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A number of birth defect cases are set for trial in 2010. Andy Vickery, who practices at the Houston firm of Vickery, Waldner and Mallia, is handling several cases, with the Novak trial set to start first. The case is unique in that it involves an infant born with heart birth defects to Derek and Laura Novak on April 4, 2002, after Laura was prescribed Paxil during pregnancy for the off-label treatment of migraine headaches.
"Although one might worry that this would cause a jury to blame the prescribing doctor," says Vickery, "in this case, we can show that GSK encouraged this use, by sending out over 1500 "medical information" letters touting the benefits of Paxil for migraine headaches, and by leaving "approved WLF reprint" articles with the prescribing doctors."
During opening statements in the first trial on September 15, 2009, Sean Tracey told the jury they were "going to see documents in this case that have never seen the light of day before."
"You will see internal GlaxoSmith documents that the FDA hasn't seen, that the United States Congress hasn't seen, and that no jury has ever laid their eyes on before," he said. "They have been under seal for over three years."
Many of the sealed documents related to the Paxil studies conducted on rats and rabbits. The world-renowned expert from the UK, Dr David Healy, testified on behalf of the plaintiffs.
Paxil was originally owned by a Danish company called Ferrosan, and that company did the preliminary animal studies on rats and rabbits to look at teratogenicity around 1979 and 1980.
Healy explained that a teratogen is an agent that will cause birth defects and "it could be a drug or maybe a virus or maybe an illness."
In addition to birth defects, he said, a teratogen can cause a fetus to be born dead or cause a miscarriage, which is death before birth.