Supplemental Expert Reports on Lipitor Diabetes Risk Allowed in MDL

The U.S. District Judge presiding over all federal Lipitor diabetes lawsuits filed by women throughout the U.S. has agreed to allow plaintiffs to file a supplemental or “rebuttal” report from two expert witnesses attacked by Pfizer, the manufacturer of the popular cholesterol drug.

There are currently more than 2,000 product liability lawsuits pending against Pfizer in the federal court system, which all involve similar allegations that the drug maker failed to adequately warn women about the diabetes risk from Lipitor side effects.

The cases have been centralized before U.S. District Judge Richard Gergel in the District of South Carolina for coordinated pretrial proceedings as part of an MDL, or Multidistricti Litigation, which is designed to reduce duplicative discovery into common issues, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

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As part of the coordinated discovery and pretrial proceedings in the MDL, a small number of Lipitor cases are being prepared for bellwether trials, which are expected to begin in November.

Following generic and case specific discovery, the parties are now working on expert witness discovery, with challenges to the admissibility of causation and liability experts expected to be addressed this summer.

Pfizer’s expert witnesses have criticized the statistical methodologies and analyses used by two experts offered by Plaintiffs, Dr. Nicholas Jewell and Dr. Martin Wells, whose testimony supports the link between Lipitor and diabetes for women.

Although Dr. Jewell has testified that he chose not to consider data from a particular trial, and offered a lengthy explanation, Pfizer has attacked the fact that he did not consider this particular data, known as the ASCOT trial. Therefore, Plaintiffs have sought to file supplemental expert reports to address the criticism.

In a case management order (PDF) issued May 4, Judge Gergel agreed to allow these reports, even though all parties previously agreed not to allow rebuttal reports.

“In abundance of caution, and to ensure this Court has the best information possible when addressing Daubert motions [challenging the admissibility of expert testimony], the Court will allow Plaintiffs to serve these two additional reports by Dr. Jewell and Dr. Wells,” wrote Judge Gergel in the order. “However, the Court agrees that Pfizer is entitled to full discovery of these new opinions.”

As a result of the decision, an amended scheduling order was issued, which allows Pfizer to request depositions necessitated by these supplemental reports, which will be held between May 25 and June 19, 2015. Pfizer can also serve supplemental expert reports in response to Plaintiffs’ new reports by June 5, following which Plaintiffs will be able to take depositions of each of these experts between June 15 and July 10, 2015.

Following briefing and arguments on Daubert motions, jury selection is still scheduled to begin on November 3, 2015 in a case filed by Wilma Daniels, who alleges that she was very healthy before she started using Lipitor as a preventative measure to lower her cholesterol levels and decrease her risk of developing cardiovascular disease. After using Lipitor for several years, Daniels claims that she developed diabetes, which now causes her to suffer from multiple health complications.

A second trial is expected to begin later this year or in early 2016, involving a lawsuit filed by Juanita Hempstead.

While the outcome of these test trials will not be binding in other cases, they may influence eventual Lipitor settlement negotiations, potentially avoiding the need for hundreds of individual trials to be scheduled nationwide.


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