The U.S. District Court for the Eastern District of Texas granted Novartis Pharmaceuticals Corporation’s motion to strike the purported alternative design declaration of MDL-wide expert Dr. Robert Marx, and then granted summary judgment in favor of Novartis in Conklin v. Novartis Pharm. Corp., No. 9:11-cv-00178-RC (E.D. Tex. Sept. 19, 2012), a case that has been part of the ongoing Aredia and Zometa multidistrict litigation, In re: Aredia and Zometa Prods. Liab. Litig., No. 3:06-MD- 01760 (TJC) (M.D. Tenn.). Plaintiff Beulah Conklin alleged that she had developed ONJ as a result of her use of Zometa, prescribed to treat her metastatic breast cancer.

In striking Dr. Marx’s alternative design theory, Judge Ron Clark found that Dr. Marx’s opinion of an alleged safer alternative dosing regime for Zometa® did not satisfy Federal Rule of Evidence 702.  Judge Clark stated that “Dr. Marx offers no evidence as to the efficacy of a reduced Zometa regimen, and he does not explain from where he draws his naked conclusion regarding efficacy.”  Judge Clark concluded that “Dr. Marx’s opinion that a lower dose regimen of Zometa will reduce the incidence of Zometa is not helpful.  His opinion that there is a lower dose regimen that will be efficacious in fighting cancer-related diseases does not meet the requirements of Rule 702 and the Daubert line of cases.”

After granting the motion to strike, Judge Clark ruled that summary judgment was appropriate for Ms. Conklin’s design defect claim because she had “no evidence of a safer alternative design” for Zometa.  Then, building on a July 2008 ruling in the MDL proceedings dismissing plaintiff’s failure-to-warn claims pursuant to a Texas statutory presumption of label adequacy for FDA-approved drugs, Judge Conklin dismissed plaintiff’s remaining negligence per se and breach of implied warranty claims as simply “re-packaged design defect or failure to warn claims.”