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A South Carolina woman has filed a product liability lawsuit against Pfizer, indicating that side effects of the blockbuster cholesterol drug Lipitor caused her to develop diabetes.
The complaint (PDF) was filed by Evalina Smalls in the U.S. District Court for the District of South Carolina on March 25, alleging that Pfizer failed to adequately warn users or the medical community about the Lipitor diabetes risk.
According to allegations raised in the Lipitor lawsuit, Smalls was diagnosed with type 2 diabetes in June 2009, after using the medication for about ten years.
Smalls indicates that prior to taking Lipitor she was very health and had a body mass index (BMI) in the range of a person with normal weight. However, she must now undergo regular testing of her blood glucose levels, adhere to a restrictive diabetic diet and take medication to control her diabetes. As a result of the disease, she is now also at an increased risk of suffering heart disease, blindness, neuropathy and kidney disease, according to the lawsuit.
“In keeping with her healthy and proactive lifestyle, Plaintiff agreed to initiate Lipitor treatment in an effort to reduce her risk of developing heart disease,” states the complaint. “She relied on claims made by Pfizer that Lipitor has been clinically shown to reduce the risk of developing heart disease.”
FDA Required Diabetes Label Warning Remains Insufficient
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.
In February 2012, the FDA announced it was requiring new label warnings for Lipitor and all other statins to warn users of the possible risk of diabetes, but some studies connecting statins to diabetes date as far back as 2004.
Prior to this label change, Pfizer never warned patients about the potential link between Lipitor and changes in blood sugar levels. However, Smalls alleges that despite the language added in 2012, the label continues to fail to adequately warn users about the serious risk of developing type 2 diabetes.
“Had [Pfizer] properly disclosed the risks associated with Lipitor, Plaintiff would have avoided the risk of diabetes by either not using Lipitor at all or by closely monitoring her blood glucose levels to see if the drug was adversely affecting her metabolism,” according to the complaint.
Smalls’ lawsuit accuses Pfizer of failure to warn, negligence, breach of warranty, fraud, and unjust enrichment. She is seeking compensatory damages for pain, suffering, medical expenses and other economic losses. She is also seeking punitive damages against Pfizer.