Pharmaceutical behemoth Pfizer is asking a federal judge to dismiss at least 10 Lipitor lawsuits filed by Texas women who are suing on the grounds that the drug maker did not adequately warn about the increased risk of developing type-2 diabetes when taking the popular heart disease drug Lipitor.
More than 2,000 Lipitor lawsuits have been filed against Pfizer accusing the drug manufacturer of failing to disclose information to both the medical field and consumers about the risks associated with the popular cholesterol-lowering statin and type-2 diabetes.
While there are thousands of Lipitor lawsuits that have been centralized as part of a multidistrict litigation, Pfizer argued in a motion that under Texas law, even if a warning label is missing vital information affecting patient safety or fails to provide adequate information to make an informed decision, such claims are barred.
The generic name of Lipitor is atorvastatin. Since 1996, Lipitor has generated some $125 billion in revenue for Pfizer.
The plaintiffs maintain that the warning label was inadequate and insufficient because diabetes is not mentioned as a potential Lipitor side effect, and information added in 2012 about the risk of changes to blood glucose levels were “vague, unclear and uninformative.”
The company asserts that under Texas law, manufacturers of prescription medications are not liable for product liability claims so long as warnings included on a drug’s label were approved by the U.S. Food and Drug Administration (FDA).
In order for the Texas plaintiffs to proceed, according to Pfizer’s motion, they would be obligated to prove that Pfizer:
- Withheld or misrepresented information to the FDA that had a material effect on the drug’s performance
- Sold the drug after the FDA ordered a Lipitor recall
- Promoted Lipitor for off-label uses
- Bribed an FDA official to accept an inadequate warning label
Lipitor lawsuits have been piling up since 2012 when the FDA ordered safety label changes for statins that would alert consumers of the need for routine monitoring of liver enzymes, information about non-serious cognitive Lipitor side effects such as memory loss or confusion, reports of increased blood sugar levels, and drug interactions.
The FDA’s new regulations came after the results of a study published indicated that women using the medication may be at an increased risk of developing type-2 diabetes. Many of the plaintiffs filing Lipitor lawsuits were diagnosed with diabetes despite living healthy lifestyles.
The first set of jury trials, known as bellwether cases, are scheduled to begin on July 1, 2015.
In general, Lipitor lawsuits are filed individually by each plaintiff and are not class actions.
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