GUEST BLOGGER Bruce Patsner, M.D., J.D.

On March 4, 2009 the United States Supreme Court decided that pharmaceutical companies can be sued in state courts for damages either from use of a drug or a failure to warn about the drug’s potential side effects, even if the Food and Drug Administration (FDA) has approved both the product and its label.  One could not have asked for a more sympathetic plaintiff:  a concert pianist who lost her arm as the direct result of receiving an intravenous injection of an anti-nausea prescription drug (Phenergan) with known potential to rarely cause vascular necrosis, information which FDA deemed too unimportant to include in the approved product label.

The bitterly contested and much-anticipated decision in Wyeth v. Levine was the most important food and drug law case to be decided by the Court in the last decade.  At issue was the question of whether the federal government’s regulation of the safety and efficacy of drugs under the Food, Drug and Cosmetic Act preempts the field and prohibits finding the manufacturer liable under state laws.  The ruling represents a clear win for injured patients and possibly the final nail in the coffin of the recently-minted doctrine of implied federal preemption of state tort claims, at least in the area of food and drug law.  Coming on the heels of the Court’s 8-1 decision last year in Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008), which forcefully affirmed the express statutory preemption provision for damages claims against manufacturers of certain types of prescription medical devices, the 6-3 vote in Wyeth v. Levine was a relief of sorts and surprising not only in outcome but also because the vote was not really even close.

The majority of the Court recognized that the statutory basis for claiming federal preemption protection for damages claims in state court for drugs and medical devices differs enormously.  The 1976 Medical Device Amendments (MDA), 71 U.S.C. § 360 (k) (a), to the 1938 Federal Food, Drug and Cosmetic Act (FDCA) contains an express preemption clause which specifically exempts manufacturers from tort liability in state court for damages from FDA-approved medical devices and prevents states from adding additional “requirements” to the existing federal medical device safety and efficacy marketing evaluation.  The Supreme Court has narrowed the scope of medical device preemption protection to only those prescription medical devices which are approved through the lengthier and more complicated pre-marketing approval (PMA) route.  There is no comparable preemption language relating to pharmaceuticals in the 1938 FDCA or any amendment to the FDCA since its inception.

The Arguments

In holding that FDA approval of a drug and its label did not protect pharmaceutical manufacturers against tort litigation in state court, the Supreme Court majority clearly rejected arguments from both manufacturers and FDA itself.  Wyeth had argued, in effect, that the information contained in an FDA-approved product label is both the floor and the ceiling for potential tort claims and that the label cannot be unilaterally changed without FDA approval.  Neither of these contentions is true.  In truth, the sponsor owns the label (i.e. it’s its intellectual property), and the label is always the last part of the new drug application (NDA) to be completed.  The contents of the label invariably represent a negotiation between FDA and industry, the label might not be written by either the most knowledgeable or competent physicians at FDA, and FDA decision-making on what to include in a prescription drug label is fraught with potential errors and omissions, as the case at hand demonstrates.

More importantly, the label is not set in stone.  Certain adverse events will not be detected in drug approval trials because the number of participants in the original research is much smaller than the number of individuals who will be exposed to the drug once it is approved.  Consequently, it is impossible for a drug label to include all of the important warning information both physicians and patients need.  Companies are always free to change an approved label to add more safety warning information.  A decision by FDA not to include newly-discovered serious adverse event information requested by a manufacturer in a label would not only be antithetical to FDA’s public health mission, it would represent a serious error on the agency’s part and, on examination, be just one more reason why the Court’s decision was correct.  The Court also appropriately rejected FDA’s argument that manufacturers deserved preemption protection based on FDA approval alone, pointing out that this contention was both an about-face of FDA’s long-held position on this issue undertaken without any rational explanation, and was clearly inconsistent with Congressional intent.

Prior to the recently departed Bush Administration, FDA had never claimed that FDA approval decisions provided a shield for pharmaceutical manufacturers from tort claims against drug manufacturers in state court.  In fact, on multiple occasions the FDA Chief Counsel had stated that state law was a necessary complement, not impediment, to FDA to regulation of the pharmaceutical industry.

What Next?

Presidential elections, and who controls Congress, have enormous consequences in the area of administrative law and how private industries are regulated.  Clearly, the combination of an Obama Presidency and a Democratic-controlled Congress is going to usher in a sea-change in oversight over the pharmaceutical and medical devices industry.  Efforts are already underway to amend the 1938 federal Food, Drug and Cosmetic Act to eliminate the express preemption protection for select medical device manufacturers and allow tort litigation against the manufacturers of implantable medical devices such as cardiac defibrillators, pacemakers, and coronary-artery stents to proceed in state courts.  These efforts and the Wyeth decision are important steps for the protection of patients.

Bruce Patsner, M.D., M.B.A. and J.D., is a Research Professor at the University of Houston Law Center.  He received his M.D. from Baylor College of Medicine, his M.B.A. from Rutgers, and his J.D. from Boalt Hall (U.Cal. Berkeley).  He previously worked at the Food and Drug Administration.