Marcos Pinares v. Raytheon Technologies Corporation

• Court: Court of Appeals for the Eleventh Circuit
• Decided: March 28, 2023
• Docket: 19-14831
• Status: Unpublished

Opinion

USCA11 Case: 19-14831 Document: 63-1 Date Filed: 03/28/2023 Page: 1 of 15

[DO NOT PUBLISH] In the United States Court of Appeals For the Eleventh Circuit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. USCA11 Case: 19-14831 Document: 63-1 Date Filed: 03/28/2023 Page: 2 of 15

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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. USCA11 Case: 19-14831 Document: 63-1 Date Filed: 03/28/2023 Page: 3 of 15

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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.” USCA11 Case: 19-14831 Document: 63-1 Date Filed: 03/28/2023 Page: 4 of 15

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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. USCA11 Case: 19-14831 Document: 63-1 Date Filed: 03/28/2023 Page: 5 of 15

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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. USCA11 Case: 19-14831 Document: 63-1 Date Filed: 03/28/2023 Page: 6 of 15

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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 USCA11 Case: 19-14831 Document: 63-1 Date Filed: 03/28/2023 Page: 7 of 15

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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. USCA11 Case: 19-14831 Document: 63-1 Date Filed: 03/28/2023 Page: 8 of 15

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“[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 USCA11 Case: 19-14831 Document: 63-1 Date Filed: 03/28/2023 Page: 9 of 15

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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 USCA11 Case: 19-14831 Document: 63-1 Date Filed: 03/28/2023 Page: 10 of 15

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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 USCA11 Case: 19-14831 Document: 63-1 Date Filed: 03/28/2023 Page: 11 of 15

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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 USCA11 Case: 19-14831 Document: 63-1 Date Filed: 03/28/2023 Page: 12 of 15

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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 USCA11 Case: 19-14831 Document: 63-1 Date Filed: 03/28/2023 Page: 13 of 15

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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. USCA11 Case: 19-14831 Document: 63-1 Date Filed: 03/28/2023 Page: 14 of 15

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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 USCA11 Case: 19-14831 Document: 63-1 Date Filed: 03/28/2023 Page: 15 of 15

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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.