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Daniel v. Fisons Corporation5/26/2000
DECISION.
Civil Appeal From: Hamilton County Court of Common Pleas
Judgment Appealed From Is: Affirmed
Raising two assignments of error, plaintiffs-appellants Douglas and Sandy Daniel appeal from the order of the Hamilton County Court of Common Pleas granting summary judgment to defendant-appellee Fisons Corporation on the products-liability claims that they had initiated on behalf of their daughter Stacey.
I. FACTS AND PROCEEDINGS
On April 16, 1981, three-year-old Stacey Daniel was admitted to Children's Hospital Medical Center with a high fever and labored breathing. Doctors diagnosed Stacey as having pneumonia and administered both an antibiotic and Somophyllin Oral Liquid, a theophylline-based drug manufactured by Fisons that was intended to ease her breathing. Fisons' package insert for the drug informed doctors that theophylline levels above the therapeutic-serum range of 10 mcg/ml to 20 mcg/ml might produce toxic effects such as nausea, vomiting, diarrhea, or even seizures; that adverse reactions to theophylline increased when serum levels exceeded 20 mcg/ml; that the great variation from patient to patient in theophylline metabolism required individualized dosing and monitoring of serum-theophylline levels; that prolonged high fever might reduce the rate of theophylline elimination; that no patient was to be maintained on any dosage that was not tolerated; and that, even absent adverse reactions, serum-theophylline levels in excess of the therapeutic range required a ten-percent reduction in dosage.
Despite the treatment she was receiving, Stacey remained extremely ill after several days of hospitalization; she continued to run a high fever, and she also began vomiting and having diarrhea. At the time, doctors noted that her pneumonia was most likely viral in nature. In addition, the serum-theophylline level in her blood began to fluctuate greatly and, on several occasions, exceeded the therapeutic range. Despite this, her doctors continued to treat her with theophylline. Then, five days into her treatment, Stacey suffered a prolonged seizure that caused irreversible brain damage. As a result of the seizure, Stacey, who is now an adult, is incapable of living independently.
In 1998, Stacey's parents filed a complaint alleging that Stacey's seizure and resulting injuries were caused by toxic levels of theophylline in her blood. Although the Daniels' complaint initially included medical-malpractice claims against Stacey's pediatricians and Children's Hospital, as well as products-liability claims against Fisons and two other manufacturers of intravenous theophylline, the other drug companies were eventually dismissed from the action, and the medical-malpractice claims against the doctors and the hospital were settled. Thereafter, Fisons, the only remaining defendant, moved for summary judgment on the two products-liability claims asserted against it by the Daniels. After hearing arguments, the trial court granted Fisons' motion on the following grounds: (1) Fisons was entitled to summary judgment on the Daniels' failure-to-warn claim given that the warnings contained in Fisons' package insert were adequate as a matter of law, and that even if the Daniels had provided sufficient evidence to raise a genuine issue as to the adequacy of the warnings, they had failed to demonstrate that the addition of a warning regarding viral illness would have altered the doctors' course of treatment; and (2) Fisons was entitled to summary judgment on the Daniels' claim for punitive damages given the absence of any evidence that Fisons withheld information from, or made misrepresentations to, the FDA.
In this timely appea
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