Women Who Used Zofran Had Babies With Cleft Palate / Cleft Lip, Various Types Of Heart-Related Problems, And Other Congenital Malformations
In July 2015 the drug company GlaxoSmithKline (GSK) filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) requesting that a multidistrict litigation (MDL) be established for all Zofran lawsuits filed in the federal court system concerning Zofran's alleged association with birth defects.
Further, Glaxo requested that the federal court Zofran MDL be assigned to the U.S. District Court, Eastern District of Pennsylvania.
However, in October 2015 the JPML decided to send all federal court Zofran lawsuits to the District Court of Massachusetts in Boston. Judge F. Dennis Saylor will be presiding over this new Zofran MDL.
From the Transfer Order establishing IN RE: ZOFRAN (ONDANSETRON) PRODUCTS LIABILITY LITIGATION MDL No. 2657:
After considering the argument of counsel, we find that the actions in this litigation involve common questions of fact, and that centralization in the District of Massachusetts will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation. These actions share factual questions arising from allegations that Zofran and its generic equivalent, a prescription medication for the treatment of nausea, causes birth defects in children when their mothers ingest the drug while pregnant. Centralization will eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel, and the judiciary.
Next Judge Saylor will start to organize this federal court Zofran MDL by means of issuing Case Management Orders. These will serve to guide the litigation through the discovery process and towards eventual "bellwether" test case trials.
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Here is a quick overview of the Zofran litigation.
Some women with severe morning sickness were prescribed Zofran (ondansetron) and have had babies born with congenital malformations such as cleft palate and cleft lip, or various types of heart-related birth defects including:
- Atrial Septal Defect / ASD (a hole in the atria of the heart)
- Ventricular Septal Defect / VSD (a hole in the ventricle of the heart)
- Tetralogy of Fallot / TOF (cardiac anomaly that refers to a combination of four related heart defects which commonly occur together; it affects normal blood flow through the heart)
However, Zofran is not approved by the FDA as treatment to reduce nausea when a woman is pregnant. Rather, this GlaxoSmithKline drug was approved by FDA for the prevention of nausea or vomiting associated with chemotherapy and radiotherapy as well as in some instances following surgery.
As such, doctors have been prescribing Zofran “off-label” for pregnant women — and sometimes there have been consequences to the baby.
We are investigating possible Zofran drug injury lawsuits against GlaxoSmithKline for cases where Zofran used by pregnant women resulted in congenital heart defects and cleft palate as well as other birth defects, deformities, and malformations in children born to those women.