Just weeks before this case was slated for trial, the U.S. District Court for the Middle District of Alabama granted summary judgment in favor of Novartis Pharmaceuticals Corporation in the products liability case, Garrison v. Novartis Pharm. Corp., 2:11-cv-00589 (M.D. Ala. July 2, 2014).  The district court held that plaintiff failed to prove proximate causation when there was no evidence that additional or different warnings would have changed the prescribing oncologist’s decision to prescribe the drugs, nor the treatment by her dental providers.  The court also held that plaintiff failed to prove specific causation because plaintiff’s designated expert failed to conduct a “scientifically sound” differential diagnosis under Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993).  The district court cited a string of Novartis wins in the Aredia /Zometa litigation on proximate causation.  Garrison at n. 13.  Deborah Garrison alleged that Novartis’s drugs Aredia and Zometa caused her to develop osteonecrosis of the jaw (“ONJ”) after she had a tooth extracted.  Aredia and Zometa are FDA-approved medications prescribed to prevent or significantly delay the deep bony pain, pathologic bone fractures, and spinal cord collapse that are complications of plaintiff’s multiple myeloma.

The district court found two meritorious grounds to grant summary judgment for Novartis.  First, in finding no proof of proximate causation, the district court recognized that the prescribing oncologist Dr. Morrison’s testimony is “unambiguous that an earlier warning would not have affected his decision to prescribe bisphosphonates, and Ms. Garrison has not refuted his testimony to create a genuine dispute of material fact.”  Id. at 21.  The district court held that Dr. Morrison’s disregard of the risk of ONJ disrupts Ms. Garrison’s theory that Novartis’s inadequate warnings were the proximate cause of her injuries.  Id. at 20.  “The court must ask “whether [Dr. Morrison’s] decision to prescribe [Aredia®] to [Ms. Garrison] ultimately hinged on the information (accurate or inaccurate) that he obtained from [Novartis]. . . .”  Id.  Dr. Morrison stated that he “still would have prescribed Aredia and Zometa because the benefit (i.e., the prevention of bone deterioration, especially in Ms. Garrison’s already vulnerable spine) outweighed the risk that she might develop ONJ.”  Id. at 17.  Separately, the district court found that “Ms. Garrison’s contention that her tooth extraction was medically necessary proves rather than defeats Novartis’s argument that proximate cause is lacking.  (See Doc. # 63, at 4–5.)  That is to say, Ms. Garrison’s unavoidable need for oral surgery was an intervening cause of the onset of ONJ, and an adequate warning would not have prevented the need to extract her tooth.  Cf. Eberhart, 867 F. Supp. 2d at 1254–56 (concluding that the plaintiff failed to raise a genuine issue of fact for trial when she failed to furnish evidence to support her theory that a tooth could have been saved and an extraction avoided).”  Id. at 21.

Second, the district court found that Ms. Garrison could not prove specific causation because her designated expert failed to conduct a “scientifically sound” differential diagnosis to support his opinion that Aredia® or Zometa® caused plaintiff’s ONJ.  Id. at 26.  The district court held that in order to survive a Daubert challenge “[i]t is not enough for the expert to simply assert that he performed differential diagnosis in reaching his opinion; he must take ‘serious account of other potential causes.’  Id. (citing Westberry v. Gislaved Gummi AB, 178 F.3d 257, 265 (4th Cir. 1999)).