Insights & Events

Following a two-day evidentiary Daubert hearing in Caraker v. Sandoz Pharm. Corp., 172 F. Supp. 2d 1046 (S.D. Ill. 2001), Judge J. Phil Gilbert granted Firm client Sandoz’s motion to exclude expert testimony of plaintiffs’ expert witnesses on Daubert grounds.

Among the holdings:

• “The [differential diagnosis] methodology, in the abstract, has been considered sound, but when it is used in the practice of science (as opposed to its use by treating physicians in the practice of medicine out of necessity) it must reliably ‘rule in’ . . . the purported potential cause on the differential diagnosis in the first place as well as reliably ‘rule out’ the other potential causes until the physician is left with the most likely one. . . . Thus if the ‘ruling in’ step is bad or if an extrapolation from the existing data is particularly questionable or involves too great an analytical leap (or several such leaps), the whole opinion is questionable.” Slip op. at 3.
• The aggregate of plaintiffs’ experts’ unscientific evidence is no more reliable than the evidence when considered individually. Slip op. at 9. The “jigsaw puzzle” methodology offered by plaintiffs’ experts is not scientifically reliable, because it involves “too many extrapolations from dissimilar data, too many analytical leaps, and involves a loose application of purportedly objective scientific causation standards.” Slip op. at 4-5.
• Anecdotal case reports on Parlodel® are not scientifically reliable and could not pass muster under Daubert. Slip op. at 6 (case reports in question “make little attempt to isolate or exclude possible alternative causes, lack adequate controls, and lack any real analysis”).
• Dechallenge/rechallenge case reports, “do not contain a testable and systematic inquiry into the mechanism of causation,” because there are too few of them, and because they lack controls. Slip op. at 6-7.
• As they have done in other Parlodel® cases, Dr. Kulig and plaintiffs’ other experts advanced what the Caraker court called the “ergot alkaloid inference,” i.e., the hypothesis that bromocriptine behaves pharmacologically like other ergot alkaloids behave.  This molecular inference is “particularly questionable given Dr. Kulig’s inability to articulate how bromocriptine would operate differently (or how it operates at all) on a molecular level.” Slip op. at 8.
• Plaintiffs’ experts’ employment of animal studies is not scientifically reliable and also fails Daubert‘s “fit” requirement. Slip op. at 7 (“Some studies involved almost poisonous doses; some involved animals that had a steel rod injected down their spinal cord to destroy it so the animal has no intact nervous system; and some were poorly documented.”).  “In some cases, it appeared as though study data adverse to [Dr. Kulig’s] hypothesis was simply ignored, suggesting that [he] was not ‘being as careful as he would be in his regular professional work outside his paid litigation consulting.'”
• Internal corporate documents, taken in context, do not stand for the propositions advanced by plaintiffs’ experts. Slip op. at 9.
• The FDA’s approach involves lesser showings than are required in this case” to prove causation. Slip op. at 9.
• Dr. Kulig’s employment of epidemiology evidence in his methodology is “fundamentally flawed,” in that he “selectively pluck[ed] favorable numbers (that are not statistically significant) and herald[ed] them as crucial pieces of [his] bromocriptine puzzle.” Slip op. at 5-6.  But the court “impose[d] no absolute epidemiology requirement or any other requirement, except reliability and relevance.” Slip op. at 5 n.6.
• Medical texts “provide no more support than the evidence upon which they rely.” Slip op. at 8.