Zofran Birth Defect Litigation To Seek Consolidation
Lawsuits from around the country alleging GlaxoSmithKline knowingly failed to warn consumers of the connection between its anti-nausea drug Zofran and birth defects while it marketed the drug off-label to pregnant mothers will be up for consolidation before the JPML October 1.
Saturday, September 19, 2015 - More than two dozen Zofran birth defect lawsuits will be presented to the Judicial Panel on Multidistrict Litigation (JPML)October 1 in hopes of receiving class certification and having the lawsuits centralized before a single federal judge. The motion to transfer the lawsuits into multidistrict litigation comes as the number of lawsuits against manufacturer GlaxoSmithKline (GSK) grows at a considerable pace around the country and an MDL could help expedite the process of processing and potentially hearing all of the claims.
The plaintiffs in the Zofran birth defect lawsuits claim that the medication caused serious abnormalities and deformities in children whose mothers had taken Zofran during pregnancy. These women did not take it out of the blue however, as most of them received a prescription from their doctor to use the high-level nausea medication to treat morning sickness. Plaintiffs have alleged GSK of marketing the drug off-label to physicians in order to have them push the drug for patients suffering from morning sickness while profiting off the new found use for the drug initially intended to help fight nausea following surgeries and chemotherapy.
The only issue however is that GSK never went through the FDA to market the drugs and thus did not have them thoroughly tested for the express use of treating morning sickness. Since the connection between Zofran and birth defects was first introduced, a number of academic studies have demonstrated a link between Zofran and birth defects, especially when prescribed during a mother‘s first trimester. The defects can range from a cleft palate to heart complications that can cost a child its life before it is even born.
These types of birth defects are rampant throughout the initial filings against GSK related to the use of Zofran to treat morning sickness. Families from around the country have complained of kidney, lung and heart complications after being prescribed Zofran while they were pregnant. THe plaintiffs claim that with the research available to them, GSK should have known that the drug was not safe to market off-label. The pharmaceutical manufacturer already got in trouble for off-label marketing with the U.S. Justice Department, having to pay more than $2 billion to settle charges filed in that 2012 investigation.
The plaintiffs claim that instead of warning customers or going through the FDA for the approval to be given for morning sickness, GSK simply marketed the drugs directly to doctors for morning sickness symptoms and then protected any information of a connection to birth defects as the drug was a large money maker for the manufacturer.
The defendants in the case actually filed the motion to centralize before the plaintiffs, likely realizing the number of lawsuits forthcoming in the litigation will be considerable and having an MDL to help expedite the litigation process would be beneficial for both parties. Eight different states are represented in the motion to transfer, although lawsuits against GSK have been filed in more since the initial filing before the JPML. The defendants have requested that the litigation be centralized in the Eastern District of Pennsylvania federal court.
