U.S. Supreme Court Rebukes Drug Industry Efforts to Gain Immunity from Liability for Adverse Effects

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In a much anticipated United States Supreme Court decision concerning the rights of consumers to seek compensation from prescription drug manufacturers for injuries caused by their products, the Court rejected the argument of pharmaceutical giant Wyeth that it should be immune from liability. The majority opinion published on March 4, 2009, in which Justices from all sides of the ideological spectrum joined, effectively ends an almost decade long campaign by the pharmaceutical industry to escape any civil liability for defective drugs.

the Supreme Court in the Wyeth case wisely and correctly acknowledged Congress' historical recognition of the critical interplay between governmental regulation and our civil justice system in assuring safety and compensation for innocent victims, and the fact that government regulation alone never has and never will adequately protect consumers from harm.

Moore Labriola LLP, Schmidt & Clark LLP, and The Schmidt Firm LLP are pleased to comment on a critical victory for the tens of thousands of Americans injured or killed each year as the result of adverse drug effects after the United States Supreme Court rejected the pharmaceutical industry's contention that they should be immune from products liability cases because their products are "approved" by the FDA.  The decision will enhance the law firms' ongoing and highly successful collaboration in representing consumers injured by defective drugs and medical devices all across the country.

In a much anticipated United States Supreme Court decision concerning the rights of consumers to seek compensation from prescription drug manufacturers for injuries caused by their products, the Court rejected the argument of pharmaceutical giant Wyeth that it should be immune from liability. The majority opinion published on March 4, 2009, in which Justices from all sides of the ideological spectrum joined, effectively ends an almost decade long campaign by the pharmaceutical industry to escape any civil liability for defective drugs.

Wyeth v. Levine, Slip Opinion, 555 U.S. (2009) involved the tragic case of a Vermont woman who was injected with the anti-nausea drug Phenergan, manufactured by Wyeth. Levine was injected by the "IV push" method, whereby the drug is injected directly into a patient's vein. The drug entered Levine's artery, she developed gangrene, and doctors amputated her forearm. Levine brought a state-law damages action, alleging that Wyeth had failed to provide an adequate warning to her doctors about the significant risks of administering Phenergan by the IV-push method.

A Vermont jury determined that Levine's injury would not have occurred if Phenergan's label included an adequate warning, and it awarded damages for her pain and suffering, substantial medical expenses, and loss of her livelihood as a professional musician. Wyeth asked the trial court to overturn the verdict on the grounds that Levine's failure-to-warn claim, even if meritorious, should have nevertheless been dismissed because Phenergan's labeling had been "approved" by the federal Food and Drug Administration (FDA) and her case was therefore "preempted" by federal regulatory law, effectively extinguishing Levine's rights to any compensation. The trial court rejected Wyeth's argument, as did the Vermont Supreme Court. Wyeth then appealed to the United States Supreme Court.

The United States Supreme Court upheld the ruling of the Vermont Supreme Court allowing the verdict against Wyeth to stand. The Court completely rejected Wyeth's contention that Congress intended to eliminate the rights of citizens to seek compensation for injuries caused by prescription drugs when it gave the FDA authority to regulate the drug approval process in the Food Drug & Cosmetic Act. Wyeth, supported in its appeal by the rest of the drug industry as well as numerous business-oriented special interest groups, had argued aggressively that FDA approval of a drug and drug labeling should eliminate the ability of consumers to sue for compensation, even in cases where it was clear that the instructions for use and warnings about potential adverse effects were inadequate to protect patients from adverse reactions.

Wyeth's position was based on the doctrine of "federal preemption" which, until the Bush Administration came to power in 2000, had been infrequently used, and almost never invoked to destroy consumer rights. However, under the Bush Administration, numerous federal agencies tasked with protecting the public, including the Environmental Protection Agency (EPA), Consumer Product Safety Commission, as well as the FDA, began to use the preemption doctrine in concert with the very industries they are supposed to regulate in order to prevent civil litigants from pursuing claims against manufacturers of defective products.

In the Wyeth case, the Supreme Court found that Congress had never intended for FDA's regulation of prescription drugs to "preempt" claims for compensation by consumers injured by adverse drug reactions which could have been prevented through better labeling. In a concurring opinion, Justice Clarence Thomas, considered by many as the Court's most "conservative" justice, joined the majority of Justices upholding the verdict and pointed out that Wyeth's attempt to use the preemption doctrine constituted an unconstitutional infringement on the rights of individual states to regulate the conduct of businesses that cause harm to their citizens.

Levine's case drew the attention of numerous consumer and health care groups, including many physicians, who filed "friends of the court" briefs in support of Levine's arguments. Many of these groups pointed out that the FDA has proven itself to be underfunded, understaffed, and largely incapable of adequately protecting the public from the enormous physical and economic consequences of adverse drug reactions, which are often not discovered until after drugs are approved by FDA and placed on the market. The Supreme Court majority correctly noted that while FDA has a critical role in assuring drug safety, Congress intended that role to operate in concert with other avenues of consumer protection, including product liability lawsuits. Such lawsuits act as a "safety net" to provide compensation to innocent consumers injured by dangerous drugs with inadequate warnings and also motivate manufacturers to update labeling based on emerging safety data.

The Levine decision sends a strong message to the pharmaceutical industry that drug makers must be vigilant in conducting proper testing and post-marketing monitoring of drug side effects so that tragedies such as what happened to Ms. Levine can be prevented. Attorney Thomas M. Moore of Moore Labriola LLP in Newport Beach, California, who has represented both drug manufacturers and injured plaintiffs in complex products liability cases during a 25-year career, noted that "the Supreme Court in the Wyeth case wisely and correctly acknowledged Congress' historical recognition of the critical interplay between governmental regulation and our civil justice system in assuring safety and compensation for innocent victims, and the fact that government regulation alone never has and never will adequately protect consumers from harm."

Robert H Hilley IV

Schmidt & Clark, LLP

(866) 588-0600

http://www.schmidtandclark.com

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