APPELLATE COURT OF ILLINOIS, FIRST DISTRICT, THIRD DIVISION
526 N.E.2d 428, 172 Ill. App. 3d 114, 122 Ill. Dec. 169 1988.IL.981
Appeal from the Circuit Court of Cook County; the Hon. Charles E. Freeman, Judge, presiding.
Rehearing Denied July 22, 1988.
JUSTICE RIZZI delivered the opinion of the court. WHITE, P.J., and LORENZ,* J., concur.
DECISION OF THE COURT DELIVERED BY THE HONORABLE JUDGE RIZZI
This is a personal injury action by plaintiffs, James and Shirley Batteast, individually and on behalf of their minor son, Marcus Batteast (Marcus), against defendants Wyeth Laboratories, Inc. (Wyeth), St. Bernard Hospital (Hospital), Dr. Edgar Dela Cruz (Dela Cruz), and Dr. Jose Abella (Abella). The action against the Hospital, Dela Cruz and Abella was based on theories of negligence and willful and wanton conduct. The action against Wyeth was based on strict liability, negligence and willful and wanton conduct. Prior to trial, plaintiffs entered into a settlement agreement with Dela Cruz and Abella. Plaintiffs also entered into a settlement agreement with the Hospital while the jury was deliberating.
In the action on behalf of Marcus, the jury returned a verdict in favor of plaintiffs and against Wyeth and the Hospital for compensatory damages in the amount of $9,200,000 (later reduced by $910,000, which is the total amount of the settlements with the Hospital, Dela Cruz and Abella); the jury also returned a verdict in favor of plaintiffs and against Wyeth for punitive damages in the amount of $13,000,000. In the action by James and Shirley Batteast, individually, the jury returned a verdict in favor of plaintiffs and against Wyeth and the Hospital in the amount of $85,000 for medical expenses incurred on behalf of Marcus. In addition to the general verdicts, the jury answered "No" to the following special interrogatory submitted by Wyeth: "Was the conduct of St. Bernard Hospital, immediately before and at the time of the occurrence complained of, the sole proximate cause of the plaintiff's injury."
After trial, Wyeth filed a motion to vacate the judgments that had been entered on the verdicts and to dismiss the complaint. Wyeth argued that the agreement entered into between plaintiffs and Abella during trial was a release and that Wyeth was therefore discharged from any liability. Wyeth's motion was denied.
Wyeth appeals from the judgments that were entered on the jury's verdicts and from the denial of its motion relating to the release that was given to Abella. Shirley and James Batteast cross-appeal from the dismissal of a count in their second consolidated complaint based on a claim of parental loss of society and companionship arising from Marcus' injuries. We affirm the judgments and orders from which the appeal and cross-appeal are taken by the respective parties.
On January 22, 1976, two-year-old Marcus Batteast was admitted to he Hospital for treatment of an upper respiratory infection and febrile convulsions. Upon admittance, Marcus' care was assigned to Dela Cruz. Marcus remained in the Hospital until January 28, 1976. On February 5, Marcus was again admitted to the Hospital. At this point, Marcus was suffering from dehydration, diarrhea and vomiting, with a temperature of 102.8 degrees. The preliminary diagnosis was acute gastroenteritis and pneumonia. Dela Cruz, Marcus' attending physician, prescribed antibiotics and ordered Marcus placed in an oxygen tent because he was wheezing. Marcus was also placed on intravenous fluids for dehydration.
On February 6, Dela Cruz prescribed oral Marax, a liquid prescription drug. Marax is used to treat bronchial asthma, chronic bronchitis and other respiratory ailments. On the evening of February 7, a Hospital staff member telephoned Dela Cruz and advised him that Marcus' intravenous had come out, that the nurses were unable to restart it, and that Marcus was vomiting. Dela Cruz directed the staff to "hold" the intravenous, and ordered Marax, which causes stomach irritation, discontinued. However, Marax was not discontinued.
On February 8, Dela Cruz ordered Marcus placed on a soft diet and, believing Marax had been discontinued, prescribed one-half of an aminophylline pediatric suppository every eight hours. Like Marax, aminophylline is used to treat bronchial asthma, chronic bronchitis and other respiratory ailments. It is used to achieve the same therapeutic effect as Marax, but without stomach irritation.
At the time Marcus was hospitalized, aminophylline suppositories were manufactured and sold by Wyeth in three sizes: (1) 125 milligrams (mg.), pediatric suppositories; (2) 250 mg., adult suppositories and (3) 500 mg., adult suppositories. Wyeth's package insert states that "when cut in half," a pediatric suppository "is suitable for a child weighing 20 pounds when administered at no less than 8-hour intervals." Marcus weighed 22 pounds on February 5, 1976.
Aminophylline's active ingredient, theophylline, is also an ingredient in Marax. However, Marax contains ephedrine, an ingredient which may react synergistically with aminophylline. The evidence suggests that ephedrine increases the toxicity of aminophylline but does not increase its therapeutic effects.
On February 8, although Dela Cruz prescribed one-half of an aminophylline pediatric suppository (i.e., 62.5 mg.) every eight hours, Marcus was also administered 125 mg. of aminophylline at 2 p.m. and at 8 p.m. Marcus was also administered Marax at 6 a.m., 12 p.m. and 6 p.m. on February 8. On February 9, Marcus was administered 125 mg. of aminophylline at 4 a.m., 2 p.m. and 8 p.m.; Marax was administered at 12 a.m., 6 a.m., 12 p.m. and 6 p.m. On February 10, Marcus was administered 125 mg. of aminophylline at 4 a.m., and Marax at 12 a.m. and 6 a.m. At 7:37 a.m. on February 10, a nurse observed that Marcus had vomited, both eyes were "stiff," and he was "twitching and grunting." At 7:45 a.m. an emergency code "Blue" was called. At 9 a.m., Marcus had a seizure and three hours later, Marcus was transferred to Children's Memorial Hospital for treatment and care.
Plaintiffs' position is that Wyeth manufactured and distributed aminophylline in a defective condition, unreasonably dangerous to children, because it (1) failed to warn the medical profession of the product's dangerous propensities to children, and (2) failed to supply sufficient information for methods of avoiding toxicity and overdose therapy. Plaintiffs also posit that the defective condition of aminophylline was a proximate cause of Marcus' injuries and that Wyeth took a course of action which shows an utter indifference to, or conscious disregard for, the safety of others.
At trial, plaintiffs introduced evidence that excessive amounts of aminophylline cause constriction of blood vessels in the brain which decrease cerebral blood flow. Plaintiffs' evidence also indicated that Marcus suffered permanent brain damage as a result of the aminophylline that he had received while a patient at the Hospital. The severity of Marcus' injuries is not contested by Wyeth. Wyeth, however, argues that there is no evidence that Wyeth proximately caused Marcus' injuries and, therefore, judgment n.o.v. is mandated.
Wyeth introduced its aminophylline suppositories into the stream of commerce in 1945. During the 33-year span, from 1950 to 1983, Wyeth made no substantive additions or changes in its package insert. However, from the 1950's to the time that Marcus was a patient in the Hospital, a number of medical reports disclosed a span of information relating to the drug's dangers, methods of protection against overdose and steps to be taken if a patient's theophylline (aminophylline is a form of theophylline) blood level rises out of the relatively narrow therapeutic blood-level range into toxicity. Much of this information is embodied in the form of guidelines that the Federal Food and Drug Administration sent to Wyeth on May 7, 1975, with the following instruction: "revise the package insert to conform to the enclosed labeling guidelines."
The 1975 FDA guidelines provide: "Warnings: . . . Many children are sensitive to aminophylline. Severe intoxications and deaths have followed rectal administration because of hypersensitivity or overdosage." Wyeth's expert, Dr. Walson, testified that studies appeared from the 1950's to the present showing theophylline-induced brain damage, deafness, blindness and death. Also, a number of articles in the 1950's discussed reports of theophylline deaths in children. However, unlike the 1975 FDA guidelines, Wyeth's package insert contains no "Warnings" section. Instead, Wyeth's package insert states: "Precautions: . . . Overdosage in infants and small children has resulted in such toxic effects as vomiting, restlessness and convulsions." Convulsions, the most serious harm mentioned in Wyeth's package insert, rarely lead to coma or death.
The 1975 FDA guidelines also provide: "Adverse Reactions: . . . Cardiovascular: . . . circulatory failure. Respiratory: . . . respiratory arrest." Unlike the 1975 FDA guidelines, Wyeth's package insert contains no "Adverse Reactions" section. Instead, Wyeth's package insert states under its "Precautions" section, that aminophylline "causes a marked increase in cerebral-vascular resistance with an accompanying decrease in cerebral blood flow." At trial, a pediatric neurologist testified that because there can be cerebral vascular resistance without consequence, since the brain's blood supply normally expands and contracts, Wyeth's "increase in cerebral-vascular resistance with an accompanying decrease in cerebral blood flow" wording does not necessarily alert the physician to the danger of anoxia, or severe decrease in blood supply resulting in brain damage.
Additionally, the 1975 FDA guidelines identify special problems encountered when aminophylline suppository treatment is utilized for children. These problems specifically include erratic absorption and metabolism and the danger of toxic accumulation. These dangers were not disclosed in Wyeth's package insert at the time of Marcus' hospitalization. Yet, the 1975 FDA guidelines provide:
"Actions: . . . Absorption from . . . rectal administration may be incomplete, sometimes slow and/or variable. Children in contrast with adults absorb the drug quite well by rectum.
Warnings: . . . Rectal absorption of aminophylline is unreliable and the possible cumulative effect of prolonged treatment by this route of administration must be kept in mind.
Dosage And Administration: . . . There is great variation from patient to patient in dosage needed in order to achieve a therapeutic blood level . . .. Because of this wide variation from patient to patient and the relatively narrow therapeutic blood level range, dosage must be individualized with monitoring of theophylline blood levels, particularly when prolonged or repeated use is planned."
However, unlike the 1975 FDA guidelines, Wyeth's insert contains no information which would alert a physician or health care provider that although children absorb the drug quite well by rectum, rectal "absorption of aminophylline is unreliable and the possible cumulative effect of prolonged treatment by this route of administration must be kept in mind." Therefore, there must be "monitoring of theophylline blood levels, particularly when prolonged or repeated use [of aminophylline] is planned." Moreover, the record clearly establishes that Wyeth was aware of background information supporting the necessity of alerting physicians of the effects of aminophylline that are stated in the 1975 FDA guidelines.
The information that is contained in the 1975 FDA guidelines, but is missing in Wyeth's package insert, must be juxtaposed to Dela Cruz' testimony. Dela Cruz testified that he was never informed that Wyeth's drug absorbed faster in a child, or that it had erratic variance from patient to patient, or that he might have to use vastly different dosages to achieve a therapeutic range in different patients. Dela Cruz further testified that if that information had been supplied by Wyeth it would have enabled him "to treat Marcus Batteast with an individual dosage monitored by blood level to make sure you stay within his therapeutic range." According to Dela Cruz, if he had been supplied this information, he would have used blood-level studies. As a result, Dela Cruz would have been required to "pay close attention to the actual medication record in the hospital sheet of Marcus Batteast." Dela Cruz specifically stated: "If the advice and demand to use blood level studies drove me to that medication record, I would have seen what was gotten, and I would have cut that and stopped it."
Moreover, the 1975 FDA guidelines also warn of the toxic synergism effect of combining aminophylline suppositories with ephedrine and other xanthine preparations or drugs. The 1975 FDA guidelines provide:
"Contraindications: . . . Aminophylline should not be administered concurrently with other xanthine preparations.
Drug Interactions: Toxic synergism with ephedrine and other sympathomimetic bronchodilator drugs may occur. Recent controlled studies suggest that the addition of ephedrine to adequate dosage regimens of aminophylline produces no increase in effectiveness over that of aminophylline alone, but does produce an increase in toxic effects."
Unlike the 1975 FDA guidelines, the Wyeth package insert contains no "Drug Interactions" section, no mention of toxic synergism and no instruction to avoid administration of aminophylline concurrently with other xanthine drugs.
Aminophylline is a member of the xanthine family which is a compound of theophylline and ethylenediamine. The active ingredient of aminophylline is theophylline. Marax contains theophylline and ephedrine. Aminophylline and Marax are xanthine preparations. A reading of the 1975 FDA guidelines indicates that the two drugs "should not be administered concurrently." Additionally, an examination of the 1975 FDA guidelines specifies that the addition of ephedrine to adequate dosage regimens of aminophylline produces a toxic synergism. Toxic synergism occurs when the cooperative action of separate drugs is such that the total toxic effect when the drugs are taken together is greater than the sum of the toxic effect when the separate drugs are taken independently. (See Webster's Third New International Dictionary 2320 (1981).) The toxicity of ephedrine is nearly tripled by the concomitant action of moderate doses of aminophylline. Conversely, the toxicity of aminophylline is nearly doubled by the concomitant action of moderate doses of ephedrine. Thus, as reflected in the record, mixtures of these drugs are "markedly synergistic."
The vice-president of medical affairs for Wyeth testified that from 1960 to 1976, he was aware of the toxic synergism of aminophylline and ephedrine. However, one of Wyeth's expert witnesses testified that in 1976 most of the medical community, including physicians in the area where the Hospital is located, were "totally unaware of that synergistic effect." He also testified that "I would guess" that "[certainly]" Dela Cruz was unaware of that synergism. Dela Cruz testified that although he knew that Marax contained ephedrine, he did not know about the toxic synergism of combining aminophylline and ephedrine. However, Cruz stated that he did not know that aminophylline should not be given concurrently with other xanthine preparations. Dela Cruz also testified that had he known of the toxic synergism potential, he either would not have prescribed aminophylline suppositories for Marcus or he would have used blood-level studies and paid close attention to the actual medication record in Marcus' hospital sheet.
The 1975 FDA guidelines also warn of adverse reactions and overdose symptoms relating to aminophylline. The 1975 FDA guidelines state:
"Adverse Reactions: The most consistent adverse reactions are: (1) Gastrointestinal irritation: nausea, vomiting and epigastric pain generally preceded by headache, hematemesis, diarrhea; (2) Central nervous system stimulation: irritability, restlessness, insomnia, reflex hyperexcitability, muscle twitching, clonic and tonic generalized convulsions, agitation; (3) Cardiovascular: . . . marked hypertension, and circulatory failure; (4) Respiratory: tachypnea [fast breathing], respiratory arrest; . . . (6) Others: fever, dehydration."
The 1975 FDA guidelines also state: "Overdosage: Symptoms. In infants and small children: agitation, headache, hyper-reflexia, fasciculations, and clonic and tonic convulsions." Wyeth's package insert contains no "Adverse Reactions" section, nor does it contain an "Overdosage" section. Instead, Wyeth's package insert has a "Precautions" section, which states:
"Overdosage in infants and small children has resulted in such toxic effects as vomiting, restlessness, and convulsions. Headache, nervousness and vomiting, abdominal cramps and diarrhea are common symptoms of sensitivity to aminophylline, especially if given intravenously in full therapeutic doses. Like other xanthines, aminophylline stimulates the cerebral cortex and may precipitate convulsions in susceptible individuals."
Although Wyeth's package insert names convulsions as one of the effects of aminophylline overdosage, it fails to specify "clonic and tonic generalized convulsions," as do the 1975 FDA guidelines. The difference is important because the evidence establishes that the symptoms of aminophylline toxicity are often mistaken for the very symptoms that the doctor is treating. As a result, indications of aminophylline poisoning are often masked by the patient's other symptoms. Here, a doctor from Children's Memorial Hospital testified that there are different kinds of convulsions, including febrile convulsions. Marcus had suffered a febrile convulsion before his first admission to the Hospital, and he had a history of fever during his second hospitalization. Dela Cruz testified that tonic and clonic convulsions are different from other kinds of convulsions and that Marcus' sudden voluntary movements of both upper and lower extremities were characteristic of tonic and clonic convulsions. Dela Cruz also testified that if he had been told by Wyeth that this was a symptom of aminophylline toxicity, it would have been a medical "tip off" to him that maybe the aminophylline suppositories were involved.
The 1975 FDA guidelines also contain a "Dosage And Administration" section, which provides as the maximum children's dosage within a 24-hour period, 12 milligrams of aminophylline per kilogram of a child's body weight, with a dose every six hours. However, the "Dosage And Administration" section also states that therapeutic blood levels are considered to be between 10 and 20 micrograms of aminophylline per milliliter of blood, and that blood levels above 20 micrograms of aminophylline per milliliter of blood may produce toxic effects. In addition, the "Dosage And Administration" section ...