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Fornoff v. Parke Davis & Co.

OPINION FILED MARCH 25, 1982.

LINDA FORNOFF ET AL., PLAINTIFFS-APPELLANTS,

v.

PARKE DAVIS & COMPANY, DEFENDANT-APPELLEE.



APPEAL from the Circuit Court of Sangamon County; the Hon. SIMON L. FRIEDMAN, Judge, presiding.

JUSTICE HEIPLE DELIVERED THE OPINION OF THE COURT:

Plaintiffs, Linda and Dale Fornoff, sued Dr. Jack Means and the Abraham Lincoln Memorial Hospital (Memorial) for medical negligence. Additionally, plaintiffs sought compensatory and exemplary damages from defendant Parke Davis & Company (Parke) in a products liability action. This latter suit, based on theories of strict liability and negligence concerned the marketing and distribution of buccal pitocin by Parke. The strict liability count was subsequently withdrawn. A Sangamon County jury returned verdicts of $750,000 for Mrs. Fornoff, and $80,000 for Mr. Fornoff, and against Dr. Means and Memorial. Such verdicts were not appealed. As to the negligence claim against Parke, however, the jury verdict was in favor of defendant and against plaintiffs. It is the propriety of these latter verdicts, and judgments entered thereon, which both plaintiffs ask us to examine in their appeal.

Generally, five issues confront us. They concern the validity of: certain jury instruction; trial rulings on various evidentiary topics; whether the jury verdicts were against the manifest weight of the evidence; dismissal of plaintiffs' counts for wilful and wanton misconduct; and, the trial conduct of defendant's counsel. We begin with the chronicle of events precipitating this litigation.

In time we regress to December 1969. Plaintiffs were married, living on and working a farm in Mason County. Mrs. Fornoff, 20 years old, was pregnant, having been so evaluated by her physician, Dr. Means. Two years previous she gave birth to a healthy, male child. A different doctor attended that delivery. Birth of the second child was expected in mid-May 1970. Dr. Means' records indicate that during Mrs. Fornoff's pregnancy no unusual complications arose.

In early May, at a regular checkup, Dr. Means told Linda Fornoff he would be out of town on May 16. He would attend a medical convention in Chicago. Linda's due date was May 15. The physician said if she wanted him to deliver the child he could induce labor artificially by the use of pills she would hold in her mouth. The only adverse effect of the drug, he explained, might be that she would not go into labor and would have to return home. The name of the drug was not mentioned. After discussing the subject with her husband, Mrs. Fornoff consented to this procedure on May 14, 1970.

That very evening she entered Memorial. During the next 12-14 hours Dr. Means or hospital staff administered 5400 units of buccal pitocin to Mrs. Fornoff. That is 27 pills. Mrs. Fornoff testified that during this span she experienced violent contractions and called for help. This account was disputed by hospital personnel and Dr. Means, who said the delivery was normal. After a healthy female child was born, Dr. Means left the patient in the care of another doctor.

After the child's birth, Mrs. Fornoff encountered cramping, mucous discharge from the rectal area, and the inability to defecate. She was given an enema. Upon returning home such problems persisted. She informed Dr. Means. He recommended mineral oil. It did not help. Mrs. Fornoff consulted other doctors. Dr. Means concluded she was neurotic and suggested she seek professional mental health care.

In the fall of 1971, Mrs. Fornoff was hospitalized and treated by Dr. Davidson in St. Louis, Missouri. A specialist in rectal and colon infirmities was summoned. He diagnosed a massive rectal prolapse. Essentially, this means several of Mrs. Fornoff's internal organs fell down from the places they normally occupy. Major reconstructive surgery and a colostomy were performed. This did not work. The draining continued. Further surgeries, including one inserting wires beneath the colon to support it, were unavailing. She deteriorated physically.

In 1975 Mrs. Fornoff sought the advice of Dr. Charles Ripstein of Miami, Florida. This physician is one of the most renowned colon and rectal surgeons in the world. Due to his expertise he pioneered a surgical technique whereby prolapsed organs in the rectal area could be corrected. This surgical method entails the insertion of a mesh screen in the area of the anal sphincter to support the displaced organs. At the request of the Fornoffs, due to proximity and traveling expenses, Dr. Ripstein recommended Dr. Bruce Thow in Champaign, Illinois, do this type of surgery. Dr. Thow performed a hysterectomy, repaired Mrs. Fornoff's bladder, and inserted the screen.

Post-operative complications arose. Linda Fornoff suffered fissures in the anal sphincter area. Thereupon, Dr. Ripstein performed a fissurectomy and reconstructive surgery after Mrs. Fornoff's body rejected, in part, the mesh screen. Crymotherapy, a very painful procedure, which involves freezing of the affected tissue, was also required.

During all of this period of disability, Mrs. Fornoff was limited in caring for her children. She could not completely discharge her household duties. In 1979 her marriage ended by divorce.

Buccal pitocin is an ethical drug which Parke manufactures and distributes. The drug is used to stimulate the uterus, thereby inducing labor and the onset of childbirth. Pitocin is produced naturally in the female's bloodstream when a child is delivered normally. The chemical equivalent allows ingestion of a greater amount than the body normally generates. Administration of the drug is done intravenously or orally by tablet held in the mouth. The former method is preferred while the latter is more convenient. Memorial did not possess adequate apparatus for intravenous administration of this chemical agent.

Inside the package of buccal pitocin which Parke sold was a six-page insert which informed the doctor of the drug's fundamental properties, directions on how to use it, warnings, precautions, adverse reactions, and literature for and against its prescription use. Such insert was received in evidence as plaintiffs' exhibit. On dosage, the insert said:

"ADMINISTRATION AND DOSAGE

Induction or Stimulation of Labor

Buccal administration of Pitocin in (oxytocin citrate) must be adapted to the patient's response. Begin by placing a 200 unit tablet in the parabuccal space adjacent to the upper molar teeth. Initial dosage should be limited to one tablet to avoid the possibility of excessive absorption before local vasoconstriction has occurred. Additional tablets are placed in the parabuccal space at half-hour intervals (Fig. 1), alternating between the two cheek pouches, until the desired response is obtained or until a total of 3000 units has been administered without satisfactory results."

Under precautions and adverse reactions it stated:

"PRECAUTIONS

Strict adherence to the instructions set forth in the preceding paragraphs under Indications and Contraindications is extremely important. As Dillon stated, `The complications of oxytocin administration are few when indications and contraindications are carefully followed.'

Administration of oxytocin in the first and second stages of labor in untrained hands is dangerous and only hospital personnel thoroughly trained in its use should administer it. Maternal deaths due to hypertensive episodes, subarachnoid hemorrhage, rupture of the uterus, and fetal deaths due to various causes have resulted from the injudicious use of parenteral oxytocic drugs in the first and second stages of labor and even for the induction of labor.

ADVERSE REACTIONS

Uterine hypertonicity, spasm, tetanic contraction or rupture has been reported and discussed (12-2) but in nearly all instances, if not all, the drug was used in the presence of conditions listed under Contraindications or at doses in excess of those we recommend."

This appeal involves the extent of the liability of a drug manufacturer in the marking of its products. It is not a strict liability case. It is a negligence case. Specifically, plaintiffs contend, Parke was negligent in breaching its duty to adequately warn of the possible adverse consequences which result from the improper administration of buccal pitocin.

I. Jury Instructions

The failure to give five of plaintiffs' tendered jury instructions is alleged as error. They are plaintiffs' instructions numbered 13, 16, 18, 19, and 30. We set out here in ...


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