Hollander v. Sandoz Pharm. Corp., 289 F.3d 1193 (10th Cir. 2002)

05/10/02

OK

10th Cir. -- United States Court of Appeals for the Tenth Circuit

Pharmaceutical Products

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On March 21, 2000, the United States District Court for the Western District of Oklahoma entered summary judgment for Firm client Sandoz Pharmaceuticals Corporation, holding that the plaintiff’s proffered expert testimony that Parlodel® caused her stroke was not scientifically reliable under the standards of Daubert. Hollander v. Sandoz Pharm. Corp., 95 F. Supp. 2d 1230 (W.D. Okla. 2000).  On May 10, 2002, a panel of the Tenth Circuit unanimously affirmed that decision.  Plaintiff’s causation evidence in Parlodel® cases has now been rejected by two federal courts of appeal (the 8th and 10th Circuits) and by six federal district courts.

Some highlights from the opinion:

  • Differential diagnosis and general causation. The Tenth Circuit held that the plaintiffs’ experts’ differential diagnosis methodology was not scientifically reliable, because “[i]n order to ‘rule in’ Parlodel® as a scientifically plausible cause of Ms. Hollander’s stroke, the Hollanders’ experts would need to present reliable evidence that the drug can cause strokes,” which they had not done.
  • Aggregation of evidence rejected.  Plaintiff argued that the district court had improperly rejected each category of evidence that she offered, without considering the evidence as a hole.  The Tenth Circuit rejected this “bricks in a wall” argument (as plaintiff characterized it), holding that “in our view, this argument is inconsistent with Daubert.”  The court explained that “[t]o suggest that those individual categories of evidence deemed unreliable by the district court may be added to form a reliable theory would be to abandon ‘the level of intellectual rigor’ of the expert in the field.”
  • Speculative leaps in causation opinions.  The Tenth Circuit concluded that plaintiff’s experts had made “several speculative leaps” in reaching their causation conclusions.
  • Specific categories of evidence rejected by the Tenth Circuit.  To prove causation, plaintiff relied, inter alia, on anecdotal case reports including dechallenge/rechallenge reports, the fact that bromocriptine is an ergot alkaloid and thus purportedly behaves like other ergot alkaloids, animal studies, epidemiological studies, and FDA findings and actions.  The Tenth Circuit reviewed and rejected each of these categories of evidence, holding that they did not constitute reliable grounds under Daubert and did not raise questions of fact on causation.