Greater than 30 legal claims have resulted from allegations made by parents that an anti-nausea prescription drug to combat morning sickness during pregnancy causes birth defects. Hundreds of similar cases could follow and a similar case has been filed by a couple in Texas. Birth defects allegedly caused by use of the drug in pregnant women includes congenital heart defects, cleft lip and cleft palate.
The lawsuits focus on off-label marketing used by the drug maker to market the drug. The drug was approved by the Food and Drug Administration (FDA) for the treatment of nausea and vomiting resulting from surgery and chemotherapy treatments, however, the legal claims allege that clinical studies demonstrate that the drug maker failed to warn doctors of side effects that could result when the drug was used for the treatment of nausea during the first trimester of pregnancy.
The drug maker paid a $3 billion settlement in 2012 related to the Justice Department's investigation into its use of off-label marketing for its drugs. The drug maker, however, denies the allegations associated with the investigation. A representative for the drug maker noted that pharmaceutical manufacturers should not be subjected to liability following appropriate labeling and decisions made between doctors and patients after considering inherent risks. Experts involved in bringing the lawsuits noted, however, that if drugs are being marketed for a certain use and the FDA has not approved the drug for that use, then that is a concern.
Pharmaceutical lawsuits can be complicated and the complex issues involved may not always be immediately clear. Because pharmaceutical liability lawsuits can involve legal and other complexities that can be significant, it is important to be prepared to properly approach a pharmaceutical liability claim.
