Prescribing a Possible Birth Defect

Worth the risk?

If a birth defect is a potential side effect, then morning sickness may be worth it.  Although not FDA approved to treat morning sickness, the manufacturer of Zofran, GlaxoSmithKline, encouraged doctors to prescribe this anti-nausea pill to expectant mothers.  In 2009, Zofran was the leading anti-nausea medication prescribed to pregnant women, however, women were not warned of the potential harm this drug could cause their unborn children.  The possible dangers of Zofran did not become known until children were born with birth defects, such as cleft palate, heart, mouth, and musculoskeletal defects, jaundice, club foot, and organ abnormalities.  Typically, Zofran is only used to treat nausea after surgery or chemotherapy.  As a result of so many cases of birth defects linked to Zofran use, many people have chosen to file mass tort lawsuits for compensation.

Prior to families filing individual lawsuits against the manufacturer, a lawsuit involving GlaxoSmithKline allegedly committing health care fraud was settled in 2012.  According to the terms of the settlement, GlaxoSmithKline agreed to pay $3 billion in fines for allegedly providing kickbacks to doctors who promoted Zofran to patients.  In addition, the manufacturer had to pay for fraudulently marketing uses of Zofran that were not approved by the FDA.

Despite the fact that the FDA has not approved its prenatal use, the FDA has not prohibited doctors from prescribing the medication, and the drug is still on the market today.  Now, doctors are required to explain to their patients the potential negative side effects from taking the anti-nausea pills.  In spite of the risks, the reported effectiveness of easing morning sickness may be enough to convince some women to use Zofran and overlook possible side effects.  Over 50% of pregnant women experience nausea in their first trimester.  Even those who were warned of the risks prior to use are still able to file a lawsuit against GlaxoSmithKline for punitive and compensatory damages.