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Novartis Denied U.S. Supreme Court Consideration

Defective Drugs

The U.S. Supreme Court has denied a request by drugmaker Novartis to revisit the issue of whether punitive damages can be awarded in product liability lawsuits.

Claiming immunity under the Food and Drug Administration (FDA), Novartis claimed that the FDA preempts state tort law which does allow punitive damages when a drugmaker has not lawfully marketed a prescription drug.

It all stems around the case of Rita Fussman who was suffering from breast cancer in 2001 when she was prescribed Aredia and Zometa, injectable bisphosphonate drugs made by Novartis. Doctors hoped to slow down the cancer which had metastasized to her bones. But one year later Fussman developed osteonecrosis of the jaw or ONJ, also known as bone death.

After she died from breast cancer, her husband claimed Novartis failed to warn about the risk of ONJ even though it was aware of the risk. A North Carolina court in 2010 awarded her husband $1.25 million in compensatory and punitive damages. Novartis claimed a series of damaging emails by the company about the ONJ risk should never have been admitted into the evidence. The jurors also took into account the fact that the label for Zometa was strengthened in 2007, four years after Fussman was prescribed the drug.

Novartis claimed that a previous ruling (Wyeth v. Levine) only allowed for compensatory damages not punitive but a federal court agreed with the lower court allowing the punitive damage award due to the evidence presented about a company cover-up.

Novartis petitioned to take the case to the U.S. Supreme Court claiming that violations of the federal Food, Drug and Cosmetic Act (FDCA) do not allow for punitive damage awards. Fussman’s attorney argued the punitive awards were for withholding information not for violating FDA requirements that oversee drug marketing. Without any comment the high court rejected the Novartis petition for a writ of certiorari (permission to bring a case before the Supreme Court) and remanded it back to the U.S. Court of Appeals for the Fifth Circuit for further consideration.

Writing to Pharmalive, a Novartis spokeswoman said that “the abilities for juries to impose punitive damages against FDA-compliant manufacturers of prescription drugs threatens the availability of necessary and often life-saving medications for patient around the world.”

This decision sets a precedent and opens the door to the imposition of punitive awards in other cases where corporate misdeeds that harm the public can be punished financially by a jury that wants to send them a message not to do it again.

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