A couple from Los Angeles, California recently filed a product liability lawsuit against one of the pharmaceutical industry’s dominant companies, GlaxoSmithKline (GSK), alleging that GSK’s prescription medication brand Zofran contributed to the tragic death of their infant daughter.
Dulce A. Morga, the expectant mother in this case, was prescribed Zofran during her pregnancy. Her daughter was then born in 2014 with severe congenital heart defects. After receiving open-heart surgery in the days following her birth, the infant passed away in the arms of her mother.
Sadly, instances linking Zofran to congenital birth defects have arisen on many occasions since physicians began prescribing the drug to treat morning sickness in pregnant women. Zofran was initially introduced by GlaxoSmithKline and approved by the U.S. Food and Drug Administration (FDA) to treat nausea and vomiting in 1991. However, prescribing guidelines confined Zofran to treatment for patients who experienced nausea after undergoing chemotherapy, radiotherapy, or surgery.
Shortly thereafter, medical professionals began prescribing Zofran for off-label use in pregnant women experiencing morning sickness. Although this use was not approved by the U.S. FDA, GlaxoSmithKline advertised to doctors and expectant mothers for this purpose. In 2012, GSK pled guilty to criminal charges after the U.S. Department of Justice accused the company of marketing off-label uses of several prescription drugs, including Zofran. Nevertheless, it is estimated that approximately 1 million pregnant women in the United States take some form of Zofran each year to treat nausea and vomiting related to their pregnancy.
In recent years, studies involving the unintended side effects of Zofran have revealed a potential link between the drug and congenital birth defects. Some research suggests that mothers who are prescribed Zofran for this off-label use have a significantly increased risk of delivering an infant with birth defects, particularly congenital heart defects.
The aforementioned lawsuit, which was filed on Friday, November 13th, brings multiple claims against GlaxoSmithKline, including negligence, strict products liability, intentional misrepresentation, concealment, and negligent misrepresentation. The plaintiffs are seeking damages resulting from what is often described as “pharmaceutical failure to warn,” which causes catastrophic and often fatal consequences for unsuspecting patients across the United States.
When pharmaceutical companies fail to protect and ensure the safety of those taking their products, they should be held accountable. Unfortunately, these powerful corporations often attempt to use their influence to silence the innocent victims who deserve to be compensated for their losses. If you or someone you love is facing a situation of this kind, please contact Fronzuto Law Group anytime for a free consultation. We are always available to answer your questions and to provide you with an understanding of your available options.