Plaintiff Cinderella Jones instituted this action to recover damages for a cancerous condition she allegedly suffered as a result of ingestion of "Ortho-Novum SQ," a contraceptive pill developed and manufactured by defendant Ortho Pharmaceutical Corporation (Ortho). At the close of plaintiff's case-in-chief, the trial court granted defendant's motion for nonsuit on the ground that the evidence was insufficient to establish a reasonable causal connection between the development or aggravation of the disease and the use of the suspect drug. On this appeal, plaintiff contends that there was sufficient evidence present to warrant the case going to the jury. We disagree and thus affirm the judgment of nonsuit.
Viewing the record in the light most favorable to plaintiff, as we must, the evidence adduced at trial reveals the following chronology of events.
Plaintiff was born in May 1952. Shortly before her 17th birthday she experienced her first act of premarital sexual intercourse. Plaintiff subsequently married and had one child. Approximately six months before the birth of that child, plaintiff underwent a vaginal examination and was diagnosed as having venereal warts but an otherwise normal cervix.
By August 1970, plaintiff had divorced her first husband and remarried. Some three weeks prior to her second marriage, plaintiff began taking oral contraceptives when a physician at Riverside General Hospital prescribed Norinyl, a product not manufactured by defendant. Prior to receiving the drug, however, a Pap test was performed, which was reported as a class II
A second Pap smear performed in December 1970, was reported as a class I, but revealed that plaintiff had contracted a trichomoniasis infection. In May 1971, some three and one-half months after discontinuing the drug, a third Pap smear indicated a class III condition with "atypical squamous cells suggestive of mild dysplasia."
In September 1971, plaintiff, then five months pregnant with her second child, underwent a cold conization procedure involving the removal of a small cone-shaped portion of her cervix. A subsequent biopsy of the cervical tissue revealed the presence of a precancerous condition known as carcinoma in situ. Thereafter, plaintiff had normal class I Pap smears, establishing that the cold conization had removed any trace of malignancy. One year later, however, plaintiff elected to have a vaginal hysterectomy by which her uterus was removed.
Ortho-Novum SQ manufactured by defendant until it was ordered off the market by the Food and Drug Administration in 1976, is termed a "sequential" birth control drug involving the administration of two different types of medication during a twenty-one-day period. The first tablet, containing an estrogenic compound known as mestranol, is generally taken for 14 consecutive days after which it is replaced by a second tablet composed of mestranol and a progestational compound, norethindrone. Ortho also manufactures a "combination" birth control drug, a mixture of mestranol and norethindrone, which is administered for 21 consecutive days of a 28-day cycle.
Plaintiff's condition, however, rapidly progressed from no dysplasia to carcinoma in situ within a 14-month period. Nevertheless, the medical experts called to testify at trial found it difficult, if not impossible, to establish a reasonable causal connection between ingestion of Ortho-Novum SQ and the development of plaintiff's disease.
Dr. Don Catlin, M.D., a specialist in pharmacology, testified that "there is a reasonable medical possibility," defined as less than a 50-50 chance, that the drug contributed to the development of the carcinoma in situ. His opinion was based in part on a review of 18 cases of carcinoma in situ which occurred during the premarketing clinical studies of Ortho-Novum SQ. Out of a total group of approximately 7,900 patients tested with the drug through February 1970, Dr. Catlin opined that there should have been only 2.04 cases of the disease instead of the 18 instances his study revealed.
Unlike Dr. Catlin, Dr. Michael Policar, M.D., a specialist in obstetrics and gynecology, was unwilling to state that the drug was a possible cause of plaintiff's carcinoma in situ. He testified "I think it [the birth control pill] may have been a contributing factor for the progression of [plaintiff's] lesion from dysplasia, whatever its starting point may have been to the end point of carcinoma in situ. I am specifically not implying that I think it caused the change from a normal to abnormal cervix."
In forming their opinions, both experts relied upon a study which revealed a statistically significant increase in the speed within which dysplasia develops into carcinoma in situ among women who use oral contraceptives. This increase, however, was observed only after five or six years of continuous use of such drugs. In relation to plaintiff's use of Ortho-Novum SQ for six months, Dr. Policar was unaware of any studies showing an acceleration of the disease process after such a short period of use.
Plaintiff's experts further testified that sexual intercourse at an early age, multiple partners, and the presence of venereal warts may also contribute to the onset of carcinoma in situ. Plaintiff denied, of course, that she fell into any of these categories.
With cancer the question of causation is especially troublesome. Cancer, a generic term covering all malignant tumors, is one of the leading causes of death in the United States today. Under the present state of scientific knowledge, however, it is frequently difficult to determine the nature and cause of a particular cancerous growth. This point was emphasized by Dr. Catlin during trial when he testified, "[F]rom what we know about cancer and drugs it is very difficult to say that there is a clear cause and effect between almost anything or any drug or any toxin and carcinoma...."
The fact that a determination of causation is difficult to establish cannot, however, provide a plaintiff with an excuse to dispense with the introduction of some reasonably reliable evidence proving this essential element of his case.
On this issue we find persuasive the following discussion from Parker v. Employer's Mutual Liability Ins. Co. of Wis., supra: "[I]n the absence of factual circumstances of probability understandable to a jury there must be some scientific testimony that can be interpreted as an inference of hypothetical probability before we can allow a jury to speculate upon the rights of citizens. [¶] ... If the experts cannot predict probability in these situations, it is difficult to see how courts can expect a jury of laymen to be able to do so. [¶] This requirement does in some instances place extraordinary burdens of proof on claimants. But once the theory of causation leaves the realm of lay knowledge for esoteric scientific theories, the scientific theory must be more than a possibility to the scientists who created it. For to the scientific mind, all things are possible. And with all things possible, citizens
In Haft, a father and son drowned in a motel pool where, in violation of statutory law, no lifeguard had been provided. There were no witnesses. Under those circumstances the Supreme Court held that the very violation of the statute — the failure to provide a lifeguard — made it impossible for the plaintiff to prove the cause of the drownings; hence the burden fell on the defendants to prove that the drownings would have occurred even if a lifeguard had been provided. In reaching this result the court reasoned that, "the shift of the burden of proof ... may be said to rest on a policy judgment that when there is a substantial probability that a defendant's negligence was a cause of an accident and when the defendant's negligence makes it impossible, as a practical matter for plaintiff to prove `proximate causation' conclusively, it is more appropriate to hold the defendant liable than to deny an innocent plaintiff recovery, unless the defendant can prove that his negligence was not a cause of the injury." (Id. at p. 774, fn. 19; italics added.)
The Haft rationale upon which plaintiff relies is in reality merely an extension of the doctrine of res ipsa loquitur. In Haft the physical cause of death was drowning. The instrumentality in which the drowning occurred, i.e., the pool water, was under the control of the defendant. Further there was a reasonable probability that the presence of a lifeguard would have prevented the drowning. Thus, the negligence being established, it was appropriate to presume causation.
Here plaintiff's case founders on the second step of the analysis. The first step, establishing the injury, was satisfied (here cancer and in Haft, drowning). The second step, the instrumentality which caused the injury and its control by the defendant (in Haft, the pool), is missing in plaintiff's case.
Plaintiff here would have us jump over step number two to step number three — the failure to comply with federal regulations (in Haft, the failure to
Under these circumstances the presumption of causation would be tantamount to a presumption of the instrumentality which caused the injury. Such a quantum leap is justified by neither logic, legal precedent nor public policy.
We are unpersuaded by plaintiff's contention that defendant's failure to comply with federal regulations made it impossible for her to prove causation. Nor will we, as plaintiff inferentially suggests, presume that had defendant conducted the clinical studies plaintiff contends should have been done, those studies would have established that defendant's product causes cancer.
There is a limit to the number of presumptions in which the court will indulge solely for the purpose of assisting plaintiff in proving a case, especially when there is no evidentiary starting point from which those presumptions can flow.
The judgment is affirmed.
Beach, J., and Gates, J., concurred.
Appellant's petition for a hearing by the Supreme Court was denied March 27, 1985. Bird, C.J., was of the opinion that the petition should be granted.