Daubert Ruling Fuels Thimerosal Debate

by Robert Ambrogi - Editor
BullsEye Newsletter: September 2006

A federal court ruling excluding all expert testimony that the drug-preservative thimerosal caused a minor child's autism is likely to have repercussions well beyond the case in which it came.

In Winston-Salem, N.C., U.S. District Judge James A. Beaty Jr. dismissed a lawsuit against the manufacturer of the drug RhoGAM. The suit alleged that thimerosal in the drug caused the minor plaintiff's autism. The judge issued the dismissal after he granted a defense motion to exclude all expert testimony drawing a link between thimerosal and autism.

"[W]ithout [the expert's] testimony, Plaintiffs are unable to meet their burden to demonstrate that the thimerosal in Defendant's RhoGAM product caused [Plaintiff's] autism, a result that leads directly to the failure of all of Plaintiffs' claims," Beaty wrote.

The ruling comes as nearly 5,000 claims await disposition in an omnibus proceeding pending before the U.S. Court of Federal Claims under the National Vaccine Injury Compensation Program. The claims allege that thimerosal in childhood vaccines is the cause of claimants' autism disorders.

Judge Beaty acknowledged the significance of his ruling in light of these cases, but said, "[T]his opinion does not determine that future plaintiffs with autistic children will never be able to establish causation in similar cases. However, what it does determine is that, at this point in time, Plaintiffs have failed to present sufficient evidence from which a jury could conclude the thimerosal in RhoGAM caused [plaintiff's] autism."

The decision to exclude all expert testimony came after a three-day Daubert hearing. The hearing focused on the testimony of Dr. Mark Geier, the leading proponent of the thimerosal-autism link and an expert witness in many of the vaccine cases.

The court noted that the bulk of Dr. Geier's testimony was "not based upon his own research, but instead upon a review of the relevant literature." But the literature he relied on, the court went on to conclude, "does not add up to the opinion and conclusion that Dr. Geier is offering."

Given this, Judge Beaty concluded that the plaintiffs had failed to establish under Federal Rule of Evidence 702 that Dr. Geier should be allowed to testify concerning the general question of whether exposure to thimerosal in RhoGAM could cause autism.

"Time and additional well-reasoned research may yet bring much needed light to the difficult question that this case poses for Plaintiffs and many others similarly situated, but no such answers can be reached on the record currently before the Court," Judge Beaty wrote.

"Accordingly, notwithstanding the valiant effort by Plaintiffs in this case, Defendant’s Motion for Summary Judgment must be allowed and this case must be dismissed with prejudice."

The case is Doe v. Ortho-Clinical Diagnostics Inc., Case No. 1:03CV00669 (M.D. N.C. July 6, 2006). It is available on the court's Web site at: www.ncmd.uscourts.gov/Opinions/Jul06/03cv669op.pdf.

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