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Glaxo Failed to Warn About Paxil Risks, Lawyer Says

GlaxoSmithKline Plc, the U.K.’s largest drugmaker, failed to properly warn consumers that its antidepressant drug Paxil could cause birth defects, a lawyer for the family of an injured teenager told jurors.

Glaxo had research from the 1980s showing Paxil caused deaths among the offspring of animal test subjects and didn’t provide clear warnings about the deaths, Kimberly Baden, a lawyer for Anna Blyth and her family, told a Philadelphia jury today. Baden said the drug caused a narrowing of the aorta leading from the heart of Anna, now 14 years old.

“We believe the evidence will show Paxil caused Anna’s birth defects,” Baden said in opening statements. “We believe the warnings and instructions put out in 1995 weren’t appropriate and reasonable.”

The Blyth family’s case is the first over Paxil’s birth-defect risks to go to trial since the company agreed in July to pay more than $1 billion to settle 800 cases alleging the company failed to adequately warn consumers and their doctors about the drug’s hazards. The Blyth case wasn’t part of the settlement.

In the first Philadelphia trial, a jury ordered Glaxo in October 2009 to pay $2.5 million to the family of a 3-year-old boy born with heart defects that his mother blamed on the drug.

$11.7 Billion in Sales

Glaxo officials contend Paxil played no role in Anna’s heart defects. They were most likely caused by genetics or the fact that her mother became pregnant late in life, Chilton Varner, a lawyer for the drugmaker, told jurors.

The deaths of Paxil animal test subjects had nothing “to do with Anna Blyth’s heart defects,” Varner said.

Approved in 1992 for U.S. use, Paxil generated about $793 million in sales in 2009, or about 1.8 percent of Glaxo’s total revenue. The company had $11.7 billion in U.S. Paxil sales over nine years starting in 1997, according to documents made public during the first Philadelphia trial last year.

Chief Executive Officer Andrew Witty has moved to replace revenue lost to generic versions of drugs such as Paxil. The drugmaker said in May it plans to double revenue from India and China by 2015 as it cuts prices to match competitors in emerging markets.

The company has paid more than $2 billion to resolve litigation over Paxil, including claims the anti-depressant caused suicides in some users and withdrawal symptoms. In July, Glaxo set aside $2.4 billion to resolve litigation over Paxil and its Avandia diabetes drug.

Second Wave

After announcing its settlement of Paxil suits, Glaxo faced a second wave of cases over the drugs, said Carl Tobias, a law professor at the University of Richmond in Virginia who teaches classes about mass-tort cases.

“You’ll have plaintiffs lawyers who hope to get in on a settlement by going out and finding some new cases,” Tobias said. “Glaxo probably feels it had to litigate this case to send a signal that it’s not going to settle every one of these birth-defect cases, especially if they are weak.”

Sarah Alspach, a Glaxo spokeswoman, declined to comment in an e-mailed statement on how many Paxil birth-defect cases remain outstanding in courts across the U.S. Fifteen cases are scheduled for trial next year in Philadelphia, she said.

In Anna’s case, the Summerville, South Carolina, resident had to undergo two rounds of open-heart surgery within nine months of her birth, Baden told jurors.

Her mother, Marsha Blyth, took Paxil for a short time during her pregnancy to deal with depression, Baden said. Glaxo’s warning label didn’t make it clear that offspring from animals on which the drug was tested had died, she said.

Volleyball Player

Varner countered that Glaxo included references to such deaths on the drug’s label in 1995, the year Marsha Blyth got pregnant. Blyth, who works in the lab of a South Carolina university “testing pharmaceutical products,” read that warning, Varner said.

Paxil’s label “contained all the knowledge it had as of 1995” about risks the drug posed to pregnant women, Varner said.

Varner also said Anna, an honor student who plays volleyball and takes tae kwon do lessons, has suffered no lasting effects from her early heart problems.

“She is not on any heart medications and hasn’t suffered any palpitations,” Varner said. “That’s the good news in the case.”

Glaxo’s American depositary receipts, each representing two ordinary shares, fell 89 cents, or 2.2 percent, to $39.61 in New York Stock Exchange composite trading.

The case is Blyth v. GlaxoSmithKline, 07-3305, Court of Common Pleas, Philadelphia County, Pennsylvania (Philadelphia).

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