SEQ CHAPTER \h \r 1THE SOPHISTICATED USER AND LEARNED  INTERMEDIARY DEFENSES IN VIRGINIA
By Thomas J. Curcio, Esquire
Cohen, Dunn & Curcio, P.C.
221 South Alfred Street
Alexandria, Virginia 22314
(703) 836-9000THE SOPHISTICATED USER DEFENSE

The sophisticated user defense arises in a product liability action alleging negligent failure to warn. Under the defense, a supplier seeks to avoid liability by claiming that an intermediary in the chain of distribution had knowledge of product dangers equal to that of the manufacture and therefore the supplier had no duty to warn of product dangers. To better understand the defense, one should think of it as the sophisticated intermediary defense since the defense focuses on knowledge of an intermediary and not the knowledge of end users.

The Virginia Supreme Court recently made clear that the sophisticated user defense lies only in a product liability action alleging negligent failure to warn. See Morgen Industries, Inc. v. Vaughan, 252 Va. 60, 471 S.E.2d 489 (1996). The defense arises from Comment n of § 388 of the Restatement (Second) of Torts.

Section 388 sets forth a supplier’s (which includes a manufacturer) duty to warn likely users of chattels known to be dangerous for their intended use. It was first adopted by the Virginia Supreme Court in Featherall v. Firestone Tire and Rubber Co., 219 Va. 949, 962, 252 S.E.2d 358 (1979). Section 388 provides as follows:

One who supplies directly or through a third person a chattel for another to use is subject to liability to those whom the supplier should expect to use the chattel with the consent of the other or to be endangered by its probable use, for physical harm caused by the use of the chattel in the manner for which and by a person for whose use it is supplied, if the supplier

(a) knows or has reason to know that the chattel is or is likely to be dangerous for the use for which it is supplied, and
(b) has no reason to believe that those for whose use the chattel is supplied will realize its dangerous condition, and
(c) fails to exercise reasonable care to inform them of its dangerous condition or of the facts which make it likely to be dangerous.

Note that there is no duty to warn foreseeable users of dangers that are open and obvious. See Besser Company v. Hansen, 243 Va. 267, 415 S.E.2d 138 (1992); Austin v. Clark Equipment Co., 48 F.3d 833 (4th Cir. 1995).

The Featherall court made clear both the policy underlying the duty to warn and to whom the duty was owed.

The duty to warn stems from the view that the manufacturer should have superior knowledge of his product and it extends not only to the immediate purchaser but to other persons who might in the ordinary and natural course of events be subjected to danger.

Featherall, 219 Va. 949 at 962 citing 2 R. Hursh & H. Bailey, American Law of Product

Liability § 8:11, at 170-71 (2d ed. 1974). See also Comment a to § 388 which provides:
The words “those whom the supplier should expect to use the chattel” and the words “a person for whose use it is supplied” include not only the person to whom the chattel is turned over by the supplier, but also all those who are members of a class whom the supplier should expect to use it or occupy it or share in its use with the consent of such person, irrespective of whether the supplier has any particular person in mind.

Under clause c of § 388 a supplier must exercise reasonable care to inform those for whose use the chattel is supplied of dangers which are peculiarly within its knowledge. If a supplier has done so, it is not subject to liability, even though the information never reaches those for whose use the chattel is supplied. See Comment l, § 388. The factors which determine whether a supplier has exercised reasonable care by giving this information to third persons to whom the chattel is supplied for others to use is stated in Comment n.

Comment n of § 388, which is entitled “Warnings given to third persons”, has been adopted as the law of Virginia. See Barnes v. Litton Indus. Products, Inc., 555 F.2d 1184, 1188 (4th Cir. 1977); Jones v. Meat Packers Equipment Co., 723 F.2d 370, 373 (4th Cir. 1983); Goodbar v. Whitehead Bros., 591 F. Supp. 552, 557 (W.D. Va. 1984), aff’d sub. nom. Beale v. Hardy, 679 F.2d 213 (4th Cir. 1985). [Comment n attached as appendix A]

To fully appreciate the sophisticated user defense, one must realize that the supplier’s duty to warn, as imposed by § 388, extends to likely users of the chattel, potentially far down the chain of distribution. In such a scenario, the question arises, as contained in Comment n, whether warnings given to an intermediary (often an employer) satisfies the duty to warn known users (often employees) of known dangers.

Under Comment n, several factors must be balanced by the court to determine what precautions the manufacturer or supplier of a product must take to satisfy the requirements of reasonable care found in § 388 (c). See Oman v. Johns’ Manville Corp., 764 F.2d 224 (4th Cir. 1984) cert. denied, sub. nom. Oman v. H.K. Porter, 474 U.S. 970, 106 S.Ct. 351, 88 L.Ed.2d 319 (1985). Those factors include: (1) The dangerous condition of the product; (2) The purpose for which the product is used; (3) The form of any warnings given; (4) The reliability of the third-party as a conduit of necessary information about the product; (5) The magnitude of the risk involved; and (6) The burdens imposed upon the supplier by requiring that it directly warn all users. Oman v. Johns’ Manville Corp., 764 F.2d 224, 233. Goodbar v. Whitehead Bros., 591 F.Supp. 552 (W.D. Va. 1984) aff’d sub. nom. Beale v. Hardy, 679 F.2d 213 (4th Cir. 1985).

This balancing of factors contained in Comment n was undertaken by the Court in Oman. In that case, the Court considered whether the trial court erred in refusing to instruct the jury that a manufacturer’s duty to warn ultimate users (employees) was satisfied when a sophisticated employer is aware of the dangers involved in the use of its product. In ruling no error was made, the Court stated as follows:

In this case the product, because it contained asbestos, was very dangerous. The burden on the manufacturers in placing a warning on the product was not great. The employer was unaware of the danger until 1964. Finally, once the employer became aware of the potential danger, it failed to convey its knowledge to its employees. We cannot say that the district court erred in refusing to give the charge requested by the manufacturers under the set of facts involved in this case.

Oman, 764 F.2d 224, 233.

In Willis v. Raymark Indus., Inc., 905 F.2d 793 (4th Cir. 1990) the Court made clear that the sophisticated user’s equal knowledge of the hazards of the product does not, per se, absolve the supplier of its duty to warn.

Simply stated, the sophisticated user defense may be permitted in cases involving an employer who was aware of the inherent dangers of a product which the employer purchased for use in his business. Such an employer has a duty to warn his employees of the dangers of the product, and the manufacturer is absolved of any concurrent duty to warn those same employees. Phrased another way, if the employer/purchaser has “equal knowledge” of the product’s dangers, then the manufacturer may be able to rely on the employer/purchaser to protect its own employees from harm. See generally In re: Asbestos Litigation (Mergenthaler) 542 A.2d 1205 (Del. Super. Ct. 1986) “Equal knowledge” alone, however, is not enough.

Willis, 905 F.2d 793, 796.

The view of the Willis court is consistent with Comment n which provide as follows:

Giving to the third person through whom the chattel is supplied all the information necessary to its safe use is not in all cases sufficient to relieve the supplier from liability. It is merely a means by which this information is to be conveyed to those who are to use the chattel. The question remains whether this method gives a reasonable assurance that the information will reach those whose safety depends upon their having it.

Comment n, Restatement (Second) of Torts, § 388.

In Willis the Court emphasized the importance of what the supplier knew of the intermediary’s knowledge of the dangers involved in the use of the product.

Celotex argues extensively that it should now be absolved of liability arising out of its failure to warn because duPont itself possessed extensive knowledge of the dangers of asbestos from at least 1960. Celotex’s proffer of proof on this issue, however, does not address one critical point: whether Celotex knew the extent of duPont’s knowledge during or prior to the period of the plaintiff’s exposure. Celotex may not escape liability by reconstructing the past to show merely what the employer/purchaser knew. Comment n clearly focuses on what the product manufacturer knew and the reasonableness of its reliance on the employer prior to and during the time the workers were exposed. Moreover, Celotex offers no evidence that it apprised duPont of the dangers of the installation or that it attempted to ascertain whether duPont could reasonably be relied upon to disseminate information about the dangers of the product. The fact that an employer possesses knowledge of a product dangers does not extinguish the manufacturer’s liability unless the manufacturer can also show that it had reason to believe that the employer was or would be acting to protect the employees. Celotex has made no such showing here. The district court did not err in excluding evidence of the sophisticated user defense.

Id. at 797.

In Jones v. Meat Packers Equipment Co., 723 F.2d 370 (4th Cir. 1983) the Court concluded that the trial court erred by instructing the jury that adequate warnings to Jones’ employer were sufficient and that the manufacturer had no duty to warn Jones directly. In so doing, the Court stated that “. . . comment n of § 388 counsels that a factual issue arises about the adequacy of a warning to an intermediary rather than to the person directly exposed to the danger. It was for the jury to determine in light of the factors mentioned in Comment n -- and not for the judge to rule as a matter of law -- whether MEPACO acted unreasonably in relying on Gwaltney to warn its employees.” Id. at 374.

In Barnes v. Litton Indus. Products, Inc., 555 F.2d 1184 (4th Cir. 1977), the Court reversed the trial court’s granting of summary judgment for the defendant distributor of burning alcohol on plaintiff’s failure to warn claim. The Court stated that it was for the jury to determine whether the burning alcohol, intended for use in a dental lab, should have carried a warning that consumption could cause blindness. Barnes at 1188.

Contrary to the cases discussed above, in Goodbar v. Whitehead Bros., 591, F. Supp. 552, (W.D. Va. 1984), aff’d sub. nom. Beale v. Hardy, 679 F.2d 213 (4th Cir. 1985), Judge Kiser ruled as a matter of law that the defendant suppliers of silica sand to a foundry had no duty to warn the foundry or its employees in light of the abundant evidence showing the foundry’s extensive knowledge of the hazards of silica sand.

Judge Kiser made clear that critical to his view was the statement contained in comment n that “[m]odern life would be intolerable unless one were permitted to rely to a certain extent on others doing what they normally do, particularly if it is their duty to do so.” Goodbar at 557. Judge Kiser concluded after analyzing Spangler v. Kranco, Inc., 481 F.2d 373 (4th Cir. 1973) and Marshall v. H.K. Ferguson Co., 623 F.2d 882 (4th Cir. 1980) that where an employer is knowledgeable as to the dangers or defective conditions of a product the supplier can reasonably rely upon the employer to protect his employees from any harm. Goodbar at 560. Judge Kiser did undertake the balancing, of sorts, called for by comment n and considered the difficulty of a supplier installing warnings that would reach the ultimate users of the sand. See Goodbar at 566. In affirming the Goodbar Court’s ruling (and adopting its opinion as its own) the 4th Circuit considered that the evidence showed that the foundry had extensive knowledge concerning the hazards associated with inhaling silica dust, the disease of silicosis, and proper dust control methods. Beale v. Hardy, 769 F.2d 213, 214-215 (4th Cir. 1985).

In conclusion, the efficacy of the sophisticated user defense depends on a balancing of the factors set out in comment n to determine whether a supplier has acted reasonably to warn users of product dangers. That analysis occurs on a case-by-case basis.

LEARNED INTERMEDIARY DOCTRINE

The learned intermediary doctrine is recognized as a defense in Virginia to a product liability suit alleging a manufacturer’s failure to warn of dangers of a prescription drug. Like the sophisticated user defense, it arises under comment n of the Restatement (Second) of Torts § 388. It is well recognized that in the area prescription drugs, “. . . it is the general rule that the duty of the drug manufacturer is to warn the physician who prescribes the drug in question. . .” Pfizer v. Jones, 221 Va. 681, 684, 272 S.E.2d 43 (1980) citing 2 R. Hursh & H. Bailey, American Law of Product Liability § 8:11, 173 (2d ed. 1974). See also Stanback v. Parke-Davis and Co., 657 F.2d 642 (4th Cir. 1981).

The Court in Stanback recognized that the duty to warn the physician alone in prescription drug cases is an exception to the general duty of manufacturers to warn ultimate consumers in products liability cases and stated the rule is supported by sound policy considerations.

Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, an individualized medical judgment bottomed on a knowledge of patient and palliative. Pharmaceutical companies then, who must warn ultimate purchasers of dangers inherent in patent drugs sold over the counter, in selling prescription drugs are required to warn only the prescribing physician, who acts as a “learned intermediary” between manufacturer and consumer.

Stanback, 657 F.2d 642, 644 citing Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1276, cert. denied, 419 U.S. 1096, 95 S.Ct. 687, 42 L.Ed.2d 688 (1974).

The standard by which the warning given is to be measured is that of reasonableness. “The duty is to give a reasonable warning, not the best possible one. . .” Pfizer v. Jones, 221 Va. 681 at 684 citing Nolan v. Dillon, 261 Md. 516, 276 A.2d 36, 40 (1971)and Featherall v. Firestone, 219 Va. 949, 962, 952 S.E.2d 358, 367 (1979). In Pfizer the court reversed a plaintiff’s verdict and entered final judgment for the defendant manufacturer finding that while the manufacturer did not specifically warn of the risk of necrosis if the drug were not injected intramuscularly it did warn that under no circumstances should the drug be injected subcutaneously. The Court entered final judgment despite the trial testimony of the treating doctor that a warning of necrosis if injected subcutaneously was necessary.

In Abbot by Abbot v. American Cyanamid Co., 844 F.2d 1108 (4th Cir. 1988), a DPT vaccine case, the Court reversed the trial court’s ruling that the warning given by the defendant manufacturer to plaintiff’s physician was adequate as a matter of law, stating that the adequacy of a warning is a question of fact for the jury. Abbot by Abbot, 844 F.2d 1108, 1115 (4th Cir. 1988), citing Pfizer v. Jones, 221 Va. 681, 683-684, 272 S.E.2d 43 (1980). Note that the Abbot court so ruled notwithstanding that the plaintiff’s physician testified in deposition that the warning given by the manufacturer was “very adequate.”

In conclusion, the learned intermediary defense applies to actions involving prescription drugs and is satisfied if a manufacturer acts reasonably in warning a prescribing physician.

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