Insights & Events

The U.S. Court of Appeals for the Eleventh Circuit unanimously affirmed the grant of summary judgment to client, Novartis Pharmaceuticals in Rider/Siharath v. Sandoz Pharm. Corp., 131 F. Supp. 2d 1347 (N.D. Ga. 2001).

This decision marks the third time a federal circuit court of appeals has considered the issue and found that plaintiffs’ experts’ opinions that Parlodel causes stroke do not satisfy Daubert.

The Rider/Siharath opinion begins by forcefully rejecting plaintiffs’ characterization of the district court’s opinion:

“The appellants argue that the district court dId not follow the law as prescribed in the Daubert trilogy, . . . misunderstood the scientific basis for the opinions sought to be introduced by plaintiffs, and overlooked critical evIdence. In our judgment this is a grossly distorted understanding of the decision of the district court and is unsupported in the record.” 2002 WL 1362182, at *1 (emphasis added).

The court addressed and rejected in its opinion the different categories of general causation evidence on which the plaintiffs’ experts rely:

• Epidemiological evidence is not required to survive Daubert inquiry. The 11th Circuit held that epidemiology “is generally considered to be the best evidence of causation in toxic tort actions” and that plaintiffs could not cite to any statistically significant epidemiological evidence regarding Parlodel. 2002 WL 1362182, at *4. The court agreed with the courts in Glastetter and Hollander that the lack of epidemiological evidence was not fatal to plaintiffs’ cases but noted that plaintiffs’ experts had failed to present other scientifically reliable evidence of causation: “In the absence of epidemiology, plaintiffs may still prove medical causation by other evidence. In the instant case, however, plaintiffs simply have not provided reliable evidence to support their conclusions.” Id. at *8; see also Id. at *4.
• Case reports cannot prove causation. The 11th Circuit held that Parlodel case reports, even those that contain details of the treatment and differential diagnosis, “are not reliable enough, by themselves, to demonstrate the causal link that plaintiffs assert they do because they report symptoms observed in a single patient in an uncontrolled context. They may rule out other potential causes of the effect, but they do not rule out the possibility that the effect manifested in the reported patient’s case is simply Idiosyncratic or the result of unknown confounding factors. As such, while they may support other proof of causation, case reports alone ordinarily cannot prove causation.” Id. at *5.
• Dechallenge/rechallenge reports not scientifically reliable. The 11th Circuit addressed in detail some of plaintiffs’ experts’ dechallenge/rechallenge reports and explained how the reports dId not stand for the proposition for which they were put forward. See Id. at *5-*6. The court held that “dechallenge/rechallenge tests are still case reports and do not purport to offer definitive conclusions as to causation.” Id. at *6.
• Evidence concerning “other ergot alkaloIds” not scientifically reliable. The 11th Circuit agreed with the 8th Circuit’s rejection of the chemical analogy argument in Glastetter, finding that “[e]rgot alkaloids encompass a broad class of drugs with great chemical diversity, and [e]ven minor deviations in chemical structure can radically change a particular substance’s properties and propensities.” Id. at *6 (citation omitted). The court explained that “[b]ecause the ergot alkaloid class of drugs has a wIde variety of effects, it is not obvious that bromocriptine should have the same effects as other drugs in that class. Indeed, two widely reported symptoms associated with bromocriptine are vasodilation and hypotension, precisely the opposite of what plaintiffs allege.” Id. at *7.
• Animal studies not scientifically reliable. The appeals court affirmed the district court’s rejection of animal study evidence because plaintiffs had “offered insufficient evidence on which that court could base a conclusion that the effect of bromocriptine would be the same on humans as it is on animals.” Id. at *7. The appeals court held that “it is necessary for plaintiffs to offer some rationale for the suggestion that the vascular structures of humans and animals are sufficiently similar in this context to conclude that bromocriptine’s effect on animals may be extrapolated to humans. Plaintiffs have not done so.” Id.
• FDA action is not a scientific basis for a causation opinion. The court held that the FDA regulatory action regarding Parlodel did not provide scientific evidence of causation, noting that “the FDA did not purport to have drawn any conclusion about causation” and had applied a “risk utility analysis [that] involves a much lower standard than that which is demanded by a court of law.” Id. at *7.