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Ramon Rossi Lopez - rlopez@lopezmchugh.com 

(California Bar Number 86361; admitted pro hac vice) 

Lopez McHugh LLP 

100 Bayview Circle, Suite 5600 

Newport Beach, California 92660 

949-812-5771 

Mark S. O’Connor (011029) – mark.oconnor@gknet.com 

Gallagher & Kennedy, P.A. 

2575 East Camelback Road 

Phoenix, Arizona 85016-9225 

602-530-8000 

IN THE UNITED STATES DISTRICT COURT 

DISTRICT OF ARIZONA 

In Re Bard IVC Filters Products 

Liability Litigation 

No. MD-15-02641-PHX-DGC 

PLAINTIFFS’ REPLY IN SUPPORT OF 

MOTION TO EXCLUDE DEFENSE 

EXPERT OPINIONS UNDER FED. R. 

EVID. 702 BASED ON THEIR USE OF 

THE CRIMINAL LAW STANDARD OF 

CERTAINTY (DOC. 7324) 

INTRODUCTION 

Bard’s opposition to Plaintiffs’ motion misstates Plaintiffs’ position and omits 

material facts. Plaintiffs address these issues in this reply brief. 

ARGUMENT

I. DRS. GRASSI AND MORRIS APPLIED THE WRONG LEGAL 

STANDARD IN DEVELOPING THEIR OPINIONS FOR LITIGATION. 

Initially, Bard objects that Plaintiffs accuse its experts of being “too certain of 

their opinions,” and argues that the preponderance of evidence standard does not prevent 

an expert from holding opinions to a very high level of certainty. Bard Mem. at 1. Bard’s 

argument misses the point and misstates Plaintiffs’ position; it confuses the level 

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confidence in an expert’s opinion with the legal standard required to form an expert’s 

opinion. 

Bard also claims (on page 1 of its brief) that Plaintiffs’ are complaining about 

“‘standards’ of their own creation.” This is belied by the actual testimony of Drs. Grassi 

and Morris, set forth below. Both testified as to the standards that they employed as part 

of their methodology. 

Bard’s brief at pp. 5-6 attempts to conflate the experts’ opinions about the 

limitations inherent in the studies in the medical literature1

 with the problem that 

Plaintiffs’ advance in this motion: the use by these experts of a heightened standard for 

assessing the evidence and forming their opinions. Bard’s experts can certainly point out 

limitations in the evidence without raising a Daubert issue, but that is not the problem at 

the core of Plaintiffs’ motion. 

While it is true that expert witnesses may permissibly hold their opinions to a high 

degree of certainty without raising a Daubert challenge, as noted in one of the cases cited 

by Bard (Iplearn), experts must nevertheless employ a methodology to evaluate the 

evidence and develop their opinions applying the proper legal standard. (“[A]n expert 

cannot base a decision on incorrect legal standards.”) See Iplearn v. Blackboard, Inc., 

No. CV 11-876 (RGA), 2014 WL 4967122, at *2 (D. Del. Oct. 2, 2014). “[A]ny step that 

renders [the expert's] analysis unreliable ... renders the expert's testimony inadmissible. 

This is true whether the step completely changes a reliable methodology or merely 

misapplies that methodology.” In re Silicone Gel Breast Implants Products Liability 

Litigation, 318 F. Supp. 2d 879 (C.D. CA 2004)

 

1

 As noted in the Reference Manual on Scientific Evidence, and as recognized by many 

courts, all studies have limitations. “It is important to emphasize that all studies have 

“flaws” in the sense of limitations that add uncertainty about the proper interpretation of 

the results.” Reference Manual on Scientific Evidence, (3d Ed. Federal Judicial Center, 

2011), p. 553. 

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Plaintiffs do not take issue with opinions about which Bard’s experts expressed 

certainty; rather, the problem here arises when experts in a civil product liability action 

decline to agree with a proposition based on the heightened, “beyond-any-reasonabledoubt” criminal law standard or “more than 90 percent” certain standard.2

 Thus, there is a 

meaningful difference between holding an opinion to a “more than 90 percent” or 

“beyond any reasonable doubt” level of certainty and using that heightened standard of 

certainty to analyze the medical evidence in forming an expert opinion, or agreeing or 

disagreeing with a relevant fact or opinion expressed by an opposing expert. Drs. Grassi 

and Morris applied the heightened standard in forming their opinions, to evaluate the 

medical literature evidence and to evaluate the opinions expressed by Plaintiffs’ experts. 

Thus, their testimony will confuse and mislead the jury and prejudice Plaintiffs by 

requiring Plaintiffs—whether explicitly or implicitly—to prove their case to a much 

higher level of certainty than the law requires. 

As Daubert instructs, “It would be unreasonable to conclude that the subject of 

scientific testimony must be ‘known’ to a certainty; arguably, there are no certainties in 

science.” Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 590 (1993). Imposing a 

“certainty” standard on expert testimony for medical proof is “wholly inconsistent with 

Daubert and the fundamental premise of Rule 702.” McClellan v. I-Flow Corp., 710 

F. Supp. 2d 1092, 1101 (9th Cir. 2010). Indeed, Daubert does not authorize courts or 

experts to increase the burden of proof beyond a preponderance of the evidence. In re 

Ephedra Prods. Liab. Litig., 393 F. Supp. 2d 181, 193 (S.D.N.Y. 2005). 

Dr. Grassi made it clear in his deposition that he applied a “beyond any reasonable 

doubt” standard to form his opinions and evaluate evidence before he would agree with it. 

After testifying that “there had not been a mechanism [to explain fractures], which has 

yet to be proven,” Ex. 2, Grassi Dep. at 91:8-10, Dr. Grassi was asked to explain what 

 

2

 Ex. 1, Morris Dep., at 143:20 (“more than 90 percent”); see also Ex. 2, Grassi Dep., at 

94:10-11 (“beyond any reasonable doubt”). 

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level of proof he would require. He responded that he needed a “convincing explanation,” 

adding that “I would look for evidence where I felt certain beyond any reasonable 

doubt.” Ex. 2, Grassi Dep. at 94:10-11. Dr. Grassi further testified that “overall,” he 

applied this standard in developing his opinions in this litigation. Id. at 94:10-15. He also 

elaborated that more studies need to be done on whether longer indwell times increase the 

risk of complications “before I’m convinced...” Id. at 128:8-13. Thus, Dr. Grassi applied 

a criminal law standard of proof as part of his method when evaluating the evidence to 

form his opinions. He rejected propositions about fractures and indwell times and intends 

to explain to the jury, for example, that no fracture mechanism has been proven and that 

longer indwell times do not lead to increased risk of complications, when the standard he 

uses is far greater than the jury must use to evaluate the same evidence. Bard’s brief 

simply ignores this testimony. 

Similarly, Dr. Morris was asked, “What level of certainty did you apply to your 

opinions?” Ex. 1, Morris Dep. at 139:2-24. After describing his methodology for how he 

typically goes about assessing evidence, he concluded—without any intervening follow 

up questions, “...I approach the litigation using the ... same methodology, essentially. So 

I would say a high level of certainty.” Id. at 140:2-4. He testified that he used a 

“benchmark for 100 percent certain[ty],” Id., at 141:22-23. He added: When I compare 

that to the literature that's available regarding IVC filters, there's basically no... 

comparison, so how can I make 100 percent certain opinions based on literature which is 

less than Level I or Level II evidence? Id.at 142:9-14. After Dr. Morris testified about 

“100 percent certain opinions,” he was then asked: 

Q: So that’s what you generally look for is more than 90 

percent certainty for your opinions in this case? 

A: Generally speaking, yes. 

Id. at 143:21-24. 

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Dr. Morris’s testimony unequivocally shows that he was not testifying about how 

confident or certain he was in expressing his opinions; he was testifying about the 

methodology he used for reaching his opinions. 

The Daubert inquiry focuses on the reliability of an expert’s methodology, not the 

conclusions it generates. Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993); 

City of Pomona v. SQM North America Corp., 750 F.3d 1036 (9th Cir. 2014). Employing 

an improper standard for assessing evidence and developing an opinion renders the 

expert’s methodology unreliable. Drs. Morris and Grassi’s testimony is not only 

inconsistent with the threshold required by Daubert and Rule 702; it is misleading and 

unhelpful to the jury in deciding the facts, and prejudicial to Plaintiffs. These opinions 

should therefore be excluded. 

Bard either fails to understand--or misrepresents--Plaintiffs’ position on this 

motion, when on page 1 of its brief Bard characterizes Plaintiffs’ motion as complaining 

about experts who are “too certain of their opinions” and then states on page 8 of its 

brief: “Plaintiffs ...[claim] ...that because a medical expert is permitted to express a 

causation opinion without proving causation to a scientific certainty, that somehow 

precludes an expert from expressing greater than 51% certainty....” As detailed above, 

Bard’s argument is flawed based on the straw man fallacy. Bard’s opposition is based on 

mischaracterizing the Plaintiffs’ position, and then arguing against the “straw man.”3

 

The cases cited by Bard are inapposite. Iplearn and Fosamax involved patent 

disputes, where experts were challenged for the opposite of what occurred here—they 

presented opinions that tended to prove a relevant fact, but, standing alone, were not 

sufficient to meet the applicable burden of proof (“clear and convincing” in the patent 

 

3

 A straw man is a common form of argument based on giving the impression 

of refuting an opponent's argument, while refuting an argument that was not presented by 

that opponent. One who engages in this fallacy is said to be "attacking a straw man." This 

type of argument is known as the straw man fallacy. 

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context). Iplearn, 2014 WL 4967122, at *2; Formax, Inc. v. Alkar-Rapidpak-MP Equip., 

Inc., No. 11-C-298, 2014 WL 3057116, at *2 (E.D. Wis. July 7, 2014). This is a 

relevance argument, and these cases demonstrate the unremarkable proposition that 

evidence—including expert opinion—may be admissible “if it has any tendency to make 

a fact more or less probable than it would be without the evidence.” Fed. R. Civ. P. 401. 

The opinions challenged here are the inverse because they are about conclusions not

reached rather than opinions based on limited information. Similarly, Ambrosini did not 

address any argument that an expert applied a heightened standard to form opinions or 

before agreeing to a proposition. Ambrosini v. Labarraque, 101 F.3d 129, 138 (D.C. Cir. 

1996). 

II. DRS. MORRIS AND GRASSI WERE NOT COERCED INTO TESTIFYING 

ABOUT THE LEVEL OF CERTAINTY. 

Bard next asserts that the Court should disregard the testimony of Drs. Grassi and 

Morris, claiming they were pressured or tricked at their depositions, suggesting that 

opposing counsel put words in their mouths. Bard Mem. at 1. Specifically, Bard 

complains that the experts were pressed “to assign a numerical level to the value of 

certainty that they applied to their opinions” even though it was difficult. Id. Bard goes so 

far as to claim that Plaintiffs’ counsel, not the experts, suggested specific numerical 

values about the level of certainty “and invited the experts to agree or disagree.” Id. Not 

true. The witnesses were neither pressured nor boxed in. Counsel simply followed up on 

Dr. Morris’s comment that he used a “high level of certainty” to form his opinions, by 

asking if that meant an 80% level of certainty. Dr. Morris freely responded that it would 

be “more than 80 percent.” Ex. 1, Morris Dep. at 143:19. Dr. Morris could have testified 

to any number—or range of numbers—he felt comfortable with, including a lower one, 

and Bard’s counsel had the opportunity to ask questions to clarify. 

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III. THE EXPERTS’ DEPOSITION TESTIMONY IS PART OF THE 

DAUBERT RECORD. 

Finally, Bard maintains that Plaintiffs’ Daubert challenge to Drs. Grassi and 

Morris is a non-issue that Plaintiffs created in their depositions, eliciting testimony the 

experts do not state in their reports. Bard Mem. at 1. This argument is spurious. It 

suggests that the Daubert inquiry is confined to the contents of an expert’s Rule 26 report 

and that the expert’s deposition testimony is irrelevant. 

Ironically, Bard takes the opposite position when raising Daubert challenges to 

Plaintiffs’ experts. Bard’s Daubert motions are replete with attacks on statements 

Plaintiffs’ experts made in their depositions. For example, Bard’s motion to exclude Dr. 

Eisenberg cites his deposition testimony repeatedly over a span of 10 pages. [Doc. No. 

7291 at 2-4, 6-9, 11, 13, 17]. And Bard’s motion to exclude Dr. Betensky quotes her 

deposition testimony at length. [Doc. No. 7288 at 4, 7, 8-9, 11, 14-15]. 

The very purpose of deposing an expert witness is to explore and probe the 

substance, basis, and methodology of the expert’s opinions. In testing the reliability and 

relevance of the testimony, it is important for the parties and the Court to know what 

methodology the experts used to evaluate the evidence and formulate their opinions. 

Because Drs. Morris and Grassi provided little or no substantive information about this 

issue in their reports, it was incumbent upon Plaintiffs’ counsel to find out. The experts’ 

deposition testimony provided that information and is part of the record the Court must 

use in screening their opinions under Daubert.

CONCLUSION 

For the reasons stated above, and in Plaintiffs moving papers, the Court should 

grant Plaintiffs’ Motion. 

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RESPECTFULLY SUBMITTED this 18th day of October, 2017. 

GALLAGHER & KENNEDY, P.A. 

By: /s/ Mark S. O’Connor Mark S. O’Connor 

2575 East Camelback Road 

Phoenix, Arizona 85016-9225 

LOPEZ McHUGH LLP 

Ramon Rossi Lopez (CA Bar No. 86361) 

(admitted pro hac vice) 

100 Bayview Circle, Suite 5600 

Newport Beach, California 92660 

Co-Lead/Liaison Counsel for Plaintiffs 

CERTIFICATE OF SERVICE 

I hereby certify that on this 18th day of October, 2017, I electronically transmitted 

the attached document to the Clerk’s Office using the CM/ECF System for filing and 

transmittal of a Notice of Electronic Filing. 

/s/ Gay Mennuti 

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