Hansen v. Wyeth Inc.
This text of 72 Pa. D. & C.4th 225 (Hansen v. Wyeth Inc.) is published on Counsel Stack Legal Research, covering Pennsylvania Court of Common Pleas, Philadelphia County primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.
Opinion
BERNSTEIN, J.,
The above captioned cases were tried together before a jury beginning on September 28,2004. Each plaintiff claimed defendant Wyeth failed to respond to a signal that Pondimin causes valvular regurgitation. Each plaintiff claimed that, as a result of this failure, defendant failed to warn their prescribing physician of this risk, resulting in injury. On November 3, 2004, the jury rendered a verdict against defendant Wyeth and for plaintiffs Mildred Hill in the amount of $395,000, Joyce Jensen in the amount of $560,000, and Lucy Hansen in the amount of $400,000. Timely post-verdict motions were filed.
For the reasons set forth below, defendants’ motions for new trial are granted as to liability only.
Effective October 1,1998, the Pennsylvania Supreme Court codified the Rules of Evidence. In that code, the Supreme Court expanded the scope of expert testimony in some respects and, in other respects, restated traditional Pennsylvania safeguards against the trial of fact deteriorating into a battle of experts. Even rules which parallel or were adopted from the Federal Rules of Evi[227]*227dence verbatim do not require that Pennsylvania courts follow federal court interpretation. For example, Pennsylvania Rule of Evidence 703 is verbatim the Federal Rule of Evidence 703 as it existed at the time of codification, yet its adoption did not transform Pennsylvania into a “Daubert” state.1 The Pennsylvania Supreme Court has continuously held that evaluation of expert testimony must be performed in accordance with the “Frye ” standard of admissibility. Other codified rules have no parallel in the Federal Rules of Evidence because they are grounded in Pennsylvania’s traditional common-law approach to expert opinion testimony. Rule 705 of the Pennsylvania Rules of Evidence has no counterpart in the Federal Rules. This rule reads:
“Disclosure of facts or data underlying expert opinion.
“The expert may testify in terms of opinion or inference and give reasons therefore; however, the expert must testify as to the facts or data on which the opinion or inference is based.”2
The comment to Rule 705 authored by the Committee on the Rules of Evidence, while not officially adopted, accurately describes the difference between longstanding Pennsylvania jurisprudence and the federal approach: “The Federal Rule generally does not require an expert witness to disclose the facts upon which an opinion is [228]*228based prior to expressing the opinion. Instead, the cross-examiner bears the burden of probing the basis of the opinion. Pennsylvania does not follow the Federal Rule. See Kozak v. Struth, 515 Pa. 554, 560, 531 A.2d 420, 423 (1987).” In Kozak v. Struth, the Pennsylvania Supreme Court was specifically asked to adopt the Federal Rule approach. The Supreme Court squarely and specifically rejected the invitation. The Supreme Court said: “requiring the proponent of an expert opinion to clarify for a jury the assumptions upon which the opinion is based avoids planting in the juror’s mind a general statement likely to remain with him in a jury room when the disputed details are lost.” The Evidence Committee’s annotation further explains: “Accordingly, Kozak requires disclosure of the facts used by the expert in forming an opinion. The disclosure can be accomplished in several ways. One way is to ask the expert to assume the truth of testimony the expert has heard or read.... Another option is to pose a hypothetical question to the expert....” The comment continues with the salutary purpose of the rule: “The salient facts relied upon as the basis of the expert opinion must be in the record so that the juiy may evaluate the opinion. See Commonwealth v. Rounds, 518 Pa. 204, 542 A.2d 997 (1988).”
Thus, although an expert may utilize material routinely relied upon in the exercise of her profession outside of the courtroom to formulate an opinion,3 and may also rely on facts or data learned outside of the courtroom to formulate an opinion,4 the case-specific factual basis upon which that opinion is based must be presented to the jury [229]*229in direct examination. As the official comment succinctly explains, the rule is needed to preclude an expert from becoming a thirteenth super-juror: “The salient facts must be in the record so the jury can factually evaluate the básis of expert opinion.”
If the material and important facts on which an expert’s opinion is based differ from the jury’s own findings of fact, then the jury can, and obviously should, reject that opinion. Thus, Rule 705 requires that the jury in direct examination be provided with testimony essential to evaluate the factual basis upon which an expert’s opinion is grounded. Rule 705 properly imposes a dual burden on the proponent of opinion evidence, 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.
In adopting Rule 705, the Supreme Court reaffirmed Pennsylvania jurisprudence of opinion evidence dating back to 19095 and repeatedly reaffirmed thereafter.6 This [230]*230tradition was profoundly articulated by the Supreme Court in Kozak v. Struth.7 In that case, the Supreme Court analyzed the differences between Pennsylvania and federal procedure. The Supreme Court recognized that the Federal Rule is based on the belief that “the proponent’s adversary can protect his client by competent cross-examination exploring facts or data underlying the [expert] opinion.” Rejecting this approach, the Supreme Court said: “[rjelying on cross-examination to illuminate the underlying assumptions may further confuse jurors already struggling to follow complex testimony. Additionally, total reliance on cross-examination permits the party propounding the expert’s evidence to introduce it generally in a conclusoiy manner without relation to the record and cast the whole burden of disqualifying it on the opponent. This is contrary to the usual practice of allocating to the proponent of evidence, as the party with the laboring oar, the duty of laying a logically understandable foundation.”8 Reliance on cross-examination also detrimentally requires the opponent to reiterate the opinion she is trying to discredit.
While most rules of evidence concern the admission of facts, Rule 705 concerns itself not with admission but disclosure. Absent a clear disclosure of the factual basis of opinion testimony, an expert’s opinion does not so much assist the jury with their determination of the facts as replace the jury’s essential fact-finding role.9 Without [231]*231a clear disclosure, the jury has no basis for determining whether the facts as understood or assumed by the expert are compatible with the facts as the jury finds them to be.
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BERNSTEIN, J.,
The above captioned cases were tried together before a jury beginning on September 28,2004. Each plaintiff claimed defendant Wyeth failed to respond to a signal that Pondimin causes valvular regurgitation. Each plaintiff claimed that, as a result of this failure, defendant failed to warn their prescribing physician of this risk, resulting in injury. On November 3, 2004, the jury rendered a verdict against defendant Wyeth and for plaintiffs Mildred Hill in the amount of $395,000, Joyce Jensen in the amount of $560,000, and Lucy Hansen in the amount of $400,000. Timely post-verdict motions were filed.
For the reasons set forth below, defendants’ motions for new trial are granted as to liability only.
Effective October 1,1998, the Pennsylvania Supreme Court codified the Rules of Evidence. In that code, the Supreme Court expanded the scope of expert testimony in some respects and, in other respects, restated traditional Pennsylvania safeguards against the trial of fact deteriorating into a battle of experts. Even rules which parallel or were adopted from the Federal Rules of Evi[227]*227dence verbatim do not require that Pennsylvania courts follow federal court interpretation. For example, Pennsylvania Rule of Evidence 703 is verbatim the Federal Rule of Evidence 703 as it existed at the time of codification, yet its adoption did not transform Pennsylvania into a “Daubert” state.1 The Pennsylvania Supreme Court has continuously held that evaluation of expert testimony must be performed in accordance with the “Frye ” standard of admissibility. Other codified rules have no parallel in the Federal Rules of Evidence because they are grounded in Pennsylvania’s traditional common-law approach to expert opinion testimony. Rule 705 of the Pennsylvania Rules of Evidence has no counterpart in the Federal Rules. This rule reads:
“Disclosure of facts or data underlying expert opinion.
“The expert may testify in terms of opinion or inference and give reasons therefore; however, the expert must testify as to the facts or data on which the opinion or inference is based.”2
The comment to Rule 705 authored by the Committee on the Rules of Evidence, while not officially adopted, accurately describes the difference between longstanding Pennsylvania jurisprudence and the federal approach: “The Federal Rule generally does not require an expert witness to disclose the facts upon which an opinion is [228]*228based prior to expressing the opinion. Instead, the cross-examiner bears the burden of probing the basis of the opinion. Pennsylvania does not follow the Federal Rule. See Kozak v. Struth, 515 Pa. 554, 560, 531 A.2d 420, 423 (1987).” In Kozak v. Struth, the Pennsylvania Supreme Court was specifically asked to adopt the Federal Rule approach. The Supreme Court squarely and specifically rejected the invitation. The Supreme Court said: “requiring the proponent of an expert opinion to clarify for a jury the assumptions upon which the opinion is based avoids planting in the juror’s mind a general statement likely to remain with him in a jury room when the disputed details are lost.” The Evidence Committee’s annotation further explains: “Accordingly, Kozak requires disclosure of the facts used by the expert in forming an opinion. The disclosure can be accomplished in several ways. One way is to ask the expert to assume the truth of testimony the expert has heard or read.... Another option is to pose a hypothetical question to the expert....” The comment continues with the salutary purpose of the rule: “The salient facts relied upon as the basis of the expert opinion must be in the record so that the juiy may evaluate the opinion. See Commonwealth v. Rounds, 518 Pa. 204, 542 A.2d 997 (1988).”
Thus, although an expert may utilize material routinely relied upon in the exercise of her profession outside of the courtroom to formulate an opinion,3 and may also rely on facts or data learned outside of the courtroom to formulate an opinion,4 the case-specific factual basis upon which that opinion is based must be presented to the jury [229]*229in direct examination. As the official comment succinctly explains, the rule is needed to preclude an expert from becoming a thirteenth super-juror: “The salient facts must be in the record so the jury can factually evaluate the básis of expert opinion.”
If the material and important facts on which an expert’s opinion is based differ from the jury’s own findings of fact, then the jury can, and obviously should, reject that opinion. Thus, Rule 705 requires that the jury in direct examination be provided with testimony essential to evaluate the factual basis upon which an expert’s opinion is grounded. Rule 705 properly imposes a dual burden on the proponent of opinion evidence, 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.
In adopting Rule 705, the Supreme Court reaffirmed Pennsylvania jurisprudence of opinion evidence dating back to 19095 and repeatedly reaffirmed thereafter.6 This [230]*230tradition was profoundly articulated by the Supreme Court in Kozak v. Struth.7 In that case, the Supreme Court analyzed the differences between Pennsylvania and federal procedure. The Supreme Court recognized that the Federal Rule is based on the belief that “the proponent’s adversary can protect his client by competent cross-examination exploring facts or data underlying the [expert] opinion.” Rejecting this approach, the Supreme Court said: “[rjelying on cross-examination to illuminate the underlying assumptions may further confuse jurors already struggling to follow complex testimony. Additionally, total reliance on cross-examination permits the party propounding the expert’s evidence to introduce it generally in a conclusoiy manner without relation to the record and cast the whole burden of disqualifying it on the opponent. This is contrary to the usual practice of allocating to the proponent of evidence, as the party with the laboring oar, the duty of laying a logically understandable foundation.”8 Reliance on cross-examination also detrimentally requires the opponent to reiterate the opinion she is trying to discredit.
While most rules of evidence concern the admission of facts, Rule 705 concerns itself not with admission but disclosure. Absent a clear disclosure of the factual basis of opinion testimony, an expert’s opinion does not so much assist the jury with their determination of the facts as replace the jury’s essential fact-finding role.9 Without [231]*231a clear disclosure, the jury has no basis for determining whether the facts as understood or assumed by the expert are compatible with the facts as the jury finds them to be. Thus, Rule 705 was adopted to preserve the exclusive fact-finding function of the jury.
While elevated in importance by codification, Rule 705 is not new, merely a new formulation of traditional concepts. Prior to codification, Pennsylvania law avoided a battle of experts by requiring the case-specific factual basis of expert opinion be both explained and independently proven. Thus, the jury could readily evaluate the basis of any opinions expressed against their own factual findings.
Once independent proof became no longer required because Rule 703 as adopted universalized a previously limited exception permitting experts to testify based on facts and data not independently proven at trial, a specifically articulated Rule 705 became essential. The fact-finding role of the jury, which could become blurred by never having the factual basis independently proven by other witnesses, could become hopelessly obscured if the case-specific factual basis for the opinion also remained hidden by the expert. Rule 705 is the solution to this problem. Rule 705 requires that the jury clearly learn the factual basis of opinion evidence from the expert herself on direct examination.
Disclosure is essential to the fact-finding function of the jury, explained the Supreme Court in Commonwealth v. Rounds, 518 Pa. 204, 209, 542 A.2d 997, 999 (1988): “If a jury disbelieves the facts upon which the opinion is based, the jury undoubtedly will disregard the expert’s opinion. Likewise, if a jury accepts the veracity of the [232]*232facts which the expert relies upon, it is more likely that the jury will accept the expert’s opinion. At the heart of any analysis is the veracity of the facts upon which the conclusion is based. Without the facts, a jury cannot make any determination as to validity of the expert’s opinion. To hold otherwise would result in a total and complete usurpation of the jury’s function in our system of justice.”
In Rounds, the Supreme Court reiterated long-standing precepts:
“If the jury accepts the foundation of fact, it then decides what credence it will impart to the doctor’s reasoning and applied medical knowledge built upon that foundation. If the jury detects fissures of undependability in that foundation, then the expert opinion necessarily falls of its own weight.” Kelly v. Martino, 375 Pa. 244, 246, 99 A.2d 901, 902 (1953).
Standard jury instructions explain to the jury that expert opinion evidence is valid only when the jury accepts the facts upon which it is based.10 If opinion evidence assumes a fact that the trier of fact finds not to be true, the jury should disregard any such opinion. Likewise, if any opinion assumes or is based upon the con- ’ elusion that a fact is not true, and the jury finds that fact [233]*233to be true, the opinion must also be disregarded. Any other principle permits the professional expert to usurp the fact-finding function. Unless the factual basis can be independently evaluated by the jury, the jury function is necessarily reduced to evaluating the credibility of the expert.11
Without an understanding of the case-specific facts on which the expert relied, the jury cannot make any determination as to the validity of the expert’s opinion. To allow an expert to obfuscate the factual basis results in the usurpation of the jury’s function and necessarily reduces the trial to a battle of experts. To force the opposing party to explicate an adverse expert’s factual basis is unacceptable because it unfairly shifts the burden. Particularly when pretrial disclosure is limited,12 expert depositions are generally prohibited,13 and the cross-examiner runs the risk of the expert presenting otherwise “inadmissible” information14 to the jury in an answer.
An expert, once properly qualified, may testify as to opinions or inferences the expert has drawn and must give reasons for that opinion. The facts upon which the testimony is based must not only be articulated in direct examination, but must also be in the record. As explained by the Supreme Court in Commonwealth v. Rounds:15 “expert opinion testimony is proper if the facts upon [234]*234which it is based are of record.” Subsequent to adoption of the code, in Viener v. Jacobs, 834 A.2d 546 (Pa. Super. 2003), the Superior Court reaffirmed this proposition in holding that a hypothetical question could not ask an expert to assume facts not in evidence. The disclosed basis of opinion testimony presented on direct testimony must still be grounded in and limited to facts “of record” and “there must be some factual predicate for the opinion identified on the record . . . .” Starr v. Veneziano, 560 Pa. 650, 663 n.10, 747 A.2d 867, 874-75 n.10 (2000). In Viener, 834 A.2d at 558, the Superior Court said: “It is well settled that expert testimony is incompetent if it lacks an adequate basis in fact. The expert is allowed only to assume the truth of testimony already in evidence. Hussey v. May Dep’t Stores Inc., 238 Pa. Super. 431,357 A.2d 635, 637 (1976). While an expert’s opinion need not be based on an absolute certainty, an opinion based on mere possibilities is not competent evidence. Niggel v. Sears, Roebuck and Co., 219 Pa. Super. 353, 281 A.2d 718 (1971). This means that expert testimony cannot be based solely upon conjecture or surmise. An expert must do more than guess. His or her assumptions must be based upon such facts as the juiy would be warranted in finding from the evidence. Houston v. Canon Bowl Inc., 443 Pa. 383, 278 A.2d 908 (1971).”
While Pa.R.E. 705 requires that the facts or data underlying an expert opinion be disclosed during the expert’s direct testimony, it does not specify the method by which such disclosure should take place. Where the expert witness reached an opinion or drew an inference based in whole or in part upon facts within the expert’s personal knowledge, Pa.R.E. 705 requires that the wit[235]*235ness testify to those facts on direct examination. Where the expert has obtained facts from a review of the litigation record, such as deposition, documents, or exhibits, the expert may simply identify the case-specific facts of record on which the opinion is based. He may not, however, obscure his factual predicate by merely identifying volumes of depositions, report, literature and records from which he has drawn the facts.
The Rule 705 requirement of presenting the “facts and data” which form the basis of the opinion may not be satisfied by a mere formalistic recitation of the material reviewed or considered. That pro forma routine absolutely obscures what Rule 705 intends to clarify and is tantamount to the clearly impermissible tactic of offering an opinion based on “all the evidence.”16
If Rule 705 is complied with, even opinion based upon equivocal data may be admissible after the factual basis has been fully explained. In Simmons v. Mullen, 231 Pa. Super. 199, 211, 331 A.2d 892, 899 (1974), the expert witness carefully explained “the testing procedure, the tests used, and how the test results were interpreted.” Because the jury had ample opportunity to analyze his methodology to asses the opinion’s value, the Superior Court considered the equivocal nature of the underlying data as only one factor in evaluating the properly admitted opinion.
[236]*236The equivalent of Pennsylvania’s Rule 705 has been proposed as an improvement to the Federal Evidence Code by Professor Paul Rice of the American University Washington College of Law and “The Evidence Project.” Speaking to the Federal Rules Committee, Dr. Rice said: “the common law requires that evidence in the record support the factual basis before a litigant can inquire as to an expert’s opinion on the subject. This requirement helps to maintain the role of the expert as ad-visor to the jury and the role of the jury as the independent finder of fact. Only if the factual basis finds support in the trial record can the jury make an independent assessment of the facts and of the expert’s interpretation of the facts. If the facts of record do not support the expert’s opinion and the jury accepts the opinion as true, the jury has deferred to the expert and has not made an independent decision on the issues.”
“Revised Rule 705 requires disclosure of the case-specific data an expert uses in forming opinions offered at trial. [The proposed rule seeks] to restore the role of jury as the independent finder of facts and the role of the expert as advisor to the jury.” “As stated earlier, the revised rules accomplish this goal by providing the jury with all the information necessary to make an informed decision about the case and by precluding expert witnesses from offering opinions based on facts the jury either has not heard or cannot accept for their truth.” The fallacious suggestion some make that the jury should be instructed that it is not being offered for the truth but simply as a basis of opinion does not solve this problem. Unless accepted for the truth, the jury has no ability whatsoever to evaluate the opinion. Certainly a jury cannot be asked to accept an expert’s opinion based upon [237]*237erroneous information. Likewise a jury cannot be expected to accept the truth of facts presented by an expert simply because it is someone who is cloaked with the imprimatur of the court as having a “reasonable pretension to expertise.”17
Although adopted in 1998 and presenting the codified formulation of traditional Pennsylvania law, Rule 705 has been cited only five times in appellate decisions. The essential principle of the rule was enforced in one other very significant Supreme Court decision. These cases establish that Rule 705 demands a gatekeeper judiciary protect the role of the jury as fact-finder.
In McIntyre v. Philadelphia Housing Authority, 816 A.2d 1204 (Pa. Commw. 2003), the Commonwealth Court found that a board certified neurologist had complied with Rule of Evidence 705 when he detailed the facts derived from a neurological examination he performed, a review of plaintiff’s medical records, survey of a neurological database, a review of plaintiff’s psychological assessments and a medical literature search on the effects of lead poisoning.
In Starr v. Veneziano, supra at 663 n.10, 747 A.2d at 874-75 n.10, the Supreme Court reaffirmed the factual predicate requirement of Rule 705: “There must be some factual predicate for the opinion identified on the record. See generally Pa.R.E. 705.”
In Luzerne County Flood Protection Authority v. Reilly, 825 A.2d 779 (Pa. Commw. 2003), the Commonwealth Court compared Rule 705 of the Eminent Domain Code [238]*238with Pennsylvania Rule of Evidence 705. Oddly, Rule number 705 in each codification contains similar but conflicting precepts. In Luzerne County Flood Protection Authority, the plaintiff appealed a jury determination of the value of seized property. Plaintiff’s expert real estate appraiser was permitted to describe his opinion on value and, in accord with Rule 705, offered the facts and data supporting this opinion. However, the trial court precluded the expert from repeating attorney hearsay opinions he had solicited concerning the marketability of title.
Section 705 of the Eminent Domain Code is merely permissive.18 It reads: “A qualification valuation expert may, on direct or cross-examination, state any and all facts and data which he considered in arriving at his opinion, whether or not he has personal knowledge there of. . ..” The parallel Pennsylvania Rule of Evidence, Rule 705, is mandatory: “However, the expert must testify as to the facts on which the opinion or inference is based.” Despite the difference, the Commonwealth Court found that: “Both rules inherently adopt the requirement that expert testimony must be grounded in judicially relevant and competent testimony.” The Commonwealth Court adopted the Superior Court’s explanation in Primavera v. Celotex Corp., 415 Pa. Super. 41, 608 A.2d 515 (1992):
“The expert is assumed to have the mastery to evaluate the trustworthiness of the data upon which he or she relies, both because the expert has demonstrated his expert qualifications and because the expert regularly relies on and uses similar data in the practice of his or her profession. The kind of data contemplated by the rule is [239]*239... the kind of data used daily by experts in making judgments, reaching diagnoses and taking actions.
“The fact that experts reasonably and regularly rely on this type of information merely to practice their profession lends strong indicia of reliability to source material when it is presented through a qualified expert’s eyes.”
“The above analysis depends, of course, on the expert actually acting as an expert and not as a mere conduit or transmitter of the content of an extrajudicial source. An expert should not be permitted simply to repeat another’s opinion or data without bringing to bear on it his own expertise and judgment. Obviously, in such a situation the non-testifying expert is not on the witness stand and truly is unavailable for cross-examination.”19 Luzerne County Flood Protection Authority v. Reilly, 825 A.2d at 782.
Affirming preclusion of the hearsay opinion of non-testifying lawyers, the Commonwealth Court held that exclusion was proper because plaintiff’s expert “was not qualified to opine on legal matters, and thus was not able to bring to bear his own expertise to evaluate the attorney’s opinions he sought to relate.” Thus, unevaluated hearsay or other case-specific factual material cannot be considered evidence “of record” to sustain an opinion.
[240]*240In Wenger v. West Pennsboro Township, 868 A.2d 638, 643 (Pa. Commw. 2005), the Commonwealth Court reaffirmed that an expert must present the factual basis of any opinion in direct examination. The Court relied upon and quoted the Supreme Court decision in Starr v. Veneziano: “[w]e need not resolve here the precise character of the evaluation which must be undertaken by a plaintiff’s expert, as the record in the present case contains no evidence that Starr’s expert undertook any such appraisal. We merely hold that there must be some factual predicate for the opinion identified on the record, see generally, Pa. R.E. 705 ....”
Finally, the Supreme Court decision Commonwealth v. Smith, 861 A.2d 892 (Pa. 2004), establishes that counsel may not bootstrap factual material into a case through opinion evidence. Expert opinion itself cannot establish any case-specific fact. While not referencing Rule 705, the Supreme Court, in Commonwealth v. Smith, held that an expert’s factual basis identified in testimony, if not independently proven “of record,” does not establish the fact and accordingly may not be argued to the jury. Following a homicide conviction, the Commonwealth called a psychiatric expert to testify at the death sentence phase of trial. The expert testified that aggravating factors existed which justified imposition of the death penalty. One aggravating factor, Dr. O’Brien explained to the jury, was the fact that the defendant had a prior conviction for assault upon a fellow prisoner. No independent proof of the conviction was offered. In closing argument, the prosecutor argued that the defendant’s prior conviction was an aggravating factor which the jury should consider. The Supreme Court reversed. The Supreme Court noted:
[241]*241“The Commonwealth accurately recounts Dr. O’Brien’s testimony. Yet that does not end our inquiry. Next we must determine whether this testimony, standing alone, serves to establish that appellant was indeed convicted of assaulting a fellow prisoner, thus rendering the prosecutor’s remark as being properly based on a fact of record.
“We conclude it does not. There is no indication that Dr. O’Brien was present at or somehow participated in, the alleged adjudication of appellant on the charge of assaulting a prisoner.”20
Significantly, the Supreme Court said: “Furthermore, Dr. O’Brien’s status as an expert does not, in and of itself, render his unsupported reference to appellant’s alleged conviction of assaulting a fellow prisoner into a fact of record. Thus, we find that the prosecutor’s reference to appellant’s alleged conviction for assaulting another prisoner improperly referenced a fact not of record.” Clearly, opinion testimony cannot bootstrap itself into becoming “facts of record” by incorporating case-specific information not independently demonstrated.
Thus Pennsylvania common-law tradition, the plain reading of Rule 705 and appellate decisions make clear that the explication of the factual predicate for opinion evidence is not the obligation of the cross-examiner. The requirement of Rule 705 to articulate the factual basis “of record” on which opinion evidence is based is on the proponent who must clearly provide the factual basis of record in direct examination so that the jury may factually evaluate the testimony.
[242]*242Juries are impaneled to determine the true facts. Only if the facts on which opinion testimony is based is presented can the opinion be evaluated. Where facts are hidden because the factual basis of opinion testimony is not revealed, the jury does not have the tools required to do their job. Rule 705 precludes a summary expert opinion trial by eliminating the possibility that the factual basis will be concealed from jury evaluation.
The requirement of Rule 705 to present “facts and data” which form the basis of an opinion presented to the jury for evaluation may not be satisfied by reciting the material reviewed and considered. A ritualistic identification of voluminous depositions, libraries of medical literature, and thousands of documents, while intended to impress the jury by quantity, in fact absolutely obscures what Rule 705 is intended to clarify. This presentation of quantity is the same as offering an opinion based on all the evidence prohibited precisely because it obscures the true basis of opinion.
The clear language of Rule 705 precludes the bare reference to litigation materials. “The expert must testify as to the fact on which the opinion is based.” While an expert certainly may rely on deposition testimony, he must testify in direct examination to the facts contained in the deposition on which the expert relied, not simply point to 12 inches of mostly irrelevant pages of testimony prominently displayed to the jury. While an expert may reasonably rely on a body of medical literature, he must testify in direct testimony to the facts or data which the expert has digested and formulated into his individual personal expert opinion. While an expert may rely on case-specific adverse incident reports or a defendant’s internal documents, he must testify in direct [243]*243examination to the information contained in the 40 or 50 reports piled high for visual display which is the factual basis of the material. The expert must also explain how the factual basis relates to his opinion.
A just trial is the application of logic to a courtroom. 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.
Thus, Pennsylvania law protects the integrity of the fact-finding process and the function of the jury by requiring the expert to explain the factual basis of any opinion, and that factual basis must be independently of record. Only if the factual basis is presented for evaluation and that factual basis is logically connected to the opinion can the application of expertise in the language of Rule 702 “assist the trier of fact to determine a fact in issue.” The court is the “gatekeeper” charged with enforcing Rule 705 so that the jury is given a sufficient factual basis to evaluate the expert opinion offer. The court must analyze the basis and logic of the testimony to insure that the highly paid expert having reasonable pretension is indeed presenting an opinion which will assist, and not merely something which is dressed up to look like science.
By requiring the expert in direct examination to present the “facts or data,” Rule 705 prohibits the expert from hiding the factual failings and discrepancies in the opinion. Application of this rule, however, requires intense judicial scrutiny. The practicing bar, imbued with the federal approach, will inadvertently or intentionally ignore the substantive difference in Pennsylvania law.
[244]*244In summary, Rule 705 contains three distinct requirements: (1) The factual basis must be explained by the expert in direct examination, (2) the factual basis must be independently “of record,” and (3) the expert cannot bootstrap an opinion by “adding” facts to the record assumptions or conclusions about which the expert has no independent knowledge.
Within this framework, we may examine the testimony of Dr. Harris Busch, the only expert presented by plaintiffs to opine that defendant Wyeth was negligent. Dr. Busch’s conclusory statement, vigorously asserted throughout his testimony, was that defendant Wyeth missed a “signal” that Fen-Phen caused valvular heart disease.
Without question, whether or not a “signal” should have been recognized by defendant Wyeth, and should have resulted in warning the medical community that Pondimin was associated with a risk of valvular heart disease, is not within the realm of ordinary experience and is the central issue in the liability phase of Fen-Phen litigation. Expert testimony is needed for a jury to determine whether the medical and scientific evidence which Wyeth knew about, or in the exercise of due diligence as a prudent pharmaceutical company should have known about, “signaled” a problem with the drug. At this trial, only Dr. Busch testified that any such “signal” existed.
Expert testimony is the personal professional opinion of a properly qualified individual, applying specialized knowledge to the evidence presented at trial, or to other “of record” facts on a subject beyond the common understanding of a juiy. “Because of this special skill or knowledge, an expert is permitted to give explanations [245]*245and draw inferences not within the range of ordinary knowledge, intelligence, and experience, and to give an opinion and state reasons for that opinion.”21 Accordingly, the first issue any court must resolve when confronted with proposed expert testimony is whether the expert meets the minimal requirements to provide expert opinion testimony. Except as codified in the MCare Act, 40 P.S. §1303.101 et seq., these requirements in Pennsylvania and throughout the nation, are remarkably lax. To testify as an expert, a witness must only present a “reasonable pretension to expertise” in the specific area under investigation.22
Dr. Busch has reasonable pretension to expertise in the area of what a reasonably prudent pharmaceutical company should consider as a signal to warn the medical community about serious potential adverse side effects of a medication. Dr. Busch has been a professor for 3 8 and a research scientist for 45 years. He was a professor of pharmacology and chairman of the Pharmacology Department at Baylor College of Medicine in the 1960s. He has been a professor at Yale, the University of Illinois, and at Baylor. In these teaching capacities he has taught medical students working on doctorate degrees in pharmacology. He has consulted for three major pharmaceutical companies, Eli Lily and Company, Bristol Myers, and SmithKline. As a consultant for SmithKline, he served as chairman of their “Scientific Advisory Committee,” reporting directly to the president of the com[246]*246pany. As a consultant, he advised on drug safety, drug labeling and package inserts. Dr. Busch has been asked on three occasions to consult in Fen-Phen litigation by the defense.23
Dr. Busch has served as an editor and peer reviewer for medical journals. He has reviewed grants from the National Science Foundation, the National Cancer Institute, the National Institutes of Health and the American Cancer Society. He considers himself an expert in pharmacology, toxicology, biochemistry and internal medicine.
Clearly, specialized knowledge beyond that possessed by a layperson is needed by the trier of fact to understand the evidence and determine the facts in issue in this case. Clearly Dr. Busch is qualified as an expert by his knowledge, skill, experience, training and education. There is no question that Dr. Busch meets the minimal requirements to render an opinion as to the appropriate response of a prudent pharmaceutical company reviewing medical literature and evaluating adverse drug event reports.
Dr. Busch, in direct examination, presented his opinion in conclusory form, generically referring to voluminous materials as the factual basis for his opinion. He offered a number of purportedly scientific bases for his opinion. On cross-examination, however, it was systematically demonstrated that many of the scientific bases on which his opinion supposedly relied were illogical, inapplicable, or employed circular reasoning. It was also demonstrated that his employer, the plaintiffs, had failed to provide him with information he reasonably required [247]*247and had specifically asked for. In a different context but applicable herein, the Superior Court eloquently said: “The question is: [I]s the science good enough to serve as the basis for the jury’s findings of fact or is it dressed up to look good enough, but basically so untrustworthy that no finding of fact can properly be based on it. If the latter is true, the integrity of the trial process would be tainted were the jury to consider it.”24
I. Dr. Busch received only limited and prescreened material. He did not get information he reasonably required and had requested.
All of the material Dr. Busch reviewed in connection with his testimony had been provided to him and screened by plaintiff’s lawyers.25 He requested, but did not receive from plaintiff’s lawyers, specific documentation which was available through discovery:26
“ Q. OK. The documents dealing with what the company did or didn’t do, you received from the plaintiff’s lawyers, correct?
“ A. That is correct.
“Q. You didn’t do your own investigation or your own study or your own research of the universe of documents from the company, correct?
“A. I have asked many times from attorneys for the company for documents that would support or alter a position but I never received one.
[248]*248“Q. Never received any from the company. Did you ask the people who have paid you three million dollars to testily in these cases for those documents?
“A. Of course.
“Q. Did they give them to you?
“A. Absolutely.
“Q. Did they give you the Servier documents when you asked for them?
“A. I did have very few Servier documents.
“Q. Did you ask for the Servier documents from plaintiff’s counsel?
“A. I have.
“Q. And they didn’t give them to you, correct?
“A. I have received very few Servier documents.”
Dr. Busch only reviewed a very small number of FDA documents provided to him by plaintiff’s counsel.27 He reviewed the portions of the MD A new drug application provided to him by plaintiff’s counsel but found no report of valvular heart disease in any body in the clinical studies.28
II. Dr. Busch’s opinion was improperly based upon “entire record.”
In direct examination, Dr. Busch generally referred to, but did not identify, 20 depositions he thought were relevant to this case. He testified he had read these depositions over thousands of hours. He reviewed internal documents and adverse drug events reports selected and provided by plaintiff’s counsel. He reviewed only attor[249]*249ney summaries of the plaintiff’s medical records. He did a complete medical literature search. These factual bases were only presented in summary form to the jury, no specific facts upon which Dr. Busch relied was ever presented to jury evaluation.
III. Without any factual basis, Dr. Busch testified in his opinion that the Wyeth surveillance department was inadequate.
Dr. Busch opined that the surveillance department of Wyeth was neither adequately staffed, trained or qualified. He testified that the defendant had no cardiologist on staff.29
Although, on direct examination, Dr. Busch generally testified that the entire surveillance department was not adequately staffed, adequately trained or qualified to their tasks, on cross-examination, he admitted he had no factual basis for this conclusion beyond the circular logic that they were unqualified because they missed the “signal” which only Dr. Busch could discern. Dr. Busch was cross-examined about “some of the opinions you have about the people who worked at Wyeth and whether they were competent and trained to do their job.” Initially he was asked about Enin Ballard.
“Q. In what way was he unqualified, to the extent you think he was unqualified?
“A. He didn’t understand the problems that were ongoing.
“Q. In terms of his training and qualifications, doctor, in what way was Enin Ballard unqualified to do his job at Wyeth Laboratories?
[250]*250“A. I can’t answer the question without a list of his qualifications.”30
The same questions were asked concerning Axle Solan:
“Q. Was he unqualified?
“A. I don’t have his qualifications here. If you have them, IT1 be happy to review them.
“Q. You don’t know one way or the other whether he was unqualified, do you?
“A. Not off the top of my head.”31
He was questioned about Mark Dietch, identified as the vice president in charge of medical affairs and the senior medical officer in the company. Dr. Busch testified that he thought he was unqualified.
“Q. In what way?
“A. He didn’t understand the problems. And he didn’t understand what to do about it. All he was concerned about was profit.”32
Dr. Busch was asked whether Amy Myers was unqualified. The witness testified: “I think so.”
“Q. Is she a pharmacist?
“A. She may be, I’m not sure.
“Q. Was she unqualified to do her job just because she wasn’t a cardiologist, is that your opinion?
“A. No.
“Q. Was she not trained to do her job, doctor?
“A. She wasn’t trained properly, no.
[251]*251“Q. What training did she have?
“A. Don’t know. She didn’t recognize the signals.”33
Dr. Busch was asked about Fred Wilson, who was identified as a pediatrician.
“Q. What was his job?
“A. He was also in safety surveillance.
“Q. Was he ever the medical monitor for Pondimin?
“A. Part-time.
“Q. Was he ever the full-time medical monitor of Pondimin?
“A. Don’t know.
“Q. Unqualified?
“A. He didn’t recognize the signals.
“Q. Was Dr. Wilson not adequately trained for his job?
“A. In my opinion, he was not.
“Q. What was the basis for that opinion?
“A. He did not recognize the signals.”34
Dr. Busch was asked about Dr. Phillip Devain, whose deposition he had read, but he did not recall anything about Dr. Phillip Devain, a cardiologist in the Medical Affairs Department at Wyeth.
Dr. Busch was asked about Roberta Michaelis, who was involved in safety and surveillance personnel.
“Q. Was she unqualified to do her job?
“A. Don’t know.”35
[252]*252This testimony was elaborated:
“Q. Is it your opinion, doctor, that Roberta Michaelis was not up to snuff?
“Q. Not your opinion?
“A. She wasn’t trained to appreciate the problems of valvular heart disease.
“Q. What training did she have?
“Q. What degrees did she have?
“Q. Did she have a medical degree?
“Q. Pharmacy degree?
“A. I don’t know what degrees she had, sir. And repeating the question won’t help my memory.”36
Dr. Busch was asked about Dr. Kelly Davis, an M.D.
“Q. Was she qualified?
“A. Don’t know.”37
He was asked about Ginger Constantine, a physician involved in clinical trials.
“Q. Do you think she was incompetent?
“Q. Qualified to do her job?
“Q. Adequately trained to do her job?
[253]*253“A. Don’t know.”
Dr. Busch was asked about Paul Menacosi, whose deposition he had read.
“Q. Who is he?
“Q. What did he do at Wyeth?
“Q. Was he competent to do his job?
“A. Can’t say.
“Q. Was he the medical monitor for Pondimin?
“A. One of.
“Q. What kind of degree did he have?
“Q. What kind of training?
“A. Don’t know.”38
Dr. Busch was asked about Jess Amgem, whose deposition he had read. Dr. Busch acknowledged that he did not know Mr. Amgem’s training.
“Q. Don’t know his qualifications?
“A. Correct.
“Q. Don’t know if he was competent to do his job, do you?
“A. Don’t know.”
No basis for Dr. Busch’s opinion that the surveillance of the department of defendant Wyeth had been neither adequately staffed nor adequately trained nor adequately qualified was in any way further explained on redirect examination. The only basis ever presented for this opin[254]*254ion was the voluminous unspecified materials that Dr. Busch claims to have read, and his circular reasoning that, because the defendant corporation missed a signal, the surveillance department must necessarily have been inadequately staffed, inadequately trained and otherwise unqualified.
An expert witness must provide a basis grounded in logic and in case-specific factual knowledge for an opinion to assist the jury. The opinion of Dr. Busch as to the qualifications of the surveillance department had no basis in fact and cannot stand as the basis of a verdict. Since we cannot determine whether this opinion was the basis for the liability verdict, without anything more, a new trial must be granted.
IV. Serotonin, and other medical literature.
On direct examination, Dr. Busch presented conclusory testimony that the medical literature contained descriptions of valvular heart disease in connection with serotonin, methysurgide ergotamine and carcinoid syndrome. Dr. Busch testified, without explanation, that the literature demonstrating that serotonin could cause valvular heart disease should have put the defendant on notice of Fen-Phen’s propensities.
“Q. In your opinion, should this literature have put Wyeth on notice that serotonin in drugs could cause valvular heart disease?
“A. Absolutely.”39
In cross-examination, he acknowledged that everyone has serotonin in their body and purported to ground his [255]*255opinion in part on the inadequacy of Wyeth’s understanding of the medical literature of carcinoid syndrome.40
“Q. And the carcinoid syndrome that you talked about as something that should have given Wyeth notice, actually caused a large increase in serotonin levels?
“A. In general, that’s correct.
“Q. But to the extent that carcinoid syndrome literature was out there, prior to 1997, all it would tell Wyeth is, if your drug is causing a large increase in circulating serotonin, there might be this possibility of valvular heart disease, right?
“A. I think so.”
He admitted that there was no indication the drugs which cause small increase in circulating serotonin cause heart valve disease.
“Q. Prior to 1997, doctor — let me ask it this way: As of today, doctor, is there any indication that drugs, like Prozac, which cause that small increase in serotonin, cause heart valve disease?
“A. Not to my knowledge.”41
Dr. Busch also acknowledged that, while Wyeth was marketing fenfluramine, there was nothing in the literature which demonstrated that a small increase in circulating serotonin posed any risk of valvular heart disease.42 He was specifically asked:43
“Q. So if Wyeth was looking at those drugs to get a sense of what effects fenfluramine might have, it would [256]*256say a small amount, a small increase in the circulating levels doesn’t cause valvular heart disease, correct?
“A. I think that is a reasonable presumption. Yes.”
Dr. Busch also acknowledged that fenfluramine did not cause any major effect on circulating serotonin and that the medical literature confirmed that fenfluramine drugs caused very little change in serotonin levels.44
“Q. Let’s talk about fenfluramine itself. I am correct, doctor, that the vast bulk of scientific literature which looks at whether fenfluramine causes increases in circulating serotonin levels shows that it decreases the level of circulating serotonin?
“A. Well, I would say — there are only a few papers and no paper to my knowledge showed a significant increase and some may have shown a small decrease, but it didn’t produce any major effect.”
Dr. Busch acknowledged the illogic of saying that car-cinoid syndrome literature was misunderstood by Wyeth because he admitted this was relevant only if Pondimin caused large increases in circulating serotonin, which it does not.
Accordingly, Dr. Busch’s generalized statement in direct examination that the literature on serotonin levels should have signaled that fenfluramine might have a causative effect of valvular heart disease is entirely belied by his own testimony on cross-examination. By his own admission, his conclusion is not supported by either record evidence or medical literature. It is opinion dressed up to look erudite.
[257]*257Along the same serotonin line of reasoning, Dr. Busch testified to a theory of biological mechanism by which Pondimin could cause heart valve disease. He testified that fenfluramine could be converted to norfenfluramine which would then bind to serotonin receptors. He acknowledged that he had done no personal research to test this theory but claims to have read articles that described it. He admitted, however, that this literature could not have been known to Wyeth at any relevant time because every one of the articles had been published long after the defendant had ceased selling Fen-Phen.45
“Q. So those articles couldn’t possibly have been noticed to Wyeth while Wyeth was selling Pondimin. Correct, doctor?
“A. Correct.”
Obviously this theory could not have been considered by Wyeth at any relevant time.
Dr. Busch testified that two drugs used for migraine headaches, ergotamine and methysurgide, which were chemically similar to serotonin, caused valvular heart disease. On cross-examination, he acknowledged that they are not chemically similar to Pondimin. He admitted that there were very significant differences between ergotamine and methysurgide and fenfluramine.46
“Q. They are not similar in their pharmacological action to fenfluramine, correct?
“A. True.
“Q. They’re not used for the same purpose.
[258]*258“Q. They have an overall side effect profile which is totally different. Correct?
“A. True.”
No basis whatsoever other than Dr. Busch’s qualifications as having reasonable pretensions to expertise were presented to the jury as the basis for any opinion that the literature concerning ergotamine or methysurgide should have put Wyeth on notice of any risks associated with fenfluramine.
V. Adverse drug events (ADEs).
The only factual basis identified in direct examination, albeit generally, were adverse drug event reports received by the defendant which were “reports of patients ingesting fenfluramine and developing valvular heart disease. . . .”47 However, the specific questions asked on direct examination did not clarify, but rather obliterated, any understanding of a factual basis for the expert’s opinion. The questions directed the expert to all adverse event reports which contained any notation of fenfluramine and of valvular heart disease with or without regard to causation. He was asked:
“Q. Now, did you also review adverse event reports specifically with regard to valvular heart disease and fenfluramine in 1993 and 1994?
“A. Yes, sir.
“Q. Did you see any evidence in those adverse event reports that you have reviewed of patients taking fen-fluramine and having valvular heart disease in 1993 and 1994?
[259]*259“A. Yes, sir, there are.”48
He was never asked on direct examination whether any adverse drug events report actually demonstrated valvular heart disease caused by fenfluramine. Instead, after testifying that there were adverse incident reports containing the two words, Dr. Busch provided the conclu-sory opinion49 that these adverse event reports “with regard to valvular heart disease and fenflurmine” indicated a signal.50 Dr. Busch was then asked to review the summaries of these ADEs contained on “line listings” and was shown plaintiff’s exhibit 52.
Rather than respond to plaintiffs’ questions as to whether exhibit 52 contained valvular heart disease reports on fenfluramine, Dr. Busch asked plaintiffs’ counsel to lead him through the exhibit. The court interjected the question of whether or not he knew whether the lines on exhibit 52 contained valvular heart disease reports on fenfluramine. The witness acknowledged that he did not.51 Thereafter, without objection, plaintiff’s counsel led Dr. Busch through the exhibit, testimony which consisted of nothing beyond the expert reading line entries displayed by counsel. This procedure was repeated with exhibit 54, another “line listing sheet.” This meaningless recitation and enumeration of reports containing designated words continued until the witness himself acknowledged that the lines containing both fenfluramine usage and a notation of valvular heart disease on exhibit [260]*26054 were “in part there a repeat”52 of the same adverse drug event reports presented to the jury line by line by counsel in exhibit 52.
In redirect examination, numerous ADE exhibits were moved into evidence and Dr. Busch was handed two notebooks entitled “ADE binder 1” and “ADE binder 2,” which were displayed before the jury on the witness stand. He testified that he reviewed the adverse drug events contained in those binders and they constituted the basis of his scientific expert opinion.53
“Q. Did you mean that every other document in that book formed the basis of your opinion?
“A. Yes.”
All the ADEs contained in those binders were accepted into evidence on that basis. However, his further testimony concerning the basis of his opinion was as follows: 54
“Q. Who assembled those notebooks?
“A. Oh, I don’t know.
“Q. It wasn’t you?
“A. Not sure.
“Q. Who selected the ADEs to go into them?
“A. I don’t know.
“Q. How many are there? How many are there? How many adverse drug events reports are there in the notebooks?
“A. I would say 20 to 40.
[261]*261“Q. And those are the ones you’re relying on for your opinions here?
“A. In part, sure.
“Q. And how many of those came from foreign reporters?
“Q. How many came from Servier?
“A. A number, but I don’t know.
“Q. How many were U.S. reports of people who use Pondimin in this country?
“Q. How many had valvular regurgitation noted only as an incidental lab report rather than as the adverse event?
“Q. How many had valvular regurgitation actually identified as the reported adverse event?
“Q. How many of them involved renal failure leading to valvular heart disease?
“A. I don’t know that any had renal failures leading to valvular heart disease.
“Q. How many had renal failure?
“Q. How many had renal failure and some degree of valvular regurgitation?
Of critical significance is his testimony that, before rendering his purportedly scientific professional opin[262]*262ion, he was unconcerned whether valvular regurgitation was noted in the ADE as only an incidental finding. Neither had he determined how many ADEs on which he relied had identified valvular regurgitation as the reported adverse event.55 Indeed, he merely concluded that, if reported, there was an association.
Dr. Busch was cross-examined about his factual analysis of the adverse drug events reports.
“Q. Can you tell the jury ... how many adverse drug event reports Wyeth got on users of Pondimin where a doctor said I gave Pondimin to somebody and one of things that developed was valvular regurgitation?
“A. I can’t give you a precise number but there were multiple reports....
“Q. On what do you base that answer, doctor?
“A. On the documents that I have from adverse reaction reports.”56
While facially reasonable and facially adequate, the function of an expert witness is to apply specialized knowledge to the analysis of these documents. Any juror can read a form to determine whether it contains the word fenfluramine and the word valvular heart disease.57 The function of an expert witness is to apply expertise [263]*263and, from the language and explanations provided by the ADE forms, to draw medically and scientifically valid conclusions. The medical and scientific conclusions presented in direct examination by Dr. Busch, purportedly from an analysis of this material, was that the adverse drug event reports received by the defendant should have demonstrated a signal that a causative relation existed. However, not one individual adverse event report was explained to the jury in direct examination and, as demonstrated in cross-examination, not one specific example could be used by Dr. Busch to provide an explanation.58
A factual basis was further lacking. Dr. Busch was asked about reports of U.S. patients with valvular heart disease through June 5, 1996.59
“Q. I want to ask you, focusing on this computer printout that was testified to yesterday by you, I want to ask you, how many reports do you see on this database printout, U.S. patients with valvular heart disease through June 5,1996?
“A. Yes, I see vascular disorder and I see two cases above that of valvular heart disorder.”
Having identified only two reports, the witness was unable to testify whether or not he had ever actually reviewed the adverse event report identified as valvular disorder. “I may well have, but I have not reviewed it recently.”
[264]*264Dr. Busch was extensively questioned about the analysis he had performed and his knowledge of the ADEs.60
“Q. How many people using Pondimin in the United States gave rise to a report of valvular heart regurgitation as an adverse event?
“A. I don’t have it separated by the United States. I have the total. And I have dexfenfluramine and Pondimin. But I don’t have them separated outside but dexfen-fluramine is Pondimin in terms of its activity, so it’s about the same.
“Q. And you can’t tell us, one way or the other, whether there was one from the United States or 10?
“A. Presumably, if it came from AHP, which is American Home Products, the predecessor of Wyeth, there are many, many reports. And I would have to say perhaps 20, many, 30, 40 until 1995, perhaps 50 or 60 reports. And they’re listed in this documents.
“Q. And what document is that, doctor?
“A. It’s called summary of reports of left side valvular heart disease prior to 12-31-95.
“Q. Have you looked at those reports, doctor?
“A. I’ve been through them, yes. I don’t have them here but I’ve been through them.
“Q. You’ve actually reviewed the adverse drug event reports?
“A. I have.
“Q. It’s your testimony to this jury that there were dozens from the United States, correct?
[265]*265“A. No. I said I can’t differentiate, I don’t know they’re from the United States or not. There are many, many reports listed here.”
Dr. Busch testified he had approximately 100 reports from foreign users of fenfluramine or dexfenfluramine. Despite testifying about hundreds from outside the United States and “perhaps 20, maybe 30, 40, perhaps 50 or 60 reports” from AHP, the predecessor of Wyeth, Dr. Busch was incapable or unwilling to testify to anything specific about any report.
“Q. And of those foreign reports, how many of those people had valvular heart disease according to the ADE forms before they ever used the drugs?
“Q. Wouldn’t it be important, if you are going to opine about a signal, to know how may of those adverse event reports actually had the condition before they used the drug?
“A. In my opinion it shouldn’t report as a ADE from the drug if they already had the disease before they took it.”
Dr. Busch was unable to determine how many of the ADEs he reviewed may have had a confounding factor caused by additional ingredients contained in foreign combinations, such as Chinese herbs, leading to renal failure.61
“Q. And of the people who use — people who reported valvular heart disease, as to whom valvular heart disease was reported from overseas, how many of those had taken Chinese herbs in conjunction?
[266]*266“A. Chinese herbs don’t cause aortic or myometrial valvular heart disease.
“Q. How many had taken Chinese herbs?
“A. Don’t know”'62
Dr. Busch identified 10 cases from Belgium. He was asked about these adverse incident reports:
“Q. And how many of those patients had taken those slimming cocktails we were discussing yesterday?63
“A. Don’t know.
“Q. How many had taken Chinese herbs?
“A. Don’t know.”
Only one of those 10 patients had just taken fenflure-mine alone.64 Either Dr. Busch has entirely disregarded the possibility that an ADE mentioned both words valvular heart disease and fenfluramine, but there was no possible causative connection, because the valvular heart disease preceded ingestion, or he chose to ignore the possibility based on the bold unsupported assumption that an ADE would not be submitted if the patient had valvular heart disease before ingestion. Whichever is true, no explanation was given to the jury.
Indeed, Dr. Busch seemed to think that submitting any ADE which mentioned fenfluramine usage and men[267]*267tioned valvular heart disease was sufficient to imply any causative relation.65
“Q. When a physician or a hospital or a pharmacist or anybody reports an adverse drug event, they’re not saying that the drug caused the event, correct?
“A. They are saying the drug is associated with the event.
“Q. They are saying the drug was being taken and the event occurred. And that’s all they are saying, right, doctor?
“A. That’s an association, yes.
“Q. Oh, to you an association is simply a coincidence in time?
“A. It is a coincidence in time, with the thought that the drug is involved in causation. Why would they report it otherwise?
“Q. But they’re not concluding that it did cause it. They’re not even saying it might have caused it. All the reporter is saying is that the person was taking the drug and the person later had this condition, correct?
“A. I don’t agree with that.”
No medical or scientific justification for this odd conclusion concerning a form which specifically asks the reporter to identify incidental findings was ever presented. Ajudicial layperson’s review of the ADEs demonstrates numerous ADEs upon which Dr. Busch purports to rely contained the valvular heart disease notation only as an additional condition of the patient.
[268]*268VI. Literature search.
Although Dr. Busch testified on direct examination that he had performed an extensive literature search which formed a scientific basis for his opinions about Pondimin, he acknowledged in cross-examination that this literature search was limited.66
“Q. Are you familiar with any literature, medical literature, published while Pondimin was on the market, which dealt with those Belgian cases?
“A. No.”
Dr. Busch did, however, acknowledge having read an article from the Lancet published in February of 1993 which included descriptions of the Belgian cases which dealt with Chinese herbs and slimming cocktails. This 1993 article found no link between fenfluramine and valvular heart disease in the Belgian examples. In fact, Dr. Busch acknowledged that there was no literature anywhere in the world prior to 1997 that demonstrated any link between fenfluramine and valvular heart disease.
“A. Not that I am aware of.67
“Q. And you have researched the world’s literature, haven’t you?
“A. I have.”68
Dr. Busch generally referred to animal studies as supporting his opinion. One animal study referred to in direct examination involved fenfluramine. Dr. Busch acknowledged that this study did not find any valvular heart disease.
[269]*269“Q. But it didn’t find any valvular heart disease, right?
“A. That’s true.”69
Likewise, a second article referenced in direct examination which did find valvular heart problems did not concern fenfluramine.70
“Q. But it didn’t have fenfluramine, right?
“A. Did not, had serotonin.”
Indeed, in cross-examination Dr. Busch confirmed that there was no animal study literature supporting any connection between fenfluramine and valvular heart problems.
“Q. And there is not a single article anywhere in the medical literature prior to the time, or during the time, Pondimin was on the market in which people gave fenfluramine to animals and showed the development of valvular heart disease, correct?
“A. True.”71
Dr. Busch presented no factual basis which the jury could possibly evaluate. 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. The remainder of the purported factual basis of the opinion, namely the 20 to 40 ADEs were not presented to the jury in any that was permitted factual evaluation.
Indeed, taken in the light most favorable to the verdict winner, toward the end of a long examination when defendant was forced into establishing the basis for Dr. [270]*270Busch’s expert opinion on cross-examination, Dr. Busch refused to answer specific questions about the basis of his opinion by stating “I don’t know” to every question about the content of the ADEs. It is possible, taking Dr. Busch literally, that he did not know. If accepted as literally true, his lack of knowledge undercuts all factual basis for his testimony. He cannot rely, at least not without scientific explanation and justification, on incidental findings contained in an adverse incident report to conclude that defendant Wyeth missed a signal. It is the definitional nature of logic that incidental findings are incidental.
However, Dr. Busch may, in fact, have a scientific medical and factual basis for his opinions. If so, it was never explained to the jury. Nonetheless, if he does have a basis, the plaintiffs should not be prohibited from proving their case. The clear violation of Rule 705 does not warrant judgment n.o.v., but does clearly warrant a new trial as to Ms. Hill, Ms. Jensen and Ms. Hansen, which is so ordered.
Rule 705 was adopted in accordance with long-standing Pennsylvania law upholding the sanctity of the jury role as fact-finder. Expert testimony is intended to assist, not supercede, the jury. Expert opinion testimony should explain and clarify the facts so that correct conclusions may be reached by lay jurors. Experts are not advocates regardless of how much a party pays them. The trial is a search for truth and may not be castrated and corseted into a battle of experts. The jury must be provided with the factual basis on which an expert grounds his opinion so that the jury remains the only finder of fact and the trial is not reduced to “a battle of experts.”
[271]*271ORDER
And now, May 10, 2005, it is hereby ordered and decreed that defendant’s post-verdict motions are granted as to the extent that a new trial is hereby ordered as to liability only.
Related
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72 Pa. D. & C.4th 225, Counsel Stack Legal Research, https://law.counselstack.com/opinion/hansen-v-wyeth-inc-pactcomplphilad-2005.