| A Connecticut Attorney Takes on Pfizer in a Lawsuit Involving Hundreds of Injured Children |
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| Written by Gregory B. Hladky | |||||||||
| Tuesday, 27 July 2010 15:00 | |||||||||
A lawsuit alleges that CT-based pharmaceutical giant Pfizer botched a test involving hundreds of Nigerian children
It’s a long-running legal guerrilla war involving alleged crimes against impoverished children, the biggest pharmaceutical company in the world, Connecticut law, medical ethics, corporate morality, international relations and billions of dollars. The drug giant is Pfizer Inc. An antibiotic called Trovan was developed at the company’s Groton-New London research facilities and tested on 100 sick African kids in 1996. For more than a decade, Pfizer has been fighting tooth and nail against charges those tests were dangerous, illegal and resulted in death and injury for many of those children. Last month, Pfizer’s attorneys failed to convince the U.S. Supreme Court to take up the case. Decisions are now being made about whether the next battles will be fought in Nigerian or American courts. There is also the possibility of criminal charges being filed in Nigeria against the company or its employees. Pfizer insists it is innocent of any wrongdoing. As unlikely as it might seem, a focal point in this saga is a small, cluttered office in an unassuming brick building at the corner of West Haven’s Main Street and Campbell Avenue. The office belongs to Richard Altschuler. He says his target is justice for those Nigerian kids and their families. He is suing Pfizer for $2 billion, and he believes recent court rulings are pointing the way to victory. Altschuler is a 62-year-old personal injury lawyer who says he just found out he has attention deficit disorder. He graduated from the University of Connecticut Law School and laughs when he recalls he never bothered to take a course in international law. When friends ask how it feels to be going up against high-powered legal teams filled with Harvard and Yale graduates, Altschuler says with a grin: “I tell them I have an advantage those guys don’t: I went to West Haven High School.” The route to Altschuler’s involvement in this case began in the 1980s when he helped defend a Nigerian college student from a Connecticut murder charge. The man returned to Nigeria and got a job in a law firm in Lagos, and recommended Altschuler to his employers when they became involved in lawsuits surrounding the Nigerian crash of a helicopter owned by a Greenwich company. It was during that case that Etigwe Uwo, a lawyer in the Nigerian firm, called Altschuler with what seemed a fantastic story about an allegedly illegal drug test performed by Pfizer in the remote northern Nigerian city of Kano. “In my wildest dreams, I couldn’t believe it was as incredible as that,” Altschuler recalls. The claim was that Pfizer got permission from the dictatorship that controlled Nigeria in 1996 to use Trovan on victims of a horrific meningitis epidemic that eventually killed more than 11,000 people. Pfizer execs and lawyers insist their motives were purely “humanitarian.” According to news reports, Pfizer executives hoped to turn Trovan into a highly profitable oral antibiotic with world-wide sales potential. But the drug was never approved by the Food and Drug Administration for use on children. The Washington Post reported the FDA authorized Trovan for use by adults in 1998 (before the Nigerian drug trial became public knowledge). The European Union banned Trovan in 1999. U.S. officials later restricted the drug’s use in this country because of reports of liver damage to patients, and Trovan is no longer in production. Lawsuits filed in Connecticut, New York and Nigeria, as well as the Nigerian investigative report, charge the company failed to get proper authorizations from Nigerian medical officials or any recognized medical ethics committee as required under international law. A Nigerian doctor has admitted to Nigerian investigators that he “back-dated” a medical ethics authorization letter and sent it to Pfizer. The suits also claim Pfizer never got written permission from parents of the 200 kids selected for the test. Pfizer officials insist they received legal authorizations from Nigerian agencies, met all international requirements, and got verbal permission from family members for all the children involved. “Before conducting the Trovan study in Kano, Pfizer sought and obtained all necessary approvals from relevant federal and state government agencies in Nigeria,” according to a prepared Pfizer statement. About 100 children suffering from meningococcal meningitis were given Trovan and a similar number were given a standard antibiotic produced by a Pfizer rival, according to both Pfizer and Nigerian investigators. Before Pfizer’s team arrived in April 1996, the group Doctors Without Borders was treating patients there. The Nigerian investigation reported that Pfizer was given control of the hospital during the test. According to the official Nigerian study, five children who were given Trovan died and six kids in the control group also died. Pfizer’s official statement on the drug trial says, “Trovan had a survival rate that was at least as effective as the best treatment available at Kano’s Infectious Disease Hospital” where the trial took place. The lawsuits also raised questions about whether the Pfizer doctors administered high enough doses of the standard drug to kids in the control group. Pfizer officials insist the dosage levels of the standard antibiotic were sufficient. Pfizer’s account concludes that “All clinical evidence points to the fact that any deaths occurring during the Trovan clinical study were the direct result of the illness and not the treatment provided to patients.” Altschuler says that, 18 months after the test, a Pfizer employee named Dr. Juan Walterspiel wrote a memo to Pfizer’s top executives saying the drug trial violated ethical standards. He was fired the following day for reasons Pfizer insists were unrelated to the test, according to the Washington Post investigative story. Pfizer maintains its treatment saved lives and the children who died were simply victims of the disease. The Nigerian study reported Pfizer’s team left after two weeks while the epidemic continued to rage. They took all medical records of the test with them. Altschuler says the kids treated by Pfizer suffered terribly, including scores who became deaf and dumb or developed deformities, blindness, and brain damage. The Trovan drug test only became public in December 2000 when the Washington Post wrote about it. Pfizer’s test drew even more publicity a few months later when John LeCarre published his novel, The Constant Gardner. LeCarre’s book, which was later turned into a movie, focused on an illegal African drug test by a giant pharmaceutical company. But the author went to great lengths to insist his novel was not based on any single test or company. His story was set in Kenya and his fictional company based in Europe. Altschuler says he was stunned a case of this magnitude would fall into the lap of “a little, two-person West Haven law firm.” He isn’t waging the fight alone: some of the families engaged a major New York City law firm, Milberg Weiss Bershad & Schulman. Altschuler says his and the New York firm represent 192 of the families involved in the Pfizer test. Altschuler filed a lawsuit against Pfizer in 2001 under Connecticut’s Fair Trade Practices law. He says the state law allows individuals to seek damages against corporations for “immoral and oppressive business practices.” Another lawsuit was filed in New York courts and the actions were combined in federal district court in that state. The case has become a matter of “intense interest to the academic community and to human rights groups,” says Jeffrey Meyer, an associate law professor at Quinnipiac University and a former assistant U.S. attorney in Connecticut. One of the lawsuits is based on a U.S. law that can, in limited circumstances, allow individuals from other nations to file lawsuits against American companies in U.S. courts. A U.S. Second Circuit Court of Appeals ruling in the case “expressly allows U.S. courts to give remedies … for the most egregious human rights violations” committed by American companies operating abroad, Meyer says. The ruling was a defeat for Pfizer, and the pharmaceutical giant hit another legal roadblock in late June when the U.S. Supreme Court declined to review the case. At the same time, a new $343 billion lawsuit against Pfizer was filed in Nigeria. Pfizer was the world’s biggest pharmaceutical company in 1996 and it remains so. It grew even larger last year with its $68 billion purchase of Wyeth, a maker of vaccines, biotechnology drugs and consumer health care products, an acquisition that helped boost Pfizer’s money-making prospects. In October 2009, the company reported a 26 percent increase in its third-quarter profits from the year before, to $2.88 billion. Pfizer is projecting revenue for this year at about $50 billion. Those increases have come despite competition from generic drug makers and reduced sales. Last year, the company also agreed to pay $2.3 billion to settle federal charges that it illegally marketed a painkiller called Bextra and other drugs. The Wall Street Journal reported that settlement of the long-running case may have helped boost Pfizer’s profit prospects. However, Pfizer is continuing to fight against the allegations of wrongdoing in the 1996 Nigerian case. “Pfizer continues to believe that the Court of Appeals’ decision represents an unprecedented expansion of international law by allowing non-U.S. citizens to bring a wide range of lawsuits in U.S. Courts that have not been recognized before,” Pfizer officials said in their prepared response to the Supreme Court’s refusal to hear the Trovan case. Meyer says the appellate decision means that “there should not be legal black holes where corporations can engage in gross human rights violations.” Altschuler argues that that appeals court “put our companies on notice that it makes economic sense to be moral.” Pfizer has consistently denied all charges. “Pfizer stands by its 1996 Trovan clinical study,” according to a recent statement, “which the company has said all along was conducted with the approval of the Nigerian government, the consent of the participants or guardians, and was consistent with Nigerian laws.” “The company looks forward to presenting its defenses in court and remains confident it will ultimately prevail in these cases,” Pfizer officials said. Yet Pfizer last year agreed to create a $35 million trust fund for families of the children involved in the lawsuit. According to Altschuler, the $75 million agreement worked out in London between Pfizer and lawyers for the Nigerian government included money for a new hospital, payments to the state of Kano, and millions in fees to those Nigerian lawyers. The arrangement resulted in Nigeria dropping criminal charges filed in that country against Pfizer and its employees. That deal is now on the verge of collapse as a result of reports that the people in charge of the trust fund for victims were wildly spending money on cars, personal secretaries and other goodies. Altschuler and his Nigerian colleague, Etigwe Uwo, filed actions to block the trust fund from operating. In a telephone interview, Etigwe revealed he is also preparing to seek permission under Nigerian law to begin a private criminal prosecution against Pfizer. (Some U.S. states also allow individuals to ask for judicial approval to wage private criminal prosecutions if state or local officials fail to do so.) If the case is ever settled, the lawyers representing those Nigerian families stand to make tens of millions of dollars in fees. Altschuler and Etigwe say neither they nor any of their clients have yet to see a penny from Pfizer. According to the West Haven lawyer, he’s averaging about $2,000 a month in telephone bills for calls to Nigeria, and has lost track of how much time he’s spent on the case in the past decade. “It’s incredible that [Pfizer officials] are letting this hang out there,” Altschuler says. “It’s incredible that Pfizer doesn’t just want to put this behind them.” “It has to end in justice for us,” he adds, looking around at the boxes of files stacked against the walls of his modest office. “Even if it doesn’t end in monetary justice, I’ll still sleep well at night.” Questions or comments? Email
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| Last Updated on Tuesday, 27 July 2010 22:35 |
