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Expert Witnesses: Are Courts Daubert Averse?
Friday, April 14, 2017

Summary judgment motions are filed in just about every case. Yet they are denied most of the time. Why is that? Is it because in each of those instances there truly was a genuine issue of material fact?

If you disagree, which is likely, it’s probably because you feel the court is generally averse to granting summary judgment because it requires a detailed analysis and supporting opinion. It is also riskier because the burden is high, making it more subject to reversal on appeal. Our question to you is this: Do you feel the same about the court’s inclination to exclude expert testimony?

​The Expert Requirements

It is a bit ironic asking that question when we are about to report on a surprisingly-lengthy opinion excluding multiple experts and their opinions, but perhaps Jones v. Novartis Pharmaceuticals Corp., 2017 WL 372246 (N.D. Ala. Jan. 26, 2017) is a rarity. The plaintiff in Jones alleged her atypical femur fracture (“AFF”) was caused—not only generally, but specifically—by the defendant, Novartis’s, prescription osteoporosis medication, Reclast, a type of bisphosphonate (“BP”) drug. The court began by digging into the three Daubert requirements an expert must meet for admission:


Sounds simple enough, but it took the court 119 pages to do it.

In applying the three-prong test above to the testimony offered by the plaintiff’s numerous experts, the court granted each—some in part, most in whole—motion to exclude based on the following Daubert-specific findings:

  • Causation expert, Dr. Suzanne Parisian, an FDA Medical Officer and FDA drug regulation specialist, was not qualified to testify as to “Novartis' intent or state of mind, so any testimony on these issues is not admissible. Additionally, Dr. Parisian is not qualified and will not be permitted to testify regarding causation or ‘causal association’; whether and when Novartis was put on ‘notice’; whether any advertising or marketing changes might have impacted the opinion of a physician; studies conducted on other BP drugs; pharmaceutical industry standards; correlations between AFF and osteonecrosis of the jaw; and other improper legal conclusions.” Jones, 2017 WL 372246, *9. 

  • Causation expert, Dr. William B. Hinshaw, a bio-organic chemist and practicing gynecologist, improperly used the Bradford Hill methodology for determining causation and he improperly extrapolated from studies of the class of BP drugs where there were significant differences, including regarding the impact on material properties of bone, between the other class BPs, which are administered orally on a weekly or monthly basis, as opposed to Reclast, which is a single IV infusion per year to form his causation opinion and he was not qualified to opine on Novartis' compliance with FDA regulations. Id. at *16-28.

  • Causation expert, Dr. Wayne A. Taylor, a statistician, used unreliable and inadequate re-analysis of medical data to form his general causation opinion by improperly including a spiral fracture from another analysis, failed to demonstrate reliability of his one-tailed test versus a two-tailed test and he was not qualified to offer expert opinions on compliance with FDA regulatory standards. Id. at *28-40.

  • Causation expert, Dr. James Worthen, a board-certified orthopedic surgeon, one of the plaintiff’s treating physicians and a non-retained expert, was not qualified to testify as to causation because he failed to reliably rule out the plaintiff’s steroid use and other risk factors as causes of her injuries. Id. at *40-44.

  • Causation expert, Dr. Timothy Mark Ricketts, an internist, general practitioner and another treating physician of the plaintiff, and a non-retained expert, was not qualified to offer an opinion that the plaintiff’s fractures were caused by Reclast because they were “of the type described in medical literature caused by BP use” because this opinion relied substantially on the opinions of other physicians. Id. at*44-45.

Conclusion 

The Jones court specifically recites the Daubert gatekeeping function as a mandate that the trial court conduct “an exacting analysis of the foundations of expert opinions to ensure they meet the standards for admissibility under Rule 702.” Id. at *2 quoting United States v. Abreu, 406 F.3d 1304, 1306 (11th Cir. 2005). In addition, as we noted in our recent Gorsuch article, the court must also include certain elements, i.e., a specific address to each Daubert objection raised, in the opinion granting a Daubert motion to ensure it will stand up on appeal. That’s a big job.

While the Jones opinion is well-supported and stands as a very helpful example of a thorough Daubert analysis, we’re curious whether courts are often not inclined to engage in this kind of detailed, documented review because it requires so much time, effort, and judicial resources.

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