New Study The “Danielsson Report” Discussed In Latest Zofran Lawsuit

October 14, 2015 – – ZofranLegal.com commented on a study noted in the most recent Zofran lawsuit, which was filed on September 9th, 2015, in the United States District Court Northern District of Alabama Southern Division under case number 2:15-cv-01552-TMP.

The complaint stated that “At least three recent epidemiological studies have examined the association between prenatal exposure to Zofran and the risk of congenital heart defects in babies.” The “Danielsson Study” is one of those three.

Researchers involved in this study examined data available through the Swedish Medical Birth Registry. A total number of 1,501,434 infants were examined. Of those, 43,658 were born with “major malformations”.

Among the infants born with major malformations, 34% had cardiovascular defects and 24% had a cardiac septum defect. The Alabama complaint notes that “the Danielsson study reported a statistically significantly elevated risk for cardiovascular defects for mothers taking Zofran versus those who did not.”

Zofran is an anti-nausea medication. Manufactured by GlaxoSmithKline, the drug was approved by the U.S. Food and Drug Administration in 1991 for the treatment of nausea in patients who were undergoing chemotherapy and radiation treatments, or for patients who had been under anesthesia. The drug was never approved for the treatment of morning sickness.

Nonetheless, GSK decided to market the drug to the medical community and the public as a safe and effective treatment for expectant mothers suffering from morning sickness. Millions of women were prescribed the drug. It has been alleged that, since GSK first began to market the drug in this way, the company has received over 200 reports of birth defects in children born to women who took Zofran while preganant.

Currently, there are over 60 lawsuits filed against GSK, all alleging that Zofran caused a birth defect in an unborn child. Birth defects noted in these complaints include atrial septal defect, transposition of the greater vessels, ventricular septal defect, cleft lip, cleft palate, and clubfoot.

On October 1st, 2015, the Judicial Panel for Multidistrict Litigation convened to hear arguments from both plaintiffs and defendants regarding the consolidation of all of the Zofran lawsuits. Both sides argued for the consolidation, indicating that the litigation process would be much smoother and would move quickly if everything was overseen by one judge, in one court.

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Contact ZofranLegal.com:

Michael Monheit
1-877-620-8411
michael@monheit.com
1368 Barrowdale Road, Rydal, PA 19046

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