Under current Food and Drug Administration laws, generic drug manufacturers are required to use the same label as the brand-name equivalent.
What happens when the brand-name manufacturer fails to warn the consumer of dangerous side effects? Is the brand-name manufacturer liable for side effects of the generic equivalent?
This is a complex question and state rulings on this topic vary. In California, the answer is yes. However, that may change potentially affecting millions of consumers.
Leslie Brueckner with The Legal Examiner discusses this issue, which is currently before the California Supreme Court. In her article, Defending the Rights of Generic Drug Victims in the California Supreme Court, Leslie states:
The risk of tort liability creates an incentive for drug companies to change their labels when new risks emerge. But when drug companies know they can’t be sued for failure to warn, all bets are off. Unless there’s a risk of liability in the courts, there’s little incentive for drug companies like Novartis to change their labels to warn of newly discovered risks.
The case in question is T.H., a Minor v Novartis Pharmaceuticals Corporation. The case involves two minors who suffered brain injuries in utero because their mother took a generic version of “Brethine.” Novartis manufactured and labeled Brethine before it sold the rights to another drug company. The Plaintiffs argued Novartis knew the drug and the generic forms could cause fetal brain damage but chose not to include this on the warning label to continue profiting from the drug. The lower court agreed. Novartis Pharmaceuticals Corporation is challenging the ruling, arguing they are not liable for side effects of the generic version of their patented product.
At Advocate Capital, Inc., we strongly believe in the rights of the consumer and support Plaintiff attorneys across the US in the work they do in protecting these rights. Will big pharma prevail again? We will continue to follow this case for the potential impact it may have on consumers.
Senior Vice President
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