October 26, 2016
Case Caption: In Re: Lipitor (Atorvastatin Calcium) Marketing, Sales Practices and Products Liability Litigation (No. II)
Jurisdiction: U.S. District Court, District of South Carolina
Docket #: 2:14-mn-02502
Case Type: Mass Tort – Pharmaceutical Drug
Defendants: Pfizer Pharmaceuticals; McKesson Corporation
Judge: Richard Mark Gergel

Lipitor is the brand name of the drug atorvastatin. It is part of the statin class of hypolipidemic drugs, which are a diverse group of pharmaceuticals used to treat abnormally elevated levels of any or all lipids and/or lipoproteins in the blood. Statins, in particular, lower cholesterol by inhibiting the enzyme HMG-CoA reductase, which produces about 70 percent of cholesterol in the body.

Pfizer manufactures and sells Lipitor as a prophylactic treatment to prevent cardiovascular disease. The generic versions of Lipitor are known as atorvastatin calcium. Drugs competing with name brand Lipitor include Vytorin and Zocor. 

Bruce Roth of Parke-Davis Warner-Lambert Company (now Pfizer) first synthesized the compound atorvastatin in 1985. In 1996, the FDA approved Lipitor as a prescription medication to treat individuals with high cholesterol. In the clinical trial data submitted to the FDA in the New Drug Application, it was divulged that those who had taken Lipitor had blood glucose levels increase threefold, or more than 1.25 times the normal upper limit. Nevertheless, the FDA can approve a drug as long as the scientific evidence shows that the benefits of a drug outweigh the risks associated with use, and that adequate instructions exist for use, since many drugs are toxic and technically not "safe" in the usual sense.

Since entering the U.S. market in 1997, Lipitor has been prescribed to more than 29 million people in the United States. It was named the best-selling drug in the world in 2011, and has been extremely profitable, earning Pfizer $13 billion annually. However, after medical studies began linking Lipitor to increased risk for diabetes in women, Pfizer’s annual profits dropped to $7.9 billion.

In a January 2012 Journal of the American Medical Association (“JAMA”) publication, Internal Medicine, reported that post-menopausal women treated with statins were at increased risk of developing diabetes. Then, in May 2013, the British Medical Journal published a study that found Lipitor patients faced a 22 percent increased risk of developing type 2 diabetes. It also found a nearly 50 percent increase in new onset diabetes among postmenopausal women on statin therapy. Although it likely lacks relevance, the complaints have also observed that in August 2013 the manufacturer of Crestor, another statin, added a diabetes warning to its labeling. 

The plaintiffs in this litigation allege that Lipitor, manufactured by Pfizer Pharmaceuticals, causes an increased risk of Type 2 diabetes in women. As a consequence, the plaintiffs contend that Lipitor is defective and unreasonably dangerous, that Pfizer knew that use of the drug increased the risk of obtaining diabetes, and that Pfizer failed to adequately warn doctors and consumers about such risk. As for causation, the plaintiffs assert that, had Pfizer disclosed the risks associated with Lipitor, they would have avoided the risk of diabetes by either not using Lipitor, or by closely monitoring their blood glucose levels to see if Lipitor was adversely affecting their metabolism. The plaintiffs are seeking actual and punitive damages for permanent physical and emotional injuries, and for past and future economic loss.