It was in June of last year when the US Food and Drug Administration (FDA) finally responded to a petition filed by the high-profile consumer advocacy group Public Citizen to position a black box warning on statins such as Crestor for rhabdomyolysis. The latter is a rare side effect characterized by the breakdown of muscle cells, which can then enter the bloodstream and potentially damage the kidneys. In extreme cases, Crestor rhabdomyolysis can be fatal.
The FDA, in its response, decided the risk to be “consistently low,” and therefore did not warrant a black box for rhabdomyolysis. The thought was that such a warning would scare patients away from Crestor and other statins in the class, thereby robbing them of the potential benefits. The nation’s drug and medical device regulator observes a position of risk acknowledgement with regard to pharmaceutical drugs and medical devices, but holds that a drug or medical device shall not be considered unsafe so long as the benefits outweigh the risk for the indicated patients.
Meanwhile, a whistleblower lawsuit originally brought by four former employees of Crestor manufacturer AstraZeneca Pharmaceuticals alleging violations under the False Claims Act on behalf of the federal government has since been declined by the feds. However, the former Attorney General of Texas and now state governor Greg Abbott moved to formally include the state of Texas in the lawsuit.
The whistleblowers originally filed their Crestor lawsuit in the state of Texas, alleging in their whistleblower case that AstraZeneca misled the Texas Medicaid program into placing Crestor on the state’s Preferred Drug List. It is alleged that the resulting placement fostered more prescriptions for Crestor on the part of physicians and qualified health care professionals.
Abbott, while still Texas Attorney General, included the state in the Crestor lawsuit. The state took the position that AstraZeneca wrongly claimed that Crestor could reverse arterial plaque buildup, reduce the risk of death and lower cholesterol more effectively than competitor Lipitor.
“AstraZeneca chose increased profits over delivering truthful and complete information to Texas Medicaid,” the state’s petition says.”“This unlawful conduct deprived both Texas Medicaid patients and doctors of the ability to make fully informed healthcare decisions.”
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Meanwhile, a lawsuit claiming that AstraZeneca LP and its distributor McKesson Corp. deceived plaintiffs by withholding test results linking rosuvastatin to Crestor diabetes and other Crestor side effects continues. The Crestor lawsuit was recently removed to federal court in California.
Patients deemed to have high levels of the so-called “bad” LDL cholesterol thought to be the villain behind clogged arteries must weigh the perceived benefits of Crestor and other statins against Crestor issues such as muscle pain, diabetes and Crestor rhabdomyolysis.
The Crestor lawsuit is Arron Ardoin et al v. AstraZeneca LP et al, Case No. 2:14-cv-04134, in California Central Court.