Paragraphs 9 & 10 read: “”Birth defects were caused solely as a result of the negligence of the defendant manufacturer. As a result of (the child’s) heart defects, the plaintiffs have been forced to live with severe psychological problems that have affected their daily lives,” Rizvi said. ‘The manufacturer was aware that knowledge must be provided to patients as to the possible side effects of the drug but ignored all of these matters’.”
“A warning about effects of the drug on pregnant women has since been put on the bottle after U.S. Food and Drug Administration (FDA) studies showing a correlation between the usage of Paxil during pregnancy and birth defects in newborn children.”
http://www.northpeel.com/news/article/59860
Local woman seeks legal action against drug maker
Thursday November 6 2008
By PETER CRISCIONE
A Brampton woman alleges her young son’s health problems are directly related to antidepressants prescribed during pregnancy, and is now taking legal action against the drug manufacturer.
Lawyers representing Shannon Cote, 29, and her 10-year-old son, say they have commenced a lawsuit against Glaxo Smith Kline, distributors of the drug Paxil.
In a formal statement sent to The Guardian, Glaxo Smith Kline corporate communication officials said the company had not received formal notification of any legal action with respect to this matter.
“Paroxetine has been used by tens of millions of patients and, when used appropriately, has been proven to be a safe and effective treatment since its launch more than 15 years ago,” read the statement. “The label contains instructions regarding the use of paroxetine and important safety information about the product. If patients have questions regarding the use of paroxetine, or the management of their depression, they should contact their health-care professional. Also, it is very important that patients do not stop taking paroxetine without first consulting with their doctor.”
In August 1997, Cote became pregnant at which time her lawyers say she began to suffer from low self-esteem and depression.
The woman claims her family physician prescribed the drug and was assured at the time that Paxil, unlike the other antidepressants, was suitable during pregnancy.
Subsequently, Cote’s child was born with heart defects that Brampton-based NAPAL Law Chambers (NLC) argues is directly linked to use of the antidepressant.
Zain Rizvi, litigation consultant for NLC, charged the drug manufacturer failed to ensure that a proper warning was placed on the drug’s prescription label, as well as proper usage instructions.
“Birth defects were caused solely as a result of the negligence of the defendant manufacturer. As a result of (the child’s) heart defects, the plaintiffs have been forced to live with severe psychological problems that have affected their daily lives,” Rizvi said. “The manufacturer was aware that knowledge must be provided to patients as to the possible side effects of the drug but ignored all of these matters.”
A warning about effects of the drug on pregnant women has since been put on the bottle after U.S. Food and Drug Administration (FDA) studies showing a correlation between the usage of Paxil during pregnancy and birth defects in newborn children.
As for the doctor who wrote the prescription, Rizvi added he is not liable as he was not aware of the potential side effects at the time he prescribed the drug.
NLC has sent Glaxo Smith Kline, which has a Canadian head office in Mississauga, a pre-action letter, Rizvi said.
The law firm is encouraging women who have taken Paxil during pregnancy and whose child has experienced birth defects to call 905-452-0348.