GlaxoSmithKline Plc, the world’s second-biggest drugmaker, begins a trial in Philadelphia in what may be a test case for more than 600 lawsuits over claims its antidepressant drug Paxil causes birth defects.
Patients and their parents claim internal company documents produced for trial show Glaxo failed to warn about the risks of Paxil until forced to do so in 2005 by the U.S. Food and Drug Administration. In a trial set for Sept. 14, Michelle David blames the drug for causing life-threatening heart defects in her son Lyam Kilker, 3.
The London-based company faces two more such trials a month from October through January in state court in Philadelphia. The first group will show both sides how the rest of the lawsuits may fare, said David Logan, dean and professor of law at Roger Williams University in Bristol, Rhode Island.
“These cases are sort of like the canary in the coal mine,” according to Logan . “The early cases set the parameters for any global settlement negotiations.”
Paxil, approved by the FDA in 1992, generated about $942 million in sales last year, 2.1 percent of the total for the company. Glaxo has settled other Paxil-related cases, including a suit brought by the New York Attorney General’s office accusing the company of withholding safety data about the antidepressant.
“The scientific evidence simply does not establish that exposure to Paxil during pregnancy caused Lyam Kilker’s condition,” according to company spokesman. “Very unfortunately, birth defects occur in 3 to 5 percent of all live births, whether or not the mother was taking medication during pregnancy.”
The FDA said in an alert to doctors on Dec. 8, 2005, that preliminary studies suggested Paxil might contribute to heart defects in infants when taken in the first three months of pregnancy. The government asked the company to update the label enclosed with the medicine, changing its birth-defect warning.
The FDA’s action doesn’t prove any connection between Paxil use and birth defects, the company said in court filings.
“Before 2005, more than two decades of studies had found no association between maternal Paxil use and birth defects,” lawyers for Glaxo said July 8 in court papers. “Since 2005, additional studies have been inconclusive with mixed results.”
“GlaxoSmithKline will show it acted properly and responsibly in conducting its clinical trial program for Paxil, in marketing the medicine, in monitoring its safety once it was approved for use and in updating pregnancy information in the medicine’s label as new information became available,” the company’s spokeman said.
Lawyers for patients claim Glaxo documents show the company knew since 1980 that Paxil could raise the risk of birth defects. They claim Glaxo didn’t sufficiently research the drug before and after it went on the market.
Animal studies didn’t show the drug was safe, company scientist John Baldwin wrote in a March 20, 1980, memo cited in court filings by David’s lawyers.
“There remains the possibility that this compound could be teratogenic at higher dose levels,” he said. A teratogenic agent is one that causes malformations of an embryo or fetus.
“In the face of this warning from Baldwin, GSK chose not to perform any additional animal studies to explore the teratogenic effects of Paxil,” the plaintiffs’ lawyers wrote.
The company in 1993 destroyed raw data from animal studies of the drug, and in 1996, 1998 and 2000 it withheld safety reports of adverse outcomes involving mothers who took Paxil, plaintiffs’ attorneys said in court papers Aug. 10, asking the court to allow punitive damages in the case.
The company designed studies to avoid triggering adverse results and stronger warnings, David’s lawyers claim. In 1994, members of the company’s Paxil team supported a low-dose study “as the best way forward and having an acceptably low risk of triggering adverse labeling worldwide,” the lawyers said, quoting minutes of a meeting.
“In 1998, GSK internally concluded that it had received an ‘alarming’ number of abnormal pregnancy adverse events for Paxil and failed to disclose this information to the FDA, physicians or the public,” the lawyers said in the Aug. 10 filing.
Judge Sandra M. Moss, who is overseeing the lawsuits in Philadelphia, denied Glaxo’s motion Aug. 17 to bar punitive damages. She said the company can ask again during the trial.
The company knew the drug was more harmful to pregnant women than cocaine, Sean Tracey, a Houston attorney for David, said during a Sept. 3 pretrial hearing. Glaxo aggressively marketed the drug to women of childbearing age, Tracey said.
David said she was prescribed Paxil during her first trimester to treat mild anxiety. Lyam was born with defects including two holes in his heart as a result of taking the drug, she said in court papers. The infant underwent multiple surgeries within six months of his birth, she said.
She said wouldn’t have taken Paxil if she knew of the risk and contends that Glaxo failed to warn her or her doctors.
“All of Ms. David’s physicians who prescribed Paxil just prior to and during her pregnancy with Lyam have testified that had they been warned that Paxil could increase the risk of cardiovascular heart defects, they would not have prescribed it to her,” according to court papers.
The company countered at the Sept. 3 hearing that there is no evidence David was taking Paxil at the time Lyam was conceived, and there is no evidence the mother’s doctors considered company promotional materials when prescribing it.
The FDA in 2005 said an analysis of data on Swedish patients showed there was a 2 percent risk of birth defects in babies whose mothers took Paxil early in the pregnancy, twice as high as the risk to the general population.
Another study showed the risk was 1.5 percent among Paxil users and 1 percent for those on other antidepressants, the FDA said.
The agency said that while the drug generally shouldn’t be used during pregnancy, its benefits may outweigh potential risks for some expectant mothers who aren’t helped by other medications.
Glaxo is also fighting lawsuits in the U.S., Canada and the U.K. over claims that Paxil, also known by the generic name paroxetine, causes homicidal and suicidal behavior. The company has settled some suicide claims, though terms of the settlements haven’t been released.
In 2004, the drugmaker agreed to pay the state of New York $2.5 million to resolve claims that officials suppressed research showing Paxil may increase suicide risk in young people. The settlement also required Glaxo to publicly disclose the studies.
In 2001, a jury in Cheyenne, Wyoming ordered Glaxo to pay $6.4 million to the relatives of a man who shot his family to death and then turned the gun on himself after taking Paxil.
The case is Kilker v. SmithKline Beecham Corp. dba GlaxoSmithKline, 2007-001813, Court of Common Pleas, Philadelphia County, Pennsylvania.
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