Guevara v. Dorsey Laboratories, Div. of Sandoz, Inc.

• Decision Date: 10 December 1987
• Docket Number: Nos. 87-1431,87-1519,s. 87-1431
• Citation: 845 F.2d 364
• Parties: Prod.Liab.Rep.(CCH)P 11,771 Ruben GUEVARA, et al., Plaintiffs, Appellees, v. DORSEY LABORATORIES, DIVISION OF SANDOZ, INC., Defendant, Appellant. Ruben GUEVARA, et al., Plaintiffs, Appellants, v. DORSEY LABORATORIES, DIVISION of SANDOZ, INC., Defendant, Appellee. . Heard
• Court: U.S. Court of Appeals — First Circuit

Page 364

845 F.2d 364

Prod.Liab.Rep.(CCH)P 11,771

Ruben GUEVARA, et al., Plaintiffs, Appellees, v. DORSEY LABORATORIES, DIVISION OF SANDOZ, INC., Defendant, Appellant.

Ruben GUEVARA, et al., Plaintiffs, Appellants, v. DORSEY LABORATORIES, DIVISION of SANDOZ, INC., Defendant, Appellee.

Nos. 87-1431, 87-1519.

United States Court of Appeals First Circuit.

Heard Dec. 10, 1987.

Decided April 26, 1988.

As Amended May 4, 1988.

David Efron, Rio Piedras, P.R., with whom Rolando A. Silva, San Juan, P.R., was on briefs, for plaintiffs.

Jose L. Gandara with whom Bauza & Davila, Old San Juan, P.R., was on briefs, for defendant.

Before COFFIN, BREYER and TORRUELLA, Circuit Judges.

TORRUELLA, Circuit Judge.

Defendant below appeals from a jury finding of liability and damages in this diversity action. The suit is against a drug manufacturer, Dorsey, for failure to adequately warn doctors of dangers associated with the use of its drug. The main issue on appeal is whether there was sufficient evidence to sustain findings of inadequate warning and causation. We find that there was not sufficient evidence, and reverse.

According to her allegations, in early 1980, plaintiff Elba Colon was treated for injuries received in the course of her employment. As part of the treatment, a Dr. Boria apparently prescribed Bellergal-S, a prescription drug manufactured by the defendant. Colon took the drug for a total of five days. After three days, however, she began to experience a skin rash that caused blisters to break out on her body. These blisters became infected, smelled badly for about five months, and left scars and hyperpygmented (dark) spots on her body that are apparently permanent. She claims that the rash was the result of an allergic reaction to phenobarbital, one of the main ingredients in Bellergal-S.

Colon then brought this action in federal court pursuant to its diversity jurisdiction. She claimed under the law of Puerto Rico that Dorsey had a duty to warn adequately of dangers inherent in the use of this drug, that it failed to do so, and that Dorsey's failure to warn adequately was the proximate cause of her injury. We must now evaluate whether the evidence introduced at trial, taken in the light most favorable to the plaintiff, and with all reasonable inferences drawn in her favor, supports the jury's finding. Valedon-Martinez v. Hospital Presbiteriano, 806 F.2d 1128, 1134 (1st Cir.1986).

The relevant law in this case is the law of Puerto Rico. Specifically, 31 L.P.R.A. Sec. 5141 (1956) makes persons responsible for the damage caused by their negligence. Under this section, the Supreme Court of Puerto Rico has developed a strict liability standard for manufacturers of defective products. See, e.g., Mendoza v. Cerveceria Corona, 97 D.P.R. 499 (1969); Montero Saldana v. American Motors Corp., 107 D.P.R. 452 (1978). While the court rejected the "unreasonably dangerous" requirement included in the Restatement (Second) of Torts Sec. 402A, in terms of the basic theory, these cases seem to track decisions in the United States making manufacturers responsible, regardless of fault, when a defective product they produced causes a harm.

An important treatise on extra-contractual damages in the law of Puerto Rico concludes that, despite a traditional negligence requirement, most civil law systems as well as the Supreme Court of Puerto Rico have been achieving results very similar to strict liability in these cases. By means of various theories and legal fictions, it claims, the Civil law countries have approximated the results achieved under the anglo-american theory of strict liability, embodied in the Restatement (Second) of Torts Sec. 402A. See 2 H. Brau del Toro, Danos y Perjuicios Extracontractuales en Puerto Rico, Sec. 16.04-05, pp. 906-18 (2d Ed. 1986).

On the precise issue before us, however, the parties have not directed us to any relevant authority in the Civil Law proper. Nor, after a diligent search, have we found authority in Puerto Rico or the civilist tradition to define what constitutes adequate warning in cases such as this one. The Supreme Court of Puerto Rico has made clear that the common law of the United States is not controlling, when filling gaps in the civil law system. Valle v. American International Insurance Co., 108 D.P.R. 692, 696-97 (1979). At the same time, however, when faced with a lack of authority, it may be appropriate to search for relevant principles in the common law. Id. Since the Supreme Court has freely taken from common law decisions in developing the concept of strict liability, see Mendoza, 97 D.P.R. 499; Montero-Saldana, 107 D.P.R. 452, and since the principles we find there are useful and persuasive, we believe the Supreme Court of Puerto Rico would follow essentially the same path we follow today.

We turn, therefore, to an analysis of relevant cases and doctrines from the United States. It is generally accepted, and the parties do not contest, that a prescription drug manufacturer has a duty to adequately warn prescribing physicians of the hazards posed by the use of its drugs. Pierluisi v. E.R. Squibb & Sons, 440 F.Supp. 691 (D.P.R.1977). The warning is directed not to the ultimate user but to the doctor prescribing the drug, who must then "take into account the propensities of the drug and the susceptibilities of the patient and make an informed decision" regarding the advisability of its use. Dalke v. Upjohn, 555 F.2d 245, 248 (9th Cir.1977) (applying Restatement (Second) Torts Sec. 402A). The warnings, in effect, cure the product of any defect for purposes of strict liability.

Comment j of Sec. 402A aptly describes Dorsey's responsibility in this case:

The seller may reasonably assume that those with common allergies, as for example to eggs or strawberries, will be aware of them, and he is not required to warn against them. Where, however, the product contains an ingredient to which a substantial number of the population are allergic, and the ingredient is one whose danger is not generally known, or if known is one which the consumer would reasonably not expect to find in the product, the seller is required to give warning against it, if he has knowledge, or by the application of reasonable, developed human skill and foresight should have knowledge, of the presence of the ingredient and the danger.

The evidence below clearly establishes that Dorsey knew that phenobarbital, and in consequence, Bellergal-S, could cause an allergic reaction in certain persons. From the evidence, the jury could have concluded that the number of these persons was substantial enough that Dorsey had a duty to warn doctors of the possibility of this allergic reaction.

Dorsey, however, unquestionably did warn of this hazard. Both the Physician's Desk Reference and the package insert that comes with the drug warned physicians not to give the drug to persons with "a demonstrated hypersensitivity to any of its components." Since phenobarbital is prominently and repeatedly said to be one of the main ingredients, the warning, read as a whole, clearly tells doctors not to administer Bellergal-S to patients known to be allergic to phenobarbital.

Plaintiff's theory goes further, however. Colon argues that the jury was entitled to determine that the warning was inadequate because it did not specifically warn of the kind of reaction she experienced, that is, a dermal reaction, causing the skin rash and the permanent dark spots all over certain parts of her body. The evidence in this case, however, does not warrant requiring such a detailed admonition, in light of the testimony of plaintiffs' own expert witness that the danger was already well known to the medical community.

The duty to warn in general is limited to hazards not commonly known to the relevant public. See Sec. 402A, Comment j, quoted above (need to warn only if "the ingredient is one whose danger is not generally known"). Section 388 of the Restatement, in a slightly different context, reflects the same principle: one who supplies another with a chattel is under a duty to inform of its dangerous character insofar as he is aware of it, "if, but only if, he has no reason to expect that those for whose use the chattel is supplied will discover its condition and realize the danger involved." Restatement (Second) of Torts, Sec. 388, Comment on clause (b). The courts have recognized this principle in their description of the scope of a drug manufacturer's duty to warn: "The warning should be sufficient to appraise a general practitioner as well as the 'unusually sophisticated medical man' of the dangerous propensities of the drug." McEwen v. Ortho Pharmaceutical Corp., 270 Or. 375, 528 P.2d 522, 529 (1974) (quoting Parke-Davis & Co. v. Stromsodt, 411 F.2d 1390, 1400 (8th Cir.1969)) (emphasis added).

The Ninth Circuit, relying on Sec. 402A, has spoken persuasively on the specific question at issue here:

"It is not the knowledge actually possessed by the plaintiff, individually [or, in this case, plaintiff's doctor], that determines whether the absence of warning renders a product unreasonably dangerous.... On the issue of duty to warn ... the question to be put to the jury is whether the danger, or potentiality of danger, is generally known and recognized; whether the product as sold was "dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it [again, in the case of prescription drugs, the general practitioner who prescribes it], with the ordinary knowledge common to the community as to its characteristics.' "

Jackson v. Coast Paint and Lacquer Company, 499 F.2d 809 (9th Cir.1974) (quoting Sec. 402A, Comments i and j) (emphasis in original).

We do not know, because neither party thought to call her as a witness, the extent of the treating doctor's knowledge of the allergenic properties of phenobarbital. Evidence of that nature would go to intervening superseding cause arguments, see ...