Pfizer lawsuit (re Nigeria)

In 1996, Pfizer conducted a drug trial in Kano, Nigeria during an epidemic of bacterial meningitis.  The company tested an experimental antibiotic drug, Trovan, on about 200 children during this time.

United States lawsuits 
In 2001, a group of Nigerian minors and their guardians sued Pfizer in US federal court under the Alien Tort Claims Act (ATCA) alleging that the company violated customary international law by administering Trovan to minors in Kano during the meningitis outbreak.  The plaintiffs in Abdullahi v. Pfizer claim that the drug was given without the informed consent of the children and their parents.  The plaintiffs further claim that the drug trial led to the deaths of 11 children and serious injuries to many others.  A second US lawsuit was filed against Pfizer, Adamu v. Pfizer, in November 2002.  These plaintiffs were also a group of Nigerians injured in the Trovan drug trial.  The Adamu plaintiffs alleged similar violations under ATCA and violations of Connecticut law.  Both of these cases were dismissed in 2005 on grounds of forum non conveniens (inconvenient forum – information on this legal doctrine available here) and failure to state a claim under ATCA.  According to the judge, the plaintiffs had failed to show a sufficient legal source for an international prohibition of non-consensual medical treatment.

In January 2009, the US court of appeals reversed the lower courts’ dismissal of the case. (The two lawsuits have been consolidated.)  A divided court found that the prohibition of non-consensual medical experimentation on humans is binding under customary international law.  In July 2009, Pfizer petitioned the US Supreme Court asking it to hear an appeal of the Court of Appeals' January 2009 ruling.  In November 2009 the Supreme Court asked the US Solicitor General to submit a brief to the court in this case.  In May 2010 the Solicitor General submitted this brief to the court urging the court to deny Pfizer's petition.

On February 23, 2011, the parties announced that they had reached a settlement in this lawsuit.  The terms of the settlement are confidential.  A joint statement issued by the parties explained that the plaintiffs in the US lawsuit will join the ongoing Healthcare/Meningitis Trust Fund process which is being managed by an independent board of trustees in Kano, Nigeria. 

Nigerian legal proceedings 
In 2001 a group of Nigerians sued Pfizer in the Federal High Court in Kano.  The plaintiffs in this case, Zango v. Pfizer International, alleged that Pfizer’s drug trials were illegal.  However, after severe delays, the plaintiffs elected to withdraw this case.  Some of the Zango plaintiffs were part of the Adamu action in the US. 

In May 2007, the state of Kano brought criminal charges and civil claims against Pfizer seeking over $2 billion in damages and restitution.  Settlement talks have been ongoing since November 2007.  In late January 2009, the state court adjourned the case until late February to allow more time for the parties to reach a settlement out of court.  In a separate action, the Nigerian federal government filed suit against Pfizer and several of its employees in June 2007 seeking nearly $7 billion in damages for the deaths of children involved in the Trovan drug trial.  In late January 2009, the Nigerian federal government informed the court that it has agreed with Pfizer to settle the lawsuit out of court.  In April 2009, the Kano state government and Pfizer announced that they have reached an agreement on the broad terms of an out-of-court settlement.  Pfizer and Kano state reached a final settlement in August 2009.  The parties agreed to a settlement figure of $75 million.  The amount of the settlement will be broken down as follows: $35 million to establish a fund for people that participated in the drug trial, $30 million will underwrite health care initiatives in Kano state and $10 million will be allocated to pay the state's legal costs.

Following reports of problems in the distribution of the settlement funds to families of the victims, Pfizer announced in August 2011 that it had made its first payments to families of four children who had died following the Trovan clinical trial. 

In November 2013, 186 victims filed a new lawsuit in a Federal High Court in Kano in which they argue Pfizer is allegedly in breach of the 2009 settlement agreement for limiting the criteria for compensation.  The hearings started in May 2014. In November 2014, Pfizer paid out compensation to victims of the 1996 Trovan clinical trial as set forth in the 2009 settlement agreement.

- "Pfizer pays out to Nigerian families of drug trial victims", David Smith, Guardian [UK], 12 Aug 2011
- "Pfizer Settles Lawsuits Over Drug Trials on Children in Nigeria", Sue Reisinger, Corporate Counsel, 23 Feb 2011
- "Pfizer settles drug testing case with Nigerian state for $75 million", Ross Todd, American Lawyer, 3 Aug 2009
- "Pfizer reaches settlement in notorious Nigerian drug trial", Joe Stephens, Washington Post, 4 Apr 2009
- “Attorney Continues Long Battle With Pfizer Over Nigerian Drug Experiments”, Douglas S. Malan, Connecticut Law Tribune [USA], 12 Feb 2009 
- “Split 2nd Circuit Revives Nigerian Families' Claims Against Pfizer Over Drug Tests”, Daniel Wise, New York Law Journal, 2 Feb 2009 
- “Fed Govt, Pfizer opt for out-of-court settlement”, The Nation [Nigeria], 27 Jan 2009 
- “Pfizer Drug Trial Case In Nigeria To Restart Feb 25”, AFP, 28 Jan 2009
- “Nigeria sues drugs giant Pfizer”, BBC News, 5 Jun 2007 
- “Pfizer faces criminal charges in Nigeria”, Joe Stephens, Washington Post, 30 May 2007

- Pfizer: [PDF] Pfizer responds to divided ruling by U.S. Court of appeals for 2nd circuit in cases related to Trovan study in Nigeria, 30 Jan 2009 
- Pfizer: [PDF] Pfizer issued the following statement in response to legal action taken against the company by the Nigerian government, 29 May 2007

- [PDF] Pfizer Inc. v. Abdullahi, et al. - Brief for the United States as amicus curiae, Solicitor General, US Department of Justice, 30 May 2010
- [PDF] Pfizer Inc. v. Abdullahi, et al. - Reply Brief for Petitioner, Quinn Emanuel Urquhart Oliver & Hedges LLP, 25 Aug 2009
- [PDF] Pfizer Inc. v. Abdullahi, et al. - Brief in Opposition, Altschuler & Altschuler, Milberg LLP, 10 Aug 2009
- [PDF] Pfizer Inc. v. Abdullahi, et al. - Petition for a Writ of Certiorari, Quinn Emanuel Urquhart Oliver & Hedges LLP, 8 jul 2009
- US Court of Appeals for the Second Circuit: [PDF] Rabi Abdullahi v. Pfizer, Inc., 30 Jan 2009 [decision reversing lower court’s dismissals] 
- US District Court for the Southern District of New York: 
     - [PDF] Adamu v. Pfizer, Inc., 8 Nov 2005 [dismissal] 
     - [PDF] Abdullahi v. Pfizer, Inc., 9 Aug 2005 [dismissal]

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Article
28 January 2009

Pfizer Drug Trial Case In Nigeria To Restart Feb 25

Author: AFP

A Nigerian court Wednesday adjourned to next month the multi-billion-dollar suit against U.S. drug firm Pfizer Inc. (PFE) by the Kano state government to allow for more time for an out-of-court settlement... Kano state is demanding $2.75 billion in compensation from Pfizer for the 1996 trial of a meningitis vaccine, Trovan, on 200 children in Kano. Pfizer and Kano state, which have been engaged in settlement talks since November 2007, are due to report to the court on details of their out-of-court deal... Some 11 children are alleged to have died from the drug test which also caused deformities in 189 others.

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Article
9 July 2008

Pfizer: Kano govt, victims reject $10m offer [Nigeria]

Author: Hassan Karofi, Daily Trust [Nigeria]

Out-of-court settlement talks between pharmaceutical giant Pfizer and the Kano State government broke down at the weekend after the government and representatives of victims’ families turned down an offer of $10 million compensation from the company... [C]hairman of the victims’ association, Alhaji Mustapha Maisikeli...said after a series of meetings...the victims turned down an offer of $10,000 to each victim with minor deformities and $100,000 to each victim with major deformities or death arising from the Trovan drug test of 1996... [C]ounsel to Pfizer...insisted that discussions were on to reach an acceptable settlement between Pfizer and the victims.

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Article
25 December 2007

Nigerian Judge Detains Pfizer Officials

Author: Associated Press

A judge in Nigeria has ordered the arrest of three top officials of the U.S.-based drug company Pfizer Inc., saying they failed to honor an order to appear in court over a $2 billion suit the company is facing for a 1996 drug trial, court papers showed... Nigeria alleges Pfizer conducted the trials illegally, without the full knowledge and consent of the government and the parents, causing the death of 11 children and injury to dozens of others...Pfizer has always denied any wrongdoing, insisting the drug saved lives.

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Author: AFP

La justice nigériane a lancé lundi des mandats d'arrêt contre trois responsables du groupe pharmaceutique américain Pfizer Inc. qui ne se sont pas présentés devant le tribunal de Kano (nord) où ils avaient été convoqués dans le cadre d'une plainte pour tests illégaux... L'Etat de Kano...accuse la compagnie d'avoir testé illégalement un médicament contre la méningite appelé Trovan sur 200 enfants en avril 1996...qui auraient entraîné la mort d'au moins onze d'entre eux. Le laboratoire a toujours nié ces accusations, affirmant que le gouvernement nigérian était parfaitement au courant de ces tests et qu'ils avaient été menés avec responsabilité et éthique.

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Article
20 July 2007

Nigeria files new Pfizer claims

Author: BBC

Nigeria has accused Pfizer of fraud in a fresh court case filed against the drugs firm over its alleged role in the deaths of Nigerian children. The government...claims Pfizer conducted illegal trials of an anti-meningitis drug that killed and disabled children...Pfizer has denied all wrongdoing and maintains that it had local and international approval for the drug trial, which it says helped to save lives. But government lawyers have now filed a new lawsuit adding a number of additional charges to the original claims, which follows the recent discovery of new evidence. This includes papers that suggest Pfizer committed fraud by not obtaining consent from the affected families as they were obliged to do under company rules, government lawyers said.

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Article
26 June 2007

Pfizer wins early Nigeria battle

Author: BBC News

A Nigerian court has…rejected a bid by the…[government]… to include 85 new claims...[in a lawsuit against]…Pfizer [agreeing]...it had been improperly filed. Officials …say more than 50 children died in the experiment, while many others developed mental and physical deformities. But Pfizer says only 11 of the 200 children…died…Pfizer denied any wrongdoing and said its trial of Trovan was conducted in accordance with Nigerian regulations.

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Article
29 May 2007

[PDF] Statement in response to legal action taken against the company by the Nigerian government

Author: Pfizer

Pfizer issued the following statement in response to legal action taken against the company by the Nigerian government. Pfizer continues to emphasize—in the strongest terms—that the 1996 Trovan clinical study was conducted with the full knowledge of the Nigerian government and in a responsible and ethical way consistent with the company's abiding commitment to patient safety. Any allegations in these lawsuits to the contrary are simply untrue—they weren't valid when they were first raised years ago and they're not valid today.

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Author: Saïd Aït-Hatrit, Afrik

L’Etat nigérian de Kano a porté plainte...contre l’entreprise pharmaceutique Pfizer pour avoir, en 1996, "secrètement utilisé des enfants comme cobayes dans les tests d’un médicament"...sous le prétexte de l’aide humanitaire...Pfizer a effectué...de façon illégale l’essai clinique d’un médicament...sur 200 enfants atteints de méningite...11 enfants sont morts ...et de nombreux autres ont subi des séquelles...[un] rapport d’un comité d’experts nigérians...jamais rendu public...recommandait que Pfizer soit "sanctionné de manière appropriée", fasse des "excuses sans réserve", paye des indemnités ...En réponse, le géant pharmaceutique a publié...un communiqué dans lequel il "s’insurge contre [les] allégations récemment publiées"...[et] insiste sur le fait que l’opération a sauvé des vies...

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Article
20 May 2007

Nigerian state sues Pfizer over 'deformity' drug

Author: Agence France Presse

Nigeria's largest state has sued US drug firm Pfizer for allegedly using 200 children as "guinea pigs" for a drug test in 1996 that led to multiple deaths and deformities, officials said Sunday...The state accuses Pfizer of "secretly using children as guinea pigs to test a drug under the guise of humanitarian gesture"...Pfizer was alleged to have administered an untested drug called Trovan Floxacin without authorisation on almost 200 children infected with meningitis in the state. Eleven of the children reportedly died, while the remaining 181 were said to have suffered from deafness, paralysis, brain damage and blindness.

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Article
7 May 2006

Pfizer Statement, 1996 Trovan Clinical Study In Nigeria - Study Saved Lives and Was Conducted Ethically and Responsibly

Author: Pfizer

...as we have stated repeatedly over the past several years, Pfizer conducted this [Trovan (trovafloxacin)] trial with the full knowledge of the Nigerian government and in a responsible way consistent with Nigerian law and Pfizer’s abiding commitment to patient safety...Pfizer is confident that no one associated with the Trovan clinical study—conducted in Kano, Nigeria during a meningitis epidemic in 1996—ever put a patient’s health at risk and that the company acted in the best interests of the children involved in the study, using the best medical knowledge available. Trovan unquestionably saved lives, and Pfizer strongly disagrees with any suggestion that the company conducted its study in an unethical manner.

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