Monday, November 26, 2007
In 2005, the Food and Drug Administration reviewed the risks of drugs such as Celebrex and Vioxx and concluded that they should include a label warning patients of increased risk of strokes and heart attacks. These FDA findings prompted thousands of individuals who suffered heart attacks, strokes, or other adverse cardiovascular events (or who had relatives suffer the same) to sue Celebrex-maker Pfizer and Vioxx-maker Merck. The plaintiffs' claims against Pfizer were subsequently consolidated in the United States District Court of the Northern District of California in San Francisco.
Last Monday, Judge Breyer of that court issued an order excluding certain expert evidence that the plaintiffs sought to introduce, causing devastating damage to their cases. For decades, both state and federal courts applied the Frye test to determine the admissibility of expert evidence. This test, which some state courts still apply, asks a court to determine whether the technique or test used by the expert has general acceptance in the relevant scientific community.
This test was displaced in all federal courts and most state courts by the Supreme Court's decision in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), a case that dealt with whether the plaintiffs' experts could tesify that the drug Bendectin was a risk factor for human birth defects. The Supreme Court found that judges should act as "gatekeepers" and determine whether expert evidence is relevant and the product of a reliable technique or test. In Daubert, the Supreme Court laid out five "general observations" about how judges should determine whether a test or technique is reliable such as whether it has been subjected to peer review or publication.
The Supreme Court, however, did not state that these "general observations" were definitive or exhaustive, and thus when the Supreme Court remanded the Bendectin case to the United States Court of Appeals for the Ninth Circuit, the Court of Appeals proceeded to consider not only factors such as peer review/publication, but also the "significant fact[or] of "whether the experts are proposing to testify about matters growing naturally and directly out of research they have conducted independent of the litigation, or whether they have developed their opinions expressly for purposes of testifying." Daubert v. Merrell Dow Pharmaceuticals, Inc., 43 F.3d 1311, 1317 (9th Cir. 1995). Because the plaintiffs' experts developed their testimony solely in anticipation of litigation and relied upon research not subjected to peer review/publication, the Ninth Circuit found that their proposed testimony was inadmissible.
Judge Breyer's order in case against Pfizer is almost a mirror image of his parent court's decision in Daubert. Breyer found that the plaintiffs' experts in the case against Pfizer developed their testimony solely in anticipation of litigation and relied upon research which was for the most part not subjected to peer review/publication and thus found that their proposed testimony was inadmissible.
Some will argue that this is yet another example of judges being too proactive and excluding expert evidence despite lacking the sceintific/medical/technical knowledge necessary to make such decisions. See, e.g., Susan Haack, An Epistemologist in the Bramble-Bush: At the Supreme Court with Mr. Joiner, 26 Journal of Health, Politics, Policy & Law 217 (2001). (Indeed, I wonder how many experts conduct tests to determine the risk factors of prescription drugs without being retained for an upcoming case?) Others will argue that the old Frye test, which the Florida Supreme Court recently reaffirmed, encourages matador judging in which courts allow in all sorts of junk scienece. Personally, I'm not really sure that either test is efficacious.
I think that the issue of expert testimony is the most important evidentiary issue facing courts today as expert testimony becomes increasingly specialized and technical, and judges are at risk of becoming Sheriff Ed Tom Bell in No County for Old Men. As Captain Jack Harkness says in Torchwood, "The 21st Century is when everything changes. And you gotta be ready." With all sorts of expert testimony presently at issue, from bullet-matching forensics to fingerprint evidence to DNA found under fingernails to profiling evidence, I'm just not sure that judges are ready.