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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 

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 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)

Defendants C. R. Bard, Inc. and Bard Peripheral Vascular, Inc. (collectively 

“Bard”) respectfully move this Court to amend its November 22, 2017, Summary 

Judgment Order (Doc. 8872) (the “Order”) to certify it for interlocutory appeal pursuant to 

28 U.S.C. § 1292(b). In support of this Motion, Bard submits the following Memorandum 

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of Points and Authorities: 

MEMORANDUM OF POINTS AND AUTHORITIES 

I. Interlocutory Appeal From the Order Is Appropriate Under 28 U.S.C. 

§ 1292(b). 

 A district court may certify an order for interlocutory appeal under 28 U.S.C. 

§ 1292(b) when the order: (1) “involves a controlling question of law” (2) “as to which 

there is a substantial ground for difference of opinion,” and (3) “an immediate appeal 

from the order may materially advance the ultimate termination of the litigation.” Id.; see 

also In re Cement Antitrust Litig., 673 F.2d 1020, 1026 (9th Cir. 1982). Bard respectfully 

requests certification here because the Court’s Order satisfies all three prerequisites. 

A. The Order Involves a Controlling Question of Law.

Under Section 1292(b), “all that must be shown in order for a question to be 

‘controlling’ is that resolution of the issue on appeal could materially affect the outcome 

of litigation in the district court.” In re Cement Antitrust Litig., 673 F.2d at 1026. 

“[Federal] preemption, by its very nature, lends itself to interlocutory appeals” and is 

“undoubtedly a controlling question of law.” Knipe v. SmithKline Beecham, 583 F. 

Supp. 2d 553, 599 (E.D. Pa. 2008) (granting interlocutory appeal under § 1292(b) on 

question of federal preemption of state-law claims under Food, Drug, and Cosmetic Act 

(“FDCA”) involving pharmaceutical product); see also, e.g., Harris By & Through 

Harris v. Ford Motor Co., 110 F.3d 1410, 1411–12 (9th Cir. 1997) (hearing interlocutory 

appeal under § 1292(b) regarding whether National Traffic and Motor Vehicle Safety Act 

preempted state tort law); 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) (certifying order 

for appeal on federal preemption issue); Brown v. Hain Celestial Grp., Inc., No. C 11-

03082 LB, 2012 WL 4364588, at *3 (N.D. Cal. Sept. 24, 2012) (same); Deming v. First 

Franklin, No. 09-5418RJB, 2010 WL 2326170, at *1 (W.D. Wash. June 7, 2010) (same); 

Helman v. Alcoa Glob. Fasteners Inc., No. CV09-1353 SVW (FFMX), 2009 WL 

2058541, at **5–7 (C.D. Cal. June 16, 2009) (same); Pac. Merch. Shipping Ass’n v. 

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Goldstene, No. 2:09-CV-01151MCEEFB, 2009 WL 2777778, at *8 (E.D. Cal. Aug. 28, 

2009) (same); Wells Fargo Bank v. Bourns, Inc., 860 F. Supp. 709, 717 (N.D. Cal. 1994) 

(same).

If the Ninth Circuit were to disagree with this Court’s conclusion that Plaintiff’s 

claims are not expressly preempted by the Medical Device Amendments of 1976 (the 

“MDA”), 21 U.S.C. § 360 et seq., nor impliedly preempted by the MDA under the 

Supreme Court’s conflict preemption principles, then Plaintiffs’ state-law claims could 

not go forward. Nutrishare, Inc., 2014 WL 2624981, at *3 (citing In re Cement Antitrust 

Litig., 673 F.2d at 1026) (“Whether CIGNA can even bring its state law claims is certainly 

a controlling question of law. If the Ninth Circuit finds the claims preempted, the 

decision would ‘materially affect the outcome of the litigation.’ Such a finding would 

also materially advance the ultimate resolution of the litigation, as it could eliminate the 

causes of action and obviate any need for the Court to address them.”). The outcome of 

this litigation will be significantly and materially affected if the question of federal 

preemption is decided in Bard’s favor. Therefore, the Order involves a controlling 

question of law appropriate for interlocutory appeal.1

B. Substantial Grounds For Difference of Opinion Exist Regarding the 

Question of Law Presented.

To be certified under § 1292(b), this Court “must examine to what extent the 

controlling law is unclear.” Couch v. Telescope Inc., 611 F.3d 629, 633 (9th Cir. 2010). 

“Courts traditionally will find that a substantial ground for difference of opinion exists 

where the circuits are in dispute on the question and the court of appeals of the circuit has 

not spoken on the point . . . or if novel and difficult questions of first impression are 

presented.” Id. (citations and quotations omitted). While “the mere presence of a 

disputed issue that is a question of first impression, standing alone, is insufficient,” id. at 

634, “[a] substantial ground for difference of opinion exists . . . when novel legal issues 

1

 “Furthermore, because this is a ‘pure legal question’ involving no factual issues, an 

interlocutory appeal is especially appropriate.” Helman, 2009 WL 2058541, at *5. 

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

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). 

The controlling law on federal preemption of 510(k)-cleared devices is unclear. As 

Justice Neil Gorsuch recently commented before his elevation to the Supreme Court, 

“[t]he Supreme Court has issued a number of opinions that embody ‘divergent views’ 

about the proper role of the MDA’s preemption provision, a fact that has yielded 

considerable ‘uncertainty’ among the lower courts.” Caplinger v. Medtronic, Inc., 784 

F.3d 1335, 1337 (10th Cir. 2015). For preemption to exist, “a device must undergo the 

premarket approval process—or, the [Supreme] Court suggested, perhaps something like 

it.” Id. at 1339. While “the Court acknowledged the possibility that ‘general’ federal 

requirements might sometimes preempt state requirements,” the Supreme Court’s 

preemption cases provide little guidance regarding “when and what kinds of ‘general 

requirements’ have preemptive effect, or what sort of device-specific regulations beyond 

the premarket approval process might bear that same power.” Id. Because of this 

uncertainty in the controlling law, Justice Gorsuch suggested that “perhaps some of those 

rules warrant revisiting and reconciliation.” Id. at 1340. This case offers the opportunity 

to do just that. 

Moreover, the Order involves novel and difficult questions of first impression “on 

which fair-minded jurists might reach contradictory conclusions.” Reese, 643 F.3d at 688. 

No court, including the Ninth Circuit, has addressed preemption where a 510(k)-cleared 

device has the kind of developed factual record, special controls, device-specific 

Guidance, history of down classification, and extensive regulatory review associated with 

Bard’s IVC filters. As this Court recognized, however, before the opinion was vacated, 

the Ninth Circuit in Degelmann held an FDA Guidance “document containing the special 

controls for lens solution” to be a specific requirement that preempted the plaintiffs’ statelaw claims. Degelmann v. Advanced Med. Optics, Inc., 659 F.3d 835, 841-42 (9th Cir. 

2011), vacated, 699 F.3d 1103 (9th Cir. 2012). This was true even though the Ninth 

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Circuit recognized that the Guidance document explicitly permitted alternative approaches 

to satisfying the requirements. Id. at 842; see also Papike v. Tambrands Inc., 107 F.3d 

737, 741 (9th Cir. 1997) (device-specific regulation preemptive). Therefore, “[i]t is not 

inconceivable that the Ninth Circuit could conclude that this Court applied an overly” 

restrictive view of federal preemption when it denied Defendants’ motion for summary 

judgment. Cal Pure Pistachios, Inc. v. Primex Farms, LLC, No. CV 09-7874-GW(RCX), 

2010 WL 11523707, at *2 (C.D. Cal. Apr. 29, 2010) (granting certification on issue of 

whether Lanham Act, which provided foundation for Plaintiff’s state-law claims, applied).

Although this Court found Papike and Degelmann to be distinguishable, Bard 

respectfully submits that substantial grounds for difference of opinion exist because the 

fair-minded jurists of the Ninth Circuit might reach a different conclusion. See, e.g.,

Reese, 643 F.3d at 688; Knipe, 583 F. Supp. 2d at 600 (finding substantial grounds for 

difference of opinion where “preemption decision involve[d] a rather novel question of 

law, which the Third Circuit ha[d] not yet had the opportunity to address,” especially 

where particular question at issue generated but a single judicial opinion finding 

preemption based on “highly distinguishable facts”). 

This case will provide an opportunity for the Ninth Circuit to revisit its vacated 

reasoning in Degelmann on the novel issue of the preemptive effect of “special controls” 

such as a Guidance document, as well as to address whether the FDA can and has 

imposed the sort of device-specific requirements beyond regulations and “beyond the 

premarket approval process [that] might bear that same [preemptive] power.” Caplinger, 

784 F.3d at 1339. That is, whether FDA’s regulatory review of Bard’s IVC Filters 

approached the “something like” premarket approval review that is entitled to 

“preemptive effect.” Id. 

Accordingly, there exists substantial grounds for difference of opinion regarding 

the difficult questions of whether Plaintiffs’ state law claims are expressly or impliedly 

preempted. Thus, these issues should be fully presented to, and decided by, the Ninth 

Circuit. 

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C. Immediate Appeal From the Order Will Materially Advance the Ultimate 

Termination of This Litigation.

A district court should certify an order for immediate appeal when there is “‘a 

highly debatable question that is easily separated from the rest of the case, that offers an 

opportunity to terminate the litigation completely, and that may spare the parties the 

burden of a trial that is expensive for them even if not for the judicial system.’” Helman, 

2009 WL 2058541, at *6 (quoting Wright, Miller, & Cooper, Federal Practice and 

Procedure Jurisdiction 2D § 3930, at 436 (1996)). The question of whether Plaintiffs’ state 

law claims are preempted (expressly or impliedly) is easily separated from the rest of the 

case as evidenced by the fact that this Court ordered dispositive briefing on the issue 

separate from the dispositive briefing specific to the individual bellwether cases. 

Moreover, allowing an interlocutory appeal on this question might “avoid 

protracted and expensive litigation,” In re Cement Antitrust Litig., 673 F.2d at 1026, 

because a determination that federal preemption does apply would eliminate Plaintiffs’ 

state law claims “and obviate any need for the Court to address them.” Nutrishare, Inc., 

2014 WL 2624981, at *3; Brown, 2012 WL 4364588, at *4 (“[I]nterlocutory appeal could 

materially advance termination of the litigation” where “successful appeal” on preemption 

could “result in dismissal of all of Plaintiff’s claims”). Indeed, such a determination could 

completely terminate the litigation of the 3,000 personal injury cases remaining in this 

MDL. See, e.g., In re Fosamax Prod. Liab. Litig., No. 06 CIV. 9455 JFK, 2011 WL 

2566074, at *10 (S.D.N.Y. June 29, 2011) (certifying order where immediate appeal “will 

materially advance termination of this [bellwether] case, as well as the Fosamax MDL”); 

see also In re Michaels Stores, Inc., Wage & Hour Employment Practices Litig., 

No. MDL 14-2531-GW(AGRX), 2014 WL 12604981, at *3 (C.D. Cal. Sept. 15, 2014). 

Furthermore, “[c]ertification is particularly appropriate in the context of MDL 

proceedings,” as a “prompt appeal now will allow a single court to review the 

[dispositive] issue presented, thus ‘enhancing the likelihood of achieving the coordination 

benefits sought by 28 U.S.C. § 1407 (the ‘just and efficient conduct’ of multidistrict 

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actions), as the circuit of the § 1407 transferee court can give the issues a unified 

treatment.’” In re Cintas Corp. Overtime Pay Arbitration Litig., No. M06-CV-01781-

SBA, 2007 WL 1302496, at *2 (N.D. Cal. May 2, 2007) (quoting Hill v. Henderson, 195 

F.3d 671, 678 (D.C. Cir. 1999)). 

Denying certification “would needlessly multiply this litigation, at extraordinary 

expense to the parties and the court system” by requiring Bard to appeal 3,000 “separate 

cases in 11 courts of appeals simply to obtain review of the MDL Court’s single order 

covering each of the consolidated cases.” Id. at *3. Such a denial “would undermine the 

very purposes of the MDL proceeding that brought the cases together before this Court. 

However, if this Court certifies the order for interlocutory appeal and the Ninth Circuit 

accepts the appeal, the Ninth Circuit’s ruling will be law of the case in these MDL 

proceedings.” Id. (following “the favored MDL practice and certif[ying] its order for 

interlocutory appeal” in MDL litigation); Hill, 195 F.3d at 677 (“[T]he practice has 

favored certification by the transferee court of potentially outcome determinative rulings 

for immediate, consolidated appeal under 28 U.S.C. § 1292(b).”); In re Korean Air Lines 

Disaster of September 1, 1983, 829 F.2d 1171, 1180 (D.C. Cir. 1987) (en banc) 

(Ginsburg, J., concurring) (“A series of inconsistent appellate judgments is not a desirable 

outcome, however, particularly since the result in some cases might be to require renewed 

pretrial or trial proceedings. This whole course of case development, starting with 

divergent paths of appeal and ending with either conflicting or duplicative results, would 

clearly frustrate the primary goals of section 1407 (a) ‘to promote the just and efficient 

conduct’ of multi-district actions.”), aff’d sub nom. Chan v. Korean Air Lines, Ltd., 490 

U.S. 122 (1989). 

Therefore, the Order satisfies the third requirement under 28 U.S.C. § 1292(b). 

II. Interlocutory Appeal Will Not Stay the Proceedings and Will Not Delay the 

Litigation. 

To be clear, Bard does not seek a stay of the underlying proceedings, nor is one 

required under 28 U.S.C. § 1292(b). Id. (“[A]pplication for an appeal hereunder shall not 

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stay proceedings in the district court unless the district judge or the Court of Appeals or a 

judge thereof shall so order.”); see also Plotkin v. Pac. Tel. & Tel. Co., 688 F.2d 1291, 

1293 (9th Cir. 1982) (citations omitted) (“[A]n appeal from an interlocutory order does 

not stay the proceedings, as it is firmly established that an appeal from an interlocutory 

order does not divest the trial court of jurisdiction to continue with other phases of the 

case.”). Furthermore, Bard’s counsel does not anticipate that an interlocutory appeal 

would delay or otherwise impede this Court’s ability to conduct the bellwether trials or 

otherwise manage the MDL pending the outcome of such an appeal. 

III. Conclusion. 

For these reasons, Bard respectfully requests that this Court amend and certify its 

November 22, 2017, Summary Judgment Order (Doc. 8872) for interlocutory appeal 

pursuant to 28 U.S.C. § 1292(b) by including the following language: 

The Court is of the opinion that this Order involves a controlling question of 

law as to which there is substantial ground for difference of opinion and that 

an immediate appeal from this Order as authorized by 28 U.S.C. § 1292(b) 

may materially advance the ultimate termination of this litigation. 

Respectfully submitted this 8th 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 

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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 on December 8, 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. 

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