Potential U.S. Supreme Court Case on Nigerian Drug Trial Presents Mixed Picture for Global Health

A still from the movie “The Constant Gardener,” starring Rachel Weisz and based on the book by John le Carre, which was reportedly inspired by the Pfizer case.In 1996, Pfizer conducted a clinical trial of Trovan, a new antibiotic, on children during an outbreak of bacterial meningitis in Kano, Nigeria. Eleven children died and others were left badly injured, according to trial participants. In 2001, 30 Nigerian families sued in U.S. federal court, arguing that Pfizer deviated from its clinical trial protocol and failed to inform the children or their guardians of Trovan’s life-threatening side effects or that Médecins Sans Frontières was providing the conventional, proven treatment for bacterial meningitis for free at the same site. Pfizer has denied wrongdoing. Years of litigation followed over whether the case should be heard in U.S. courts. Earlier this year, a U.S. appeals court ruled that the Pfizer case could proceed.The U.S. Supreme Court is now deciding whether to hear the Pfizer case. If the Court hears the case, and there is a good chance it will, the Court will be asked to decide two important questions: (1) whether Pfizer acted in sufficiently close concert with the Nigerian government to be considered a “state actor” and, thus, possibly liable under the U.S. Alien Tort Statute (ATS) and (2) whether nonconsensual human medical experimentation violates customary international law. These questions sound pretty technical, but the Court’s answers could have significant practical implications for corporate responsibility, development, and global health.Implications for Corporate Responsibility under International LawCorporations, and private actors generally, are not subject to international law except in a few well-defined instances – war crimes, piracy, airplane hijackings, slave trade, and genocide. International law applies more broadly to countries (“states” in international law speak), however, and U.S. courts have found corporations liable under the ATS for violations of international law when a corporation acted in sufficiently close concert with a state that it was behaving like a “state actor.” U.S. courts have differed, sometimes significantly, on the degree of state involvement necessary for a corporation to be considered a state actor and which violations of international law are actionable. The Pfizer case presents the perfect opportunity for the Supreme Court to resolve those questions.A Supreme Court decision in Pfizer could significantly affect the availability of civil lawsuits against corporations for international law violations. The U.S. is the only country that allows its courts to hear civil lawsuits by non-residents against corporations for international law violations committed in a foreign country. Indeed, after lying largely dormant for nearly 200 years after its enactment in 1789, the ATS has become a popular tool for lawyers and international human rights organizations to ask U.S. courts to decide corporate responsibility for Apartheid, slave labor in World War II Japan and Germany, Holocaust victims’ missing Swiss bank assets, mass environmental accidents in India, and many other claims.Why do foreign plaintiffs bring U.S. ATS cases for harms suffered abroad? At least three reasons. First, there is, in some cases, no alternative. Lawsuits alleging corporate involvement in ethnic-cleansing or human rights abuses cannot be brought in countries where such acts are ongoing. Second, there may be advantages to U.S. courts and laws over the domestic alternatives. U.S. courts may be less biased and susceptible to corruption. U.S. laws offer: liberal evidentiary discovery rules; jury trials, punitive damages, and higher average compensatory damage awards; class actions; and contingency fee arrangements. Third, there are advantages for plaintiffs to ATS claims. Personal injury laws require that claims be brought within a defined period of time after the alleged violation; the ATS contains no such statute of limitations and U.S. courts have not agreed on what time limit, if any, should apply.Why did the Pfizer plaintiffs bring their ATS suit in the U.S.? Many of the plaintiffs in Pfizer brought their lawsuit initially in Nigerian courts; it was dismissed in 2003 (the plaintiffs argue because of corruption). In 2007, 11 years after the Trovan clinical trial, the Nigerian government launched several lawsuits on its own behalf; Pfizer settled for a reported $75 million. That settlement includes a Pfizer-Nigerian government administered $35 million fund for Trovan trial participants, but the government's cases were not brought on behalf of those trial subjects and do not resolve all their claims in the U.S. lawsuit.Implications for International DevelopmentLike many things in life and law, the benefit of corporate ATS liability for development is a question of degree – the question at the heart of Pfizer.Liability for well-defined and recognized international law violations is an important source of corporate accountability. It may deter companies from supporting or participating in torture, forced labor, and gross human rights violations as well as doing business with government regimes such as those in Sudan and Myanmar that regularly commit repressive acts against their own citizens.Some have argued, however, that ATS litigation discourages international trade and foreign direct investment in the developing countries that most need it. Uncertainty regarding the parameters of corporate liability under the ATS breeds lawsuits. Even when corporate defendants prevail, they incur substantial litigation expenses and years of negative publicity. ATS suits can be abused by plaintiffs’ attorneys seeking to extract large settlements and corresponding fees from deep pocket corporate defendants.Implications for Global HealthAn increasing number of clinical trials are conducted internationally and, in particular, in developing countries. The reasons are manifold: spiraling trial costs and difficulty of recruiting large numbers of treatment-naïve people in developed countries; strategic interest in emerging markets like China and India; and, in some instances, more conducive regulatory environments for clinical research. The Pfizer case has implications for most clinical trials being conducted internationally. The U.S. represents roughly half of the world’s pharmaceutical market in terms of revenue. The overwhelming majority of actors in this industry – from multinationals to small biotechs to developing country producers – have some U.S. presence that could subject them to U.S. courts’ jurisdiction and, thus, to potential ATS litigation. The issue of informed consent arises in every clinical trial involving a human subject. Under the reasoning of the Court of Appeals in the Pfizer case, most, if not all, entities conducting clinical trials will qualify as “state actors” and, thus, are potentially liable under ATS. Clinical trials are heavily regulated; outside of the U.S., health infrastructure is often government-run. Most of the alleged involvement of the Nigerian government in Pfizer – requesting FDA authorization to export an experimental drug, approval of clinical trial protocols, and the conduct of the trial at a government facility – will be true for many international clinical trials.In some respects, the effect of Pfizer on international clinical trials would be unremarkable. Organized international efforts to prohibit nonconsensual human experimentation began 60 years ago. There are numerous international legal instruments that require informed consent from clinical trial subjects. While these instruments were not, heretofore, actionable in U.S. courts, companies have long been liable under domestic laws for obtaining informed consent. Further, while the FDA permits data generated through clinical research conducted in foreign countries to support applications for FDA approval of new drugs, it requires, among many other things, that data come from clinical trials in which subjects gave their informed consent.In other respects, Pfizer may have significant positive and negative consequences on global health.It is not clear whether failure to obtain informed consent in international clinical drug trials is a widespread problem. If it is, potential ATS liability may provide additional incentive to do so, help protect patients, and have systemic benefits for global health. Some claim that the Trovan trial left northern Nigerians distrustful of Western medical interventions and is partially to blame for the 2003 Nigerian boycott of polio vaccination. That boycott led to a polio outbreak that cost US$500 million to control and ended the hopes of eradicating polio in this decade.The Pfizer case may also have negative effects on global health. ATS liability, and clinical trial liability more generally, is a risk for sponsors of clinical trials. Win or lose, ATS suits are expensive and trial sponsors would need to insure against that risk. ATS liability exposure will not keep large pharmaceutical companies from conducting clinical trials abroad generally. It may, however, discourage clinical trials in developing countries and for medicines for neglected diseases.It is not yet clear what happened in the Trovan trial. If trial subjects are adequately protected, it is a good thing when companies test life-saving products for use in vulnerable populations like children and in settings like Nigeria. There are more than 300 products for neglected diseases under development around the world. Even with expected attrition in that pipeline, many of those products will need to be tested in the particularly poor developing countries in which neglected diseases are endemic and on the highly vulnerable clinical trial subjects who suffer from those diseases. Potential ATS liability is most likely to arise and be the greatest in this context in which the question of what qualifies as fully informed consent is not always simple. Insuring against large ATS liability exposure would stress the already insufficient funding that exists to support clinical development of these products. Beyond the issue of costs, overly prescriptive and cookie-cutter approaches to informed consent would unduly delay or preclude much-needed research on vulnerable populations in developing countries.For more on Tom's research, watch his YouTube Interview.