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United States Supreme Court Rules Regarding Federal Pre-Emption

The United States Supreme Court ruled against the drug manufacturer, Wyeth, on Wednesday the 4th March 2009, holding that pharmaceutical manufacturers can be held liable for harm and damages caused by medicines that carry warnings approved by federal regulators...

...The high court ruled that the United States Food & Drug Administration approvals with regard to labelling does not pre-empt state laws including tort laws thereby shielding the pharmaceutical companies from liability when their drug causes patient's harm.

History of the Claim

In 2000, Diane Levine, a guitarist, was administered the prescription drug Phenergan improperly whilst being treated for a migraine headache. As a result, the drug caused gangrene, or death of the tissue in her arm resulting in part of her arm being amputated.

A Vermont jury who heard the complex case awarded Ms Levine $7 million in damages resulting from her serious injuries.

Issues Before the Supreme Court

The question before the Supreme Court was whether a warning label approved by the United States Food & Drug Administration provided Wyeth, the pharmaceutical manufacturer with a complete defence to Miss Levine's claim for personal injuries.

The majority opinion concluded that Wyeth was not shielded from liability despite the FDA's approval of its warning label for the drug. The high court held that under both federal law and FDA regulations, the pharmaceutical manufacturer bears responsibility for the content of its labels at all times. The Court also held that the FDA has traditionally regarded state law as a complimentary form of drug regulation.

Why is this important to patients?

Pharmaceutical companies had been advancing "pre-emption" argument (i.e., the FDA regulations would supersede state law), which has been a major drug industry objective and was backed by the Republican Bush administration, in an effort to shield themselves from liability when their drugs cause harm to patients and tort claims are advanced.

In essence, the "pre-emption" position made by the pharmaceutical manufacturers would have meant that once the US FDA approved a warning label for a particular drug then any claimant who was injured as a result of the pharmaceutical company's failure to warn or inadequate warnings regarding the drug would be barred or unable to bring a claim in the state courts for such damages. Simply put, a US FDA approval for a warning label would "pre-empt" state laws and shield the pharmaceutical companies from damages in liability claims for the harm caused by the drugs they manufacture.

It was noted in the Supreme Court's majority opinion that the FDA has limited resources to monitor the 11,000 drugs on the US market and that manufactures have superior access to information about their drugs especially in the "post marketing phase" as new risks emerge.

From a patient and consumer perspective, this is a welcome ruling because it properly puts the responsibility for warning the patient/consumer regarding the dangers and/or risks associated with the drug they manufacture. This includes updating risk information as it becomes known after the drug is on the market.

Seeking Health Law Advice

For further information and advice regarding your legal rights and entitlements, please contact Malcomson Law by calling 01 8744422 or complete an Online Enquiry Form. Your enquiry will be forwarded to a solicitor who specialises in Medical Negligence.

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