Jones v. Ortho Pharmaceutical Corp.

Decision Date03 January 1985
PartiesCinderella R. JONES, Plaintiff and Appellant, v. ORTHO PHARMACEUTICAL CORPORATION, et al., Defendants and Respondents. Civ. B004876.
CourtCalifornia Court of Appeals Court of Appeals

Terence J. Mix & Associates by Terence J. Mix, Redondo Beach, for plaintiff and appellant.

Gibson, Dunn & Crutcher, Newport Beach by G. Edward Fitzgerald, Los Angeles, and Robert W. Loewen, Newport Beach, for defendants and respondents.

COMPTON, Acting Presiding Justice.

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 seventeenth 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 smear. 1 When the medication failed to alter her menstrual period, she returned to the hospital and received her first prescription of Ortho-Novum SQ. Plaintiff continued taking the drug for a period of six months through January 1971.

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." 2 A repeat Pap examination in June 1971, was again reported as a Class III, showing "squamous dysplasia of cervix." A cervical biopsy performed one week later diagnosed plaintiff as suffering from "moderate squamous dysplasia." Another Pap smear taken in July 1971, produced a similar diagnosis.

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. 3

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 fourteen 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 twenty-one consecutive days of a twenty-eight day cycle.

At trial, plaintiff contended that the ingestion of Ortho-Novum SQ was the cause of the carcinoma in situ or, in the alternative, that it caused an acceleration of the normal progression of the disease. Expert testimony was introduced to establish that carcinoma in situ of the cervix normally develops over a period of eighty-six months. 4

Plaintiff's condition, however, rapidly progressed from no dysplasia to carcinoma in situ within a fourteen 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 fifty-fifty chance, that the drug contributed to the development of the carcinoma in situ. His opinion was based in part on a review of eighteen cases of carcinoma in situ which occurred during the pre-marketing 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 eighteen 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.

Based upon the foregoing evidence, the trial court concluded that it was "beyond the capabilities of the jury to decide the issue of whether or not Ortho-Novum SQ caused plaintiff to suffer carcinoma in situ of the cervix, [or to determine] whether or not it accelerated the development of the dysplasia into a carcinoma in situ unless there was expert medical testimony on which the jury could reasonably base a finding of causation."

A nonsuit may be granted only where, disregarding conflicting evidence on behalf of the defendant and giving to plaintiff's evidence all the value to which it is legally entitled, therein indulging in every legitimate inference which may be drawn from that evidence, the result is a determination that there is no evidence of sufficient substantiality to support a verdict in favor of the plaintiff. (O'Keefe v. South End Rowing Club (1966) 64 Cal.2d 729, 733, 51 Cal.Rptr. 534, 414 P.2d 830; Reynolds v. Willson (1958) 51 Cal.2d 94, 99, 331 P.2d 48.) Neither the appellate court nor the trial court may weigh the evidence nor consider the credibility of the witnesses. (Lasry v. Lederman (1957) 147 Cal.App.2d 480, 488, 305 P.2d 663.)

In determining whether a nonsuit was properly granted the reviewing court must resolve every conflict in testimony in favor of the plaintiff and at the same time indulge in every presumption and inference which could reasonably support the plaintiff's case. (Salter v. Keller (1964) 224 Cal.App.2d 126, 128, 36 Cal.Rptr. 430.) The rules governing the granting of a nonsuit, however, do not relieve the plaintiff of the burden of establishing the elements of his case. The plaintiff must therefore produce evidence which supports a logical inference in his favor and which does more than merely permit speculation or conjecture. (Morgenroth v. Pacific Medical Center, Inc. (1976) 54 Cal.App.3d 521, 530, 531, 126 Cal.Rptr. 681.) If a plaintiff produces no substantial evidence of liability or proximate cause then the granting of a nonsuit is proper. (Rufo v. Nat. Broadcasting Co. (1959) 166 Cal.App.2d 714, 720, 334 P.2d 16.)

In the instant case, the only evidence relating to the causal connection between Ortho-Novum SQ and plaintiff's precancerous condition is the highly conjectural and ambiguous testimony of Drs. Catlin and Policar that the ingestion of the drug may have had some effect on the development or progression of the disease. The question is whether such evidence meets the test of proximate cause. We believe it does not.

The law is well settled that in a personal injury action causation must be proven within a reasonable medical probability based upon competent expert testimony. Mere possibility alone is insufficient to establish a prima facie case. (Morgenroth v. Pacific Medical Center, supra, 54 Cal.App.3d at p. 533, 126 Cal.Rptr. 681; Johnston v. Brother (1961) 190 Cal.App.2d 464, 473, 12 Cal.Rptr. 23; Pacific Employers Insurance Co. v. Industrial Accident Commission (1960) 182 Cal.App.2d 162, 165, 5 Cal.Rptr. 738.) That there is a distinction between a reasonable medical "probability" and a medical "possibility" needs little...

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