Kano Trovafloxacin trial litigation
Encyclopedia
Pharmaceutical company
The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices...
Pfizer
Pfizer
Pfizer, Inc. is an American multinational pharmaceutical corporation. The company is based in New York City, New York with its research headquarters in Groton, Connecticut, United States...
conducted tests of trovafloxacin
Trovafloxacin
Trovafloxacin is a broad spectrum antibiotic that inhibits the uncoiling of supercoiled DNA in various bacteria by blocking the activity of DNA gyrase and topoisomerase IV. It was withdrawn from the market due to the risk of hepatotoxicity...
(a quinolone
Quinolone
The quinolones are a family of synthetic broad-spectrum antibiotics. The term quinolone refers to potent synthetic chemotherapeutic antibacterials....
antibiotic) in Nigeria
Nigeria
Nigeria , officially the Federal Republic of Nigeria, is a federal constitutional republic comprising 36 states and its Federal Capital Territory, Abuja. The country is located in West Africa and shares land borders with the Republic of Benin in the west, Chad and Cameroon in the east, and Niger in...
on 100 children, five of whom died, with many others suffering life-altering injuries. All of the children treated with the drug were already severely ill with meningitis
Meningitis
Meningitis is inflammation of the protective membranes covering the brain and spinal cord, known collectively as the meninges. The inflammation may be caused by infection with viruses, bacteria, or other microorganisms, and less commonly by certain drugs...
. Pfizer also treated 100 children with the standard anti-meningitis drug ceftriaxone
Ceftriaxone
Ceftriaxone is a third-generation cephalosporin antibiotic. Like other third-generation cephalosporins, it has broad spectrum activity against Gram-positive and Gram-negative bacteria. In most cases, it is considered to be equivalent to cefotaxime in terms of safety and efficacy...
(a cephalosporin
Cephalosporin
The cephalosporins are a class of β-lactam antibiotics originally derived from Acremonium, which was previously known as "Cephalosporium".Together with cephamycins they constitute a subgroup of β-lactam antibiotics called cephems.-Medical use:...
antibiotic), albeit at a lower dose than was standard. Six of those 100 children died. The lead investigator was Dr. Abdulhamid Isa Dutse. Dr. Dutse falsified the letter for research ethics approval.
Overall, the 1996 meningitis epidemic
Epidemic
In epidemiology, an epidemic , occurs when new cases of a certain disease, in a given human population, and during a given period, substantially exceed what is expected based on recent experience...
in northern Nigeria
Northern Nigeria
Northern Nigeria is a geographical region of Nigeria. It is more arid and less densely populated than the south. The people are largely Muslim, and many are Hausa...
killed about 12,000 people, during the worst known meningitis outbreak in Sub-Saharan Africa
Sub-Saharan Africa
Sub-Saharan Africa as a geographical term refers to the area of the African continent which lies south of the Sahara. A political definition of Sub-Saharan Africa, instead, covers all African countries which are fully or partially located south of the Sahara...
.
The survivors of the trovafloxacin test attempted to bring a number of legal actions against Pfizer in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
. These attempts to bring suit against Pfizer resulted in four judicial opinions, with no decision on the merits. For a time, it seemed that the end result would be that the Nigerian plaintiffs would be barred from bringing suit in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
. However in late January 2009 the United States Court of Appeals for the Second Circuit
United States Court of Appeals for the Second Circuit
The United States Court of Appeals for the Second Circuit is one of the thirteen United States Courts of Appeals...
ruled that the Nigerian victims and their families are entitled to bring suit against Pfizer in the United States under the Alien Tort Statute
Alien Tort Statute
The Alien Tort Statute ) is a section of the United States Code that reads: "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." This statute is notable for allowing...
.
After four attempts to sue Pfizer in America, the plaintiffs' putative claims had been dismissed three times. In May 2006, however, at least one member of the United States Congress
United States Congress
The United States Congress is the bicameral legislature of the federal government of the United States, consisting of the Senate and the House of Representatives. The Congress meets in the United States Capitol in Washington, D.C....
, Representative Tom Lantos
Tom Lantos
Thomas Peter "Tom" Lantos was a Democratic member of the United States House of Representatives from 1981 until his death, representing the northern two-thirds of San Mateo County and a portion of southwest San Francisco...
of California
California
California is a state located on the West Coast of the United States. It is by far the most populous U.S. state, and the third-largest by land area...
, the senior Democrat
Democratic Party (United States)
The Democratic Party is one of two major contemporary political parties in the United States, along with the Republican Party. The party's socially liberal and progressive platform is largely considered center-left in the U.S. political spectrum. The party has the lengthiest record of continuous...
on the House International Relations Committee, described the report’s findings as “absolutely appalling” and called for Pfizer to open its records.
Abdullahi v. Pfizer, Inc. I
In 2002, a group of Nigerian minors and their guardians sued Pfizer in the United States District Court for the Southern District of New YorkUnited States District Court for the Southern District of New York
The United States District Court for the Southern District of New York is a federal district court. Appeals from the Southern District of New York are taken to the United States Court of Appeals for the Second Circuit The United States District Court for the Southern District of New York (in case...
. Plaintiffs alleged that “they suffered grave injuries from an experimental antibiotic administered by defendant Pfizer Inc. (“Pfizer”) without their informed consent
Informed consent
Informed consent is a phrase often used in law to indicate that the consent a person gives meets certain minimum standards. As a literal matter, in the absence of fraud, it is redundant. An informed consent can be said to have been given based upon a clear appreciation and understanding of the...
.” On 29 August 2001, plaintiffs brought this action under the Alien Tort Claims Act, 28 U.S.C. § 1350, to recover damages for Pfizer’s alleged violations of the Nuremberg Code
Nuremberg Code
The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg Trials at the end of the Second World War.-Background:...
, the Declaration of Helsinki
Declaration of Helsinki
The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association . It is widely regarded as the cornerstone document of human research ethics...
, the International Covenant on Civil and Political Rights
International Covenant on Civil and Political Rights
The International Covenant on Civil and Political Rights is a multilateral treaty adopted by the United Nations General Assembly on December 16, 1966, and in force from March 23, 1976...
and customary international law
Customary international law
Customary international law are those aspects of international law that derive from custom. Along with general principles of law and treaties, custom is considered by the International Court of Justice, jurists, the United Nations, and its member states to be among the primary sources of...
(otherwise known as the “law of nations”).
The District Court summarized the Nigerian plaintiffs’ allegations as follows:
In the mid-1990s, Pfizer developed Trovafloxacin Mesylate, an antibiotic that is also known by its brand name as “Trovan.” Pfizer projected that its total annual sales could exceed $ 1 billion a year. (Compl. P 96.) Beginning in 1996, Pfizer conducted the largest drug testing program ever undertaken by enrolling thousands of participants in clinical tests. (Compl. P 97.) However, prior animal testingAnimal testingAnimal testing, also known as animal experimentation, animal research, and in vivo testing, is the use of non-human animals in experiments. Worldwide it is estimated that the number of vertebrate animals—from zebrafish to non-human primates—ranges from the tens of millions to more than 100 million...
indicated that Trovan might cause significant side effects in children such as joint disease, abnormal cartilage growth (osteochondrosisOsteochondrosisOsteochondrosis is a family of orthopedic diseases of the joint that occur in children and adolescents and in rapidly growing animals, particularly pigs, horses, and dogs. They are characterized by interruption of the blood supply of a bone, in particular to the epiphysis, followed by localized...
, a disease resulting in bone deformation) and liver damage. (Compl. PP 98-99.)
In 1996, epidemics of bacterial meningitisBacterial meningitisBacterial meningitis refers to meningitis that is caused by bacterial infection.-Signs and Symptoms:*Fever*Seizures*Meningismus*Headache*Vomiting*Photophobia*Altered mental status and coma*Anorexia...
, measlesMeaslesMeasles, also known as rubeola or morbilli, is an infection of the respiratory system caused by a virus, specifically a paramyxovirus of the genus Morbillivirus. Morbilliviruses, like other paramyxoviruses, are enveloped, single-stranded, negative-sense RNA viruses...
and choleraCholeraCholera is an infection of the small intestine that is caused by the bacterium Vibrio cholerae. The main symptoms are profuse watery diarrhea and vomiting. Transmission occurs primarily by drinking or eating water or food that has been contaminated by the diarrhea of an infected person or the feces...
besieged the impoverished Nigerian city of Kano. (Compl. PP 2, 5, 101.) In April 1996, six weeks after it first learned of the epidemics, Pfizer dispatched a medical team to establish a treatment center at Kano's Infectious Disease Hospital (“IDH”). (Compl. PP 2, 8, 101-02, 101-07, 109.)
In addition to Pfizer team, humanitarian organizations such as Medecins Sans Frontieres ("MSF"), also known as Doctors Without Borders, traveled to Kano’s IDH to treat the sick. (Compl. P 5.) The medical teams operated under squalid conditions in a hospital consisting of several single story cinder block buildings, some of which lacked electricity and running water. (Compl. P 110.) The beds were filled to capacity and patients seeking care overflowed on to the hospital's grounds. (Compl. P 110.) Plaintiffs allege that while MSF and other organizations offered safe and effective treatments for bacterial meningitis, Pfizer embarked on a medical experiment involving the “new, untested and unproven” antibiotic “Trovan.” (Compl. PP 2-3, 6, 8, 95.)
To travel to Kano, Pfizer needed the U.S. Food and Drug AdministrationFood and Drug AdministrationThe Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
’s (“FDA”) authorization to export Trovan. On 15 March 1996, Pfizer informed the FDA of its intent to conduct the Kano study. (Compl. P 108.) Thereafter, Pfizer obtained a 20 March letter from the Nigerian government and a 28 March letter from IDH’s ethics committee permitting Pfizer to export Trovan to Kano. (Compl. P 108.) Although both letters predate Pfizer’s departure for Kano, plaintiffs allege that no IDH ethics committee existed as of 28 March 1996 and that the 28 March letter was back-dated in response to a 1997 FDA audit. (Compl. PP 132-33.) Pfizer,
Plaintiffs further contend that Pfizer’s sole purpose for traveling to Kano was to expedite the FDA's approval of Trovan to treat pediatric victims. (Compl. P 7.) Prior to Kano, only one child had ever been treated with Trovan, and then only after all other antibiotics failed. No child had ever received it orally. (Compl. P 105-06.) According to plaintiffs, Nigerian officials allocated to Pfizer two of IDH’s wards to conduct the testing. (Compl. P 113.) Pfizer selected, from lines of those awaiting treatment, children ranging in age from one to thirteen years who exhibited symptoms of neck stiffnessMeningismMeningism is the triad of nuchal rigidity , photophobia and headache. It is a sign of irritation of the meninges, such as seen in meningitis, subarachnoid hemorrhages and various other diseases...
, joint stiffness, and high fevers with headaches. (Compl. P 3, 115.) Pfizer divided them into two groups and treated half with Trovan. (Compl. P 3.) The other half was “purposefully ‘low-dosed’” with ceftriaxone, an FDA-approved drug shown to be effective in treating meningitis. (Compl. P 125.) In order to enhance the comparative results of Trovan, Pfizer administered only one-third of ceftriaxone's recommended dosage. (Compl. P 3, 124-25.)
Meanwhile, MSF established their headquarters in tents beside the IDH due to space constraints. (Compl. P 111.) There, MSF admitted their sickest patients to hospital beds in the IDH and confined the less ill to floor mats in their tents. (Compl. P 112.) MSF treated pediatric meningitis patients with chloramphenicol, a drug recommended by the World Health OrganizationWorld Health OrganizationThe World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...
to treat bacterial meningitis in epidemic situations. (Compl. PP 11, 111.)
Pfizer’s protocol also called for the children selected to have their blood tested on arrival and five days later. (Compl. P 126.) If a child was not responding well to Trovan, Pfizer switched his or her treatment to ceftriaxone. (Compl. P 126.) Plaintiffs allege, however, that Pfizer neglected to analyze the patients’ blood samples and therefore could not determine if a patient had a negative reaction until the manifestation of a visible and permanent injury. (Compl. P 126.) Plaintiffs further allege that low-dosing ceftriaxone resulted in injuries and deaths among the control group. (Compl. P 3.)
Although Pfizer’s protocol called for its team to obtain consent from the parents of the children treated who were too young to sign, few parents could speak or read EnglishEnglish languageEnglish is a West Germanic language that arose in the Anglo-Saxon kingdoms of England and spread into what was to become south-east Scotland under the influence of the Anglian medieval kingdom of Northumbria...
. (Compl. P 127.) Plaintiffs claim that Pfizer failed to explain to the children’s parents that the proposed treatment was experimental, that they could refuse it, or that other organizations offered more conventional treatments at the same site free of charge. (Compl. PP 3, 117-20, 128-30, 154-55, 157.) After two weeks, the Pfizer team left Kano and never returned for follow-up evaluations. (Compl. P 122.) Plaintiffs allege that five children who received Trovan and six children whom Pfizer “low-dosed” died. (Compl. P 120.) Others suffered paralysisParalysisParalysis is loss of muscle function for one or more muscles. Paralysis can be accompanied by a loss of feeling in the affected area if there is sensory damage as well as motor. A study conducted by the Christopher & Dana Reeve Foundation, suggests that about 1 in 50 people have been diagnosed...
, deafness and blindnessBlindnessBlindness is the condition of lacking visual perception due to physiological or neurological factors.Various scales have been developed to describe the extent of vision loss and define blindness...
. (Compl. PP 16-50.)
On 30 December 1996, Pfizer applied with the FDA for approval to market Trovan in the United States for various uses including the treatment of pediatric infectious diseases. (Compl. P 216.) In June 1997, FDA inspectors discovered inconsistencies in the data resulting from Pfizer’s Kano treatments. (Compl. P 217.) Thereafter, regulators informed Pfizer that they planned to deny its application to use the drug against epidemic meningitis and expressed several concerns including Pfizer's failure to conduct follow-up examinations. In response, Pfizer withdrew its application. (Compl. P 217.)
On 18 February 1998, Pfizer launched Trovan after it received FDA authorization for treatment of a number of adult illnesses. (Compl. P 218.) Shortly thereafter, Pfizer and the FDA received reports regarding Trovan patients suffering liver damage. (Compl. P 219.)
In January 1999, the FDA recommended that Trovan be prescribed only for patients in nursing homes or hospitals suffering from life-threatening conditions. (Compl. P 223.) That following June, the FDA issued a public health advisory on liver toxicityHepatotoxicityHepatotoxicity implies chemical-driven liver damage.The liver plays a central role in transforming and clearing chemicals and is susceptible to the toxicity from these agents. Certain medicinal agents, when taken in overdoses and sometimes even when introduced within therapeutic ranges, may injure...
associated with oral and intravenous Trovan following post-marketing reports of acute liver failureLiver failureAcute liver failure is the appearance of severe complications rapidly after the first signs of liver disease , and indicates that the liver has sustained severe damage . The complications are hepatic encephalopathy and impaired protein synthesis...
strongly associated with the drug. (Compl. P 224.) The FDA announced that it received reports of more than 100 cases where Trovan patients exhibited clinically symptomatic liver toxicity and advised physicians to use Trovan only for patients who met certain criteria. (Compl. P 224-25.) In addition, Pfizer agreed to limit distribution of Trovan to hospitals and long term nursing facilities. (Compl. P 224.) Further, the European UnionEuropean UnionThe European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
's Committee for Proprietary Medicinal Products suspended all sales of Trovan in part due to results from the Kano tests. (Compl. PP 221-22.)
In response to Plaintiffs’ allegations, Pfizer filed a motion to dismiss
Motion (legal)
In law, a motion is a procedural device to bring a limited, contested issue before a court for decision. A motion may be thought of as a request to the judge to make a decision about the case. Motions may be made at any point in administrative, criminal or civil proceedings, although that right is...
, pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure, alleging that the Plaintiffs’ fail to plead a violation of the law of nations
International law
Public international law concerns the structure and conduct of sovereign states; analogous entities, such as the Holy See; and intergovernmental organizations. To a lesser degree, international law also may affect multinational corporations and individuals, an impact increasingly evolving beyond...
, because their actions did not fit the narrow exceptions when a private party will be held liable for the “law of nations.” However, the court denied the motion to dismiss on these grounds, because the complaint sufficiently alleged that Pfizer had worked in concert with the Nigeria government, thereby Pfizer acted as a “de facto state actor
State actor
In United States law, a state actor is a person who is acting on behalf of a governmental body, and is therefore subject to regulation under the United States Bill of Rights, including the First, Fifth and Fourteenth Amendments, which prohibit the federal and state governments from violating...
.”
Next, Pfizer sought dismissal on grounds of forum non conveniens
Forum non conveniens
Forum non conveniens is a common law legal doctrine whereby courts may refuse to take jurisdiction over matters where there is a more appropriate forum available to the parties...
. Despite the plaintiff’s claims that the Nigerian court system is corrupt and could not provide an adequate alternative forum, the court ultimately found that Nigeria did provide an adequate alternative forum and the “Gilbert factors” weighed in favor of transferring the case to Nigeria. Accordingly, the court granted the defendant’s motion to dismiss this action on grounds of forum non conveniens, provided Pfizer consented to suit and acceptance of process in Nigeria; Pfizer waived possible statute of limitation problems; Pfizer made available documents and employees, and; Pfizer agreed to return to the United States if Nigeria declined to accept jurisdiction.
Abdullahi v. Pfizer, Inc. II
Affidavit
An affidavit is a written sworn statement of fact voluntarily made by an affiant or deponent under an oath or affirmation administered by a person authorized to do so by law. Such statement is witnessed as to the authenticity of the affiant's signature by a taker of oaths, such as a notary public...
s from State Department and United Nations
United Nations
The United Nations is an international organization whose stated aims are facilitating cooperation in international law, international security, economic development, social progress, human rights, and achievement of world peace...
officials to buttress their claims about corruption in the Nigerian judiciary.
Next, the Court of Appeals acknowledged that on appeal
Appeal
An appeal is a petition for review of a case that has been decided by a court of law. The petition is made to a higher court for the purpose of overturning the lower court's decision....
both parties had requested judicial notice
Judicial notice
Judicial notice is a rule in the law of evidence that allows a fact to be introduced into evidence if the truth of that fact is so notorious or well known that it cannot be refuted. This is done upon the request of the party seeking to have the fact at issue determined by the court...
of facts contained within the record of a parallel proceeding, involving different plaintiffs, in a Nigerian Court. The Court of Appeals referred to the Nigerian litigation as Zango v. Pfizer (“Zango litigation”). The Zango litigation had recently been dismissed in Nigeria. The court declined to take judicial notice of the "Zango litigation", instead opting to vacate the district court’s dismissal on grounds of forum non conveniens and remanding the case to the district court to consider the implications of the "Zango litigation" on its forum non conveniens analysis.
For these reasons, the Court of Appeals vacated and remanded to the District Court.
Abdullahi v. Pfizer, Inc. III
After the Court of Appeals vacated and remanded, the District Court readdressed the dual grounds for dismissal, both dismissal pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure and dismissal pursuant to the doctrine of forum non conveniens. On remand, the District Court granted Pfizer’s dismissal under Rule 12(b)(6) and found that the Zango litigation did not preclude dismissal for forum non conveniens.Adequate Alternative Forum Analysis
After setting forth the factual and procedural background the District Court turned its attention to the Zango litigation. The court’s somewhat searching review of the Zango litigation came in direct response to the Court of Appeals holding, which questioned whether Nigeria was in fact an adequate alternative forum, because the "Zango litigation" had ended in dismissal. The District Court discussed the "Zango litigation"’s procedural history, concluding that the Plaintiffs’ filed a Notice of Discontinuance, based upon the Federal High Court, “having declined jurisdiction in this matter for personal reasons.”Next, the court addressed the Plaintiff’s allegations of corruption within the Nigerian judiciary. Although Plaintiff’s provided allegations of corruption and anecdotal evidence, the court ultimately held that Plaintiffs were unable to establish corruption and bias in the "Zango litigation". Finding instead, that dismissal was a result of the Plaintiff’s waiting “endlessly for a new judge to replace Judge Hobon,” who had recused himself for personal reasons. For these reasons, the District Court, again found that Nigeria provided an adequate alternative forum.
Applying Sosa
Supreme Court of the United States
The Supreme Court of the United States is the highest court in the United States. It has ultimate appellate jurisdiction over all state and federal courts, and original jurisdiction over a small range of cases...
did leave the door open for courts, exercising a vigorous gatekeeping function, to recognized new actionable rules based on evolving principles of international law. However, “federal 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.” Having set forth the relevant standard, the court evaluated whether Pfizer did in fact violate customary international law. First, the District Court found that the Nuremberg Code
Nuremberg Code
The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg Trials at the end of the Second World War.-Background:...
, which governs scientific research on human subjects, does not contain a private cause of action. Second, the District Court found that the Declaration of Helsinki
Declaration of Helsinki
The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association . It is widely regarded as the cornerstone document of human research ethics...
and the CIOMS guidelines does not contain a private cause of action. Instead, finding these guidelines are merely a “general statement of policy that is unlikely to give rise to obligations in any strict sense.” [Id. at 34.] Third, the District Court found that the ICCPR was not “self executing” and that a private right of action
Implied cause of action
Implied cause of action is a term used in United States statutory and constitutional law for circumstances when a court will determine that a law that creates rights also allows private parties to bring a lawsuit, even though no such remedy is explicitly provided for in the law...
should not be implied. Finally, the District Court found that the Universal Declaration of Human Rights
Universal Declaration of Human Rights
The Universal Declaration of Human Rights is a declaration adopted by the United Nations General Assembly . The Declaration arose directly from the experience of the Second World War and represents the first global expression of rights to which all human beings are inherently entitled...
does not impose obligations as a matter of international law. Instead, it is “merely aspirational.” None of the sources of international law cited by the Plaintiffs were a proper predicate for jurisdiction under the Alien Tort Claims Act.
For the reasons discussed, the court granted Pfizer’s motion to dismiss, for failure to state a claim
Demurrer
A demurrer is a pleading in a lawsuit that objects to or challenges a pleading filed by an opposing party. The word demur means "to object"; a demurrer is the document that makes the objection...
under the Alien Tort Claims Act and, even if subject matter jurisdiction were found, the action would be dismissed on forum non conveniens grounds (under the same conditions set forth in Abdullahi I).
Ajudu Ismaila Adamu v. Pfizer, Inc
The District Court recites the facts set forth in Abdullahi I, and the analysis of the Alien Tort Claims Act set forth in Abdullahi III, before turning to the claims under the Connecticut Unfair Trade Practices Act and the Connecticut Products Liability Statute. The court began by analyzing Connecticut’s choice of lawChoice of law
Choice of law is a procedural stage in the litigation of a case involving the conflict of laws when it is necessary to reconcile the differences between the laws of different legal jurisdictions, such as sovereign states, federated states , or provinces...
principles. Under Connecticut’s qualified lex loci delicti doctrine, the District Court concluded that Nigerian — not Connecticut
Connecticut
Connecticut is a state in the New England region of the northeastern United States. It is bordered by Rhode Island to the east, Massachusetts to the north, and the state of New York to the west and the south .Connecticut is named for the Connecticut River, the major U.S. river that approximately...
— substantive law
Substantive law
Substantive law is the statutory or written law that defines rights and duties, such as crimes and punishments , civil rights and responsibilities in civil law. It is codified in legislated statutes or can be enacted through the initiative process.Substantive law stands in contrast to procedural...
governs, and accordingly, both Connecticut law claims were dismissed. In addition to lack of subject matter jurisdiction, under both the Alien Tort Claims Act and the Connecticut
Connecticut
Connecticut is a state in the New England region of the northeastern United States. It is bordered by Rhode Island to the east, Massachusetts to the north, and the state of New York to the west and the south .Connecticut is named for the Connecticut River, the major U.S. river that approximately...
statutory causes of action, the court also granted the motion to dismiss on grounds of forum non conveniens, with the same additional conditions required by Abdullahi I and Abdullahi III.
Nigerian government lawsuit
On 5 June 2007, the government of Nigeria filed against Pfizer in the Nigerian Federal High Court, seeking US$6.95 billion in damages. Nigeria claimed that Pfizer "never obtained approval of the relevant regulatory agencies... nor did the defendant seek or receive approval to conduct any clinical trial at any time before their illegal conduct". After preliminary arguments, the case was adjourned until 26 June of that year.2009 settlement
In February 2009, Pfizer decided to settle its legal case with the 200 plaintiffs. An out-of-court settlementSettlement (law)
In law, a settlement is a resolution between disputing parties about a legal case, reached either before or after court action begins. The term "settlement" also has other meanings in the context of law.-Basis:...
was reached and will be put in writing at a meeting scheduled to take place in Rome
Rome
Rome is the capital of Italy and the country's largest and most populated city and comune, with over 2.7 million residents in . The city is located in the central-western portion of the Italian Peninsula, on the Tiber River within the Lazio region of Italy.Rome's history spans two and a half...
, Italy
Italy
Italy , officially the Italian Republic languages]] under the European Charter for Regional or Minority Languages. In each of these, Italy's official name is as follows:;;;;;;;;), is a unitary parliamentary republic in South-Central Europe. To the north it borders France, Switzerland, Austria and...
in March 2009. The settlement followed months of negotiations between Pfizer and the Kano state
Kano State
Kano State is a state located in North-Western Nigeria. Created on May 27, 1967 from part of the Northern Region, Kano state borders Katsina State to the north-west, Jigawa State to the north-east, Bauchi State to the south-east and Kaduna State to the south-west...
government which represented the plaintiffs. According to Wikileaked US embassy cables , Pfizer's country manager admitted that "Pfizer had hired investigators to uncover corruption links to federal attorney general Michael Aondoakaa to expose him and put pressure on him to drop the federal cases."
The talks were brokered by the former Nigerian military leader Yakubu Gowon
Yakubu Gowon
General Yakubu "Jack" Dan-Yumma Gowon was the head of state of Nigeria from 1966 to 1975. He took power after one military coup d'etat and was overthrown in another...
and the former U.S.
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
President
President of the United States
The President of the United States of America is the head of state and head of government of the United States. The president leads the executive branch of the federal government and is the commander-in-chief of the United States Armed Forces....
Jimmy Carter
Jimmy Carter
James Earl "Jimmy" Carter, Jr. is an American politician who served as the 39th President of the United States and was the recipient of the 2002 Nobel Peace Prize, the only U.S. President to have received the Prize after leaving office...
.
In October 2009, it was announced that the medical records of the victims of the 1996 Pfizer Trovan clinical trial could not be found at the Kano State Ministry of Health nor at the Infectious Diseases Hospital (IDH) where the trials were conducted according to the state's Attorney General and Commissioner for Justice Barrister Aliyu Umar. The announcement was made shortly after Umar confirmed that the state government had received $10million from Pfizer as part of the $75million settlement of the protracted dispute. Additionally, the Nigerian government conducted their own investigation. This report was kept secret for five years with the only three printed copies being lost and disappearing.
See also
- The Constant GardenerThe Constant GardenerThe Constant Gardener is a 2001 novel by John le Carré. It tells the story of Justin Quayle, a British diplomat whose activist wife is murdered...
, a book (and filmThe Constant Gardener (film)The Constant Gardener is a 2005 drama film directed by Fernando Meirelles. The screenplay by Jeffrey Caine is based on the John le Carré novel of the same name. It tells the story of Justin Quayle, a man who seeks to find the motivating forces behind his wife's murder.The film stars Ralph Fiennes,...
) inspired by the scandal
External links
- Statement of Defense on Trovan, Kano State Civil Case