Incollingo v. Ewing

• Decision Date: 25 January 1971
• Docket Number: 410,No. 410,No. 395,408,No. 408,Nos. 395,395,s. 395
• Parties: , 444 Pa. 299 Mary Ann INCOLLINGO, a minor, by Vincent Incollingo, her guardian, and Vincent Incollingo and Connie Incollingo v. Peirce G. EWING, Defendant, and Parke, Davis and Company, Domenico Cucinotta, M.D., Lederle Laboratories, Division of American Cyanamid Company, and Samuel I. Levin, D.O., Additional Defendants. Appeal of PARKE, DAVIS AND COMPARNY, Additional Defendants (). Appeal of Samuel I. LEVIN, D.O., Additional Defendant (). Appeal of Domenico CUCINOTTA, M.D., Additional Defendant ().
• Court: Pennsylvania Supreme Court

Page 206

282 A.2d 206

444 Pa. 263, 444 Pa. 299

Mary Ann INCOLLINGO, a minor, by Vincent Incollingo, her guardian, and Vincent Incollingo and Connie Incollingo v. Peirce G. EWING, Defendant, and Parke, Davis and Company, Domenico Cucinotta, M.D., Lederle

Laboratories, Division of American Cyanamid

Company, and Samuel I. Levin, D.O.,

Additional Defendants.

Appeal of PARKE, DAVIS AND COMPARNY, Additional Defendants

(No. 395).

Appeal of Samuel I. LEVIN, D.O., Additional Defendant (No. 408).

Appeal of Domenico CUCINOTTA, M.D., Additional Defendant (No. 410).

Nos. 395, 408, 410.

Supreme Court of Pennsylvania.

Jan. 25, 1971.

On Rehearing Oct. 12, 1971.

Roberts, J., concurred and filed opinion.

Bell, C.J., dissented in part and filed opinion.

Cohen, J., did not participate in decision.

Roberts, J., dissented from opinion on reargument and filed opinion.

Jones, J., did not participate in consideration or decision of the case.

[444 Pa. 300] William B. Freilich, Philadelphia (Joseph G. Manta, Philadelphia, on rehearing) for Samuel I. Levin, D.O.

Edward W. Madeira, Jr., Philadelphia, (Marilyn Mauskopf, James T. Giles, Philadelphia, on rehearing) for Parke, Davis and Co.

Francis E. Shields, Philadelphia (Dolores B. Spina, Pepper, Hamilton & Scheetz, Philadelphia, of counsel, on rehearing) for Domenico Cucinotta, M.D.

James E. Beasley, Philadelphia (Jeffrey M. Stopford, Beasley, Hewson & Casey, Philadelphia, on rehearing) for appelees.

Before BELL, C.J., and JONES, COHEN, EAGEN, O'BRIEN, ROBERTS and POMEROY, JJ.

OPINION OF THE COURT

POMEROY, Justice.

We have before us three appeals from the judgments entered on jury verdicts in favor of plaintiffs, the parents and administrators of the Estate of Mary Ann Incollingo (herein 'Mary Ann'), a minor, on account of injuries to and the death of the minor allegedly caused by the wrongful administration of the drug known as Chloromycetin, a trade name for Chloramphenicol, a broad spectrum antibiotic. ¹ The original defendant was Peirce G. Ewing, a druggist, the complaint charging that he negligently provided Chloromycetin without prescription. Ewing joined as additional Following is an abbreviated recitation of the facts given rise to the suit. Mary Ann was born on December 29, 1955. Dr. Cucinotta was her pediatrician and first saw her five days after birth. In the four years following he saw and treated Mary Ann for the ordinary childhood diseases. In October, 1958 and again in July, 1959 he saw Mary Ann for a condition he diagnosed as 'acute catarrhal rhinopharyngo tonsillitis.' On the latter occasion he noted a 'complicating abdominal pain, possibly mesenteric adenitis' (an infection of the mesentery glands of the stomach). He considered her condition to be caused by a staphylococcus aureus coagulose positive infection. On both occasions he prescribed Chloromycetin, and the child responded well. On January 22, 1960, some six months later, her parents brought Mary Ann to the doctor's office. Dr. Cucinotta made the same diagnosis, and again prescribed Chloromycetin. The prescription was for 2 ounces, and could be refilled but once. At no time did Dr. Cucinotta take blood tests or make bacteriologic cultures.

defendants Domenico Cucinotta, M.D., Samuel Levin, D.O., and Parke, Davis and Company (Parke, Davis). ² The third party complaints against both Dr. Cucinotta and Dr. Levin alleged that they had caused or contributed to the injuries of the minor plaintiff by negligently prescribing Chloromycetin in disregard of its possible dangerous side effects. The third party complaint against Parke, Davis, the manufacturer of the drug, alleged that it negligently failed to warn the plaintiffs, the defendant and the additional defendants of the dangerous effects of the drug, failed to perform proper tests on the drug, and failed to take necessary precautions to avert the injuries complained of. After a [444 Pa. 270] lengthy (7 week) trial, a jury verdict was returned in favor of the original defendant, Ewing, ³ and against all additional defendants in the sum of $215,000. The verdict was comprised of $200,000 to Mary Ann's estate and $15,000 to her parents in their own right. Motions for judgments notwithstanding the verdict and, alternatively, for a new trial, filed by each additional defendant, were refused and judgments entered on the verdicts, and from such judgments these appeals were taken. We affirm.

In February, 1960 Mary Ann's mother felt that Mary Ann had a respiratory infection (she had developed a cold and some hoarseness). Mrs. Incollingo asked Ewing to refill the January 22 prescription of Chloromycetin. One refill having already been furnished, Ewing told her that a physician's authorization would be required. According to Dr. Cucinotta, Ewing telephoned him to ask if the prescription could be refilled, and he answered in the negative. Mrs. Incollingo then called Dr. Levin, an osteopathic physician of whom she was a patient, asking that he authorize renewal of the prescription. Dr. Levin testified that Mrs. Incollingo told him Dr. Cucinotta was not available. Without seeing or examining Mary Ann, Dr. Levin telephoned Ewing and authorized a refill of the prescription. At least one additional refill of the prescription was obtained in the same manner. Mrs. Incollingo did not administer the medicine to her daughter in accordance with the prescription instructions, but as she felt Mary Ann needed it.

In May, 1960 Mrs. Incollingo again brought her daughter to Dr. Cucinotta, who found her to be suffering from aplastic anemia, a form of blood dyscrasia. His diagnosis at the time was that this was secondary to (i.e., resultant from) Chloromycetin. Mary Ann's condition gradually At this point it is necessary to describe briefly the nature of the drug here involved. As mentioned at the outset, Chloromycetin is a 'broad spectrum' antibiotic, meaning that is efficacious in the control and cure of a wide range of infectious diseases. Parke, Davis first offered Chloromycetin for sale in 1949 and was the sole producer until 1967. Chloromycetin was properly obtainable only upon the prescription of a licensed physician, and was not advertised to the general public. Because of its therapeutic effectiveness and low incidence of side effects, such as nausea and vomiting, Chloromycetin became a popular, widely used drug. Prior to and during the period that Chloromycetin was prescribed for Mary Ann the following language appeared on the immediate container and the outer carton:

worsened until her death in March, 1962. Although in his testimony Dr. Cucinotta qualified the causative role of the drug to 'most probably' giving rise to the anemia, there was no real medical disagreement at trial that Chloromycetin was in fact the underlying cause of Mary Ann's death.

'WARNING--Blood dyscrasias (disorders) may be associated with intermittent or prolonged use. It is essential that adequate blood studies be made.'

'CAUTION--Federal Law prohibits dispensing without prescription.'

In addition, the literature distributed by Parke, Davis pertaining to the drug contained the following statement:

'Chloromycetin is a potent therapeutic agent and, because certain blood dyscrasias have been associated with its administration, it should not be used indiscriminately or for minor infections. Furthermore, as with certain other drugs, adequate blood studies should be made when the patient requires prolonged or intermittent therapy.'

There is no question that the foregoing quotations, based on a Federal Food and Drug Administration announcement, were correct statements of fact as far as they went; there was, however, considerable dispute at trial as to whether they were sufficiently explicit and went far enough in describing the dangerous potential toxicity of the drug, whether they were given sufficient prominence on the containers and in the Parke, Davis literature, and whether the printed warnings were not in effect counteracted by the alleged overpromotion of the product by Parke, Davis salesmen, called in the trade 'detail men'.

With the foregoing general background in mind, we turn to the contentions of appellants. While the case was not separated as to the several defendants at trial, they have raised on appeal somewhat different issues as to liability, and we shall for convenience discuss them separately. A common question as to damages will be treated thereafter.

1. The Case as to Dr. Cucinotta

Appellant Cucinotta's argument in support of his motion for judgment n.o.v. is that plaintiffs did not carry their burden of proving that his conduct was not in accordance with the accepted standards of the medical profession in Philadelphia in 1960. By the same token, a primary argument in support of his new trial motion is that the trial judge erred in his charge to the jury as to what constitutes malpractice.

Dr. Cucinotta, called by plaintiffs as for cross-examination, testified that he considered Mary Ann's condition on January 22, 1960 to be a serious one requiring immediate therapy which could not be withheld until his clinical diagnosis could be confirmed by laboratory tests, and that in view of this condition it was his judgment that Chloromycetin was the appropriate drug to prescribe. Upon the two occasions in 1958 and 1959 when he had prescribed Chloromycetin for the same condition, Mary Ann had responded well and had shown no signs of adverse effects from the drug. He stated that it was because he was aware of the possible side effects of the drug that he had prescribed a small Dr. Cucinotta asserts that no evidence was introduced to the contrary as to the practice in the profession. Indeed, as he points out, the plaintiffs' chief expert witness, Dr. Edward H. McGehee, testified that in his opinion 75% To 80% ⁴ of the practicing physicians in Philadelphia in the period 1958--1960 would have prescribed Chloromycetin for Mary Ann's condition, and approximately 50% Of these would...