Leibowitz v. Ortho Pharmaceutical Corp.

• Decision Date: 14 June 1973
• Citation: 307 A.2d 449,224 Pa.Super. 418
• Parties: Bernard LEIBOWITZ and Doris Leibowitz, his wife, Appellants, v. ORTHO PHARMACEUTICAL CORP. (two cases).
• Court: Pennsylvania Superior Court

307 A.2d 449

224 Pa.Super. 418

Bernard LEIBOWITZ and Doris Leibowitz, his wife, Appellants, v. ORTHO PHARMACEUTICAL CORP. (two cases).

Superior Court of Pennsylvania.

June 14, 1973.

Rosen, Sherwin & Seltzer, David N. Rosen Philadelphia, for appellants.

Edward W. Madeira, Jr., Philadelphia, for appellee.

Before WRIGHT, President Judge, and WATKINS JACOBS, HOFFMAN, SPAULDING, CERCONE and PACKEL, JJ.

PER CURIAM.

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

HOFFMAN, J., files an opinion in support of affirmance, in which JACOBS and SPAULDING, JJ., join.

CERCONE, J files an opinion in support of reversal in which WRIGHT President Judge and WATKINS, J., join.

HOFFMAN, Judge, 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 County, sitting without a jury, found for the defendant. Post trial motions were denied by a court en banc, and this appeal followed.

The original cause 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 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 for Ortho-Novum, which was approved in 1962. The drug was marketed sometime in 1963. ^[1]

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. Teh 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 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.' ^[2]

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:

'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 contra-indication 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 thereapeutic 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 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...