Wooderson v. Ortho Pharmaceutical Corp.

• Decision Date: 27 April 1984
• Docket Number: No. 55655,55655
• Citation: 681 P.2d 1038,235 Kan. 387
• Parties: Carol Lynn WOODERSON, Appellee, v. ORTHO PHARMACEUTICAL CORPORATION, Appellant.
• Court: Kansas Supreme Court

Page 1038

681 P.2d 1038

235 Kan. 387

Carol Lynn WOODERSON, Appellee, v. ORTHO PHARMACEUTICAL CORPORATION, Appellant.

No. 55655.

Supreme Court of Kansas.

April 27, 1984.

Syllabus by the Court

1. When a verdict is attacked for insufficiency of the evidence, the duty of the appellate court extends only to a search of the record for the purpose of determining whether there is any competent substantial evidence to support the findings. The appellate court will not weigh the evidence or pass upon the credibility of the witnesses. Under these circumstances, the reviewing court must review the evidence in the light most favorable to the party prevailing below.

2. "Substantial evidence" is defined as evidence which possesses both relevance and substance and which furnishes a substantial basis of fact from which the issues can reasonably be resolved.

3. The manufacturer of ethical or prescription drugs has a duty to give timely and adequate warnings to the medical profession of any dangerous side effects produced by its drugs of which it knows, or has reason to know.

4. The duty to warn must be commensurate with the seriousness of the danger. The greater the danger, the greater the duty.

5. Although the duty of the ethical drug manufacturer is ordinarily to warn the doctor rather than the patient, the manufacturer is directly liable to the patient for a breach of such duty.

6. In the case of drug manufacturers, the standard of constructive knowledge is that of an expert in that particular field.

7. Because a manufacturer cannot be required to warn of a risk unknown to science, the knowledge chargeable to the manufacturer of an ethical drug must be limited to that of the period during which the plaintiff was using the product in question.

8. The duty to warn is a continuous one, requiring the manufacturer to keep abreast of the current state of knowledge relevant to its products as gained through research, adverse reaction reports, scientific literature, and other available methods.

9. An adequate warning is one reasonable under the circumstances.

10. Where scientific or medical evidence exists tending to show that a certain danger is associated with use of a drug, the manufacturer may not ignore or discount that information in drafting its warning solely because it finds it to be unconvincing.

11. There is a presumption that an adequate warning would be heeded. This operates to the benefit of a manufacturer where adequate warnings are in fact given. Where warnings are inadequate, however, the presumption is in essence a presumption of causation.

12. What a doctor might or might not have done had he or she been adequately warned is not an element plaintiff must prove as a part of his or her case.

13. The intent and purpose of the legislature in adopting K.S.A. 60-258a is to impose individual liability for damages based on the proportionate fault of all of the parties to an occurrence which gave rise to the injuries and damages, whether or not those persons are joined as parties to the action.

14. A party who seeks to reduce his percentage of fault by comparing the fault of another party has the burden of proving the other party's fault by a preponderance of the evidence.

15. Where there is no evidence of causal negligence on the part of a person, the question of that person's negligence need not be submitted to the jury.

16. Punitive damages are permitted whenever the elements of fraud, malice, gross negligence, or oppression mingle in the controversy.

17. Punitive damages are allowed not because of any special merit in the injured party's case, but are imposed to punish the wrongdoer for malicious, vindictive or willful and wanton invasion of the injured party's rights, the purpose being to restrain and deter others from the commission of like wrongs.

David F. Dobbins of Patterson, Belknap, Webb & Tyler, New York City, argued the cause, and Donald R. Newkirk of Fleeson, Gooing, Coulson & Kitch, Wichita, was on briefs for appellant.

Gerald L. Michaud of Michaud, Cordry, Michaud, Hutton & Hutton, Wichita, argued the cause, and Andrew H. Hutton and Dwight A. Corrin, Wichita, were with him on brief for appellee.

MILLER, Justice:

Plaintiff, Carol Lynn Wooderson, brought this action in the District Court of Sedgwick County for damages for personal injuries which she claims resulted from her ingestion, over a period of years, of the oral contraceptive Ortho-Novum 1/80, manufactured by the defendant, Ortho Pharmaceutical Corporation (Ortho). At the conclusion of a six-week trial, the jury returned a verdict and the court entered judgment for plaintiff and against Ortho for actual damages of $2,000,000 and punitive damages of $2,750,000. Ortho appeals. The primary issues are whether there was sufficient competent evidence to support the verdict, and whether the trial court properly submitted the matter of punitive damages to the jury. Other issues will be stated in the opinion.

Carol Lynn Wooderson consulted Dr. Richard L. Hermes of Lawrence, Kansas, a physician specializing in obstetrics and gynecology, in the fall of 1972. She was planning to be married and wanted some method of contraception. Dr. Hermes prescribed an oral contraceptive (o.c.), Ortho-Novum 1/80, manufactured by the defendant. This is an "ethical" drug, one obtainable only upon prescription, as distinguished from a "proprietary" or "patent" drug, one sold over the counter. Plaintiff was in good health at that time; her blood pressure was 100/56, and she had never had any problems with her kidneys or with high blood pressure. She took Ortho-Novum 1/80, as prescribed by her physician, continuously from the fall of 1972 until June 1976, with the exception of about thirty days in early 1974 when she had a rash on her hand and a physician suggested that she stop taking the pill until the rash went away. She saw Dr. Hermes in December 1974; his notes reveal nothing remarkable about her health at that time except that her blood pressure was 130/80. The prescription for Ortho-Novum 1/80 was extended for another year. Mrs. Wooderson next saw the doctor in January 1976. His notes reveal nothing remarkable except that her blood pressure was 120/90. She had a cold, and Tuss-Ornade was prescribed for that. The Ortho-Novum 1/80 prescription was also extended for one year. On May 4, 1976, she called Dr. Hermes; she still had a cold, and he called in a prescription for Tuss-Ornade. On June 25, 1976, she again called him. She reported stomach pains and vomiting. Medication to stop the vomiting was prescribed, as was bed rest. Dr. Hermes advised her to go to the emergency room at the hospital if she had no relief by that night. Next, on June 28, 1976, Mrs. Wooderson went to the office. Dr. Hermes was not in, and she was examined by one of his associates, Dr. Howard Wilcox. Her blood pressure was 160/88. She complained of abdominal pain, nausea, dizziness, headaches and weakness. She felt like she was coming down with the flu. Dr. Wilcox took her off of the oral contraceptives and prescribed Equagesic. On the following day, she called Dr. Wilcox. She still had headaches, felt weak, was short of breath, and had a sore throat and cough. He directed her to continue with the Tuss-Ornade and the Equagesic. On June 30, she called the office and talked with Dr. Buck, another associate. He authorized a refill of the Tuss-Ornade prescription. Two days later, on July 2, she saw Dr. Wilcox in his office. She was still vomiting; she complained of exhaustion upon slight exertion; her legs ached; and she had a sore throat but no fever. Her blood pressure had reached 186/104. Dr. Wilcox ordered some tests and later that same day referred her to Dr. Reid, an internist, who examined her and saw all of the laboratory reports. He directed her to the Lawrence Memorial Hospital, which she entered on July 2. Her blood pressure was 202/102. She was diagnosed as having chronic renal disease. Two days later, on Sunday, July 4, 1976, she was transferred by ambulance to the K.U. Medical Center in Kansas City, Kansas.

Upon her arrival at the medical center, she was described as being in poor condition, and she was initially diagnosed as suffering from "renal failure." Peritoneal dialysis was commenced immediately. A few days later, surgery was performed so that she could be connected to the hemodialysis machine. Her kidneys had utterly failed, and she was completely dependent upon hemodialysis. She was released from the K.U. Medical Center on July 28, 1976. The hospital records upon her discharge contain the following case summary:

"FINAL DIAGNOSIS: Renal failure secondary to hemolytic uremic syndrome, oral contraceptive induced.

Hypertension, volume dependent.

Congestive heart failure secondary to volume overload.

Anemia secondary to # 1.

"OPERATIONS AND PROCEDURES:

Peritoneal dialysis.

Renal biopsy, open.

External leg shunt.

Internal fistula placement in the left arm.

"DISPOSITION: The patient is discharged on the following medications--

Inderal, 20 mg. p.o. q.i.d.; Atarax, 25 mg. p.o. p.r.n. itching

Dalmane, 15 mg. p.o. p.r.n. sleep; Coumadin, 2.5 mg. p.o. daily; Colace, 1 tablet p.o. t.i.d.; Alu-Caps, 2 tablets p.o. t.i.d.; Renal Vitamin, 1 p.o. daily. The patient will be returning to the Outpatient Dialysis Clinic for thrice weekly in-center dialysis. The patient and husband will undergo home dialysis training in the late summer or early fall.

"PROGNOSIS: Fair."

After plaintiff was discharged, she had to return to the hospital three times weekly from her home in Lawrence for dialysis treatments. In October 1976, she and her husband travelled to the medical center daily for four weeks and took training for home dialysis. In November, plaintiff got a home dialysis machine, and thereafter her husband gave her the treatments at home. At first, the dialysis took six hours; later it was reduced to five hours, then to four hours. Mrs. Wooderson continued to have...