Pfizer lawsuit (re Nigeria)
|In 2001, a group of Nigerian minors and their guardian sued Pfizer in US court alleging the company violated customary international law by administering an experimental drug to Nigerian minors. In 2011, the parties announced they had reached a settlement in this lawsuit.|
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]
All components of this story
Author: Bello Fagge, Nigerian Pilot
Pfizer Pharmaceutical company has at the weekend paid N70million compensation to the second batch of four victims of the 1996 controversial Trovan clinical test...According to [the board chairman of the Meningitis/Healthcare Trust Fund, Justice Abubakar Wali], other batches of beneficiaries would follow, as soon as their DNA results were released...The board...contacted six other successful claimants and invited them for full medical examination, so as to determine the extent of their disabilities for the purpose of compensating them as per protocol...However, he still appeal to them to come forward, so that the Board could process the amount of compensation each is entitled to...
Author: Kolade Adeyemi, Nation [Nigeria]
Victims of the Trovan drug test in Kano State have threatened to sue Pfizer...if it does not release the results of the DNA screening it conducted earlier this year within seven days.
Author: David Smith, Guardian [UK]
The parents of four Nigerian children who died of meningitis have become the first winners of a 15-year legal battle against Pfizer over a fiercely controversial drug trial…[Pfizer] announced…that it had made payments of $175,000 (£108,000) to each family. More such compensation settlements are expected to follow. Pfizer was sued after 11 children died in a clinical trial…in 1996…"We are pleased that these four individuals, the first group of qualified claimants of the Healthcare/Meningitis Trust Fund, have received compensation," said a spokesman. "This is the first step in a multiphase review process by which the independent board of trustees that manages the funds will deliver payments to all other claimants.
[PDF] Exaggerated rumours of the death of an Alien tort? Corporations, human rights and the remarkable case of Kiobel
Author: Odette Murray, David Kinley (Sydney University) & Chip Pitts (Stanford Law School), in Melbourne Journal of International Law
...[W]e have become accustomed to assuming that corporations are proper subjects of litigation for alleged infringements of the ‘law of nations’ under the Alien Tort Statute (‘ATS’). But, in a dramatic reversal of this line of reasoning, the United States Court of Appeals for the Second Circuit in Kiobel v Royal Dutch...has dismissed this assumption and concluded that corporations cannot be sued under the ATS. This article explores the Court’s reasoning and the ramifications of the decision, highlighting the ways in which the Kiobel judgment departs from both Supreme Court and Second Circuit precedent. The authors take to task the critical failure of the majority in Kiobel to distinguish between the requirements of legal responsibility at international law and that which is necessary to invoke ATS jurisdiction in the US District Courts...
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Author: Yvonne Ndege, Al Jazeera
Trovan, a Pfizer drug tested on 200 children and intended to treat a deadly regional outbreak of meningitis, killed 11 children and left several more permanently injured in 1996. In 2009, the US pharmaceutical company agreed to pay $75m to the claimants in compensation. However, Pfizer introduced DNA testing as part of the process to qualify for the payment. Many of the victims do not understand what DNA testing is and, fearing it is an attempt by the company to use them in another drug trial, have abandoned their compensation claims...[transcript] Pfizer denies all wrongdoing.
Author: Ben Hirschler, Reuters
[T]he clinical trials business has gone global as drugmakers seek cheaper venues for studies…The increasing reliance on clinical trials in Eastern Europe, Asia and Latin America raises serious questions…are ethical standards in testing new drugs properly upheld in poorer countries?...[I]s it right to test an expensive new drug in a country where local people may never be able to afford it? And do patients always understand the risks associated with testing an unlicensed drug?...Annelies den Boer of the Dutch non-profit Wemos Foundation...says..."...There's an entire chain -- vulnerable patients, doctors with conflicts of interests, CROs [contract research organisations] that are geared to doing trials extremely fast -- which is detrimental to ethical guidelines."...[C]ommon complaints center on the lack of follow-up support and…jargon-filled contracts...Cases alleging serious side effects are rare, but not unknown…controversial cases...have involved the testing of AIDS drugs in Africa, breast cancer and anti-psychosis drugs in India, and vaccines in Latin America [refers to AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Sanofi-Aventis, Bristol-Myers Squibb, Merck, Pfizer]
Author: Sue Reisinger, Corporate Counsel [USA]
Nearly 15 years after its controversial drug trial on 200 children with meningitis in Nigeria, Pfizer Inc. and all plaintiffs in the cases related to the trial announced today that they have reached a global settlement. In a joint statement, the parties said, "…the plaintiffs will join the ongoing Healthcare/Meningitis Trust Fund process, which [was initiated by Pfizer and] is being managed by an independent Board of Trustees in Kano, Nigeria. The cases have been amicably resolved after many years of litigation. The settlement will bring an end to all litigation pertaining to Trovan in the United States and Nigeria and allow for just compensation for participants in the study and their families."
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Author: Sue Reisinger, Corporate Counsel
A doctor has alleged anew that Pfizer Inc. violated medical and ethical standards, appeared to have paid off foreign officials, and oversaw acts "which may have led to criminally negligent homicide" during Pfizer's 1996 drug trials on children with meningitis in Nigeria. The allegations are contained in a letter (pdf) sent last week from Dr. Juan Walterspiel to U.S. District Court Judge William Pauley III in Manhattan, who is presiding over the pending suit brought by families of the children who died or suffered serious side effects from the drug trial for the antibiotic Trovan…Pfizer spokesman Christopher Loder said Tuesday that the claims are actually 10 years old. "Pfizer had investigated the allegations and found that they were not supported by the facts," Loder said.
Author: Susan Aaronson, Professor & Ian Higham, Research Assistant - Elliott School of Intl. Affairs, George Washington Univ in Policy Innovations
...Building on years of research and multi-stakeholder dialogue, [UN Special Representative on business & human rights John] Ruggie outlined a framework and Guiding Principles to help firms “operationalize” their human rights responsibilities...While some business associations have expressed generic support for Ruggie’s efforts, most firms have said little. BASF, Talisman, and Novo Nordisk are among the few firms that commented on...the Guiding Principles...The Guiding Principles are not perfect, but they will help firms operationalize, monitor, and audit their human rights performance. Therefore, they represent a strategy that firms should test. Most firms have done very little to ensure that they do not undermine the human rights... [also refers to SNCF, Aetna, JPMorgan Chase, Wachovia (now part of Wells Fargo), Nestle, Mars, Whirlpool, Toyota, General Motors, Cisco Systems, Wal-Mart, Freeport-McMoRan, Yahoo!, Unocal (now Chevron), Barclays, BP, Control Risks, Credit Suisse, ExxonMobil, Gap, Hewlett-Packard, Imperial Tobacco, Shell, Cerrejón Coal (joint venture Anglo American, BHP Billiton, Xstrata), Phillips Van Heusen ]
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Author: Sue Reisinger, Corporate Counsel [USA]
Nearly 15 years after trying an experimental drug on children in Nigeria during a deadly meningitis epidemic, Pfizer Inc. is still battling the legal claims brought by the children's families; the families are still waiting for some sort of compensation; and, the case is still bogged down in pretrial motions…Pfizer continues to insist that the case should be dismissed…A key issue is whether the case can be tried under the Alien Tort Statute…But as the case drags along in Manhattan, new developments are drawing more attention to it. It started with WikiLeaks in December disclosing diplomatic cables that discussed Pfizer's efforts to settle two other cases brought in Nigeria…WikiLeaks has sparked renewed interest in the case in Nigeria, and at least one newspaper has begun an investigation of the drug trial.