On appeal from Superior Court of New Jersey, Law Division, Monmouth County.
Deighan and Landau. The opinion of the court was delivered by Deighan, J.A.D.
[229 NJSuper Page 232] Plaintiffs John Thompson, an infant, by his Guardian ad litem, Carol Thompson, and Carol Thompson, individually*fn1 instituted a malpractice action against defendants for deformities sustained at birth by John as a result of Carol's ingestion
of Bendectin*fn2 during the early stages of her pregnancy. The drug is manufactured by defendant Merrell Dow Pharmaceuticals, Inc. (Merrell Dow) and was allegedly prescribed by defendant obstetricians Massimo Maresca, M.D. and William Kaufman, M.D., trading as Shore Ob/Gyn, plaintiff's original obstetricians.
Plaintiffs filed an action against Merrell Dow for breach of expressed and implied warranties of fitness and merchantability, and strict liability in the manufacture and distribution of a defective product. Plaintiffs contend that the doctors were negligent in prescribing the drug and failing to warn plaintiff Carol Thompson of its dangers. They also contend that the doctors are liable under the concept of strict liability. Plaintiff John sued for the birth defects he sustained as the result of his mother's ingestion of the drug, and plaintiff sued for loss of consortium.
Summary judgment was entered in favor of defendant doctors after plaintiff conceded that she had no medical expert who could testify that they had deviated from acceptable standards of medical care in allegedly prescribing the drug to her. The motion judge also rejected plaintiffs' claim under strict liability against the medical doctors. After commencement of the trial against Merrell Dow, the trial judge refused to qualify plaintiffs' expert as a witness on the issue of causation. Since plaintiff had no other expert on that issue, the trial court granted defendants' motion for a judgment of involuntary
dismissal. R. 4:37-2(b). Plaintiffs also challenge an order which bifurcated the issues of liability and damages.
Plaintiff further challenges the trial court's refusal to allow her to introduce into evidence the transcripts or video taped testimony of 12 expert witnesses who had testified at a consolidated proceeding in the United States District Court in Ohio. In re Richardson-Merrell, Inc. Bendectin Products, 624 F. Supp. 1212 (S.D.Ohio 1985), aff'd in part, vacated in part, and remanded, sub nom. In re Bendectin Litigation, 857 F.2d 290 (6th Cir.1988) (hereinafter Bendectin Products). This action was brought by a group of plaintiffs who sued Merrell Dow for birth defects allegedly caused by Bendectin.
Essentially, the relevant facts concerning the legal issues raised are not in dispute. Plaintiff became pregnant sometime during the end of May or the beginning of June 1980. She first consulted with Drs. Maresca and Kaufman in August 1980. She testified that beginning in June she was nauseous every morning and that she vomited and felt light-headed. On her first visit Dr. Kaufman gave her an internal examination and some vitamins and iron. On her second visit, approximately two weeks later, she stated that Dr. Kaufman gave her a prescription for Bendectin for her symptoms. She claimed that she had the prescription filled and took approximately three pills each day for a period of two weeks until the prescription ran out. Since she did not feel any better, she spoke to Dr. Wiley, her family physician who advised her to stop taking the Bendectin. She testified she took no other drugs before her son, John, who was born on March 1, 1981, was delivered by another doctor. It was stipulated that John was born with three birth defects: an imperforate anus, one kidney, and a microphalalmic (abnormally small and blind) right eye. Plaintiff claimed that there were no warnings concerning Bendectin and that, had she been told about the risks of Bendectin to her baby, she would not have taken the drug.
Plaintiffs' only expert, Dr. Earl E. Aldinger, has a Bachelor of Science degree in chemistry, a Master of Science degree in pharmacology, and a Doctor of Philosophy degree in pharmacology. He taught pharmacology and toxicology from 1961 until 1973, when he had become the director of basic science research at the United States Public Health Service Hospital in Louisiana. He also did research over the years in the fields of cardiovascular pharmacology, physiology and biochemistry. In 1980, he went into semi-retirement and in 1982 became a clinical consultant. Aldinger had won two awards in the field of heart research and wrote 22 articles which appeared in various publications dealing with the effects of drugs on animals used in experimentation. He admitted that all of these articles and all of his research dealt with the cardiovascular field only and that he never performed any drug screening, drug evaluation, or experimental or laboratory work on Bendectin. On November 8, 1985, he gave a terse written opinion concerning the causal relation between John's present condition and Bendectin:
John Thompson was born with severe birth defects on March 1, 1981 at Monmouth Medical Hospital (Center). These defects included a non-patent anus (imperforate anus), absence of a kidney and blindness in the right eye. The child underwent a colostomy on March 1, 1981, cystoscopy on March 16, 1981, surgical repair of his imperforated anus on March 27, 1982, excision of rectal prolapse on September 16, 1982 and closure of the colostomy on November 1, 1982.
The patient's mother, Carol Ann Thompson, was prescribed the antinausea drug Bendectin (doxylamine succinate and pyridoxine hydrochloride) during her first trimester of pregnancy. The fetus is in a crucial stage of development during this period of gestation and is extremely susceptible to the toxic effects of drugs. Bendectin has been shown to have severe terotogenic effects in both animals and humans.
It is my professional opinion as a pharmacologist that Bendectin was the probable cause of John Thompson's severe birth defects.
All opinions expressed above are with probable medical*fn* certainty and I will support them at deposition and in court.
On voir dire Aldinger admitted that he was prepared to give only a pharmacological opinion as to the toxic effect of Bendectin. On cross-examination, he further conceded that the relationship
between Bendectin and John's physical condition would have to be determined by a physician:
Q. Is it my understanding, sir, that you believe that you are here to give an opinion upon the issue of a product known as Bendectin and whether or not that product caused a birth defect in the fetus of a pregnant woman; in other words, caused an adverse birth outcome?
A. No, I'm here to give a pharmacological opinion as to Bendectin and what the toxic effect of this drug has been shown to do and can do.
A. -- and how it relates to this child would have to be up to the physician.
Aldinger acknowledged that he was not qualified to render a diagnosis on the etiology, or cause, of John's condition, and that such a diagnosis would have to be made by a physician. He also acknowledged that he was not qualified to render an opinion in the fields of teratology (the study of the malformation of an embryo or fetus) or epidemiology (the study of the rate of occurrence of a disease or the effects of drugs on such diseases).
Defendant then moved to preclude Aldinger from further testimony because of his lack of expertise. At this point plaintiffs' attorney, at a sidebar conference, requested an opportunity to re-open his direct examination concerning the background and expertise of Aldinger concerning "the particular studies that he's [Aldinger] done that enable him to offer an opinion as to the effects of Bendectin on the baby in this case." Plaintiffs' counsel related that Aldinger relied on some four publications to formulate his opinion.*fn3 At this point Judge Selikoff suggested an Evid.R. 8 hearing to further determine whether the witness could offer an expert opinion on the issue of causation between Bendectin and John's physical condition at birth. However, defense counsel was permitted to finish his initial voir dire cross-examination before the jury during which
he again admitted that he was not qualified to examine John concerning the cause of his condition.
After further cross-examination, plaintiffs' counsel renewed his application for an opportunity to re-open direct examination on voir dire in order to attempt to demonstrate that Aldinger was
a qualified pharmacologist even though he has not dealt with this particular drug based upon his studies which I would develop if I get past this stage -- that based upon his studies of the drug as reported in the literature is qualified to offer his opinion as a pharmacologist of the effects of the drug.
At the Rule 8 hearing, Aldinger again testified that he had never done any "hands-on" work regarding the effects of Bendectin, the effects of any drug on any area other than the cardiovascular system, or the effects of any drug on a developing embryo or fetus. He claimed that he had studied antihistamines, a group in which one of the components of Bendectin belonged, and that he knew that antihistamines were known to be teratogenic, i.e., causing defects in embryos or fetuses.
Aldinger's opinion that antihistamines could have a teratogenic effect was based solely on what he had read, largely in preparation for this litigation. Aldinger then referred to a list of teratogenic drugs published in Casarett and Doull's Toxicology. Actually this list was only of drugs "thought" to be teratogenic but which had never been so proven. Moreover, Bendectin itself was not on the list of teratogenic drugs, but only antihistamines as a group was on the list.*fn4 Nevertheless, Aldinger opined that all antihistamines were central nervous system depressants and since the molecular weight of doxylamine succinate (the component of Bendectin which was classified as an antihistamine) was less than 600, it could pass through the placenta barrier and reach the fetus. Based on
this, Aldinger felt that Bendectin probably played a part in John's birth defects. While Aldinger relied upon the table entitled "Drug and Chemical Toxicity in the Human Fetus" at page 171 for his opinion that Bendectin is a teratogen, page 172 of the same publication states:
Antihistamine antiemetics, such as meclizine and cyclizine, used in treatment of nausea and vomiting of early pregnancy, have also been incriminated as suspect teratogens. Large doses of meclizine produce a high incidence of cleft palate in rats. The evidence, although scanty, circumstantial, and mostly retrospective, prompted one European country to remove the drug from the market. Subsequently, other studies emerged, some incriminating the drug as teratogenic and others declaring it innocent. Retrospective studies have been inconclusive and prospective data available do not show any cause-and-effect relationship. [Emphasis supplied.]
In forming his opinion, Aldinger also relied upon a 1981 article in 2 Lancet (1981), a British medical journal, which was written by J. B. Hall, whom he believed to be the editor. He pointed out that the article demonstrated that doxylamine succinate was responsible for five out of 1,000 malformations at birth. Id. at 154-155.
On cross-examination of Aldinger concerning the validity of the letter in the Lancet publication, it was revealed that the article he relied upon actually was a letter to the editor by a layman who is the parent of an English child with birth defects. J. B. Hall, the writer, signed himself as the Secretary to the Debendox Action Group, a parents' association which seeks to promote litigation on behalf of children with birth defects allegedly attributable to Debendox, the English tradename for Bendectin. The letter to the editor by Hall was followed by an editor's note.
A paper . . . in last week's B.M.J. [British Medical Journal], with some information on the timing of ingestion, concluded that 'Debendox' "is not specifically incriminated as a cause of fetal malformation." The Committee on Safety of Medicines [C.S.M.] has reached a similar conclusion. [ Id. at 155; emphasis supplied.]
Page 159 of that volume of Lancet states that, "[t]he C.S.M. sticks to its view of 'Debendox' . . . there is no scientifically acceptable evidence that Debendox causes harm to the fetus."
Finally, Aldinger claimed that he had relied on an article written by Kolata and found on page 518 of the October 31, 1980 issue of Science, entitled "How Safe is Bendectin?" The article was a report by a layperson of a hearing conducted by the Federal Drug Administration concerning evidence that Bendectin causes birth defects. The sub-heading of the article stated ...