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Zofran Lawsuit Alleges Severe Heart Defects

zofran bottle

On August 14, 2015, the mother of a minor child allegedly injured by the anti-nausea drug Zofran filed a claim for compensatory damages in U.S. District Court for the Northern District of California.

Named in the complaint are the drug makers responsible for the development, marketing and distribution of the drug, including GlaxoSmithKline, Inc. and McKesson Corporation (hereinafter, the “defendants”).

The case follows several other Zofran lawsuits recently filed by parents alleging the onset of severe birth defects allegedly caused by the drug, which has never been FDA approved for the treatment of morning sickness.

Plaintiff alleges fraudulent marketing

The drug Zofran was approved in the 1990’s for use by chemotherapy and post-operative patients battling severe nausea and vomiting. Shortly thereafter, the makers of Zofran began to market and promote the drug for use by pregnant women who were enduring similar symptoms – known by many as the hallmark telltale sign of early pregnancy. For women experiencing severe pregnancy-related nausea and vomiting – resulting in dehydration and hospitalization – Zofran was introduced as a curative measure to help patients manage the symptoms and retain much-needed nutrients and hydration for their growing babies.

According to the complaint, the defendants did not perform necessary trials regarding the safety of Zofran for morning sickness – and may have even been aware that it could cause severe complications for the developing fetus. Put simply, the plaintiff alleges that placing Zofran through the rigorous testing procedures involved in marketing a drug to pregnant women would necessarily reveal the potential for fetal birth defects and therefore decrease profits exponentially.

Plaintiff describes her child’s experience

The plaintiff in this case was prescribed Zofran in 2005 after suffering debilitating pregnancy-related nausea and vomiting. At 20 weeks gestation, an ultrasound revealed a “double right ventrical outlet of the Taussig-Bing nature, coronary arteries in the wrong place, and an extremely narrow aortic arch.. and a leaky heart valve.”  Despite extensive investigation, there are no genetic causes for the child’s heart defects. Accordingly, the plaintiff has linked the onset of these cardiac abnormalities to the first trimester use of Zofran, a time when the risk of “medical insult” is at its peak as vital fetal tissue continues to develop.

Following her birth, the child endured three open-heart surgeries to attempt repairs of the aforementioned cardiac issues. The first surgery occurred when she was just four days old, and required extensive work on her heart. The second surgery occurred during her third year, and required the replacement of a cardiac stent. The third surgery, which was conducted when she was seven years old, involved an expansion of her aortic arch. The plaintiff contends that the child will require lifelong monitoring and care, and that additional follow-up surgeries will be inevitable.

Causes of action related to the defendants’ alleged misconduct

The plaintiff raises several causes of action against the defendants, and requests both compensatory damages and equitable relief to ensure future mothers-to-be are not placed in a similar precarious and risky situation when faced with unrelenting morning sickness.

The plaintiff has alleged the following causes of action against the defendants:

  • Negligence
  • Negligence per se
  • Strict products liability
  • Fraudulent misrepresentation & concealment
  • Negligent misrepresentation
  • Breach of express warranties
  • Breach of implied warranties of merchantability and fitness for particular use

The plaintiff specifically contends that the defendants knew of the dangers associated with Zofran for years, and continued to market and promote the drug to pregnant women nonetheless.

  1. The Toronto Star, Birth defects blamed on unapproved morning sickness treatment,

  2. U.S. Department of Justice, GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data,