The duty to warn - a matter of reasonableness, not arbitrariness.

In the January 1999 issue of The Florida Bar Journal, "Welcome the `Sophisticated User Doctrine,'" Gene Kissane and Michael Metta advocate that the courts or the legislature adopt a new "complete defense" for product manufacturers who either provided warnings to sophisticated purchasers or an opportunity to inspect products built to the purchasers' specifications. Their proposal is based mainly on the so-called "sophisticated user doctrine" as derived from Restatement (Second) of Torts [sections] 388, comment n. Notwithstanding some courts' faulty interpretations, the principles at issue are not a defense, however, but only a means for analyzing the reasonableness of a lack of warning to product end-users. Hopefully the legislature will not and courts should not heed their call because what has been proposed obfuscates and confuses the law; would substitute arbitrariness for reason; and would be bad policy.

The authors claim that a new defense is needed because current law is "ill-equipped" to protect "innocent" manufacturers who gave "legally sufficient warnings." Supposedly these defendants are being "ravaged" by "unjustified" claims brought by employees who "misused" products. A moment's thought exposes the hollowness of such advocacy. Innocent manufacturers do not need to give any warnings; legally sufficient warnings will not support liability; misuse already is a products liability defense;[1] and remedies already exist for frivolous lawsuits.[2] Beyond that, the specter of manufacturers being ravaged by hordes of unjustified claims--a part of standard industry propaganda--has been thoroughly discredited by empirical studies of the civil justice system which all show that product liability filings are drastically down, plaintiff win rates are plummeting, and verdicts are not rising. Indeed, present day products liability litigation is one of the most difficult claims that can be made by an injured party.[3]

Aside from no demonstrable need for a new defense, the article's arguments also do not stand up to substantive analysis. Fundamental principles concerning the reasonableness of a warning are confused with when a warning is required; established law is overlooked; and arguments appear to be result driven. The linchpin of Kissane and Metta's argument is that for defensive purposes all product liability cases should be categorized into one of two classes of users, "sophisticated" and unsophisticated users. They get to this remarkable point by a curious, illogical process. First, they claim that there is a threshold question present in every products liability case which often is overlooked but which the courts should recognize. It is whether a product is "unreasonably dangerous" or "potentially dangerous for its intended use." While a potential danger during use could theoretically never be realized, both conditions expose the user to danger and, if not corrected or warned about, can result in harm. Nonetheless, this "distinction" between products is then used as the basis for a leap from product categorization to a "distinction" based on type of user. The authors have to make this leap because they mistakenly believe that under the general rules concerning warnings contained in Restatement (Second) of Torts [sections] 388, the classification of the purchaser[4] dictates when an end-user must be warned of product dangers and those rules are different than the rules for products liability. The authors finally conclude that [sections] 388 should apply to product manufacturers, that in the case of "sophisticated" product purchasers there should be no duty to warn end-users and, therefore, a finding of a "sophisticated user" should be a complete defense in all product liability cases. This reasoning represents a fundamental misunderstanding of the Restatement as well as when a duty to warn exists, how the scope of that duty is to be measured.

The duty to warn arises from the obligation to exercise reasonable care. When one supplying a product knows (or should know) of danger in the use of the product, a duty to warn users of such danger arises. This is a duty owed not just by manufacturers, but all suppliers, and it is not based on the characterization of the product or the classification of the user. Restatement (Second) of Torts [sections] 388 et seq.[5] Florida has expressly adopted [sections] 388, Sowell v. American Cyanamid Co., 888 F. 2d 802 (11th Cir. 1989); Square D Co. v. Hayson, 621 So. 2d 1373 (Fla. 1st DCA 1993).

Analysis of the duty to warn required under [sections] 388 becomes more complex when a product is supplied to or purchased by someone who then furnishes it to the ultimate user. In such cases, a question can arise as to what conduct suffices to satisfy the duty to warn.[6] In many cases it will be practical, feasible, and necessary to warn the end-user of danger. In other cases, circumstances may exist making it reasonable for the product supplier to rely on others to convey the warning, such as where the purchaser is a so-called "sophisticated user." Section 388, comment n[7] makes clear, however, that in all cases a warning must be given, the focus remains on the conduct of the supplier, and a balancing test is used to assess the reasonableness of the scope of the warning. A variety of factors are to be considered, Such as the feasibility and burden of directly warning end-users, the reasonableness of relying on the purchaser to convey the warning and the danger involved. There is no general rule and each case must be decided on its particular circumstances. The supplier is not, however, ever relieved or excused from a duty to warn of dangers and in all cases remains under a duty to warn at least the purchaser. Comment n, therefore, is not a "defense," but only a basis for analyzing the reasonableness of the scope of the warning given and only when reasonable minds cannot differ can a case be summarily terminated on a judicial determination of reasonableness.

The cases cited in the article illustrate how some courts have failed to grasp these concepts. The courts in Portelli v. I.R. Construction Products, Inc., 554 N.W. 2d 591 (Mich. App. 1996), and Carpenter v. Rust Engineering Co., 25 F. 3d 1047 (unpublished opinion 6th Cir. 1994), both state that there was no "duty" to warn sophisticated purchasers of the products. But, those courts have confused the absence of any duty to warn of known danger, Portelli at 601, or of the safe use of a "non-defective product," Carpenter at 4, with the reasonableness of not warning the ultimate user. If there was no duty to warn in the first instance, then the courts should never have reached issues concerning the reasonableness of not warning the end-user employees. In other words, the decisions should have been based on simply no duty to warn.

Courts also confuse bulk-seller rules with reasonableness of the scope of the warning given. In Phillips v. Green, 630 A.2d 894 (Pa. Super. 1993), for example, the court held the sophisticated user doctrine to be a defense. The defendant, however, was a bulk seller who supplied silica sand that was neither defective nor unreasonably dangerous. Under such circumstances, there should have been no duty to warn and no need to analyze the reasonableness of the lack of warning to the end-users.

Courts similarly have confused warning and causation issues. O'Neal v. Celanese Corp., 10 F.3d 249 (4th Cir. 1993), is a case in point. While the court affirmed on the basis of a sophisticated user "defense"--a reasonableness of warning issue--the court also held that the condition was "an open and obvious hazard" and that the actions of the plaintiff's employer "were the sole proximate cause of the injury." Id. at 254, 255. If the condition was obvious so that there was no duty to warn and the plaintiff's employer was the sole cause, the court should have never reached whether it was reasonable to not warn the end-user employees.

The warnings analysis for product manufacturers is different because of the special duties owed by manufacturers to consumers. The difference, however, deals with the obligation to design a safe product so that warnings of danger will not be necessary rather that the reasonableness of scope of warnings that were given.

As the Scope Note to Ch. 14 of the Restatement (Second) of Torts makes clear, there are additional duties that arise to consumers by reason of the manufacturing and marketing of products.[8] It is universally established that manufacturers are obligated to design reasonably safe products. In the design process manufacturers are held to the standard of experts in the field of their products,[9] must test their products accordingly, must discover risks inherent in their design, and must adopt risk avoidance measures.[10] This is a fundamental obligation that cannot be avoided by simply warning of dangers. As noted in the most recent Restatement, while manufacturers may have duties to warn to render a product safe, warnings are not a substitute for a safer design. Restatement Third, Torts: Products Liability [sections] 2, comment 1; Rogers v. Ingersoll-Rand Co., 144 F. 3d 841 (D.C. Cir. 1998); Uniroyal Goodrich Tire Co. v. Martinez, 977 S.W. 2d 328 (Tex. 1998). Thus, while the absence of necessary warnings will render a product not reasonably safe,[11] Restatement Third, Torts: Products Liability [sections] 2(c), the emphasis in products liability is not on warnings but rather safe design.

When warnings are required, the product liability analysis of the reasonableness of the scope of the manufacturer's warnings is essentially identical to [sections] 388, comment n. Manufacturers who cannot design danger out of their products must warn of that danger and may be required to warn the ultimate user.

There is no general rule as to whether one supplying a product for the use of others through an intermediary has a duty to warn the ultimate product user directly or may rely on the intermediary to relay warnings. The standard is one of reasonableness in the circumstances. Among the factors to be considered are the gravity of the risks posed by the product, the likelihood that the intermediary will convey the information to the ultimate user, and the feasibility and effectiveness of giving a warning directly to the user. Thus, when the purchaser of machinery is the owner of a workplace who provides the machinery to employees for their use, and there is reason to doubt that the employer will pass warnings on to employees, the seller is required to reach the employees directly with necessary instructions and warnings if doing so is reasonably feasible.

Restatement Third, Torts: Products Liability [sections] 2, comment i.

Thus, there is no difference between the general rule of [sections] 388, comment n and the specific product liability rule of [sections] 2, comment i. In both instances the issue is one of reasonableness, a variety of factors are to be considered, and, unless reasonable minds cannot differ, the issue is one for a jury to decide. Sowell v. American Cyanamid Co., 888 F.2d 882; Square D. Co. v. Hayson, 621 So. 2d 1373.

Kissane and Metta claim, however, that the new complete defense they propose is supported by Florida's learned intermediary defense and cases where the end-user's employer was "fully informed" of the product danger.[12] That claim misunderstands both the case holdings and the "learned intermediary" rule. The cases cited involve two different situations. Zunck and Shell Oil both involve bulk sales, liquid petroleum gas in the former and a soil fumigant in the latter. The LP gas was sold to a retailer, who was supposed to add an odorant and who then sold the reformulated gas at retail. The fumigant likewise was sold to a distributer who reformulated it and sold it at retail. Neither manufacturer had any involvement in creating the reformulated products. Under such circumstances, courts uniformly have recognized as a matter of policy that bulk or raw product suppliers cannot be held liable for the defective condition of the end-product and that, consequently, they have no duty to warn either purchasers or users of dangers in the completed product. Restatement Third, Torts: Products Liability [sections] 5, comment a and c. This "no duty" rule is conceptually quite different from the reasonableness of the scope of warning under [sections] 388, comment n and the companion products liability rules of [sections] 2, comment i. Indeed, it has been specifically held that the two doctrines do not operate in tandem and should not be merged into a single defense. Little v. Liquid Air Corp., 952 F.2d 841 (5th Cir. 1992); Donahue v. Phillips Petroleum Co., 866 F. 2d 1008 (8th Cir. 1989); Sharp v. Wyatt, 627 A.2d 1347 (Conn. App. 1993).

The third case, Prather, turned on a finding that the plaintiffs failed to prove that the product, polyurethane form, was defective or unreasonably dangerous. That conclusion was based in part on a finding that the product was accompanied by adequate warnings and there was no other way to convey the warnings. The decision hardly supports a new "complete defense" for all cases.

The "learned intermediary" rule, on the other hand, is a specific, no-duty rule based on the unique circumstances involved in the sale of prescription drugs and medical devices. Although the rule has been eroded, and can be impacted further by recent trends in the mass-marketing of prescription drugs, manufacturers of drugs and devices that can be sold only pursuant to a prescription have only been required to direct warnings to health care providers and not to patients. The rationale behind the rule is that only the health care professionals are in a position to understand the risks involved and to assess the relative benefits of any particular therapy. Restatement Third, Torts: Products Liability [sections] 6. Thus, while warnings must be given, the scope of the warnings are narrowly and precisely fixed. While efforts have been made to extend this rule to the sale of other products to "learned intermediaries," it has been limited to just prescription drugs and medical devices, e.g., Menschik v. Mid-Atlantic Pipeline Co., 812 S.W. 2d 861 (Mo. App. 1991).[13]

The rationale underlying the learned intermediary rule has no relevance to ordinary manufacturers. Unlike the case of prescription medicine and devices, manufacturers directly market other products to consumers. They do not rely on a professionally educated intermediary to make a judgement of the risks and benefits of using the product. Indeed, most manufacturers employ skilled marketing and promotional programs to create demand for their products based on the claims and representations they make. When the use of those products poses a danger, the manufacturer must first try to produce an alternative, safe design. When they cannot do so, and only then, the manufacturer must warn of the danger. Rather than no duty to warn, failure to warn the end-user under such circumstances raises an issue of reasonableness, which a court can decide as a matter of "defense" only if reasonable minds cannot differ.

The authors' "next logical step" of also extending the so-called "Slavin rule"[14] to protect product manufacturers likewise should be rejected. Constructing a building pursuant to a contract and according to plans[15] is a far cry from the duty of a manufacturer as an expert to design, test, and build a reasonably safe product. A contractor is not the designer of the building, has no duty to assure a safe design and often no opportunity to correct defects once the project has been turned over to the owner. Under such circumstances, the Slavin court reasoned it would be unfair to hold a contractor liable to third parties for open and obvious defects that have been accepted by the owner. Nonetheless, contractors are liable for latent or inherently dangerous defects.

At one level, the Slavin rule is nothing more than a specific application of general proximate causation rules whereby the owner's negligence in not remedying open and obvious defects constitutes an intervening cause and also of the general rule that there is no duty to warn of open and obvious dangers. At another level, it can be readily distinguished from the rules that apply to products designed for sale to the public, the manufacturers of which have much broader responsibilities and attendant duties. See Edward M. Chadbourne, Inc. v. Vaughn, 491 So. 2d 551,553 (Fla. 1986). Thus, to hold as Kissane and Metta advocate that if a manufacturer builds a product to the purchaser's specifications it should be shielded from liability for defects in the design would eviscerate the manufacturer's obligations as an expert to design, build, and test products. Indeed, under their proposal, a manufacturer could be aware of or learn of a defect in the product design and yet assume an ostrich-like posture by strictly following the purchaser's defective specifications and escape all liability for failing to correct the design or warn of danger. Such a bizarre rule would totally undermine the public policies underlying manufacturer responsibility.

Not only are these proposals not supportable on the merits, but, in their arbitrariness, they depart from sound policies of Florida law. A quarter of a century ago Florida recognized that arbitrary liability rules were unjust when the harsh rule of contributory negligence was rejected.[16] Since then there has been a steady march against the type of arbitrariness proposed by the January article.[17]

Finally, these proposals are not supportable by either of the principle rationales of modern tort law. From a corrective justice perspective, if these new "complete defenses" were recognized, many injured parties would be left without the ability to be made whole. From the perspective of economic efficiency, the other major doctrinaire basis of tort law, rather than requiring products and their manufacturers to bear the cost of the injuries caused by inherent dangers in their products, the article's proposals would do just the opposite by allowing them to escape responsibility. In short, these proposals lack merit, are contrary to established principles and policy, and constitute an idea whose time should never come.

[1] E.g., Clark v. Boeing Co., 395 So. 2d 1226 (Fla. 3d D.C.A. 1981); Restatement Third, Torts: Products Liability [sections] 17, comment c.

[2] FLA. STAT. [sections] 57.105.

[3] E.g., Chesebro, Galileo's Retort: Peter Huber's Junk Scholarship, 42 AM. UNIV. L. REV. 1637, 1717 (1993); Eisenberg & Henderson, Inside the Quiet Revolution in Products Liability, 39 UCLA L. REV. 731-770 (1992); "Tort Reform ... Florida's Manufactured Crisis" (Mar. 18, 1998) prepared by David M. Griffith & Associates for the Trial Lawyers Section of The Florida Bar.

[4] The term "sophisticated user" is unnecessarily confusing. It is not contained in Restatement which refers to only third persons and users. Even those terms are not a model of clarity and it would be much clearer to refer to sophisticated purchasers and end-users since the issue under comment n is whether it is reasonable to warn just the purchaser and not the end-user. Since comment n assumes there is a product danger which must be warned about, whether the end-user is also "sophisticate& does not bear on the duty to warn but only on whether there exists any comparative negligence on the user's part.

[5] There is, however, no duty to warn of an obvious danger. Restatement (Second) of Torts [sections] 388, comment k; Cohen v. General Motors Corp., 427 So. 2d 389 (Fla. 4th D.C.A. 1983).

[6] An issue may also arise over the adequacy or reasonableness of the content of the warning. See, for example, Restatement Third, Torts: Products Liability [sections] 2, comment i. That is, however, a different issue than the one addressed in this article.

[7] Kissane and Metta purport to quote from comment n at p. 36. The quote is not from the comment, but rather from the Superior Court of Pennsylvania's interpretation of comment n. See, Phillips v. Green, 630 A.2d 874, 882 (Pa. Super. 1993).

[8] West v. Caterpillar Tractor Co., 336 So. 2d 80 (Fla. 1976) "The manufacturer, by placing on the market a potentially dangerous product for use and consumption and by inducement and promotion encouraging the use of these products, thereby undertakes a certain and special responsibility toward the consuming public who may be injured by it." Id. at 86.

[9] Advance Chemical Co. v. Harter, 478 So. 2d 444 (Fla. 1st D.C.A. 1985), rev. denied, 488 So. 2d 829 (Fla. 1986).

[10] Restatement Third, Torts: Products Liability [sections] 2, comment m. In May 1997, the American Law Institute adopted a new Restatement for Products Liability. The central thesis for design cases in [sections] 2(b)--requiring proof of an alternative design to establish a defective design--was highly controversial and has already been severely criticized. E.g., Potter v. Chicago Pneumatic Tire Co., 694 A.2d 1319 (1996). On the other hand, the warning rules contained in [sections] 2(c) and the comments thereto received broad support.

[11] As is true generally, manufacturers do not have a duty to warn of generally known or obvious dangers. Clark v. Boeing Co., 395 So. 2d 1226 (Fla. 3d D.C.A. 1981); Knox v. Delta Inter'l Machinery Corp., 554 So. 2d 6 (Fla. 3d D.C.A. 1989); Restatement Third, Torts: Products Liability [sections] 2, comment j; but see [sections] 2, comment 1.

[12] Pranther v. Upjohn Co., 797 F. 2d 923 (11th Cir. 1986); Zunck v. Gulf Oil Co., 224 So. 2d 386 (Fla. 1st D.C.A. 1969); and Shell Oil v. Harrison, 425 So. 2d 67 (Fla. 1st D.C.A. 1982).

[13] Two Florida decisions have discussed "learned intermediary." Both held the parties at issue to not be learned intermediaries and never reached the issue of whether, if they were, warnings to learned intermediaries would be a defense. See Hayes v. Spartan Chem. Co., 622 So. 2d 1352 (Fla. 2d D.C.A. 1993); Brito v. County of Palm Beach, Florida, 1998 WL 821757 (Fla. 4th D.C.A. 1998). For the reasons stated infra, in discussing a learned intermediary concept these decisions represent at best a failure to recognize the issues or the rationales underlying the issues. Moreover, in both cases it appeared that the warnings were inadequate. Inadequate warnings, regardless to whom given, render a product not reasonably safe.

[14] Slavin v. Kay, 108 So. 2d 462 (Fla. 1958).

[15] In most instances, local law requires professionally designed plans for any building and corresponding inspections and approvals by qualified public officials.

[16] Hoffman v. Jones, 280 So. 2d 431 (Fla. 1973).

[17] See, for example, West v. Caterpillar Tractor Co., 336 So. 2d 80 (Fla. 1976); Blackburn v. Dorta, 348 So. 2d 287 (Fla. 1977); Auburn Machine Works Co. v. Jones, 366 So. 2d 1167 (Fla. 1979); Mosher v. Speedstar Division of AMCA Inter'l, Inc., 979 F. 2d 823 (11th Cir. 1992).

Larry S. Stewart is a partner at Stewart Tilghman Fox & Bianchi, P.A. in Miami. A substantial part of his practice involves products liability. He also is a member of the American Law Institute, where he serves as an advisor to its torts general principles and apportionment projects. Stewart served as a special consultant to the recently completed Products Liability Restatement, is board certified in civil trial law by The Florida Bar and the National Board of Trial Advocates, and is a past president of the Association of Trial Lawyers of America.