1 

IN THE UNITED STATES DISTRICT COURT 

SOUTHERN DISTRICT OF OHIO 

EASTERN DIVISION 

IN RE: E. I. DU PONT DE CASE NO. 2:13-md-2433 

NEMOURS AND COMPANY C-8 

PERSONAL INJURY LITIGATION 

JUDGE EDMUND A. SARGUS, JR.

MAGISTRATE JUDGE ELIZABETH P. 

DEAVERS 

This document relates to: Angela Swartz and Teddy Swartz v. E. I. du Pont de 

Nemours and Company, Case No. 2:18-cv-00136.

DUPONT’S MOTION TO EXCLUDE THE SPECIFIC CAUSATION TESTIMONY OF 

DR. VITALY MARGULIS 

Defendant E. I. du Pont de Nemours and Company (“DuPont”) respectfully requests that 

the Court preclude Plaintiff Angela Swartz (“Plaintiff”) from introducing at trial the unreliable 

testimony of Dr. Vitaly Margulis regarding specific causation. Dr. Margulis’s specific causation 

opinions are fundamentally flawed because they are based on an unreliable, results-driven 

methodology that was not reliably applied. As a result, Dr. Margulis’s specific causation opinions 

do not satisfy the requirements for expert testimony under Federal Rule of Evidence 702 and 

Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993) and its progeny. DuPont respectfully 

requests that this Court exercise its gatekeeping function to strike these opinions and preclude Dr. 

Margulis from testifying about specific causation at trial.1 

 

1

 The Court previously ruled on Dr. Margulis’s specific causation testimony in Bartlett. See EMO 

1. However, DuPont presents additional arguments in support of excluding his different testimony in this 

case. Among other things, Dr. Margulis’s opinions in this case are based on new improper theories not 

advanced in Bartlett, including a “no safe dose” theory (his opinions would be the same even if Mrs. Swartz 

had only been exposed to one molecule of C-8), and an unscientific subjective belief that the same criteria 

that he uses to summarily rule out all other risk factors for Mrs. Swartz’s cancer does not apply to C-8. He 

also did not follow the professional practices that he uses outside the courtroom. 

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Dr. Margulis reached his opinions in this case by employing a results-driven methodology 

based on an improper presumption of specific causation, as evidenced by Dr. Margulis’s 

concession at his deposition that his primary specific causation opinion in this case would have 

been the same if Plaintiff “had only been exposed to one molecule of C-8.” Tr. of June 13, 2019 

Deposition of Vitaly Margulis, M.D. (Margulis Depo.) at 27:3-7 (Ex. A).2 Dr. Margulis’s opinions 

fall far short of satisfying Federal Rule 702 and Daubert and its progeny for at least the following 

independent reasons. 

First, contrary to DuPont’s fully preserved, unlimited right to challenge specific causation 

in the Leach Agreement, Dr. Margulis improperly started with a presumption of specific causation 

based solely on: (1) the Science Panel’s Probable Link report on kidney cancer; and (2) another 

expert’s opinion (Dr. MacIntosh) regarding Leach class membership. 

Second, Dr. Margulis based his primary specific causation opinion on the fiction that the 

Science Panel made a scientific determination of causation for C-8. Dr. Margulis compounded 

this fundamental error by subjectively and unreliably employing two different methodologies: one 

for C-8, and a different one for summarily dismissing all alternative explanations for Plaintiff’s 

kidney cancer. 

Third, Dr. Margulis adopted the “no safe dose” theory, which has been resoundingly 

rejected as an unreliable basis for specific causation expert testimony. Further, Dr. Margulis took 

no account of what Mrs. Swartz’s actual specific amount of increased risk was from her specific 

individual level of exposure to C-8, and failed to weigh the amount of increased risk from her 

exposure to C-8 as compared to the amount of her substantially greater increased risk of developing 

 

2

 DuPont incorporates here by reference the separately filed Motion for Interpretation of the Leach 

Agreement With Respect to Specific Causation In the Swartz Case, And Motion to Exclude 

Mischaracterizations Related to the Science Panel in the Probable Link Findings From the Swartz Trial. 

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kidney cancer from her decades of obesity and decades of high blood pressure, among other 

alternative risk factors for her kidney cancer. 

Fourth, Dr. Margulis did not follow the professional practices that he uses outside the 

courtroom. 

Because Dr. Margulis’s opinions suffer from these numerous fundamental errors, DuPont 

respectfully requests that this Court exercise its gatekeeping function to exclude Dr. Margulis’s 

opinions on specific causation. 

RELEVANT BACKGROUND 

Plaintiff alleges that her small kidney tumor that was removed in early 2017 resulted from 

exposure to C-8 in drinking water from (1) a private well at her residential property in Letart, West 

Virginia during the years 1979-86, despite the fact that she has no evidence that the water in that 

well contained C-8 at any time; (2) a drinking fountain at a Big Ben Food Land store, which 

received water from the Village of Pomeroy and where she worked as a cashier and clerk on a 

part-time basis for parts of seventeen months in the early 1990s; (3) transient visits to her Mother’s 

apartment, also served by the Village of Pomeroy between 1990 and 1992; and (4) transient visits 

to her sister’s mobile home, which is served by the Tuppers Plains-Chester Water District starting 

in 1988. See Second Am. Pltf. Fact Sheet (“PFS”) for Angela Swartz (April 12, 2019) (Ex. B) 

(“Swartz PFS”) at § 26;3 Tr. of Apr. 12, 2019 Depo. of Angela Renee Casto Swartz (Ex. C) 

(“Swartz Depo.”) at 282:10-18 (testifying that the private well was never tested, and she does not 

know whether or how much C-8 was in the well); 270:17-22, 271:10-272:9 (testifying that she 

would “get a glass of her tea” or Kool-Aid when she visited her mother, and occasionally a meal 

 

3

 Plaintiff’s Second Amended PFS has been filed under seal. 

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such as beans, pork, or meatloaf); 279:5-18 (testifying that she would drink “[o]ne drink” when 

she visited her sister). 

LEGAL STANDARD 

I. Plaintiff Bears the Burden of Demonstrating That Dr. Margulis’s Opinions are 

Admissible. 

The burden is on Plaintiff to demonstrate by a preponderance of proof that the opinions of 

Dr. Margulis are admissible. Nelson v. Tenn. Gas Pipeline Co., 243 F.3d 244, 251 (6th Cir. 2001). 

Plaintiff can only meet this burden by “objective, independent validation of the expert’s 

methodology; the expert’s bald assurance of validity is not enough.” Smelser v. Norfolk S. Ry., 

105 F.3d 299, 303 (6th Cir. 1997). 

Because expert testimony “can be both powerful and quite misleading,” district courts must 

act as gatekeepers to ensure that expert testimony “is not only relevant, but reliable.” Daubert v. 

Merrell Dow Pharms., 509 U.S. 579, 589, 592 (U.S. 1993); Thomas v. Novartis Pharms. Corp., 

443 Fed. Appx. 58, 60 (6th Cir. 2011) (“Under Daubert and its progeny, district courts must 

exercise a gatekeeping role in screening the reliability of expert testimony to keep ‘junk science’ 

away from juries.”). Federal Rule of Evidence 702 embodies this Daubert principle by only 

permitting an expert witness to offer opinions that are “reliable”—meaning based on sound 

scientific reasoning and methodology. See Fed. R. Evid. 702. If an expert does not employ sound 

scientific reasoning and methodology, the expert’s testimony is mere ipse dixit and inadmissible. 

General Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997). 

To determine whether expert testimony is reliable, the court must “make certain that an 

expert . . . employs in the courtroom the same level of intellectual rigor that characterizes the 

practice of an expert in the relevant field.” Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 

(U.S. 1999); see also Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 318 (7th Cir. 1996) (“[A] Court’s 

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duty under Daubert is to weed out courtroom science from real science.”). To meet this burden, 

the expert’s opinions must reflect “scientific knowledge . . . derived by the scientific method,” 

representing “good science.” See Daubert, 509 U.S. at 590, 593. 

District courts have flexibility to consider numerous factors in determining whether an 

expert’s opinions reflect “good science,” including “whether an expert developed his opinions for 

the purposes of testifying.” Adams v. Cooper Indus., 2007 U.S. Dist. LEXIS 55131, at *16 (E.D. 

Ky. July 30, 2007); see also Kolesar v. United Agri Prods., 412 F. Supp. 2d 686, 697 (W.D. Mich. 

2006) (rejecting opinion of expert witness because “her hypothesis [had] all the appearances of a 

conclusion made for convenience (to support a pre-existing notion) rather than one supported by 

scientific fact”). 

ARGUMENT

I. Dr. Margulis Improperly Assumed Specific Causation for Plaintiff. 

It is undisputed that nothing about the Science Panel’s findings established specific 

causation for Mrs. Swartz.4 To the contrary, it is undisputed that the Class Members expressly 

agreed that DuPont’s ability to contest specific causation was fully preserved. Despite these facts, 

and instead of conducting any independent scientific or medical analysis, Dr. Margulis started and 

finished his purported differential analysis with a false presumption of specific causation from 

exposure to C-8. Dr. Margulis presumed that the Science Panel determined that Mrs. Swartz was 

at some unknown increased risk of kidney cancer from exposure to C-8, and summarily excluded 

all other risk factors for kidney cancer from his differential analysis: 

Q. Based on Dr. MacIntosh, you assumed she was a Class Member, you also 

assumed that she was at an increased risk for kidney cancer? 

 

4

 The fact that the Science Panel did not address or determine the issue of specific causation for 

Mrs. Swartz is discussed more fully in DuPont’s contemporaneously filed Motion For Interpretation Of 

The Leach Agreement With Respect To Specific Causation In The Swartz Case, which has been 

incorporated by reference. 

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A. Based on his report, yes. 

Q. And, sir, the way that you did [] your differential analysis, it didn’t matter 

to you how low the amount of her increased risk was since you didn’t 

include anything else in your differential. It had to be C-8 that caused her 

kidney cancer, right? 

A. Correct. 

Margulis Depo. at 27:18-28:4. 

Dr. Margulis ignores that a specific causation expert cannot simply rely on a finding of 

general causation (or an agreement not to contest general causation) to establish specific causation 

in an individual. Indeed, courts exclude specific causation experts when their opinions “rest 

primarily” on methodologies “which relate to general causation.” See, Lipitor (Atorvastatin 

Calcium) Mktg. v. Pfizer, Inc., 892 F.3d 624, 643 (4th Cir. 2018); see also Milward v. Acuity 

Specialty Prods. Grp., 969 F. Supp. 2d 101, 108-09 (D. Mass. 2013). As one court has recognized, 

“[a]n expert . . . cannot merely conclude that all risk factors for a disease are substantial 

contributing factors in its development. ‘The fact that exposure to [a substance] may be a risk 

factor for [a disease] does not make it an actual cause simply because [the disease] developed.’” 

Guinn v. AstraZeneca Pharms. LP, 602 F.3d 1245, 1255 (11th Cir. 2010). 

Assuming a conclusion—as Dr. Margulis did here—is not a reliable methodology for 

assessing specific causation. For this reason alone, Dr. Margulis should be precluded from 

testifying on specific causation at trial. 

II. Dr. Margulis’s Opinions Are Unreliable Because They Are Based on the False 

Assumption That the Science Panel Made a Determination That C-8 Was a Scientific 

“Cause” of Kidney Cancer. 

Dr. Margulis gave unwarranted weight to C-8 in his differential etiology because he falsely 

assumed that the Science Panel made a scientific determination that C-8 was a “cause” of kidney 

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cancer. Margulis Report at 2, 6 (Swartz ECF No. 27-1); Margulis Depo. at 47:21-48:4. But the 

Science Panel did not make any such determination; instead, the Science Panel’s ‘probable link’ 

findings were based on a much lower standard of proof than a finding of causation.5 

This distinction is critical here, because the false assumption that the Science Panel 

determined that C-8 was a scientific “cause” of kidney cancer was the foundation on which Dr. 

Margulis built his specific causation opinion in this case. Specifically, Dr. Margulis claims to have 

summarily ruled out obesity and high blood pressure, two other well-accepted risk factors for 

Plaintiff’s kidney cancer, from his purported differential etiology because he claimed that these 

risk factors are merely associated with C-8, not scientifically proven “causes” of kidney cancer 

like he assumed C-8 was. See Margulis Report at 6; Margulis Depo. at 12:19-13:5; 15:16-17:12; 

18:10-15; 19:19-20:8; 47:21-48:4. 

The Science Panel, after seven years of study, and using the lower standard of proof for a 

probable link finding for a medical monitoring claim, found a Probable Link between C-8 and 

kidney cancer, but went no further. The Probable Link Finding regarding cancer was not a 

scientific determination that C-8 actually “causes” cancer, or specifically “caused” cancer in Mrs. 

Swartz—and Class Members promised that DuPont expressly preserved its ability to contest 

specific causation. Dr. Margulis’s conclusions improperly conflates the Science Panel’s finding, 

and improperly skips over every analytical step required to properly opine that C-8 specifically 

caused Mrs. Swartz’s kidney cancer. Instead, Dr. Margulis assumes without any legitimate 

scientific basis that a Probable Link Finding was a determinative finding of specific causation. 

 

5

 As DuPont explains in its contemporaneously filed Motion For Interpretation Of The Leach

Agreement With Respect To Specific Causation in the Swartz Case, incorporated in relevant part here, the 

parties agreed that the Science Panel’s determinations could be made using the lesser standard of “probable 

link” that the West Virginia Supreme Court developed for medical monitoring claims in the Bower case, 

rather than the much higher standard of general causation, because the main relief sought in Leach was 

medical monitoring. 

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In short, Dr. Margulis’s opinion that C-8 was more likely than obesity and high blood 

pressure to be the cause of Plaintiff’s kidney cancer is unreliable at its very core, because it is 

based on a false scientific assumption, and the opinion should therefore be excluded. See, e.g., 

Paz v. Brush Engineered Materials Inc., 555 F.3d 383 (5th Cir. 2009) (lower court properly 

excluded testimony of causation expert that based testimony on a “false assumption” and 

“erroneous information”); In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices & Prods. 

Liab. Litig., 2016 U.S. Dist. LEXIS 30355 (D.S.C. Feb. 29, 2016) (excluding expert testimony, 

and stating: “Allowing testimony based on an obviously false assumption, as conceded by 

Plaintiffs' clinical expert, would be abdicating this Court's role as a gatekeeper under Daubert.”). 

Here, Dr. Margulis compounded this error because he subjectively and unreliably 

employed two different methodologies: one methodology for C-8, and a different methodology for 

ruling out all alternative explanations of Plaintiff’s kidney cancer. Specifically, Dr. Margulis 

claimed that he was able to rule out obesity and high blood pressure from his differential analysis 

because he was not aware of any “conclusive evidence of [a] direct mechanism of action” by which 

obesity or high blood pressure can cause kidney cancer. Margulis Depo. at 17:3-12. 

However, while Dr. Margulis placed determinative weight on his view that there has been 

no scientific proof of the mechanism of action for how obesity and how high blood pressure cause 

kidney cancer, Dr. Margulis conceded at his deposition that he also did not know of any scientific 

proof of the mechanism of action by which C-8 causes kidney cancer. See Margulis Depo. at 31:3-

20. 

Dr. Margulis should not be permitted to use a results-oriented, invalid, subjective, and selfserving methodology, invented for litigation, which summarily rules out obesity, high blood 

pressure, smoking and all other risk factors for kidney cancer, while ignoring that the exact same 

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methodology he uses to rule out all other risk factors would require him to rule out C-8. Tellingly, 

Dr. Margulis admitted that he is not aware of any peer-reviewed paper (or even a non-peer 

reviewed paper) that says you should exclude obesity or high blood pressure from a specific 

causation analysis for a patient with kidney cancer. See Margulis Depo. at 17:15 – 18:9. 

In short, Dr. Margulis used an unreliable, subjective and made solely for this litigation 

methodology of reaching an expert opinion on specific causation, and Dr. Margulis’s opinions 

based on this unreliable and scientifically dishonest approach should be excluded. See Soldo v. 

Sandoz Pharmaceuticals Corp., 244 F. Supp. 2d 434, 560-61 (W.D. Pa. 2003) (noting unreliability 

of experts who demand multiple solid epidemiology studies before they will agree to place certain 

other plausible causes of plaintiff’s stroke on the differential etiology, but abandon that standard 

when it comes to defendant’s product); In re Rezulin Products Liab. Litig., 369 F. Supp. 2d 398, 

425 (S.D.N.Y. 2005) (“[I]f the relevant scientific literature contains evidence tending to refute the 

expert’s theory and the expert does not acknowledge or account for that evidence, the expert’s 

opinion is unreliable.”) (internal quote marks omitted); Barber v. United Airlines, Inc., 17 Fed. 

Appx. 433, 437 (7th Cir. 2001) (finding expert opinion unreliable where expert “ignored certain 

facts and data, while accepting others”) 

III. Dr. Margulis’s Methodology is Also Unreliable Because He Adopted a “No Safe Dose” 

Theory and Failed To Account For Plaintiff’s Specific Level of Exposure to C-8. 

Dr. Margulis’s specific causation opinions also are fundamentally unreliable because they 

take absolutely no account of the Plaintiff’s individual’s level of exposure to C-8. Dr. Margulis 

expressly conceded this fundamental error when he admitted at his deposition that his specific 

causation opinions would not have changed in any way even if he had assumed that Plaintiff 

“had only been exposed to one molecule of C-8.” Margulis Depo. at 27:3-7 (emphasis supplied). 

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Dr. Margulis’s specific causation opinions are based on the “no safe dose” theory, which 

has been resoundingly rejected by other courts as an unreliable specific causation methodology, 

and the Court should do the same here. Pluck v. BP Oil Pipeline Co., 640 F.3d 671 (6th Cir. 2011) 

(affirming exclusion of specific causation expert partly because “he relied upon a ‘no safe dose’ 

theory that had been discredited by other courts as a basis for establishing specific causation”); 

Stallings v. Ga. Pacific Corp., 675 F. App'x 548 (6th Cir. 2017) (rejecting “any” or “every 

exposure” theory of causation); Adams v. Cooper Indus., 2007 U.S. Dist. LEXIS 55131 (E.D. Ky. 

July 30, 2007) (“The court finds that the ‘no-safe-dose’ theory is not a reliable methodology, and 

it rejects the plaintiffs’ claim that said theory entitled their specific causation experts to pay so 

little attention to the level of exposure in the bellwether plaintiffs.”). 

Dr. Margulis admitted that he did nothing to evaluate the amount of Plaintiff’s risk of 

developing kidney cancer based on her exposure to C-8. Margulis Depo at 26:11-26:20; 29:10-

20. Without this plaintiff-specific risk information, Dr. Margulis’s primary specific causation 

opinion is fundamentally unreliable because he did not do the required “weighing of risks” 

between Plaintiff’s C-8 exposure and other alternative explanations, including Plaintiff’s decades 

of obesity and high blood pressure. Margulis Depo. at 10:7-11; 13:15-14:3; 26:22-27:1. See, e.g., 

Magistrini v. One Hour Martinizing Dry Cleaning, 180 F. Supp. 2d 584, 610 (D.N.J. 2002) (“In 

order to properly assess the specific cause of an individual’s illness, a quantitative risk assessment 

must be undertaken, which assesses the risk that a particular exposure caused a particular illness. 

When an individual is exposed to two or more risk factors, the same method for both risk factors 

would have to be applied in order to assess the risk attributable to each of those risk factors.”)6

 

6 See also Stout et al., Bayes’ Law, Sequential Uncertainties, And Evidence Of Causation In Toxic 

Tort Cases, 38 U. Mich. J.L. Reform 781, 784 (2005) (“the causation expert must conduct a quantitative 

causation analysis (sometimes called risk analysis) to establish that the agent at issue is the most likely 

cause of the disease or injury (specific causation). To conduct a valid causation analysis, the expert must 

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IV. Dr. Margulis’s Methodology Is Also Unreliable Because He Did Not Follow the 

Professional Practices That He Uses Outside the Courtroom. 

Dr. Margulis conceded that, in his regular professional practice of medicine outside the 

courtroom, he tells patients the various risk factors that contribute to kidney cancer, but does not

tell them that one thing was the cause or a substantial contributing cause of their kidney cancer. 

See Margulis Depo. at 52:1-9.7 In his regular professional practice outside the courtroom, he also 

does not use the unique, artificial and unsupported methodology (discussed above) that he used 

for his work in this case. 

For this additional reason, that the made for litigation approach he used here differs from 

the approach he has used in his regular professional practice outside the courtroom for the past 10 

years, his opinions on specific causation should be excluded. United States EEOC v. Rockwell 

Int'l Corp., 60 F. Supp. 2d 791, 797 (N.D. Ill. 1999) (excluding expert testimony where the expert 

“failed to employ the same level of intellectual rigor that characterizes the practice of experts in 

his field, or even his own normal practice.”); In re Silica Prods. Liab. Litig., 398 F. Supp. 2d 563, 

639 (S.D. Tex. 2005) (excluding expert testimony where “the gulf between” the methodology used 

in the litigation and the methodology the expert advocated for in his academic work “starkly 

contravene[d]” the requirements of Daubert). 

CONCLUSION 

For each of these reasons, and in the interests of justice, DuPont respectfully requests that 

the Court preclude Dr. Margulis from offering any specific causation opinions at trial. 

 

apply relevant medical, toxicological, and epidemiologic principles to the facts of the case, weighing 

alternative potential causes of the injury to identify the most likely cause.” ). 

7

 The only exception to this is if he is treating a patient with a known hereditary gene issue. 

Margulis Depo. at 52:1-9. 

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Respectfully submitted, 

s/ Damond R. Mace 

Damond R. Mace (0017102) (Trial Attorney) 

Aneca E. Lasley (0072366) 

Nathan A. Leber (0090770) 

Jesse L. Taylor (0088209) 

SQUIRE PATTON BOGGS (US) LLP 

4900 Key Tower 

127 Public Square 

Cleveland, Ohio 44114 

(216) 479-8500 (Phone) 

(216) 479-8780 (Fax) 

Attorneys for Defendant E. I. du Pont de Nemours and 

Company 

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CERTIFICATE OF SERVICE 

A true and correct copy of the foregoing was electronically filed with this Court’s CM/ECF 

system on this 9th day of July, 2019 and accordingly served automatically upon all counsel of 

record for this matter. 

s/ Damond R. Mace 

Damond R. Mace (0017102) 

Attorney for Defendant 

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