Gravis v. Parke-Davis & Co.

• Decision Date: 15 November 1973
• Docket Number: No. 788,PARKE-DAVIS,788
• Citation: 502 S.W.2d 863
• Parties: C. K. GRAVIS, Jr., et ux., Appellants, v.& CO. et al., Appellees.
• Court: Texas Court of Appeals

Page 863

502 S.W.2d 863

C. K. GRAVIS, Jr., et ux., Appellants, v. PARKE-DAVIS & CO. et al., Appellees.

No. 788.

Court of Civil Appeals of Texas Corpus Christi.

Nov. 15, 1973.

Rehearing Denied Dec. 21, 1973.

Sidney P. Chandler, Corpus Christi, for appellants.

Kenneth Oden, Alice, Ronald B. Brin, Allison, Maddin, White & Brin, Corpus Christi, for appellees.

OPINION

NYE, Chief Justice.

This is a products liability case. C. K. Gravis and his wife Elma Gravis, appellants, brought suit against Parke-Davis and Co., Winthrop Laboratories, Inc., and Sterling Drug Company, appellees, for personal injuries sustained by Mrs. Gravis. The case was tried before a jury. At the conclusion of plaintiffs' case in chief the appellees moved for an instructed verdict or in the alternative, to withdraw the case from the jury and render judgment as a matter of law. The motion was granted by the trial court.

Orginally, Mrs. Gravis sued the hospital, the doctors, and the anesthetist for various acts of negligence which caused Mrs. Elma Gravis to be partially paralyzed and suffering from othe rinjuries from an abdominal operation. In the former suit the plaintiffs also sued Abbott Laboratories with regard to drugs used in the operation. Summary judgment was entered for all defendants including Abbott Laboratories. Since there was no appeal by the plaintiffs as to Abbott Laboratories, that judgment became final. As to the other defendants the case was ultimately reversed and remanded for trial. ¹

Thereafter Mr. and Mrs. Gravis settled their suit with the doctors, the anesthetist and the hospital. Subsequently, they instituted this lawsuit against the drug firms whose products were used in the operation. The trial court again entered summary judgment for all defendants and the case was ultimately reversed and remanded for trial. ²

On October 22, 1963 Mrs. Gravis complained of pain in her abdomen. Her husband telephoned Dr. Joseph, the family physician who agreed to and did meet them at the Physicians and Surgeons Hospital of Alice. The doctor's initial examination in the emergency room at the hospital and subsequent examinations and tests necessitated an exploratory operation. On October 24 Mrs. Gravis received the operation. It lasted one hour. Mrs. Ruth Grose administered a spinal anesthetic (containing three different drugs furnished by appellees) and pentothal sodium (furnished by Abbott Laboratories) to Mrs. Gravis which was given during the operation. An intestinal obstruction was found and corrected. Later, after she had been moved back to her own room Mrs. Gravis felt abnormal and couldn't move her legs. She was suffering from a number of physical disabilities including bladder trouble requiring a catheter continuously, phlebitis of the left leg, high blood pressure and other problems of the lower extremities.

The testimony showed that Dr. Joseph directed the anesthetist to use a spinal anesthetic composed of novocaine, dextrose, and adrenalin. The anesthetist followed a formula previously worked out by Dr. Joseph in preparing the anesthetic solution. The formula called for 2cc of novocaine and .5 cc of dextrose. These drugs were manufactured by Winthrop Laboratories and Sterling Drug Co. The other drug used was (1 cc) adrenalin which was manufactured by Parke-Davis and Co.

The evidence showed that epenephrine is produced by the adrenal gland in the body. Parke-Davis produces a synthetic epenephrine under the trade name of adrenalin. This drug is studied in medical schools and is one of the most commonly known drugs in the medical profession. It has a number of uses such as treating asthmatic conditions, controlling excessive bleeding, and is commonly used by dentists in a combination with local anesthetic because it tends to prolong the local anesthetic and constricts the vessels and therefore cuts down on bleeding. The adrenalin drug is a vaso constrictor. It acts to constrict the blood vessels. It is not an anesthetic agent nor does it have any anesthetic effect or quality. The dextrose is mixed with the other drugs so as to make the total solution heavier than the spinal fluid so that all of the drugs in solution can float along the spinal canal and anesthetize the specific area according to the location of the surgery. The adrenalin was used to prolong the anesthesia. Each drug had a different purpose, but all of the drugs were compatible and such drugs had been used together as an anesthetic for many years. Spinal anesthesia may be effectuated by novocaine alone and for operations under 45 minutes in duration, novocaine is often used alone.

The procedures for the administration of the spinal anesthetic were testified to by Mrs. Grose, the anesthetist. She stated that she prepared the instruments needed for administering the anesthetic . The surgical instruments were autoclaved (heat treated) for sterilization. She described the procedure she followed on Mrs. Gravis as follows:

'You put the head, flex the head upon the chest and bring the knees up sharply as far as possible so that the back is rounded, and support the head with a pillow. Then the back is scrubbed with an antiseptic solution. Then you do a surgical scrub of your hands, put on gloves, assemble the needles and syringes and open the ampules, draw up the drugs that you want to use, agitate them, mix them or rotate them so that it's all one solution. Then you inject a small amount of novocain and ephedrine (sic) into the skin, into the skin so that the skin becomes numb, like the dentist does for your gums, and you put it a little deeper because you're going to use a longer needle for the spinal. When a minute or two has lapsed, that area is numb. Then you use the spinal needle which is a twenty gauge, three inch needle and put it in the proper interspace through the various layers of the back until you feel a slight snap or give, and then you are in the spinal column. When you take the stillette out of the needle, you will get the spinal fluid.

"In the syringe that you have the drugs ready to give, you attach that to the spinal needle and draw the spinal fluid to dilute your drugs further to make it all one solution and to be sure you're in the right space and everything is correct. Then you give your solution, take your needle out, wipe it off, turn the patient quickly on the back, and raise the head up, and the spinal--the drugs float along and anesthetize the area that you want it."

Nurse Grose stated that she examined the drugs for defects. She testified that she had previously given 2500 spinals without any adverse effect; that if there was a defect in the ampule the contents would be 'cloudy or granular or not look right'. She stated that there was no cracks in the ampules and no discoloration of the drugs. She testified that these ampules came in a box of 100 and that she had used 75 out of the box without incident. The ampules were sterilized overnight before use. The anesthetist further testified that she continued to use the ampules thereafter and each was pure and did what it was supposed to do. She stated that the drugs used had given their desired results; that ampules from that box were used in two operations on that day; and that the remainder of the empules were used without any reaction from any other patient.

Dr. Robert L. Fordtran, a diagnostician and a specialist in internal medicine, testified at great length. He had treated Mrs. Gravis following her stay at the Physicians and Surgeons Hospital in Alice. He was asked to see Mrs. Gravis in consultation with Dr. Klotz at Sphon Hospital in Corpus Christi, primarily to handle a phlebitis which Mrs. Gravis had developed in her leg. He had done a complete physical examination on her prior to trial. His initial diagnosis in 1969 was phlebothrombosis in the leg and peripheral neuropathy caused by the spinal anesthetic. He testified that there is a hazard in the administration of any kind of anesthetic that could in some cases cause death; that bad results do occur from use of bad anesthetics and occur sufficiently enough that manufacturers of anesthetics such as novocaine warn of that possibility in their literature. He testified as to such a package insert, (disclosure) on the part of Winthrop Laboratories with respect to novocaine. He concluded by testifying that it was his opinion that Mrs. Gravis' condition was related somehow to the spinal anesthetic. He was questioned:

'Q. Okay. And when you say that, you mean to say that like one of those cases that just happens once in every 200,000 times, this just happened, is that what you mean?

A. Yes, sir. Because like I say, this is something people have knowledge of, but it's extremely rare and I personally have never seen before.

Q. And indicates no wrongdoing on anybody's part?

A It doesn't indicate any wrongdoing on anybody's part as far as I can tell.

Q. Or any defect in any of the procedures or the Medication?

A. According to the information I have.' (emphasis supplied)

Dr. Fordtran testified that Mrs. Gravis' condition is described on the Winthrop Laboratories exhibit 1 (the disclosure warning) and 'that's essentially what we have here. . . .' The Winthrop brochure lists a number of permanent complications associated with spinal anesthetic. The one that Dr. Fordtran was testifying about described the complications and side effects as follows:

'In isolated instances one or several of the following complications or side effects may be observed during or after spinal anesthesia.

Cauda equina and lumbosacral cord complications (usually consisting of arachnoiditis and demelinization) Result in loss or impairment of motor and sensory function of the saddle area (bladder, rectum) and one or both legs. These complications have occurred after the use of most, if not all, spinal anesthetics. The loss or impairment of motor function may be permanent, or partial recovery may slowly occur. Various explanations for such complications...