GlaxoSmithKline Plc’s scientists were alarmed by a rising number of birth defects among pregnant women taking the antidepressant Paxil in 1997, according to internal documents revealed in a trial in Philadelphia.
There was a 13.3 percent rate of incidence for congenital abnormalities as of November 1997, according to the documents presented by lawyers for the family of an injured child suing the company.
“Taken at face value this presents an alarming finding,” according to the internal report. That language was later deleted, the documents show. The information was never submitted to the U.S. Food and Drug Administration, former FDA doctor Suzanne Parisian told jurors Sept. 18.
“Under the rules, it should have been” submitted, said Parisian, who testified on behalf of 3-year-old Lyam Kilker and his family.
The documents were revealed in the state-court trial of a lawsuit brought by Kilker’s mother, Michelle David, who blames her Paxil use for her son’s life-threatening heart defects. She accuses the company of withholding information from consumers and regulators about the risk of birth defects and failing to properly test Paxil.
The trial is the first out of more than 600 cases alleging that Glaxo, the U.K.’s largest drugmaker, 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 Glaxo’s total revenue.
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 case is Kilker v. SmithKline Beecham Corp. dba GlaxoSmithKline, 2007-001813, Court of Common Pleas, Philadelphia County, Pennsylvania (Philadelphia).
If you or a family member has been personally injured because of the fault of someone else: by the use of dangerous and defective drugs, bad products, or toxic injury etc then please contact the Fort Worth Texas Defective Drugs Product Liability Attorney Dr. Shezad Malik. For a no obligation, free case analysis, please call 817-255-4001 or Contact Me Online.
The Dr. Shezad Malik Law is currently evaluating and accepting Paxil Heart Defect cases.