Lipitor Effectiveness Claims Will Be Subject of Additional Briefing on Preemption Question

As hundreds of Lipitor lawsuits continue to move forward in the federal court system, the U.S. District Judge presiding over the litigation has asked both sides to provide additional briefings on whether claims that Pfizer wrongly marketed the popular cholesterol drug as effective in preventing heart disease in women are preempted by federal law.

There are currently about 2,500 product liability lawsuits pending in the federal court system, which allege that women developed diabetes from side effects of Lipitor, alleging that Pfizer negligently promoted their medication and withheld information from consumers and the medical community about the potential risks faced by women.

Given the similar questions of face and law presented in the cases, all complaints filed in U.S. District Courts throughout the country are currently centralized for pretrial proceedings before U.S. District Richard Gergel in the District of South Carolina, as part of a federal MDL or multidistrict litigation.

In a case management order (PDF) issued on November 18, Judge Gergel called on both parties to submit additional briefings by December 11, to better delineate a dispute about claims over Pfizer’s marketing of Lipitor to women.

At issue are claims included in the diabetes lawsuits that say that Pfizer wrongly advertised Lipitor as effective for the primary prevention of cardiovascular disease in women. Plaintiffs’ attorneys state that there is insufficient evidence to make claims that the drug is effective in that role, but Pfizer advertised it as such anyway.

“This issue is significant because of the increased risk of diabetes that has been shown to exist, especially in women. While this risk might be outweighed, for some patients, in the face of certain benefits in the reduction of coronary heart disease, the risk/benefit analysis looks quite different if the benefits are uncertain or unknown,” plaintiffs stated in a brief (PDF) filed on the issue in August. “Thus, Pfizer’s attempts to persuade doctors and patients of the benefits of Lipitor in women prevented those doctors and patients from appropriately assessing the value of taking the drug. (This problem was, of course, compounded by Pfizer’s failure to warn about the risks of diabetes.)”

Pfizer has called for these efficacy claims to be dismissed, arguing that since the FDA approved Lipitor as safe and effective for women, plaintiffs’ state court claims should be pre-empted by federal regulations. The drug maker claims that the expert witnesses employed by the plaintiffs are arguing against the FDA’s expert opinions using unsound scientific theories, which plaintiffs deny.

“Contrary to Pfizer’s formulation, Plaintiffs do not assert, and their experts do not opine, that Lipitor is not effective for primary prevention in women,” argue plaintiffs in the litigation. “Rather, these experts opine that there is insufficient evidence to show that Lipitor is effective for primary prevention in women. The distinction between these two statements is both enormous and significant, in precisely the same way that the burden of proof at a trial differentiates between what a plaintiff has affirmatively proven, and what a defendant may demonstrate to be simply unproven. As the traditional aphorism reminds, ‘absence of evidence is not evidence of absence.’”

At oral arguments on the motion, the parties disagreed about whether efficacy claims based on the marketing of Lipitor are also preempted if Judge Gergel finds that claims regarding efficacy and based on Lipitor’s label were preempted. Therefore, the Court has ordered additional briefing on the question. Pfizer has been directed to file its brief by December 1, with a Plaintiffs’ response by December 11.

The first Lipitor bellwether trial is expected to begin in January, involving a claim filed by 67 year old Wilma Daniels, who alleges that she developed type 2 diabetes after she began using the cholesterol drug in 1997. While the outcome of this trial will not be binding on other claims, it will be closely watched by lawyers involved in the litigation, as it may influence eventual negotiations to reach Lipitor settlements with Pfizer.