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December 29, 1997


Appeal from the Order Dated September 15, 1995, Docketed September 28, 1995, In the Court of Common Pleas of Philadelphia County, Civil No. 1027 September Term, 1982.

Before: Beck and Hudock, JJ., and Cercone, P.j.e. Opinion BY Beck, J.

The opinion of the court was delivered by: Beck


Filed December 29, 1997

This is a pharmaceutical products liability action. Plaintiffs-appellees are Jeffrey Blum, a minor, and his parents and natural guardians Joan and Fred Blum. Jeffrey Blum was born with clubfeet. The Blums filed this action against defendant-appellant Merrell Dow Pharmaceuticals, Inc. ("Merrell Dow"), the manufacturer of the drug Bendectin. While pregnant with Jeffrey, Joan Blum took Bendectin, which was prescribed by her doctor to relieve pregnancy-related nausea. After trial in 1986, the jury returned a verdict in favor of the Blums, finding specifically that his mother's ingestion of Bendectin during pregnancy caused Jeffrey Blum's clubfeet. However, the verdict was ultimately vacated because it was rendered by only eleven jurors. Blum v. Merrell Dow Pharmaceuticals, Inc., 385 Pa. Super. 151, 560 A.2d 212 (1989), aff'd, 534 Pa. 97, 626 A.2d 537 (1993) (Blum I).

The matter was remanded for a new trial, which was held between May 5 and June 14, 1994, when the jury found in favor of the Blums, awarding $4 million in compensatory damages to Jeffrey Blum, $200,000 in compensatory damages to his parents, and $15 million in punitive damages. The court denied appellant's motions for judgment notwithstanding the verdict (j.n.o.v.) or for a new trial, and molded the verdict to include delay damages for a total award of $24,111,147. This timely appeal followed.

On appeal, Merrell Dow argues that the trial court should have entered j.n.o.v. in its favor because the Blums did not present sufficient admissible evidence of causation to hold Merrell Dow liable for Jeffrey Blum's injuries. Merrell Dow further argues that, even if j.n.o.v. is not entered, it is entitled to a new trial because of several trial court errors, including: 1) the admission of incompetent expert testimony on the issue of causation; 2) permitting the jury to learn that Merrell Dow lost the first trial of this case; 3) instructing the jury on fraud despite the fact that there was no evidence of fraud; 4) instructing the jury on implied warranty of fitness for a particular purpose where no evidence of a particular purpose was shown and where there is no such cause of action in a prescription drug case; 5) instructing the jury on express warranty where a breach was not shown; and 6) instructing the jury on punitive damages where Merrell Dow's conduct was neither outrageous nor reckless and where the award of punitive damages in this case violates the United States Constitution. After our exhaustive review of the complex arguments and extensive record, we reluctantly reverse and remand with instructions to the trial court to enter j.n.o.v. in favor of Merrell Dow.

Standard of Review

Faced with a motion for j.n.o.v., the court must decide whether, viewing the evidence in the light most favorable to the verdict winner, there was sufficient evidence to sustain the verdict; if there was, j.n.o.v. should not be granted. Sheely v. Beard, Pa. Super. , 696 A.2d 214 (1997); Gray v. H.C. Duke & Sons, Inc., 387 Pa. Super. 95, 563 A.2d 1201 (1989). We hold that the trial Judge abused his discretion in allowing certain scientific expert testimony on causation to be admitted at trial. In the absence of this causation evidence, judgment should have been entered in favor of Merrell Dow as a matter of law. We therefore reverse the trial court's order denying judgment n.o.v. We need not reach appellant's other issues on appeal.

Plaintiffs Must Prove Causation

In any tort action based on a theory of negligence or products liability, the plaintiff is required to prove by a preponderance of the evidence that the defendant's conduct was the proximate cause of the plaintiff's damage. Sherk v. Daisy-Heddon, 498 Pa. 594, 450 A.2d 615 (1982); Christian v. Pennsylvania Financial Responsibility Assigned Claims Plan, 454 Pa. Super. 512, 686 A.2d 1 (1996). The test for proximate causation is whether the defendant's acts or omissions were a substantial factor in bringing about the plaintiff's harm. First v. Zem Zem Temple, 454 Pa. Super. 548, 686 A.2d 18 (1996). In this case, the Blums were required to prove that Joan Blum's ingestion of Bendectin during her pregnancy was the proximate cause of her son's injuries. This general causation issue involves two underlying questions: 1) Does the drug Bendectin cause birth defects such as clubfeet? and 2) Did Bendectin cause Jeffery Blum's clubfeet?

It is extremely difficult to answer these basic questions. Birth defects occur in two to three percent of births regardless of exposure to Bendectin. Daubert v. Merrell Dow Pharmaceuticals, Inc., 43 F.3d 1311, 1313 (9th Cir. 1995). Most birth defects occur for no known reason. Id. The causation evidence in this case, therefore, must necessarily come in the form of probabilities rather than certainties. Of course, circumstantial evidence may suffice to prove causation in a tort case, but it must establish by a preponderance of the evidence that the alleged cause was a substantial factor in bringing about the claimed effect. Finney v. G.C. Murphy Co., 406 Pa. 555, 178 A.2d 719 (1962) (plaintiff in tort case is not required to prove with mathematical exactness and caliper precision that an incident could only happen in one manner to the exclusion of all other possibilities).

In an effort to answer the critical causation question, the Blums proffered scientific expert testimony from several witnesses. Alan K. Done, M.D., and Adrian Gross, D.V.M., testified at the first trial, and their testimony was read to the jury during the second trial. In the second trial, Stuart Newman, Ph.D., testified via videotaped deposition. These witnesses offered their opinions that Bendectin is a human "teratogen" *fn1 while conceding that birth defects occur even in the absence of Bendectin exposure. Done, Gross and Newman all testified as to general causation, that is, the teratogenic potential of Bendectin. Only Dr. Done opined more specifically that Bendectin caused Jeffery Blum's clubfeet. An expert witness is qualified to offer an opinion if he or she has sufficient skill, knowledge, or experience in a field or calling as to make it appear that his or her opinion or inference will probably aid the trier in its search for truth. Dambacher v. Mallis, 336 Pa. Super. 22, 485 A.2d 408 (1984). To be admissible, expert evidence on scientific matters must pass through an additional hoop.

The Frye Test

Our law is well established that the trial court enjoys broad discretion in admitting or excluding evidence. However, this discretion is tempered with regard to the admission of scientific evidence, that which "draws its convincing force from some principle of science, mathematics and the like." Before scientifically adduced evidence may be considered admissible, it must first be shown that it meets the standard established in Frye v. United States. . . .

Commonwealth v. Rodgers, 413 Pa. Super. 498, 605 A.2d 1228, 1234 (1992) (citations omitted).

Merrell Dow challenged the admissibility of the causation evidence proffered by the Blums, arguing that the opinions held by the Blums' expert witnesses did not meet the requirements for admissibility of scientific evidence set forth in Frye v. United States, 54 App. D.C. 46, 293 F. 1013 (D.C. Cir. 1923), and adopted by our supreme court in Commonwealth v. Topa, 471 Pa. 223, 369 A.2d 1277 (1977). The Frye test represents an attempt to measure the quality of scientific evidence prior to admission, so that jurors are not misled by unreliable evidence. Our courts have considered this to be necessary whenever science enters the courtroom, because "there is the danger that the trial Judge or jury will ascribe a degree of certainty to the testimony of the expert . . . which may not be deserved." Topa, 471 Pa. at , 369 A.2d at 1281. Therefore, because scientific testimony should aid jurors rather than mislead them, admissibility of scientific evidence depends upon "the general acceptance of its validity by those scientists active in the field to which the evidence belongs." Id. at , 369 A.2d at 1281 . *fn2

Frye v. United States involved the admissibility of the "systolic blood pressure deception test," a test designed to determine whether a defendant was answering questions truthfully based on variations in blood pressure. 293 F. at 1013-1014. In rejecting evidence of Frye's test results, the court concluded that "the systolic blood pressure deception test had not yet gained such standing and scientific recognition among physiological and psychological authorities as would justify the courts in admitting expert testimony deduced" from it. Id. at 1014. The court rejected the test because its results were not "deduced from a well-recognized scientific principle or discovery." Id. In other words, the concept that a suspect's blood pressure rises while telling a lie must be a scientific fact that is "sufficiently established to have gained general acceptance in the particular field to which it belongs," before the results of a test based on this concept can be admitted in a court of law. Id.

In Commonwealth v. Topa, the Pennsylvania Supreme Court adopted this line of reasoning in rejecting expert testimony by a police lieutenant based on spectrograph, or "voiceprint" analysis of a recorded telephone call. The Commonwealth had proffered evidence of the defendant's voiceprint in order to prove that he had made a crucial telephone call. The voiceprint analysis was based on the theory that "if you use unique voice mechanisms to produce the sounds of your voice, then the sounds will also be unique," and the voiceprint would serve as a tool to identify a suspect's voice. The supreme court decided ...

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