Inadequate Warning Lawsuits Can Proceed Against Drug Manufacturers

The Supreme Court of the United States decided the case of Wyeth v. Levine today and held that injured plaintiffs can bring lawsuits against drug manufacturers based on inadequate warning theories even where the FDA has approved the warning.  A personal injury lawyer can be indispensable in helping injured persons take on huge drug manufacturers, and this case is a significant help in that fight.

Plaintiff Diana Levine’s arm had to be amputated after she was injected with Phenergan, a drug manufactured by New Jersey-based Wyeth.  The clinician who injected Ms. Levine used the “IV-push” method to inject the drug directly into Ms. Levine’s artery, instead of the safer “IV-drip” method, where the drug is injected through a catheter inserted in the patient’s arm after passing through a hanging bag of saline solution.  However, the warning for the drug, which is provided to physicians, did not state that this method of injection involved significant risks to the patient.  After being injected, Ms. Levine developed gangrene and her arm had to be amputated.

Ms. Levine brought a lawsuit against Wyeth.  Her lawyers argued that the warning provided with the drug did not adequately instruct clinicians on the dangers of using the “IV-push” method and did not instruct clinicians to use the safer “IV-drip” method, instead of the “IV-push” method.  Ms. Levine’s lawyers also argued that the risk of gangrene and amputation was so great, that Phenergan was not safe for direct intravenous injection.

Wyeth argued that because the federal Food and Drug Administration (“FDA”) approved Wyeth’s label for Phenergan, the plaintiff should not have been permitted to argue that the warning was inadequate and individuals states cannot impose a duty on the company to provide a stronger warning than the warning required by the FDA.  Wyeth based this argument on the federal government’s power to preempt state law in areas where the federal government is permitted to legislate and the federal government has expressed an intent to preempt the state law.  Essentially, Wyeth argued that: (1) if it had complied with Vermont’s state laws regarding labeling of Phenergan (which required a stronger warning than federal law), it would be violating federal law; and (2) requiring it to comply with Vermont’s state law duty to provide a stronger warning than the warning required by the FDA would obstruct the purposes and objectives of the federal drug labeling laws.

The Supreme Court rejected both of these arguments.  With respect to Wyath’s first argument, the Supreme Court cited a regulation that permits a drug manufacturer to use a stronger warning without prior FDA approval as long as it makes a supplemental application to the FDA at the same time as the label change.  With respect to Wyeth’s second argument, the Supreme Court held that Congress has not expressed an intent to invalidate state laws that impose a duty on drug manufacturers to include a stronger warning that the warning required by the FDA.  In the case of the federal laws governing the FDA, Congress specifically stated that state law would only be preempted, and therefore made invalid, where there was a “direct and positive conflict” with the federal law.  As further support for the position that the federal government did not intend to invalidate state laws related to inadequate warnings, when the federal government last amended laws related to prescription drugs and medical devices, the federal government specifically stated that it was preempting state law related to medical devices, but made no such statement related to prescription drugs.  Therefore, the Supreme Court reasoned, state laws that require stronger warnings do not obstruct the purposes of federal law.

This case is a significant victory for injured parties seeking compensation for their injuries from drug manufacturers.  This case is also a significant victory for the rights of individual states to require stronger warnings from drug manufacturers and to hold drug manufacturers accountable when their failure to include a stronger warning results in an injury.  If you have suffered an injury from the use of a prescription drug, contact a New Jersey personal injury lawyer to help you analyze whether you can seek compensation from the drug manufacturer.