Crestor was a blockbuster cholesterol drug when it hit the market in 2003. Less than 10 years later, it would be the subject of hundreds of lawsuits as studies revealed a litany of serious side effects and the U.S. Food and Drug Administration (FDA) repeatedly warned its manufacturer about “false and misleading” marketing of the drug.
Crestor is part of a class of drugs called statins that block a liver enzyme that creates cholesterol while helping the liver remove and break down cholesterol already in the blood.
While considered effective for its indications, Crestor has been associated with serious side effects including muscle damage, organ failure and death.
Potential Serious Side Effects from Crestor:
- Rhabdomyolysis (serious muscle damage)
- Type 2 diabetes
- Kidney damage
- Liver damage
- Memory loss
- Kidney failure
The consequences of these serious side effects can be expensive for the people who experience them. They can also inflict substantial pain on patients. As people taking Crestor began to suffer injuries associated with these side effects, many filed lawsuits to recover their losses and to hold the manufacturer, AstraZeneca, accountable for failing to warn of risks.
By 2017, more than 600 lawsuits over Crestor’s side effects would be combined in a coordinated proceeding in California state court.
Why Do People File Crestor Lawsuits?
People who file lawsuits involving medicines usually experience a side effect that causes a serious injury after taking a drug. Plaintiffs may say the manufacturer did not warn or insufficiently warned of the side effect. Deceptive marketing or negligence on the part of the manufacturer that leads to a plaintiff’s injury may also be a reason behind lawsuits.
With Crestor, plaintiffs list several of these reasons for their lawsuits when they filed legal complaints in California courts against AstraZeneca and Crestor distributor McKesson Corporation.
Complaints in Crestor Lawsuits Claim Defendants:
- Knew the drug “to be defective, unreasonably dangerous and hazardous”
- Knew Crestor was “substantially certain to cause injury”
- “Negligently, recklessly and wantonly” failed to warn plaintiffs and the public of Crestor’s risks
- Promoted Crestor in ways that “were deceptive, false, incomplete [and/or] misleading”
- Suppressed, concealed and/or misrepresented Crestor’s “true relationship and various diseases”
- Knew or should have known their promotions and statements were false or misleading
- Provided inadequate warnings, instructions and/or labeling
- Inadequately tested Crestor
Before a new drug can be marketed in the U.S., its manufacturer must show that the drug is safe and effective for the condition for which it is indicated. This is accomplished through laboratory, animal and human tests. These don’t always turn up all the potential side effects. Many are discovered only after the drug has been on the market for a while and are uncovered in what are called “post-marketing studies.”
For example, the JUPITER trial that first found an increased diabetes risk for patients taking Crestor was a post-marketing trial – published roughly five years after the FDA had already approved Crestor.
In the case of rhabdomyolysis(severe muscle injury that can lead to kidney damage), at least three cases were reported in patient studies before the FDA approved the drug. But Crestor was sold without a warning about the serious side effect until roughly a year later when the rhabdomyolysis warning was finally added to the drug label.
In situations like these, lawsuits may sometimes allege a manufacturer either “knew or should have known” about a particular risk and should have warned patients sooner than it did.
Plaintiffs may also point to the methods a manufacturer uses to promote and market a drug. Crestor was AstraZeneca’s biggest selling drug for years, and the company aggressively marketed it.
Drug Company-Sponsored Meals Tied to More Crestor Prescriptions
“There’s no such thing as a free meal,” the old saying goes, but free meals for doctors may have increased Crestor sales by millions of dollars.
A 2016 study in JAMA Internal Medicine looked at how pharmaceutical companies marketed different drugs to convince doctors to write more prescriptions for their products than for competing medicines. Crestor was one of the four drugs researchers followed.
Researchers found that 95% of the inducements drug manufacturers gave away were simply meals – with an average value of just $20.
Researchers looked at 279,669 doctors who received a total of 63,524 payments of some kind from drug companies. Doctors who received a free meal were more likely to prescribe the drug being pitched than a competing medicine. As the number of meals or their value increased, so did the doctors’ relative prescribing rates.
“Receipt of industry-sponsored meals was associated with an increased rate of prescribing the brand-name medication that was being promoted,” the researchers concluded.
“In 2014, payments for food and beverages, by far the most frequent type of payment to physicians, totaled $224.5 million,” Dr. Robert Steinbrook, an editor at JAMA Internal Medicine, wrote in an editorial comment about the study.
It is legal for pharmaceutical companies to purchase meals for doctors, often at industry events, but marketing practices may sometimes be listed in lawsuits against drug manufacturers.
FDA Called Crestor Ads ‘False and Misleading’
In December 2004, AstraZeneca ran full-page newspaper ads defending the safety of Crestor. The ads came as consumer advocacy group Public Citizen had raised safety concerns over Crestor and was petitioning the FDA to recall the drug. The FDA was still weighing Public Citizen’s petition at the time.
Crestor ads the FDA considered ‘False and Misleading’:
- The ads from AstraZeneca proclaimed that “the FDA has confidence in the safety and efficacy of Crestor” and “publicly confirmed that Crestor is safe and effective.”
- In a warning letter the FDA called both of the claims false and the ads themselves, “false and misleading.”
- The ads also claimed Crestor “lowers bad cholesterol better than the leading medications in its class.”
- The FDA called the claim misleading “because it minimizes the risks” associated with the maximum dose of Crestor – 40 mg.
- In March 2005, the FDA fired off another warning letter, ordering AstraZeneca to pull another series of ads for Crestor titled “Simply the Best.” The FDA said the ad campaign made “false or misleading claims regarding the superiority of Crestor.”
The single television commercial and three print ads targeting consumers compared Crestor to competing statins. The comparison was based on results from the 2003 STELLAR study compared four statins – Crestor, Lipitor, Pravachol and Zocor.
"All cholesterol drugs simply aren’t the same. When Crestor performed in a head-to-head test, its lowering effect was clearly the best."
- Crestor Television Spot
The FDA said the comparison wasn’t accurate and the ads were misleading because their comparisons were not relevant. For instance, the maximum doses of Crestor and Lipitor are 40 mg and 80 mg. But the ads compared 40 mg of Crestor to 80 mg of Lipitor.
“Specifically,” the FDA warning letter said, “the comparison with Lipitor is misleading because it suggests that Crestor is superior to Lipitor when in fact none of the approved doses of Crestor was significantly superior to 80 mg of Lipitor in the STELLAR study.”
When people began filing lawsuits over Crestor-related injuries, their complaints included “deceptive, false, incomplete and/or misleading” claims in advertising and marketing the drug.
Lawsuits Filed Over Injuries Patients, Families Blame on Crestor
In March 2012, several people who were injured after taking Crestor, or their families, filed lawsuits against the drug’s manufacturers, AstraZeneca LP and AstraZeneca Pharmaceuticals, as well as its distributor, McKesson Corporation, in California state court.
They claimed that the defendants designed, manufactured, marketed and distributed Crestor despite knowing about the drug’s “dangerous and defective nature.” Their complaint said the dangers included the possibility of sudden cardiac death.
In its 2013 annual report, AstraZeneca said it was defending 26 lawsuits in California over injuries related to Crestor. Twenty-one of the cases had been consolidated into a single coordinated proceeding in Los Angeles. The company reported a total of 708 plaintiffs claimed physical injuries as a result of Crestor.
Injuries in the claims against Crestor include:
- Various cardiac injuries
- Rhabdomyolysis (severe muscle injury that can lead to kidney damage)
- Various kidney injuries
- Liver damage
In its 2016 annual report, AstraZeneca reported a total of 1,230 lawsuits had been filed in California over injuries related to Crestor. The report said 600 had been consolidated into a coordinated proceeding in Los Angeles. Another 600 lawsuits filed in California state courts by non-state residents had been dismissed. And 30 other lawsuits were pending elsewhere in the state.
Because lawsuits over defective drugs usually involve several patients — sometimes hundreds or thousands — with similar complaints, they are sometimes consolidated into a single legal action to save time and money. These are called multidistrict litigations (MDL) in federal courts and multicounty litigations, coordinated proceedings or other designations in state courts, depending on individual state laws.
If successful in a lawsuit, the plaintiffs may be entitled to money damages for their injuries, including the costs of ongoing medical treatment, loss of wages, loss of consortium, and pain and suffering.
Terry Turner is an Emmy-winning, former television journalist. As a Washington-based reporter for a group of 100 local news departments across the U.S., he routinely reported on health and medical policy issues before Congress, the FDA and other federal agencies. Prior to that, he covered state and federal courts for several local television stations in the Midwest and on the East Coast.