Glaxo Linked Birth Defect Of Fetus to Paxil, Ex-executive Says
After analyzing a 2001 e-mail from a Paxil user who aborted her fetus because it had a heart defect, Glaxo officials noted in company files they were “almost certain” the drug was related to the problem, Jane Nieman, a former Glaxo drug-safety executive, told a Pennsylvania jury.
“I dont know who made that assessment, but its there,” Nieman testified in a videotaped deposition played yesterday for jurors. Niemans testimony came in the trial of another Paxil users lawsuit over birth defects suffered by her now 3-year-old son.
The state-court trial in Philadelphia is the first of more than 600 cases alleging Glaxo knew Paxil caused birth defects and hid those risks to increase profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, 2.1 percent of Glaxos total revenue.
The family of Lyam Kilker claims Glaxo withheld information from consumers and regulators about the risk of birth defects and failed to properly test Paxil. Lyams mother, Michelle David, blames Paxil for causing her sons life-threatening heart defects.
Safety Information
Glaxos lawyers contend the London-based drugmaker isnt liable for Lyams heart defects and acted responsibly in testing Paxil and updating safety information.
The companys provision for legal and other non-tax disputes as of June 30 was 1.7 billion pounds ($2.8 billion), the company said in a July 22 regulatory filing that didnt mention the Paxil litigation.
“It would be inappropriate to comment on evidence during the middle of a trial,” Kevin Colgan, a Glaxo spokesman, said in an e-mail.
Glaxo officials learned about the womans experience with Paxil in 2001 after she e-mailed the company seeking information on studies done about Paxils links to birth defects, said Nieman, who was the companys director for evaluation and training for global clinical safety at the time.
The woman, whose identity was withheld by Glaxo, said shed been taking Paxil for anxiety when she found out she was pregnant, Neiman said. The woman praised Paxil as a “miracle drug” that provided relief from panic attacks, the executive added.
Made A Mistake
Nieman said she didnt know who at Glaxo made the note in the companys database that the aborted fetus heart defects were likely linked to the womans Paxil use.
“Somebody from GSK filled that in,” she said. “Theres a possibility someone made a mistake and checked the box wrong.”
Lawyers for Kilker allege Glaxo mounted a marketing campaign to persuade doctors to write more Paxil prescriptions for pregnant women dealing with anxiety.
The drugmaker undertook that campaign while withholding information about birth-defect reports from doctors, the family contends.
Glaxos American depositary receipts, each representing two ordinary shares, fell 7 cents to $38.86 in New York Stock Exchange composite trading. Glaxo rose 1 pence to 1,177 pence in London trading.
The case is Kilker v. SmithKline Beecham Corp. dba GlaxoSmithKline, 2007-001813, Court of Common Pleas, Philadelphia County, Pennsylvania (Philadelphia).