A generic manufacturer of the antidepressant Prozac could have warned about an increased risk of suicide associated with its prescription medication by changing its labels without approval from the U.S. Food and Drug Administration, according to a federal judge in California.
The decision, issued in a March 26 ruling, creates a split in the district courts within the 9th U.S. Circuit Court of Appeals on whether generic manufacturers of prescription drugs are allowed to change their own warning labels, said Bijan Esfandiari, lead law and motion attorney at Baum, Hedlund, Aristei & Goldman in Los Angeles, who is representing the plaintiff. But the ruling aligned with at least three other circuit court decisions, as well as the U.S. Supreme Court’s 2009 decision in Wyeth v. Levine, which prevents drug companies in most cases from arguing that state tort claims are pre-empted by federal law because the FDA regulates their products.
