How do Birth Defect Lawsuits Work?

LAW BLOG  •

June 2, 2016

Birth defects can be completely unexpected, and the reasons for them vary. Some are the unavoidable consequence of a difficult pregnancy or labor; others are the result of negligence by those who should have taken better care of the infant or mother. In some cases, physicians prescribe drugs during a woman’s pregnancy that could cause birth defects.

Because of the way these drugs were marketed, most physicians prescribed them in good conscience as a method of controlling disabling nausea in some expectant mothers. The physicians had no indication that there were harmful side effects associated with certain drugs’ use during pregnancy. In fact, a drug created for cancer patients was marketed as a safe treatment option for morning sickness.

Complications from Zofran, Zuplenz, and ondansetron

The pharmaceutical giant GlaxoSmithKline created Zofran to ease the devastating nausea of those going through chemotherapy. The FDA approved this use. However, it did not approve Zofran’s use for women during pregnancy, which the company later marketed for women suffering from morning sickness.

Doctors began prescribing Zofran and its incarnations – Zuplenz and ondansetron – to women during pregnancy. But Glaxo, which knew as early as 1992 that the drug could be potentially harmful (it passes through the placenta and therefore to the fetus) never tested its use on women during pregnancy. Regardless, it promoted the drug as an option for women suffering during pregnancy. The results of this negligence have been devastating to many families.

How Birth Defect Lawsuits Work

Families have been filing lawsuits against Glaxo for marketing Zofran as acceptable during pregnancy on very specific grounds:

  • The company had a duty to make sure the drug was safe before it was released, which it failed to do. Glaxo did not adequately evaluate all the data before marketing the drug.
  • Glaxo failed to warn patients or physicians about the drug’s dangerous side effects and claimed the drug was safe when evidence was questionable.
  • Though not approved for use, Glaxo marketed the drug as a safe treatment for morning sickness and hyperemesis gravidarum – extreme morning sickness.
  • The company misrepresented the findings of its animal study, which indicated toxicity and abnormal bone growth.

In addition to these, some accuse the company of paying doctors to prescribe the medication to pregnant women as a treatment for morning sickness.

For Women who Took Zofran during Pregnancy

For families whose lives have been changed because of this company’s negligence, there are legal options. Some of the birth defects that may result from a woman taking Zofran during her pregnancy are:

  • Craniosynostosis – skull deformities
  • Cleft lip or cleft palate
  • Heart abnormalities – including holes in the heart
  • Club foot

Mothers who took Zofran, Zuplenz, or ondansetron to combat hyperemesis gravidarum or pervasive morning sickness and as a result had children who suffer from a birth defect do have recourse. A successful lawsuit can ensure families have the financial capabilities to cover continued medical care, time lost from work to care for the baby, and other costs. Holding a giant like Glaxo accountable can also mean safer drugs and a more responsible system of medicinal distribution. When pharmaceutical companies pay for willful negligence, they are less likely to gamble with the lives of children in the future.

Contact

To discuss a birth defect your child suffered because of improperly prescribed medication during pregnancy, contact a team of attorneys who understand the difficulty of your situation. At Gordan, Elias, & Seely, LLP, we take only the number of cases to which we can give our full attention. We offer free consultations and accept fees only when we win. Contact us today for an honest evaluation of your case.

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