Zofran is an anti-nausea drug. It has been linked to serious birth defects when used during pregnancy. In 2015, a federal panel created the special multidistrict litigation docket for victims who had been using the Zofran drug made by GlaxoSmithKline (GSK).
The defendant, GSK, filed a motion in this federal district court claiming that the lawsuit was pre-empted by federal law under the U.S. Supreme Court decision in Wyeth v. Levine. In that case, it was held that federal regulatory clearance of a medication does not shield the manufacturer from liability under state law. The U.S. District Court in the Massachusetts district, however, denied the motion stating that the judge was “loath to dismiss” the claims without giving families a chance to develop the facts of their respective cases through discovery.
Zofran was first approved by the federal Food and Drug Administration in 1991. It is intended to control extreme cases of nausea such as with cancer medications or following an invasive surgery. It has not been approved for use during a pregnancy. However, the drug Zofran has been prescribed by physicians to expectant mothers to lessen the symptoms of morning sickness.
In 2012, GSK was fined a record $3 billion by the U.S. government for illegally promoting Zofran for unapproved purposes.
Although no discovery has been completed in the multidistrict litigation, the plaintiff families for those affected by taking Zofran during pregnancy believe that GSK has evidence that links Zofran and birth defects. It is believed that Zofran has the documents that prove animal studies conducted by the company in Japan show the same cardiac birth defects alleged by many in the lawsuit.
The judge ruled against GSK’s motion for the most part because GSK has exclusive access to documents that would show it had previous knowledge of the risks associated with the use of Zofran during pregnancies. Accordingly, hundreds of plaintiffs will be able to pursue their claim in multidistrict litigation against GSK, and they will have an opportunity to proceed.
In re: Zofran (Ondansetron) Products Liability Litigation, No. 1:15-md-02657, in the U.S. District Court for the District of Massachusetts.
Kreisman Law Offices has been handling pharmaceutical product defect cases, dietary supplement injury cases and medical device injury cases for individuals and families who have been injured or killed by the negligence of another for more than 40 years, in and around Chicago, Cook County and its surrounding areas including, Calumet City, South Holland, Blue Island, Grayslake, Gurnee, Lake Bluff, Bensenville, South Barrington, St. Charles, Elgin, South Elgin, Romeoville, Bolingbrook, Winfield and Lemont, Ill.
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