Lawsuits Over Crestor, Lipitor, and Other Cholesterol Drugs (Statins)

Learn about the history of statin lawsuits and recalls, what you should know about a potential claim, and more.

Updated by Charles Crain, Attorney (UC Berkeley School of Law)

Statins are drugs that lower the amount of "bad" cholesterol in the blood and raise the amount of "good" cholesterol. This effect on cholesterol results in a lower risk of heart disease and stroke, and statins have become extremely popular medications. In 2020 the most commonly prescribed drug in the United States was the statin atorvastatin (sold as Lipitor). The statins simvastatin (sold as Zocor) and rosuvastatin (sold as Crestor and Ezallor) were also among the 20 most-prescribed drugs in the country.

But statins have also caused uncomfortable and even dangerous side effects in some people who take them These side effects have resulted in recalls, lawsuits, and more detailed warning labels for the medication. If you've suffered health problems from taking a statin, you may have a product liability claim. But it's important to understand how previous lawsuits and other factors may limit your chances of filing a successful lawsuit.

Lawsuits Over Statin Side Effects

The Food and Drug Administration (FDA) has issued warnings that statins can cause health problems including:

  • memory loss while the drug is being used
  • serious liver problems in rare cases, and
  • damage to muscle tissue, the heart, and the kidneys when taken at the same time as certain other medications.

Statin side effects have been the subject of thousands of lawsuits over the past several decades. For example:

  • Bayer was sued over its statin Baycol by thousands of people who used the drug. The plaintiffs argued that the Baycol caused muscle tissue damage, and it was linked to 31 deaths. The drug was taken off the market in 2001, and in 2005 Bayer paid $1 billion to settle the lawsuits.
  • AstraZenica was sued over its statin Crestor, which plaintiffs argued was responsible for health problems including diabetes, muscle tissue damage, and kidney problems. The company reported in 2018 that it had resolved these lawsuits.
  • Pfizer has faced lawsuits over several alleged side effects of Lipitor, including neuropathy, muscle tissue damage, and diabetes.

Keep in mind that lawsuits over a drug's possible side effects don't necessarily mean that the drug is dangerous, or that the plaintiffs will receive compensation from the drug company. For example, a federal judge ruled in 2017 that there was not enough evidence to link Lipitor to an increased risk of diabetes in women.

Evaluating a Statin Liability Claim

When someone files a lawsuit arguing that they were harmed by a prescription drug, they are typically making a product liability claim. They might also have other legal claims, like medical malpractice cases against doctors or pharmacists who endangered them with substandard care.

Proving a Statin Claim

As with other personal injury lawsuits, in a product liability case the plaintiff has to prove that they were hurt because of the defendant's negligence. A successful lawsuit over statin side effects would require the plaintiff to show that they were injured by their use of the drug. They would also have to show either that:

  • the statin caused unreasonably dangerous side effects, or
  • the drug manufacturer didn't provide adequate warnings or instructions regarding the use of the statin.

If You Knew the Risks of Taking Statins

Many drugs are prescribed and sold over the counter even though they might pose risks to the people who take them. In a lawsuit over statins you don't just have to prove that you were harmed by the drug, you also have to prove that you weren't adequately warned about that harm.

Proving you weren't aware of the potential risks of taking statins may be difficult. Over the years, the government has required pharmaceutical companies to add warning labels to their statins. People are expected to read those warnings so they can decide if they're willing to risk the potential side effects. They are also expected to read warning labels and consult with their health care providers so they can avoid drugs that pose a particular risk to them. For example, some statins are generally safe, but can pose health risks when mixed with other medications.

In a lawsuit over statin side effects the drug company (and any other defendants) will almost certainly try to argue that you were aware of the possible risks but decided to take the medication anyway. They will be able to use the discovery process to ask you questions about your decision to use the drug, and to see medical records relevant to that aspect of the case.

Keep in mind, though, that the presence of warning labels doesn't always mean you were properly informed of the dangers posed by a drug. This can be a complicated legal issue; if you have questions about how it might affect your situation you should consider speaking with an attorney.

How Other Statin Lawsuits Can Affect Yours

If you've suffered severe side effects from taking a stain, other people may have experienced the same issue. When many people have all suffered similar harms from using the same drug, courts often use class action lawsuits or multidistrict litigation to deal with all of the cases more efficiently.

Class Action Lawsuits

In a class action lawsuit, all of the people suing a drug company are combined into one "class." Decisions that affect the class apply to all of the plaintiffs. For example, each plaintiff receives a percentage of any settlement or award, and once the case is over they can't file a new lawsuit over the same issue.

The existence of a class action lawsuit can limit your options if you want to file your own lawsuit. You must join the class before a court-ordered deadline, or else you lose your right to sue.

Multidistrict Litigation

In multidistrict litigation (MDL), the cases stay separate but are all sent to the same federal district court. Since all of the lawsuits in the MDL involve the same facts and the same legal issues, one judge can make decisions that apply in the same way to each case.

If your lawsuit against a drug company is similar to cases filed by many other people, it could become part of MDL even if you and your lawyer would rather keep your case separate.

When MDL or Class Actions Have Already Finished

If you're considering suing a drug company over a statin side effect, it's important to know if there has already been litigation against the same company over the same issue.

If you missed the deadline for joining a class action, you may be prohibited from filing your own case. Keep in mind, though, that the deadline only applies if you knew about (or should have known about) the harm you were suffering because of the drug. If your symptoms only showed up later, you could still have a case.

If there has already been multidistrict litigation over the drug that you took, the MDL rulings will be important as you and your lawyer decide how to handle your case. If plaintiffs like you have had their cases dismissed, your own case may not be worth pursuing. On the other hand, successful MDL may make it easier for other plaintiffs to receive fair settlements.

The question of how other litigation could affect your case, either positively or negatively, is another topic you should discuss with an attorney if you're considering filing a statin lawsuit.

Time Limits for Filing a Statin Lawsuit

If you think you've been harmed by taking a statin, it's important to act quickly to protect your legal rights.

States have laws called "statutes of limitations" that set deadlines for bringing product liability claims. The clock starts ticking when you know (or should have known) that you've been harmed by a drug, so it's important to know the time limit in your state.

In addition to these legal requirements, there are other good reasons to decide quickly if you want to file a lawsuit. The longer you wait the harder it might become to convince a court that you've suffered serious harm because you took a statin.

Getting Help With Your Case

Product liability cases involving statins or other pharmaceuticals usually involve complicated legal and scientific issues. In addition, there have been many lawsuits over statins that could limit or even eliminate your ability to pursue your own case. So if you think you've been harmed by a statin and have questions about your legal options, you should consult an attorney with experience handling these kinds of cases.

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