Zofran Lawsuit Alleges Heart Birth Defects In Virginia Child

zofranBy Michael Monheit of Monheit Law, Rydal, PA.

Among several more Zofran birth defect lawsuits filed in the month of February, including one filed by a mother in Virginia Beach, VA, who took Zofran and discovered in the 29th week of her pregnancy that her unborn daughter had heart and lung defects.

The case is Magan Stahl, on behalf of her daughter C.S. V. GlaxoSmithKline LLC, filed February 2, 2016, case number 1:16-cv-10153-FDS, US District Court of the District Of Massachusetts.

In this suit, Stahl alleges that both she and her daughter “have suffered and incurred harm including severe and permanent pain and suffering, mental anguish, medical expenses, and other economic and noneconomic damages.” She believes the only reason she and her child have suffered these losses is because her child was exposed to the drug Zofran while still in the womb.

In this case, her daughter suffers from a heart defect known as Tetralogy of Fallot. This defect is particularly dangerous because it involves not just on abnormality of the heart, but four. It is considered to be a cyanotic defect, which means that the abnormalities lead to a lack of oxygen in the blood. When she was just three months old, the child in question underwent open heart surgery so that doctors could repair her heart.

The mother claims that there is no known genetic cause for her condition and that she has no family history of the condition.

“Although FDA approval was only ever obtained for seriously ill patients, as early
as January 1998, GSK proceeded to market Zofran “off label” as a safe and effective treatment for
the pregnancy-related nausea and vomiting otherwise known as “morning sickness.” GSK further
marketed Zofran as a “wonder drug” for pregnant women, despite knowing that it had never
undertaken a single study establishing that this powerful drug was safe for pregnant mothers and
their unborn children,” the complaint states.

220 lawsuits filed

This plaintiff isn’t the first one to claim that Zofran caused a birth defect in their child. More than 220 lawsuits have been filed against GlaxoSmithKline (GSK), alleging that if a mother hadn’t taken the drug, their child wouldn’t have been harmed. In addition to Tetralogy of Fallot, parents are claiming that the drug caused clubfoot, cleft lip, cleft palate, respiratory distress syndrome, atrial septal defect, ventricular septal defect, and kidney defects.

Additionally, parents allege that GSK knew the drug was dangerous, and yet, they still chose to promote the drug as a “safe” and “effective” treatment for morning sickness, a condition commonly diagnosed in pregnant women during the first trimester. The drug certainly wasn’t approved for this condition, in fact, the U.S. Food and Drug Administration only approved it for patients undergoing anesthesia, radiation, or chemotherapy.

The litigation has grown steadily over the past year and the majority of these complaints have been consolidated into MDL 2657. Each of these cases will be tried in the District of Massachusetts by Judge F. Dennis Saylor. Plaintiffs are eager for the discovery phase to begin and are hopeful that they can obtain compensation for their children’s medical expenses and pain and suffering.


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