Bristol-Myers Co. v. Gonzales

Decision Date30 December 1976
Docket NumberNo. 1016,BRISTOL-MYERS,1016
Citation548 S.W.2d 416
PartiesCOMPANY, Appellant, v. Ramon GONZALES et al., Appellees.
CourtTexas Court of Appeals

YOUNG, Justice.

In this products liability case, Bristol-Myers Company, defendant below, appeals from an $800,000 judgment against it and in favor of Ramon Gonzales, plaintiff below, for plaintiff's deafness allegedly resulting from claimed inadequacies in the warnings given by Bristol concerning its prescription drug "Kantrex". The judgment also denied Bristol any indemnity or contribution against the prescribing and treating physician, Dr. Rufino H. Gonzalez, cross-defendant below.

This suit originally sought recovery against Bristol, the manufacturer of Kantrex (kanamycin sulfate), the Upjohn Company, the manufacturer of Mycifradin (neomycin sulfate), and Dr. Gonzalez, for total, irreversible, bilateral deafness brought about by treatment with those drugs for a hip infection while in Memorial Medical Center in Corpus Christi, Texas, in December 1970 and January 1971. The liability of Bristol and Upjohn was claimed to be predicated on their failure to provide adequate warnings and instructions for the safe use of their drugs to the physician and for affirmative misrepresentation with regard to the use of such drugs under theories of negligence and strict products liability (Sections 402A and 402B of the Restatement (Second) of Torts) and on Dr. Gonzalez for negligence in his treatment of plaintiff with the drugs. Prior to trial, plaintiff compromised his claims against Dr. Gonzalez for $100,000.00. He then non-suited both Dr. Gonzalez and Upjohn.

Bristol denied plaintiff's claims and filed a cross-claim against Dr. Gonzalez alleging as defenses negligence and misuse of its drug Kantrex in treating plaintiff, and requesting indemnity or contribution from the physician. In turn, Dr. Gonzalez filed a third-party complaint against Bristol and Upjohn for misrepresentation and inadequate warnings as to the use of its drugs, requesting indemnity and contribution from the manufacturers, but prior to trial he non-suited Upjohn.

In that posture, plaintiff, Dr. Gonzalez and Bristol (the three parties before this Court) went to trial before a jury that found in answer to special issues: 1) that in the 1970 PDR (Physicians' Desk Reference) Bristol failed to give Dr. Gonzalez adequate warnings or instructions (as defined in the charge of the court) with respect to the use of Kantrex; 2) that such failure was a producing cause of plaintiff's deafness; 3) that the statement "Kantrex injection (kanamycin sulfate injection) in concentrations of 0.25 percent in abscess cavities" reasonably implied to Dr. Gonzalez that he could use the drug in such concentration for the irrigation on plaintiff without fear of hearing damage; 4) that Dr. Gonzalez relied on that statement; 5) that the statement was false; 6) that reliance on that false statement was a producing cause of plaintiff's deafness; 7) that Dr. Gonzalez failed to use ordinary care (as defined in the charge of the court) in treating plaintiff; 8) that such failure was a proximate cause of plaintiff's deafness; and 9) that plaintiff's damages for loss of hearing were $800,000.00.

The trial court, having previously overruled Bristol's motions for directed verdict at the close of all the evidence, thereafter entered judgment on the verdict in favor of plaintiff and against Bristol in the amount of $800,000.00 and overruled Bristol's motion for judgment N.O.V. and alternative motions on the verdict for indemnity or contribution from Dr. Gonzalez. Bristol's amended motion for new trial was likewise overruled. Bristol appeals from that judgment.

A fair summary of the background facts shows these events and circumstances. On November 22, 1970, appellee Ramon Gonzales, then 25 years old, was admitted to Memorial Medical Center, Corpus Christi, Texas, by Dr. Gonzalez, an orthopedist. Ramon had been complaining of pain in his left hip and knee. After some tests, Dr. Gonzalez diagnosed infection in Ramon's hip. On December 20th, Dr. Gonzalez started Ramon on Kantrex tablets. On December 22nd, he changed the administration of Kantrex to intramuscular injection, and between December 22nd and January 5, 1971, a total of 20.5 grams of Kantrex was administered in this way. Dr. Gonzalez performed surgery on Ramon's infected hip on December 23rd. Beginning on that day and continuing to January 4, 1971, the wound in Ramon's hip was subjected to continuous irrigation (or washing) with alternating solutions of Bristol's Kantrex and Upjohn's neomycin sulfate.

Both Bristol's Kantrex and Upjohn's neomycin were known to be "ototoxic" (having potential to cause deafness). The mechanical way in which each drug affects hearing (damage to the eighth cranial nerve) is the same. It is not disputed the some portion of the Kantrex and neomycin used in the irrigation was absorbed in the blood and that the cumulative effect of all those ototoxic drugs in the blood, the unknown amount of absorbed Kantrex and neomycin plus the injected Kantrex, resulted in Ramon's deafness.

The literature which Dr. Gonzalez consulted regarding the use of Kantrex at the time of treatment was Bristol's insert for Kantrex injection in the 1970 PDR (Physicians' Desk Reference).

In any event, by the time Ramon was taken off the two drugs on January 5th, damage had been done to his hearing. By February, he was totally and permanently deaf.

Appellant has brought forward 38 points of error. It has, however, summarized the points into categories for purposes of argument. We will use appellant's format, generally, in considering its contentions. Among appellant's points of error are several legal insufficiency points ("no evidence" and "as a matter of law"). With each such point, we shall view the evidence in a light most favorable in support of the jury findings and consider only the evidence and inferences which support the findings and reject the evidence and inferences contrary to the findings. Miller v. Riata Cadillac Company, 517 S.W.2d 773 (Tex.Sup.1975). In considering the appellant's factual insufficiency points of error ("insufficient evidence" and "against the great weight and preponderance of the evidence"), we shall examine the whole record to determine whether the evidence supports the jury findings. In re King's Estate, 150 Tex. 662, 244 S.W.2d 660 (1951).

In its first category (points 1, 2, 3 and 4), Bristol contends that recovery is not sustainable under Section 402A, Restatement of Torts (Second) because Dr. Gonzalez misused Kantrex and because Bristol complied with Federal Food and Drug Administration requirements; the warning therefore was adequate as a matter of law. Primarily, Bristol attacks the jury findings favorable to Ramon in special issues 1 (inadequate warning) and 2 (producing cause).

For misuse to be a defense, the supplier must show that the use which caused the injury was not reasonably foreseeable. Heil Co. v. Grant, 534 S.W.2d 916 (Tex.Civ.App., Tyler 1976, writ ref'd n.r.e.). And if the injury resulting from foreseeable misuse of a product is one which an adequate warning concerning the use of the product would likely prevent, such misuse is no defense. Bituminous Casualty Corporation v. Black and Decker Manufacturing Co., 518 S.W.2d 868 (Tex.Civ.App., Dallas 1974, writ ref'd n.r.e.).

In the 1970 PDR, the appellant Bristol stated:

"Other Routes of Administration: Kantrex injection . . . in concentrations of 0.25 per cent (2.5 mg./ml.) has been used satisfactorily as an irrigating solution in abscess cavities, pleural space, peritoneal and ventricular cavities." (Emphasis supplied.)

Without further clarification about what type of irrigation was appropriate, the jury was entitled to infer that Bristol left the door open for a treating physician to use Kantrex as a continuous irrigant. The testimony of Dr. Jones, a witness for Bristol, showed that Bristol intended Kantrex to be used only as a one-time washing of surgical wounds, not as a continuous irrigation. The foregoing demonstrates a reasonable inference that continuous irrigation with Kantrex was reasonably foreseeable because of the statement by Bristol in the 1970 PDR and that the warning was not adequate against using Kantrex as a continuous irrigant. Bristol's misuse as a matter of law contention is without merit.

We now consider Bristol's contention that its warning in the 1970 PDR was adequate as a matter of law because it complied with FDA requirements. In that regard, we deem applicable the reasoning in Rumsey v. Freeway Manor Minimax, 423 S.W.2d 387 (Tex.Civ.App., Houston (1st Dist.) 1968, no writ). In Rumsey, the defendant claimed no liability because he had complied with the respective State and Federal Acts and his label had been approved by the appropriate governmental agencies. The Court of Civil Appeals there said:

". . . Neither the State nor the Federal Act purports to change to the common law duty to warn. It merely authorizes the marketing of specified economic poisons if the statutes and the regulations promulgated are complied with. Neither Act purports to deal with property rights. It makes it a crime to market such a product without complying with the Act. Failure to comply with the Act would be negligence per se. However, a mere compliance does not as a matter of law, in all cases, mean that the party is free from negligence. . . . Whether there is negligence depends on the facts of each case. We are of the view that the statutes and regulations by the agencies merely set minimum standards. Compliance with the standards is evidence...

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