Abdullahi v. Pfizer, Inc.

[1] Pfizer gave the children a substantially reduced dose of the ceftriaxone (specifically, 33 mg/kg)[2] relative to that described on the US FDA-approved prescribing information.

The lead investigator, Abdulhamid Isa Dutse, later provided a letter of approval for human trials that was found to be falsified.

[6] Pfizer acknowledged reducing the dose of the standard treatment, but said this was done to minimize injection-site pain and that the mortality rates in both the trovafloxin and ceftriaxone arms of its trial were lower than among those treated with chloramphenicol by Médecins Sans Frontières.

[5] According to Ben Goldacre, Pfizer argued that it was not required to obtain informed consent for experimental drug trials in Africa, and that any case should be heard in Nigeria.

[6] In May 2006, Representative Tom Lantos of California, the senior Democrat on the House International Relations Committee, described the findings of a report compiled about the case by the Nigerian government as "absolutely appalling" and called for Pfizer to open its records.

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".

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).

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.

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.

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".

To travel to Kano, Pfizer needed the U.S. Food and Drug Administration's (FDA) authorization to export Trovan.

In order to enhance the comparative results of Trovan, Pfizer administered only one-third of ceftriaxone's recommended dosage.

There, MSF admitted their sickest patients to hospital beds in the IDH and confined the less ill to floor mats in their tents.

On 30 December 1996, Pfizer applied for FDA approval to market Trovan in the United States for various uses including the treatment of pediatric infectious diseases.

On 18 February 1998, Pfizer launched Trovan after it received FDA authorization for treatment of a number of adult illnesses.

In January 1999, the FDA recommended that Trovan be prescribed only for patients in nursing homes or hospitals suffering from life-threatening conditions.

In addition, Pfizer agreed to limit distribution of Trovan to hospitals and long term nursing facilities.

Further, the European Union's Committee for Proprietary Medicinal Products suspended all sales of Trovan in part due to results from the Kano tests.

)[3]In response to plaintiffs' allegations, Pfizer filed a motion to dismiss, pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure,[11] alleging that the Plaintiffs' fail to plead a violation of the law of nations, because their actions did not fit the narrow exceptions when a private party will be held liable for the "law of nations".

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" weighted in favor of transferring the case to Nigeria.

[13] The Court of Appeals noted that plaintiffs had submitted a number of affidavits from State Department and United Nations officials to buttress their claims about corruption in the Nigerian judiciary.

[14][citation needed] After setting forth the factual and procedural background the District Court turned its attention to the Zango litigation.

[17] 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".

First, the District Court found that the Nuremberg Code, which governs scientific research on human subjects, does not contain a private cause of action[citation needed].

Instead, finding these guidelines are merely a "general statement of policy that is unlikely to give rise to obligations in any strict sense"[citation needed].

[citation needed]Finally, the District Court found that the Universal Declaration of Human Rights does not impose obligations as a matter of international law.

None of the sources of international law cited by the Plaintiffs were a proper predicate for jurisdiction under the Alien Tort Claims Act.

[citation needed] For the reasons discussed, the court granted Pfizer's motion to dismiss, for failure to state a claim 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).

[citation needed] 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.

[citation needed] On 5 June 2007, the government of Nigeria filed against Pfizer in the Nigerian Federal High Court, seeking US$6.95 billion in damages.