Bichler v. Eli Lilly and Co.

• Decision Date: 24 February 1981
• Citation: 436 N.Y.S.2d 625,79 A.D.2d 317
• Parties: Joyce BICHLER, Plaintiff-Respondent-Appellant, and Max Bichler, Plaintiff, v. ELI LILLY AND COMPANY, Defendant-Appellant-Respondent, Bronx-Lebanon Hospital Center and Abraham Fleischer, Defendants.
• Court: New York Supreme Court — Appellate Division

Page 625

436 N.Y.S.2d 625

79 A.D.2d 317

Joyce BICHLER, Plaintiff-Respondent-Appellant and Max Bichler, Plaintiff, v. ELI LILLY AND COMPANY, Defendant-Appellant-Respondent Bronx-Lebanon Hospital Center and Abraham Fleischer, Defendants.

Supreme Court, Appellate Division, First Department.

Feb. 24, 1981.

Russel H. Beatie, Jr., New York City, of counsel (Blair C. Fensterstock and Colin W. Ewing, New York City, with him on the brief; Dewey, Ballantine, Bushby, Palmer & Wood, New York City, attorneys), for defendant-appellant-respondent.

Alfred S. Julien, New York City, of counsel (Sybil Shainwald, Leonard J. Finz and David Jaroslawicz, New York City, with him on the brief; Julien, Schlesinger & Finz, P. C., New York City, attorneys), for plaintiff-respondent-appellant.

Robert J. Sisk, New York City, of counsel (Hughes, Hubbard & Reed, New York City, attorneys), for Merck & Co., Inc., amicus curiae.

Kathy Ann Bennett, New York City, for New York State Consumer Protection Bd., amicus curiae.

Myrna P. Field and Joseph W. Marshall, III, Philadelphia, Pa., of counsel (John G. Collins, New York City, attorney), for Mid-Atlantic Legal Foundation, Inc., and Leonard J. Theberge, amici curiae.

Before KUPFERMAN, J. P., and BIRNS, FEIN and SANDLER, JJ.

KUPFERMAN, Justice.

Plaintiff Joyce Bichler brought this product liability action against defendant Eli Lilly and Company (Lilly) and two other defendants for damages sustained by her as a result of the use of the prescription drug diethylstilbestrol (DES), a synthetic estrogen, which her mother ingested in 1953 while pregnant with plaintiff.

At the age of seventeen, plaintiff was diagnosed as having carcinoma of the cervix and vagina. In 1972, she underwent a radical hysterectomy which removed her ovaries, both fallopian tubes and two-thirds of her vagina. As a result of that operation, she cannot bear children and, as she has testified, her sexual relations with her husband are also impaired.

In 1974, she and her father brought this action against Lilly as the alleged manufacturer of the DES pills plaintiff's mother ingested, and against two other defendants who are no longer parties to the action. The claims of Mr. Bichler, the father, were barred due to the running of the statute of limitations.

A bifurcated trial was ordered by the trial court at Lilly's request. The first, a trial on the issue of manufacturer identification, commenced in May, 1979. At this identification trial, the jury found that plaintiff had not established by a fair preponderance of the credible evidence that defendant Lilly was the manufacturer of the DES pills her mother had taken. DES, as a generic drug, was, and still is, manufactured by a number of drug companies. Lilly dominated the market at the time DES was approved by the Food and Drug Administration (FDA) and at the time plaintiff's mother used it. ¹ As a major producer of the drug, Lilly also sold DES in bulk to other drug companies for use under their own names, a common practice in the drug industry. The pills Mrs. Bichler ingested were not identifiable by any markings. The dispensing pharmacist testified at this trial that he had stocked DES from four or five manufacturers, including Lilly, but was not able to recall, nor did he have the records to establish, which pills he chose to fill the prescription for plaintiff's mother. Plaintiff appeals from this verdict as against the weight of the evidence and claiming other errors committed by the trial court.

First, although the trial court did conduct most of the voir dire itself, objection to that practice is rendered meaningless where, as here, the record is clear that counsel for both parties had ample opportunity to scrutinize prospective jurors. Secondly, no prejudice to either party is shown by the fact that the court, after a thorough questioning by himself and both counsel, permitted a pharmacist's wife to become a juror. We find it significant that in this instance plaintiff did not challenge the juror for cause. We also find plaintiff's other claims of error to be without merit and further hold that upon review of the record, the jury's finding that Lilly was not proven to be the manufacturer of the DES pills ingested by Mrs. Bichler is not against the weight of the evidence.

Plaintiff, in her amended complaint, had claimed in the alternative that Lilly could be found liable even if it had not manufactured the DES Mrs. Bichler ingested. At the second trial on this issue, the jury answered seven interrogatories, found Lilly liable and awarded damages in the sum of $500,000, plus costs, disbursements and interest. The verdict was reduced by the amount of a settlement with defendant doctor who prescribed the drug. In this second phase of the action, plaintiff proceeded against Lilly alone, as a tortfeasor jointly and severally liable. Plaintiff did so on an expanded theory of concerted action claiming Lilly and other manufacturers of DES did wrongfully test and market this drug for treatment of accidents of pregnancy. Lilly appeals from that part of the judgment based on the second verdict.

DES is synthesized from a coal tar derivative and is two and a half times more potent than natural estrogen. DES was developed in England in the late 1930's. It has never been patented.

As early as 1939, Lilly and other drug manufacturers filed applications with the FDA for permission to market the drug. These first filings were rejected because the basis of these applications were entirely foreign studies. In order to facilitate the second filing, twelve manufacturers, including Lilly, were convened at the behest of the FDA and agreed to cooperate with each other in the approval process. Thereafter, these twelve worked through a voluntarily formed committee known as the "Small Committee", which consisted of representatives of four of these companies and which was chaired by Lilly. Dr. Klumpp, the Chief Medical Officer of the FDA, who had requested the meeting, testified that he was told the Small Committee was formed to expedite the handling of the investigations and would represent the industry. The Small Committee pooled all clinical data pertaining to DES for submission. Lilly's literature became the model for the literature used as the package insert. This literature contained warnings that use of the drug was contraindicated only for women who had cancer or precancerous lesions of the breast or cervix, or had a family history of high incidence of breast or genital malignancy. At this trial, Dr. Hines, Chairman of the Small Committee and the physician heading Lilly's DES project in 1939 and 1940, testified that in conjunction with the work on the drug, he believed he had read every article he could obtain on DES. Although the subsequent FDA approval was limited to use for several conditions, none of which related to pregnancy, there was evidence presented at trial that Lilly was even then contemplating use of DES for toxemia in pregnancy.

In 1947, Lilly and other drug companies filed supplemental applications with the FDA for permission to market DES for treatment of certain complications of pregnancy involving early termination of the pregnancy or death of the fetus. The dosage contemplated for this use was several times stronger than the maximum permitted in 1941. This application was made primarily on the strength of two studies by independent researchers, which indicated that DES therapy saved a significant percentage of such high risk pregnancies. ²

Despite the favorable indications of the specific studies relied on, ³ serious questions had also been presented, some prior to FDA approval and others prior to use by plaintiff's mother, concerning the drug's potential carcinogenic effect and its efficacy for accidents of pregnancy. ⁴

Expert testimony was presented at trial to establish the state of scientific knowledge at the time of application to the FDA and during the following years prior to the date DES was prescribed for Mrs. Bichler. It was well known, before FDA approval was sought, that substances given a pregnant woman would pass through the placenta into the fetus. It was also well known that there were available tests on mice which, if conducted, would have demonstrated within six months the danger of cancer developing in the fetus after it had reached its maturity. In fact, three prominent Chicago physiologists had administered DES to rats and mice in 1939 and concluded that the hormone crossed the placenta and had malforming action on the fetus. In 1938, Dr. Charles Dodd, one of the British researchers responsible for synthesizing DES, had published a paper with respect to his findings in relation to DES. In his summary of conclusions, Dr. Dodd stated that DES could actually cause miscarriages or abortions, not save them. In the late '40's, one of the studies cited in Lilly's supplemental application specifically questioned:

1. Will diethylstilbestrol in large doses cause pituitary or other glandular imbalance which will become manifest later in life?

2. Is diethylstilbestrol in such large doses carcinogenic, and as such unsafe to give even to pregnant women?

3. Can diethylstilbestrol in any way affect the glandular balance of the child in utero, particularly the male child?

Rosenblum, G., Melinkoff, E., Preservation of the Threatened Pregnancy with Particular Reference to the Use of Diethylstilbestrol, 55 Western J.Surg.Obstet. & Gynec. 597, at 601 (Nov. 1947). These reservations, however, were not noted on the application. Several other studies appearing in the period 1950-1953 questioned the efficacy of DES for complications of pregnancy. ⁵ There was, therefore, in existence in the period before Mrs. Bichler's consumption of DES not only doubts as to efficacy but also scientific criticism of the lack of proper controls in those studies which had advocated use of DES. Despite these reservations, it is undisputed that none of the companies...