A Conflict in the Interpretation of the Medical Device Amendments: Developing a Preemption Test for Hybrid Medical Devices

by Lisa Virgen

In 1976, Congress passed the Medical Device Amendments (MDA) to charge the U.S. Food and Drug Administration (FDA) with reviewing the safety and effectiveness of medical devices.^[1] The MDA heavily regulates high-risk medical devices that are capable of supporting human life through a premarket approval (PMA) process.[2] The PMA process requires medical device manufacturers to show that a high-risk device, such as a heart valve or pacemaker, is safe and effective with “reasonable assurance” before they can introduce the device to the market.[3]

Given the rigorous requirements of the PMA process, the MDA bars lawsuits involving state law claims that challenge the safety or effectiveness of PMA devices.[4] Specifically, MDA § 360k(a)(1) expressly preempts state requirements that are different from, or in addition to, any MDA requirement applicable to the device and that relates to the safety or effectiveness of the device.[5] The U.S. Supreme Court has held that state requirements include tort laws and the applicable requirements under the MDA include the PMA process.[6] Because tort laws would subject PMA devices to standards inconsistent with what the FDA has already required through the PMA process, the MDA preempts tort claims that challenge PMA devices.[7] Without this preemption, state tort law would disrupt the federal regulatory scheme by imposing additional requirements on medical device manufacturers.[8]

But not all high-risk devices require approval through the PMA process. Through an exception to the PMA process, manufacturers can introduce a high-risk device by showing that the device is substantially equivalent to an existing device on the market.^[9] This streamlined process, named § 510(k) after the statutory provision that created it, does not require clinical testing.[10] Because the process does not impose MDA requirements in accordance with § 360k, the MDA does not automatically preempt claims involving § 510(k) devices.[11] However, § 510(k) devices can contain PMA components.[12] If a plaintiff brings a tort claim involving a hybrid device with both § 510(k) and PMA components, courts must determine whether the MDA preempts the claim.

When a PMA component is used with a § 510(k) device, some courts have preempted all claims related to the entire device.[13] In applying preemption, one federal district court in Minnesota based its rationale on the language of § 360k(a)(1), stating that “the question is not whether there are federal requirements applicable to a particular use of a device; the question is whether there are federal requirements applicable ‘to the device.’”[14] The court then concluded that preemption attaches to the device regardless of its use.[15] This has the effect of preempting claims involving a § 510(k) device. But this rationale is not accepted by all courts.

Other courts have refused to apply preemption to hybrid devices.[16] In contrast to the above quoted case, a federal district court in West Virginia stated that “[p]reemption is based on FDA premarket approval of a medical device, not its component parts.”[17] When a PMA component is used in a § 510(k) device, preemption does not automatically apply.[18] Based on these separate lines of cases, a medical device manufacturer may be protected in one jurisdiction from state claims involving its hybrid device while being subject to state claims in another jurisdiction.

This note addresses the preemption issues that arise when a plaintiff’s alleged injuries are caused by a device comprised of § 510(k) and PMA components. Part I provides an overview of the statutory history of medical device regulation. Part II discusses the MDA’s express federal preemption clause.  And Part III addresses the conflict within existing case law involving the issue of hybrid medical devices and preemption. This note proposes a bright-line, two-step test that harmonizes the conflicting case law to determine when preemption applies to a hybrid medical device.

1. Background of the FDA Medical Device Regulatory Scheme

The FDA is the federal regulatory agency that reviews the safety of drugs and medical devices.^[19] Through the MDA, Congress delegated medical device regulation to the FDA and authorized the agency to regulate the labeling and promotion of these devices.^[20] The agency’s mission is to protect the public by ensuring the safety of medical devices and to advance the public health by encouraging innovation that makes medical products safer, effective, and affordable.^[21] Before the passage of the MDA, faulty medical devices had caused approximately 10,000 injuries and 731 deaths in the U.S.^[22] Following the MDA’s enactment, medical device manufacturers are required to register with the FDA and adhere to quality control standards before taking a device to market.^[23]

The MDA established three regulatory classes for medical devices: Class I, Class II, and Class III.^[24] A “device” is broadly defined as instruments, machines, implants, and “other similar or related articles, including any component, part, or accessory. . . .”[25] The classification of medical devices is based on their risk to the user.^[26] As examples, an examination glove is a Class I device and a heart valve is a Class III device.[27]

The most regulated group of the three classes is Class III, which are devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury.^[28] Class III devices are considered high-risk.^[29] As a result, all devices placed into Class III are subject to PMA requirements—the mandatory and rigorous review process that ensures safety and effectiveness.^[30] There are four steps to the PMA review.[31] First, FDA staff conduct administrative and limited scientific review to determine completeness of the application.[32] Second, FDA personnel conduct an in-depth scientific, regulatory, and quality system review of the device.[33] Third, the device is reviewed by the appropriate advisory committee that makes recommendations.[34] Finally, FDA deliberations take place and the manufacturer receives notification of the FDA decision.[35] Once it is determined that a Class III device offers a reasonable assurance of safety and effectiveness, the FDA grants PMA status.^[36] This process on average requires the FDA to spend 1,200 hours reviewing the manufacturer’s application and data.[37]

Considering that the PMA process is rigorous, Congress had to address what to do with devices predating the MDA that were already on the market.^[38] Instead of removing well-established and important devices from the market to conduct PMA testing, the MDA grandfathered in pre-MDA devices.[39] As a result, pre-MDA devices were not subject to the PMA process.[40] And to avoid giving grandfathered devices an unfair advantage, the FDA created an accelerated approval process, the § 510(k) process, for post-MDA devices “substantially equivalent” to a grandfathered device.^[41] The new device must have the same intended use as the preexisting device to be substantially equivalent.^[42] Through this process, the FDA conducts “limited form of review” and spends about 20 hours reviewing the device.[43] There is no need to subject the new substantially equivalent device to the PMA process.^[44]

Since the MDA’s enactment, the § 510(k) process has become the predominant way in which most Class III devices enter the market.^[45] Although the PMA process is generally required for all Class III devices, only two percent of devices obtain PMA approval.^[46] Between 1976 and 1990, 98 percent of new medical devices entered the market through the § 510(k) process.^[47] Notably, the FDA does not have the capacity to review each Class III device under the PMA process.[48] In addition, PMA is more costly for the medical device manufacturer and makes it more difficult for start-up businesses to introduce medical devices to the market.^[49] For the 2021 fiscal year, the FDA’s fee for conducting the PMA review was $365,657.^[50] Whereas the fee for § 510(k) review is $112,432.^[51] As such, the § 510(k) process has become a useful exception to the PMA process for medical device manufacturers.

1. Federal Preemption of PMA Devices

The MDA contains a preemption clause that applies to tort claims involving PMA devices.^[52] Under MDA § 360k(a), no state may establish or continue in effect 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.”[53] In other words, the MDA expressly preempts state requirements that are different from, or in addition to the MDA’s requirements and that challenge the safety or effectiveness of the medical device.^[54]

In Reigel v. Medtronic, Inc. the U.S. Supreme Court held that state requirements include tort law, which is based on the “existence of a legal duty” under a state’s laws, such as negligence and breach of warranty.^[55] A negligence claim is therefore preempted because it would challenge the safety or effectiveness of a PMA device.^[56] Without this restriction, the claim would effectively impose additional requirements on manufacturers in designing medical devices that are in addition to the rigorous PMA process.^[57] To dismiss tort claims against PMA devices, manufacturers commonly file dispositive motions based on § 360k(a) preemption.[58]

As held by the U.S. Supreme Court in Medtronic, Inc. v. Lohr, the MDA’s preemption clause does not apply to claims involving § 510(k) devices.^[59] Unlike the PMA process, the § 510(k) process does not have applicable FDA requirements related to the device’s safety and effectiveness.^[60] As stated by the U.S. Supreme Court, “[n]either the statutory scheme nor legislative history suggests that the § 510(k) process was intended to do anything other than maintain the status quo, which included the possibility that a device’s manufacturer would have to defend itself against state-law negligent design claims.”[61] Without applicable FDA requirements, tort claims against § 510(k) devices do not impose additional or different requirements. Therefore, medical device manufacturers generally cannot use § 360k(a) preemption to defeat tort claims involving a § 510(k) device.

The U.S. Supreme Court in Reigel and Lohr, however, dealt with devices that will approved either through the PMA or § 510(k) process. With the advancement of technology and doctors’ specific uses of the devices, it is now common for a device to contain  § 510(k) and PMA components.[62] This issue of hybrid devices has not been specifically addressed by the U.S. Supreme Court. When confronted with a device involving a PMA component and a § 510(k) component, lower federal courts disagree on whether preemption applies.^[63]

• A Bright-Line Test

Federal courts have grappled with whether to preempt state law claims involving a medical device with both PMA and § 510(k) components. This has led to courts deviating in their application of preemption. First, the U.S. District Court for the Eastern District of New York Court has focused on whether the plaintiff’s tort claims were “substantially caused” by the PMA component or the § 510(k) component.[64] If the plaintiff’s allegations center around a PMA device, the tort claims are preempted.[65] Second, the U.S. District Court for the Southern District of West Virginia has analyzed whether the PMA component is being used as approved by the FDA. If not, then there are no federal requirements that apply to the device and preemption does not apply. At first glance these cases appear to suggest two tests based on differing rationales. But both cases can be harmonized to create one bright-line test for determining whether to preempt state claims involving a device with both PMA and § 510(k) components.

The first set of courts have held that when the plaintiffs’ claims revolve around the PMA component of a § 510(k) device, the entire device is preempted from state laws.^[66] In these cases, the PMA component was the alleged cause of the injuries—not the § 510(k) device.^[67] For example, in Bertini v. Smith & Nephew, the plaintiff had a hip replacement that used a metal liner held in place through a locking mechanism.^[68] The plaintiff alleged a design defect claim because the locking mechanism failed to keep the liner in place, causing his injuries.^[69] The locking mechanism was approved through the § 510(k) process.^[70] The metal liner, however, was approved through the PMA process for use with a separate hip replacement system.^[71] Normally, the plaintiff’s claims arising from the PMA metal liner would be preempted.^[72] And the claims related to the § 510(k) hip replacement system would not be preempted.^[73]

Faced with a hybrid device, the Bertini court held that it “must apply a preemption analysis for the hip replacement system as one unit, and not examine each individual component.”^[74] The PMA device was the “main focus” of the plaintiff’s claim.^[75] “Although plaintiffs describe these device failures as two separate defects, they are in large part describing the same phenomena—the [] metal liner’s inability to attach to the [] acetabular shell, which resulted in plaintiffs’ injuries.”[76] Because the PMA device played a significant role in the alleged injuries, plaintiff’s claims involving the entire device were preempted.^[77] To defeat preemption of their claims, the plaintiffs had to prove that the § 510(k) locking mechanism alone was the cause of the injuries.^[78]

The Bertini court further stated that the preemption analysis is not concerned with how a particular device is used or whether there are federal requirements imposed on a particular use of the device.^[79] Rather, preemption is focused on whether there are federal requirements applicable to the device itself.^[80] A use of a device for a purpose not approved by the FDA (off-label use) with § 510(k) components does not deprive the liner of the protections of the PMA process.^[81] Because off‑label use is accepted by the FDA and corollary to its mission to regulate “without directly interfering with the practice of medicine,” the court found that off-label use does not affect the preemption analysis.^[82] Although the metal liner received premarket approval for use with a different hip replacement system, it was enough that the liner received premarket approval at all.^[83] Thus, the MDA preempted the plaintiff’s tort claim because the device at issue received premarket approval.[84]

The Bertini decision was later criticized by the West Virginia U.S. District Court in Huskey v. Ethicon.[85] The Huskey court disagreed with the Bertini analysis of applying preemption based on one PMA component.[86] Instead, the court held that the MDA did not preempt the plaintiff’s tort claims because the medical device at issue had not been approved, licensed, or recognized as safe by the FDA.^[87] The court stated that applying preemption to a predominantly § 510(k) device is inconsistent with precedent and the regulatory scheme.^[88] The U.S. Supreme Court and federal regulations instruct that state requirements are preempted “only when the FDA has established specific counterpart regulations or there are other specific requirements applicable to a particular device.”^[89] The court further stated that “[i]t is difficult to understand why the Bertini court found that premarket approval of one medical device means that claims against an entirely different medical device were preempted.”[90]

The Huskey court was confronted with a § 510(k) pelvic mesh containing a mesh material, Prolene, that had received premarket approval for use as a suture, not as a pelvic mesh material.^[91] The court stated that the suture’s PMA status was irrelevant to whether the § 510(k) device set forth specific requirements that preempt state tort claims.^[92] According to the Huskey court, preemption is based on premarket approval of a medical device, not its component parts.^[93] “Although purportedly constructed of the same material, [the PMA suture] is a different product, used in a different manner, for a different purpose.”^[94] Unlike the PMA metal liner in Bertini, which was approved for use with a similar hip replacement system, the PMA suture in Huskey was never approved for use in any pelvic device.^[95] The Huskey court ultimately denied the manufacturer’s motion for summary judgment based on preemption because the § 510(k) device with the PMA Prolene suture did not have applicable requirements under the MDA.[96]

Prior to Huskey, the West Virginia District Court had previously examined the same § 510(k) pelvic mesh in Lewis v. Johnson & Johnson and similarly denied the manufacturer’s dispositive motion.^[97] The manufacturer in that case argued that because the FDA confirmed the safety and effectiveness of Prolene through the PMA process the plaintiffs’ tort claims were preempted.^[98] The court disagreed and found that the safety of a PMA component could not carry over to a new device.^[99] According to the court, the FDA’s approval of the Prolene suture necessarily related to its use as a suture; it did not categorically approve Prolene for use in medical devices.^[100]

While the Huskey and Lewis decisions appear to contradict the Bertini analysis, these decisions can be harmonized to develop a bright-line test for determining when to preempt claims involving hybrid devices. First, the Bertini decision states that off-label use of a PMA device does not affect the preemption analysis. This is consistent with the FDA’s mission to encourage medical innovation.[101] Second, Huskey and Lewis emphasize that premarket approval no longer attaches to a component that is used in a device completely different than the device that it was originally approved to be used in. This is consistent with the PMA process that the device have a reasonable assurance of safety and effectiveness. Although this reasoning conflicts with the Bertini court’s holding that off-label use does not affect the preemption analysis, the Bertini court was not faced with a PMA device that was being used in a completely different manner.

The Bertini decision can be consistent with Huskey and Lewis if courts distinguish whether the PMA device was used in an off-label manner in a similar device like in Bertini. The Bertini metal liner received premarket approval for use with a different hip replacement system. But the § 510(k) device at issue was also a hip replacement system. In Huskey and Lewis, the medical device at issue was a pelvic mesh. The pelvic mesh was § 510(k) approved, and the material used in the mesh received premarket approval for use as a suture. As recognized by Lewis, a suture and a pelvic mesh are two separate medical products.[102] Combining the rationale of these decisions creates the first element of the bright-line test for hybrid devices:

• The PMA component was not used in a § 510(k) device in a manner consistent with the FDA-approved use.

In a Bertini fact pattern, the analysis would stop and preemption would apply. If the PMA component is being used in a manner inconsistent with its PMA status, then the component is no longer automatically immune to state law claims. Therefore, in a Lewis or Huskey fact pattern, the analysis would continue to the second element:

(2) The PMA device was a substantial cause of the injury at issue.

This second element is based on the Bertini court’s determination that the plaintiff’s claim was substantially tied to the PMA component of the device at issue. This is consistent with the MDA’s intent not to expose a manufacturer to more rigorous state requirements, tort claims, if the device received PMA status. If the PMA component was a substantial cause of the alleged injury, meaning that the alleged injuries would not have occurred but for the PMA component, the manufacturer is immune from state law claims. This element also recognizes the Bertini’s rationale that claims must be viewed against the device as one unit, not to individual components, for the purposes of preemption.[103] Thus, when the PMA component works in conjunction with the § 510(k) device to cause the alleged injuries, the courts must look at the whole device to apply preemption.

If both these elements are met, then the MDA preempts state law claims. This test combines the rationales of Bertini and Huskey, which both further the MDA’s purpose. As stated by the U.S. Supreme Court, the MDA preempts additional or differing state requirements on PMA, not § 510(k), devices, because only PMA devices are subject to federal requirements.[104] 

Conclusion

By preempting tort claims against PMA devices, the MDA ensures that state law does not disturb the federal regulatory scheme by imposing additional legal requirements on manufacturers. The law is established that PMA devices are entitled to federal preemption and that § 510(k) devices are not. Recently, courts have been confronted as to whether hybrid devices comprising of both § 510(k) and PMA components are entitled to federal preemption. One side of this issue has held that preemption attaches to claims involving PMA and § 510(k) devices. Another side has held that preemption does not apply where a PMA component is used in a § 510(k) device completely different than the use the component obtained premarket approval for. A two-part test for hybrid medical devices would guide the courts in applying preemption to hybrid devices that addresses both sides of this issue. Thus, tort claims are preempted against a hybrid device if (1) the PMA component was used in a manner consistent with the use approved by the FDA; and (2) the PMA component was the substantial cause of the injuries at issue. This test will remove the uncertainty of whether medical device manufacturers will be subject to tort claims involving hybrid devices.

About the author: Lisa Virgen is a litigation associate in BakerHostetler’s Houston office. Lisa has experience representing clients in a wide variety of matters, including contract disputes, administrative state actions and trucking accidents. Prior to joining BakerHostetler, she clerked for the Honorable Nelva Gonzales Ramos, U.S. District Judge in the Southern District of Texas.

^[1] Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat 539 (1974); Riegel v. Medtronic, Inc., 552 U.S. 312, 316, 128 S. Ct. 999, 1003, 169 L. Ed. 2d 892 (2008); Burgunda V. Sweet et al., Review of the Processes for FDA Oversight of Drugs, Medical Devices, and Combination Products, 17 J. Managed Care Pharmacy 40, 45 (2011).

[2] 21 U.S.C.A. § 360e(c).

[3] 21 U.S.C.A. § 360e(d)(1)(A); Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008).

[4] 21 U.S.C.A. § 360k.

[5] Id.

[6] Riegel, 552 U.S. at 324.

[7] Id.at 324-25.

[8] Id. at 325.

^[9] U.S. Food & Drug Admin., Deciding When to Submit a § 510(k) for a Change to an Existing Device, 8 (Oct. 25, 2017), https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm514771.pdf; see Medtronic, Inc. v. Lohr, 518 U.S. 470, 479 (1996).

[10] U.S. Food & Drug Admin., Deciding When to Submit a § 510(k) for a Change to an Existing Device, 8 (Oct. 25, 2017), https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm514771.pdf.

[11] Medtronic, Inc. v. Lohr, 518 U.S. 470, 494 (1996).

[12] Medical Devices and the Public’s Health: The FDA § 510(k) Clearance Process at 35 Years, p. 153, Committee on the Public Health Effectiveness of the FDA § 510(k) Clearance Process, (2011) [hereinafter Medical Devices and the Public’s Health].

[13] See, e.g., Bertini v. Smith & Nephew, Inc., 8 F. Supp. 3d 246, 254 (E.D.N.Y. 2014); Simon v. Smith & Nephew, Inc., 990 F. Supp. 2d 395 (S.D.N.Y. 2013); Shuker v. Smith Nephew PLC, 2015 WL 1475368, at *1 (E.D. Pa. 2015).

[14] Riley v. Cordis Corp., 625 F. Supp. 2d 769, 779 (D. Minn. 2009) (emphasis in the original).

[15] Id.

[16] Huskey v. Ethicon, Inc., 29 F. Supp. 3d 736, 748 (S.D.W. Va. 2014); LaFountain v. Smith & Nephew, Inc., 2016 WL 3919796, at *6 (D. Conn.).

[17] Huskey, 29 F. Supp. 3d  at 752.

[18] Id.

^[19] U.S. Food & Drug Admin., About FDA, What We Do, https://www.fda.gov/AboutFDA/WhatWeDo/default.htm (last accessed July 6, 2021); Judith Johnson, FDA regulation of medical devices, Congressional research service, https://www.fas.org/sgp/crs/misc/R42130.pdf (Sept. 14, 2016).

^[20] 21 U.S.C.A. § 360c(a).

^[21] U.S. Food & Drug Admin., About FDA, What We Do, https://www.fda.gov/AboutFDA/WhatWeDo/default.htm (last accessed July 6, 2021).

^[22] U.S. Fed. Drug Admin, Laws Enforced by FDA, https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/default.htm (last accessed August 15, 2021).

^[23] Burgunda V. Sweet et al., Review of the Processes for FDA Oversight of Drugs, Medical Devices and Combination Products, 17 J. Managed Care Pharmacy 40, 42 (2011).

^[24] 21 U.S.C.A. § 360c(a).

[25] 21 U.S.C.A. § 321(h).

^[26] Id.

[27] Johnson, supra note 19.

^[28] 21 U.S.C.A. § 360c(a)(1)(C)(ii)(I)-(II).

^[29] Id.

^[30] 21 U.S.C.A. § 360e.

[31] U.S. Fed. Drug Admin, PMA Review Process, https://www.fda.gov/medical-devices/premarket-approval-pma/pma-review-process, (May 22, 2020).

[32] Id.

[33] Id.

[34] Id.

[35] Id.

^[36] Medtronic, Inc. v. Lohr, 518 U.S. 470, 477 (1996); Riegel v. Medtronic, Inc., 552 U.S. 312, 323 (2008).

[37] Lohr, 518 U.S. at 477.

^[38] Peter Barton Hutt et al., Food and Drug Law 39 (3d. ed. 2007).

[39] James M. Flaherty, Jr., Defending Substantial Equivalence: An Argument for the Continuing Validity of the § 510(k) Premarket Notification Process, 63 Food & Drug L.J. 901, 907 (2008)

[40] Id.

^[41] Id.

^[42] Flaherty, supra note 39, at 904 (citing Guidance on the CDRH Premarket Notification Review Program 6/30/86 (K86-3), June 30, 1986, https://www.fda.gov/cdrh/k863.html).

[43] Lohr, 518 U.S. at 479, 116 S. Ct. at 2247.

^[44] Jonathan S. Kahan, Premarket Approval Versus Premarket Notification: Different Routes to the Same Market, 39 Food Drug Cosm. L.J. 510, 514 (1984).

^[45] Lohr, 518 U.S. at 479.

^[46] Burgunda V. Sweet et al., Review of the Processes for FDA Oversight of Drugs, Medical Devices, and Combination Products, 17 J. Managed Care Pharmacy 40, 45 (2011).

^[47] Medical Devices and the Public’s Health, supra note 12, at 36.

[48] Id. at 33.

^[49] Jonathan S. Kahan, Premarket Approval Versus Premarket Notification: Different Routes to the Same Market, 39 Food Drug Cosm. L.J. 510, 514 (1984).

^[50] U.S. Fed. Drug Admin, For Industry, FY 2021 MDUFA User Fees, https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa

^[51] Id.

^[52] 21 U.S.C.A. § 360k(a); see Riegel v. Medtronic, Inc., 552 U.S. 312, 333 (2008) (Ginsburg, R., dissenting).

[53] 21 U.S.C.A. § 360k(a).

^[54] See 21 U.S.C.A. § 360k; Riegel, 552 U.S. at 312.

^[55] Riegel, 552 U.S. at 324.

^[56] Bertini, 8 F. Supp. 3d at 254.

^[57] Riegel, 552 U.S. at 325.

[58] See, e.g., ., Bertini v. Smith & Nephew, Inc., 8 F. Supp. 3d 246, 254 (E.D.N.Y. 2014); Simon v. Smith & Nephew, Inc., 990 F. Supp. 2d 395 (S.D.N.Y. 2013); Shuker v. Smith, 2015 WL 1475368, at *1 (E.D. Pa. 2015).

^[59] Medtronic, Inc. v. Lohr, 518 U.S. 470, 501-02 (1996).

^[60] Id.

[61] Id. at 471.

[62] Medical Devices and the Public’s Health, supra note 12, at 153.

^[63] See Bertini, 8 F. Supp. 3d at 255; but see Huskey v. Ethicon, Inc., 29 F. Supp. 3d 736, 749 (S.D.W. Va. 2014); LaFountain v. Smith & Nephew, Inc., 2016 WL 3919796, at *6 (D. Conn.).

[64] Bertini, 8 F. Supp. 3d at 255.

[65] Id.

^[66] See id. at 246; see also Simon v. Smith & Nephew, Inc., 990 F. Supp. 2d 395 (S.D.N.Y. 2013); Shuker v. Smith & Nephew PLC, 2015 WL 1475368, at *1 (E.D. Pa. 2015).

^[67] Id.

^[68] Bertini, 8 F. Supp. 3d at 253.

^[69] Id.

^[70] Id. at 252.

^[71] Id. at 252-53.

^[72] Id. at 254.

^[73] Id.

^[74] Id. at 255.

^[75] Id. at 253.

[76] Id. at 254.

^[77] Id.

^[78] Id.

^[79] Id.

^[80] Id.

^[81] Id.

^[82] Id; see Shuker v. Smith & Nephew PLC, No. CIV.A. 13-6158, 2015 WL 1475368, at *9 (E.D. Pa. Mar. 31, 2015), aff’d, 885 F.3d 760 (3d Cir. 2018) (T]he FDA does not regulate the use of medical devices—or their components—by physicians, who remain free to use such devices in an off-label manner.”).

^[83] Bertini, 8 F. Supp. 3d at 255.

[84] Id.

[85] Huskey v. Ethicon, Inc., 29 F. Supp. 3d 736, 749 (S.D.W. Va. 2014).

[86] Id.

^[87] Id. at 752.

^[88] Id.

^[89] Id. (citing Riegel v. Medtronic, Inc., 552 U.S. 312, 322 (2008)) (emphasis in original).

[90] Id.

^[91] Id. at 747.

^[92] Id. at 752.

^[93] Id.

^[94] Id. at 747.

^[95] Id.

[96] Id. at 753.

^[97] Lewis v. Johnson & Johnson, 991 F. Supp. 2d 748 (S.D.W. Va. 2014).

^[98] Lewis, 991 F. Supp. 2d at 757.

^[99] Id. at 758.

^[100] Id.

[101] U.S. Food & Drug Admin., supra note 21.

[102] Huskey v. Ethicon, Inc., 29 F. Supp. 3d 736, 758 (S.D.W. Va. 2014).

[103] Bertini v. Smith & Nephew, Inc., 8 F. Supp. 3d 246, 254 (E.D.N.Y. 2014).

[104] Riegel v. Medtronic, Inc., 552 U.S. 312, 324 (2008); Medtronic, Inc. v. Lohr, 518 U.S. 470, 501-02 (1996).

[1] Bertini v. Smith & Nephew, Inc., 8 F. Supp. 3d 246, 254 (E.D.N.Y. 2014).

[1] Riegel v. Medtronic, Inc., 552 U.S. 312, 324 (2008); Medtronic, Inc. v. Lohr, 518 U.S. 470, 501-02 (1996).