By Michael Hoenig - New York Law
Journal - December 8, 2014
A law review article by professors Aaron D. Twerski and James
A. Henderson Jr. is about to be published in the Indiana Law
Journal, and it merits serious attention by the bench and
litigation bar. Provocatively titled, "Fixing Failure to Warn,"
the noted authors once again reveal serious ills in the current
system of warnings litigation and provide a logical, simple
"fix" that is analogous to a widely accepted construct in
product design litigation.1 They suggest that, just
as a claimant alleging a defective product design must prove the
practicable feasibility of defendant incorporating a safer
"reasonable alternative design" (RAD), so too, a claimant urging
a product's inadequate warning should have to prove a safer
reasonable alternative warning (RAW).
These noted scholars—Twerski is a professor of Brooklyn Law
School and Henderson, is professor emeritus at Cornell Law
School—are no strangers to products liability law, and the legal
standards for gauging when designs or warnings are to be
considered "defective." Both were Reporters for the Restatement
of Torts, Third: Products Liability, the American Law
Institute's prestigious and oft-cited collection of black-letter
rules and commentary governing products liability. They also
authored the 1990 "Doctrinal Collapse" article about warnings in
the New York University Law Review which, 10 years later, was
cited as one of the 25 most influential articles published by
the NYU Law Review over the previous 75 years.2 There
the authors unmasked major shortcomings in how courts handled
warning litigation. Prior to surveying some highlights of
Twerski and Henderson's brand new proposal to "fix" the law of
warnings, let's review some of the major problems.
I previously referred to the failure to warn cause of action
as a "poor man's design claim."3 That reference has
nothing to do with the wealth or poverty of the lawyer asserting
it. Rather, it reflects a relatively inexpensive, albeit
circuitous and indirect, way of attacking a product's design.
The true design claim usually requires competent expert proofs
that a reasonable, practicable alternative design existed at the
time of manufacture or sale that would have prevented or
mitigated the harm. The warnings claim, on the other hand,
usually posits that some (or additional) verbiage, text, label,
sticker or symbol, if only given, would have obviated the
The superficial appeal of this simplistic notion is
devilishly beguiling. Indeed, some courts not only buy into it
but help it along with application of a "rebuttable" so-called
"heeding presumption," i.e., that, had the warning alleged been
given, the law presumes that the user would have heeded it and
thereby would have prevented the injury. Sometimes, this aid is
referred to as the "causation presumption." The "heeding
presumption," however, has been so thoroughly debunked and shown
to be so flawed,4 one wonders how some courts can
intellectually justify such a skewing of the law of warnings.
In any event, warnings litigation has perhaps graver ills
than occasional court allowance of the heeding presumption. One
is that the range of possible dangers to be warned against
attending product use is virtually limitless. The universe of
potential warnings one can conjure up is markedly open-ended.
One simply identifies a risk or danger that accompanies a
product's design, its packaging, its parameters of normal use
and all varieties of misuse and then alleges that the risk
selected should have been warned against.
And if a warning was issued, then one just needs to allege
that it could have been made better or safer. The print could
have been bolder or larger or more emphatic. Or the text might
have been more eye-catching if it had employed different colors
or used pictorial symbols. Or it could have been conveyed in the
language frequented in the community where the injury occurred,
and so on. In effect, says the willing warnings expert, show me
the accident and injury, and I will give you the warning or
admonition or modified warning that could have helped the
plaintiff in this mishap. All too often courts hold such
testimony to be enough—without demanding or injecting rigor into
the analysis and without subjecting the expert's opinion or
methodology to the kind of Daubert/Frye "reliability" probe
courts employ in design or manufacturing defect cases.
Another ill of open-ended warnings litigation is that
risk/utility balancing in warnings cases proceeds ineffectively.
As Henderson and Twerski in their "Doctrinal Collapse" article
noted, proliferative warnings about every conceivable risk, no
matter how remote, bombard consumers with "nearly useless
warnings about risks that rarely materialize in harm" and that
cause consumers "to give up on warnings altogether."
The courts' assumption that the risks and costs of additional
warnings are low is erroneous. Instead, "overwarning" causes
users "to discount or ignore warnings that should be heeded,
leading to higher accident costs that, although very real, are
not before the court in failure-to-warn litigation," the authors
wrote. Courts simply pile up warning after warning in case after
case without looking at the total picture of countervailing
Moreover, unlike design cases, warnings jurisprudence has no
"available body of hard science from which to draw the data
necessary to run sensible risk-utility analyses," Henderson and
Twerski wrote in their "Doctrinal Collapse" article. The
relevant sciences tend to be soft, undeveloped and largely
under-utilized. The problems involved are polycentric. Since the
capacity to give and receive warnings is limited, when those
limits are reached, new warnings inevitably "crowd out existing
But a court will usually not know when those limits will be
reached because it typically focuses on the precise case before
it and solely upon the additional verbiage plaintiff says should
have been used. Here the "lack of hard science and dependable
data comes back to haunt the courts with a vengeance," the
authors of "Doctrinal Collapse" wrote. These problems are
dramatically exacerbated by the "empty shell" that causation
analysis then becomes. The claimant offers little more than
self-serving testimony and anecdotal evidence to establish the
causation case. The incisiveness of the scientific evidence that
should be presented suffers. In light of available empirical
data, rank speculation thus abounds.5
In their 1990 "Doctrinal Collapse" article, the authors
further recounted what considerable empirical evidence shows:
(1) many people do not process information in a logical and
predictable manner; (2) both the type of information and manner
of presentation can have a substantial effect on
decision-making; (3) an individual's prior beliefs and
information significantly affect the impact of receiving
additional information; (4) the order in which information is
presented impacts upon an individual's perception of new data;
(5) suggested alternative or additional warnings cannot be
comprehended by the user all in one piece; they must be read
sequentially and digested piecemeal; (6) the hierarchy of
warnings is important: as one moves from more important warnings
to those of lesser urgency, the number of warnings that must be
supplied increases exponentially at each descending level; (7)
there are many variables attending how a hypothetical new
warning should have appeared and how the user would have reacted
to them; (8) physical causation problems may complicate the
process of determination.6
The foregoing complexities should invite rigorous and probing
court scrutiny under Daubert7 and Frye8
reliability standards as to whether an expert's opinion that
this verbiage or that text or the size and placement of some
proposed warning would have made a causal difference. I covered
that topic in some depth in a column years ago,9
citing, among others, impressive writings by warnings
specialist, William H. Hardie. Indeed, a federal court nearly
two decades ago correctly observed, "[I]n a warning case, a
plaintiff must do more than simply present an expert who
espouses a new or different warning. He must establish that
warning's feasibility, adequacy and effectiveness. In this case,
plaintiffs' experts' testimony fell woefully short of meeting
Shepherd v. Michelin Tire Corp.,11 an
experienced tire worker died from an accident that occurred when
he mounted and inflated a tire on a mismatched-size rim.
Plaintiff's expert, Dr. Kenneth Laughery, opined that the tire
did not have an adequate warning and that the accident would
have been averted with his alternative warning had it been
affixed to the tire. The district court held a Daubert hearing
and precluded the proposed testimony. The court observed that
warnings research generally concludes that warnings are not
particularly effective behavior modifiers. Moreover, males and
experienced persons are more likely to ignore warnings than
females or novices. The two persons injured in the Shepherd case
were experienced males. Further, Laughery conceded that
variables such as the cost of compliance, familiarity with the
product, hazard perception, ease of instructions, task load,
training and gender are all factors affecting a warning's
A warning overload devalues whatever warnings are on a dangerous
product. Laughery conceded that he conducted no field testing to
support his theoretical conclusions. He agreed that "no
empirical data…supports [his] opinion that any particular
sidewall warning will make tires safer because there's been no
testing, jurying, or test marketing of any particular sidewall
warnings." Bottom line, Laughery could not state with any degree
of certainty that his proposed warning system would probably
have prevented this accident. He could not even state that the
probability the accident would not have occurred was 50 percent
or more. "In other words, Laughery's testimony does not meet the
preponderance test on proximate causation, even if he were
allowed to testify."
Some more recent decisions also confirm that rigorous Daubert
reliability analysis should probe experts' warning opinions.12
Therefore, given the ubiquity of failure to adequately warn
claims, we should expect to see a rather robust body of
decisional law involving Daubert gatekeeping analyses of
proposed warnings, much as we do for designs in product design
cases. But we don't. Are courts letting warnings opinions too
easily slide past the admissibility gate? If so, why? Are
reliability challenges to warnings testimony too limp? Is
warnings law still in need of a "fix"?
Twerski and Henderson suggest in their new Indiana Law Journal
article, available as a forthcoming article on the Social
Science Research Network,13 that failure-to-warn
"remains a doctrine in distress." Part of the problem is that,
while design claims need proof of a "specifically-identified
reasonable alternative design (RAD)" available at the time of
marketing, many courts "impose no parallel burdens" on the
plaintiff in warning cases. The claimant in some jurisdictions
needs only assert "in conclusory fashion that the defendant's
warnings of nonobvious product-related risks were inadequate,
without specifying exactly what warning the defendant should
have given or proving that a different warning would have done
Their solution is that plaintiffs asserting warning claims
"should be required to specify, by suggesting a RAW [a
reasonable alternative warning], exactly how the
defendant…should have effectively communicated product-related
risks and to prove…how the RAW would have reduced or prevented
the plaintiff's harm." Part I of their new article establishes
the conceptual groundwork for this adjustment in perspective. It
explains how, notwithstanding interesting differences, design
and warning claims "share very similar foundations." In Part II,
the authors demonstrate that the failure to provide a RAW has
resulted in the imposition of liability without proof of
causation. Part III discusses cases that actually did require a
RAW. In Part IV, the noted scholars set forth their proposal for
the RAW "fix."
Thus, in a warning case plaintiff should be required "to spell
out the text, location, size and mode of warning (verbal or
pictorial)." Failure to provide the reasonable alternative
warning should allow the defendant to prevail on a motion for
summary judgment. Once the specific RAW is identified, defendant
may argue that the proposed warning would not have made a
difference and that plaintiff has not proven specific causation.
Or the defendant may argue that, if plaintiff's proposed RAW is
given for this particular scenario, then a multiplicity of
warnings of the same risk-level would have to be given as well
for other situations, creating sensory overload and rendering
the suggested RAW useless.
The authors' newly proposed "fix" can be viewed as part of a
continuum of their scholarly writings on warning law which I
have cited in endnote 4 of this column. The new proposal merits
serious reflection if not immediate adoption.
From the standpoint of practicalities of litigation, I would add
that mere assertion of a RAW is insufficient. It cannot be a
mere conclusory opinion exercise. The RAW must be adequately
proved and that means, in many cases, providing reliable expert
testimony that passes muster under Daubert's (or
Frye's) reliability criteria. Fortunately, the courts'
gatekeeping task and means to perform it are now very
well-defined. All that is necessary is that gatekeeping
challenges are properly and incisively joined in warning cases.
That will require reliable proof of a RAW.
1. Twerski and Henderson, "Fixing Failure to Warn," 90 Ind. L.
J. ___ (vol. 1 Fall 2014).
2. Henderson and Twerski, "Doctrinal Collapse in Products
Liability: The Empty Shell of Failure to Warn," 65 N.Y.U. L.
Rev. 265 (1990); See "Seventy-Fifth Anniversary Retrospective:
Most Influential Articles," 75 N.Y.U. L. Rev. 1517, 1558 (2000).
3. Hoenig, "The Ills of Open-Ended Warnings Litigation," New
York Law Journal, Feb. 14, 2011, p.3.
4. See James A. Henderson and Aaron D. Twerski, "Doctrinal
Collapse in Products Liability: The Empty Shell of Failure to
Warn," 65 N.Y.U. L. Rev. 265, 267, 289-310 (1990); Twerski and
Cohen, "Resolving the Dilemma of Nonjusticiable Causation in
Failure-to-Warn Litigation," 84 So. Cal. L. Rev. 125 (2011);
Hoenig, supra n. 3, NYLJ, Feb. 14, 2011, p. 3.
5. Henderson and Twerski, "Doctrinal Collapse," supra n. 2, 65
N.Y.U.L. Rev. at 298-310.
6. Id. at 307-309.
Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579
Frye v. United States, 293 F. 1013 (D.C. Cir. 1923).
9. Hoenig, "The Influence of 'Daubert' on Warnings," NYLJ, June
8, 1998, p. 3 (also available on Westlaw).
Meyerhoff v. Michelin Tire Corp., 852 F.Supp.
933, 947 (D. Kan. 1994), aff'd, 70 F.3d 1175 (10th Cir. 1995).
11. 6 F.Supp.2d 1307 (N.D. Ala. 1997) (appeal dismissed).
12. E.g., Roman v. Sprint Nextel Corp., 2014 U.S. Dist.
LEXIS 159707 (S.D.N.Y. Nov. 13, 2014) (burn on breast allegedly
caused by cellular phone; plaintiff challenged reliability of
defense expert's warnings opinion but court held the proposed
testimony admissible); Calisi v. Abbott Laboratories,
2013 U.S. Dist. LEXIS 139257 (D. Mass. Sept. 27, 2013)
(plaintiff's expert precluded from opining that drug's labels
"failed to provide adequate information to doctors" and that his
proposed alternative label would do so); Moore v.
P&G-Clairol, 781 F.Supp.2d 694 (N.D. Ill. 2011) (allergic
reaction to Clairol hair dye; plaintiff's expert opined that
allergy test instructions were vague and imprecise; opinions
regarding warnings precluded as unreliable).
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