E.D. of Washington Grants Summary Judgment to Novartis in Pharmaceuticals Case

October 2, 2012

The U.S. District Court for the Eastern District of Washington granted Novartis Pharmaceuticals Corporation’s Daubert motion and so excluded plaintiff’s expert witnesses and then granted summary judgment in favor of Novartis in Luttrell v. Novartis Pharm. Corp., No. 2:07-cv-03015-TOR (E.D. Wash. Oct. 2, 2012), a case that had 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.).

In Luttrell, plaintiff Duane E. Luttrell alleged that he developed osteonecrosis of the jaw (“ONJ”) as a result of his use of Aredia and Zometa to prevent or significantly delay the deep bony pain, pathologic bone fractures, and spinal cord collapse that accompany multiple myeloma.  Following a single dose of Zometa in June 2005, Mr. Luttrell alleged that he subsequently had eleven doses of Aredia, leading to the alleged ONJ by June 2006.  Mr. Luttrell filed his lawsuit against NPC in March 2007 – and then restarted his Aredia therapy in May 2007.  By the time of motions practice, plaintiff had abandoned his manufacturing defect and express warranty claims and had not provided any substantive argument in favor of his implied warranty claim, leaving as his remaining claims those denominated as strict liability and negligent failure to warn.  The Court found these collapsed by the Washington Products Liability Act into a failure to warn claim that requires plaintiff to prove cause in fact and legal cause.  Slip op. at 30, 35.

The court began its analysis with Novartis’s Daubert motion, which it granted. Judge Thomas O. Rice found that Dr. Richard Jackson, the expert witness plaintiff retained to opine on specific causation, i.e., whether Aredia® and/or Zometa® caused plaintiff to develop ONJ, did not satisfy Federal Rule of Evidence 702.  Dr. Jackson purported to apply a differential diagnosis to identify plaintiff as having Bisphosphonate-Related ONJ (“BRONJ”).  While the court noted that Dr. Jackson’s BRONJ diagnosis was not equivalent to an opinion that Mr. Luttrell’s BRONJ was actually caused by bisphosphonate use, calling into close question the “fit” of Dr. Jackson’s expected testimony, the court held that Dr. Jackson failed to provide any scientific basis for how he ruled out other potential causes of Mr. Luttrell’s alleged BRONJ:  “Several bald assertions buried in the transcript of a deposition as to the ‘unique’ behavior of BRONJ as compared to other causes of ONJ or other contributing factors does not qualify Dr. Jackson’s testimony as sufficiently reliable under Daubert.”  Slip op. at 28.

Plaintiff also designated five of his treating physicians as non-retained expert witnesses: Dr. Albert Brady; Dr. Sean Cleary; Dr. Dolphine Oda; Dr. Darrell Tew; and Dr. Mark Young.  Judge Rice concluded that plaintiff’s reliance on statements in medical records authored by these doctors was insufficient evidence that the doctors had admissible causation opinions, particularly where several of the doctors had testified to the contrary at deposition.  Judge Rice further found that plaintiff had failed to meet his burden of establishing that certain of the doctors had sufficient expertise to support causation testimony.  Because the plaintiff lacked evidence to establish that his alleged injury was caused by Aredia and Zometa, the court granted summary judgment.

The court also granted summary judgment on an independent basis, plaintiff’s inability to establish proximate cause, i.e., that if adequately warned of the risk, his physician would have “‘take[n] a different course of action.’”  Slip op. at 40.  After acknowledging that “[t]he legal standard for the court to remove the issue of causation from the jury is extremely high,” slip op. at 42, the court found “compelling evidence” in the fact that Dr. Brady prescribed, and Mr. Luttrell accepted, continued Aredia® therapy shortly after Mr. Luttrell filed suit against NPC – at which point “both Dr. Brady and Luttrell were aware of the possible dangers of bisphosphonates, but still decided to use the drug.”  Slip op. at 44.  “Restarting the drug after filing the lawsuit is powerful and conclusive evidence that is incapable of a difference of opinion by any reasonable trier of fact.”  Id.