Washington, DCAs we prepare to head into the ninth year since the US Food and Drug Administration (FDA) first released its safety advisory with regard to Selective Serotonin Reuptake Inhibitors (SSRIs) and their use by pregnant women, pundits will be watching the legal horizon for SSRI birth defect lawsuits scheduled to get underway in 2015. As of October there were about 200 lawsuits alleging SSRI and Lexapro birth defects in multidistrict litigation in Cole County Circuit Court Missouri.
The first of these is set for April 2015. Other lawsuits alleging Lexapro persistent pulmonary hypertension (Lexapro PPH) and other SSRI birth defect allegations are pending in New Jersey and California, with another case set to begin trial in Orange County in March.
Plaintiffs have been taking the manufacturer of Lexapro, Forest Laboratories (now part of Actavis), to task for allegedly concealing risks to pregnant women and their unborn children. And while it has been asserted that risks of Lexapro birth defects could have been presented more openly, there were and continue to be veiled references to potential risks nonetheless.
Thus, the question remains, where does the plaintiff’s physician fit into all of this? And does a patient’s doctor share in the liability if he or she was aware of the risk and failed to inform the patient in order to secure informed consent to take Lexapro while pregnant? If the doctor was not aware of the risks, should he or she have been? Regardless of allegations that manufacturers were not forthcoming with risks for newborn birth defects, could the physician have nonetheless secured the necessary risk profile through medical due diligence?
The FDA’s release of a health advisory in 2006 was based upon a study published in the New England Journal of Medicine in the same year suggesting that taking an SSRI such as Lexapro in the second and third trimester could produce a six-fold increased risk for Lexapro PPH over pregnant women who did not take an SSRI during the second half of their pregnancies.
Prior to its acquisition by Actavis, Forest maintained a website at Lexapro.com that at one time carried this statement under an FAQ section: “There have been no studies done to show that Lexapro is safe to use in pregnant women. Therefore, Lexapro should be used during pregnancy only if the potential benefit justifies the potential risk to the unborn child.”
Since Actavis’ acquisition of Forest in July 2014, web presence has changed. Now, a search for Lexapro.com takes the viewer to an all-encompassing site listing all the products in the Actavis/Forest portfolio. Lexapro is one of them. While a Frequently Asked Questions page doesn’t appear to be readily apparent, Actavis/Forest has nonetheless posted a summary of official prescribing information for escitalopram (Lexapro). On page 25 of this 26-page document, the manufacturer advises “It is not known if Lexapro will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy.”
And, on page 16: “There are no adequate and well-controlled studies in pregnant women; therefore, escitalopram [Lexapro] should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.”
Escitalopram (Lexapro) is classed by the FDA as a Category C medication within the context of pregnancy: “Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.”
At the end of the day, the message is there: newborn birth defects are possible. The question remains: within the context of conversation or debate over whether a patient and potential plaintiff should be weaned off an SSRI such as Lexapro during pregnancy, are Lexapro side effects pertaining to potential harms to the newborn adequately explained by both the manufacturer and the physician? And if not, what roles do either camps play in a Lexapro lawsuit?
We’ll find out at the conclusion of two SSRI lawsuits coming soon in the New Year…
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