Associated Press
December 4, 2006
By
Tom Breen
CHARLESTON, W.Va. - The maker of the antidepressant Paxil has been hit with several new lawsuits, including two involving Ohio residents, that claim the drug caused heart defects with serious health consequences, including death.
Baum Hedlund, a Los Angeles-based law firm specializing in pharmaceutical product liability claims, filed the lawsuits in Pennsylvania state court Monday charging that use of the drug by pregnant women led to heart defects in their children. The suits also allege that the birth defects led to the deaths of three children, and have seriously impaired the health of two others.
The families represented by the firm are seeking unspecified damages from GlaxoSmithKline PLC, the world's second-largest pharmaceutical company and the maker of the drug.
Patricia Seif, director of corporate media relations at GlaxoSmithKline, said in an e-mail statement that the company does not comment on pending litigation.
However, Seif said the company has been sending letters to physicians and posting safety information about using the drug during pregnancy since 2005. Those communications, Seif said, addressed reports of heart abnormalities found in some infants.
"These reports involved infants whose mothers used Paxil during early pregnancy, but no causal link with the medication has been established," Seif said.
Karen Barth Menzies, a partner with Baum Hedlund, said those reports, which began in 2005, came too late for many pregnant women.
"It's not only that they waited too long, it's that the warning itself wasn't adequate," she said. "There are so many mothers and physicians out there who still don't know."
Among the lawsuits filed Monday was one on behalf of the Mobley family of Dunbar. The lawsuit alleges that Chasity Mobley's use of the medication while pregnant with twins Hannah and Taylor led to heart defects in both the girls, who were born on Oct. 17, 2002.
After four surgeries meant to correct numerous congenital heart defects, Hannah died at 20 months. Taylor Mobley, 4, was born with a condition called a ventricular septal defect, sometimes referred to as a hole in the heart. The suit alleges she will need regular monitoring as she grows to determine whether she needs further treatment.
The suits also allege that Paxil use by pregnant mothers led to heart defects that killed Kenndyl Gueldenzoph of Toledo, Ohio, and Keagan Hargitt of Omaha, Neb. Another suit was filed charging the drug caused heart defects in Westerville, Ohio, toddler Mark Fromm. The lawsuits filed Monday join three others previously filed by Baum Hedlund and two others filed by different firms, Menzies said.
In October, GlaxoSmithKline agreed to pay $63.8 million to settle a class action lawsuit's claims that it promoted Paxil for use by children and adolescents while withholding negative information about the medication's safety and effectiveness. As part of the settlement, the company denies the suit's claims.
In March, the company also agreed to settle a lawsuit for $14 million that charged it improperly attempted to delay the introduction of generic competitors to Paxil to the market. As part of that settlement, the company denied any wrongdoing.