Lipitor Diabetes Lawsuit Upheld By 2nd Circuit

Lipitor Diabetes Lawsuit Upheld By 2nd Circuit

Introduction

Plaintiffs appeal alleging Pfizer Inc. of failing to warn that its cholesterol drug Lipitor caused their type 2 diabetes is denied by the Second Circuit

The reasons for the denial are still unclear and the three-judge panel stated that the decision has come after considering the substantial reasons provided by the district court.

As per a lawsuit filed by the plaintiffs in April 2019, Lipitor's label changed in 2012 claiming that it included drug statin which can increase glucose levels and hemoglobin A1c. The plaintiffs even alleged that the label did not warn that Lipitor caused Type 2 diabetes and the doctors prescribed the drug without knowing its side effects.

U.S. District Judge William H. Pauley III dismissed this case with prejudice in April 2020 by stating that Pfizer label change in 2012 complied with the Federal Food, Drug, and Cosmetic Act. He even said that the claims before April 2016 fall outside the three-year statute of limitations so the pleading cannot be considered.

Plaintiffs appealed to the Second Circuit in August as their claims were not acknowledged because the pharmaceutical company could have changed its label warning about diabetes without the U.S. Food and Drug Administration's approval.

The best-selling drug of all time, with sales of more than $130 billion since it hit the market in 1996, more than 29 million people in America have been prescribed Lipitor. Unsurprisingly, this number suggests that there is a vast pool of potential plaintiffs.

Lipitor (Atorvastatin calcium tablets) brought to market by Pfizer. Atorvastatin belongs to a class of drugs called statin, which is used to lower blood cholesterol levels. It also stabilizes the skin and prevents strokes using its anti-inflammatory and other methods.

Lipitor is given to patients with Dyslipidemia (an abnormal amount of lipids such as cholesterol and/or fat in the blood) and prevention of cardiovascular disease.

Lipitor was approved by FDA in the year 1996 as a preventive measure against cardiovascular disease that helps lowering cholesterol. Pfizer first presented the drug in February 2012 to treat patients with high blood sugar and who have higher chances to develop diabetes. After the FDA’s Division of Metabolism and Endocrinology Products request, the Lipitor maker had to update the warning label of the drug.

As per lawsuits, Pfizer promoted Lipitor as safe and effective, despite being aware of the risks associated with the increase in blood glucose levels and development of type 2 diabetes. Plaintiffs alleged that Pfizer engaged in misleading marketing where they aggressively made their products safe and superior to other drugs. However, they did not provide patients and their healthcare providers with warnings that could have avoided injuries.

Plaintiffs highlighted the fact that post-2012 FDA approval when the defendant received new information Lipitor's link to diabetes, it could have added the label or sought FDA approval to change the label based on these reports; however, it did not do anything to alert the users and doctors.

Pfizer argued that the post-2012 claims made by the plaintiffs are barred because the FDA approved the updated label, while any claims before 2016 fall outside New York's statute of limitations in October. The company also stated that the adverse event reports should not be considered as new evidence, based on which the label change was justified.