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LEIBOWITZ ET UX. v. ORTHO PHARMACEUTICAL CORP. (06/14/73)

decided: June 14, 1973.

LEIBOWITZ ET UX., APPELLANTS,
v.
ORTHO PHARMACEUTICAL CORP.



Appeals from judgment of Court of Common Pleas, Trial Division, of Philadelphia, March T., 1966, Nos. 6053 and 6054, in case of Bernard Leibowitz and Doris Leibowitz v. Ortho Pharmaceutical Corp.

COUNSEL

David N. Rosen, with him Rosen, Sherwin & Seltzer, for appellant.

Edward W. Madeira, Jr., with him Murray S. Levin, for appellee.

Wright, P. J., Watkins, Jacobs, Hoffman, Spaulding, and Cercone, JJ. (Packel, J., absent.) Opinion by Hoffman, J., in Support of Affirmance. Jacobs and Spaulding, JJ., join in this opinion. Opinion by Cercone, J., in Support of Reversal. Wright, P. J. and Watkins, J., join in this opinion.

Author: Per Curiam

[ 224 Pa. Super. Page 419]

The six judges who heard this appeal being equally divided, the judgment is affirmed.

Disposition

Judgment affirmed.

Opinion by Hoffman, J., in Support of Affirmance:

This appeal involves two lawsuits which were consolidated for trial. One action was in Trespass alleging negligence, the other in Assumpsit alleging breach of express and implied warranties. On September 8, 1970, the late Judge Joseph Sloane of the Common Pleas Court of Philadelphia, sitting without a jury, found for the defendant. Post trial motions were denied by a court en banc, and this appeal followed.

The original causes of action were instituted by Doris Leibowitz and her husband, the appellants herein, to recover damages for a thrombophlebitic condition that allegedly was suffered as a result of ingestion of "Ortho-Novum", a contraceptive pill developed by Ortho Pharmaceutical Corporation, the appellee.

The experimental life of this product and the medical history of the wife-plaintiff are crucial to this case. Therefore, a full discussion of events which took place before the instant cause of action accrued is necessary.

Doris Leibowitz was born in 1922 and enjoyed good health until 1947. In that year, as a result of an abruption of the placenta, she delivered a still-born child by

[ 224 Pa. Super. Page 420]

Caesarian section. Several days after delivery and while hospitalized, Mrs. Leibowitz developed thrombophlebitis, and was treated with anti-coagulants. After two Caesarian births, it was decided that further pregnancies might be injurious to appellant's health, and a tubal ligation was performed. During convalescence, appellant experienced pain in her hip and lower extremities, which was diagnosed as a mild thrombophlebitis.

During the next several years, various gynecological and systemic difficulties were observed by her physician. During 1962, appellant developed irregular menstrual periods, hemorrhoids, obesity, and periodic swelling of her legs, as well as a musculoskeletal problem evidenced by an antalgic gait favoring the left side. Early in 1963, in an attempt to regulate menses, appellant's gynecologist, Dr. Laurence Lundy, prescribed Enovid, a prescription drug. Because of breakthrough bleeding, Enovid was discontinued. In February of 1964, Dr. Lundy prescribed Ortho-Novum in a further attempt to regulate menses. Use of Ortho-Novum proved successful and no untoward results were experienced until August 27, 1964. While at her employment as a legal secretary, Mrs. Leibowitz suffered what was diagnosed as an acute thrombophlebitis in her left leg. She was treated for several weeks by Dr. Raymond Penneys and Dr. Robert Brooks as an in-patient at the Hospital of the University of Pennsylvania. Following this hospitalization, plaintiffs instituted suit against Ortho Pharmaceutical.

Ortho manufactures pharmaceutical products, including Ortho-Novum. This product is a combination of a progestational compound, norethindrone, and an estrogenic compound, mestranol, which was tested and shown to be effective and reliable for the prevention of conception. In 1960, Ortho prepared and submitted to the Food and Drug Administration a New Drug Application

[ 224 Pa. Super. Page 421]

    for Ortho-Novum, which was approved in 1962. The drug was marketed sometime in 1963.*fn1

Following FDA approval, a package insert accompanying the drug was supplied to the medical profession for guidance in writing prescriptions. The insert stated that Ortho-Novum was an oral contraceptive agent, and set forth the dosage and form of administration recommended to prevent conception. The insert could not be changed without FDA authorization.

Beginning in 1962, there were some medical discussions as to the possible association between thrombophlebitis and the use of progestin-estrogen combinations, as in Enovid and Ortho-Novum. Some individual case reports appeared as to the development of thrombophlebitis in patients taking Enovid. As a result of this debate, the FDA summoned a special ad hoc committee headed by Dr. Irving Wright to investigate the question of the possible association. The Committee conducted careful and comprehensive studies and concluded: "In summary, on the basis of the available data . . . no significant increase in the risk of thromboembolic death from the use of Enovid in this population group has been demonstrated."

On the basis of the Wright Committee Report, and with the approval of the FDA, Ortho inserted the following, in 1963, in its package insert accompanying its product:

"While this study does not resolve completely the possible relationship between progestational agents and intravascular clotting, it tends to confirm the opinions

[ 224 Pa. Super. Page 422]

    expressed by the Wright Committee. This Committee appointed by the United States Food and Drug Administration to review this problem published their deliberations in the J.A.M.A. It was their conclusion '. . . on the basis of the available data, there was no significant increase in the risk of thromboembolic death. . . .'

"The relationship of a contraceptive combination of an Estrogen-Progestational agent with thromboembolism and death therefrom, particularly in the older age group, is currently under investigation." Finally, under the heading Contraindications, the following appeared: "A few cases of thrombophlebitis have been reported on patients taking Ortho-Novum. Although there is no evidence to support a causal relationship between the use of Ortho-Novum and the occurrence of venous thrombosis, a definite recent history of thrombophlebitis and/or pulmonary embolism is considered a contraindication to the use of Ortho-Novum."*fn2

An article appearing in the Journal of the American Medical Association (JAMA), on February 22, 1964, reviewed the state of medical knowledge to that date, and reported that ". . . to date, there is no definite evidence etiologically linking intravascular thrombosis or embolism with the use of oral contraceptives."

In 1965, the World Health Organization (WHO) conducted further extensive investigation into the causal relationship between thrombophlebitis and oral contraceptives. Examining worldwide statistics of both users and nonusers of contraceptive drugs, the WHO reported:

[ 224 Pa. Super. Page 423]

"Thrombo-embolic disease has been encountered among women using oral contraceptives, just as it is among non-users. . . . The incidence of thrombophlebitis in non-pregnant women between the ages of 15 and 45 years is not known with certainty, but the best available estimates suggest that it is between 1 and 3 per thousand women per annum. The incidence in women using oral contraceptives is also uncertain . . . but in no reported series has it exceeded the above range. Further, the vital statistics from the United States of America show that while the age-specific death-rates attributed to this condition have risen during the period from 1950 to 1964 inclusive, a similar rise has occurred in the male. Finally, the trend shows no change during the 1960s, when oral contraceptives came increasingly into use in the USA." The WHO Report published in 1966 concluded:

"8.1 Little is known with certainty about contraindications to the use of oral contraceptives. It can be stated as a general principle that the prescribing physician should, in each individual case, weigh possible effects of the treatment against the effectiveness, acceptability and safety of available alternative contraceptive methods and against the known hazards of pregnancy. . . .

"8.4 From time to time yet other conditions have been suggested as contraindications to oral contraceptive use in the absence of convincing evidence of a cause-and-effect relationship but without a priori reasons for assuming one. These include thrombo-embolic disease. . . . There appears to be no justification for regarding these several conditions as contra-indications. However, it must be emphasized that, as with any therapeutic agent, the possibility of rare, individual idiosyncrasy cannot be overlooked."

There is little argument that the information contained in the package insert with regard to the possible

[ 224 Pa. Super. Page 424]

    association between the product and thrombophlebitis adequately reflected the facts known to Ortho, the medical profession and the research study groups at the time plaintiff sustained her illness on August 27, 1964. What is argued is that such causal connection existed and by reason of later studies indicating same plaintiff established a causative "link" between her condition and the use of Ortho-Novum. Plaintiff relies heavily on a British Report which appeared in April of 1968; that Report estimated a 7 to 10-fold increase in mortality and morbidity due to the embolic diseases in women taking oral contraceptives. As a result of the British study, the FDA caused Ortho to revise its insert to reflect the new findings.

At trial, plaintiffs called two expert witnesses, Dr. Penneys and Dr. Brook, who had seen Mrs. Leibowitz at the Hospital of University of Pennsylvania.

On direct examination, Dr. Penneys testified in the following manner in response to a question by plaintiff's counsel as to the cause of the thrombophlebitis:

"A. I didn't make up my mind any more than I do in any patient with thrombophlebitis. It is a condition which exists if a clot is there. . . . Q. Now, you mentioned that you had encircled Ortho-Novum. A. Yes. Q. Why did you do that? A. I think probably either in her mind or mine, or both, already there was a question as to this thing. . . . But so you encircle something you think might be directly pertinent, and that must have registered with me as something, bang, you have got to keep in your mind as you were going over this. . . . Q. Did you reach a conclusion or opinion as to the relationship? A. Enough, enough to convince myself as a practicing physician . . . to tell her what to do . . . to discontinue taking the pill, the Ortho-Novum." The net effect of this testimony was to create serious doubt if Dr. Penneys' "conclusion" expressed any opinion as to causal connection. As a result of the confusion, the

[ 224 Pa. Super. Page 425]

    trial court asked for a direct answer to the following: "Q. Have you reached an opinion as to cause and effect with reasonable medical certainty as to this episode which you began to see on August 27, 1964? A. I could say I have. Q. All right, Doctor, what is that opinion? A. I would say, and I can't give you a one word answer on that, but I could say that cause in all biology is never a pure situation. Q. Of course, with reasonable medical certainty. A. I would have to explain that. . . . A significant factor would have been taking the oral contraceptive. That's all -- based on my general impression."

Defense counsel cross-examined Dr. Penneys on this "opinion" to determine the true meaning and effect of it. Dr. Penneys reviewed plaintiff's previous medical history and admitted that she was predisposed (to thrombophlebitis). As such Dr. Penneys finally admitted that while the fact that plaintiff took oral contraceptives was "pertinent", he admitted that the condition suffered by plaintiff could have resulted from "other possible causes". Then, in determining at what point, Dr. Penneys had formed his "opinion" as to association, counsel asked the following: "Q. Doctor, some time after in 1965, I think, your file indicates that Mr. Rosen got in touch with you requesting your opinion on causation. Now, could you refer to your letter of May 8, 1965, and read it, please? A. '. . . In reply to your question concerning my thoughts on the relationship between Ortho-Novum and thrombophlebitis, I have no set ideas. . . . I know that there is a debate pro and con as to the relationship between this drug and thrombophlebitis, but it will take much research to establish the relationship. . . . My own opinion is that I have no strong fixed idea on the relationship between drugs such as Ortho-Novum and thrombophlebitis.' Q. That was your opinion at that time? A. Yes." Plaintiff's counsel tried to rehabilitate the opinion previously stated

[ 224 Pa. Super. Page 426]

    by Dr. Penneys to substantiate the causal connection. Defense counsel, however, established on re-cross that Dr. Penneys was basing his opinion on medical literature and studies that were published subsequent to 1964. Furthermore, counsel cast into serious doubt whether in fact Dr. Penneys had any concrete opinion with regard to causal connection. Counsel directed a question as to whether, despite plaintiff's previous medical history which evidenced a predisposition to a recurrence of thrombophlebitis, Dr. Penneys could conclude that Ortho-Novum was the cause of the 1964 thrombophlebitis. Dr. Penneys responded: "A. Is causally related? I refuse to use the term "cause" in any part of my practice. Q. What do you mean? I am at a loss, Doctor. Do you mean that it is something you want to rule out, that it is a possibility in there? A. . . . There is no one cause known in biological ...


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