Lipitor (atorvastatin), a cholesterol medication made by Pfizer, Inc., is the bestselling drug of all time, with $130 billion in sales.
It belongs to a group of drugs known as statins, which lower cholesterol production in the liver. Lipitor has helped many patients to manage cardiovascular risks such as heart disease, heart attack, and stroke, but research shows that Lipitor can also raise blood sugar levels and lead to type 2 diabetes.
Hundreds of Lipitor patients who developed type 2 diabetes have filed lawsuits against Pfizer.
A new warning label for this side effect was added to Lipitor in 2012, but many believe that the warning came too late and is insufficient.
As a result, hundreds of Lipitor patients who developed type 2 diabetes have filed lawsuits against Pfizer alleging that the company should have included stronger warnings on Lipitor labels.
LIPITOR AND DIABETES
Researchers don’t know exactly how statins can lead to diabetes. One theory is that statins can increase a patient’s insulin resistance. Another is that statins impair the ability of the pancreas to secrete insulin.
While it isn’t perfectly understood how Lipitor increases diabetes risk, the association is well established in medical literature, including studies published in MBJ, Journal of the American College of Cardiology, Journal of General Internal Medicine, Diabetologia, and JAMA.
Studies have typically found that statins increase the risk for diabetes by 10-25%, but newer research suggests that statin therapies such as Lipitor increase the risk of type 2 diabetes by 46%.
Statin therapies such as Lipitor increase the risk of type 2 diabetes by 46%.
A separate analysis, based on beneficiaries of the military’s Tricare health system, found that statin drug users were 87% more likely to develop diabetes. This study is significant because it was the first to look at the link in relatively healthy patients. The study also found that patients on statins were 250% more likely to develop diabetes with complications compared to non-statin users.
Some evidence suggest that statin-associated diabetes may be more common in women, the elderly, and Asians. Most of the thousands of people who have filed lawsuits against Pfizer have been women. Type 2 diabetes is a lifelong condition that can be managed, but not cured.
FDA WARNINGS ABOUT LIPITOR
The FDA released a statement in 2012 announcing that it had approved label changes for statin drugs. The new labels indicate that statins may cause increased blood sugar levels (hyperglycemia) and diabetes. (In the same statement, the FDA also reported on a Lipitor labeling change related to possible brain-related effects, such as memory loss, confusion, and memory impairment.)
But the FDA approved Lipitor in 1996. So for 16 years (from 1996 to 2012), Pfizer did not warn Lipitor patients about the increased risk of diabetes.
Many patients developed diabetes during this period, and many have decided to take legal action.
With the news that FDA was updating Lipitor labels to warn about the risk of developing diabetes, lawsuits patients began filing lawsuits against Pfizer alleging that the company knew about this serious side effect but failed to properly warn the public. As Lipitor diabetes lawsuits increased, they were consolidated into a single federal courtroom in Charleston, South Carolina.
The Lipitor MDL (multidistrict litigation) now consists of roughly 3,000 lawsuits. Nearly 30 million U.S. patients have been prescribed Lipitor since 2006, suggesting a vast number of potential plaintiffs.
Plaintiffs who join the MDL retain their own attorneys and maintain their own lawsuits.
The first trials in the Lipitor MDL are scheduled to begin in 2016.
Though the Lipitor lawsuits have not yet gone to trial, and there have been no settlements, similar cases suggest enormous rewards for plaintiffs:
- In 2016, Pfizer paid $468 million to settle a shareholder lawsuitthat accused the company of causing financial losses when they covered up the safety risks of taking their pain relievers Celebrex and Bextra (which were linked to an increase risk of heart attacks and strokes).
- In 2011, AstraZeneca paid $647 million to settle nearly 30,000 lawsuitsclaiming the company’s Seroquel medication caused diabetes and other health issues.
- In 2005, Bayer paid $1 billion to settle 3,000 cases(about the same number Pfizer faces) alleging that its own statin, Baycol, caused rhabdomyolysis (a condition that erodes muscle tissue).
Pfizer may want to take its chances in court (at least early on) in order to see if it can beat these allegations and spare itself the kind of mammoth settlement cited above. But the diabetes warning the FDA added to Lipitor in 2012 is fairly damning, and Pfizer faces so many cases that a settlement would save the company considerable time and energy. So, in the end, Pfizer will likely settle most if not all of these cases.
DID PFIZER ADEQUATELY WARN ABOUT THE DIABETES RISK?
The main allegation of Lipitor diabetes plaintiffs is that Pfizer knew or should have known about the drug’s diabetes risk and that the company did not properly warn the public about the potential side effect.
This argument is particularly strong for patients who took Lipitor prior to the 2012 labeling change that warned about diabetes. But others argue that the updated label still does not go far enough.
The new Lipitor diabetes warning states, “Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including Lipitor.” Some plaintiffs argue that because this warning does not explicitly describe the diabetes risk in plain English, it is insufficient.