The Judicial Panel on Multidistrict Litigation (JPML) has consolidated lawsuits filed around the country against the pharmaceutical company Pfizer under the style In Re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices and Products Liability Litigation (No. II), No. MDL-2502. The cases involve allegations that the plaintiffs developed type 2 diabetes after taking the cholesterol-lowering drug marketed by Pfizer as Lipitor. As of April 15, 2014, the JPML has consolidated 464 claims in the U.S. District Court for the District of South Carolina. Consolidation is appropriate, according to federal statute, when multiple lawsuits involving common questions of fact are pending in multiple federal courts around the country, and a single court could efficiently handle various pretrial proceedings. 28 U.S.C. § 1407.
Atorvastatin, marketed under the brand name Lipitor, is part of the family of drugs known as statins, commonly used to reduce a patient’s cholesterol levels. Statins work by inhibiting an enzyme used by the liver to produce cholesterol. High cholesterol levels have been associated with an increased risk of heart disease, and statins have demonstrated the ability to prevent heart disease in high-risk patients. A paper published in the Lancet in February 2010 identified a slight risk of diabetes associated with statins, while a paper published in the January 2012 Archives of Internal Medicine found an increased risk of diabetes among postmenopausal women who take statins. These and other studies led to a series of lawsuits alleging that Lipitor caused plaintiffs to develop type 2 diabetes.
The U.S. Food and Drug Administration requested in August 2011 that Pfizer change the Lipitor label to include warnings about the risk of type 2 diabetes. The company changed the label in February 2012, but allegedly did not include specific warnings about the diabetes risk. The plaintiff in Jennings v. Pfizer, No. 1:14-cv-00096, complaint at 2 (D. Md., Jan. 13, 2014), describes the revised Lipitor label as “extremely vague.” The complaint in Gaines v. Pfizer, No. 1:14-cv-00170, complaint (D. Md., Jan. 22, 2014), alleges that Pfizer did not issue any warnings about the possible connection between Lipitor and type 2 diabetes before making the requested changes to the drug label. It further claims that, while the new label “warns in the most obtuse terms” about the risk of elevated blood sugar, it makes no direct warning about diabetes risk. Id. at 5.
The Jennings plaintiff states that she took Lipitor from 2005 to 2013 in order to lower her cholesterol and prevent cardiovascular disease. She alleges that she was diagnosed with type 2 diabetes in January 2011, and now requires regular blood tests, medication, and lifelong behavioral and dietary restrictions. In Gaines, the plaintiff claims that she started taking Lipitor for similar reasons in May 2004. After taking the drug for over five years, she was diagnosed with type 2 diabetes in December 2009. Both plaintiffs are asserting causes of action for negligence, strict liability, failure to warn under a products liability theory, and several consumer claims. Their lawsuits were added to the JPML proceeding on February 28, 2014.
The pharmacy error attorneys at Lebowitz & Mzhen can assist Maryland individuals who have been injured by drugs prescribed, dispensed, or administered incorrectly. To schedule a free and confidential consultation to discuss your case, contact us today online or at (800) 654-1949.
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Photo credit: U.S. Food and Drug Administration [Public domain (United States Government Work)], via Flickr.