22 Şubat 2013 Cuma

A One-Two Punch in the Aredia/Zometa Litigation

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Here's another quasi-guest post from our quasi-regular blogger - Reed Smith's Melissa Wojtylak.  It's her post, I'm just the piano player.

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Novartis scored a double victory in the Northern Districtof California last week, when the court granted a Daubert motion to preclude Plaintiff’s experts’ specific causationtestimony, then granted summary judgment on the basis that without thattestimony, Plaintiff couldn’t prove her case. The Plaintiff in Messick had receivedtherapy with the bisphosphonate drugs Aredia or Zometa for approximately twoyears, and alleged that she developed osteonecrosis of the jaw (“ONJ”)approximately a year and four months after stopping therapy. See Messick v. Novartis Pharmaceuticals Corp., No. 3:12-cv-00693-SI, slip. op. (N.D. Cal. Feb. 15, 2013).  (As an aside, duringthe time in which she was on Aredia and/or Zometa therapy, Plaintiff also had alitany of dental maladies – unrelated to her therapy - that would make even themost lax flosser repent of their ways.) 
The court first looked at Plaintiff’s oral andmaxillofacial surgery expert, Dr. Jackson, who opined that Ms. Messick’sAredia/Zometa use was the cause of her ONJ. While the court found that that Dr. Jackson had pointed to reliableevidence to support general causation, it found that his evidence on specificcausation was not reliable.  Dr. Jacksonpurported to rely on a pathology analysis of a fragment of bone that had beenremoved from Ms. Messick’s jaw in November 2008, claiming that this analysisdemonstrated that her ONJ was caused by her Aredia and Zometa use.  Opinion, p. 7.  Here’s the problem:  the fragment was three years old when Dr.Jackson analyzed it, and in that three years, the fragment had merely beenstored “in a plastic container,” and not preserved in any way.  Opinion, p. 6.  (As a certain teenage niece might say, “Um, ewww.”)   Notsurprisingly, even Dr. Jackson had to admit that this sort of testing was notscientifically reliable.  Opinion, p.7. 
 Dr. Jackson also purportedto rely on a differential diagnosis to support his conclusion that Ms.Messick’s ONJ was caused by the drugs. The Court was not persuaded, noting that while Dr. Jackson had been ableto rule out three conditions that could have caused this patient to developONJ, he also identified five other risk factors that Plaintiff had fordeveloping ONJ.  The support for theso-called differential diagnosis boiled down to Dr. Jackson’s assertion that“it just doesn’t happen” that someone with Ms. Messick’s risk factors woulddevelop ONJ without also being exposed to bisphosphonates.  Opinion, p. 7.  As the court pointed out, Dr. Jackson neverexplained the scientific basis for his conclusion.  Opinion, p. 7.  After the “it just doesn’t happen” comment,it seems pretty clear to us that there wasn’t one – the doctor’s “differentialdiagnosis” was nothing more than a litigation-driven guess.   Ultimately, Dr. Jackson admitted that in apatient with multiple risk factors, there was no scientifically reliable wayfor him to determine which one had caused the injury.  Opinion, p. 7.  Because his specific causation opinion wasnot based on reliable methodology, it was out. Opinion, pp. 7-8.   We liked thefact that at this point, the court cited to a 2012 opinion from the EasternDistrict of Washington, in which that court also excluded Dr. Jackson’scausation testimony.  Opinion, p. 8. 
But the court wasn’t finished with Dr. Jackson.  It next found that Dr. Jackson’s testimony alsodid not meet Rule 702’s relevance requirement, as under California law, Dr.Jackson’s testimony did not demonstrate that bisphosphonate therapy had morelikely than not caused Ms. Messick’s injury. Opinion, p. 8.  The best Dr.Jackson could do was to assert that a patient “like” Ms. Messick would not havegotten ONJ without bisphosphonate exposure – he never said that it had actuallycaused Ms. Messick’s ONJ.  Opinion, p.8.  The court pointed out again that Dr.Jackson had specifically stated that he could not say this.  Id. 
After disposing of Dr. Jackson, the court moved on to theopinions of two of Plaintiff’s treaters, Drs. Silverman and Lam, and precluded themon the basis that neither of them had any reliable scientific basis forconcluding that Aredia and Zometa had caused Ms. Messick’s ONJ.  Dr. Silverman performed no differentialdiagnosis (not even the lame-o Jackson variety), no research and no literaturereview; he merely testified that he “assumed” her ONJ was caused by thebisphosphonates, because “[t]here was a possibility of an association.”  Opinion, p. 9.  Dr. Lam brought even less to the table,testifying that it was his “impression” that the ONJ wasbisphosphonate-related, but that he relied upon Dr. Silverman for a definitivediagnosis.  Opinion, p. 9.  The court rejected this Pete and Repeat act, holding
Dr. Silverman’s “assumption” and Dr. Lam’s“impression” are simply inadequate to satisfy the Ninth Circuit’s requirementunder Rule 702, that where evidence of pre-litigation research or researchsubject to peer review is unavailable, the expert must point to an objectivesource, such as a treatise, policy statement of a professional association, ora published article in a reputable scientific journal.
Opinion, p. 9.   Thecourt also noted that the doctors’ “impression” and “assumption” couldn’t getthem past the Rule 702 relevance requirement either.  Opinion, p. 10.
After making short work of Drs. Jackson, Silverman and Lam,the court found that without their testimony, there was “a complete absence ofaffirmative evidence in the record that Aredia and Zometa more likely than notcaused Ms. Messick’s ONJ.”  Opinion, p.11.  Because this proof of specificcausation was a required element on each of the Plaintiff’s claims, the courtthen entered summary judgment in Novartis’ favor. 
Congratulations to Frank Leone and Robert Johnson ofHollingsworth LLP and Jim Colopy of Farella Bruen. 

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