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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Contact staff writer Miriam Hill at 215-854-5520 or hillmb@phillynews.com.

This story contains information from Bloomberg
News.