Lipitor Diabetes Risk for Women Was Known by Pfizer: Plaintiffs

Plaintiffs calling for the consolidation of all Lipitor diabetes lawsuits brought throughout the federal court system indicate that the currently pending cases are only the “tip of the iceberg,” as it has only recently been discovered how long Pfizer knew about the increased risk of diabetes from Lipitor among women.  

Earlier this month, a request was filed to establish a Lipitor MDL, or multidistrict litigation, which would centralize complaints filed against Pfizer in U.S. District Courts throughout the country before one judge for coordinated handling during pretrial proceedings.

According to a motion in support of consolidation (PDF) filed on October 29, attorneys representing plaintiff Evalina Smalls indicate that it is appropriate to centralize the cases because a large number of additional claims are going to be filed. Smalls indicates that clinical trial data submitted by Pfizer as early as 1997 showed that side effects of Lipitor increase blood glucose levels and the drug warning label was not adequately updated to inform consumers and the medical community about the diabetes risk.

In August 2013, the U.S. Judicial Panel on Multidistrict Litigation (JPML) rejected a prior attempt to formally coordinate the Lipitor diabetes litigation. At that time, the Panel pointed out that only a small number of complaints had been filed by women diagnosed with diabetes from Lipitor, even though the medication has been a best-selling prescription drug since the late 1990s and information about the impact of Lipitor on blood sugar levels was added to the label in February 2012.

Since a second request was filed earlier this month, the number of new Lipitor lawsuits has skyrocketed, with at least 70 new complaints brought during the two weeks after the motion was filed. According to the response filed in support of consolidation by Smalls, the currently filed lawsuits only represent a small portion of the claims to come, because the depth of Pfizer’s actions was not previously known to women nationwide.

“It has long been known that if women do develop diabetes, their risk of cardiovascular problems is higher than in men. But it is only recently that the scientific community has discovered that Pfizer knew or should have known since 1996, that the use of Lipitor increases the risk of diabetes in both men and women,” the motion states. “And it is even more recently that researchers outside Pfizer have discovered that women using statins have a higher risk of contracting diabetes than men. That is why there are so few cases on file in July of 2013 and why the cases filed to date are only the tip of the iceberg.”

At the time the first MDL request was filed, there were only 24 cases pending nationwide in federal courts. But now there are more than 130 and many Lipitor lawyers reviewing cases expect that thousands of complaints will ultimately be filed by women who claim that Pfizer withheld information about the risk of diabetes from Lipitor.

Lawsuits Claim Pfizer Failed to Warn

Lipitor (atorvastatin) is one of the most widely used brand-name medications in the United States, with millions of Americans taking the medication to help lower cholesterol and improve their health. Before it became available as a generic in 2011, Pfizer generated more than $125 billion in Lipitor sales.

In February 2012, the FDA required new diabetes warnings for Lipitor and other similar statin-based medications, informing users for the first time that they may face an increased risk of changes to blood glucose levels. However, plaintiffs allege that Pfizer knew or should have known about the possible risk of diabetes long before these warnings were issued, and maintain that the current warnings remain vague and misleading, especially for women.

In nearly all of the complaints filed to date, women allege they developed diabetes from Lipitor, maintaining that if they had been provided proper warnings about the risks associated with the medication, they could have avoided diabetes by choosing not to take the cholesterol drug or by diligently monitoring their blood glucose levels during treatment.

Centralizing the Lipitor diabetes litigation as part of an MDL is designed to reduce duplicative discovery in a large number of cases, avoid conflicting pretrial orders from different judges and to serve the convenience of the parties, witnesses and the courts. Coordinated management of the litigation also promotes possible Lipitor settlement agreements that may resolve cases without hundreds of individual trials being scheduled in courts throughout the country.

Pfizer previously opposed the first attempt to establish a Lipitor MDL, and the drug maker is not expected to respond to this latest Motion until early next month. It is likely that the U.S. JPML will schedule oral arguments on the issue for an upcoming hearing session set to occur on January 30, 2014 in New Orleans, Louisiana. There is an earlier hearing set for December 5 in Las Vegas, but to date the Lipitor oral arguments have not been scheduled for that hearing.