PENNSYLVANIA RECORD

A Philadelphia woman is suing the makers of the cholesterol drug Lipitor

over allegations that she developed diabetes as a result of ingesting the pharmaceutical.

Doris Brown says she developed Type 2 diabetes soon after starting a treatment regimen of Lipitor, which her doctors put her on beginning around 2009 as a way to reduce the plaintiff’s chances of developing heart disease.

The woman says she was diagnosed with Type 2 diabetes in 2011.

Brown claims she was in good health prior to taking Lipitor. She was physically active, adhered to a healthy diet, and had a total body mass index of about 20.1.

The plaintiff also says she suffered from no chronic injuries or illnesses.

As a result of her diagnosis, the lawsuit states, Brown will have to undergo regular testing of her blood glucose levels, adhere to a restrictive diabetic diet, and take medication to control her diabetes for the rest of her life.

Also because of her diabetes, the suit says, Brown is now at a “markedly” increased risk of developing heart disease, blindness, neuropathy and kidney disease.

The complaint claims that had drugmaker Pfizer properly disclosed the risks associated with Lipitor use, Brown would have avoided the risk of developing diabetes either by not using the medication or by closely monitoring her blood glucose levels to see if the drug was adversely affecting her metabolism.

Brown, the suit claims, has endured pain and suffering, and she has experienced economic loss including the need to spend substantial sums of money on medical attention to treat her physical condition.

The complaint maintains that up until February 2012, the makers of Lipitor had never warned patients of any potential relationship between changes in blood sugar levels and Lipitor usage.

The medication, an HMG-CoA reductase inhibitor, and a member of the drug class known as statins, was developed back in the mid 1990s by Parke-Davis Pharmaceutical Research, a division of Warner-Lambert Company, according to the complaint.

Warner-Lambert entered into a co-marketing agreement with Pfizer to sell Lipitor soon after the former obtained FDA approval to market the medication, the suit shows.

Pfizer ultimately acquired Warner-Lambert and all rights to Lipitor in the summer of 2000.

“Despite its knowledge of data indicating that Lipitor is causally related to the development of type 2 diabetes and/or blood glucose levels diagnostic for type 2 diabetes, Pfizer promoted and marketed Lipitor as safe and effective for persons such as Plaintiff Doris Brown in the United States as well as in this judicial district,” the complaint reads.

In August 2011, the suit states, Pfizer began making labeling changes to the Lipitor packaging based upon a review by the FDA’s Division of Metabolism and Endocrinology Products.

Then, in early 2012, the defendant added language to Lipitor’s labels that warn that increases in glucose levels have been reported with the class of drugs that includes Lipitor, according to the lawsuit.

Despite the label change, however, Lipitor’s label continues to fail to warn consumers of the serious risk of developing Type 2 diabetes when using the drug, the complaint alleges.

Pfizer strongly backs its product, with company officials vowing to defend against cases such as these in civil court.

“Lipitor is a prescription medication used by millions of patients for lowering cholesterol and triglycerides in a patient’s bloodstream,” Pfizer spokesman Steve Danehy said in an emailed message. “Backed by more than 19 years of research, Lipitor has been proven to lower the risk of heart attack and stroke in patients with diabetes and other risk factors such as diabetic eye or kidney problems, smoking, or high blood pressure.”

The lawsuit contains counts of product liability, negligence, breach of warranty, fraud, constructive fraud, and unjust enrichment.

Brown seeks unspecified compensatory and punitive damages, as well as interest, attorneys’ fees and other legal relief.

The plaintiff is being represented by Philadelphia attorney Carrie R. Capouellez.

The suit was filed on Aug. 23 at the U.S. District Court for the Eastern District of Pennsylvania.

 

The federal case number is 2:13-cv-04951-TJS.