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In a closely watched decision handed down on March 4, 2009, the United States Supreme Court in the case of Wyeth v. Levine, denied the drug manufacturer’s defense that federal regulations completely preempted state injury law claims filed by consumer Diana Levine, who was a musician and suffered amputation of a part of her arm because of complications from an injection of the medication called Phenergan, injected into her arm by a method called push IV. Levine won a jury verdict after a Vermont jury concluded that the product warnings did not adequately give medical doctors or clinicians the truth about the irreversible effect of Phenergan which-if injected in this fashion can reach the arteries of the human body and can cause gangrene, or here, amputation. The decision marks the official rollback of a Bush administration backed legal trend to wrongfully wipe out consumer’s injury lawsuits in state courts under the (unconstitutional) guise of “complete immunity preemption.”

In the underlying case, the Vermont jury found for Levine and awarded substantial damages, medical expenses, and loss of livelihood compensation. Essentially, her musical career was wiped out, due to partial amputation of her arm. The Vermont Supreme Court affirmed the trial court jury verdict and rejected the drug manufacturer claim that the Food and Drug Administration law and regulations wiped out any state law failure to warn claim.

Writing for the Court, Justice Stevens said:

“If Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express preemption provision at some point during the Food, Drug and Cosmetic Act’s 70 year history…Its silence on the issue, coupled with its certain awareness of the prevalence of state tort litigation, is powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.”

Wyeth claimed that a Bush administration statement in a preamble to a 2006 FDA regulation declared that failure to warn claims would violate the FDA’s regulatory role, and would disrupt national uniformity. However, the court properly noted that Congress has not authorized the federal agency to preempt state law directly, and that the high court would not give any weight to the agency’s explanation of state law based on a mere “preamble” unless there was thoroughness, consistency, and persuasiveness in the federal agency’s assertion. Here, but court noted there was nothing more than a bare preamble in FDA regulation which had not met public comment or scrutiny. Ultimately, the high court ruled that state law is a complementary form of drug regulation that supplements the FDA role in regulating drugs. The decision of the court was 6-3, with one of the six votes being Justice Thomas, who concurred in the result and filed a separate opinion and interestingly conservative Justice Thomas stated as follows:

“Because such a sweeping approach to pre-emption leads to the illegitimate – and thus, unconstitutional – invalidation of state laws, I can no longer assent to a doctrine that preempts state laws merely because they ‘stand as an obstacle to the accomplishment and execution of the full purposes and objectives’ of federal law.”

This was a huge decision in favor of consumers, and will assure that drug manufacturers have the financial incentive to constantly monitor their drugs marketed to the public—based on the disincentive of tort lawsuits that can be filed against them for not properly warning patients and consumers of the dangers involving their drugs. As a matter of fact, this is the entire basis of our civil justice personal injury/tort system: there is the financial disincentive on a corporation or drug manufacturer by virtue of the power of a jury or judge to penalize for negligent or wrongful conduct.

The decision has broad impact on state court injury claims in North Carolina (NC), Virginia (VA) and every state court in the USA.

Shapiro, Cooper Lewis & Appleton personal injury law firm is based in Virginia, with offices in northeast NC and Virginia Beach (VA), practicing primarily in the southeastern U.S. and handles only injury law, including car, truck, railroad, and medical negligence cases and more. The firm’s website is:, the firm edits three injury law blogs: Virginia Beach Injuryboard & Norfolk Injuryboard, as well as the Northeast North Carolina Injuryboard and also hosts a video library covering many FAQ’s on personal injury subjects.

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