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James R. Condo (#005867)

Amanda C. Sheridan (#027360) 

SNELL & WILMER L.L.P. 

One Arizona Center 

400 E. Van Buren, Suite 1900 

Phoenix, Arizona 85004-2202 

Telephone: 602.382.6000 

Facsimile: 602.382.6070 

jcondo@swlaw.com 

asheridan@swlaw.com 

Richard B. North, Jr. (admitted pro hac vice) 

Georgia Bar No. 545599 

Matthew B. Lerner (admitted pro hac vice) 

Georgia Bar No. 446986 

Taylor Tapley Daly (admitted pro hac vice) 

Georgia Bar No. 697887 

NELSON MULLINS RILEY & SCARBOROUGH LLP 

201 17th Street, NW / Suite 1700 

Atlanta, GA 30363 

Telephone: (404) 322-6000 

Telephone: (404) 322-6050 

richard.north@nelsonmullins.com 

matthew.lerner@nelsonmullins.com 

Attorneys for Defendants 

C. R. Bard, Inc. and 

Bard Peripheral Vascular, Inc.

IN THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF ARIZONA 

IN RE: Bard IVC Filters Products Liability 

Litigation 

No. 2:15-MD-02641-DGC

DEFENDANTS C. R. BARD, INC. 

AND BARD PERIPHERAL 

VASCULAR, INC.’S REPLY IN 

SUPPORT OF MOTION TO 

EXCLUDE THE OPINIONS OF 

SUZANNE PARISIAN, M.D. 

(Assigned to the Honorable David G. 

Campbell) 

(Oral Argument Requested) 

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INTRODUCTION 

Faced with the weight of authority Bard cited, and in light of the numerous 

examples of Dr. Parisian’s improper opinions in this case, Plaintiffs ultimately acquiesce 

to the majority of Bard’s arguments. As a result, Plaintiffs concede that Dr. Parisian: 

• “will follow the limitations on her testimony imposed by the plethora of 

other courts” that have addressed her opinions. (Pl. Br. at 12.) 

• “is not an engineer.... Plaintiffs thus concede that, to the extent that any 

opinion offered by Dr. Parisian at trial could be reasonably construed as 

being an opinion only on ‘design’ or ‘causation’ that Dr. Parisian will not 

offer such testimony.” (Id. at 14.) 

• “is not a medical specialist in areas relevant to causation in this case, such as 

an interventional radiologist, cardiologist, internal medicine doctor, or 

hematologist.” (Id. at 12.) 

• “cannot testify as to alternative design or design defects in Bard’s IVC 

filters.” (Id.) 

• “is not being proffered to testify in a narrative form.” (Id.) 

• “will not express any opinions on Bard’s intent, motives, or state of mind.” 

(Id.) 

The opposition makes clear, however, that Plaintiffs intend to circumvent their own 

concessions if they can. For example, although Plaintiffs admit that “Dr. Parisian cannot 

testify about what Bard ‘intended’ and will not offer any such testimony at trial,” (Pl. Br. 

at 19, FN 10), they argue on the same page that “Dr. Parisian’s opinions about what ... 

other entities ... intended” are entirely proper. Id. (emphasis added) Plaintiffs cannot 

have it both ways. The Court should hold Plaintiffs to their word and exclude the 

improper opinions identified above they conceded Dr. Parisian would not offer. 

Moreover, against the holding of nearly every case that has considered the 

admissibility of Dr. Parisian’s testimony, Plaintiffs dig in and argue she should be 

permitted to offer legal opinions. “The principle that legal opinion evidence concerning 

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the law is inadmissible is so well-established that it is often deemed a basic premise or 

assumption of evidence law—a kind of axiomatic principle.” Pinal Creek Grp. v. 

Newmont Mining Corp., 352 F. Supp. 2d 1037, 1042 (D. Ariz. 2005) (internal quotation 

omitted). Moreover, in the context of the FDA, these legal conclusions are also 

preempted. Indeed, Plaintiffs repeatedly conceded that Dr. Kessler, another of their 

regulatory witnesses, would not offer such opinions. (Dkt. No. 7805 at pp. 7-8.) Dr. 

Parisian should be precluded from offering legal opinions as well. 

Finally, the Court should exclude Dr. Parisian’s opinions because she did not 

employ a reliable methodology because she makes no attempt to connect her opinions 

with any meaningful regulatory analysis.1

COURT OPINIONS ADDRESSING DR. PARISIAN 

Plaintiffs state that Dr. Parisian “will follow the limitations on her testimony 

imposed by the plethora of other courts” that have considered her testimony. (Pl. Br. At 

12.) While it goes without saying that Dr. Parisian must follow the limitations this Court

imposes, the weight of authority excluding Dr. Parisian’s opinions is instructive. There is 

no dispute that virtually every Court exercising its gatekeeping function has excluded Dr. 

Parisians opinions in part, if not in full. Indeed, of the scores of opinions addressing Dr. 

Parisian’s testimony, Plaintiffs identified only one that permitted her opinions without 

limitation. By contrast, at least ten courts, including two decisions from this jurisdiction, 

excluded Dr. Parisian’s opinions in full. It’s no surprise Plaintiffs disregard these 

decisions, disingenuously describing them as a “handful” of older cases, notwithstanding 

a 2015 order from a case in this litigation excluding Dr. Parisian’s opinions. See Lopez v. 

I-Flow Inc., No. CV 08–1063–PHX–SRB, 2011 WL 1897548, at *9-10 (D. Ariz. Jan. 26, 

2011); Miller v. Stryker Instruments, No. CV 09–813–PHX–SRB, 2012 WL 1718825, at 

1

 Plaintiffs filed a separate Omnibus Statement Of Law And Generally-Applicable 

Arguments In Opposition To Bard’s Motions To Exclude Plaintiffs’ Experts Under Rule 

702 And Daubert (Doc. 7799). Plaintiffs’ Omnibus Statement is not directed at any 

specific Daubert motion Bard filed. As such, Bard does not respond to the Omnibus 

Statement but instead will address any necessary issues in the context of its individual 

Daubert replies. 

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*10-12 (D. Ariz. Mar. 29, 2012); Mot. Ex. C, Robles v. C. R. Bard, Inc., Civil Action No. 

5:13-CV-250, United States District Court for the Northern District of Texas. Rather, 

Plaintiffs rely on other cases that have, only in part, admitted Dr. Parisian’s testimony, and 

claim that these cases better reflect Dr. Parisian’s opinions here. Critically, however, 

Plaintiffs do not compare Dr. Parisian’s opinions in those cases with her opinions in this 

case. Even in Phillips v. C.R. Bard, Inc., 3:12-CV-00344-RCJ, 2014 WL 7177256 (D. 

Nev. Dec. 16, 2014), a Recovery Filter case, Dr. Parisian offered a totally different expert 

report than she does in this case (180 pages shorter, different “summary of opinions,” and 

addressed only the Recovery).2 Indeed, the case law Plaintiffs offer actually supports 

Bard’s arguments because it excludes the categories of Dr. Parisian’s testimony Bard 

identified in its underlying motion. A chart comparing the case law Plaintiffs cited with 

the categories of testimony they excluded is attached as Exhibit A. Tellingly, Plaintiffs 

only address three of the numerous examples of Dr. Parisian’s specific opinions in Bard’s 

motion. This is because a closer inspection reveals that Dr. Parisian is offering precisely 

the same types of opinions that other courts have excluded. 

I. ARGUMENT AND CITATION OF AUTHORITY

A. Plaintiffs Concede Dr. Parisian Will Not Testify About IVC Filter 

Design, Testing, and Causation. 

Plaintiffs concede that design and causation are “obviously outside Dr. Parisian’s 

area of expertise” because she has no engineering experience, and no medical experience 

relevant to IVC filters. (Pl. Br. at 14-15.) Plaintiffs attempt to circumvent this concession, 

however, arguing that “none of Dr. Parisian’s seven primary opinions in this case 

remotely touch on design or causation issues.” Yet Plaintiffs ignore the specific examples 

from Bard’s motion and the hundreds of additional pages of opinions in Dr. Parisian’s 

report beyond her seven “primary” opinions. Plaintiffs even contradict themselves in their 

own brief. (See Pl. Br. at 17-18 (arguing that “Bard’s violations of FDA regulations as 

2

 In contrast, Dr. Parisian’s testimony from her Phillips deposition is a reliable indicator of 

the types of impermissible testimony she will attempt to offer here. 

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described by Dr. Parisian are merely evidence...that its IVC filters were defectively 

designed”).) Dr. Parisian’s report and deposition are filled with these design and causation 

opinions, and also contain what other courts have excluded as “regulatory causation” 

opinions (i.e., if Bard had disclosed X to the FDA, the FDA would not have cleared the 

510(k) application, or would have changed the IFU or recalled the product because of a 

“causal association” between X and patient injury).3 See e.g., June 21, 2017, Deposition of 

Suzanne Parisian (“Parisian Dep.”), at 80:12 – 81:16 (testifying that Bard should have 

updated its IFU “based on the design of the device and what they were seeing in terms of 

the – the fracture of metal, the perforation, the risks that they were seeing internally, the 

difference between the Simon Nitinol filter and the recovery filter, that a reasonable 

manufacturer would have tried to have provided some guidance as to removal.”). 

Plaintiffs separately maintain that Dr. Parisian can testify regarding the adequacy 

of Bard’s IVC filter testing, and “the notice [testing or literature] provide[s] to medical 

device manufacturers about potential problems with their products.” (Pl. Br. 15.) Plaintiffs 

simply assert that because Dr. Parisian reviewed product testing at FDA, she can opine on 

the adequacy of testing and whether that testing provided “notice” to manufacturers for 

any marketed drug or device. This is not the case, as even the authority Plaintiffs rely on 

recognizes. See e.g., Jones v. Novartis Pharm. Corp., 235 F. Supp. 3d 1244, 1260 (N.D. 

Ala. 2017) (“Dr. Parisian will not be permitted to testify to ‘notice’ as a method of 

circumventing the court’s ruling preventing her from discussing causation...Dr. Parisian 

is a regulatory expert, yet in her report she opines that certain drug potencies, a study on 

match factory workers in the 19th century, and causal associations between other 

[biophasphate] drugs and femur fractures should all have put Novartis on ‘notice.’ Dr. 

3

See e.g., Georges v. Novartis Pharm. Corp., 2012 WL 9064768 at *10 (C.D. Cal. Nov. 2, 2012) 

(excluding testimony and citing other Novartis cases that have done the same); Guenther v. 

Novartis Pharm. Corp., 6:08-CV-456-ORL-31, 2013 WL 1278089 (M.D. Fla. Mar. 28, 2013) 

(recognizing “that to opine as to whether the label should have been revised, Parisian would need 

to discuss whether there was a causal association between Zometa and ONJ, which is essentially 

the same as discussing whether there was a causal relationship between Zometa and ONJ”). 

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Parisian is not an expert on bisphosphonate medications, a toxicologist, or a 

pharmacologist, and she will not be permitted to opine that Novartis should have 

conducted safety evaluations more quickly or should have noticed a link between 

bisphosphonates and femur fractures earlier.”). Compare with (Ex. B, Parisian Dep., at 

103:7 – 105:8 (opining that “Bard’s performance of Meridian corrosion testing is flawed 

and raises significant questions about filter durability and safety” but conceding that “I’m 

not a person that would market myself as – as people who would be experts in that.”).) As 

a result, Dr. Parisian’s design, testing, and causation opinions should be excluded. 

B. The Court Should Exclude Dr. Parisian’s Narrative Testimony. 

Plaintiffs concede that Dr. Parisian cannot offer narrative testimony, but a few 

pages later, argue that her narrative is necessary to support her opinions. (Pl. Br. at 12; 

14.) Plaintiffs, however, confuse the issue of narrative testimony. The problem is not the 

volume of documents on which Dr. Parisian relies. Rather, Dr. Parisian’s total lack of 

regulatory analysis renders her testimony inadmissible because it is unhelpful to the jury.4

Dr. Parisian makes no attempt to connect what amounts to a closing argument better heard 

from counsel to any FDA regulations. For example, on page 160 of her report, Dr. 

Parisian cites applicable regulations for her opinion that “Bard developed its ‘next 

generation’ of IVC filters based on piecemeal reactive modifications to its flawed original 

RNF filter platform rather than use quality science and medical device design principles,” 

which contains sub-opinions including that “Bard’s evolution of changes starting with the 

RNF were not primarily made to improve quality, safety, and efficacy or to protect 

patients but rather primarily to address sales force and physician perceptions about device 

problems and help keep and expand market share.” Dr. Parisian cites the following 

regulations and statute: 

• 21 CFR § 820.198 – outlining complaint file requirements; 

4

 Regarding Plaintiffs’ contention that Dr. Parisian is not an advocate, Bard will let Dr. 

Parisian’s deposition testimony and expert reports speak for themselves as to whether her 

advocacy renders her opinions unreliable or unhelpful. 

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• 21 CFR § 820.30 – establishing and maintaining design controls “to ensure 

that specified design requirements are met”; 

• 21 CFR § 820.100 – requiring manufacturers to “establish and maintain 

procedures for implementing corrective and preventative action”; 

• 21 CFR § 820.75 – requiring manufacturers to establish and maintain 

processes for validating manufacturing procedures; 

• 21 CFR § 820.250 – requiring manufacturers to establish “valid statistical 

techniques”; 

• 21 USC § 352(a)(f)(1)(2) – defining that a “drug or device shall be deemed 

to be misbranded” for a “false or misleading label.” 

Dr. Parisian makes no attempt to connect any of these generic regulations with her 

specific opinion, or how the voluminous Bard documents that supposedly support her 

opinion relate to any analysis under these regulations. This “analytical gap” exemplifies 

why courts regularly exclude Dr. Parisian’s opinions because there is no useful expert 

analysis. See e.g., Lopez, 2011 WL 1897548, at *10 (“Dr. Parisian's report simply presents 

a narrative of selected regulatory and corporate events and quotations and then leaps to a 

conclusion without sufficient explanation...This deficiency has also been noted by other 

courts in excluding such testimony from Dr. Parisian.”) (citing Gen.Elec. Co. v. Joiner, 

522 U.S. 136, 146, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997) (“[N]othing in either Daubert

or the Federal Rules of Evidence requires a district court to admit opinion evidence that is 

connected to existing data only by the ipse dixit of the expert. A court may conclude that 

there is simply too great an analytical gap between the data and the opinion proffered.”)). 

Dr. Parisian’s narrative testimony, devoid of regulatory analysis, should be excluded. 

C. The Court Should Exclude Dr. Parisian’s Statutory and Regulatory 

Compliance Opinions Because They Are Legal Conclusions and 

Preempted. 

It is universally accepted that expert witnesses cannot give legal opinions. See 

Pinal Creek, 352 F. Supp. 2d at 1042. Plaintiffs repeatedly conceded that Dr. Kessler, 

another of their regulatory witnesses, would not offer such opinions. (Dkt. No. 7805 at 

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pp. 7-8.) Here, however, Plaintiffs double down, maintaining that Dr. Parisian can offer 

legal conclusions because they do not reach an “ultimate issue.” (Pl. Br. at 17-18) Even 

assuming that Plaintiffs’ argument is correct, Plaintiffs do not address any of the specific 

examples in Bard’s motion, or explain how those opinions, such as concluding that Bard 

“failed to adequately warn physicians, patients, and its own sales force of the risks,” and 

that Bard’s post-market procedures were “flawed, helped underestimate patient risk, and 

permitted continued commercial release of misbranded and dangerous products,” do not 

embrace ultimate issues. (Mot. at 3-4.) Plaintiffs cite a few opinions that, without citing 

any legal authority, distinguish violating FDA statutes and regulations from other legal 

conclusions. Plaintiffs, however, cannot overcome the overwhelming weight of authority 

that an expert cannot provide legal conclusions, including violating FDA regulations. 

(Compare, e.g. Ex. A (including cases cited by Plaintiffs prohibiting legal conclusions) 

with June 13, 2014, Deposition of Suzanne Parisian, attached as Exhibit C, at 123:16-23 

(“It’s your opinion that the Recovery filter was adulterated and misbranded?” “Yeah. It 

didn’t perform as cleared. It was cleared as a permanent filter, and it did not perform as a 

– it didn’t perform like the SNF or any other permanent filter. So that makes it adulterated 

right there.”); 206:7-9 (“[I]t’s a prohibited act to sell a product that’s adulterated and 

misbranded.”); 244:2-7 (“[Bard] can’t do that. That’s not allowed in terms of the 

requirements. It’s a prohibited act to sell a device that’s not safe and effective and 

adequately labeled. You are not adequately informing the physician about this device 

before he implants it in a patient.”).) 

Plaintiffs gloss over Bard’s preemption argument, including the fact that FDA 

never removed any of Bard’s IVC filters from the market, and never found that Bard 

violated any FDA regulations. In other words, Dr. Parisian speculates that if Bard had 

disclosed certain information manufacturers never customarily submit to FDA, such as 

internal emails and memoranda, draft testing documents, draft PowerPoint presentations, 

and other documents that the FDA would not ordinarily review or rely on, then FDA 

would have taken certain actions or that Bard would have been required to stop selling its 

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IVC filters. The United States Supreme Court squarely rejected this reasoning and held it 

preempted. Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466, 2477, 186 L. Ed. 2d 607 (2013) 

(“We reject this ‘stop-selling’ rationale as incompatible with our pre-emption 

jurisprudence. Our pre-emption cases presume that an actor seeking to satisfy both his 

federal- and state-law obligations is not required to cease acting altogether in order to 

avoid liability. Indeed, if the option of ceasing to act defeated a claim of impossibility, 

impossibility pre-emption would be ‘all but meaningless.’) (internal quotation omitted). 

Plaintiffs argue that this is permitted because they are not alleging a stand-alone fraud on 

the FDA claim, but fail to explain why using the exact same “fraud on the FDA” evidence 

somehow exempts them from Buckman Co. v. Pls.’ Legal Comm., 531 U.S. 341 (2001).5

Plaintiffs rely on two cases to claim that this second-guessing the FDA is 

permissible, In re Yasmin & YAZ (Drospirenone) Mktg., Sales Practices & Prod. Liab. 

Litig., No. 3:09-MD-02100-DRH, 2011 WL 6302287 (S.D. Ill. Dec. 16, 2011) and In re 

Vioxx Prods. Liab. Litig., 401 F. Supp. 2d 565 (E.D. La. 2005), but both were decided 

before Bartlett. (Pl. Br. 22-23.) More generally, Plaintiffs cite In re C.R. Bard, Inc., 948 F. 

Supp. 2d 589 (S.D.W. Va. 2013), which was also decided before Bartlett, and only stated 

that “Dr. Kessler may testify, for example, that Bard did not disclose certain information 

to the FDA that Dr. Kessler, as a former Commissioner of the FDA, would have found 

pertinent.” (emphasis added). Dr. Kessler opining that he would have wanted to know 

“X”, versus Dr. Kessler opining that Bard violated FDA regulations because the FDA was 

never told “X”, are two very different opinions. The court recognized this in concluding 

that “Dr. Kessler may not testify that Bard violated FDA regulations—such testimony 

would be drawing legal conclusions.” Id. at 629 (excluding opinions such as “Bard failed 

to adequately disclose adverse risks associated with their products,” “Bard failed to warn

on its label,” and prohibiting Dr. Kessler from using any terms that “have a separate, 

5

 Plaintiffs also incorporate by reference their response to Bard’s preemption argument in 

its Motion to Exclude Dr. David Kessler. To the extent that this is permitted, Bard 

incorporates its reply brief related to that motion. 

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distinct, and specialized meaning in the law.”) (emphasis original). The same goes for Dr. 

Parisian. 

Furthermore, Plaintiffs fail to address the inherently speculative nature of secondguessing the FDA. The weight of authority clearly rejects opinions second-guessing the 

FDA as preempted or speculative, because “[u]nder Plaintiffs’ reasoning, a plaintiff could 

always cite to a particular piece of data, presumably unconsidered by the FDA, and 

overcome conflict preemption.” In re Incretin-Based Therapies Prod. Liab. Litig., 142 F. 

Supp. 3d 1108, 1130–31 (S.D. Cal. 2015) (“Thus, although Plaintiffs reframe this data as 

new safety information, the Court declines to consider it as undermining the FDA’s 

conclusion...the Court notes that it remains unclear whether the FDA considered this 

information, and if it did not, whether this data would have altered the FDA’s conclusion. 

The parties’ experts dispute whether the information was material to the FDA’s analysis 

and offer little clarity on this point. However, as noted at the hearing on these motions, it 

is unlikely that a conflict preemption proponent, or a plaintiff opposing the defense, would 

ever know the full extent of what the FDA reviewed in evaluating a safety signal....A 

reevaluation of scientific data or a judicial challenge to the accuracy of the FDA's 

conclusions would disrupt the ‘delicate balance of statutory objectives’ the Buckman

Court sought to preserve.”) (emphasis added). 

As a result, this Court should exclude such speculative and preempted testimony as 

numerous other courts have done. See e.g., Rheinfrank v. Abbott Labs., Inc., 119 F. Supp. 

3d 749, 767–68 (S.D. Ohio), aff'd, 680 F. App'x 369 (6th Cir. 2017) (“Plaintiffs’ argument 

that Abbott withheld certain information or misrepresented the results of studies in its 

2005 and 2007 submissions to the FDA appears to be a fraud-on-the-FDA theory, which 

is preempted...Regardless, an expert's opinion that the FDA would have reacted 

differently if the submissions to the FDA in 2005 and 2007 had been supported by 

different evidence is speculative.”) (citations omitted); In re Trasylol Products Liab. 

Litig., No. 08-MD-01928, 2010 WL 4259332, *12 (S.D.Fla. Oct. 21, 2010) (“[An expert] 

may not speculate as to what the FDA would have done in hypothetical circumstances.”); 

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Webster v. Pacesetter, Inc., 259 F.Supp.2d 27, 37 (D.D.C. 2003) (“Nor can plaintiffs 

create an issue of fact regarding their defective warning claim by speculating that if the 

FDA had known of the delayed perforation and tamponade incidents during the clinical 

trials and if defendant had investigated all the adverse incidents, the FDA would have 

either recalled the [product] or placed it on alert.” (emphasis in original)). 

D. Plaintiffs Concede that Dr. Parisian Cannot Opine on Corporate Intent 

or Ethics. 

Much like Plaintiffs contradictory arguments about Dr. Parisian’s legal 

conclusions, Plaintiffs first concede that Dr. Parisian cannot testify about Bard’s intent, 

but then claim that Dr. Parisian can opine about “what Bard knew internally,” “why the 

FDA took the actions it did,” and “what the intent of the SIR Guidelines are” because she 

“relies on the record.” (Pl. Br. at 19.) Courts preclude experts from opining about intent 

because witnesses are not mind readers. If Dr. Parisian, as Plaintiffs concede, cannot 

opine about Bard’s intent, she cannot opine about anyone’s intent. Plaintiffs also fail to 

address any of the deposition testimony Bard cited regarding Dr. Parisian’s speculation as 

to what Bard knew at certain times. Plaintiffs provide no legal authority for their position 

that an expert can speculate as to third parties’ state of mind, or that Dr. Parisian’s 

speculation as to what Bard “knew” at certain times is different than any other “state of 

mind” testimony. Regardless of Dr. Parisian’s particular phrasing, numerous courts have 

excluded identical state of mind opinions. See e.g., Johnson v. Wyeth, 2012 WL 1204081 

(D. Ariz. Apr. 11, 2012) (“Dr. Parisian...may not offer opinions concerning defendants’ 

motive, intent, knowledge, or other state of mind,” including examples such as “[i]nternal 

Wyeth documents demonstrate that the company did not intend...”); Jones, 235 F. Supp. 

3d at 1264 (“Dr. Parisian has no specialized knowledge or scientific/medical expertise that 

provides her with a superior ability to judge Novartis’s knowledge, and there is no basis 

for finding that the jury needs her assistance in evaluating Novartis’s knowledge” and 

excluding opinions such as “Novartis chose not to accurately update its sales force or 

prescribers about the growing risk of association.”). 

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As a result, all of Dr. Parisian’s state of mind opinions, regarding Bard’s or third 

parties’ knowledge, intent, or other state of mind, should be excluded. Pritchett v. I-Flow 

Corp., No. 09-CV-02433-WJM-KLM, 2012 WL 1059948, at *6 (D. Colo. Mar. 28, 2012) 

(“Obviously, [Dr. Parisian] therefore has no direct knowledge of I–Flow's state of mind or 

intent regarding development, use, marketing or promotion of the pain pump. Her written 

opinion is riddled with conclusory statements about I–Flow's purported knowledge and 

intent based on her review of documents or circumstances related to the FDA process.”). 

E. Dr. Parisian’s Testimony is Not Reliable Because She Does Not Employ 

A Reliable Methodology. 

Plaintiffs argue against a straw man. Bard never argued that Dr. Parisian needed to 

apply the scientific method to her regulatory opinions. Instead, Bard argued that Dr. 

Parisian provides no meaningful link between her opinions and the regulations and 

statutes she cites. She does not explain why the documents she cites run afoul of the cited 

regulations, or why Bard was required to disclose those documents to the FDA in the first 

place. As discussed above in Section II(B), and as noted by other courts, Dr. Parisian’s 

opinions suffer from a “striking disconnect” between opinions and seemingly unrelated 

regulations. In re Trasylol, 709 F. Supp. 2d at 1339 (S.D. Fla. 2010). In other words, the 

Court should “conclude that there is simply too great an analytical gap between the data 

and the opinion proffered.” Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146, 118 S. Ct. 512, 

519, 139 L. Ed. 2d 508 (1997). 

CONCLUSION

Dr. Parisian’s opinions are not only inadmissible under Rule 702, but are also 

unhelpful and unreliable under Daubert. Accordingly, the Dr. Parisian’s opinions should 

be excluded in their entirety. 

// 

// 

// 

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DATED this 18th day of October, 2017. 

s/ Richard B. North, Jr. 

Richard B. North, Jr. 

Georgia Bar No. 545599 

Matthew B. Lerner 

Georgia Bar No. 446986 

Taylor Tapley Daly 

Georgia Bar No. 697887 

NELSON MULLINS RILEY & SCARBOROUGH, LLP 

Atlantic Station 

201 17th Street, NW / Suite 1700 

Atlanta, GA 30363 

PH: (404) 322-6000 

FX: (404) 322-6050 

richard.north@nelsonmullins.com 

matthew.lerner@nelsonmullins.com 

taylor.daly@nelsonmullins.com 

James R. Condo (#005867) 

Amanda Sheridan (#005867) 

SNELL & WILMER L.L.P. 

One Arizona Center 

400 E. Van Buren 

Phoenix, AZ 85004-2204 

PH: (602) 382-6000 

JCondo@swlaw.com 

ASheridan@swlaw.com 

Attorneys for Defendants C. R. Bard, Inc. and 

Bard Peripheral Vascular, Inc. 

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CERTIFICATE OF SERVICE 

I hereby certify that October 18, 2017, the foregoing was electronically filed with 

the Clerk of Court using the CM/ECF system which will automatically send e-mail 

notification of such filing to all attorneys of record. 

s/ Richard B. North, Jr. 

Richard B. North, Jr. 

Case 2:15-md-02641-DGC Document 8226 Filed 10/18/17 Page 14 of 14