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Zofran Was Never Approved For Pregnant Women, Here’s What Happened

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zofran lawsuits - Goldwater Law Firm

There are few circumstances more tragic than a child born with severe birth defects. Many women who took GlaxoSmithKline’s drug Zofran for morning sickness during their pregnancies gave birth to babies born with congenital heart defects, cleft palates and other abnormalities. Zofran was approved by the FDA to prevent nausea and vomiting in cancer patients undergoing chemotherapy. Soon after, it became the drug of choice prescribed by obstetricians for treating morning sickness in pregnant women. However, the FDA never approved Zofran for that purpose. In addition to its link to birth defects in unborn children, in 2011 the FDA warned that the drug may “increase the risk of developing abnormal changes in the electrical activity of the heart, which can result in a potentially fatal abnormal heart rhythm.”

The drug is marketed generically as ondansetron, and manufactured by Novartis. GlaxoSmithKline markets a medication similar to Zofran called Zuplenz, which dissolves in the mouth. These other versions of the drug are also not approved for use in pregnant women, but are prescribed to them. Approximately one million pregnant women have been prescribed these medications. In the United States, it is possible that 25 percent of all pregnant women have received a prescription for some form of this drug. According to a 2012 article appearing in Canadian Family Physician, fetal safety data for ondansetron is based on less than 200 births.”

GlaxoSmithKline Fraud Case

GlaxoSmithKline settled a huge fraud case brought by the U.S. Department of Justice, agreeing to pay a fine of $3 billion.  Among the complaints brought by the USDOJ was that the company marketed Zofran to pregnant women without FDA approval, and paid kickbacks to health care providers to prescribe the drug to patients.

Waiving Formal Service of Process

The initial lawsuits against GlaxoSmithKline regarding Zofran were filed in early 2015, and more than 200 have been filed to date. These lawsuits are consolidated in the U.S. District Court of Massachusetts as of October, 2015. In December, Judge F. Dennis Saylor IV announced that GlaxoSmithKline agreed to waive the formal service of process. This means that the way a defendant is usually served notice of legal action – by giving appropriate notice and documents to the party being served – is not required. Instead, after filing their complaint against GlaxoSmithKline, plaintiffs now have 30 days in which to email GlaxoSmithKline’s attorneys all necessary documents.  This includes a formal document asking for the waiver of service. The law firm will then sign the waiver and return it to the plaintiffs. In essence, this allows GlaxoSmithKline additional time to review the plaintiffs’ complaints and respond.

The Goldwater Law Firm – Nationwide Drug Injury Lawyers

If you or a loved one have given birth to a child with certain birth defects after taking Zofran, you may be eligible to seek compensation. The Goldwater Law Firm can help.  Our attorneys will evaluate the details of your case to help you determine the best legal strategy for moving forward. Contact the Goldwater Law Firm today for a free consultation about your case.