Fen-phen lung injury lawsuits are to move forward after Pfizer Inc. lost its bid to have claims related to the banned diet drug thrown out. More than 15 years ago, the appetite suppressant, fen-phen, was pulled from the market after it was linked to heart-valve abnormalities.
Fen-phen has been linked to fatal disease, even years after patients discontinued taking them, said Bloomberg.com. U.S. District Judge Harvey Bartle III rejected Pfizer’s arguments that no reliable evidence existed to confirm that the deadly diet pills could lead to an often-fatal lung disease that struck patients years after the pills were stopped. The drug maker’s Wyeth unit put aside more than $21 billion to settle lawsuits.
Plaintiffs experts can now “properly rely on” studies and case reports that state that primary pulmonary hypertension (PPH) can be caused by the dangerous diet-drug combination, even more than a decade since the appetite suppressant was last used, said Bartle in his 22-page ruling, wrote Bloomberg.com. Plaintiff’s attorneys told Bloomberg.com that the decision was a total victory for patients. Not surprisingly, Pfizer spokesman, Chris Loder said, in an emailed statement, that the company was disappointed with Bartle’s ruling and was “weighing its legal options.”
Pfizer, the world’s largest drug maker, acquired Wyeth in 2009 in a $68 billion buyout, also acquiring a $21.1 billion liability for the fen-phen cases, noted Bloomberg.com. Many of the fen-phen cases have been consolidated in federal court in Philadelphia. Meanwhile, more than six million prescriptions were written for fen-phen before it was withdrawn from the market. At one time, said Bloomberg.com, Wyeth faced in excess of 175,000 claims over the diet combination.
Former fen-phen users accused Wyeth of hiding the drug combo’s health risks so that it could generate billions in profits. In 2000, Wyeth officials, in an attempt to resolve the litigation, set up a $3.75 billion national settlement program for former fen-phen users, said FiercePharma. Settlement costs, said Bloomberg.com, forced the addition of $1.3 billion to the fund in 2004; Wyeth finally increased reserves to more than $21 billion. Claims over the fatal fen-phen lung disease have generated verdicts and settlements in the tens of millions of dollars.
In April 2004, a state-court jury in Beaumont, Texas, ordered Wyeth to pay more than $1 billion to the family of Cynthia Cappel-Coffey, who died from PPH after having used fen-phen. Cynthia’s family was awarded $113 million in compensatory damages and $900 million in punitive damages, said Bloomberg.com.
The drug maker’s lawyers filed a PPH latency challenge in 2012 when two new cases were set for trial in the federal and state courts in Philadelphia. Wyeth’s attorneys argued that Jamie Cheek and Valarie Farmer were unable to prove their PPH was caused by fen-phen use in the 1990s; Cheek’s symptoms did not appear for nine years after she last used the drug, Farmer’s symptoms showed up 11 years after she stopped the drug, explained Bloomberg.com. Cheek’s case is among those consolidated before Judge Bartle; Farmer’s suit is pending in state court, also in Philadelphia.
The women’s attorneys argued that there are sufficient studies and case reports to help prove that PPH can have a latency period of at least ten years, noting that respected medical researchers have linked PPH to diet-drug use. According to Judge Bartle, the experts hired by the plaintiffs appropriately relied on those data and that it is up to the jury to make the final determination, said Bloomberg.com. 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,” wrote Judge Bartle, said Bloomberg.com. “That is a matter for the jury to decide after hearing from the experts on both sides and considering all other relevant evidence,” he added.
