Zofran MDL Grows in First Months

Boston, MANow that the Zofran lawsuits have been consolidated into a multidistrict litigation for pretrial proceedings, the number of lawsuits alleging Zofran side effects included in the MDL has begun to increase. The Zofran side effects lawsuits allege women who used Zofran while pregnant gave birth to infants with birth defects, including cleft palate and respiratory distress.

According to the Judicial Panel on Multidistrict Litigation, as of November 16, 2015, there were 112 lawsuits included in MDL 2657 before US District Judge F. Dennis Saylor in Massachusetts. By comparison, there were only 15 lawsuits included in the MDL as of October 15, 2015. Consolidation of lawsuits is done when lawsuits have similar questions of fact, but is not a comment on the merits of the lawsuits.

The MDL was only set up in mid-October, so there is still time for plaintiffs to file a lawsuit and potentially be added to proceedings.

Zofran lawsuits allege women were prescribed the antinausea medication for vomiting and nausea associated with pregnancy even though the medication was not approved for such use. Zofran was approved to treat nausea and vomiting linked to surgery, radiation therapy and chemotherapy. Doctors are within their rights to prescribe medications off-label, but marketing of drugs for unapproved uses is illegal.

GlaxoSmithKline, the maker of Zofran, has previously faced sanctions linked to alleged illegal marketing of drugs, including Zofran. Plaintiffs allege in their lawsuits that their infants had birth defects, including heart and kidney defects, as a result of exposure to Zofran prior to birth. Furthermore, they allege GlaxoSmithKline not only illegally marketed Zofran but did so without having done any studies in pregnant women to prove the drug was safe or effective.

Beth Bothelho filed such a lawsuit, alleging her daughter, referred to in court documents as MM, was born with transposition of the greater vessels (TGV) and pulmonary stenosis. MM required arterial switch procedure and a failed balloon atrial septostomy. She will also require continuous monitoring, and may have stunted growth and learning.

GlaxoSmithKline has reportedly responded to the lawsuits saying they are unfounded and noting that the FDA recently denied a citizen petition to change the pregnancy risk category for the medication, according to Fox News (11/16/15).

But plaintiffs say Zofran wasn't adequately tested to prove the risks are worth the benefits, and they say their babies’ birth defects - some of which allegedly require open heart surgery and feeding tubes - are directly linked to the use of Zofran.