furthering consumer safety of medical …cardozolawreview.com/joomla1.5/content/27-1/mervis... ·...

387

FURTHERING CONSUMER SAFETY OF MEDICAL DEVICES: THE NECESSITY OF A DEVICE-SPECIFIC

STATE LAW AS REQUIRED FOR EXPRESS PREEMPTION UNDER THE MDA

Rachel Mervis*

INTRODUCTION The Supreme Court of the United States is the ultimate tiebreaker

in the American legal system and the institution that guides all the lower courts.1 Congress may write and pass the laws, but the Supreme Court bears the decisive responsibility of interpreting them.2 So how should lower courts proceed when their definitive guide leaves them without a clear interpretation of the law? The Seventh Circuit Court of Appeals voiced its frustration with one such situation in the wake of the Court’s complex Medtronic v. Lohr3 opinion:

[A]lthough we have an obligation to be absolutely faithful to the holdings of the Supreme Court of the United States, the holding in Medtronic contains several ambiguities that impair our ability to perceive with absolute clarity the path that the Court has chosen for us to follow. The ambiguity central to our task is the tension between the [plurality and the concurrence].4 Differing interpretations of the Lohr opinion, resulting from

confusion over the Court’s true holding, left judges and consumers alike

* Managing Editor, Cardozo Law Review. J.D. Candidate (June 2006). The author would like to thank the editors from Cardozo Law Review for their tireless efforts in editing this Note. The author would also like to thank her parents for their continual support throughout law school and life. 1 See JOHN J. COUND ET AL., CIVIL PROCEDURE: CASES AND MATERIALS 1218 (8th ed. 2001). Congress established the appellate courts in 1891. Evarts Act, ch. 517, 26 Stat. 826 (1891) (currently codified as 28 U.S.C. § 43 (2000)). The Act granted the discretionary power of certiorari to the Supreme Court. COUND, supra, at 1218. 2 See KATHLEEN M. SULLIVAN & GERALD GUNTHER, CONSTITUTIONAL LAW § 1 (14th ed. 2001). The power of judicial review is not constitutionally granted to the Supreme Court. The Court established the power in Marbury v. Madison, 5 U.S. 137 (1803). As Justice Marshall said in Marbury, “[i]t is emphatically the province and duty of the judicial department to say what the law is.” Marbury, 5 U.S. at 178. 3 518 U.S. 470 (1996). 4 Mitchell v. Collagen Corp., 126 F.3d 902, 910 (7th Cir. 1997).

388 CARDOZO LAW REVIEW [Vol. 27:1

struggling with the question of whether consumers injured by medical devices may sue the device manufacturers under state common-law claims or whether federal law preempts those claims, leaving those injured without remedy.

In Lohr, the Supreme Court attempted to address a federal circuit split regarding the express federal preemption of state common-law claims by the Medical Device Amendments (MDA or “the Act”) of the Food, Drug, and Cosmetic Act (FDCA).5 Instead of clarifying the criteria for when preemption applies, however, the Court complicated the matter by failing to issue a clear majority opinion, issuing instead a seven-part plurality opinion followed by a concurrence and a dissent.6 A circuit split resulted,7 leaving unresolved whether the MDA preempts general state common-law claims brought by consumers injured by medical devices, even though the state laws are not specific to medical devices (i.e., the state laws are not device-specific).8 Some courts therefore find that the MDA preempts such claims because the adjudication of such claims would result in the imposition of requirements on medical device manufacturers that may conflict with or add to the federal medical device requirements.9

5 Lohr, 518 U.S. at 484 (granting certiorari because the “Courts of Appeals are divided over the extent to which state common-law claims are pre-empted by the MDA,” citing three cases finding against preemption and two cases finding for preemption). Prior to Lohr, nine federal appeals courts found that common-law claims may be preempted by the MDA. The debate between the courts concerned the extent of MDA preemption. Elizabeth G. Harkins, Issues in the Third Circuit: Products Liability—The Effect of Medtronic, Inc. v. Lohr on Third Circuit Products Liability Litigation: Medical Device Amendments Do Not Preempt State Law Tort Claims, 44 VILL. L. REV. 873, 881-83 (1999). 6 Lohr, 518 U.S. at 474; see also Kemp v. Medtronic, Inc., 231 F.3d 216, 224 (6th Cir. 2000) (finding that “[t]he various courts of appeals that have confronted issues of preemption arising under the MDA have struggled mightily with Lohr’s language in the effort to discern its holding”). 7 The aftermath of Lohr generated several circuit splits on MDA preemption of state common-law claims. One such split addressed quite frequently by both the courts and scholars questions whether the Act requires a device-specific federal law. See infra note 37. The preeminent issue is whether the Food and Drug Administration’s (FDA) premarket approval satisfies the federal device-specificity requirement. Also, the Supreme Court in Buckman Co. v. Plaintiffs’ Legal Committee recently settled a second split between circuits, holding that state fraud claims on the Food and Drug Administration are preempted by the MDA. Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 343-44 (2001) (holding that claims of fraud on the FDA are impliedly preempted under the MDA). The Court did not decide whether claims for fraudulent representations to the FDA are expressly preempted under the MDA. Id. at 348 n.2. 8 This Note uses the term “device-specific law” throughout. The phrase simply means a law, either state or federal, that has regulations specific to medical devices, as opposed to a general law. For example, a device-specific state law regulating product marketing would create marketing requirements specific to medical devices, whereas a general state law regulating marketing would apply to any product, including medical devices. 9 Most recently, the Third Circuit Court of Appeals debated the issue in Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir. 2004). Other circuit courts of appeals directly addressed the issue. See Mitchell, 126 F.3d at 912; Oja v. Howmedica, Inc., 111 F.3d 782, 789 (10th Cir. 1997); Papike v. Tambrands, Inc., 107 F.3d 737, 742 (9th Cir. 1997). State cases also have addressed

2005] FURTHERING CONSUMER SAFETY 389

In deciphering the meaning of the MDA, courts analyze the language of the MDA’s express preemption clause, section 360k,10 and the Food and Drug Administration’s (FDA) explanation of the MDA preemption clause in the Code of Federal Regulations (C.F.R.).11 However, neither the MDA nor the C.F.R. provide the courts with a clear definition of whether federal preemption of state claims pertaining to medical devices requires a device-specific law from either the federal or the state regulations.12 Courts then must turn to Lohr, where questions surrounding the Supreme Court’s opinion on MDA preemption derive from the same source: interpreting Justice Stephen Breyer’s concurrence in Lohr.13 Most circuit courts form a majority opinion in Lohr, by reconciling various Justices’ opinions, which supports a holding preempting state common-law claims.14 However, courts divide on the issues of whether Justice Breyer agreed with the plurality or dissent in Lohr and what such an agreement suggests in terms of preemption under the MDA.15

The Supreme Court’s decision is unclear as to the meaning of the MDA, but the Court has provided general guidance for interpreting express preemption clauses. Express preemption of state laws subsists because, in the Supremacy Clause, the United States Constitution grants Congress the power to preempt state laws.16 The MDA clearly includes the issue of whether a device-specific state law is required. See Niehoff v. Surgidev Corp., 950 S.W.2d 816 (Ky. 1997); Armstrong v. Optical Radiation Corp., 57 Cal. Rptr. 2d 763 (Cal. Ct. App. 1996), review denied, No. S057644, 1997 Cal. LEXIS 833, at *1 (Cal. Feb. 19, 1997). 10 21 U.S.C. § 360k(a) (2000) states:

(a) General rule. Except as provided in subsection (b), 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 Act 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 Act.

11 21 C.F.R. § 808.1(d) (2005) states: 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.

12 See 21 U.S.C. § 360k(a); 21 C.F.R. § 808.1(d). 13 See, e.g., Horn, 376 F.3d at 174-76; Martin v. Medtronic, Inc., 254 F.3d 573, 582-83 (5th Cir. 2001); Mitchell, 126 F.3d at 908-11; Papike, 107 F.3d at 742. 14 See, e.g., Brooks v. Howmedica, Inc., 273 F.3d 785, 795 (8th Cir. 2001) (holding that “[m]ost courts of appeal have interpreted Lohr to mean that the MDA preempts common law claims to the extent that they interfere or conflict with specific federal requirements”). 15 See discussion infra Part III.B-C. 16 See U.S. CONST. art. VI, cl. 2, which states:

This Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State to the


an express preemption clause.17 Therefore, the issue becomes how the courts should define the scope of the statute. The Supreme Court stated that, when analyzing express preemption clauses, “the purpose of Congress is the ultimate touch-stone.”18 Thus, the judiciary must determine the congressional purpose of the Act, which the Supreme Court has interpreted as ensuring the safety and effectiveness of medical devices for consumers.19 While this provides the best starting point for analysis, Congress unfortunately did not provide specifics as to how the courts should apply the ambiguous preemption provisions in fulfilling the Act’s purpose.20 Thus, the courts must consider the purpose of the Act when preempting state laws. Effectuating the purpose of the Act requires a thorough legal analysis and necessarily incorporates the public policy concerns surrounding preemption of state common-law claims in medical device suits.

Since Congress did not clarify its intentions in preempting state laws under the MDA, the courts must bear the responsibility and decide the issue. This Note argues that the MDA does not require a device-specific state law along with a device-specific federal law for preemption in order to effectuate the purpose of the MDA—consumer safety. Satisfaction of the preeminent purpose, on behalf of consumers at large, does not require a device-specific state law because of the benefits that accrue when suits against medical device manufacturers are limited. Part I of this Note presents an overview of the MDA itself with an explanation of the different device classifications and various manners in which medical devices gain FDA approval. Part II then provides an explanation of the three Lohr opinions with particular attention to the Justices’ discussions on the specificity of law. Part III reviews the conflict in reconciling Justice Breyer’s concurrence with either the plurality or the dissenting opinion in Lohr. Part IV focuses on the most recent debate on the device-specific state law requirement in the Third Circuit Court of Appeals case of Horn v. Thoratec Corp. Finally, Part V discusses the consequences that a device-specific state law requirement imposes on consumers, including the creation of a stringent narrow MDA preemption test resulting in almost no

Contrary notwithstanding. Preemption in terms of Constitutional law is defined as “[t]he principle (derived from the Supremacy Clause) that a federal law can supersede or supplant any inconsistent state law or regulation.” BLACK’S LAW DICTIONARY 545 (2d Pocket ed. 2001). 17 21 U.S.C. 360k(a). See supra note 10 for the full text of the statute. 18 Medtronic v. Lohr, 518 U.S. 480, 485 (1996) (internal quotation marks and citations omitted); Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992) (internal quotation marks and citation omitted). 19 See infra note 24. 20 See Lohr, 518 U.S. at 489, 491. Congress is silent on the issue of preemption of state common-law remedies, leading the Court to believe that some common-law claims may be maintained following the enactment of the MDA. Id.


preemption of general common-law claims. Although the resulting preemption test enhances an injured consumer’s chances for compensation from medical device manufacturers, courts must also consider the FDA’s position on the preemption issue, as well as the negative effects on the overall consumer population from the likely increase in common-law suits. This part concludes that the MDA should preempt state common-law claims in order to afford consumers the overall benefit of medical devices. Thus, to effectuate the purpose of the MDA, namely to ensure consumer safety, courts should determine that the MDA preempts state common-law claims.

I. THE MEDICAL DEVICE AMENDMENTS OF 1976

A. The History of the Medical Device Act Congress enacted the Medical Device Amendments of 1976 as a

revision of the Food, Drug, and Cosmetic Act of 1938.21 Congress sought to tackle the inadequacy of the FDCA in handling the technological developments spurring from the “sophistication of modern medical devices.”22 In addition, Congress addressed public fear that developed in the 1970s from the rising number of injuries to consumers caused by medical devices.23 Addressing these various concerns, Congress made clear when enacting the MDA that ensuring device safety was its primary goal.24 The Supreme Court reinforced this contention by rejecting a defendant’s interpretation that Congress included the MDA’s preemption clause to promote technological innovation in the field of medical devices by limiting restrictions.25 The

21 Medical Device Amendments of 1976, Pub. L. No. 94-295, § 1(a), 90 Stat. 539 (1976). 22 S. REP. NO. 94-33, at 5 (1975), reprinted in 1976 U.S.C.C.A.N. 1070, 1075. 23 See Lohr, 518 U.S. at 476; Quentin F. Urquhart, Jr. & Robert E. Durgin, Medtronic v. Lohr: Is There a Future for Preemption in Medical Device Cases?, 64 DEF. COUNS. J. 45, 46 (1997). The Dalkon Shield contraceptive device in particular resulted in a significant number of injuries despite reassurances that the product was safe and effective. Id. 24 See Lohr, 518 U.S. at 490 (citing Medical Device Amendments § 1(a), 90 Stat. 539 (holding “[t]he MDA was enacted ‘to provide for the safety and effectiveness of medical devices intended for human use’”)); see also FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 133 (2000) (finding that “[v]iewing the FDCA as a whole, it is evident that one of the Act’s core objectives is to ensure that any product regulated by the FDA is ‘safe’ and ‘effective’ for its intended use”). 25 See Lohr, 518 U.S. at 490 (noting that “the legislative history indicates that any fears regarding regulatory burdens were related more to the risk of additional federal and state regulation rather than the danger of pre-existing duties under common law”). The Senate did acknowledge that the continuing development of medical devices was a concern, however the primary focus of the Senate report was safety issues associated with medical device use. S. REP. NO. 94-33, at 2 (“The Committee wants to encourage their research and development. The Committee also wants to be sure that the FDA has the proper authority to regulate that process so


Court cited the absence of evidence in the congressional hearing and committee reports that Congress intended the MDA to protect manufacturers of defective devices.26 Thus, the MDA’s accepted primary purpose supports protection of consumers, rather than protection of medical device manufacturers, from state common-law claims. This purpose guides the interpretation of the preemption provision, for safety and effectiveness must become the central concern in any MDA preemption clause analysis.27

B. Methods of FDA Approval of Medical Devices

To effectuate the safety purpose of the Act, the FDA Secretary

began classifying medical devices into three different categories based on risk level.28 The FDA uses fewer controls to regulate Class I and II devices than it uses to regulate Class III devices, which support human life. Class III devices, having a “potential unreasonable risk,”29 require that Americans are not put at risk from the use of unsafe and ineffective medical devices.”). 26 Lohr, 518 U.S. at 491 (finding that there is “nothing in the hearings, the committee reports, or the debates suggesting that any proponent of the legislation intended a sweeping pre-emption of traditional common-law remedies against manufacturers and distributors of defective devices”). 27 See supra note 18 and accompanying text. 28 See Brown & Williamson Tobacco Corp., 529 U.S. at 134 (finding that “[r]egardless of which category the FDA chooses, there must be a ‘reasonable assurance of the safety and effectiveness of the device’”) (quoting 21 U.S.C §§ 360c(a)(1)(A)(i), (B), (C) (1994 ed. and Supp. III)); 61 Fed. Reg. 44412 (1996). Medical devices are defined in FDCA § 321(h):

The term “device” . . . means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is— (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

21 U.S.C. § 321(h) (1997). “Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology.” U.S. Food and Drug Administration, Center for Devices and Radiological Health,, Device Advice, Is the Product a Medical Device?, http://www.fda.gov/cdrh/devadvice/312.html (last visited Sept. 18, 2005). 29 21 U.S.C. 360c(a)(1)(C)(ii)(II) (1997); Lohr, 518 U.S. at 477. Class I devices are regulated by general controls and do “not present a potential unreasonable risk of illness or injury”. 21 U.S.C. § 360c(a)(1)(A)(ii)(II); Lohr, 518 U.S. at 477. General controls are those controls required under 21 U.S.C. §§ 351, 352, 360, 360f, 360h, 360i, and 360j. 21 U.S.C. § 360c(h)(1). Class II devices are those devices where general controls are insufficient protection against harm and special controls are instituted. 21 U.S.C. § 360c(a)(1)(B); Lohr, 518 U.S. at 477. Class III


the highest level of FDA controls and represent the majority of preemption cases in the federal courts.30

The medical device classification determines the marketing application routes available for the device manufacturer to take for approval.31 Three different routes to FDA approval apply to Class III devices. The first route, known as substantial equivalence or “the 510(k) process,” requires that a device be safe and effective and “substantially equivalent” to a device not subject to the premarket approval (PMA) process.32 The 510(k) process exempts manufacturers from submitting their device to a full premarket approval. Thus, the 510(k) process’s intent preserves the present marketing requirements of devices that entered the market prior to enactment of the MDA and those devices’ “substantial equivalents.”33 If no substantial equivalent exists for a new device, the 510(k) process is not applicable and the manufacturer must use the second route, the PMA process. The PMA process involves the most stringent approval path and the FDA must successfully approve a medical device via the PMA process prior to devices require even further controls in the form of Premarket Approval because they either support or sustain human life or present “a potential unreasonable risk of illness or injury.” 21 U.S.C. § 360c(a)(1)(C)(ii)(I), (II). 30 For Class III device PMA preemption cases and an explanation of the PMA process, see infra notes 34, 37. While the majority of preemption cases in federal appeals courts involve Class III devices, some significant cases have involved Class II devices. Class II device MDA preemption cases have been heard in both the Ninth and Tenth Circuits. See Papike v. Tambrands Inc., 107 F.3d 737, 739 (9th Cir. 1997) (considering Tampax’s warnings of Toxic Shock Syndrome associated with the use of tampons); Oja v. Howmedica, Inc., 111 F.3d 782, 787 (10th Cir. 1997) (considering a prosthetic hip replacement system following device reclassification from Class III to Class II by the FDA). 31 See U.S. Food and Drug Administration, Center for Devices and Radiological Health, Device Advice, Getting to Market with a Medical Device, http://www.fda.gov/ cdrh/devadvice/3122.html (last visited Sept. 18, 2005). 32 U.S. Food and Drug Administration, Center for Devices and Radiological Health, Device Advice, Premarket Notification 510(k), http://www.fda.gov/cdrh/devadvice/314.html (last visited Sept. 18, 2005). Substantial equivalents are devices that are comparable to a device currently on the market and are therefore, not subject to PMA approval:

Applicants must compare their 510(k) device to one or more similar devices currently on the U.S. market and make and support their substantial equivalency claims. A legally marketed device is a device that was legally marketed prior to May 28, 1976 (preamendments device), or a device which has been reclassified from Class III to Class II or I, a device which has been found to be substantially equivalent to such a device through the 510(k) process, or one established through Evaluation of Automatic Class III Definition. The legally marketed device(s) to which equivalence is drawn is known as the “predicate” device(s). Applicants must submit descriptive data and, when necessary, performance data to establish that their device is SE to a predicate device. Again, the data in a 510(k) is to show comparability, that is, substantial equivalency (SE) of a new device to a predicate device.

Id. 33 Lohr, 518 U.S. at 493-94 (finding no evidence in either the statutes or legislative history that the 510(k) process was intended to substitute for a complete premarket approval and instead was intended to allow manufacturers to compete under the same terms as medical device manufacturers that released equivalent products prior to 1976).


marketing.34 The third route, an “IDE approval,” allows for the use of the medical device in a study for the collection of scientific evidence on safety and effectiveness without meeting all the requirements of either a PMA or a 510(k) approval.35

The type of FDA approval process utilized for a medical device significantly impacts the courts’ federal preemption analyses.36 Most courts have found that the 510(k) approval process fails to meet the device-specific federal law requirement, whereas the PMA process satisfies the requirement.37 Although the type of approval process used

34 See U.S. Food and Drug Administration, Center for Devices and Radiological Health, Device Advice, Overview, http://www.fda.gov/cdrh/devadvice/pma/ (last visited Sept. 18, 2005). The premarket approval process is defined in 21 U.S.C. § 360e. The requirements and procedures for approval are extremely complex. Some of the requirements involved include:

(A) full reports of all information, published or known to or which should reasonably be known to the applicant, concerning investigations which have been made to show whether or not such device is safe and effective; (B) a full statement of the components, ingredients, and properties and of the principle or principles of operation, of such device; (C) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such device; (D) an identifying reference to any performance standard under section 514 [21 USCS § 360d] which would be applicable to any aspect of such device if it were a class II device, and either adequate information to show that such aspect of such device fully meets such performance standard or adequate information to justify any deviation from such standard; (E) such samples of such device and of components thereof as the Secretary may reasonably require, except that where the submission of such samples is impracticable or unduly burdensome, the requirement of this subparagraph may be met by the submission of complete information concerning the location of one or more such devices readily available for examination and testing; (F) specimens of the labeling proposed to be used for such device; and (G) such other information relevant to the subject matter of the application as the Secretary, with the concurrence of the appropriate panel under section 513 [21 USCS § 360c], may require.

21 U.S.C. § 360e(c)(1) (2000). 35 See U.S. Food and Drug Administration, Center for Devices and Radiological Health, Device Advice, IDE Overview, http://www.fda.gov/cdrh/devadvice/ide/index.shtml (last visited Sept. 18, 2005). The IDE process does not subject the device to the same requirements as other commercially distributed devices, but it does require: 1) study approval by the Institutional Review Board and, if necessary, the FDA; 2) informed consent by all patients utilizing the device; 3) “investigational use only” labeling; 4) monitoring of the study; and 5) records and reports. Id. 36 See, e.g., Martin v. Medtronic, Inc., 254 F.3d 573, 577-78 & n.4 (5th Cir. 2001):

In Lohr, the Supreme Court considered whether state tort claims were preempted when the FDA subjected the medical device to § 510(k) notification under the MDA, a process, as we have noted, far less thorough than the PMA process presented in this case. . . . As the Supreme Court itself has observed, the PMA process and the § 510(k) process are clearly distinguishable.

See also Horn v. Thoratec Corp., 376 F.3d 163, 169 (3d Cir. 2004); Brooks v. Howmedica, Inc., 273 F.3d 785, 794-95 (8th Cir. 2001); Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1369-70 (11th Cir. 1999). 37 The issue of whether or not a device-specific federal law is required for preemption has been addressed by the majority of appellate courts in connection with devices approved under the PMA process of the MDA. All but the Eleventh Circuit held after Lohr that PMA approval of a Class III medical device satisfies the device-specific federal law requirement under the MDA.


assists courts in determining whether the federal device-specific requirement is satisfied, it provides no insight as to the state device-specificity issue. The courts should therefore look to the guiding principles outlined by the Supreme Court in interpreting the MDA preemption clause in terms of state device-specificity.

C. Federal Preemption of State Laws

The Supreme Court identified two presumptions associated with

the interpretation of a federal express preemption clause.38 First, federal laws do not preempt state powers unless it is the “clear and manifest purpose” of Congress to do so.39 Second, the Congressional purpose for a federal law develops into the “ultimate touchstone” in deciding a preemption case.40 Thus, defining the scope of the preemption clause focuses on the intent of Congress in creating such a provision. Primarily, the language of the statute and the statutory framework determine Congress’s intent, although the court will also analyze the overall regulatory scheme.41 In addition, if Congress includes an express preemption provision, the courts should not consider implied See Horn, 376 F.3d 163; Brooks, 273 F.3d 785; Martin, 254 F.3d 573; Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000); Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 1997). But see Goodlin, 167 F.3d 1367. Courts have rejected the 510(k) process as satisfying the device-specific federal law requirement. See, e.g., Martin, 254 F.3d at 582 (stating that “the federal § 510k requirements were not specific [with respect to medical devices]”); Mitchell, 126 F.3d at 911 (holding that “the PMA process, as opposed to the ‘substantially equivalent’ process at issue in Medtronic, can constitute the sort of specific federal regulation of a product that can have preemptive effect”). 38 There are three ways Congress can statutorily preempt state laws: express, implied, and conflict preemption. Hawkins v. Leslie’s Pool Mart, Inc., 184 F.3d 244, 247 (3d Cir. 1999). Express preemption occurs when the statutory language explicitly preempts state law. See Robin H. Turner, Preemption of State Product Liability Claims Involving Medical Devices: Premarket Approval As a Shield Against Liability, 72 WASH. L. REV. 963, 970 (1997) (stating that “[e]xpress preemption occurs when Congress declares in a statute its intent to displace state law”). Implied preemption occurs when a federal law encompasses a field so thoroughly that there is no room for the states to supplement the area with their own laws. See Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992) (finding implied preemption where “federal law so thoroughly occupies a field as to make reasonable the inference that Congress left no room for the States to supplement it”) (internal quotation marks omitted); Turner, supra, at 970 (stating that “[i]mplied preemption occurs when a court infers from a statute’s structure and purpose that Congress intended to preempt state law”). Conflict preemption occurs when there is an actual conflict between a state and federal law. Cipollone, 505 U.S. at 516 (finding that “state law is pre-empted if that law actually conflicts with federal law”). 39 Medtronic v. Lohr, 518 U.S. 470, 485 (1996) (holding that there are “two presumptions about the nature of preemption. First . . . that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress . . . [and second,] that the purpose of Congress is the ultimate touchstone in every pre-emption case”) (internal quotation marks and citations omitted). 40 Id. 41 Id. at 487.


preemption in analyzing that statute.42 However, application of the two express preemption presumptions to the MDA becomes complicated due to the ambiguous language of the preemption clause itself.

D. The MDA Express Preemption Clause

Found within chapter nine of the FDCA, the MDA express

preemption clause asserts that a state may not establish any statute or ordinance that conflicts with or adds additional requirements to the federal device-marketing requirements.43 However, the Act does not define the term “requirement,” producing much controversy surrounding the need for device-specificity in both the state and federal laws in the preemption analysis.44 The express preemption provision of the MDA asserts that no state may establish a requirement “which is different from, or in addition to, any requirement applicable under this Act to the device.”45 It is not clear whether “requirement” includes state common-law claims, and the FDA’s explanation provides no further insight.

The FDA’s attempt to explain section 360k in its regulations provided little assistance in clarifying the term “requirement.” The C.F.R., in section 808.1(d), states that the MDA preempts a state or local law only when the FDA establishes “specific” regulations or requirements applicable to a “particular device.”46 Accordingly, the FDA finds that the MDA would preempt any current state law that is “divergent” from the federal law.47 The regulation reads as ambiguously as the statute and provides no clarification as to whether the MDA preempts state common-law claims. Thus, the statutes and regulations themselves lack a solid foundation for determining the requirements for MDA preemption, leaving the Supreme Court’s Lohr opinion as the lower courts’ best resource. 48 42 Kemp, 231 F.3d at 222 (holding that “where as here, Congress has included an express preemption provision in a statute, a court may not look beyond it to consider implied preemption. Rather, ‘Congress’ [sic] enactment of a provision defining the pre-emptive reach of a statute implies that matters beyond that reach are not pre-empted.’” (quoting Cipollone, 505 U.S. at 517)); SULLIVAN & GUNTHER, supra note 2, at 319 (noting that “[w]hen preemption is express, the only issue is whether a state statute falls within the area preempted. The two types of implied preemption, however, require further analysis.”). 43 21 U.S.C § 360k(a) (2000). 44 See, e.g., Lohr, 518 U.S. at 487-89; Brooks v. Howmedica, Inc., 273 F.3d 785, 794 (8th Cir. 2001) (noting that “[t]he crux of the disagreement in Lohr between the Stevens majority and the dissenters is the meaning to be given to the statutory phrase ‘a requirement different from, or in addition to’”); Mitchell v. Collagen Corp., 126 F.3d 902, 906 (7th Cir. 1997). 45 21 U.S.C § 360k(a). See supra note 10 for the full text of the statute. 46 21 CFR § 808.1(d) (2005). See supra note 11 for the full text of the regulation. 47 21 C.F.R. § 808.1(d). 48 See Horn v. Thoratec Corp., 376 F.3d 163, 174 (3d Cir. 2004).


E. Problems in Interpreting the MDA Preemption Clause Prior to Medtronic v. Lohr

Prior to Lohr, courts struggled with the preemptive effect of the

MDA’s express preemption clause. Until the Supreme Court ruling in Cipollone v. Liggett Group, Inc.,49 courts often rejected preemption of state common-law claims.50 However, after Cipollone, the majority of appeals courts found that the MDA preempted state common-law claims.51 Yet the Ninth Circuit Court of Appeals, in Kennedy v. Collagen Corp., rejected this position and found that the MDA did not preempt common-law claims because they are general liability claims.52 Also, the Fifth Circuit Court of Appeals, in Feldt v. Mentor Corp., found that the MDA preempted only some common-law claims, depending on whether federal rules already existed in that area of regulation.53 In addition, the federal courts used different criteria to determine the extent of preemption under the MDA. These criteria included: the FDA approval process utilized; the classification of the device; and whether specific state and/or federal regulations existed.54 A fervent need for clarification on the issue of MDA preemption developed and, thus, the Supreme Court granted certiorari in Lohr.

II. THE MEDTRONIC V. LOHR OPINIONS

Three different opinions comprise Lohr—a plurality, a dissent, and

a concurrence written by Justices Stevens, O’Connor, and Breyer, respectively.55 In granting certiorari to the Eleventh Circuit Court of Appeals, the Supreme Court sought to resolve the split among the federal courts of appeals as to whether the MDA preempts state common-law claims.56 Lohr brought the case when her pacemaker

49 505 U.S. 504 (1992). 50 See Turner, supra note 38, at 973 (noting that “[u]ntil the 1990s, courts generally rejected the argument that the MDA preempted state product liability claims. . . . However, courts became more amenable to preemption arguments after Cipollone v. Liggett Group, Inc.”). 51 See id. 52 Kennedy v. Collagen Corp., 67 F.3d 1453, 1458 (9th Cir. 1995) (holding that “[w]hile most courts have found that at least some, if not all, state common-law claims are preempted by the MDA, these courts have failed to devote any attention to the meaning of ‘general applicability’ within the context of the MDA and its accompanying regulations”). 53 Feldt v. Mentor Corp., 61 F.3d 431, 436 (5th Cir. 1995) (holding that preemption depends “on whether there are any specific federal requirements applicable to the device . . . these regulations need not be device-specific; they need only apply generally to the device at issue”). 54 See Harkins, supra note 5, at 883 & nn.56-58. 55 Medtronic v. Lohr, 518 U.S. 470, 474 (1996). 56 Id. at 484 (granting certiorari “[b]ecause the Courts of Appeals are divided over the extent to which state common-law claims are pre-empted by the MDA”).


failed, resulting in emergency surgery, due to a faulty lead57 manufactured by Medtronic.58 The pacemaker graded as a Class III device and received approval by the FDA under the “substantially equivalent” section 510(k) process.59 The circuit court found that the MDA did not preempt Lohr’s negligent design claims, but that the MDA did preempt her negligent manufacturing and failure to warn claims.60 The Supreme Court reversed, holding no MDA preemption of any of the Lohr’s claims. However, the reasoning of the plurality opinion did not resolve many of the crucial issues that arise when applying Lohr to PMA cases.61

A. Justice Stevens’s Plurality Opinion

Justice Stevens spent a significant part of his opinion comparing

the preemption clause in the MDA to the preemption provision previously reviewed by the Supreme Court in Cipollone.62 The Court rendered another split opinion in Cipollone, where the plurality held that the Federal Cigarette Labeling and Advertising Act, as amended in 1969, preempts state common-law claims requiring additional or different warnings in the defendant’s advertising or promotion.63 The central inquiry concerned the same key word found in the MDA, “requirement,” and whether this term included state common-law claims.64 Distinguishing Cipollone, where the federal statute directly conflicts with any state cigarette advertising statute, Justice Stevens determined that the MDA only preempts a state law when the FDA creates a “relevant federal ‘requirement.’”65 Medtronic interpreted “requirement” as preempting all common-law claims, because they impose duties that conflict with those of the FDA.66 Justice Stevens’s

57 A pacemaker lead transmits an electrical signal from the “pulse generator” to the heart in order to steady the heartbeat. Id. at 480. 58 Id. at 481. 59 Id. at 477, 480. 60 Id. at 483. The Eleventh Circuit interpreted 21 C.F.R. § 808.1(d) to mean “that the federal requirement should, in some way, be restricted by nature to a particular process, procedure, or device and should not be completely openended” in preempting two of Lohr’s claims. Id. (internal quotation marks and citation omitted). 61 See, e.g., supra note 7. 62 Lohr, 518 U.S. at 484-502. 63 Cipollone v. Liggett Group, Inc., 505 U.S. 470, 524 (1992). 64 See id. at 523-24. 65 Lohr, 518 U.S. at 496. The plurality stated that Congress delegated the authority to the FDA to implement the MDA and that the FDA is “uniquely qualified” to determine whether the objective of the MDA is being met. Id. 66 Id. at 486 (stating that “Medtronic suggests that any common-law cause of action is a ‘requirement’ which alters incentives and imposes duties ‘different from, or in addition to,’ the generic federal standards that the FDA has promulgated in response to mandates under the


concern in rejecting such an interpretation centered on the fact that Congress did not intend to preempt all state common-law claims. Preempting all common-law claims denies injured consumers any form of relief against medical device manufacturers and grants immunity to the industry the MDA intended to regulate.67

In Part V of his opinion, however, Justice Stevens did not rule out a “general” state requirement from MDA preemption. He stated that preemption of a “specific” state requirement properly arises under section 360k when it “threatens to interfere” with a federal requirement.68 On the whole, the plurality held that the Act does not preempt state common-law claims because of their general requirements and, therefore, that the claims cannot be “with respect to” a specific medical device.69 Since state common-law claims fail to meet the device-specific requirement of the MDA, the plurality stated that “few, if any” of the state common laws fell within MDA preemption.70 Thus, the plurality held that since the state common-law claims brought by Lohr were not specific to the medical device in question, they were not the type of state requirements that Congress intended to preempt.71

MDA”). 67 See id. at 487. Justice Stevens provided three reasons why Medtronic’s interpretation of “requirement” was “not only unpersuasive, it [was] implausible”:

Under Medtronic’s view of the statute, Congress effectively precluded state courts from affording state consumers any protection from injuries resulting from a defective medical device. Moreover, because there is no explicit private cause of action against manufacturers contained in the MDA, and no suggestion that the Act created an implied private right of action, Congress would have barred most, if not all, relief for persons injured by medical devices. Medtronic’s construction of [section] 360k would therefore have the perverse effect of granting complete immunity from design defect liability to an entire industry that, in the judgment of Congress, needed more stringent regulation in order ‘to provide for the safety and effective of medical devices intended for human use’ . . . and it would take language much plainer than the text of § 360k to convince us that Congress intended that result.

Id. 68 Id. at 500 (holding that “it is impossible to ignore [the statute’s] overarching concern that pre-emption occur only where a particular state requirement threatens to interfere with a specific federal interest”). 69 Id. at 502 (holding that “state requirements escape preemption not because the source of the duty is a judge made common-law rule, but rather because their generality leaves them outside the category of requirements that [section] 360k envisioned to be ‘with respect to’ specific devices such as pacemakers”). 70 Id. (holding that “few, if any, common-law duties have been pre-empted by this statute”). 71 Id. at 501.


B. Justice O’Connor’s Dissenting Opinion Justice O’Connor disagreed with the plurality in viewing the

“specificity” of the state law as an incidental element of the preemption analysis.72 Focusing on the statutory language itself, O’Connor noted that the Act contained no explicit mention of a specificity requirement.73 Instead, the dissent interpreted the MDA as finding preemption when the state common-law claim presents “any requirement” different from or in addition to an FDA device requirement.74 In Lohr, such an interpretation would have preempted the common-law claims regarding manufacturing and labeling requirements, for such claims develop into requirements “different from or in addition to” those required by the FDA.75 Justice O’Connor held that adjudicating common-law claims created “requirements” for medical device manufacturers. Since manufacturers must comply with any resulting judicial requirements, the MDA must preempt those state common-law claims that would produce different or additional requirements.76

72 Id. at 511; Kemp v. Medtronic, Inc., 231 F.3d 216, 224 (6th Cir. 2000) (interpreting Justice O’Connor’s dissent and finding that “[i]n stark contrast to the Justices joining Justice Stevens’ [sic] opinion, the O’Connor block did not believe that the state common-law had to be ‘specific’ to be preempted”). Justice O’Connor commented that both Justice Stevens’s plurality opinion and Justice Breyer’s concurrence gave too much deference to the FDA’s interpretation of the MDA, which relied on device-specificity. Justice O’Connor noted that “[w]here the language of the statute is clear, resort to the agency’s interpretation is improper.” Lohr, 518 U.S. at 512. 73 Lohr, 518 U.S. at 512. (finding that “[b]ecause the statutory language does not indicate that a ‘requirement’ must be ‘specific,’ either to pre-empt or be pre-empted, I conclude a state common-law claim is pre-empted if it would impose ‘any requirement applicable to the device under the FDCA’”). 74 Id. (finding that “a fair reading of [section] 360k indicates that state common-law claims are pre-empted, as the statute itself states, to the extent that their recognition would impose ‘any requirement’ different from, or in addition to, FDCA requirements applicable to the device”). 75 Id. at 513 (finding that “[s]ome, if not all, of the Lohrs’ common-law claims regarding the manufacturing and labeling of Medtronic’s device would compel Medtronic to comply with requirements different from, or in addition to, those required by the FDA”). The manufacturing and labeling claims are governed by the FDA’s Good Manufacturing Practices and Justice O’Connor held that such federal regulations were enough to preempt state common-law claims. Id. Justice O’Connor noted that the state damage remedy itself was not preempted by the MDA, for “[s]ection 360k does not preclude States from imposing different or additional remedies, but only different or additional requirements.” Id. 76 Id. at 510 (“[t]he phrase, ‘no requirement or prohibition’ sweeps broadly and suggests no distinction between positive enactments and common-law; to the contrary those words easily encompass obligations that take the form of common-law rules”) (quoting Cipollone v. Liggett Group, Inc., 505 U.S. 504, 521 (1992)). Furthermore, Justice O’Connor asserted that, “state common-law damages actions operate to require manufacturers to comply with common-law duties” and that the MDA would preempt any conflicting state common-law action “just as it would pre-empt a state statute or regulation that had that effect.” Id. at 510-11. Justice O’Connor also noted that Justice Breyer reached the same conclusion in his opinion. Id. at 511.


C. Justice Breyer’s Concurring Opinion Justice Breyer’s opinion creates confusion in that it concurs with

the plurality, yet courts may also interpret the opinion as an agreement with the dissent. Justice Breyer began his opinion by agreeing with Justice O’Connor’s dissenting opinion in that the MDA may preempt a state common-law claim. He argued that without such an interpretation, “anomalous consequences” would result.77 Justice Breyer then followed with a specific example involving a hearing aid to demonstrate when a federal FDA regulation preempts a state common-law tort action.78 The hearing aid example highlighted the concept that a state common-law claim, once adjudicated, may create a device-specific requirement as a result of the rendered judgment.79 Justice Breyer ended his opinion by clarifying that he did not join the plurality in their emphasis of the distinction between the preemption statutes here and in Cipollone, because of its irrelevancy to the case at bar.80 He also disagreed with the plurality’s belief that preemption of state common-law claims by the MDA would be “rare.”81 Justice Breyer delivered an unclear position, however, because he stated that he agreed with Justice O’Connor’s dissent but joined Justice Stevens in Part V of the plurality opinion.82

77 Id. at 503-04. 78 Id. at 504. Justice Breyer’s state common-law preemption example is as follows:

Imagine that, in respect to a particular hearing aid component, a federal MDA regulation requires a 2-inch wire, but a state agency regulation requires a 1-inch wire. If the federal law, embodied in the “2-inch” MDA regulation, pre-empts the state “1-inch” agency regulation, why would it not similarly pre-empt a state-law tort action that premises liability upon the defendant manufacturer’s failure to use a 1-inch wire . . . ? The effects of the state agency regulation and the state tort suit are identical.

Id. 79 See id. at 504-05 (clarifying the meaning of his example, Justice Breyer stated that “insofar as the MDA pre-empts a state requirement embodied in a state statute, rule, regulation, or other administrative action, it would also pre-empt a similar requirement that takes the form of a standard of care or behavior imposed by a state-law tort action”). 80 Id. at 508. 81 Id. 82 Id. at 474; Urquhart & Durgin, supra note 23, at 50 (suggesting that “[a]lthough Justice Breyer joined Part V of the opinion, it is highly unlikely that he would subscribe to Justice Stevens’ [sic] analysis of this particular issue [that general state laws imposing due care are not specific enough for preemption], for to do so would be at odds with the reasoning of his own concurring opinion”).


III. THE DEBATE OVER JUSTICE BREYER’S OPINION The Seventh Circuit expressed that the “ambiguity” in Lohr made

interpreting the holding of the case a difficult task.83 To form a majority holding in Lohr, a court must reconcile Justice Breyer’s opinion with either the plurality or the dissent.84 Justice Breyer, however, did not side completely with either the dissent or the plurality as to device-specificity and, instead, several different splits of five to four Justices, depending upon the interpreting court’s determination, developed out of the three Lohr opinions.85 On the issue of state device-specificity, Justice Breyer sided with Justice Stevens to the extent that he joined in Part V.86 As to state device-specificity, Justice Stevens interpreted the statutory and regulatory language as requiring that state requirements be “with respect to” medical devices. He therefore found that the language stays preemption of state requirements of “general applicability,” i.e., common-law claims.87 Justice Breyer’s hearing aid example,88 however, demonstrates that he did not fully agree with the extent of Justice Stevens’s “generality.” Like Justice O’Connor, Justice Breyer instead looked at the “actual conflict” created between the state and federal law to determine if a device-specific state requirement includes common-law claims.89 Different resolutions of these two opinions by the lower courts created a circuit split on the requirement of device-specific state laws for preemption under the MDA.

83 Mitchell v. Collagen Corp., 126 F.3d 902, 910 (7th Cir. 1997) (finding that “[t]he ambiguity central to our task is the tension between the holding of the Court . . . and Justice Breyer’s belief, essential to the formation of a majority”). 84 The Fifth Circuit narrowly interpreted the plurality opinion to allow for the incorporation of Justice Breyer’s opinion. The resulting interpretation holds that general common-law claims may create specific requirements that conflict with FDA requirements and, thus, are subject to preemption under the MDA. Martin v. Medtronic, Inc., 254 F.3d 573, 582 (5th Cir. 2001) (holding that “[u]sing Justice Breyer’s concurrence as a guide, we can conclude only that general duties of care can generate specific requirements that conflict with specific FDA requirements”). A majority of circuits interpreted Lohr similarly in finding preemption if the resulting common-law requirements “interfere or conflict” with federal requirements. See supra note 14. The Fifth Circuit, like most courts struggling to interpret Lohr for PMA situations, recognized that “[o]n its face, therefore, Lohr is limited to a finding that the § 501(k) process does not create specific federal requirements that conflict with state tort actions. . . . Thus, the fact that the § 501(k) process did not preempt state causes of action in Lohr does not indicate that the PMA process cannot preempt state tort causes of action.” Martin, 254 F.3d at 584. 85 See Scott W. Sayler & Steven M. Thomas, Post-Decision Diagnosis: Medical Device Preemption Alive and Mostly Well After Medtronic, Inc. v. Lohr, 6 ANNALS HEALTH L. 185, 198-99 (1997) (laying out five-to-four splits that favored and opposed defendants from the “labyrinth” of the Lohr opinions). 86 See id. 87 Lohr, 518 U.S. at 500. 88 See supra note 78. 89 See Lohr, 518 U.S. at 508. See also Urquhart & Durgin, supra note 23, at 56-57.


A. The Development of Circuit Court Preemption Tests Following Medtronic v. Lohr

Justice Stevens attempted to outline the requirements for

preemption of state common-law requirements through use of the statutory language of section 360k(a).90 Although not literally declaring this a “preemption test,” several federal circuit courts took Justice Stevens’s words and converted them into three-prong tests in their struggle to interpret the Lohr opinion. The Sixth Circuit Court of Appeals applied a test that provides that preemption occurs when: (1) FDA regulations or other federal laws establish specific federal requirements; (2) the federal requirements apply to a particular medical device; and (3) state regulations that are “different from, or in addition to” the specific federal requirements are preempted.91 The Fifth, Eighth, and Eleventh Circuit Courts of Appeals also developed three-prong preemption tests, with minor variations to that of the Sixth Circuit. 92 The common prong of all the three-part tests is the 90 See Lohr, 518 U.S. at 500. 91 Kemp v. Medtronic, Inc., 231 F.3d 216, 224 (6th Cir. 2000) (commenting that courts of appeals considering MDA preemption have “translated Lohr’s emphasis on the FDA regulations to focus on whether (1) the FDA has established specific counterpart regulations or other specific federal requirements; that are (2) applicable to a particular device; and thus (3) make state regulations different from, or in addition to, the specific FDA requirements”) (citations omitted). The Sixth Circuit did include a disclaimer after the above three prongs, holding that state requirements “that merely ‘affect devices’ are not preempted if such regulations are not ‘requirements applicable to a device’ within the meaning of the MDA.” Id. at 225. 92 See Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1372 (11th Cir. 1999) (holding that “the Lohr Court read section 360k(a) to demand three things: (1) the imposition of a specific federal requirement that (2) applied to a particular device and (3) focused on the safety and effectiveness of the device”); Martin v. Medtronic, Inc., 254 F.3d 573, 578 (5th Cir. 2001). The Fifth Circuit test states:

First, there must be a state requirement specifically developed with respect to medical devices that is different from or in addition to federal requirements. Second, the state requirement must relate to the safety or effectiveness of the device, or ‘other matter included in a requirement applicable to the device.’ State requirements of ‘general applicability are not preempted except where they have the effect of establishing a substantive requirement for a specific device.’ Third, the federal requirements must be specific to the particular device.

Id. (citations omitted). The Eighth Circuit test is similar to that of the Fifth Circuit, except that the Fifth Circuit does not use the terminology of “different from, or in addition to” in the second prong of its test. See Brooks v. Howmedica, Inc., 273 F.3d 785, 793 (8th Cir. 2001). It should be noted that the Eleventh Circuit provides an alternative reading of the Supreme Court’s interpretation of section 360k(a)’s “safety and effectiveness” requirement. The court points out that, although the Supreme Court interpreted the provision as modifying the federal requirement, “an argument could be made that the more natural reading of the provision is as a limitation on the state requirement.” Goodlin, 167 F.3d at 1374 n.12. In Armstrong, the California Court of Appeal also outlined a three-prong test based on Lohr. It identified three factors required for preemption of a state common-law claim: “(1) a state requirement specifically developed with respect to medical devices (2) which is different from or in addition to (3) a federal requirement specific to a particular device.” Armstrong v. Optical Radiation Corp., 57 Cal. Rptr. 2d 763, 770 (Cal. Ct. App. 1996). The device-specific federal law requirement is present in this analysis as


application of the federal requirement to a particular device, i.e., the requirement of a device-specific federal law, followed by an analysis of the state common-law claim to determine whether it conflicts with the federal law.93

The Tenth Circuit Court of Appeals breaks with the other circuit courts in creating three-prong tests and instead establishes a two-prong test for preemption based on section 360k’s language.94 A simple summary of the two-prong test reveals that preemption under the MDA must meet two requirements: the inclusion of (1) a device-specific federal law; and (2) a device-specific state law.95 The Tenth Circuit repeats the language used by the other circuit courts in the second prong of its test. Thus, what at first glance appear as clear, mechanical tests developed by the circuit courts in order to perform a preemption analysis under the MDA, instead propagate the confusion over the language in Lohr.

B. Federal Circuit Courts Holding that Lohr Supports Preemption of

Common-Law Claims The Fifth and Sixth Circuit Courts of Appeals’ interpretations of

state requirements “with respect to” a particular device and “different from, or in addition to” federal requirements conflicted with that of the Tenth Circuit. The Fifth Circuit attempted to reconcile Lohr with its pre-Lohr circuit precedent, Stamps v. Collagen Corp.96 In doing so, the Fifth Circuit determined that their inquiry must focus on whether the common-law duties created specific state requirements that conflicted with the specific federal requirements.97 The court determined that well. 93 See supra note 37 for cases on the federal-device specific law requirement. 94 See Oja v. Howmedica, Inc., 111 F.3d 782, 788 (10th Cir. 1997). 95 See id. The Tenth Circuit test is as follows:

Based on the MDA’s statutory language and the FDA’s regulation, the [Supreme] Court developed a two-prong inquiry to determine the preemptive scope of the MDA. First, a federal requirement must be “applicable to the device” in question. In other words, a federal requirement will preempt state law only if “specific” to a “particular device.” Second, a state requirement must be “with respect to” a medical device and must be “different from, or in addition to” a federal requirement.

Id. 96 See Martin, 254 F.3d at 579 (holding that “[b]ecause these holdings [from the Lohr opinion] do not explicitly decide the case before us, we must compare Lohr with Stamps, the circuit precedent that we are required to follow”). In Stamps, the Fifth Circuit held that state product liability claims were preempted by the MDA. Id. at 575 (citing Stamps v. Collagen Corp., 984 F.2d 1416, 1422 (5th Cir. 1993)). 97 See id. at 583 (finding that “[a]fter Lohr, however, we need to consider more than whether the common-law duties relate to safety, effectiveness, or other MDA requirements; we need to focus on whether the specific requirements imposed by those common-law duties threaten to interfere with specific federal requirements”).


Lohr narrowed, rather than contradicted, Stamps.98 Thus, the Fifth Circuit kept with its precedent in that the “substantive requirements” of the state law must “potentially conflict” with the federal law for preemption.99 The Sixth Circuit followed a similar process and analyzed each claim to determine whether the specific state requirements added requirements “different from, or in addition to” the federal requirements when applied to the case at hand.100 Five circuit courts follow Justice Breyer’s concurrence and look for “actual conflict” between the specific federal requirement and the state common-law claim.101

The Fifth Circuit found that Lohr supports preemption by reconciling Justice Breyer’s opinion with Justice Stevens’s plurality opinion.102 The Ninth Circuit reached the same result, but included Justice Breyer’s concurrence with Justice O’Connor’s dissent to form a five-justice majority in Lohr.103 Thus, these circuit courts acknowledged that the MDA preempts state common-law claims because they may create “requirements” conflicting with device-specific federal regulations.104 Yet, these courts developed inconsistent reasoning in citing Lohr.

98 See id. 99 Id. at 585. 100 Kemp v. Medtronic, Inc., 231 F.3d 216, 229 (6th Cir. 2000). In analyzing the plaintiff’s negligence per se claim the court found that:

[T]he specific federal requirements established by the FDA approval of the Model 4004M PMA Supplement do not include a requirement as to the thickness or coverage of the platinum sputter barrier. To permit a jury to find Medtronic negligent for failing to manufacture the Model 4004M with a platinum sputter barrier of uniform 500 angstroms thickness would be to impose a requirement different from or in addition to those established by the FDA.

Id. at 230. 101 In addition to the Fifth and Sixth Circuits, the Seventh, Eighth and Ninth Circuits follow Justice Breyer’s concurrence on this point. See Brooks v. Howmedica, Inc., 273 F.3d 785, 799 (8th Cir. 2001) (holding that “[t]he specific state requirement Brooks seeks to establish by her common-law claim would interfere with the specific federal requirements set for Simplex”); Mitchell v. Collagen Corp., 126 F.3d 902, 912 (7th Cir. 1997) (holding that “it is necessary to examine the state law cause of action at a sufficiently precise level of generality to determine whether the final judgment of the state court would impose on the manufacturer a burden incompatible with the requirements impose by the FDA”); Papike v. Tambrands Inc., 107 F.3d 737, 741 (9th Cir. 1997) (holding that “Papike alleges generally applicable state law principles are involved, but there is a specific FDA regulation to which these generally applicable principles would be imposing additional or different requirements”). 102 See Martin, 254 F.3d at 583 (interpreting Lohr by “reading the language in the majority opinion through the lens of Justice Breyer’s concurrence”). 103 See Papike, 107 F.3d at 741 (noting that “[f]ive justices did, however, conclude that ‘requirement’ encompasses state common-law claims to the extent that their recognition would impose any requirements different from, or in addition to, FDA requirements applicable to a particular device”) (citing Breyer, J., concurring in part, and O’Connor, J., joined by three other Justices, concurring in part). 104 For example, the Eighth Circuit stated:

A jury finding of negligent failure to warn would be premised on the fact that the label


C. Circuit Courts Not Finding Support in Lohr for Preemption of Common-Law Claims

The Tenth Circuit interpreted the same language, but reached a

different result. The court in Oja v. Howmedica, Inc. compared the plaintiff’s “failure to warn” claim to a similar claim in Lohr, reiterating that common-law claims were “predicated upon a general duty” applicable to all manufacturers and, thus, were not specific to medical devices.105 The court further stated that the claim did not establish a “substantive” device-specific state requirement and therefore found that the MDA did not preempt the plaintiff’s state failure-to-warn claim.106 In explaining the Tenth Circuit approach, the Seventh Circuit took note of its “colleagues” requirement for a device-specific state law.107 The Tenth Circuit interpretation recognized only Justice Stevens’s plurality opinion and Justice Breyer’s concurrence in its analysis.108 The court used the language of Part V to form its preemption test, creating the requirement for a device-specific state law not found in the other circuit

for Simplex was not written in a particular way or did not contain certain information. This would be equivalent to a state regulation imposing specific label requirements. Justice Breyer illustrated this principle in his concurring opinion in Lohr . . . .

Brooks, 273 F.3d at 796; see also Martin, 254 F.3d at 582: This reasoning is consistent with the majority opinion; while the general duty, standing on its own, is not a threat to federal requirements and is not developed specifically “with respect to” medical devices, the elements needed to prove a violation of that general duty may be very specifically tailored to the device, and the state court action may therefore threaten specific federal requirements.

105 Oja v. Howmedica, Inc., 111 F.3d 782, 789 (10th Cir. 1997) (holding that “general state common-law requirements imposed by Oja’s negligent failure to warn claim were not specifically developed ‘with respect to’ medical devices. Instead, Oja’s failure to warn claim is predicated upon a general duty applicable to every manufacturer.”). 106 Id. 107 The Seventh Circuit stated:

Our colleagues in the Tenth Circuit appear to have deviated . . . and require that the state “requirement” be developed specifically “with respect to” the medical device. It appears that the Tenth Circuit would hold therefore that generic common-law causes of action do not meet this test because, when stated without application to a particular product, they cannot be said to have been developed “in relation to” the medical device in question.

Mitchell v. Collagen Corp., 126 F.3d 902, 913 n.4 (7th Cir. 1997). The court did not establish a test based on the Lohr opinion, but the court did acknowledge that it had adopted the same “essential analysis” as had the Sixth Circuit in Martin v. Telectronics Pacing Systems, Inc. Mitchell, 126 F.3d at 912. Martin v. Telectronics pre-dating Kemp, involving a Class III medical device approved under the IDE process. See Martin v. Telectronics Pacing Sys., Inc., 105 F.3d 1090, 1098 (6th Cir. 1997). In Kemp, the Sixth Circuit upheld the analysis performed in Martin v. Telectronics and followed the “logic of Martin” in the Kemp holding. See Kemp, 231 F.3d at 227. 108 See Oja, 111 F.3d at 788 n.3 (noting that in Lohr “[i]n a five to four decision, . . . Justice Stevens authored the plurality opinion . . . [and] Justice Breyer, who concurred in the judgment, joined in Parts I, II, III, V, and VII of the plurality opinion. Thus, only those five sections constitute the opinion of the Court.”).


courts’ MDA preemption tests.109 Thus, the Tenth Circuit reconciled Justice Stevens’s and Justice Breyer’s opinions, resulting in a different holding from that of the Fifth Circuit.

IV. THE RESURRECTION OF THE DEVICE-SPECIFIC STATE LAW DEBATE:

HORN V. THORATEC CORP. Eight years after Lohr, the debate over the MDA express

preemption clause continues, as evidenced in the Third Circuit case of Horn v. Thoratec Corp.110 Mrs. Horn sued Thoratec Corp. on state common-law claims following the death of her husband, caused by the defendant’s HeartMate pump.111 Judge Garth, writing for the majority, engaged in a lively debate with dissenting Judge Fuentes over the issue of device-specific state laws as requirements for preemption.112 Judge Fuentes made it very clear that he supports a holding that the PMA process satisfies the device-specific federal requirement.113 However, he made it equally clear that the district court erred in not inquiring into the presence of a device-specific state law.114

Judge Fuentes recognized three prior circuit court holdings as precedents to the device-specific state law debate.115 The Ninth Circuit stated, and the Seventh Circuit agreed, that Part V of the Lohr plurality opinion allows for preemption of “general” state requirements, thus eliminating the need for a device-specific state requirement.116 109 See id. at 788 (citing Lohr, 518 U.S. at 500, and stating that “[b]ased on the MDA’s statutory language and the FDA’s regulation, the Court developed a two-prong inquiry to determine the preemptive scope of the MDA”). 110 376 F.3d 163 (3d Cir. 2004). 111 Id. at 165. 112 See id. Throughout the majority opinion in Horn, “disagreements” with the dissent’s analysis are addressed. See id. at 168-80. 113 Id. at 180, 181 n.27 (Fuentes, J., dissenting) (stating “my disagreement with the majority is not over the federal side of the equation at all, but rather over whether Horn’s suit implicates the state-law specificity requirement in Lohr”). For a discussion of the device-specific federal law requirement and the accompanying circuit split, see supra notes 7, 37. 114 Horn, 376 F.3d at 180. 115 Id. at 180-81 (referring to the Seventh Circuit case of Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 1997), the Ninth Circuit case of Papike v. Tambrands, Inc., 107 F.3d 737 (9th Cir. 1997), and the Tenth Circuit case of Oja v. Howmedica, Inc., 111 F.3d 782 (10th Cir. 1997)). 116 See Papike, 107 F.3d at 742 (holding that, “[i]n summary, preemption is triggered by and the scope of preemption is limited to instances where there are specific FDA requirements applicable to a particular device,” the Ninth Circuit does not include the device-specific state law as a requirement for preemption). Id. (citation omitted). The Seventh Circuit clearly agreed with the Ninth Circuit, referencing the Ninth Circuit’s argument that Justice Breyer would not have included his hearing aid example if he did not intend for general state common-law claims to be subject to MDA preemption. See Mitchell, 126 F.3d at 912. See supra note 78 for Justice Breyer’s hearing aid example. The Seventh Circuit stated that:

[I]t makes little sense to argue that Justice Breyer would write separately to make clear his position that duties arising under state common-law can constitute state law


However, the Tenth Circuit required the presence of a device-specific state law and held that since the state common-law claim in the case would not “threaten” the federal law, there was no preemption under the MDA.117 Although all three holdings pertain to a device-specific state law discussion,118 none of the decisions directly stated concern with the requirement; specifically, none of the courts used language that identified a device-specific state law “issue.”119 The court in Horn clearly recognized and debated the device-specific state law issue.120 Again, to resolve this issue, the Third Circuit turned to Justice Breyer’s concurring opinion in Lohr.

A. Judge Fuentes’s Dissent in Horn v. Thoratec Corp.

Justice Fuentes began his argument in support of a device-specific

state law requirement for MDA preemption by citing the language of 21 C.F.R. §808.1(d).121 He noted that section 808.1(d) referenced the “specificity of state regulations” and found the reference “superfluous” if the only device-specific requirement under the MDA related to the federal regulation.122

“requirements” which can be preempted by the MDA, and then agree that because tort law consists of generally applicable principles, it is always preempted, even in the face of specific federal requirements.

Mitchell, 126 F.3d at 912 (quoting Papike, 107 F.3d at 742). 117 Oja, 111 F.3d at 789 (holding that “Oja’s negligent failure to warn claim is not the type of device-specific requirement that would threaten the MDA’s federal interests”) (emphasis added). 118 It should be noted that the courts of appeals also differed as to whether the federal device-specific requirement was met. The Ninth Circuit stated that the Lohr court did not determine that the state common-law claims were preempted in main part because there were no FDA regulations specific to the pacemaker, and, in particular, there was no device-specific federal law. See Papike, 107 F.3d at 742 (holding that “it is clear enough that the Court [in Lohr] found no preemption of the common-law claims largely because the pacemaker was not subject to any device-specific FDA regulations”). However, the Tenth Circuit found a device-specific federal law in the FDA warning requirements. Oja, 111 F.3d at 789 (finding that “the FDA state[ment] that Howmedica could not label or promote the PCA hip for non-cemented use . . . constitutes a specific federal requirement”). 119 See Mitchell, 126 F.3d 902; Oja, 111 F.3d 782; Papike, 107 F.3d 737. 120 Horn, 376 F.3d at 173:

Horn has never claimed that Pennsylvania has established a requirement of specific device content pertaining to the HeartMate. . . .

In the absence of any specific device requirements, we are left with Horn’s general common-law claims of negligence, general design, etc. The question that remains is: can Horn’s common-law “general” claims, which are not specific “with respect to” the HeartMate, constitute “requirements” that survive preemption under § 360k(a)?

121 Id. at 181. See supra note 11 for the text of 21 C.F.R. §808.1(d) (2005). 122 Horn, 376 F.3d at 182 (finding that “[t]his reference to the specificity of state regulations would be superfluous if all that mattered was the specificity of the federal regulation”). The sections of 21 C.F.R. § 808.1(d) referenced by Judge Fuentes include: “when the FDA has established specific counterpart regulations or there are other specific requirements applicable to a


Judge Fuentes also analyzed Justice Breyer’s opinion in Lohr, focusing on his joining in Part V of the plurality opinion.123 He found that Part V excluded general common-law claims from preemption under the MDA because they lacked device-specificity.124 Judge Fuentes, however, expressed his belief that Justice Breyer’s language in his concurrence did not conflict with the language in Part V.125 In particular, he found that the hearing aid example demonstrated that a state common-law could create a device-specific requirement.126 He found the example distinguishable from a “simple negligence” action where the resulting judgment imposes no specific requirements on the manufacturer.127 Instead, Judge Fuentes determined that Justice Breyer agreed that the MDA required a device-specific state law for preemption, but disagreed with Justice Stevens as to the “rare” frequency with which a common-law claim creates a device-specific state requirement.128 Thus, Judge Fuentes formed a five-justice majority requiring a device-specific state law for MDA preemption by reconciling Justice Breyer’s concurrence with Justice Stevens’s plurality opinion.129 particular device under the act” and “that there are other State and local requirements that affect devices that are not preempted by [§ 360k(a)] because they are not ‘requirements applicable to a device’ within the meaning of [§ 360k(a)].” Id. (internal quotation marks and citations omitted). Judge Fuentes notes further, “the exemption of generalized state requirements is never qualified by the further condition that those requirements infringe on a generalized federal requirement.” Id. 123 See id. at 181. 124 Id. at 181-82 (finding that “[p]art V of the Lohr opinion, which represents the views of five Justices, excepted generalized common-law claims like failure to warn and negligent manufacture from the ambit of MDA preemption”) (citation omitted). 125 Id. at 183. Judge Fuentes held that, even if Justice Breyer’s language conflicts with Part V of the Lohr opinion, “the correct course would be to follow Part V as the majority opinion of the Supreme Court, not to elevate a one-justice concurrence above the five-justice majority.” Id. at 184. The Supreme Court provides some instruction for lower courts interpreting split opinions of the Court. The instruction is to find a holding based on “those Members who concurred in the judgments on the narrowest grounds.” Id. at 175 (citing Gregg v. Georgia, 428 U.S. 153, 169 n.15 (1976) (plurality opinion)). However, the “narrowest ground” approach is also debated between the majority and dissent in Horn. Where the majority finds the “narrowest grounds” approach applicable in analyzing Lohr, Judge Fuentes finds its use as a means for the majority to avoid recognizing Justice Breyer’s joinder in Part V of the Lohr opinion. Id. at 175, 184. 126 Id. at 183 (noting that “Justice Breyer’s opinion shows concern that in certain situations a state could fashion, through its common-law, a specific state requirement for a particular device”). 127 Id. at 184 (finding that the hearing aid example “involve[s] a specific requirement being imposed upon a device by the state through its common-law”). 128 Id. (finding that “the plurality [in Lohr] expressed its views on the frequency of preemption in Part VI of its opinion, which Justice Breyer refused to join”). In Part VI Justice Stevens states that “[i]t will be rare indeed for a court hearing a common-law cause of action to issue a decree that has ‘the effect of establishing a substantive requirement for a specific device.’” Medtronic, Inc. v. Lohr, 518 U.S. 470, 502-03 (1996). Judge Fuentes continues the dissenting opinion with an analysis of the implied preemption argument of the defendant and finds no implied preemption. See Horn, 376 F.3d at 184-85. 129 See Horn, 376 F.3d at 184 (noting that “Justice Breyer endorsed a state-law specificity


B. The Majority Holding in Horn v. Thoratec Corp. The majority in Horn began directly with the Lohr opinions and

Justice Breyer and found no device-specific state law requirement for MDA preemption.130 In recognizing the “unique” situation of the multi-layered Lohr opinion, the majority found that Justice Breyer, despite joining in Part V, did not agree with Justice Stevens, as evidenced by his statement of agreement with Justice O’Connor’s dissenting opinion.131 The majority thus found that preemption occurs when a state common-law claim “conflicts with, or adds a greater burden to” a device-specific federal law.132 By reconciling Justice Breyer’s concurrence with the dissent, the majority in Horn, like the Ninth Circuit, found preemption, under the MDA, of state common-law claims.

C. State Cases Discussing the Device-Specific

State Law Requirement State courts have also interpreted the provisions of the MDA,

including the preemption clause. Some state court MDA cases lend support to the Tenth Circuit and Judge Fuentes’s arguments for a device-specific state law requirement. Both Kentucky and California courts have addressed the issue and have held that preemption under the MDA requires a device-specific state law.133

The California Court of Appeal heard Armstrong v. Optical Radiation Corp. in 1996.134 The California court laid out a three-prong test for preemption, with similar language to that of the Tenth Circuit’s two-prong test requiring both device-specific federal laws and device-specific state laws.135 The California court found a device-specific requirement by joining Part V of Justice Stevens’s opinion, and this requirement therefore ‘enjoys the assent of five Justices’”). 130 See id. at 174 (holding that “a state common-law claim need not be developed specifically ‘with respect to’ a particular medical device in order to be preempted”). 131 Id. at 175-76 (holding that “on the state requirement issue, Justice Breyer joined with the four-member dissent to make a majority”). The majority also notes that the FDA agrees with their finding of preemption based on the amicus curiae letter briefs provided. Id. at 177. Judge Fuentes disagrees with this reliance, finding “that Lohr mandates that we obey the regulations issued by the FDA, rather than the amicus brief relied upon by the majority.” Id. at 182 n.29. 132 Id. at 174. 133 See, e.g., Niehoff v. Surgidev Corp., 950 S.W.2d 816, 819 (Ky. 1997); Armstrong v. Optical Radiation Corp., 57 Cal. Rptr. 2d 763, 771 (Cal. Ct. App. 1996). 134 Armstrong, 57 Cal. Rptr. 2d 763. The case centers on an intraocular fluid called Orcolon, a Class III device approved by the FDA under the PMA process. Id. at 766. 135 See Oja v. Howmedica, Inc., 111 F.3d 782, 789 (10th Cir. 1997); Armstrong, 57 Cal. Rptr. 2d at 770. The Armstrong court stated that “[Lohr] teaches that three factors must be present before section 360k will preempt a state common-law claim: (1) a state requirement specifically


federal law requirement and noted that it represents only one of three factors required for preemption of a state law claim.136 The court then performed an analysis of each common-law claim with respect to meeting the device-specific state law requirement. The court ultimately found that none of the plaintiff’s state claims had met the requirement.137

A Kentucky case, Niehoff v. Surgidev Corp., rose to the Kentucky Supreme Court in 1997.138 That court interpreted Lohr as holding that the MDA preempts a device-specific state law only if it conflicts with a device-specific federal regulation.139 Thus, the Kentucky Supreme Court clearly required that both a device-specific federal law as well as a device-specific state law exist for preemption under the Act.140 Yet, like Horn, a strong dissenting opinion influenced the issue of requiring a device-specific state law.141 The dissent argued that the majority misinterpreted Justice Breyer’s concurrence in finding that it supports the need for a device-specific state law requirement.142 Unlike Horn,

developed with respect to medical devices (2) which is different from or in addition to (3) a federal requirement specific to a particular device. If any of these factors is absent, the state law claim is not preempted.” Armstrong, 57 Cal. Rptr. 2d at 770. 136 See Armstrong, 57 Cal. Rptr. 2d at 771 (finding that “the existence of a device-specific federal [law] requirement is not sufficient to preempt a state law claim, that is only one of the three necessary factors”). 137 Id. at 771-73 (holding that the plaintiff’s negligence claim, strict liability claim, and breach of warranty claim were not preempted under section 360k of the MDA). The California appellate court’s requirement of a device-specific state law is clear: “As with Armstrong’s negligence claim, her theory of strict liability as to a manufacturing defect is based on general principles of state tort law which were not specifically developed with respect to medical devices. Thus, it is not preempted.” Id. at 772. 138 Niefhoff, 950 S.W.2d 816. This case centers on an intraocular lens, a Class III device approved by the FDA under the IDE process. See id. at 817-18. 139 Id. at 819 (holding that “the medical device amendments of 1976 do not preempt state law unless a specific state requirement contravenes a specific regulation”). 140 See James P. Walsh, Niehoff v. Surgidev Corp.: No Preemption of Kentucky Tort Law Claims By the Federal Medical Device Amendments, 25 N. KY. L. REV. 615, 646 (1998) (stating that “[t]he Niehoff majority interpreted Lohr as requiring both device-specific state and federal requirements before preemption could occur . . . [and that t]herefore, under a strict reading of the Lohr device-specific analysis, state common-law damages will almost never be preempted by the MDA, because warranty and tort law theories apply to all products generally”). 141 See Niehoff, 950 S.W.2d at 823-32 (Ison, J., dissenting). 142 See id. at 829 (dissenting that “the Majority in this Court has read Justice Breyer’s opinion to imply that a certain degree of specificity is required for state requirements to be preempted by the MDA”). The dissent in Niehoff also disagrees with the majority over its comparison of the IDE process in that case with the “substantially equivalent” process in Lohr. Id. at 825. The dissent argues that the IDE creates a device-specific federal law, which should preempt any claims creating requirements that are “different than and in addition to the federal law.” Id. at 827. The majority finds that there is “no specific counterpart regulation that can preempt a Kentucky common-law judgment.” Id. at 822. It is unclear from the majority opinion whether the device-specific federal law requirement is met, the majority seeming to “overlook this step of the Lohr analysis.” Walsh, supra note 140, at 641. The majority also states that the Kentucky strict liability claim is a law of “general applicability to all products and fall[s] beyond the scope of the federal preemption under § 360k.” Id. However, whether or not the decision of the


however, support for the device-specific state law requirement outweighed its opposition and the majority found no preemption of the plaintiff’s Kentucky common-law claims.143

V. PREEMPTION OF STATE COMMON-LAW CLAIMS FULFILLS THE

PURPOSE OF THE MDA If Judge Fuentes correctly presented his case in Horn and

preemption under the MDA requires a device-specific state law, the result is that preemption of state common-law claims under the MDA becomes an exception. First, requiring a device-specific state law results in a narrow MDA preemption test. The majority of state common-law claims are general in nature; they do not involve regulations specific to medical devices and thus fail the device-specific state law requirement.144 Second, following this logic, the preponderance of common-law claims would survive federal preemption and go on to trial. Third, an increase in claims going to trial would result in additional claims for the medical device manufacturers to defend. If reinforcing the purpose of the MDA is the goal of the preemption test, then safety and effectiveness for consumers should arise as the primary concern.145 The courts should thus structure any MDA preemption tests to achieve such an end. Yet, both positive and negative effects on consumers may result from instituting a narrower preemption test.146

majority is based on a failure of the IDE to meet the device-specific federal requirement or the device-specific state law requirement, the majority holding remains clear that a device-specific state law is required for preemption. 143 See Niehoff, 950 S.W.2d at 822-23 (holding “the medical device amendments of 1976 do not preempt Kentucky law because there is no specific state requirement which contravenes, contradicts or conflicts with a specific federal regulation”). The majority opinion lacks the “claim-by-claim analysis” of most courts in holding that there is no preemption of the state claims. Walsh, supra note 140, at 641. 144 Justice Stevens expressed this opinion in Lohr. See supra note 71 and accompanying text. In analyzing the effect of the Kentucky Supreme Court requiring, in Niehoff, a device-specific state law for preemption under the MDA, one commentator notes that “under a strict reading of the Lohr device-specific analysis, state common-law damages will almost never be preempted by the MDA, because warranty and tort law theories apply to all products generally, and are not only ‘specific’ or ‘with respect to’ medical devices.” Walsh, supra note 140, at 646. 145 See supra note 24. 146 See Harkins, supra note 5, at 893 (noting that in “two perspectives on the effect that [Lohr] might have on consumers . . . [o]ne point of view posits that the possibility of liability harms consumers through its deterrent effect on drug and device development and marketing . . . [and] [a]nother suggests that this threat of liability is favorable to consumers”).


A. The Circuit Courts’ Interpretations of the MDA Preemption Requirement

The MDA’s express preemption clause provides no clear

delineation as to which state laws federal medical device laws preempt. Both the language of the statute and the Supreme Court opinion in Lohr leave this question up for much debate.147 The MDA preemption tests developed by the circuit courts of appeals best demonstrate the difficulty in interpreting the statutory language. All of the tests used language from the MDA preemption clause, section 360k, yet the Tenth Circuit’s interpretation differed from those of the Fifth, Sixth, and Eighth Circuits.148 Even the Supreme Court in Lohr acknowledged the confusing language of section 360k.149 Due to the unclear statutory language, the cases following Lohr expressed varying legal opinions on preemption of common-law claims.

In Lohr, Justice Stevens’s plurality held that the MDA would rarely preempt state common-law claims, for they fail to meet the device-specific state law requirement. Justice O’Connor’s dissenting opinion found, on the other hand, that state common-law claims, in essence, become state “requirements” once adjudicated and, thus, courts must determine that the MDA preempts such claims.150 Various courts of appeals reconciled Justice Breyer’s concurring opinion with either the plurality or the dissent. Both the Fifth and Tenth Circuits reconciled Justice Breyer’s concurrence with Justice Stevens’s plurality. In doing so, the Fifth Circuit found preemption of state common-law claims by narrowing Justice Stevens’s opinion to find preemption of general state common-law claims where conflicting state specific requirements are created.151 The Fifth Circuit overlooked the plurality’s device-specific state law requirement and the emphasis they placed on the rarity of preemption, whereas, the Tenth Circuit remained truer to Justice Stevens and found no preemption of state common-law claims.152 Thus, the reconciliation of Justice Breyer’s opinion with Justice Stevens’s brings the issue of preemption no closer to a resolution.

Both the Ninth Circuit and the Third Circuit in Horn found preemption of common-law claims under the MDA’s express preemption clause. These courts took the words of Justice Breyer to heart and reconciled his opinion with the dissent despite his concurrence 147 See supra Part I.D. 148 See supra Part III.A. 149 See Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996) (noting that “[t]he different views expressed by the Courts of Appeals regarding the appropriate scope of federal pre-emption under [section] 360k demonstrate that the language of that section is not entirely clear”). 150 See supra Part II. 151 See supra note 84. 152 See supra notes 105, 107 and accompanying text.


in Part V of the plurality opinion.153 Justice Breyer clearly acknowledged that the dissent properly interpreted section 360k to preempt state common-law claims because they create requirements that conflict with federal requirements.154 His concurrence in Part V must take a second seat to this clear expression of agreement. Forming a majority opinion by resolving the concurrence with the dissenting opinion leads to the proper conclusion. Fulfilling the Supreme Court’s presumptions regarding interpretation of preemptive clauses further supports this proposition.

The Supreme Court provided lower courts with two presumptions in interpreting federal preemption clauses. Both require that courts look to the congressional purpose of the Act, in this case, the safety and effectiveness of medical devices for consumers.155 A narrow interpretation of the Act’s purpose, i.e., protecting individual consumers, may support the inclusion of Justice Stevens’s device-specific state law requirement. The inclusion of this requirement results in a narrow preemption test, with most state claims surviving the preemption analysis. In considering a broader purpose, however, such as protecting the class of medical device consumers as a whole, preemption of state common-law claims, as Justice O’Connor suggests, best fulfills the purpose of the MDA.

B. The Positive Effects for Medical Device Consumers of

Incorporating a Device-Specific State Law Requirement The survival of state common-law claims through a narrower

preemption standard may result in two important consumer benefits: 1) safety requirements imposed by medical device manufacturers themselves beyond those required for FDA approval;156 and 2) compensation for injuries under state product liability laws.157 An 153 See supra notes 102, 131. 154 Lohr, 518 U.S. at 503 (questioning whether “the Medical Device Amendments of 1976 (MDA) to the Federal Food, Drug, and Cosmetic Act ever pre-empt a state law tort action,” and Justice Breyer answering that “the MDA will sometimes pre-empt a state-law tort suit. I basically agree with JUSTICE O’CONNOR’s discussion of this point and with her conclusion.”). 155 See supra notes 24, 39. 156 See Horn v. Thoratec Corp., 376 F.3d 163, 186-87 (3d Cir. 2004) (Fuentes, J., dissenting) (arguing that “allowing common-law liability would simply have the effect of encouraging TCI and other device manufacturers to go above and beyond FDA standards, and this effect would clearly not contradict the MDA’s purpose of enhancing medical device safety”). It may be argued that there is no greater incentive for manufacturers to increase device safety than the threat of lawsuits. This is due to the stringent requirements of PMA approval and a manufacturer’s desire to move through the PMA process as smoothly as possible. Turner, supra note 38, at 991-92. 157 State product liability laws typically allow for recovery under three different theories: 1) breach of express or implied warranty, 2) negligence or 3) strict liability. Turner, supra note 38,


increase in safety requirements instituted by manufacturers no doubt furthers the purpose of the MDA.158 However, an increase in safety precautions will inevitably come at a cost—an increase in development expenses and an increase in time required to create a market for new devices. Although the devices may become safer,159 the manufacturers will pass the costs onto consumers and delay help to those consumers who need the benefits brought by new technological advancements.

New technology may create advancements in the medical device industry, but it also creates the very safety problems the MDA intended to regulate. Unfortunately, those problems may lead to physical harm and a desire for compensation for the resulting pain. Lawsuits often develop as a result of American consumers attempting to gain compensation for pain. However, even if most plaintiffs deserve compensation, one must pose the question whether the resulting dollar compensation to the injured outweighs the negative consequences to consumers-at-large that may result from such suits.160

C. The Negative Effects for Medical Device Consumers of

Incorporating a Device-Specific State Law Requirement Despite the positive possibilities for consumers upon adoption of

the device-specific state law requirement, negative effects may result from a likely increase in the survival of state common-law claims against medical device manufacturers. The increase in money and effort161 expended by manufacturers in defending these suits could result in: 1) an increase in medical device costs for consumers;162 and 2) at 986-87. 158 See supra note 24. 159 There is also a chance that devices may become unsafe as a result of safety modifications implemented in response to lawsuits because of the “complexity and sensitivity” of such medical devices. Turner, supra note 38, at 992. 160 See infra notes 161-63. 161 See Alex Berenson, Trial Lawyers Are Now Focusing on Lawsuits Against Drug Makers, N.Y. TIMES, May 18, 2003, § 1, at 1 (noting that “the drug makers say that they are now spending several billion dollars each year to defend themselves from lawsuits and settle claims”). Class-action lawsuits are not unusual in the medical device industry and cost manufacturers millions in settlements and legal fees. One such class-action suit regarded Telectronic “J” pacemaker leads sold from 1988 through 1994. The faulty leads broke through the insulation of the pacemaker and penetrated the heart or blood vessels. Four hundred and fifty-six individual cases were consolidated into a national class-action suit and, in August 1988, a preliminary settlement was approved for $57.2 million. With 25,000 pacemaker implants and a twelve to twenty percent break through rate, up to 5000 consumers faced potential harm by the faulty device. CBC News, CBC Marketplace, Medical Device Lawsuits (Apr. 1, 2003), http://www.cbc.ca/consumers/ market/files/health/medical_devices/lawsuits.html. 162 See Turner, supra note 38, at 991 (noting that “[m]anufacturers who are forced to pay damage awards can pass on the costs to their other customers in the form of higher sales prices”); David J. Damiani, Comment, Proposals for Reform in the Evaluation of Expert Testimony in


a decline in research and development (R&D) expenditures, and thus, a decrease in new products, from fear of future lawsuits.163 Passing on costs to consumers arises as an expected corollary to product liability laws. Yet, unlike most commercial products, a price increase for a potentially life-saving product is a serious concern for society. A dire concern for society results if manufacturers limit the output of new, potentially life saving devices to avoid liability.164 If manufacturers Pharmaceutical Mass Tort Cases, 13 ALB. L.J. SCI. & TECH. 517, 523 (2003) (noting that “[t]he costs of litigation pass on to consumers through increased product costs and are absorbed through blue-collar employees sacrificed to cost-saving job cuts”). 163 See Turner, supra note 38, at 993 (noting that “many device manufacturers will not invest money in the research and development of devices that have high potential liability costs”); Michael Freedman, Forbes.com, The Tort Mess (May 13, 2002), http://www.forbes.com/forbes/ 2002/0513/090_print.html.

Steven Garber, a researcher at the Rand Research Institute for Civil Justice, says drug companies are willing to take on the risk of lawsuits in marketing blockbusters . . . [b]ut in other cases the chance of liability is too great. . . . [C]ompanies also limit research on orphan drugs–those that cure rare, often fatal illnesses–because the potential tort liability outweighs the profit potential.

Id. In advising medical device manufacturers on insurance, even the insurance industry recognizes “avoidance” as one technique to deal with losses resulting from product liability. As a senior vice-president of Medmarc Insurance Group notes, “due to liability lawsuits, there are now few companies that manufacture Intra-uterine devices. Some device companies have found lawsuits so prevalent and costly that they have made a conscious decision to stay out of these product lines.” Kevin M. Quinley, Medmarc: The Hartford, Risk Management 101 For Medical Device Companies, http://www.advamed.org/business-solutions/risk_management_101.html (last visited Sept. 18, 2005). 164 See Berenson, supra note 161, at 1 (noting that, according to Kenneth I. Kaitin, director of the Tufts Center for the Study of Drug Development, “companies have begun to consider the threat of lawsuits when deciding which new medicines to pursue”). In particular, biomaterial makers were hit hard by medical device lawsuits. See San Diego County Citizens Against Lawsuit Abuse, CALA: Lawsuits are Making Us Sick (May 6, 2003), http://www.sdcala.org/Press% 20Releases/PR_144_Cala_%20Lawsuits%20Are%20Making%20Us%20Sick_May_03.htm.

According to a study by New York-based Arnoff Associates, each year over 7.5 million lives in America are either saved or improved through implantable medical devices or products. Yet, due to the threat of liability, 75% of suppliers of biomaterials used to make medical implants banned sales to U.S. manufacturers. Although the Biomaterials Assurance Act of 2000 aimed to remedy this by providing important legal protections to suppliers in liability lawsuits, numerous medical device producers choose to remain overseas.

Id. The development of life-saving medical devices like brain shunts, pacemakers and other implants is being slowed and in danger of being made publicly unavailable because of U.S product liability laws. Currently anyone associated with any aspect of product development can be sued under U.S. product liability laws. For instance, a company that merely provides the raw materials for a medical device is subject to costly and time-consuming lawsuits based not on the composition of the device, but on how the device operates.

Tina Bruno & John Opelt, Citizens Against Lawsuit Abuse, Taint Like It Was but Lawsuit Abuse Tarnish Remains, http://www.calahouston.org/tarnish.html (last visited Sept. 18, 2005); see also National Center for Public Policy Research, Legal Briefs No. 9, Monitoring the Legal System that Rules Our Lives: Child’s Illness Demonstrates Need for Product Liability Reform (Oct. 17, 1997), http://www.nationalcenter.org/LB9.html (noting the personal struggle of Virginia Representative


find that the litigation costs on new products outweigh the profits from the sale of the new products, the economic incentive to invest in new devices vanishes.165 In addition, necessary budget cuts may result for a manufacturer facing large settlements and lawyers’ fees. Research and development is often the first department to receive such cuts, eliminating a manufacturer’s source of new devices.166 Such results fall short of fulfilling the broader purpose of the MDA. Medical device consumers are not safer. Rather, they merely spend more for, or become deprived completely of, life-sustaining medical devices.

Despite the importance placed on consumer safety in the MDA, consumer safety is not necessarily the major influence on a court’s analysis of the Act. In Horn, the majority did not hesitate to apply the FDA’s interpretation, outlined in the FDA’s amicus brief, in regards to its position on preemption of state common laws under the MDA.167 The majority acknowledged that the FDA’s position was “not fully dispositive,” but found its interpretation “significant.” The court sided with the FDA’s position supporting preemption of claims such as those in Horn.168 The Horn majority relied on the Supreme Court’s language in Lohr where it found the FDA “uniquely qualified” to address preemption issues under the MDA, based on the agency’s authority granted by Congress and the ambiguity of the statute.169 The Supreme Jim Moran’s daughter and her survival of brain cancer due to the use of medical devices); National Center for Public Policy Research, Legal Briefs No. 30, Fighting Lawsuit Abuse and Exposing Frivolous Lawsuits: Why Are Medical Costs So High? Courtrooms Are a Culprit (Aug. 15, 2003), http://www.nationalcenter.org/LB30.html (noting the increased price of medical devices and the “chill” to new discoveries due to increased litigation against pharmaceutical manufacturers). 165 See Turner, supra note 38, at 993 (stating that “[w]hen it is not cost effective for manufacturers to develop new devices, consumers pay the price in unnecessary and unrelieved suffering”). 166 See supra note 163. 167 See Horn v. Thoratec Corp., 376 F.3d 163, 171 (3d Cir. 2004) (holding that “we have no hesitation in looking to the FDA for its interpretation of [section] 360k(a) in the medical device context”). The Horn majority acknowledges the dissent’s position that the FDA’s opinion is entitled only to “near indifference.” Id. at 170 n.12. However, the majority argues that this position does not follow the Supreme Court’s “instruction” provided in Lohr. Id. Judge Fuentes states that amicus briefs “are only as persuasive as their own merits dictate.” Id. at 182 n.29. He “believe[s] that Lohr mandates that [the court] obey the regulations issued by the FDA, rather than the amicus brief relied upon by the majority.” Id. 168 See id. at 171 (stating that, “[w]hile we acknowledge that the FDA’s interpretation of statutes that it has been charged by Congress with enforcing is not fully dispositive of the issues here, the Supreme Court has instructed us that the FDA’s preemption determinations are significant and should inform our interpretation of [section] 360k(a)”). 169 Medtronic, Inc. v. Lohr, 518 U.S. 470, 496 (1996) (stating that “[t]he ambiguity in the statute—and the congressional grant of authority to the agency on the matter contained within it—provide a ‘sound basis[]’ . . . for giving substantial weight to the agency’s view of the statute”). The Supreme Court determined that “[b]ecause the FDA is the federal agency to which Congress has delegated its authority to implement the provision of the Act, the agency is uniquely qualified to determine whether a particular form of state law ‘stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.’” Id. (quoting


Court relied on its opinion in Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc.170 in making such strong statements in deference to FDA opinions.

The Chevron doctrine instructs courts to defer to agency statutory interpretations if Congress has not explicitly answered the question at hand.171 However, applying this doctrine may conflict with the two presumptions courts should consider when analyzing express preemption provisions.172 Current political considerations may easily sway the FDA in its statutory interpretation, without regard to the congressional purpose behind the statute.173 In addition, the FDA personnel interpreting the statute may overlook implications in their interpretation that affect areas beyond those the agency administers and, as a result, find unfamiliar.174 The FDA has considerable expertise in

Hines v. Davidowitz, 312 U.S. 52, 67 (1941)). 170 467 U.S. 837 (1984). 171 See Chevron, 467 U.S. at 842-43. Chevron held that:

When a court reviews an agency’s construction of the statute which it administers, it is confronted with two questions. First, always, is the question whether Congress has directly spoken to the precise question at issue. If the intent of Congress is clear, that is the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress. If, however, the court determines Congress has not directly addressed the precise question at issue, the court does not simply impose its own construction on the statute, as would be necessary in the absence of an administrative interpretation. Rather, if the statute is silent or ambiguous with respect to the specific issue, the question for the court is whether the agency’s answer is based on a permissible construction of the statute.

Id.; see also Nina A. Mendelson, Chevron and Preemption, 102 MICH. L. REV. 737, 739 (2004) (stating that “the doctrine of Chevron v. Natural Resources Defense Council calls generally for judicial deference to agency statutory interpretations”). Furthermore, “[u]nless Congress has clearly answered the question at hand, Chevron instructs a court to defer to the agency’s reasonable interpretation of a statute it administers. . . . Chevron presumes that Congress has implicitly delegated interpretive authority to the agency because it is more expert and more politically accountable than the courts.” Mendelson, supra, at 739. 172 See supra note 39 and accompanying text. 173 See Robert Pear, In a Shift, Bush Moves to Block Medical Suits, N. Y. TIMES, July 24, 2004, § 1, at 1 (stating that the FDA’s amicus brief in Horn reflects the Bush administration’s push for “tort reform”). In 1997, under the Clinton administration, the FDA held a different position than it put forth in its recent amicus brief in Horn. In previous medical device cases, the FDA’s position was that approval by the federal agency was a minimum standard and that states could establish additional safety precautions. Whereas, under the Bush administration, the FDA’s position is that device approval is “a ceiling as well as a floor.” Id. The Bush administration is not attempting to “shield drug companies but to vindicate the federal government’s authority to regulate drug products.” Id. The administration feels that if a drug is found to be unsafe in a court of law, it directly conflicts with the FDA’s conclusions. Id. The administration also argues that it is protecting the public by preventing manufacturers from withdrawing beneficial drugs because of the threat of lawsuits. Id. The Association for the Advancement of Medical Instrumentation took note of the FDA’s change in position on preemption. Calling Horn a “Landmark Medical Device Lawsuit,” the association cited The New York Times in recognizing the Bush administration’s alliance with medical device manufacturers. Association for the Advancement of Medical Instrumentation, Appeals Court Throws Out Landmark Medical Device Lawsuit (July 27, 2004), http://www.aami.org/news/2004/072704.lawcom.html. 174 See Mendelson, supra note 171, at 779 (stating that “courts should still perceive strong


the area of medical devices, but that does not make it an expert in the area of federal preemption. Thus, both the FDA and the executive branch may affect any future Supreme Court ruling on the MDA preemption issue.

CONCLUSION

Mrs. Horn has yet to give up the fight she commenced in Horn v.

Thoratec. Despite losing on appeal, she petitioned for the Third Circuit to rehear the case en banc.175 She, and others like her, will continue to fight against medical device manufacturers by filing state common-law claims until the Supreme Court settles the issue of whether preemption of such claims under the MDA requires a device-specific state law. The answer to this question involves more than a simple interpretation of a federal statute, as evidenced by the continuing disputes throughout federal and state courts.

Congress’s purpose in enacting the MDA seems clear enough: to ensure “the safety and effectiveness” of medical devices for consumers.176 Congress delegated the task of ensuring fulfillment of this purpose to the FDA. The FDA’s approval process for bringing devices to market reflects its attempt in doing so.177 No doubt exists that, in the case of Mrs. Horn, the device, although approved by the FDA, failed and caused death.178 If this narrow interpretation prevails reasons not to defer to agency decisions on preemption questions. In particular, the relative institutional competence of agencies in considering federalism values weighs against deferring to agency interpretations on preemption questions.”). 175 See Rebecca Porter, FDA Approval Preempts Medical-Device Injury Claims, Third Circuit Says, 40 ASS’N TRIAL LAW. AM. 19, 80 (Oct. 2004) (noting that “Horn has requested a rehearing by the full Third Circuit”). 176 See supra note 24. 177 The FDA has recently come under scrutiny for its approval of Vioxx, a pain pill manufactured by Merck & Co. Merck withdrew Vioxx from the market on September 30, 2004, once studies revealed that the pill significantly increased the risk of heart attack or stroke with prolonged use. Associated Press, Researcher Rips FDA (Nov. 18, 2004), http://aolsvc.news.aol.com/news/article.adp?id=20041118084309990001. Senator Charles E. Grassley called a hearing before the Senate Finance Committee in which Dr. David Graham, the reviewer in the FDA’s Office of Drug Safety, testified. Dr. Graham commented that “[w]e are faced with what may be the single greatest drug safety catastrophe in the history of this country or the history of the world.” Gardiner Harris, F.D.A. Failing in Drug Safety, Official Asserts, N.Y. TIMES, Nov. 19, 2004, at A1. He concluded that the FDA was “‘virtually incapable of protecting America’ from unsafe drugs.” Id. Although the current news controversy surrounds the approval process of drug products, the doubts raised by accusations of the FDA approving unsafe drugs are easily transferred to medical device approvals. As noted in an editorial following the Horn decision, “[t]he facts of the case as alleged in court documents suggests that the heart pump, though approved by the agency, was designed poorly . . . [t]he F.D.A. is not infallible.” Editorial, Blocking Medical Product Suits, N.Y. TIMES, Aug. 1, 2004, § 4, at 1 [hereinafter Blocking Medical Product Suits]. 178 See Horn v. Thoratec Corp., 376 F.3d 163, 165 (3d Cir. 2004). The facts as stated in Horn


as the sole purpose of the Act, then Mrs. Horn’s suit may fulfill the purpose by ensuring that the heart pump at issue is either fixed or pulled from the market. But, the broader purpose of the Act reflects a desire to help all consumers of medical devices. From that perspective, the answer in fulfilling the purpose of the Act as related to the issue of preemption seems to counsel against allowing claims like those in Horn to prevail.

If Judge Fuentes is right, and both the Act itself and the Supreme Court’s own precedent in Lohr support the requirement of a device-specific state law, then the preemption test becomes extremely arduous. Although the required device-specific federal law is very likely the PMA itself,179 the rarity of device-specific state laws renders preemption of state common-law claims unlikely. Without preemption of state claims, the likely result is an increase in the number of claims versus medical device manufacturers. One may argue that stopping such claims benefits the medical device manufacturers, which, on its face, goes against the broad purpose of the MDA. A closer look, however, reveals that consumers-at-large benefit as well when preemption bars such claims.

The medical device manufacturers, in reacting to a significant increase in state common-law claims, will likely take action to the detriment of consumers. The money required to defend such suits must come from somewhere; two likely sources are an increase in medical device prices and a decrease in R&D budgets. Both deprive consumers of potentially life-saving medical devices either because they will become unaffordable, or simply will never be marketed to the public. Manufacturers may possibly institute more stringent safety measures as a result, an obvious benefit to consumers. However, additional safety measures take time to implement, delaying device release to market and perhaps preventing devices whose potential benefits outweigh their risks from reaching market at all for fear of suit.180

No question arises in the case of Mrs. Horn that a medical device killed her husband and that the survival of her claim provides her with

confirm that the HeartMate indeed killed Mr. Horn:

On May 3, 1998 Mr. Horn began to bleed from the spot where the HeartMate tube exited the body. Thereupon, he underwent exploratory surgery at Hershey Medical Center, during which Dr. Benjamin Sun discovered that the suture on Mr. Horn’s HeartMate had worn off and the screw ring linking the pump to the output side elbow had disconnected. The disconnection had allowed an air embolus to travel to Mr. Horn’s brain. Although Dr. Sun reconnected the screw ring and once again linked the pump to the elbow, it was too late. Mr. Horn suffered a brain hemorrhage, and he was rendered brain dead. On May 8, 1998, his organs were donated for transplant and he was pronounced dead.

Id. 179 See supra note 37. 180 See supra Parts V.A-B.


compensation through her lawsuit.181 But, for the good of society overall, the MDA must preempt such state claims. Thus, the majority of federal courts of appeals holdings align with the broad purpose of the MDA in not requiring device-specific state laws and preempting common-law claims. For, in the long run, allowing state common-law suits may result in more anguish than comfort—in the from of monetary compensation for those who already suffered a loss—if less preemption under the MDA denies consumers life-saving devices.

181 See Blocking Medical Product Suits, supra note 177, at 1 (stating that “[w]hatever the legal merits of this close two-to-one decision . . . most fair-minded Americans would probably think that the widow got a bum deal . . . . Simple justice suggests that victims harmed by a product should be able to seek compensation.”).

furthering consumer safety of medical …cardozolawreview.com/joomla1.5/content/27-1/mervis... ·...

Documents