Glaxosmithkline to Defend Paxil In Birth Defect Test-case Trial
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,” Logan said in a phone interview. “The early cases set the parameters for any global settlement negotiations.”
The medication, approved by the FDA in 1992, generated about $942 million in sales last year, 2.1 percent of the total for the company.
GlaxoSmithKline isnt liable for Lyams heart defects and acted responsibly in testing Paxil and updating safety information, Kevin Colgan, a company spokesman, said by e-mail.
“The scientific evidence simply does not establish that exposure to Paxil during pregnancy caused Lyam Kilkers condition,” Colgan said. “Very unfortunately, birth defects occur in 3 to 5 percent of all live births, whether or not the mother was taking medication during pregnancy.”
Alert to Doctors
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 FDAs action doesnt 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,” the company said.
“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 medicines label as new information became available,” the companys Colgan 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 didnt sufficiently research the drug before and after it went on the market.
Animal studies didnt show the drug was safe, company scientist John Baldwin wrote in a March 20, 1980, memo cited in court filings by Davids 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.
Avoiding Bad Results
The company designed studies to avoid triggering adverse results and stronger warnings, Davids lawyers claim. In 1994, members of the companys 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.