Lipitor, drugs, white pills

Fourth Circuit Upholds Exclusion of Expert Testimony in Lipitor Trial

Written on Wednesday, July 4th, 2018 by Kimberly DelMonico
Filed under: ExpertWitness

The Fourth Circuit has upheld a lower court’s ruling that excluded expert testimony in a multidistrict litigation claiming that Lipitor causes Type 2 diabetes.

Lipitor Multidistrict Litigation

Lipitor is a cholesterol drug manufactured by Pfizer.  More than 3,000 women sued Pfizer, claiming that they developed diabetes as a result of taking Lipitor.  The women claimed that Pfizer was negligent in its design and promotion of Lipitor and that it failed to warn against Lipitor’s known risks.

The lawsuits were transferred to the district of South Carolina for consolidated proceedings and four plaintiffs were chosen to serve as bellwether cases.  The plaintiffs retained general causation experts to testify about the causal association between Lipitor and diabetes and specific causation experts to testify that Lipitor proximately caused the onset of diabetes for each of the bellwether patients.  The plaintiffs also retained an expert biostatistician to testify that taking Lipitor led to a statistically increased risk in diabetes.

Exclusion of Experts

Pfizer moved to exclude the plaintiffs’ expert witnesses under Daubert and Federal Rule of Evidence 702.  Following hearings and an opportunity for the experts to amend their reports, the lower court excluded testimony from three experts.  The court’s rulings left plaintiffs without their bellwether cases and limited them to a small subset of patients who had taken an 80 mg dose. The district court issued show cause orders asking any plaintiff to submit evidence that would enable her to survive summary judgment.  When no plaintiff was able to provide sufficient evidence, the district court granted summary judgment against all plaintiffs.

The plaintiffs appealed the lower court’s decision.  A panel from the Fourth Circuit Court of Appeals reviewed the district court’s decision and found that the lower court did not abuse its discretion.

The district court ruled that statistician Dr. Nicholas Jewell’s methodology was too tainted with potential bias and error.  The district court decided that Jewell was not qualified to make determinations about what data should have alerted Pfizer to a possible link between Lipitor and Type 2 diabetes.  The district court took issue with Jewell’s choice to include in his report only the test results that supported the plaintiffs.  The panel wrote, “The district court concluded (we think reasonably) that such an approach lacked the hallmark of science properly performed.”

The district court also excluded the testimony of Dr. Sonal Singh.  Singh testified about the association between various dosages of Lipitor and diabetes.  The district court found that Singh didn’t reliably apply the Bradford Hill criteria for causation to the data to determine if using Lipitor caused an increased risk in diabetes.  The panel agreed with the district court, “where, as here, each plaintiff took one of only several commercially available doses, clinical data exist that enable an expert to perform a causation analysis at each dose, and experts (including plaintiffs’ own) acknowledge that there is some relationship between dosage and harm, the district court doesn’t abuse its discretion in asking the expert to produce a dose-by-dose analysis.”

The district court also excluded the testimony of Dr. Elizabeth Murphy.  Murphy testified in a bellwether case that Lipitor specifically caused the patient’s diabetes.  The district court found that Dr. Murphy had dismissed other possible causes of the patient’s diabetes in a “cursory” fashion.  The panel concluded that the district court acted within its discretion in excluding Dr. Murphy’s testimony.

About Kimberly DelMonico

Kimberly DelMonico is a licensed attorney in New York and Nevada. She received her law degree from William S. Boyd School of Law at University of Nevada, Las Vegas and her undergraduate degree from New York University, where she studied psychology and broadcast journalism.

About Kimberly DelMonico

Kimberly DelMonico is a licensed attorney in New York and Nevada. She received her law degree from William S. Boyd School of Law at University of Nevada, Las Vegas and her undergraduate degree from New York University, where she studied psychology and broadcast journalism.

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