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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 

Co-Lead/Liaison Counsel for Plaintiffs 

UNITED STATES DISTRICT COURT 

DISTRICT OF ARIZONA 

In Re Bard IVC Filters Products 

Liability Litigation 

No. MD-15-02641-PHX-DGC

REPLY IN SUPPORT OF PLAINTIFF’S 

MOTION IN LIMINE #1 

(Assigned to the Honorable David G. 

Campbell) 

(Oral Argument Requested)

REPLY MEMORANDUM IN SUPPORT OF PLAINTIFF’S MOTION IN LIMINE 

TO EXCLUDE REFERENCE TO FDA 510(k) CLEARANCE AND LACK OF 

FDA ENFORCEMENT 

Case 2:15-md-02641-DGC Document 9824 Filed 01/25/18 Page 1 of 7
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A. FDA 510(k) Clearance Regulations Are Not Safety Regulations 

 Bard’s opposition rehashes many of its preemption arguments, putting forth the same 

unsuccessful argument that the post-Lohr medical devices have been reviewed for safety 

and efficacy. But as this court has already held, regulations governing the 510(k) clearance 

process are not safety standards as the clearance process does not independently establish 

the safety of medical devices. Rather, the process renders a comparative determination. 

(Doc. 8872, at 12-13). 

 Georgia Suggested Pattern Jury Instruction 62.670 states as follows: 

62.670 Strict Liability; Design Defect; Compliance with Industry 

Standards or Government Regulations 

In determining whether a product was defective, you may consider proof 

of a manufacturer’s compliance with federal or state safety standards or 

regulations and industrywide customs, practices, or design standards. 

Compliance with such standards or regulations is a factor to consider in 

deciding whether the product design selected was reasonable considering 

the feasible choices of which the manufacturer knew or should have 

known. However, a product may comply with such standards or 

regulations and still contain a design defect.

(Exhibit A, Georgia Suggested Pattern Jury Instructions, January 17, 2017 (5th Ed.) 

(emphasis added).) This pattern jury instruction limits the jury’s consideration to only those 

standards and regulations related to “safety,” which would exclude anything to do with 

510(k) clearance. Moreover, these pattern jury instructions are born of and have evolved 

from the same cases1

 on which Defendants rely in claiming the federal standards a jury may 

consider are not limited to “safety” standards. Def. Resp. Mot., at 4. 

 Bard also admits that it does not intend to simply introduce evidence of its alleged 

compliance with applicable law and regulations. Rather Bard intends to argue that the FDA 

510(k) process determined its IVC filters were safe and effective. Def. Resp. Mot., at 6. 

 

1

 The Banks v. ICI Americas, Inc., 450 S.E.2d 671 (Ga. 1994), case does not provide the 

broad scope Bard suggests but rather states that compliance with federal regulations does 

not conclusively eliminate liability. Id. at 675. Doyle v. Volkswagenwerk 

Aktiengesellschaft, 481 S.E.2d 518, 521 (Ga. 1997), similarly states that compliance with a 

federal regulation is a factor to determine if a manufacturer was reasonable in selecting a 

design. Yet the 510(k) clearance regulations do not require a product to take a particular 

form or adhere to particular specifications. Riegel v. Medtronic, 552 U.S. 312, 323 (2008). 

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This argument is wrong. To make matters worse and add confusion, Bard intends to rely 

on hearsay communications with the FDA to argue that compliance with 510(k) standards 

is steeped in safety review. The hearsay problem is exemplified by Plaintiff’s inability to 

cross examine at trial (or even depose or informally interview) FDA witnesses regarding 

their internal documents and communications with Bard. Notably, the Cisson case applied 

Georgia law and recognized evidentiary issues that led to the exclusion of 510(k) clearance 

evidence. See Cisson v. C.R. Bard, Inc. 86 F. Supp. 3d 510 (S.D. W. Va. 2015), aff’d sub 

nom, 810 F.3d 913 (4th Cir. 2016). 

 Likewise, Bard’s alleged compliance with 510(k) is not relevant to respond to or 

rebut a claim for punitive damages under Georgia law. Georgia’s Annotated Code provides 

that punitive damages are available when the defendant's actions exhibit “willful 

misconduct, malice, fraud, wantonness, or oppression.” Ga.Code Ann. § 51-12-5.1(b) 

(2014). “Such conduct is not mitigated by compliance with 510(k), a regulation ‘intended 

merely to give manufactures the freedom to compete.’” Cisson, 86 F. Supp. 3d at 516 

(quoting Lohr, 518 U.S. at 492) 

 Bard also indicates it will seek to introduce evidence of communications with the 

FDA concerning the EVEREST retrievability study conducted under the investigational 

device exception (IDE) code section of the FDA regulations. In addition to being more 

hearsay, this evidence is irrelevant and not probative of material facts or issues in this trial. 

Fed. R. Evid. 401. This Court has already recognized that under 21 C.F.R. § 807.87(l) the 

FDA can request additional information during the 510(k) process to determine substantial 

equivalence without implicating any type of safety determination. (Doc. 8872, at 12.) Even 

documents submitted by Bard to support its unsuccessful preemption motion clearly state 

IDE distribution and use of its devices is a means of collecting more data to determine 

substantial equivalence, not to support an independent determination of safety or 

effectiveness. (Doc. 5396, Exhibit A: “Declaration of Robert Carr In Support Of 

Defendants’ Motion for Summary Judgment Regarding Preemption,” Exhibit. 7, Sec. 17, 

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para 4)2

 This misplaced argument actually undermines Bard’s claim that the FDA required 

Bard to conduct the EVEREST study since IDEs are not only voluntary applications, but 

also optional to manufacturers just like making a 510(k) application. Such additional 

information provided by a manufacturer to the FDA while seeking 510(k) clearance does 

not establish safety standards. In the end, there is no “clinical study” requirement under the 

510(k) process because the FDA does not make an independent determine as to whether the 

product is safe, only that it is comparatively as safe as another product already on the 

market. This is precisely why the process is irrelevant here.3

 

 Furthermore, Bard relies almost exclusively on case law which does not involve and 

had nothing to do with 510(k) cleared products. The only4

 potentially relevant case Bard 

cites involving a 510(k) cleared product, Winebarger v. Boston Scientific Corp., is a 

revisitation of a prior MDL ruling excluding 510(k) clearance evidence. The Winebarger

matter was part of MDL 2326 where the Cisson line5

 of rulings excluding 510(k) clearance 

 

2

 Bard’s own submitted documents state that the FDA communicated, “You may, however, 

distribute this device for investigational purposes to obtain clinical data if needed to 

establish substantial equivalence. Clinical investigations of this device must be conducted 

in accordance with the investigational device exemption (IDE) regulations.” Id. (emphasis 

added). 

3

 As the Fourth Circuit recognized prior to its Cisson decision in Almy v. Sebelius, 679 F.3d 

297 (4th Cir.2012), “‘[A] section 510(k) notice generally does not involve clinical data

showing safety and effectiveness.’ 54 Fed. Reg. 4307. Section 510(k) approval requires 

only that a device be ‘substantially equivalent’ to another device that the FDA has already 

approved for marketing, and not that the device have been clinically examined for safety 

and effectiveness. The Supreme Court has emphasized this distinction, noting that a device 

approved under 510(k) ‘has never been formally reviewed ... for safety or efficacy.’” Id. 

at 308 (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 493 (1996) (emphasis added)). 

4

 Bard cites to this Court’s opinion in Placencia v. I-Flow Corp., 2012 WL 5877624 (D. 

Ariz. Nov. 20, 2012) as if it made an evidentiary ruling on the admissibility of 510(k) 

clearance evidence, yet Plaintiff’s understanding of that opinion is that it was the Court’s 

ruling on a motion for summary judgment and admissibility of such evidence was not yet 

before the Court. See Def. Resp. Mot., at 4, fn. 5. 

5

 The “Cisson line” of rulings excluding 510(k) clearance evidence and lack of enforcement 

by the FDA are cited in Footnote 2 of Plaintiff’s Memorandum of Law in Support of 

Plaintiff’s Motion in Limine to Exclude Reference to FDA 510(k) Clearance and Lack of 

FDA Enforcement. (Doc. 9529). 

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evidence and lack of enforcement emanated and were upheld by the Fourth Circuit. 

However, Winebarger was remanded back to its transferor court after the MDL’s decision; 

the District Court of the Western District of North Carolina. 2015 WL 5567578 (W.D.N.C. 

Sep. 21, 2015). There, the district court reconsidered the plaintiff’s motion in limine to 

exclude FDA-related evidence and, based on what it described as the broad language of the 

North Carolina Product Liability Statute, deemed FDA clearance evidence was a criterion 

to be considered, i.e., the transferor court didn’t find it to be a “standard” but deemed it a 

“criterion” to be considered under North Carolina law. 2015 WL 5567578 at *4-5. But due 

to the “risk of misleading and confusing the jury”, the court’s recognition that “[a] minitrial6

 on the FDA 510(k) clearance process would be a waste of time,” and finding that there 

was “a legitimate concern that jurors might place too much emphasis on the 510(k) 

clearance” process, the district court ruled that 510(k) clearance evidence could only be 

admissible if specific limiting instructions addressed these concerns. Id. at 7. Thus the one 

relevant case Bard relies on recognized the problems of time wasting, jury confusion, risk 

of a mini-trial, and the potential unwarranted gravitas a jury may assign to the clearance 

process. These problems will inevitably arise should such questionable evidence be 

presented in a trial where strict time limits have been imposed and advance rulings have 

already been made to keep out evidence of questionable probative value. 

 Plaintiff’s position, on the other hand, is legally sound and supported by multiple 

well-reasoned decisions in addition to the Cisson line of cases excluding FDA evidence 

where any minimal probative value is substantially outweighed by the significant risk of 

prejudice that jurors will accord some credibility to a government agency that will not 

appear in the trial or be subject to cross-examination. 

 

6

 Plaintiff presented evidence in her brief that could potentially be excluded to include the 

FDA Warning Letter, certain regulatory expert testimony, and testimony of Bard witnesses 

(e.g., Mary Edwards as far as clearance testimony; some witnesses such as Ms. Edwards 

offer non-clearance related testimony that would still be relevant). 

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B. Lack of FDA Enforcement Action Is Irrelevant and Immaterial. 

Evidence of lack of FDA enforcement action against Bard would mislead a jury into 

drawing conclusions and making up its own inferences about something that didn’t happen. 

Therefore it should be excluded as prejudicial, confusing, and misleading. Fed. R. Evid. 

402, 403. Whether the G2 filter was on the market for two years prior to Ms. Booker 

receiving it is irrelevant. Fed R. Evid. 401. Inviting speculation as to why the G2 filter was 

not subject to either FDA action or inaction is impermissible. FDA’s motive, intent, or state 

of mind is inadmissible because it is unknowable since FDA was never a party to these 

actions. See, e.g., In re Fosamax Prod. Liab., Litig., 645 F. Supp. 2d 164, 192 (S.D.N.Y 

2009). Also, Bard cannot suggest to the jury that it draw inferences regarding FDA’s “broad 

authority” to regulate medical devices. Def. Resp. Mot., at 8. Moreover, the Supreme Court 

acknowledged in Lohr that “FDA’s authority to require manufacturers to recall, replace, or 

refund defective devices is of little use to injured plaintiffs since ... the authority is rarely 

invoked, if at all.” Medtronic v. Lohr, 518, U.S. 470, 487, n.7 (1996) (emphasis added). 

C. Conclusion 

Accordingly, Plaintiff respectfully requests that this Court enter an Order (1) 

granting this motion; (2) prohibiting at trial all evidence and argument relating to the 510(k) 

clearance process and regulatory scheme; and (3) prohibiting at trial all evidence and 

argument regarding the FDA’s lack of enforcement action as to Bard’s IVC filters. 

RESPECTFULLY SUBMITTED this 25th day of January, 2018. 

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 

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CERTIFICATE OF SERVICE 

I hereby certify that on this 25th day of January 2018, 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 

Case 2:15-md-02641-DGC Document 9824 Filed 01/25/18 Page 7 of 7