John Giordano v. Market America, Inc. and The Chemins Company, Inc.
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This opinion is uncorrected and subject to revision before
publication in the New York Reports.
----------------------------------------------------------------No. 180
John Giordano,
Appellant,
v.
Market America, Inc. and The
Chemins Company, Inc.,
Respondents.
Brian J. Isaac, for appellant.
Andrew J. Zajac, for respondent Market America, Inc.
Edward J. Stolarski, Jr., for respondent The Chemins
Company.
SMITH, J.:
The United States Court of Appeals for the Second
Circuit has asked us three questions about the interpretation of
CPLR 214-c (4), which extends the statute of limitations for
certain tort victims who do not, for some time, know the cause of
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No. 180
We answer the questions by holding that:
(1) the provisions of CPLR 214-c (4) are limited to actions
for injuries caused by the latent effects of exposure to a
substance;
(2) an injury that occurs within hours of exposure to a
substance can be considered "latent" for these purposes; and
(3) "technical, scientific or medical knowledge and
information sufficient to ascertain the cause of [the
plaintiff's] injury" is "discovered, identified or determined"
within the meaning of the statute when the existence of the
causal relationship is generally accepted within the relevant
technical, scientific or medical community.
I
Plaintiff suffered a series of strokes in March of
1999.
The strokes were caused, we assume for present purposes,
by ephedra, a substance contained in a dietary supplement that
plaintiff had been using for about two years.
Ephedra causes in
some users a short-term elevation in blood pressure, heart rate
or both, and a temporary constriction of certain blood vessels.
This effect, which increases the risk of stroke, typically occurs
within a few hours after ephedra is consumed.
Neither plaintiff nor the doctors who treated him for
his strokes knew at the time that ephedra was to blame.
When
they could, or reasonably should, have known of the causal
connection is disputed.
The United States District Court for the
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No. 180
Southern District of New York has found that studies published as
early as 1996 suggested a link between ephedra and stroke, but
that as late as 2005 scientific evidence did not establish the
link "with any degree of medical or scientific 'certainty'" (In
re Ephedra Prods. Liab. Litig., 598 F Supp 2d 535, 536 [SD NY
2009]).
Plaintiff claims that he became aware of a possible
link between ephedra and stroke in February 2003, when news
reports suggested that the sudden death of a major league
baseball player might have been caused by ephedra.
On July 28,
2003 -- about four years, four months after his strokes -plaintiff sued the distributor of the product he had taken in New
York State Supreme Court.
The case was removed to federal court,
the manufacturer of the product was added as a defendant, and the
case was consolidated with other ephedra-related litigation in
the Southern District of New York.
Defendants moved to dismiss the case as barred by the
statute of limitations, relying on CPLR 214 (5), which imposes a
three-year limitation period, with certain exceptions, on "an
action to recover damages for a personal injury."
It is
undisputed that the claim is barred by CPLR 214 (5) unless it is
saved by the exception in CPLR 214-c (4), which we quote in the
next section of this opinion.
Defendants' statute of limitations motion generated a
series of opinions in the District Court and the Second Circuit.
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No. 180
Initially, the District Court granted the motion to dismiss (In
re Ephedra Prods., 2006 WL 944705, 2006 US Dist LEXIS 18691 [SD
NY 2006]).
Plaintiff appealed to the Second Circuit, which
remanded the case for determination of an issue the District
Court had not reached (Giordano v Market America, Inc., 289 Fed
Appx 467 [2d Cir 2008]).
Following the District Court's ruling
on that issue (In re Ephedra Prods. Liab. Litig., 598 F Supp 2d
535 [SD NY 2009]), the Second Circuit certified to us the three
questions that we now address (Giordano v Market America, Inc.,
599 F3d 87 [2d Cir 2010]).
II
Directly in issue here is subdivision four of CPLR 214c, which refers to subdivisions two and three of the same
section.
The text of the three relevant subdivisions is:
"2. Notwithstanding the provisions of
section 214, the three year period within
which an action to recover damages for
personal injury or injury to property caused
by the latent effects of exposure to any
substance or combination of substances, in
any form, upon or within the body or upon or
within property must be commenced shall be
computed from the date of discovery of the
injury by the plaintiff or from the date when
through the exercise of reasonable diligence
such injury should have been discovered by
the plaintiff, whichever is earlier.
"3. For the purposes of sections fifty-e and
fifty-i of the general municipal law, section
thirty-eight hundred thirteen of the
education law and the provisions of any
general, special or local law or charter
requiring as a condition precedent to
commencement of an action or special
proceeding that a notice of claim be filed or
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No. 180
presented within a specified period of time
after the claim or action accrued, a claim or
action for personal injury or injury to
property caused by the latent effects of
exposure to any substance or combination of
substances, in any form, upon or within the
body or upon or within property shall be
deemed to have accrued on the date of
discovery of the injury by the plaintiff or
on the date when through the exercise of
reasonable diligence the injury should have
been discovered, whichever is earlier.
"4. Notwithstanding the provisions of
subdivisions two and three of this section,
where the discovery of the cause of the
injury is alleged to have occurred less than
five years after discovery of the injury or
when with reasonable diligence such injury
should have been discovered, whichever is
earlier, an action may be commenced or a
claim filed within one year of such discovery
of the cause of the injury; provided,
however, if any such action is commenced or
claim filed after the period in which it
would otherwise have been authorized pursuant
to subdivision two or three of this section
the plaintiff or claimant shall be required
to allege and prove that technical,
scientific or medical knowledge and
information sufficient to ascertain the cause
of his injury had not been discovered,
identified or determined prior to the
expiration of the period within which the
action or claim would have been authorized
and that he has otherwise satisfied the
requirements of subdivisions two and three of
this section."
The three questions that the Second Circuit has asked
us are:
"1. Are the provisions of N.Y. C.P.L.R. §
214-c (4) providing for an extension of the
statute of limitations in certain
circumstances limited to actions for injuries
caused by the latent effects of exposure to a
substance?
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No. 180
"2. Can an injury that occurs within 24 to
48 hours of exposure to a substance be
considered 'latent' for these purposes?
"3. What standards should be applied to
determine whether a genuine issue of material
fact exists for resolution by a trier of fact
as to whether 'technical, scientific or
medical knowledge and information sufficient
to ascertain the cause of [the plaintiff's]
injury' was 'discovered, identified or
determined' for N.Y. C.P.L.R. § 214-c (4)
purposes?"
We answer yes to both of the first two questions; thus,
our answers are favorable to defendants on question one but to
plaintiff on question two.
We answer question three by saying,
as we explain more fully below, that the test is one of general
acceptance in the relevant technical, scientific or medical
community.
Question One: Is the statute limited to injuries caused by latent
effects?
CPLR 214-c (2), providing a statute of limitations that
runs "from the date of discovery of the injury . . . or from the
date when . . . such injury should have been discovered," is
expressly restricted to cases of injury "caused by the latent
effects of exposure to any substance or combination of
substances."
CPLR 214-c (3), relating to notice of claim
requirements, contains an identical restriction.
The Second
Circuit's first question is, in essence, whether the same
restriction is incorporated into CPLR 214-c (4), governing cases
in which "discovery of the cause of the injury" was allegedly
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No. 180
We conclude that it is.
CPLR 214-c (4) mentions "subdivisions two and three of
this section" three times.
The third mention, we conclude,
answers the Second Circuit's question: "The plaintiff or claimant
shall be required to allege and prove . . . that he has otherwise
satisfied the requirements of subdivisions two and three of this
section."
Since subdivisions two and three require that the
claim or action be one for injury "caused by the latent effects"
of exposure, subdivision four, on its face, also imposes a
latency requirement.
Even if subdivision four could be read otherwise -- if
it could be read as creating an independent exception to the
general three-year statute of limitations, not one dependent on
the provisions of subdivisions two and three -- such a reading
would be inconsistent with the statute's history and purpose.
CPLR 214-c was enacted in 1986 to give relief to plaintiffs in
certain toxic tort cases.
Its legislative history, which we
discussed in Matter of New York County DES Litig. (89 NY2d 506,
513-514 [1997]), shows that it was intended to overrule decisions
in which we had held that toxic tort claims accrued upon
exposure, even though the illness resulting from that exposure
might be long delayed (see e.g., Fleishman v Lilly & Co., 62 NY2d
888 [1984]; Schwartz v Heyden Newport Chem. Corp., 12 NY2d 212
[1963]).
The Legislature's concern when it enacted the statute
was the problems raised by toxic tort cases in which the latency
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No. 180
of a substance's effect could prevent the plaintiff from bringing
a timely lawsuit.
Plaintiff stresses that the word "latent" does not
appear in CPLR 214-c (4).
Indeed, the words "exposure to any
substance" do not appear there either.
But the whole point of
CPLR 214-c was to deal with substance exposure cases.
No other
kind of case is discussed in the legislative history, and the
Governor, when he signed the bill, identified it as the "Toxic
Tort Bill" (see Public Papers of Governor Cuomo, "Governor
Approves Toxic Tort Bill" [July 30, 1986]).
It can hardly be
argued, and plaintiff does not argue, that CPLR 214-c (4) extends
beyond substance exposure cases -- that for example, it would
benefit a plaintiff injured by a hit and run driver or an
unidentified falling object.
It is thus undisputed that the
words "exposure to any substance" in subdivisions two and three
are incorporated into subdivision four of CPLR 214-c.
We see no
possible reading of the statute under which those words are
incorporated but the word "latent" is not.
Question Two: Can an effect that appears within a matter of hours
be considered "latent"?
While we think it clear that CPLR 214-c (4) is limited
to injuries from "latent effects," whether effects that are
concealed only briefly count as "latent" is a harder question.
The Second Circuit's question to us implies that the harmful
effects of ephedra show themselves within "24 to 48 hours of
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- 9 exposure."
No. 180
Opinions of the District Court suggest that the time
may be even shorter -- a matter of a "few hours" (In re Ephedra
Prods. Liab. Litig., 393 F Supp 2d 181, 193 [SD NY 2005]; see
also In re Ephedra Prods., 2006 WL 944705, *1, 2006 US Dist LEXIS
18691, *3).
This discrepancy need not concern us, because we
conclude that even effects concealed for a few hours may be
"latent" within the meaning of the statute.
The dictionary definition of "latent" is "not now
visible, obvious, active, or symptomatic" (Merriam-Webster's
Collegiate Dictionary 702 [11th ed 2003]).
Using that word to
describe a condition that exists only for hours puts no strain on
its literal meaning.
But in interpreting this statute, it might
intuitively seem that so brief a period of latency should be
disregarded as insignificant -- that, as the District Court put
it in its opinion granting defendants' motion to dismiss, to
treat the stroke-causing effects of ephedra as latent "would
effectively eliminate the statute's limitation to 'latent
effects'" (In re Ephedra Prods., 2006 WL 944705, *1, 2006 US Dist
LEXIS 18691, *4).
In fact, however, even a brief period of
latency can be important when the problem is one of determining
an injury's cause -- the problem with which CPLR 214-c (4) is
concerned.
Perhaps the task, often confronted by doctors or
scientists, of finding a causal connection between exposure to a
toxic substance and an injury is never an easy one.
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It is
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No. 180
certainly less difficult, however, when the effect of the toxic
substance can be seen immediately -- when, for example, someone
breaks out in a rash as soon as his skin touches a suspected
toxin.
Or, to suggest an example closer to this case, if
plaintiff had suffered symptoms of a stroke at once upon
swallowing a pill containing ephedra, his chances and those of
his doctors of inferring the causal link would have been
immeasurably better.
Indeed, if that had occurred, it seems
highly likely that plaintiff could have discovered the cause of
his injury within the normal three-year limitation period.
But
because his symptoms showed themselves hours later, it may have
been very hard to say whether ephedra and the strokes were
causally connected.
Thus cases where a toxin's effects are latent for hours
are much more likely than those in which there is no latency
period to present the problem addressed by CPLR 214-c (4): a
difficulty in promptly learning the cause of an injury.
It is
entirely plausible that several hours' delay in the manifestation
of symptoms could lead to a delay of years in detecting an
injury's cause.
It thus seems reasonable that the authors of
CPLR 214-c (4) would have considered even a few hours of latency
enough to justify the extension of the statute of limitations
authorized by that subdivision.
Defendants, and our dissenting colleagues, argue
otherwise, contending that, as we said in New York County DES,
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No. 180
CPLR 214-c shows that the Legislature
that enacted it was concerned with long-term latency -- with
plaintiffs who were unaware that they had been injured "until
after the limitations period had expired" (89 NY2d at 514;
internal quotation omitted).
There is no doubt that the problem
of injuries that go undiscovered for years was the Legislature's
primary concern.
But that was not its sole concern, for if it
was there was no need to enact subdivision four of CPLR 214-c at
all.
That subdivision benefits only those plaintiffs and
claimants who, having already discovered they were injured, have
not discovered "the cause of the injury."
A few hours of latency
might well cause a plaintiff to be in such a predicament -- as
plaintiff here says he was.
Defendants, and the dissenters, argue in substance that
the benefits of CPLR 214-c (4) should be afforded only to those
plaintiffs and claimants who also benefit from CPLR 214-c (2) or
CPLR 214-c (3) -- i.e., those who cannot discover their injury
within the limitations period.
But the statute does not say
that, and we see no reason to read it in that way.
Defendants'
and the dissent's reading would produce anomalous results.
Those
who benefit from subdivisions two and three may bring suits or
make claims many years, even decades, after their exposure to a
substance.
For such plaintiffs and claimants, it is undisputed,
the already-long delay can be extended by subdivision four for up
to another six years (five years from the discovery of the injury
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No. 180
to the discovery of its cause, plus another year to sue or file a
claim).
But defendants and the dissenters would deny the benefit
of subdivision four to plaintiffs, like the present one, whose
injuries are discovered within hours of exposure -- even though
subdivision four would effectively require those plaintiffs to
sue no more than six years after that exposure.
In other words, for plaintiffs like the present one,
subdivision four would replace the three-year tort statute of
limitations with at most a six-year statute -- an extension less
generous to plaintiffs, and risking less hardship to defendants,
than the indefinite extensions that can result from long-term
latency.
Defendants and the dissent would have us read the
statute to countenance extremely old claims, but to bar
relatively fresh ones.
We reject that reading.
Question 3: What standards apply to the issue of when sufficient
information "to ascertain the cause" of an injury has been
"discovered, identified or determined"?
The Second Circuit's third question arises from CPLR
214-c (4)'s requirement that plaintiff "allege and prove that
technical, scientific or medical knowledge and information
sufficient to ascertain the cause of his injury had not been
discovered, identified or determined" before the expiration of
the otherwise-applicable limitation period.
That question calls
on us to resolve two possible ambiguities noted by both the
District Court and the Second Circuit: Is it the plaintiff and
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No. 180
his lawyers or the technical, scientific or medical community
that must be able to "ascertain the cause of his injury"?
what level of certainty is implied by the word "ascertain"?
And
Both
aspects of this question have been previously addressed by New
York courts.
As to the first of them, we said in New York County
DES:
"It is apparent from the over-all statutory
plan . . . that only the technical knowledge
of the scientific and medical communities
[was] to be considered in determining whether
the injured's delay following the discovery
of injury should be excused."
(89 NY2d at 515).
We now reaffirm that the statute refers to the
time when information is sufficient for the technical, medical or
scientific community "to ascertain" the cause of an injury.
It
is not reasonable to extend the statute of limitations until the
time when a reasonable lay person or lawyer could "ascertain" the
cause without consulting an expert -- in many cases, that time
might never come.
Plaintiff suggests that the statute of
limitations in his case did not begin to run until the relevant
scientific findings were publicized in the non-expert community,
but the statute's language does not create a "publicity" test.
We see no unfairness in requiring that injured people who want to
protect their rights seek out expert advice, rather than waiting
for the media to bring a possible cause of the injury to their
attention.
The other aspect of the Second Circuit's third question
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No. 180
-- the issue of what level of certainty "to ascertain" implies -is not one we have previously discussed.
We generally agree,
however, with the Appellate Division's comments on that issue in
Pompa v Burroughs Wellcome Co. (259 AD2d 18 [3d Dept 1999]).
The
statute
"does not require medical certainty or
information sufficient to prevail at trial,
but does entail showing that sufficient
information and knowledge existed to enable
the medical or scientific community to
ascertain the probable causal relationship
between the substance and plaintiff's injury"
(id. at 24).
Making the Appellate Division's "probable causal
relationship" test a bit more specific, we hold that the test is
one of general acceptance of that relationship in the relevant
technical, scientific or medical community.
familiar to New York lawyers and judges.
That test is
Our courts follow Frye
v United States (293 Fed 1013 [DC Cir 1923]) in making "general
acceptance" the test for admitting expert testimony about
scientific principles or discoveries (see People v LeGrand, 8
NY3d 449, 457 [2007]; People v Wesley, 83 NY2d 417, 422 [1994]).
Thus, under our holding today a causal relationship will be
sufficiently ascertained for CPLR 214-c (4) purposes at, but not
before, the point at which expert testimony to the existence of
the relationship would be admissible in New York courts.
The above, we believe, answers the Second Circuit's
third question: "What standards should be applied?"
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We have not
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No. 180
been asked to, and do not, apply those standards to the facts of
this case.
The federal courts dealing with this and related
cases are more familiar than we with the science relating to the
effects of ephedra, and are thus better able to perform that
task.
Accordingly, the first and second questions should be
answered in the affirmative, and the third question should be
answered in accordance with this opinion.
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Giordano v Market America
No. 180
READ, J. (DISSENTING):
The majority opines that "effects [of an exposure to
substances] concealed for a few hours may be 'latent'" for
purposes of CPLR 214-c because "even a brief period of latency
can be important when the problem is one of determining an
injury's cause" (majority opn at 9).
In effect, the majority
defines effects as "latent" so long as symptoms do not appear "as
soon as [someone's] skin touches a suspected toxin" or "at once
upon swallowing a pill" (id. at 10).
And whatever "as soon as"
and "at once" may mean, it would seem to be something less than
the 24 to 48 hours referred to in the second certified question.
This approach finds no support in the statutory text or
legislative history, which uniformly demonstrate that section
214-c was intended to relieve the plight of plaintiffs who became
sick long after their initial exposure to a toxic substance,
which is when their causes of action would otherwise accrue.
I.
A latent disease is generally understood to be an
illness that does not manifest clinically diagnosable symptoms
until years after initial exposure to the disease-causing agent
(see e.g. David Schottenfeld and Joanna F. Haas, "Carcinogens in
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No. 180
the Workplace," in Cancer Causing Chemicals, at 23 [Newton I. Sax
ed. 1981]).
And as we have recounted numerous times, the
Legislature enacted CPLR 214-c to "overcome the effect of a line
of Court of Appeals decisions" beginning with Schmidt v Merchants
Despatch Transp. Co. (270 NY 287 [1936]), which held that the
claims of plaintiffs suffering from latent diseases "accrue[d]
upon 'impact' or exposure even though the resulting illness
[might not have been] manifested for a long time thereafter"
(Matter of New York County DES Litig. [Wetherill v Eli Lilly &
Co.], 89 NY2d 506, 513 [1997] [emphasis added]; see also Snyder v
Town Insulation, 81 NY2d 429, 433 [1993] [noting that Schmidt and
its progeny addressed the "question of how accrual should be
determined when an injury was latent and went undiscovered until
long after exposure" [emphasis added]; Consorti v Owens-Corning
Fiberglass Corp., 86 NY2d 449, 454 [1995] [reviewing history of
Court's adherence to "the Schmidt rule fixing the occurrence of
tortious injury as the date when the toxic substance invades or
is introduced into the body"] [emphasis added]).
As a result of
the Schmidt rule, the three-year statute of limitations in CPLR
214 (5) lapsed before these plaintiffs even became aware they
were sick.
To remedy this injustice, the Legislature adopted CPLR
214-c, which replaced the Schmidt rule in such cases with a rule
of accrual keyed to "the discovery of the manifestations or
symptoms of the latent disease that the harmful substance
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- 3 produced" (Wetherill, 89 NY2d at 514).
No. 180
Section 214-c, adopted as
a part of a larger tort reform package (L 1986 ch 682), reflected
numerous compromises.
In particular, the bills passed by the
Assembly in the run-up to the Legislature's adoption of CPLR 214c invariably provided for accrual not only upon discovery of the
injury, but also upon discovery of the injury's cause.
For
example, in 1984 the Assembly passed Assembly Bill A. 3547-A,
which called for commencement of an action for personal injuries
attributable to the latent effects of exposure to a substance
"within two years of the date of discovery of the illness or
injury, or the date of death, or the discovery of the cause of
such injury, illness or death, whichever is later" (emphases
added).
By contrast, the Senate majority's versions of a time-
of-discovery rule did not require discovery of causation before
the statute of limitations would begin to run (see generally
Steven L. White, Note, "Toward a Time-of Discovery Rule for the
Statute of Limitations in Latent Injury Cases in New York State,"
13 Fordham Urb L J 113, 154-160 [1984-1985]).
The Legislature ultimately compromised on this issue
and adopted related time-of-discovery provisions for actions
brought by plaintiffs to recover for latent injuries, CPLR 214-c
(2) and CPLR 214-c (4).
CPLR 214-c (2) enacts a three-year
statute of limitations commencing upon a plaintiff's discovery
(actual or constructive) of latent injuries from exposure to a
substance.
This provision assumes that the plaintiff knows the
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No. 180
cause of the injuries at the time they are discovered -- i.e.,
become manifest (see generally Wetherill, 89 NY2d at 513 ["That
CPLR 214-c (2)'s reference to 'discovery of the injury' was
intended to mean discovery of the condition on which the claim
was based and nothing more is . . . apparent from the legislative
history of the provision"]).
Section 214-c (4), which "has to be read in conjunction
with subdivision 2" (McLaughlin, Practice Commentaries,
McKinney's Cons Laws of NY, Book 7B, CPLR 214-c, 1990 Supp Pamph
at 340; see also Siegel, NYS Law Digest, No. 321, Sept. 1986, at
1), specifies that if the cause of the injury is discovered less
than five years after the injury is suffered, the plaintiff may
commence an action within one year after identifying the cause.
In order to take advantage of section 214-c (4), however, the
plaintiff must show that there was insufficient medical or
scientific information available to make out the injury's cause
within the three-year period otherwise prescribed in CPLR 214-c
(2) (see id. [commenting that "[t]he issues of causation and
knowledge on which this alternative time measure depends will
often generate heavy fact disputes . . . likely to be intertwined
with the merits"]).
The majority acknowledges that "[t]here is no doubt
that the problem of injuries that go undiscovered for years was
the Legislature's primary concern," but then adds that this was
not the Legislature's
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No. 180
"sole concern, for if it was there was no need to enact
subdivision four of CPLR 214-c at all. That
subdivision benefits only those plaintiffs . . . who,
having already discovered they were injured, have not
discovered 'the cause of the injury.' A few hours of
latency might well cause a plaintiff to be in such a
predicament . . . " (majority opn at 11).
As Judge McLaughlin (coincidentally a member of the
Second Circuit panel in this case) observed, "[i]t need not be
said that [CPLR 214-c (4)] is a complicated statute," which
"reeks of the midnight oil of political compromise.
And the
draftsmanship cannot be described as commendable" (McLaughlin,
Practice Commentaries, McKinney's Cons Laws of NY, Book 7B, CPLR
214-c, 1990 Supp Pamph at 340).
There is no suggestion in the
statutory text or the legislative history or the contemporary
commentary, however, that the Legislature adopted section 214-c
(4) to address any effects of exposure to substances so long as
the cause was difficult to figure out when the injuries became
manifest, as the majority concludes.
Rather, the Legislature was
concerned only with the latent effects of exposure -- i.e.,
latent diseases triggered by (but manifest well after) an initial
(and sometimes prolonged) exposure to a toxic substance.
Sections 214-c (2) and 214-c (4) simply represent the compromise
struck by the Assembly and the Senate to reconcile their
differing time-of-discovery rules for latent diseases, previously
discussed.
The majority further speculates that "it seems
reasonable that the authors of CPLR 214-c (4) would have
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No. 180
considered even a few hours of latency enough to justify the
extension of the statute of limitations authorized by that
subdivision" (majority opn at 10).
If this was part of the
authors' design, they kept it well hidden.
The statute's
legislative history evidences only a desire to enact a time-ofdiscovery rule for plaintiffs afflicted with latent diseases,
such as workers exposed to asbestos or the adult daughters of
mothers who ingested DES during pregnancy, not a free-floating
intention to alter the accrual rule in every case where a
disease's etiology is difficult to divine.
II.
In this case, the scientific evidence does not provide
a sound basis for a jury to conclude that plaintiff's strokes
were a latent effect of his exposure to dietary supplements
containing ephedra.
At least, this is what I glean from the
District Court's opinion addressing general causation (see In re
Ephedra Products Liability Litigation, 393 F Supp 2d 181 [SDNY
2005]), handed down in the consolidated ephedra litigation, and
the same Judge's later decision concluding that this plaintiff's
lawsuit was time-barred.
Ephedra is a plant that contains several chemically
related biologically active substances known as ephedrine
alkaloids.
The ephedra products at issue in the consolidated
litigation combined ephedra with caffeine, and were marketed to
consumers seeking weight loss, increased energy and improved
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- 7 athletic performance (id. at 186).
No. 180
The District Court Judge
conducted a Daubert hearing to assess, as particularly relevant
here, whether evidence might be introduced at trial that dietary
supplements containing ephedra/ephedrine cause strokes.
After a two-week evidentiary hearing at which various
scientists testified as generic experts for plaintiffs and the
defense, the District Court Judge concluded that none of
plaintiff's experts would be permitted to testify "within a
reasonable degree of scientific certainty" that ephedra causes
strokes.
He did, however, also rule that some of plaintiff's
experts would be permitted to testify (based on such things as
animal studies, analogous human studies, and plausible theories
of the biological mechanisms involved) that there was a reliable
basis to believe that ephedra might be a contributing cause of
strokes in people with, for example, high blood pressure or a
genetic sensitivity to ephedra -- provided that such experts
qualified their testimony with the acknowledgment that none of
this had been the subject of a definitive study and might in the
future be disproved (id. at 186-187).
The biologically plausible theory about how ephedra
might cause injury -- one of the factors that persuaded the
District Court Judge to allow some of plaintiffs' generic experts
to offer an opinion that ephedra might be a contributing cause of
strokes in susceptible individuals -- was that ephedra was known
to "stimulate cardiovascular activity and constrict blood
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No. 180
vessels, thereby increasing stress on the heart and circulatory
system" (id. at 194; see also id. at 192 [discussing hypothesis
that heart attacks, strokes or sudden death might be triggered by
the coincidence of peak events, such as transient peak blood
pressure due to other causes, occurring at the same time as peak
ephedrine blood level]).
The Judge also noted that ephedra is
short-acting (id. at 193).
The District Court Judge subsequently dismissed
plaintiff's complaint as time-barred under CPLR 214-c.
He
specifically commented that
"evidence admitted during the Court's extensive Daubert
hearings showed that ephedra acts within a few hours to
cause a transitory elevation of blood pressure and
heart rate and a temporary constriction of blood
vessels. Experts designated by [plaintiffs] have
submitted reports stating that these immediate effects
of ephedra may likely be a contributing cause of stroke
in some people" (emphases added).
He then cited a decision by the Second Circuit holding that an
injury manifest "within a few weeks" after exposure to a toxic
substance was latent and therefore governed by section 214-c.
The Judge observed, however, that "[b]y contrast" with this
decision, "researchers in a study of ephedra and stroke . . . did
not consider stroke patients to have been relevantly exposed . .
. unless they used [ephedra] within three days before their
stroke"; and that "indeed, because of ephedra's short-acting
properties, the researchers studied strokes that occurred within
24 hours after using ephedra."
He therefore concluded that "[t]o
hold § 214-c applicable to a stroke allegedly caused by ephedra
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No. 180
would effectively eliminate the statute's limitation to 'latent
effects.'"
In other words, based upon scientific evidence adduced
at the Daubert hearing and credited by the District Court Judge,
he concluded that any stroke attributable to ephedra would have
been caused by an exposure occurring shortly (24 hours to three
days) beforehand.
This is because ephedra is short-acting and
its effects transitory, not permanent; therefore, it is not
biologically plausible for plaintiff's strokes to have been
caused by his initial exposure to ephedra, or the cumulative
effect of his exposures over time.
As a result, plaintiff's
strokes were not a latent disease within the meaning of section
214-c (4).
Plaintiff's attorney argues in his reply brief that
"assuming latency is a requirement for applying [CPLR 214-c (4)],
same is present because the stroke resulted from ingestion of the
product over time"; and that "plaintiff did become ill after
using Ephedra based products for two years."*
In other words, he
proposes that it was, in fact, plaintiff's initial and repeated
exposures to ephedra over a two-year period which rendered him
*
Plaintiff's attorney does not indicate how frequently
plaintiff may have ingested ephedra over a two-year period. The
District Court Judge noted that the label on one of the ephedra
products did not state any maximum period for continuing the
daily "suggested use" of up to 96 mg, while a competing product
recommended a maximum daily dosage for a healthy adult of no more
than 100 mg in a 24-hour period for not more than 12 weeks (393 F
Supp 2d at 194 n 10).
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No. 180
susceptible to a stroke by effecting permanent physiological
change, presumably by creating a condition of permanently
elevated blood pressure.
I simply do not think the District
Court Judge accepted as reasonably based on good science the
notion that ephedra might act on the human body to cause a stroke
in this manner (see e.g. 393 F Supp 2d at 194 [noting three
points on which the scientific evidence is "sparse and
inconclusive"]).
If I am wrong about that, I would agree with
plaintiff that section 214-c (4) governs the timeliness of his
cause of action, and that this would be the case whether he
suffered a stroke 24 hours or 24 years after he last ingested
ephedra.
III.
The majority's interpretation of section 214-c (4) -divorcing it from whether the exposure to a substance may have
caused a latent disease and focusing solely on the lapse of time
from last exposure to manifestation of illness -- creates a
number of practical problems.
The Second Circuit asked if
injuries occurring within 24 to 48 hours after exposure to a
substance were "latent" within the meaning of section 214-c.
In
response, the majority holds that "an injury that occurs within
hours of exposure to a substance can be considered 'latent' for
these purposes" (majority opn at 2 [emphasis added]).
Is "within
hours" the same as 24 to 48 hours, or is it a shorter period of
time?
What about 12 hours?
eight hours?
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Presumably, "within
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No. 180
hours" must mean at least two hours, or does it?
Is this purely
a legal judgment, or is scientific evidence relevant?
When an
effect occurs "within hours" of exposure to a substance, does it
matter whether a scientist would consider such an effect to be
latent?
The majority acknowledges that a disease is not latent
if symptoms appear "as soon as" or "at once" upon exposure.
Indeed, the majority almost has to make this concession or it
would be even more obvious than it already is that section 214-c
(4) now covers lawsuits relating to the "effects" -- not just the
"latent" effects -- of exposure to a substance, despite the
majority's answer to the first certified question.
"as soon as" or "at once" mean in this context?
But what do
Most substances
that are ingested, for example, are not instantaneously absorbed.
Does whether an injury is latent depend upon scientific evidence
about how quickly a substance is taken up in the body or reaches
a certain concentration in the blood?
It is difficult to predict the practical effects of the
majority opinion.
Certainly we now have a six-year statute of
limitations in New York, running from the date an injury becomes
manifest, for every purported side effect of a drug or other
substance that may be ingested, subject to the restrictions in
section 214-c (4) -- the five-year and one-year limits and the
necessity for proof about the state of medical or scientific
evidence at the relevant time.
Because there is no reason to
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No. 180
believe that the Legislature had any such result in mind when it
enacted CPLR 214-c (4), I respectfully dissent.
*
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Following certification of questions by the United States Court
of Appeals for the Second Circuit and acceptance of the questions
by this Court pursuant to section 500.27 of the Rules of Practice
of the New York State Court of Appeals, and after hearing
argument by counsel for the parties and consideration of the
briefs and the record submitted, certified questions answered in
accordance with the opinion herein. Opinion by Judge Smith.
Chief Judge Lippman and Judges Ciparick and Jones concur.
Judge Read dissents in an opinion in which Judges Graffeo and
Pigott concur.
Decided November 18, 2010
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