SSRI Birth Defects: Glaxo must pay $2.5M in Paxil case

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.

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.


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

This story contains information from Bloomberg
News.

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10/17/1999 – Fen-Phen Settlement on Shaky Ground

To our ICFDA Subscribers–

It was announced on Friday that American Home Products, maker of Redux
and Pondimin, is being sued by 11,000 plaintiffs. Now the majority
of those afflicted with heart and lung problems from the drug, 8,000
in all, say they are not interested in the proposed $3.75 billion
settlement offer.

Why should they be?

“I don’t know if there is an individual in the United States that would
qualify for $1.5 million under this settlement,” said Marc Bern, whose
New York City law firm represents 5,000 plaintiffs.

This case should serve as a warning to those companies now marketing
other SSRI medications which can have similar adverse effects in their
patient population. The users of these serotonergic medications
represent a much larger population than Fen-Phen users–now upwards
of 50 million individuals worldwide!

If this is the largest product liability suit to date, what might the
future bring?

For the full story, click on the link below.–Dr Ann Tracy, Executive
Director, ICFDA

Settlement on Shaky Ground
Thousands of Fen-Phen Users May Reject Offer

By Amy Westfeldt
The Associated Press

N E W A R K, N.J., Oct. 14 — Thousands of people suing American Home
Products Corp. for injuries allegedly suffered while taking the
fen-phen diet drug combination won’t participate in a proposed $3.75
billion settlement, threatening the resolution of one of the largest
product liability cases ever, lawyers say.

http://abcnews.go.com/sections/living/DailyNews/fenphen991014.html

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