Teamsters Sue Drug Giant

NEW YORK The Teamsters union sued Pfizer yesterday, alleging it has been defrauded into paying for Lipitor prescriptions that were written for unapproved uses that the company illegally promoted.

The suit requests class-action status, and alleges that Medicare and Medicaid also paid for prescriptions that were written “off label,” meaning for uses not approved by the federal government.

The suit’s consequences are potentially enormous—the cholesterol-fighting brand has nearly $13 billion in sales annually, making up about one-fifth of all Pfizer’s revenue. It is the world’s No. 1 selling drug.

The suit is complicated, hinging on the arcane language that details under what conditions Lipitor should be taken, according to the Food and Drug Administration. In fact, several pages of the suit are devoted to describing the complex nature of the science behind who should and should not be prescribed the drug.

It alleges that Lipitor was only approved for use in certain populations. One such population is defined as those whose cholesterol “LDL” level is “160 ml/dL” or higher. The suit claims, however, Pfizer created marketing materials that suggested Lipitor be used in patients with LDL levels of 130 ml/dL—thus including millions more people than the government had intended.

One curious aspect to the suit is that the plaintiffs—the union’s welfare fund for Local 863 in New Jersey, among others—claim that Pfizer’s off-label activity was conducted in an open, seemingly above-board manner via seminars, slide shows, analyst conference calls and sales materials.

Usually, when off-label allegations are made against drug marketers, the claims revolve around nebulous situations where the company may have looked the other way while its representatives made inappropriate claims for the medicine.

In an e-mailed statement, the New York-based drug giant said: “Pfizer has and continues to take seriously its responsibility to provide appropriate information to physicians and patients and to comply with all federal laws and regulations regarding the promotion of our medicines. Based on the information provided to us, we believe there is absolutely no merit to the claims regarding the promotion of Lipitor.”

The suit was filed in U.S. District Court in Newark, N.J.