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Issues for the Supreme Court to Consider - Part II

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

On November 3rd 2008, counsel for Wyeth Pharmaceuticals and for Vermont resident Diane Levine presented oral arguments to the Supreme Court of the United States. 

In Part One of this series, we covered the key issues the Supreme Court will need to consider in this case. Specifically, whether the FDA or a Jury should determine Drug Safety Standards? 

Part Two of the Wyeth v. Levine series covers issues the Supreme Court may consider in light of the election of President-elect Obama and the state of the US economy.

The Obama Paradigm of Information and Patient Safety

On January 20, 2009, President-Elect Barack Obama will be sworn in and will focus on using technology to manage information, requiring full transparency regarding quality of care and promoting patient safety.  According to Obama’s plan to lower health care costs for Americans, the Obama administration is expected to spend $10 billion dollars over the next 5 years on Health Care Information Technology.

Preparing for this Obama paradigm of information and patient safety, the Court may decide that Wyeth did not do all that it could have to utilize available information regarding the drug’s risks to ensure patient safety. The Court may decide to hold Wyeth out as an example, to the community of  pharmaceutical and health care providers of a company that failed to adequately protect patients due to its delinquent  use of information. As  Levine argued in her brief, possibly, Wyeth knew of the serious risks and could have added a stronger warning or instruction against the IV-push injection method even after the drug was approved by FDA. If the Court agrees that Wyeth had access to greater specific information about Phenergan and the IV push method than the FDA, then the Court may find Wyeth responsible for Levine’s amputated arm. Moreover, since Wyeth is responsible for drafting the label on the drug, the Court could also decide that ultimately it was Wyeth’s responsibility to strengthen the warning even absent a mandate from the FDA to do so.

However, the Court may instead accept Wyeth’s response that it complied with all of the laws and regulations by disclosing to the FDA all of the information in its possession. Moreover, Wyeth relied on the FDA’s concurrence that the warnings were adequate. Wyeth complied with FDA’s instructions to include prominent warnings that IV administration required extreme care or gangrene requiring amputation was likely to follow. The Court may find that Wyeth did all it was required to do to prevent patients from suffering any harm. The Court may agree that it would be unreasonable to expect Wyeth to go above and beyond the required FDA standard safety warnings since the FDA, currently, is the ultimate standard for drug approvals.

Can the Current U.S. Economy Afford More State Claims?

Moreover, as Levine’s counsel asserted in their brief, permitting state actions would incentivize drug manufacturers to stay abreast of all potential injuries stemming from their products. However, how much would this cost? If Wyeth was responsible to protect against every potential harm that could result from its drug, how much more would that cost the drug companies to research, manufacture and market these drugs? How much more would Medicare and Medicaid have to pay for these drugs? And at the bottom line, how much more would that cost middle America, already barely able to afford the cost of drug prescriptions?

As America stands today in a slowing economy with many Americans who struggle to purchase their medications, a Court decision permitting state actions against drug manufacturers may continue to drive this economy into a deeper hole. If every patient who suffered any side effect or harm from a drug sued the drug manufacturer, would these companies be able to afford to research and develop the next new drug? Ultimately, a decision in favor of state actions, might also affect the development of our pipeline of medications available to the American public. Is permitting state actions against drug companies truly in the best interest of this country and should this enter into the Court’s analysis?

As we await a decision from the Court, these are just a few of the issues that the Court may consider in its adjudication.  Ultimately, the Court will decide whether the FDA’s approval of a drug should preempt state tort actions brought against a drug manufacturer based on an unintended side effect suffered by one patient which was caused by a drug that has helped millions of patients.

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.

Iana 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.

Judith 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. 

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.

Iana 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.

Judith 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.