Supreme Court Rejects Novartis Bid To Hear Punitive Damages Case

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The US Supreme Court has decided not to review a case in which Novartis argued that punitive damages should not be awarded in product liability jury verdicts. The issue once again was FDA preemption. What's preemption? It is a principle of determining which law should supersede when local, state, or federal laws have been enacted which are in conflict. It states that federal law supersedes state law and state law supersedes local law. This article explains the preemption argument made by Novartis. The essential argument was the FDA's approval should preempt state laws allowing the injured party to sue for punitive damages. In this case, the jury determined the drug company did not adequately warn the patient of the risks involved. Subsequently, a federal judge upheld the damages after reviewing evidence suggesting an effort to conceal the scope of the risk.

About FDA Approval

Richard Pazdur is the director of the Food and Drug Administration's Office of Oncology and Hematology Products. In an article published on he is quoted as saying:

"I think our jobs are getting easier because the drugs are better," Pazdur says. Frequently, he isn't even calling together the public expert panels whose approval had become a rite of passage for new cancer drugs. There's simply nothing to ask. "We don't have a lot of questions on drugs because they're slam dunks. It's not if we're going to approve them. It's how fast we're going to approve them."

The FDA has numerous designations which speed up the approval process. For example, Priority Review cuts the targeted review time for a drug from 10 months to six. Another named Fast Track streamlines the review process for drugs that are determined to meet an unmet medical need. There is even an Accelerated Approval permitting approval based on preliminary data pending the completion of larger studies. If the drug companies had it their way, you would not be able to seek punitive damages if you were injured following one of these expedited approvals.

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