Data generated through research conducted in foreign countries may be offered to support applications to FDA for approval to market new drugs in the U.S. 21 C.F.R. § 314.106(b)(1). FDA grants approval through one of two routes: either through an IND controlled by federal regulations regardless of location, or under ICH (International Conference on Harmonization) Guideline E6 “Good Clinical Practices” to “help ensure data quality and integrity.” 21 C.F.R. § 312.120 (October 27, 2008). A study relied upon must be documented to be “credible and accurate” and trials must be properly conducted. Among other requirements, the data generated must have arisen in studies of humans who have given proper consent. See, 21 C.F.R. §§ 50.20, 50.23, 50.25, 50.27, 312.20, 312.120 (2008); 45 C.F.R. §§ 46.111, 46.116-117 (2008).
Increasingly, U.S. pharmaceutical companies are conducting clinical trials abroad. This practice reflects a desire to bring the benefits of modern medicines to nations where they might otherwise be hard to obtain. There are other benefits as well. The cost of conducting studies in foreign nations is often lower than it is in the United States. Individuals with particular disorders that are not already under treatment, or with manifestations of disease not often seen in the U.S., may be easier to find, especially in Third World nations. The regulatory climate there may be more conducive to performance of scientific research. As a result, trials can often be more readily completed elsewhere than they can be at home. Sometimes, however, controversy arises in connection with this practice. Recently, case law has moved in the direction of permitting foreign nationals to seek damages in tort against domestic defendants for harms allegedly related to performance of clinical trials abroad.
In Abdullahi v. Pfizer, No. 05-4863 and 05-6768-c, 2009 WL 214649 (2d Cir. 2009), plaintiffs alleged that when the defendant tested Trovan (trovofloxacin, a fluoroquinolone antibiotic) for use against bacterial meningitis in Nigeria, eleven children died unnecessarily. The plaintiffs claimed that by recruiting children for testing, and failing to disclose that Trovan had been linked to life-threatening side effects in animal studies, the defendant violated a customary international law norm prohibiting involuntary medical experimentation on humans. Because Pfizer allegedly developed Trovan in Connecticut, plaintiffs also claimed violations of that state’s Unfair Trade Practice Act and Products Liability Act.
The Southern District of New York dismissed the case for lack of subject matter jurisdiction under the Alien Tort Statute (ATS), 28 U.S.C. § 1350. That statute, which dates from the 18th Century, gives U.S. courts original jurisdiction over “any civil action by any alien for a tort only, committed in violation of the law of nations or a treaty of the United States.” For a cause of action to lie, the norm violated must be 1) defined with a specificity comparable to that of the original 18th Century paradigm, such as piracy; 2) based upon a norm of international character accepted by the civilized world; and 3) one that states universally abide by, or accede to, out of a sense of legal obligation and mutual concern. Sosa v. Alvarez-Machain, 542 U.S. 692, 724-32 (2004). The trial court agreed that “non-consensual medical experimentation violates the law of nations and, therefore, the laws of the U.S.,” but Plaintiffs had “failed to identify a source of international law that ‘provides a proper predicate for jurisdiction under the ATS’.” The district court concluded that because no single source recognizing the norm was legally binding in the U.S. and created a private right of action, it could not infer such a right under the ATS. In a two-to-one decision, however, the Second Circuit reversed the district court and consolidated the cases and remanded them on the basis that the trial judge had inadequately inquired whether the law recognized “a norm of customary international law prohibiting medical experimentation on non-consenting human subjects.” It wrote,
Sosa makes clear that the critical inquiry is whether the variety of sources that we are required to consult establish a customary international law norm that is sufficiently specific, universally accepted, and obligatory for courts to recognize a cause of action to enforce the norm. Nothing in Sosa suggests that this inquiry can be halted if some of the sources of international law giving rise to the norm are found not to be binding or not to explicitly authorize a cause of action.
2009 WL 214649 at *18.
Additionally, Pfizer faces civil and criminal lawsuits filed in Nigeria by Nigerian state and federal authorities. Recent press reports suggest that Pfizer has reached a monetary settlement with the Nigerian government. While the terms are not disclosed, the reports suggests the settlement was approximately $75 million. That settlement is independent of the ongoing civil action in the Southern District of New York revived by the Second Circuit’s opinion in Abdullahi.
This case certainly does not mean that pharmaceutical companies should abandon clinical trials in foreign lands. It does raise concerns about liability exposure not previously established in tort in the U.S., independent of exposure to the host countries’ legal system . Companies considering trials abroad may wish to factor in the Court’s reasoning in Abdullahi as they contemplate their risk exposure, and analyze whether a non-IND study complies with Guideline E-6 “Good Clinical Practices” from the International Conference on Harmonization.
For more information, please contact the authors or any member of our Life Sciences industry team.