Friday, February 22, 2013

A One-Two Punch in the Aredia/Zometa Litigation

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 District of California last week, when the court granted a Daubert motion to preclude Plaintiff’s experts’ specific causation testimony, then granted summary judgment on the basis that without that testimony, Plaintiff couldn’t prove her case.  The Plaintiff in Messick had received therapy with the bisphosphonate drugs Aredia or Zometa for approximately two years, 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, during the time in which she was on Aredia and/or Zometa therapy, Plaintiff also had a litany of dental maladies – unrelated to her therapy - that would make even the most lax flosser repent of their ways.) 

The court first looked at Plaintiff’s oral and maxillofacial surgery expert, Dr. Jackson, who opined that Ms. Messick’s Aredia/Zometa use was the cause of her ONJ.  While the court found that that Dr. Jackson had pointed to reliable evidence to support general causation, it found that his evidence on specific causation was not reliable.  Dr. Jackson purported to rely on a pathology analysis of a fragment of bone that had been removed from Ms. Messick’s jaw in November 2008, claiming that this analysis demonstrated 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 been stored “in a plastic container,” and not preserved in any way.  Opinion, p. 6.  (As a certain teenage niece might say, “Um, ewww.”)   Not surprisingly, even Dr. Jackson had to admit that this sort of testing was not scientifically reliable.  Opinion, p. 7. 

 Dr. Jackson also purported to 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 able to rule out three conditions that could have caused this patient to develop ONJ, he also identified five other risk factors that Plaintiff had for developing ONJ.  The support for the so-called differential diagnosis boiled down to Dr. Jackson’s assertion that “it just doesn’t happen” that someone with Ms. Messick’s risk factors would develop ONJ without also being exposed to bisphosphonates.  Opinion, p. 7.  As the court pointed out, Dr. Jackson never explained 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 “differential diagnosis” was nothing more than a litigation-driven guess.   Ultimately, Dr. Jackson admitted that in a patient with multiple risk factors, there was no scientifically reliable way for him to determine which one had caused the injury.  Opinion, p. 7.  Because his specific causation opinion was not based on reliable methodology, it was out.  Opinion, pp. 7-8.   We liked the fact that at this point, the court cited to a 2012 opinion from the Eastern District of Washington, in which that court also excluded Dr. Jackson’s causation testimony.  Opinion, p. 8. 

But the court wasn’t finished with Dr. Jackson.  It next found that Dr. Jackson’s testimony also did not meet Rule 702’s relevance requirement, as under California law, Dr. Jackson’s testimony did not demonstrate that bisphosphonate therapy had more likely 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 have gotten ONJ without bisphosphonate exposure – he never said that it had actually caused 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 the opinions of two of Plaintiff’s treaters, Drs. Silverman and Lam, and precluded them on the basis that neither of them had any reliable scientific basis for concluding that Aredia and Zometa had caused Ms. Messick’s ONJ.  Dr. Silverman performed no differential diagnosis (not even the lame-o Jackson variety), no research and no literature review; he merely testified that he “assumed” her ONJ was caused by the bisphosphonates, 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 was bisphosphonate-related, but that he relied upon Dr. Silverman for a definitive diagnosis.  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 requirement under Rule 702, that where evidence of pre-litigation research or research subject to peer review is unavailable, the expert must point to an objective source, such as a treatise, policy statement of a professional association, or a published article in a reputable scientific journal.

Opinion, p. 9.   The court also noted that the doctors’ “impression” and “assumption” couldn’t get them 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 of affirmative evidence in the record that Aredia and Zometa more likely than not caused Ms. Messick’s ONJ.”  Opinion, p. 11.  Because this proof of specific causation was a required element on each of the Plaintiff’s claims, the court then entered summary judgment in Novartis’ favor. 

Congratulations to Frank Leone and Robert Johnson of Hollingsworth LLP and Jim Colopy of Farella Bruen. 

1 comment:

Anonymous said...

So, is this blogger an expert? What does this person know about ONJ?