U.S. Proper Forum for Trovan Lawsuit

The U.S. Court of Appeals for the 2nd Circuit in New York ruled on January 31st that Nigerian lawsuits against Pfizer can now go forward in the U.S. courts. Previously, the District Court had dismissed the case on the grounds that it could not be pursued under the 1789 Alien Tort Claims Act, a statute that permits foreigners to sue in the US courts.

The Nigeria plaintiff's case has been flailing around for some time - since 1996 - and there are a lot of related claims, including violation of Nigerian and International Law, and possible fraudulent alliances. Read more about the tangled genesis of this case here and here.

In essence, it is alleged that during a meningitis epidemic, Pfizer tested the oral antibiotic, Trovan, on some 200 ill children in a hospital in Kano, without first getting the consent of their parents. Trovan was initially approved by the FDA for an unprecedented fourteen indications.

Pfizer has since denied the charges and settlement talks are at a stalemate. Even then, hugh questions remain. According to the testimony of Dr. Sidney M. Wolfe before the House Health Subcommittee in 2005, "there was clear evidence of liver damage caused by Trovan (in animals and in humans) before the drug was approved in December 1997."

Yet on June 9, 1999, at the time that the FDA issued its public health advisory to physicians concerning the risks of liver toxicity associated with the use of Trovan, the FDA permitted the continued sale of Trovan, “limit[ing]” its use in the United States to patients who were either hospitalized or in nursing homes! Shockingly, the demonstrated issues with the drug’s safety, efficacy and quality did not apply to the most vulnerable class of certain U.S. recipients.

Sale of Trovan waned in Europe following the FDA boxed warning , but then it required more and more cases of liver failure and death to occur before Pfizer quietly discontinued making the drug in 2002. Even so, during the latest year for which U.S. sales data are available (March 2004 through February 2005), there were still 18,000 prescriptions for Trovan filled in the U.S - long after Pfizer had reportedly stopped manufacturing the drug.

This author suggests that the 2nd Circuit opinion is sound in all respects: Pfizer should not be permitted to use the US judicial system to effectively deny access to foreigners injured or killed by its lethal drugs.

Drug Company Sidelined for Kickbacks

"Pharmacia excluded permanently from participation in all federal health care programs." Yahoo News

Pharmacia and Upjohn Company Inc., a unit of Pfizer Inc. was sentenced to pay a criminal fine of $19.68 million related to its guilty plea of offering a kickback to a pharmacy benefit manager. Read a report here and here. Pharmacy benefit managers can properly and often do recommend drugs [a list of recommended drugs called a "formulary"] to health plans. The problem with Pharmacia, according to Prosecutors, is that it offered the pharmacy benefit manager of a Federal health plan inflated payments in the amount of $12.3 million.

This is not an isolated case. Last year Schering-Plough, the maker of Claritin was subject to federal criminal anti-kickback charges, but was merely placed under a strict scrutiny for 5 years. These cases are clear evidence that Americans are being bilked for over-priced prescription drugs, that pharmaceutical companies are exploiting the system for maximum profit and that the practice is widespread. Enforcement under the Federal Anti-Kickback Statute reaches drug companies' financial relationships with foreign physicians and hospitals as well and so will likely be stepped-up to combat these illegal practices.