The lawsuit alleges that Glaxo, "by directly and indirectly advertising, marketing, and promoting Paxil for the treatment of women during pregnancy and by placing this drug in the stream of commerce knowing that Paxil would be prescribed to pregnant women in reliance upon the representations ... that Paxil was safe and effective for the treatment of women during pregnancy and without significant risk to the fetus."
The complaint also alleges that Glaxo "did not timely warn the medical community and consumers generally that taking Paxil during pregnancy is associated with a significant increased risk of birth defects and abnormal development of the unborn child."
In reviewing Glaxo's entanglements in the legal system over the last five years, the first guilty verdict in a Paxil-related suicide case was issued on July 7, 2001, when a jury in Cheyenne, Wyoming, ordered SmithKline Beecham (now GlaxoSmithKline) to pay $6.4 million to the relatives of Donald Schell, who after taking Paxil for only 2 days, shot and killed his wife, daughter, and granddaughter before killing himself.
At trial, the jury heard the expert testimony of British psychiatrist and SSRI researcher, Dr. David Healy, who told the panel that all SSRIs could trigger suicidal and violent behavior in some patients. On the stand, Dr Healy described his own studies that showed that SSRIs could even cause one in four "healthy volunteers" to become agitated, and in some cases suicidal.
"Healthy volunteers" means the subjects were not mentally ill to begin with.
Dr. Healy further revealed internal SmithKline documents from clinical trials conducted by the company to support his findings. He presented a summary of a study involving more than 2,000 healthy volunteers, taking either a placebo or Paxil, that found that hundreds of healthy volunteers on Paxil had experienced adverse reactions, ranging from insomnia or anxiety to attempted suicide, that doctors in the study coded as "possibly," "probably" or "definitely" caused by Paxil.
Glaxo's defense team told the jury that taking 2 Paxil pills could not have caused Mr. Schell's violent and suicidal behaviors. However, the summary of the company's own study showed that some healthy volunteers experienced anxiety, nightmares, hallucinations and other side effects coded as "definitely" caused by Paxil within two days.
In as early as four days, another volunteer experienced akathisia, a severe form of agitation that experts believe increases the risk of violence and suicide, and 2 other volunteers attempted suicide after taking Paxil for 11 and 18 days.
In the end, after considering all the evidence, the jury placed 80% of the blame for the tragedy on Glaxo.
Glaxo is notorious for concealing negative information from Paxil and legal experts say civil litigation has played a major role in exposing the dangers kept hidden for so long. According to Attorney Menzies, "Civil lawsuits uncover internal company documents to which not even the FDA has access."
"Through our Paxil litigation," she notes, "we've obtained documents that show a seriously troubling mentality of profit over safety and a callous disregard for the welfare of children."
"That's about as reprehensible as you can get," Ms Menzies says.
There is certainly enough available evidence to back up that assertion. For instance, on July 15, 2003, after meeting with the Canadian regulatory agency, Health Canada, Glaxo issued a public advisory in Canada alerting pediatric patients, their parents or guardians, and healthcare professionals that until further information was available that Paxil should not be given to pediatric patients, due to concerns of a possible increased risk of suicidal thinking, suicidal attempts or self-harm.
The advisory also said, "Paxil must not be used in pediatric patients with major depressive disorder due to the additional fact that studies have failed to show that Paxil was effective in this patient population."
In addition, Glaxo distributed letters to physicians in Canada and the UK, informing them that studies had failed to demonstrate the efficacy of Paxil in the pediatric population and that there was a doubling of the rate of adverse events, including emotional lability. However, Glaxo did not provide American physicians with this information.
Instead, it sent Medical Information Letters only to those physicians who specifically requested information concerning Paxil as a treatment for children and adolescents.
The complaint also alleges that Glaxo "did not timely warn the medical community and consumers generally that taking Paxil during pregnancy is associated with a significant increased risk of birth defects and abnormal development of the unborn child."
In reviewing Glaxo's entanglements in the legal system over the last five years, the first guilty verdict in a Paxil-related suicide case was issued on July 7, 2001, when a jury in Cheyenne, Wyoming, ordered SmithKline Beecham (now GlaxoSmithKline) to pay $6.4 million to the relatives of Donald Schell, who after taking Paxil for only 2 days, shot and killed his wife, daughter, and granddaughter before killing himself.
At trial, the jury heard the expert testimony of British psychiatrist and SSRI researcher, Dr. David Healy, who told the panel that all SSRIs could trigger suicidal and violent behavior in some patients. On the stand, Dr Healy described his own studies that showed that SSRIs could even cause one in four "healthy volunteers" to become agitated, and in some cases suicidal.
Dr. Healy further revealed internal SmithKline documents from clinical trials conducted by the company to support his findings. He presented a summary of a study involving more than 2,000 healthy volunteers, taking either a placebo or Paxil, that found that hundreds of healthy volunteers on Paxil had experienced adverse reactions, ranging from insomnia or anxiety to attempted suicide, that doctors in the study coded as "possibly," "probably" or "definitely" caused by Paxil.
Glaxo's defense team told the jury that taking 2 Paxil pills could not have caused Mr. Schell's violent and suicidal behaviors. However, the summary of the company's own study showed that some healthy volunteers experienced anxiety, nightmares, hallucinations and other side effects coded as "definitely" caused by Paxil within two days.
In as early as four days, another volunteer experienced akathisia, a severe form of agitation that experts believe increases the risk of violence and suicide, and 2 other volunteers attempted suicide after taking Paxil for 11 and 18 days.
In the end, after considering all the evidence, the jury placed 80% of the blame for the tragedy on Glaxo.
Glaxo is notorious for concealing negative information from Paxil and legal experts say civil litigation has played a major role in exposing the dangers kept hidden for so long. According to Attorney Menzies, "Civil lawsuits uncover internal company documents to which not even the FDA has access."
"Through our Paxil litigation," she notes, "we've obtained documents that show a seriously troubling mentality of profit over safety and a callous disregard for the welfare of children."
"That's about as reprehensible as you can get," Ms Menzies says.
There is certainly enough available evidence to back up that assertion. For instance, on July 15, 2003, after meeting with the Canadian regulatory agency, Health Canada, Glaxo issued a public advisory in Canada alerting pediatric patients, their parents or guardians, and healthcare professionals that until further information was available that Paxil should not be given to pediatric patients, due to concerns of a possible increased risk of suicidal thinking, suicidal attempts or self-harm.
The advisory also said, "Paxil must not be used in pediatric patients with major depressive disorder due to the additional fact that studies have failed to show that Paxil was effective in this patient population."
In addition, Glaxo distributed letters to physicians in Canada and the UK, informing them that studies had failed to demonstrate the efficacy of Paxil in the pediatric population and that there was a doubling of the rate of adverse events, including emotional lability. However, Glaxo did not provide American physicians with this information.
Instead, it sent Medical Information Letters only to those physicians who specifically requested information concerning Paxil as a treatment for children and adolescents.
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