July 1, 2008
By HunterMaclean Attorneys, published on July 1, 2008, in Products Liability Perspectives.
This article was co-authored by Melissa Beare, General Counsel with Peerless Manufacturing, Inc.
In a landmark decision, the U.S. Supreme Court in Riegel v. Medtronic, Inc., 552 U.S. __, 128 S. Ct. 999, 169 L. Ed. 2d 892 (2008), ruled that Section 360k of Title 21 of the United States Code, also known as the Medical Device Amendments to the Food, Drug & Cosmetic Act of 1938 (“FDC Act”), establishes “federal requirements” for purposes of preempting state defective design and labeling claims made against Class III medical devices that receive premarket approval (“PMA”) by the U.S. Food and Drug Administration.
Federal preemption of state laws is based on the Supremacy Clause of the U.S. Constitution, Art. VI, Section 2, which holds that certain matters are of such a national, as opposed to local, character that federal laws preempt, or take precedence over, the state laws. As such, a state may not pass a law inconsistent with the federal law. To determine whether a state law is preempted by federal law, courts first determine whether a specific requirement is imposed by the federal law, and, if so, whether the state law imposes different or additional requirements to the federal law. 128 S.Ct. at 1006-1007. When it is clearly established that a federal law preempts a state law, the state law must be declared invalid. A state law may be struck down even when it does not explicitly conflict with federal law, if a court finds that Congress has legitimately occupied the field with federal legislation.
Prior to Riegel, while some federal and state courts recognized the preemptive effect the FDA’s premarket approval process has on a Class III device, this was not a universal rule and some courts still permitted strict liability, negligent design/manufacture, failure to warn, and breach of implied warranty claims to be decided by juries with respect to these medical devices. The 8-to-1 decision in Riegel upholds the FDA’s regulatory authority, and cleared the way with respect to challenges to its rigorous PMA process. Legislation currently pending in Congress, however, may take away what the U.S. Supreme Court recently recognized.
The history of medical device regulation
Prior to the FDC Act, the only pertinent federal statute, the Food and Drugs Act of 1906, did not regulate medical devices. At that point, the FDA could only control medical devices through lawsuits against a manufacturer for marketing an unsafe product based on adulteration or misbranding. However, there was no requirement for premarket testing, review, or approval. Then in the early 1960’s, Congress held extensive hearings in an effort to revise the FDC Act to impose requirements on the development and marketing of medical devices. However, it was not until several years later that any substantive legislation was created in the form of the Medical Device Amendments of 1976 (“MDA”).
In the words of the MDA’s preamble, the purpose of the amendments is “to provide for the safety and effectiveness of medical devices intended for human use.” 90 Stat. 539. The Act classifies medical devices in three categories based on the risk that they pose to the public. Devices that present no unreasonable risk of illness or injury are designated Class I and are subject only to minimal regulation by “general controls.” 21 U.S.C. §§ 360c(a)(1)(A). Devices that are potentially more harmful are designated Class II; although they may be marketed without advance approval, manufacturers of such devices must comply with federal performance regulations known as “special controls.” § 360c(a)(1)(B). Finally, devices that either “present a potential unreasonable risk of illness or injury,” or which are “purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health,” are designated Class III. § 360c(a)(1)(C). See Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S. Ct. 2240 (1996). Of great significance to the medical device industry and to the Court in Riegel is the preemption clause contained in the MDA, which states as follows:
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).
Pre- and Post-Amendment Medical Devices
Following the passage of the MDA, the FDA was faced with preamendment, post amendment and transitional devices. A preamendment device is one that was in commercial distribution before May 28, 1976, the date the MDA was signed into law. In order to continue marketing a preamendment Class III device, a PMA will be required to be submitted once the FDA publishes a regulation calling for the PMA submission. Eventually all Class III devices will require a PMA. Prior to the PMA effective date, these devices must have a cleared Premarket Notification, commonly referred to as a § 510(k) notice, prior to marketing. Examples of Preamendment devices include intra-aortic balloon and control systems (21 CFR § 870.3535), ventricular bypass (assist) devices (21 CFR § 870.3545), cardiovascular permanent pacemaker electrodes (21 CFR § 870.3680), and topical oxygen chambers for extremities (21 CFR § 870.5650).
A post amendment device is one that was first distributed commercially on or after May 28, 1976. Post amendment devices equivalent to preamendment Class III devices are subject to the same requirements as the preamendment devices.
Transitional devices are devices that were regulated by FDA as new drugs before May 28, 1976. Any Class III device that was approved by a New Drug Application (“NDA”) is now governed by the PMA regulations. The Code of Federal Regulations requires these Class III devices to obtain §515 approval before they may be commercially distributed. See, e.g., 21 C.F.R. § 886.3600.
The Premarket Approval Process
Before a new Class III device may be introduced to the market, the manufacturer must provide the FDA with a “reasonable assurance” that the device is both safe and effective. See 21 U.S.C. § 360e(d)(2). Despite its relatively innocuous phrasing, the process of establishing this “reasonable assurance,” is accomplished through a very rigorous “premarket approval,” or “PMA” process. The PMA process involves extensive scientific and regulatory review to evaluate the safety and effectiveness of medical devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. 128 S.Ct. at 1004. Federal law requires that a PMA application and any supplements to the PMA contain the full reports of all investigations of the safety and effectiveness of the device; a full statement of the components, properties and principles of operation of the device; a complete description of the manufacturing methods and processes; performance standards; and all proposed labeling for the device. 21 U.S.C. § 360e(c)(1); 21 C.F.R. §814.20; see also Riegel, 128 S.Ct. at 1004 . The FDA spends on the average 1200 hours on each PMA application. Id. It is only these Class III medical devices marketed pursuant to the PMA process that are subject to the preemption provision of the MDA. Following its review, the FDA may grant or deny premarket approval. 21 U. S. C. § 360e(d). The agency is also free to impose device specific restrictions by regulation. 21 U. S. C. § 360j(e)(1).
It is important to note that the PMA process is a continuing process that does not end once the FDA approves the PMA. 128 S.Ct. at 1004-1005. Following approval, the manufacturer is required to comply with the standards in the PMA approval order. 21 C.F.R. §814.80. Moreover, most pre-market approvals are granted with “conditions of approval” that allow the FDA to continue its oversight of the medical device once the FDA approves the original PMA and any supplements. These conditions include submitting annual reports to the FDA. See 21 C.F.R. §814.84(b); see also www.devadvice.gov/pma. These annual reports identify, among other things, all changes made to the device, 21 C.F.R. §814.84(b)(1), and summarize all unpublished clinical and nonclinical test results, as well as published literature pertaining to the device during the reporting period. 21 C.F.R. §814.84(b)(2)(i) and (2)(ii). The FDA may also issue an order temporarily suspending or withdrawing approval of a PMA. See 21 C.F.R. §§ 814.46 and 814.47.
This continuing oversight applies to all changes that affect the safety or effectiveness of the device including changes to the labeling of the device. See 21 C.F.R. §814.39(a). Once a device receives premarket approval, “the [Medical Device Amendments of 1976] forbid a manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling or any other attribute, that would affect safety or effectiveness.” 21 U.S.C. §360e(d)(6)(A)(i) (emphasis added). “[I]t therefore naturally follows that any changes to a PMA-approved device that might affect the device’s safety and effectiveness will require further FDA approval.” Riegel v. Medtronic, Inc., 451 F.3d 104, 118 (2d Cir. 2006). If a manufacturer makes such a change, it must submit and the FDA must approve, an application for supplemental premarket approval. See 21 U.S.C. 360e (d)(6); 21 C.F.R. 814.39(a) (emphasis added); 128 S.Ct. at 1005. “All procedures and actions that apply to an [original application] * * * also apply to PMA supplements except that the information required in a supplement is limited to that needed to support the change.” 21 C.F.R. 814.39(c). Thus, even the PMA supplementation process imposes requirements specific to the device at issue. See128 S.Ct. at 1005; Riegel, 451 F.3d at 118 (PMA Supplement must be submitted for review and approval by the FDA before any change is made).
A less stringent FDA review process for marketing new Class III medical devices is known as the §510(k) process. Pursuant to §510(k), a medical device may be deemed to be “substantially equivalent” to another medical device already authorized to be marketed pursuant to 21 U.S.C. §510(k). Riegel, 128 S.Ct. at 1004. The §510(k) process is by far the most widely used method to get a new Class III medical device to market. Based on information published by the FDA, the PMA process only accounts for approximately one percent of all Class III medical devices approved by the FDA. Riegel, 128 S.Ct. at 1004 citing P. Hutt, R. Merrill & L. Grossman, Food and Drug Law 992 (3d Ed. 2007). In fiscal year 2005, out of the 3,148 new Class III devices that received approval to enter the market through either the § 510(k) (“substantially equivalent”) or PMA processes, only 32 went through the PMA process. Id. Hence, merely because a Class III medical device is authorized to be marketed does not mean it completed the rigorous PMA process. Significantly, Riegel affects only medical devices that receive premarket approval.
The facts of Riegel and application of the MDA
Riegel involved a Class III medical device, a balloon catheter, used during surgeries to open clogged arteries. Riegel, 128 S.Ct. at 1005. Prior to the marketing and sale of the catheter, Medtronic received approval, through the PMA process, to market the device. Id. Specifically, on August 30, 1994, the FDA approved Medtronic’s PMA application for the Evergreen Balloon Catheter, and on April 27, 1995 and April 8, 1996, the FDA approved Medtronic’s PMA supplements, which requested approval for revised design and labeling for the device. Riegel, 451 F.3d at 107. Riegel was injured after one of these catheters ruptured while he was undergoing coronary angioplasty. Riegel, 128 S.Ct. at 1005.
Following FDA approval of the catheter, his physician used the device during Riegel’s surgery. 128 S.Ct. at 1005. The device burst during the procedure causing complications. Id. Riegel and his wife subsequently filed suit against Medtronic in the Northern District of New York, alleging five state common law causes of action: (1) negligence in the design, testing, inspection, manufacture, distribution, labeling, marketing, and sale of the balloon catheter; (2) strict liability; (3) breach of express warranty; (4) breach of implied warranty; and (5) loss of consortium. Id. In its amended answer, Medtronic raised the affirmative defense of federal preemption by §360k(a) of the 1976 Medical Device Amendments, 21 U.S.C. § 360c-k, to the FDC Act, 21 U.S.C. § 301 et. seq.
Based on the MDA’s preemption clause, Medtronic filed a motion for summary judgment arguing that plaintiffs’ strict liability, breach of implied warranty, and negligent design, testing, inspection, distribution, labeling, marketing and sale of the catheter claims, which were all premised on New York law, were pre-empted based on 21 U.S.C. §360k. Riegel, 128 S.Ct. at 1006 ; 451 F.3d at 107. The district court granted the motion as to these claims, as well as to a claim for negligent manufacturing, “insofar as it was not premised on the theory that Medtronic violated federal law.” Riegel, 128 S.Ct. at 1006. The Second Circuit Court of Appeals affirmed, concluding that the defendant was “clearly subject to the federal device-specific requirement of adhering to the standards contained in its individual, federally approved” premarket approval application. Riegel, 451 F.3d at 118. That court found Riegels’ claims to be preempted because they “would, if successful, impose state requirements that differed from, or added to” the device-specific federal requirements. 451 F.3d at 121. The United States Supreme Court granted certiorari to determine whether the MDA’s preemption clause bars state common-law and statutory claims challenging the safety and effectiveness of a medical device that had received premarket approval by the FDA. In addressing this issue, the Court analyzed whether the PMA process establishes specific federal “requirements” and whether those requirements are “different from, or are in addition to” state requirements that arise through a state-based tort claim. 128 S.Ct. at 1005-6. The Court all but presumed that the safety or effectiveness of the medical device was placed at issue by the claims raised in Riegel.
Prior to Riegel, the issue of preemption of state law claims for premarket approved medical devices was not universal. Much debate still existed over the interpretation of the U.S. Supreme Court’s 1996 decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which addressed the MDA and preemption of state law claims for a medical device that was marketed pursuant to §510(k), and not the PMA process. In Lohr the Court rejected the contention that §510(k) approval imposes federal requirements specific to a given medical device. 129 S.Ct. 1007. However, the door to preemption as it applied to premarket approved devices was left open following Lohr. In order to reach the decision it did, the Court distinguished the Lohr holding that §510(k)-approved devices are not subject to specific federal requirements by noting that a §510(k) device must merely remain substantially equivalent to its relevant pre-1976 device “as a qualification for an exemption rather than a requirement.” 518 U.S. at 493-494. As the Court noted in Lohr, the FDA regulations governing the §510(k) process, “were not requirements specific to the device in question – – they reflected ‘entirely generic concerns about device regulation generally.'” 518 U.S. at 501 cited in 128 S.Ct. at 1006. On the other hand, the Court found that premarket approval does impose requirements specific to individual devices, “[a]nd it is in no sense an exemption from federal safety review – – it is federal safety review.” 128 S.Ct. at 1007 (emphasis in original). The distinction, as noted by the Court, is that §510(k), and not premarket approval, is “focused on equivalence, not safety.” 128 S.Ct. at 1007.
With respect to whether state tort claims establish different or additional requirements, the Court adhered to the view reached in Lohr that state “common-law causes of action for negligence and strict liability do impose ‘requirements’ and would be preempted by federal requirements specific to a medical device.” Riegel, 128 S.Ct. at 1007.
Understandably, Petitioners in Riegel seized on the reasoning in Lohr that state-law damages suits were not preempted, notwithstanding the MDA. Although, Riegel asserted that federal and state appellate courts are divided regarding the proper application of Lohr to the question of preemption under the PMA process, in reality, the majority of the federal courts of appeal that have considered the issue agreed with the Second Circuit. Merely the Eleventh Circuit Court of Appeals and at least one state supreme court have held that the PMA approval process does not preempt state-law damages claims. See Goodlin v. Medtronic, Inc., 167 F.3d 1367 (11th Cir. 1999), Weiland v. Telectronics Pacing System, Inc., 721 N.E.2d 1149 ((Ill. 1999). The Supreme Court resolved this Circuit dispute in favor of preemption.
Ramifications of Riegel
The impact of Riegel is seen in the two significant issues it decided. First, the Court held that the PMA process for Class III medical devices establishes specific federal “requirements” within the meaning of § 360k for each device. 128 S.Ct. at 1006. Second, state law claims similar to those alleged in Riegel establish “requirements” that are “different from, or in addition to” and “relate to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device.” 128 S.Ct. at 1006, citing § 360k(a). Thus, the preemption clause contained in the MDA bars state statutory and common law tort claims challenging the safety and effectiveness of medical devices marketed through the PMA process.
The type of claims that potentially remain are “parallel” state law claims “premised on the theory that [the manufacturer] violated federal law”, i.e., the FDA regulations governing the PMA application. Riegel makes clear that such claims are not preempted. However, some members of Congress are taking steps to ensure plaintiffs are no longer hampered by the preemption clause of the MDA. U.S. Congressman Frank Pallone of New Jersey, and Henry Waxman of California, the chairman of the House Committee on Oversight and Government Reform, are co-sponsoring a bill to amend the FDC Act. The bill, called the Medical Device Safety Act of 2008, was introduced on June 26, 2008 and would amend § 360k to state that the MDA is not intended to “modify or otherwise affect” lawsuits brought in state courts. As the bill is currently written, it would apply to any civil action pending or filed on or after the date of enactment. A companion bill is expected to be introduced in the Senate. Until the Medical Device Safety Act of 2008, or some similar bill becomes law manufacturers of Class III medical devices marketed through the PMA process can remain confident that state tort law claims are all but a thing of the past.
Dennis Keene is a partner with the Savannah, Georgia ALFA firm of Hunter, Maclean, Exley & Dunn, P.C., where he practices in the firm’s business litigation group with an emphasis in products liability and transportation law. For questions concerning this article, he may be reached at (912) 236-0261, or via e-mail at dkeene@huntermaclean.com.
Melissa Beare is the Associate General Counsel for Advanced Neuromodulation Systems, Inc., a division of St. Jude Medical, Inc., which manufactures FDA-approved spinal cord stimulation systems. For questions concerning this article, she may be reached at (972) 309-8636, or via e-mail at Melissa.beare@ans-medical.com.
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1 Investigational devices marketed under an investigational device exemption (IDE) for purposes of a clinical trial constitute another category. See 21 C.F.R. §§ 812-813.
2 See, e.g. Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir. 2004); Martin v. Medtronic, Inc., 254 F.3d 573 (5th Cir. 2001); Brooks v. Howmedica, Inc., 273 F.3d 785 (8th Cir. 2001); Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000); Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 1997).
3 Moreover, it is unclear whether a fraudulent concealment claim would be preempted. See, e.g., In Re: Medtronic, Inc., Implantable Defibrillators Litigation, 05-MDL-1726, D.Minn., Nov. 28, 2006). Such claims assert that the manufacturer withheld “key information” from the FDA. Public policy seems to dictate that the PMA is not complete if information affecting safety and effectiveness is concealed, thus, there would not be any conflicting state requirements at issue to invoke the preemption doctrine.
4 The status of the proposed legislation is current as of June 30, 2008.
