Product News and Recalls

GlaxoSmithKline Files to Create Zofran MDL

GSK files to consolidate zofran casesRecognizing the number of cases currently filed against it; and the potential for a significant number more, pharmaceutical giant GlaxoSmtihKline has requested that all Zofran birth defect lawsuits be consolidated into one multi-district litigation, or MDL.

MDLs are generally used as a tool for increasing the efficiency of of legal proceedings when a number of similar lawsuits are filed. When a large number of lawsuits are filed across a range of locations that all pertain to the same matter – in this case, Zofran’s link to birth defects – a consolidation can be requested.

If granted, a consolidation essentially recognizes that the facts of a case filed in Louisiana are likely similar to facts in a case filed in Colorado which are also likely similar to facts in a case filed in Maine. As such, a single federal judge can manage all of the federal cases rather than using the recourses of federal courts across the country independently.

GSK has requested that the 12 Zofran cases currently filed in federal courts across the country be consolidated into one MDL in the U.S. District Court for the Eastern District of Pennsylvania. This district encompasses the county and city of Philadelphia which is home to GSK’s U.S. headquarters. The pharmaceutical manufacturer has also requested two specific judges, specifically for their prior experience with drug defect multi-district litigations.

Zofran birth defect lawsuits have been filed against GSK based on claims that the corporation marketed the drug for “off-label” use; or use that was not approved by the FDA. Approved for the treatment of nausea brought on by serious conditions like the use of chemotherapy medications or surgical anesthetics, Zofran was also allegedly marketed to physicians as a treatment for the nausea that frequently accompanies morning sickness.

Some studies indicate that children born to women who took Zofran to treat morning sickness may show increased instances of cleft lip and cleft palate as well as cardiac defects including holes in the atrial and ventricular sides of the heart. Each of these conditions may require surgery to treat and can have life-long ramifications for the child.