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Lipitor belongs to a family of cholesterol-lowering drugs known as statins. Atorvastatin is a well-known generic version of the treatment. Along with dietary intervention, this medicine should increase levels of “good” cholesterol in the bloodstream, while reducing levels of “bad” cholesterol and fats.
Over the last decade, several scientific studies have established a link between the use of Lipitor and diagnoses of Type 2 diabetes, particularly in women.
By 2014, over 1,000 individuals with diabetes had sued Pfizer, Lipitor’s developer, claiming the pharmaceutical giant knew about the link between the drug and the condition. However, a federal court eventually ruled against the plaintiffs in 2017, and this decision was held up on appeal.
This post delves into the history of Lipitor diabetes lawsuits in more detail, explaining the legalities behind the action as well as the risks associated with taking Lipitor.
What Is Lipitor?
The Parke-Davis Company (which Pfizer later acquired) first released Lipitor in 1996, after it had received FDA approval following four clinical trials.
Researchers first created the compound in 1985 under the name Atorvastatin, but it would take 11 years to emerge on pharmacy shelves as Lipitor. By 2012, it had become the best-selling prescription drug of all time, and its lifetime sales exceeded $160 billion in 2021.
Like other statins, Lipitor works by reducing the amount of cholesterol the liver produces. This helps to increase the amount of “good” (HDL) cholesterol and lower the amount of “bad” (LDL) cholesterol and triglycerides in the body, which manages the risk of heart disease, heart attack, and stroke.
Doctors generally prescribe Lipitor to patients presenting with high levels of LDL cholesterol and/or total cholesterol, as well as other risk factors for stroke and cardiac problems.
The drug works best if patients also adopt cholesterol-lowering lifestyle habits, such as a low-fat or low-cholesterol diet, maintaining a healthy weight, and abstaining from smoking cigarettes. Users generally take Lipitor once a day without food.
The Link Between Lipitor & Diabetes
Type 2 diabetes is a chronic condition that affects the way in which your body produces or uses insulin, leading to high blood sugar levels. Researchers discovered that Lipitor could decrease bodily sensitivity to insulin and could also have an impact on the cells in the pancreas responsible for storing and releasing insulin.
A Canadian study published in 2013 reported that patients on Lipitor experienced a 22% increase in their diabetes risk compared to patients on pravastatin, another cholesterol drug. In 2011, the Journal of the American Medical Association posted a meta-analysis which found that “intensive-dose statin therapy” led to an increased risk of Type 2 diabetes compared to treatment with more moderate doses.
The alleged risk of developing Type 2 diabetes after using Lipitor is reportedly more pronounced in women than men. The majority of the plaintiffs who filed suit against Pfizer after a diabetes diagnosis were female.
Some individuals who filed Lipitor lawsuits noted their frustration over the fact that, as Type 2 diabetes patients, they found themselves at increased risk of heart disease, one of the conditions they started taking Lipitor to prevent.
Multidistrict Litigation Against Pfizer
The first plaintiffs began filing Lipitor diabetes lawsuits in 2012. There was an attempt to centralize claims under a federal multidistrict litigation (MDL) in April 2013, but many of the plaintiffs were represented by the same counsel and around half of the applications were in one district.
Because the court was not inclined to consider the possibility of future filings, it denied the motion to centralize.
Following this initial failed attempt at centralization, a group of plaintiffs again requested that ongoing and future claims be brought together in the state of South Carolina in 2014.
Pfizer opposed the plaintiffs’ application to consolidate the pre-trial motion, ostensibly to discourage potential future lawsuits, but the court granted it on the second occasion.
There were 56 actions against the pharmaceutical company under the centralization application in 2014, with over 170 actions of a similar nature pending across 40 districts at the time.
Therefore, the court decided to allow a multidistrict litigation for the sake of convenience. After it took this step, the number of Lipitor diabetes suits against Pfizer increased rapidly.
A multidistrict litigation allows a large number of plaintiffs with separate cases arising from similar case facts to have their pre-trial proceedings heard in court simultaneously.
The MDL structure helps to relieve backlogs in the courts as it removes the need for the duplication of tasks (such as discovery and witness testimony) in the collection of evidence. It differs from a class action in that the latter brings all plaintiffs together in a single lawsuit.
The Hon. Richard M. Gergel, who was already hearing 14 Lipitor diabetes lawsuits at the time, was put in charge of the South Carolina MDL in February 2014.
The US Judicial Panel on Multidistrict Litigation commented that it would be “easier to coordinate” the lawsuits against Pfizer with a single judge presiding over the federal cases (a number of suits were also ongoing at the state level). The panel also opined that the MDL structure would avoid inconsistencies in pretrial decisions.
In March 2016, the court decided to exclude testimony that medical experts had provided on behalf of the plaintiffs.
The court looked at the studies the experts used to investigate the causal relationship between Lipitor and Type 2 diabetes and expressed concern that the experts did not have access to “sufficient facts and data” to establish this relationship in cases involving low dosages of Lipitor.
The court held that some experts had “cherry-picked” sources and used unreliable methods to reach their conclusions. The experts also testified that they could not determine whether individual cases of Type 2 diabetes came about because of a patient’s use of Lipitor or some other factor.
The court did allow the testimony of one epidemiologist, Dr. Singh, which claimed that Lipitor 80 mg was a cause of diabetes. None of the plaintiffs in the MDL were taking Lipitor at that high a dosage.
Justice Gergel eventually dismissed over 2,000 Lipitor lawsuits with prejudice in 2017. The US Court of Appeals for the Fourth Circuit supported this ruling in June 2018.
The district court’s reasoning was that the plaintiffs had not provided sufficient evidence of a causal link between taking Lipitor at a dosage under 80 mg and developing diabetes for a jury to infer liability on Pfizer’s part.
This marked the official closure of the MDL. The panel no longer transferred new motions to the MDL after the ruling. However, this did not mark the end of Pfizer’s legal concerns in relation to the apparent diabetes risk associated with Lipitor, as plaintiffs across the country had filed suit in state courts on similar grounds.
The 2nd US Circuit Court of Appeals decided against picking up a Lipitor diabetes lawsuit in May 2021, agreeing with the district court ruling that the plaintiffs’ complaint in relation to labeling was preempted by federal law.
The Key Legal Issues
The plaintiffs in this MDL alleged that Pfizer “knew or should have known” about a link between Lipitor and Type 2 diabetes, and that the company “negligently, recklessly, and carelessly” marketed the drug without warning patients of this risk properly.
The main issue plaintiffs raised in cases against Pfizer was the possibility the pharma giant knew about the link between using Lipitor and developing Type 2 diabetes, but neglected to warn users and physicians about it properly.
They contended that this failure to warn deprived patients of the proper information required to make important health decisions involving the drug.
Some said they might not have decided to use Lipitor if they had known about the diabetes risk associated with the treatment, or that they could have monitored their blood sugar levels while on Lipitor to mitigate the risk.
Between 1996 and 2012, the warning labels on Lipitor allegedly “never warned patients” of a relationship between the use of Lipitor and an increase in blood sugar levels.
Pfizer added a new warning label to the drug in 2012, following approval from the FDA. The revised message highlighted risks of increased blood sugar, cognitive effects like memory loss, drug interactions with medications such as lovastatin, and serious liver problems (the latter occur rarely).
During the MDL, the court noted that Pfizer did not agree to change the label on the drug, and that the label change therefore could not amount to an admission of Lipitor’s supposed diabetes risk by the firm.
Some Lipitor lawsuits also took issue with the marketing strategies Pfizer employed in relation to the drug. Plaintiffs alleged the defendant employed aggressive tactics to sell Lipitor to potential users, but did so without properly highlighting the associated health risks.
Most of the plaintiffs who filed suit against Pfizer under the MDL were women with healthy diets and lifestyles who developed Type 2 diabetes after taking Lipitor.
The FDA’s Treatment of Lipitor’s Diabetes Risk
As evidence of the link between Lipitor and Type 2 diabetes emerged, the FDA issued warnings about the potential dangers associated with taking the drug.
Along with diabetes, the FDA has also stressed the heightened risk of muscle, liver, and kidney damage in patients taking Lipitor. The agency also required Pfizer to update the labeling on Lipitor’s label to reflect these dangers.
FDA Recalls on Atorvastatin
The FDA issued a warning about the potential for increased blood sugar levels in people using statins in 2012, leading Pfizer to update the warning label on Lipitor. The FDA did not recall Lipitor over this issue.
However, there were recent voluntary recalls of statin products. Dr. Reddy’s Laboratories Inc. voluntarily recalled two lots of atorvastatin calcium tablets in June 2021, citing issues with impurities.
Frequently Asked Questions (FAQs)
Question: Is It Too Late to File a Claim?
Answer: Because a federal judge dismissed the claims against Pfizer with prejudice, the plaintiffs in that matter cannot file another Lipitor lawsuit with the same complaint. If you were not previously involved in a Lipitor lawsuit, you could file a claim in state court, but there have been no reported instances of Pfizer paying out following disputes with Lipitor users who developed Type 2 diabetes.
Pfizer added a warning label to Lipitor packaging in 2012 highlighting the possibility of increased blood sugar levels in patients and the associated risk of Type 2 diabetes.
If you began taking Lipitor after the addition of this label, you may find it more difficult to make a case that you were not aware of the risk of developing diabetes before you began taking the medication.
Question: How Severe Is the Risk from Taking Lipitor?
Answer: The settlement of the multidistrict litigation against Pfizer has not assuaged doubts in the media and general public about the risks of Lipitor. In 2019, for example, Medical News Today published an article claiming that statins “may double the risk of type 2 diabetes,” citing new research.
However, the broader medical community has stressed the insignificance of the potential side-effects of statins compared with their benefits.
In an effort to address concerns around statin use and Type 2 diabetes, the American Heart Association published a 2018 report on the safety of statins, subtitling the article “Big Benefit with Low Risk.”
The report covers a range of the reported side-effects associated with Lipitor, including muscle damage, liver damage, and drug-drug interactions, as well as diabetes. In relation to diabetes specifically, the AHA said that there is a “minimal risk” of developing the condition among statin users with “pre-existing risk factors.”
If you’re concerned about the possibility of experiencing adverse effects from Lipitor, you should discuss the matter with your physician and assess the costs and benefits in your own case.
Question: Are There Any Other Side Effects of Lipitor?
Answer: As noted above, researchers have also discovered other risks in relation to the use of Lipitor. These include:
Liver problems: These are rare but potentially serious.
Memory loss and confusion: Most events of this nature are mild in severity and go away after discontinuation of Lipitor use.
Drug-drug interactions: There are a number of drugs with which statins may interact unfavorably in the body, notably anticoagulants like warfarin.
You should not use Lipitor if you are pregnant or breastfeeding, as the drug can pass to your child and damage its health. You should also avoid taking it if you have liver disease.
If you are unsure about whether to begin taking Lipitor, or whether to continue taking it after a change in your personal circumstances, you should always consult with a physician.
- Medical News Today: Statins may double the risk of type 2 diabetes
- The BMJ: Risk of incident diabetes among patients treated with statins: population based study
- The United States District Court: Re: Lipitor
- The United States Judicial Panel on Multidistrict Litigation: Re: Lipitor
- The American Heart Association: AHA’s Statement on the Safety Profile of Statins: Big Benefit with Low Risk
- The Food & Drug Administration: FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs