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ATCA

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The Alien Tort Claims Act

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									AMERICAN UNIVERSITY
Washington College of Law

THE ALIEN TORT CLAIMS ACT: An Analysis of Abdullahi v. Pfizer Inc. and Subject Matter Jurisdiction under “The Law of Nations” (This version has been summarized to fit requirements)

By Gunther Sanabria LAW-675-001 Transnational Litigation



LLM International Business Program Washington College of Law

THE ALIEN TORT CLAIMS ACT An Analysis of Abdullahi v. Pfizer Inc. and Subject Matter Jurisdiction under “The Law of Nations” The Alien Tort Claims Act (ATCA) 1 was enacted by the first Congress of 1789. Since then, the ATCA remained dormant for almost 200 years until recent interpretations of the language used in the Act made it the subject of debate and far-reaching litigation. Furthermore, current use of the ATCA as a tool against transnational corporations’ complicity with international human rights violations has made the Act more controversial than ever. The controversy mainly revolves around whether the statute simply grants “jurisdiction,” or whether it authorizes suits to be brought directly on the basis of “the law of nations.” This article will first briefly describe the ATCA, as well as its history and interpretations. Next, the article will present a review of the important facts regarding the Abdullahi v. Pfizer, Inc.2 case and its relationship with the decision in Sosa v. Alvarez-Machain.3 The article will also set forth an analysis of the “law of nations” and its interpretation by the court in Abdullahi. Lastly, the article will conclude with a look at opinions from academia regarding the ATCA, and with a brief summary of cases involving litigation under the ATCA. The Alien Tort Claims Act reads today as follows: “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.”4 Until Filartiga v. Pena-Irala5 there was not a clear understanding of what the drafters of the Act intended at the time of its creation. Although original intent can only be speculated, it is mostly accepted that Congress intended to protect the physical integrity of foreign ambassadors serving in the United States and to persuade European countries that the United States would not become a haven for pirates or other international tortfeasors.6 A more contemporaneous approach indicates that the Act was intended to address public and private human rights abuses in violation of the law of nations. The Act provides Federal Courts with subject matter jurisdiction over violations of recognized international common law and violations of United States signed treaties that have the force of law.7 Under ATCA, to establish personal jurisdiction the accused must either be physically present in the United States when he or she is served with process or must have purposefully availed him or herself to suit within the United States by maintaining

28 U.S.C. §1350 (also known as the Alien Tort Act and the Alien Tort Statute). See Filartiga v. Pena-Irala, 630 F.2d 876 (2nd Cir 1980). 2 Abdullahi v. Pfizer Inc., 77 F. App’x. 48 (2nd. Cir. 2003). 3 Sosa v. Alvarez-Machain, 124 S. Ct. 2739 (2004). 4 28 U.S.C. § 1350. 5 Filartiga v. Pena-Irala, 630 F.2d 876. 6 Id. (holding that the Alien Tort Claims Act allows victims to sue in U.S. courts for serious violations of international human rights law.) 7 See Id.
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certain minimum contacts requirements. 8 The Act considers exceptions for sovereign leaders and/or countries, as well as for those who have immunity under United States law. The Judicial history of the Act is limited regarding jurisdiction; Bolchos V. Darrell 9 was the first case to reference the Act, and Adra v. Cliff10 was the last case before Filartiga to establish jurisdiction. THE MILESTONE CASE: In Filartiga, the claim aroused from the kidnapping, detention, torture, and death of Joelito Filartiga, the son of Paraguayan citizens, by the defendant Americo Pena-Irala, former Inspector General of Police in Paraguay. The plaintiffs alleged violations of the United Nations (UN) charter, the universal declaration of human rights, and customary international law. The plaintiffs did not base their claim on the violation of any treaty with the United States, but instead claimed torture as a violation of the law of nations. The court found that federal subject matter jurisdiction existed because the claim "arises under" federal law. The tort complaint is a violation of public international law, and international law is incorporated into United States federal law without specific adoption by Congress.11 The question for the court was whether the acts allegedly committed by Pena-Irala in Paraguay fit the definition of a tort committed in violation of the law of nations. The United States District Court for the Eastern District of New York dismissed the action for lack of subject matter jurisdiction and appeal was taken. The Court of Appeals reversed; Irving R. Kaufman, Circuit Judge, held that “deliberate torture perpetrated under color of official authority violates universally accepted norms of the international law of human rights, regardless of the nationality of the parties. Thus, whenever an alleged torturer is found and served with process by an alien within our borders, §1350 provides federal jurisdiction.”12 The most important elements in Filartiga are the construction of the Act to provide a cause of action for aliens and the availability of the United States federal courts to claims of human right violations; thereby construing “the law of nations” as it has evolved today. Since Filartiga in 1980, an avalanche of cases against multinationals has flooded the courts claiming jurisdiction under the ATCA.13 After carefully analyzing the validity of the claims, the courts have dismissed every case involving industrial activities abroad by private corporations.

Personal jurisdiction should not be confused with subject-matter jurisdiction. Subject-matter jurisdiction defines the court's authority to hear a given type of case, whereas personal jurisdiction protects the individual interest that is implicated when a nonresident defendant is haled into a distant and possibly inconvenient forum. See International Shoe v. Washington, 326 U.S. 310, 316 (1945). 9Bolchos V. Darrell, 3 F. Cas. 810 (D. S.C. 1795) (concluding that the ATCA granted jurisdiction with respect to a dispute concerning title to slaves seized on a captured enemy vessel). 10 Adra v. Cliff, 195 F. Supp. 857 (D. Md. 1961) (involving a child custody suit between two aliens and holding that wrongful withholding of custody constituted an actionable tort and that the misuse of a passport to gain the child’s entry into the United States was a violation of international law). 11 See Filartiga, 630 F.2d at 878. 12 Id. 13 See “Defend the Alien Tort Claims Act”, editorial, by Human Rights Watch, (“Since 1979, only 25 cases against corporations have been brought under the ATCA; the cases are hard to bring. Because the plaintiffs are rarely able to collect any money, even when they win, the lawyers who bring these cases are working basically for free.”) Available at http://www.hrw.org/campaigns/atca/.
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Abdullahi v. Pfizer, Inc.14 is one of the cases since Filartiga where plaintiffs invoked ATCA to establish subject matter jurisdiction. In August of 2001, Pfizer, Inc., a pharmaceutical giant, was the subject of a lawsuit in the Southern District of New York.15 The case involved a corporation showing something other than an economic interest based on statistical data and capital asset pricing models. Pfizer traveled to Nigeria in a humanitarian effort to save the lives of children affected by an epidemic. The Abdullahi case illustrates an unprecedented violation of human rights regarding a recognized principle in medical testing, which states that voluntary informed consent is required prior to conducting any medical or scientific experimentation.16 I. BACKGROUND OF ABDULLAHHI v. PFIZER Statement of the case/issues: The events of this case occurred in 1996, when an outbreak of bacterial meningitis and cholera in the town of Kano, located in the northern region of Nigeria, brought the Pfizer Corporation to establish a treatment center in the area. The Nigerian Government made available to Pfizer the Infectious Disease Hospital (IDH) in Kano for treatment of those infected with the disease. Pfizer had just developed a new drug called Trovan for the treatment of meningitis, but the drug had not been approved by the FDA. Although earlier tests of the drug showed potential treatment for the disease, Pfizer offered to treat the patients with an FDA approved drug Ceftriaxone in conjunction with the experimental antibiotic Trovan. The Nigerian Government and the FDA agreed to Pfizer’s plan and authorized treatment for the ill children at the IDH in Kano. According to Pfizer’s statements, half of the children were treated with Trovan and half with Ceftriaxone. Since the patients were children, an issue of consent had to be discussed with their parents; Pfizer’s doctors did not speak the language and had to rely on the information provided by local nurses indicating that consent was authorized by the parents.17 On the other hand, the parents of the treated children, the plaintiffs, alleged that Pfizer conducted unauthorized biomedical research experiments on the Nigerian children. They alleged the use of a new, unproven, and untested antibiotic better know as Trovan. They also alleged that they had no knowledge that the treatment was experimental, that Pfizer failed to explain to them their right to refuse, and that other organizations offered more conventional treatments free of charge at the same site. Furthermore, they alleged that Pfizer provided half of the children with lower doses of a competitor’s FDA approved antibiotic Ceftriaxone so Trovan would appear more effective. 18 The plaintiffs were represented by attorney Elaine Kusel 19 from Milberg, Weiss, Bershad, Hynes & Lerach LLP a New York City firm.
Abdullahi, 77 F. App’x. 48. See Abdullahi, 77 F. App’x. 48. 16 Id. 17 See Abdullahi v. Pfizer, Inc., No. 01 CIV. 8118, 2002 WL 31082956, at * 1 (S. D. N. Y. Sep. 17, 2002) for a detailed description of the background of the case. 18 Abdullahi, 77 F. App’x. 48. 19 “Ms. Kusel is the lead attorney in the Abdullah v. Pfizer case, in which she represents Nigerian children enrolled in a clinical trial by Pfizer without their families’ informed consent. The Abdullah case is notable because it is one of the first cases in which a Court determined that plaintiffs could proceed with a claim under
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The Charges against Pfizer: The plaintiffs filed a suit in the Southern District of New York. They invoked the Alien Tort Claim Act to establish jurisdiction against Pfizer with allegations of violations of international law, specifically the International Covenant on Civil and Political Rights (ICCPR), the Universal Declaration of Human Rights, the Nuremberg Code, the Declaration of Helsinki, Guidelines of the Council for International Organizations of Medical Sciences (“CIOMS”), FDA regulations, and other norms of international law. 20 The Pfizer Corporation was represented by attorney Steven Glickstein 21 from the law firm of Kaye Scholer, LLP. The Proceedings: The NY Southern District Judge William Pauley said the Nigerian claims were not covered by the Law. Judge Pauley dismissed the case solely on the grounds that the Nigerian court was the proper forum for the suit. The United States Court of Appeals for the Second Circuit, however, remanded the case in 2003 for further considerations of bias and corruption in the Nigerian Court System. Pfizer filed a motion to dismiss for failure to state a claim under the ATCA and on forum non-convenience grounds. The court dismissed the suit for lack of subject-matter jurisdiction. In his latest decision of the case, Judge Pauley stated that none of the international declarations cited by the plaintiffs specified a private right of action or rose to the level of recognized international law,22 such as laws governing treatment of diplomats or acts of piracy on the high seas.23 II. ANALYSIS:

1. THE FACTS: In the present case, the plaintiffs alleged that Pfizer violated the Nuremberg Code, the Declaration of Helsinki, Guidelines authored by the CIOMS, Article 7 of the ICCPR and the Universal Declaration of Human Rights.24 The main arguments in the case were related to the types of actions that can be brought under the ATCA, the validity of any treaty of the United States, and the understanding of the language of the law of nations as accepted by the civilized world.

the Alien Tort Claims Act against a corporate defendant for claims other than those related to war time conduct.” See Ms. Kusel’s bio available at https://www.milbergweiss.com. 20 Abdullahi, 77 F. Appx. 48. 21 “Mr. Glickstein was lead counsel to Pfizer in Viagra litigation, winning summary judgment in various cases alleging that Viagra causes heart attacks.” See Mr. Glickstein’s bio available at http://www.kayescholer.com. 22 Abdullahi v. Pfizer, Inc., No. 01 CIV. 8118 (WHP), 2005 WL 1870811, at * 8 (S. D. N. Y. Aug. 9, 2005) (citing the U.S. Supreme Court's June 2004 decision in Sosa and ruling that, though some claims charging violations of international law could be brought under the Alien Tort Statute, it would not support claims based on international laws "with less definite content and acceptance among civilized nations" than those in place when the statute was adopted in 1789). 23 Id. 24 Abdullahi, 77 F. Appx. 48.

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The question regarding which actions can be brought under ATCA was identified in Sosa v. Alvarez-Machain, where the Court ruled that an action lies under the ATCA when there is evidence of a violation of treaties or customary international law.25 Also, the court held that claims under the ATCA must “rest on a norm of international character accepted by the civilized world and defined with specificity comparable to the features of the 18th century paradigms we have recognized.”26 The meaning intended by the first Congress regarding the definition of international law has been the subject of great debate and interpretation. Initially, Filartiga v. Pena-Irala set the standard explaining that there must be a violation of "clear and unambiguous" international law to accept a claim under ATCA. 27 Later, the meaning and interpretation of the statute was again addressed in Flores v. Southern Peru Copper Corp.28 Setting the standard again, the Court in Sosa ruled that, although some cases charging violations of international law could be brought under ATCA, the Act would not support claims based on international laws with less definite content and acceptance among civilized nations than those in place when the statute was enacted in 1789.29 The Court meant that the purpose of the Act was to include universally accepted customary law, such as international laws governing treatment of diplomats and acts of piracy on the high seas. In the present case, Judge Pauley said that the international laws cited by the plaintiffs did not rise to that level. Further, he stated that the Nuremberg Code had not been adopted by many prominent states and had never been adopted by the UN. Also, that the Declaration of Helsinki did not contain specific guidelines regarding the laws of torts in relation to human experimentation. Consequently, these international declarations did not specify a private right of action, and the creation of such private right rested with Congress.30 Before analyzing the validity of the arguments presented by both parties, it is prudent to keep in mind the court’s assertion in Filartiga regarding international law and the “understand[ing] that traditionally the Law of nations may be ascertained by consulting the works of jurists, writing professedly on public law; or by the general usage and practice of nations; or by judicial decisions recognizing and enforcing such law.”31 Further, we should understand that the law of nations is an evolving concept.32 In Kadic, the court held that international law should be interpreted as “it has evolved and exists among the nations of the world today.”33

See Sosa, 124 S. Ct. at 2761-62. Id. at 2761. 27 See Filartiga, 630 F.2d at 884 (holding that because the prohibition on official torture is "clear and unambiguous," it can serve as a basis for suit under the ATCA). 28 Flores v. Southern Peru Copper Corp., 343 F. 3d 140, 154 (2d Cir. 2003) (stating that customary international law consists of “those rules that States universally abide by, or accede to, out of a sense of legal obligation and mutual concern.”). 29 See Sosa, 124 S. Ct. 2739. 30 See Abdullahi, 77 F. Appx. 48. 31 See Filartiga, 630 F.2d at 880. 32 See Kadic v. Karadzic, 70 F. 3d 232, 232-238 (2nd Cir. 1995). 33 Id.
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2. THE LAW OF NATIONS: The ICCPR Warrants a Cause of Action Under the ATCA The International Covenant on Civil and Political Rights (ICCPR) is a United Nations treaty, which was based on the Universal Declaration of Human Rights, created in 1966 and entered into force on March 23, 1976. The plaintiffs alleged Pfizer violated Article 7 of this treaty which states in pertinent part the following: “No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation.”34 The United States Senate ratified the ICCPR in 1992, with a number of reservations, understandings, and declarations. In particular, the Senate declared that "the provisions of Article 1 through 26 of the Covenant are not self-executing."35 The Senate stated that the declaration was meant to "clarify that the Covenant will not create a private cause of action in U.S. Courts."36 The courts have recognized that where a treaty or covenant is not selfexecuting, and where Congress has not acted to implement the agreement with legislation, no private right of action is created by ratification.37 In Sosa, the Court stated that although the ICCPR “does bind the United States as a matter of international law, the United States ratified the ICCPR on the express understanding that it was not self-executing and so did not itself create obligations enforceable in the federal courts.”38 It is not disputed that the charter is a treaty and our federal Constitution provides that treaties made under the authority of the United States are part the supreme law of the land. A treaty, however, does not automatically supersede inconsistent local laws unless the treaty provisions are selfexecuting.39 In Flores, the Court held that the ICCPR is not a self-executing treaty and, because none of its provisions are sufficiently definite, the ICCPR cannot give rise to a rule of customary international law. 40 The Justice system has defined as self-executing those treaties that either expressly or implicitly create a private right of action to enforce rights described in the treaty. 41 Additionally, the issue of voluntary consent is fully discussed within the ICCPR and its concept is widely recognized by the civilized world as a fundamental principle of research

See The United Nations International Covenant on Civil and Political, Dec. 16, 1966, Part III, Section 7. See Senate declaration, 138th Cong. Rec. S4781-84 (1992). 36 See S. Exec. Rep. No. 102-23, at 15 (1992), Sei Fujii v. State 38 Cal. 2d 718 (1952). 37 See Fujii, 38 Cal. 2d 718 38 Sosa, 124 S. Ct. at 2767. 39 See Fujii, 38 Cal. 2d 718. 40 Flores, 343 F. 3d at 169. 41 In the words of Chief Justice Marshall: A treaty is "to be regarded in courts of justice as equivalent to an act of the Legislature, whenever it operates of itself, without the aid of any legislative provision. But when the terms of the stipulation import a contract -- when either of the parties engages to perform a particular act, the treaty addresses itself to the political, not the judicial department; and the Legislature must execute the contract, before it can become a rule for the court." See Sei Fujii, 38 Cal. 2d 718 (quoting (Foster v. Neilson, 2 Pet. (U.S.) 253, 314 (1829), [7 L.Ed. 415])).
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ethics.42 Notwithstanding that the United States is a party of the International Covenant on Civil and Political Rights, the language of Article 7 could also be found within the text of the Federal Policy for the Protection of Human Subjects. This policy is better known as common rule 45 CFR 46.117, which states in pertinent part as follows: Sec. 46.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form. (b) Except as provided in paragraph (c) of this section, the consent form may be either of the following: (1) A written consent document that embodies the elements of informed consent required by Sec. 46.116. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed; or (2) A short form written consent document stating that the elements of informed consent required by Sec. 46.116 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. (emphasis added) The United States designated Title 45-Public Welfare, subsection 46 of the Code of Federal Regulations for the Department of Health and Human Services to the protection of human subjects against any research conducted, supported, or otherwise subject to regulation by any federal department or agency. 43 The Code also includes research conducted, supported, or otherwise subject to regulation by the federal government outside the United States.44 Furthermore, the Code recognizes international law when the action at issue happened in foreign countries. It should be noted that the Code recognizes international law in section 46.101(h). The code states in pertinent part as follows: Sec. 46.101 To what does this policy apply? (h) When research covered by this policy takes place in foreign countries, procedures normally followed in the foreign countries to protect human subjects may differ from those set forth in this policy. [An example is a foreign institution which complies with guidelines consistent with the World Medical Assembly Declaration (Declaration of Helsinki amended 1989) issued either by sovereign states or by an
See International Covenant on Civil and Political Rights, Dec. 16 1966, article III. (Adopted and opened for signature, ratification, and accession by General Assembly resolution 2200A (XXI), and entered into force on March23, 1976, in accordance with Article 49.) 43 See 45 C.F.R. 46. Welfare Department of Health and Human, Protection of Human Subjects. 44 See 45 C.F.R 46.101(a)
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organization whose function for the protection of human research subjects is internationally recognized.] In these circumstances, if a department or agency head determines that the procedures prescribed by the institution afford protections that are at least equivalent to those provided in this policy, the department or agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this policy. Except when otherwise required by statute, Executive Order, or the department or agency head, notices of these actions as they occur will be published in the Federal Register or will be otherwise published as provided in department or agency procedures. (emphasis added) Although there are many questions regarding the interpretation and application of the rules of voluntary informed consent, the United States recognizes that consent is a fundamental right as shown in the federal code and in the text of other agencies regulated by the federal government. It is clear that the language in the ATCA, as written by the first Congress, only requires a tort in violation of the law of nations to grant jurisdiction. 45 Subject matter jurisdiction is based on the violation, but the tort is the origin of the cause of action. No additional requirement is mentioned in the language of the ATCA regarding the need of a separate enabling statute or provision for a private right of action. CIOMS Guidelines Rise to the Standards of International Law In the case at hand, the plaintiffs alleged that Pfizer violated the Guidelines of the Council for International Organizations of Medical Sciences (CIOMS), which state in pertinent part the following: Guideline 14, Research Involving Children Before undertaking research involving children, the investigator must ensure that:  the research might not equally well be carried out with adults;  the purpose of the research is to obtain knowledge relevant to the health needs of children;  a parent or legal representative of each child has given permission;  the assent of each child has been obtained to the extent of the child's capabilities; and  a child's refusal to participate or continue in the research will be respected. Although courts would not dispute the validity of the treaty or its content, they would closely analyze its validity under the ATCA. In Flores, the court addressed the issue of customary international law and held that declarations of private organizations cannot
See Sosa, 124 S. Ct. at 2755 ("federal courts could entertain claims once the jurisdictional grant was on the books, because torts in violation of the law of nations would have been recognized within the common law of the time.").
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establish customary international law because “such declarations are almost invariably political statements - expressing the sensibilities and the asserted aspirations and demands of some countries and organizations – rather than statements of universally recognized legal obligations.”46 Furthermore, the court ruled that the CIOMS Guidelines are declarations of a private organization and cannot establish customary international law. 47 The CIOMS International Ethical Guidelines, Common Rule 45 of Code of Federal Regulations, and Title 21 of the CFR 50 for the Federal Drug Administration (FDA) are regulatory standards listed at the Office for Human Research Protection (OHRP) from the United States Department of Health and Human Services. This office also lists the Declaration of Helsinki and the Belmont report as its current codes of ethics.48 The Declaration of Helsinki Warrants a Claim under the ATCA The Declaration of Helsinki was issued by the World Medical Association in 1964.49 The Declaration of Helsinki, Articles 9 and 32 state in pertinent part: Article 9: any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she is free to withdraw his or her consent to participation at any time. The physician should then obtain the subject’s freely given informed consent, preferably in writing. (emphasis added) Article 32: In the treatment of a patient, where proven prophylactic, diagnostic and therapeutic methods do not exist or have been ineffective, the physician, with informed consent from the patient, must be free to use unproven or new prophylactic, diagnostic and therapeutic measures, if in the physician's judgment it offers hope of saving life, reestablishing health or alleviating suffering. Where possible, these measures should be made the object of research, designed to evaluate their safety and efficacy. In all cases, new information should be recorded and, where appropriate, published. The other relevant guidelines of this Declaration should be followed. (emphasis added) In continuing its analysis, the court in Flores held that the Declaration of Helsinki is a document produced by a private organization, and therefore, not qualified to establish customary international law.50 Additionally, the Court in Sosa held that the Declaration of
Flores, 343 F. 3d at 169. Id. at 168. 48 The OHSR was established to help IRP investigators understand and comply with the ethical guidelines and regulatory requirements for research involving human subjects, available at http://www.hhs.gov/ohrp/ 49 See The International Ethical Guidelines for Biomedical Research Involving Human Subjects prepared by the Council for International Organizations of Medical Sciences (CIOMS), Geneva 2002. 50 See Flores, 343 F. 3d at 168.
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Helsinki “does not of its own force impose obligations as a matter of international law.”51 The Declaration of Helsinki, Article 22 was amended in October of 2000 regarding the informed consent process, and states that “if the consent cannot be obtained in writing, the non-written consent must be formally documented and witnessed.”52 Similar definitions and explanations regarding the voluntary informed consent process can also be found in similar documents originated by institutions dedicated to the protection of human subjects and their freedom of choice. Some examples of these documents are the Common Rule 45 (46.116 and 46.117), the FDA regulations (21 CFR 56), and the Council for International Organizations of Medical Sciences (CIOMS). The United States has recognized the importance of international law in some specific cases regardless of private origin or non-ratified status. A clear example is United States v. Iran,53 where the Department of State, citing the Vienna convention, declared in its letter of Submittal to the President that “although not yet in force, the convention is already generally recognized as the authoritative guide to current treaty law and practice.” 54 The United States has never ratified the Vienna Convention on the Law of Treaties, and more recently the United States has withdrawn from an international agreement that gives the International Court of Justice the right to adjudicate violations of the Vienna Convention regarding the incarceration of non-U.S. citizens.55 III. CONCLUSION:

An argument could be made that the ATCA would deter corporations from reaching and helping other countries facing devastating epidemics or life threatening crisis, even when some of these corporations could have the means or products that could provide relief for such crisis. We live in a time where globalization must oblige corporations to face more regulations and scrutiny than ever. Regulations about the environment and human health issues in other nations are the subject of every summit around the world. Unfortunately, the cultural differences and governmental policies make the process of global integration a long and sometimes painful one. As noted in a study by the National Bioethics Advisory Commission, Nigerians would react negatively to a full disclosure of all possible risks associated with a medical research procedure. Therefore, it would be nearly impossible for a
Sosa, 124 S. Ct. at 2767. See The Declaration of Helsinki, available at http://www.FDA.gov/oc/health/helsinki.html 53 International Court of Justice (1980 ICJ Rep.3), "The Government of the United States respectfully requests that the Court adjudge and declare as follows: (a) that the Government of the Islamic Republic of Iran, in permitting, tolerating, encouraging, adopting, and endeavoring to exploit, as well as in failing to prevent and punish, the conduct described in the Statement of the Facts, violated its international legal obligations to the Unites States as provided by: --Articles 22, 24, 25, 26, 27, 29, 31, 37, 44 and 47 of the Vienna Convention on Diplomatic Relations. --Articles 5, 27, 28, 31, 33, 34, 35, 36, 40 and 72 of the Vienna Convention on Consular Relations; --Articles II(4), XIII, XVIII and XIX of the Treaty of Amity Economic Relations, and Consular Rights between the United States of America and Iran; and --Articles 2, 4 and 7 of the Convention on the Prevention and Punishment of Crimes against Internationally Protected Persons, including Diplomatic Agents.” 54 S. Exec. Doc. L., 92nd Cong., 1st Sess. 1 (1971). 55 See CNN special report “U.S. quits foreign inmate accord”, March 11, 2005, available at http://www.cnn.com/2005/US/03/11/vienna.convention/
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foreign corporation to enroll participants in the Nigerian communities in these studies if the corporation had to adhere to disclosure and voluntary written consent regulations prior to using unregulated and unapproved medication. These problems, however, should not be the basis to deny Nigerians their right to choose between voluntary participation and complete rejection of the drug. As noted in Sosa, the courts of the United States “must consider the foreign relations consequences before finding that certain conduct should be actionable under the ATCA.” 56 Corporations involved in humanitarian acts with other nations should be regulated to consider important factors, such as language and cultural differences, when dealing with foreign nations. Accordingly, the next time a corporation travels abroad to provide medical aid to foreign nationals, it will follow international guidelines, such as obtaining written consent for medical trials or executing full disclosure explaining all the risks and consequences associated with the medical research in the appropriate foreign language. The National Bioethics Commission (NBAC) recommends that United States sponsors of research in developing countries adhere to high internationally recognized standards of voluntary informed consent before outreaching to other countries. Pfizer should have acknowledged the importance of these internationally recognized standards when approaching a less informed nation like Nigeria, especially under the stress and desperation that an epidemic of this magnitude would create among its people and its government. Jurisdiction under the ATCA could very well be our only option to bring to the courts corporations that currently do not follow the law of nations in international matters. A costly and lengthy procedure would awaken the multinational corporate world to find a more appropriate remedy which could incorporate human rights, such as minimum wages, basic health insurance, safety, and sexual harassment, in future international trade negotiations. The aforementioned reasons are therefore enough evidence that a claim under the ATCA existed in this case, and Pfizer should have stood for trial due to its violation to the law of nations.

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Sosa, 124 S. Ct. 2739.

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