearly 15 years later, defendants are entitled to the benefit of their bargained-for release,” the lawyers wrote.
Lawyers for PPH claimants counter in their filings that respected medical researchers have concluded diet-drug use can be one of the triggers of the lung disease and that it has an undetermined latency period.
Attorneys for former users said another federal judge who studied the PPH latency issue found in 2002 that experts dismissed the idea that there “is no risk beyond 12 months of last use,” according to an Aug. 6 filing by Michael Fishbein, a Philadelphia-based lawyer representing fen-phen claimants.
Medical researchers agree that “every known cause of PPH has a significant period of latency of up to a decade or more,” Fishbein told Bartle at today’s hearing.
Sean Tracey, a Houston-based lawyer who has PPH cases pending against Wyeth, said the company’s filings show the push to have the cases thrown out is motivated more by frustration over the long-running diet-drug litigation than scientific positions on the latency issue.
“They seem to be tired of writing checks,” Tracey said in an interview this month. “I’ve told them that my clients are tired of dying and that these cases deserve to go forward.”
Loder, Pfizer’s spokesman, declined to comment on whether Pfizer officials were frustrated by the continuing PPH litigation.
The cases are in Re Diet Drugs Products Liability Litigation, MDL No. 1203, and Brown v. American Home Products Corp., 2:99-cv-20593, U.S. District Court, Eastern District of Pennsylvania (Philadelphia).