Batteast by Batteast v. Wyeth Laboratories, Inc.
| Decision Date | 22 June 1988 |
| Docket Number | No. 84-2818,84-2818 |
| Parties | , 122 Ill.Dec. 169, Prod.Liab.Rep. (CCH) P 11,899 Marcus BATTEAST, a minor, by his parents and next friends, James and Shirley BATTEAST, and James and Shirly Batteast, individually, Plaintiffs-Appellees/Cross-Appellants, v. WYETH LABORATORIES, INC., a division of American Home Products Corporation (previously sued as American Home Products Corporation, d/b/a Wyeth Laboratories, Inc.), and American Home Products Corporation, Defendants-Appellants/Cross-Appellees. |
| Court | United States Appellate Court of Illinois |
Sidley & Austin, Chicago (Robert A. Downing, Sara J. Gourley, Eugene A. Schoon, of counsel); Crooks & Gilligan, Chicago (Kendal A. Crooks, John W. Gilligan, John P. Prusik, of counsel), for defendants-appellants/cross-appellees.
Holstein, Mack & Associates and William Harte, Ltd., Chicago (William J. Harte, Robert A. Holstein, John M. Mack, John B. Austin, of counsel), for plaintiffs-appellees/cross-appellants.
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 the 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? . 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 8 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 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 8 hours, Marcus was 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 (FDA) 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: 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: 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...
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