DAVENPORT v. BP EXPLORATION & PRODUCTION INC

UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF FLORIDA

PENSACOLA DIVISION

IN RE: DEEPWATER HORIZON

BELO CASES

Case No. 3:19cv963-MCR-HTC

This Order Relates to:

Lester Jenkins, 5:19cv260

Dwight Siples, 5:19cv310

Kenneth Davenport, 5:18cv245

Michael Moulder, 5:19cv12

__________________________/

ORDER and

REPORT AND RECOMMENDATION

Plaintiffs, represented by the Downs Law Group, P.A., in this second group

of test cases, were clean-up workers hired to assist with the aftermath of the

Deepwater Horizon oil spill. Plaintiffs sue Defendants BP Exploration and

Production, Inc., and BP America Production Co. (collectively “BP”) for chronic

sinusitis and ocular disease,1 which were diagnosed years after the spill occurred,

and which they contend were caused by exposure to the chemicals in the weathered

oil or the dispersants used as part of the clean-up efforts. To succeed on their claims,

Plaintiffs must show, through expert testimony, that a chemical or mixture of

1 Plaintiffs Davenport and Moulder complain of ocular conditions, namely, Keratoconjunctivitis

Sicca and Chronic Eye Irritation/Chronic Conjunctivitis, respectively. Plaintiffs Jenkins and

Siples complain of a sinus condition, Chronic Sinusitis.

chemicals related to the oil spill caused their complained of medical conditions. To

do this, Plaintiffs must establish both general causation and specific causation. The

question before the Court today, however, is solely whether Plaintiffs have met their

burden for general causation, at least sufficiently to send the question to the jury,

and proceed to specific causation.

Pending before the Court are BP’s motions to exclude Plaintiffs’ general

causation experts,2 Dr. Ranajit Sahu, ECF Doc. 459; Dr. Gina Solomon, ECF Doc.

466; Dr. David Carpenter, ECF Doc. 468, and Dr. Michael Freeman, ECF Doc. 469,

and BP’s related motion for summary judgment, ECF Doc. 470. Upon careful

consideration of the evidence presented, after extensive briefing, and following an

all-day hearing, the undersigned finds BP’s motions to exclude should be

GRANTED and the motion for summary judgment should be GRANTED.

2 At oral argument, Plaintiffs withdrew the expert opinions of Dr. James J.J. Clark for general

causation. Thus, BP’s motion to exclude Dr. Clark, ECF Doc. 460, and related motion to strike

Dr. Clark’s supplemental declaration, ECF Doc. 525, need not be addressed. The clerk will be

directed to terminate those motions as MOOT. Additionally, Plaintiffs designated two diagnosis

experts, Dr. Robert Cykiert and Dr. David Greene. Dr. Cykiert diagnosed Plaintiffs Davenport

and Moulder with ocular conditions and Dr. Greene diagnosed Jenkins and Siples with chronic

sinusitis. Although Plaintiffs initially identified these experts as offering opinions on diagnosis

and general causation, Plaintiffs clarified at the hearing that they are not designating either expert

for general causation. Also, at the hearing, BP clarified they do not contest the qualifications of

these experts to provide a diagnosis but dispute the method they used to do so. See BP’s Daubert

motions, ECF Doc. 462 (Dr. Cykiert) and ECF Doc. 467 (Dr. Greene). Given the undersigned’s

finding that the general causation experts should be excluded, the undersigned finds it unnecessary

to address the motions to exclude the diagnoses experts. Thus, the clerk will also be directed to

terminate the Greene and Cykiert motions as MOOT.

The undersigned does not write this Report and Recommendation on a blank

slate. The Eleventh Circuit, this Court, and the courts in the Eastern District of

Louisiana (which have addressed similar issues in over 100 Deepwater Horizon

cases) have discussed at length the minimal requirements an expert’s opinion must

meet to pass Daubert3 muster on general causation in toxic tort cases. Notably, this

Court granted summary judgment in favor of BP in the First Trial Pool Cases,4 after

excluding general causation expert Dr. Patricia Williams, and in doing so, issued a

58-page opinion (hereinafter referenced as the “Williams Order”) detailing the

shortfalls with Dr. Williams’ opinions. See In re Deepwater Horizon Belo Cases,

No. 3:19cv963, 2020 WL 6689212, at *12 (N.D. Fla. Nov. 4, 2020), aff’d sub nom.,

In re Deepwater Horizon BELO Cases, No. 20-14544, 2022 WL 104243 (11th Cir.

Jan. 11, 2022).5

Plaintiffs’ experts in this second group of test cases have failed to cure the

same “analytical gaps” that plagued Dr. Williams’ opinions. Specifically, Plaintiffs’

general causation experts (1) do not identify a statistically significant association in

relevant epidemiological studies between any chemical or mixture of chemicals in

the weathered oil or dispersants and the LMPCs at issue; (2) do not meaningfully

3 Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).

4 The First Trial Pool Cases consisted of 26 cases, represented by the Falcon firm and the Downs

firm. In re Deepwater Horizon BELO Cases, 2020 WL 6689212, at *6.

5 The Williams Order can also be found at ECF Doc. 97.

critique the strengths and weaknesses of the epidemiological studies on which they

rely; (3) do not engage in a more than superficial analysis of the Bradford Hill

factors; and (4) do not identify a harmful level at which any chemical or mixture of

chemicals can cause Plaintiffs’ LMPCs. While Plaintiffs attribute these failures to

the lack of, or skewed, data collected by BP in the months after the oil spill, the

reality appears to be that the science simply is not there to support Plaintiffs’ claims.

As the Southern District of Florida recently stated in the Zantac MDL litigation, “[a]

common refrain in Daubert jurisprudence is that ‘law lags science,’ because the

courtroom is not the appropriate forum for new scientific methodologies and theories

to be tested; laboratories and published journals are the appropriate forum.” In Re:

Zantac (Ranitidine) Products Liability Litigation, 2022 WL 17480906, at *3–4 (S.D.

Fla. Dec. 6, 2022) (granting Daubert motions on all general causation experts

because “there is no scientist outside this litigation who concluded ranitidine causes

cancer, and the Plaintiffs’ scientists within this litigation systemically utilized

unreliable methodologies with a lack of documentation on how experiments were

conducted, a lack of substantiation for analytical leaps, a lack of statistically

significant data, and a lack of internally consistent, objective, science-based

standards for the evenhanded evaluation of data”).

I. BACKGROUND6

On April 20, 2010, a massive and unprecedented oil spill occurred in the Gulf

of Mexico when the Deepwater Horizon mobile offshore oil-drilling rig located

approximately 125 miles offshore of Florida exploded. During the months

immediately following the explosion, over 90,000 people and 7,000 vessels were

employed to address the Deepwater Horizon oil spill (“DWH Spill”). The incident

resulted in thousands of claims being filed against BP, which were all originally

consolidated in the Eastern District of Louisiana as part of the Deepwater Horizon

multidistrict litigation (MDL No. 2179). The MDL court approved a comprehensive

Medical Benefits Class Action Settlement Agreement (“Settlement Agreement”) for

personal injury plaintiffs. The Settlement Agreement provided a claims process for

eligible class members who were diagnosed with a specified physical condition on

or before April 16, 2012, and a separate litigation option for those seeking

compensation for “Later-Manifested Physical Conditions” (“LMPCs”), defined as a

physical condition diagnosed after the April 2012 cutoff date.7

Over 500 BELO cases have been filed in, or transferred to, this District by

plaintiffs claiming LMPCs. The Court consolidated those cases into this master

6 The Williams Order contains a detailed discussion of the background of this litigation, the DWH

Spill, response and data collection, and a discussion of the makeup and constituents of crude oil

and dispersants.

7 This separate litigation of claims is known as the “Back End Litigation Option” (“BELO”).

action. The Court initially selected the First Trial Pool Cases for discovery and

stayed the remaining cases. The discovery was bifurcated between general causation

and specific causation.8 Plaintiffs designated Patricia Williams, Ph.D., a

toxicologist, as their sole general causation expert. BP moved to exclude Dr.

Williams under Daubert, arguing her opinions were unreliable and unhelpful, and

also moved for summary judgment. “After carefully reviewing Dr. Williams’s

reports and her deposition testimony,” the Court agreed with BP and found her

opinions fell “woefully short of the Daubert and Rule 702 standards” because Dr.

Williams: (1) failed to identify relevant statistically significant associations in the

epidemiologic literature; and (2) failed to provide anything more than a conclusory

analysis of the Bradford Hill factors to explain her opinions. In re Deepwater

Horizon Belo Cases, 2020 WL 6689212, at *12. The Court also found Dr.

Williams’s opinions to be unhelpful because she failed to consider available

exposure data for the relevant geographical area. Id. The Court, thus, entered

judgment in favor of BP. Id. at 17.

After the First Trial Pool Cases were dismissed, the Court proceeded to select

a second group of test cases for discovery. On September 30, 2021, the Court

8 Bifurcation promotes judicial efficiency, particularly in mass toxic tort cases, because if plaintiffs

are unable to establish general causation, the Court need not address specific causation. See Knight

v. Kirby Inland Marine Inc., 482 F.3d 347, 351 (5th Cir. 2007) (“Evidence concerning specific

causation in toxic tort cases is admissible only as a follow-up to admissible general-causation

evidence.”).

entered an Order setting four ocular and four sinus test cases on a discovery schedule.

See ECF Doc. 342, Corrected Amended and Revised Case Management Order

(“CARCMO”). Plaintiffs, represented by the Falcon/Lindsay firms and the Downs

firm, selected two of the ocular cases and two of the sinus cases, and BP selected

two of the ocular cases and two of the sinus cases. See ECF Doc. 348 (identifying

the test cases). Unlike the plaintiffs in the First Trial Pool Cases, the Falcon Group

Plaintiffs and the Downs Group Plaintiffs in this second group designated different

experts. As set forth in the CARCMO, “if the Daubert or dispositive motions are

decided adversely to the test plaintiffs, then all remaining BELO plaintiffs with

similar LMPCs in the respective Falcon/Lindsay cases or in the Downs Law Group

cases will be bound by the Court’s rulings—after appeal, if any—and their cases will

be dismissed with prejudice and without further litigation.” ECF Doc. 342 at 5

(discussing preclusive effect of Daubert rulings).

II. LEGAL STANDARDS

A. Summary Judgment

Summary judgment is appropriate if “there is no genuine dispute as to any

material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ.

P. 56(a); see Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247–248 (1986) (“[T]he

mere existence of some alleged factual dispute between the parties will not defeat an

otherwise properly supported motion for summary judgment.”) (emphasis in

original). The moving party bears the burden of establishing that there is no genuine

dispute of fact and that the plaintiff has failed to establish an essential element of the

claim. See Allen v. Bd. of Pub. Educ., 495 F.3d 1306, 1313 (11th Cir. 2007); see

also Celotex Corp. v. Catrett, 477 U.S. 317, 322–23 (1986). To avoid summary

judgment, the nonmoving party must then go beyond the pleadings and “designate

specific facts showing that there is a genuine issue for trial.” Celotex, 477 U.S. at

324 (internal quotation marks omitted). However, summary judgment cannot be

avoided through evidence that is “inadmissible at trial.” Chapman v. Procter &

Gamble Distrib., LLC, 766 F.3d 1296, 1313 (11th Cir. 2014) (quoting Corwin v.

Walt Disney Co., 475 F.3d 1239, 1249 (11th Cir. 2007)).

B. 702 and Daubert

In a toxic tort case, such as this, a plaintiff must establish both general and

specific causation through admissible, reliable expert testimony. McClain v.

Metabolife Int’l, Inc., 401 F.3d 1233, 1239 (11th Cir. 2005). Under Federal Rule of

Evidence 702, expert testimony regarding scientific, technical, or other specialized

knowledge is admissible if it is: (1) helpful to the jury, (2) based on sufficient facts

or data, (3) the product of reliable principles and methods, and (4) demonstrates that

“the expert has reliably applied the principles and methods to the facts of the case.”

The Eleventh Circuit has distilled the Rule 702 requirements into three inquiries: (1)

whether the expert is qualified; (2) whether “the methodology by which the expert

reaches [a] conclusion[] is sufficiently reliable” under the principles of Daubert; and

(3) whether the testimony will assist the trier of fact to understand the evidence or

determine a fact in issue through the application of scientific, technical, or other

specialized knowledge. Rink v. Cheminova, Inc., 400 F.3d 1286, 1291–92 (11th Cir.

2005).

Reliability under Daubert is determined by considering: (1) whether the

expert’s methodology can or has been tested; (2) whether the scientific technique

or theory has been subjected to peer review and publication; (3) whether there is a

known rate of error for the method; and (4) whether the technique is generally

accepted in the scientific community. See 509 U.S. at 593–94; Rink, 400 F.3d at

1292. The court considers “whether the reasoning or methodology underlying the

testimony is scientifically valid and whether that reasoning or methodology

properly can be applied to the facts in issue.” Seamon v. Remington Arms Co., LLC,

813 F.3d 983, 988 (11th Cir. 2016) (quoting Daubert, 509 U.S. at 592–93) (internal

quotation marks and alteration omitted).

The helpfulness prong of Rule 702 is concerned with ensuring that expert

testimony is not only scientifically reliable but also “relevant to the task at hand.”

Daubert, 509 U.S. at 597. Under Daubert the court’s role as a “gatekeeper” is to

ensure expert testimony is admitted only if it is reliable and relevant. Id. at 589,

597. The party offering the expert testimony has the burden to establish “these

basic requirements–––qualification, reliability, and helpfulness.” United States v.

Frazier, 387 F.3d 1244, 1260 (11th Cir. 2004).

Under Daubert, the court’s role as a “gatekeeper” is to ensure expert

testimony is admitted only if it is reliable and relevant. Id. at 589, 597. The party

offering the expert testimony has the burden to establish “these basic requirements–

–qualification, reliability and helpfulness.” United States v. Frazier, 387 F.3d

1244, 1260 (11th Cir. 2004).

III. GENERAL CAUSATION

There are two broad categories of toxic tort cases. In the first category, the

toxicity of a drug or chemical has been recognized by the medical community as

being toxic and capable of causing the injuries alleged by a plaintiff. See McClain,

401 F.3d at 1239. In those cases, plaintiffs do not need to prove general causation.

See id. In the second category of cases, there has been no such recognition by the

medical community. Id. Therefore, a plaintiff proceeding in the second category

of cases must prove both general and specific causation. Id. In the Williams Order,

this Court determined Plaintiffs’ cases fall under the second category. See In re

Deepwater Horizon Belo Cases, 2020 WL 6689212, at *9.

As this Court previously stated, “[g]eneral causation . . . is concerned with

whether a ‘drug or chemical can cause the harm plaintiff alleges,’ that is, whether a

chemical agent ‘increases the incidence of disease in a group.’” Id. at *8 (citing

McClain, 401 F.3d at 1239). The Eleventh Circuit has recognized three “primary”

scientific methodologies as being “indispensable” to proving general causation in

a toxic tort case: (1) epidemiological evidence, (2) dose-response relationship, and

(3) the background risk of disease. Chapman, 766 F.3d at 1308. “A general

causation opinion that is not supported by at least one of these primary

methodologies is unreliable as a matter of law.” In re Abilify (Aripiprazole) Prods.

Liab. Litig., 299 F. Supp. 3d 1291, 1306 (N.D. Fla. 2018). By the same token, the

reliability of a general causation opinion is called into question if it considers only

one of these primary methods and ignores the others. See Chapman, 766 F.3d at

1307–08. Each of these methodologies are discussed below.

A. Epidemiology

Epidemiology “is generally considered to be the best evidence of causation

in toxic tort actions.” Rider v. Sandoz Pharm. Corp., 295 F.3d 1194, 1198 (11th

Cir. 2002). Epidemiology is “the branch of science that studies the incidence,

distribution, and cause of disease in human populations,” In re Abilify, 299 F. Supp.

3d at 1306, and “examine[s] the pattern of disease in human populations,” Gen.

Elec. Co. v. Joiner, 522 U.S. 136, 144 n.2 (1997). There are two steps in

establishing causation through epidemiology. The first step requires the expert to

identify an association noted in the literature between the drug or chemical in

question and the complained of condition. In re Deepwater Horizon Belo Cases,

2020 WL 6689212, at *10 (citing Michael D. Green et al., Reference Guide on

Epidemiology, in Reference Manual on Scientific Evidence 566 (Federal Judicial

Center, 3d ed. 2011) (hereinafter, “Ref. Man.”)). As this Court stated in the

Williams Order, “in the absence of a statistical association supported by an

epidemiologic study, ‘secondary’ evidence, even within the Bradford Hill factors,

such as biological plausibility, case studies, adverse event reports, animal and in

vitro studies, standing alone or in the aggregate, are ‘insufficient proof of general

causation.’” Id. (citations omitted).

Once an association is identified, in the second step, the expert determines

whether the association represents “a true cause-effect relationship” between

exposure and the disease. Id. (citing Ref. Man. at 597). To make that

determination, an expert applies the following nine factors developed by Sir Austin

Bradford Hill (“the Bradford Hill Factors”):9 (1) temporal relationship; (2) strength

of the association; (3) dose-response relationship; (4) replication of the findings;

(5) biological plausibility; (6) consideration of alternative explanations; (7)

cessation of exposure; (8) specificity of the association; and (9) consistency with

other knowledge. See id. (citing Ref. Man. at 599–600). No one factor is

dispositive and one or more factors may be absent even when a true causal

9 See Austin Bradford Hill, The Environment and Disease: Association or Causation? 58 Proc.

Royal Soc’y Med. 295 (1965).

relationship exists. Ref. Man. at 600. Determining whether an association is causal

is a matter of scientific judgment, and scientists reliably applying the Bradford Hill

factors may reasonably come to different conclusions about whether a causal

inference may be drawn. Milward v. Acuity Specialty Prods. Group, Inc., 639 F.3d

11, 18 (1st Cir. 2011); see also Ref. Man. at 553, 600.

B. Dose-Response

Another primary methodology for establishing causation is through evidence

of a dose-response relationship, which is a “relationship in which a change in

amount, intensity, or duration of exposure to [a chemical] is associated with a

change—either an increase or decrease—in risk of” adverse effects from that

exposure. McClain, 401 F.3d at 1241–42. The relationship between dose and

response is “the hallmark of basic toxicology” and the “single most important factor

to consider” in evaluating the toxicity of a drug or chemical. Id. at 1242; see also

Chapman, 766 F.3d at 1307. This is because virtually all substances have the

potential to be harmful at high enough doses. See id; see also Bernard D. Goldstein

et al., Reference Guide on Toxicology, in Ref. Man. at 636. Inherent in this

principle is the fact that, for the vast majority of substances, there are threshold

doses below which no individual will respond and doses above which nearly

everyone responds. See McClain, 401 F.3d at 1242. Consequently, a reliable expert

opinion on general causation should address what levels of exposure to a drug or

chemical increase the risk of adverse effects. See id. at 1241. Indeed, “‘[t]he expert

who avoids or neglects [this] principle of toxic torts without justification casts

suspicion on the reliability of his methodology.’” Kilpatrick v. Breg., Inc., 613 F.3d

1329, 1339 (quoting McClain, 401 F.3d at 1242).

C. Background Risk of Disease

Finally, “background risk” of disease “is the risk a plaintiff and other

members of the general public have of suffering the disease or injury that plaintiff

alleges without exposure to the drug or chemical in question. The background risks

include all those causes of a disease, whether known or unknown, excluding the

drug or chemical in question.” McClain. 401 F.3d at 1243 (emphasis in original).

This is important because the aim of the other primary methodologies is to identify

“agents that are associated with an increased risk of disease.” See Ref. Man. at 552.

An expert must know the background prevalence of a disease before he can

determine whether the risk of that disease is increased as a result of exposure to the

agent. See In re Denture Cream Prods. Liab. Litig., 795 F. Supp. 2d 1345, 1355

(S.D. Fla. 2011), aff’d sub nom., Chapman, 766 F.3d 1296. Without background

risk to establish a baseline, it is difficult to determine whether any incidence of a

disease in individuals exposed to an agent is anything more than a coincidence.

Chapman, 766 F.3d at 1308. Thus, a failure to identify or describe the background

risk of a disease is a “serious methodological deficiency” and “substantial

weakness” in an expert’s general causation opinion. See id. at 1307–08.

IV. IDENTIFYING A HARMFUL DOSE

Before discussing each expert’s opinions, the undersigned will address an

argument Plaintiffs raise as to all of their experts and to which Plaintiffs devoted a

significant amount of argument at the hearing – that is whether their experts have

to identify a harmful dose or level at this stage of the proceedings.

In the Williams Order, this Court held that “[t]o carry the burden on general

causation in this toxic tort case, reliable expert testimony ‘must demonstrate the

levels of exposure that are hazardous to human beings generally,’ and the

substance’s ‘general toxicity for the harm Plaintiffs allege.’” In re Deepwater

Horizon Belo Cases, 2020 WL 6689212, at *9 (internal citations omitted). The

Court went on to state that an “opinion on general causation in the context of the

instant cases is only helpful and a good ‘fit’ if it reliably shows ‘general toxicity for

the harm Plaintiffs allege’ and establishes an exposure level that is considered

‘hazardous to human beings generally.’” Id. at 15 (quoting McClain, 401 F.3d at

1239, 1241).

As the Eleventh Circuit stated in McClain, “scientific knowledge of the

harmful level of exposure to a chemical” is considered “a minimal fact[ ] necessary

to sustain the plaintiff’s burden” in a toxic tort case. McClain, 401 F.3d at 1241

(quoting Allen v. Pa. Eng’g Corp., 102 F.3d 194, 199 (5th Cir. 1996)) (alterations

and internal quotation marks omitted). Consistent therewith, courts in the Eastern

District of Louisiana have excluded an expert in a plethora of BELO cases for the

expert’s failure “to identify a harmful level of exposure to a specific chemical.” See,

e.g., Coleman v. BP Expl. & Prod., Inc., 2022 WL 2314400, at *6 (E.D. La. June 28,

2022), reconsideration denied sub nom., Dawkins v. BP Expl. & Prod., Inc., 2022

WL 4355818 (E.D. La. Sept. 20, 2022).10

Nonetheless, Plaintiffs argue their experts do not have to identify a harmful

level at which any chemical in the weathered oil or dispersants can cause the LMPCs

at issue. While acknowledging a harmful level must be established for specific

causation, they argue it is not a general causation requirement, unless the expert is

proceeding under the dose-response method.11 They argue the Eleventh Circuit’s

reference to a harmful level requirement in McClain related to specific, rather than

general causation. They argue the Eastern District of Louisiana courts in the other

BELO cases simply got it wrong. They distinguish this Court’s holding in the

10 These cases relate to the exclusion of general causation expert Dr. James Cook who, while not

designated by the Downs Group Plaintiffs, has been designated by the Falcon Group Plaintiffs in

these test cases. See, e.g., Dawkins v. BP Exploration & Prod., Inc., 2022 WL 2315846, at *6

(E.D. La. June 28, 2022), reconsideration denied, 2022 WL 4355818 (E.D. La. Sept. 20, 2022);

Williams v. BP Expl. & Prod., Inc., No. 18-9753, 2019 WL 6615504, at *8 (E.D. La. Dec. 5, 2019)

(citing Knight, 482 F.3d at 351); Lee v. BP Expl. & Prod., Inc., No. 18-10381, 2020 WL 6106889,

at *4 (E.D. La. Sept. 29, 2020) (internal citations, alterations, and quotation marks omitted).

11 Plaintiffs’ argument makes no practical sense. Why would one methodology require a hazardous

level to be established at general causation, while another does not.

Williams Order as being limited to a toxicologist seeking to prove general causation

through a dose-response relationship. They argue this Court recognized that failure

to identify a harmful dose is not fatal to general causation in In re Abilify, 299 F.

Supp. 3d at 1291. According to Plaintiffs, requiring them to identify a harmful dose

“is an impossible, and unfair, standard.” ECF Doc. 513 at 34. The undersigned

finds Plaintiffs’ arguments to be strained at best.

First, Plaintiffs improperly recast Dr. Williams’ opinions. Although Dr.

Williams was a toxicologist, it is inaccurate to say Dr. Williams relied on the dose-

response methodology as her primary method for establishing causation. To the

contrary, in the Williams Order, the Court specifically noted that “a review of

epidemiological studies forms the basis of” Dr. Williams’ opinions. In re Deepwater

Horizon Belo Cases, 2020 WL 6689212, at *10. The majority of the Court’s 58-

page opinion is dedicated to discussing Dr. Williams’ failure to critique the

epidemiological studies, failure to rely on relevant studies, and failure to adequately

apply the Bradford Hill factors to the epidemiological studies she considered. In

fact, the only time the Court discusses the dose-response relationship is to note that

Dr. Williams did not give any meaningful consideration to it in her Bradford Hill

analysis. See id. at *14.

Second, this Court did not hold in In re Abilify that a general causation expert

need not identify a harmful dose. Unlike BP, the defendant in In re Abilify did not

seek to exclude plaintiffs’ general causation experts for failure to identify a harmful

dose; thus, whether a harmful dose was needed was not addressed. Regardless,

unlike this case, the plaintiffs’ experts in In re Abilify offered evidence of a harmful

dose, through both case studies and adverse event reports.12 In re Abilify, 299 F.

Supp. 3d at 1330. While the Court questioned the strength of such evidence and thus

found it lacked “the intrinsic reliability that is the hallmark of a primary methodology

under Eleventh Circuit Daubert jurisprudence,” the Court nonetheless found the

evidence “relevant and admissible” as a supplement to plaintiffs’ epidemiological

study. Id. at 1330–31, 1345. Thus, Plaintiffs’ reliance on In re Abilify as negating

a requirement for their experts to provide a harmful dose is simply misplaced.

Plaintiffs also rely on the Eastern District of Tennessee’s decision in Adkisson

v. Jacobs Engineering Group, Inc., 342 F. Supp. 3d 791 (E.D. Tenn. 2018). In

Adkisson the court rejected defendant’s argument that plaintiffs needed to prove their

individualized dose or exposure at the general causation stage. Id. at 799 (“Because

general causation is something all plaintiffs have in common, individualized proof

cannot be necessary. Indeed, that is why general causation is often litigated on a

class-wide, or at least collective or consolidated, basis.”). The court went on to

explain, however, that it was not suggesting exposure and dose are irrelevant to the

12 The undersigned also notes that the Etminan study relied upon by the experts was a study

involving at least one prescription of Abilify; thus, a threshold dose was included in the study. In

re Abilify, 299 F. Supp. 3d at 1313.

general causation inquiry. Id. Noting “the dose makes the poison,” the court stated

that “to say that a chemical agent is capable of causing a disease—i.e., that plaintiffs’

burden on general causation is satisfied—without some reference to a particular

dose, would be incoherent.” Id. at 799–800. Moreover, the court noted that, unlike

the expert in McClain who concluded that “any amount of Metabolife is too much,”

the expert before it “identified the levels of many toxic constituents present in the

Kingston fly ash, analyzed hundreds of peer-reviewed epidemiological studies, and

has applied the Bradford-Hill criteria to evaluate the strength of the associations

found in the literature, to conclude that plaintiffs’ exposure . . . was capable of

causing the complained-of diseases.” Id. at 803. Thus, Adkisson is directly contrary

to Plaintiffs’ position.

Finally, an argument similar to the one Plaintiffs make here was recently

rejected by the Southern District of Florida in the Zantac MDL litigation. In re:

Zantac, 2022 WL 17480906, at *16. Similar to Plaintiffs here, in In re: Zantac, the

plaintiffs argued “they d[id] not have to identify how much ranitidine consumption

can cause cancer—the threshold—and may instead show that the highest dosage any

Plaintiff could have realistically consumed could cause cancer.” Id. at 16 (emphasis

in original). The In re: Zantac defendants, like BP, argued “Plaintiffs must identify

the point at which ranitidine consumption becomes toxic—the threshold.” The court

agreed with defendants because “[their] position on threshold dose is well grounded

in binding, published, and analogous Eleventh Circuit case law.” Id. at 17. The

undersigned notes that the plaintiffs’ experts in In re: Zantac included an

epidemiologist and the issue before the court was general causation. Id.

Thus, as an initial matter, the undersigned finds, consistent with McClain,

other cases from this Circuit, and other BELO cases, that to be reliable and helpful,

a general causation expert in these BELO cases must identify a harmful level at

which a chemical in the oil or dispersant can cause the LMPCs at issue here. See

McClain, 401 F.3d at 1241–42 (because all substances have the potential to be toxic,

an expert’s failure to identify a harmful dose renders their opinions unreliable and

unhelpful).

V. THE EXPERTS’ OPINIONS

The Downs Group Plaintiffs have designated four (4) general causation

experts: Dr. David Carpenter, Dr. Gina Solomon, Dr. Michael Freeman, and Dr.

Ranajit Sanhu. Except for Dr. Carpenter, BP does not contest the qualifications of

the experts to provide opinions on general causation. Each opinion is discussed

below.

A. Dr. Gina Solomon

Gina Solomon, M.D., is a medical doctor trained and certified in the field of

occupational and environmental medicine. ECF Doc. 466-1 at 3. Among other

roles, Dr. Solomon currently serves as a clinical professor of medicine at the

University of California San Francisco. Id. Dr. Solomon provided two 17-page

reports (excluding references), one for Plaintiff Jenkins and one for Plaintiff Siples.

ECF Doc. 466-1 and ECF Doc. 466-2 (Exhibits A and B to the Daubert motion)

(Since the reports are essentially identical, the undersigned cites to Jenkins’ report

only).

In paragraph 4 of her reports, Dr. Solomon offers the following general

causation opinions:13 (1) “inhalation of aerosols that consist of petroleum

hydrocarbons14 and dispersant cause damage to the protective cilia that line the

interior upper respiratory tract,” (2) “these same aerosols cause inflammation of the

upper respiratory tract, including mucous membranes of the nose, sinuses, and

throat,” (3) which “manifests as acute sinusitis [and] which may become chronic

sinusitis over time.” ECF Doc. 466-1 at 3. BP seeks to exclude Dr. Solomon’s

opinions as both unreliable and unhelpful because Dr. Solomon does not provide a

13 Dr. Solomon also offers the opinion that exposure to aerosol mixtures of petroleum and

dispersants from the BP oil spill caused or substantially contributed to Jenkins’ and Siples’

development of chronic sinusitis. The parties agreed this is a specific causation opinion, which

the Court need not address at this stage of the proceedings. ECF Doc. 466-1 at 3.

14 Although it is Dr. Solomon’s opinion that particulate matter in the oil can cause chronic sinusitis,

she has not been able to isolate the properties of the particulate matter. G. Solomon Depo., at

43:10–14.

dose level at which an exposure to hydrocarbons can cause chronic sinusitis and Dr.

Solomon fails to follow the well settled methodology for evaluating the cause and

effect in epidemiological studies. After reviewing the voluminous evidence

presented by the parties, including BP’s motion, ECF Doc. 466, Dr. Solomon’s

reports, ECF Docs. 466-1 & 466-2, Dr. Solomon’s deposition testimony, ECF Doc.

466-3, Plaintiffs’ response, ECF Doc. 514, and Dr. Solomon’s two supplemental

declarations,15 ECF Docs. 514-3 and 556-1, the undersigned finds Dr. Solomon’s

opinions should be excluded as unreliable and unhelpful.

1. Failure to Identify a Harmful Dose

As discussed above, the undersigned disagrees with Plaintiffs that a general

causation expert in these BELO cases does not have to identify a harmful dose. Dr.

Solomon, however, does not do so. Dr. Solomon admits in her deposition that her

reports do not identify a harmful level of exposure to crude oil or dispersant that

would cause the chronic sinus conditions at issue, G. Solomon Depo., at 78:15–21,

15 In response to BP’s Daubert motion, Plaintiffs submitted two declarations from Dr. Solomon,

ECF Docs. 514-3 (attached to the Opposition) and 556-1 (attached to the Sur-reply). BP filed a

motion to strike the second declaration, but not the first. ECF Doc. 561. As to the first declaration,

BP chose, instead, to seek leave to file a reply, ECF Doc. 530, to address the additional materials

contained in the declaration. The undersigned granted that request, and BP filed a reply, ECF Doc.

543, which included declarations from its own experts, Robert Cox, M.D., Ph.D., and Dominik

Alexander, Ph.D. In response, Plaintiffs filed a request to file a sur-reply, which was granted, and

in that sur-reply, Plaintiff included a second declaration from Dr. Solomon. ECF Doc. 556. BP

filed a motion to strike that second declaration, ECF Doc. 561, and, after the hearing, Plaintiffs

filed a response, ECF Doc. 565. The Court will consider the second declaration over BP’s

objection as it merely contains arguments in response to the declarations of BP’s experts. Thus,

BP’s motion to strike, ECF Doc. 561, is DENIED.

and she has made no attempt to do so, id. at 79:3–8. Dr. Solomon admits she does

not “have enough information in the literature to be able to identify a harmful level

of exposure.” Id. at 79:16–25, 80:1–9.

In her second supplemental declaration, Dr. Solomon argues identifying a

specific chemical or a dose level is not feasible. ECF Doc. 556-1. She references

the lack of dose information when considering whether asbestos causes

mesothelioma or tobacco causes lung cancer. Id. at 3. This argument is not well-

taken. As the Eleventh Circuit stated in McClain, asbestos and cigarette smoke are

toxins that the medical community generally has recognized as being toxic and as

causing cancer. 401 F.3d at 1239. Thus, those chemicals fall in the “first category”

of toxic tort cases for which only specific causation is at issue. Id. As stated above,

this is not a first-category case. To the contrary, it is not widely accepted in the

medical community that oil, dispersants, or any chemicals therein can cause

common conditions such as chronic sinusitis or conjunctivitis at any level.

Plaintiffs argued at the hearing that Dr. Solomon has provided a “qualitative”

rather than a “quantitative” dose, and points to paragraphs 32 and 33 of the report,

wherein she opines that an exposure to hydrocarbons in the oil for “multiple weeks

or months” is sufficient “to overwhelm the body’s natural defenses against

particles.” ECF Doc. 466-1 at 13. The undersigned finds no merit to this argument.

Plaintiff cites to no authority finding a qualitative dose to be sufficient. Regardless,

the duration identified by Dr. Solomon of “weeks” or “months” is simply too

imprecise to be helpful. Likewise, an opinion about the minimum duration of

exposure without quantifying a harmful level is also not helpful. Putting it in the

most basic terms, the chance an individual is going to be harmed cannot be the same

for an individual exposed to one tarball a day for a month as an individual exposed

to 15 tarballs a day. Moreover, even if the Court were to accept Dr. Solomon’s

“qualitative” dose opinion, Dr. Solomon failed to follow acceptable methodology in

identifying an association between the hydrocarbons and the LMPCs at issue or

identifying the cause-and-effect relationship between hydrocarbons and chronic

sinusitis.

2. Failure to Identify an Association, to Critique the Epidemiology

Studies, or to Apply the Bradford Hill Factors

Under Daubert, “courts must carefully analyze the studies on which experts

rely for their opinions before admitting their testimony.”16 Knight, 482 F.3d at 355.

Courts “may exclude expert testimony based on epidemiological studies where the

studies are insufficient, whether considered individually or collectively, to support

16 There are three different types of epidemiological studies: cohort studies, case control studies

and cross-sectional studies. “A cohort study measures and compares the incidence of disease in

the exposed and unexposed (control) groups.” In re Deepwater Horizon Belo Cases, 2020 WL

6689212, at *9 n.30 (citation and internal quotation marks omitted). “A case-control study

measures and compares the frequency of exposure between a group where participants have the

disease (cases) and a control group where participants do not have the disease.” Id. “In a cross-

sectional study, both exposure and disease are determined in an individual at the same point in

time, and therefore, it is not possible to establish the temporal relation between exposure and

disease from this type of study.” Id.

the expert’s causation opinion.” Baker v. Chevron USA, Inc., 680 F. Supp. 2d 865,

875 (S. D. Ohio 2010) (citing Joiner, 522 U.S. at 146–47). A court may conclude

“there is simply too great an analytical gap between the data and the opinion”

offered. Joiner, 522 U.S. at 146. Courts have excluded expert opinions on

causation based on epidemiological and other scientific studies for several reasons,

including: (1) the studies “do not represent statistically significant results,” (2) the

studies merely provide “a suggestion or possibility of a relationship;” (3) the studies

are “inconclusive;” (4) the studies note “that the subjects were exposed to a range

of substances and then nonspecifically notes increases in disease incidence;” (5) the

studies “do not examine the precise disease at issue;” and (6) the studies’ authors

“expressly disclaim the causal relationship that the expert relies upon the study to

prove.” Burst v. Shell Oil Co., 2015 WL 3755953, at *6–7 (E.D. La. June 16, 2015)

(collecting cases), aff’d, 650 F. App’x 170 (5th Cir. 2016).

Here, while Dr. Solomon relies on epidemiological studies to support her

general causation opinions, she fails to provide more than a cursory discussion,

limited mostly to a few sentences describing the study, for the five (5) studies in her

report. See ECF Doc. 466-1 at 15–16. For example, all she writes about the

McGowan 2017 study is that it is “[a] study in BP oil spill clean-up workers exposed

to Corexit EC9527A/EC9500A [which] found significant evidence of respiratory

toxicity with significant increases in burning and irritation of the nose, throat and

lungs in exposed workers.” Id. at 15. Dr. Solomon omits other critical limitations

of the McGowan study, including that it is a cross-sectional study based on self-

reported symptoms, which could result in bias, over-reporting of symptoms and

exposure misclassification. D. Alexander Expert Report, ECF Doc. 469-4 (attached

to Daubert motion for Dr. Freeman).17 Additionally, the study focused on acute,

rather than chronic conditions. Id. at 43. Because of these limitations, the authors

specifically stated the results “do not allow exploration of exposure-response

relationships.” Id. at 47.

In her first declaration, submitted in response to BP’s motion, Dr. Solomon

points out that she “critiqued” the studies. ECF Doc. 514-3 at 3. Dr. Solomon uses

that term liberally. Aside from a one-sentence description of the Velazquez 2020

study, Dr. Solomon merely notes that the study does not “differentiate between

specific types of vapors, gases, fumes and mists.” ECF Doc. 466-1 at 15. She does

not explain how the study is relevant to her opinions or even how she relied upon it.

She further does not explain the “extent to which [these] limitations compromise

[her] findings … about causation.” Ref. Man. at 553 (“Assessing whether an

association is causal requires an understanding of the strengths and weaknesses of

17 As noted in the discussion of Dr. Carpenter’s opinions, infra, Dr. Carpenter agreed cross-

sectional studies, such as the McGowan study, are not designed to determine causal relationships.

the study’s design and implementation, as well as a judgment about how the study

findings fit with other scientific knowledge.”).

Also, of the five (5) studies included in the report, the only study which Dr.

Solomon considered to be of “low reliability” was the Dietz de Loos 2021 study, a

cross-sectional study which identified no association between exposure to household

cleaning products and sinusitis. ECF Doc. 466-1 at 16. Even so, she does not discuss

how that failure affected her reliance on the study or even how the study played into

her opinion. Dr. Solomon’s report contains no “discussion, critique, or assessment

of the quality, design, or relevance” of any study on which she relies. See In re

Deepwater Horizon Belo Cases, 2020 WL 6689212, at *12.

According to Dr. Solomon’s declarations, she primarily relied on the Rusiecki

2022 study (sometimes referenced by others as the 2021 study) to show an

association between exposure to the DWH Spill and chronic sinusitis. The Rusiecki

study, titled “Incidence of Chronic Respiratory Conditions Among Oil Spill

Responders: Five Years of Follow-up in the Deepwater Horizon Oil Spill Coast

Guard Cohort Study,” is a prospective cohort study of over 40,000 U.S. Coast Guard

(“USCG”) members identified as those who responded to the DWH Spill versus non-

responders, which contains some cross-sectional components. ECF Doc. 543-1.

The cohort group, consisting of those who responded to the DWH Spill, included

8,696 USCG personnel. Id. at 3. Within the responders group, the study then

considered different types of exposures: (1) exposure to crude oil via any route

versus no exposure; (2) exposure to crude oil via inhalation versus no exposure; (3)

ever being in the vicinity of burning oil; and (4) exposure to crude oil and dispersants

versus no exposure. Id. at 4. While the authors of the study identified symptoms

based on available medical records, exposure was based on self-reporting obtained

via surveys. Id.

Calculated in terms of an adjusted hazard ratio a/k/a relative risk ratio,18 the

study found no increased risk of chronic sinusitis (1) between Coast Guard

responders versus non-responders (the largest group) (Table 2); (2) between Coast

Guard responders reporting exposure to oil versus those who reported no exposure19

(Table 3); (3) between Coast Guard responders reporting exposure to oil and

dispersants versus those who did not report any exposure (Table 5); and (4) Coast

18 “Relative risk is simply a comparison of the incidence of a disease in exposed individuals with

its incidence in unexposed individuals. A relative risk of 1.0 means there is no difference in risk

between the exposed and unexposed groups; in other words, there is no association between

exposure to the [chemical] and the disease. A relative risk above 1.0 indicates an increased risk in

the exposed group, and risks greater than 2.0 permit an inference that the disease was more likely

than not caused by the [chemical]. Relative risk estimates are often accompanied by a confidence

interval, which provides, in essence, a margin of error. Confidence intervals identify the range of

likely values, on either side of the relative risk estimate for a population sample, that would be

expected to encompass the results a specified percentage of the time (e.g., 95%) if random samples

were repeatedly drawn from the same population as the subject study. Importantly, if the

confidence interval contains the value 1.0 or less, then the results of the study are not considered

statistically significant. On the other hand, if the lower bound of the confidence interval exceeds

1.0, then the results are considered statistically significant.” In re Abilify, 299 F. Supp. 3d at 1313–

14 (internal citations, quotation marks, and alterations omitted).

19 When the study for this group was restricted to never smokers, the results were essentially the

same – no elevated risk for chronic sinusitis and a reduced risk for chronic rhinitis. ECF Doc. 543-

1 at 21, Supplemental Table 4.

Guard responders in the vicinity of in-situ burns versus those who were not there

(Supplemental Table 6). ECF Doc. 543-1. Interestingly, the study also found a

reduced risk for sinusitis for those USCG responders exposed to both crude oil and

dispersants (Table 5) and a reduced risk for chronic rhinitis for those who were

exposed to oil versus those who were not (Table 3)20. Id.

Although the study found no statistically significant association between (1)

chronic sinusitis and exposure to crude oil between responders and non-responders,

(2) those responders exposed to crude oil versus those who had never been exposed;

or (3) those who were exposed to in situ burns versus those who had never been

exposed; the study found an increased risk in chronic sinusitis, at a hazard ratio of

1.48 for chronic sinusitis and 1.55 for unspecified chronic sinusitis, for Coast Guard

responders who reported inhalation exposure to oil (Table 4). Id. at 7. However,

when the cofounders for smokers were removed (i.e., the study was restricted to

“never” smokers), the results were statistically insignificant. ECF Doc. 543-1 at 23

(Supplemental Table 5).

Despite the study’s limitations, Dr. Solomon found the study to be “very

reliable” because “(1) [i]t is a large prospective cohort study without any selection

20 In her deposition, Dr. Solomon explained chronic rhinitis occurs extremely frequently in the

absence of chronic sinusitis. Thus, if someone has chronic sinusitis, they are very likely to have

rhinitis, but the converse may not be true. G. Solomon Depo., at 146. This explanation, however,

furthers calls the study into question given the negative results for chronic rhinitis.

bias in the cohort; (2) the participants generally had complete medical records both

before and after the spill, allowing evaluation of temporality; (3) exposure histories

were detailed and collected soon after deployment (in June and November 2010) so

would not suffer from recall bias; and (4) the comparisons were limited to never-

smokers, so the results were not confounded by smoking.” ECF Doc. 466-1 at 16.

The only limitation Dr. Solomon discussed in her reports was that the population

was limited to Coast Guard workers, which were likely healthier overall as compared

to the general population of cleanup workers. Id. at 17. Dr. Solomon’s perfunctory

analysis is not sufficient.

When evaluating epidemiological evidence, “the methodological soundness

of a study . . . must be assessed,” with “the key questions” being whether a study’s

limitations compromise its findings and the extent to which the study permits an

inference regarding causation. Ref. Man. at 553–54. Dr. Solomon, however,

ignored the limitations in the Rusiecki study in her report. She makes no mention

of the internal inconsistencies in the findings for the subgroups, and when asked

about those inconsistences in her deposition, she stated those issues did not cause

her to question the quality of the study. G. Solomon Depo., at 150:11–14. She does

not discuss the fact that the study included self-reported exposure, even though she

admitted in her deposition such self-reports “clearly [make a study] less reliable.”

G. Solomon Depo., at 61:1–6. She summarily dismissed the lack of a statistically

significant association between crude oil inhalation exposure and chronic sinusitis

when the study was adjusted to exclude ever smokers to the reduction in sample size.

G. Solomon Depo., at 165–67; ECF Doc. 514-3 at 3. Dr. Solomon’s wholesale

failure to discuss these clear limitations in the Rusiecki study renders her opinions

unreliable. See Joiner, 522 U.S. at 146 (“Trained experts commonly extrapolate

from existing data. But nothing in either Daubert or the Federal Rules of Evidence

requires a district court to admit opinion evidence that is connected to existing data

only by the ipse dixit of the expert.”).

In Dr. Solomon’s supplemental declaration, she attempts to address these

limitations in more detail, but even then fails to provide a sufficient analysis because

all she does is address the specific issues raised by BP’s expert. That is not how the

epidemiological method works. As part of the methodology, Dr. Solomon was

required to critique the studies she relied on, address the limitations she clearly

acknowledged existed, and apply the Bradford Hill factors. The methodology is not

for Dr. Solomon to ignore the limitations until someone points them out to her.

Also, in Dr. Solomon’s declarations, she references the Lawrence 2022 study.

As an initial matter, Dr. Solomon cannot rely on the Lawrence study to support her

opinions because it was not available until after Dr. Solomon issued her report and

after she was deposed. Regardless, the Lawrence study is not relevant because it

does not address chronic sinusitis. Instead, it is a cohort study of over 19,000

cleanup workers and 7,671 nonworkers designed to assess the relationship between

exposure to the DWH Spill and asthma for workers and non-workers – not the

LMPCs at issue here. See Anderson v. Bristol Myers Squibb Co., 1998 WL

35178199, at *9–11 (S.D. Tex. April 20, 1998) (finding that an expert may not use

studies purporting to prove one fact in order to infer that the same studies prove a

different fact). Regardless, the study contained several limitations which were not

discussed by Dr. Solomon. For example, the study was based on self-reported

symptoms of wheezing and self-reported physician diagnoses of asthma. See ECF

Doc. 543-4 at 1, 6 (Lawrence Study); see also ECF Doc. 543-3 at 3–4 (Alexander

Decl.) (discussing limitations). Also, although the study found the DWH Spill

workers had a greater risk of asthma than nonworkers, no statistically significant

association was identified once self-reported symptoms of wheezing were removed.

Id. at 4.

Even if the Rusiecki (or Lawrence) study was sufficient to establish an

association and Dr. Solomon had provided a critical analysis of the studies, Dr.

Solomon failed to meaningfully consider the Bradford Hill factors as is necessary to

determine a cause-and-effect relationship. In her report, Dr. Solomon acknowledges

“the original conception of causal inference” was developed by Sir Austin Bradford

Hill. ECF Doc. 466-1 at 8. Dr. Solomon, however, expends no effort in discussing

any of the factors. Instead, Dr. Solomon merely addresses three factors in summary

fashion by stating (1) she evaluated the quality of the evidence to ensure bias or

confounding is minimal; (2) she considered whether the findings from multiple

streams of evidence are coherent; and (3) she ensured that temporality is met, i.e.,

that the exposure occurred before the disease. Id. at 8–9. Although the Bradford

Hill factors should not be rigidly applied, an expert must provide more than “lip

service” to the factors. See In re Deepwater Horizon Belo Cases, 2020 WL 6689212,

at *14; see also Burst, 2015 WL 3755953, at *10 (finding expert failed “to provide

a meaningful analysis in which he reconciles conflicting studies or applies the

Bradford Hill criteria to the gasoline-specific studies”). Thus, to the extent Dr.

Solomon relies on epidemiology to support her causation opinions, she has failed to

employ a reliable methodology.

3. Failure to Discuss Dose Response

In her first declaration, Dr. Solomon argues the Rusiecki study establishes a

dose-response relationship. That, however, can simply not be the case. A dose-

response relationship exists when “a change in amount, intensity, or duration of

exposure to an agent is associated with a change—either an increase or decrease—

in risk of disease.” McClain, 401 F.3d at 1241–42. The Rusiecki study is an

“ever/never” categorical study, which compares those who were ever exposed with

those who were never exposed.21 The study did not examine the length of any

participant’s exposure, the amount of any exposure, or even when the sinusitis was

diagnosed. The study did not provide “any assessment of actual exposure, let alone

the level of exposure to a particular chemical.” See Schexnayder v. BP Expl. &

Prod., Inc., 2022 WL 11767540, at *8 (E.D. La. Oct. 20, 2022) (noting that the study

was “silent on the level of exposure”) (citation, internal quotation marks, and

emphasis omitted). Thus, the study does not show an increased exposure to

hydrocarbons resulted in an increased risk of chronic sinusitis. As the Eleventh

Circuit stated and this Court reiterated in the Williams Order, “an expert who

‘neglects this principle of toxic torts without justification casts suspicion on the

reliability of his methodology.’” In re Deepwater Horizon Belo Cases, 2020 WL

6689212, at *9 n.29 (quoting McClain, 401 F.3d at 1241–42).

21 BP filed a notice of supplemental authority, ECF Doc. 529, attaching an opinion from the

Eastern District of Louisiana, English v. BP, No. 17-cv-4325, ECF Doc. 80 (E.D. La. Sept. 26,

2022), granting a motion to exclude James Cook as an expert and describing the Rusiecki study as

an “ever/never” study which does not “answer the essential question of what level of exposure is

necessary to cause the particular symptoms.” ECF Doc. 529-1 at 19 (emphasis omitted). Plaintiffs

moved to strike the notice, ECF Doc. 537, contending Judge Vitter should be disqualified from

deciding BELO cases because she is biased. See also Smith v. BP Expl. & Prod., Inc., 2022 WL

17403568, at *1 (E.D. La. Dec. 2, 2022) (denying motion to disqualify and recuse). The

undersigned can consider any opinion from another court as persuasive and does so here. Thus,

the motion to strike is DENIED. Moreover, although Plaintiffs take issue with Judge Vitter’s

description of the Rusiecki study as an “ever/never” study as “lay-person speak,” that term is used

by the authors of the study. ECF Doc. 543-1 at 10.

4. Failure to Consider Background Risk of Disease

Dr. Solomon also does not address the background risk of disease in her

report, even though she acknowledged the background risk of chronic rhinosinusitis

in the general population is over 10%. G. Solomon Depo., at 55:4–13. In her

deposition, Dr. Solomon contends she thought about the background rates of disease

and simply did not discuss it in her report. Id. at 55:14–20. Nonetheless, in her first

declaration, Dr. Solomon explains a consideration of background risk of disease is

not necessary because exposed and unexposed Coast Guardsmen in the Rusiecki

study, “which is a basis of [her] opinion,” “face the normal background risk of

sinusitis.” ECF Doc. 514-3 at 6. Dr. Solomon’s explanation is a non-starter. “[A]

failure to identify or describe the background risk of a disease is a ‘serious

methodological deficiency’ and ‘substantial weakness’ in an expert’s general

causation opinion.” In re Abilify, 299 F. Supp. 3d at 1308 (quoting Chapman, 766

F.3d at 1308). Indeed, “[i]gnoring available evidence about background risks may

be fatal to an expert’s general causation opinion.” Jones v. Novartis Pharms. Corp.,

235 F. Supp. 3d 1244, 1280 (N.D. Ala. 2017), aff’d in part sub nom., Jones v.

Novartis Pharms. Co., 720 F. App’x 1006 (11th Cir. 2018).

Because Dr. Solomon failed to identify a statistically significant association

in the literature, failed to meaningfully critique the Rusiecki 2022 study, or any other

epidemiological study, failed to provide more than a hasty discussion of the Bradford

Hill factors, failed to discuss the dose-response relationship or background risk of

disease, and failed to identify a harmful dose, the undersigned finds Dr. Solomon’s

opinions to be neither reliable nor helpful; thus, the opinions should be excluded.

B. Dr. David Carpenter

David O. Carpenter, M.D., is a public health expert. Although he was trained

as a medical doctor, he pursued a career in biomedical research and public health

rather than patient care. ECF Doc. 513-1 at 2. Dr. Carpenter offers the following

general causation opinion: “[t]here is strong evidence that exposure to all of the

components of crude oil, and especially when the oil exposure is accompanied by

exposure to dispersants containing 2-butoxyethanol, increases risk of allergic

conjunctivitis and dry eye disease.”22 Id. at 10. BP argues Dr. Carpenter’s

qualifications “do not fit” this case. ECF Doc. 468 at 1. BP also argues, even if

qualified, Dr. Carpenter’s opinions are neither reliable nor helpful because Dr.

Carpenter (1) failed to identify a chemical or mixture of chemicals he contends could

have caused the harm alleged by Plaintiffs or the level of such chemical that can

cause the harm; (2) failed to use a reliable methodology to arrive at a statistically

significant association; and (3) failed to use any of the three “indispensable” methods

22 Dr. Carpenter also offers the following specific causation opinion: “the keratoconjunctivitis

sicca suffered by Mr. Kenneth Davenport and the chronic allergic conjunctivitis and chronic eye

irritation suffered by Mr. Michael Moulder were caused by the exposure to crude oil coming from

the [DWH Spill] and the dispersant chemicals applied to the Gulf.” ECF Doc. 513-1 at 10. The

parties agreed the Court need not address that opinion at this stage.

for establishing general causation. Id. at 1, 13–30. Upon consideration of the

voluminous evidence presented by the parties, including BP’s motion, ECF Doc.

468, Dr. Carpenter’s report, ECF Doc. 468-1, his deposition, ECF Doc. 468-2,

Plaintiffs’ response, ECF Doc. 513, and his supplemental declaration, ECF Doc.

513-2, the undersigned finds Dr. Carpenter to be qualified to provide an opinion in

these cases on general causation but finds his opinions to be unreliable and

unhelpful.

1. Qualification

BP argues Dr. Carpenter lacks the requisite expertise to offer opinions

regarding general causation because he is not an epidemiologist or toxicologist, is

not a practicing doctor, and is “new” to the study of eye conditions and oil spills.

ECF Doc. 468 at 4–5. These facts, however, do not disqualify him from providing

an opinion on general causation.

“An expert is not necessarily unqualified simply because [his] experience

does not precisely match the matter at hand.” Furmanite Am., Inc. v. T.D.

Williamson, Inc., 506 F. Supp. 2d 1126, 1129 (M.D. Fla. 2007) (citing Maiz v.

Virani, 253 F.3d 641, 665 (11th Cir. 2001)). “So long as the [expert] is minimally

qualified, objections to the level of [his] expertise go to credibility and weight, not

admissibility.” Hendrix v. Evenflo Co., 255 F.R.D. 568, 585 (N.D. Fla. 2009), aff’d

sub nom., Hendrix ex rel. G.P. v. Evenflo Co., Inc., 609 F.3d 1183 (11th Cir. 2010)

(citation, internal quotation marks, and alteration omitted). “The critical question

for qualification purposes is whether the proffered expert has such ‘knowledge, skill,

experience, training, or education’ that his opinion will aid the trier of fact in

understanding the evidence or resolving a factual issue.” In re Abilify, 299 F. Supp.

3d at 1348 (quoting Fed. R. Evid. 702).

The fact that Dr. Carpenter is neither an epidemiologist nor a toxicologist does

not disqualify him from testifying about epidemiological studies or providing a

general causation opinion based on those studies. See id. at 1349; In re Mirena IUD

Prods. Liab. Litig., 169 F. Supp. 3d 396, 426 (S.D.N.Y. 2016) (stating that “medical

doctors do not need to be epidemiologists in order to testify regarding

epidemiological studies”). Dr. Carpenter is experienced in public health, a branch

of medicine that seeks to identify causes of disease and steps that can be taken to

reduce exposure to disease. D. Carpenter Depo., at 10:1–14. His research over the

last 25 years has included examining the health effects of persistent organic

chemicals, air pollutions, environmental exposures, and the diseases that result from

those exposures. Id. at 10–11. While he does not consider himself an epidemiologist

or toxicologist, he has published peer-reviewed articles on those topics. Id. at 12.

Moreover, BP has not demonstrated that Dr. Carpenter “does not have the

skills or the knowledge to examine epidemiological studies meaningfully.”

Wagoner v. Exxon Mobil Corp., 813 F. Supp. 2d 771, 800 (E.D. La. 2011). Instead,

BP points out that the opinions offered here appear to be the first time Dr. Carpenter

has issued an opinion on the oil spill or the LMPCs at issue. ECF Doc. 468 at 13–

15. That, however, does not mean he is not qualified to do so. Thus, while Dr.

Carpenter may not be the best or most qualified authority in the field of

epidemiology or toxicology, the undersigned finds, given the liberal standards for

qualification under Rule 702, that Dr. Carpenter’s background and education qualify

him to provide a general causation opinion. In re Abilify, 299 F. Supp. 3d at 1349

(“A witness need not be the best or most qualified authority in a field to be admitted

as an expert”); Wagoner, 813 F. Supp. 2d at 800 (“In keeping with the spirit of Rule

702, Dr. Saux will be considered an expert although obviously he would not be held

in the same esteem as an expert who is, in fact, an epidemiologist.”) (citation,

internal quotation marks, and alteration omitted).

2. Failure to Identify Harmful Chemical(s) or a Threshold Level

As set forth in Dr. Carpenter’s report, there are over 17,000 chemicals in crude

oil. ECF Doc. 468-1 at 7. Dr. Carpenter acknowledges “some are not very toxic to

humans.” Id. Dr. Carpenter discusses volatile organic compounds (“VOCs”) in

crude oil, identifies some of those as being benzene, toluene, ethyl benzene and

xylene (“BTEX”), and states that of those, benzene is a potent carcinogen. Id.

Nowhere in Dr. Carpenter’s report, however, does he link any specific chemical or

mixture of chemicals to the LMPCs at issue. As stated above, Dr. Carpenter’s

opinion is based on “exposure to all of the components of crude oil, and especially

when the oil exposure is accompanied by exposure to dispersants containing 2-

butoxyethanol.” Id. at 10 (emphasis added).

Although Dr. Carpenter references several chemicals that “likely” caused

chronic conjunctivitis, id. at 7, he admits in his deposition he does not have sufficient

information to “focus on individual chemicals,” D. Carpenter Depo., at 22:5–7. He

cannot point to any study that shows exposure to VOCs can cause chronic eye

conditions. Id. at 39–41, 50–53. According to Dr. Carpenter, conjunctivitis is

caused by an allergic reaction to some chemical – what chemical, however, Dr.

Carpenter cannot say. Id. at 49–50. It “could be 2-butoxyethanol because it’s

present in so many consumer products,” “[i]t could be a component of the oil itself.”

Id. at 50. In his supplemental declaration, Dr. Carpenter contends the chemicals he

links to chronic conjunctivitis are benzene, propylene-glycol, and 2-butoxyethanol.

ECF Doc. 513-2 at 5–6. Dr. Carpenter acknowledges, however, that benzene has

been connected to an increased risk of cancer – not chronic conjunctivitis, and 2-

butoxyethanol to signs of eye and other “irritations” – not chronic conjunctivitis.

Id.; see D. Carpenter Depo., at 41–42 (admitting there is no evidence benzene can

cause chronic eye conditions). He also acknowledges 2-butoxyethanol is a chemical

included in many consumer products. Id. at 47–48.

Dr. Carpenter’s opinion that exposure to “components of crude oil” caused an

allergy, without the identification of any particular chemical or mixture of

chemicals, is insufficient. As this Court23 and other BELO courts have found, the

failure of an expert to “link any specific chemical that [plaintiff] was allegedly

exposed to,” renders the opinion unhelpful. See, e.g., Wade v. BP Expl. & Prod.,

Inc., 2022 WL 4448232, at *8 (E.D. La. Sept. 23, 2022) (“Dr. Cook’s conclusion

that there is a cause-and-effect relationship between the respiratory, ocular, and

dermal conditions he analyzed and exposure to crude oil, including weathered crude

oil, is unhelpful without identifying the specific chemicals and exposure levels

capable of causing specific conditions alleged by plaintiff.”) (internal quotation

marks omitted); Schexnayder, 2022 WL 11767540, at *8 (excluding Dr. Cook on

the same basis).

Dr. Carpenter also does not identify the minimum dose at which any chemical

in the tarballs can cause ocular conjunctivitis. Instead, in his deposition, Dr.

Carpenter explains his opinion is premised on there being no “safe level” for any

chemical, much less any chemical in the weathered oil, because, while such chemical

“certainly doesn’t cause disease,” even “one molecule perturbs the physiological

23 In arguing the Court need not consider general causation, as that issue was decided by the MSA,

Plaintiffs relied upon some comments made by BP’s expert, Dr. Shea. This Court rejected

Plaintiffs’ position, however, on several grounds, including that Dr. Shea was “generally

referencing the entire universe of substances related to the Deepwater Horizon incident and was

not recognizing a scientific link between any specific substance and any particular medical

condition.” In re Deepwater Horizon Belo Cases, 2020 WL 6689212, at *9.

system.” D. Carpenter Depo., at 35:2–20. An opinion that any amount is harmful

is simply contrary to the law in this Circuit. As stated above, the identification of a

harmful dose is a minimum requirement for establishing general causation in these

BELO cases and without this information, an expert’s opinion is neither reliable nor

helpful.

In sum, Dr. Carpenter’s “assum[ption]” a link exists between the LMPCs at

issue and “one of the components of either the oil itself manifested in tar balls or the

dispersant that was incorporated into those tarballs” simply does not move the needle

on general causation. D. Carpenter Depo., at 70:3–16. Moreover, as discussed

below, even if Dr. Carpenter’s reference to “tarballs,” generally, was sufficient, the

studies Dr. Carpenter relied upon to identify an association between the tarballs and

the subject eye disease are not relevant.

3. Failure to Identify an Association, to Critique Epidemiological

Studies, or to Apply Bradford Hill Factors

As discussed above, a reliable epidemiology method involves two steps. The

first is to identify an association through the literature between the exposure and the

LMPCs at issue. The second is to apply the Bradford Hill factors to establish a cause

and effect relationship. Dr. Carpenter, however, failed to follow either step.

Dr. Carpenter admitted during his deposition there are “no peer-reviewed

studies that [he] can point to that identify which component in those tarballs, or the

whatever was washing up on the beach, is responsible for the acute and the chronic

event,” complained of by the Plaintiffs. D. Carpenter Depo., at 73:12–17. Instead,

Dr. Carpenter relies on “the aggregate scientific literature,” pertaining to other oil

spills and the DWH Spill in an attempt to establish an association between

conjunctivitis and oil, id. at 22:15–16, and argues the association does not have to

be statistically significant.

Starting with the latter argument, several courts have determined that to be

reliable and helpful an association must be statistically significant. See, e.g., In re

Seroquel Prods. Liab. Litig., 2009 WL 3806434, at *12 (M.D. Fla. June 18, 2009)

(“the reliability of an expert’s opinion should be seriously questioned, and perhaps

even excluded altogether, when the expert can point to no evidence showing a

statistically significant increased risk of disease”) (emphasis in original); Soldo v.

Sandoz Pharms. Corp., 244 F. Supp. 2d 434, 533–34 (W.D. Pa. 2003) (finding

medical experts’ general causation opinions unreliable because none of the

epidemiologic studies upon which they relied showed a statistically significant

positive association between the drug and the disease at issue). “The Bradford–Hill

criteria can only be applied after a statistically significant association has been

identified.” See, e.g., Frischhertz v. SmithKline Beecham Corp., 2012 WL 6697124,

at *3 (E.D. La. Dec. 21, 2012); see also In re Lipitor (Atorvastatin Calcium) Mktg.,

Sales Practices and Prods. Liab. Litig., 174 F. Supp. 3d 911, 924 (D.S.C. 2016)

(“[w]hile a causation opinion need not be based on epidemiological studies, it is well

established that the Bradford Hill method used by epidemiologists does require that

an association be established through studies with statistically significant results”)

(internal citation omitted) (emphasis in original).24

The Court, however, need not decide whether an association must be

statistically significant here because, as discussed below, none of the studies relied

upon by Dr. Carpenter, alone or in totality, identify an association, much less a

statistically significant one, between any chemical or mixture of chemicals in the oil

and conjunctivitis, and Dr. Carpenter’s attempt to extrapolate an association from

the studies is too great a leap. Moreover, Dr. Carpenter’s analysis of those studies

is conclusory, at best.

The analysis section of Dr. Carpenter’s 9-page report includes a 1½-page

description of the DWH Spill, a ½-page description of conjunctivitis, and a 1-page

description of the conclusions of the studies he relied upon in reaching his general

causation opinion. ECF Doc. 468-1 at 6–9. Those other studies include the

following:

24 Plaintiffs cite to Acerra v. Trulieve Cannabis Corp., 2021 WL 1269919, at *5 (N.D. Fla. Mar.

18, 2021), as supporting their position that Dr. Carpenter is not required to prove a statistically

significant association. ECF Doc. 513 at 29-30. Plaintiffs’ reliance on Acerra is misplaced.

Accerra was a suit brought under the Private Securities Litigation Reform Act based on material

misstatements or omissions in defendant’s public filings. The language Plaintiffs quote from

Judge Hinkle pertains to the requirement that plaintiffs show “something more” than the existence

of reports of adverse events for a drug to succeed on a fraudulent omission claim. Neither that

case nor the Supreme Court’s decision in Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27

(2011) cited by Judge Hinkle, has anything to do with general causation in a toxic torts case.

• The Sea Empress oil spill, discussed in the Lyons (1998) article, occurred in

1996 at the harbor entrance off the coast of Wales. The oil reached the

shoreline within a week. Residents living in the nearby coast area reported

sore eyes.

• The Awoyesuku cross-sectional study of 1,726 residents of communities

affected by crude oil spillage in Nigeria. The residents attended a free eye

screening event in 2018, which showed 6.5% had allergic conjunctivitis. But

there was no unexposed comparison group.

• The Na (2012) and Kim (2013) studies of the Hebei Spirit oil spill which

occurred 5 miles off coast of South Korea. The Na study evaluated the long-

term health effects on responders. The Kim study evaluated the long-term

health effects of residents living near the oil spill and found elevated rates of

conjunctivitis in both men and women.

• The Omoti study, which showed a higher rate of allergic conjunctivitis among

technical workers than non-technical workers of the Nigerian National

Petroleum Corporation who worked in refineries.

Nowhere in the report does Dr. Carpenter explain how other oil spills (e.g.,

Sea Empress spill, Hebei Spirit spill), which occurred close to shore, support his

opinions or are relevant to the DWH Spill, which occurred over 100 miles from

shore, and took more than a month to reach the shoreline. He does not discuss the

differences between the composition of crude oil in those other spills and the

composition of weathered oil at issue for the DHW Spill. He does not address how

oil spills, which occurred in Wales and South Korea, respectively, are relevant to the

DWH Spill, which occurred off the coast of Florida. He does not discuss the fact

that some of these studies involved acute health symptoms rather than chronic ocular

disease. Instead, all he provides is the place of the spill, the year of the spill, and the

results of the studies. ECF Doc. 468-1 at 9.

When questioned about these differences in his deposition, Dr. Carpenter

stated he was not sure he found such differences to be “very important.” D.

Carpenter Depo., at 62:2–9. In the Williams Order, however, this Court determined

such differences are important and such studies have no relevance to the issues at

hand without explanation. In re Deepwater Horizon Belo Cases, 2020 WL 6689212,

at * 13 (criticizing Dr. Williams’ reliance on studies that “occurred close to shore

and involved fresh crude oil, whereas the Deepwater Horizon spill occurred

approximately 125 miles offshore of Florida . . . , and exposed cleanup workers on

Florida beaches to weathered oil”).

Dr. Carpenter’s discussion of studies related to the DWH Spill is likewise

deficient.25 Dr. Carpenter identifies Alexander 2018 and Rusiecki 2018 as two

studies he considered. ECF Doc. 468-1 at 10. He admits in his deposition, however,

that neither reported on eye symptoms. D. Carpenter Depo., at 81:10–17. He

references the Krishnamurthy 2019 study as a study reporting health effects of clean-

up workers in the Coast Guard cohort at the end of their deployment. ECF Doc.

468-1 at 10. Other than briefly describing the study and its results, Dr. Carpenter

25 In Dr. Carpenter’s declaration he also discusses the Lawrence 2022 study. As discussed above

under Dr. Solomon’s opinion, that study was also not based on Plaintiffs’ illnesses, but on asthma.

says no more about the study. See id. Yet, in his deposition he acknowledged the

study was based on self-reports, was a cross-sectional study, and was based on acute

neurological symptoms, not conjunctivitis. D. Carpenter Depo., at 81–85. Dr.

Carpenter claims he considered those limitations, but neither his report nor his

declaration bear that out. Plaintiffs also argue “[a]ll chronic illnesses started as acute

illnesses,” to support Dr. Carpenter’s reliance on studies such as the McGowan 2017

study, the Na 2012 study, and the Lawrence 2022 study, which are based on self-

reported or other reports of acute symptoms. ECF Doc. 513 at 25. This cursory and

circular explanation, however, is not sufficient. While certainly some acute

symptoms can lead to chronic conditions, that is not always the case. Thus, it was

incumbent upon Dr. Carpenter to discuss how he makes that extrapolation for these

particular LMPCs.26

Dr. Carpenter relies on the D’Andrea 2013 study,27 but fails to address

selection bias, which was a limitation of the study Dr. Carpenter acknowledged in

his deposition. D. Carpenter Depo., at 95-97. He does not discuss the fact or effect

of the study looking at people from Louisiana versus Florida. Id. at 92:6–9. He does

26 In the Williams Order, the Court noted that BP’s expert, Dr. Cox, stated, “it is not medically or

toxicologically acceptable to do a causation analysis for acute conditions, then to substitute that

analysis to support conclusions about chronic conditions.” In re Deepwater Horizon Belo Cases,

2020 WL 6689212, at *13 (internal quotation marks and alteration omitted).

27 Dr. Carpenter describes the D’Andrea study as a retrospective study of 117 clean-up workers as

compared to 130 unexposed persons, which reported elevated risks of double vision and blindness

for the cleanup workers. ECF Doc. 468-1 at 10. The participants were referred to the clinic for

medical evaluation by their legal representatives.

not address the fact that this study, like the others, was also based on acute symptoms

and was not based on conjunctivitis. Id. at 91:2–16. There are no discussions of the

fact the McGowan 2017 study was a cross-sectional study, which by Dr. Carpenter’s

own admission is “not designed to determine causal relationships.” Id. at 87:2–9.

Dr. Carpenter did not discuss any of the limitations associated with any of the studies

he relies upon, despite admitting in his depositions that the limitations exist. Id. at

81–87. As this Court stated in the Williams Order, “[a]n expert opinion, even if

supported by a lengthy list of case studies and treatises, is not reliable without an

explanation of the logical steps supporting it.” In re Deepwater Horizon Belo Cases,

2020 WL 6689212, at *12.

Second, despite acknowledging that in his practice when he examines

evidence for causation, he employs the Bradford Hill factors, ECF Doc. 468-1 at 4–

5, in his report, Dr. Carpenter merely identifies the factors without discussing their

application to any study. Dr. Carpenter does not indicate which factors were met or

how they were met. He does not even identify in the report which factors he

considered. Simply listing the factors and defining them do not equate to an analysis.

As this Court stated in In re Abilify, “it is crucial that the expert describe each step

in the process by which he gathered and assessed relevant scientific evidence.” In

re Abilify, 299 F. Supp. 3d at 1311. Otherwise, what the expert is asking the Court

to do is accept his ipse dixit as evidence of causation, which the Court cannot do.

See id. Thus, the undersigned finds that, to the extent Dr. Carpenter relies on

epidemiology to support his general causation opinion, he has failed to follow

acceptable methodology.

4. Failure to Consider Dose Response

Dr. Carpenter has also not provided any discussion of a dose-response

relationship. Dr. Carpenter explains in his deposition that he considered dose-

response as one of the Bradford Hill factors. D. Carpenter Depo., at 31–32. His

report, however, contains no evidence of any such consideration. Instead, in the

report, after identifying dose-response as a “key” factor, he contends it is often

difficult to quantify and “the lack of a clear dose-response relation does not

invalidate causal connection.” ECF Doc. 468-1 at 5. Plaintiffs argue “[a] dose

response relationship was demonstrated in all 18 epidemiological studies evaluating

oil spills and eye disease that Dr. Carpenter relied on,” with “varying degree of

statistical significance”. ECF Doc. 513 at 38. As discussed above, the studies Dr.

Carpenter relies upon are inapposite. Also, despite Plaintiffs’ broad statement,

neither Plaintiffs nor Dr. Carpenter point to any place in those studies where a dose-

response relationship between a chemical in the oil and chronic conjunctivitis is

identified.

5. Failure to Consider Background Risk of Disease

Plaintiffs do not dispute Dr. Carpenter has engaged in no background risk

analysis. Instead, Plaintiff argues “[a]ny epidemiological studies that include

‘control groups,’ by default, account for the background risk for disease.” Id. at 39.

Regardless of whether background risk is taken into consideration in those studies,

it is nonetheless necessary for Dr. Carpenter, if he is going to give a general causation

opinion, to consider whether the Plaintiffs could have suffered from conjunctivitis

based on other sources. This is particularly true since Dr. Carpenter acknowledged,

“[c]onjunctivitis is a common disease,” of which there are “multiple causes.” ECF

ECF Doc. 468-1 at 8. Moreover, as stated above, according to Dr. Carpenter, 2-

butoxyethanol is present in many consumer products; and yet there is no analysis of

whether the “allergy” Plaintiffs developed to that chemical came from the cleanup

efforts versus exposure to those common consumer products. See id. Instead, Dr.

Carpenter simply assumes the reverse – that Plaintiffs must have developed the

allergy from exposure to the dispersants, and because 2-butoxyethanol is in other

consumer products and Plaintiffs continued to be exposed to the chemical even after

the cleanup efforts had ended, the allergy became permanent. Id. That assumption,

however, is purely speculative and not based on any of the three primary methods

for supporting general causation. See Benkwith v. Matrixx Initiatives, Inc., 467 F.

Supp. 2d 1316, 1329 (M.D. Ala. 2006) (“Dr. Jafek admits in his report that there are

hundreds of reported causes of anosmia. However, Dr. Jafek has not identified the

additional risk that Zicam exposure poses over the risk of anosmia to the general

population.”).

6. Weight of the Evidence

Plaintiffs argue in their written opposition that Dr. Carpenter employed a

“weight of the evidence approach,” using epidemiological principles. ECF Doc. 513

at 26. Similarly, in his declaration submitted in response to BP’s motion, Dr.

Carpenter discounts the limitations in the studies he relies upon because “all the

studies of the health effects of oil spills on humans add to the weight of evidence.”

ECF Doc. 513-2 at 9 (emphasis added). As this Court explained in In re Abilify, a

“weight of the evidence approach to analyzing causation can be considered reliable,

provided the expert considers all available evidence carefully and explains how the

relative weight of the various pieces of evidence led to his conclusion.” 299 F. Supp.

3d at 1311 (citation and internal quotation marks omitted). To use the method, an

expert must “(1) identify an association between an exposure and a disease, (2)

consider a range of plausible explanations for the association, (3) rank the rival

explanations according to their plausibility, (4) seek additional evidence to separate

the more plausible from the less plausible explanations, (5) consider all of the

relevant available evidence, and (6) integrate the evidence using professional

judgment to come to a conclusion about the best explanation.” Id. Dr. Carpenter,

however, has not engaged in any such analysis.

As stated above, Dr. Carpenter admitted there are no-peer reviewed studies

showing an association between exposure to weathered oil and chronic

conjunctivitis. His 9-page report is devoid of any indication he considered other

plausible explanations or that he considered all relevant available evidence. Also,

despite Plaintiffs arguing Dr. Carpenter’s “causation conclusions [are] based on the

total weight of the evidence because no particular Hill criterion is dispositive or

probative,” ECF Doc. 513 at 27, Dr. Carpenter’s report is devoid of an analysis of

any Bradford Hill factors.

Based on the reasons set forth above, the undersigned finds Dr. Carpenter

should be excluded as an expert on general causation.

C. Dr. Michael Freeman

Dr. Michael Freeman is a consultant in the fields of forensic medicine and

forensic epidemiology. ECF Doc. 469-1 at 3. He works as a professor at multiple

universities, has an extensive publication history, has served as an editor of peer-

reviewed journals, and has provided testimony in civil and criminal trials in multiple

jurisdictions. ECF Doc. 469-1 at 3-4. Dr. Freeman authored two expert reports in

this case — one regarding chronic rhinosinusitis for Plaintiffs Jenkins and Siples,

ECF Doc. 469-1, and one regarding chronic conjunctivitis for Plaintiffs Davenport

and Moulder, ECF Doc. 469-2.

In Dr. Freeman’s reports, he concludes “[t]he results of [his] critical review

of the relevant scientific and epidemiologic evidence support a general causal

relationship between occupational exposure to chemicals associated [with] the BP

Deepwater Horizon oil spill” and subsequent chronic rhinosinusitis, chronic

conjunctivitis, and dry eye. ECF Docs. 469-1 at 24; 469-2 at 27. Dr. Freeman

believes: (1) “[b]ased upon the adjusted hazard ratio for chronic sinusitis associated

with crude oil inhalation, there is a minimum additional 55% risk attributable to the

exposure, among those who have been exposed and have the condition”; and (2)

“[t]he evidence indicates an association of [at] least a 24% increased risk in the

general population of exposed workers” for chronic conjunctivitis. Id. BP seeks to

exclude Dr. Freeman’s opinions, arguing (1) he does not provide a dose level at

which an exposure to any particular chemical or mixture of chemicals can cause

chronic rhinosinusitis or conjunctivitis; (2) he ignored or misapplied the three

indispensable methodologies; and (3) his methodology is flawed and unreliable.

After reviewing the evidence presented by the parties, including BP’s motion,

ECF Doc. 469, Dr. Freeman’s reports, ECF Docs. 469-1, 469-2, Dr. Freeman’s

deposition testimony, ECF Doc. 469-3, and Plaintiff’s opposition, ECF Doc. 512,

the undersigned agrees with BP that Dr. Freeman’s general causation opinions

should be excluded as being unreliable and unhelpful. The undersigned also agrees

with BP that Dr. Freeman’s supplemental report should be stricken.

1. Failure to Identify a Harmful Dose or Specific Chemical

As with Dr. Carpenter’s opinions, Dr. Freeman’s general causation opinions

fail to identify a particular chemical or mixture of chemicals capable of causing

Plaintiffs’ LMPCs.28 Instead, his reports refer only generally to “chemicals

associated” with the DWH oil spill. Such a failure is problematic, as not all workers

had the same types of exposures and the available epidemiological studies do not all

address the same exposure scenario. Furthermore, the crude oil emitted from the

wellhead underwent weathering as it traveled to the shore, which changed its

chemical composition. Dr. Freeman acknowledged as much in his report, as he

noted volatile organic compounds found in crude oil evaporate within hours of

reaching the water’s surface. ECF Doc. 469-1 at 13. As stated above, supra Section

V.B.2., other BELO courts have excluded the opinion of plaintiffs’ expert, Dr. Cook,

as being unhelpful for failing to “link any specific chemical that [plaintiff] was

allegedly exposed to . . . to the conditions that he alleges in his complaint.” See, e.g.,

Wade, 2022 WL 4448232, at *8.

28 Dr. Freeman testified he did not attempt to identify the specific chemical or chemicals that

caused the LMPCs and he was leaving that to the toxicological and environmental hygiene experts.

M. Freeman Depo., at 54:19-25, 55:1-3.

And like Plaintiffs’ other general causation experts, Dr. Freeman does not

describe a threshold dose of a chemical which is capable of causing Plaintiffs’

LMPCs. This latter failure is fatal to the admissibility of his opinion, as caselaw

requires Plaintiffs to present at least a threshold range of exposure which is

considered capable of causing their chronic conditions. Cf. In re: Zantac, 2022 WL

17480906, at *17 (“Courts universally reject general causation theories based upon

the idea that any amount of a carcinogen, no matter how small, is actionable because

an infinitesimal risk can neither be proven nor disproven. Thus, since an actionable

exposure threshold dose cannot, as a matter of law, be merely anything, that means

it must be something provable.”); see also Seaman v. Seacor Marine, LLC, 326 F.

App’x 721, 726 (5th Cir. 2009) (finding expert did not establish general causation

because she provided “no clue regarding what would be a harmful level of Ferox

exposure”).

2. Failure to Identify a Reliable Association in the Epidemiological

Studies

To support his claim that “abundant evidence” supports statistically

significant associations between exposure to “products” of the DWH Spill and

chronic rhinosinusitis, Dr. Freeman cites his analysis of data collected by the

National Institute for Occupational Safety and Health (“NIOSH”), the D’Andrea

2018 study, and the Rusiecki 2022 study.

At the request of BP, NIOSH performed a health hazard evaluation (“HHE”)

of DWH onshore response workers. ECF Doc. 469-1 at 14. The HHE involved

observing working conditions and conducting surveys of workers regarding their

exposures and symptoms. Id. Dr. Freeman says his analysis of the NIOSH data

showed 18% of shoreline workers reporting any exposure to dripping oil, tar balls,

dispersant, or dust reported sinus problems, while 4.7% of those reporting no such

exposure reported sinus problems. ECF Doc. 469-1 at 22.

But Dr. Freeman’s use of the NIOSH data was flawed in several fatal respects.

First, the NIOSH HHE was a cross-sectional study. M. Freeman Depo., at 164:7-9

(stating the NIOSH report “is a cross-sectional study, in that it’s looking for the

prevalence of certain conditions in -- in groups”). Participants reported information

regarding their exposure and health symptoms during the cleanup by completing a

single survey. Cross-sectional studies “are rarely useful in identifying toxic agents.”

Ref. Man. at 556. And the authors of the HHE report expressly stated the goals of

the HHE assessments “were to describe acute health effects” and “were not intended

to describe or investigate potential long-term or chronic health effects.”29 M.

Freeman Depo., at 139:20-25, 140:1-2. Despite these red flags, Dr. Freeman used

the report and data to conclude a “product” of the DWH Spill can cause a chronic

29 Similarly, the NIOSH HHE Interim Report 7 indicated “[t]he survey was not specifically

designed for determinations of the cause(s) of reported health conditions.”

condition. See In re Accutane Prods. Liab., 2009 WL 2496444, at *2 (M.D. Fla.

Aug. 11, 2009) (“[W]hen an expert relies on the studies of others, he must not exceed

the limitations the authors themselves place on the study.”).

Plaintiffs argue Dr. Freeman’s reliance on studies regarding acute effects is

permissible, claiming “[a]ll chronic illnesses started as acute illnesses.” ECF Doc.

512 at 16. While that claim may be true, as stated above, supra, Section V.B.3., not

all acute illnesses develop into chronic ones, as symptoms may resolve on their own

or cease when exposure to an irritant ends.30 Thus, as with Dr. Carpenter, Dr.

Freeman’s failure to offer a reasonable explanation for how or why surveys about

acute symptoms can be used to demonstrate an association between exposure and

the development of chronic sinusitis and conjunctivitis undermines the reliability of

his methodology.31 See McClain, 401 F.3d at 1242 (noting that one of the criteria

30 In his declaration, Dr. Freeman states: “[T]he larger the subpopulation with acute symptoms

(e.g., 30% in the group with greater exposure versus 10% in a group with lesser exposure), the

higher the risk of chronic illness diagnosis in the group with the higher frequency of acute

symptoms. Thus, although not an exact measurement of the risk of chronic illness diagnosis, the

frequency of acute symptoms in an exposed population is a proxy for the risk of the chronic disease

which is stable across populations (i.e., there is no reason to believe that acute symptoms convert

to chronic disease at a different rate in the 10% versus 30% acute symptoms groups from the above

example).” ECF Doc. 512-1 at 12. This reasoning is simply too speculative, as Dr. Freeman

admits the probability that acute symptoms will develop into a chronic condition is “unknown”

and it is possible acute symptoms arising from a particular exposure or scenario may develop into

a chronic condition at a different rate than a different exposure or scenario.

31 In his deposition, Dr. Freeman suggested an extrapolation for chronic conjunctivitis was

reasonable because the NIOSH survey participants had reported experiencing symptoms for more

than four weeks. M. Freeman Depo., p. 150:20-25, 151:1-2. However, he then admitted the data

did not indicate the participants had symptoms for any length of time. M. Freeman Depo. P. 152:2-

11. Indeed, the survey form only asked workers, “During oil spill clean-up have you had any of

the following symptoms?” ECF Doc. 512-1 at 23.

for proving causation is “the toxic substance in question must have been

demonstrated to cause the type of illness or disease in question”) (emphasis added)

(quoting David Eaton, Scientific Judgment and Toxic Torts—A Primer in Toxicology

for Judges and Lawyers, 12 J.L. & POL’Y 1, 38 (2003)).

Other features of the NIOSH data weaken its ability to support a general

causation opinion in this case. Because the data was derived from survey responses,

it was based on workers’ self-reported exposures and symptoms and not verified

through other means. Self-reports have the potential to introduce inaccurate

information into a study and skew the results. Cf. Ref. Man. at 585 (Research has

shown that individuals with disease (cases) tend to recall past exposures more readily

than individuals with no disease (controls); this creates a potential for bias called

recall bias.”) (footnote omitted). Considering all of these limitations, the NIOSH

data does not provide reliable support for Dr. Freeman’s general causation opinion.

See ECF Doc. 469-6 at 51 (Dr. Alexander notes the NIOSH data is self-reported

“using a cross-sectional design with no statistical adjustments for confounding

factors” and Dr. Freeman’s analysis of it “provides no reliable or credible evidence

to determine risk of chronic symptoms or conditions.”).

Dr. Freeman’s reliance on the Rusiecki 2022 study is also problematic. Dr.

Freeman uses the 1.55 adjusted hazard ratio the Rusiecki study found between crude

oil inhalation and chronic sinusitis, before smokers were removed, to conclude

“there is a minimum additional 55% risk attributable to the exposure[.]” ECF Doc.

512-1 at 5. However, as with Dr. Solomon’s reports, Dr. Freeman’s reports fail to

acknowledge or grapple with the inherent inconsistencies among the results for the

subgroups, see supra, Section V.A.2. See In re Zoloft (Sertralinehydrochloride)

Prods. Liab. Litig., 176 F. Supp. 3d 483, 493 (E.D. Pa. 2016) (“[W]hen

epidemiological studies are equivocal or inconsistent with a causation opinion,

experts asserting causation opinions must thoroughly analyze the strengths and

weaknesses of the epidemiological research and explain why that body of research

does not contradict or undermine their opinion.”). Furthermore, Dr. Freeman’s

general causation opinion was not limited to the association identified in the

Rusiecki study between crude oil inhalation and chronic sinusitis. Instead, he

offered a much broader opinion indicating there was “a general causal relationship

between occupational exposure to chemicals associated [with] the BP Deepwater

Horizon oil spill” and subsequent chronic rhinosinusitis. ECF Doc. 469-1 at 24.

In his deposition, Dr. Freeman stated he disregarded the analyses in the

Rusiecki study which did not show a statistically significant association between

exposure and chronic sinusitis because he believed crude oil inhalation was a “more

sensitive measure of really being around crude oil.” M. Freeman Depo., at 246:8-

16. This explanation shows the significance of Dr. Freeman’s failure to identify a

harmful level of exposure and casts additional doubt on his reliance on the NIOSH

data, as the NIOSH survey asked only generally about the frequency of exposure

and did not ask the “more sensitive measure” about crude oil inhalation. See ECF

Docs. 469-1 at 22; 469-2 at 26 (Dr. Freeman relies on NIOSH data regarding

shoreline workers reporting any exposure to dripping oil, tar balls, dispersant, or dust

to support the existence of an association with chronic sinusitis and conjunctivitis).

In other words, it does not make sense for Dr. Freeman to ignore the analyses in

Rusiecki that examined exposure generally, but then rely on similar analyses in the

NIOSH data, D’Andrea 2018 study, and McGowan study to support his general

causation opinions.

Furthermore, Dr. Freeman did not know, nor did he attempt to learn, whether

the Coast Guard members in the Rusiecki study performed the same type of work as

Plaintiffs or would have suffered comparable exposures. M. Freeman Depo., at

250:25, 251:1-4. In effect, Dr. Freeman cherry picked a favorable analysis from the

Rusiecki study, while disregarding the analyses which undermined his ultimate

opinion on general causation. Such a practice does not constitute a reliable method.

See In re Lipitor, 174 F. Supp. 3d at 931 (“[C]herry-picking of data is unreliable and

‘fails to satisfy the scientific method and Daubert.’”) (quoting Barber v. United

Airlines, Inc., 17 F. App’x 433, 437 (7th Cir. 2001)).

Dr. Freeman also cited the D’Andrea 2018 study (a followup to the 2013

study) in his assessment of the strength of association between exposure and chronic

rhinosinusitis. Like Dr. Carpenter, Dr. Freeman acknowledged the study suffers

from selection bias, but failed to address this limitation in his report. M. Freeman

Depo., at 110:9-1 (“So everybody who’s in a compensation program reports

symptoms more often than people who aren’t in a compensation program.”). The

study suffered from other limitations as well. For example, only 44 of the 117

workers who participated in the initial study elected to participate in the follow-up

study. The authors recognized this “limited sample size may have influenced the

statistics of the study.” M. Freeman Depo., at 209:17-18. And although the study

asserted that 91% of the exposed group had developed chronic rhinosinusitis at the

follow-up, it did not compare that figure to the percentage of the unexposed group

that had chronic rhinosinusitis. M. Freeman Depo., at 211:1-10. Without such a

comparison, a relative risk cannot be determined; thus, it is unclear why Dr. Freeman

would use the D’Andrea study to suggest a strong association exists between

exposure and chronic sinusitis. See Ref. Man. at 602 (“Relative risk measures the

strength of the association.”). The flaws in the D’Andrea study indicate it cannot be

used as part of a reliable method for arriving at a general causation opinion,

particularly where the expert fails to engage in any meaningful critique of the study

and its impact on the expert’s ultimate conclusion.

In his chronic conjunctivitis report, Dr. Freeman relies on the NIOSH data and

the McGowan 2017 study to support the existence of an association between that

condition and exposure. However, he admitted that none of the DWH studies he

“reviewed specifically mentioned chronic conjunctivitis as a health condition that

they were reporting on.” M. Freeman Depo., at 313:5-9. Furthermore, the

McGowan study, like the NIOSH data, addressed symptoms and not the diagnosed

chronic conditions at issue here.32 The authors of the McGowan study also indicated

“[t]he exposure measures used in this analysis were based on self-reported responses

to questions about work locations and dispersant-related tasks and do not allow

exploration of exposure-response relationships.” ECF Doc. 469-5 at 108. Most

importantly, McGowan’s eye irritation analysis studied individuals who worked

directly with or around dispersants.33 But Plaintiffs Davenport and Moulder did not

perform such work with dispersants, NIOSH investigators found “no evidence of

exposure to dispersant” at onshore worksites, ECF Doc. 469-1 at 22, and Dr.

Freeman agreed that persons that worked on land would not have been exposed to

dispersants, M. Freeman Depo., at 219:2-7. See also M. Freeman Depo., at 52:19-

32 The workers examined by the McGowan study did report their symptoms both at the time of the

cleanup and at the time of study enrollment, which was one to three years after the cleanup.

33 McGowan indicated: “For respiratory and eye irritation analyses, dispersant exposure for

workers was classified as ‘ever/never’ based on a positive response to any interview question

asking about direct work with dispersants or work on a ship from which dispersants were applied

(see Table S1). Additionally, participants were classified as exposed if they responded positively

to working on any task that involved dispersant-related equipment, such as pumps, for more than

half of the time.” McGowan CJ, Kwok RK, Engel LS, Stenzel MR, Stewart PA, Sandler DP.

Respiratory, Dermal, and Eye Irritation Symptoms Associated with Corexit™

EC9527A/EC9500A following the Deepwater Horizon Oil Spill: Findings from the GuLF

STUDY. Environ Health Perspect. 2017 Sep 15;125(9):097015. doi: 10.1289/EHP1677. PMID:

28934097; PMCID: PMC5915187.

22 (testifying it was his understanding that dispersants were “dropped out around

where the spill and the slick was, so it would have been a ways off of the . . . shore”).

Because McGowan evaluated a dissimilar group of workers who did not have the

same exposures as Plaintiffs, the study is not a good “fit” for the facts of this case

and does not support an opinion that the chemicals Plaintiffs were exposed to could

cause chronic conjunctivitis.34 See In re Deepwater Horizon Belo Cases, 2020 WL

6689212, at *15 (“As with reliability, there is ‘no fit’ if a large analytical leap must

be made between the facts and the opinion.”) (quotation omitted).

Dr. Freeman’s chronic conjunctivitis report also references studies about

different oil spills or oil exposures but fails to adequately explain their relevance to

his own analysis. He cites to several of the same studies as Dr. Carpenter, such as

the ones by Na and Kim of the Hebei Spirit oil spill off the coast of the South Korea.

ECF Doc. 469-2 at 23-24. However, he testified he did not know whether the

chemical composition of the oil involved in that spill was similar to the DWH Spill,

M. Freeman Depo., at 266:1-4, and did not know what types of cleanup activities the

persons in the study performed, M. Freeman Depo., at 267:18-21. He also testified

it did not matter to his assessment of general causation that the Hebei Spirit spill

occurred only 5 miles offshore, while the DWH spill occurred over 100 miles

34 The distinct exposures suffered by Plaintiffs and the McGowan study participants highlights the

problems associated with Dr. Freeman’s failure to identify a particular chemical or mixture of

chemicals which he believes can cause the LMPCs.

offshore, M. Freeman Depo., at 266:9-24, which ignores the effect weathering has

on oil’s composition. See ECF Doc. 469-7 at 13 (“The chemical composition

changed as the oil took approximately one hour to rise through one-mile of ocean

water and then changed further as the oil took approximately six weeks to travel 125-

180 miles to reach the Florida Coast.”).

Dr. Freeman also cites two studies referred to by Dr. Carpenter regarding oil

exposure in Nigeria. However, the Awoyesuku study was a cross-sectional study

that did not include a comparison with a control population that would permit

assessment of the relative risk between exposed and unexposed individuals. M.

Freeman Depo., at 278:11-25, 279:1-2. The Omoti study evaluated workers in the

petroleum refining industry, and Dr. Freeman admitted those workers would have

been exposed to different chemicals than DWH shore workers. M. Freeman Depo.,

at 282:4-25, 283:1-25, 284:1-4. Because the exposure scenarios in these studies

differed from those of Plaintiffs, the studies are not relevant or helpful to formulating

a general causation opinion. Cf. Knight v. Kirby Inland Marine Inc., 482 F.3d 347,

353 (5th Cir. 2007) (“Knight, who worked as a tankerman for only one year, does

not allege the type of exposure, either in terms of the chemicals involved or the

length of exposure, experienced by ‘shipyard workers’ in the Olsson study. Thus,

the Olsson study does not appear to be very relevant to Knight’s claim.”).

Based on the foregoing, Dr. Freeman failed to meet the first step for relying

on epidemiological data – that is, he failed to identify a reliable statistical association

between exposure and chronic sinusitis or conjunctivitis in the epidemiological

literature. He also failed to meet the second step.

3. Failure to Reliably Apply the Bradford Hill Factors

Both of Dr. Freeman’s reports contain sections devoted to consideration of

the Bradford Hill factors. However, his analysis of the Bradford Hill factors is

cursory and superficial. In the “Consistency” section of his chronic rhinosinusitis

report, Dr. Freeman states “[i]n addition to demonstrating strength of association,

the [NIOSH data, the D’Andrea 2018 study, and the Rusiecki 2022 study]

demonstrate consistent associations between exposure to products of the BPDWH

oil spill and sinusitis or chronic rhinosinusitis.” ECF Doc. 469-1 at 22. However,

those three studies did not examine the same exposure-disease relationship. See Ref.

Man. at 604 (“Different studies that examine the same exposure-disease relationship

generally should yield similar results.”). As discussed above, the NIOSH data

involved acute symptoms while the other two studies involved chronic sinusitis.

Similarly, Dr. Freeman relied on the Rusiecki study for its findings based on crude

oil inhalation, while the other two studies included additional exposure scenarios.

And within the Rusiecki study itself, the analyses of different types of exposure did

not show consistent associations. Thus, Dr. Freeman’s explanation of the

consistency factor is misplaced and indicates he did not reliably apply the Bradford

Hill criteria.

The “coherence” section of Dr. Freeman’s chronic rhinosinusitis report

provides an example of cursory nature of some of his Bradford Hill analysis. That

section contains a single sentence stating: “It certainly ‘makes sense’ that exposure

to inhaled irritants can cause acute and chronic upper respiratory illnesses.” ECF

Doc. 469-1 at 23. Likewise, he claims “[t]he chain of causation between the acute

and chronic symptoms in the populations studied over time is clearly established,

and contiguous.” ECF Doc. 469-1 at 23. However, his report offers no explanation

for this claim.

In the “biological gradient” section of Dr. Freeman’s reports, he asserts his

analysis of the NIOSH data revealed significant dose-response relationships between

the frequency of exposure to: (1) both solid tar balls and dust and self-reported nose

irritation, sinus problems, or sore throat; and (2) solid tar balls and self-reported eye

redness or itching. ECF Docs. 469-1 at 23; 469-2 at 26. However, this analysis does

not address the dose-response relationship between exposure and chronic sinusitis

or conjunctivitis because, as discussed above, the NIOSH data concerned only

symptoms and Dr. Freeman has not provided reasonable basis for using symptoms

as a proxy for chronic conditions. This analysis does not represent a reliable

application of the Bradford Hill factors.

4. Dr. Freeman’s Supplemental Declaration

In response to BP’s motion, Dr. Freeman submitted a declaration with an

attached supplemental report. ECF Doc. 512-1. The supplemental report was

created after Dr. Freeman submitted Freedom of Information Act requests in March

and April 2022 to obtain NIOSH’s full dataset and an additional NIOSH survey

form. ECF Doc. 512-1 at 17. Using this additional information, Dr. Freeman

concluded: (1) a dose-response relationship was observed for exposure duration, i.e.,

“sinus and ocular symptoms were reported more often with increasing duration of

employment”; (2) “symptoms were also reported more often with increasing

frequency of exposure to tar balls, dust, dripping oil, and dispersants.” ECF Doc.

512-1 at 18. Specifically, Dr. Freeman concluded: (1) “each 30-day increase in the

duration of employment was associated with a 43% increase in the odds of sinus

symptoms”; (2) “each level increase in the frequency of exposure to tar balls (from

not at all to a few days to almost every day to daily) was associated with a 27%

increase in the odds of sinus symptoms; for dust the increase was 38% per level”;

(3) “each 30-day increase in the duration of employment was associated with a 41%

increase in the odds of ocular symptoms”; and (4) “each level increase in the

frequency of exposure to tar balls was associated with a 28% increase in the odds of

ocular symptoms; for dust the increase was 47% per level.” ECF Doc. 512-1 at 21.

Based on the foregoing, Dr. Freeman believed “exposures to oil spill-associated

irritants during [Plaintiffs’] response work were a substantial factor in causing their

chronic conditions.” ECF Doc. 512-1 at 22.

Dr. Freeman states the “results of [his] updated analyses demonstrate

statistically significant dose-response relationships between the number of days

worked in BPDWH onshore clean-up and sinus and ocular symptoms. In addition,

significant dose-response relationships were found between the frequency with

which workers were exposed to tar balls, dust, dispersants, and dripping oil and these

symptoms.” ECF Doc. 512-1 at 16.

BP has moved to strike Dr. Freeman’s declaration and supplemental report,

arguing they are untimely and contain new opinions and analysis. ECF Doc. 527.

Under Fed. R. Civ. P. 26(a)(2)(A), “a party must disclose to the other parties the

identity of any witnesses it may use at trial to present evidence under Federal Rule

of Evidence 702, 703, or 705.” These disclosures must be made “at the times and in

the sequence that the court orders.” Fed. R. Civ. P. 26(a)(2)(C). Compliance with

Rule 26 “is not merely aspirational.” Cooper v. Southern Co., 390 F.3d 695, 728

(11th Cir. 2004) (internal citation omitted), overruled in part on other grounds, 126

S. Ct. 1195 (2006). Compliance is necessary to allow “both sides in a case to prepare

their cases adequately and to prevent surprise.” Id.

A party who fails to comply with Rule 26 may be prohibited from using the

identified witness at trial “unless the failure was substantially justified or is

harmless.” Fed. R. Civ. P. 37(c)(1) (emphasis added). “The burden of establishing

that a failure to disclose was substantially justified or harmless rests on the non-

disclosing party.” Mitchell v. Ford Motor Co., 318 F. App’x 821, 824 (11th Cir.

2009) (citing Leathers v. Pfizer, Inc., 233 F.R.D. 687, 697 (N.D. Ga. 2006)).

“Courts enjoy broad discretion under Rule 37(c)(1) to exclude evidence.” In

re 3M Combat Arms Earplug Prod. Liab. Litig., No. 3:19-MD-2885, 2021 WL

763778, at *2 (N.D. Fla. Jan. 15, 2021) (quoting Guevara v. NCL (Bahamas) Ltd.,

920 F.3d 710, 718 (11th Cir. 2019) (noting that appellate courts review a district

court’s exclusion of evidence based on an abuse of discretion)). In exercising that

discretion, courts generally consider the following four (4) factors: “(1) the

importance of the excluded testimony; (2) the explanation of the party for its failure

to comply with the required disclosure; (3) the potential prejudice that would arise

from allowing the testimony; and (4) the availability of a continuance to cure such

prejudice.” See id. (citing Howe v. City of Akron, 801 F.3d 718, 747 (6th Cir.

2015)); David v. Caterpillar, Inc., 324 F.3d 851, 857 (7th Cir. 2003); S. States Rack

& Fixture, Inc. v. Sherwin-Williams Co., 318 F.3d 592, 596 (4th Cir. 2003).

Considering those factors here, the Court finds BP’s motion to strike should be

granted to the extent Dr. Freeman’s supplemental report, and the portions of his

declaration which reference the supplemental report, should be stricken.

Dr. Freeman’s declaration and supplemental report clearly contain new

opinions and did not merely clarify opinions offered in the initial reports.35 The

supplemental report contains new analyses of NIOSH data and new conclusions

regarding dose-response relationships based on exposure duration and frequency.

ECF Doc. 512-1 at 15-29.

Plaintiffs, however, have offered no real justification for the untimeliness of

the supplemental report. Dr. Freeman submitted his FOIA requests for the additional

NIOSH data in March and April 2022, after his February 2022 deposition. Based

on this timing, it appears the requests may have been precipitated by BP’s questions

at the deposition. Regardless, Plaintiffs failed to provide any justification for the

delay in seeking the additional information. Dr. Freeman could have easily done it

at any time after he was retained. Moreover, at no point did Plaintiffs inform BP Dr.

Freeman was writing a supplemental report or performing an analysis of newly

acquired (but previously available) data. Instead, on September 13, 2022, Plaintiffs

surprised BP with Dr. Freeman’s declaration and supplemental report in their

response to BP’s Daubert motion. This untimely disclosure deprived BP of the

opportunity to question Dr. Freeman regarding the analysis contained in the

35 Although Plaintiffs’ response to BP’s motion to strike asserts Dr. Freeman’s declaration and

supplemental report “do not seek to change his opinions or add new ones,” ECF Doc. 535 at 2, at

oral argument Plaintiffs’ counsel admitted Dr. Freeman’s analysis of the dose-response

relationship in terms of duration of exposure was a new opinion.

supplemental report and prevented BP’s expert from formulating a rebuttal.

Although Plaintiffs suggest any prejudice could be cured by reopening discovery or

allowing BP to file a reply, the undersigned finds such actions would unnecessarily

delay the progression of this case. Indeed, the supplemental report was filed within

weeks of the Court setting this matter for oral argument; Plaintiffs’ conduct warrants

the exclusion of the supplemental report.

Accordingly, BP’s motion to strike should be granted to the extent Dr.

Freeman’s entire supplemental report (ECF Doc. 512-1 at 15-29) should be stricken.

In addition, the portions of Dr. Freeman’s declaration which refer to the analysis

contained in the supplemental report should also be stricken. However, the

undersigned finds the portions of Dr. Freeman’s which do not reference the

supplemental report and instead merely attempt to explain the methodology he used

to formulate his original reports should not be stricken.

Regardless, even assuming Dr. Freeman’s supplemental report and the

associated portions of his declaration should not be stricken, they do not render his

general causation opinion reliable and helpful. First, because Dr. Freeman’s

“updated” analysis is based on the NIOSH data, it still suffers from the same

problems identified above (e.g., it provides information only on self-reported

exposures and symptoms, not the diagnosed chronic conditions alleged by

Plaintiffs). Second, Dr. Freeman’s analysis of the dose-response relationship and

identification of a harmful dose in terms of days is still flawed in that it does not

include consideration of the amount of exposure. As discussed above in regard to

Dr. Solomon’s opinion, a dose level based on duration without an accompanying

level is simply not helpful. Thus, even if the Court were to consider Dr. Freeman’s

supplemental report as being timely, it would still not make his general causation

opinions admissible.

In sum, Dr. Freeman fails to identify a harmful dose of any particular chemical

or mixture of chemicals, and the studies he relied on, and his use of those studies, do

not provide an adequate basis for his general causation opinion. Thus, Dr. Freeman’s

opinions should be excluded.

D. Dr. Ranajit Sahu36

Ranajit Sahu, Ph.D., is a mechanical engineer who provides consulting

services in environmental, energy, and engineering matters. ECF Doc. 459-1 at 14.

Relying on the actual sampling data for the DWH Spill and affidavits from the

Plaintiffs, Dr. Sahu offers the following opinions:

• Oil and related materials, including dispersants, resulting from the

Deepwater Horizon blowout reached the Florida Coast;

• Plaintiffs were deployed to the locations where oil had arrived either

on beaches, in the water along the shoreline, or in the adjacent Gulf

waters;

36 The parties agreed the Court could decide the motion to exclude Dr. Sahu without oral argument.

• Plaintiffs were given various work tasks, generally involving cleaning

the oil from the impacted areas on land and/or water, or in some cases

had support functions such as boat captains or equipment maintenance

workers, etc.

• In all instances, there were multiple opportunities for Plaintiffs (i.e.,

any Plaintiff in the class) to be exposed to a wide range of oil-spill

related CoCs37 via one or more pathways such as inhalation, dermal

contact, or ingestion.

• Any PPE that was provided or used did not prevent such exposures to

the point of cutting-off one or more pathways. Thus, exposure

pathways were present regardless of PPE.

ECF Doc. 459-2 at 85.

BP argues Dr. Sahu’s opinions should be excluded because they are not

relevant or helpful to the trier of fact. ECF Doc. 459. Specifically, BP argues Dr.

Sahu’s opinions do not identify the exposure levels of any chemical or chemicals

that could have caused Plaintiffs’ alleged LMPCs. Id. at 8–9. Plaintiffs admit they

did not retain Dr. Sahu to provide an opinion on medical causation. ECF Doc. 491

at 3. They argue, however, that Dr. Sahu’s opinions nonetheless meet Daubert

muster as to general causation because Dr. Sahu reviewed the actual exposure data

for the DWH Spill, which Dr. Williams did not do, and identified the chemicals and

levels of those chemicals to which Plaintiffs were exposed. See id. at 9–10.

Identifying all the chemicals and levels of exposure without any determination as to

37 “CoCs” are contaminants of concern, which according to Dr. Sahu, are all substances any of the

Plaintiffs “were exposed to or could potentially have been exposed to.” Sahu Depo., at 17:1–6.

which chemical(s) could have caused the complained of LMPCs, and at what level,

however, does not meet the threshold requirements for establishing general

causation. Thus, after reviewing the voluminous evidence presented by the parties,

including BP’s motion, ECF Doc. 459, Plaintiffs’ response, ECF Doc. 491, including

the supplemental declaration of Dr. Sahu, ECF Doc. 491-1, and Dr. Sahu’s

deposition, ECF Doc. 459-2, the undersigned recommends Dr. Sahu’s opinions be

excluded.

As stated above, “[g]eneral causation is whether a substance is capable of

causing a particular injury or condition in the general population.” In re Mirena IUS

Levonorgestrel-Related Prods. Liab. Litig. (No. II), 387 F. Supp. 3d 323, 336

(S.D.N.Y. 2019), aff’d, 982 F.3d 113 (2d Cir. 2020). Dr. Sahu’s opinions, however,

do not speak to general causation. Nowhere in Dr. Sahu’s report does he identify

whether any of the CoCs were capable of causing the type of harm alleged by

Plaintiffs or at what levels. Dr. Sahu admits he is “not offering expert opinions on

whether exposure to any particular contaminant of concern caused any medical

condition alleged by any plaintiff.” R. Sahu Depo., at 20:23–25; 21: 1–2. Dr. Sahu

admits no “actual levels” of CoCs are shown in his report; instead, the report “just

shows the names of the various CoCs.” Id. at 34:11-15.38 Dr. Sahu’s report does

38 Dr. Sahu does not know if any of the sampling results he reviewed indicate that CoCs exceeded

any occupational exposure limit, EPA or OSHA regulatory limit, permissive exposure limit, or

not identify any specific health effects that are supposedly caused by any of the CoCs

he identifies. Id. at 172:18–24; 220:3–13. While Plaintiffs are correct that a general

causation expert does not need to determine the “precise level of exposure,” see ECF

Doc. 491 at 9, Dr. Sahu has not provided any toxic level of exposure. See, e.g.,

Zantac, 2022 WL 17480906, at *17 (agreeing that a “threshold range” would satisfy

Eleventh Circuit case law). Dr. Sahu’s report merely provides a listing of the

numerous chemicals released by the oil spill and an opinion that Plaintiffs could

have been exposed to those chemicals. ECF Doc. 459-1 at 22, 24–28; R. Sahu Depo.,

at 11: 4–12; 17:1–18. This is not enough.

Moreover, Dr. Sahu did not utilize any of the three primary methodologies for

determining general causation. Dr. Sahu discusses no epidemiological studies and

does not rely on epidemiology, other than as it relates to “routes of exposure.” R.

Sahu Depo., at 12:9–17. Dr. Sahu does not provide a dose-response assessment or

a dose reconstruction. Id. at 21:3–9. Dr. Sahu discusses no background risk of

disease. Instead, Dr. Sahu described his methodology as “general,” “pretty

standard,” and not “documented per se.” Id. at 81–82. It consisted of reviewing

affidavits and sampling data compiled by an analyst with No Pollution Enterprises,

who was requested to search some databases for any contaminant of concern that

any other work protection or exposure protection limit. R. Sahu Depo, at 34:6–9; 128: 4–25;

129:1–10.

was detected in any way in the databases and put those on a graph. Id. at 29–30, 33–

35, 68–69. The “reconstruction” Dr. Sahu performed “was to see if the plaintiffs

were working in the same area doing the kind of work they were doing and they

would have had potential contact with oil and the chemicals of concern.” Id. at 80:9–

13. As Dr. Sahu explains, the “sum totality of the methodology” he used was “a

forensic superposition of these different facts, looking at the data that was collected

by others . . . and relying on the documents that [he] reviewed for the plaintiffs, that

they were engaged, A, in cleanup and; B, in this stretch of the coast.” Id. at 84:15–

21.

Plaintiffs argue the Court should allow Dr. Sahu’s opinions because they are

relied upon by other experts. Plaintiffs, however, do not identify which experts rely

on Dr. Sahu’s work or opinions. Regardless, since Dr. Sahu merely relied on

sampling data and the Plaintiffs’ affidavits to reach his opinions, the other experts

could have done the same. Also, while Dr. Sahu’s opinion may remedy the concern

the Court had with Dr. Williams’ opinion, which did not include an analysis of the

actual exposure data collected in the relevant geographical area or determine

whether Plaintiffs were potentially exposed, it does not meet the minimum standard

of connecting any level of, or any CoC, for that matter, to the harm alleged.39

39 In Dr. Sahu’s Declaration, he specifically states that he was attempting to remedy this complaint

by BP. ECF Doc. 491-1 at 3.

Plaintiffs also argue BP is conflating general causation with specific causation

by requiring Dr. Sahu to provide an opinion regarding Plaintiffs’ alleged exposures.

The Court agrees the degree of exposure suffered by Plaintiffs is not an issue to be

addressed on general causation. Nonetheless, Dr. Sahu’s opinions, which are

“limited to identifying potential exposures of the plaintiffs to contaminants of

concern,” R. Sahu Depo., at 22:13–16, simply do not establish general causation.

See McClain, 401 F.3d at 1241–42. Dr. Sahu’s opinions do not have a “valid

scientific connection to the pertinent inquiry” of whether levels of any CoC existed

at the Florida Gulf Coast which could cause the type of harm alleged by Plaintiffs.

See Boca Raton Cmty. Hosp., Inc. v. Tenet Health Care Corp., 582 F.3d 1227, 1232

(11th Cir. 2009) (quoting Daubert, 509 U.S. at 591–92) (internal quotation marks

omitted). Thus, the undersigned agrees with BP – Dr. Sahu’s opinions are irrelevant

and unhelpful.

VI. MOTION FOR SUMMARY JUDGMENT

As stated above, Federal Rule of Civil Procedure 56 requires a court to grant

summary judgment for a moving party when the party proves that there is no genuine

dispute of material fact and that the party is entitled to judgment as a matter of law.

In a toxic tort case, the plaintiff must have admissible primary evidence with which

to establish general causation. See Chapman, 766 F.3d at 1308, 1316. Because the

undersigned finds Plaintiffs’ general causation experts should be excluded, Plaintiffs

do not have evidence to create genuine dispute of material fact. Thus, the

undersigned recommends the motion for summary judgment be granted.

Accordingly, it is ORDERED:

1. The clerk shall terminate BP’s Daubert motion to exclude the opinions

of Dr. James J.J. Clark, ECF Doc. 460, as MOOT, based on Plaintiffs’ withdrawal

of Dr. Clark as an expert on general causation. The clerk shall also terminate as

MOOT, BP’s related motion to strike the supplemental declaration of Dr. Clark, ECF

Doc. 525.

2. The clerk shall terminate BP’s Daubert motion to exclude the opinions

of Dr. Robert Cykiert on diagnosis, ECF Doc. 462, as MOOT, given the

undersigned’s finding that Plaintiffs’ general causation experts should be excluded

and judgment entered in favor of BP.

3. The clerk shall terminate BP’s Daubert motion to exclude the opinions

of Dr. David Greene on diagnosis, ECF Doc. 467, as MOOT, given the

undersigned’s finding that Plaintiffs’ general causation experts should be excluded

and judgment entered in favor of BP.

4. BP’s motion to strike the second supplemental declaration of Dr. Gina

Solomon, ECF Doc. 561, is DENIED.

5. Plaintiffs’ motion to strike BP’s notice of supplemental authority, ECF

Doc. 537, is DENIED.

6. BP’s motion to strike the supplemental declaration of Dr. Michael

Freeman, ECF Doc. 527, is GRANTED to the extent set forth in this Order and

Report and Recommendation.

It is further RECOMMENDED:

1. BP’s Daubert motion to exclude the opinions of Dr. Ranajit Sahu, ECF

Doc. 459, be GRANTED.

2. BP’s Daubert motion to exclude the opinions of Dr. Gina Solomon,

ECF Doc. 466, be GRANTED.

3. BP’s Daubert motion to exclude the opinions of Dr. David Carpenter,

ECF Doc. 468, be GRANTED.

4. BP’s Daubert motion to exclude the opinions of Dr. Michael Freeman,

ECF Doc. 469, be GRANTED.

5. BP’s motion for summary judgment, ECF Doc. 470, be GRANTED.

6. Judgment be entered in favor of BP in these test cases as well as in all

cases represented by the Downs Group in this Master Action, involving plaintiffs

with the same LMPCs at issue in these test cases, which have been stayed.

At Pensacola, Florida, this 15th day of December 2022.

s/ Hope Thai Cannon

/

HOPE THAI CANNON

UNITED STATES MAGISTRATE JUDGE

NOTICE TO THE PARTIES

Objections to these proposed findings and recommendations must be

filed within fourteen days of the date of the Report and Recommendation. Any

different deadline that may appear on the electronic docket is for the court’s

internal use only and does not control. An objecting party must serve a copy of

its objections upon all other parties. A party who fails to object to the

magistrate judge’s findings or recommendations contained in a report and

recommendation waives the right to challenge on appeal the district court’s

order based on the unobjected-to factual and legal conclusions. See 11th Cir.

Rule 3-1; 28 U.S.C. § 636.