Almost like an episode of the TV show, Cold Case Files, the first Paxil birth defect trial was dominated by a story about what happened to the rat pups that died around 1979 and1980, involved in a study in which Paxil was being tested on pregnant female rats.
The animal studies giving Paxil to rats and rabbits were conducted by a Danish company called Ferrosan before the drug maker, that later became part of GlaxoSmithKline, purchased the drug.
The family's lead attorney in the case of Kilker v Glaxo, Sean Tracey from Houston, brought in the world-famous neuropsychopharmocology expert from Wales, Dr David Healy, to testify extensively about rat pup study 295.
In summary, Healy told the jury that all the rat pups born to mothers who received Paxil were dead four days after they were born, while eighty-eight percent of the pups not exposed to Paxil were still alive on day four.
In fact, of the 415 rat pups born to mothers who received Paxil, Healy testified that, "One in every ten or actually maybe more like possibly one in every eight or so were born dead."
As far as he could make make out, all the rats were not autopsied, Healy said, so the question was why the pups died.
"It's clearly the drug that has caused the death," he told the jury.
"One of the possible reasons for their death is they're born with birth defects that lead to them actually dying early in infant life," he testified. "A responsible approach to data like this is to investigate it further and find out just what the cause is."
Doctor Suzanne Parisian, a former FDA scientist, also served as an expert for the plaintiffs. She testified that the first safety signals that indicated Paxil could cause birth defects were seen in the animal studies conducted in 1979-1981 period, as well.
Parisian said the studies showed birth defects, embryos that died, and rat pups that did not survive.
Adam Peavy, of the Houston firm of Bailey, Perrin and Bailey, handled her testimony. While testifying, Peavy had Parisian review comments in a memo by a Doctor John Baldwin to Glaxo in 1980, discussing the Ferrosan studies, which stated: "There remains the possibility that this compound could be teratogenic at high-dose levels."
"We need to ascertain whether Ferrosan have conducted or are conducting or intend to conduct a peri- and postnatal study and a neonatal acute toxicity study," Baldwin wrote.
Based on her review the documents, Parisian told the jury, Glaxo never ascertained whether Ferrosan did the studies and Glaxo never conducted the studies.
As far as she knew, the company never told the FDA about Baldwin's statements either, she said, but "they should have."
On October 13, 2009, the jury in Philadelphia rendered a verdict against Glaxo and awarded the family $2.5 million. More than 600 Paxil birth defect cases are pending in the multi-litigation in Pennsylvania.
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