Johns v. CR Bard

UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF OHIO

EASTERN DIVISION

IN RE: DAVOL, INC./C.R. BARD, INC., Case No. 2:18-md-2846

POLYPROPYLENE HERNIA MESH

PRODUCTS LIABILITY LITIGATION

JUDGE EDMUND A. SARGUS, JR.

Magistrate Judge Kimberly A. Jolson

This document relates to:

Johns v. CR Bard et al.,

Case No. 2:18-cv-01509

MOTIONS IN LIMINE OPINION & ORDER No. 8

Plaintiff Steven Johns and Defendants C.R. Bard, Inc. and Davol, Inc. filed various motions

in limine to exclude evidence in this case. Now before the Court are Parts 13, 18, and 19 of

Plaintiff’s Motion in Limine No. 1 to Exclude Certain Subjects from Evidence at Trial (ECF No.

235), Defendants’ Motion in Limine No. 17 to Exclude Evidence and Argument Concerning

Unrelated Investigations, Convictions, Congressional Committee Proceedings and Letters,

Settlements, or Alleged Bad Acts (ECF No. 220), and Plaintiff’s Motion in Limine No. 8 to

Exclude Certain Evidence Related to UCSF (ECF No. 237).

I. Background1

This case is the first bellwether trial, selected from thousands of cases in this multidistrict

litigation, alleging “that defects in defendants’ polypropylene hernia mesh products can lead to

complications when implanted in patients, including adhesions, damage to organs, inflammatory

and allergic responses, foreign body rejection, migration of the mesh, and infections.” (No. 2:18-

1 The Court assumes that the parties and other interested readers are familiar with the history of this case. For

a more complete factual background, the reader is directed to the Court’s summary judgment opinion and order. In re

Davol, Inc., Polypropylene Hernia Mesh Prods. Liab. Litig., Nos. 2:18-md-2486, 2:18-cv-01509, 2020 WL 5223363,

at *1–6 (S. D. Ohio Sept. 1, 2020).

md-02846, ECF No. 1 at PageID #1–2.)2 This includes the Ventralight ST, the device implanted

in Plaintiff. The Ventralight ST is a prescription medical device used for hernia repairs. 2020 WL

5223363, at *1. The Food and Drug Administration (“FDA”) cleared it for use through the

premarket notification § 510(k) process in 2010 and later cleared it for use with the Echo

Positioning System in 2011. It is a multicomponent device made of a mesh, which consists of

polypropylene, polyglycolic acid (“PGA”) fibers, and a bioresorbable coating called “Sepra

Technology” (“ST”). The ST-coated side of the mesh is placed against organs, such as the bowels,

while the uncoated polypropylene side is placed against the fascia because the uncoated side

maximizes tissue attachment and thus supports the hernia repair. Id. at *1–2.

Plaintiff brings this action to recover for injuries sustained as a result of the implantation

of Defendants’ allegedly defective Ventralight ST device. Plaintiff claims that Defendants knew

that polypropylene is unsuitable for permanent implantation in the human body and that the PGA

fibers created an increased inflammatory response. Id. at *4. The crux of Plaintiff’s claims is that

the ST coating on Ventralight ST devices resorbs too quickly. This leads to the exposure of bare

polypropylene to internal organs and tissues, increasing the risk of potential complications.

Plaintiff alleges that this occurrence led to omental adhesions after his laparoscopic hernia repair

surgery in 2015. The adhesions were diagnosed during a subsequent laparoscopic surgery in

October 2016 by Plaintiff’s implanting surgeon. Id. at *5.3 After summary judgment, the following

claims remain for trial: design defect, under negligence and strict liability theories; failure to warn,

under negligence and strict liability theories; breach of express warranty; breach of implied

warranty; breach of implied warranty of merchantability; negligent misrepresentation; and

2 Unless otherwise noted, record citations are to the docket for this case, No. 18-cv-01509.

3 The Court granted Defendants’ motion for summary judgment on Plaintiff’s other alleged injuries because

Plaintiff failed to demonstrate a material fact dispute regarding causation. 2020 WL 5223363, at *14.

punitive damages. Id. at *6–25. Now, various motions in limine and other evidentiary motions are

ripe for adjudication.

This opinion addresses three motions in limine: Plaintiff’s Motion in Limine No. 1,

specifically Parts 13, 18, and 19 (ECF No. 235 at PageID #12918–20), Defendants’ Motion in

Limine No. 17 (ECF No. 220), and Plaintiff’s Motion in Limine No. 8 (ECF No. 237).

II. Legal Standards

“Neither the Federal Rules of Evidence nor the Federal Rules of Civil Procedure explicitly

authorize a court to rule on an evidentiary motion in limine.” In re E.I. du Pont de Nemours & Co.

C-8 Pers. Injury Litig., 348 F. Supp. 3d 698, 721 (S.D. Ohio 2016). The practice of ruling on such

motions “has developed pursuant to the district court’s inherent authority to manage the course of

trials.” Luce v. United States, 469 U.S. 38, 41 n.4 (1984). “The purpose of a motion in limine is to

allow a court to rule on issues pertaining to evidence prior to trial to avoid delay and ensure an

evenhanded and expedient trial.” In re E.I. du Pont, 348 F. Supp. 3d at 721 (citing Ind. Ins. Co. v.

Gen. Elec. Co., 326 F. Supp. 2d 844, 846 (N.D. Ohio 2004)). However, courts are generally

reluctant to grant broad exclusions of evidence before trial because “a court is almost always better

situated during the actual trial to assess the value and utility of evidence.” Koch v. Koch Indus.,

Inc., 2 F. Supp. 2d 1385, 1388 (D. Kan. 1998); accord Sperberg v. Goodyear Tire & Rubber Co.,

519 F.2d 708, 712 (6th Cir. 1975). Unless the moving party proves that the evidence is clearly

inadmissible on all potential grounds—a demanding requirement—“evidentiary rulings should be

deferred until trial so that questions of foundation, relevancy and potential prejudice may be

resolved in proper context.” Ind. Ins. Co., 326 F. Supp. 2d at 846; see also Koch, 2 F. Supp. 2d at

1388 (“[A] court is almost always better situated during the actual trial to assess the value and

utility of evidence.”). The denial, in whole or in part, of a motion in limine does not give a party

license to admit all evidence contemplated by the motion; it simply means that the Court cannot

adjudicate the motion outside of the trial context. Ind. Ins Co., 326 F. Supp. 2d at 846.

Relevant evidence is “evidence having any tendency to make the existence of any fact that

is of consequence to the determination of the action more probable or less probable than it would

be without the evidence.” Fed. R. Evid. 401. “Irrelevant evidence is” inadmissible. Fed. R. Evid.

402. A court may exclude relevant evidence under Federal Rule of Evidence 403 “if its probative

value is substantially outweighed by a danger of . . . unfair prejudice, confusing the issues,

misleading the jury, undue delay, wasting time, or needlessly presenting cumulative evidence.”

Fed. R. Evid. 403. Evidentiary rulings are made subject to the district court’s sound discretion.

Frye v. CSX Trans., Inc., 933 F.3d 591, 598 (6th Cir. 2019); see also Paschal v. Flagstar Bank,

295 F.3d 565, 576 (6th Cir. 2002) (“In reviewing the trial court’s decision for an abuse of

discretion, the appellate court must view the evidence in the light most favorable to its proponent,

giving the evidence its maximum reasonable probative force and its minimum reasonable

prejudicial value.”).

III. Analysis

A. Plaintiff’s Motion in Limine No. 1

In this motion, Plaintiff argues that twenty subjects should be excluded at trial. (ECF No.

235.) During the hearing, the parties confirmed that on almost all subjects, they had reached an

agreement, leading the Court to grant Plaintiff’s motion in limine as to seventeen of the twenty

parts. (ECF No. 311 at PageID #16824–37.) The Court reserved judgment on Parts 13, 18, and

19 and ordered supplemental briefing. In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia

Mesh Prods. Liab. Litig., Nos. 2:18-md-2486, 2:18-cv-01509, 2020 WL 6605576, at *1 (S.D.

Ohio Sept. 11, 2020). The briefing is complete.

1. Part 13

In Part 13 of his motion, Plaintiff argues that any evidence about Defendants’ actions for

societal good either by manufacturing devices or by performing charitable acts should be excluded.

(ECF No. 235 at PageID #12918.) This part of the motion includes refence to Defendants’ devices

as “lifesaving,” COVID-19 related endeavors, and charitable acts, including a donation of devices

to Dr. Jensen. (Id. at PageID #12918–19.) Motions in Limine Opinion and Order No. 7 addresses

the characterization of Defendants’ devices as “lifesaving.” In re Davol, Inc./C.R. Bard, Inc.,

Polypropylene Hernia Mesh Prods. Liab. Litig., Nos. 2:18-md-2486, 2:18-cv-01509, 2020 WL

7065764, at *9 (S.D. Ohio Dec. 3, 2020). And Defendants will be permitted to explain briefly what

their companies do and produce, which may include some reference to COVID-19 related efforts

(if they are significant and form a large part of Defendants’ business) or the fact that their devices

are designed to be useful, treat medical conditions, etc. (ECF No. 311 at PageID #16836–37.) As

Defendants correctly point out, parties are generally allowed to describe the nature of their business

so long as it will assist the jury in understanding the factual issues in the case. E.g., In Re Bard

IVC Filters Prods. Liab. Litig., Nos. MDL 15-02641-PHX DGC, CV-16-00474-PHX-DGC, 2018

WL 934795, at *2 (D. Ariz. Feb. 15, 2018); Knight v. Boehringer Ingelheim Pharms., Inc., 323 F.

Supp. 3d 837, 854 (S.D.W. Va. 2018). Therefore, Plaintiff’s motion is denied with regard to these

aspects.

This leaves evidence of Defendants’ “good acts in the community and relationship with

surgeons,” including their device donation to Dr. Jensen for his mission trip. (ECF No. 257 at

PageID #13602.)

i. Good acts

Evidence of Defendants’ good or charitable acts in the community fall within a different

category than flattering background information about Defendants. Rule 404(a) prohibits character

or propensity evidence, “[e]vidence of a person’s character or character trait” used “to prove that

on a particular occasion the person acted in accordance with the character or trait.” Fed. R. Evid.

404(a). Rule 404(b) prohibits evidence of other acts “to show that on a particular occasion the

person acted in accordance with the character.” Fed. R. Evid. 404(b)(1). Evidence of Defendants’

charitable acts that are unrelated to the development of its devices is propensity evidence,

attempting to induce the jury to conclude that because Defendants have a good corporate character,

it is unlikely that they behaved poorly in manufacturing and marketing the Ventralight ST. See

Knight, 323 F. Supp 3d. at 854 (“The Court will not permit Defendant to adduce evidence or

argument related to its own good, company-wide reputation, its unrelated “good” or charitable

acts, or other corporate practices indicative of its social conscious that are unrelated to [the product

at issue].”). Accordingly, Plaintiff’s motion is granted on this point and the evidence will be

excluded.

Defendants counter that this evidence is relevant to whether punitive damages are

appropriate. (ECF No. 257 at PageID #13602; ECF No. 307 at PageID #16691–92.) Evidence of

Defendants’ conduct in relation to the Ventralight ST, whether merely negligent or, as required by

Utah law for punitive damages, Utah Code. Ann. § 78B-8-201, willful, malicious, intentionally

fraudulent or knowingly and recklessly indifferent is relevant because the nature of Defendants’

conduct is at issue at this liability stage. See 2020 WL 6605576, at *2 (explaining that evidence of

Defendants’ “financial condition” would be the subject of separate punitive damages proceedings).

But general evidence of Defendants’ charitableness has no relevance to the nature of Defendants’

conduct in relation to the Ventralight ST. Therefore, this evidence is inadmissible, and this part of

Plaintiff’s motion is granted.

ii. Donation to Dr. Jensen

In his supplemental brief, Plaintiff argues that this evidence is irrelevant under Rules 401

and 402, prejudicial under Rule 403, and improper evidence of good character under Federal Rule

of Evidence 404. Defendants contend that this evidence is relevant to rebut the bad intent that

Plaintiff “ascribe[s]” to Defendants in his argument that Defendants concealed certain evidence

from Dr. Jensen, which Dr. Jensen averred would have led him to not use the Ventralight ST in

Plaintiff’s surgery. (ECF No. 307 at PageID #16690.)

Plaintiff is clear that he will argue that Defendants intentionally concealed information

from Dr. Jensen and all medical providers (ECF No. 320 at PageID #17188), which is relevant to

Plaintiff’s failure-to-warn claims, specifically whether the warning for the Ventralight ST was

adequate. Defendants are free to rebut this evidence, but only with relevant evidence. It is unclear

how evidence that Defendants donated devices, which do not appear to have been the Ventralight

ST or a similar device, for charitable mission trips challenges evidence that Defendants

purposefully concealed from Dr. Jensen information related to the Ventralight ST.

Defendants argue that this evidence contextualizes Dr. Jensen’s relationship with

Defendants and helps explain why he decided to use the Ventralight ST in Plaintiff’s surgery. (ECF

No. 307 at PageID #16692.) But this evidence has no probative value to whether Defendants

concealed important information about the Ventralight ST from Dr. Jensen. Rather, is character

evidence, enticing the jury to infer that because Defendants previously acted benevolently toward

Dr. Jensen, they are less likely to have misled him here. Fed. R. Evid. 404(a), (b).

Defendants do not provide any authorities to the contrary. They cite In re Bard IVC Filters

Products Liability Litigation, Nos. MDL 15-02641-PHS-DGC, CV-16-00474-PHX-DGC, 2018

WL 934795 (D. Ariz. Feb. 15, 2018), but the court in that case did not consider similar evidence.

There, the district court considered and admitted “evidence regarding the nature, quality, and

usefulness of their products . . . and the fact that their products are designed to promote health and

save lives.” Id. at *2. The court concluded that Defendants could “rebut Plaintiffs’ themes” by

presenting “evidence regarding the nature of Defendants’ business.” Id. Evidence of donations

made to Dr. Jensen’s Guatemala mission trip is not evidence of the nature of Defendants’ business.

This is a discrete instance that has little to do with the nature of Defendants’ businesses as device

manufacturers.

For these reasons, the Court grants Plaintiff’s motion in this respect.

2. Parts 18 & 19

Next, Plaintiff argues in his motion that evidence should be excluded if offered to prove

“that state warning defect or failure-to-warn laws pressure manufacturers to add unsubstantiated,

false, or invalid warnings in order to avoid lawsuits” and “that too many warnings of serious

injuries will dilute the effectiveness of warnings generally.” (ECF No. 235 at PageID #12919–20.)

The Court ordered the parties to further clarify their positions in supplemental briefing. 2020 WL

6605576, at *1. In his supplemental brief, Plaintiff identified his chief concern, that Defendants

would argue generally that the state-law tort systems undermine congressional intent, presumably

as represented by the Food, Drug, and Cosmetic Act of 1938, 21 U.S.C. §§ 301–399g, and

undermine FDA regulations. (ECF No. 308 at PageID #16708.) He also explains that if the

Defendants argue generally that too many warnings dilute the effectiveness of warnings, the jury

may conclude that they cannot find for Plaintiff even if his failure to warn claims have merit. (Id.

at PageID #16711.) Defendants respond that they agree that this sort of generalized evidence is

inappropriate, but that evidence from a qualified expert about the adequacy of Defendants’

warnings is admissible. (ECF No. 317 at PageID #17121–22.)

The adequacy of Defendants’ warnings is a crucial element of Plaintiff’s failure to warn

claims. Feasel v. Tracker Marine, LLC, 460 P.3d 145, 152 (Utah Ct. App.) (negligence), cert.

granted sub nom., Feasel v. Tracker Marine, 466 P.3d 1072 (Utah 2020); Christison v. Biogen

Idec Inc., No. 2:11-CV-01140-DN-DBP, 2014 WL 7261300, at *8 (D. Utah Dec. 18, 2014) (strict

liability). Evidence that Defendants considered the effects of warning dilution in writing the

instructions for use and evidence that surgeon end-users are impacted by warning dilution may be

relevant and admissible to the adequacy of a warning. See, e.g., Mahaney ex rel. estate of Kyle v.

Novartis Pharms. Corp., 835 F. Supp. 2d 299, 321 (W.D. Ky. 2011) (“Overwarning, or warning

fatigue, is a legitimate concern of manufacturers when creating labels for consumers.”) (denying

Plaintiff’s motion to exclude any evidence about warning dilution), vacated on other grounds, No.

1:06-CV-00035-R, 2012 WL 12996015 (W.D. Ky. Jan. 4, 2012).4 The Court notes that the precise

testimony to be offered on this point has not been identified.

Therefore, the Court grants in part Parts 18 and 19 of Plaintiff’s motion regarding

generalized evidence but denies it in part to the extent that it would prevent the admission of

evidence regarding the adequacy of the warnings for the Ventralight ST, including the possible

effect of warning dilution here. The Court reiterates, however, that an expert must be qualified to

testify as to the adequacy of warnings from a regulatory or legal perspective and an expert must

be qualified to testify as to whether a warning adequately disclosed risks to the surgeon end-user.

4 In Evidentiary Motion Opinion No. 5, the Court explained that Dr. Grischkan was qualified to give an

opinion about whether the Ventralight ST’s instructions for use completely disclosed the pertinent risks to a medical

provider as the end-user of the device. In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Prods. Liab.

Litig., Nos. 2:18-md-2486, 2:18-cv-01509, 2020 WL 6605542, at *16 (S.D. Ohio Sept. 1, 2020).

In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Prods. Liab. Litig., 2020 WL

6605542, at *16–17.

B. Defendants’ Motion in Limine No. 17

In this motion in limine, Defendants argue that three discrete types of evidence should be

excluded. Each is addressed in turn.

1. Evidence of guilty pleas in relation to cardiac catheter devices

First, Defendants argue that evidence of Bard’s and former employees’ 1994 guilty pleas

to concealing issues from the FDA and selling defective heart catheters that the FDA did not

approve for use should be excluded under Federal Rules of Evidence 401, 402, 403, 404, and 609.

(ECF No. 220 at PageID #12070–75.) Plaintiff responds that he will only offer this evidence under

Rule 609 in the event that Defendants open the door by discussing their good character5 or history

of prioritizing patient safety. (ECF No. 289 at PageID #16028.) The parties stumble into two gray

areas of law in this circuit: the applicability of Rule 609 to impeachment-by-contradiction evidence

and the applicability of Rule 609 to corporate witnesses.

Rule 609 governs impeachment of a witness with evidence of a criminal conviction. Under

this rule, the use of prior convictions attacks a witness’s general character for truthfulness or

untruthfulness. Fed. R. Evid.609(a); Victor J. Gold, 28 Fed. Prac. & Proc. Evid. § 6133 (2d ed.),

Westlaw (database updated Oct. 2020). This rule is premised on the idea that those who have been

convicted before of a felony or other crimes based upon dishonesty or false statements are more

likely to commit perjury now. United States v. Noble, 754 F.2d 1324, 1331 (7th Cir. 1985)

(citing Conf. Rep. No. 1597, 93rd Cong., 2d Sess., reprinted in 1974 U.S.C.C.A.N. 7051, 7098,

5 Rule 404 prohibits the admission of character evidence without exception, i.e. whether the propensity

evidence addresses a good or bad character. Fed. R. Evid. 404. The Court proceeds with this in mind, specifically that

Defendants cannot introduce evidence of their good character to prove that they acted in a manner consistent with this

character.

7103). Impeachment under Rule 609 is a blanket attack, used to demonstrate that the witness’s

testimony should not be credited in any regard. Extrinsic evidence of a conviction is permissible.

Fed. R. Evid. 608(b).

Impeachment-by-contradiction evidence, however, is a targeted attack upon a witness’s

credibility. This type of evidence “permits courts to admit extrinsic evidence that specific

testimony is false, because [the testimony is] contradicted by other evidence.” United States v.

Craig, 953 F.3d 898, 904 (6th Cir. 2020) (quoting United States v. Kincaid-Chauncey, 556 F.3d

923, 932 (9th Cir. 2009)). More precisely, impeachment by contradiction shows that the witness

is mistaken, “that something he said is not so,” but does not identify the source of the witness’s

mistake, be it an instance of untruthfulness, bias, misperception, lack of knowledge, etc.

Christopher B. Mueller & Laird C. Kirkpatrick, Federal Evidence § 6:85 (4th ed.), Westlaw

(database updated May 2020); see also Roger Park & Tom Lininger, The New Wigmore. A

Treatise on Evidence § 4.1 (1st ed. Supp. 2021) (“This form of impeachment shows an indefinite

capacity to err. It does not tell us the source of the error.”). Impeachment by contradiction is a

custom inherent to our adversarial system, recognized by the vast majority of federal courts and

commentators alike, though the Federal Rules of Evidence do not expressly contemplate (much

less forbid) the method. Mueller & Kirkpatrick, supra, at § 6:90; see also Park & Lininger, supra,

at § 4.1. Extrinsic evidence of prior convictions offered to impeach via contradiction of a witness’s

specific testimony is not prohibited by Rules 608 and 609, or even Rule 404; it is governed simply

by Rule 403. E.g., United States v. Gilmore, 553 F.3d 266, 271–73 (3d Cir. 2009); United States

v. Benavides, 470 F. App’x 782, 790 (11th Cir. 2012); see also Fed. R. Evid. 608 advisory

committee’s note to 2003 amendment (“The Rule has been amended to clarify that the absolute

prohibition on extrinsic evidence applies only when the sole reason for proffering that evidence is

to attack or support the witness’ character for truthfulness.” (collecting authorities)). Although the

Sixth Circuit has “expressed skepticism as to whether impeachment by contradiction is permissible

in this circuit,” Craig, 953 F.3d at 905, the Sixth Circuit has upheld the admission of such evidence,

though it does not specify that it is doing so and often purports to be applying Rule 609, e.g.,

United States v. Bender, 265 F.3d 464, 471 (6th Cir. 2001).

The distinction between Rule 609 evidence and prior convictions serving as impeachment-

by-contradiction evidence frequently does not matter for the ultimate question of admissibility.

For example, in a civil case, evidence of a prior felony conviction would be subject to Rule 403

whether introduced under Rule 609 or to impeach by contradiction. Fed. R. Evid. 609(a)(1)(A).

The distinction matters in some cases, however. A conviction for a crime requiring proof of

dishonesty or false statements that is less than ten years old must be admitted in a civil case or

criminal case against a witness under Rule 609(a)(2); there is no Rule 403 backstop. Fed. R. Evid.

609(a)(2) (including mandatory language, “must be admitted”). And if a conviction is more than

ten years old, the more demanding balancing test in Rule 609(b)(a)(2) applies, presenting a higher

hurdle for the party offering the conviction to impeach a witness’s general character for

truthfulness, as opposed to a party offering the conviction to contradict a witness’s specific

statement, to which Rule 403 applies. The Sixth Circuit has not yet expressly considered the

distinction between convictions offered under Rule 609 and those offered to impeach by

contradiction.

Even another wrinkle presented by Rule 609 must be addressed. When a corporate witness

will testify, it is undecided if evidence of the corporation’s conviction is properly admissible under

Rule 609 to impeach the testifying corporate witness when the witness was uninvolved in the

conduct giving rise to the prior conviction. Hickson Corp. v. Norfolk S. Ry. Co., 124 F. App’x 336,

342–43 (6th Cir. 2005) (declining to decide this issue).6 If a corporate witness were uninvolved in

the conduct underlying the conviction, it would not tend to suggest that this particular corporate

witness has an untruthful character. Gold, supra, at § 6133 n.49 (“There is limited authority

suggesting that a conviction of a corporation may be employed to impeach the officers, directors,

or managing agent of the corporation, even if they were not personally convicted themselves.”

(collecting cases)). The Third Circuit—the only court of appeals to decide this issue—put it

succinctly: “Criminal acts are relevant to a witness’ credibility only if that witness actually

participated in the criminal conduct. It strains logic to argue that an employee’s credibility is

properly brought into question by the mere fact that he or she is presently employed by a

corporation that in some unrelated manner was guilty of dishonest acts, no matter how egregious

those acts may have been.” Walden v. Ga.-Pac. Corp., 126 F.3d 50, 523–24 (3d Cir. 1997).7

However, impeachment-by-contradiction would clearly be permissible for a corporate witness

regardless of their involvement in acts giving rise to a corporate conviction because the aim is to

demonstrate that the witness is objectively mistaken.

6 The parties do not expressly state whether the witnesses were involved in the 1994 convictions. But based

on the arguments, the Court assumes that none of the corporate witnesses were involved in the conduct leading up to

the 1994 convictions, nor were they themselves convicted of a crime. (See ECF No. 220 at PageID #12073; ECF No.

289 at PageID #16030.)

7 Plaintiff points to one case permitting use of a corporation’s convictions to impeach a corporate witness,

reaching this conclusion because “a corporation cannot testify as a witness but through testimony of its employees

and representatives.” (ECF No. 289 at PageID #16030 (quoting Stone v. C.R. Bard, No. 02 CIV 3433 WHP, 2003 WL

22902564, at *2 (S.D.N.Y. Dec. 8, 2003).) This may be the case, but this statement does nothing to show that Rule

609 should be applied when the corporate witness was uninvolved in the activity giving rise to the conviction. The

court in Stone relied on agency theory to permit impeachment of a corporate witness’s testimony under Rule 609.

Stone, 2003 WL 22902564, at *2. But if the corporate witness was uninvolved in the activity underlying the conviction,

the witness was not then the corporation’s agent, and agency law provides no rationale for permitting impeachment

of the corporate witness under Rule 609. This rationale is only sensible when the witness was somehow involved in

the conduct leading to a conviction. See CGM Contractors, Inc. v. Contractors Env’t Servs., Inc., 383 S.E.2d 861, 866

(W. Va. 1989) (holding that a corporate conviction is admissible against a witness only if the witness “held a

managerial position at the time the crime occurred such that it may be fairly inferred that he shared responsibility for

the criminal act, or have actually participated in the criminal act”); see also Walden, 126 F.3d at 524 n.16 (declining

to expressly adopt West Virginia’s conclusion, but concluding that it was consistent with its own reasoning).

The Court concludes that Rule 609 does not govern the admissibility of the 1994

convictions because Plaintiff seeks does not propose an attack on a corporate witness’s general

character for truthfulness. Instead, Plaintiff explains that he will offer evidence of Defendants’

guilty plea to contradict specific testimony that Defendants may offer. This is not Rule 609

evidence, or evidence that the witness generally has an untruthful character; this is impeachment-

by-contradiction evidence, or evidence that contradicts a witness’s specific assertion.8 But even if

Rule 609 applied under these circumstances, it is inapplicable to these corporate witnesses. As the

Third Circuit concluded, it would make little sense to apply Rule 609 when the prior convictions

offered by the opposing party go to corporate conduct in which the corporate witness played no

part.9 Therefore, Defendants’ Rule 609 argument does not find traction.10

This does not end the analysis, however. Evidence that directly contradicts a witness’s

testimony is relevant impeachment evidence, but it still must pass Rule 403’s balancing test. In the

Rule 403 context, the age of a prior conviction may lessen its probative value and increase the risk

of prejudice. See Gilmore, 553 F.3d at 266. The weighing of the probative value of the

8 Because the issue is contradiction, not character, Plaintiff’s argument that Rule 405 permits admission of

extrinsic evidence of character once a party opens the door to it is similarly off base. (ECF No. 289 at PageID #16031.)

As with Rule 609, Rule 405 finds no foothold when the corporate witness was uninvolved in the criminal conduct

leading to the corporate convictions because the conviction does not speak to the witness’s character.

9 If it were the witness’s conviction or if the witness were involved in the criminal activity such that the 1994

convictions were proper evidence of a character for untruthfulness, it would be necessary to contend with the overlap

of impeachment-by-contradiction evidence and Rule 608’s prohibition on introducing extrinsic evidence of to

demonstrate a witness’s character for untruthfulness. A party must take the witness’s answer pursuant to Rule 608 if

the party “first asks a witness about something she did that suggests untruthfulness,” as opposed to “the very different

situation in which a witness gives direct testimony on some point that bears in the case.” Mueller & Kirkpatrick, supra,

at § 6:90 (emphasis in original).

10 In any case, Plaintiff incorrectly argues that Defendants’ 1994 conviction is covered by Rule 609(a)(2)

(ECF No. 289 at PageID #16030), which requires the admission of convictions based on fraud or dishonesty, Fed. R.

Evid. 609(a)(2). Defendants’ conviction, though fraud-based, is over ten years old. Rule 609(b), the limit on using

convictions older than ten years, applies regardless of what type of conviction is at issue. Fed. R. Evid. 609(b) (“This

subdivision (b) applies if more than 10 years have passed since the witness’s conviction . . . . .”). This makes no

difference for Plaintiff, however, because convictions older than ten years are admissible to impeach a witness once

the witness opens the door to his criminal history, or here, his corporation’s criminal history, with his testimony.

Fathera v. Smyrna Police Dep’t, 646 F. App’x 395, 401 (6th Cir. 2016); Bender, 265 F.3d at 471 (concluding that the

door had been opened to the admission of a more-then-ten-year-old conviction).

contradiction, however, depends in part on the exact testimony offered. For example, a “broad

denial” of ever misleading the FDA would increase the probative value of Defendants’ 1994

conviction, though “[a] more limited denial,” such as one that denies ever misleading the FDA in

relation to the Ventralight ST, would decrease the probative value of the prior conviction while

drastically raising the risk of unfair prejudice to Defendants. See id. at 273. For this reason, the

Court cannot determine outside of trial whether evidence of Defendants’ prior convictions is

admissible to impeach Defendants.

Defendants offer no compelling arguments that the Court should decide the Rule 403 issue

now. Defendants argue that any evidence of their 1994 convictions would lead the jury punish

them for their actions in 1994, instead of those at issue here. (ECF No. 220 at PageID #12074.)

But this risk is small if used only to impeach a defense witness on a narrow and specific assertion.

Moreover, Defendants can avoid the issue in the first place by avoiding opening the door, which

suggests that the Court should withhold its judgment until trial.

Defendants also argue that if evidence of the 1994 convictions were admitted, they would

have to describe the actions they took to rectify their alleged transgressions against the FDA, such

as selling the division of Bard implicated in 1994 and implementing a new compliance program.

(Id. at PageID #12074.) Evidence about selling off unrelated divisions appears to be inadmissible

because it is irrelevant to the merits of Plaintiff’s claims and does not appear to serve a

rehabilitative purpose. As for evidence of corporate changes to avoid further liability, this would

appear to behoove Defendants, lengthening the trial only to demonstrate how Defendants’

corporation is now in compliance with FDA regulations, which help define the standard of care.

Downing, 194 P.3d at 948. The prejudice to Defendants is not so clear that the Court can grant

Defendants’ motion on the basis of Rule 403.

For these reasons, this part of Defendants’ motion is denied, subject to the following.

Because the prior conviction has a high degree of potentially unfair prejudice, no party may

mention or introduce testimony on the subject without prior approval of the Court.

2. Evidence of 2013 investigation and settlement related to Defendants’

brachytherapy seeds

Next Defendants argue that evidence of a 2013 False Claims Act settlement and

investigation related to Defendants’ brachytherapy seeds, a treatment for prostate cancer, is

irrelevant under 401, likely to cause confusion under Rule 403, and inadmissible as evidence of a

settlement under Federal Rule of Evidence Rule 408. (ECF No. 220 at PageID #12075.) During

the hearing, Defendants confirmed that this settlement did not contain an admission of liability.

(ECF No. 380 at PageID #20390.) Plaintiff argues, as he did in relation to the 1994 guilty plea and

conviction, that if Defendants open the door, he may present this evidence. (ECF No. 289 at

PageID #16029.)

Evidence of the fact that this settlement exists is not categorically prohibited by Rule 408.

Rule 408 prohibits admission of offers and promises of “valuable consideration in compromising

or attempting to compromise the claim” and conduct and statements made during these

negotiations if offered “to prove or disprove the validity or amount of a disputed claim or to

impeach by a prior inconsistent statement or a contradiction.” Fed. R. Evid. 408(a). Such evidence

may be admitted for another purpose, however. Fed. R. Evid. 408(b). The dispositive inquiry for

Rule 408 is whether the settlement or evidence of statements made during settlement negotiations

are offered to prove or disprove the validity or amount of a claim. Appalachian Reg’l Healthcare,

Inc. v. U.S. Nursing Corp., 824 F. App’x 360, 373 (6th Cir. 2020); Arnold v. Wilder, 657 F.3d 353,

367 (6th Cir. 2011). Here, evidence of the settlement would not be introduced to prove or disprove

the validity of that 2013 settlement. Accordingly, Rule 408 is inapplicable.

The relevance and prejudice of this evidence is unclear. Plaintiff argues he would offer this

evidence to impeach and rebut witness testimony, but just how probative and material or how

prejudicial and confusing this evidence is depends on the context at trial. For example, if a

corporate witness for Defendants testified that Bard or Davol has never made a false statement

about its devices, evidence of this settlement would likely be relevant and admissible.

Additionally, the parties pay little attention to this argument, focusing more on the 1994 conviction

arguments. Thus, this part of the motion generally lacks detail and context necessary to decide

before trial whether evidence of the 2013 settlement is admissible.

Therefore, this part of Defendants’ motion is denied, subject to the following. Neither party

shall mention or offer testimony on the 2013 settlement without prior approval of the Court.

3. Evidence of congressional proceedings and correspondence

Finally, Defendants argue that evidence of correspondence from the United States Senate

Special Committee on Aging, specifically a letter sent eight months after a hearing, should be

excluded as irrelevant, confusing, and inadmissible hearsay. (ECF No. 220 at PageID #12076.)

Defendants explain that this letter notes the FDA’s 2011 Public Health Notification addressing

vaginal mesh, discusses the lawsuits regarding vaginal and hernia mesh, and makes inquiries about

Defendants’ recall and post-marketing surveillance practices. (Id.) Plaintiff counters that this

evidence is relevant to demonstrate what Defendants knew or should have known about the risks

caused by polypropylene in mesh implants, that any correspondence from Defendants is admissible

as a party-opponent statement, and that the correspondence is a public report admissible under

Federal Rule of Evidence 803(8)(iii). (ECF No. 289 at PageID #16032–35.)

Plaintiff is right on the first two points. To the extent that evidence related to the

congressional Committee is indicative of Defendants’ understanding of the risk posed by

polypropylene, which is the raw material used in both vaginal and hernia mesh, and how this

knowledge informed Defendants’ conduct goes to the reasonableness of Defendants’ conduct.

Notice or knowledge is a non-hearsay use for out-of-court statements. Biegas v. Quickway

Carriers, Inc., 573 F.3d 365, 379 (6th Cir. 2009). And any of Defendants’ correspondence with

Congress would fall within the party-opponent exemption from hearsay. Fed. R. Evid. 801(d)(2).

However, not every piece of congressional correspondence necessarily falls within Rule

803(8)(iii). The Rule provides, in relevant part, that a public record is an exception to the rule

against hearsay if the statement from a public office sets out “factual findings from a legally

authorized investigation.” Fed. R. Evid. 803(8)(A)(iii). The requirement that the statement contain

factual findings is inflexible. For example, subjective findings from Congress do not satisfy Rule

803(8)(A)(iii). Bright v. Firestone Tire & Rubber Co., 756 F.2d 19, 23 (6th Cir. 1984). Plaintiff

points to nothing that would suggest that a record of the proceedings or the letter from a

congressional committee to Defendants would qualify as factual findings from an investigation.

Rather, the letter appears to ask questions of Defendants and set forth concerns. But neither

Defendants nor Plaintiff attaches the evidence at issue or provides a record citation so that the

Court may view the evidence regarding the congressional proceedings.11 The Court declines to

rule definitively without the benefit of viewing the letter.

For these reasons, this part of Defendants’ motion is denied, subject to the following.

Neither party may refer to or offer testimony of the congressional correspondence, referenced here

and without prior approval of the Court.

C. Plaintiff’s Motion in Limine No. 8

11 Of course, Plaintiff bears the ultimate burden of demonstrating admissibility as the proponent of the

evidence. United States v. Brika, 416 F.3d 514, 529 (6th Cir. 2005). But the movant bears the burden at the motion-

in-limine stage. Supra, Part II.

Finally, the Court turns to Plaintiff’s Motion in Limine No. 8. (ECF No. 237.) In his motion,

Plaintiff raises three arguments, some of which the Court has already addressed. Plaintiff argues

that evidence of the exemption of his expert, Dr. David Kessler, from a compensation policy at

University of California San Francisco (“UCSF”) should be excluded. (ECF No. 237 at PageID

#12957.) The Court granted in part and denied in part this aspect of Plaintiff’s motion. (ECF No.

266 at PageID #18932.) He also contends that a webpage on UCSF’s website is inadmissible. (ECF

No. 237 at PageID #12958.) The Court granted in part and denied in part this part of Plaintiff’s

motion and stated that a reasoned decision would follow. (ECF No. 366 at PageID #18932.)

Plaintiff finally argues that evidence of Dr. Kessler’s termination should be excluded (ECF No.

237 at PageID #12956), which led Defendants to argue that evidence of related to the employment

history of their expert, Dr. Donna Bea-Tillman, from the FDA should also be excluded (ECF No.

264 at PageID #14084 & n.1; ECF No. 360 at PageID #18848–49.) The Court ordered

supplemental briefing on the exclusion of Dr. Tillman’s employment history and reserved

judgment as to the admissibility of both Dr. Kessler’s and Dr. Tillman’s employment histories.

(ECF No. 366 at PageID#18932.)

1. UCSF Webpage

Plaintiff argues that a webpage from UCSF’s Department of Surgery titled “Laparoscopic

Ventral Hernia Repair” should be excluded because it is an unauthenticated document and

inadmissible hearsay. (ECF No. 237 at PageID #12958–59.) Defendants counter that the webpage

is admissible hearsay, like FDA websites, and that they should be permitted to examine Dr. Kessler

regarding the opinion of his employer during cross examination. (ECF No. 264 at PageID #14086–

87.) The Court concluded that substantively, the webpage was inadmissible, though it may be

admissible for cross-examination purposes. (ECF No. 360 at PageID #18852–53.)

The webpage is not admissible substantively because it is inadmissible hearsay. Hearsay is

an out-of-court statement offered for the truth of the matter asserted, Fed. R. Evid. 801(c), and it

is inadmissible unless a federal statute, the Federal Rules of Evidence, or a Supreme Court opinion

provide otherwise, Fed R. Evid. 802. To the extent that Defendants offer the webpage to prove its

content, it is hearsay, and Defendants do not successfully show that the webpage is admissible.

Defendants cite to cases that rely on Federal Rule of Evidence 803(8) while concluding FDA

webpages are admissible, such as Musgrave v. Breg, Inc., No. 2:09-cv-01029, 2011 WL 450232,

at *6 (S.D. Ohio Sept. 28, 2011), though they do not address Rule 803(8) themselves. (ECF No.

264 at PageID #14086–87.) Rule 803(8) encompasses statements from public offices, Fed. R. Evid.

803(8), which UCSF is not.

However, it is possible that the UCSF webpage would be admissible to cross examine Dr.

Kessler as an expert witness at trial. Under these circumstances, the webpage would be admitted

not to demonstrate the truth of the webpage’s contents, but to test Dr. Kessler’s awareness or

knowledge of the webpage posted by his employer and colleagues.

The relevance, prejudice, delay, and risk of confusion of this evidence is uncertain at this

time. The Court has ruled that it will explain the premarket notification § 510(k) process. (ECF

No. 355 at PageID #18767–69.) It is unclear in light of this decision how much FDA-related expert

testimony will be presented at trial. The risk of the jury mistaking the webpage as substantive

evidence that adhesions are a common risk of laparoscopic hernia repairs (ECF No. 360 at PageID

#18852 (explaining the contents of the webpage)) also cannot be predicted outside of the context

of Plaintiff’s impeachment of Dr. Kessler. Although Rule 403 concerns lurk, at this time it is

inappropriate at this time to exclude all possible uses of the UCSF webpage.

Therefore, this part of Plaintiff’s motion is denied.

2. Experts’ Termination Histories

The parties also argue that aspects of their FDA experts’ employment histories should be

excluded. In his motion, Plaintiff argues that evidence related to Dr. Kessler’s termination as a

dean at UCSF should be excluded because he was terminated as a result of a whistleblower

complaint regarding financial irregularities, he maintained his medical employment, and UCSF

later apologized for the termination from his deanship. (ECF No. 237 at PageID #12956–57.) In

response, Defendants contend that Dr. Kessler’s employment history is relevant for impeachment

purposes, but that they will agree to a limitation regarding Dr. Kessler’s termination as dean if

Plaintiff agrees not to introduce certain employment-history evidence of Defendants’ FDA expert,

Dr. Tillman. (ECF No. 264 at PageID #14083.) Plaintiff explains that he will not agree to this

limitation because Dr. Tillman draws from her FDA experience—the source of the disputed

employment history—while Dr. Kessler does not, and that this particular aspect of her employment

history is relevant to her credibility. (ECF No. 363 at PageID #18868.) Dr. Tillman was accused

of a manufacturer-slanted bias in employee complaints while she was at the FDA. (ECF No. 363

at PageID #18871.)

Federal Rule of Evidence 702 makes clear that an expert witness’s experience and training,

i.e. their employment, forms a part of their expertise. Fed. R. Evid. 702. But Rules 401 and 403

still apply. Dr. Kessler’s termination from a deanship does not form any basis for his expertise as

offered in this case. Accordingly, Defendants may not attack Dr. Kessler’s credibility by referring

to his termination. Any discussion about the details of his termination as a dean would also unduly

delay trial, confuse the jury, and prejudice Plaintiff. However, Defendants will be permitted to

walk through the door if Plaintiff opens it, such as by asking Dr. Kessler if he was ever fired and

if Dr. Kessler responds, “no,” because this would go to Dr. Kessler’s truthfulness as a witness.

Dr. Tillman presents a harder case. The employment history at issue here pertains to Dr.

Tillman’s tenure at the FDA, upon which she bases her expertise—a feature of her testimony that

Defendants do not dispute. Thus, Dr. Tillman’s experience at the FDA would be generally relevant

to her expertise. Aspects of otherwise relevant employment history, however, can be excluded

under Rules 401, 402, and 403 if it is irrelevant to the expert’s expertise or their credibility. Dr.

Kessler’s termination above is such an example. Similarly, if an FDA expert were accused of

mishandling an interpersonal dispute between two subordinates at the FDA, it is difficult to

conclude that this is relevant work history to their expert testimony about the FDA.

Here, however, Plaintiff points to complaints that Dr. Tillman had a bias toward

manufacturers. The Supreme Court has defined bias as “the relationship between a party and a

witness which might lead the witness to slant, unconsciously or otherwise, [her] testimony in favor

of or against a party.” United States v. Sumlin, 956 F.3d 879, 890 (6th Cir. 2020) (alteration in

original) (quoting United States v. Abel, 469 U.S. 45, 52 (1984)). But courts recognize that bias

may be even broader, including “[f]avor or friendly feeling toward a party [as] evidenced by . . .

the witness’s conduct or expressions evincing such feeling.” 1 McCormick on Evid. § 39 (8th ed.

Westlaw Jan. 2020 Update) (emphasis in original) (collecting cases); see also Robinson v. Mills,

592 F.3d 730, 737 (6th Cir. 2010) (explaining that “[b]ias is ‘not limited to personal animosity

against a defendant or pecuniary gain.’” (quoting Schledwitz v. United States, 169 F.3d 1003, 1015

(6th Cir.1999))). Indeed, the Sixth Circuit has recognized the vast variety of situations from which

biases may stem:

Extrinsic testimony, or that elicited by cross examination to show the bias or

interest of a witness in a cause, covers a wide range and the field of external

circumstances from which probable bias or interest may be inferred is infinite. The

rule encompasses all facts and circumstances which, when tested by human

experience, tend to show that a witness may shade his testimony for the purpose of

helping to establish one side of a cause only.

Majestic v. Louisville & N.R. Co., 147 F.2d 621, 627 (6th Cir. 1945) (citations omitted).

Most importantly, “[t]he partiality of a witness is subject to exploration at trial, and is

‘always relevant as discrediting the witness and affecting the weight of his testimony.’” Davis v.

Alaska, 415 U.S. 308, 316–17 (1974) (quoting 3A Wigmore, Evidence § 940 (Chadbourn rev.

1970))); Schledwitz, 169 F.3d at 1015 (“Bias is always relevant in assessing a witness’s

credibility.”). And although “the Federal Rules of Evidence do not specifically so state, prior

misconduct of a witness which is probative of the bias of that witness may be proved by extrinsic

evidence.” United States v. Phillips, 888 F.2d 38, 41 (6th Cir. 1989); Abel, 469 U.S. at 51

(concluding that Rules 608 and 610 contemplate impeachment of a witness for bias and the

inclusion of extrinsic evidence to do so). Determining the credibility of a witness, which includes

“[a]ssessing the potential bias of the expert witness,” is ultimately an issue for the jury. Cruz-

Vazquez v. Mennonite General Hosp., Inc., 613 F.3d 54, 59 (1st Cir. 2010).

Dr. Tillman’s alleged bias in favor of manufacturers could shade her expert testimony on

behalf of Defendants, making these complaints about her supposed bias relevant. Although a bias

in favor of manufacturers is perhaps a less typical bias with which an expert is normally

impeached, Majestic is clear that bias may come in many forms. Accordingly, evidence of the

complaints against Dr. Tillman are not inadmissible.

Defendants’ arguments to the contrary are unsuccessful. First, they argue that this amounts

to a collateral attack upon Dr. Tillman. (ECF No. 365 at PageID #18882.) But as set forth above,

a witness’s bias is not a collateral matter. Next, Defendants contend that “courts routinely exclude

evidence about the prior litigation history and the disciplinary records of expert witnesses.” (Id. at

PageID #18883 (quoting Ferris v. Tennessee Log Homes, Inc., 2010 WL 1049852 (W.D. Ky. Mar.

19, 2010).) But Defendants dodge the key inquiry, which is whether that history “is of sufficiently

probative value.” Ferris, 2010 WL 1049852, at *2. This line of cases is no bar to the admission of

the complaints about Dr. Tillman because they are probative of her credibility as a witness in that

the complaints address a potential bias.

Defendants then argue that courts exclude attacks on an expert’s credibility when those

attacks are based on allegations and rely on extrinsic evidence (ECF No. 365 at PageID #18883–

85), but this argument fails because it does not recognize the difference between bias and a

character for truthfulness or mendacity. Defendants are correct that Plaintiff only references

complaints against Dr. Tillman, not findings. But this is no bar to admission. Rule 608, upon which

Defendants’ authorities rely, e.g. United States v. Ahmed, No. 14-cr-277 (DLI), 2016 WL 3647686,

at *3 (E.D.N.Y. July 1, 2016), provides that when impeaching a witness for a character for

truthfulness or untruthfulness, only reputation or opinion evidence is admissible; no extrinsic

evidence is permitted except for prior criminal convictions permitted under Rule 609. Fed. R. Evid.

608. But because Plaintiff offers the complaints to impeach Dr. Tillman’s credibility by

demonstrating a bias, Rule 608 and its narrow allowance of convictions as extrinsic evidence is

inapplicable. United States v. Baker, 494 F.2d 1262, 1266 (6th Cir. 1974) (“And, although a

witness's credibility generally cannot be impeached by showing arrest, indictments or other acts

of misconduct not resulting in a conviction, acts demonstrating a basis for bias and prejudice may

be explored to a reasonable degree.”). Thus, Plaintiff need not show that the complaints resulted

in a formal finding of wrongdoing, much less a conviction. Of course, Defendants are free to point

out to the jury that the FDA declined to act in response to the complaints against Dr. Tillman,

which the jury may use to weigh the impeachment value of the complaints.

Defendants’ generalized argument against extrinsic evidence fails for the same reason:

Rule 608 is inapplicable, and so its bar on extrinsic evidence is inapplicable. A witness’s bias may

indicate that the witness is testifying untruthfully, but “if offered for another purpose,” such as to

show bias, Rue 608 does not apply. Adams v. Mem’l Hermann, 973 F.3d 343, 351 (5th Cir. 2020).

The Supreme Court has held as much, stating that “[i]t would be a strange rule of law which held

that relevant, competent evidence which tended to show a bias on the part of a witness was

nonetheless inadmissible because it also tended to show that the witness was a liar.” Abel, 469

U.S. at 56.

Although evidence of the complaints against Dr. Tillman are not clearly inadmissible at

this pretrial stage, there are several issues that must be resolved prior to any admission of the

complaints. Evidence of the complaints offered to show Dr. Tillman’s bias are not prohibited by

Rule 608 and the complaints are clearly relevant because they go to her credibility, but the rule

against hearsay and Rule 403 still apply. Marcus & Millichap Inv. Servs. of Chi., Inc. v. Sekulovski,

639 F.3d 301, 308 (7th Cir. 2011). At this point, the Court cannot assess whether the evidence

Plaintiff intends to introduce is hearsay. Plaintiff argues that the records he will admit are “an

official FDA record” (ECF No. 363 at PageID #18871), but he does not attach these records. It

would be inappropriate to assess whether the complaints satisfy Rule 803(8) without the records

in front of the Court.

Similarly, the probative value of this impeachment evidence in relation to the length of

time it would take to present of trial and the risk of confusing the jury is unclear. Defendants

provide Dr. Tillman’s affidavit, in which she explains that the complaints involve different

devices, FDA advisory committees, and FDA regulations, policies, and practices not at issue here.

(ECF No. 365 at PageID #18884.) These features could unnecessarily prolong the trial. But it is

difficult to determine now if this would result in an undue delay because it is unclear what these

policies are and why the FDA rejected the complaints. For example, if the FDA assessed the

complaints for evidence of Dr. Tillman’s bias, it would be a different analysis than if the FDA

simply concluded that Dr. Tillman followed FDA procedure. Moreover, the Rule 403 analysis is

informed by the probative value of the impeachment evidence. Outside of the trial context, the

court cannot determine what FDA expert testimony will be offered for and how much the parties

will rely on it.

For these reasons, this part of Plaintiff’s motion in limine is granted, which only pertains

to Dr. Kessler, and the Court declines to decide whether the complaints against Dr. Tillman are

ultimately admissible.

IV. Conclusion

For the reasons set forth above, the remaining parts of Plaintiff’s Motion in Limine No. 1

(ECF No. 235) are GRANTED IN PART AND DENIED IN PART, Defendants’ Motion in

Limine No. 17 (ECF No. 220) is DENIED, and Plaintiff’s Motion in Limine No. 8 (ECF No. 237)

is GRANTED IN PART AND DENIED IN PART. And, though not a motion in limine, the

Court declines to decide whether evidence of the complaints against Dr. Tillman are admissible at

this stage of the litigation.

IT IS SO ORDERED.

12/30/2020 s/Edmund A. Sargus, Jr.

DATE EDMUND A. SARGUS, JR.

UNITED STATES DISTRICT JUDGE