Novartis hit by court loss, could spur numerous cases across industry

In a landmark ruling, a Californian court has found that a brand name manufacturer of a drug could be held liable for medical complications that occur from a generic equivalent, if they are found to have inadequately labelled the original product.

The finding has gone against previous nationwide consensus, opening up the possibility of numerous copycat cases being trialled in California or across the US.

The particular case relates to Novartis and the product it previously owned, Brethine. A generic version of the drug was used in 2007 to prevent premature birth in a mother of twins who then experienced developmental delay and autism.

The case, brought against the company by the father of the twins, suggested that there was inadequate labelling of the generic medicine to warn away from using the drug in this way. It argued that Novartis should have included a warning on the label about the side-effect, or should have known about such potential.

Due to a 2011 US Supreme Court decision, generic manufacturers cannot be sued for not providing labelled warnings against potential side-effects, as they are obligated to use the brand name product’s label.

The case against Novartis then argued that the company should have been responsible for updating the label, despite the pharma giant already having divested the drug to another company, aaiPharma, at the time of its use.

Despite this, the prosecution had argued that the onus lies on the original owner of the brand drug to maintain that the label carried adequate safety warnings, given that they were in full knowledge of the medical knowledge on the product.

Justice Mariano-Florentino Cuéllar concluded: "So a duty of care on behalf of all those who consume the brand-name drug or its bioequivalent ensures that the brand name manufacturer has sufficient incentive to prevent a known or reasonably knowable harm".

The verdict against Novartis was marginal victory for the prosecutor, with the court finding 4-3 in favour of the plaintiff. The company has said that it plans to appeal the decision.

The decision could be big news for pharma industry because it means that, even if drugs with insufficient warnings on their labels but are already sold onto other company, they could still be retrospectively liable. It potentially exposes the industry to a number of new cases, though that may depend on whether the decision is upheld on appeal.