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.