Judge Helen Berrigan, who presides over the Paxil birth defects MDL in New Orleans, has issued a nicely reasoned Rule 702 opinion, upholding defense objections to plaintiffs expert witnesses, Paul Goldstein, Ph.D., and Shira Kramer, Ph.D. Frischhertz v SmithKline Beecham EDLa 2012 702 MSJ Op.

The plaintiff, Andrea Frischhertz, took GSK’s Paxil, a selective serotonin reuptake inhibitor (SSRI), for depression while pregnant with her daughter, E.F. The parties agreed that E.F. was born with a deformity of her right hand.  Plaintiffs originally claimed that E.F. had a heart defect, but their expert witnesses appeared to give up this claim at deposition, as lacking evidential support.

Adhering to Daubert’s Epistemiologic Lesson

Like many other lower federal courts, Judge Berrigan focused her analysis on the language of Daubert v. Merrell Dow Pharmaceuticals Inc., 509 U.S. 579 (1993), a case that has been superseded by subsequent cases and a revision to the operative statute, Rule 702.  Fortunately, the trial court did not lose sight of the key epistemological teaching of Daubert, which is based upon Rule 702:

“Regarding reliability, the [Daubert] Court said: ‘the subject of an expert’s testimony must be “scientific . . . knowledge.” The adjective “scientific” implies a grounding in the methods and procedures of science. Similarly, the word “knowledge” connotes more than subjective belief or unsupported speculation’.”

Slip Op. at 3 (quoting Daubert, 509 U.S. at 589-590).

There was not much to the plaintiffs’ expert witnesses’ opinion beyond speculation, but many other courts have been beguiled by speculation dressed up as “scientific … knowledge.”  Dr. Goldstein relied upon whole embryo culture testing of SSRIs, but in the face overwhelming evidence, Dr. Goldstein was forced to concede that this test may generate hypotheses about, but cannot predict, human risk of birth defects.  No doubt this concession made the trial court’s decision easier, but the result would have been required regardless of Dr. Goldstein’s exhibition of truthfulness at deposition.

Statistical Association – A Good Place to Begin

More interestingly, the trial court rejected the plaintiffs’ expert witnesses’ efforts to leapfrog finding a statistically significant association to parsing the so-called Bradford Hill factors:

“The Bradford-Hill criteria can only be applied after a statistically significant association has been identified. Federal Judicial Center, Reference Manual on Scientific Evidence, 599, n.141 (3d. ed. 2011) (“In a number of cases, experts attempted to use these guidelines to support the existence of causation in the absence of any epidemiologic studies finding an association . . . . There may be some logic to that effort, but it does not reflect accepted epidemiologic methodology.”). See, e.g., Dunn v. Sandoz Pharms., 275 F. Supp. 2d 672, 678 (M.D.N.C. 2003). Here, Dr. Goldstein attempted to use the Bradford-Hill criteria to prove causation without first identifying a valid statistically significant association. He first developed a hypothesis and then attempted to use the Bradford-Hill criteria to prove it. Rec. Doc. 187, Exh. 2, depo. Goldstein, p. 103. Because there is no data showing an association between Paxil and limb defects, no association existed for Dr. Goldstein to apply the Bradford-Hill criteria. Hence, Dr. Goldstein’s general causation opinion is not reliable.”

Slip op. at 6.

The trial court’s rejection of Dr. Goldstein’s attempted end run is particularly noteworthy given the Reference Manual’s weak-kneed attempt to suggest that this reasoning has “some logic” to it.  The Manual never articulates what “logic” commends Dr. Goldstein’s approach; nor does it identify any causal relationship ever established with such paltry evidence in the real world of science. The Manual does cite several legal cases that excused or overlooked the need to find a statistically significant association, and even elevated such reasoning into legally acceptable, admissibility method.  See Reference Manual on Scientific Evidence at 599 n. 141 (describing cases in which purported expert witnesses attempted to use Bradford Hill factors in the absence of a statistically significant association; citing Rains v. PPG Indus., Inc., 361 F. Supp. 2d 829, 836–37 (S.D. Ill. 2004); ); Soldo v. Sandoz Pharms. Corp., 244 F. Supp. 2d 434, 460–61 (W.D. Pa. 2003).  The Reference Manual also cited cases, without obvious disapproval, which completely dispatched with any necessity of considering any of the Bradford Hill factors, or the precondition of a statistically significant association.  See Reference Manual at 599 n. 144 (citing Cook v. Rockwell Int’l Corp., 580 F. Supp. 2d 1071, 1098 (D. Colo. 2006) (“Defendants cite no authority, scientific or legal, that compliance with all, or even one, of these factors is required. . . . The scientific consensus is, in fact, to the contrary. It identifies Defendants’ list of factors as some of the nine factors or lenses that guide epidemiologists in making judgments about causation. . . . These factors are not tests for determining the reliability of any study or the causal inferences drawn from it.“).

Shira Kramer Takes Her Lumpings

The plaintiffs’ other key expert witness, Dr. Shira Kramer, was a more sophisticated and experienced obfuscator.  Kramer attempted to provide plaintiffs with a necessary association by “lumping” all birth defects together in her analysis of epidemiologic data of birth defects among children of women who had ingested Paxil (or other SSRIs).  Given the clear evidence that different birth defects arise at different times, based upon interference with different embryological processes, the trial court discerned this “lumping” of end points to be methodologically inappropriate.  Slip op. at 8 (citing Chamber v. Exxon Corp., 81 F. Supp. 2d 661 (M.D. La. 2000), aff’d, 247 F.3d 240 (5th Cir. 2001) (unpublished).

Without her “lumping”, Dr. Kramer was left with only a weak, inconsistent claim of biological plausibility and temporality. Finding that Dr. Kramer’s opinion had outrun her headlights, Judge Berrigan, excluded Dr. Kramer as an expert witness, and granted GSK summary judgment.

Merry Christmas!


Print Friendly, PDF & Email

Comments are closed.