Finding no medical or factual basis for an expert's opinion that drugmaker Wyeth missed signals about the danger of a diet drug, a Pennsylvania judge set aside a $1.36 million verdict for three plaintiffs and ordered a new trial on the issue of Wyeth's liability.
In a ruling that offers lessons to litigators everywhere, Philadelphia Court of Common Pleas Judge Mark I. Bernstein criticized the expert's testimony for providing no factual basis by which the jury could evaluate his conclusions. "The vast bulk of the purported basis of his opinion was conceded in cross-examination to be logically irrelevant, factually incorrect or purely of circular reasoning," Bernstein wrote in his May 10 decision in Hansen v. Wyeth.
The three plaintiffs - Lucy Hansen, Mildred Hill and Joyce Jensen - alleged that they suffered heart valve damage as a result of taking Pondimin, a component of the diet cocktail fen-phen. A jury returned verdicts in their favor on Nov. 3, 2004.
Wyeth voluntarily agreed to recall Pondimin, its brand name for fenfluramine, from the market in 1997 after the Food and Drug Administration linked it to heart valve problems.
Judge Bernstein's opinion applied Pennsylvania evidence rule 705, which requires that an expert, in giving an opinion or inference, "testify as to the facts or data on which the opinion or inference is based."
Although rule 705 has no corollary in the federal rules, The Evidence Project at Washington College of Law has proposed amending the federal rules to mirror the Pennsylvania rule.
"Rule 705 properly imposes a dual burden on the proponent of opinion evidence," Judge Bernstein wrote. "First, to present in direct examination the complete factual foundation and basis for the opinion testimony, and secondly, to demonstrate that this basis is independently supported by facts of record."
Plaintiffs presented a single pharmacology expert to establish Wyeth's negligence, Dr. Harris Busch. A professor for 38 years and a research scientist for 45 years, Dr. Busch had been a consultant to major pharmaceutical companies and three times earlier had consulted for the defense in fen-phen litigation. "Clearly Dr. Busch is qualified as an expert," Judge Bernstein concluded.
(Editor's note: IMS Expert Services had no involvement in this case.)
Qualified though the expert was, the judge found that on direct examination, he presented his opinion in conclusory form, generically referring to voluminous materials as providing the factual basis.
But on cross-examination, Judge Bernstein said, "it was systematically demonstrated that many of the scientific bases on which his opinion supposedly relied were illogical, inapplicable or employed circular reasoning."
Among the faults Judge Bernstein found in Dr. Busch's testimony:
- The plaintiffs' lawyers prescreened the material they provided him to review and failed to give him all the information he requested.
- He based his opinion on the "entire record," without ever describing the specific facts on which he based his opinion.
- He testified that Wyeth's surveillance department was not adequately staffed, but he admitted on cross-examination that he had no factual basis for saying this.
- His testimony that medical literature should have signaled fenfluremine's danger was not supported by the evidence or the literature.
- His testimony regarding adverse drug events was not supported by the evidence.
- Although he testified that he had performed an extensive literature search, he acknowledged on cross-examination that the search was limited and that studies he referred to failed to support his opinion.
Given these faults, Judge Bernstein said, the jury had no factual basis on which to evaluate the expert's testimony.
"A just trial is the application of logic to a courtroom," the judge wrote. "Where it becomes clear that the facts on which an expert opinion is based cannot logically support the conclusions offered, the trial judge as gatekeeper must exclude the testimony."
While Judge Bernstein found that Dr. Busch failed to explain to the jury the factual basis for his opinions, he concluded that, "if he does have a basis, the plaintiffs should not be prohibited from proving their case." For this reason, rather than enter judgment for Wyeth, he ordered a new trial limited to the issue of liability.