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Your Case
An Oregon Perspective on Warnings
Don Corson and Nancy Erfle1
Editor's Note: This article is condensed from material presented at the Oregon State Bar Product Liability Section's November 18, 2005 annual meeting and continuing education program. It is intended only as a general overview of the issues involved in a warnings case, and does not address all of the relevant issues.
I. INTRODUCTION
Product liability claims are usually based on a manufacturing or design defect. One type of design defect occurs when a product is made unreasonably dangerous by a lack of warnings or instructions, or by inadequately communicated warnings or instructions. ORS 30.900; Harris v. Northwest Natural Gas Co., 284 Or 571, 576, 588 P2d 18 (1978). Warnings describe product risks and provide information on how a product should not be used in order to avoid harm. Instructions tell how a product should be used in order for the product to be effective and to minimize safety risks. Warnings and instructions are treated similarly under product liability law and are both referred to as "warnings" throughout this paper.
Any qualified safety engineer should agree that the design of a product should eliminate risks as practicable. If a risk or hazard cannot be eliminated, the product design should incorporate guards to protect against the danger. If risks cannot be eliminated or properly guarded, adequate warnings are required, assuming that the utility of the product warrants its presence in the market. This same hierarchy comes into play in product liability cases. From a plaintiff's perspective, the better defective design cases involve failures to eliminate risks or to guard against dangers. It is our view that warnings cases may be the most difficult for the plaintiff, although a lack of warnings or inadequate warnings may be a good part of a case that has some other basis for liability besides the warnings alone.
II. SUMMARY OF LEGAL ISSUES
A. ELEMENTS OF A CLAIM
A product liability case can be brought using legal theories of strict product liability or negligence. Both strict product liability and negligence are commonly pleaded in an Oregon product liability action (some practitioners also plead breach of warranty in appropriate cases). It is our view that Oregon juries typically want to see some element of fault before finding liability, and so from a practical perspective there may not be a great deal of difference in the proof that should be offered under either theory.
1. Strict Product Liability
The product liability statutes (ORS 30.900 et seq.) govern product liability claims and defenses. Griffith v. Blatt, 334 Or 456, 51 P3d 1256 (2002). The most common approach for a plaintiff to take in an Oregon strict product liability warnings case is to follow Comments h and j of Restatement (Second) of Torts, §402A (1965).2 ORS 30.920(3). Both Comments h and j inject concepts of reasonableness into the strict liability warnings case.In order to bring a strict product liability warnings case consistent with Comments h and j, the plaintiff would apparently have to show (in addition to those elements that apply to all strict product liability claims3):
- The defendant had reason to anticipate that danger could result from a particular use of its product;
- The product was unreasonably dangerous when defendant sold the product without adequate warning about what harm could occur as a result of that particular use; and
- Had such a warning been given, it likely would have prevented the risk of harm arising from the particular use.
Waddill v. Anchor Hocking, 149 Or App 464, 473-74, 944 P2d 957 (1997), reversed on other grounds, 330 Or 376, 8 P3d 200 (2000) (discussing Smith v. Fred Meyer, 70 Or App 30, 33, 687 P2d 1128 (1984)). As to the last element, plaintiff should be prepared to show that an adequate warning would have made the product safe for use.
2. Negligence
In negligence, the status attributed to a supplier gives rise to a duty to warn and instruct expected users regarding the dangerous propensities of the product of which the supplier knows or reasonably should know. State ex rel. Western Seed Prod. v. Campbell, 250 Or 262, 270, 442P2d 215 (1968). This duty is described by Restatement (Second) of Torts, §388 (1965).4 The general foreseeability standard of Fazzolari does not appear to apply. Waddill, 149 Or App at 474-76 (discussing Hoyt v. Vitek, 134 Or App 271, 287, 894 P2d 1225 (1995)).
Under §388, a plaintiff must (in addition to supplier status, causation, and damages) show the defendant:
- Knew or should have known of the danger of using the product in the particular manner alleged (includes foreseeable use and misuse of the product);
- Had no reason to believe that those persons for whose use the product was supplied would realize the dangerous condition of the product; and
- Failed to exercise reasonable care to inform plaintiff and other expected users of the product's dangerous condition and/or of the facts which made it likely to be dangerous.
Waddill, 149 Or App at 475-76; Hoyt, 134 Or App at 287-89. Similar to strict product liability, causation in a negligence case requires proof that an adequate warning about the dangers of a particular use likely would have prevented that use and plaintiff's resulting injuries.
B. WHO MUST BE WARNED?
The duty to warn extends to foreseeable users and purchasers of the product as well as those who are likely to come into contact with the product. See Brizendine v. Visador Co., 437 F2d 822, 826 (9th Cir. 1970) (applying Oregon law and holding glass manufacturer liable for injuries to plaintiff who suffered an eye injury when glass in a nearby church door shattered); Wood v. Ford Motor Co., 71 Or App 87, 90 (1984) (duty to warn purchasers of product); see also Restatement (Second) of Torts, Section 388, comment a.5
The issue of who to warn may become more complex when third parties or "learned intermediaries" such as physicians are within or affect the chain of distribution. (See section E(8), below).
C. WHAT IS AN ADEQUATE WARNING?
The adequacy or inadequacy of a warning is of paramount importance in a deficient warnings case. First, whether or not the alleged deficiency is a failure to warn or an inadequate warning, the plaintiff should be able to show that an adequate warning would have rendered the product safe. Second, a manufacturer is liable for injuries caused by an otherwise faultlessly made product if an adequate warning did not accompany the product and the lack of warning rendered that product unreasonably dangerous. Anderson v. Klix Chemical Co., 256 Or 199, 202, 472 P2d 806 (1970); Comment j to §402A. Conversely, there is no manufacturer liability based on a warning deficiency if a faultlessly made product is accompanied by an adequate warning. Glover v. BIC Corp., 6 F3d 1318 (9th Cir. 1993) (interpreting Oregon law); see also Schmeiser v. Trus Joist Corp., 273 Or 120, 132, 540 P2d 998 (1975)(en banc) (no liability for failure to give an adequate warning where a proper warning was actually given); and Comment j to §402A. Where the product is only defective due to its manufacture, however, warnings should be a nonissue under Oregon law, as no type of warning will render an improperly manufactured product safe. Glover, supra.
In general terms, a warning should be adequate if it communicates the risk of danger in a manner that is comprehensible by the average consumer and that, if followed, would prevent injury. Anderson, 256 Or at 207-08. The warning must give due consideration to the likelihood of accident and severity of harm that could result from a failure to warn of any dangers inherent in the product and its use, including those dangers that may arise from reasonably foreseeable mishandling or misuse. Id.; Schmeiser, 273 Or at 132; Cole v. Builders Square, Inc., 48 Fed Appx 684 (9th Cir. 2002) cert denied, 38 US 1032 (2003) (manufacturer's duty to warn is not necessarily satisfied if warnings are not provided concerning reasonable foreseeable misuse); and Comment h, §402A.
An adequate warning must embody two characteristics. First, the form of the warning must be such that it could be reasonably expected to catch the attention of the reasonably prudent person in the circumstances of its use. Second, the content of the warning must be of such a nature as to be comprehensible to the average user and must fairly communicate the nature and extent of the danger to the mind of a reasonably prudent person. Anderson, 256 Or at 207-08 (quoting from Crane v. Sears Roebuck & Co., 218 Cal App2d 855, 860, 32 CalRptr 754, 757 (1963)); Spruill v. Boyle-Midway, Inc., 308 F2d 79, 85 (4th Cir. 1962).
A recent application of Oregon's approach is found in Benjamin v. Wal-Mart, 185 Or App 444, 61 P3d 257 (2002). The wrongful death case involved a man who asphyxiated after he slept with a propane heater in an enclosed space; plaintiff claimed that warning defects led to the death. On appeal, defendant challenged the sufficiency of the causation evidence, arguing that there was no evidence that different warnings would have made any difference because there was no evidence the warnings were read. The Court held that circumstantial evidence "allowing a jury to draw an inference that an adequate warning generally is effective in preventing a particular type of accident can be sufficient to prove causation," and concluded that there was sufficient evidence to support the verdict.
Under the federal courts' summary judgment standard, the adequacy of a warning, although still governed by a reasonableness standard, can be determined as a matter of law. See Safeco Ins. Co. of Am. v. Olstedt Constr., 2004 U.S. District LEXIS 8761 (D Or 2004) (no liability for failure to have a glow-in-the-dark warning label on a propane tank that was used in the early hours of the morning).
Counsel should also consider product advertising and promotional materials that give an impression of safety, because a warning may be inadequate in light of that advertising and promotion. Where the manufacturer provides safety warnings or instructions that conflict with the product advertising and promotional materials, the marketing representations may justify a reasonable expectation in the average consumer that the product would perform a particular activity safely. However, while evidence of advertising and promotional materials may be sufficient to demonstrate what an ordinary consumer expects from a product, "such evidence by itself rarely will demonstrate that a product is defective." McCathern v. Toyota, 332 Or 59, 79, 23 P3d 320 (2001).
D. DUTY TO WARN AFTER SALE
The nature, extent, and even the existence of post-sale duty claims is a hotly contested area. The Oregon Court of Appeals' recent opinion in Simonsen v. Ford, 196 Or App 460, (2004), rev den 338 Or 681 (2005), adds to the argument. The conventional view has been that there is no post-sale duty to warn absent an "active, continuous relationship between" the parties, and that the "ordinary contract relationship for the sale of goods" does not create such an active and continuous relationship. See Josephs v. Burns, 260 Or 493, 501-02, 491 P2d 203 (1971) (no continuing duty to warn or remedy post-sale absent "an active, continuous relationship between plaintiff and defendant"), rev'd in part, Smothers v. Gresham Transfer, Inc., 332 Or 83, 23 P3d 333 (2001) (overturning portion of opinion regarding constitutional analysis); Cavan v. General Motors Corp., 280 Or 455, 458, 571 P2d 1249 (1977) (the "ordinary contract relationship for the sale of goods" does not create an active and continuous relationship and consequently "does not call for the imposition of a special rule" creating a post-sale duty to warn).
However, where such an active, continuous relationship exists, a claim for negligence can arise separate and apart from the Oregon product liability statutory scheme. See Erickson Air-Crane Co. v. United Tech. Corp., 303 Or 281 (1987) (recognizing negligence claim where manufacturer had representative assigned to provide continued assistance in operation of helicopter and provided inaccurate information post-sale regarding usable life of engine component).
In Simonsen v. Ford, 196 Or App 460, plaintiff made a claim against an automobile manufacturer for injuries she received in an automobile collision. Plaintiff initiated her suit against the manufacturer more than ten years after the original sale of the vehicle. Plaintiff's claims, among others, alleged that the manufacturer was negligent: (A) In failing to timely discover the latent defect in the control arm and issue a recall; (B) by delaying the recall notice; and (C) by failing to adequately test to discover the latent defect once Defendant began receiving reports of serious injury. Id. at 466. The trial court reasoned that, as each specification of negligence related to the condition of the product at the time of sale, each fell within the scope of ORS 30.900, and consequently, were time barred by the product liability statue of ultimate repose, ORS 30.905.
The Court of Appeals considered whether each specification alleged a pre-sale negligent act which continued post-sale. The court held that "[s]pecifications A and B of plaintiff's negligence claim are subject to ORS 30.905, but specification C is not" Id. at 468.6
The two sides of the bar will likely pursue the teachings Simonsen differently. Plaintiffs will argue that the Court of Appeals made a clear distinction between warning cases that arise because of defects in a product at the time of sale and those cases that arise because of some negligent act that occurred after the date of sale. Defendants will argue that Simonsen does not expand the duties articulated by the Oregon Supreme Court in Cavan or Josephs; rather, the procedural posture of Simonsen forced the Court of Appeals into a limited examination under ORCP 21A(9) of whether there were allegations of negligent post-sale conduct.
E. POTENTIAL DEFENSES
1. Federal Preemption of a State Law
Warnings Claim
A manufacturer may avoid liability altogether if it can prove that it complied
with a federal law that Congress intended as preemptory. See Cipollone v. Liggett
Group, Inc., 505 US 504, 112 SCt 2608 (1992). Whether federal law will bar
a plaintiff's state law claim will turn on the court's determination of whether
Congress intended preemption when it enacted the specific legislation at issue.
In many cases, a crucial component of the analysis will involve a detailed
examination of the claims alleged by the plaintiff and, in particular, how
the claims were framed. See Geier v. American Honda Motor Co., Inc., 529 US
861, 120 SCt 1913 (2000); Buckman Company v. Plaintiffs' Legal Committee, 531
US 341, 121 SCt 1012 (2001). In Oregon, "a federal law will have preemptive
effect only ... when the federal law imposes specific requirements on the manufacturing
or labeling of a product and when the state common-law 'requirement' has been
specifically developed 'with respect to' the product that is subject to the
federal requirements in a way that would impede the ability of federal regulators
to implement and enforce the specific federal requirements." Brown v. Chas
H. Lilly Co., 161 Or App 402, 412-13, 985 P2d 846 (1999), rev. denied, 330
Or 138, 6 P3d 1098 (2000) (quoting Mears v. Marshall, 149 Or App 641, 944 P2d
984 (1997), rev denied, 327 Or 192, 961 P2d 217 (1998)). However, as a general
rule, compliance with statutes and regulations is not an affirmative defense
to a strict product liability or negligence claim. See McCathern v. Toyota,
160 Or App 201, 227-28, 985 P2d 804 (1999), aff'd 332 Or 59, 23 P3d 320 (2001)
(federal requirement that all sport utility vehicles warn of rollover does
not preclude a claim of inadequate warning); Brown v. Chas H. Lilly Co., supra,
( FIFRA labeling requirements do not preempt negligence or strict liability
claims based on failure to warn); Bates v. Dow AgroSciences, LLC, 554 U.S.
__ , 125 S.Ct. 788, 161 LEd2d 687 (2005) (FIFRA labeling requirements preempt
only state labeling requirements that are "in addition to or different from" FIFRA's
labeling requirements); Mears v. Marshall, supra, (MDA does not preempt patient's
strict liability or negligence claims); Wilson v. Piper Aircraft Corp., 282
Or 61, 64-65, 577 P2d 1322 (1978) (FAA regulations do not preclude strict liability);
Lunda v. Matthews, 46 Or App 701, 707, 613 P2d 63 (1980) (conformance with
pollution standards does not preclude a private suit); McEwen v. Ortho Pharmaceutical,
270 Or 275, 397-98, 528 P2d 522 (1974) (FDA labeling requirements do not preclude
a claim of inadequate warning); Koch v. Southern Pacific Transportation Co.,
274 Or 499, 504, 547 P2d 589 (1976) (governmental requirements should generally
be treated as minimal requirements only, no preclusive effect in the absence
of contrary indication).
2. Common Knowledge (Danger that is
Commonly Known and Recognized)
A defendant may have no duty to warn of a danger presented by a product that
is "generally known and recognized," for such a product should not generally
be considered to be unreasonably dangerous due to a lack of warning. Gunstone
v. Blum, 111 Or App 332, 336-37, 825 P2d 1389, rev. denied, 313 Or 354, 833
P2d 1283 (1992). That same product may, however, be found to be unreasonably
dangerous and defective for other reasons. Id.
3. Adequate Warning and/or Instructions
were Given
The defendant is not liable where adequate warnings and/or instructions were
given but plaintiff failed to heed them and such failure was the cause of plaintiff's
injuries. However, a warning will not necessarily cure a non-warning design
defect and, according to the Ninth Circuit's interpretation of Oregon law,
a manufacturing defect can never by cured by the giving of a warning. See,
Glover v. BIC Corp., 6 F3d 1318, 1323-24 (9th Cir. 1993) (en banc) (interpreting
Oregon law; however, cases elsewhere are mixed).
4. Unforeseeable and Substantial Change
in Product that Created the Danger
ORS 30.915 provides a defense where the defendant can prove an unauthorized
alteration or modification was made to the product after it left the manufacturer
or supplier's hands and the alteration or modification substantially contributed
to plaintiff's injuries. However, if the alteration or modification was reasonably
foreseeable and the manufacturer failed to provide an adequate warning, the
defense will fail.
5. Plaintiff's unique sensitivity
A defendant may not be liable to an injured consumer if the injury occurred
because the consumer was peculiarly sensitive to the product. A plaintiff's
sensitivity must be unique, however, to overcome a defendant's duty to give
notice of concealed dangers. See Anderson v. Klix Chemical Co., supra, 256
Or at 211-14.
6. Unforeseeable Misuse
If misuse was unforeseeable, it may bar a plaintiff's claim as a manufacturer
has no duty to protect against injuries caused by it. Unforeseeable misuse
involves a use or handling of the product in a manner so unusual that the
average consumer could not reasonably expect the product to be designed and
manufactured to withstand it. Findlay v. Copeland Lumber Co, 265 Or 300,
304-05, 509 P2d 28 (1973) (interpreting Comment h to §402A).
7. Comparative Fault
A defendant may properly allege comparative fault based on plaintiff's unreasonable
misuse of the product, or unreasonable use despite knowledge of a dangerous
defect in the product and awareness of the risk posed by that defect. Hernandez,
327 Or at 109; Lakin v. Senco Products, Inc., 144 Or App 52, 66, 925 P2d
107 (1996). However, comparative fault is no defense where a defendant's
allegations are based on plaintiff's unobservant, inattentive, ignorant,
or awkward failure to discover or to guard against the defect that made the
product unreasonably dangerous. See Hernandez v. Barbo Machinery Co., 327
Or 99, 107-112, 957 P2d 147 (1998); Sandford v. Chev. Div. Gen. Motors, 292
Or 590, 610, 642 P2d 624 (1982).
8. Learned intermediary
Historically, in Oregon product liability warnings
claims based on negligence, defendants have relied on the defense that
adequate warnings from a drug manufacturer to a physician or other "learned
intermediary" insulate the manufacturer from liability to the patient.
See Oskenholt v. Lederle Laboratories, 294 Or 213, 656 P2d 293 (1982);
McEwen v. Ortho Pharmaceuticals, 270 Or 375, 528 P2d 522 (1974). The application
of that doctrine to warnings claims based on strict product liability
became uncertain with Griffith v. Blatt, supra. In Griffith, a pharmacist
attempted to invoke a learned intermediary defense. The Oregon Supreme
Court concluded that "[n]either the text nor the context of ...[Oregon's
strict product liability] statutes indicates that the legislature intended
to relieve a seller from potential strict product liability on the basis
of the adequacy of a manufacturer's product warnings to another intermediary." 334
Or at 467.
III. SOME PRACTICAL CONSIDERATIONS AND THOUGHTS
Product warnings are ubiquitous. Perhaps for that reason, cases premised on a failure to warn appear to be much less common than cases based on inadequate warnings. Inadequate warnings are often part of a product liability case, but less often the sole basis for liability. Where inadequate warnings are alleged, it tends to expand the scope of information that is available to the plaintiff in discovery, and the scope of relevancy at trial.
Deciding whether a warning is inadequate, and whether a better warnings would likely have made a difference, depends on the unique factual circumstances of the case. Sooner or later, counsel will need to employ some kind of a warning expert to assist in the evaluation and possible prosecution or defense of the case. There are all kinds of possible witnesses with some expertise and experience in warnings, including psychologists, human factors experts, safety engineers, and product designers and engineers. Although an expert with relevant industry experience may more easily pass the respective state and federal requirements for expert testimony, such experience does not guarantee an understanding of how people perceive and process information, including information that identifies hazards and the consequences of not following a warning's directions.
Both sides will want to identify and apply applicable standards for warnings for the subject product. While a manufacturer's meeting a standard is generally not an affirmative defense (absent federal preemption), what standards exist and whether or not they were followed will be important to both plaintiff and defendant. There are many organizations that develop standards, and depending on the organization they may carry some weight in a case. There may be governmental regulations that either apply or could be considered; OSHA standards may also be relevant in certain cases.
One of the most commonly-encountered private organizations setting standards is ANSI, the American National Standards Institute. Particular ANSI Standards that may provide a starting point include:
ANSI Z 535.1 - Safety Color Code
ANSI Z 535.2 - Environmental and Facility Safety Signs
ANSI Z 535.3 - Criteria of Safety Symbols
ANSI Z 535.4 - Product Safety Signs and Labels
ANSI Z 535.5 - Accident Prevention Tags
Based on these and other standards, counsel can develop some general sense of the qualities of an adequate warning. The following working considerations may assist counsel in a preliminary assessment of a case, but are not definitive, and are no substitute for an expert evaluation:
- Is the warning located where it will likely be seen by the user when needed?
- Is the warning done in such a manner that it will likely be conspicuous even after a long period of product use?
- Does the warning clearly identify the hazard?
- Does the warning clearly identify the proscribed conduct?
- Does the warning clearly identify the consequences of not following the warning (property damage, type of injury, death)?
- Does the warning use the appropriate signal word for the degree of risk ("DANGER," "WARNING," or "CAUTION")?
- Does the warning use appropriate colors?
- Does the warning have an appropriate format, considering such things as safety alert symbols, border, word message, font size, spacing, and arrangement?
Another important consideration in a potential warnings case may be the plaintiff. In addition to all of the other plaintiff factors that can make a case better or worse, there are questions to explore in a warnings case, both in plaintiff's counsel interviews, and in defense deposition of the plaintiff:
- Is the plaintiff literate and, if so, in what language? How does that compare to the foreseeable users of the product, or to product advertising?
- What is the plaintiff's intelligence and education, and how does that compare to other foreseeable product users?
- If warnings were provided, did the plaintiff see and read them? If not, why not?
- If warnings were not provided, does the plaintiff generally read and follow warnings elsewhere?
- Would the plaintiff have followed an adequate warning if one had been given?
Both counsel need to learn what warnings and instructions came with the product, including originally-placed signs and instructions, which are often in a document that is separate from the product. Similarly, both sides will be interested in the warnings that came with prior and subsequent versions of the product, warnings for similar products from the same manufacturer, prototype warnings, and relevant warnings and instructions obtained by defendant from other sources. Other documents of interest concern the manufacturer's identification of product hazards and risks, and its knowledge of those hazards and risks, such as risk assessment studies, failure analyses, and internal company communications on the subject. Another important discovery issue is prior and subsequent injuries for both the same product and for similar products.
Plaintiff will need to use depositions to explore the defendant's knowledge of product hazards and risks and consideration, development, and possible testing of warnings and instructions. Depositions often include inquiries about defendant's possible involvement with creating or changing industry standards, and any lobbying efforts with relevant standard-setting organizations. Obviously, defense counsel need to anticipate and prepare for these expected lines of questioning.
At trial, the Oregon State Bar Uniform Jury Instructions address product liability cases based on a theory of failure to warn or inadequate warnings. The general strict product liability instructions are UCJI 48.01 and 48.02; the latter instructs that a product may be in a defective condition "[b]y the absence of adequate warnings or instructions." The specific warnings instruction is UCJI 48.08:
"In order to prevent a product from being unreasonably dangerous, the manufacturer/seller/lessor] may be required to give a warning or instruction regarding the use of the product. If you determine that the product would be unreasonably dangerous in the absence of an adequate warning or instruction, and if you determine that an adequate warning or instruction did not accompany the product, then the product was unreasonably dangerous."
"However, a [manufacturer/seller/lessor] is not require to warn or instruct with regard to a danger which is generally known and recognized. Where an adequate warning or instruction is given, the [manufacturer/seller/lessor] may reasonably assume that it will be read and heeded, and a product bearing such a warning or instruction, which is safe for use if it is followed, is not in a defective condition, nor is it unreasonably dangerous."
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