A federal judge recently denied Pfizer’s attempt to block 10 lawsuits brought against the drug company over its popular cholesterol drug Lipitor.

Pfizer argued that the plaintiffs’ claims were preempted by the Federal Food, Drug, and Cosmetic Act (FDCA) under a concept that defers to federal law when there’s a conflict with state law.

The 10 Lipitor lawsuits are based on Texas state law. Texas statutes create an affirmative defense that prevents pharmaceutical manufacturers from being held liable in failure-to-warn cases if the U.S. Food and Drug Administration (FDA) approved of the product’s warning labels.

This affirmative defense has four state-created exceptions that allow plaintiffs to still sue pharmaceutical companies regardless of the affirmative defense. The state exception relevant to these Lipitor lawsuits allows a plaintiff to sue a pharmaceutical manufacturer before or after pre-market approval by the FDA or licensing of the product, if the company allegedly withheld information from or misrepresented information to the FDA that is related to the plaintiff’s injury.

In its motion, Pfizer argued that the state exception was preempted by existing federal laws prohibiting fraud against a federal agency. Pfizer claimed that since the federal government already regulates this area, the states cannot create statutes that interfere with those regulations.

Pfizer also argued that allowing plaintiffs to sue manufacturers under this exception would cause the FDA to suffer an onslaught of unnecessary pharmaceutical information during drug approval processes by drug manufacturers. Currently there is a split among the federal circuit courts regarding this issue.

In the current Pfizer multidistrict litigation, the Judge rejected Pfizer’s theory of preemption. The court noted that a strong presumption exists against finding preemption, and that it is important to look at Congress’s original intent behind any potentially conflicting laws. In the case at hand, the judge noted that Congress is well aware of state court drug litigation and since Congress has not provided a remedy for consumers harmed by unsafe drugs, the Texas statute is not preempted by federal law.

Overview of Lipitor Lawsuits

Thousands of cases have been filed against Lipitor, claiming the cholesterol-lowering medication causes type-2 diabetes in older women. Over a thousand cases were consolidated in 2014 and the first test trials are scheduled to begin in October.

These Lipitor lawsuits claim that Pfizer failed to warn the medical community and general public about the increased risk of developing diabetes while taking Lipitor.

Type-2 diabetes is a serious life-long condition. A study published in the Archives of Internal Medicine found that women between the ages of 50-79 who took Lipitor, or a similar functioning medication, were 49 percent more likely to develop type-2 diabetes than women who were not taking the medications.

Symptoms of Lipitor diabetes include areas of darkened skin, fatigue, unexplained weight loss, dry mouth, headaches and many more symptoms. Type-2 diabetes can be deadly if left untreated and people experiencing Lipitor diabetes symptoms should seek medical advice.

The Lipitor Diabetes Multidistrict Litigation is In re: Lipitor (Atorvastatin Calcium) Marketing Sales Practices and Products Liability Litigation, MDL No. 2502, in the U.S. District Court for the District of South Carolina, Charleston Division.