Bocci v. Key Pharmaceuticals, Inc.
| Decision Date | 17 February 1999 |
| Citation | 158 Or.App. 521,974 P.2d 758 |
| Parties | Paul R. BOCCI, Jr., guardian ad litem for Paul R. Bocci, III, an incapacitated individual, Plaintiff, v. KEY PHARMACEUTICALS, INC., a foreign corporation, Schering-Plough Corporation, a foreign corporation, and Schering Corporation, a foreign corporation, Appellants, and Miles, Inc., an Indiana corporation, Miles, Inc., Pharmaceutical Division, an Indiana Corporation, Legacy Health System, an Oregon Corporation, Legacy Immediate Care Clinic, Frederick D. Edwards, M.D., and The Eugene Clinic, a partnership, Defendants. Frederick D. Edwards, M.D., Cross-Claim Plaintiff--Respondent, v. Key Pharmaceuticals, Inc., a foreign corporation, Schering-Plough Corporation, a foreign corporation, and Schering Corporation, a foreign corporation, Cross-Claim Defendants--Appellants. A9210-07050; CA A86556. |
| Court | Oregon Court of Appeals |
William F. Gary, Eugene, argued the cause for appellants. With him on the briefs were Sharon A. Rudnick, James E. Mountain, Jr., and Harrang Long Gary Rudnick, P.C.
Mary Spillane argued the cause for respondent. On the brief were Margaret A. Sundberg, and Williams, Kastner & Gibbs LLP, and Daniel M. Holland, Ronald B. Terzenbach and Loomis & Holland.
Before DEITS, Chief Judge, WARREN, EDMONDS, LANDAU, HASELTON, ARMSTRONG and WOLLHEIM, Judges, and RIGGS, Judge pro tempore.
Affirmed by an equally divided court.
Defendant Key Pharmaceuticals, Inc. (Key) 1 appeals from a jury verdict in favor of defendant/cross-claim plaintiff Dr. Frederick Edwards (Edwards), that awarded a total of $23 million in compensatory and punitive damages. Key manufactures the prescription drug Theo-Dur, an asthma medication containing theophylline. This action was brought on behalf of Paul Bocci, III (Bocci), a long-time user of Theo-Dur, against Key for negligence and strict products liability after he suffered permanent brain damage as a result of theophylline toxicity. A claim was also brought against Edwards for medical malpractice for failing to diagnose and treat Bocci for theophylline toxicity. Edwards cross-claimed against Key for negligence and fraud, alleging that Key failed to advise physicians appropriately concerning theophylline toxicity caused by Theo-Dur. At trial, Bocci's claim against Edwards was dismissed, and the jury returned verdicts in favor of Bocci and Edwards against Key. After trial, Key settled with Bocci. 2 Key appeals from the judgment in favor of Edwards.
Because Edwards prevailed by jury verdict below, we state the facts in the light most favorable to him. Baker v. English, 324 Or. 585, 587, 932 P.2d 57 (1997).
The drug theophylline is a bronchodilator that has been used to treat asthma for many decades. Theophylline has a narrow therapeutic range: In order to prevent asthma symptoms, the serum levels of the drug in the blood generally must be at least 10 micrograms per milliliter (mcg/ml), but serum levels above 20 mcg/ml can be toxic. Saturation kinetics play a part in the way in which this drug may be metabolized; when the level of the drug in the body increases but the liver's ability to metabolize it does not increase, or when the amount of the drug entering the body stays the same but the liver's ability to metabolize it decreases for some reason, saturation can occur. This causes the serum levels of theophylline in the blood to increase. The ability of a body to metabolize theophylline may be affected by many things, such as smoking or the presence of a virus. Interactions between theophylline and other drugs may cause a body to metabolize theophylline at a slower rate, thus increasing the serum levels of theophylline in the blood and leading to theophylline toxicity. Theophylline toxicity can cause nausea, vomiting, headaches, diarrhea, tachycardia, seizures, and death.
Before the 1970s, theophylline therapy was difficult because a great deal of monitoring and adjustment of dosage was necessary to keep stable the amount of the drug in a patient's blood at any given time. In the 1970s, Key introduced a new theophylline product, Theo-Dur, a timed-release capsule that it claimed had zero-order absorption. Zero-order absorption occurs when a drug is constantly absorbed by the system and eliminated at the same rate, thus keeping the serum levels of the drug in the blood stable. Key promoted Theo-Dur as being safer than other theophylline products; because of its zero-rate absorption, Key claimed, the risk of "toxic peaks" could be avoided. Key aggressively promoted Theo-Dur to physicians through sales representatives, journal advertising, and direct-mail campaigns. Promotional materials also urged patients, physicians and pharmacists not to accept generic or brand-name substitute theophylline products, as switching from Theo-Dur could cause "excessive toxicity." In 1987, the Food and Drug Administration (FDA) informed Key that it must cease claiming that Theo-Dur was superior to other theophylline products due to zero-order absorption, because the claim was not sufficiently supported by clinical data. In 1989, the FDA again found that Key was making false and misleading claims that Theo-Dur was superior to other theophylline products.
In October 1987, Key became aware of several medical journal articles reporting a drug interaction causing theophylline toxicity when both theophylline and ciprofloxacin, a newly available antibiotic often used to treat respiratory tract infections common among asthmatics, were administered. A Key internal memorandum dated October 30, 1987, stated: In March 1988, Key proposed to the FDA that a warning be added to its Theo-Dur package insert concerning the interaction between theophylline and ciprofloxacin. Key's application for the labeling change, however, was not submitted in proper form, and it was not until March 1989 that the labeling change was approved. The labeling change was not reflected in the 1990 volume of the Physician's Desk Reference (PDR), although it was included in a May 1990 PDR supplement. Information such as a warning about theophylline-ciprofloxacin interaction is generally imparted to the medical community by drug manufacturers through "Dear Doctor" and "Dear Pharmacist" letters or statograms, through promotional materials sent to physicians, or through representatives of pharmaceutical companies (detailers) who call on physicians. The Code of Federal Regulations (CFR) allows for distribution of such warnings to physicians before revised labeling is approved by the FDA. The CFRs also allow a pharmaceutical company to change its labeling without preauthorization from the FDA in order to add warnings, precautions, or information concerning adverse reactions.
Between October 1987, when Key became aware of the theophylline-ciprofloxacin interaction, and Bocci's injury in October 1990, Key took no steps to inform physicians or patients of this potential toxicity problem, although it knew of several cases of serious toxicity and one death caused by the interaction of theophylline and ciprofloxacin. During this period, Key continued to promote Theo-Dur as the only theophylline product that "protects against toxicity."
Bocci began taking Theo-Dur when he was seven years old. On October 21, 1990, when Bocci was 20 years old, he went to a medical clinic for treatment of a skin rash and was treated by Dr. Davis. Bocci indicated to Davis that he was not taking any medications, although he was taking 900 milligrams of Theo-Dur a day. Davis prescribed ciprofloxacin for the skin rash. Bocci took both ciprofloxacin and Theo-Dur from October 21 to October 26, 1990. On October 27, 1990, Bocci went to an urgent care clinic, The Eugene Clinic, with symptoms including nausea, vomiting and diarrhea. He was seen by Dr. Edwards. Edwards discovered that Bocci had been on a stable dose of Theo-Dur for a long time, and, although he considered a diagnosis of theophylline toxicity, he did not diagnose that condition. Edwards did not consult the PDR or the PDR supplement. Edwards did not think that a patient on a stable dose of Theo-Dur could experience severe theophylline toxicity that could lead to brain damage unless the patient had taken an overdose, because Theo-Dur had been marketed and promoted to him as a "safe" drug. The detailer who had promoted the drug to Edwards and the Eugene Clinic in 1989 and 1990 testified that he would tell physicians that Theo-Dur had zero-order absorption and that it was safe. Edwards testified that he did not make a connection between a patient on a stable dose of a safe drug such as Theo-Dur and a serious toxicity problem. He therefore diagnosed gastroenteritis, treated Bocci with antinausea medication and intravenous fluids, and then sent him home.
Several hours later, Bocci had violent seizures and was taken to a hospital emergency room. Anticonvulsant medications were administered but failed to control the seizures, and the physicians attending him had difficulty diagnosing the cause of the seizures. Late that evening, after learning that Bocci had been taking asthma medication, they tested for theophylline toxicity and discovered that Bocci's theophylline level was 63 mcg/ml, well into the toxic range. The theophylline was removed from Bocci's blood through dialysis and the seizures ceased. However, Bocci suffered permanent brain damage as a result of the seizures.
A number of physicians testified about their knowledge and understanding of Theo-Dur as of October 1990, when Bocci sustained his injury. Those physicians did not know about the theophylline-ciprofloxacin interaction and did not know that patients stabilized on...
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