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People take Lipitor with the hope of supporting a healthy lifestyle and not with the idea of developing diabetes. But according to a 2012 warning by the U.S. Food and Drug Administration (FDA), some cholesterol-reducing statins, including Lipitor, may increase the risks of elevated blood sugar levels and developing type-2 diabetes. The FDA ordered Pfizer, the maker of Lipitor, to add warnings about diabetes risks to Lipitor’s labels.
The warning came too late for people who suffered serious side effects from Lipitor, also known as atorvastatin calcium. Some of them filed lawsuits against Pfizer because of their injuries. More lawsuits are expected, perhaps enough to warrant the creation of federal Multidistrict Litigation (MDL) to handle Lipitor personal injury claims.
Millions of people filled prescriptions for Lipitor, and the drug is one of the world’s best-selling prescription drugs. The FDA approved the drug in 1996 as a treatment to help lower cholesterol, which an increasing number of people are fighting. Approval to market Lipitor was initially granted to a division of Warner Lambert Company. Shortly after, Pfizer entered into an agreement with Warner-Lambert to market the drug and later acquired that company and all rights to Lipitor.
By 2012, Lipitor sales topped $130 billion.
Patients taking Lipitor to lower their blood pressure don't expect to develop unintended side effects like type 2 diabetes, nor are they prepared to deal with resulting medical costs and lost income. With proper warnings, injured people and their doctors could have decided not to use Lipitor. Armed with more information, they also could have monitored their blood glucose levels to determine if the drug was having an adverse affect on them. In other words, their injuries could have been prevented. In some cases, punitive damages awards may be available to discourage similar negligence by pharmaceutical companies.
Adequate prescription drug warnings are critical for ensuring consumer safety. When pharmaceutical companies fail to warn the public about risks associated with their prescription drugs, they deprive consumers of important information needed to make health decisions. That’s what happened with people who say they were injured because Pfizer did not warn them about Lipitor and its related risks of type-2 diabetes.
Diabetes and elevated blood glucose levels are serious conditions that can reduce a person’s quality of life significantly. They require ongoing monitoring, medication, and doctor’s visits. Sometimes they can also lead to hospitalization, serious medical interventions like surgery, and even death. In addition to being accompanied by major lifestyle changes, serious conditions like diabetes can interfere with the ability to work and carry out other daily tasks.
In April 2013, a group of plaintiffs who filed Lipitor claims asked the U.S. Judicial Panel on Multidistrict Litigation to transfer pending and future federal lawsuits to the District of South Carolina for consolidated pretrial proceedings. The women requesting creation of the MDL filed their cases in South Carolina.
Pfizer opposed the motion to transfer the cases, arguing that it could encourage more people to file lawsuits. In February 2014, the panel agreed to establish a Lipitor MDL, which now includes nearly 300 cases. More Lipitor case filings are expected in federal and state courts.
Marketed Lipitor as safe and effective, although it knew or should have known about the risks of increasing blood glucose levels and developing type 2 diabetes
Is liable for “negligent and wrongful conduct in connection with the design, development, manufacture, testing, packaging, promoting, marketing, distribution, labeling, and/or sale of Lipitor.”
Failed in its duty to monitor Lipitor’s safety.
Engaged in overly aggressive and misleading marketing, but did not provide patients and their physicians with information that could have prevented injuries.
Original labeling and prescribing information printed between December 1996 and February 2012 “never warned patients of any potential relation between changes in blood sugar levels and taking Lipitor,” and did not warn consumers of “the serious risk of developing type 2 diabetes … when using Lipitor.”
Like others who allege injuries caused by Lipitor, Evalina Smalls was healthy before she started taking the prescription drug. Her body mass index was 24.8 and she had healthy diet. She began taking Lipitor in 1999 as a preventative measure to maintain her healthy lifestyle and decrease the risk of developing heart disease.
In 2009, she was diagnosed with type 2 diabetes while still taking Lipitor. She was previously in good health and now must undergo regular glucose level monitoring, follow “a restrictive diabetic diet,” take diabetes medication for the rest of her life and deal with the stigma associated with type 2 diabetes. She alleges that, as a result of taking Lipitor, she faces a substantially increased risk of developing blindness, neuropathy and kidney disease. Perhaps the most frustrating part of her injury is that she is now at a greater risk for developing heart disease – the very condition Pfizer claimed Lipitor could help prevent.
Smalls filed personal injury claims in March 2013 against Pfizer in federal court in South Carolina. Other people who relied on Pfizer’s claims that Lipitor reduced cardiovascular disease risks have also suffered similar injuries and filed lawsuits.
Patricia Colbert of Virginia, who was prescribed Lipitor in 2010 to lower low-density lipoprotein (LDL) and as a preventative measure to lower heart disease risks. Despite her healthy weight and diet, Colbert was diagnosed with type-2 diabetes in 2012 while still taking Lipitor. She filed a lawsuit against Pfizer in the United States District Court for the Eastern District of Virginia in April 2013.
Kimberly Hines of Illinois was prescribed the drug in 2008. She was healthy with a body mass index of only 22.3 before taking Lipitor to regulate LDL and to reduce the risk of heart disease. Although she had a healthy lifestyle, she was diagnosed with type 2 diabetes in 2010 while still taking Lipitor. She filed her case in the U.S. District Court for Southern District of Illinois in April 2013.