Birth Defects Research for Children, Inc.

JEFFREY BLUM, a minor by his parents and natural guardians, JOAN and FRED BLUM, and JOAN and FRED BLUM, in their own right SEPTEMBER TERM, 1982	SEPTEMBER TERM, 1982
VS.
MERRELL DOW PHARMACEUTICALS, INC.	NO. 1027

"Q: Sir, it has been the pattern and practice and custom of the Merrell Company, in reporting to the FDA, to pick and choose selective information over the past thirty years, relating to the drug Bendectin; correct?

On the day Jeffrey Blum was born with clubfeet, which would require eleven surgical procedures in thirteen years, James Newberne, Merrell Dow VicePresident for drug safety, was addressing the Maternal Advisory Committee of the Food and Drug Administration. He testified unequivocally that Bendectin was safe for maternal use during pregnancy He under-represented the incidence of clubfeet found in animal studies. He overstated the number of animals studied. He failed to disclose that an inadequate number of animals had been tested, or that test animals had died due to improper care. He did not disclose that dosing accidents had killed test animals. He did not reveal that the tests were scientifically inadequate due to insufficient dosing levels. He did not tell the FDA that he was not proud of Merrell Dow's testing procedures. He did not reveal that Merrell Dow "chose" what information to report to the FDA, or that relevant testing on Bendectin was hidden by being reported to the FDA Decapryn file.² Fifteen years later, at this trial, a jury of twelve citizens learned the rest of the story.

After nine weeks of testimony in 1986, a jury found that the drug Bendectin, taken by Joan Blum to control morning sickness in pregnancy,³ was a legal cause of Jeffrey Blum's clubfeet. That jury awarded one million dollars in compensatory and one million dollars in punitive damages. On June 3, 1993, the Supreme Court reversed that verdict because ". . . Merrell Dow was deprived of its constitutional right of trial by jury when the trial judge overruled its Motion for Mistrial and proceeded to verdict with only eleven jurors, after one juror became ill."⁴ The Supreme Court affirmed the order of the Superior Court which had declared that verdict "a nullity."⁵

At the retrial in 1994, after seven weeks of evidence, twelve jurors rendered a constitutionally valid, unanimous verdict awarding Joan and Fred Blum two hundred thousand dollars for medical expenses. They also rendered a constitutionally valid unanimous verdict of four million dollars as compensation for the pain and the disfigurement and the emotional affliction Jeffrey Blum endured during his twelve years of life prior to trial, as well as for all the injury he will suffer for the remainder of his life. The jury also awarded fifteen million dollars in punitive damages. Following this verdict, damages for delay pursuant to Rule 238 were awarded in the amount of four million, nine hundred eighteen, one hundred forty seven dollars ($ 4,918,147.00).

Defendant seeks Judgment Notwithstanding the Verdict; or, in the alternative, a new trial.

It is obvious that appellate review must be strictly grounded upon the evidence presented at this trial. A reviewing court is precluded from considering "facts" not of record.⁶ The essence of the "rule of law" requires that each party has a due process right to present all relevant evidence⁷ and to have appellate review based solely upon the evidence as it was presented to the jury. There is no right to base an appeal upon extraneous material outside of the record created in the court below.⁸

The defendant acknowledges that this is a unique case.⁹ Despite years of "Bendectin" litigation, this is the only case in which a causal connection between maternal use of Bendectin and clubfeet has been claimed. Nonetheless, ignoring the basic precept of the "rule of law," the defendant offers written opinions of other judges, grounded in materially different factual records from the voluminous and significant factual record created in this case. The defendant offers opinions in other cases, based upon different systems of jurisprudence, in support of the novel proposition that the judge, rather than the jury, should determine the facts in this case."¹⁰

Plaintiffs' right to appellate review exclusively upon the record as presented to the jury in this trial is as basic a principle of Anglo-American due process as the right of cross-examination.¹¹ Indeed, the record of this case demonstrates that these two principal rights are inextricably intertwined and both are central to the absolute right to trial by jury reaffirmed by the Supreme Court in their review of the prior trial in this very case.

Defendant claims that plaintiff's experts employed an unscientific methodology in formulating the opinion that the drug Bendectin caused Jeffrey Blum's clubfeet. Through cross-examination, plaintiff demonstrated at this trial that the experts called by the defendant differ from plaintiff's experts not in scientific methodology, but only in their ultimate conclusion. Stripped of a false forensic illusion of scientific infallibility and uniformity, defendant simply claims that the factual findings of the jury, reached after seven weeks of serious study of testimony, including eleven well-qualified experts, should be replaced by judicial fact-finding more to defendant's liking.

Blum vs. Merrell Dow"¹² affirms the inviolate and absolute right to trial by a jury of twelve citizens. In this appeal, the defendant seeks to castrate the same jury held so precious in their prior appeal. The, defendant asks this court to rule that judicial fact-finding is mandated in birth defect cases."¹³ Defendant Merrell Dow further asks this court to decree, as a matter of law, that the Bendectin which Joan Blum took at the time of her pregnancy, during the period when Jeffrey Blum's legs were forming in utero, did not cause the bilateral clubfoot condition with which he has been afflicted since birth. In essence, defendant asks this court to declare, as an unalterable precept of Pennsylvania law, that the drug Bendectin cannot cause birth defects.¹⁴

The proposition that a finding of fact by the jury should be changed into a legal precept of its opposite is unprecedented. The contention stands in stark contrast to long established law that the determination of legal cause is exclusively the provence of the fact-finder. Pennsylvania jurisprudence has consistently affirmed the central role of the jury, leading inexorably to and culminating in the Supreme Court's decision in this very case two years ago.¹⁵ With neither justification in reason nor precedent in law, defendant wants this court to ignore centuries of Pennsylvania jurisprudence and transmogrify the role of the jury. Even if this court would have made different findings of fact, it would be a gross abuse of judicial power to overturn this verdict.¹⁶ The essence of defendant's post-trial motions is the claim that Bendectin cannot cause birth defects and that any opinion to the contrary, no matter how qualified the expert witness who sincerely holds that opinion, must be based upon unscientific methodology as a matter of law.

A detailed review of the evidence reveals that plaintiffs experts employed the same methodology as did defendant's experts, and that plaintiffs experts' methodology was specifically approved by several of defendant's expert witnesses. Additionally, plaintiff's expert conclusions, themselves, were confirmed by defendant's expert witnesses. Defendant's claim for relief is legally insupportable and factually inaccurate.

Plaintiff presented the testimony of Dr. Allan K. Done, a board-certified pediatrician and toxicologist; Dr. Adrian Gross, a veterinarian and former FDA official; and Dr. Stuart Newman, Ph.D, a cellular biologist. Plaintiff also read into evidence deposition testimony from experts called to testify by the defense at the first trial. Plaintiffs experts relied upon the same material and employed the same methodology as the defendant's experts.

Plaintiff's experts based their testimony on four recognized and approved scientific approaches employed in analyzing causation in birth defects: chemical structure analysis, in-vitro studies, animal studies, and-epidemiological studies. Plaintiff's experts concluded that Bendectin was a drug capable of causing birth defects; and, in fact, did cause Jeffrey Blum's clubfoot condition.

Dr. Adrian Gross provided expert testimony concerning animal studies on the effects of Bendectin. Dr. Gross is a doctor of veterinarian medicine with a Master's Degree in pathology, and advanced studies in statistics and biometry. Dr. Gross was employed by the FDA for fifteen years, evaluating animal testing of drug safety. The defendant does not challenge Dr. Gross' qualifications to provide expert testimony.

Dr. Gross extensively reviewed the drug testing performed by Merrell Dow and concluded that significant numbers of abnormalities in test animals had never been reported to the FDA. Included in the abnormalities not reported were animals having the musculoskeletal defect of club limbs. Dr. Gross outlined serious deficiencies in the Merrell Dow studies, including too few animals, too low an experimental dosage and avoidable mishaps to animals studied. Dr. Gross testified that defendant, Merrell Dow actively concealed from the FDA data which demonstrated that Bendectin caused birth defects generally, and clubfeet specifically, in laboratory animals.¹⁷

Dr. Gross testified: ".......in each of the studies, the agent on test, which was either Bendectin, the three ingredients, Bendectin or doxylamine succinate or one of its ingredients, can be regarded as a teratogen..in that it significantly affects and it increases the frequency of birth defects…in the totality of these studies and it may be manifested somewhat different in each study, but, in sum total, adds up to the same picture. These agents interfere with normal development of the young." ¹⁸

Dr. Gross testified: "…from everything that I have said here for two days, Bendectin does induce such birth defects in animals. That is clear. Such results are significant. They are unambiguous. They are non-equivocal. They are clear beyond anything one could desire. It stares you in the face. The drug itself is a teratogen." ¹⁹ Dr. Gross testified that animal studies performed by Merrell Dow specifically Ied to the conclusion that Bendectin causes clubfeet in animals. ²⁰ He testified further that the teratogen effect of Bendectin was manifest at lower doses than the drug Thalidomide, which is known to cause severe birth defects in humans. ²¹

Dr. Alan Done is a Board Certified pediatrician and toxicologist. He served as an official with the FDA and on the faculty of a number of medical schools. He has done birth defect research and published three hundred articles in the medical literature. He has taught in the field of "teratology." No general challenge to his qualifications to offer expert opinion on causation in birth defects is presented.

Defendant claims to challenge the scientific validity of his methodology. The reality is, defendant challenges only his conclusion. Dr. Done testified that the chemical structure of Bendectin is similar to other known teratogens. He also testified that in-vitro studies demonstrated the detrimental effects of Bendectin upon cells grown in test tubes. Dr. Done described a scientific study performed by Dr. John Hassell at the National Institute of Dental Health which concluded that Bendectin adversely affected the development of limb bud cells and had a teratogenic potential comparable to Dilantin, a known human teratogen.²² Dr. Done testified to other studies which confirmed the teratogenicity of Bendectin, including epidemiological studies which supported his conclusion that Bendectin is a teratogen. Dr. Done evaluated the "Heinonen study, ²³ applied his scientific expertise and concluded: "the likelihood of having a baby with clubfeet is 2.1 times as great if doxylamine [the main ingredient in Bendectin] is taken during the first four months of pregnancy than if it is not taken. It's 97 % I likely that this is a real difference that did not occur by chance alone.²⁴

Dr. Done referred to a report authored by Dr. Jick: "There was thirteen times the likelihood that a woman exposed to Bendectin with more than two prescriptions worth of exposure would have a malformed baby with a limb disorder, as opposed to those not exposed. And that again is significant as reflected by the confidence intervals.²⁵ Dr. Done concluded that the Bendectin taken by Joan Blum during pregnancy caused Jeffrey Blum's clubfeet.

Initially, defendant objected to the use of Dr. Done's testimony through the notes of testimony from the prior trial. Pre-trial, defendants sought to preclude Dr. Done's testimony, claiming that the use of his prior testimony precluded them from confronting him with "subsequently published scientific research." Defendant initially claimed that without confronting Dr. Done with these subsequent studies would permit the plaintiff to present misleading testimony to the jury.

Taking this claim as a seriously presented objection, the court insisted that plaintiff make Dr. Done available for a deposition to enable the defendant to question him about studies published subsequent to his testimony at the first trial. Argument on this objection and the insistence of the court that Dr. Done be made available for a deposition recurred over several court days between May 2 and May 9. When plaintiff agreed to make Dr. Done available, and a time and place for Dr. Done's deposition in California was established, the defendant abruptly decided that it did not wish to pose any additional questions at all.²⁶ This objection has clearly been knowingly, intelligently and voluntarily waived.

No objection to Dr. Done's testimony was raised at the prior trial."²⁷ The plaintiffs had a statutory right to offer the notes of Dr. Done's prior testimony as presented at the earlier trial by virtue of statute, enacted as 42 Pa.C.S. §5934.

The Pennsylvania Rules of Civil Procedure also gave plaintiffs a right to present Dr. Done's prior testimony. Pa.R.C.P. 4020 provides:

Clearly, if deposition testimony is admissible at a subsequent trial which occurs when the witness is outside the Commonwealth, notes of testimony from a prior trial in the same case involving the same parties must also be admissible. By failing to object to Dr. Done's testimony at the first trial, the defense has waived objections to the testimony presented pursuant to statute and Rule. Defendant's technical objections to Dr. Done's testimony are entirely devoid of merit. As is demonstrated, Dr. Done relied upon acceptable scientific methodology in reaching his opinion.

Plaintiffs third expert, Dr. Newman, has a Ph.D. in chemistry and extensive experience in the biological aspects of complex chemical systems. Dr. Newman presented an analysis based on the molecular structure of Bendectin. Dr. Newman testified that one of the active ingredients in Bendectin, doxylamine, can pass through the placental barrier and cause effects in a developing embryo.

Plaintiff offered into evidence expert testimony presented by the defendant at the prior trial. Plaintiff read into evidence the testimony of Dr. Paul Stolley. At the time of the first trial, Dr. Stolley was a physician and co-director of the Clinical Epidemiology Unit at the University of Pennsylvania and a Professor of Medicine at the University of Pennsylvania School of Medicine. Dr. Stolley testified there was three times the risk of malformation in the babies of mothers who had filled more than one prescription for Bendectin.²⁸

The defense called seven expert witnesses. All opined that Bendectin did not cause birth defects. All conceded that some scientific studies confirmed a connection between Bendectin and birth defects.

Dr. Bracken, a professor of epidemiology at Yale University, was presented as an expert in the field of epidemiology.²⁹ Dr. Bracken published "Bendectin (Debendox) as a Risk Factor for Pyloric Stenosis" in the American Journal of Obstetrics and Gynecology. This study found no significant increase in birth defects among women who had used Bendectin during pregnancy except a statistically significant association with the birth defect pyloric stenosis.³⁰ Dr. Bracken explained to the jury, in detail, what epidemiologists mean by a " confidence interval,"³¹ stating that an association with a 95% confidence interval is generally accepted as proof of causation in the field of epidemiology.³²

On cross-examination, Dr. Bracken testified that epidemiology, as a science, is incapable of proving that a drug is safe for ingestion.³³ Dr. Bracken's own epidemiological study consisted of interviews with 1,427 mothers, of whom only 122 had taken Bendectin during pregnancy. Dr. Bracken testified that there was a 2.91 increase in the odds of mothers who used Bendectin and smoked having a child with a birth defect:

Dr. Bracken was asked to address the concept of scientific peer review journals. Dr. Bracken was asked:

The defense called Dr. Klebanoff, a medical officer with the Epidemiological Branch of the National Institute of Child Health and Human Development, part of the National Institute of Health. Long after Bendectin was removed from the market and unavailable for use, Dr. Klebanoff analyzed data on Bendectin. This study was published in the Journal of Teratology as "Bendectin and the Human Congenital Malformations.''³⁷ Dr. Klebanoff collected data on pregnant women from the Kaiser Health Plan in California during the 1970's. Information on 58 different kinds-of birth defects were analyzed. Dr. Klebanoff's study found three statistically significant birth defects associated with Bendectin exposure: congenital cataracts, under-development of the lungs and microcephaly.³⁸ Despite these statistically significant associations, Dr. Klebanoff testified on direct examination that Bendectin does not cause any birth defects.³⁹ Dr. Klebanoff further offered his opinion that it is impossible to prove that Bendectin did not cause birth defects.⁴⁰

Dr. Klebanoff confirmed plaintiff 's experts' conclusion on the central issue at the trial and on this appeal. He testified on cross-examination that Bendectin is positively associated with bilateral clubfeet:

The defense called Dr. Rochelle W. Tyl, research director for the Center for Life Sciences and Toxicology at‑ the Research Triangle Institute as an expert in the field of developmental biology, teratology and experimental teratology. Dr.Tyl is a developmental toxicologist, who considers herself a "research teratologist." Dr. Tyl defined a "teratologist" as follows:" . . . the term . . . is based on the Greek 'terata,' which means monster or malformations. So the old term for looking at birth defects, as well as other effects from exposure during in utero development, was called teratology. So a teratologist studied the causes and effects of in utero exposure to some agents."⁴²

Dr. Tyl does research into birth defects by performing animal studies involving rats, mice and rabbits. Dr. Tyl has a Ph.D. in developmental genetics and is board-certified in toxicology. She has no degree in "teratology." Dr. Tyl has done no scientific work whatsoever on human systems or human cells.⁴³

Dr. Tyl testified that when she received her degree in developmental genetics in 1968, there were no courses offered in "teratology."⁴⁴ Dr. Tyl testified that even today, there is no degree offered by any institution of higher learning nor any certification by any authority in teratology:

Dr. Tyl further testified that an embryologist, a biochemist, pharmacologist, or a toxicologist who is interested in issues of teratology could have appropriate credentials to offer an opinion as to the teratogenicity of a drug.⁴⁶

The National Toxicology Program, an umbrella agency of the Federal Government, including the Food and Drug Administration, asked Dr. Tyl to perform an animal study on the effects of Bendectin. Dr. Tyl reported the results of this study in "Developmental Toxicity Evaluation of Bendectin in CD Rats"47 and "Final Report, Teratologic Evaluation of Bendectin."⁴⁸ Dr. Tyl's study revealed "an increased incidence of a skeletal malformation, which was a short thirteenth rib, but only at the top dose, which killed 17 % of the mothers, caused profound maternal toxicity, profound other developmental toxicity."⁴⁹

Dr. Tyl was specifically asked for her opinion as to whether Bendectin was teratogenic in rats. Dr. Tyl said based on the definition of a teratogen, which says, if you see malformations only at doses where the mothers are severely affected, then the effects on the conceptus may be due to the effect on the mothers. The mothers were sick. Then it is not -- in my estimation, it is not a teratogen in rats, based on my study."⁵⁰ Dr. Tyl's study did not segregate clubfeet as a defect studied.

Dr. Tyl was hired by the Federal Government to perform animal studies on Bendectin long after Bendectin had been withdrawn from sale in the United States.⁵¹ At that time, numerous epidemiological studies had been performed on the effects of Bendectin use.⁵² Dr. Tyl's opinion is that Bendectin is not a teratogen, but it is a "developmental toxicant."⁵³ As a result of her study, Bendectin was placed on the "List of Developmental Toxicants"⁵⁴ and is listed on the list of reproductive toxicants maintained by the United States Government.⁵⁵

On cross-examination, Dr. Tyl discussed well-established requirements for any scientific animal study. Dr. Tyl testified that maternal toxicity at the highest doses was necessary for a good scientific study and that the animals needed to be carefully selected and cared for to avoid sickness. In Dr. Tyl's opinion, sick animals would invalidate a scientific study.⁵⁶ Dr. Tyl believes that even in studies involving small numbers of animals, results cannot be understood without using statistical analysis.⁵⁷

Outside of the jury's presence,⁵⁸ the court asked Dr. Tyl a series of general questions concerning teratology as a scientific field. Referring to previous expert testimony which had employed a concept of results "suggesting" a causal association, Dr. Tyl was asked if the science of teratology had any clear definition of the term "suggestion." Dr. Tyl reported that there was no general definition, but in her opinion, the word "suggest" connotated an anecdotal suggestion, a concept of suspicion.⁵⁹ Likewise, Dr. Tyl stated that there is no teratological definition of the word "associated." although the witness stated that it was a term routinely used with statistical analysis, she understood it as follows:

When asked whether an association is an evaluation by the principal investigator or a scientific concept determined by the application of clear and specific standards, Dr. Tyl responded: "You can use statistics to show significant associations, or you can look at the data and evaluate whether or not there's an association; and, usually, you do both." 61 Dr. Tyl was asked whether any teratological definition of "proof" existed: "Is there a teratological definition of proving teratogenicity?" Dr. Tyl responded: "I don't think there is. You just beat it to death with a bunch of studies."⁶²

Dr. Tyl's opinion is that teratological studies deal with the reality of causation only "indirectly."⁶³ Dr. Tyl said, "That word is probably rarely used, because cause and effect is so difficult to prove. Most of us don't touch the word 'cause' with a ten-foot pole. We'll use 'results in', 'is associated with'".⁶⁴ With respect to Dr. Tyl's specialty of animal studies, Dr. Tyl was asked: "Do teratological animal studies attempt to say something about cause?" Dr. Tyl responded, "Yes. But they rarely use the word 'cause'." The court asked, "What words do they use instead of 'cause'?" and the witness responded, ";Results in' or 'associated with.' But they are tippy-toeing around 'cause'...[b]ecause you can't ever say with absolute certainly that treatment 'X' results in outcome 'Y'. You can talk about statistical association, or biological association."⁶⁵

Dr. Tyl testified that the science of teratology has no generally accepted definition of "aberration" either: "The terms 'aberration', 'variation', 'alteration' [all of which are found in the studies] can be used interchangeable. Some people are trying to give specific definitions to these terms; and it's not really working."⁶⁶

Dr. Tyl did provide a scientific definition of "malformation" that she "assumed" that everyone would agree to. She said that although she would not use an "aberration" interchangeable with the term "malformation", other scientists might. Dr. Tyl further confirmed that there is no generally accepted teratological standard as to whether the term "aberration" includes the term "malformation,"⁶⁷ and conceded that the term "aberration," itself, has no clear scientific meaning.⁶⁸

Dr. Shapiro was called as a witness by Merrell Dow to provide an expert opinion in the field of epidemiology. He is the head of the epidemiology department of Boston University.⁶⁹ His formal training was minimal, consisting of only eleven credits towards a Master's Degree in Epidemiology.⁷⁰ In his initial testimony, Dr. Shapiro misstated his formal education in the field of epidemiology.⁷¹ Dr. Shapiro is co-author of "Birth Defects and Drugs and Pregnancy." Considering only Dr. Shapiro's true academic qualifications and experience, he is qualified to provide expert testimony. The weight of that testimony is for jury evaluation.

Dr. Shapiro testified that epidemiological studies could never prove the safety of a drug⁷² and conceded that there was a positive association between minor malformations, the category in which he classified clubfoot, and the use of Doxylamine Succinate (the active ingredient in Bendectin).⁷³ Dr. Shapiro stated that absent statistically significant epidemiological findings, no valid conclusion on causation could ever be scientifically reached. Nonetheless, Dr.Shapiro's opinion was that Bendectin could not cause birth defects.⁷⁴

Dr. Shapiro testified that a drug taken by the mother after the time of fetal limb formation in-utero could not possibly cause a limb defect because all limbs had already developed. Nonetheless, the data on which his opinion was based grouped together, in one group, both women who took Bendectin during the time when limb formation was occurring and women who took Bendectin after the baby's limbs ]lad already formed. Dr. Shapiro conceded that the data he used to evaluate whether or not Bendectin caused limb defects, diluted. the number of women who could possibly show any effect of the drug⁷⁵ by including many women who could show no effect from Bendectin.⁷⁶ No scientific basis or justification was ever presented for this illogical grouping.

Dr. Shapiro conceded that to include those women for whom no causal connection between Bendectin exposure and a limb defect was possible would increase the number of women in the group supposedly being evaluated for birth defect causation due to Bendectin. Dr. Shapiro admitted that this illogical grouping resulted in an underestimate of the risk of clubfeet in offspring.⁷⁷ He admitted that this resulted in a lower percentage of incidents of clubfoot in the "Bendectin exposed" group.⁷⁸ He refused, however, to attribute any significance to this underestimation.⁷⁹ Dr. Shapiro's grouping significantly underestimated the risk of birth defects by categorizing women who could not demonstrate the effect together with women who could. Dr. Shapiro admitted that his study underestimated the risk of harm from Bendectin.⁸⁰

When asked specifically whether the inclusion of inappropriate women in the total number would change these figures ("would [this] result in an underestimate of the magnitude of the effect?"), his testimony was, "If there were a causal effect, yes."⁸²

The circularity of this reasoning is obvious, revealing transparent, pseudoscientific thought. It demonstrates justification science not inquisitive science. Clearly revealed in this testimony is the unalterable preconception from which Dr. Shapiro's "scientific conclusion" was derived. Believing that Bendectin could not cause birth defects his analysis demonstrated his predetermined conclusions and thereby, in his own mind, confirmed his preconceptions with the sanctity of immutable "scientific" truth.

Dr. Newberne was a Vice-President of defendant, Merrell Dow, with responsibility for animal testing and drug safety. Testifying on behalf of the defendant before the Maternal Advisory Committee of the FDA in September of 1980, Dr. Newberne ignored numerous musculoskeletal defects recorded in the original data of his own studies.⁸³ At this trial, Dr. Newberne acknowledged a consistent pattern of under-reporting to the FDA. Dr. Newberne testified:

Dr. Newberne reviewed the animal studies on which the defendant relied to market Bendectin as a safe product. One "scientific" study by Dr. Smithells, presented to the medical community to provide evidence for the safety of Bendectin, was rejected for publication in three widely respected peer review journals: the "British Medical Journal," "Lancet" and the "New England Journal of Medicine" before being finally accepted in "Teratology."⁸⁶ During this time, Dr. Smithells was actively soliciting funds from defendant Merrell Dow. In his letters, Dr. Smithells identified his understanding of the purpose of his study. In one groveling letter, he said: "Much clearly depends upon the value of this publication ⁸⁷ to Merrell Dow National Labs. If it may save the company large sums of money, large sums in the California court (which is rather what I thought when we undertook this study), they may feel magnanimous. If with the passage of time, the study is of no great significance, I can only regard the figure you suggest as generous and welcome."⁸⁸

In September of 1975, Dr. Smithells again wrote to the defendant: "I would not like you to think that in writing at this time I am threatening not to publish or any such nonsense. . . . [N]eedless to say, I should appreciate any gesture Merrell felt inclined to make, but I imagine that if we are able to give Debendox 89 a clean bill of health with regard to teratogenesis, this would be of substantial help in the courtrooms of California."⁹⁰

Through Dr. Newberne, the jury heard testimony about two studies on Bendectin conducted by Dr. Roll in Germany. In 1982, Dr. Roll wrote a report for the German Official Health Agency published in the German Literature. The Roll study of the drug Lenotan, the German equivalent of Bendectin, concluded: "It can be said that Lenotan has teratogenic potential in the animal study under certain conditions."91 The first Roll study using a strain of rats bred for the German Government (Wistar or "government rat") found that Bendectin was associated with the birth defect of diaphragmatic hernia. The study concluded: "Doxylamine has proven itself in the present case to be teratogenic in Wistar rats bred by the Federal Health Agency."⁹²

Upon learning that the Roll study determined that Bendectin was a teratogen in Wistar rats, Dr. Newberne hired a third-party "consultant." ⁹³

Professor Tuchmann-DuPlessis received a letter from Dr. Newberne asking him to meet with Dr. Roll informally.⁹⁴Copies of this correspondence were sent directly to Merrell Dow's lawyers. Following a meeting with Professor Tuchmarin-Duplessis, Dr. Roll did a second study but made significant changes in procedure: he did not use Wistar rats, nor did he examine skeletons, as he had in the first study. ⁹⁵ Dr. Roll's second study utilized rats whose natural incidence of diaphragmatic hernia was so high that it masked any increased defects created by Bendectin.⁹⁶ Not surprisingly, Dr. Roll's second study failed to confirm his first study's conclusion that Beridectin was teratogenic.

In the early 1980's, an animal study was performed by Dr. Hendrickx, a researcher at the University of California in Davis. As did Dr. Roll, Dr. Hendrickx performed two animal studies on the safety of Bendectin. In his first study, Dr. Hendrickx found a statistically significant increase in heart defects in Bendectin treated monkeys.⁹⁷ Again, the defendant funded a second study which attained much more positive results for defendant.

In a letter dated September 22, 1981, Dr. Hendrickx wrote to Dr. Newberne discussing funding for a second study. In that letter, Dr. Hendrickx said, "I also indicated that we would be willing to discuss or modify any part of the proposal with you in order to meet a common objective." ⁹⁸ Dr. Newberne denied that the common objective was the defense of Bendectin litigation.⁹⁹ However, Plaintiff's Exhibit 328 was presented to the jury. This single line from the defendant's financial records revealed that the defendant funded Dr. Hendrickx' second study in excess of three-hundred thousand dollars. This ledger stated: "Hendrickx' monkey study - defense". The second "scientific" Hendrickx study was funded out of the defense budget for the purpose of defending litigation. Dr. Newberne had no explanation: "As I say, Mr. Klein, I don't how that got on there. It has nothing to do with -- from my perspective, of defending the litigation."¹⁰⁰ Nonetheless, from both Hendrickx studies, Dr. Newberne conceded that "there is… an effect by Bendectin on the developing fetus which delays the closure of the ventricular septum.¹⁰¹

Defendant Merrell Dow performed only one epidemiological evaluation, the Bunde-Bowles study."¹⁰² Dr. Newberne testified that this study contained design and supervision problems, as well as other errors and irregularities.

The interaction of "scientific studies" and litigation defense were further exposed in Dr. Newberne's testimony:

Trial in this case continued for eight days after this testimony. Numerous witnesses were called to testify for defendant, Merrell Dow. At no time was any explanation offered as to why legal defense funds paid for these "scientific"studies.

The concluding expert witness called by defendant to consolidate disparate studies into a comprehensive refutation of plaintiff's evidence was Dr. Robert L. Brent. Dr. Brent is Board-certified in pediatrics. He has degrees from Rochester Medical School and Ph.D. degrees in radiology, biology and embryology. Dr. Brent was in the Genetics Division of the Atomic Energy Commission during World War II. Board eligible in genetics, he never presented himself for certification testing. He has been a professor, associate professor or assistant professor in pediatrics at Jefferson University Hospital since 1957. He has been Chairman of the Department of Pediatrics since 1966.

Dr. Brent is a member of numerous professional organizations, including the Teratology Society, the European Teratology Society and the Japanese Teratology Society. He has made presentations around the world, and published three hundred articles in the scientific literature and two hundred seventy nine articles in the medical literature. For fifteen years, he was Editor of the Journal of Teratology. For eighteen years, he has been a retained expert for defendant, Merrell Dow. Described as the originator of the field of teratology, his only formal education in epidemiology was an isolated course in statistics in medical school.¹⁰⁴ Nonetheless, Dr. Brent considers himself "very, very knowledgeable in the field of epidemiology.¹⁰⁵ The majority of Dr. Brent's research work involves animal research.¹⁰⁶ He has never performed any study concerning the drug Bendectin.¹⁰⁷ Dr. Brent was presented as an expert witness in the field of pediatrics, genetics, clinical teratology, "and encompassed in the field of teratology will be expertise in the understanding and analysis of Epidemiology and animal studies."¹⁰⁸

Teratology, itself, is not a specialty certified by any board. According to Dr. Brent, anyone who believes they have "appropriate training, education and experience" can self-annoint as a teratologist. Dr. Brent classified teratology as a sub-specialty of developmental biology, and agreed that teratologists can have academic degrees in many fields, including pharmacology, toxicology, pediatrics, obstetrics, pathology, anatomy, physiology, nutrition, medicine, or veterinary medicine.¹⁰⁹

Dr. Brent considers himself the world's only authority in "secular trend data."¹¹⁰ This, he claims, is a relevant field of science, although not referred to by any other expert who testified during this trial. This "scientific field" has never been subjected to "peer review" and has only one practitioner, the originator of teratology," Dr. Brent himself. Despite the unique nature of this "scientific field," it was presented by the defense as scientific opinion worthy of belief by the jury.

Dr. Brent also claims expertise in legal matters. He has published a number of articles concerning litigation in "peer review" journals. Dr. Brent has published his opinion that congenital malformation lawsuits are rarely meritorious. An article published in his journal, "Teratology," was entitled, "Litigation-Produced Pain, Disease, and Suffering: An Experience With Congenital Malformation Lawsuits."¹¹¹ This publication was based on Dr. Brent's personal review of deposition and trial transcripts, and reported his idiosyncratic credibility decisions in a chart entitled "Distortion of the Facts by Participants in Medical Negligence Litigation."¹¹²

In this article, Dr. Brent concluded that seventeen out of seventeen plaintiffs lied¹¹³ and 82.6% of plaintiffs' lawyers "distorted" the facts."¹¹⁴ Dr. Brent further concluded that plaintiffs' experts were lying or distorting the facts 61% of the time.¹¹⁵ According to Dr. Brent, twenty-five percent of the defendants distorted the facts, but only one defense attorney, out of twenty-one, made any distortions.¹¹⁶ Not surprisingly, Dr. Brent concluded that only two of twenty-seven defense experts distorted any facts."¹¹⁷ Dr. Brent wrote, "...the medical expert who testifies for the plaintiff usually demands and receives substantial fees resulting in a sycophantic alliance between the expert witness and the plaintiff's attorney."¹¹⁸

The testimony in this trial revealed a sycophantic relationship between Dr. Brent and the attorneys representing Merrell Dow, a relationship which clearly affected the objectivity of his approach and the validity of his writing on the drug Bendectin. Dr. Brent submitted draft articles for approval by the attorneys representing Merrell Dow at the trial of this case. Plaintiffs presented to the jury Exhibit 344, an article entitled: "Bendectin: The Most Comprehensively Studied Human Non-Teratogen, and the Foremost Teratogen-Litigen." Dr. Brent expects to publish this article, as if medical literature, in a prestigious peer review journal, such as the New England Journal of Medicine, the Journal of American Medical Association or Obstetrics and Gynecology.¹¹⁹ The attorneys representing Merrell Dow at this trial had been sent drafts of this article for editing in June and, again, in July, 1993.¹²⁰ Dr. Brent testified he did not know whether it was common practice to permit attorneys to edit articles prior to publication in the medical literature."¹²¹ Dr. Brent perceived no ethical problem in the practice. Plaintiffs Exhibit 349 demonstrated attorney editing of this supposedly scientific literature. Dr. Brent was questioned concerning the substance of the editing of the "scientific" literature by Merrell Dow's lawyers:

Dr. Brent testified, unequivocally, that Bendectin cannot cause birth defects. Dr. Brent believes that the most common causes of birth malformations are due to inappropriate behavior by the mother during pregnancy."¹²³

Dr. Brent confirmed the same methodological approaches utilized by plaintiffs experts. Dr. Brent's methodology for determining teratogenicity was grounded in the same four scientific methodologies employed by plaintiffs experts: chemical structure activity; in vitro-analysis; animal studies; and human epidemiological data. Dr. Brent agreed with Dr. Done that "structure activity analysis" can be helpful.¹²⁴ Dr. Brent stated, "If you look --- if you look at a compound, a structure of a chemical compound, you can infer that there may be certain types of biological activity to that compound. In other words, it would fit into a certain class or have certain effects."¹²⁵ Plaintiff's experts testified, in part, based upon "structural activity analysis."

Dr. Brent testified that he has performed in vitro-studies and they "...can be considered with regard to determining whether there's a mechanism for a known teratogen."¹²⁶ In vitro-studies can be considered with regard to "determining whether there's an effect on those cells, or parts of tissues, in an effort to determine the mechanism of, possibly, how a drug or chemical works."¹²⁷ Plaintiff's experts testified, in part, based upon "in-vitro" studies.

Dr. Brent acknowledged the use of animal studies as a scientifically valid procedure in determining teratogeni city. Dr. Brent testified:

Plaintiff's experts relied in part upon the use of animal studies. Dr. Brent explained proper scientific methodology prior to human ingestion of a drug:

Dr. Brent placed preeminent value on epiderniologic results. Plaintiff's experts also relied on epidemiological data. The differences are not of methodology; only of conclusion.

By this appeal, defendant asks that the law of Pennsylvania be transmogrified so that each trial court can preside over a "scientific court whose primary function is to embody, as precepts of law, the current "generally accepted" opinion of any self-identified scientific establishment. Counsel claims that only generally accepted scientific principles and only subjects having "general agreement" should ever be permitted in court.¹³⁰ By this view, the trial judge becomes the courtroom door guardian for scientific conformity: and each trial judge creates, as precepts of law, his or her own individual determination of proper scientific orthodoxy.

Scientific understanding necessarily evolves and must continually create new concepts and theories which evolve into a new consensus, overthrowing outdated orthodoxy. From the retrospective of centuries, or possibly only decades hence, today's absolute truth will be seen as inadequate, naive or superstitious. This is the essence of the modern scientific endeavor. Nonetheless, by defendant's legal theory, judges, as doorkeepers, must seal the courtroom until "science," itself, reaches a new consensus. Defendant's principle would have precluded testimony by every seminal thinker in the history of the world, including Newton, Pasteur, Freud, Darwin and Einstein. The principles espoused by the defense would have precluded testimony on dynamics, noneuclidean geometry, calculus, the germ theory of disease, the subconscious mind, evolution and relativity. The courts, and thereby all society, would be locked into out-moded thought, erroneous principles and false "truths."

If the law becomes the handmaiden of every self-defining "science," each trial judge ran delusionally become the arbiter of ultimate reality; and whatever the judge accepts as a "generally accepted scientific principle" precludes any courtroom challenge. Castrating the fact-finding role of the jury, the judiciary becomes an absolute bar to legal inquiry, until a new "scientific consensus" claims the mantle of the divine revelation required to open the courtroom doors, but only to let in the new established orthodoxy. The testimony in this case demonstrates how "scientific consensus" can be created through purchased research and the manipulation of a "scientific" literature, funded as part of litigation defense, and choreographed by counsel. The courts of Pennsylvania need no self-appointed scientific door guardians in birth defect cases.

When ruling, on the Motion for Judgment Notwithstanding the Verdict, the court must review all testimony at the trial in the light most favorable to the plaintiff: "[the] evidence must be considered in the light most favorable to the verdict winner, and he must be given the benefit of every reasonable inference of fact arising therefrom; and any conflict in the evidence must be resolved in his favor."¹³¹

Each of the four approaches in scientific analysis employed by plaintiff's experts were endorsed by defense experts. In-vitro studies were accepted and never attacked by any expert as an unacceptable scientific methodology applicable to birth defect research.¹³² Chemical structure analysis was confirmed as an appropriate investigation into the likelihood or compatibility of the substance in question with the potential for birth defect.¹³³ In-vitro or animal studies formed the basis of defense testimony, and all the research conducted by Dr. Brent and Dr. Tyl: two self-proclaimed teratologists¹³⁴Results from animal studies are relevant even after epiderniologic results are available. Dr. Tyl and her research institute were retained by the FDA to re-examine Bendectin, through animal studies, lona after significant epidemiological data had become available and had been analyzed:

The conclusions reached by plaintiff's experts were, themselves, confirmed by expert defense testimony based upon epidemiological studies.¹³⁶ Although, the defense asks for adoption as an absolute principle of law that Bendectin can never cause birth defects, the studies and opinions offered at this trial are to the contrary. Dr. Klebanoff testified that Bendectin is positively associated with bilateral clubfeet.¹³⁷ Dr. Shapiro admitted that his work underestimated the risks of Bendectin causing birth defects.¹³⁸ Dr. Bracken found a statistically significant association between Bendectin with pyloricstenosis and heart failure anomalies;¹³⁹ and, in smoking mothers, a statistically significant association with "all defect categories . . . [including] clubbed feet (sic).¹⁴⁰ Dr. Stolley found that the data demonstrated "a woman who is exposed to Bendectin during the first twelve weeks [and took one more than one prescription^141], is three times more likely to have a malformation than a woman exposed later than twelve weeks. "¹⁴²

The jury was presented with different opinions, not different approaches; different conclusions based upon the same data. In sworn expert testimony, both in the presence of the jury and in colloquy outside of the presence of the jury, this court evaluated the methodology presented by plaintiffs experts and that methodology was affirmed. ¹⁴³

V. It is Not the Methodology of Plaintiff's Experts to Which Defendant Obiects: Onlv the Conclusion that Bendectin Caused Jeffrey Blum's Clubfeet

The fallacy of the principle that "scientific consensus" must control access to the courtroom is demonstrated by the testimony in this case. The potentially horrendous consequences of this ideological approach for any court system concerned with justice is vividly portrayed in the founding premise of the entire.. science of "teratology."¹⁴⁴ Teratology is the "science" that defendants claim to be the exclusive discipline for the issues raised in this case. Teratology is the science whose father is also the defendant's leading expert guru, Dr. Brent, and whose Bible appears to be the "peer review" journal, "Teratology."

The "science" of teratology was born with a simple basic premise upon which a consensus of teratologists agreed. This founding premise was the impermeability of the maternal womb."¹⁴⁵ Only after thousands of babies were born with stubs for arms and legs, doomed to a stunted and frustrating life of misery caused by maternal use of "Thalidomide," did the teratological "scientific community' consider that, possibly, it was mistaken in the basic organizing principle of their "science." Only when the incidence and causation of this human terata¹⁴⁶ became incontrovertible did the teratological establishment modify its consensus and consider the possibility that the placenta did not protect developing babies from harmful drugs. The impermeability of the placenta is a scientific principle tested and proven inaccurate, through epidemiologic studies in human misery.¹⁴⁷"Science" can wait for its truths to become tested and rejected. No just court system can permit orthodoxy to preclude redress.¹⁴⁸

The defendant claims that plaintiff's failure-to-warn claim is preempted by federal law. Without justification, defendant asked this trial court to overrule the Pennsylvania Supreme Court. In its own brief, defendant Merrell Dow states we recognize that the Pennsylvania Supreme Court has refused to find such preemption."¹⁴⁹ Defendant presents neither precedent, public policy, or purpose for adopting this extension of Federal preemption. There is no preemption.

The defendant asks this court to selectively reinstate the 1986 verdict which they had previously successfully contended was a constitutional nullity on appeal. Defendant claims that the prior jury verdict, which found no fraud, nullifies the fraud verdict rendered at this retrial.¹⁵⁰ The right to a jury twelve citizens can be waived. Since Merrell Dow did not waive their right to a jury of twelve in 1986, the verdict was a nullity.¹⁵¹ The defendant may not now choose which parts of a constitutionally invalid verdict it wishes to retain.¹⁵² This principle was recently reaffirmed by the Pennsylvania Supreme Court: "It has long been the law of this Commonwealth that the grant of a new trial restores the case to its original status to be tried de novo as to all parties and all issues."¹⁵³

Defendant claims that the evidence was insufficient to support the jury verdict of fraud. As more fully set forth above, the evidence presented demonstrated a manipulation of "scientific" literature amounting to fraud upon the medical community, upon the FDA, upon Joan Blum's doctor and upon Joan and Jeffrey Blum sufficient to sustain the jury verdict.

Defendant Merrell Dow purports to claim error in the instructions given to the jury. A jury charge must be reviewed in its entirety to determine whether any error was committed; and if so, whether any such error was prejudicial.154 Defendant does not contest any language contained in the charge; but rather, claims that plaintiffs fraud and warranty theories should never have been presented to the jury.

There is, of course, no direct connection between any prescription drug and the ultimate consumer, the patient, except that the drug manufacturer "educates" and markets the drug to the medical community. Few patients have any independent ability to evaluate either the usefulness of, or the dangers in the use of any prescription drug. That is why Federal law prohibited Joan Blum from obtaining Bendectin without a prescription from her doctor. Every patient must rely upon the skill and knowledge of her attending physician.

Dr. Jorgenson, Joan Blum's physician, prescribed Bendectin based on her belief that it was both effective and safe for the developing child in utero. This belief was based entirely upon the defendant's representations. As part of their campaign to aggressively market the drug to obstetricians, defendant represented Bendectin as a totally safe drug for the developing child in utero.

The Physicians' Desk Reference is the standard reference on which physicians rely to learn the proper use, efficiency, potential side effects and negative consequences of any prescription drug. Defendant inserted the following language into the PDR entry on Bendectin:

Through the language inserted in the PDR, the defendant expressly warranted to the ultimate consumer, Joan Blum, that there was no danger of birth defects in the use of Bendectin. Defendant further warranted that rat and rabbit studies revealed "no suggestion of drug-induced fetal abnormalities". This unambiguous and absolute language was chosen by defendant. The evidence presented at trial clearly demonstrated the inadequate and fraudulent data on which defendant based these assurances to the medical community. This express warranty upon which Dr. Jorgenson relied, to the detriment of Jeffrey Blum, was properly presented to the jury, which appropriately determined it was a legal cause of the injury.

Defendant Merrell Dow further claims that the issue of implied warranty should not have been presented to the jury. No objection to this charge was presented at either the first trial or the retrial of this matter. The issue has not been properly preserved for appeal. Even had objection been timely made, it is without merit. In Mellon vs. Barre-National Drug Co.,"¹⁵⁷ the Superior Court recognized the applicability of an implied warranty theory against a drug manufacturer. The only permissible use for Bendectin was avoiding nausea during pregnancy. The defendant wrongfully warranted Bendectin as safe for its only permissible use.

Likewise, Merrell Dow claims that it was an error to submit any failure to warn claim to the jury, alleging that, thereby, products liability concepts were injected into the case. The charge, as given, presented only a theory in negligence. The court instructed: "A pharmaceutical manufacturer is not required to warn of dangers which were impossible to know, given the state of knowledge at the time; but a pharmaceutical manufacturer is required to warn of dangers of which it knew, or, in the exercise of due diligence, should have known about at the time it marketed the drug in question."¹⁵⁸ The court, in its charge, clearly distinguished between a negligent failure to warn of the possible risks of using the product and any design or manufacturing defect. A fair reading of the entire jury instruction¹⁵⁹ clearly demonstrates the instructions are fully in accordance with the Superior Court ruling in Hahn vs. Richter.¹⁶⁰ There was no error in this charge and the claim of error is a post-trial construction. This claim was waived at trial.

In seven weeks of testimony encompassing over twenty-six thousand pages of transcript, the defendant claims error in three evidentiary rulings. Defendant claims that reversible error occurred when the court permitted reference to the first trial,¹⁶¹ reference to evidence of three hundred prior lawsuits and to a single reference to the Unisom label as reported in the PDR.

cross-examination to permit the jury to properly evaluate the objectivity with which the study was designed, conducted and reported. There was no error.

With regard to this issue, plaintiff offered the following point for charge: "Members of the jury, you are aware that this is the second trial of the case. The first case, as I have told you, ended in a verdict with eleven jurors. You are to decide this case on the evidence which was presented to you at this trial, without any speculation regarding the outcome of the first trial." Merrell Dow objected to this instruction. The jury was, nonetheless, clearly instructed that the verdict was to be based on evidence presented in this case. There can be no reversible error premised upon this oblique reference to the first trial and to the three hundred prior lawsuits.

Finally, defendant claims error in permitting into evidence the Unisom label as reported in the PDR. The content of this label was testified about by Dr. Done. This issue was discussed extensively at sidebar. The admission of the label, itself, was proper. There was no prejudice to outweigh its evidentiary value.

Finally, defendant Merrell Dow claims error in the court failing to instruct on proportionality in punitive damages. Again, the defendant claims error, even though this court followed the clearly established law of Pennsylvania.¹⁶³ It is well-established that the reasonableness of a punitive damage award is not evaluated in relation to the compensatory damages awarded. The jury is granted broad discretion to assess punitive damages to effectuate "punishment deterrence". In Kirkbride, the Supreme Court stated: "If the amount of punitive damages must bear a reasonable relationship to the injury suffered, then those damages probably would not.serve as a deterrent.¹⁶⁴ The punitive damages award must bear a reasonable relationship to "the character of the tortious act, the nature of plaintiffs harm, the extent of the harm suffered, the wealth of the defendant and the deterrent effect of the award.¹⁶⁵

In determining its punitive damages award, this jury reasonably considered the character of the act, the nature and extent of the harm and the wealth of the defendant. For eight weeks, this jury was presented with a defense premised upon a continuing claim of scientific validity to admittedly inadequate animal studies, the results of which had been fraudulently presented to the FDA on the very day that Jeffrey Blum was born. The jury learned that the wealth of the defendant was in excess of seven hundred and eighty million dollars.¹⁶⁶ The punitive damages actually awarded is a small percentage of the net worth of the defendant, and less than four times the compensatory damage award.¹⁶⁷

The jury heard testimony from thirteen year old Jeffrey Blum. The extent of the injury to this child is not limited to the operations he has had, or the future surgeries he faces. The extent of his loss was presented to the jury in his own words, prepared not for litigation, but as homework.

The beliefs we call science, in contrast to those we label magic or superstition, derive from conclusions drawn by methodical testing of hypotheses employing precision of definition, accuracy of observation and integrity of dispassionate analysis performed without preconception.

The record of this trial clearly demonstrated imprecision and inaccuracy in "scientific studies", including those which appeared in supposedly "peer-review" journals. Defendant claims there is a uniformity of scientific opinion. The extensive cross-examination of defendant's experts in this case shows this to be a mythological uniformity.¹⁶⁹

I. Is statistical analysis necessary to draw scientifically valid conclusions from studies?

While marketing Bendectin as a totally safe drug and proclaiming the safety of its use, defendant Merrell Dow relied upon the result of its own animal studies, results were never subjected to any statistical analysis. Thirty years later, at trial, Dr. Newberne testified in 1994 that statistical analysis is not necessary for scientific validity:

Is there no scientific consensus on this basic principle? Is Dr. Newberne, the only representative of defendant to take the witness stand at this trial, scientifically naive? Is this a question for the judiciary, acting as a "science court" to determine and then preclude Dr. Newberne or Dr. Tyl from testifying because one is wrong; or out of step with proper scientific orthodoxy; or is this the classic situation where a credibility determination (truthfulness and accuracy) should be made by a jury of twelve citizens?

II. Only a "statistically significant" correlation can be used to demonstrate scientifically acceptable causation, and only a 95 % interval can demonstrate statistical significance.

Defendant proposes the proposition that epidemiologic studies that demonstrate statistically significant positive association between the use of Bendectin by a pregnant mother and clubfeet in the progeny must be an absolute prerequisite to a finding of causation in court.¹⁷²

Dr. Shapiro, an epidemiologist called by defendant, testified that a positive association is statistically significant only if it is expressed to a "95 % confidence interval." On cross-examination, however, Dr. Shapiro acknowledged Dr. that Kenneth J. Rothman is a reputable authority in epidemiology. Dr. Shapiro acknowledged that in Dr. Rothman's works, he accepted a "90% confidence interval" as a valid scientific test for statistical significance.¹⁷³ In fact, Dr. Rothman wrote: ". . . the notion of 'statistical significance' could be expunged from the lexicon of the epidemiologist with no loss.¹⁷⁴

Dr. Klebanoff found a "strong positive association" between cataracts and vomiting despite wide confidence intervals.¹⁷⁵ Dr. Klebanoff was also willing to rule out an association between Bendectin and clubfeet despite the same confidence interval he found sufficient to associate cataracts with vomiting:

Can scientists employ intuition and understanding and make exceptions to the confidence interval requirement in their own writings and opinions, but insist that only strict scientific orthodoxy can be presented in court? Are these discrepancies for resolution as a matter of law; or is this not, again, the classic jury question?

The defendant contends that modern scientific inquiry is verified through publication in "peer review" journals which expose opinion to the critical inquiry of the scientific community. The defendant claims that modern scientific methodology and conclusions can only be evaluated through the use of peer review journal articles, and that all "peer review" journals are created equal.¹⁷⁷Testimony in this case clearly demonstrated that not all "peer review" journals are created equal. 'Studies on Bendectin., were published in the "Peer review" journal "Teratology "after having been rejected for publication by other more Prestigious journals. The testimony revealed that not all the articles contained in "peer review" journals were even reviewed for scientific validity before publication.¹⁷⁸ Articles were intentionally inserted in peer review journals for use in court. Studies for publication in peer review journals were tailored to the needs of litigation, and paid for out of defense funds. Most significantly, for the integrity of a judicial system, "scientific" articles for publication in "peer review" journals were edited before publication by lawyers litigating the issues presented in the article.¹⁷⁹ The testimony revealed that "follow-up" studies were solicited by the defendant through intermediaries, funded by the defendant: but the scientific methodology changed, to obscure positive findings. Peer review journals publish studies which are not good.

Experts Dr. Newberne and Dr. Tyl disagreed on scientifically acceptable dosing techniques in laboratory animals:

President Eisenhower warned the nation of a military industrial complex. The testimony in this case clearly demonstrates what a medical industrial complex can accomplish. The testimony demonstrated a medical-scientific peer review journal literature created and manipulated for use in the courts of