Lipitor Diabetes Warning Remains Inadequate, Lawsuit Alleges

A South Carolina woman has filed a product liability lawsuit against Pfizer, alleging that the blockbuster cholesterol drug Lipitor caused her to develop diabetes.  

The complaint (PDF) was filed by Margaret Clark in the U.S. District Court for the District of South Carolina on April 30, alleging that Pfizer has failed to adequately warn about the diabetes risk from Lipitor, even after updating the label last year at the request of the FDA.

According to allegations raised in the Lipitor diabetes lawsuit, Clark was prescribed the cholesterol drug in 2002 to help reduce her risk of heart disease. At that time, she indicates that she had a body mass index of 22.7, which is considered a healthy and normal weight.

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Clark maintains that she agreed to take Lipitor to help maintain her healthy and active lifestyle, but instead the drug allegedly resulted in her diagnosis of type 2 diabetes in February 2012.

Clark is one of a growing number of women filing Lipitor lawsuits after developing diabetes. The complaints allege that Pfizer failed to adequately warn consumers or the medical community about the risks associated with using Lipitor and the importance of closely monitoring blood glucose levels to see if the drug was adversely affecting their metabolism.

Lipitor Warnings for Diabetes

Lipitor (atorvastatin) is a cholesterol-fighting drug that belongs to a class of medications known as statins, which are used to lower cholesterol by reducing blood levels of low-density lipoprotein (LDL) cholesterol, or “bad” cholesterol. LDL cholesterol is a major contributor to coronary artery disease.

The cholesterol medications are one of the best-selling classes of drugs in the United States, with more than $14.5 billion in combined sales in 2008. Some other commonly marketed prescriptions of statins include: Advicor, Altoprev, Crestor Lescol, Lovalo, Mevacor, Pravachol, Simcor, Vytorin and Zocor.

Out of all medications sold in the United States, Lipitor is one of the most commonly used brand-name medications, generating an estimated $125 billion in sales for Pfizer before it became available as a generic in 2011. The medication has been heavily promoted in direct-to-consumer advertisement, encouraging patients to speak to their doctor about whether they need to be placed on Lipitor to maintain their health.

According to Clark’s lawsuit, Pfizer knew or should have known that there was a connection between Lipitor and diabetes before it was even placed on the market in 1997. However, there was no warning added to the label until February 2012, after the FDA’s Division of Metabolism and Endocrinology Products requested that a warning be provided for consumers and the medical community.

Even then, the warning never actually mentioned type 2 diabetes, stating instead : “Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including LIPITOR.”

“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,” according to allegations raised in Clark’s complaint. “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.”

The lawsuit accuses Pfizer of failure to warn, negligence, breach of warranty, fraud, and unjust enrichment. Clark is seeking both compensatory and punitive damages.

Late last month, a request was filed to centralize the Lipitor diabetes litigation before one judge for coordinated handling as part of an MDL or multi-district litigation. The U.S. Judicial Panel on Multidistrict Litigation is expected to hear oral arguments on the motion in July. If a Lipitor MDL is established, Clark’s lawsuit will be transferred into the consolidated pretrial proceedings.


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