New York, NY: Personal injury lawsuits filed against Pfizer, the maker of the cholesterol-lowering drug Lipitor (atorvastatin) are mounting and, as a consequence, are being consolidated into Multi District Litigation (MDL). The Lipitor lawsuits allege that Pfizer has failed to adequately warn consumers of the risk for developing diabetes associated with the statin. In 2012 Pfizer updated the Lipitor labeling to include warnings of increased risk for diabetes, however, the lawsuits contend that this was insufficient.
Lipitor belongs to a class of drugs called statins, which are used to lower cholesterol by reducing blood levels of low-density lipoprotein (LDL) cholesterol, or “bad” cholesterol, a contributing factor in heart disease. A study (Culver AL, Ockene IS, Balasubramanian R, et al. "Statin Use and Risk of Diabetes Mellitus in Postmenopausal Women in the Women's Health Initiative." Archives of Internal Medicine, 2012,172(2): pp.144-152.), completed in 2012, as part of the Women’s Health Initiative (WHI) found an association between the statin class of medications and the development of type 2 diabetes in women, particularly post-menopausal women.
Among the most recent Lipitor diabetes lawsuits filed is that of Margaret Clark, filed in the US District of South Carolina, this April. She contends she was prescribed Lipitor in 2002 to address her risk for heart disease. At the time, according to her lawsuit, she was considered a healthy weight. However, in February 2012, Clark was diagnosed with type 2 diabetes.
Clark’s lawsuit alleges Pfizer knew or should have known that there was a connection between Lipitor and diabetes before it was made publically available in 1997. Instead, the warning was only added to the product labeling in February 2012, after the FDA’s Division of Metabolism and Endocrinology Products requested that a warning be provided for consumers and the medical community.
According to the lawsuit, the warning did not actually mention type 2 diabetes, but rather stated “Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including LIPITOR.”
The Lipitor lawsuit also states “Until the February 2012 label change, Lipitor’s label never warned patients of any potential relation between changes in blood sugar levels and taking Lipitor.” And, “Despite the February 2012 label change, Lipitor’s label continues to fail to warn consumers of the serious risk of developing type 2 diabetes per se when using Lipitor.”
Recently, a request was filed to centralize the Lipitor diabetes litigation before one judge for coordinated handling as part of an MDL, and the request was granted. MDLs are frequently confused with class action lawsuits however, they differ in that each complaint remains individual and is argued on an individual basis.