Pharmaceutical Liability for Prescription Drugs Possibly Pre-empted by FDA Regulations and Policies

Since early 2006, drug and medical device companies have been on an unprecedented roll as pre-emption clauses become more and more prevalent. Despite recent controversies over prescription drugs like Vioxx and Celebrex, drug companies continue to successfully utilize Federal Drug Administration (FDA) policies to shield drug companies from civil lawsuits in the form of pre-emption clauses. This has far-reaching effects on pharmaceutical liability lawsuits in Illinois and the rest of the country.

And not just the FDA are upholding and propagating these preemption clauses- the U.S. Supreme Court has also supported pre-emption laws that prevent claimants from filing civil law suits against deep-pocketed drug and medical device companies in state courts.

The beginning of the preemption era can be traced back to January 2006, when the FDA issued a statement of its new labeling policy under the “Laws, Acts, and Rules > New Requirements for Prescribing Information.pdf.” This policy not only set out labeling requirements, but also deemed that if the FDA approved the labeling then this alone “pre-empts conflicting or contrary state law”.

The federal pre-emption clauses have little or no bearing on FDA drug recalls, which can be initiated by the FDA, by FDA statutory authority, or by the drug company itself. The FDA maintains a list of recent drug recalls.

Yet the seemingly simple pre-emption declaration had far-reaching effects within the legal community and reversed decades of policies enforcing state’s rights to civil enforcement of liability law. This was done without a public notice or hearing- instead it was quietly tacked on to the labeling policy.

In 2000, the FDA began considering changes to their drug-labeling rules and continued to do so for over six years. When the new rules on labels were first proposed the FDA specifically stated that there would be no pre-emption effect. But when the policy was released in 2006 there was a pre-emption clause included.

Also included in the 2006 policy was a new rule limiting a drug company’s ability to change drug labeling on their own without “data, analyses or other information not previously submitted to the [FDA].” This essentially released drug companies of liability if they failed to warn patients or physicians of dangers and/or side effects that had not previously been reported directly to the FDA.

This additional rule also lent support to Supreme Court’s consideration of the pre-emption clause. Recently the Supreme Court heard arguments in a pre-emption case which may determine the future of federal regulation versus state liability law. This case was the third of its kind on pre-emption that had been taken on by the court in the past terms.

But in July 2008, a federal judge in the Southern District of Indiana reversed himself on a motion to reconsider in a controversial drug-labeling case. Just ten months earlier the federal judge had dismissed the case, Tucker v. Smith-Kline Beecham Corp (1:04-cv-1748-DFH-WTL). Tucker was filed after a Catholic priest committed suicide just 22 days after starting Paxil, an antidepressant drug. The case was brought by the priest’s sister who claimed that the drug’s labeling had not warned patients and physicians of the increased risk of suicide.

The defendant, SmithKline, argued that the FDA had approved their labeling. If they had changed their labeling to include warnings of an increased risk of suicide the company could face criminal charges.

Initially the district judge had ruled that the drug company had first and foremost been required to follow FDA labeling regulations. According to the judge he had strongly considered the FDA federal pre-emption clause in that decision.

However, he now reversed his prior dismissal because he felt that the if reasonable evidence exists that a drug company’s product presents a serious hazard then FDA rules allow changes to the labeling without prior approval. This could mean a shift in how federal judge’s now view a drug company’s liability under the new labeling regulations.

For more than 30 years Kreisman Law Offices has been practicing product liability law in Illinois and Cook County, serving areas such as Brookfield, Glenview, Naperville, and Wilmette.