Clifford’s Notes: A more even playing field

By Robert A. Clifford
Clifford Law Group

Diana Levine, a Vermont musician, 54, was suffering from migraine headaches. She went to a clinic where she was given an injection of Phenergan for nausea, and Demerol for pain. A doctor injected Phenergan through a higher-risk intravenous push method, and the drug made its way into an artery instead of a vein.

Her right hand and forearm turned purple and black, and ultimately she had to have most of her arm amputated. The label on the drug, which was approved by the Food and Drug Administration, specifically warned that ”inadvertent intra-arterial injection” can cause gangrene requiring amputation, a tragedy that at least 20 other people had suffered from.

Levine argued that the label had inadequate warnings and instructions under state law. A jury agreed and awarded her $6.8 million against the drug manufacturer, Wyeth. Wyeth took the case to the U.S. Supreme Court, contending that the issue is preempted by federal law.

In what is being viewed as one of the most significant decisions in years, the Supreme Court in March found that the drug company is not protected from personal injury claims in state court because the federal government approved the products and its labeling. The case is being heralded for preserving access to justice for victims of drug companies’ negligence on an issue that was long awaited by lawyers and the pharmaceutical industry.

In writing the opinion for the 6-3 majority, Justice John Paul Stevens upheld the opinion of the Vermont Supreme Court, which held that federal law ” ‘provides a floor, not a ceiling, for state regulation.’ ” Wyeth v. Levine, __ U.S. __, No. 06-1249 (decided March 4, 2009), quoting, __ Vt. __, 944 A.2d 179, 184 (2006).

A majority of the justices decided that, despite the FDA approval of drug labels, ”It is the central premise of the Food, Drug and Cosmetic Act [FDCA] and the FDA’s regulations that the manufacturer bears responsibility for the content of its label at all times.”

The act did not contain any provision that expressly preempted injured consumers’ claims against drug manufacturers, and the Court rejected the drug companies’ argument that failure-to-warn claims by the drug company were implicitly preempted. It also rejected Wyeth’s argument that the company was prohibited by the FDA from unilaterally issuing a stricter warning.

Stevens wrote that ”The purpose of Congress is the ultimate touchstone in every pre-emption case” and that ”In all preemption cases, we start with the assumption that the historic police powers of the States were not to be superseded unless that was the clear and manifest purpose of Congress.”

Justices Anthony Kennedy, David Souter, Ruth Bader Ginsburg, and Stephen Breyer joined in the opinion. Justice Clarence Thomas filed an opinion concurring in the overall judgment, but disagreeing with the notion of implied preemption as a viable doctrine, a view that is certain to have consequences in future cases before the Court.

Justice Samuel Alito Jr. wrote a dissent that was joined by Chief Justice John Roberts Jr. and Justice Antonin Scalia. What was comforting was the Court’s language in recognizing the important role of state-court personal injury lawsuits as a valuable vehicle to assist the FDA in recognizing risks.

The Court said, ”The FDA has limited resources to monitor the 11,000 drugs on the market, and manufacturers have superior access to information about their drugs, especially in the post-marketing phase as new risks emerge. State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information. Failure-to-warn actions, in particular, lend force to the FDCA’s premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times.”

What is also significant is that the case may serve as a roadmap for Congress in its examination of legislation on similar issues regarding the Medical Device Safety Act.

Medical device makers, like drug manufacturers, use preemption theories to try to prevent injured consumers from bringing lawsuits. Lawyers for Levine said that they were heartened that the decision was written so that it could be given an expansive interpretation to include medical devices.

Acting swiftly, Sen. Ted Kennedy (D-Mass.) sponsored the Medical Device Safety Act, S. 540, and Rep. Frank Pallone (D-N.J.) sponsored the bill in the House (H.R. 1346), which would allow those who are hurt by unsafe medical devices, even if approved by the FDA, to have their cases heard in state court.

It took nine years for Levine to see justice. That demonstrates the strength and money behind the drug companies and what they are willing to do to squelch the rights of consumers and patients who have been hurt by companies’ negligence.

Courts certainly cannot perform that miracle, but it has helped empower Levine so that she feels her life has meaning and her loss was not in vain. This decision will reverberate for years, helping victims come to terms with their losses on a more even playing field.