Pfizer Nigeria Trovan Case

Pfizer Nigeria Trovan Case

Pfizer Nigeria Trovan Case

Re: the Legality of Pfizer’s procedures to trial & administer a new drug without consent that resulted in deaths & severe injury of children

 

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Facts of the Case

aka: Rabi Abdullahi, et al. v. Pfizer, Inc., 562 F.3d (2d Cir. 2009)

  • Argued: July 12, 2007
  • Location: New York
  • Court: U.S. 2nd Circuit Court of Appeals – Southern District of New York
  • Citations #: 562 F.3d 163
  • Docket #: 05-4863
  • Plaintiff: Rabi Abdullahi, et al
  • Defendant: Pfizer
  • Trial Type:
  • Judges: Pooler, B.D. Parker & Wesley
  • Status: End
  • Verdict: For the Plaintiff
  • Decided: Jan 30, 2009


 

Background

The case involved Pfizer which conducted an unapproved, trial of its experimental antibiotic, Trovan on children in Nigeria. (1)

Plaintiffs-Appellants Rabi Abdullahi and other Nigerian children and their guardians sued Defendant-Appellee Pfizer, Inc. under the ATS (“the Abdullahi action”).

They alleged that Pfizer violated a customary international law norm prohibiting involuntary medical experimentation on humans when it tested an experimental antibiotic on children in Nigeria, including themselves, without their consent or knowledge. Plaintiffs-Appellants Ajudu Ismaila Adamu and others, also children and their guardians who were part of Pfizer’s Nigerian drug experiment, brought a similar action against Pfizer, alleging violations of the ATS, the Connecticut Unfair Trade Practices Act (“CUTPA”), and the Connecticut Products Liability Act (“CPLA”) (“the Adamu action”) (2)

The appellants allege that at that time, Pfizer, the world’s largest pharmaceutical corporation, sought to gain the approval of the U.S. Food and Drug Administration (“FDA”) for the use on children of its new antibiotic, Trovafloxacin Mesylate, marketed as “Trovan.” They contend that in April 1996, Pfizer, dispatched three of its American physicians to work with four Nigerian doctors to experiment with Trovan on children who were patients in Nigeria’s Infectious Disease Hospital (“IDH”) in Kano, Nigeria. Working in concert with Nigerian government officials, the team allegedly recruited two hundred sick children who sought treatment at the IDH and gave half of the children Trovan and the other half Ceftriaxone, an FDA-approved antibiotic the safety and efficacy of which was well-established. Appellants contend that Pfizer knew that Trovan had never previously been tested on children in the form being used and that animal tests showed that Trovan had life-threatening side effects, including joint disease, abnormal cartilage growth, liver damage, and a degenerative bone condition. Pfizer purportedly gave the children who were in the Ceftriaxone control group a deliberately low dose in order to misrepresent the effectiveness of Trovan in relation to Ceftriaxone. After approximately two weeks, Pfizer allegedly concluded the experiment and left without administering follow-up care. According to the appellants, the tests caused the deaths of eleven children, five of whom had taken Trovan and six of whom had taken the lowered dose of Ceftriaxone, and left many others blind, deaf, paralyzed, or brain-damaged. (2)

Appellants claim that Pfizer, working in partnership with the Nigerian government, failed to secure the informed consent of either the children or their guardians and specifically failed to disclose or explain the experimental nature of the study or the serious risks involved. Although the treatment protocol required the researchers to offer or read the subjects documents requesting and facilitating their informed consent, this was allegedly not done in *170 either English or the subjects’ native language of Hausa. The appellants also contend that Pfizer deviated from its treatment protocol by not alerting the children or their guardians to the side effects of Trovan or other risks of the experiment, not providing them with the option of choosing alternative treatment, and not informing them that the non-governmental organization Médecins Sans Frontières (Doctors Without Borders) was providing a conventional and effective treatment for bacterial meningitis, free of charge, at the same site.[2] (2)

The appellants allege that, in an effort to rapidly secure FDA approval, Pfizer hastily assembled its test protocol at its research headquarters in Groton, Connecticut, and requested and received permission to proceed from the Nigerian government in March 1996. At the time, Pfizer also claimed to have secured approval from an IDH ethics committee. Appellants allege, however, that the March 1996 approval letter was backdated by Nigerian officials working at the government hospital well after the experiments had taken place and that at the time the letter was purportedly written, the IDH had no ethics committee.[3] Appellants also contend that the experiments were condemned by doctors, including one on Pfizer’s staff at the time of the Kano trial. (2)

*    *    *                   *    *    *                   *    *    *                   *    *    *                    *    *    *

In 1998, the FDA approved Trovan for use on adult patients only.

After reports of liver failure in patients who took Trovan, its use in America was eventually restricted to adult emergency care.

In 1999, the European Union banned its use.

*    *    *                   *    *    *                   *    *    *                   *    *    *                    *    *    *

 

Starting in 2001 several suits were taken to Nigerian courts, but without success.

Since then, a tectonic change has altered the relevant political landscape. In May 2007, the state of Kano brought criminal charges and civil claims against Pfizer, seeking over $2 billion in damages and restitution.[4] Around the same time, the federal government of Nigeria sued Pfizer and several of its employees, seeking $7 billion in damages.[5] None of these cases seek compensation for the subjects of the tests, who are the appellants before this Court. Pfizer then notified this Court that in light of these recent developments, which it believed required further consideration by the district court, it would not seek affirmance on the basis of forum non conveniens. (2)

In their twin complaints, which total 628 paragraphs, Plaintiffs make only four allegations concerning the role of the Nigerian government in the Trovan experiments:

(1) in order for the FDA to authorize the export of Trovan, “Pfizer obtained the required letter of request from the Nigerian government”; (

2) the government “arrang[ed] for Pfizer’s accommodation in Kano”;

(3) the government acted “to silence Nigerian physicians critical of [Pfizer’s] test”; and

(4) the government “assign[ed] Nigerian physicians to assist in the project.”[18] Elsewhere in their complaints, Plaintiffs note in conclusory fashion that a Nigerian doctor did not publicly object to the Trovan study because it “seemed to have the backing of the Nigerian government.” (2)

 

Significance

This case is significant as it challenges the legality of informed consent and the notion that the pharmaceutical company Pfizer may or may not experiment on people even in a foreign nation. It is further significant that the court cited the Nuremberg Code as: “the universally accepted norm in customary international law regarding nonconsensual medical experimentation.” (2)

 

Plaintiff’s Argument

The appellants ground their claims in four sources of international law that categorically forbid medical experimentation on non-consenting human subjects: (1) the Nuremberg Code, which states as its first principle that “[t]he voluntary consent of the human subject is absolutely essential”; (2) the World Medical Association’s Declaration of Helsinki, which sets forth ethical principles to guide physicians world-wide and provides that human subjects should be volunteers and grant their informed consent to participate in research; (3) the guidelines authored by the Council for International Organizations of Medical Services (“CIOMS”), which require “the voluntary informed consent of [a] prospective subject”; and (4) Article 7 of the International Covenant on Civil and Political Rights (“ICCPR”), which provides that “no one shall be subjected without his free consent to medical or scientific experimentation.”[7] (2)

The district court found that “non-consensual medical experimentation violates the law of nations and, therefore, the laws of the United States” and cited the Nuremberg Code for support. (2)

The Defendants argued that the Nuremberg Code was relevant:

This history illustrates that from its origins with the trial of the Nazi doctors at Nuremburg through its evolution in international conventions, agreements, declarations, and domestic laws and regulations, the norm prohibiting nonconsensual medical experimentation on human subjects has become firmly embedded and has secured *184 universal acceptance in the community of nations. Unlike our dissenting colleague’s customary international law analysis, which essentially rests on the mistaken assumption that ratified international treaties are the only valid sources of customary international law for ATS purposes, see Dissent at 200-02, we reach this conclusion as a result of our review of the multiplicity of sources—including international conventions, whether general or particular, and international custom as identified through international agreements, declarations and a consistent pattern of action by national law-making authorities—that our precedent requires us to examine for the purpose of determining the existence of a norm of customary international law. Our dissenting colleague’s reasoning fails to engage the incompatibility of nonconsensual human testing with key sources of customary international law identified in Article 38 of the ICJ’s statute, most importantly international custom, as evidence of a general practice accepted as law, as well as the general principles of law recognized by civilized nations. See supra pp. 174-75. (2)

 

Defendant’s Argument

…More information is needed…

 

Related Previous Cases

The ruling cites the Nuremberg Code as an important precedent for the following reasons:

In August 1947, Military Tribunal 1, staffed by American judges and prosecutors and conducted under American procedural rules, see George J. Annas, The Nuremberg Code in U.S. Courts: Ethics versus Expediency, in The Nazi Doctors and the Nuremberg Code 201, 201 (George J. Annas & Michael A. Grodin eds., 1992), promulgated the Nuremberg Code as part of the tribunal’s final judgment against fifteen doctors who were found guilty of war crimes and crimes against humanity for conducting medical experiments without the subjects’ consent, Brandt, 2 Nuremberg Trials, at 181-82. Among the nonconsensual experiments that the tribunal cited as a basis for their convictions were the testing of drugs for immunization against malaria, epidemic jaundice, typhus, smallpox and cholera. Id. at 175-178. Seven of the convicted doctors were sentenced to death and the remaining eight were sentenced to varying terms of imprisonment. Id. at 298-300. The tribunal emphasized that (2)

[i]n every single instance appearing in the record, subjects were used who did not consent to the experiments; indeed, as to some of the experiments, it is not even contended by the defendants that the subjects occupied the status of volunteers. (2)

Id. at 183. The judgment concluded that “[m]anifestly human experiments under such conditions are contrary to the principles of the law of nations as they result from usages established among civilized *179 peoples, from the laws of humanity, and from the dictates of public conscience.” Id. (emphasis added and internal quotation marks omitted). The Code created as part of the tribunal’s judgment therefore emphasized as its first principle that “[t]he voluntary consent of the human subject is absolutely essential.” Id. at 181. (2)

The American tribunal’s conclusion that action that contravened the Code’s first principle constituted a crime against humanity is a lucid indication of the international legal significance of the prohibition on nonconsensual medical experimentation. As Justices of the Supreme Court have recognized, “[t]he medical trials at Nuremberg in 1947 deeply impressed upon the world that experimentation with unknowing human subjects is morally and legally unacceptable.United States v. Stanley, 483 U.S. 669, 687, 107 S. Ct. 3054, 97 L. Ed. 2d 550 (1987) (Brennan, J., concurring in part and dissenting in part) (emphasis added); see also id. at 709-10, 107 S. Ct. 3054 (O’Connor, J., concurring in part and dissenting in part). (2)

Moreover, both the legal principles articulated in the trials’ authorizing documents and their application in judgments at Nuremberg occupy a position of special importance in the development of bedrock norms of international law. United States courts examining the Nuremberg judgments have recognized that “[t]he universal and fundamental rights of human beings identified by Nuremberg—rights against genocide, enslavement, and other inhumane acts …—are the direct ancestors of the universal and fundamental norms recognized as jus cogens,” from which no derogation is permitted, irrespective of the consent or practice of a given State. Siderman de Blake v. Republic of Arg., 965 F.2d 699, 715 (9th Cir.1992) (cited in Sampson v. F.R.G., 250 F.3d 1145, 1150 (7th Cir.2001)). As Telford Taylor, who first served as an assistant to Justice Robert Jackson during his time as Chief Prosecutor for the IMT and then became Chief of Counsel for War Crimes on the Nuremberg trials held under the authority of Control Council Law No. 10, explained, “Nuremberg was based on enduring [legal] principles and not on temporary political expedients, and this fundamental point is apparent from the reaffirmation of the Nuernberg principles in Control Council Law No. 10, and their application and refinement in the 12 judgments rendered under that law during the 3-year period, 1947 to 1949.” Taylor, Report on Nuernberg War Crimes Trials, at 107 (emphasis added). (2)

  •  

Additional international law sources support the norm’s status as customary international law.

  • The European Union embraced the norm prohibiting nonconsensual medical experimentation through a 2001 Directive passed by the European Parliament and the Council of the European Union. The Directive accepted the informed consent principles of the 1996 version of the Declaration of Helsinki. Council Directive 2001/20/EC, preamble (2), 2001 O.J. (L 121) 37(EC) [hereinafter 2001 Clinical Trial Directive]. It also required member States to adopt rules protecting individuals incapable of giving informed consent and permitting clinical trials only where “the trial subject or, when the person is not able to give informed consent, his legal representative has given his written consent after being informed of the nature, significance, implications and risks of the clinical trial.Id. at art. (1), (2)(d). The Directive further required all member States to implement by 2004 domestic laws, regulations, and administrative provisions to comply with its informed consent requirements. Id. at art. 22(1). (2)
  • Since 1997, thirty-four member States of the Council of Europe have also signed the Convention on Human Rights and Biomedicine, a binding convention and a source of customary international law. (2)
  • In 2005, the General Conference of the United Nations Educational, Scientific and Cultural Organization (UNESCO) adopted the Universal Declaration on Bioethics and Human Rights, which requires “the prior, free, express and informed consent of the person concerned” for research-oriented treatments. Universal Declaration on Bioethics and Human Rights, UNESCO Gen. Conf. Res., at art. 6, 33rd Sess., 33 C/Resolution 36, (Oct. 19, 2005). (2)

 

Decision

The court ruled to ” REVERSE the judgments of the district court and REMAND for further proceedings.”
 
Regarding the Nuremberg Code it said “The Nuremberg trials are unquestionably one of this country’s greatest and most enduring contributions to the field of international law.” (2)

 

Aftermath

Pfizer agreed to pay 75 million dollars in damages if the plaintiffs take DNS tests. Many refused as they did not trust Pfizer with further “medical” procedures.

 

Further Research

Court Documents:
In the news:
  • …More information is needed…

 

Media

Pfizer’s Trovan Trial & Settlement

source: Al Jazeera English

Pfizer Criminal case adjourned until October 2015

source: AP Archive

Pfizer Criminal History

source: Odysee

 

References

  1. The Significance of the Nuremberg Code
  2. Court Ruling

 

Keyword

Pfizer, Informed Consent, Trovan, Nigeria, Nuremberg, Court of Appeals, USA


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UC Students v Vaccine Mandates Case

UC Students v Vaccine Mandates Case

UC Students Vaccine Mandate Case

Re: Legality of Vaccine Mandates as a condition to study at the University of Cincinnati

 

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Facts of the Case

aka: Benjamin Lipp, et al. v. University of Cincinnati

  • Dates: filed 12/10/2021
  • Location: Hamilton County, Ohio USA
  • Court: Common Pleas Civil Court
  • Case #: A 2104238
  • Plaintiff: Benjamin Lipp, et al.
  • Defendant: University of Cincinnati
  • Trial Type:
  • Judge: Leslie Ghiz
  • Status: Ongoing
  • Verdict: TBD


 

Background

Calling it a civil rights issue designed to check a university’s abuse of power, Akron-based Mendenhall Law Group filed a lawsuit against the University of Cincinnati (UC) and its board of trustees over the school’s COVID-19 vaccine mandate. (4)

The action was introduced in the Hamilton County Court of Common Pleas on Wednesday and includes four plaintiffs: students Benjamin Lipp, Danielle Seymore, Katelyn Verbarg and Nicholai Lekson. Warner Mendenhall and Kyle Wenning are representing the plaintiffs. (4)

The plaintiffs all were students at University of Cincinnati. Three of the plaintiffs had received exemptions from the school’s vaccine mandates. One of the plaintiffs met the vaccination requirement but he objects to the University’s mandatory vaccine policy and the possibility of having to receive a booster shot to stay in school. (1)

Multiple students told The Ohio Press Network (OPN) that they have received coercive emails from UC officials, and those who have questioned the mandate have been subject to derogatory remarks, including “you freedom people are annoying.” (4)

Lipp, who is also a plaintiff, is 24 and a senior majoring in finance. He points out that the virus has a more than 99% survival rate for Ohioans in his age range and the vaccine does not prevent transmission or infection of the virus.

“Even as an unvaccinated student, I have low risk of dying from COVID, and I’ve had the virus, so that puts me in a different class because of my natural immunity,” he explained. “If someone else is vaccinated, why do I need to be vaccinated?”

His personal opinion aside, Lipp said that he chose to join the lawsuit as a plaintiff because he believes university officials are violating his rights.

“You don’t have to have an opinion on COVID-19 to agree with the lawsuit. It’s not about whether or not masks and the vaccine works. It’s about public officials not acting within legal authority,” Lipp said. “If they can get away with this, what else will they try? This lawsuit is important because it is designed to hold them accountable.”

In September, UC instituted a COVID-19 vaccine mandate for students, faculty and staff. Students were required to show proof of at least one dose of the shot by October 15 and two doses of the inoculation by November 15. (4)

The mandate applies to students and university employees who visit campus for class or work, and individuals who use campus facilities. Medical and religious exemptions to the vaccine requirement can be requested, according to the mandate. (4)

Students who do not comply by January 3 will be unenrolled from spring semester classes. Weekly testing is required between November 15 and January 3 for anyone not in compliance with the mandate. (4)

The website also includes: “The university will consider disciplinary measures in accordance with established policies for faculty and staff who are not fully vaccinated or have not been granted an exemption before the beginning of spring semester. Discipline for represented employees will proceed in accordance with agreed-upon processes currently being discussed with their collective bargaining units.” (4)

OPN (the Ohio Press Network) was provided with numerous emails obtained by a public records request that show UC officials attempting to implement their COVID-19 vaccine mandate despite the passage of HB 244, which was signed into law by Gov. Mike DeWine and became effective on October 13. (4)

The legislation prohibits Ohio public schools from requiring vaccines not yet approved by the U.S. Food and Drug Administration (FDA). HB 244 also says that public schools cannot discriminate against people not vaccinated by mandating that they perform different activities from their vaccinated counterparts. Schools covered by the bill include state colleges and universities along with public schools, joint vocational school districts, college-prep boarding schools and STEM schools. (4)

 

Significance

This case covers multiple issues including discrimination, abuse of power and government over reach, illegal mandates, sovereignty of their own bodies, and the veracity of the Covid and Inoculation narrative

 

Plaintiff’s Argument

According to the lawsuit filing, “this is a civil action for declaratory and injunctive relief involving the statutory and constitutional validity of UC’s vaccination and health measure mandates effective Sept. 1, 2021.

“By reason of Ohio Revised Code 3709.212 and Ohio case law, the defendants lack authority to order those not diagnosed with a disease or have not come into direct contact with someone who has not been diagnosed with a disease to wear masks, undergo testing or limit their activities.”

The filing adds that the mandate also violates Ohio Revised Code 3792.04 because UC is a state school of higher education and is “discriminating by requiring plaintiffs to engage in or refrain from engaging in activities or precautions that differ from the activities or precautions of an individual who has received a vaccine that has not been fully approved by the FDA.”

The school’s vaccine mandate violates revised code 3792.04. The mandate violates Article I, Section 1 of the Ohio Constitution in that it violates Plaintiffs’ right to refuse medical treatment. The Mandate violates R.C. 2905.12 to the extent that it coerces Plaintiffs from taking or refraining from actions over which they should have legal freedom by choice, by taking, withholding or threatening to take or withhold official action. (1)

 
“One of the things we have seen across the country is exactly what we are pointing out in this lawsuit, that authorities are stepping outside the bounds of their authority,” Mendenhall said. “That equals an abuse of power, and it’s happening at federal, state and local level and at colleges and universities. Our lawsuit is designed to check the abuse of power.
 
“We have autonomy in our medical-decision making,”… “It is unprecedented that a university would require an experimental medical procedure on students or masking.

“We are waking up to the fact that the COVID-19 injection is not stopping spread,” … “Those who get the shot do not provide protection to anyone else. It is absurd that people are mistreated because they choose to not get a shot.” He noted that natural immunity is overlooked and it can be at least six times stronger than the vaccine.

“We would like [university officials] to end all mandates and not treat people differently,”

 

Defendant’s Argument

???

 

Decision

TBD

 

Aftermath

???

 

 

Media

IU students file lawsuit over vaccine mandate

source: WHAS11

Judge halts vaccine mandate in 10 states

source: Fox News

Pfizer Vaccine Effectiveness Analyzed

source: Canadian Covid Care Alliance


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PDF-Shannon-MO-DOH-Ruling

Shannon v MO DOH Ruling

Re: The Legality of Covid Lockdowns & Emergency Measures

 

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Official Court Ruling for Shannon v The Missouri Department of Health from Nov 22 2021 (case # 20AC-CC00515)


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