Massachusetts Mother Alleges Zofran Birth Defects Caused Premature Death of Baby

August 25, 2015 – – ZofranLegal.com has reported that in April 2015, a new lawsuit has been filed in the United States District Court for the District of Massachusetts Eastern Division, alleging that the use of the drug Zofran by a Massachusetts woman during the first trimester of her pregnancy resulted in the premature death of her unborn child.

The complaint notes that in 2013, the mother was prescribed Zofran to treat her morning sickness. Not long after she began taking Zofran, the unborn child was found to have severe and life-threatening birth defects, including an abdominal defect. As a result, the plaintiff was left no option but to terminate her pregnancy on October 16th, 2013. The lawsuit alleges that the life-threatening birth defects “were the direct and proximate results of the Plaintiff’s exposure to Zofran.”

Zofran is an anti-nausea medication that was originally approved for use by the U.S. Food and Drug Administration in 1991 for use in cancer patients being treated with chemotherapy and radiation. The FDA never approved the drug for use in pregnant women, and gave Zofran a Category B label. This indicates that there have not been enough human clinical studies to determine if a drug is safe for use in pregnant women. Regardless of the lack of clinical trials and the FDA Category B label, GlaxoSmithKline, the manufacturer of Zofran, began to market the drug “off-label” as a safe treatment for morning sickness in pregnant women.

In the Massachusetts case, the lawsuit alleges that “GSK knew as early as 1992 that Zofran passed through the placenta and into a developing fetus,” and that “Zofran presented ‘unreasonable risk of harm’ to developing babies because the drug passes through the human placenta.” Furthermore, the plaintiff has suffered ongoing pain and suffering due to the early termination of her pregnancy. This is the first Zofran lawsuit to allege that a pregnancy had to be terminated in utero due to birth defects caused by Zofran.

Other birth defects that have been listed in the thirty-four total Zofran complaints include atrial septal defect, atrioventricular septal defect, supraventricular tachycardia, cleft palate, cleft lip, and kidney malformations.

For more information regarding this press release, contact Michael Monheit, Esquire of ZofranLegal.com at 877-620-8411.

###

Contact ZofranLegal.com:

Michael Monheit
1-877-620-8411
michael@monheit.com
1368 Barrowdale Road, Rydal, PA 19046

ReleaseID: 60003653