Impotentie brengt een constant ongemak met zich mee, net als fysieke en psychologische problemen in uw leven cialis kopen terwijl generieke medicijnen al bewezen en geperfectioneerd zijn
Legally Adequate Warning Labels:
A Conundrum for Every Manufacturer
BY KENNETH ROSS
AND MATTHEW W. ADAMS
Atraditional axiom of products liability law is that a manu- DUTY TO WARN
facturer or supplier of goods has a duty to warn of any
Generally, the manufacturer has a duty to warn where: (1) the prod-
danger from the intended or unintended but reasonably
uct supplied is dangerous; (2) the danger is or should be known by
foreseeable use of its products. This duty extends to those using or
the manufacturer; (3) the danger is present when the product is
purchasing the product, as well as to those who could reasonably
used in the usual and expected manner; and (4) the danger is not
be expected to be harmed by its use. While there are many ways in
obvious or well known to the user. See Billiar v. Minnesota Min-
which to warn, warning labels attached to the product are a tradi-
ing & Manufacturing Co.
, 623 F.2d 240, 243 (2d Cir. 1980).
tional method of fulfilling this duty. However, merely warning of
Once a duty to warn arises, the manufacturer who has provided
the danger may not be enough. Even where a warning is provided,
a warning may still be liable for harm if the warning provided is
a manufacturer may still be liable if the warning is not deemed to
inadequate. That is, even if the manufacturer has provided a warn-
ing, a qualitative evaluation may result in a finding that the warn-
Under current products liability law, a determination of ad-
ing did not sufficiently warn of the product’s potential dangers.
equacy is a highly subjective and fact-intensive evaluation. As
“Providing an inadequate warning is no better than providing no
such, defining a step-by-step procedure for creating unassailably
warning at all.” American Law of Products Liability 3d
adequate warning labels is impossible. Nonetheless, an examina-
The difficulty for manufacturers is, therefore, to prospectively
tion of current statutes and case law, voluntary consensus stan-
determine what may be considered an “adequate” warning for each
dards, and the new Restatement (Third) of the Law of Torts:
foreseeable risk. A lack of objective criteria makes this determina-
(hereinafter Third Restatement
) does provide
tion difficult. Third Restatement
§2, comment i. The problem is
substantial insight into what information a court may consider
compounded by the fact that adequacy determination is a factual
when evaluating the adequacy of a warning.
issue most often left to the fact finder. The finder of fact often con-
This article will examine the law and standards and how they
cludes that, if the plaintiff was injured, the warning must per se
apply when a court is making a determination of legal suffi-
inadequate. See Schwartz & Driver, “Warnings in The Workplace:
ciency. With a clear understanding of this information, a manu-
The Need for a Synthesis of Law and
facturer will be better able to develop warning labels that will
52 U.Cin.L.Rev. 38, 54 (1983). These problems have made it dif-
ficult for even the most well intentioned manufacturers to ensurethat they can successfully defend against a claim of inadequacy.
What, then, should a manufacturer do to ensure that its warn-
ing labels are legally adequate? To better answer that question, itis helpful to understand the social policy justification for impos-ing liability on manufacturers.
• The Requirement of Adequacy
The policy justification for the duty to warn is rooted in the no-
tion that product manufacturers are best able to anticipate what
dangers are inherent during the use of their products. The manu-
facturer then is in a better position to warn of these dangers. It
would be fundamentally wrong to permit an exploitative manu-
Kenneth Ross is a partner in the Minneapolis office of Bowman and
facturer to profit from the sale of a product it knows or should
Brooke LLP, where he counsels manufacturers and product sellers
know to be dangerous. By allocating the burden in this way, man-
on safety and liability prevention. Mr. Ross is Vice Chair of the Man-
ufacturers are additionally provided an incentive to “achieve op-
ufacturers’ Risk Prevention Subcommittee of the DRI Product Lia-
timal levels of safety in designing and marketing products.” Third
bility Committee. Matthew W. Adams is an engineer and recent law
school graduate who plans to join the Minneapolis intellectual
§2, comment a. This is not to say that, as a society,
property firm of Schwegman Lundberg Woessner & Kluth.
we believe a manufacturer should be absolutely liable for its
products. Society does not benefit from “excessively safe” prod-
to an intermediary. This is a common occurrence with medical
ucts that overly sacrifice utility any more than it benefits from
devices and pharmaceutical products. Under the “learned inter-
unreasonably risky products. Rather, we are interested in encour-
mediary” doctrine, a drug manufacturer may typically rely on the
aging the optimal balance of product safety and utility. Thus, the
doctor to provide the warnings to the patient. See Ortho Pharma-
duty to warn enhances society’s goal of risk reduction without
ceutical Corp. v. Chapman
, 388 N.E.2d 541, 548-49 (Ind.App.
eliminating the manufacturer’s incentive to produce useful goods.
1979). However, the drug manufacturer may not always discharge
There are three types of warning defects: (1) failure to warn; (2)
his duty by warning the intermediary. The sufficiency of a warn-
failure to provide an adequate warning; and (3) failure to adequately
ing to third parties is evaluated using a reasonableness standard.
instruct. An inadequate warning differs from failure to warn in that
See generally, Second Restatement
§388, comment n.
adequacy addresses the qualitative characteristics of a warning while
A manufacturer may also be relieved of his duty to warn under
failure to warn addresses the quantitative aspects (i.e.
, failure to warn
the “sophisticated user” doctrine. As previously discussed, the duty
asks: “is there a warning at all?” while adequacy asks “was the warn-
to warn arises because it is assumed the manufacturer knows more
ing provided adequate?”). Adequacy of warnings may also be
about the product’s dangers than the user. However, where the
distinguished from adequacy of instructions. The fact that ad-
user is sophisticated (i.e.
, the dangers of the product are known
equate instructions are provided that assist the operator in the
to the user), there is no duty to warn. See White v. Amoco Oil Co.
correct operation of the product does not necessarily discharge
835 F.2d 1113, 1118 (5th Cir. 1988). Similarly, “[t]he manufac-
the duty to provide an adequate warning. A warning may still be
turer… need not warn of dangers that users know or should know
required to call attention to the dangers of using the product.
or of dangers that are or should be obvious to ordinary users.” Id.
While not the exclusive method of providing a warning, labels
at 1118. Finally, courts have generally found that a manufacturer
are one of the most effective in communicating danger. This is es-
is not liable for failure to warn of an “open and obvious” danger.
pecially true where the warning label is attached directly to the
“It is… well settled that a manufacturer is under no duty to warn a
product. One reason for this increased effectiveness is that a
user of every danger which may exist during the use of the prod-
warning label affixed directly to the product stays with the prod-
uct, especially when such danger is open and obvious.” Gurley v.
uct even after transfer to subsequent users. This assures that the
American Honda Motor Co.
, 505 So.2d 358, 361 (Ala. 1987).
subsequent users are also warned. Additionally, warning labels
Accordingly, the duty to warn extends to others besides the
attached to the product may improve effectiveness by warning
user/purchaser. Determining whether a warning will be consid-
non-users of the potential dangers. As discussed below, this is
ered adequate to all reasonably foreseeable parties is therefore a
critical in some instances as a manufacturer may be liable for
complex task. A manufacturer must be constantly aware of those
warning others in addition to the product user.
affected by the use of its product and take reasonable steps towarn that audience. This burden can appear daunting, especially
• Who Must be Warned
where a potential cause of action is brought under strict liability.
Generally, one who supplies a product directly or through a third
However, modern courts have applied a more relaxed interpreta-
party is subject to liability to those whom the manufacturer should
tion of strict liability to warning defect cases.
expect to use the product or to be endangered by its probable use.Restatement (Second) of Torts
§388. This may include not only the
• Strict Liability or Negligence
party to whom the product is given, but also friends or employees
As it pertains to warning defects, a claim under strict liability
of the purchaser. While there is little doubt that a purchaser or
would presume a defendant has constructive knowledge of all
known user should be warned, more difficult questions arise when
product dangers, known and unknown, related to the use of its
a third party not in the chain of title alleges a warning defect.
products, and must warn accordingly. Not only is holding a
Many courts have, in accordance with section 388 of the Re-
manufacturer to have knowledge not yet in existence unreason-
statement, held that a manufacturer or distributor is required to
able, enforcement of such a standard hinders innovation.
warn only those that it could “reasonably foresee would be likely
However, the modern view in warnings cases has been to hold
to use its product or who are likely to come into contact with the
defendants responsible for only that knowledge they had or
danger, if any, inherent in the use of its product.” Am.Law
should reasonably have had when they sold the product (ignoring
§33:15. The warning given must be adequate to
for the moment any post-sale duty to warn). This effectively ap-
protect any and all foreseeable users from hidden dangers. While
plies negligence principles to what is considered strict liability.
this duty may also extend to bystanders, warnings need not be
Most courts have reasoned that under either strict liability or neg-
given to the general public. See, e.g., Harrison v. McDonough
ligence, the standard applied is the same.
Power Equipment, Inc.
, 381 F.Supp. 926, 929 (S.D.Fla. 1974)
Consequently, the current trend is to analyze warning defects
(the distributor of an inherently dangerous product must take rea-
under a reasonableness standard regardless of whether the claim
sonable precautions to avoid injuries to users and bystanders);
is brought in strict liability, negligence, or contract/warranty.
Eagle-Picher Industries, Inc. v. Balbos
, 84 Md.App.10, 578 A.2d
Reasonableness does not mean that the warning has to be the best
228, 251 (1990) (“[t]here is no longer any doubt that the negli-
possible, but rather requires that it be one that a reasonably pru-
gence liability extends to any lawful use of the thing supplied, as
dent manufacturer would provide under similar circumstances.
Gurley v. Honda, supra
, 505 So.2d at 361.
There are also exceptions when certain intermediaries are in-
volved. For example, where the user is not sufficiently sophisti-
ELEMENTS OF AN ADEQUATE WARNING
cated to evaluate the warning or when directly warning the user
What, then, constitutes an adequate warning? The Third Restate-
is not feasible, a warning may, in some circumstances, be given
, at §2(c),
states that “[a] product… is defective because of
inadequate instructions or warnings when the foreseeable risks of
product, taking into account the characteristics of, and the ordi-
harm posed by the product could have been reduced or avoided
nary knowledge common to, the persons by whom the product isintended to be used.
by the provision of reasonable instructions or warnings by theseller or other distributor, or a predecessor in the commercial chain
N.J.S.A. 2A:58C-4. Mississippi has enacted a statute effectively
of distribution, and the omission of the instructions or warnings
identical to that of New Jersey. See
renders the product not reasonably safe.”
The state of Washington has defined a product as not reasonably
While this reiterates the aspects of foreseeability and reason-
safe by virtue of inadequate warnings “if, at the time of manufacture
ableness already discussed, it does little to
the likelihood that the product would cause
the claimant’s harm or similar harms, and
general concepts. Case law, however, does
h e c u r r e n t t r e n d i s
the warnings or instructions of the manu-
making a determination of legal adequacy.
In Bituminous Casualty Corp. v. Black
t o a n a l y z e w a r n i n g
& Decker Manufacturing Co.
, 518 S.W.2d
structions which the claimant alleges would
d e f e c t s u n d e r
have been adequate.” RCW 7.72.030(1)(b).
Civil Appeals summarized the state of the
a r e a s o n a b l e n e s s
law. It said, at 872-73, that a warning is
the policy objective that a warning should
s t a n d a r d r e g a r d l e s s
(1) it is in a form that could reasonably
decline purchasing the product if desired.
o f w h e t h e r t h e c l a i m
instruction that would lead an ordinary rea-
i s b r o u g h t i n s t r i c t
sonable user or handler of a product to con-
(2) the content is of such a nature as to
l i a b i l i t y , n e g l i g e n c e ,
the product and either to decline to use or
(3) it conveys a fair indication of the na-
o r c o n t r a c t / w a r r a n t y .
handle the product or, if possible, to use or
handle the product in such a manner as to
mind of a reasonably prudent person.
In Shanks v. Upjohn Co.
, 835 P.2d 1189,
made.” La.Rev.Stat. §9:2800.53(9).
1200 (Alaska 1992), the court similarly found that, for a warning to
Thus, an analysis of the case law and existing state statutes suggests
be adequate, it should: “1) clearly indicate the scope of the risk or
to the authors that a judicial determination of adequacy will depend on
danger posed by the product; 2) reasonably communicate the ex-
a factual evaluation of eight questions. These are discussed in detail
tent or seriousness of harm that could result from the risk or dan-
below. Only by careful consideration of these questions can a
ger; and 3) be conveyed in such a manner as to alert the
manufacturer reasonably predict the result of subsequent litigation.
Other cases have stressed: that the warning must inform the
user of the product’s potential risks, see Hendrix v. Raybestos-
While the eight questions listed below begin to provide some in-
, 776 F.2d 1492, 1497 n.7 (11th Cir. 1985); that
sight into what constitutes an adequate warning, an analysis of re-
adequacy requires complete disclosure of the existence and ex-
cent court opinions clarifies just how these questions are answered.
tent of risk involved in the use of a product, see Thornton v. E.I.
Adequacy is a factual issue and, as such, is typically a question for
DuPont de Nemours & Co.
, 22 F.3d 284, 289 (11th Cir. 1994);
the trier of fact. Therefore, using the reasonableness standard and
and that whether a warning is legally adequate depends on the
risk-utility balancing test, the fact finder need only conclude that,
language used and the impression that language is calculated to
after balancing certain factors, the warning is reasonable (or un-
make upon the mind of the average product user, id.
reasonable) under the circumstances. For an earlier analysis of
say that adequacy must be evaluated in conjunction with knowl-
this question under New York law, see Suhr, “Marketing Defects:
edge and expertise of those who may be reasonably expected to
What is a Legally Adequate Warning?,” February 1991 New York
use or otherwise come in contact with the product. Id.
Many states have adopted legislation to address warning de-
fects. For example, to determine whether a warning is adequate,
• Was it likely that the product would cause the harm
Connecticut requires a trier of fact to consider: “(1) [t]he likeli-
hood that the product would cause the harm suffered by claimant;
When evaluating the likelihood that the product would cause the
(2) the ability of the product seller to anticipate at the time of
harm alleged, there are several sub-issues to examine. First, it is
manufacture that the expected product user would be aware of the
necessary to examine whether the product itself was in a danger-
product risk, and the nature of the potential harm; and (3) the
ous condition. See Oman v. Johns-Manville Corp.
, 764 F.2d 224,
technological feasibility and cost of warnings and instructions.”
233 (4th Cir. 1985). This is highly dependent on the complexity
Conn.Gen.Stat. §52-572q(b). New Jersey similarly defines an
of the product. Simple products may require only minimal warn-
ings while complicated or extremely dangerous products typi-cally require more detailed warnings.
a reasonably prudent person in the same or similar circumstanceswould have provided with respect to the danger and that commu-
Second, it is necessary to evaluate the purpose for which the
nicates adequate information on the dangers and safe use of the
product is used. If the product is or could reasonably be used in
a dangerous way, it may require more explicit warnings than it
fendant’s control or whether the defect is discovered after sale (in
which case a post-sale duty to warn may exist). In either case, the
Third, it is necessary to determine whether the product was be-
burden imposed on the defendant manufacturer for disseminating
ing used in a reasonably foreseeable manner. For example, con-
the revised warning is weighed against the beneficial effect such
sider a power tool having a removable safety guard. Depending on
a revised warning would provide to the user.
the circumstances, it may be reasonable to assume that a consumer
One factor used when evaluating feasibility and cost is the
will operate the tool without the guard. If so, a warning about the
burden imposed on the manufacturer. See Oman
, 764 F.2d at 233.
dangers of operating the tool in such a man-
or additional warnings is low, a court is
foreseeable use or misuse is a difficult de-
f a p a r t i c u l a r p r o d u c t
termination. As a starting point, however,
especially true where the plaintiff’s pro-
p o s e s a r i s k t h a t
§2, comment m. This
c a n b e r e a s o n a b l y
section makes it clear that, at a minimum,
“[the] manufacturer is charged with knowl-
a d d r e s s e d w i t h
edge of what reasonable testing would re-
veal.” That is, a manufacturer is deemed to
a r e d e s i g n , a w a r n i n g
cost of revising or adding another warning
is generally perceived to be minimal. This
discoverable during product testing.
a b o u t t h a t r i s k m a y
is particularly true during the marketing of
If a particular product poses a risk that
the product (the post-sale burden is typi-
b e i n a d e q u a t e .
can be reasonably addressed with a redesign,
cally higher as the manufacturer has costs
a warning about that risk may be inadequate.
associated with finding and notifying af-
See Uloth v. City Tank Corp.
, 376 Mass. 874,
384 N.E.2d 1188 (1978). Some case law and the Third Restatement
While the defendant cannot typically show that its burden
hold that the risk should be eliminated through redesign rather than
would be substantial in providing a more in-depth warning, it may
reduced through warning on the theory that warnings are less effec-
often claim that more detailed warnings lead to warning dilution.
tive. Third Restatement
§2, comment l; Uniroyal Goodrich Tire Co.
For example, in Broussard v. Continental Oil Co.
, 433 So.2d 354
41 Tex.Sup.Ct.J. 1047, 1998 Westlaw 352929 (July 3,
(La.App. 1983), the plaintiff was using a hand tool produced by the
1998). However, “when an alternative design to avoid risks cannot
defendant. The tool had one warning label that instructed the user
reasonably be implemented, adequate instructions and warnings will
to read the operator’s manual before use. The plaintiff failed to do
normally be sufficient to render the product reasonably safe.” Id.
so and was injured when the tool was used in an explosive envi-ronment (the manual included an adequate warning regarding op-
• How serious was the harm suffered?
eration in an explosive environment). The plaintiff argued that ten
The probability and severity of the harm suffered weighs heavily
warnings should have been placed on the tool itself. The court re-
in the evaluation of the adequacy of a warning. See Oman v. Johns-
jected this view, noting that an otherwise adequate warning provided
, 764 F.2d at 233. Generally speaking, the more se-
in the operator’s manual was sufficient in this context. Placing
rious the potential harm, the more descriptive the warning must be.
too many warnings on the product, the court concluded, would
Thus, a manufacturer must consider not only whether a warning
“decrease the effectiveness of all of the warnings.” Broussard
is required but also whether the warning is sufficient to place the
433 So.2d at 358. See also, Third Restatement
§2, comment i
user on notice of the severity of the potential harm.
(“excessive detail may detract from the ability of typical users to
This is not to say that a manufacturer must warn of every con-
focus on the important aspects of the warnings…”).
ceivable danger. Rather, it must warn only of those dangers that
Consequently, a manufacturer may have a valid reason for not
are reasonably foreseeable. This concept deserves due consider-
providing more in-depth warning labels and similarly, for not at-
ation because it may be possible to overwarn a potential user.
taching all warning labels directly to the product itself. Nonethe-
“Overwarning,” or dilution as it is more often called, occurs when
less, the diligent manufacturer should pursue every available
the manufacturer attempts either to warn about every conceivable
means to ensure that warnings reach the intended audience. Pro-
danger or to warn in excessive detail. Overwarning will be dis-
viding warning labels directly on the product is a preferred
method as they are then available to any user. If this is not possi-
Accordingly, where the magnitude of the danger is significant,
ble, a warning to first review the operator’s manual may be suf-
a manufacturer should avoid all ambiguity in warning about that
ficient under a Broussard
danger, both on the product warning label and in all other prod-uct information.
• What knowledge could the defendant reasonably presume
the user had of the potential risks?
• What was the technological feasibility and cost of
As discussed earlier, a manufacturer is not required to warn a user
providing a warning which the plaintiff now alleges
who is already aware of the product risks (e.g.
, sophisticated user,
would have been adequate?
user warned by a third party, informed intermediary). In these
The answer to this question has varying impact depending on
situations, the harm suffered is deemed not to have been caused
whether the allegedly defective product has not yet left the de-
by the defendant (i.e.
, no causation). As such, courts have al-
lowed a defendant to escape liability for an otherwise defective
specific instances. Accordingly, such reliance on third parties is
warning when the defendant proves that the user was aware of or
discouraged. When at all possible, directly warning the ultimate
should have been aware of the risk that caused the harm.
user is preferred. When not possible, a manufacturer should make
There are several avenues by which a potential defendant may
every effort possible to ensure that it has adequately warned a re-
argue that it reasonably relied on the user having knowledge of
liable intermediary or pursued some other course that assures that
product risks. First and most obvious, the manufacturer can di-
the warnings will reach the ultimate users. To adequately protect
rectly warn the user (e.g.
, verbal warning). Second, the defen-
itself, a manufacturer should ensure that the intermediary has
that no warning is required. And finally,
m a n u f a c t u r e r
the manufacturer may, under certain cir-cumstances, rely on an intermediary to
c a n n o t d o w n p l a y
• Does the warning convey a fair
indication of the nature and extent
t h e d a n g e r o f a p r o d u c t
use of its products where the manufacturer
of the danger in the mind of a
reasonably prudent person?
t o i n c r e a s e i t s a p p e a l
This question is closely related to the extent
t o t h e p u r c h a s i n g
of potential harm, as discussed above in the
second question in this list. However, this
a u d i e n c e . A f a i r
fifth question is directed to the relation-
ship of the potential harm to the content of
i n d i c a t i o n o f t h e
herein. In the second instance, the manu-
the label instead of merely focusing on the
facturer alleges reliance on the fact that
extent of the injury. When answering this
a c t u a l h a r m m u s t
user or group of users allows the manufac-
b e c o n v e y e d .
turer to reasonably assume that the user(s)
had adequate knowledge of the dangers.
ing is critical to conveying the level of dan-
cumstances, is permitted to rely on a third party to disseminate
ger associated with the use of the product. For example, in General
warnings to the ultimate user. While a manufacturer cannot com-
Chemical Corp. v. De La Lastra
, 815 S.W.2d 750 (Tex.App.
pletely delegate its duty to warn, the doctrine of superseding/in-
1991), two shrimpers died from sulphur dioxide poisoning while
tervening cause may allow a manufacturer to escape liability
processing shrimp with defendant’s chemical. The defendant’s
under some circumstances. See generally Restatement (Second)
warning noted that the product “[r]eacts with acids and water, re-
§388, comment n. For example, when the product is distributed
leasing toxic sulfur dioxide gas.” The court affirmed the lower
for incorporation into another product over which the manufac-
court’s verdict that this warning did not adequately emphasize
turer has no control, it would be impossible to know and warn of
that the product could potentially produce a deadly gas. Thus,
where a product’s use or reasonably foreseeable misuse can cause
Alternatively, a manufacturer selling a product to a company
death, the magnitude of that harm should be conveyed.
does not know who will actually be using the product. For these
The accuracy of the warning is equally as important. For ex-
reasons, a court, in making an adequacy determination, may ex-
ample, a warning has been found inadequate where it gives some
amine the knowledge of the intermediary and the reasonableness
indication that the danger may be eliminated or controlled by the
of relying on that party to disseminate warnings.
user when in fact it cannot. See Thompson v. Tuggle
, 486 So.2d
While fulfilling the duty to warn by informing an intermedi-
144, 151 (La.App. 1986). Similarly, a label has been found inad-
ary can be of significant benefit to a manufacturer when defend-
equate where “it was unduly delayed, reluctant in tone or lacking
ing an inadequacy allegation, it is important to note that this
in a sense of urgency.” MacDonald v. Ortho Pharmaceutical
factor is subject to heightened judicial scrutiny. For example, in
, 394 Mass. 131, 475 N.E.2d 65, 71 (1985).
Reed v. Pennwalt Corp.,
22 Wash.App. 718, 591 P.2d 478 (1979),
Some cases indicate that product information (e.g.
a caustic substance used during the course of employment injured
promotional activities) as a whole may be evaluated in determin-
an employee. While the defendant had provided warnings to the
ing whether a particular warning is inadequate. For example, in
employer, the plaintiff alleged the defendant did not adequately
Incollingo v. Ewing
, 444 Pa. 299, 282 A.2d 206, 221 (1971), the
warn the ultimate users about the dangers of the chemical. The
adequacy of a drug manufacturer’s warning was tainted by the
court found that the plaintiff could not recover here, and specifi-
defendant’s promotional efforts which minimized the dangers of
cally noted that: (1) the manufacturer had adequately warned the
the drug while emphasizing its effectiveness. The Incollingo
employer; (2) the product had been removed from its original
thus acknowledged that the adequacy of written warnings may be
container when it reached the end user; and (3) it was reasonable
diluted by the manufacturer’s contrary advertising practices.
to expect that the plaintiff’s employer had its own safety/training
Accordingly, a manufacturer cannot downplay the danger of a
product to increase its appeal to the purchasing audience. A fair
and subsequent decisions indicate that courts are not
indication of the actual harm must be conveyed. If a manufacturer
willing to permit delegation entirely to a third party except in
is generally in doubt about the specificity and content of a particu-
lar label, it should err on the side of caution and include a more
courts gave great deference does not exist for most
specific warning. Several publications exist which may assist the
products. In the context of non-English language warnings, a court
user in formulating warnings. For example, ANSI Z535.4-1998,
may evaluate other products under the more common reasonable-
discussed below, provides a manufacturer with a standardized
ness standard. Therefore, if a manufacturer may reasonably an-
procedure for developing warning labels.
ticipate that its products will be used by non-English-readingusers, it should make an effort to warn in an alternative way.
• Was the warning comprehensible to the average user?
One generally acceptable method of communicating a warn-
anticipated users of the product cannot un-
users is through the use of symbols or pic-
derstand the warning, it is considered in-
torial warnings. For example, a skull and
adequate. Am.Law Prod.Liab.3d
f a m a n u f a c t u r e r m a y
is therefore important to consider the in-
tellectual and communication skills of the
r e a s o n a b l y a n t i c i p a t e
product’s intended audience. These con-
tional standard for the design and use of
t h a t i t s p r o d u c t s w i l l
siderations are especially important when
product safety labels. This standard, re-
the product can reasonably be anticipated
ferred to as ANSI Z535.4, provides for the
b e u s e d b y i l l i t e r a t e
o r n o n - E n g l i s h - r e a d i n g
states that “[s]ymbols and pictorials may
be used to clarify, supplement or substitute
by such groups depends on several factors
u s e r s , i t s h o u l d m a k e
[on the label]. Only symbols validated for
a n e f f o r t t o w a r n i n a n
ods and the expected appeal of the product
a l t e r n a t i v e w a y, t h r o u g h
pictorial may be validated for recognition
Ramirez v. Plough, Inc.
, 6 Cal.4th 539, 25
t h e u s e o f s y m b o l s o r
if it is: included in a U.S. or international
could not understand or read English gave
p i c t o r i a l w a r n i n g s .
“meet[s] the comprehensive test criteria
the defendant’s drug product to the four-
The court in Torres-Rios
Reye’s Syndrome in young children. However, the caretaker
mented on the flammability pictorial contained on the cleaner’s
could not read the directions and made no effort to have them
label. One problem with the use of pictorials is that it is usually
translated. The child then suffered damage as a result of the drug.
impossible to fully communicate the entire safety message. The
The child’s guardian sued, alleging that the defendant’s warnings
hope, therefore, is that the non-English reader will have the En-
were inadequate because they were not in Spanish.
glish translated. The court confirmed the validity of this approach
The California Supreme Court concluded that, although it
by stating that although this pictorial did not fully explain the
may be reasonable to anticipate a non-English-reading person
danger, it provided a clear enough warning to the user to either
would use the product, legislative and regulatory standards in the
read the safety instructions or to find someone to translate them.
area of drug warnings were substantial and required only English
Another possible method of warning non-English-reading users
language warnings. The court acknowledged that both state and
is to warn in their native language. This assures that the user has
federal agencies were aware of possible dangers to those unable
received the same or similar warnings as the English reading users.
to read English warning labels and had still mandated English-
However, multi-lingual warnings present several problems. First,
only labels. The court was compelled to defer to the expertise of
linguistic idiosyncracies may make a literal translation difficult.
these governmental bodies. Ramirez
, 25 Cal.Rptr.2d at 107.
Since these foreign language labels are evaluated identically to
In another recent decision, on an appeal from the federal dis-
their English language counterparts, they may well be found in-
trict court in Puerto Rico, the First Circuit held that warnings on
adequate when analyzed separately. Additionally, a manufacturer
industrial cleaners need not be in Spanish because the labeling
who chooses to include one foreign language on its product la-
regulation, at 29 C.F.R. §1910.1200(f)(1), does not explicitly con-
bels may be liable for not including other languages. See Ross,
tain a language requirement. Torres-Rios v. LPS Laboratories, Inc.
“The Duty To Warn Illiterate and Non-English-Reading Product
CCH Products Liability Reports p.15,303, 1998 Westlaw 429337.
Users,” BNA Product Safety and Liability Reporter
This regulation makes it clear that it is the employer’s responsi-
(October 13, 1995). There is also no guarantee that the users for
bility to add other languages if appropriate. The court cited the
which the foreign language label is directed are even literate. Id.
decision’s deference to legislative and administrative
at 1101. In addition, inclusion of a foreign language can dimin-
bodies to decide when other languages might be required.
ish the conspicuity of the English text which, by all measures, is
It must be emphasized that the Ramirez
the most important part of the label. Id
. Therefore, multi-lingual
sions concerned warning labels on regulated products. Attempts to
warnings may not be the most effective method of warning non-
apply their holdings to non-regulated products should be under-
taken with great care. Generally speaking, the regulatory interven-
While it is not clear exactly what is required of a manufacturer
tion in drug and industrial cleaner warnings to which the Ramirez
regarding warnings to non-English-reading users, a manufacturer
should attempt to ensure that its warnings are understandable to
potential danger inherent in not abiding by this direction. At the
reasonably anticipated users. While English language warnings
other end of the spectrum, the operator, where feasible, may be
may be sufficient, multi-lingual or pictorial representations of the
required to place all warning labels on the product itself. Most
warning may better satisfy the ultimate goal of providing a safer
cases will fall somewhere in between these two extremes.
product. Multi-lingual warnings, however, may raise more trou-
The color, organization, and shape of the label are other im-
bling issues for the concerned manufacturer than simply using
portant factors to consider in making an adequacy determination.
pictorial representations (see discussion above). Although such
Once again, hard and fast rules do not exist. However, guidelines
inadequate, they are at least evidence of the
manufacturer’s reasonable care in attempt-
ing to improve the understandability of its
label. Label colors, the size of label, and
warnings and the safety of the product.
the size of print are also important factors
m a n u f a c t u r e r c a n
• Was the warning in such a form
s i g n i f i c a n t l y i m p r o v e
that it could reasonably be expected
to catch the attention of a
i t s c h a n c e s o f r e b u t t i n g
reasonably prudent person?
a n i n a d e q u a c y c h a r g e
• What procedures did the defendant
heavily on the presentation of the warning
utilize in designing the warning
label itself. A manufacturer who has sup-
b y d e m o n s t r a t i n g t h a t
plied an otherwise adequate warning label
As indicated throughout this article, the
a r e a s o n a b l e , d e t a i l e d
cannot then attach the label in an incon-
defendant’s actions are measured against
spicuous place or make it difficult to read
the standard of reasonableness. While this
p r o c e d u r e w a s f o l l o w e d
and still expect that he has complied with
is a subjective standard, a prudent manufac-
the law. On the other hand, a manufacturer
w h e n d e v e l o p i n g t h e
turer can significantly improve its chances
cannot plaster his product with every con-
of rebutting an inadequacy charge by dem-
ceivable warning as this may dilute the ef-
a l l e g e d l y d e f e c t i v e
onstrating that a reasonable, detailed pro-
w a r n i n g l a b e l .
“form” of the warning label is an impor-
allegedly defective warning label. The im-
tant aspect of adequacy determination.
Factors that a court looks to when evalu-
parent when one considers that no warning
ating form include the manner in which the
label is 100% effective. As such, any infor-
warning is stated and the conspicuity of the warning. Conspicuity
mation a manufacturer can provide that shows it made a diligent
refers to the aspects of the label that make it conspicuous. For
attempt to maximize the effectiveness of an allegedly defective
example, the location, position, color, size of label and size of
print, and shape of the label are all evaluated in making an ad-
There are several sources to assist the manufacturer in devel-
oping legally adequate warning labels. While adherence to these
Location is important in two contexts. First, the location of the
standards will not typically result in per se
adequacy, it is at least
label should be such that it is reasonably expected to catch the
evidence of due care. Courts may also look to industry standards
attention of the user—meaning it is located near the hazard. In
as an indicator that a warning is adequate. Some plaintiffs’ attor-
this context, a court will evaluate whether the label is located in
neys have publicly stated that compliance with a recognized stan-
a conspicuous location (e.g.
, not underneath a cover or mounted
dard such as ANSI Z535 will encourage them not to allege failure
to a part commonly removed from the product).
to warn unless the content of the text was inadequate.
Second, the location of the warning is closely related to the di-
One method for evaluating adequacy that is currently receiving
lution problem discussed earlier in the context of Broussard v. Con-
increased attention is the testing of warning labels. Proponents of
tinental Oil Co.
Specifically, a manufacturer who attempts to locate
this practice believe that the duty to warn should be measured not
too many labels in one area runs the risk of dilution. While there
by the factors discussed above, but rather by a testing procedure
are no cases known to the authors where a defendant has been at
used to develop the warning. William H. Hardie discusses this idea
fault merely for providing too many labels, dilution remains a con-
at length in his article “Liability Based on
Testing Product Warn-
stant concern for manufacturers. In theory, it sets an unclear upper
ing Labels,” October 1997 For The Defense
27. While Mr. Hardie
limit which, if exceeded, may nullify otherwise adequate warnings.
acknowledges the appeal to manufacturers of having some assur-
While attempting to draw the line between effective warning
ance of label adequacy, he ultimately believes the approach is
and dilution is not realistic, the manufacturer is reminded that its
flawed. He bases his conclusion on several factors.
efforts are measured against the standard of reasonableness. At
First, he believes that measuring the duty to warn based on test-
one extreme, a product should minimally include a warning di-
ing will result in an adequacy determination based on scientific
recting the user to read the operator’s manual prior to use. In such
interpretation of behavior theory rather than on law. That is, the
a case, the warnings in the manual should be clearly distin-
standard of reasonableness will be replaced by generalized studies
guished from the operating instructions. Additionally, the warn-
of human behavior and questionable conclusions drawn therefrom.
ing placed on the product itself should convey the extent of the
Second, Mr. Hardie believes that a duty to test will unnecessarily
burden the court with new issues concerning validity of test meth-
e.g., Cipollone v. Liggett Group, Inc.
, 505 U.S. 504 (1992) (fed-
ods and scientific techniques. Third, Mr. Hardie asserts that, as
eral labeling requirements for cigarettes preempt state law) and
with the law, there is no agreement in the behavioral sciences as to
27 U.S.C. §216 (federal labeling requirements for alcoholic bev-
what constitutes an “adequate” warning. Finally, Mr. Hardie con-
erages preempt state law)), it is generally understood that these
cludes that no reliable empirical data exists that shows test results
findings of preemption are the exception to the rule.
are an accurate reflection of real world responses. Id
. at 30.
Meeting statutory minimums does not necessarily assure a
William Hardie concludes that testing alone is not a suitable
subsequent finding of adequacy, although it is evidence of due
indicator of adequacy. In reality, he continues, determining ad-
care. Failure to meet statutory minimums, on the other hand, per-
equacy based on testing will actually increase the court’s burden
mits a court to find a warning inadequate per se
. Thus, regula-
by raising questions about the test methods themselves. Whether
tions for warning labels should be viewed as a minimum which
or not Mr. Hardie’s conclusions are correct, it is presently unclear
the manufacturer must either comply or exceed.
how courts will ultimately interpret an alleged “duty to test”
Other cases have found adequacy as a matter of law where the
warning clearly met the requirements discussed herein. For ex-
This area of the law is still developing and its future is uncer-
ample, in Ruggles v. R.D. Werner Co.,
203 App.Div.2d 913, 611
tain. While testing of warning labels may be particularly benefi-
N.Y.S.2d 84 (1994), the plaintiff was injured when he fell from
cial under some circumstances, the high cost associated with
a damaged ladder. The warning label on the ladder instructed the
testing may lead a fact finder to conclude that, under a risk-util-
user to inspect the ladder before use and to “never climb a dam-
ity balancing test, it is not economically feasible. However, the
aged ladder.” The court concluded the warning was adequate as
defendant should keep in mind that the ultimate goal is to protect
a matter of law. In Phan v. Presrite Corp.
, 100 Ohio App.3d 195,
the user. Where testing is the only way to ensure adequacy (e.g.
653 N.E.2d 708 (1994), the plaintiff alleged that the warning re-
where a product is so unique that industry customs or standards
garding a foot switch for a power tool was inadequate. The ex-
do not yet exist), testing may be a reasonable requirement. Un-
perts agreed that, had the label instructions been followed, the
der most circumstances though, adequacy of warning labels may
accident would not have occurred. The court concluded that this
be determined by consideration of the other factors described
necessitated a finding that the warning was adequate as a matter
The manufacturer should ask the eight above-mentioned ques-
Note too that adequacy determined as a matter of law can just
tions and answer them with reference to the relevant factors. While
as easily work against a manufacturer. In Delery v. Prudential
there is no guarantee, adhering to such a procedure should signifi-
Insurance Co. of America
, 643 So.2d 807 (La.App. 1994), the
cantly improve the chances of prevailing in subsequent litigation.
defendant placed an otherwise adequate warning label on the bot-tom side of a chair, reasoning that placement elsewhere would
ADEQUACY DECIDED AS A MATTER OF LAW
result in removal of the label. The plaintiff was then injured by
While adequacy of warning is typically a question for the trier of
the chair. While the trial court found the plaintiff partially liable,
fact, it is occasionally decided as a matter of law. One area where
the appeal court reversed, concluding that the location of the
adequacy is often summarily determined is where a specific fed-
warning label alone mandated a finding that it was inadequate.
eral statute defines the extent of a warning that must be provided.
While these cases show that, in some circumstances, a court
Where federal law is involved, the federal statute may preempt
will determine adequacy as a matter of law, it is evident that they
both state statutes and state common law actions.
do so only where the factors discussed above so clearly weigh in
For example, in Moe v. MTD Products, Inc.
, 73 F.3d 179 (8th
one direction or the other that a reasonable jury could not con-
Cir. 1995), the plaintiff alleged the defendant had failed to ad-
clude otherwise. As such, a manufacturer is encouraged to direct
equately warn users of the possible failure of the control cable for
its attention to the eight questions discussed above. By properly
the blade brake/clutch on a lawn mower. In this instance, the
addressing these issues, a potential defendant is in a much better
cable had frayed and the blade failed to stop as it was supposed
position to argue that its warnings are adequate as a matter of law
to. The defendant argued that its label satisfied the regulations
or at least reasonable in light of the facts.
promulgated by the Consumer Product Safety Commission(CPSC) in its “Safety Standard for Walk-Behind Power Lawn
Mowers.” 16 C.F.R., Part 1205. The enabling act of the CPSC
It is critical that a manufacturer develop adequate warning labels
to protect itself from product liability claims. Warning defect
Whenever a consumer product safety standard under this chapter
claims are often added as a matter of course to products liability
is in effect and applies to a risk of injury associated with a con-
complaints. With more manufacturers aware of the warning issue
sumer product, no State or political subdivision of a State shall
and thus providing more warnings, modern warning defect
have any authority either to establish or to continue in effect any
claims often allege inadequacy instead of failure to warn.
provision of a safety standard or regulation which prescribes anyrequirements as to the… labeling of such product which are de-
Unfortunately, adequacy of warnings is often overlooked dur-
signed to deal with the same risk of injury associated with such
ing warning label design. Then, the unfortunate manufacturer is
consumer product, unless such requirements are identical to the
left fighting to prove retrospectively that it took all reasonable
requirements of the Federal standard.
steps to ensure the allegedly defective label was adequate. It is
court then concluded, as a matter of law, that adherence
often too late at this point. By instituting a procedure that ana-
to the CPSC standard was all that the defendant was required to
lyzes the questions and factors listed herein, a manufacturer
prove. While other courts have found adherence to other federal
stands a substantially greater chance of prevailing during a sub-
statutes to also demonstrate sufficient proof of adequacy (see,
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