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Nelson Mullins Riley & Scarborough

L.L.P.

201 17t h Street NW, Suite 1700

Atlanta, GA 30363

(404) 322-6000

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

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.’S

AND BARD PERIPHERAL 

VASCULAR, INC.’S REPLY IN 

SUPPORT OF ITS MOTION TO 

AMEND AND CERTIFY THE 

COURT’S NOVEMBER 22, 2017

ORDER FOR INTERLOCUTORY 

APPEAL PURSUANT TO 28 U.S.C. 

§ 1292(B)

(Assigned to the Honorable David G. 

Campbell)

The Court’s November 22, 2017, Summary Judgment Order involves pure and 

controlling questions of law, involving novel legal issues on which fair-minded jurists 

might reach contradictory conclusions, and an immediate appeal, if successful, will 

materially advance the ultimate termination of this litigation. 28 U.S.C. § 1292(b). 

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Atlanta, GA 30363

(404) 322-6000

Certification is especially appropriate given the MDL setting. For each of these reasons, 

and as discussed in Bard’s Motion, certification is appropriate:

I. The Order Involves “Pure Questions of Law” Appropriate for Interlocutory 

Review.

“A ‘question of law’ for purposes of § 1292(b) means a ‘pure question of law’ 

rather than a mixed question of law and fact or the application of established law to a 

particular set of facts.” BDPJ Houston, LLC v. Cont'l Cas. Co., No. 2:10-CV-01018-

TMB, 2012 WL 13018736, at *2 (D. Ariz. Dec. 27, 2012). “So long as a pure legal 

question is identified, however, an order can be certified for appeal to resolve all questions 

‘material to the order.’” Steering Comm. v. United States, 6 F.3d 572, 575 (9th Cir. 1993) 

(finding it proper to certify a mixed question of law and fact material to the order when it 

is coupled with a pure legal question).” TCL Commc’ns Tech. Holdings Ltd v. 

Telefonaktenbologet LM Ericsson, No. SACV1400341JVSANX, 2014 WL 12588293, at 

*3 (C.D. Cal. Sept. 30, 2014); Flores v. Velocity Express, LLC, No. 12-CV-05790-JST, 

2015 WL 4463639, at *3 (N.D. Cal. July 21, 2015) (“[T]his prong is satisfied because at 

least one ‘pure’ question of law is presented.”). Bard acknowledges that the Order 

involves some mixed questions of law and fact. But these questions “are material to the 

order” and can be resolved alongside the multiple “pure questions of law” also presented

for certification.

A. Whether Plaintiffs’ State Law Claims Are Impliedly Preempted Is a Purely 

Legal Question.

Federal preemption under the FDCA is a “purely legal” question. Delarosa v. 

Boiron, Inc., No. 10-1569-JST (CWX), 2011 WL 13130856, at *4 (C.D. Cal. Dec. 29, 

2011). It is “undoubtedly a controlling question of law.” Knipe v. SmithKline Beecham, 

583 F. Supp. 2d 553, 599 (E.D. Pa. 2008). As here, the plaintiff in Knipe argued “that the 

issue of preemption is fact-intensive and, thus, not a pure question of law. . . . This 

argument disregards the very nature of the conflict preemption analysis, which turns 

precisely on whether two laws or regulations—one state, one federal—conflict, such that 

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Atlanta, GA 30363

(404) 322-6000

the latter preempts the former.” Id. “The mere fact that the preemption issue may require a 

detailed review of the regulatory records does not deprive it of its dispositive nature.” Id.

As in Knipe, the Ninth Circuit and its district courts have repeatedly recognized 

that preemption, by its very nature, is a controlling question of law. E.g., Movsesian v. 

Victoria Versicherung AG, 578 F.3d 1052, 1053 (9th Cir. 2009); Harris By & Through 

Harris v. Ford Motor Co., 110 F.3d 1410, 1411-12 (9th Cir. 1997); TOTAL TV v. Palmer 

Commc’ns, Inc., 69 F. 3d 298, 300–01 (9th Cir. 1995) (hearing interlocutory appeal of 

denial of federal preemption defense that presented an issue of first impression in the 

Circuit); Delarosa, 2011 WL 13130856, at *4 (“[W]hether the FDCA expressly or 

impliedly preempts each of Plaintiff’s state law claims” is controlling question of law);

Hansen Beverage Co. v. Innovation Ventures, LLC., No. 08CV1166 IEG(POR), 2010 WL 

743750, at *2 (S.D. Cal. Feb. 25, 2010) (“Hansen satisfies the first criterion for 

interlocutory appeal because federal preemption [under the FDCA] is a controlling issue 

of law.”); see also Nutrishare, Inc. v. Connecticut Gen. Life Ins. Co., No. 2:13-CV-02378-

JAM-AC, 2014 WL 2624981, at *4 (E.D. Cal. June 12, 2014) (granting certification; 

finding federal preemption “certainly a controlling question of law”); Brown v. Hain 

Celestial Grp., Inc., No. C 11-03082 LB, 2012 WL 4364588, at *3 (N.D. Cal. Sept. 24, 

2012) (granting certification; federal “preemption question presents a controlling question 

of law”); Deming v. First Franklin, No. 09-5418RJB, 2010 WL 2326170, at *1 (W.D. 

Wash. June 7, 2010) (whether federal statute and regulations preempted plaintiff’s state 

common law claims was a question of law); Helman v. Alcoa Glob. Fasteners Inc., No. 

CV09-1353 SVW (FFMX), 2009 WL 2058541, at *5 (C.D. Cal. June 16, 2009) 

(preemption is a “pure legal question”).

1

 

1 Other district courts have similarly found federal preemption under the FDCA to be a 

controlling question of law. E.g., Huber v. Howmedica Osteonics Corp., No. CIV A 07-

2400 JLL, 2009 WL 2998160, at *2 (D.N.J. Mar. 10, 2009) (granting certification in 

medical device case; “whether the MDA preempts a claim for breach of express warranty 

is a ‘controlling question of law.’ . . . As such, there is no question that the first 1292(b) 

factor is satisfied.”); Shuker v. Smith & Nephew PLC, No. CIV.A. 13-6158, 2015 WL 

4770987, at *4 (E.D. Pa. Aug. 13, 2015) (“[P]reemption ruling presents controlling 

questions of law, including whether the MDA preempts state tort claims concerning the 

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(404) 322-6000

B. Whether Special Controls, Such as a FDA Guidance Document, Can Ever 

Impose Device-Specific Requirements With Preemptive Power Is a Pure 

Legal Question.

Whether special controls and/or FDA Guidance documents can “ever” bear 

preemptive power is a “purely legal question.” Flores, 2015 WL 4463639, at *2 

(“[W]hether successor liability ever applies . . . is a question of law. The question of 

whether it applies to this particular acquisition is a mixed question of law and fact.”); 

This question requires interpretation of the legal import of 21 C.F.R. § 870.3375, and 

FDA’s Filter Guidance, within the Supreme Court’s preemption jurisprudence, not “the 

parties’ factual circumstances.” Nat’l Credit Union Admin. Bd. v. Goldman Sachs & Co., 

No. CV 11-6521-GW(JEMX), 2013 WL 12306438, at *6 (C.D. Cal. July 11, 2013) 

(question is “purely legal” where “order merely deals with a question of statutory 

interpretation” and “appellate court need not address the parties’ factual circumstances.”). 

C. Whether the Statutory and Regulatory Framework of 510(k) Has Evolved 

With The Passage of the SMDA Such That 510(k) Review Can Ever 

Impose Device-Specific Requirements Entitled to Preemptive Effect 

Outside of a Counterpart Regulation is a Pure Question of Law.

Similarly, whether 510(k) review itself can “ever” bear preemptive power is a 

“purely legal question.” Flores, 2015 WL 4463639, at *2. This question requires 

interpretation of the current statutory and regulatory framework of 510(k) review within 

the context of the Supreme Court’s preemption jurisprudence, not the parties’ factual 

circumstances. Therefore, “this prong is satisfied because at least one ‘pure’ question of 

law is presented.” Id. at *3.

II. Substantial Grounds for Difference of Opinion Do Exist.

“A substantial ground for difference of opinion exists . . . when novel legal issues 

are presented[] on which fair-minded jurists might reach contradictory conclusions,” even 

 

safety or effectiveness of a non-FDA-approved medical device.”); McNellis v. Pfizer, Inc., 

No. Civ. 05-1286, 2006 WL 2819046 (D.N.J. Sept. 29, 2006) (certifying order denying 

summary judgment argument that plaintiffs’ state law claims were preempted by FDCA);

Drake v. Laboratory Corp. of America Holdings, 290 F. Supp. 2d 352 (E.D.N.Y 2003) 

(certifying issue whether drug testing regulations preempted common law tort claims).

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if “there are no cases directly conflicting with the district court’s construction of the law.” 

Reese v. BP Expl. (Alaska) Inc., 643 F.3d 681, 688 (9th Cir. 2011). Contrary to Plaintiffs’ 

contention, the Ninth Circuit’s “interlocutory appellate jurisdiction does not turn on a 

prior court’s having reached a conclusion adverse to that from which appellants seek 

relief.” Id. Plaintiffs ignore this authority in favor of citing out of circuit authority that 

directly conflicts with Reese. (See Pl. Resp. at 6 (citing White v. Nix, 43 F.3d 374, 378 

(8th Cir. 1994)).)

As Bard explained in its Motion, the Ninth Circuit’s opinions in Degelmann and 

Papike, as well as Justice Gorsuch’s comments regarding the “considerable ‘uncertainty’” 

in the controlling law on FDCA preemption—rules which may “warrant revisiting and 

reconciliation”—demonstrate that fair-minded jurists might reach contradictory 

conclusions on these novel legal issues. Caplinger v. Medtronic, Inc., 784 F.3d 1335, 

1337, 1340 (10th Cir. 2015); Degelmann v. Advanced Med. Optics, Inc., 659 F.3d 835, 

841-42 (9th Cir. 2011) (FDA Guidance can be preemptive), vacated, 699 F.3d 1103 (9th 

Cir. 2012); Papike v. Tambrands Inc., 107 F.3d 737 (9th Cir. 1997) (device-specific 

regulation preemptive). Therefore, substantial grounds for difference of opinion do exist. 

Reese, 643 F.3d at 688.

III. Immediate Appeal Will Materially Advance This Litigation.

All that must be shown to satisfy § 1292(b) is that an immediate appeal, if

successful, “may materially advance the ultimate termination of the litigation.” 28 U.S.C. 

§ 1292(b) (emphasis added); Brown, 2012 WL 4364588, at *3 (“[C]ertification is 

appropriate where a successful appeal would materially advance, though not completely 

dispose of, the litigation.”). Bard made this showing in its opening Motion. Plaintiffs’ 

Response does not contradict that showing. Instead, Plaintiffs appear to import additional

requirements into this criterion of § 1292(b) suggesting that Bard must show: (a) that the 

Ninth Circuit will accept its petition, (b) that Bard will succeed on appeal, and (b) that the 

litigation “would [] be terminated.” (Pl. Resp. at 8-9.) Plaintiffs’ position is not supported 

by the law. See In re City of San Bernardino, California, 260 F. Supp. 3d 1216 (C.D. Cal. 

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(404) 322-6000

2013) (rejecting contention that the movant “must prove ‘that resolution of a controlling 

legal question would serve to avoid a trial or otherwise substantially shorten the 

litigation’” as “an incorrect statement of the law”); Reese, 643 F.3d at 688 (litigation 

sufficiently likely to be materially advanced where the Ninth Circuit’s “possible reversal” 

“may” remove one defendant and eliminate a set of claims against remaining defendants).

An appeal “must only possess the possibility of materially advancing the 

litigation.” Shell Gulf of Mexico, Inc v. Ctr. for Biological Diversity, Inc., No. 3:12-CV0096-RRB, 2012 WL 12871660, at *2 (D. Alaska Sept. 13, 2012). “In determining such 

possibility, ‘the court should consider the effect of a reversal by the court of appeals on 

the management of the case.’” Id. (granting certification after finding that “if the Ninth 

Circuit finds any of this Court’s conclusions to be erroneous, the current litigation would 

end immediately, with all of the Defendants and all of the claims being removed from the 

case. Additionally, in ending the current litigation, any further expensive or protracted

litigation could be avoided.”); see also Brown, 2012 WL 4364588, at *3 (granting 

certification of federal preemption issue after finding that if court’s preemption “order 

were reversed on appeal, it would limit the legal theories under which Plaintiffs could 

prove their case.”). Bard has shown in its Motion how a reversal of the Summary 

Judgment Order would materially advance the ultimate termination of the litigation.

Furthermore, Plaintiffs do not address, and therefore concede, that “certification is 

particularly appropriate in the context of MDL proceedings.” In re Cintas Corp. Overtime 

Pay Arbitration Litig., No. M06-CV-01781-SBA, 2007 WL 1302496, at *2 (N.D. Cal. 

May 2, 2007). Indeed, it is the “favored MDL” practice to certify dispositive rulings for 

immediate appeal, id., to avoid “the sort of piecemeal litigation that the multidistrict 

litigation scheme was intended to discourage.” In re Food Lion, Inc., Fair Labor 

Standards Act Effective Scheduling Litig., 73 F.3d 528, 532 (4th Cir. 1996) (“[P]ermitting 

the transferor courts (and, possibly, the Courts of Appeal[]) to reconsider the transferee 

court’s summary judgment orders will frustrate the aims of § 1407. The overriding 

purpose of the multidistrict procedure dictates that these claims be decided in the same 

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(404) 322-6000

appellate forum.”); In re Microsoft Corp. Antitrust Litig., 274 F. Supp. 2d 741, 743 (D. 

Md. 2003) (granting certification; finding it especially “relevant that this is an MDL 

proceeding”); see also Lovett v. Omni Hotels Mgmt. Corp., No. 14-CV-02844-RS, 2016 

WL 7732622, at *3 (N.D. Cal. Apr. 18, 2016) (certification inappropriate in relatively 

simple tort dispute as opposed to “a large, multi-district litigation, where immediate 

resolution of a legal issue will streamline protracted litigation.”).

Therefore, the Order satisfies all prerequisites for certification under 28 U.S.C. 

§ 1292(b), and is especially appropriate here in the context of this MDL.

IV. Conclusion.

For these reasons, Bard respectfully requests that this Court grant Bard’s Motion.

Respectfully submitted this 18th day of December, 2017.

s/Richard B. North, Jr.

Richard B. North, Jr.

Georgia Bar No. 545599

Matthew B. Lerner

Georgia Bar No. 446986

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

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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201 17t h Street NW, Suite 1700

Atlanta, GA 30363

(404) 322-6000

CERTIFICATE OF SERVICE

I hereby certify that on December 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 9401 Filed 12/18/17 Page 8 of 8