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[DO NOT PUBLISH]
In the
United States Court of Appeals
For the Eleventh Circuit
____________________
No. 19-14831
____________________
MAGALY PINARES,
Plaintiff,
MARCOS PINARES,
Plaintiff-Appellant,
RICHARD COTROMANO, et al.,
Consol Plaintiffs,
versus
RAYTHEON TECHNOLOGIES CORPORATION,
d.b.a. Pratt & Whitney,
Defendant-Appellee.
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2 Opinion of the Court 19-14831
____________________
Appeal from the United States District Court
for the Southern District of Florida
D.C. Docket No. 9:10-cv-80883-KAM
____________________
Before ROSENBAUM and LUCK, Circuit Judges. *
LUCK, Circuit Judge:
Magaly and Marcos Pinares appeal the district court’s order
granting summary judgment in favor of Raytheon Technologies
Corporation.1 In this toxic tort case, the Pinareses alleged a Ray-
theon facility had leaked chemicals that poisoned their water and
ultimately gave Mrs. Pinares kidney cancer. To prove their claims,
they offered expert witness testimony connecting Mrs. Pinares’s
cancer to chemicals from the facility. But the district court ex-
cluded those experts’ opinions and entered summary judgment for
Raytheon. After careful consideration and with the benefit of oral
argument, we affirm.
*
This opinion is being entered by a quorum pursuant to
28 U.S.C. § 46(d).
1
United Technologies Corporation, which owned the facility during the
events at issue, merged with Raytheon during this appeal. For simplicity’s
sake, we refer only to Raytheon.
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19-14831 Opinion of the Court 3
FACTUAL BACKGROUND AND PROCEDURAL HISTORY
Raytheon operates a facility in Palm Beach County, Florida,
where jet engines have been tested and manufactured since the fa-
cility opened in 1958. The Pinareses lived in The Acreage, a neigh-
borhood about eight miles from the facility. In 2006, Mrs. Pinares
was diagnosed with renal cell carcinoma—a form of kidney cancer.
Two other residents of The Acreage were diagnosed with kidney
cancer around the same time.
In November 2008, “the Environmental Protection Agency
found 24 contaminants in the soil and water on [Raytheon’s] prop-
erty.” Adinolfe v. United Techs. Corp.,
768 F.3d 1161, 1169 (11th
Cir. 2014). Raytheon’s own testing “confirmed” that contaminants
were “present in high concentration[s] in the groundwater under
and around its property.”
Id. In 2009, the Florida Department of
Health concluded that The Acreage residents experienced in-
creased rates of brain cancer from 1995 to 2007 and particularly
from 2005 through 2007.
The Pinareses tested a well on their property and found
three chemical compounds in their water: bromodichloro-
methane, chloroform, and methylene chloride. The federal gov-
ernment classifies each of these compounds as “[r]easonably
[a]nticipated to be a [h]uman [c]arcinogen.”
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The Pinareses sued Raytheon in 2010. 2 Their fifth amended
complaint alleged common-law strict liability, statutory strict lia-
bility, negligence, and loss of consortium. They alleged that chem-
icals from Raytheon’s facility contaminated the aquifer and trav-
eled through the aquifer to their property. The Pinareses alleged
that Raytheon “failed to take adequate or reasonable measures to
prevent the escape of [contaminants] from its property or warn”
them that Raytheon’s “byproducts would contaminate the ground-
water underlying The Acreage.” The Pinareses contended that the
contaminants caused Mrs. Pinares’s kidney cancer.
During discovery, the Pinareses offered testimony from sev-
eral expert witnesses—including toxicologist Dr. Lawrence Wylie
and physicians Dr. Dudley Danoff and Dr. Arnold Schecter—to
show that the contaminants caused Mrs. Pinares’s kidney cancer.
Raytheon moved to exclude the experts’ testimony under Daubert
v. Merrell Dow Pharmaceuticals, Inc.,
509 U.S. 579 (1993), and Fed-
eral Rule of Evidence 702. Raytheon then moved for summary
judgment.
The district court granted Raytheon’s motions. It found that
Dr. Wylie hadn’t conducted a reliable dose-response assessment to
show that the amount of contaminants Mrs. Pinares was exposed
to could have caused her cancer. Specifically, the district court rea-
soned that Dr. Wylie: (1) failed to show whether “the alleged
2
The Pinareses sued in Florida state court, and Raytheon removed the case to
the Southern District of Florida based on diversity of citizenship.
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19-14831 Opinion of the Court 5
carcinogens were present” in the Pinareses’ water before Mrs. Pina-
res’s diagnosis and “how long they were present”; (2) overlooked
“the effects of the body in metabolizing or eliminating chemicals
before any toxic effect t[ook] hold”; (3) relied on an invalid “one-
hit model” of causation; (4) provided no evidence to support his
calculation of Mrs. Pinares’s exposure to the contaminants; and
(5) failed to “isolate” Mrs. Pinares’s “exposure to each of the vari-
ous chemicals separately, which [wa]s necessary to analyze the po-
tential cancer causing likelihood of each compound.” The district
court excluded Dr. Danoff’s and Dr. Schecter’s testimony, too—
they hadn’t performed independent dose-response assessments, so
their conclusions relied on Dr. Wylie’s deficient report.
After excluding the causation experts’ testimony, the district
court granted summary judgment for Raytheon because the Pina-
reses couldn’t show that Raytheon caused Mrs. Pinares’s cancer.
Mr. Pinares 3 timely appealed the district court’s three exclusion or-
ders and summary judgment.
STANDARD OF REVIEW
We review de novo the district court’s grant of summary
judgment. Williams v. Mosaic Fertilizer, LLC,
889 F.3d 1239, 1244
(11th Cir. 2018). We review a district court’s Daubert rulings for
abuse of discretion, and we “will affirm unless the court ‘has made
3
Mrs. Pinares passed away in 2018, and Mr. Pinares was appointed personal
representative of her estate.
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6 Opinion of the Court 19-14831
a clear error of judgment[] or has applied an incorrect legal stand-
ard.’”
Id. at 1245 (marks omitted). We give the district court “con-
siderable leeway in deciding in a particular case how to go about
determining whether particular expert testimony is reliable.”
Kumho Tire Co. v. Carmichael,
526 U.S. 137, 152 (1999). “Even
where a ruling excluding expert testimony is ‘outcome determina-
tive’ and the basis for a grant of summary judgment, our review is
not more searching than it would otherwise be.” Adams v. Lab’y
Corp. of Am.,
760 F.3d 1322, 1327 (11th Cir. 2014) (quoting Gen.
Elec. Co. v. Joiner,
522 U.S. 136, 142–43 (1973)).
DISCUSSION
Under the Federal Rules of Evidence, expert opinion testi-
mony is admissible only if “the testimony is based upon sufficient
facts or data,” “the testimony is the product of reliable principles
and methods,” and “the expert has reliably applied the principles
and methods to the facts of the case.” Fed. R. Evid. 702(c)–(d). The
district court “act[s] as a gatekeeper to [e]nsure that speculative and
unreliable opinions do not reach the jury.” McClain v. Metabolife
Int’l, Inc.,
401 F.3d 1233, 1237 (11th Cir. 2005) (citing Daubert,
509
U.S. at 589 n.7, 597). This gatekeeping role requires performing “a
preliminary assessment of whether the reasoning or methodology
underlying the testimony is scientifically valid and of whether that
reasoning or methodology properly can be applied to the facts in
issue.” Daubert,
509 U.S. at 592–93. “When doing so, ‘the court
must consider the testimony with the understanding that the bur-
den of establishing qualification, reliability, and helpfulness rests on
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19-14831 Opinion of the Court 7
the proponent of the expert opinion.’” Williams,
889 F.3d at 1245
(quoting McClain,
401 F.3d at 1238).
In toxic tort cases, we use an additional framework to sift
out reliable expert testimony from unscientific speculation. Where
“the medical community does not generally recognize the agent as
both toxic and causing the injury plaintiff alleges,” as here, 4 we con-
duct a two-part Daubert analysis that “covers not only the expert’s
methodology for the plaintiff-specific questions about individual
causation but also the general question of whether the drug or
chemical can cause the harm plaintiff alleges.” McClain,
401 F.3d
at 1239. “General causation is concerned with whether an agent
increases the incidence of disease in a group and not whether the
agent caused any given individual’s disease.”
Id.
“When analyzing an expert’s methodology in toxic tort
cases, the court should pay careful attention to the expert’s testi-
mony about the dose-response relationship.”
Id. at 1241. “This
attention is due because dose-response is ‘the hallmark of basic tox-
icology.’ Stripped to its bare essentials, a dose-response assessment
estimates scientifically ‘the dose or level of exposure at which the
substance at issue causes harm.’” Williams,
889 F.3d at 1246
(cleaned up). “Dose is the single most important factor to consider
in evaluating whether an alleged exposure caused a specific adverse
effect.” McClain,
401 F.3d at 1242.
4
Neither party argues that there is a scientific consensus that the contaminants
at issue cause kidney cancer.
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8 Opinion of the Court 19-14831
“[G]iven the ‘importance of individual responses to toxins,’
a plaintiff must demonstrate both [1] the level of exposure to the
allegedly harmful chemical that is hazardous to a human being and
[2] the amount of the chemical to which the plaintiff was exposed.”
Taylor v. Mentor Worldwide LLC,
940 F.3d 582, 595 (11th Cir.
2019) (quoting McClain,
401 F.3d at 1241). An “expert who avoids
or neglects the dose-response principle of toxic torts without justi-
fication casts suspicion on the reliability of his methodology.” Kil-
patrick v. Breg, Inc.,
613 F.3d 1329, 1339 (11th Cir. 2010) (alteration
adopted) (quoting McClain,
401 F.3d at 1242). Although “we have
never required an expert to ‘give precise numbers about a dose-
response relationship,’ . . . we do require an expert to lay a ‘reliable
groundwork for determining the dose-response relationship.’”
Williams,
889 F.3d at 1248 (quoting McClain,
401 F.3d at 1241 &
n.6).
Our toxic tort cases illustrate the importance of a dose-re-
sponse assessment when evaluating the reliability of expert testi-
mony. In McClain, for example, the plaintiffs offered expert testi-
mony that a supplement containing ephedrine caused heart attacks
and strokes.
401 F.3d at 1239–40. We held that the district court
erred in admitting the expert testimony because the expert had
drawn “speculative conclusions about [the supplement’s] toxicity”
and had “neglect[ed] the hallmark of the science of toxic torts—the
dose-response relationship.”
Id. at 1240. The expert in McClain
“offered no testimony about the dose of [the supplement] required
to injure [the p]laintiffs or anyone else” and “could not say how
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much [wa]s too much.”
Id. at 1241. The expert also admitted that
“hundreds of over-the-counter products” contained equal or
greater levels of ephedrine than the supplement at issue, which
level was “roughly half the [Food and Drug Administration’s] al-
lowable limits on ephedrine.”
Id. Without testifying about the
dose-response relationship and in light of other “vague testimony
about significant individual variations,” the expert had “laid no re-
liable groundwork for determining the dose-response relation-
ship,” so we held the evidence should have been excluded.
Id.
In Chapman v. Procter & Gamble Distributing, LLC, we af-
firmed the district court’s exclusion of expert testimony that failed
to show “dose-response, epidemiological evidence, and back-
ground risk of disease, methodologies [that] this circuit has recog-
nized as indispensable to proving the effect of an ingested sub-
stance.”
766 F.3d 1296, 1308 (11th Cir. 2014). There, the plaintiffs’
general causation experts, and the articles upon which they relied,
didn’t determine “how much” of the substance needed to “be used
for how long” to cause harm.
Id. at 1307. We concluded that the
district court did not abuse its discretion in excluding the testimony
because the experts “failed to demonstrate the primary methods
for proving” the substance caused harm, and the experts’ “second-
ary methodologies, including plausible explanations, generalized
case reports, hypotheses, and animal studies [we]re insufficient
proof of general causation.”
Id. at 1308.
We arrived at a similar conclusion in Williams.
889 F.3d at
1244–48. There, the expert purported to conduct a dose-response
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10 Opinion of the Court 19-14831
assessment, but the district court excluded the expert’s testimony
because “his methodology was undermined by multiple defects,”
especially the “failure to properly assess dose-response.”
Id. at
1245. We affirmed the district court’s exclusion because the expert
“never conducted an independent dose calculation specific to” the
plaintiff and “failed to demonstrate a scientific basis for concluding
that [the plaintiff’s] exposure levels would likely produce, contrib-
ute to, or exacerbate, [her] conditions.”
Id. at 1246. We explained
that the plaintiff “bore the burden of demonstrating” that the ex-
pert’s determinations were “methodologically sound.”
Id. at 1248.
And “when put to the task of identifying the bases of [the expert]’s
dose-response conclusions with specificity,” the expert and the
plaintiff provided no clear answer.
Id. at 1248 n.3. Because the
plaintiff failed to establish that the expert’s opinions were method-
ologically sound, we concluded that the district court did not abuse
its discretion in excluding the testimony.
Id. at 1245.
Exclusion of the Causation Experts’ Testimony
Mr. Pinares argues that the district court’s exclusion of the
causation experts’ testimony was “manifestly erroneous” because
the experts “employed widely accepted methodologies to reach
their opinions.” We first discuss Dr. Wylie’s opinion, then Drs.
Danoff and Schecter’s.
Dr. Wylie
Dr. Wylie reported that “toxic and carcinogenic chemical
contaminants” were “present in The Acreage groundwater in
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sufficient concentrations to cause illness in humans” and that “suf-
ficient human exposure occurred in the case of [Mrs.] Pinares . . .
to induce” her kidney cancer. The district court excluded Dr.
Wylie’s testimony because it found that his dose-response assess-
ment was “lacking.” We agree.
Like the expert in Williams, Dr. Wylie purported to conduct
a dose-response assessment, but his testimony didn’t identify what
dose of the contaminants was “too much.” See
889 F.3d at 1245–
49; McClain,
401 F.3d at 1241–43. Dr. Wylie concluded that Mrs.
Pinares was exposed to 8.24 micrograms of the contaminants per
day, an annual dose of 3,009 micrograms. He concluded that this
dosage was a “sufficient concentration[] to have provide[d] a daily
dose over the years of exposure to induce a total dose that directly
caused [Mrs. Pinares’s] renal cell carcinoma[].” Dr. Wylie con-
ceded, though, that this amount was “generally recognized by tox-
icologists” as “low.” Dr. Wylie also acknowledged that this
amount was well within the “safe drinking water standard” in Flor-
ida. Nevertheless, Dr. Wylie posited that “a ‘threshold’ or pre-
dicted ‘safe’ dose d[id] not likely exist for these chemicals” and that
“every dose greater than zero” implicated “some human health
risk.” Dr. Wylie cited no authority to support his opinion that this
amount of the contaminants could cause cancer.
The district court correctly held that Dr. Wylie failed to sup-
port his opinion with scientific evidence. Cf. McClain,
401 F.3d at
1242 (excluding expert when he “simply substituted his own ipse
dixit for scientific proof”). As in McClain, Dr. Wylie didn’t establish
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12 Opinion of the Court 19-14831
a dose-response relationship but asserted that any amount of the
contaminants was too much. See
id. at 1243. But McClain rejected
the “any amount” approach because it “clearly contradicts the prin-
ciples of reliable methodology.”
Id. We explained that “low dose
exposures—even for many years—will [often] have no conse-
quence at all,” because “the body is often able to completely detox-
ify low doses before they do any damage.”
Id. at 1242 (citation
omitted). And we observed that, “for most types of dose-response
relationships following chronic (repeated) exposure, thresholds ex-
ist, such that there is some dose below which even repeated, long-
term exposure would not cause an effect in any individual.”
Id.
(citation omitted).
Because Dr. Wylie didn’t explain how much exposure to the
Raytheon facility chemicals is “too much,” his opinion wasn’t suf-
ficiently reliable under Daubert to be admissible expert testimony.
See
id. at 1242–43; Chapman,
766 F.3d at 1307; Williams,
889 F.3d
at 1246–48. Rather than provide a scientifically rigorous basis for
his opinion, Dr. Wylie stated only that the level of contaminants in
the Pinareses’ water supply was “sufficient to support a [one]- or
two- . . . hit model[] of cancer initiation and promotion” given Mrs.
Pinares’s “low-dose exposure to multiple toxic and carcinogenic
chemicals.” The one-hit theory of causation “posits that [a] dece-
dent’s cancer was caused by a single exposure—regardless of the
quantity of the dosage—of toxic chemicals.” Wills v. Amerada
Hess Corp.,
379 F.3d 32, 49 (2d Cir. 2004) (rejecting expert witness’s
one-hit theory of causation as unreliable). But Dr. Wylie provided
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19-14831 Opinion of the Court 13
no explanation for why a model that ignores dosage, which we’ve
deemed “the single most important factor to consider” in toxic tort
cases, is appropriate here. See McClain,
401 F.3d at 1242.
Mr. Pinares argues that this case is distinguishable from
McClain, Chapman, and Williams, “where the experts failed to cal-
culate the dose-response relationship,” because Dr. Wylie “per-
formed” the dose-response assessment when he concluded that
eight thousand micrograms was a sufficient dose to cause Mrs.
Pinares’s kidney cancer. But Dr. Wylie skipped the first step of a
reliable dose-response assessment: he never “demonstrate[d] . . .
the level of exposure to the allegedly harmful chemical that is haz-
ardous to a human being.” See Taylor, 940 F.3d at 595. He thus
provided no reliable baseline against which the district court could
evaluate his conclusions as to Mrs. Pinares’s estimated exposure.
Because Dr. Wylie “laid no reliable groundwork for deter-
mining the dose-response relationship,” we cannot say that the dis-
trict court “made a clear error of judgment” or “applied an incor-
rect legal standard.” See McClain,
401 F.3d at 1238, 1241 (quotation
omitted). The district court thus did not abuse its discretion in ex-
cluding Dr. Wylie’s testimony.
Dr. Danoff and Dr. Schecter
Dr. Danoff concluded that Mrs. Pinares’s kidney cancer was
“caused by exposure to carcinogenic chemicals known to be pre-
sent in the well water that [she] . . . consumed and [was] exposed
to through other means in [her] community.” Similarly, Dr.
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14 Opinion of the Court 19-14831
Schecter concluded that Mrs. Pinares’s kidney cancer “was more
likely than not caused by or contributed to by exposure to multiple
carcinogenic chemicals present in the well water that she con-
sumed and was exposed to through ingestion, inhalation, and der-
mal exposure.” The district court excluded both experts’ testimony
because the experts “did not perform a dose-response calculation,”
couldn’t have relied on Dr. Wylie’s dose-response assessment, and
needed a dose-response relationship for their opinions to be relia-
ble. We agree.
Dr. Danoff and Dr. Schecter couldn’t rely on Dr. Wylie’s
dose-response assessment because Dr. Wylie’s report was properly
excluded by the district court. See Rink v. Cheminova, Inc.,
400
F.3d 1286, 1294 (11th Cir. 2005) (holding that the specific causation
experts’ testimony was “irrelevant” once toxicologist’s general cau-
sation “foundational testimony” had been excluded). And without
a dose-response assessment to establish general causation that the
contaminants could generally cause kidney cancer, Dr. Danoff and
Dr. Schecter had no “reliable groundwork” to support their specific
causation opinions that the contaminants specifically caused Mrs.
Pinares’s kidney cancer. See Williams,
889 F.3d at 1248 (quotation
omitted).
To demonstrate specific causation, Dr. Danoff and Dr.
Schecter “needed to perform or rely upon a methodologically
sound dose-response assessment specifically relevant” to Mrs. Pina-
res.
Id. at 1245 n.2. Mr. Pinares argues that Dr. Danoff and Dr.
Schecter “employed a differential diagnosis,” excluding other
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19-14831 Opinion of the Court 15
possible causes to conclude that chemicals from the Raytheon fa-
cility caused her cancer. But a differential diagnosis “will not usu-
ally overcome the fundamental failure of laying a scientific ground-
work for the general toxicity of the drug and that it can cause the
harm the plaintiff suffered.” McClain,
401 F.3d at 1252. “Setting
general causation aside,” an expert must still “reliably calculate”
whether a plaintiff was “exposed to enough of the toxin to cause
the alleged injury” to show specific causation. Williams,
889 F.3d
at 1245 n.2. The Pinareses admit that Drs. Danoff and Schecter
“buil[t] upon” Dr. Wylie’s report as to the dose-response relation-
ship, so their derivative reports did not “reliably calculate[e] how
much exposure would have adversely affected” Ms. Pinares.
Id.
The district court did not abuse its discretion in excluding their tes-
timony.
CONCLUSION
The district court didn’t abuse its discretion in excluding the
causation experts’ testimony. Without that testimony, the Pina-
reses could not establish that Raytheon caused Mrs. Pinares’s can-
cer. Raytheon was thus entitled to summary judgment.
AFFIRMED.
