Trial Magazine

During the 510(k) approval process, a manufacturer represents to the FDA that its new medical device is “substantially equivalent” to a product already on the market.₁ If satisfied, the FDA then clears the device without evaluating its safety and efficacy. Despite this lack of safety and efficacy review, defendants in cases involving harmful 510(k) devices are increasingly filing motions for summary judgment (MSJ), arguing that state law claims such as labeling, warranty, and failure to warn, as well as some federal law claims, are preempted because the FDA has approved the new device.² Defendants also argue that the 510(k) process preemptively protects the devices from litigation.³ Knowing federal law, as well as the state-specific law that applies to your case, is critical to defeat these motions.

To obtain 510(k) clearance, the manufacturer must provide the FDA “sufficient detail to provide an understanding of the basis for a determination of substantial equivalence.”⁴ A device is substantially equivalent if, compared to the predicate device, the new device has the same intended use, has “‘the same technological characteristics,’” and has no “‘significant change[s] in the materials . . . or other features of the device’ . . . [that] raise different questions of safety and effectiveness.”⁵

When moving for summary judgment based on express or implied preemption, the defendant often alleges that federal law precludes any medical device litigation based on federal or state laws because a manufacturer cannot make any changes to a device, including design changes, without FDA approval.⁶ The defendant typically asserts that products liability claims such as strict liability and failure to warn are preempted because the FDA has imposed requirements implemented though clinical studies, testing, and design information gathering; special controls in the form of FDA guidance documents; labeling; and other mechanisms that prohibit the manufacturer from making changes absent FDA approval.⁷ A court will then determine whether the state law or rule is an obstacle to fully accomplishing the federal law’s objectives.⁸

Express Preemption Motions

Defendants primarily argue express preemption—that federal law pronounces a clear intent to preempt state law—by relying on the Medical Device Amendments of 1976 (MDA), which amended the Federal Food, Drug, and Cosmetic Act (FDCA).⁹ They point to §360(k) of the MDA, which preempts any state law requirement for a medical device that is “different from, or in addition to” FDCA requirements or any requirement “relat[ing] to the safety or effectiveness of the device.”¹⁰

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The FDA does not analyze each medical device's safety and efficacy when determining 510(k) clearance and, therefore, the 510(k) process does not have any device-specific requirement to trigger express preemption.

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The U.S. Supreme Court and other courts, however, have clarified that the 510(k) process has neither a device-specific requirement nor a safety and effectiveness analysis for the new device.¹¹ The premarket approval (PMA) process, by contrast, includes a device-specific requirement for “federal safety review.”¹² Using this case law, plaintiffs can argue that the FDA does not analyze each medical device’s safety and efficacy when determining 510(k) clearance and, therefore, the 510(k) process does not have any ­device-specific requirement to trigger express preemption.¹

Relevant case law. In opposition to an express preemption MSJ, cite Riegel v. Medtronic, Inc., in which the Supreme Court explained that “§510(k) is ‘focused on equivalence, not safety.’”¹⁴ Distinguishing the 510(k) process from the rigorous PMA process, the Court held that only claims involving the latter may be subjected to an express preemption analysis.

Also reference the Court’s earlier decision in Medtronic, Inc. v. Lohr establishing that 510(k) requirements are “general” standards that do not preempt state law claims.¹⁵ Importantly, Lohr explains that a state law is preempted by the MDA only when its requirements are different from or in addition to the FDA’s “specific counterpart regulations or . . . other specific requirements applicable to a particular device.”¹⁶

If relevant, you also can cite lower court decisions holding that §360(k) “does not apply to products liability claims regarding medical devices that underwent 510(k) clearance” as there are no specific federal requirements with which such claims could conflict, including no federal requirements for medical device design.¹⁷

Some courts also have interpreted Lohr to mean that the 510(k) process does not preempt manufacturing and labeling claims as the FDA’s manufacturing and labeling requirements for the 510(k) process are not device specific.¹⁸ Examples of this include Lohr’s pacemaker and Riegel’s cardiovascular catheter, 510(k) devices that did not go through any device-specific requirements before entering the market.¹⁹

The Safe Medical Device Act. When their §360(k) express preemption argument fails, defendants may then argue that the Safe Medical Device Act of 1990 (SMDA) established a more stringent 510(k) process and that because the SMDA was passed after the device at issue in Lohr was placed on the market, it provides new requirements that preempt state law claims.

You can note, however, that the SMDA was passed before the Lohr decision, so it does not affect Lohr’s analysis or holding. Cite the cases discussed above, and reiterate how the FDA evidentiary standard for the 510(k) review process does not require a safety and efficacy analysis. Courts have continued to reject that SMDA argument; Riegel was decided years after the SMDA was enacted and to date, the SMDA has not been interpreted as overturning that decision.²⁰

FDA guidance documents. Defendants also may argue in MSJ that the FDA’s 2014 guidance document on “evaluating substantial equivalence in premarket notifications” in the 510(k) process is specific enough to be a requirement that preempts claims.²¹ During discovery, you should not refer to FDA guidance documents as requirements or documents setting forth the standard of care for manufacturers—that may trigger a defendant’s successful preemption argument.

Instead, you may want to ask the device manufacturer’s witness about its knowledge and consideration of these guidance documents. In briefing, you can then respond by ­highlighting that this guidance document is not a law or requirement, that guidance documents in general are not specific enough to be requirements or directives, and that manufacturers are not required to follow guidance documents.

Moreover, the Supreme Court in Riegel explained that generic requirements applicable to all medical devices, such as some guidance documents, do not preempt state common law claims.²² For example, while the 510(k) application process may request clinical data to establish substantial equivalency, this requirement is not device specific or a determination of safety and effectiveness.²³ In fact, the 2014 guidance document can help you oppose a preemption MSJ because it distinguishes 510(k) applications from the PMA process.²⁴ For example, courts have found that the “Guidance for Cardiovascular Intravascular Filter 510(k) Submissions” from November 1999 is guidance, not a directive or mandate, and so it does not trigger preemption issues.²⁵

Implied Preemption MSJ

Implied preemption arises when a federal law and state law conflict so that simultaneous compliance is impossible.²⁶ Implied preemption MSJ arguments primarily rely on 21 U.S.C. §337(a) and the Supreme Court’s decision in Buckman Co. v. Plaintiffs’ Legal Committee.²⁷ Typically, the defense argues the claim conflicts with the FDA’s investigative and enforcement authority under the FDCA and therefore is impliedly preempted.²⁸

Defendants often argue that §337(a) specifies that the federal government has exclusive authority for MDA enforcement actions and suits for noncompliance with the FDCA, MDA, or SMDA—essentially prohibiting private litigants from filing such suits.²⁹ Defendants often also contend that under Buckman, state law claims, such as breach of implied warranty, that arise “solely from the violation of FDCA requirements” are impliedly preempted, as are any state law fraud claims.³⁰

Buckman’s implied preemption analysis, however, can be easily distinguished from most cases as it was limited to claims of fraud on the FDA that existed “solely by virtue of the FDCA disclosure requirements.”³¹ Courts have held that a person cannot sue for off-label marketing of a device because the FDA has authority to regulate such actions, which are not grounded in traditional state law claims.³² However, if a plaintiff was deceived and injured by a manufacturer’s marketing, such as its failure to advise of available safer models, then implied preemption does not exist as the state has an interest in protecting its citizens from fraud and personal injuries.³³ Moreover, as discussed below, courts have widely held that implied preemption does not exist when a state law has parallel requirements to the federal one.³⁴

The defense may also cite another Supreme Court decision, Cipollone v. Liggett Group, Inc., but this reliance is misplaced as that case involved a state requirement about cigarette advertising, not a medical device.³⁵ Although courts have held that the state claim cannot conflict with the FDA’s investigative and enforcement abilities, a conflict between state and federal law does not mean that the federal law automatically preempts every state law.

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Oppose implied preemption arguments by emphasizing how the state law does not impede the FDA's ability to police violations and impose judgment.

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Parallel Claims and Other Arguments

Courts are reluctant to find a claim is preempted when the subject is “traditionally governed by state law.”³⁶ So oppose implied preemption arguments by emphasizing how the state law does not impede the FDA’s ability to police violations and impose judgment, meaning the requirements are generally equivalent. Cite Lohr, in which the Supreme Court confirmed that plaintiffs may assert parallel claims in the initial pleadings and that common law negligence may be a parallel claim to FDCA violations.³⁷

When pleading parallel claims, such as failure to warn or breach of warranty, identify the state law in your initial pleading and the state law duties in your preemption MSJ briefs.³⁸ You can do this in your brief by including a chart that compares the state and federal laws and shows that the state law does not require different or additional duties or steps to comply with the parallel federal law.

Showing the existence of parallel claims can be key in responding to implied preemption MSJ arguments.³⁹ The Supreme Court stated in Riegel, for example, that preemption “does not prevent a State from providing a damages remedy” for claims based on violations of FDA regulations.⁴⁰ And as summarized by the Ninth Circuit,

“[T]he MDA does not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty under the MDA.”⁴¹ You may also want to consult 21 C.F.R. §808, which provides guidance on whether a state statute is exempt from preemption.⁴²

Parallel claim or not, the court may rule that negligence per se is preempted, but careful pleadings may help get around this issue. In medical device suits, negligence per se claims often arise when the plaintiff alleges violations of the FDCA, MDA, or SMDA—claims that are generally preempted under Buckman.⁴³ However, a claim may proceed if carefully pleaded not as negligence per se but as, for example, failure to warn. This may allow it to survive as a parallel claim.⁴⁴

Failure-to-warn claims. When the case involves a failure-to-warn claim, the defendant may cite the Supreme Court’s Mutual Pharmaceutical Co. v. Bartlett and PLIVA, Inc. v. Mensing decisions.⁴⁵ These cases, however, are distinguishable from device cases: Both involve whether a generic drug manufacturer can be sued for allegedly inadequate drug labels.⁴⁶ Lohr again will support opposition to an MSJ as it describes how the 510(k) labeling requirements are not device specific and do not trigger preemption.⁴⁷

Be aware, however, of lower court decisions in two PMA device cases, Brooks v. Howmedica Inc., and In re St. Jude Medical, Inc. Silzone Heart Valves Products Liability Litigation: They suggest that a failure-to-warn claim will be preempted if the FDA knew about the risk at issue at the time the device was placed on the market.⁴⁸ In such situations, determine whether the defendant is arguing that a federal or state law is allegedly causing preemption issues, as well as whether the FDA’s knowledge of the risk at the time of 510(k) clearance was based on improper or incorrect information, thereby overcoming a preemption argument.

Warranty claims. In cases involving warranty claims and consumer protection acts, In re St. Jude assists plaintiffs opposing preemption MSJ because it found that consumer protection statutes and implied warranty claims are not preempted.⁴⁹ Other supporting case law includes Brooks, which held that express warranty claims alleging a breach of the FDA labeling or packaging requirements are not preempted,⁵⁰ and Davenport v. Medtronic, Inc., which held that “any ‘requirements’ imposed by the warranty are created by the warrantor” and are not a state-imposed requirement and, therefore, not preempted.⁵¹

As the number of preemption MSJ in 510(k) device litigation increases, plaintiff attorneys must anticipate what arguments defendants are likely to make and what case law can be referenced in response.

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Karen H. Beyea-Schroeder is an attorney at Schroeder Law Office and the Burnett Law Firm in Houston. She can be reached at karen.schroeder@schroeder-lawoffice.com or karen.schroeder@rburnettlaw.com.

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Notes

1. To obtain 510(k) clearance, the manufacturer must provide the FDA “sufficient detail to provide an understanding of the basis for a determination of substantial equivalence.” 21 C.F.R. §807.92(a) (2018); see also 21 U.S.C. §360c(f)(1) (2018); 21 C.F.R. §807.81(a). The substantially equivalent device on the market may be a product on the market since before the 1976 Medical Device Amendments passed, a class I or class II device that went through PMA, or a device that went through the 510(k) process. 21 C.F.R. §807.92(a)(3).
2. See Andrew Tauber et al., How to Argue Medical Device Preemption, For Def. (Oct. 2012), https://tinyurl.com/yb3eck43.
3. See, e.g., In re Bard IVC Filters Prods. Liab. Litig., No. 2:15-md-02641 (D. Ariz. Nov. 21, 2017); In re Medtronic, Inc., Implantable Defibrillators Prods. Liab. Litig., No. 05-md-1726 (D. Minn. Nov. 28, 2006). 
4. 21 CFR §807.92(a).
5. Fed. Drug Admin., The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration Staff 6 (July 28, 2014), www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm284443.htm [hereinafter Guidance Document] (citing 21 U.S.C. §360c(i)(1)(A) & (B)).
6. See Hughes v. Talen Energy Mktg., LLC, 136 S. Ct. 1288 (2016).
7. See id.; see, e.g., 21 C.F.R. §§807.87(e), 807.100(b)(2)(ii)(B) & 870.3375(b)(2)(ii). See generally Guidance Document, supra note 5.
8. Livadas v. Bradshaw, 512 U.S. 107, 120 (1994) (citation omitted).
9. To determine express preemption, courts apply a two-part test. See McLaughlin v. Bayer Corp., 172 F. Supp. 3d 804, 813–14 (E.D. Pa. 2016); see also Medtronic, Inc. v. Lohr, 518 U.S. 470, 501 (1996).
10. 21 U.S.C. §360(k).
11. Riegel v. Medtronic, Inc., 552 U.S. 312, 323 (2008); see also Perez v. Nidek Co., Ltd., 711 F.3d 1109, 1118–19 (9th Cir. 2013).
12. Riegel, 522 U.S. at 323. 
13. See id. at 322-23; Lohr, 518 U.S. at 502; see also Perez, 711 F.3d at 1118; Stengel v. Medtronic, Inc., 704 F.3d 1224, 1230 (9th Cir. 2013) (en banc).
14. Riegel, 522 U.S. at 323 (quoting Lohr, 518 U.S. at 493). For more on responding to Riegel preemption arguments, see Martin D. Crump & Wes Stevenson, Attacking Preemption: Combat Riegel Expansion, Trial 24 (July 2016). 
15. Lohr, 518 U.S. at 501. Lohr states that 510(k) “federal requirements reflect important but entirely generic concerns about device regulation generally.” Id. 
16. Id. at 498 (citing 21 C.F.R. §808.1(d)); see also Perez, 711 F.3d at 1109 (citing 21 C.F.R. §808.1(d)).
17. Hovey v. Cook Inc., 97 F. Supp. 3d 836, 844–45 (S.D. W. Va. 2015); see also In re Bard IVC Filters, No. 2: 15-md-02641, at 11, 13; In re Medtronic, Inc., No. 05-md-1726, at 11.
18. In re Medtronic, Inc., No. 05-md-1726, at 11.
19. See Riegel, 522 U.S. at 322–23; Lohr, 518 U.S. at 502.  
20. See In re Bard IVC Filters, No. 2:15-md-02641, at 8–14; see also Hovey, 97 F. Supp. 3d at 844–46.
21. See Guidance Document, supra note 5.
22. Riegel, 522 U.S. at 322.
23. See In re Bard IVC Filters, No. 2:15-md-02641, at 17. 
24. The guidance document also explains the 510(k) “evidentiary standard” and how the FDA simply “evaluates differences between the new device and the predicate device to determine their effect on safety and effectiveness.” Guidance Document, supra note 5, at 7.
25. See In re Bard IVC Filters, No. 2:15-md-02641, at 15–16.
26. See Mo. Bd. of Exam’rs for Hearing Instrument Specialists v. Hearing Help Express, Inc., 447 F.3d 1033, 1035 (8th Cir. 2006).
27. Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001).
28. Id. at 348–49; see also Perez, 711 F.3d at 1119.
29. 21 U.S.C. §337(a).
30. Buckman, 531 U.S. at 352–53.
31. Id. at 353; see also Dawson ex rel. Thompson v. Ciba-Geigy Corp., USA, 145 F. Supp. 2d 565 (D.N.J. 2001).
32. Perez, 711 F.3d at 1119-20; Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166 (C.D. Cal. 2013).
33. In re Medtronic, Inc., No. 05-md-1726, at 29.
34. Id.; see also Lohr, 518 U.S. at 495–97; Brooks v. Howmedica Inc., 273 F.3d 795, 798–99 (8th Cir. 2001); Horn v. Thoratec Corp., 376 F.3d 163, 179 (3d Cir. 2004); Martin v. Telectronics Pacing Sys., Inc., 105 F.3d 1090, 1100–01 (6th Cir. 1997). 
35. Cipollone v. Liggett Grp., Inc., 505 U.S. 504, 515–17 (1992).
36. CSX Transp., Inc. v. Easterwood, 507 U.S. 658, 664 (1993).
37. Lohr, 518 U.S. 470; see also Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1300 (11th Cir. 2011); Erickson v. Boston Sci. Corp., 846 F. Supp. 2d 1085, 1092 (C.D. Cal. 2011); Simmons v. Boston Sci. Corp., 2013 WL 1207421, at *4 (C.D. Cal. Mar. 25, 2013).
38. See Eckhardt v. Qualitest Pharm., Inc., 751 F.3d 674 (5th Cir. 2014); see also McLaughlin, 172 F. Supp. 3d at 804.
39. Lohr, 518 U.S. 470.
40. Riegel, 522 U.S. at 330. 
41. Stengel, 704 F.3d at 1228.
42. 21 C.F.R. §808.
43. Buckman, 531 U.S. at 352–53; see also McClellan v. I-Flow Corp., 2015 WL 294292 (9th Cir. Jan. 23, 2015); Marvin v. Zydus Pharm. (USA) Inc., 203 F. Supp. 3d 985, 987–88 (W.D. Wis. 2016).
44. See Monk v. Wyeth Pharm., Inc., 2017 WL 2063008 (W.D. Tex. May 11, 2017); see also Eckhardt, 751 F.3d at 678–79.
45. Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013); PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).
46. Bartlett, 570 U.S. 472; Mensing, 564 U.S. 604.
47. Lohr, 518 U.S. at 501–02; see also Riegel, 552 U.S. at 323; Hovey, 97 F. Supp. 3d 836; In re Medtronic, Inc., No. 05-md-1726, at 11.  
48. Brooks, 273 F.3d at 797-98; In re St. Jude Med., Inc. Silzone Heart Valves Prods. Liab. Litig., 2004 WL 45503, at *11 (D. Minn. Jan. 5, 2004). For more information on the “clear evidence defense,” see Thomas V. Ayala & M. Elizabeth Graham, Attacking Preemption: Overcome the Clear Evidence Defense, Trial 32 (July 2016). 
49. In re St. Jude, 2004 WL 45503, at *11; see also 21 C.F.R. §808.1.
50. Brooks, 273 F.3d at 798–99.
51. Davenport v. Medtronic, Inc., 302 F. Supp. 2d 419, 433 (E.D. Pa. 2004); see also Cipollone, 505 U.S. at 525–26.