Paxil and birth defects = $2.5 million fine.

Dr.  Weeks’ Comment: 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.


Michelle David had claimed that her 3-year-old son Lyam Kilker suffered life-threatening heart defects because she took Paxil while she was pregnant with him.

Posted on Tue, Oct. 13, 2009

Glaxo must pay $2.5M in Paxil case

By Miriam Hill

INQUIRER STAFF WRITER

GlaxoSmithKline P.L.C. must pay $2.5 million to settle a claim that its Paxil antidepressant caused severe heart defects in a 3-year-old Bensalem boy, a Philadelphia common pleas jury ruled today.

The verdict is the first in 600 cases alleging that London-based Glaxo knew Paxil caused birth defects and hid those risks to boost 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.

London-based Glaxo has major operations in the Philadelphia region.

Michelle David had claimed that her 3-year-old son Lyam Kilker suffered life-threatening heart defects because she took Paxil while she was pregnant with him.

Glaxo issued a statement saying it disagrees with the verdict and will appeal.

“While we sympathize with Lyam Kilker and his family, the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition. Very unfortunately, birth defects occur in three to five percent of all live births, whether or not the mother was taking medication during pregnancy,” the company’s statement said.

David and Kilker’s lawyers, Sean Tracey of Houston and Jamie Sheller of the Philadelphia firm Sheller P.C., argued that Glaxo withheld information from consumers and regulators about the risk of birth defects and failed to properly test Paxil.

“The first win is always huge, especially when you get a jury saying the drug caused the injury,” Sean Tracey, Kilker’s lawyer, told Bloomberg in an interview after the jury reached its decision.

Glaxo’s lawyer, Chilton Varner of King & Spalding in Atlanta, countered that the company reported any sign of problems to federal authorities. She had accused Tracey of cherry-picking sentences from documents.

During the trial, she also noted that Kilker, who underwent several surgeries to fix his heart problems today “has no cardiac symptoms . . .. is at preschool and runs and walks like an [almost] 4-year-old should.”

In its statement today, Glaxo said it “acted properly and responsibly in conducting its clinical trial program for Paxil, including sharing documentation and submitting results from studies on Paxil to regulators.”

Kilker will require more surgeries as he grows.

David was a former cheerleader for the Philadelphia 76ers.

The case was heard by Judge Stephen Levin in Common Pleas Court.

The FDA initially classified Paxil as a drug with no known connections to birth defects. In 2005, the agency reclassified it as a drug with some evidence of human fetal risk but allowed doctors to continue prescribing it to women of childbearing age if the benefits outweigh the risks.

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