The Second Circuit's recent opinion allowing a pharmaceutical company to be sued in federal court under the Alien Tort Statute for allegedly conducting clinical trials abroad without the minor patients' informed consent is a dangerous -- and standardless -- expansion of tort law that should cause every product manufacturer grave concern. See Abdullahi v. Pfizer, Inc., Docket Nos. 05-4863-cv (L), 05-6768-cv (CON), slip op. (2d Cir. Jan. 30, 2009). The majority's opinion scours the globe for multinational accords and documents from "world" organizations for statements that scientific experimentation without informed consent is bad, and from these statements concludes that a non-governmental corporate actor may be held liable in federal court under international common law for violating this so-called "standard." If this decision is not corrected either by rehearing en banc or on appeal, can similar suits about pollution, climate change, or even products liability be far behind?
Let's be clear at the outset: no one is advocating studying the effectiveness of new medicines without obtaining informed consent from the patients being treated. The question raised by Abdullahi is what is the source of the legal obligation that an entity or individual may be sued for violating? Is it international law? Or is it -- as is the case with nearly all civil liability -- a question of national law embodied in statute and/or common law with recognizable elements and types of allowable damages?
Judge Richard Wesley, in his Abdullahi dissent, properly recognized that any claim brought under the Alien Tort Statute must be analyzed within that statute's historical context. The ATS originally was passed in 1789, and now provides that the "district courts shall have original jurisdiction of any civil action by an alien for a tort only, committed in violation of the law of nations or a treaty of the United States." 28 U.S.C. sec. 1350. As Justice Souter explained in his opinion in Sosa v. Alvarez-Machain, 542 U.S. 692, 714-15 (2004), the "law of nations" at that time encompassed three basic spheres: (1) general norms governing the behavior of nation states with each other, (2) judge-made law regulating the conduct of individuals outside domestic boundaries (such as admiralty law), and (3) rules binding individuals for the benefit of nation states. Blackstone had defined three specific offenses for this third sphere: violation of safe conduct requests, infringement of the rights of ambassadors, and piracy.
According to Justice Souter, "[i]t was this [third] narrow set of violations of the law of nations, admitting of a judicial remedy and at the same time threatening serious consequences in international affairs, that was probably on the minds of the men who drafted the ATS with its reference to tort." Id. at 715; see also id. at 720.
Sosa counsels that courts exercise great caution when asked to apply the ATS beyond the issues of safe conduct, ambassadorial infringement, and piracy:
Still, there are good reasons for a restrained conception of the discretion a federal court should exercise in considering a new cause of action of this kind. Accordingly, we think courts should require any claim based on the present-day law of nations to rest on a norm of international character accepted by the civilized world and defined with a specificity comparable to the features of the 18th-century paradigms we have recognized.
Id. at 725 (emphasis added).
Justice Souter identified five reasons for exercising such caution. First, unlike in 1789, when the "common law" was viewed to exist outside of any state and was to be "discovered," today we understand that the "common law" is created and chosen by human beings. Second, and as a result, the federal courts have gotten out of the business of making common law, looking "for legislative guidance before exercising innovative authority over substantive law. It would be remarkable to take a more aggressive role in exercising a jurisdiction that remained largely in shadow for much of the prior two centuries." Id. at 726. Third, the Supreme Court has repeatedly eschewed creating private rights of action -- and thereby deferring to Congress -- because of the practical policy considerations about how the proscriptions should be enforced. Fourth, creating common law under the ATS would necessarily result in placing limitations on the power of foreign governments and their citizens, which is not the typical role of the judiciary. And fifth, "[w]e have no congressional mandate to seek out and define new and debatable violations of the law of nations, and modern indications of Congressional understanding of the judicial role in the field have not affirmatively encouraged greater judicial creativity." Id. at 728.
Thus, the Supreme Court concluded that:
[W]e are persuaded that federal courts should not recognize private claims under federal common law for violations of any international law norm with less definite content and acceptance among civilized nations than the historical paradigms familiar when section 1350 was enacted. . . . And the determination whether a norm is sufficiently definite to support a cause of action should (and, indeed, inevitably must) involve an element of judgment about the practical consequences of making that cause available to litigants in the federal courts.
Id. at 732-33.
In Sosa, the plaintiff had alleged that Mexican citizens had arbitrarily detained him and transported him across the border to the United States, where he was arrested by the DEA. Plaintiff pointed to the Universal Declaration of Human Rights and the International Covenant on Civil and Political Rights, as well as other sources, to support his claim that this violated clear and accepted standards under the law of nations. The Supreme Court concluded that these documents -- while expressing aspirations of avoiding such detention -- did not create legal obligations on individuals as a matter of international law. Id. at 734-38.
It would be ironic, to say the least, if a person who forcibly abducts another person cannot be sued under the ATS for lack of clear and accepted standards, but a company responding to a meningitis outbreak by providing medicines as part of a clinical trial actually could be sued under the ATS. What, exactly, are the clear and accepted standards under international law for addressing language and cultural barriers in obtaining informed consent? And in the case of minors, must consents be obtained from both parents? Where the parents are unavailable and the State is the guardian, what obligation does international law impose then? Other than repeating the mantra that "informed consent" is necessary, the majority opinion in Abdullahi does not say. It does acknowledge in footnote 15 that "disagreements" exist over how to secure consent in illiterate populations and whether informed consent is even possible in double-blind experiments, but it dismisses these as "fringe" concerns. The problem, of course, is that the trial court is being asked to create the elements of a common law cause of action based on universally recognized international standards, but none actually exist.
Judge Wesley, in his dissent, agreed with the majority that three criteria must be satisfied before a violation of international law can be actionable under the ATS: "the norm is (1) specific and definable, (2) universally adhered to out of a sense of legal obligation, and (3) a matter of mutual concern, namely a matter 'involving States' actions performed towards or with regard to the other.'" Abdullahi, slip op. at 52 (citing Flores v. Southern Peru Copper Corp., 414 F.3d 233 (2d Cir. 2003)). But his analysis reached very different conclusions.
To begin with, Judge Wesley scrutinized the plaintiffs' sources of customary international law. One had been described by the U.S. Supreme Court as having little utility in defining international obligations, despite its "moral authority." The second had been promulgated after the conduct at issue in the litigation and was a European regional convention that had not been ratified by France, Germany, Italy, the United Kingdom, Russia or the Netherlands, and thus could hardly be deemed "universal." Using it as evidence also would amount to an international ex post facto definition of legal obligations. Two more statements from international organizations post-dated the relevant timeframe by several years. Two more guidelines were from private entities, and one merely purported to express the "asserted aspirations and demands of some countries," but not "statements of universally-recognized legal obligations." Plaintiffs also cited states' domestic laws, but Judge Wesley -- relying on Flores -- reasoned that these are irrelevant for the purpose of defining international law. Finally, plaintiff's citation to the Nuremberg Code -- which is a statement of principles accompanying a criminal verdict -- possessed "at best 'subsidiary' value as a judicial decision." Abdullahi, slip op. at 52-53. Thus, Judge Wesley concluded, "this evidence falls short of charting the existence of a universal and obligatory international norm actionable against non-governmental actors under the ATS." Id.
One of the fundamental flaws in the majority's analysis was that it analyzed so-called obligations without regard for who was bound by them: state actors, or private actors. As Judge Wesley pointed out, the majority provided no evidence for the imposition of liability on private actors as a matter of customary international law.
Judge Wesley also looked to the Restatement (Third) of Foreign Relations Law, section 404, for an analogy. Although section 404 does not purport to state what is actionable under the ATS, it does identify certain offenses for which there is universal criminal jurisdiction over non-state entities: "piracy, slave trade, attacks on or hijacking of aircraft, genocide, war crimes, and perhaps certain acts of terrorism.'" Slip op. at 71. The crimes are listed there not because they are "particularly reprehensible," but rather because they "occur in locations where, or during times when, sovereignty, and a fortiori criminal jurisdiction, are incapable of being exercised." Id. That, of course, is not the case for the conduct of medical studies.
Judge Wesley also took issue with the majority's conclusion that the matter was one of mutual concern among nations. In reaching its conclusion, the majority cited no international accords. Rather, it posited that conducting studies without informed consent would make people less likely to seek medical treatment in the future. Judge Wesley conceded that the majority might be quite right, but that this did not establish a problem among nations:
In fact, the majority's theory would be no different when evaluating the medical malpractice of [the defendant's] research physicians or the strict products liability for its allegedly defective drug, but malpractice and products liability are among the quintessential subjects of domestic law.
Id. at 80; see also Flores, 414 F.3d at 249 (murder is not a violation of the ATS because "'nations of the world' have not demonstrated that this wrong is 'of mutual, and not merely several, concern'"). Indeed, as Judge Wesley noted, the three original offenses covered by the ATS (infringing rights of ambassadors, violating safe conducts, and piracy) all "threatened serious consequences in international affairs because the norms were, and still are, the foundation for states' formal relationships with one another." Abdullahi, slip op. at 81.
Ultimately, it is Judge Wesley's dissent -- rather than the majority's opinion -- that reflects the caution mandated by the Supreme Court in Sosa, recognizing the institutional reluctance of the federal courts to make new substantive common law rather than deferring to the legislative and executive branches for making such policy choices, particularly in the international arena.
One final matter merits mention. The complaint pled causes of action under Connecticut's Unfair Trade Practices Act and its Products Liability Act. The District Court concluded that under Connecticut's choice of law principles, Nigerian law would apply, since Nigeria is the place of the injury, plaintiffs' residence, and where the conduct giving rise to the action occurred. The Second Circuit vacated that determination, urging the District Court to apply all of the factors in Section 6(2) of the Restatement (Second) of Conflicts of Law. Specifically, it criticized the District Court for not analyzing the relevant policies of the forum and other interested states, as well as the parties' expectations. The dissent fails to address this part of the opinion.
The majority's opinion implies that the District Court got it wrong, and that Connecticut's UTPA and PLA should apply to transactions occurring in Nigeria, where injury occurred in Nigeria to Nigerian citizens. As a practical matter, there is no way Connecticut law would prevail over Nigerian law in such a governmental interest or most significant relationship analysis. To the extent the majority is advocating the use of the law of the manufacturer's residence, courts that have conducted such analyses in putative US class actions generally have rejected the conclusion that the law of the manufacturer's residence controls. See, e.g., Barbara's Sales, Inc. v. Intel Corp., 879 N.E.2d 910 (Ill. 2007).