GlaxoSmithKline, maker of the selective serotonin reuptake inhibitor Paxil, is mired in a class action lawsuit in Canada that alleges the antidepressant caused birth defects in children whose expectant mothers took the drug without the corporation’s adequate warning of the heightened risks. A British Columbia judge permitted the class action.
This is the sort of thing that cost the manufacturer legal and financial setbacks in the U.S. The corporation spent millions on legal defense and paid millions in compensation awarded in Paxil lawsuits based on similar causes of action. The pharmaceutical litigation team at Reich & Binstock represents Paxil victims. The damage to children and to families frankly defies description, but the recovery of damages, including exorbitant medical costs, is welcome relief. Reich & Binstock’s personal injury attorneys are proud and fulfilled to help victims receive the justice they deserve.
Apparently, the Canadian mothers took the drug before warnings existed about the heightened risks of Paxil birth defects, such as a rare heart and lung condition known as persistent pulmonary hypertension — risks that the manufacturer should have known and had a duty to provide. Certainly bewildered women of childbearing age, who were taking either Paxil or another SSRI for that matter, wish they had known.
Imagine how they felt when their newborns were diagnosed with serious heart and lung conditions and then they learned that they and their babies were unwitting Paxil casualties. Put yourself upon careful reflection in such a mother’s shoes for a moment, as best you can.
The U.S. Food and Drug Administration in July 2006 updated its prescribing information for Paxil and for other SSRIs, including, Celexa, Fluvoxamine, Lexapro, Prozac, Symbyax and Zoloft. Those medications are in the same boat, and thank goodness there is a judicial process to redress the injuries associated with taking those drugs.
The FDA’s safety alert was based on a study that showed “infants born to mothers who took selective serotonin reuptake inhibitors after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension than infants born to mothers who did not take antidepressants during pregnancy. The background risk of a woman giving birth to an infant affected by PPHN in the general population is estimated to be about 1 to 2 infants per 1,000 live births. Neonatal PPHN is associated with significant morbidity and mortality.”
The FDA backpedaled from its own safety alert on Dec. 14, 2011. Based on subsequent conflicting scientific findings, the administration concluded that it could not nail down whether “SSRI use in pregnancy causes PPHN.” A possible causal relationship notwithstanding, the science nevertheless put potential serious risks on the radar of patients and health care professionals, which has been a propitious development, albeit too little too late for too many.
This manufacturer was in hot water in the U.S. during the second half of 2012.
In July 2012, GlaxoSmithKline pleaded guilty and agreed to pay $3 billion to resolve its “criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices,” the U.S. Justice Department announced.
As a part of the misdemeanor plea agreement for misbranding Paxil, as the Justice Department announced, the U.S. “government alleges that, from April 1998 to August 2003, GSK unlawfully promoted Paxil for treating depression in patients under age 18, even though the FDA has never approved it for pediatric use.” Indeed, since 2004, Paxil has carried a black box warning, as has other antidepressants, stating that “antidepressants may increase the risk of suicidal thinking and behavior in short-term studies in patients under age 18.”
The use of SSRIs in general and of Paxil in particular can be dangerous to infants born of mothers who took them. Women who took Paxil while they were pregnant and whose children have been diagnosed with a birth defect may be entitled to compensation in a Paxil lawsuit. There is a no-cost way to determine whether there is a viable case. The experienced Paxil attorneys at Reich & Binstock [www.reichandbinstock.com] offer free consultations to anyone in the U.S. who may have been injured by Paxil or by any SSRI. Reich & Binstock may be reached toll-free at 1-866-LAW-2400.