On June 8, 2001, in a unanimous decision, the United States Court of Appeals affirmed the grant of summary judgment to Firm client, Novartis Pharmaceuticals Corporation.

06/08/01

MO

8th Cir. -- United States Court of Appeals for the Eighth Circuit

Pharmaceutical Products

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On June 8, 2001, in a unanimous decision, the United States Court of Appeals affirmed the grant of summary judgment to Firm client Novartis in Glastetter v. Novartis Pharm. Corp., 252 F.3d 986 (8th Cir. 2001).  This significant Daubert decision and the decision below (107 F. Supp. 2d 1015 (E.D. Mo. 2000)) have received extensive national press coverage.  The Glastetters’ petition for rehearing and rehearing en banc was denied on July 13, 2001.

Among the holdings:

  • The differential diagnosis methodology employed by plaintiffs’ experts Drs. Kulig and Petro was scientifically invalid because it lacked a valid basis for “ruling in” Parlodel as a potential cause of stroke in a human. Op. at 4-5.
  • The published case reports, medical treatises, human rechallenge/dechallenge data, animal studies, internal corporate documents, and the Food & Drug Administration’s regulatory actions did “not demonstrate to an acceptable degree of medical certainty” that Parlodel can cause stroke. Op. at 5.
  • Associations noted in case reports are “not scientifically valid proof of causation.” Op. at 5-6.
  • Medical texts which offered tentative conclusions or conclusions based on case reports and generic comparisons to other chemicals “do not present persuasive scientific evidence” of causation. Op. at 6.
  • Generic assumptions about chemical behavior carry “little scientific value” because “minor deviations in molecular structure can radically change a particular substance’s properties and propensities.” Op. at 7.
  • The animal studies relied upon were insufficient proof of causation. Op. at 7-8.
  • The internal documents were cited out of context and do not constitute admissions. Op. at 8.
  • FDA’s balancing test “is irrelevant in determining the threshold question posed in this appeal” regarding medical causation, and the FDA employs a “reduced standard (vis-à-vis tort liability) for gauging causation. Op. at 8-9.
  • The absence of epidemiology “limited the available tools with which [plaintiff] could prove causation,” and the evidence she did present was not sufficiently reliable. Op. at 10.
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