Insights & Events

The U.S. District Court for the Northern District of Georgia issued a 69-page Daubert opinion in favor of our client in Rider/Siharath v. Sandoz Pharmaceuticals Corp., 131 F. Supp. 2d 1347 (N.D. Ga. 2001).

Among the holdings:

• The Daubert “reliability” standard requires “[a]t its core, [a] ‘scientific knowledge’ inquiry [that] seeks to determine whether there is ‘some objective, independent validation of the expert’s methodology.” Op. at 9 (citations omitted).
• The Daubert “relevance” standard means “[t]here is no ‘fit’ where there is ‘simply too great an analytical gap between the data and the opinion offered,’ as when an expert offers animal studies showing one type of cancer in laboratory mice to support causation of another type of cancer in humans.” Op. at 10 (citations omitted).
• “Applying the Daubert criteria literally, the testimony of Plaintiffs’ experts should be excluded as unreliable and irrelevant” because their theory is not adequately tested, peer reviewed or generally accepted and because its error rate is unknown. Op. at 20; see also Op. at 58-60 (summarizing “totality of the evidence”).
• With respect to the epidemiology of Parlodel® and stroke, plaintiffs’ “criticism of the epidemiological studies does not satisfy their burden of proof. . . .   No evidence has been offered of an increase in postpartum strokes after the drug was approved for suppression of lactation; no evidence has been offered of a decrease in postpartum strokes after the approval for suppression of lactation was withdrawn.  The absence of epidemiological support raises the question of whether the causation opinions of Plaintiffs’ experts are merely speculative and not based on scientific evidence.” Op. at 27-28 (citing, e.g., Glastetter v. Novartis Pharms. Corp., 107 F. Supp. 2d 1015 (E.D. Mo. 2000) and Brumbaugh v. Sandoz Pharm. Corp., 77 F. Supp. 1153 (D. Mont. 1999) (parentheticals omitted)).
• “In the absence of statistically significant epidemiological studies to support their general causation theories, Plaintiffs’ experts rely most heavily on case reports.  Case reports are a form of anecdotal evidence where one event is reported as following another.” Opn. at 30.  “The adverse drug reports in this case lack the requisite quantity, nature and content.  From 1980 to 1994, millions of women took Parlodel.  The modest number of case reports associating the drug with stroke or even postpartum hypertension is not what would be expected if there was a significant increased risk.” Op. at 35. “The fact of the matter is that even if relevant case reports existed, they cannot establish general causation.” Op. at 35 (citing, e.g., Glastetter, 107 F. Supp. 2d 1015, Hollander v. Sandoz Pharms. Corp., 95 F. Supp. 2d 1230 (W.D. Okla. 2000), and Brumbaugh, 77 F. Supp. 2d 1153) (parentheticals omitted).
• “Learned treatises” which merely cite to case report evidence “do not add any additional scientific knowledge.” Op. at 57 (citing, e.g., Glastetter, 107 F. Supp. 2d at 1034 n.18).
• “Plaintiffs’ experts in this case cannot show that bromocriptine, the active ingredient in Parlodel, affects the body in a manner similar to other ergot alkaloids . . . . No evidence exists that other ergot alkaloids cause [bromocripine’s] peculiar effects.  This scientific fact supports both the finding that small differences in chemical structure often have significant consequences and the conclusion that testimony about similar drugs often does not meet Daubert’s requirements of reliability.” Op. at 43-44 (citing, e.g., Brumbaugh, 77 F. Supp. 2d at 1157).
• Plaintiffs’ experts’ reliance on animal studies fails.  “Extrapolations from animal studies to human beings generally are not considered reliable in the absence of a credible scientific explanation of why such extrapolation is warranted.” Opn. at 48 (citations omitted).  In this case, “none of these studies establish that Parlodel® causes stroke in humans – or even in animals, for that matter.” Op. at 51; see also Op. at 51-56 (detailing flaws in animal studies).
• Plaintiffs’ experts’ reliance on FDA determinations “ignores the lower standard of proof for agency determinations based upon a risk-utility analysis than the standard of proof required for the imposition of tort liability.” Op. at 46-47 (citations omitted); see also Op. at 47-48 (citing, e.g., Glastetter, 107 F. Supp. 2d at 1036, and Hollander, 95 F. Supp. 2d at 1234 n.9).
• Differential diagnosis must be faithfully applied:  “Experts must do something more that just “rule out” other possible causes.  They must explain how they were able to “rule in” the product in question. . . . When an expert only rules out causes, the trier of fact knows only what did not cause the harm. This does not necessarily aid the trier of fact in determining what did cause the harm. . . .” Op. at 62; see also Opn. at 38-39.
• The “totality of the evidence” is unreliable:  “one cannot lump together lots of hollow evidence in an attempt to determine what caused a medical harm.” Op. at 60.
• “Plaintiffs’ causal chain also is seriously flawed.” Opn. at 60.  “Three scientifically unwarranted ‘leaps of faith’ exist,” to wit, whether bromocriptine acts like other ergot alkaloids; whether, even if bromocriptine can cause hypertension, it can cause hypertension so severe as to cause stroke; whether bromocriptine then causes hemorrhagic stroke as opposed to ischemic stroke. Op. at 60.