The details of a whistleblower lawsuit against Pfizer, over its marketing and sale of Lipitor, were unsealed this month after the government declined to take part in the case.
The Lipitor whistleblower lawsuit was originally filed by Health Support Awareness, Inc., in August 2013, but was not publicly released until now in accordance with rules surrounding qui tam claims, which require that whistleblowers not publicize the case until the Department of Justice decides whether to join the prosecution of the lawsuit.
According to the complaint (PDF), Pfizer has provided misleading information about the cholesterol drug Lipitor, which was designed to keep the drug in demand and its price high. As a result of the deceptive marketing, the lawsuit claims that billions in additional costs have been incurred by customers, the government and the American health care system.
Pfizer allegedly used a number of tactics to artificially inflate the Lipitor price, including paying generic drug maker Ranbaxy to delay the release of a generic equivalent that would have brought prices down and introduced competition. The plaintiff also claims that the company manipulated the medical community’s beliefs regarding what constitutes safe levels of cholesterol; pushing for doctor-recommended limits to be lowered.
“Health groups, many of whom were supported in part by Pfizer, kept lowering the cholesterol targets in national guidelines, thereby causing millions more patients to believe they were good candidates for statin treatment,” the lawsuit claims. “In addition, clinical researchers, many of whom were supported financially by Pfizer, established a link between cholesterol levels and health consequences such as heart attacks.”
As a result, the lawsuit claims, about 43% of all Medicare patients were on either Lipitor or drug belonging to the same class of medications, known as statins, between 2007 and 2010. This cost the Medicare program $6.7 billion in 2010 alone. The lawsuit claims this resulted in Medicare fraud.
Under the qui tam provisions of the False Claims Act, whistleblowers who expose fraud by revealing information not publicly accessible that results in the recovery of money by the U.S. government are entitled to a portion of funds. Whistleblowers must be the first to bring the case to the government’s attention, and may be entitled to receive between 15% and 30% of the money collected by the government if the lawsuits result in a monetary settlement or fines.
Lipitor Problems for Pfizer
The whistleblower case comes amid an increasing number of Lipitor injury lawsuits filed against Pfizer by women who allege that the drug maker withheld information about the risk of diabetes from the medication. The product liability complaints involves some similar allegations, suggesting that Pfizer artificially created demand for the cholesterol drug as a preventative measure to health otherwise healthy women, despite questions about the efficacy and potential side effects of Lipitor.
Prior to becoming available as a generic in 2011, Lipitor generated $125 billion in sales for Pfizer.
Lipitor is part of a class of medications known as statins, which are among the best selling drugs in the United States. They use the liver to block the body’s creation of cholesterol, which is a key contributor to coronary artery disease. However, a number of studies have linked the drugs to an increased risk of potentially serious injuries, including muscle damage, kidney problems and diabetes.
In February 2012, the FDA required the makers of Lipitor, Crestor and other statins to add new warnings about the potential impact of the medication on blood glucose levels. However, some critics have suggested that the warnings are not strong enough for certain medications, indicating that users and the medical community should be provided with more accurate information about the diabetes risks from Lipitor, Crestor and other statins.
Plaintiffs who are pursuing individual lawsuits over a diabetes diagnosis from Lipitor indicate that they could have avoided the serious medical condition if Pfizer had provided more accurate information for consumers and the medical community, which would have allowed them to choose not to take the drug or to more closely monitor blood glucose levels during treatment. Plaintiffs claim that the drug maker knew or should have known about Lipitor diabetes problems for years, but withheld information to avoid a negative impact on sales and growth of the blockbuster medication.
Later this month, a panel of federal judges are scheduled to hear oral arguments in a motion to centralize all product liability lawsuits over Lipitor filed in U.S. District Courts throughout the United States. Plaintiffs indicate that as Lipitor diabetes lawyers continue to review and file cases, thousands of complaints will likely be brought against Pfizer throughout the federal court system.