Whistleblower Lawsuit Accuses Pfizer of Deceptive Lipitor Marketing

In August 2013, a Lipitor lawsuit was filed on behalf of Health Support Awareness, Inc., against Pfizer. The complaint is a whistleblower lawsuit, also known as a qui tam complaint. The plaintiffs, known as the relators, allege that the defendants engaged in deceptive marketing practices that constitute fraud. As per standard practice in qui tam complaints, the details of the lawsuit were kept sealed until recently. Whistleblowers are required to remain quiet about the complaint to allow the U.S. Department of Justice (DOJ) time to consider whether to join in the prosecution efforts. Recently, the DOJ declined to take part.

Under the False Claims Act, anyone with knowledge of fraud committed against the U.S. government has the right to file a qui tam complaint. The lawsuit is filed in a U.S. District Court to recover compensatory damages on behalf of the government. However, the relators are entitled to receive a whistleblower award, or a portion of the funds recovered.

Lawsuit alleges Medicare fraud

Health Support Awareness, Inc., is a nonprofit organization run by Louis H. Mueller, a pharmacist who resides in Florida. The relator has direct experience in assisting uninsured and underinsured individuals to obtain medications such as Lipitor. Through the relator’s professional experience in helping patients reduce the costs of their prescription medications, he became aware of a discrepancy in the marketing literature of Pfizer as compared to the professional literature.

The marketing literature strongly advised patients against splitting their pills, a common cost-saving measure whereby a patient is prescribed a higher dosage of pill to split into two dosages. This common practice is endorsed by the Veterans Administration. However, the relator became aware that there was no clear medical reason for advising patients against splitting Lipitor.

The relator’s Lipitor lawsuit alleges that the misleading marketing information distributed by Pfizer has cost consumers and government-sponsored health care programs, including Medicare, billions of dollars over the course of about 10 years. According to the lawsuit, “Pfizer’s aggressive attitude to increase sales and market share resulted in unprecedented profits at the expense of the entire health care system.”

The lawsuit went on to note that according to the Centers for Disease Control (CDC), Medicare prescriptions for Lipitor and other statin drugs amounted to 113 million in 2008, and this number continued to climb over subsequent years. The refusal to allow patients to safely split their pills has cost Medicare an estimated $1.4 billion per year. From 2007 to 2010, about 43 percent of all Medicare patients were on statin medications.

The relator alleges additional deceptive marketing practices, such as artificial inflation of the drug’s price by paying off a generic drug maker in order to delay the introduction of a generic equivalent into the marketplace. Furthermore, the relator alleges that Pfizer manipulated the guidelines for the prescription of cholesterol-lowering medications so that patients with reasonable levels of cholesterol would be prescribed drugs despite a lack of medical necessity.

Studies link Lipitor and diabetes

This lawsuit filed with regard to Lipitor isn’t the only legal action Pfizer faces. The company is currently under fire for the connection between the cholesterol-lowering medication and the development of diabetes. Patients who have filed lawsuits against the company claim that Pfizer put profits ahead of their safety, noting that the drug places women in particular at a higher risk of diabetes.

A study published in the British Medical Journal by Canadian researchers evaluated 500,000 residents in Ontario who used Lipitor. The study found that those taking Lipitor had a 22 percent higher risk of type 2 diabetes, as compared to only a 10 percent higher risk in patients taking Zocor, another type of statin drug.

A study from the University of Massachusetts determined that women who take Lipitor had a 50 percent higher risk of diabetes, as compared to those who do not take the drug. The FDA has required drug manufacturers of statins to add new warning labels to the products.

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