Should FDA or a Jury Determine Drug Safety Standards?

Issues for the Supreme Court to Consider on Wyeth v. Levine Case

By: Iana DeSouza, Esq. and Judith Meritz, Esq.

On November 3, 2008, while most of America anxiously awaited Election Day to cast their vote, counsel for Wyeth Pharmaceuticals and for Vermont resident Diane Levine presented oral arguments to the Supreme Court of the United States on this issue.  This two part article will cover the key issues the Court may need to consider on the Wyeth v. Levine case.

“Intra-Venous (IV) administration requires extreme care or gangrene requiring amputation will likely follow.”

Is this an adequate warning? Should the Food and Drug Administration (“FDA”) or a state jury determine the adequacy of the warning?

FDA approved a drug label for a Wyeth Pharmaceuticals Inc., drug named Phenergan. Diana Levine, was injected with Phenergan to treat nausea. Levine experienced an unintended side effect that led to the amputation of her arm. Levine sued Wyeth on a tort state claim. The Vermont Supreme Court upheld the lower courts verdict for the plaintiff and Wyeth appealed and brought the matter to the U.S. Supreme Court (the “Court”). The Court will soon decide this issue in the Wyeth Pharmaceuticals Inc. versus Diana Levine suit.

When the FDA has determined a drug to be safe and efficacious, and authorizes a drug manufacturer to sell and distribute that drug, should individuals, such as Diana Levine who lost her arm due to an unintended effect of the drug’s IV push administration, have recourse to sue the drug manufacturer under state law when the drug does not perform as it was expected? This is the question in front of the Highest Court of the U.S. Judiciary system.

Counsel for Wyeth urged the Court to overturn the $7 million dollar state verdict and rule that state tort claims against Wyeth are preempted by federal law. Levine’s counsel argued that individuals should be able to sue drug manufactures in spite of the drug’s approval by the FDA. The Supreme Court is asked to decide this question which could significantly change the landscape of the drug industry.

If the Supreme Court decides that federal law preempts the state claims and that FDA approval is a sufficient standard, patients will not be able to assert state tort claims against manufacturers of FDA approved drugs. However, if the Supreme Court decides to permit state claims, then drug manufactures could be exposed to potential suits brought by patients from every state. These drug companies might then need to significantly increase their budget and their efforts to anticipate and avoid all drug risks. Perhaps the Court will render a decision that will consider both the interests of patients who have been harmed by a drug and yet still protect drug manufacturers from excessive risk of state claims.

The Court might decide this case on one or more of several sub-issues.

Who Is Better Suited to Determine Drug Safety Standards?

Is the FDA or a state jury better suited to decide drug manufacturer’s drug safety standards? Wyeth argues that the FDA is better suited to decide which product label warning standards are required. Wyeth asserts that the FDA’s expertise enables it to possess the training and experience necessary to properly decide which drug warnings are necessary on a drug label. Thus, Wyeth’s briefs argued that Wyeth was justified in relying on the FDA’s approval of the drug’s labeling as adequate and safe to distribute in the market.  Levine’s counsels point of view prefers to substitute lay jurors opinions’ of a single victim’s injury, gathered during the time of the trial, as adequate perspective on the overall pharmaceutical system. Wyeth’s counsel asserts that this process is not optimum in order to decide the adequacy or inadequacy of a drug label.

However, a jury that has heard the arguments delineating that the drug manufacturer complied with FDA regulation and utilized best efforts to warn of drug risks and has also witnessed how the patient was harmed, may be able to make the best decision as to which drug safety standard is adequate. For example, in one state claim case, a jury might find that a drug manufacturer did do everything it could have done to prevent the patient harm and thus the drug manufacturer should not be liable. However, in another state claim case, a jury might find that the warnings were not adequate in light for the risks associated with that drug.

Risks and Benefits of Federal Pre-Emption

The Supreme Court could resort to a risks-benefits analysis to assess whether or not to permit FDA’s drug approval to pre-empt state tort claims. If plaintiffs were prohibited from bringing suit against drug companies for FDA approved drugs, the risks would include the following possibilities: 1) drug manufacturers may become less concerned with safety if there was no risk of state tort claims; 2) the FDA may realize it is the final judge on product safety and might become ultra conservative in reaching drug approval determinations; and 3) people harmed by a drug may not adequately financially recover for  harm suffered from a drug’s unintended effect if the drug companies are protected from lawsuits.

Possible benefits of preempting state claims and allowing the FDA to be the final authority on drug labels include:

  1. drug manufacturers would avoid drug labeling requirements from the various states;
  2. drug manufacturers would not be subject to juries focused solely on the harm caused by the drug and not on the benefit;
  3. plaintiffs may be forced to shift liability  to other parties, such as the hospital or physicians, who may have had more control over the administration of the drug; and
  4. maintain a national, uniform regulation of drug labels.

After weighing the risks and benefits of preempting state claims, the Court could decide that the benefits of preempting state claims justify the risks and thus preemption is necessary. This would mean that state claims would be prohibited from being brought once the FDA has approved a drug and its labeling. However, the Court might also decide that the risks of preempting state claims do not justify the benefits of preemption and thus disallow preemption as it relates to state tort claims. Plaintiffs would still be able to file state claims contesting an FDA approved drug label.

Part Two of this article will cover issues the Supreme Court may consider in light of the election of President-elect Obama and the state of the US economy.

The views expressed in this article are those of the authors and do not necessarily represent those of Life-Science Panorama, its editor or Axendia, Inc.

DesouzaI-80.jpgIana DeSouza Esq. is an associate in the Health Law Practice Group at Blank Rome LLP. She concentrates her practice on healthcare with a focus on FDA compliance, licensure, certification, accreditation, contract drafting and negotiation, fraud and abuse, and corporate transactions.

Ms. DeSouza provides counsel to clients regarding due diligence for new acquisitions, business ventures, and strategic partnerships. She also advises clients on all aspects of regulatory affairs and governmental compliance including quality assurance, product labeling, registrations, recalls, the handling of adverse events, security breach and consumer notifications. Prior to this position, she obtained pharmaceutical industry experience while working for a global drug manufacturer.

MeritzJ-80.jpgJudith K. Meritz, Esq. is a partner in the Health Law Practice Group at Blank Rome LLP.  She concentrates her practice in FDA compliance counseling in the areas of drugs, devices and biologics. She also offers regulatory expertise in the areas of DEA, OSHA, DOT and EPA.

Judith Meritz served as Assistant General Counsel for the American Red Cross responsible for regulatory affairs.  In this capacity, she was the chief counsel to the Biomedical Services group providing guidance to ARC headquarters staff, as well as field blood regions and national testing labs, with particular emphasis on compliance with FDA regulations and the FDA Amended Consent Decree.  

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