McDaniel v. McNeil Laboratories, Inc.

• Decision Date: 19 May 1976
• Docket Number: No. 40270,40270
• Citation: 196 Neb. 190,241 N.W.2d 822
• Parties: Marjorie McDANIEL, by her appointed guardian, Everett McDaniel, Appellant, v. McNEIL LABORATORIES, INC., a Pennsylvania Corporation, Appellee. Everett D. McDANIEL, Appellant, v. McNEIL LABORATORIES, INC., a Pennsylvania Corporation, Appellee.
• Court: Nebraska Supreme Court

Page 822

241 N.W.2d 822

196 Neb. 190

Marjorie McDANIEL, by her appointed guardian, Everett McDaniel, Appellant, v. McNEIL LABORATORIES, INC., a Pennsylvania Corporation, Appellee.

Everett D. McDANIEL, Appellant, v. McNEIL LABORATORIES, INC., a Pennsylvania Corporation, Appellee.

No. 40270.

Supreme Court of Nebraska.

May 19, 1976.

Syllabus by the Court

1. Under the doctrine of strict liability, an unavoidably unsafe product, properly prepared and accompanied by proper directions and warning, is not defective, nor is it Unreasonably dangerous.

2. A drug, properly tested, labeled with appropriate directions and warnings, approved by the United States Food and Drug Administration, and marketed properly under federal regulation, is presumptively a reasonably safe product, in the absence of clear and convincing evidence to the contrary.

3. An unavoidably unsafe drug which has been approved for marketing by the United States Food and Drug Administration, properly prepared and distributed, and accompanied by appropriate directions and warnings, is not defective nor unreasonably dangerous, as a matter of law, in the absence of proof of inaccurate, incomplete, misleading, or fraudulent information furnished by the manufacturer in connection with such federal approval or later revisions or extensions thereof.

4. Where there are appropriate directions and warnings, a manufacturer of a properly prepared drug may not be held liable either on a breach of warranty theory or a strict liability in tort theory.

5. The standard or reasonable care never varies but the degree of care required varies with the danger involved in the act and is proportionate to it.

6. If an act involves a risk of death or serious bodily harm and is capable of causing such results to a number of persons, the highest attention and caution are required, even if the act has a very considerable utility.

7. It is not error to refuse a requested instruction of the legal principles announced therein are either incorrectly stated or inapplicable to the issues involved.

Warren C. Schrempp, Richard J. Dinsmore, Richard E. Shugrue of Schrempp, Dinsmore & McQuade, Joseph N. Lindquist, Omaha, for appellants.

Charles F. Gotch, Terry J. Grennan of Cassem, Tierney, Adams & Gotch, Omaha, for appellee.

Heard before WHIFE, C.J., BOSLAUGH, McCOWN and CLINTON, JJ., and KUNS, Retired District Judge.

McCOWN, Justice.

This case involves consolidated causes of action by the plaintiff, Everett D. McDaniel, on his own behalf and as guardian of his wife, Marjorie McDaniel. The actions seek recovery for injuries and damages resulting from a surgical operation performed on Marjorie McDaniel on February 2, 1971, at an Omaha hospital.

Five defendants were named in the actions: McNeil Laboratories, Inc.; the hospital; the operating surgeon; the anesthesiologist; and the head of the anesthesiology department of the hospital. The hospital and the operating surgeon were dismissed prior to trial. The active anesthesiologist and the head of the anesthesiology department, by settlement and agreement, were dismissed on the third day of trial, and the case continued against the sole remaining defendant, McNeil Laboratories, Inc. The issue of whether that defendant was or was not negligent was submitted to the jury. The jury returned its verdict for the defendant and the plaintiffs have appealed.

Although only the liability of the defendant, McNeil Laboratories, Inc., is involved in this appeal, it is necessary to detail many of the facts involved to furnish the appropriate background for consideration of the issues involving the defendant, McNeil. The actions, duties, and responsibilities of the various defendants are intermingled and interrelated.

The plaintiff, Marjorie McDaniel, was admitted to the hospital on January 31, 1971, for what was expected to be a routine hemorrhoidectomy. Mrs. McDaniel was 47 years old and the mother of three children. She was examined and rated as one of the class considered to be the best risks for surgery. At about 8 a.m. on the morning of February 2, 1971, she was given 100 mg. of nembutal, a barbiturate. At 8:30 a.m., she was given 75 mg. of demerol, and .3 mg. of scopolamine as preoperative medication. She was taken into surgery around 9 a.m. Shortly after Mrs. McDaniel arrived in the operating room, the attending anesthesiologist decided that Mrs. McDaniel was not satisfactorily sedated and give her 1/2 cc of the drug Innovar, and a few minutes later another 1/2 cc of Innovar. The next drug administered was the main anesthetic, Xylocaine, which was administered as a caudal block. A 5--cc test amount was injected in the spine and then a 17--cc dose was injected at 9:40. The surgery began shortly after 9:45 a.m., and until about 10 a.m., the operation was apparently proceeding normally. Shortly before 10 a.m., Mrs. McDaniel unemotionally told the anesthesiologist that she could still feel 'what they are doing.' The anesthesiologist then gave her 2 cc's of Innovar through the IV. Almost immediately shortly after 10 a.m., there was a dramatic drop in her blood pressure and pulse. The anesthesiologist thereafter inserted a plastic airway in her mouth and began administering oxygen through a mask. The circulating nurse noticed her color was very blue some minutes before the operation was over. She found no pulse in the patient's wrist. She asked the anesthesiologist about it and was told that the patient was all right and that he had a temporal pulse. The operating surgeon reported on two occasions that the blood was very black and inquired about the patient's condition but the anesthesiologist responded that it was all right to go ahead and finish. Just before the operation was finished, the anesthesiologist reported that he could not get a pulse. Mrs. McDaniel was then turned over onto her back and was found to be in cardiac arrest. At that point emergency procedures of several kinds were instituted. Mrs. McDaniel's life was saved but because of the severe brain damage, she has never regained consciousness. She is comatose. Her organs continue to function, but she is unconscious and completely unable to respond to stimuli or move any part of her body. She has a tracheotomy which facilitates breathing. She is fed by a tube into her stomach and there is a catheter to the bladder. The damage is permanent and there is no expectation of recovery.

The drug involved here is manufactured by the defendant, McNeil Laboratories, Inc. It is called Innovar. It is used as an anesthetic. Its pharmacologic action produces analgesia and sedation. It contains two drugs, both of which are also marketed separately by McNeil. These drugs are fentanyl, a synthetic narcotic analgesic, and droperidol, a major sedative tranquilizer. These two drugs are combined in a fixed ratio of 50 parts of droperidol to 1 part of fentanyl to produce Innovar.

Fentanyl is a synthetic narcotic which is 100 to 150 times more powerful than morphine. It takes effect almost immediately when used intravenously, reaches maximal analgesic effect in a very few minutes, and is then effective for a period of 30 to 60 minutes. Fentanyl may cause respiratory depression and, in turn, carbon dioxide is not adequately disposed of and adequate oxygen is not taken in. Fentanyl can also cause muscle rigidity, particularly of the chest walls, which then interferes with breathing. Respiratory depression occurs with all narcotics, as does muscle rigidity if enough is given.

Droperidol is a major tranquilizer which takes effect within 5 to 10 minutes when given intravenously and continues to be effective anywhere from 4 to 12 hours, and on occasion, even longer. Droperidol may cause hypotension, a decrease in blood pressure. The lowered blood pressure may lead to Hypoxia, which means that insufficient oxygen is delivered to the tissues and damage may result. Brain tissues are the most sensitive to lack of oxygon. Most tranquilizers, if enough is given, can cause low blood pressure and impaired circulation.

McNeil Laboratories, Inc., began its studies and clinical investigations of the drug Innovar in the United States in 1963, sometime after Innovar had been introduced for clinical use in Germany and the Netherlands. An investigative new drug application was filed by McNeil with the United States Food and Drug Administration in 1963. A new drug application was filed in May of 1964, and amended in May of 1966. During these years, clinical investigation was conducted by several hundred investigators. The information collected and filed with the FDA covered approximately 5,800 patients. Innovar was approved by the FDA on January 31, 1968. There have been no changes in composition since that time. Fentanyl was approved for marketing on February 19, 1968, and the distribution of Innovar and fentanyl was started in March 1968. Droperidol was approved by the FDA for marketing on June 11, 1970, and marketed shortly thereafter.

Printed package inserts containing pharmacological information, safety evaluations, recommended dosages and administration, and warnings as to adverse reactions and control measures to be taken in such event, are included in the approval by the Food and Drug Administration. This approved printed material is distributed with the drug as a package insert. The package insert at the time of the operation in this case was printed March 19, 1968, and used thereafter until it was revised September 14, 1973. Primarily the revised material emphasized the severity of adverse reactions and was more specific with recommendations as to precautions and control measures available.

No new adverse reactions have been discovered since the approval of Innovar by the FDA, and there is evidence that there was nothing known at the time of trial about the nature of adverse reactions which was not known at the time the application was submitted to and approved by the Food and Drug...