DOJ Aids Lipitor Whistleblower Lawsuit but Declines to Intervene

The Department of Justice (DOJ) has declined to take part in a whistleblower lawsuit claiming that Pfizer misled doctors about the health benefits of the cholesterol drug Lipitor. However, the DOJ did file a brief supporting the plaintiff, who claims that the company also participated in kickbacks and promoted Lipitor for off-label uses in order to boost sales. 

Last week the DOJ filed a “statement of interest” backing up claims against Pfizer by Jesse Polansky, a former company executive, but has said it will not join in the lawsuit. The DOJ brief came on the heels of a Pfizer motion to have the lawsuit dismissed, and argues on behalf of Polansky, attacking several of Pfizer’s grounds for dismissal.

Polansky is Pfizer’s former director of outcomes management and was employed with the company from 2001 through 2003. He claims that Pfizer misled doctors with educational programs, product labeling and by manipulating federal guidelines to get them to prescribe Lipitor more frequently than was necessary. The lawsuit also claims that Pfizer was involved in sampling kickback schemes. According to allegations raised in the complaint, 18% of Lipitor sales were for off-label uses that the government unknowingly reimbursed through Medicare and Medicaid payments in violation of the False Claims Act.

Whistleblowers who report a false claim against the government may be entitled to receive a portion of any money that the government recovers from the offenders under the qui tam provision of the False Claims Act. In return, the whistleblower must be the first to bring the case to the government’s attention, and must not publicize the claim until the DOJ decides to prosecute the case.

Lipitor (Atorvastatin) was approved by FDA in December 1996 for use in lowering cholesterol. It is a member of a class of drugs called statins and works by inhibiting an enzyme in the liver that takes part in cholesterol production. Lipitor brought in $12.4 billion in sales for Pfizer in 2008.

Pfizer has filed a motion in the U.S. District Court for the Eastern District of New York, which is handling the case, to have the lawsuit dismissed. The company claims that Polansky’s claims conflict with what is actually on the label of Lipitor, and fails to allege any legally false claim and fails to allege that Pfizer caused the submission or approval of a false claim.

The DOJ’s statement attacks those arguments however, noting the Pfizer changed the label of Lipitor five years after allegedly false claims were submitted in 2004, and notes that changing the label after-the-fact does not address false claims made before that change. The government also notes in its brief that Pfizer does not have to make a conscious or deliberate lie to constitute a false claim. It is enough if the company can be shown to have presented or caused the presentment of a false claim.

The side effects of Lipitor and other statins have come under increasing scrutiny recently. In February, a study published in the medical journal, The Lancet, found that people using cholesterol drugs faced a 9% increased risk of being diagnosed with type 2 diabetes.  Other studies have found that about 1 in 10,000 statin users develop a sometimes-fatal muscle condition known as rhabdomyolysis. The rare condition causes skeletal muscle damage and releases myoglobin into the bloodstream. The myoglobin can cause severe kidney failure or death.

In 2002 and 2008, the FDA issued warnings about the increased risk of rhabdomylosis when statins are used in combination with heart medication containing amiodarone. In 2001, the statin-based drug Baycol was removed from the market due to its links with rhabdomyolysis.