By Elise Alpert RN, MPA, JD

Lipitor is in the class of drugs commonly known as statins. 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 drug to an increased risk of potentially serious injuries, including muscle damage, kidney problems and diabetes. Current Lipitor litigation is focused on women who have developed type 2 diabetes particularly with a Base Metabolic Index (BMI) less than 31. Therefore, the focus of this article will the development of diabetes in women.

WHAT IS LIPITOR AND WHAT DOES IT DO?

According to the U.S. Food and Drug Administration (FDA), cholesterol, a waxy substance that occurs in the blood, isn’t necessarily bad for you. In fact your body needs it to make hormones, vitamin D and bile acid that assist in digestion.

There is a type of cholesterol called low-density lipoproteins (LDL) that can lead to the build-up of fatty deposits in blood vessels, obstructing the flow of blood and increasing your risk for stroke, heart disease or heart attacks.

Lipitor works by blocking an enzyme in the liver from creating low density lipids your body needs to make cholesterol which blocks the arteries and has other side effects.

WHAT IS THE PROBLEM WITH WOMEN TAKING LIPITOR?

Studies have linked the use of Lipitor and other statins with a higher incidence of diabetes. The FDA has cited studies linking the use of statins, like Lipitor, to an increase in blood sugar levels which is often a precursor to diabetes. This specifically relates to Type 11, new onset diabetes.

According to a report in Reuters, researchers at the University of Massachusetts Medical School in Worster studied data on more than 150,000 women in their 50’s, 60’s and 70’s. They found that the women who reported using any kind of statin, including Lipitor, at the start of the study were 48% more likely to be diagnosed with diabetes than those not taking the drugs. Another large study, known as Jupiter, found a 27% increase in the risk of diabetes, particularly among women.

FDA APPROVAL

Statins are among the best-selling drugs in the United States with 14.5 billion in combined sales in in 2008. In fact it is one of the most prescribed drugs in recent history.

Crestor (rosuvaststin) was approved by the FDA in 2003 and is manufactured by Astra Zeneca. It is currently the bestselling statin in the country with 5.4 billion in sales over the last 12 months. It is also the most widely prescribed dug in the nation.

Lipitor (atorvastatin) was approved by the FDA in 1996. It is prescribed in 10-80 mg tablets that are taken daily.

It was previously the bestselling statin, generating more than $125 billion in sales for Pfizer before it became a generic in 2011.

FDA WARNING/INCREASED RISK OF DIABETES

Lipitor and other statins have been found to cause diabetes in post-menopausal women. In spite of this, The FDA has yet to issue a warning to consumers.

Recently, Lipitor Crestor and other statins have been linked to an increased risk of diabetes, leading the FDA to require new warnings in February 2012 about the potential impact the medications may have on blood sugar levels. In spite of this, the FDA has yet to issue a diabetes warning to consumers. On February 28, 2012 the FDA ordered a label change to warn of the possible increases in HbA1c and fasting serum glucose levels, but was silent as to diabetes connection. No monitoring of HbA1c or fasting bold glucose levels were recommended.

Studies have suggested that otherwise healthy individuals who begin taking statins to reduce the risk of heart disease, may actually face an increased risk of serious Liver Problems, memory loss and confusion, a form of muscle injury called sympathy.

Other manufacturers of cholesterol lowering statins were also required to comply with these new guidelines.

Pfizer has known since 1996 that the drug carried a risk of diabetes, but only warned doctors and patients about the risk when it was forced by the FDA in 2012.

STUDIES THAT SHOW AN INCREASED RISK OF DIABETES

A study published in the medical journal Circulation: Cardiovascular Quality and Outcomes (July 2013)found that statin users face about a 9% increase in the risk of diabetes.

University of Glasgow scientists analyzed the results of 13 different studies into the side effects of statins and found that people using the cholesterol drug faced a 9% increased risk of being diagnosed with type 2 diabetes. The results of this study were published in the medical journal The Lancet (February 2010).

A study published in the May 2013`British Medical Journal suggested that certain statins may carry an increased diabetes risk. Lipitor users faced a 22% increased risk of diabetes, those taking Crestor were at an 18% increased risk and patients taking Zocor faced a 10% increased risk.

A study conducted by the Women’s Health Initiative of 150,000 postmenopausal women found that those taking a statin were 48% more likely to get diabetes. The statistic rose to 86% with a low BMI under 30 or normal weight.

LAWSUITS

Pfizer faces  a growing number of Lipitor diabetes lawsuits by plaintiffs who contend that the company failed to warn about the potential risks associated with using the medication.

Plaintiffs allege that Pfizer withheld information about the risks of Diabetes from Lipitor side effects, particularly among women with a BMI under 30, who do not have other risk factors for the disease.

Hundreds of complaints have been filled in US District Courts nationwide.  Plaintiffs maintain that had they been provided proper warnings about the potential risk of side effects of Lipitor, in particular the risk of diabetes, they could have avoided developing diabetes by proper glucose monitoring during treatment or by taking a different medication.

In April of 2013, Ms. Smalls and other plaintiffs from South Carolina filed a request to consolidate the Lipitor diabetes lawsuits and before one Judge (MDL Docket No. 2459 JPML) in South Carolina.

In May of 2013, Pfizer opposed the motion to transfer the cases out of the plaintiff’s home jurisdiction, stating Pfizer would prefer to fight each case individually. Pfizer argued that the consolidation of the Lipitor diabetes lawsuit would encourage more people to file lawsuits resulting in the exposure of trade secrets behind Lipitor.

In June 2013, the Multidistrict Litigation (MDL) Panel met in June and established the national Lipitor diabetes lawsuit, in the United States District Court for the District of South Carolina.

In July 2013, the MDL panel met again to determine whether out of state cases should be transferred to the MDL.

On Feb. 18, 2012014 a MDL was established in South Carolina. The Honorable Richard M. Gergel is currently presiding over the MDL.

By consolidating these lawsuits from across the United States into a mass tort, the court will be able to conserve resources, avoid duplication of discovery, and prevent inconsistent pretrial rulings.

If you or one of your clients suspect the onset of diabetes due to the use of a statin drug, please call our office for a free consultation.

Elise Alpert, RN, MPA, JD, is of counsel to our office. She has the distinction of being both an attorney and registered nurse. She concentrates in the areas of dangerous drugs, defective medical devices, and medical malpractice. She invites your inquiries on any other drug or medical device. Her profile can be found here.