Failure to Warn and the Knowledgeable User

Plaintiffs in product liability personal injury actions frequently choose to attack the representations manufacturers have made about their product as providing inadequate warning. However, the success of any such claim depends not just on the adequacy of the warning in question, but also on the plaintiff's own knowledge of the product.

The elements of a failure to warn claim are derived from the principle that manufacturers are ordinarily in a position of superior knowledge with respect to their product and should thus be obliged to pass knowledge of possible risks on to consumers. Product warnings are therefore designed to inform a consumer how to use a product safely, either by articulating instructions for proper use or by alerting the consumer to potential risks of use.(1) Section 2(c) of the Restatement (Third) of Torts describes the principles of a traditional 'failure-to-warn' claim:

"A product is defective because of inadequate instructions or warnings when the foreseeable risks of harm posed by the product could have been reduced or avoided by the provision of reasonable instructions or warnings by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the instructions or warnings renders the product not reasonably safe."(2)

A number of jurisdictions consider strict liability failure-to-warn claims equivalent to negligent failure-to-warn claims, and thus require plaintiffs to show that the manufacturer knew or should have known of the danger associated with its product.(3) Other jurisdictions instead require a showing that the risk was "known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture".(4) A successful plaintiff must further demonstrate that the manufacturer failed adequately to warn of that risk, and that this failure led to the plaintiff's injury.

The adequacy of a warning is determined under a 'reasonableness' test,(5) generally left to the fact finder.(6) From a defendant's perspective, such a fact-intensive determination poses the risk of unpredictability.(7) However, the Restatement (Third) of Torts itself offers some general guidelines: "Courts must focus on various factors, such as content and comprehensibility, intensity of expression and the characteristics of expected user groups." Moreover, the Restatement (Third) of Torts cautions that product warnings:

"can rarely communicate all potentially relevant information, and the ability of a plaintiff to imagine a hypothetical better warning in the aftermath of an accident does not establish that the warning actually accompanying the product was not adequate."(8)

Traditional warning defect claims are subject to a number of potential exceptions and defences, pursuant to which a defendant's duty to warn a consumer may be discharged by informing an intermediary or by demonstrating the plaintiff's own knowledge. A defendant does not have a duty to warn a plaintiff of an "open and obvious" or "readily ascertainable" danger.(9) Also, even in courts that presume that a proper warning would have been read and heeded by a plaintiff, the presumption may be rebutted by showing that the plaintiff already knew of the danger,(10) or in some cases by showing the plaintiff would not have read the warning.(11)

Under certain circumstances, most typically in prescription medication or medical device cases, a manufacturer fulfils its duty to warn by adequately informing a 'learned intermediary'.(12) Although the sufficiency of the warning may still be contested, the manufacturer's duty runs to professionals in the medical field, rather than to the ultimate consumer of the product. The concept of a well-informed intermediary is sometimes extended to areas outside the medical profession. For example, some jurisdictions recognize a 'bulk supplier' affirmative defence, whereby a manufacturer involved in bulk transactions may fulfil its duty to warn by properly informing an intermediary vendee.(13) Similarly, a manufacturer may be relieved of its duty to warn a consumer if that consumer is a 'sophisticated user'.(14) Under the 'sophisticated user' doctrine, although no intermediary exists, the consumer himself acts as the well-informed, 'learned' individual, thus removing the manufacturer's duty to inform the consumer about a product with which that consumer is already familiar.

For a user to be considered 'sophisticated', he or she must possess knowledge or expertise regarding product risk equivalent to that of the manufacturer. For example, in Haase v Badger Mining Corp(15) a foundry was considered to be a sophisticated user of silica because it was "knowledgeable, technologically advanced and a leader in the foundry industry", in possession of "extensive knowledge of the hazards of inhaling silica dust". In another instance, in Taylor v Monsanto Co,(16) an electric company was deemed a sophisticated user of polychlorinated biphenyls where it had used the chemicals for 40 years and developed in-house expertise including its own safety data sheets. Similar to the situation of an individual consumer who gains actual knowledge of a product's risk, the manufacturer is relieved of the duty to warn when the consumer gains awareness by virtue of being an industry expert or otherwise 'sophisticated'.

The sophisticated user doctrine may also be used to absolve the manufacturer not only from the duty to warn the direct 'sophisticated' consumer, but also from a duty to warn any consumers further down the purchasing chain. When the defence is applied in this manner, the sophisticated user functions in a role like that of a learned intermediary in a prescription drug case. For instance, in First Nat'l Bank & Trust Corp v American Eurocopter Corp(17) licensed pilots of a helicopter were found to be sophisticated intermediaries who provided adequate warnings about disembarking to a plaintiff passenger. Thus, the helicopter manufacturer could not be held liable for failing to warn the plaintiff directly. However, the presence of a sophisticated user does not automatically relieve the manufacturer from its duty to warn down-the-chain purchasers.(18) Whether such a duty exists will depend not just on whether the initial user is determined to be 'sophisticated', but also on whether reliance on that sophisticated intermediary is reasonable under the circumstances.(19)

Liability for failure to warn is designed to promote the distribution of information from those with superior knowledge to those who are unfamiliar with the potential dangers of a given product. While under typical circumstances the manufacturer may possess superior information, this is not necessarily the case when a knowledgeable user is involved. A 'sophisticated' or 'learned' user relies on his or her own awareness or expertise to make decisions about the safety of the product, not solely on any warning issued by the manufacturer. Any warning given to a sophisticated user would be redundant because such a user makes his or her determination independent of manufacturers' representations about the safety of its product.(20) Thus, while manufacturers generally have a duty to warn of known dangers of their product, this duty does not extend equally to all consumers. Existing warnings are not evaluated in a vacuum - what the consumer knows matters. A manufacturer rightly has a viable defence against a consumer claiming that a product's warning was insufficient when the consumer was already aware of the product's dangers.(21)

The 'sophisticated user' and other related defences illustrate that warnings are meant to place the consumer in the position of being able to make well-informed decisions about foreseeable risks, but not to place the manufacturer in the position of being an insurer for any and all risks.(22) If the purpose of the warning - informing the consumer of potential harm - is accomplished from a source even other than the manufacturer itself, the manufacturer may be absolved from liability. Thus, if the plaintiff (or intermediary) already knew of the alleged danger, then totally apart from what the defendant's warning states, any inadequacy may be trumped by the plaintiff's actual understanding.

For further information on this topic please contact Mary T Yelenick or Laura Jastrem at Chadbourne & Parke LLP by telephone (+1 212 408 5100) or by fax (+1 212 541 5369) or by email (myelenick@chadbourne.com or ljastrem@chadbourne.com).

Endnotes

(1) Finn v GD Searle, 677 P2d 1147, 1152 (Cal 1984) ("The requisite warnings may be of two kinds... First, the manufacturer may be required adequately to instruct the consumer as to how the product should be used... A second distinctive form of warning is that which informs a consumer (or, in the case of prescription drugs, the physician) of potential risks or side effects which may follow the foreseeable use of the product").

(2) Restatement (Third) of Torts: Products Liability Section 2(c) (ALI 1998).

(3) See, for example, Immormino v J& M Powers, Inc, 698 NE 2d 516, 517 (Ohio Ct CP, Cuyahog County, 1998) (finding warning "CAUTION - CONTENTS ARE HOT" on fast-food hot tea adequate as a matter of law, stating "[a] product is defective due to an inadequate warning or instruction if the manufacturer knew or should have known of the danger and whether the warning allowed the consumer to use the product safely"); see also Russell v GAF Corp, 422 A 2d 989, 991 (DC App 1980); accord Crislip v TCH Liquidating Co, 556 NE 2d 1177 (Ohio 1990).

(4) Ferayorni v Hyundai Motor Co, 711 So 2d 1167, 1172 (Fla Dist Ct App 1998), citing Anderson v Owens-Corning Fiberglas Corp, 810 P 2d 549, 558 (Cal 1991).

(5) See Levin v Walter Kidde & Co, 248 A 2d 151, 153 (Md 1968) (finding that a warning on a siphon bottle "need only be one that is reasonable under the circumstances"); see also Morrison v Grand Forks Housing Authority, 436 NW 2d 221 (ND 1989); Pfizer, Inc v Jones, 272 SE 2d 43 (Va 1980).

(6) Richard Alexander, "Products Liability Warnings Cases", The Consumer Law Page (Alexander, Hawes & Audet, LLP, 1994-2004), at www.consumerlawpage.com/article/failure.shtml ("That juries have been relied upon to determine the adequacy of warnings in the case of defective products has been with us since the inception of products liability law").

(7) Bowman & Brooke, LLP, "Legally Adequate Warning Labels: A Conundrum for Every Manufacturer" (August 1999), at http://library.lp.findlaw.com/productsliability_2_5039_1.html.

(8) Restatement (Third) of Torts: Products Liability Section 2 cmt i (ALI 1998).

(9) See, for example, Gurley v Am Honda Motor Co, 505 So 2d 358, 361 (Ala 1987) ("It is...well settled that a manufacturer is under no duty to warn a user of every danger which may exist during the use of the product, especially when such a danger is open and obvious"); see also Petrie v BF Goodridge Co, 572 NY S 2d 595, 596 (4th Dep't 1991) (holding the defendant tyre purchaser had no duty to warn the plaintiff of the potential danger of mounting mismatched tyres where the plaintiff admitted he had failed to check the tyre sizes and had been instructed by his employer to do so before mounting them. "[D]efendant had not duty to warn plaintiff of a danger that was readily ascertainable"); Neff v Coleco Indus, Inc, 760 F Supp 864 (D Kan 1991) (applying Kansas law, finding proximate cause of plaintiff's injuries was his own action of jumping into a pool he knew to be shallow).

(10) See, for example, Goldstein v Phillip Morris, Inc, 854 A 2d 585, 587-88 (Pa Super 2004) (presumption that a plaintiff would have heeded an adequate warning is rebutted by evidence that the plaintiff was fully aware of the risk involved); see accord Sharpe v Bestop, Inc, 713 A 2d 1079, 1089 (NJ Super Ct App Div 1998); Town of Bridport v Sterling Clark Lurton Corp, 693 A 2d 701, 704 (Vt 1997) citing Menard v Newhall, 373 A 2d 505, 506-07 (Vt 1977) ("if the user is cautioned of the risk and ignores that advice, there is no reasonable basis to assume that the user would have heeded a warning from the manufacturer").

(11) See, for example, Anderson v Hedstrom Corp, 76 F Supp 2d 422, 441 (SD NY 1999) (under New York law, the heeding presumption can be rebutted by proof that plaintiff would not have read an adequate warning); see also Daniel v Ben E Keith Co, 97 F 3d 1329, 1332-33 (10th Cir 1996) (under Oklahoma law, "once the opposing party meets its burden to come forward with evidence rebutting the presumption, the presumption disappears", finding that the presumption was rebutted in this case where plaintiff testified he did not look at the label on a bottle of bleach).

(12) See Ortho Pharm Corp v Chapman, 388 NE 2d 541, 548 (Ind App 1979) ("Since such drugs are available only by prescription, a manufacturer's duty to warn extends only to the medical profession, and not the ultimate users"); see also Nancy K Plant, The Learned Intermediary Doctrine: Some New Medicine for an Old Ailment, 81 Iowa L Rev 1007 (May 1996); Barbara Pope Flannagan, Products Liability: The Continued Viability of the Learned Intermediary Rule as it Applies to Product Warnings for Prescription Drugs, 20 U Rich L Rev 405 (Winter 1986); Diane Schmauder Kane, JD, Annotation, Construction and Application of Learned-Intermediary Doctrine, 57 ALR 5th 1 (West Group 1998-2004).

(13) See Hoffman v Houghton Chem Corp, 751 NE 2d 848, 854-56 (Mass 2001) (adopting the 'bulk supplier' doctrine and affirming dismissal of manufacturers of chemicals involved in a fire at an ink manufacturing company); see also In re Silicone Gel Breast Implants Prods Liab Litig, CV 92-P-10000-S (ND Ala 20, 1996) ("[t]he bulk supplier defence is generally applied to preclude strict liability against a manufacturer of a component part that is combined with other parts to make a device or machine, when the component part itself is not inherently defective").

(14) Morgan v Brush Wellman, Inc, 165 F Supp 2d 704, 718 (ED Tenn 2001) (applying Tennessee law and finding that a manufacturer did not owe a duty to warn workers exposed to its Beryllium products where the United States and its contractors were sophisticated users who dictated the warnings the employees would receive); Taylor v Monsanto Co, 150 F 3d 806, 808 (7th Cir 1998) (Indiana law recognizes "the 'sophisticated intermediary' defence, which holds that there is no duty to warn an ultimate user when the product is sold to a 'knowledgeable or sophisticated intermediary' whom the manufacturer has adequately warned"); White v Amoco Oil Co, 835 F 2d 1113, 1118 (5th Cir 1988) ("manufacturers need not warn sophisticated users of dangers that they should know of").

(15) 669 NW 2d 737, 744 (Wis Ct App 2003).

(16) 150 F 3d 806, 808-09 (7th Cir 1998).

(17) 378 F 3d 682, 692-93 (7th Cir 2004).

(18) See Natural Gas Odorizing, Inc v Downs, 685 NE 2d 155, 164 (Ind Ct App 1997) ("Whether a manufacturer has discharged its duty under the sophisticated intermediary doctrine is almost always a question for the trier of fact") .

(19) See Ritchie v Glidden Co, 242 F 3d 713, 724 (7th Cir 2001) (in order for a manufacturer to discharge its duty to warn based upon a sophisticated intermediary defence, the manufacturer "must be able to reasonably rely on the intermediary to warn the ultimate user").

(20) Kenneth M Willner, Failures to Warn and the Sophisticated User Defence, 74 Va L Rev 579, 588 (1988) ("When the person endangered by a product is already aware of the risks he faces, a warning serves no purpose").

(21) See, for example, Jones v Am Tobacco Co, 17 F Supp 2d 706, 716 (ND Ohio 1998) ("common knowledge of a product's inherent risks precludes liability under a failure to warn theory") (citing Ohio Rev Code Section 2307.76(B)).

(22) See Ferayorni, 711 So 2d at 1172 ("strict liability does not make the manufacturer or seller an insurer").