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DISTRICT COURT, JEFFERSON COUNTY, STATE
OF COLORADO
100 Jefferson County Parkway DATE FILED: July 28, 2023 10:00 PM
FILING ID: 97BE4B26BD946
Golden, Colorado 80401 CASE NUMBER: 2020CV31481
Plaintiff: BLAKE RICHARD DARNELL
v.
Defendants: TERUMO BCT STERILIZATION
SERVICES, INC.; TERUMO BCT, INC.; and JOHN
DOES NO. 1-20. ▲ COURT USE ONLY ▲
Attorney for Defendants:
Case No. 2020CV31481
J. Lucas McFarland
McFarland Litigation Partners, LLC Div. 15
910 13th Street, Suite 200
Golden, Colorado 80401
Phone: (302) 279-8300
Email: luke@mcfarland.law
DEFENDANTS’ OMNIBUS MOTION IN LIMINE
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TABLE OF CONTENTS
Page
I. LEGAL STANDARD ......................................................................................................... 1
II. MOTIONS IN LIMINE ....................................................................................................... 1
1. Precluding Argument and Questions Designed to Incite Emotion Over
Rationality. .............................................................................................................. 1
2. Precluding Evidence or Argument Alleging Harm to and Protection of “the
Community.”........................................................................................................... 4
3. Precluding Evidence or Argument Regarding Other EtO Lawsuits and
Verdicts. .................................................................................................................. 5
4. Precluding Use of “NATA” Risk Estimates as Causation Evidence. ..................... 6
5. Precluding Improper Legal Conclusions Regarding the Industry “Standard
of Care.” .................................................................................................................. 7
6. Precluding Argument and Evidence Regarding Never-Enacted Backvent
Regulations as Evidence of Negligence. ................................................................. 8
7. Precluding Evidence Regarding Different Chemical, Ethylene Glycol. ................. 9
8. Precluding Plaintiffs’ Experts from Relying on “Privileged” Undisclosed
Data But Refuse to Produce the Underlying Privileged Information. .................... 9
9. Precluding Opinions Based on “Background” EtO Levels Plaintiffs Never
Calculated. ............................................................................................................ 11
10. Precluding Evidence or Argument that Defendants Had a Duty to Provide
Employee Protections to Plaintiff or the General Public. ..................................... 13
11. Precluding Plaintiffs’ Experts from Interpreting Intent of Company
Documents. ........................................................................................................... 13
12. Precluding Argument that Terumo Improperly Lobbied Federal / State
Regulators. ............................................................................................................ 14
III. CONCLUSION ................................................................................................................. 15
ii
The Terumo Defendants move in limine as outlined in the 14 individual Motions below:
I. LEGAL STANDARD
Motions in limine are essential to forestall introduction of prejudicial evidence at trial.
Bruckman v. Pena, 487 P.2d 566, 568 (Colo. App. 1971). Trial courts have inherent authority to
rule on such motions and are further authorized by C.R.C.P. 7 & 16(c) and C.R.E. 103 & 104 to
exclude prejudicial evidence. Good v. A.B. Chance Co., 565 P.2d 217 (Colo. App. 1977),
superseded by statute on other grounds. Indeed, a trial court “may exclude [even relevant]
evidence if its probative value is substantially outweighed by danger of unfair prejudice.” Quigly
v. Jobe, 851 P.2d 236, 238 (Colo. App. 1992). The Court should do so here.
II. MOTIONS IN LIMINE
1. Precluding Argument and Questions Designed to Incite Emotion Over a Decision on
the Merits.
Based on their deposition questions and media statements, it is evident that Plaintiffs’
counsel intend to try this case by inflaming the jury and appealing to their personal instincts,
emotions, and sympathy rather than a careful consideration of the facts. This is impermissible.
This strategy, often called the “golden rule” strategy, asks jurors to put themselves in the
plaintiff’s shoes. Similarly, a newer offshoot referred to as the “reptile” theory (named after the
2009 book discussed below), uses jurors’ emotions to trigger safety instincts on behalf of the
community as a whole. Both strategies are precluded by Colorado law, and they are two sides of
the same coin. Terumo thus seeks an order precluding these types of “send a message” arguments
and emotional ploys, such as by invoking terms like “EtO kills,” “guardians of the community,”
“eyes and ears of the community,” “conscience of the community,” and any argument asking the
jurors to put themselves in Plaintiffs’ shoes, or to decide this case on emotion and not fact.
The bar on golden rule argument is nearly universal and has a long history. E.g., Granfield
v. CSX Transp., Inc., 597 F.3d 474, 491 (1st Cir. 2010) (A “Golden Rule” argument is
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“‘universally condemned because it encourages the jury to depart from neutrality and to decide the
case on the basis of personal interest and bias rather than on evidence’”); Arnold v. E. Air Lines,
Inc., 681 F.2d 186, 199 (4th Cir. 1982) on reh’g, 712 F.2d 899 (4th Cir. 1983) (“The Golden Rule
and sympathy appeals are . . . obviously improper arguments . . . . Having no legal relevance to
any of the real issues, they were per se objectionable”); Loose v. Offshore Navigation, Inc., 670
F.2d 493, 496 (5th Cir. 1982) (a “Golden Rule” argument “encourages the jury to depart from
neutrality and to decide the case on the basis of personal interest and bias rather than on the
evidence”); Caudle v. D.C., 707 F.3d 354, 359–60 (D.C. Cir. 2013); DuBois v. Grant, 835 P.2d
14, 16 (Nev. 1992) (banned golden rule argument is the impermissible suggestion that the jurors
trade places with the victim); Boyd v. Pernicano, 385 P.2d 342, 343 (Nev. 1963) (improper to ask
the jurors to place themselves in the shoes of the victim because such argument interferes with the
objectivity of the jury); Horn v. Atchison, Topeka & Santa Fe Ry. Co., 394 P.2d 561, 565 (Cal.
1964) (“it was improper to appeal to the jurors to fix damages as if they or a loved one were the
injured party”); Collins v. Union Pac. R.R. Co., 143 Cal. Rptr. 3d 849, 861 (Ct. App. 2012) (“A
‘golden rule’ argument is one where counsel asks the jury to place itself in the victim’s shoes and
award such damages as they would charge to undergo equivalent pain and suffering” and is
prohibited).
The Colorado Supreme Court agrees: “[t]he ‘golden rule’ argument . . . is improper in a
civil case.” People v. Rodriguez, 794 P.2d 965, 973 (Colo. 1990). Rodriguez cited a Washington
Supreme Court decision approvingly, explaining the prohibition on these questions:
[A]n argument in a civil case is improper which appeals to the jurors to place
themselves in the position of a litigant and to decide the case based upon what
they would want under the circumstances. . . . Whether a plaintiff recovers at
all, and the amount of a plaintiff’s recovery, if any, or whether a defendant
prevails, are questions the jury must resolve solely on the evidence and the
law, and not on the basis of appeals to sympathy, passion or prejudice.
Adkins v. Aluminum Co. of Am., 750 P.2d 1257, 1265 (Wash. 1988) (emphasis added); accord
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Mitchell v. Rosenthal, 2022 WL 16962263, at *17 (D. Colo. Oct. 11, 2022) (precluding “golden
rule” and “reptile theory” arguments); Blevins v. Cessna Aircraft Co., 728 F.2d 1576, 1580 (10th
Cir. 1984) (finding “golden rule” arguments universally improper). Although the reptile theory is a
newer plaintiff-lawyer strategy, which appeals to broader self- and community-based interests, it is
premised on the same idea—getting jurors to rule based on emotion and not fact.
If Plaintiffs’ deposition questioning is any indication, trial is likely to be rife with such
improper questioning techniques. When deposing Terumo’s corporate representative, Jessi Done,
Plaintiffs’ counsel asked page after page of such questions, such as whether Terumo agrees that:
• “[S]afety should be an ethylene oxide sterilizer’s top priority?”;
• “[A] company running a sterilization facility should not put profits over the safety of
its employees [or] those living in the nearby community?”;
• “[P]eople living in the community around the facility should be able to expect clean air
to breathe in?”
See Done Dep. at 297-298, 303, Excerpts of Terumo Witness Deps., attached as Ex. A.
Likewise, while questioning Terumo’s regulatory expert, Plaintiffs’ counsel asked:
• “Would you agree that if a company knowingly misleads the EPA they would be
subject to criminal prosecution?”;
• “Would you also agree that generally a best practice would be regulatory agencies to
not allow companies to emit carcinogenic chemicals next to daycares?”; and
• “[W]ould you agree that every life matters?”
Benevento Dep. at 151-52 (Ex. A). This questioning, in some form or another, appeared
throughout Plaintiffs’ depositions of Terumo’s witnesses.
Plaintiffs also use these types of inflammatory phrases in argument. For example, in their
Motion for Leave to Amend the Complaint to Add a Claim for Exemplary Damages (filed May
11, 2023) (“Damages Mot.”), Plaintiffs’ opening line is EtO—“a potent and dangerous
carcinogen—has one application: to kill.” Id. at 1. This phrasing is clearly designed to invoke fear
of and anger against Terumo. Plaintiffs should be precluded from referring to EtO as a killing tool,
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or other similarly prejudicial phrasing intended to inflame the jury. BNSF Ry. Co. v. LaFarge Sw.,
Inc., 2009 WL 9144604, at *13 (D.N.M. Feb. 16, 2009) (use of word “kill” or “similar
inflammatory terminology suggesting a crime” is improper). Terumo seeks broadly to exclude the
use of this tactic, and in particular the phrases identified within this Motion.
2. Precluding Evidence or Argument Alleging Harm to and Protection of “the
Community.”
While Terumo expects Plaintiffs at trial to invoke references to what the “community”
should do, or how the “community” should react, the “community” is not a plaintiff in this case.
Only the 13 individuals who filed complaints in this case are. Those claims concern (1) only those
13 Plaintiffs’ alleged exposures to EtO at particular locations, at particular time periods, and in
circumstances specific to those Plaintiffs only; and (2) the causation of only those 13 Plaintiffs’
alleged diseases. The relevant questions are whether Terumo’s emission of EtO put those
Plaintiffs at risk and caused those Plaintiffs’ cancer.
It would be misleading and confusing to the jury and unduly prejudicial to Defendants for
Plaintiffs or their counsel to make arguments and present evidence of alleged risk or harm to the
“community,” which necessarily implicates undefined persons, distances, locations, purported
risks or harms, time periods, and circumstances that are not at issue in this case, and potentially
include jurors themselves. Worse still, Plaintiffs’ tactics are meant to appeal to the biases and fears
of the jury, people from the surrounding community, who have been inundated with thousands of
advertisements, flyers from Plaintiffs’ counsel, online advertising, and billboards with
fearmongering statements and imagery from Plaintiffs’ counsel. And Plaintiffs have shown that
they fully intend to present such evidence. See Damages Mot. at 2 (“Yet, Terumo chose to ignore
the gross amount of EtO it spewed into Lakewood and then justified its cost-saving pollution
control choices based on this deliberate ignorance to the volume of EtO it polluted into the
community.”). This evidence and argument are prejudicial and has no probative value.
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3. Precluding Evidence or Argument Regarding Other EtO Lawsuits and Verdicts.
Plaintiffs’ counsel and other law firms have filed hundreds (if not thousands) of cases
against EtO sterilizers like Terumo in jurisdictions across the country, and, by Terumo’s count,
this will be the third such trial nationwide. Terumo moves to exclude evidence or argument
regarding other lawsuits involving EtO, whether against Terumo or other medical sterilizers, such
as Sterigenics, as well as any verdicts or rulings rendered in those cases (specifically including the
$363 million verdict against Sterigenics, later appealed and then settled out of court).
Colorado courts commonly hold that evidence of prior or concurrent litigation is
inadmissible. Predator Int’l, Inc. v. Gamo Outdoor USA, Inc., 2014 WL 348637, at *3 (D. Colo.
Jan. 31, 2014) (evidence of prior or concurrent litigation was irrelevant and inadmissible);
Shostrom v. Ethicon, Inc., 2022 WL 2237341, at *2 (D. Colo. June 22, 2022) (barring plaintiff
from introducing evidence of other lawsuits). This prohibition includes mentioning the dollar
amount of such verdicts. Engquist v. Or. Dep’t of Agr., 478 F.3d 985, 1009 (9th Cir. 2007), aff’d
sub nom. Engquist v. Oregon Dep't of Agr., 553 U.S. 591, (2008) (“most courts forbid the mention
of verdicts or damage amounts obtained in former or related cases”).
The basis for that rule in Colorado is clear: allegations and insinuations about other
lawsuits are not relevant to the specific facts at issue in this case—i.e., whether EtO emissions
from the Lakewood facility caused Plaintiffs’ alleged injuries. Similarly, the mention of prior or
current lawsuits would unfairly prejudice Terumo, leading a jury to incorrectly assume that
Plaintiffs’ case must be meritorious based on the number of other plaintiffs who have sued. Allen
v. Zavaras, 2010 WL 1348748, at *2 (D. Colo. Mar. 30, 2010) (finding that discovery seeking
number of suits filed against defendants was irrelevant). Accordingly, any such argument or
evidence about other lawsuits and verdicts be precluded because such evidence is clearly
prejudicial and has no probative value.
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4. Precluding Use of “NATA” Risk Estimates as Causation Evidence.
In their case, Plaintiffs (and more specifically, their retained expert witnesses) are expected
to opine that EtO can and did cause their injuries. To support these opinions, Plaintiffs will try to
introduce the EPA’s National Air Toxics Assessment (“NATA”)—a 2018 EPA report providing
information on outdoor air quality and the potential impact of EtO and other airborne toxins on
communities nationwide. Indeed, this NATA report is the genesis of this entire litigation, see
generally Plaintiffs’ Complaint, as the EPA conservatively increased its risk assessment (“IRIS”
level) of EtO to 30-60 times of what was previously understood, creating a cascade of litigation.
But the NATA report is not a study linking EtO to cancer, and it cannot be used as
evidence of causation. EPA itself has warned against such uses on numerous occasions:
• NATA is a “screening tool intended to help EPA and state, local and tribal air agencies
determine if areas, pollutants or types of pollution sources need to be examined further.”
NATA Fact Sheet, attached as Ex. B (emphasis added).
• NATA is “largely driven” by IRIS risk values not intended to predict disease and that do
“not estimate any person’s individual risk.” Id. at 1 (emphasis added).
• NATA is “performed with few data and many conservative assumptions.” EPA Air Toxics
Risk Assessment Reference Library, Vol. 1 Technical Resource Manual (Apr. 2004),
relevant excerpts attached as Ex. C, Glossary at 34 (emphasis added).
• The inhalation risk unit value (“IUR”) for a substance, like EtO, is “typically upper-bound
estimates, [so] actual risks may be lower than predicted, [and] the true value of the risk is
unknown and may be as low as zero. Id. at 13-6 (emphasis added).
• Moreover, NATA should not be used to “pinpoint specific risk values within a census
tract,” “to compare risks at local levels (such as between neighborhoods),” or “as a
definitive means to specify risk values within a census tract.” Fact Sheet, Ex. B at 1.
Inevitably, Plaintiffs will seek to present these public health specific risk values as
causation evidence. Indeed, their causation theory is based on Dr. Clark’s invented “IRIS Lifetime
Dose,” through which he compares his dose reconstruction of each Plaintiff to the IRIS values,
despite EPA’s clear instruction to the contrary. See 4/10/23 Mot. to Preclude Clark (“Clark Mot.”).
Statements by regulatory and public health agencies in the risk-assessment context do not
meet legal standards of proof of causation. Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27, 42
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(2011) (FDA may act on “evidence that suggests, but does not prove, causation”); Indus. Union
Dep’t, AFL-CIO v. Am. Petro. Inst., 448 U.S. 607, 656 (1980) (Stevens, J., concurring) (agency “is
free to use conservative assumptions in interpreting . . . data with respect to carcinogens, risking
error on the side of overprotection rather than underprotection”); McLain v. Metabolife Int’l, Inc.,
401 F.3d 1233, 1249–50 (11th Cir. 2005) (government agencies often “err on the side of caution”).
Accordingly, the NATA report is not probative of whether Terumo’s emissions actually
caused Plaintiffs’ injuries, and Plaintiffs cannot meet their burden of proof by relying on
regulatory assessments that, by their own terms, do not bear on individual causation.
5. Precluding Improper Legal Conclusions Regarding the Industry “Standard of Care.”
At trial, Plaintiffs’ expert, Dr. Sahu, will attempt to offer legal conclusions on a wide range
of issues. However, the “trial judge is obligated to correctly instruct the jury on the law applicable
to the case,” Jordan v. Bogner, 844 P.2d 664, 667 (Colo. 1993), which of course means that an
expert is prohibited from offering legal conclusions. Equal Emp. Opp. Comm’n v. W. Distrib. Co.,
2022 WL 17351984 (D. Colo. Dec. 1, 2022) (“An expert may not offer an opinion that is a legal
conclusion even when he or she has provided his or her underlying analysis.”).
It is the Court’s duty to instruct on the standard of care, which is typically “based on the
standard of care owed by a reasonable person in the defendant's position.” Scott v. Matlack, 39
P.3d 1160, 1166 (Colo. 2002); United Blood Servs. v. Quintana, 827 P.2d 509, 519 (Colo. 1992)
(“The court determines, as a matter of law, the existence and scope of the duty”). And importantly,
in Colorado, compliance with “generally accepted industry standards” is critical to assessing
negligence. Scott, 39 P.3d at 1170. Rather, an expert may only offer “testimony concerning
standard industry customs and practices” that is “relevant.” Gerrity Oil & Gas Corp. v. Magness,
946 P.2d 913, 931 (Colo. 1997), as modified on denial of reh’g (Oct. 20, 1997) (emphasis added).
Dr. Sahu is Plaintiffs’ supposed “standard of care” expert. But Dr. Sahu, an engineer-
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turned-full-time-plaintiff expert who has no relevant EtO experience aside from working on EtO-
related litigation in the past couple of years, cannot opine on industry standard customs and
practices for two reasons. First, Dr. Sahu completely lacks experience in the industry. Dr. Sahu
admitted to his lack of experience readily at his deposition, and his lack of experience is discussed
in Terumo’s 4/12/23 Motion to Exclude Sahu (“Sahu Mot.”), including that he never set foot in a
commercial sterilizer until a year and a half ago as of April 2023, and that the first operating EtO
sterilizer he went to was in Smyrna, Georgia in March of 2023 (only four months ago). Sahu Dep.,
Ex. B to Sahu Mot., at 43:5-17.
Second, Dr. Sahu is unequivocal that he believes industry standards are irrelevant, even in
the face of contrary Colorado law. Dr. Sahu has not “looked to see whether there has been or has
not been” an industry standard for the EtO sterilization industry, and he believes “[i]t is not
relevant what the majority was doing because . . . whatever the majority was doing would only
deal with their respective circumstances.” Id. at 130:17-23, 166:8-13. As Dr. Sahu has no
foundation to opine on the industry standard of care, his opinions on that should be precluded.
Stenson v. Edmonds, 2022 WL 19299121, at *9 (D. Colo. Aug. 26, 2022) (when expert does not
“lay adequate foundation” to opine on an aspect of the case, those opinions are inadmissible).
6. Precluding Argument and Evidence Regarding Never-Enacted Backvent Regulations
as Evidence of Negligence.
Given Plaintiffs’ repeated emphasis of this issue, Terumo expects Plaintiffs to argue at trial
that Terumo was legally required to connect the chamber backvents to emission control systems,
even though there never was such a requirement by EPA or CDPHE. Colorado law is clear—
evidence of regulations that were not in effect during the relevant time cannot be introduced. See,
e.g., Bennett v. Greeley Gas Co., 969 P.2d 754, 759 (Colo. App. 1998) (“[E]vidence concerning
[regulations] is not admissible to establish the standard of care at a time before their enactment.”).
Dr. Sahu’s opinion is irrelevant because a failure to comply with regulations that are under
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consideration—but never adopted—has no bearing on whether a defendant was negligent. Id.
Deceptively, Plaintiffs’ emissions expert, Dr. Sahu, suggested that such a requirement
existed until it was removed in 2001. Sahu Rept., Ex. A to Sahu Mot., App’x A at 118 (“EPA
removed MACT requirements for the chamber back vents in 2001”). In fact, however, EPA never
required that backvents be connected to emissions controls; such language was removed at the
drafting stage before the final rule was published it in the Federal Register due to safety concerns
about explosions at similar facilities.1 Since Terumo was never legally required to connect the
backvents to emissions controls equipment, Plaintiffs cannot argue or insinuate otherwise.2
7. Precluding Evidence Regarding Different Chemical, Ethylene Glycol.
Terumo expects Plaintiffs will introduce evidence regarding Terumo’s use or disposal of
ethylene glycol. See Damages Mot. at 31. Despite similar names, ethylene glycol and ethylene
oxide are very different chemicals. And Plaintiffs do not allege that ethylene glycol caused or
contributed to their cancers in any way. (Nor do any of their experts suggest that ethylene glycol
caused Plaintiffs’ cancers.) Because evidence about ethylene glycol will not make the existence of
any relevant fact more or less probable, all such evidence should be excluded. Quigly, 851 P.2d at
238 (affirming exclusion of evidence that was prejudicial even if it “had any marginal relevance”).
8. Precluding Plaintiffs’ Experts from Relying on “Privileged” or “Confidential”
Undisclosed Data but Refuse to Produce the Underlying Information.
At trial, Plaintiffs’ experts are also expected to offer opinions based on privileged or
confidential information, but they refuse to provide that information to Defendants. Plaintiffs can’t
have it both ways. For example, Dr. Clark admitted that he relied on memos from interviews with
1
See EtO Standards for Sterilization Facilities, 66 Fed. Reg. 55577, 55578 (Nov. 2, 2001),
available at https://www.govinfo.gov/content/pkg/FR-2001-11-02/pdf/01-27594.pdf.
2
When EPA released its NATA Report in 2018, with the knowledge and cooperation of CDPHE,
Terumo connected its back vents to emissions controls, as CDPHE felt the explosion risks could
be safely mitigated and the increased toxicity value for EtO altered the cost-benefit analysis.
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Plaintiffs as an input to his modeling. But Plaintiffs refuse to provide those documents. 3/26/23
Email to Special Master, Ex. J to Clark Mot. Dr. Sahu also relies on material allegedly subject to a
confidentiality order in another case, but he says he cannot produce the data. To avoid his clear
obligation to do so, Dr. Sahu calls his reliance on that allegedly privileged information his
“engineering judgment.” 6/28/23 Mot. to Compel Documents Relied on by Dr. Sahu. Terumo thus
moves to exclude any opinions based on any data relied on by Plaintiffs’ experts that they claim is
privilege and has not been disclosed.
Again, the case law is unambiguous. If a retained expert wishes to offer an opinion, the
expert must disclose all of the sources supporting that information, including confidential
information. See, e.g., Clements v. Davies, 217 P.3d 912, 916 (Colo. App. 2009) (affirming
exclusion of podiatrist’s expert testimony for failure to fully produce expert file containing
materials in support of his opinion, explaining that “[w]ithout such access, the opposing party will
be unable to conduct a full and fair cross-examination of the expert” (internal citation omitted));
Gall ex rel. Gall v. Jamison, 44 P.3d 233, 239 (Colo. 2002) (holding “opinion work product that is
reviewed or considered by an expert in preparation for testimony at trial is discoverable”); U.S. ex
rel. Maxwell v. Kerr-McGee Chem. Worldwide, LLC, 2006 WL 2053534, at *7-8 (D. Colo. July
21, 2006). Failure to do so requires that those opinions be precluded. Camp Bird Colo., Inc. v. Bd.
of Cty. Comm’rs of Ouray, 215 P.3d 1277, 1290 (Colo. App. 2009) (“when a party violates
discovery rules, the trial court may choose appropriate sanctions, which may include evidence
preclusion”); Longoria v. Kodiak Concepts, LLC, 2021 WL 1100373, at *14 (D. Ariz. Mar. 23,
2021) (“It doesn't matter that the data on which [the expert] relied was “confidential”—it still
needed to be disclosed.”).
Because Plaintiffs refuse to produce these materials—preventing Terumo’s experts from
analyzing and evaluating them—Plaintiffs may not present opinions that rely on these materials at
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trial. Maxwell, 2006 WL 2053534, at *7-8 (instructing moving party to renew motion to strike if
opposing party does not supplement expert disclosures to include confidential information relied
upon by expert); United States v. 1003.58 Acres of Land, 2018 WL 4945309, at *1 (C.D. Cal. Jan.
31, 2018) (excluding expert opinion where expert withheld the “information he relied on as
‘confidential’” because “in order for the defense to examine the data upon which Mr. Frahme
[expert] relied, it needed the very information he declined to detail”). No expert can rely on
privileged information to prepare opinions, and then refuse to produce it. Under that theory, as is
the case here, Defendants could never adequately cross-examine and discover the truth.
9. Precluding Opinions Based on “Background” EtO Levels Plaintiffs Never Calculated.
Plaintiffs base their negligence case on a theory that only those exposures to EtO above
“background” (also known as “ambient” air) levels are harmful—but Plaintiffs’ experts never
calculated or determined what those background levels are. Background EtO (or background
levels of any substance) is what exists in the ambient air, not including the source of alleged
exposure. As EtO is a naturally occurring chemical (one that is even produced in our bodies), and
is also a byproduct of smoking, car exhaust, propane, and myriad other common daily activities, it
is universally recognized that background concentrations of EtO are present that are not otherwise
attributable to a single industrial source like Terumo.
Ultimately, despite over a thousand pages of reports across five experts who invoke the
term “background” EtO, not a single one ever quantifies or calculates a level of background EtO
that is the benchmark from which that amount would be, as they argue, cancer causing. In other
words, they never identified the denominator on which their exposure claims depend. Thus, any
opinion based on levels “over background” should be precluded. Indeed, all four of Plaintiffs’
general causation experts—Drs. Felsher, Stayner, Salem and Dahlgren—are expected to testify
that any exposure to EtO above “background” is capable of causing cancer. For example:
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• Dr. Felsher: “[m]y opinion is that exposure above whatever background will be a necessary
and substantial contributing cause.” 7/20/20 Felsher Dep. (Rough), attached as Ex. D, at
410:10-12.
• Dr. Salem: “I believe that any amount of ethylene oxide above background is not good for
you.” Salem Dep., Ex. H to 4/10/23 Mot. to Exclude General Cause Experts (“Gen. Cause
Mot.”), at 197:7-11.
• Dr. Dahlgren: “[A] direct alkylating agent that causes cancer is usually considered not to
have a safe level above background levels.” Dahlgren Rep., Ex. D to Gen. Cause Mot., at 2.
(Emphases added). Recognizing this fundamental gap in their case, Plaintiffs’ dose reconstruction
expert, Dr. Clark, is expected to testify that background is “irrelevant.” Such testimony completely
defies EPA guidance issued as recently as March 2023.3
Well settled law, as well as Plaintiffs’ own experts’ scientific testimony, requires Plaintiffs
to prove that excess EtO—specifically excess EtO from Terumo—caused their cancers. Courts
require proof of a threshold level above background levels in order to be considered reliable.
Vedros v. Northrop Grumman Shipbuilding, Inc., 119 F. Supp. 3d 556, 565-66 (E.D. La. 2015)
(excluding “every exposure above background theory” (emphasis added)). One court explained:
We fail to see how the theory can, as a matter of logic, exclude higher than normal
background levels as the cause of the plaintiff’s disease, but accept that any
exposure from an individual defendant, no matter how small, should be accepted
as a cause in fact of the disease.
Bostic v. Georgia-Pacific Corp., 439 S.W. 3d 332, 341 (Tex. 2014); see also Baker v. Chevron
USA, Inc., 680 F. Supp. 2d 865, 878 n.9 (S.D. Ohio 2010) aff’d 533 App’x 509 (6th Cir. 2013)
(“ambient benzene was [just as likely] the cause of Plaintiffs’ illnesses” (emphasis added)). In
other words, they cannot prove excess EtO is the cause if they simply assume Plaintiffs were
exposed over background because there was a source of EtO nearby. See Clark Dep., Ex. I to
Clark Mot., at 37:23-25 (“whatever the background level of the non-man-made EtO in the
environment would only be enhanced by what Terumo was putting out”).
3
Available at https://www.epa.gov/system/files/documents/2023-04/eto-draft-human-healh-ra-
add.pdf (extensively citing to “ambient” EtO as required measurement to better understand risk).
12
It is basic logic that proving an airborne substance is harmful is impossible without
considering the level present in the ambient air at status quo. Rather, Plaintiffs’ experts have gone
so far as to ignore the background levels of EtO as measured by CDPHE across the state of
Colorado. For example, while Dr. Clark spends pages of his report critiquing the CDPHE
sampling, he does not use any other actual background samples in their stead—he simply
disclaims their relevance. Plaintiffs’ experts must be required to state what background is if they
are to use it as a benchmark—and since they have not, those opinions should be excluded.
10. Precluding Evidence or Argument that Defendants Had a Duty to Provide Employee
Protections to Plaintiff or the General Public.
At trial, Plaintiffs’ experts likely will argue or try to testify that Defendants owed a duty to
Plaintiffs or the general public to provide them the same safety and health protections that Terumo
provides its employees under federal occupational safety and health standards. Neither statutory
nor common law imposes such a duty on Terumo, and to allow Plaintiffs to argue such a duty
would be legally erroneous and carry a significant risk of jury confusion and undue prejudice.
To prove liability in negligence, Plaintiffs must show that Terumo breached a duty owed to
Plaintiffs under the ordinary standard of care. Scott, 39 P.3d at 1166. As a matter of law and logic,
reasonable care does not require Terumo to provide to Plaintiffs or the general public outside
Terumo’s facility the same protective measures mandated by the Occupational Health and Safety
Administration (“OSHA”) for employees working directly with or around EtO inside the facility.
As such, Plaintiffs should be precluded from invoking OSHA regulatory requirements for the
inside of the facility (e.g., warning signs, training on dangers of EtO, provision of respirators,
badge monitoring, alarms, and adequate ventilation) to support an inference that Terumo had a
duty to provide these same protections to the general public outside the facility for miles around.
11. Precluding Plaintiffs’ Experts from Interpreting Intent of Company Documents.
At trial, Plaintiffs should be precluded from using their experts as a mouthpiece to infer the
13
intent of Terumo’s employees through company documents. In re Fosamax Prods. Liab. Litig.,
645 F. Supp. 2d 164, 192 (S.D.N.Y. 2009) (granting MIL as to experts “testifying as to the
knowledge, motivations, intent, state of mind, or purposes of [defendant], its employees, the FDA,
or FDA officials” as such it “is not a proper subject for expert or even lay testimony”).
For example, in Dr. Sahu’s Report, adopting the entirety of Dr. Rockstraw’s standard of
care opinions, he improperly editorializes company emails without restraint. See Sahu Rept.,
App’x A (Ex. A to Sahu Mot.) at 192 (regarding Oct. 27, 2017 email, “Freeman’s response
provides further indication of Defendant’s ignorance of the process equipment”); id. at 143
(opining that Terumo commissioned the 1996 inhalation risk study “for the sole purposes of
avoiding having to comply with the EPA’s new NESHAP of 1994 in Terumo 1”); id. at 123
(interpreting witness’s use of term “strategic value” to mean that “Terumo was more concerned
with playing the permit compliance game than providing the community and the regulatory
agencies with the actual amount of EtO that was escaping”).
Sahu’s opinions are not based on any expert experience or personal knowledge but serve
only as a megaphone for legal argument and conclusions from counsel. Accordingly, such opinion
testimony is not probative and unduly prejudicial.
12. Precluding Argument that Terumo Improperly Lobbied Federal / State Regulators.
In briefing, Plaintiffs have argued that the EPA’s removal of their draft guidance for
backvents to be connected to an emission control source was due to efforts by Terumo and others
in the EtO industry to “lobby” or otherwise influence government and science. Damages Mot. at
12 n.12 (“[T]he EPA removed the requirement of the back vent at the urging of the EtO industry
lobbying efforts.”). The anticipated arguments are factually incorrect and inflammatory and, if
admitted, would substantially and unfairly prejudice and mislead the jury.
Plaintiffs’ fabricated narrative of improper “lobbying” misconstrues the regulatory
14
rulemaking process. As part of that process, the Administrative Procedure Act (“APA”) provides
for a public comment period to allow any member of the public to communicate with the
rulemaking body.4 Notice-and-comment rulemaking under the APA is intended to provide all
stakeholders a chance to participate in the process, as well as to help EPA educate itself before
promulgating regulations that would have a substantial effect on the regulated community. Indeed,
EPA openly invited comments on the draft regulations, particularly from industry members and
stakeholders. Of course, this regulatory process is a constitutionally protected and longstanding
procedure and cannot be held against Terumo to paint it in a negative light to the jury. Computer
Assocs. Int’l, Inc. v. Am. Fundware, Inc., 831 F. Supp. 1516, 1522 (D. Colo. 1993) (Noerr-
Pennington doctrine “bars litigation arising from injuries received as a consequence of First
Amendment petitioning activity, regardless of the underlying cause of action asserted by the
Plaintiffs”).
Defendants’ communications with EPA and other regulatory agencies, whether direct or
indirect, served a constitutionally protected purpose of engagement with the rulemaking
procedure, and evidence of such conduct cannot be used against Terumo. As such, Plaintiffs, their
counsel, their expert witnesses, and their fact witnesses should not be permitted to introduce
evidence that Defendants “lobbied” any regulatory agency, or to make any reference to such
evidence, or to use communications with regulators or industry groups, such as the American
Chemistry Council, for same.
III. CONCLUSION
For the foregoing reasons, the Court should grant the relief Terumo seeks and limit
Plaintiffs’ evidence and testimony as described above.
4
EPA, Public Comment Process, available at https://www.epa.gov/superfund/public-comment-
process.
15
DATED this 28th day of July, 2023
MCFARLAND LITIGATION PARTNERS, LLC
The original signature is on file at McFarland
Litigation Partners, LLC
By: /s/ J. Lucas McFarland
J. Lucas McFarland
KING & SPALDING LLP
Douglas A. Henderson
Joseph A. Eisert
Rachael M. Trummel
Nicholas H. Howell
ATTORNEYS FOR DEFENDANTS
16
CERTIFICATE OF CONFERRAL
Pursuant to C.R.C.P. 121, §1-15(8), undersigned counsel for Terumo certifies that they
have conferred in good faith about this motion with Plaintiffs’ counsel, who has stated that they
will oppose the relief requested herein.
By: /s/ Luke McFarland
Luke McFarland
CERTIFICATE OF SERVICE
The undersigned hereby certifies that on this 28th day of July, 2023, a true and correct
copy of the foregoing was filed and served via ICCES upon all counsel of record.
By: /s/ Gina Bowermaster_____________
Gina Bowermaster
1
Preview
DISTRICT COURT, JEFFERSON COUNTY, STATE OF COLORADO 100 Jefferson County Parkway DATE FILED: July 28, 2023 10:00 PM FILING ID: 97BE4B26BD946 Golden, Colorado 80401 CASE NUMBER: 2020CV31481 Plaintiff: BLAKE RICHARD DARNELL v. Defendants: TERUMO BCT STERILIZATION SERVICES, INC.; TERUMO BCT, INC.; and JOHN DOES NO. 1-20. ▲ COURT USE ONLY ▲ Attorney for Defendants: Case No. 2020CV31481 J. Lucas McFarland McFarland Litigation Partners, LLC Div. 15 910 13th Street, Suite 200 Golden, Colorado 80401 Phone: (302) 279-8300 Email: luke@mcfarland.law DEFENDANTS’ OMNIBUS MOTION IN LIMINE i TABLE OF CONTENTS Page I. LEGAL STANDARD ......................................................................................................... 1 II. MOTIONS IN LIMINE ....................................................................................................... 1 1. Precluding Argument and Questions Designed to Incite Emotion Over Rationality. .............................................................................................................. 1 2. Precluding Evidence or Argument Alleging Harm to and Protection of “the Community.”........................................................................................................... 4 3. Precluding Evidence or Argument Regarding Other EtO Lawsuits and Verdicts. .................................................................................................................. 5 4. Precluding Use of “NATA” Risk Estimates as Causation Evidence. ..................... 6 5. Precluding Improper Legal Conclusions Regarding the Industry “Standard of Care.” .................................................................................................................. 7 6. Precluding Argument and Evidence Regarding Never-Enacted Backvent Regulations as Evidence of Negligence. ................................................................. 8 7. Precluding Evidence Regarding Different Chemical, Ethylene Glycol. ................. 9 8. Precluding Plaintiffs’ Experts from Relying on “Privileged” Undisclosed Data But Refuse to Produce the Underlying Privileged Information. .................... 9 9. Precluding Opinions Based on “Background” EtO Levels Plaintiffs Never Calculated. ............................................................................................................ 11 10. Precluding Evidence or Argument that Defendants Had a Duty to Provide Employee Protections to Plaintiff or the General Public. ..................................... 13 11. Precluding Plaintiffs’ Experts from Interpreting Intent of Company Documents. ........................................................................................................... 13 12. Precluding Argument that Terumo Improperly Lobbied Federal / State Regulators. ............................................................................................................ 14 III. CONCLUSION ................................................................................................................. 15 ii The Terumo Defendants move in limine as outlined in the 14 individual Motions below: I. LEGAL STANDARD Motions in limine are essential to forestall introduction of prejudicial evidence at trial. Bruckman v. Pena, 487 P.2d 566, 568 (Colo. App. 1971). Trial courts have inherent authority to rule on such motions and are further authorized by C.R.C.P. 7 & 16(c) and C.R.E. 103 & 104 to exclude prejudicial evidence. Good v. A.B. Chance Co., 565 P.2d 217 (Colo. App. 1977), superseded by statute on other grounds. Indeed, a trial court “may exclude [even relevant] evidence if its probative value is substantially outweighed by danger of unfair prejudice.” Quigly v. Jobe, 851 P.2d 236, 238 (Colo. App. 1992). The Court should do so here. II. MOTIONS IN LIMINE 1. Precluding Argument and Questions Designed to Incite Emotion Over a Decision on the Merits. Based on their deposition questions and media statements, it is evident that Plaintiffs’ counsel intend to try this case by inflaming the jury and appealing to their personal instincts, emotions, and sympathy rather than a careful consideration of the facts. This is impermissible. This strategy, often called the “golden rule” strategy, asks jurors to put themselves in the plaintiff’s shoes. Similarly, a newer offshoot referred to as the “reptile” theory (named after the 2009 book discussed below), uses jurors’ emotions to trigger safety instincts on behalf of the community as a whole. Both strategies are precluded by Colorado law, and they are two sides of the same coin. Terumo thus seeks an order precluding these types of “send a message” arguments and emotional ploys, such as by invoking terms like “EtO kills,” “guardians of the community,” “eyes and ears of the community,” “conscience of the community,” and any argument asking the jurors to put themselves in Plaintiffs’ shoes, or to decide this case on emotion and not fact. The bar on golden rule argument is nearly universal and has a long history. E.g., Granfield v. CSX Transp., Inc., 597 F.3d 474, 491 (1st Cir. 2010) (A “Golden Rule” argument is 1 “‘universally condemned because it encourages the jury to depart from neutrality and to decide the case on the basis of personal interest and bias rather than on evidence’”); Arnold v. E. Air Lines, Inc., 681 F.2d 186, 199 (4th Cir. 1982) on reh’g, 712 F.2d 899 (4th Cir. 1983) (“The Golden Rule and sympathy appeals are . . . obviously improper arguments . . . . Having no legal relevance to any of the real issues, they were per se objectionable”); Loose v. Offshore Navigation, Inc., 670 F.2d 493, 496 (5th Cir. 1982) (a “Golden Rule” argument “encourages the jury to depart from neutrality and to decide the case on the basis of personal interest and bias rather than on the evidence”); Caudle v. D.C., 707 F.3d 354, 359–60 (D.C. Cir. 2013); DuBois v. Grant, 835 P.2d 14, 16 (Nev. 1992) (banned golden rule argument is the impermissible suggestion that the jurors trade places with the victim); Boyd v. Pernicano, 385 P.2d 342, 343 (Nev. 1963) (improper to ask the jurors to place themselves in the shoes of the victim because such argument interferes with the objectivity of the jury); Horn v. Atchison, Topeka & Santa Fe Ry. Co., 394 P.2d 561, 565 (Cal. 1964) (“it was improper to appeal to the jurors to fix damages as if they or a loved one were the injured party”); Collins v. Union Pac. R.R. Co., 143 Cal. Rptr. 3d 849, 861 (Ct. App. 2012) (“A ‘golden rule’ argument is one where counsel asks the jury to place itself in the victim’s shoes and award such damages as they would charge to undergo equivalent pain and suffering” and is prohibited). The Colorado Supreme Court agrees: “[t]he ‘golden rule’ argument . . . is improper in a civil case.” People v. Rodriguez, 794 P.2d 965, 973 (Colo. 1990). Rodriguez cited a Washington Supreme Court decision approvingly, explaining the prohibition on these questions: [A]n argument in a civil case is improper which appeals to the jurors to place themselves in the position of a litigant and to decide the case based upon what they would want under the circumstances. . . . Whether a plaintiff recovers at all, and the amount of a plaintiff’s recovery, if any, or whether a defendant prevails, are questions the jury must resolve solely on the evidence and the law, and not on the basis of appeals to sympathy, passion or prejudice. Adkins v. Aluminum Co. of Am., 750 P.2d 1257, 1265 (Wash. 1988) (emphasis added); accord 2 Mitchell v. Rosenthal, 2022 WL 16962263, at *17 (D. Colo. Oct. 11, 2022) (precluding “golden rule” and “reptile theory” arguments); Blevins v. Cessna Aircraft Co., 728 F.2d 1576, 1580 (10th Cir. 1984) (finding “golden rule” arguments universally improper). Although the reptile theory is a newer plaintiff-lawyer strategy, which appeals to broader self- and community-based interests, it is premised on the same idea—getting jurors to rule based on emotion and not fact. If Plaintiffs’ deposition questioning is any indication, trial is likely to be rife with such improper questioning techniques. When deposing Terumo’s corporate representative, Jessi Done, Plaintiffs’ counsel asked page after page of such questions, such as whether Terumo agrees that: • “[S]afety should be an ethylene oxide sterilizer’s top priority?”; • “[A] company running a sterilization facility should not put profits over the safety of its employees [or] those living in the nearby community?”; • “[P]eople living in the community around the facility should be able to expect clean air to breathe in?” See Done Dep. at 297-298, 303, Excerpts of Terumo Witness Deps., attached as Ex. A. Likewise, while questioning Terumo’s regulatory expert, Plaintiffs’ counsel asked: • “Would you agree that if a company knowingly misleads the EPA they would be subject to criminal prosecution?”; • “Would you also agree that generally a best practice would be regulatory agencies to not allow companies to emit carcinogenic chemicals next to daycares?”; and • “[W]ould you agree that every life matters?” Benevento Dep. at 151-52 (Ex. A). This questioning, in some form or another, appeared throughout Plaintiffs’ depositions of Terumo’s witnesses. Plaintiffs also use these types of inflammatory phrases in argument. For example, in their Motion for Leave to Amend the Complaint to Add a Claim for Exemplary Damages (filed May 11, 2023) (“Damages Mot.”), Plaintiffs’ opening line is EtO—“a potent and dangerous carcinogen—has one application: to kill.” Id. at 1. This phrasing is clearly designed to invoke fear of and anger against Terumo. Plaintiffs should be precluded from referring to EtO as a killing tool, 3 or other similarly prejudicial phrasing intended to inflame the jury. BNSF Ry. Co. v. LaFarge Sw., Inc., 2009 WL 9144604, at *13 (D.N.M. Feb. 16, 2009) (use of word “kill” or “similar inflammatory terminology suggesting a crime” is improper). Terumo seeks broadly to exclude the use of this tactic, and in particular the phrases identified within this Motion. 2. Precluding Evidence or Argument Alleging Harm to and Protection of “the Community.” While Terumo expects Plaintiffs at trial to invoke references to what the “community” should do, or how the “community” should react, the “community” is not a plaintiff in this case. Only the 13 individuals who filed complaints in this case are. Those claims concern (1) only those 13 Plaintiffs’ alleged exposures to EtO at particular locations, at particular time periods, and in circumstances specific to those Plaintiffs only; and (2) the causation of only those 13 Plaintiffs’ alleged diseases. The relevant questions are whether Terumo’s emission of EtO put those Plaintiffs at risk and caused those Plaintiffs’ cancer. It would be misleading and confusing to the jury and unduly prejudicial to Defendants for Plaintiffs or their counsel to make arguments and present evidence of alleged risk or harm to the “community,” which necessarily implicates undefined persons, distances, locations, purported risks or harms, time periods, and circumstances that are not at issue in this case, and potentially include jurors themselves. Worse still, Plaintiffs’ tactics are meant to appeal to the biases and fears of the jury, people from the surrounding community, who have been inundated with thousands of advertisements, flyers from Plaintiffs’ counsel, online advertising, and billboards with fearmongering statements and imagery from Plaintiffs’ counsel. And Plaintiffs have shown that they fully intend to present such evidence. See Damages Mot. at 2 (“Yet, Terumo chose to ignore the gross amount of EtO it spewed into Lakewood and then justified its cost-saving pollution control choices based on this deliberate ignorance to the volume of EtO it polluted into the community.”). This evidence and argument are prejudicial and has no probative value. 4 3. Precluding Evidence or Argument Regarding Other EtO Lawsuits and Verdicts. Plaintiffs’ counsel and other law firms have filed hundreds (if not thousands) of cases against EtO sterilizers like Terumo in jurisdictions across the country, and, by Terumo’s count, this will be the third such trial nationwide. Terumo moves to exclude evidence or argument regarding other lawsuits involving EtO, whether against Terumo or other medical sterilizers, such as Sterigenics, as well as any verdicts or rulings rendered in those cases (specifically including the $363 million verdict against Sterigenics, later appealed and then settled out of court). Colorado courts commonly hold that evidence of prior or concurrent litigation is inadmissible. Predator Int’l, Inc. v. Gamo Outdoor USA, Inc., 2014 WL 348637, at *3 (D. Colo. Jan. 31, 2014) (evidence of prior or concurrent litigation was irrelevant and inadmissible); Shostrom v. Ethicon, Inc., 2022 WL 2237341, at *2 (D. Colo. June 22, 2022) (barring plaintiff from introducing evidence of other lawsuits). This prohibition includes mentioning the dollar amount of such verdicts. Engquist v. Or. Dep’t of Agr., 478 F.3d 985, 1009 (9th Cir. 2007), aff’d sub nom. Engquist v. Oregon Dep't of Agr., 553 U.S. 591, (2008) (“most courts forbid the mention of verdicts or damage amounts obtained in former or related cases”). The basis for that rule in Colorado is clear: allegations and insinuations about other lawsuits are not relevant to the specific facts at issue in this case—i.e., whether EtO emissions from the Lakewood facility caused Plaintiffs’ alleged injuries. Similarly, the mention of prior or current lawsuits would unfairly prejudice Terumo, leading a jury to incorrectly assume that Plaintiffs’ case must be meritorious based on the number of other plaintiffs who have sued. Allen v. Zavaras, 2010 WL 1348748, at *2 (D. Colo. Mar. 30, 2010) (finding that discovery seeking number of suits filed against defendants was irrelevant). Accordingly, any such argument or evidence about other lawsuits and verdicts be precluded because such evidence is clearly prejudicial and has no probative value. 5 4. Precluding Use of “NATA” Risk Estimates as Causation Evidence. In their case, Plaintiffs (and more specifically, their retained expert witnesses) are expected to opine that EtO can and did cause their injuries. To support these opinions, Plaintiffs will try to introduce the EPA’s National Air Toxics Assessment (“NATA”)—a 2018 EPA report providing information on outdoor air quality and the potential impact of EtO and other airborne toxins on communities nationwide. Indeed, this NATA report is the genesis of this entire litigation, see generally Plaintiffs’ Complaint, as the EPA conservatively increased its risk assessment (“IRIS” level) of EtO to 30-60 times of what was previously understood, creating a cascade of litigation. But the NATA report is not a study linking EtO to cancer, and it cannot be used as evidence of causation. EPA itself has warned against such uses on numerous occasions: • NATA is a “screening tool intended to help EPA and state, local and tribal air agencies determine if areas, pollutants or types of pollution sources need to be examined further.” NATA Fact Sheet, attached as Ex. B (emphasis added). • NATA is “largely driven” by IRIS risk values not intended to predict disease and that do “not estimate any person’s individual risk.” Id. at 1 (emphasis added). • NATA is “performed with few data and many conservative assumptions.” EPA Air Toxics Risk Assessment Reference Library, Vol. 1 Technical Resource Manual (Apr. 2004), relevant excerpts attached as Ex. C, Glossary at 34 (emphasis added). • The inhalation risk unit value (“IUR”) for a substance, like EtO, is “typically upper-bound estimates, [so] actual risks may be lower than predicted, [and] the true value of the risk is unknown and may be as low as zero. Id. at 13-6 (emphasis added). • Moreover, NATA should not be used to “pinpoint specific risk values within a census tract,” “to compare risks at local levels (such as between neighborhoods),” or “as a definitive means to specify risk values within a census tract.” Fact Sheet, Ex. B at 1. Inevitably, Plaintiffs will seek to present these public health specific risk values as causation evidence. Indeed, their causation theory is based on Dr. Clark’s invented “IRIS Lifetime Dose,” through which he compares his dose reconstruction of each Plaintiff to the IRIS values, despite EPA’s clear instruction to the contrary. See 4/10/23 Mot. to Preclude Clark (“Clark Mot.”). Statements by regulatory and public health agencies in the risk-assessment context do not meet legal standards of proof of causation. Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27, 42 6 (2011) (FDA may act on “evidence that suggests, but does not prove, causation”); Indus. Union Dep’t, AFL-CIO v. Am. Petro. Inst., 448 U.S. 607, 656 (1980) (Stevens, J., concurring) (agency “is free to use conservative assumptions in interpreting . . . data with respect to carcinogens, risking error on the side of overprotection rather than underprotection”); McLain v. Metabolife Int’l, Inc., 401 F.3d 1233, 1249–50 (11th Cir. 2005) (government agencies often “err on the side of caution”). Accordingly, the NATA report is not probative of whether Terumo’s emissions actually caused Plaintiffs’ injuries, and Plaintiffs cannot meet their burden of proof by relying on regulatory assessments that, by their own terms, do not bear on individual causation. 5. Precluding Improper Legal Conclusions Regarding the Industry “Standard of Care.” At trial, Plaintiffs’ expert, Dr. Sahu, will attempt to offer legal conclusions on a wide range of issues. However, the “trial judge is obligated to correctly instruct the jury on the law applicable to the case,” Jordan v. Bogner, 844 P.2d 664, 667 (Colo. 1993), which of course means that an expert is prohibited from offering legal conclusions. Equal Emp. Opp. Comm’n v. W. Distrib. Co., 2022 WL 17351984 (D. Colo. Dec. 1, 2022) (“An expert may not offer an opinion that is a legal conclusion even when he or she has provided his or her underlying analysis.”). It is the Court’s duty to instruct on the standard of care, which is typically “based on the standard of care owed by a reasonable person in the defendant's position.” Scott v. Matlack, 39 P.3d 1160, 1166 (Colo. 2002); United Blood Servs. v. Quintana, 827 P.2d 509, 519 (Colo. 1992) (“The court determines, as a matter of law, the existence and scope of the duty”). And importantly, in Colorado, compliance with “generally accepted industry standards” is critical to assessing negligence. Scott, 39 P.3d at 1170. Rather, an expert may only offer “testimony concerning standard industry customs and practices” that is “relevant.” Gerrity Oil & Gas Corp. v. Magness, 946 P.2d 913, 931 (Colo. 1997), as modified on denial of reh’g (Oct. 20, 1997) (emphasis added). Dr. Sahu is Plaintiffs’ supposed “standard of care” expert. But Dr. Sahu, an engineer- 7 turned-full-time-plaintiff expert who has no relevant EtO experience aside from working on EtO- related litigation in the past couple of years, cannot opine on industry standard customs and practices for two reasons. First, Dr. Sahu completely lacks experience in the industry. Dr. Sahu admitted to his lack of experience readily at his deposition, and his lack of experience is discussed in Terumo’s 4/12/23 Motion to Exclude Sahu (“Sahu Mot.”), including that he never set foot in a commercial sterilizer until a year and a half ago as of April 2023, and that the first operating EtO sterilizer he went to was in Smyrna, Georgia in March of 2023 (only four months ago). Sahu Dep., Ex. B to Sahu Mot., at 43:5-17. Second, Dr. Sahu is unequivocal that he believes industry standards are irrelevant, even in the face of contrary Colorado law. Dr. Sahu has not “looked to see whether there has been or has not been” an industry standard for the EtO sterilization industry, and he believes “[i]t is not relevant what the majority was doing because . . . whatever the majority was doing would only deal with their respective circumstances.” Id. at 130:17-23, 166:8-13. As Dr. Sahu has no foundation to opine on the industry standard of care, his opinions on that should be precluded. Stenson v. Edmonds, 2022 WL 19299121, at *9 (D. Colo. Aug. 26, 2022) (when expert does not “lay adequate foundation” to opine on an aspect of the case, those opinions are inadmissible). 6. Precluding Argument and Evidence Regarding Never-Enacted Backvent Regulations as Evidence of Negligence. Given Plaintiffs’ repeated emphasis of this issue, Terumo expects Plaintiffs to argue at trial that Terumo was legally required to connect the chamber backvents to emission control systems, even though there never was such a requirement by EPA or CDPHE. Colorado law is clear— evidence of regulations that were not in effect during the relevant time cannot be introduced. See, e.g., Bennett v. Greeley Gas Co., 969 P.2d 754, 759 (Colo. App. 1998) (“[E]vidence concerning [regulations] is not admissible to establish the standard of care at a time before their enactment.”). Dr. Sahu’s opinion is irrelevant because a failure to comply with regulations that are under 8 consideration—but never adopted—has no bearing on whether a defendant was negligent. Id. Deceptively, Plaintiffs’ emissions expert, Dr. Sahu, suggested that such a requirement existed until it was removed in 2001. Sahu Rept., Ex. A to Sahu Mot., App’x A at 118 (“EPA removed MACT requirements for the chamber back vents in 2001”). In fact, however, EPA never required that backvents be connected to emissions controls; such language was removed at the drafting stage before the final rule was published it in the Federal Register due to safety concerns about explosions at similar facilities.1 Since Terumo was never legally required to connect the backvents to emissions controls equipment, Plaintiffs cannot argue or insinuate otherwise.2 7. Precluding Evidence Regarding Different Chemical, Ethylene Glycol. Terumo expects Plaintiffs will introduce evidence regarding Terumo’s use or disposal of ethylene glycol. See Damages Mot. at 31. Despite similar names, ethylene glycol and ethylene oxide are very different chemicals. And Plaintiffs do not allege that ethylene glycol caused or contributed to their cancers in any way. (Nor do any of their experts suggest that ethylene glycol caused Plaintiffs’ cancers.) Because evidence about ethylene glycol will not make the existence of any relevant fact more or less probable, all such evidence should be excluded. Quigly, 851 P.2d at 238 (affirming exclusion of evidence that was prejudicial even if it “had any marginal relevance”). 8. Precluding Plaintiffs’ Experts from Relying on “Privileged” or “Confidential” Undisclosed Data but Refuse to Produce the Underlying Information. At trial, Plaintiffs’ experts are also expected to offer opinions based on privileged or confidential information, but they refuse to provide that information to Defendants. Plaintiffs can’t have it both ways. For example, Dr. Clark admitted that he relied on memos from interviews with 1 See EtO Standards for Sterilization Facilities, 66 Fed. Reg. 55577, 55578 (Nov. 2, 2001), available at https://www.govinfo.gov/content/pkg/FR-2001-11-02/pdf/01-27594.pdf. 2 When EPA released its NATA Report in 2018, with the knowledge and cooperation of CDPHE, Terumo connected its back vents to emissions controls, as CDPHE felt the explosion risks could be safely mitigated and the increased toxicity value for EtO altered the cost-benefit analysis. 9 Plaintiffs as an input to his modeling. But Plaintiffs refuse to provide those documents. 3/26/23 Email to Special Master, Ex. J to Clark Mot. Dr. Sahu also relies on material allegedly subject to a confidentiality order in another case, but he says he cannot produce the data. To avoid his clear obligation to do so, Dr. Sahu calls his reliance on that allegedly privileged information his “engineering judgment.” 6/28/23 Mot. to Compel Documents Relied on by Dr. Sahu. Terumo thus moves to exclude any opinions based on any data relied on by Plaintiffs’ experts that they claim is privilege and has not been disclosed. Again, the case law is unambiguous. If a retained expert wishes to offer an opinion, the expert must disclose all of the sources supporting that information, including confidential information. See, e.g., Clements v. Davies, 217 P.3d 912, 916 (Colo. App. 2009) (affirming exclusion of podiatrist’s expert testimony for failure to fully produce expert file containing materials in support of his opinion, explaining that “[w]ithout such access, the opposing party will be unable to conduct a full and fair cross-examination of the expert” (internal citation omitted)); Gall ex rel. Gall v. Jamison, 44 P.3d 233, 239 (Colo. 2002) (holding “opinion work product that is reviewed or considered by an expert in preparation for testimony at trial is discoverable”); U.S. ex rel. Maxwell v. Kerr-McGee Chem. Worldwide, LLC, 2006 WL 2053534, at *7-8 (D. Colo. July 21, 2006). Failure to do so requires that those opinions be precluded. Camp Bird Colo., Inc. v. Bd. of Cty. Comm’rs of Ouray, 215 P.3d 1277, 1290 (Colo. App. 2009) (“when a party violates discovery rules, the trial court may choose appropriate sanctions, which may include evidence preclusion”); Longoria v. Kodiak Concepts, LLC, 2021 WL 1100373, at *14 (D. Ariz. Mar. 23, 2021) (“It doesn't matter that the data on which [the expert] relied was “confidential”—it still needed to be disclosed.”). Because Plaintiffs refuse to produce these materials—preventing Terumo’s experts from analyzing and evaluating them—Plaintiffs may not present opinions that rely on these materials at 10 trial. Maxwell, 2006 WL 2053534, at *7-8 (instructing moving party to renew motion to strike if opposing party does not supplement expert disclosures to include confidential information relied upon by expert); United States v. 1003.58 Acres of Land, 2018 WL 4945309, at *1 (C.D. Cal. Jan. 31, 2018) (excluding expert opinion where expert withheld the “information he relied on as ‘confidential’” because “in order for the defense to examine the data upon which Mr. Frahme [expert] relied, it needed the very information he declined to detail”). No expert can rely on privileged information to prepare opinions, and then refuse to produce it. Under that theory, as is the case here, Defendants could never adequately cross-examine and discover the truth. 9. Precluding Opinions Based on “Background” EtO Levels Plaintiffs Never Calculated. Plaintiffs base their negligence case on a theory that only those exposures to EtO above “background” (also known as “ambient” air) levels are harmful—but Plaintiffs’ experts never calculated or determined what those background levels are. Background EtO (or background levels of any substance) is what exists in the ambient air, not including the source of alleged exposure. As EtO is a naturally occurring chemical (one that is even produced in our bodies), and is also a byproduct of smoking, car exhaust, propane, and myriad other common daily activities, it is universally recognized that background concentrations of EtO are present that are not otherwise attributable to a single industrial source like Terumo. Ultimately, despite over a thousand pages of reports across five experts who invoke the term “background” EtO, not a single one ever quantifies or calculates a level of background EtO that is the benchmark from which that amount would be, as they argue, cancer causing. In other words, they never identified the denominator on which their exposure claims depend. Thus, any opinion based on levels “over background” should be precluded. Indeed, all four of Plaintiffs’ general causation experts—Drs. Felsher, Stayner, Salem and Dahlgren—are expected to testify that any exposure to EtO above “background” is capable of causing cancer. For example: 11 • Dr. Felsher: “[m]y opinion is that exposure above whatever background will be a necessary and substantial contributing cause.” 7/20/20 Felsher Dep. (Rough), attached as Ex. D, at 410:10-12. • Dr. Salem: “I believe that any amount of ethylene oxide above background is not good for you.” Salem Dep., Ex. H to 4/10/23 Mot. to Exclude General Cause Experts (“Gen. Cause Mot.”), at 197:7-11. • Dr. Dahlgren: “[A] direct alkylating agent that causes cancer is usually considered not to have a safe level above background levels.” Dahlgren Rep., Ex. D to Gen. Cause Mot., at 2. (Emphases added). Recognizing this fundamental gap in their case, Plaintiffs’ dose reconstruction expert, Dr. Clark, is expected to testify that background is “irrelevant.” Such testimony completely defies EPA guidance issued as recently as March 2023.3 Well settled law, as well as Plaintiffs’ own experts’ scientific testimony, requires Plaintiffs to prove that excess EtO—specifically excess EtO from Terumo—caused their cancers. Courts require proof of a threshold level above background levels in order to be considered reliable. Vedros v. Northrop Grumman Shipbuilding, Inc., 119 F. Supp. 3d 556, 565-66 (E.D. La. 2015) (excluding “every exposure above background theory” (emphasis added)). One court explained: We fail to see how the theory can, as a matter of logic, exclude higher than normal background levels as the cause of the plaintiff’s disease, but accept that any exposure from an individual defendant, no matter how small, should be accepted as a cause in fact of the disease. Bostic v. Georgia-Pacific Corp., 439 S.W. 3d 332, 341 (Tex. 2014); see also Baker v. Chevron USA, Inc., 680 F. Supp. 2d 865, 878 n.9 (S.D. Ohio 2010) aff’d 533 App’x 509 (6th Cir. 2013) (“ambient benzene was [just as likely] the cause of Plaintiffs’ illnesses” (emphasis added)). In other words, they cannot prove excess EtO is the cause if they simply assume Plaintiffs were exposed over background because there was a source of EtO nearby. See Clark Dep., Ex. I to Clark Mot., at 37:23-25 (“whatever the background level of the non-man-made EtO in the environment would only be enhanced by what Terumo was putting out”). 3 Available at https://www.epa.gov/system/files/documents/2023-04/eto-draft-human-healh-ra- add.pdf (extensively citing to “ambient” EtO as required measurement to better understand risk). 12 It is basic logic that proving an airborne substance is harmful is impossible without considering the level present in the ambient air at status quo. Rather, Plaintiffs’ experts have gone so far as to ignore the background levels of EtO as measured by CDPHE across the state of Colorado. For example, while Dr. Clark spends pages of his report critiquing the CDPHE sampling, he does not use any other actual background samples in their stead—he simply disclaims their relevance. Plaintiffs’ experts must be required to state what background is if they are to use it as a benchmark—and since they have not, those opinions should be excluded. 10. Precluding Evidence or Argument that Defendants Had a Duty to Provide Employee Protections to Plaintiff or the General Public. At trial, Plaintiffs’ experts likely will argue or try to testify that Defendants owed a duty to Plaintiffs or the general public to provide them the same safety and health protections that Terumo provides its employees under federal occupational safety and health standards. Neither statutory nor common law imposes such a duty on Terumo, and to allow Plaintiffs to argue such a duty would be legally erroneous and carry a significant risk of jury confusion and undue prejudice. To prove liability in negligence, Plaintiffs must show that Terumo breached a duty owed to Plaintiffs under the ordinary standard of care. Scott, 39 P.3d at 1166. As a matter of law and logic, reasonable care does not require Terumo to provide to Plaintiffs or the general public outside Terumo’s facility the same protective measures mandated by the Occupational Health and Safety Administration (“OSHA”) for employees working directly with or around EtO inside the facility. As such, Plaintiffs should be precluded from invoking OSHA regulatory requirements for the inside of the facility (e.g., warning signs, training on dangers of EtO, provision of respirators, badge monitoring, alarms, and adequate ventilation) to support an inference that Terumo had a duty to provide these same protections to the general public outside the facility for miles around. 11. Precluding Plaintiffs’ Experts from Interpreting Intent of Company Documents. At trial, Plaintiffs should be precluded from using their experts as a mouthpiece to infer the 13 intent of Terumo’s employees through company documents. In re Fosamax Prods. Liab. Litig., 645 F. Supp. 2d 164, 192 (S.D.N.Y. 2009) (granting MIL as to experts “testifying as to the knowledge, motivations, intent, state of mind, or purposes of [defendant], its employees, the FDA, or FDA officials” as such it “is not a proper subject for expert or even lay testimony”). For example, in Dr. Sahu’s Report, adopting the entirety of Dr. Rockstraw’s standard of care opinions, he improperly editorializes company emails without restraint. See Sahu Rept., App’x A (Ex. A to Sahu Mot.) at 192 (regarding Oct. 27, 2017 email, “Freeman’s response provides further indication of Defendant’s ignorance of the process equipment”); id. at 143 (opining that Terumo commissioned the 1996 inhalation risk study “for the sole purposes of avoiding having to comply with the EPA’s new NESHAP of 1994 in Terumo 1”); id. at 123 (interpreting witness’s use of term “strategic value” to mean that “Terumo was more concerned with playing the permit compliance game than providing the community and the regulatory agencies with the actual amount of EtO that was escaping”). Sahu’s opinions are not based on any expert experience or personal knowledge but serve only as a megaphone for legal argument and conclusions from counsel. Accordingly, such opinion testimony is not probative and unduly prejudicial. 12. Precluding Argument that Terumo Improperly Lobbied Federal / State Regulators. In briefing, Plaintiffs have argued that the EPA’s removal of their draft guidance for backvents to be connected to an emission control source was due to efforts by Terumo and others in the EtO industry to “lobby” or otherwise influence government and science. Damages Mot. at 12 n.12 (“[T]he EPA removed the requirement of the back vent at the urging of the EtO industry lobbying efforts.”). The anticipated arguments are factually incorrect and inflammatory and, if admitted, would substantially and unfairly prejudice and mislead the jury. Plaintiffs’ fabricated narrative of improper “lobbying” misconstrues the regulatory 14 rulemaking process. As part of that process, the Administrative Procedure Act (“APA”) provides for a public comment period to allow any member of the public to communicate with the rulemaking body.4 Notice-and-comment rulemaking under the APA is intended to provide all stakeholders a chance to participate in the process, as well as to help EPA educate itself before promulgating regulations that would have a substantial effect on the regulated community. Indeed, EPA openly invited comments on the draft regulations, particularly from industry members and stakeholders. Of course, this regulatory process is a constitutionally protected and longstanding procedure and cannot be held against Terumo to paint it in a negative light to the jury. Computer Assocs. Int’l, Inc. v. Am. Fundware, Inc., 831 F. Supp. 1516, 1522 (D. Colo. 1993) (Noerr- Pennington doctrine “bars litigation arising from injuries received as a consequence of First Amendment petitioning activity, regardless of the underlying cause of action asserted by the Plaintiffs”). Defendants’ communications with EPA and other regulatory agencies, whether direct or indirect, served a constitutionally protected purpose of engagement with the rulemaking procedure, and evidence of such conduct cannot be used against Terumo. As such, Plaintiffs, their counsel, their expert witnesses, and their fact witnesses should not be permitted to introduce evidence that Defendants “lobbied” any regulatory agency, or to make any reference to such evidence, or to use communications with regulators or industry groups, such as the American Chemistry Council, for same. III. CONCLUSION For the foregoing reasons, the Court should grant the relief Terumo seeks and limit Plaintiffs’ evidence and testimony as described above. 4 EPA, Public Comment Process, available at https://www.epa.gov/superfund/public-comment- process. 15 DATED this 28th day of July, 2023 MCFARLAND LITIGATION PARTNERS, LLC The original signature is on file at McFarland Litigation Partners, LLC By: /s/ J. Lucas McFarland J. Lucas McFarland KING & SPALDING LLP Douglas A. Henderson Joseph A. Eisert Rachael M. Trummel Nicholas H. Howell ATTORNEYS FOR DEFENDANTS 16 CERTIFICATE OF CONFERRAL Pursuant to C.R.C.P. 121, §1-15(8), undersigned counsel for Terumo certifies that they have conferred in good faith about this motion with Plaintiffs’ counsel, who has stated that they will oppose the relief requested herein. By: /s/ Luke McFarland Luke McFarland CERTIFICATE OF SERVICE The undersigned hereby certifies that on this 28th day of July, 2023, a true and correct copy of the foregoing was filed and served via ICCES upon all counsel of record. By: /s/ Gina Bowermaster_____________ Gina Bowermaster 1