1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

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

PLAINTIFFS’ RESPONSE IN 

OPPOSITION TO DEFENDANTS’ 

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) 

Plaintiffs oppose Defendants’ C.R. Bard, Inc.’s and Bard Peripheral Vascular, Inc.’s 

(collectively “Bard’s”) Motion to Amend and Certify the Court’s November 22, 2017 

Order (“Motion”). In support of this Opposition, Plaintiffs submit the following 

Memorandum of Points and Authorities. 

MEMORANDUM OF POINTS AND AUTHORITIES 

Bard’s Motion to Amend and Certify the Court’s November 22, 2017 Order 

regarding preemption should be denied because Bard cannot meet all three certification 

requirements under 28 U.S.C. §1292(b). Bard attempts to re-package its original 

argument—for which it produced no supporting evidence— that this case was different 

from any other cases involving 510(k)-cleared products for which preemption was denied, 

Case 2:15-md-02641-DGC Document 9300 Filed 12/12/17 Page 1 of 10
2 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

that its products’ histories were different than other 510(k) reviewed devices, that 

Medtronic v. Lohr is now superseded1

, and that its products had received FDA review 

equivalent to the PMA process such that preemption should be applied despite Lohr’s 

holding. For the reasons set forth below, Bard’s Motion to Amend and Certify the Court’s 

November 22, 2017 Order should be denied. 

The Ninth Circuit has long held “[t]hat §1292(b) is to be applied sparingly and only 

in exceptional cases[.]” United States v. Woodbury, 263 F.2d 784, 788 (9th Cir. 1959); see 

also Villarreal v. Caremark LLC, 85 F. Supp. 3d 1063, 1067 (D. Ariz. 2015)(stating that 

Congress did not intend for the courts to abandon the final judgment doctrine and embrace 

the principle of piecemeal appeals). The party seeking interlocutory appeal bears the 

burden of demonstrating three criteria. Couch v. Telescope, Inc., 611 F.3d 629, 633 (9th 

Cir. 2010); Fukuda v. County of Los Angeles, 630 F. Supp. 228, 229 (C.D.Cal. 

1986)(stating that the moving party has the burden of showing exceptional circumstances 

justifying departure from the basic policy of postponing appellate review until final 

judgment). The three criteria are: (1) that there is a controlling question of law, (2) that 

there are substantial grounds for difference of opinion, and (3) that an immediate appeal 

may materially advance the ultimate termination of the litigation. In re Cement Antitrust 

Litig, 673 F.2d 1020, 1026 (9th Cir. 1982). 

 

1

 Bard argues that “Lohr only decided express preemption under the now-superseded 510(k) 

process in place in 1982.” Def. Reply Papers (Doc. 7828), at 16. This argument has been 

made to other courts with the same result this Court reached. Specifically, where other IVC 

filter defendants claim Lohr is superseded — that the SMDA 1990 materially changed 

medical device regulation and specifically increased the robustness of the 510(k) process 

by incorporating a safety and effectiveness review of each medical device undergoing 

510(k) review — the courts have met the argument with rulings that include doubt that the 

Supreme Court has changed its clear position on 510(k) review based on the SMDA. “In 

fact, any changes imposed by the SMDA, which had already been in place for six years at 

the time of the Lohr decision, were available to the Court in interpreting Congress’s intent 

for 510(k).” Hovey v. Cook Inc., 97 F.Supp.3d 836, 845-846 (S.D. W.Va. 2015)(finding that 

these arguments “do not persuade me to abandon the Supreme Court’s clear position on this 

matter.”); See also, In re: Cook Medical Inc., IVC Filters Marketing, Sales Practices and 

Product Liability Litigation MDL 2570, No. 1:14-ml-02570-RLY-TAB MDL No. 2570 

(S.D. Ind., Sep. 25, 2017); Horrillo v. Cook, Inc., 2014 WL 8186704 (S.D. Fla, Jun. 6, 

2014). 

Case 2:15-md-02641-DGC Document 9300 Filed 12/12/17 Page 2 of 10
3 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

These three requirements are jurisdictional. If the moving party cannot satisfy all 

three, the Ninth Circuit must reject a §1292(b) appeal even if the district court has certified 

it. Couch, 611 F.3d at 633. Even if the Court were to issue the requested certification, the 

Ninth Circuit nevertheless “has discretion to reject the interlocutory appeal, and does so 

quite frequently.” James v. Price Stern Sloan, Inc., 283 F.3d 1064, 1068 n.6 (9th Cir. 2002). 

In short, even if all three requirements are met, which clearly they are not, the Ninth Circuit 

may still choose not to exercise jurisdiction. Caterpillar Inc. v. Lewis, 519 U.S. 61, 74, n. 

10 (1996). 

The decision to deny certification for interlocutory appeal is committed to the sound 

discretion of the district court. Villarreal, 85 F. Supp. 3d at 1068. As such, even when a 

party seeking certification satisfies all three statutory criteria, “district court judges have 

‘unfettered discretion’ to deny certification.” Brizzee v. Fred Meyer Stores, Inc., 2008 WL 

426510, at *3 (D. Or. Feb. 13, 2008)(quoting Ryan, Beck & Co., LLC v. Fakih, 275 F. 

Supp. 2d 393, 396 (E.D.N.Y. 2003)). The sparing use of this exception and resulting 

appeals are “hen’s-teeth rare.” Hightower v. Schwarzenegger, 2009 WL 3756342, at *2 

(E.D. Cal. Nov. 6, 2009)(quoting Camacho v. Puerto Rico Ports Authority, 369 F.3d 570, 

573 (1st Cir.2004). Moreover, a district court’s decision whether to certify its order under 

28 U.S.C. § 1292(b) is unreviewable by the appellate court. Executive Software N. Am., 

Inc. v. United States Dist. Ct. for the Cent. Dist. of Cal., 24 F3d 1545, 1550 (9th Cir. 1994). 

On the rare occasion interlocutory appeals are heard and granted at the appellate 

level, it is because there are unique circumstances including a split in authority amongst 

the circuit courts and the district court’s challenged decision conflicts with the decisions of 

several other courts, which is inapposite to the circumstances here. In re Cintas Corp. 

Overtime Pay Arbitration Litig., 2007 WL 1302496, at *2 (N.D. Cal. May 2, 2007). Bard 

fails to show that the Court’s summary judgment Order regarding preemption created the 

exceptional circumstance in which an immediate appeal is appropriate, nor can Bard’s 

preemption argument satisfy the three criteria for certification for interlocutory appeal. 

Case 2:15-md-02641-DGC Document 9300 Filed 12/12/17 Page 3 of 10
4 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

A. Bard’s Alleged Controlling Question of Law Is One of Fact and Law, 

Not Pure Law 

Bard’s broad and sweeping contention that “federal preemption” is a question of 

pure law represents a startling about-face from its original motion for summary judgment. 

That motion framed preemption as a fact-dependent inquiry, purportedly necessitating two 

declarations and a statement of facts running to more than 800 paragraphs. Bard further 

insisted that the Court delve deeply into the regulatory history of Bard’s filters. Now, Bard 

takes the direct opposite position and presents preemption as a generalized legal question; 

one not of pure law. 

A controlling question of law means “a ‘pure question of law,’ not a mixed question 

of law and fact, or an application of law to a particular set of facts.” Brizzee, 2008 WL 

426510, at *4 (D. Or. Feb. 13, 2008)(citing Ahrenholz v. Bd. of Trs. of the Univ. of Illinois, 

219 F3d 674, 675–77 (7th Cir. 2000). The first criterion described as a controlling 

“question of law” does not mean applying settled law to fact as Bard attempts to do here. 

Simmons v. Akanno, 2011 WL 1566583, at *3 (E.D. Cal. Apr. 22, 2011) (citing Ahrenholz, 

219 F.3d 674, 676). Nor does it mean a question that would require “rooting through the 

record in search of the facts or of genuine issues of fact.” Id., at *3. 

Rather, what is contemplated under the §1292(b) exception is more of an abstract 

legal issue that might arise, i.e., a matter of pure law a court of appeals can resolve quickly 

and easily without having to study the record. See id. Some examples of controlling 

questions of pure law include fundamental issues like determining the proper parties, 

proper jurisdiction, or when state or federal law should apply. Woodbury, 263 F.2d at 787; 

Villarreal, 85 F. Supp. 3d at 1068; see also Heaton v. Soc. Fin., Inc., 2016 WL 232433 at 

*3 (N.D. Cal. Jan. 20, 2016). 

Under no circumstances should an appellate court have to “delve beyond the surface 

of the record” in order to examine facts. Hightower v. Schwarzenegger, 2009 WL 3756342, 

at *2 (E.D. Cal. Nov. 6, 2009)(quoting McFarlin v. Conseco Services, LLC, 381 F.3d 1251, 

1259 (11th Cir. 2004)). That is because the alleged controlling question must be a legal 

Case 2:15-md-02641-DGC Document 9300 Filed 12/12/17 Page 4 of 10
5 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

question and one that “must be stated at a high enough level of abstraction to lift the 

question out of the details of the evidence or facts.” McFarlin, 381 F.3d at 1259. The 

“antithesis of a proper §1292(b) appeal is one that turns on whether there is a genuine issue 

of material fact.” Id. 

The Supreme Court recognizes that the §1292(b) exception was created as a “safety 

valve for ‘serious legal questions taking the case out of the ordinary run.’” Estate of 

Kennedy v. Bell Helicopter Textron, Inc., 283 F.3d 1107, 1116 (9th Cir. 2002)(quoting 

Digital Equipment Corp. v. Desktop Direct, Inc., 511 U.S. 863, 883 (1994)). Bard cannot 

meet this criterion because it based its motion for summary judgement on what it contended 

was a uniquely detailed factual record of communications between itself and the FDA. 

Bard’s mantra from the first moment in seeking preemption of all Plaintiffs claims 

has been the uniqueness of the facts of the 510(k) review of its retrievable IVC filters, as 

demonstrated by its 239 exhibits underlying 818 statements of fact it presented to the Court 

in support of its Motion for Summary Judgment Regarding Preemption. It repeatedly 

insisted that the Court conduct a necessarily factually specific “careful comparison” of the 

regulatory history of Bard’s filters to decide Bard’s summary judgment motion. See, ECF. 

No. 5396, at 13-14; ECF No. 7828 (Bard’s facts allege that this case involves an elevated 

and exceptional level of FDA review imposing device-specific requirements.). In its 

current papers Bard again reiterates that its alleged unique factual record is what 

purportedly sets it apart from other preemption cases. Motion, at 4 (arguing that this case 

uniquely involves a “developed factual record, special controls, device-specific Guidance, 

history of down classification, and extensive regulatory review associated with Bard’s IVC 

filters”). Yet factual issues are not subject to interlocutory appeal. See e.g., Simmons, 2011 

WL 1566583, at *3 (stating “[t]he antithesis of a proper §1292(b) appeal is on that turns 

on whether there is a genuine issue of fact, or whether the district court properly applied 

settled law to the facts...”)(internal quotation and citation omitted); Hightower, 2009 WL 

3756342, at *2; Brizzee, 2008 WL 426510, at *4. 

Case 2:15-md-02641-DGC Document 9300 Filed 12/12/17 Page 5 of 10
6 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

Bard’s alleged controlling question of law would require the Ninth Circuit to delve 

into the massive record of evidence this Court has already reviewed in reaching its sound 

decision. This is exactly the extensive factual review and re-screening of factual support 

that renders the §1292 exception inapplicable. See Simmons, 2011 WL 1566583, at *3; 

Hightower, 2009 WL 3756342, at *3. Moreover, Bard seeks to have well-settled U.S. 

Supreme Court preemption case law re-applied to its factual record essentially seeking a 

re-interpretation of controlling case law directly contrary to its position. See, Simmons, 

2011 WL 1566583, at *3. Accordingly, Bard fails to articulate a controlling issue of pure 

law and fails the first criterion. 

B. Bard Has Not Identified Substantial Grounds For Difference of Opinion 

In determining whether to certify a decision for appeal, the district judge is to 

analyze the strength of the arguments in opposition to the challenged ruling to decide 

“whether the issue for appeal is truly one on which there is a substantial ground for 

dispute.” Barrer v. Chase Bank, USA, N.A., 2011 WL 1979718, at *4–5 (D. Or. May 18, 

2011)(denying motion to certify)(quoting In re Flor, 79 F.3d 281, 284 (2d Cir.1996)). An 

indicator of whether there are substantial grounds for disagreement on a question of law is 

that other courts have, in fact, disagreed. Couch, 611 F.3d at 633. A substantial ground for 

dispute exists where the challenged decision conflicts with the decisions of several other 

courts or where there is no controlling precedent in the jurisdiction. In re Cintas Corp. 

Overtime Pay Arbitration Litig., 2007 WL 1302496, at *2 (N.D. Cal. May 2, 2007) 

(granting certification, inter alia, because there was a clear split in the circuit courts). Bard 

must show a difference in legal opinion in order to show substantial grounds for a 

difference of opinion. Semeneck v. Ahlin, 2010 WL 2510996, at *3 (E.D. Cal. June 17, 

2010). Where the party seeking appeal cannot produce any law to the contrary, it cannot 

show substantial grounds for difference of opinion worthy of appeal. White v. Nix, 43 F.3d 

374, 378 (8th Cir. 1994). 

Case 2:15-md-02641-DGC Document 9300 Filed 12/12/17 Page 6 of 10
7 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

Nothing in the Court’s detailed and well-reasoned decision indicated any substantial 

grounds for dispute, or even that the decision presented a close call.2

 Bard seems to rely on 

the difference between its view and the Court’s as a basis for what it believes are substantial 

grounds for dispute which do not satisfy the second criterion. See Semeneck, 2010 WL 

2510996 at *3 (articulating that the difference of view between the challenging party and 

the challenged opinion is not a basis for a difference of opinion to satisfy the second 

criterion of a §1292(b) challenge); Hightower, 2009 WL 3756342 at *4 (stating that a 

party’s difference between his view and the court’s ruling does not give rise to substantial 

grounds for dispute under a §1292(b) appeal); Ass’n of Irritated Residents v. Fred Schakel 

Dairy, 634 F. Supp. 2d 1081, 1090-91 (E.D. Cal. 2008)(stating that disagreement with the 

Court’s ruling does not create a substantial ground for difference). 

Moreover, Bard fails to point to any split in the circuits or lack of precedent. Nor 

has Bard shown that the Court’s ruling is inconsistent with any reported decisions. That is 

because it is not; the Court followed United States Supreme Court precedent in Lohr3

 and 

Riegel.

4

 The only cases that are on point as to Bard’s preemption argument—that the 510(k) 

review process has allegedly changed since Lohr and purportedly now incorporates safety 

and effectiveness determinations—are three district court cases Horrillo, Hovey, and Cook. 

These three cases unanimously found that Lohr is the precedent for these sorts of express 

preemption challenges and that no such change in 510(k) review process has taken place; 

it is still based on substantial equivalence and still focused on the status quo. Consequently, 

this is not a situation where courts facing this argument have produced disparate rulings. 

The Court in its Order essentially agreed with the holdings in these cases; Lohr is not out 

dated. See, ECF No. 8872. 

 

2 See Simmons v. Akanno, 2011 WL 1566583, at *4 (E.D. Cal. Apr. 22, 2011)(considering 

a review of the challenged decision did not reveal substantial grounds for difference of 

opinion and neither did re-review); Hightower v. Schwarzenegger, 2009 WL 3756342, at 

*4 (E.D. Cal. Nov. 6, 2009)(same). 

3 Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). 4 Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). 

Case 2:15-md-02641-DGC Document 9300 Filed 12/12/17 Page 7 of 10
8 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

In what may be an attempt to point out some sort of split in the circuit courts, Bard 

repeatedly cites to dicta from a single circuit court opinion, Caplinger v. Medtronic, 784 

F.3d 1335 (10th Cir. 2015). But Caplinger does not support Bard’s position. First, 

Caplinger is inapplicable; it dealt with a PMA-approved medical device, not the 510(k) 

process. Yet even if Caplinger were on point, “just because counsel contends that one 

precedent rather than another is controlling does not mean there is such a substantial 

difference of opinion as will support an interlocutory appeal.” Couch, 611 F.3d at 633. A 

single, inapplicable case does not establish a split amongst the circuits, particularly where 

the Supreme Court has established the clear law be applied and other courts issuing 

opinions that are actually on point, including this Court, agree. 

Thus, Bard cannot satisfy the second criterion either. Rather than identify substantial 

grounds for disagreement, it has simply stated its own disagreement with the Court’s ruling 

and its assumption of what the Ninth Circuit wishes to hear. Neither is an acceptable basis 

to grant certification. 

C. Immediate Appeal Will Not Materially Advance the Ultimate 

Termination 

A party seeking interlocutory certification must show that an immediate appeal may 

“materially advance the ultimate termination of the litigation. In re Cement Antitrust Litig., 

673 F.2d at 1026. When litigation will continue in substantially the same manner regardless 

of a decision, an appeal cannot be said to materially advance the ultimate termination of 

the litigation. Hightower, 2009 WL 3756342, at *4–5 (citing White, 43 F.3d at 378–379). 

There is no guarantee an interlocutory appeal will be accepted because Bard would still 

have the burden to persuade the Ninth Circuit that exceptional circumstances justify a 

departure from the practice of postponing appellate review until after the entry of final 

judgment. Id. 

Under the second criterion, a district court judge must analyze the strength of the 

arguments in opposition to the challenged ruling. Barrer, 2011 WL 1979718, at *4–5. Part 

of the weakness in Bard’s argument regardless of its alleged uniqueness with regard to 

Case 2:15-md-02641-DGC Document 9300 Filed 12/12/17 Page 8 of 10
9 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

facts, special controls, regulatory history or anything else, is that under no previous 

circumstances has a design defect claim ever been preempted with regard to a 510(k)-

cleared product. Even in the early “menstrual tampon cases”5

 where failure to warn claims 

were preempted based on compliance with warning language promulgated by the FDA and 

found in a specific counterpart regulation, design defect claims were not preempted. Bard 

cites to no case law where a special control guidance document has ever preempted a failure 

to warn or design defect claim associated with a 510(k)-cleared medical device6

. Even if 

Degelmann7

 were still good law, there was no preemption with regard to product liability 

claims (as opposed to state consumer protection and false advertising claims), and it would 

provide no precedent to preempt the Plaintiffs failure to warn and design defect claims, as 

the Court recognized. See Order at 21. 

Additionally, Bard would have the Ninth Circuit compare the guidance document 

applicable to all IVC filters to the guidance document at issue in the now vacated 

Degelmann matter, a comparison that would require a deep dive into the factual record. 

This is a far cry from examining a pure question of law. As such, the litigation would not 

be terminated and would in fact soldier forward as currently scheduled. 

 

5

 This line of successful preemption challenges associated with 510(k) devices (menstrual 

tampons) with specific counterpart regulations promulgated by FDA (with verbatim, 

disease-specific warning language) only preempted failure to warn claims. Where the 

regulation was silent as to design or construction, design defect claims survived preemption 

challenges. Papike v. Tambrands Inc., 107 F.3d 737, 740-41 (9th Cir. 1997; see also, Moore 

v. Kimberly-Clarke, 867 F.2d 243, 246 (5th Cir. 1989). 6

 In its underlying motion Bard relied on Tuttle v. CIBA Vision Corp. 2007 WL 677134 (D. 

Utah 2007) in support of its argument that special control documents are federal 

requirements. Yet the Tuttle court provided no analysis of special controls. Instead it 

accepted the factual allegations that specificity of the guidance document and that the 

proposed warnings had been reviewed and accepted by the FDA as undisputed, and the 

design defect claims were not preempted but rather dismissed for lack of appropriate 

evidence. Tuttle, 2007 WL 677134 at *1-22 (emphasis added). 7 Degelmann v. Advanced Med. Optics, Inc., 659 F.3d 835, 838–39 (9th Cir. 2011), vacated, 699 F.3d 1103 (9th Cir. 2012). 

Case 2:15-md-02641-DGC Document 9300 Filed 12/12/17 Page 9 of 10
10 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

RESPECTFULLY SUBMITTED this 12th day of December, 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 12th day of December, 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 

6340602 

Case 2:15-md-02641-DGC Document 9300 Filed 12/12/17 Page 10 of 10