Bristol-Myers Co. v. Gonzales

• Decision Date: 01 February 1978
• Docket Number: BRISTOL-MYERS,No. B-6707,B-6707
• Citation: 561 S.W.2d 801
• Parties: COMPANY, Petitioner, v. Ramon GONZALES et al., Respondents.
• Court: Texas Supreme Court

Page 801

561 S.W.2d 801

BRISTOL-MYERS COMPANY, Petitioner,

v. Ramon GONZALES et al., Respondents.

No. B-6707.

Supreme Court of Texas.

Feb. 1, 1978.

Rehearing Denied March 8, 1978.

Graves, Dougherty, Hearon, Moody & Garwood, William L. Garwood, Austin, Meredith & Donnell, M. William Meredith, Jr., Corpus Christi, for petitioner.

William R. Edwards, Charles R. Cunningham, Corpus Christi, for respondents.

BARROW, Justice.

Ramon Gonzales sued Bristol-Myers Company, the Upjohn Company, and Dr. Rufino Gonzalez for deafness resulting from administration by Dr. Gonzalez of Bristol-Myers' Kantrex and Upjohn's neomycin. Bristol-Myers and Upjohn were sued in strict liability for improper warnings, and Dr. Gonzalez was sued in negligence for improper treatment. Shortly before the trial, plaintiff Gonzales entered into a settlement agreement with Dr. Gonzalez and non-suited both Dr. Gonzalez and Upjohn. ¹ Dr. Gonzalez remained in the case as a third party defendant to Bristol-Myers' claim for indemnity or contribution. Dr. Gonzalez also filed a third party complaint against Bristol-Myers seeking indemnity or contribution. The trial court rendered judgment for plaintiff on the jury verdict against Bristol-Myers for $800,000 and denied Bristol-Myers any relief from Dr. Gonzalez. The court of civil appeals reformed the judgment by granting Bristol-Myers contribution from Dr. Gonzalez by reducing the award for plaintiff Gonzales against Bristol-Myers to $400,000. 548 S.W.2d 416. Applications for writ of error were filed by Bristol-Myers, Dr. Gonzalez, and plaintiff Gonzales. We reverse the judgment of the courts below and remand the cause for another trial.

Plaintiff, then 25 years of age, was admitted to the Memorial Medical Center in Corpus Christi on November 22, 1970, as a patient of Dr. Gonzalez because of a severe, but undiagnosed, pain in his left leg. The pain was traced to an infection in his left hip and, on December 20th, Dr. Gonzalez started plaintiff on Kantrex tablets. On December 22nd, Dr. Gonzalez changed the administration of Kantrex to intramuscular injection; and between December 22nd and January 5, 1971, a total of 20.5 grams were administered in this way, according to the nurses' notes. ² On December 23rd, Dr. Gonzalez made a deep six-to-eight inch incision in the hip and removed the infected tissue. Following the surgery, Dr. Gonzalez started continuous irrigation (washing) of the wound with alternating solutions of Kantrex and Upjohn's neomycin. It is not known how much of these solutions was absorbed into plaintiff's body, but it is uncontradicted that plaintiff's deafness was produced by excessive administration, by tablets, injections, and irrigation, of these two drugs. Plaintiff did not contend that Bristol-Myers' drug, Kantrex, was adulterated or was itself defective, but rather that the drug was "ototoxic" (having the potential to cause deafness) and that the warnings given by Bristol-Myers for its use were inadequate and improper.

Kantrex is the trade name for kanamycin sulfate and is one of about seven antibiotics which may be used to treat the type of bacteria discovered in plaintiff's infection. It is manufactured exclusively in this country by Bristol-Myers and has been sold by it since 1958. Neomycin, another of the antibiotics used to treat the type bacteria found in plaintiff, is manufactured by several drug companies, but the neomycin used by Dr. Gonzalez on plaintiff was distributed by Upjohn. Both Kantrex and neomycin are prescription drugs and, as such, must have package inserts, which are approved by the Food and Drug Administration (FDA), describing the drug and its use. See 21 Code of Federal Regulations 130.9 (1970). The description of each drug is prepared by the drug manufacturer, although it must be approved by the FDA.

These package inserts, in addition to being placed in each package at the time of manufacture, are compiled and published annually by a private company in the Physicians' Desk Reference (PDR). The PDR, published primarily for the guidance of physicians, is distributed to all members of the American Medical Association (AMA), hospitals and other interested persons. The PDR is kept reasonably current through distribution of periodic supplements each year which reflect any change in the package insert. The Kantrex package insert was changed several times between 1958 and the time of the trial as additional information was learned concerning the use and dangers of the drug. There was evidence that a package of Kantrex would retain its effectiveness and could be used from four to five years after its manufacture. Accordingly, the insert in a package could have been published long before use of the drug and could be inaccurate.

The jury found that Bristol-Myers failed to give Dr. Gonzalez adequate warnings and specific instructions in the 1970 PDR with respect to the use of Kantrex. They also found that a statement in the 1970 PDR ³ reasonably implied to Dr. Gonzalez that he could use Kantrex in concentrations of 0.25 percent for the continuous irrigation of plaintiff's wound without fear of hearing damage. The jury further found that this statement was false and that it was relied upon by Dr. Gonzalez. The inadequate warnings and the false statement were each found to be a producing cause of plaintiff's deafness. These findings support a recovery against Bristol-Myers on strict liability under Sections 402A and 402B of the Restatement (Second) of Torts. The jury also found that Dr. Gonzalez' failure to use ordinary care in treating plaintiff with Kantrex and neomycin was a proximate cause of plaintiff's deafness. No complaint was raised by anyone as to the findings against Dr. Gonzalez.

Bristol-Myers seeks by its first two contentions a reversal of the judgment and rendition of a take nothing judgment against plaintiff on the ground that there is no evidence to sustain a recovery under strict liability as set forth in Section 402A or Section 402B. In considering these no evidence points we must consider the evidence in the light...