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From Health Law Daily, June 14, 2018

Fourth Circuit dismisses MDL Over Lipitor® link to Diabetes

By Dietrich Knauth

The Fourth Circuit affirmed the dismissal of a multidistrict litigation alleging that the anti-cholesterol drug Lipitor® caused diabetes in more than three thousand women, finding that the district court properly dismissed all of the cases due to insufficient evidence (In re Lipitor Marketing, Sales Practices, and Products Liability Litigation, June 12, 2018, Diaz, A.).

The case consolidated thousands of women's claims against Lipitor’s manufacturer, Pfizer, in the Southern District of South Carolina. After significant litigation, the district court granted summary judgment to Pfizer in all of the cases. The court first excluded the testimony of the patients' expert witnesses as unreliable, and then remained unpersuaded after giving each individual patient the opportunity to provide additional evidence unique to their particular case.

On appeal, the plaintiffs argued that the lower court improperly excluded the testimony of three of the plaintiffs’ expert witnesses—a statistician, a general causation expert, and the specific causation expert who opined on the case of one particular patient. The plaintiffs also argued that the individual cases should have been separated from each other and returned back to the courts where they were filed, rather than being dismissed en masse, if the court was unsatisfied with the expert testimony.

But the Fourth Circuit found that the lower court had properly handled both the expert testimony dispute and the summary judgment decision. For example, the district court had properly excluded the testimony of a statistician who claimed to have found a link between Lipitor and new-onset diabetes based on Pfizer's clinical trial data, finding that the statistician's methodology was "too tainted with potential bias and error" to pass muster. The statistician's expert report included some tests he performed, which supported the plaintiffs’ argument, but excluded another test which did not, and also made links between certain blood-sugar data and diabetes which the statistician was not qualified to make, according to the court.

Similarly, the plaintiffs' general causation expert, who found an association between the use of Lipitor and increased risk of diabetes, was unpersuasive, because he did not look at all the different doses of Lipitor involved in the cases, and he failed to find a statistically significant association between certain doses of Lipitor and new-onset diabetes before opining as to causation, according to the court. The court declined to establish a clear line rule requiring experts to rely only on statistically significant evidence, but it found that unanswered questions about the expert's conclusions "suggest a lack of reliability" in his opinions.

The court also rejected the testimony offered by specific causation expert who testified that Lipitor had caused diabetes in one of the women whose case was used as a bellwether. Although the doctor said that the methodology she used in making her determination was "commonly used," she could not identify any organizations or peer-reviewed texts that contain this methodology, nor had she personally used the methodology to determine the cause of her own patients’ diabetes and had never diagnosed one of her patients as suffering from statin-induced diabetes, according to the court. She also failed to properly examine other risk factors that could have caused the patient's diabetes, according to the court.

Without sufficient expert testimony, the district court found that there was no genuine dispute of a material fact, and granted summary judgment. Allowing a jury to weigh in on the existing evidence "would be farcical and would likely result in a verdict steeped in speculation," according to the Fourth Circuit.

While the plaintiffs argued that the consolidated cases should have been returned to their original courts for individual resolution, the Fourth Circuit disagreed. The district court was within its discretion to resolve the cases on their merits, especially after going through extensive litigation to understand the science and issues presented in the cases, according to the appeals court. Remanding, rather than dismissing the cases, would essentially undo all of work involved in the multidistrict litigation, and defeat the purpose of consolidating the cases in the first place, the Fourth Circuit found.

The case is No. 17-1140.

Attorneys: Hilary Potash Gerzhoy (Kellogg, Hansen, Todd, Figel & Frederick, PLLC) and H. Blair Hahn (Richardson, Patrick, Westbrook & Brickman, LLC) for Appealing Case Management Order 100. Sheila L. Birnbaum (Quinn Emanuel Urquhart & Sullivan LLP) and Mark Cheffo (Dechert LLP) for Pfizer, Inc., Greenstone, LLC and Pfizer International LLC.

Companies: Appealing Case Management Order 100; Pfizer, Inc.; Greenstone, LLC; Pfizer International LLC

MainStory: TopStory CaseDecisions FDCActNews DrugBiologicNews PLDrugNews SafetyNews MarylandNews NorthCarolinaNews SouthCarolinaNews VirginiaNews WestVirginiaNews

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