More from Glaxo’s current trial in the USA.
This from Jef Feeley and Sophia Pearson at Bloomberg:
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. Lyam’s mother, Michelle David, blames Paxil for causing her son’s life-threatening heart defects.
Glaxo’s lawyers contend the London-based drugmaker isn’t liable for Lyam’s heart defects and acted responsibly in testing Paxil and updating safety information.
The company’s 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 didn’t 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 woman’s experience with Paxil in 2001 after she e-mailed the company seeking information on studies done about Paxil’s links to birth defects, said Nieman, who was the company’s director for evaluation and training for global clinical safety at the time.
The woman, whose identity was withheld by Glaxo, said she’d 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’
“If there is a chance that this might hurt or affect the baby I want to know up front and I will somehow stop taking it for the time being,” the woman said in the e-mail. “I love everything this drug has done for me. Please contact me as soon as possible. Please don’t forget about me.”
Nieman said she didn’t know who at Glaxo made the note in the company’s database that the aborted fetus’ heart defects were likely linked to the woman’s Paxil use.
“Somebody from GSK filled that in,” she said. “There’s 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.
Glaxo’s 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).