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WO

IN THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF ARIZONA 

IN RE: Bard IVC Filters Products Liability 

Litigation, 

No. MDL 15-02641-PHX DGC 

ORDER 

This multidistrict litigation (“MDL”) involves more than 3,000 personal injury 

cases brought against Defendants C. R. Bard, Inc. and Bard Peripheral Vascular, Inc. 

(collectively, “Bard”). Bard manufactures and markets medical devices, including 

inferior vena cava (“IVC”) filters. Each Plaintiff received a Bard IVC filter implant and 

claims that the filter is defective and has caused Plaintiff to suffer serious injury or death. 

Plaintiffs assert various state law claims and seek both compensatory and punitive 

damages. 

In this motion, Bard seeks summary judgment on the ground that Plaintiffs’ state 

claims are expressly preempted by the Medical Device Amendments of 1976 (“MDA”), 

21 U.S.C. § 360 et seq., and impliedly preempted by the MDA under the Supreme 

Court’s conflict preemption principles. Doc. 5396. The motion is fully briefed, and the 

Court heard oral arguments on November 17, 2017. The Court will deny Bard’s motion. 

I. Background.

 The Court will begin by describing IVC filters and their uses, the history of the 

MDA, the relevant regulatory process, and the claims asserted by Plaintiffs. 

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A. IVC Filters. 

 The IVC is a large vein that carries de-oxygenated blood from the lower body to 

the heart. IVC filters are small metal devices implanted in the upper portion of the IVC 

to stop blood clots from travelling to the heart and lungs. Blood clots often develop in 

the legs from a condition called deep vein thrombosis or “DVT.” Once blood clots reach 

the lungs, they are deemed pulmonary emboli or “PE.” Pulmonary emboli and other 

thromboembolic events, such as strokes, can cause serious injury or death. 

 People at risk for DVT and PE may be prescribed blood thinners such as Heparin 

or Warfarin to help prevent blood clots. But these medications do not prevent blood 

clotting for certain people at high risk for DVT or PE, and blood thinners may not be an 

option for bariatric and trauma patients who could experience thromboembolic events 

during surgery. In those situations, physicians may recommend implanting an IVC filter 

to catch any blood clots before they reach a vital organ. 

 IVC filters originally were designed to be implanted permanently. Because some 

patients need only temporary filters, however, medical device manufacturers such as 

Bard developed retrievable filters. Bard first obtained Food and Drug Administration 

(“FDA”) clearance to market a retrievable IVC filter in 2003. Seven different versions of 

Bard filters are at issue in this MDL – the Recovery, G2, G2 Express, G2X, Eclipse, 

Meridian, and Denali. They are spider-shaped devices with multiple struts fanning out 

from a cone-shaped head. The struts consist of legs with hooks that attach to the IVC 

wall, and shorter curved arms that serve to catch or break up blood clots. Each of these 

filters is a variation of its predecessor. The last-generation Denali filter received FDA 

clearance in May 2013. The filters are designed to be retrievable using Bard’s Recovery 

Cone Removal System. 

B. History of the MDA. 

 Throughout our history, states have exercised police powers to protect the health 

and safety of their residents. The federal government first entered this field more than a 

century ago with passage of the Food and Drug Act of 1906, 34 Stat. 768, which 

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prohibited the manufacture of adulterated or misbranded food and drugs. Congress 

broadened the coverage of the statute to include misbranded or adulterated cosmetics 

and medical devices in the Food, Drug, and Cosmetic Act of 1938 (“FDCA”), 52 Stat. 

1040, as amended, 21 U.S.C. § 301 et seq. 

 The FDCA required premarket approval for new drugs, but not new medical 

devices. As technology advanced and reliance on medical devices grew, policymakers 

and the public became concerned about the increasing number of injuries resulting from 

device failures. Notable in this regard were injuries women suffered from the Dalkon 

Shield contraceptive device in the 1960s and early 1970s. Other devices, including 

catheters, artificial heart valves, and pacemakers, also created possible health risks. 

Several states responded with regulatory measures, such as California’s 1970 law 

requiring premarket approval of medical devices. 1970 Cal. Stats. ch. 1573, §§ 26670-

26693. 

 In 1976, Congress passed the MDA “to provide for the safety and effectiveness of 

medical device[s] intended for human use[.]” Pub. L. No. 94-295, 90 Stat. 539 (1976). 

The MDA extends coverage of the FDCA to medical devices through federal oversight 

measures implemented by the FDA. It also curtails state regulation of medical devices 

through a provision that preempts state requirements that differ from or add to federal 

requirements. 21 U.S.C. § 360k.

C. FDA Regulatory Process.

 The MDA gives the FDA broad powers to classify and regulate medical devices. 

The FDA assigns medical devices to Class I, Class II, or Class III based on their risk 

levels. Class I devices, which include products such as bandages and tongue depressors, 

are low-risk and subject to oversight only through “general controls” such as labeling 

requirements. 21 U.S.C. § 360c(a)(1)(A). Class II devices pose moderate health risks. 

The original MDA definition of a Class II device identified performance standards as the 

means by which the FDA could reasonably ensure safety and effectiveness. The Safe 

Medical Devices Act of 1990 (“SMDA”), Pub. L. 101-629, added various “special 

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controls” for this purpose. The special controls may include FDA guidance documents, 

premarket data requirements, performance standards, postmarket surveillance measures, 

and patient registries. 21 U.S.C. § 360c(a)(1)(B). Class III includes devices used to 

support human life, such as pacemakers and hearts valves, and devices that pose a high 

risk of injury. 21 U.S.C. § 360c(a)(1)(C). They receive the highest level of regulatory 

control.1

 IVC filters originally were designated as Class III devices, but were moved to 

Class II, along with many other pre-MDA devices, in 2000. See 65 Fed. Reg. 17138, 

17144 (Mar. 31, 2000); 21 C.F.R. § 870.3375. 

 The FDA applies different levels of scrutiny to medical devices before approving 

or clearing them for market, and the level of scrutiny can affect whether state laws are 

preempted. The most rigorous level of scrutiny is known as “premarket approval,” often 

referred to as the “PMA process.” 21 U.S.C. § 360e(a). To comply, a manufacturer must 

file an application that provides a wide range of detailed information to the FDA in order 

to demonstrate that the device is safe and effective. See 21 U.S.C. § 360e(c). If the FDA 

finds the device safe and effective, it approves the device for marketing.2

 Others medical devices can be cleared for market through a less rigorous process 

known as section “510(k)” review after the original statutory provision describing the 

review. A manufacture can satisfy this level of review, and be exempt from the PMA 

process, by providing premarket notice to the FDA that its device is “substantially 

equivalent” to a predicate device already on the market.3

 § 360c(f)(1)(A). This 510(k) 

 

1 See generally FDA Medical Devices, Regulatory Controls (last updated June 26, 2014), available at https://www.fda.gov/ MedicalDevices/DeviceRegulationandGuidance /Overview/GeneralandSpecialControls/default.htm (last visited Nov. 17, 2017). 

2 See generally FDA Medical Devices, Device Advice: Comprehensive Regulatory 

Assistance (last updated Sept. 29, 2017), available at https://www.fda.gov/Medical Devices/DeviceRegulationandGuidance/ (last visited Nov. 17, 2017). 

3

 A “predicate device” is one that (1) was legally marketed before passage of the MDA and no PMA process was required, (2) has been reclassified from Class III to Class 

II or I, or (3) has been found to be a substantially equivalent device through 510(k) review. 21 C.F.R § 807.92(a)(3). A device is “substantially equivalent” to a predicate device where it has the same intended use and (1) has “the same technological characteristics as the predicate device,” or (2) any technological differences “do not raise different questions of safety and effectiveness than the predicate device.” 

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review is more streamlined than the PMA process and focuses primarily on equivalence 

rather than safety and effectiveness. If a 510(k) notice results in an FDA finding of 

substantial equivalence, the device is cleared for marketing. 

 The FDA maintains a bright line between devices “approved” through the PMA 

process and devices “cleared” through 510(k) review. PMA approval results in a finding 

of safety and effectiveness, while 510(k) clearance results only in a finding of substantial 

equivalence. FDA regulations require manufacturers to maintain this distinction: 

Submission of a [510(k) notice] in accordance with this subpart, and a 

subsequent determination by the Commissioner that the device intended for 

introduction into commercial distribution is substantially equivalent to a 

device in commercial distribution . . . does not in any way denote official 

approval of the device. Any representation that creates an impression of 

official approval of a device because of complying with [510(k) 

notification] is misleading and constitutes misbranding. 

21 C.F.R § 807.97. 

 The Bard IVC filters at issue in this case, like most medical devices on the market 

today, received FDA clearance through 510(k) review. Each Bard filter was deemed to 

be substantially equivalent to a predicate filter already on the market. No Bard filter has 

received FDA approval through the PMA process.

D. Plaintiffs’ Claims. 

 Plaintiffs allege that Bard IVC filters are defective. Plaintiffs contend that the 

filters tilt, perforate the IVC, and fracture and migrate to neighboring organs such as the 

heart and lungs. Plaintiffs claim that Bard filters are more dangerous than other kinds of 

IVC filters, and that Bard concealed adverse information and otherwise failed to warn the 

medical community and the public about the risks posed by its filters. Bard vigorously 

disputes Plaintiffs’ allegations of high risk levels, contending that overall complication 

rates associated with Bard filters are low and comparable to those of other IVC filters. 

 § 360c(i)(1)(A); see 21 C.F.R. § 807.100(b) (describing criteria the FDA uses in its substantial equivalence review). 

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 Plaintiffs’ master complaint asserts 17 causes of action under various state laws: 

strict product liability claims for manufacturing, information, and design defects (Counts 

I-III); negligence claims for design, manufacturing, failure to recall or retrofit, failure to 

warn, misrepresentation, and per se negligence (Counts IV-IX); breach of warranties 

(Counts X-XI); fraudulent misrepresentation and concealment (Counts XII-XIII); 

consumer fraud and unfair trade practices (Count XIV); loss of consortium (Count XV); 

wrongful death (Count XVI); and survival claims (Count XVII). Doc. 303-1.4

 Bard seeks summary judgment on each cause of action, arguing that the MDA 

preempts them all. Doc. 5396 at 14-34.5 For reasons explained below, the Court finds 

that Bard has not met its burden of establishing preemption and therefore will deny 

summary judgment. 

II. Summary Judgment Standard.

 A party seeking summary judgment “bears the initial responsibility of informing 

the district court of the basis for its motion, and identifying those portions of [the record] 

which it believes demonstrate the absence of a genuine issue of material fact.” Celotex 

Corp. v. Catrett, 477 U.S. 317, 323 (1986). Summary judgment is appropriate if the 

moving party shows that there is no genuine dispute as to any material fact and the 

movant is entitled to judgment as a matter of law. Fed. R. Civ. P. 56(a). Only disputes 

over facts that might affect the outcome of the suit will preclude summary judgment, and 

the disputed evidence must be “such that a reasonable jury could return a verdict for the 

nonmoving party.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). The 

evidence of the nonmoving party is to be believed, and all reasonable inferences are to be 

 

4

 The master complaint is the operative pleading for most of the cases in this MDL. It was created for the sake of convenience and serves as a long-form complaint giving notice, pursuant to Rule 8, of the allegations that Plaintiffs assert in this case. 

Plaintiff -specific allegations are contained in individual short-form complaints or certain complaints served on Bard before the filing of the master complaint. See Doc. 249. 

Plaintiffs also provide Bard with fact sheets that describe their individual conditions and 

claims. See Doc. 365. 

5

 Page citations are to numbers placed at the top of each page by the Court’s electronic filing system rather than the document’s original page numbers. 

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drawn in that party’s favor, because the weighing of evidence and drawing of inferences 

are jury functions. Id. at 255. 

III. Basic Preemption Principles.

 “When a transferee court receives a case from the MDL Panel, the transferee court 

applies the law of the circuit in which it is located to issues of federal law.” In re Gen. 

Am. Life Ins. Co. Sales Practices Litig., 391 F.3d 907, 911 (8th Cir. 2004). In this case, 

that would be the law of the Ninth Circuit. Thus, in performing its federal preemption 

analysis, the Court will look primarily to Supreme Court and Ninth Circuit cases. 

 “The Supremacy Clause provides a clear rule that federal law ‘shall be the 

supreme Law of the Land; and the Judges in every State shall be bound thereby, anything 

in the Constitution or Laws of any State to the Contrary notwithstanding.’” Arizona v. 

United States, 567 U.S. 387, 399 (2012) (quoting U.S. Const. art. VI, cl. 2). Under this 

clause, “Congress has the power to preempt state law.” Crosby v. Nat’l Foreign Trade 

Council, 530 U.S. 363, 372, (2000). 

 “‘[T]he purpose of Congress is the ultimate touchstone’” in determining whether 

Congress has preempted a state law. Cipollone v. Liggett Grp., Inc., 505 U.S. 504, 516 

(1992) (quoting Malone v. White Motor Corp., 435 U.S. 497, 504 (1978)). Federal 

preemption may be either express or implied. Attay v. Cty. of Maui, 842 F.3d 688, 699 

(9th Cir. 2016). Where there is no express congressional command, a state law is 

impliedly preempted if “it actually conflicts with federal law[.]” Id. (citing Cipollone, 

505 U.S. at 516). Conflict preemption occurs “where compliance with both federal and 

state regulations is a physical impossibility[.]” Arizona, 567 U.S. at 399 (internal 

citations and quotation marks omitted). 

 “Where the intent of a statutory provision that speaks expressly to the question of 

preemption is at issue, ‘[courts] do not invoke any presumption against pre-emption but 

instead focus on the plain wording of the clause, which necessarily contains the best 

evidence of Congress’ pre-emptive intent.’” Attay, 842 F.3d at 699 (quoting Puerto Rico 

v. Franklin Cal. Tax-Free Trust, ––– U.S. –––, 136 S. Ct. 1938, 1946 (2016)). Where 

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there is no express preemption and a federal statute regulates in an area “traditionally 

occupied by states, such as health, safety, and land use, a ‘presumption against 

preemption’ adheres.” Gobeille v. Liberty Mut. Ins. Co., –– U.S. –––, 136 S. Ct 936, 946 

(2016) (quoting Wyeth v. Levine, 555 U.S. 555, 565 n.3 (2009)). 

 The Court first will discuss express preemption under § 360k of the MDA, and 

then turn to implied preemption. 

IV. Express Preemption. 

Section 360k of the MDA includes this express preemption clause: 

Except as provided in subsection (b) of this section, no State or political 

subdivision of a State may establish or continue in effect with respect to a 

device intended for human use any requirement-- 

(1) which is different from, or in addition to, any requirement applicable 

under this chapter to the device, and 

(2) which relates to the safety or effectiveness of the device or to any other 

matter included in a requirement applicable to the device under this chapter. 

21 U.S.C. § 360k(a). The Supreme Court has held that this clause applies when (1) the 

federal government has established “requirements” applicable to the device in question, 

and (2) state law claims are based on state requirements that are different from, or in 

addition to, the federal requirements, and that relate to safety and effectiveness. Riegel v. 

Medtronic, Inc., 552 U.S. 312, 321-22 (2008). Consistent with this guidance, the Court 

first will determine whether the FDA’s 510(k) review established federal “requirements” 

for the Bard IVC filters, and then whether Plaintiffs’ state law claims would impose 

“requirements” different from, or in addition to, any federal requirements. 

A. Federal Requirements. 

 1. Supreme Court Precedent. 

The Supreme Court has interpreted § 360k in two cases, Riegel and Medtronic, 

Inc. v. Lohr, 518 U.S. 470 (1996).6

 Lohr involved a pacemaker that was cleared by the 

 

6

 The Supreme Court addressed implied preemption under the MDA in Buckman 

Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), but declined to express a view on whether the state claims were expressly preempted under § 360k. Id. at 348 n.2. 

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FDA in 1982 through 510(k) review. The plaintiff, who suffered injuries when her 

pacemaker failed, brought state common law claims for negligence and strict liability 

against the manufacturer, Medtronic. The majority opinion in Lohr held that § 360k does 

not preempt state law claims directed at medical devices cleared through the 510(k) 

process because the substantial equivalence review of that process places no federal 

requirements on a device. 518 U.S. at 492-94; see Riegel, 552 U.S. at 322-23. 

 Central to the holding in Lohr was the Supreme Court’s finding that “[t]he 

§ 510(k) notification process is by no means comparable to the PMA process[.]” 518 

U.S. at 478-79. Lohr noted that the PMA process is a “rigorous” examination of the 

product in question that takes an average of 1,200 hours to complete, while “the 510(k) 

review is completed in an average of only 20 hours.” Id. at 477-79. Lohr noted that the 

“510(k) process is focused on equivalence, not safety[.]” Id. at 493 (emphasis in original; 

citation and quotation marks omitted). Lohr concluded that the FDA’s 510(k) review 

“did not ‘require’ Medtronics’ pacemaker to take any particular form for any particular 

reason; the agency simply allowed the pacemaker, as a device substantially equivalent to 

one that existed before 1976, to be marketed without running the gauntlet of the PMA 

process.” Id. at 493-94. 

Riegel involved a cardiovascular catheter approved by the FDA through the PMA 

process. Riegel did not disagree with Lohr’s conclusion that 510(k) review imposes no 

federal requirements on manufacturers, but held that the more rigorous PMA process 

does impose such requirements. 552 U.S. at 322. Riegel disagreed with Lohr’s view of 

state law claims and held that such claims can impose requirements within the meaning 

of § 360k. Id. at 322-24. Because the common law tort claims asserted in Riegel would 

impose requirements different from federal requirements established through the PMA 

process, Riegel found the plaintiffs’ state law tort claims preempted by § 360k. Id.

at 323-25. 

Riegel was decided nearly 20 years after passage of the SMDA and the start of 

FDA’s use of “special controls” during 510(k) review, and yet the Supreme Court still 

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found that 510(k) review was not close to the PMA process. Riegel described the PMA 

process in detail and held that it imposes federal “requirements” within the meaning of 

§ 360k. In doing so, Riegel distinguished 510(k) review: 

Premarket approval, in contrast [to 510(k) clearance], imposes 

“requirements” under the MDA as we interpreted it in Lohr. Unlike 

general labeling duties, premarket approval is specific to individual 

devices. And it is in no sense an exemption from federal safety review—

it is federal safety review. Thus, the attributes that Lohr found lacking in 

510(k) review are present here. 

552 U.S. at 322-23 (emphasis in original). 

Riegel explicitly addressed, and did not disagree with, Lohr’s finding that 510(k) 

review imposes no device-specific requirements on manufacturers: 

Even though substantial-equivalence review under 510(k) is device 

specific, Lohr also rejected the manufacturer’s contention that 510(k) 

approval imposed device-specific “requirements.” We regarded the fact 

that products entering the market through 510(k) may be marketed only so 

long as they remain substantial equivalents of the relevant 1976 devices as 

a qualification for an exemption rather than a requirement. 

552 U.S. at 322. 

 The Ninth Circuit likewise has recognized significant differences between 510(k) 

review and the PMA process. In Perez v. Nidek Co., 711 F.3d 1109 (9th Cir. 2013), the 

circuit court found a state law fraud claim preempted by the MDA because the device at 

issue, “[l]ike the device in Riegel, . . . was subject to device-specific requirements under 

the PMA [process].” Id. at 1118. Perez contrasted the 510(k) review in Lohr, which 

imposes no “requirements,” with the more rigorous PMA process: 

None of the federal laws or regulations at issue [in Lohr] imposed devicespecific requirements. In contrast, the Court in Riegel held that § 360k 

preempted common-law claims challenging the safety and effectiveness of 

a medical device that had received premarket approval from the FDA. 

Unlike the federal laws and regulations at issue in Lohr, premarket approval 

imposes device-specific requirements. 

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711 F.3d at 1118; see also Stengel v. Medtronic, Inc., 704 F.3d 1224, 1230 (9th Cir. 

2013) (en banc) (noting that the Court in Riegel “was careful to state that . . . Lohr

remained good law”). 

 Many cases interpret Riegel and Lohr to mean that PMA approval preempts 

different or additional requirements imposed by state tort law, while 510(k) clearance 

does not. See, e.g., Hovey v. Cook Inc., 97 F. Supp. 3d 836, 844-46 (S.D. W. Va. Apr. 1, 

2015) (rejecting the manufacturer’s preemption argument under § 360k and finding that 

510(k) clearance of the medical device did not preempt state law tort claims in light of 

Lohr and Riegel); Horrillo v. Cook Inc., No. 08-60931-CIV, 2014 WL 8186704, at *3 

(S.D. Fla. June 6, 2014) (“[U]nder Lohr and Riegel, because the stent received FDA 

approval under the § 510(k) process, Defendant is precluded, as a matter of law, from 

arguing that Plaintiff’s claims are preempted under the express preemption provision set 

forth in § 360k(a).”); Cisson v. C. R. Bard, Inc., No. 2:11-cv-00195, 2013 WL 5700513, 

at *12 (S.D. W. Va. Oct. 18, 2013) (“[T]he 510(k) process does not address product 

safety and efficacy and therefore is not relevant to Bard’s obligations under Georgia state 

tort law”) (citing Lohr and Riegel); James v. Diva Int’l, Inc., 803 F. Supp. 2d 945, 951 

(Mar. 18, 2011) (“The device at issue before the Court was approved by the ‘substantially 

equivalent’ process. Defendant argues that this is of no consequence. However, it is 

worth noting that the Supreme Court has held that this process implements only generally 

applicable standards and does are not constitute sufficient ‘requirements’ to trigger 

preemption under Section 360k(a).”) (citing Lohr, 518 U.S. at 492-93).7

 Bard argues that Lohr is outdated and does not control this case. Bard notes that 

Lohr concerned a pacemaker cleared by the FDA in 1982, and argues that the 510(k) 

clearance process was dramatically altered when Congress passed the SMDA in 1990. 

Doc. 5396 at 19-20. Bard emphasizes that § 12 of the SMDA authorizes the FDA to find 

 

7

 This Court reached a similar conclusion in another case, finding that 510(k) review for a pain pump device did not preempt Arizona negligence and strict liability claims. Placencia v. I-Flow Corp., No. CV10-2520 PHX DGC, 2012 WL 5877624, at *5 

(D. Ariz. Nov. 20, 2012).

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a device “substantially equivalent” under 510(k) review if it is “as safe and effective as a 

legally marketed device” and “does not raise different questions of safety and efficacy 

than the predicate device.” PL 101-629 § 12. Bard argues that this consideration of 

safety and effectiveness was not present in Lohr, and, when combined with FDA 

discretion to require clinical data and testing information, can result in 510(k) clearance 

procedures that are closer to PMA approval and have preemptive effect. Bard argues that 

its IVC filters went through a rigorous 510(k) review focused on safety and effectiveness. 

The Court does not agree that Lohr is outdated. The SMDA did introduce safety 

and effectiveness considerations into 510(k) review, but only comparatively. Under § 12, 

the FDA does not make a determination that the device being cleared is safe and 

effective; it concludes that the device is substantially equivalent to the predicate device. 

Id. True, the FDA may do this by finding that the device “is as safe and effective” as the 

predicate device, but that is still a comparative exercise. The assumption is that the 

predicate device is safe and effective enough to be on the market, and that the proposed 

device, if sufficiently similar, must be so as well. The FDA’s 510(k) review “continues 

to primarily focus on equivalence as opposed to safety.” Hovey, 97 F. Supp. 3d at 845; 

see Riegel, 552 U.S. at 323. 

A 510(k) notice must include information regarding the device, its intended use, 

and its planned labelling and advertising; whether it is similar to or different from 

comparable products in commercial distribution; an assurance that the information 

submitted is truthful and accurate; and any additional information regarding the device 

requested by the FDA that is necessary to make a finding as to whether or not the device 

is substantially equivalent to a predicate device. 21C.F.R § 807.87. FDA regulations 

provide that a 510(k) notice can result in one of several possible outcomes. The FDA can 

(1) declare the device substantially equivalent to a predicate device, (2) declare the device 

not substantially equivalent to any predicate device, (3) request additional information, 

(4) withhold the decision, or (5) advise the applicant that 510(k) clearance is not required. 

21 C.F.R. § 807.100(a). Determining that the device is safe and effective is not one of 

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the available FDA options. Indeed, because the FDA makes no determination regarding 

the device’s safety and effectiveness comparable to PMA approval, FDA regulations 

specifically prohibit a manufacturer from “misbranding” a 510(k)-cleared device by 

claiming that it has been “approved” by the FDA. 21 C.F.R. § 807.97. 

The PMA process, by contrast, requires a manufacturer to show that its product is 

sufficiently safe and effective for the U.S. market. See Buckman, 531 U.S. at 344-45. If 

successful, the process results in an FDA finding of safety and effectiveness. Indeed, 

after PMA approval, the manufacturer cannot change the design, manufacturing process, 

labeling, or any other attribute of the product that could affect its safety or effectiveness 

without FDA permission. § 360e(d)(6)(A)(i). The manufacturer must also report to the 

FDA any information concerning the safety of the device that it learns after receiving 

approval. § 360i. “[P]remarket approval is focused on safety, not equivalence.” Riegel, 

552 U.S. at 323. It remains fundamentally different from 510(k) review. 

The Court cannot conclude that the Lohr majority was ignorant of current FDA 

practices or the 1990 changes made by the SDMA. Lohr was decided six years after 

passage of the SMDA, and any changes to 510(k) review were available to the Court in 

interpreting Congress’s intent. 518 U.S. at 480 n. 4. And yet the Court still concluded 

that “[t]here is no suggestion in either the statutory scheme or the legislative history that 

the § 510(k) exemption process was intended to do anything other than maintain the 

status quo with respect to the marketing of existing medical devices and their substantial 

equivalents.” Id. at 494. That status quo, Lohr noted, “included the possibility that the 

manufacturer of the device would have to defend itself against state-law claims of 

negligent design.” Id.

In short, Lohr remains good law, and clearance of a product under 510(k) usually 

does not preempt state common law claims. But this does not mean that 510(k) clearance 

can never result in preemption. As Bard notes, the fifth and concurring justice in the 

Lohr majority, Justice Breyer, acknowledged that preemption could occur if specific 

federal requirements were imposed on a device by the FDA. Id. at 503-04. And the 

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Ninth Circuit has held that state law failure-to-warn claims were preempted for a 510(k) 

device on which the FDA imposed specific product and disease warning requirements. 

See Papike v. Tambrands Inc., 107 F.3d 737, 740 (9th Cir. 1997). 

How, then, does one identify 510(k) cases where state law claims are preempted? 

The preemption provision itself provides some helpful guidance. Section 360(k) gives 

preemptive power only to requirements “applicable to the device.” 21 U.S.C. § 360(k). 

The requirements must be device-specific. In Lohr, the Supreme Court also looked to a 

regulation promulgated by the FDA – 21 C.F.R. § 808.1(d) – for help on the preemptive 

scope of § 360(k). 518 U.S. at 498-501; see also id. at 506-07 (Breyer, J., concurring). 

That regulation confirms that any preemptive requirement must specifically apply to the 

device in question: 

State or local requirements are preempted only when the Food and Drug 

Administration has established specific counterpart regulations or there are 

other specific requirements applicable to a particular device under the act, 

thereby making any existing divergent State or local requirements 

applicable to the device different from, or in addition to, the specific Food 

and Drug Administration requirements. 

21 C.F.R. § 808.1(d) (emphasis added). 

 Thus, preemption can occur under the 510(k) process only when the FDA has 

imposed requirements specific to the device in question. More general FDA 

requirements – what Riegel calls “federal manufacturing and labeling requirements 

applicable across the board to almost all medical devices” – do not preempt state law 

claims. 552 U.S. at 322. The FDA requirements must do more than reflect “entirely 

generic concerns about device regulation generally.” Id. (citations to Lohr omitted). 

 2. Has the FDA Imposed Specific Requirements on Bard Filters? 

 Bard argues that the FDA has imposed three categories of specific requirements on 

its filters: (1) special controls, primarily in the form of FDA guidance documents; 

(2) clinical studies, and testing and design information; and (3) labelling and other 

information requirements. Doc. 5396 at 24-30. The Court will review each category. 

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 a. Special Controls (Guidance Documents). 

Bard relies heavily on the special controls issued by the FDA in connection with 

510(k) review of IVC filters generally. One of the special controls is a guidance 

document issued in November 1999 and titled “Guidance for Cardiovascular 

Intravascular Filter 510(k) Submissions.” 21 C.F.R. § 870.3375(b)(2)(ii); see Doc. 5398 

¶ 29, Ex. F. Bard contends that this guidance document is a “specific and detailed 

directive the FDA issued” for IVC filters. Doc. 5396 at 24. The Court does not agree. 

The 1999 guidance document is not a “directive” as Bard claims. It contains this 

disclaimer: “This document is intended to provide guidance. It represents the [FDA’s] 

current thinking . . . . It does not create or confer any rights for or on any person and 

does not operate to bind the FDA or the public.” Doc. 5398 ¶ 29, Ex. F at 1 n.1. 

The document describes itself as a “draft,” and makes clear that it does not 

mandate any particular course of action. IVC filter manufacturers can obtain 510(k) 

clearance by following “either the specific recommendations of this guidance or some 

alternate control that provides equivalent assurances of safety and effectiveness.” Id. 

at 1. Thus, manufacturers can choose between following the “recommendations” in the 

guidance document or alternative approaches. 

Bard emphasized at oral argument that the guidance document contains a section 

on “Filter Performance,” but this section simply includes “an outline of the general issues 

that need to be addressed when seeking premarket clearance for a filter” under 510(k). 

Id. at 3. The section leaves it to the manufacturer to determine what tests or data should 

be submitted: “Test protocols and acceptance criteria for these tests are the responsibility 

of the submitter. FDA recognizes that there are many different testing methods that may 

be used to satisfy the objective.” Id. The document also includes a suggested general 

format for filter labels, but no specific regulatory mandate. Manufacturers are free to 

include other language “specific to [their] particular device design.” Id. at 9-10. In short, 

the document leaves much to the discretion of filter manufacturers and provides guidance 

instead of imposing specific requirements. See Thompson v. DePuy Orthopaedics, Inc., 

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No. 1:13-CV-00602, 2015 WL 7888387, at *10 (S.D. Ohio Dec. 4, 2015) (noting that the 

guidance document at issue was “directed mostly to what needs to be submitted to the 

FDA to facilitate review of the 510(k) application” and contained no “language that 

mandates anything from the manufacturers”).8

The two other documents identified by the FDA as special controls for IVC filters 

are (1) “Use of International Standards Organization’s ISO 10993 ‘Biological Evaluation 

of Medical Devices Part I: Evaluation and Testing,’” and (2) “510(k) Sterility Review 

Guidance and Revision of 2/12/90 (K90-1)” 21 U.S.C. § 870.3375(b)(1), (b)(2)(i); see

Doc. 5398 ¶ 28. These documents impose only generic requirements for all implantable 

medical devices and offer nothing specific to IVC filter design, manufacturing, 

performance, or labeling. Doc. 7369 at 24 n.17. As Riegel noted, “federal manufacturing 

and labeling requirements applicable across the board to almost all medical devices” do 

not preempt state common law claims. 552 U.S. at 322. Bard does not contend 

otherwise.9

 b. Clinical Studies and Testing and Design Information. 

Bard places much emphasis on the fact that clinical studies were required by FDA 

for 510(k) clearance of the Recovery, G2, and Denali filters. Doc. 5396 at 26-28. But 

the FDA regulations state that clinical studies can be requested for the purpose of 

deciding whether a device is substantially equivalent to a predicate device: 

FDA will determine that a device is substantially equivalent to a predicate 

device using the following criteria: . . . 

 

8 Whitson v. Safeskin, 313 F. Supp. 2d 473 (M.D. Pa. 2004), is distinguishable because the FDA had established clear and specific requirements for the product in a manual titled “Regulatory Requirements for Medical Gloves.” Id. at 477. 

9

 In its reply brief, Bard discusses internal FDA documents relating to the decision to reclassify IVC filters from Class III to Class II devices. Doc. 7828 at 8-9. Bard notes 

that the FDA had determined that special controls would provide reasonable assurance of the safety and effectiveness of IVC filters. Id. at 9. But this is true for all Class II 

devices subject to special controls, or at least those reclassified along with IVC filters in 2000. See 65 Fed. Reg. 17138-01 (Mar. 31, 200). Bard cites no legal authority for the proposition that mere reclassification, or assignment of special controls to a device cleared through 510(k) review, imposes “requirements” for purposes of § 360k. 

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(B) The data submitted establishes that the device is substantially 

equivalent to the predicate device and contains information, including 

clinical data if deemed necessary by the Commissioner, that demonstrates 

that the device is as safe and as effective as a legally marketed device[.] 

21 C.F.R. § 807.100(b)(2)(ii)(B) (emphasis added). Two points are relevant. First, 

requesting such clinical studies is a recognized part of 510(k) review. Second, analysis of 

the clinical data remains comparative – deciding whether the device is substantially 

equivalent to the predicate. Bard cites no authority for the proposition that clinical 

studies required during 510(k) review constitute preemptive requirements for purposes of 

§ 360k. Nor does Bard identify the specific clinical study “requirements” that the Court 

could compare to the various state law duties to determine whether those duties are 

preempted. 

Bard also notes that the FDA sought information about the testing and design of its 

IVC filters. Id. at 29-30. But the FDA may request additional information, including 

information concerning safety and effectiveness, to determine “whether or not the device 

is substantially equivalent to a [predicate] device[.]” 21 C.F.R § 807.87(l); see James, 

803 F. Supp. 2d at 947-48. Bard has not shown that the FDA’s request for testing and 

design information was outside the scope of a normal 510(k) review or sufficient to make 

it as rigorous as the PMA process. 

Bard suggests that its EVEREST and Denali clinical studies were similar to the 

rigorous FDA review in Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir. 2004). Doc. 5396 

at 27-28. But Horn involved the PMA process, not 510(k) review, a distinction the 

Third Circuit found critical: “The primary element distinguishing Lohr from the instant 

case is the fact that the [device] received FDA approval through the rigorous § 360e(c) 

PMA process, not through the § 510(k) ‘substantial equivalence’ process.” Id. at 169. 

After Riegel, there is nothing remarkable about the conclusion in Horn that “the PMA 

process imposed requirements that were specifically applicable to the [device], and that 

triggered preemption under § 360k(a).” Id. at 170; see also Kemp v. Medtronic, Inc., 231 

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F.3d 216, 227-28 (6th Cir. 2000) (finding FDA approval of a PMA supplement to be a 

“specific federal requirement applicable to the device”). 

 What is more, the heart pump at issue in Horn took nearly twenty years to receive 

FDA approval. 376 F.3d at 169-70. The device underwent ten years of live animal and 

human cadaver studies before it was granted an investigational device exemption (“IDE”) 

by the FDA in order to permit human clinical trials. Id. at 169. The manufacturer then 

conducted seven years of clinical studies at hospitals, during which it submitted 90 

supplements to the FDA. Id. The FDA approved the PMA application only after 

extensive review that spanned three years and included a substantial number of 

amendments and responses to FDA questions. Id. at 170. This process was clearly more 

rigorous than the 510(k) review of the Bard IVC filters. 

 Bard cites Kemp, 231 F.3d at 227, for the proposition that the IDE clinical trials 

for the G2 and Denali filters are device-specific and therefore preemptive. Doc. 5396 

at 25-26; see also Martin v. Telectronics Pacing Sys., Inc., 105 F.3d 1090, 1097 (6th Cir. 

1997) (regulations governing investigational devices are device-specific); Parks v. 

Howmedica Osteonics Corp., No. 8:15-cv-0075-MSS-MAP, 2016 WL 7220707, at *7 

(M.D. Fla. Mar. 11, 2016) (IDE approval process is device-specific). But as Plaintiffs 

correctly note, the G2 and Denali filters were given 510(k) clearance before completion 

of their respective IDE clinical studies. Doc. 7369 at 28. Moreover, Bard fails to explain 

how IDE clinical studies conducted as part of the 510(k) substantial equivalence review 

impose requirements for purposes of § 360k. In other words, even if the FDA required 

IDE clinical studies, Bard does not describe any resulting § 360k “requirements” that 

would preempt Plaintiffs’ state law claims. See Oja v. Howmedica, Inc., 111 F.3d 782, 

787-89 (10th Cir. 1997) (rejecting hip implant manufacturer’s arguments that discussions 

with the FDA to obtain 510(k) clearance including IDE clinical study of cement-less use 

constituted a specific requirement under Lohr).10

 

10 Bard notes in its reply that clinical trials are required as part of the PMA process. Doc. 7828 at 12 (citing Scovil v. Medtronic, Inc., 995 F. Supp. 2d 1082, 1093 (D. Ariz. 2014)). True, but the rigorous PMA process requires more than clinical trials, 

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 c. Labelling and Other Requirements. 

Bard argues that, pursuant 21 U.S.C. § 807.87(e), the FDA required proposed 

labeling for each Bard IVC filter. Doc. 5396 at 28. But proposed labeling is required for 

every 501(k) submission. Section 807.87 simply describes the information that “[e]ach 

premarket notification shall contain[.]” These are “federal . . . labeling requirements 

applicable across the board to almost all medical devices” – requirements which do not 

preempt state common law claims. Riegel, 552 U.S. at 322. They are not like the deviceand disease-specific labelling regulation at issue in Papike. 107 F.3d at 739-40. 

Bard contends that the FDA reviewed and made specific changes to its labels, 

including adding language regarding bariatric patients and off-label use for the G2 filter 

and language regarding potential nickel leaching for the Meridian and Denali filters. 

Doc. 5396 at 28-29. But these changes did not preclude Bard from strengthening its 

warnings about the risks posed by filter migration, fractures, and perforation. The FDA 

allows – and in fact encourages – medical device manufactures to “monitor device usage 

and promptly revise the warning and precautions section [of a label] based on use 

experience.” Doc. 5398 ¶ 38, Ex. G at 11. 

Bards notes that the FDA has issued post-SMDA design controls and “good 

manufacturing” rules, and that these procedures were applied to Bard filters. Doc. 5396 

at 22 (citing 21 C.F.R. §820.30; Medical Devices; Current Good Manufacturing Practice 

(CGMP) Final Rule; Quality System Regulation, 61 Fed. Reg. 52615 (FDA Oct. 7, 

1996)). But Bard fails to explain how these generally applicable rules constitute filterspecific requirements that would preempt Plaintiffs’ state law claims.11

 see Scovil, 995 F. Supp. 2d at 1088-89, and Bard has not shown that the two IDE clinical 

trials in this case reflect the rigor that makes FDA premarket approval preemptive. 

11 Bard notes that the FDA has itself indicated that special controls are “regulatory requirements for class II devices.” Doc. 5396 at 20 n.16 (citing FDA Medical Devices, 

Regulatory Controls, https://www.fda.gov/MedicalDevices/DeviceRegulationand Guidance/Overview/GeneralandSpecialControls/default.htm (last updated June 26, 2014). Yet Bard cites no legal authority showing that this statement by the agency is controlling for purposes of preemption. See Wyeth, 555 U.S. at 556 (giving no deference to the FDA’s mere assertion that state law is preempted where it had enacted no regulation to this effect). 

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Finally, Bard has submitted more than 800 factual paragraphs to illustrate its 

extensive communications with the FDA concerning the seven generations of filters at 

issue in this case. Doc. 5398. But the Court agrees with Plaintiffs’ suggestion that these 

communications merely reflect the back-and-forth of 510(k) review. See Doc. 7369 

at 25-29. The FDA invoked its regulatory power to require additional information from 

Bard as a condition for clearance. See 21 U.S.C. § 807.87(l). The mere volume of these 

communications does not show that the FDA’s review imposed specific requirements on 

Bard filters or departed from the 510(k) substantial equivalence standard.12 

 d. Papike and Degelmann Are Distinguishable. 

Bard cites other cases in support of their argument, but the Court finds them 

distinguishable. Papike involved various claims under California law based on injuries 

the plaintiff sustained when she contracted Toxic Shock Syndrome (“TSS”) while using 

Tampax tampons. 107 F.3d at 738. The Ninth Circuit found the state failure-to-warn 

claim preempted under § 360k, but not the state claims for negligence, design defect, and 

breach of warranties. Id. at 738, 742-44. Although tampons are Class II devices subject 

to special controls, see id. at 739, this was not the reason for preemption. Rather, Papike

found that the FDA had promulgated a device-specific regulation “mandating the specific 

substantive content of the TSS warnings on tampon boxes[.]” Id. at 740. The regulation 

was “not only device-specific (tampons), but also disease-specific (TSS).” Id. “This fact 

distinguishe[d] Papike’s case from prior relevant MDA preemption cases, including 

[Lohr].” Id.; see also Rasheed v. Church & Dwight Co., No. 5:11CV80, 2012 WL 

262619, at *7-8 (E.D. Tex. Jan. 12, 2012) (finding failure-to-warn claim preempted 

 

12 Bard asserts that its more than 800 paragraphs of facts are both material and 

undisputed, and that “there is no genuine issue to be tried.” Doc. 5398 at 1. But as 

Plaintiffs correctly note, Bard’s statement includes many documents and communications that are not central to the issues in this case – whether the 510(k) review imposed device- specific requirements. And the sheer volume of the submission proves nothing. “Lawyers are tasked with bringing clarity out of chaos, and voluminous filings rarely do that.” State Compensation Ins. Fund v. Drobot, No. CV 13-0956 AG, 2016 WL 

6661338, at *1 (C.D. Cal. Aug. 10, 2016). 

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where the FDA had issued a specific regulation governing labels for condoms under the 

same rule subpart as tampons). Bard cites no similar regulation in this case. 

 Bard’s reliance on Degelmann v. Advanced Medical Optics Inc., 659 F.3d 835 (9th 

Cir. 2011), fares no better. Degelmann has been vacated by the Ninth Circuit. See 

Placencia, 2012 WL 5877624, at *5 n.3. Moreover, even if Degelmann was still good 

law, it would not control here. Doc. 5396 at 13, 19. Degelmann concerned contact lens 

solution approved through 510(k) review and the plaintiffs’ state-law claims that the 

solution was mislabeled as “disinfecting.” 659 F.3d at 840-42. The FDA had issued a 

guidance document containing special controls that “mandate” specific stand-alone 

performance criteria with which manufacturers “must comply” in order to label their 

contact lens products as a “disinfecting solution.” Id. at 341-42. The Ninth Circuit found 

the guidance document to be a specific requirement that the manufacturer undisputedly 

had met, and held that the state consumer protection and false advertising claims were 

preempted because they would impose a state requirement in addition to the federal 

requirements. Id. at 842; see also Tuttle v. CIBA Vision Corp., No. 2:05-CV-340 TS, 

2007 WL 677134, at *2 (D. Utah Mar. 1, 2007) (finding same guidance document to be a 

requirement because it is comprehensive and “governs the form, content, and 

requirements for labels on hydrogen peroxide-based solutions”). 

 e. Federal Requirements Conclusion.

 The various FDA reviews of Bard filters do appear to have been more extensive 

than the 510(k) review at issue in Lohr. But Bard has not shown that the reviews 

imposed device-specific requirements as needed for preemption under § 360(k). The 

“requirements” identified by Bard are either general, non-preemptive regulations or 

normal parts of the 510(k) substantial equivalence inquiry. 

B. State Requirements.

Lohr instructs courts to undertake a “careful comparison” between the federal 

requirements at issue and the allegedly preempted state requirements to determine 

whether they fall within the preemptive scope of § 360k. 518 U.S. at 500. The state law 

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must be compared to the federal requirements to determine whether the state law 

establishes requirements “different from, or in addition to,” the federal requirements. 21 

U.S.C. § 360k(a)(1)(1). But such a comparison is impossible where, as here, no devicespecific federal requirements can be ascertained. 

The claims asserted by Plaintiffs involve the laws of 50 states – laws the Court 

must apply in this MDL. See Am. Life Ins., 391 F.3d at 911. Plaintiffs assert multiple 

causes of action, including claims for strict liability, negligence, breach of warranty, 

misrepresentation, concealment, and consumer fraud. Doc. 303-1. And yet Bard does 

not discuss the specific law of any particular state. Bard instead summarizes general state 

law duties and asserts that those duties impose requirements that are preempted by the 

requirements imposed on its products through the 510(k) reviews. Doc. 5396 at 30. Such 

conclusory assertions are insufficient to meet the “careful comparison” required by Lohr. 

For this reason as well, Bard has failed to show that any state law claim is expressly 

preempted by federal requirements. 

V. Implied Preemption.

 Because the health and safety of citizens are “‘primarily, and historically, matters 

of local concern,’ the ‘States traditionally have had great latitude under their police 

powers to legislate as to the protection of the lives, limbs, health, comfort, and quiet of all 

persons.” Lohr, 518 U.S. at 475 (internal citations omitted). Thus, this case presents a 

classic example of Congress legislating in a field – public health and safety – historically 

occupied by state police powers. For purposes of implied preemption, therefore, the 

Court begins with a presumption that state laws are not superseded by the federal statute, 

a presumption that can be overcome only if preemption “‘was the clear and manifest 

purpose of Congress.’” Id. (citation omitted). 

 Bard contends that Plaintiffs’ state law claims are impliedly preempted because it 

is impossible for Bard to do under federal law what the state laws require. Doc. 5396 

at 32-34. The Court does not agree. 

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 Bard relies on two Supreme Court cases that involved the FDCA’s labeling 

requirements for generic prescription drugs, PLIVA, Inc. v. Mensing, 564 U.S. 604 

(2011), and Mutual Pharmaceutical Co. v. Bartlett, ––– U.S. –––, 133 S.Ct. 2466 (2013). 

Under the FDCA, a manufacturer can obtain FDA approval to market a drug only by 

submitting a new-drug application (“NDA”) that is similar to the comprehensive PMA 

application. 21 U.S.C. § 355(a)-(b); see Bartlett, 133 S. Ct. at 2471 (noting that the 

“process of submitting an NDA is both onerous and lengthy”). The FDA’s approval of 

an NDA includes the approval of the exact text of the proposed label. 21 U.S.C. 

§ 355(d). Generally speaking, a manufacturer may change a drug label only after the 

FDA approves a supplemental NDA. See Wyeth, 555 U.S. at 568. Manufacturers 

essentially are prohibited from making any change to a generic drug label because the 

label must at all times be the same as the label of the corresponding brand-name drug. 

21 U.S.C. § 314.150(b). 

 In Mensing and Bartlett, the Supreme Court found state law failure-to-warn claims 

preempted by the FDCA because it was impossible under federal law for the 

manufacturers to do what state law required. Mensing, 564 U.S. at 618; Bartlett, 133 S. 

Ct. at 2476-78. As the Court explained: “it was impossible for the [m]anufacturers to 

comply with both their state-law duty to change the label and their federal law duty to 

keep the label the same.” Mensing, 564 U.S. at 618. “Federal law require[d] a very 

specific label for [the drug], and state law [forbade] the use of that label.” Bartlett, 133 

S. Ct. at 2479. 

 Bard has identified no similar conflict in this case. Bard asserts that it is 

prohibited from making changes to their filters without FDA approval, but changing a 

product is quite different from changing a label. FDA regulations understandably 

provide that FDA clearance is required when a manufacturer’s product “is about to be 

significantly changed or modified in design, components, method of manufacture, or 

intended use.” 21 C.F.R. § 807.81(a)(3). The Court does not find such a change 

comparable to the label changes at issue in Mensing and Bartlett. 

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 Bard also asserts that the FDA prohibits it from making unilateral labeling changes 

that significantly impact safety and effectiveness without first submitting a new 510(k) 

notification. Doc. 5396 at 33. In support, Bard cites to an FDA guidance document on 

when 510(k) submissions are required. Id.; Doc. 5398, ¶ 38. The most relevant part of 

this guidance document for purposes of Plaintiffs’ failure-to-warn claims would seem to 

be the section on changes in warnings or precautions. That section reads as follows: 

In order to facilitate a continuous upgrading in device labelling, 

manufacturers should monitor device usage and promptly revise the 

warning and precautions section based on use experience. Events that 

precipitate changes of this type are routinely reported under the medical 

device reporting regulation. 510(k)s for such labelling changes are 

generally unnecessary however, manufacturer’s [sic] are encouraged to 

discuss these situations with [the FDA’s Center for Devices and 

Radiological Health]. 

Doc. 5398, Ex. G at 11. This guidance clearly does not prohibit Bard from making 

warning changes without FDA approval.13

 “Impossibility pre-emption is a demanding defense.” Wyeth, 555 U.S. at 573. 

Bard has failed to show that it is impossible to make any labeling changes that may be 

required by state law. Indeed, Bard acknowledges that the FDA previously has cleared 

labeling changes to Bard IVC filters and in one instance found that no 510(k) was 

needed. Doc. 5396 at 33. Bard’s impossibility preemption defense is without merit. See 

Wyeth, 555 at 571 (“[A]bsent clear evidence that the FDA would not have approved a 

change to [the drug’s] label, we will not conclude that it was impossible for Wyeth to 

comply with both federal and state requirements.”); Mullins v. Ethicon, Inc., 147 F. Supp. 

3d 478, 480-85 (S.D. W. Va. 2015) (rejecting impossibility preemption given “Congress’ 

purpose in enacting the 510(k) provision and the absence of any actual conflict between 

 

13 The guidance document recently has been superseded. See FDA, Deciding When to Submit a 510(k) for a Change to an Existing Device, Guidance for Industry and 

FDA Staff (Oct. 25, 2017), available at https://www.fda.gov/downloads/medicaldevices/ deviceregulationandguidance/guidancedocuments/ucm514771.pdf (last visited Nov. 16, 2017). The new guidance document also allows for changes in warnings without a 510(k) submission. See id. at 22. Moreover, both documents make clear that they are meant to provide guidance only and do not bind the FDA or the regulated industry. 

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state and federal law”). Bard has also failed to overcome the presumption against 

preemption that applies to its implied preemption argument. 

IT IS ORDERED that Defendants’ motion for summary judgment regarding 

preemption (Doc. 5396) is denied. 

 Dated this 22nd day of November, 2017. 

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