Amid increased warnings that the anti-nausea drug Zofran may be linked to serious birth defects when used during pregnancy, a federal panel last year created a special court for victims to seek compensation from the drug’s maker, GlaxoSmithKline.
In January, with hundreds of lawsuits already filed, Glaxo filed a request to have them thrown out of court before families had a chance to prove their case.
Now, the judge overseeing the Zofran birth defect lawsuits has denied GSK’s attempts to keep the cases out of court.
Illegal Marketing Leads to Dangerous Zofran Use
Zofran, first approved by the FDA in 1991, is intended for extreme cases of nausea, such as with cancer medications or following surgery. It is not approved for use during pregnancy. However, over the years it has increasingly been prescribed to expectant mothers for morning sickness.
In 2012, GSK was fined a record $3 billion by the federal government for illegally promoting Zofran, along with other drugs, for such unapproved purposes. However, they earned over $1.5 billion per year in sales from their efforts.
Recent Studies Highlight Zofran Birth Defect Risks
Although the FDA has not yet assigned a pregnancy risk to Zofran, there is a push from consumers to do so based on several recent studies that suggest links to birth defects.
In 2011, a study of over 20,000 women in the United States was released that indicated those taking Zofran had twice the chance of having babies with cleft palate birth defects.
Then, in 2013, research out of Denmark that followed almost 1 million women showed that those taking the drug during pregnancy also had twice the risk of giving birth to babies with heart defects.
Finally, a study from Swedish doctors published in 2014 showed infants exposed to Zofran during pregnancy had a 62% higher risk of heart defects.
At the same time, the FDA has disclosed receiving over 500 reports of children born with various birth defects after mothers took Zofran during pregnancy.
Judge Says Zofran Birth Defect Suits Can Continue
As word spread of the dangers of Zofran, more and more families that had been affected sought legal counsel to file a claim against Glaxo. The reason: not only did the company fail to warn women of any of these birth defect risks, but it illegally promoted it for use during pregnancy despite the fact it wasn’t approved for this purpose.
By October of last year, with different cases pending around the country, the Judicial Panel on Multidistrict Litigation stepped in to move all Zofran cases to a centralized court for easier handling.
Now, there are over 225 cases pending in the Zofran MDL.
In asking Judge Saylor to dismiss the cases, Glaxo argued that 1) birth defect risks were only indicated in animal studies, not human studies; 2) that the FDA had already denied a consumer petition to add birth defect warnings to the drug; and 3) that federal laws prevented the cases.
However, Judge Saylor disagreed. This month, he ruled that victims needed more time to uncover facts alleged in their complaints, such as did GSK conceal studies showing birth defects from the FDA that would have led to the agency requiring greater warnings.
Judge Saylor also entered an order allowing victims of Zofran birth defects to file their cases directly in the federal MDL court, without having to go through state court first then seek a transfer. This will further streamline the legal process and hopefully allow for a quicker resolution.
Zofran Lawyers Still Helping Those Affected
A number of lawyers around the country have joined the Zofran litigation in order to help those families affected. DrugNews works only with those who specialize in defective drug litigation such as this and have filed thousands of birth defect lawsuits.
For more information on the current litigation, or to speak directly with a lawyer at no cost to see if your case qualifies, contact us today.
Field, E. Judge Won’t Toss Birth Defect Claims In Zofran MDL. Law360. (January 22, 2016). Retrieved from www.law360.com
JPML Pending Lawsuits as of January 15, 2016. Retrieved from www.jpml.uscourts.gov
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