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10 February 2005
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
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:
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 (firstname.lastname@example.org or email@example.com).
(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").
(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).
(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
(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.
(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").
(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)).
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Mary T Yelenick
Laura M Jastrem