Can a drug have side effects that don’t appear for over a decade? The answer is yes! Even though you may not see any current adverse events, there are some medications that can cause terrible effects, years and years after initial ingestion.
In a lawsuit alleging that the diet drug fen-phen caused pulmonary hypertension in a young woman, U.S. District Judge Harvey Bartle III ruled that the condition can arise 10 years after the last use of the drug.
(MORE: What is pulmonary hypertension?)
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.
Chris Loder, a Pfizer spokesman, said in an e-mailed statement 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. With the company 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More than 6 million prescriptions were written for the diet combination before it was withdrawn.
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.
With fear of future large settlements ensuing, Pfizer’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.
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.”[hr]
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