Product Label Doublespeak at the Root of Lipitor Diabetes Lawsuits

Charleston, SCIf someone offered you a million dollars to identify, off the top of your head, disaccharide C12H22O11 in layman’s terms, what are your chances you’d walk away a millionaire? You might have a clue if they threw the word “sucrose” in there, but the point is already made: unless you’re a scientist or chemist, you’d have no idea that sucrose disaccharide C12H22O11 is, in reality, ordinary table sugar. And that’s the very point Lipitor plaintiff Margaret Clark is making in her Lipitor lawsuit...

Lipitor manufacturer Pfizer Inc. has stated that product labels properly identified the risks at the time Clark was using Lipitor to maintain healthy cholesterol levels. Clark’s lawsuit holds that the Lipitor label stated, “Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including LIPITOR.”

Huh?

In reality, Pfizer’s med speak was a warning pertaining to the risk for atorvastatin type 2 diabetes. And that’s Clark’s point: unless you utilize language that most people would understand, the warning is lost. “Until the February 2012 label change,” Clark’s lawsuit continues, “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.”

Other Lipitor lawsuits allege similar doublespeak with regard to the Lipitor label prior to 2012. To that end, the recent approval of the Lipitor Diabetes Lawsuits MDL, which consolidates various individual lawsuits into a single jurisdiction, will help streamline proceedings of not only the 56 initial lawsuits, but other actions that come along in the meantime.

The Lipitor mdl, approved in February, includes some 170 “tag-along” actions that are pending in more than 40 districts before more than 100 different judges. In consolidating the various lawsuits in a single multidistrict litigation, those 100 judges have more time to devote to other cases in their respective jurisdictions.

Almost 50 percent of post-menopausal women at higher risk for diabetes: study

Meanwhile, we’re into the third year now since the Women’s Health Initiative (WHI) statin study was released. The research, conducted by Yunsheng Ma, MD, PhD and colleagues of the University of Massachusetts School of Medicine, concluded that post-menopausal women who were on a statin at study entry exhibited an almost 50 percent higher risk for diabetes than those study participants not taking statin drugs of any kind. Specifically, a total of 153,840 women with a mean age of 63 were studied. When the participants enrolled in the study in 1993, it was reported that about 7 percent of the participants were on statins at the time. Follow-ups concluded in 2005, with a total of 10,242 cases of new-onset diabetes reported.

The findings were published in the Archives of Internal Medicine (now JAMA Internal Medicine) in January 2012.

Meanwhile, additional Lipitor lawsuits continue to appear, with plaintiffs alleging that their atorvastatin type 2 diabetes would never have happened if the warning label on Lipitor, prior to 2012, had warned them about the potential for type 2 diabetes, rather than “increases in HbA1c and fasting serum glucose levels” with “HMG-CoA reductase inhibitors.”

The Lipitor MDL is In re Lipitor (atorvastatin) Litigation, MDL No. 2502, US District Court, District of South Carolina. Oh, and enjoy your morning cup of 1,3,7-Trimethyl-3,7-dihydro- purine-2,6-dione as you ponder the aforementioned…