May 15, 2008

New Developments in Abbott’s Norvir Court Case

Documents involved in a class-action lawsuit against Abbott Laboratories, over a 400 percent price increase of its protease inhibitor (PI) Norvir (ritonavir) in 2003, have been unsealed, according to an announcement by Prescription Access Litigation (PAL), a coalition of 130 health-advocacy groups. One of the unsealed documents, made publicly available on PAL’s website, reveals that Abbott considered withdrawing Norvir capsules from the market in an effort to protect market share for its other PI, Kaletra (ritonavir/lopinavir).

Full-dose Norvir was once a popular cornerstone of antiretroviral (ARV) therapy. It eventually became used less frequently because of its significant side-effect profile and the fact that it causes the blood levels of many other drugs to increase to toxic levels. This tendency for extensive drug interactions turned out to be a boon for other HIV drugs, however, and it soon became standard-of-care to use low doses of Norvir to boost other PIs. Abbott took advantage of this quality by bundling a low dose of Norvir along with the PI lopinavir, selling them in a single pill as Kaletra.

In December 2003, Abbott raised the wholesale price of Norvir by 400 percent. At the time, the company said that this was because Norvir was now being used most commonly at very low doses and Abbott needed to be able to recover its investments in research and development for Norvir and future HIV drugs. In October 2004, however, a PAL member group, the Service Employees International Union (SEIU) Health and Welfare fund, filed a suit against Abbott in northern California, claiming that the company was trying to monopolize the HIV marketplace. The SEIU pointed out that when Abbott raised the price of Norvir, it did not raise the price of Kaletra, which also contains the drug. This meant the total price of a regimen containing Kaletra stayed the same, while Norvir-boosted regimens using competitor PIs suddenly became much more expensive. The SEIU claims that this constitutes an unfair and illegal business practice designed to stifle competition against Kaletra.

Motions filed by Abbott to dismiss the suit or issue summary judgments have been denied thus far. In June 2007, the lawsuit became a class-action lawsuit allowing others plaintiffs to join the suit. The trial is scheduled to go forward in August 2008.

This past month, the court ordered the unsealing of a number of documents that pertained to the lawsuit, overruling Abbott’s objections that the documents contained proprietary information about “business strategies.”

The documents reveal several strategies considered in 2003, including making Norvir available only in its liquid formulation (despite the fact that an Abbott executive stated in his deposition that the liquid formulation of Norvir tastes like “someone else’s vomit”). Another strategy under consideration was to remove Norvir from the market altogether, essentially forcing most people wishing to use a PI to take Kaletra instead of other PIs.

PAL director Alex Sugerman-Brozan says, “These documents show that Abbott put profits ahead of the needs of seriously ill HIV/AIDS patients in quintupling Norvir’s price.”

To view background information on the court case and the unsealed court documents, click here.

Search: Norvir, ritonavir, Abbott, Kaletra, lopinavir, Prescription Access Litigation, PAL, Service Employers International Union, SEIU, lawsuit, court, unsealed

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