Tracy v. Merrell Dow Pharmaceuticals, Inc.
| Decision Date | 27 March 1991 |
| Docket Number | No. 89-2138,89-2138 |
| Parties | , Prod.Liab.Rep. (CCH) P 12,950 TRACY, Admx., et al., Appellees, v. MERRELL DOW PHARMACEUTICALS, INC. et al., Appellants. |
| Court | Ohio Supreme Court |
Syllabus by the Court
1. Where a prescription drug has been prescribed for a patient by the patient's physician, the manufacturer discharges its duty to warn if the manufacturer adequately warns the physician.
2. If a product is properly labeled with the appropriate warnings and instructions to fully inform a physician (a learned intermediary) of the risks involved and the procedures for use, the manufacturer may reasonably assume that the physician will exercise his informed judgment in the patient's best interests.
3. The use of investigational drugs may require greater warning and more physician supervision, but the status of the drug with the Food and Drug Administration does not alter the relationship between drug manufacturer, physician and patient.
In July 1983 decedent Larry Tracy visited Dr. Donald Epstein, a specialist in pulmonary medicine at the Pulmonary Department at Huron Road Hospital, to inquire about a smoking cessation program. Tracy had been an employee at the hospital since 1960, and was supervisor of the hospital equipment room. He had a habit of smoking one and one-half packs of cigarettes per day. He was also a drinker, consuming between six and twelve beers a day, more on days when he was not working. Tracy had been admitted to the hospital in 1981 under a diagnosis of alcoholism.
The smoking cessation program about which Larry Tracy inquired was an investigational drug study--called "Protocol 691"--of Nicorette, a product of Merrell Dow Pharmaceuticals, Inc. ("Merrell Dow"). Nicorette is a prescription medication that gradually releases nicotine into the body at a much lower level than when inhaled through cigarette smoke. Nicorette is designed for use in a behavioral modification program to stop smoking. Although the Food and Drug Administration later approved Nicorette for marketing in its 2 mg. form on January 13, 1984, Nicorette was still in its late phase of investigation when Tracy went to Dr. Epstein in 1983.
Protocol 691 set general criteria for types of patients that ought to be included in or excluded from the study. In the materials that Merrell Dow sent to the physicians participating in the study, Merrell Dow included warnings from previously collected data about side effects that patients using Nicorette might experience.
Each physician participating in the study selected the patients to be included in the study. As part of his screening process, Dr. Epstein physically examined and questioned prospective patients. From his examination of Tracy, Dr. Epstein found no evidence of severe or symptomatic heart disease. Tracy confirmed the finding. Tracy did not, however, tell Dr. Epstein about his drinking habits or 1981 hospitalization for alcoholism.
On July 26, 1983, Tracy signed a patient agreement and entered the study, taking between four and eight Nicorette tablets per day over a twenty-three day period from August 23 to September 15, 1983. The patient agreement specifically included a warning against use of alcohol or other drugs while taking Nicorette. Dr. Epstein told Tracy to let him know if he had questions or if anything bothered him. Dr. Epstein and the written patient materials warned Tracy not to smoke while using Nicorette. Despite these warnings, Tracy continued to smoke and drink during the Nicorette study, although he did cut back on his cigarette consumption.
On September 15, 1983, Tracy was found slumped forward in his car after having run through a parking gate. Tracy had been on vacation for two weeks and had returned to the hospital to pick up his paycheck. At the time of the accident he had alcohol on his breath, elevated blood-alcohol levels, and a variety of other symptoms. Tracy was admitted to Huron Road Hospital Emergency Room with a preliminary diagnosis of nicotine poisoning. Tracy recovered and the hospital released him on September 19, 1983. At that time Tracy stopped using Nicorette and returned to work. He resumed his previous pattern of drinking beer and smoking cigarettes.
On October 17, 1983, Tracy stated that he did not feel well enough to go to work. He did, however, drive to the store to get beer. Later that day he suffered a cardiac arrest and was pronounced dead on arrival at Huron Road Hospital. An autopsy showed a congested liver, and congestion and edema in the lungs. Tracy also had an elevated blood-alcohol level at the time of his death.
On April 5, 1985, Betty G. Tracy, as administratrix of Larry Tracy's estate and on her own behalf, along with Vincent Tracy, Larry Tracy's son, filed this action. Plaintiffs-appellees alleged medical malpractice and products liability claims against defendants-appellants Dr. Epstein, Merrell Dow Pharmaceuticals, Inc., and Huron Road Hospital. Before trial, plaintiffs dismissed Huron Road Hospital.
Also before trial, plaintiffs-appellees filed a motion in limine to restrict opinion testimony of defendants' expert witnesses to those opinions contained in their previously filed expert reports. The trial court reserved ruling on the scope of expert testimony until the question arose during the trial.
During trial, plaintiffs filed a motion for mistrial claiming prejudice from Merrell Dow's failure to produce certain requested documents. The trial court denied their motion.
At the close of evidence, the trial court instructed the jury on the doctrine of unavoidably unsafe drugs as well as the learned intermediary doctrine. The jury returned general verdicts for both defendants.
The court of appeals found that the trial court erred when it instructed the jury on the learned intermediary doctrine. The appellate court also held that the trial court abused its discretion in allowing defendants' experts to testify beyond the scope of the pretrial reports. The appellate court reversed the judgment and remanded to the trial court for a new trial.
This cause is before us pursuant to the allowance of a motion to certify the record.
Nurenberg, Plevin, Heller & McCarthy Co., L.P.A., Thomas Mester, Richard C. Alkire and Joel Levin, Cleveland, for appellees.
Reminger & Reminger Co., L.P.A., Craig A. Marvinney and Gary H. Goldwasser, Cleveland, for appellants.
Arter & Hadden, R. Crawford Morris, George Gore and Irene C. Keyse-Walker, Cleveland, urging reversal for amicus curiae, Pharmaceutical Mfrs. Ass'n.
Rohrbacher, Nicholson & Light, David J. Rohrbacher and Barbara A. Braun Hafner, Toledo, urging reversal for amicus curiae, Sandoz Pharmaceuticals Corp.
In this civil action alleging medical malpractice and products liability, we consider two issues: (1) whether a jury instruction on the learned intermediary doctrine was appropriate with respect to an investigational drug, and (2) whether the trial court abused its discretion with respect to alleged discovery rule violations. For the reasons which follow we reverse the court of appeals and reinstate the jury verdict.
In Temple v. Wean United, Inc. (1977), 50 Ohio St.2d 317, 322, 4 O.O.3d 466, 469, 364 N.E.2d 267, 271, this court adopted the Restatement of the Law 2d, Torts (1965), Section 402A. Comment k to Section 402A contemplates that a drug manufacturer will not be held strictly liable for injuries caused by an unavoidably dangerous drug, such as prescription drugs, if the warning is adequate.
The duty to warn depends, in the case law that has developed, upon the drug manufacturer's relationship to the user. Where a prescription drug has been prescribed for a patient by the patient's physician, the manufacturer has been held to discharge its duty to warn if the manufacturer adequately warns the physician. Reyes v. Wyeth Laboratories (C.A.5, 1974), 498 F.2d 1264, 1276; Basko v. Sterling Drugs, Inc. (C.A.2, 1969), 416 F.2d 417, 426; Williams v. Lederle Laboratories (S.D. Ohio 1984), 591 F.Supp. 381, 388; McKee v. Moore (Okla.1982), 648 P.2d 21, 24; Terhune v. A.H. Robins Co. (1978), 90 Wash.2d 9, 13, 577 P.2d 975, 977.
The rationale behind these holdings is that the physician stands between the manufacturer and the patient as a learned intermediary. The physician has the duty to know the patient's condition as well as the qualities and characteristics of the drugs or products to be prescribed for the patient's use. The physician is in the best position, therefore, to balance the needs of patients against the risks and benefits of a particular drug or therapy, and then to supervise its use. McKee, supra; Terhune, supra, 577 P.2d at 978.
This shift in the duty to warn has been called the learned intermediary doctrine. In Ohio, we adopted the learned intermediary doctrine in Seley v. G.D. Searle & Co. (1981), 67 Ohio St.2d 192, 21 O.O.3d 121, 423 N.E.2d 831. The learned intermediary doctrine achieves a proper allocation of responsibility since not all patients are alike and it is the physician who best knows the patient.
The learned intermediary doctrine does not relieve the manufacturer of liability to the ultimate user for an inadequate or misleading warning; it only provides that the warning reaches the ultimate user through the learned intermediary. Alm v. Aluminum Co. of America (Tex.1986), 717 S.W.2d 588, 592; McEwen v. Ortho Pharmaceutical Corp. (1974), 270 Or. 375, 386-387, 528 P.2d 522, 529. If the product is properly labeled with the appropriate warnings and instructions to fully inform the physician (a learned intermediary) of the risks involved and the procedures for use, the manufacturer may reasonably assume that the physician will exercise his informed judgment in the patient's best interests. McKee, supra; Terhune, supra.
The issue presented to us in this case turns upon the relationship between Merrell...
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