Thanks for visiting! Welcome to a new way to research case law. You are viewing a free summary from Descrybe.ai. For citation and good law / bad law checking, legal issue analysis, and other advanced tools, explore our Legal Research Toolkit — not free, but close.
Charles R. Riegel and Donna S. Riegel v. Medtronic, Inc., Docket No. 04-0412-Cv
Citation: 451 F.3d 104Docket: 104
Court: Court of Appeals for the Second Circuit; May 16, 2006; Federal Appellate Court
The United States Court of Appeals for the Second Circuit addressed the preemption provision of Section 360k(a) of the 1976 Medical Device Amendments, specifically whether it preempts common law tort claims regarding medical devices approved through the FDA's premarket approval (PMA) process. The court noted that the Supreme Court in Medtronic v. Lohr had previously established that tort claims related to devices approved via the less rigorous Section 510(k) process were not preempted. However, a majority of circuits have since determined that claims regarding PMA-approved devices are preempted. In this case, the court aligned with that consensus, ruling that tort claims alleging liability against a PMA-approved medical device—regardless of the device's compliance with FDA standards—are indeed preempted by Section 360k(a). Consequently, the court affirmed the district court's summary judgment dismissing the plaintiffs' claims of strict liability, breach of implied warranty, and negligent design, among others, regarding the Evergreen Balloon Catheter. However, the court found that the plaintiffs' claim for negligent manufacturing, based on the argument that the specific catheter used did not meet PMA-approved standards, was not preempted. The court agreed with the district court that while this claim was not preempted, there were no genuine material facts in dispute, leading to the affirmation of the dismissal of that claim as well. The court clarified that its ruling on preemption was limited to claims that allege liability despite adherence to PMA standards and did not extend to all state tort claims against PMA-approved devices. Claims based on a deviation from the approved PMA standards, like the negligent manufacturing claim, remain viable. The Evergreen Balloon Catheter, developed by Medtronic, Inc., is a prescription medical device used in angioplasties to treat coronary disease by opening clogged arteries. It received FDA approval through the PMA process, with its initial application approved on August 30, 1994, followed by supplemental approvals in 1995 and 1996 for revised labeling. On May 10, 1996, Charles Riegel underwent an angioplasty where the Evergreen Balloon Catheter was employed to dilate his severely calcified right coronary artery. The device’s labeling contraindicates its use for patients with such conditions and specifies a maximum inflation pressure of eight atmospheres. During the procedure, the catheter burst after being inflated to ten atmospheres, leading to Riegel suffering severe injuries requiring emergency surgery. Riegel and his wife filed a lawsuit against Medtronic in the Northern District of New York, asserting five common law claims: negligence, strict liability, breach of express and implied warranty, and loss of consortium. Medtronic asserted federal preemption under Section 360k(a) of the Medical Device Amendments, which led to the dismissal of several claims, including strict liability and most negligence claims, while allowing the breach of express warranty claim to proceed. Later, the district court granted summary judgment in favor of Medtronic on the remaining claims, dismissing the breach of express warranty on the basis that the device’s instructions disclaimed any express warranty and the negligent manufacturing claim due to lack of evidence linking the catheter's failure to negligent manufacture instead of other potential factors. The Riegels filed an appeal challenging two summary judgment rulings from the district court: one dated March 14, 2002, and another from December 2, 2003. They contend that their claims were not preempted by law in the first ruling and that there were genuine issues of material fact regarding their negligent manufacturing claim in the second ruling. The standard for reviewing summary judgment orders requires affirmance only when there are no genuine issues of material fact and the moving party is entitled to judgment as a matter of law. In addressing the preemption issue from the March 14, 2002 ruling, the court noted that there are no disputed facts and the focus is on the correct application of the law. For the December 2, 2003 ruling regarding the negligent manufacturing claim, the court will consider the evidence in favor of the non-moving party to determine if genuine issues of material fact exist. The Medical Device Amendments (MDA) of 1976, amending the Food, Drug, and Cosmetic Act, established a regulatory framework for medical devices to ensure their safety and effectiveness. Medical devices are classified into three categories: Class I devices, which present minimal harm and require only general controls; Class II devices, which may require special controls in addition to general controls; and Class III devices, which require more stringent oversight due to their potential risks. The Evergreen Balloon Catheter in question is classified as a Class III device. A Class III medical device must undergo a premarket approval (PMA) process to demonstrate its safety and effectiveness before being marketed, as mandated by 21 U.S.C. 360c(a)(1)(C). This process is extensive, with the FDA dedicating approximately 1,200 hours to each PMA submission. The manufacturer is required to submit a comprehensive application that includes detailed reports on safety and effectiveness investigations, descriptions of the device's components and operation, manufacturing methods, performance standards, device samples, proposed labeling, and any relevant information as outlined in 21 U.S.C. 360e(c). During the PMA process, there is considerable interaction between the FDA and the manufacturer. Clinical investigation data, which must be included in the PMA application, can only be conducted with FDA permission. The FDA reviews the submission for completeness; if insufficient, it may refuse to file it (21 C.F.R. 814.42). After acceptance, the FDA's review may involve an advisory committee, and within 100 days of filing, the FDA will meet with the applicant to discuss application status and deficiencies (21 U.S.C. 360e(d)(3)). Upon concluding its review, the FDA may approve the device, impose additional requirements, or issue either an 'approvable letter' indicating potential approval with conditions or a 'not approvable letter' outlining application deficiencies (21 C.F.R. 814.44). Once approved, the applicant must adhere to the PMA approval order's standards, ensuring that any changes affecting safety or effectiveness are submitted to the FDA for approval through a 'PMA supplement' (21 C.F.R. 814.80 and 814.39(a)). An applicant must submit a PMA supplement to the FDA for review and approval before implementing any changes that may impact the safety or effectiveness of a device after receiving PMA approval. The responsibility to determine if a supplement is necessary lies primarily with the PMA holder. Required supplement submissions include, but are not limited to: new indications for device use, labeling changes, alterations in manufacturing facilities, modifications in sterilization procedures, packaging changes, adjustments in performance or design specifications, and extensions of the device's expiration date. Additionally, the FDA mandates annual postapproval reports, submitted within one year of the original PMA approval, which must include: identification of all changes (regardless of their effect on safety or effectiveness), summaries and bibliographies of unpublished clinical and nonclinical studies related to the device, and relevant scientific literature. Manufacturers are also required to submit Adverse Reaction Reports or Device Defect Reports to the FDA within ten days of becoming aware of specific issues, such as mix-ups, unexpected adverse reactions, or significant device deterioration. Furthermore, the FDA may establish additional conditions for PMA approval, including limitations on the device's sale or distribution, ongoing evaluations, clear warnings, record-keeping requirements, and batch testing. These conditions may be set forth in the initial PMA approval order, through regulations at the time of approval, or through subsequent regulatory actions. The Medical Device Amendments (MDA) allow most Class III medical devices to enter the market without undergoing the rigorous Premarket Approval (PMA) process due to a 'grandfathering' provision for pre-1976 devices, which can remain on the market without FDA approval until the FDA completes the PMA. To prevent monopolization and facilitate improvements, the MDA permits new devices that are 'substantially equivalent' to these pre-existing devices to enter the market via the premarket notification, or 510(k), process. The Supreme Court in Lohr noted that the 510(k) process is now the primary pathway for new medical devices, with approximately 99% of new Class III devices in 2005 utilizing this route, compared to only 1% via the PMA process. The 510(k) process, unlike the PMA process, requires manufacturers to demonstrate that a device is substantially equivalent to a legally marketed device rather than proving safety and efficacy. The 510(k) review is significantly less rigorous, averaging 20 hours compared to the 1,200 hours required for a PMA review. Furthermore, the FDA regulations clarify that a 510(k) determination does not equate to FDA approval, and any misleading representation suggesting approval constitutes misbranding. Once a device is cleared through the 510(k) process, its manufacturer can make changes more freely than a PMA-approved device, needing only to show continued substantial equivalence to the predicate device. A PMA supplement requires FDA review prior to any changes impacting device safety or effectiveness, while a 510(k) supplement is necessary only for significant modifications in design, components, manufacturing methods, or intended use. The MDA contains a preemption provision, Section 360k(a), which prohibits states from establishing or maintaining requirements that differ from or add to federal requirements concerning the safety or effectiveness of medical devices. This preemption is central to the current case involving devices marketed via PMA or 510(k) routes. Over the years, courts have debated the scope of Section 360k(a) regarding state requirements arising from common law versus statutory enactments and whether PMA or 510(k) approvals constitute federal requirements. In Becker v. Optical Radiation Corp., the court ruled that state common law claims alleging defects in PMA-approved devices are preempted by Section 360k(a) as they would impose additional requirements beyond federal standards. However, the issue of whether claims regarding 510(k)-cleared devices are similarly preempted was not addressed in Becker but was later considered by the Supreme Court in Lohr, where plaintiffs raised state tort claims related to a 510(k) approved pacemaker design and labeling. All nine justices concurred that the 510(k) process does not impose federal design requirements for medical devices, indicating that clearance merely signifies that a new device is substantially equivalent to an existing one. Consequently, design defect claims regarding 510(k)-cleared devices are not preempted by Section 360k(a) of the Medical Device Amendments (MDA), as there are no federal requirements with which these claims could conflict. In addressing manufacturing and labeling claims, the justices split on two key issues concerning the interpretation of preemption under Section 360k(a). Firstly, there was disagreement on whether preemption applies solely to device-specific federal requirements or to any FDA requirements. Justices Stevens, Kennedy, Souter, Ginsburg, and Breyer held that only device-specific requirements could trigger preemption, resulting in their conclusion that the plaintiffs' claims were not preempted since the relevant FDA requirements were general. Conversely, Justices Rehnquist, O'Connor, Scalia, and Thomas contended that general FDA requirements could also lead to preemption and dissented on this basis. Secondly, the justices were divided on whether a state "requirement" under Section 360k(a) could originate from state common law or was limited to state statutes and regulations. The majority, including Justices Stevens, Kennedy, Souter, and Ginsburg, asserted that Congress's intent in enacting 360k was primarily focused on conflicting state statutes and regulations, suggesting that common law duties are seldom preempted. They noted that it is unlikely for a common law cause of action to establish substantive requirements for specific devices. Justice Breyer expressed reservations about the notion that incidents of Medical Device Amendments (MDA) preemption of common-law claims will be infrequent. He referenced the Supreme Court's decision in Cipollone v. Liggett Group, Inc., suggesting that the term "requirement" could encompass legal obligations arising from state tort law. Breyer provided a hypothetical scenario where federal MDA regulations mandating a 2-inch wire could preempt a state regulation requiring a 1-inch wire. This raises the question of whether a state tort claim based on the alleged negligence of using a longer wire would also be preempted, given the identical effects of both regulations and the tort suit. The decision in Lohr, supported by five justices, established two key principles for evaluating the preemption of common law tort actions concerning medical devices under the MDA. First, courts must identify any specific federal requirements applicable to the device. Second, they need to assess whether a conflict exists between this federal requirement and the liability premises of the state tort claim. Subsequent circuit court rulings have generally aligned with this framework, concluding that common law tort actions regarding PMA-approved devices are preempted by the MDA, in contrast to 510(k)-cleared devices. The majority of circuits, including the Third, Fifth, Eighth, Sixth, and Seventh, have affirmed that PMA approval constitutes a federal device-specific requirement that conflicts with state tort claims. Conversely, the Eleventh Circuit has disagreed, asserting that PMA approval does not amount to such a requirement. The discussion shifts to the current appeal concerning the district court's March 14, 2002 order, which dismissed several claims from the Riegels based on preemption. The Becker decision previously indicated that tort claims related to PMA-approved devices would be preempted under Section 360k(a) of the MDA. However, due to the Supreme Court's clarification on this issue in Lohr, there is a need to reassess whether Becker remains valid law. Analysis of the Evergreen Balloon Catheter's approval under the PMA process reveals two critical considerations: whether it meets a federal device-specific requirement and if there is a conflict between this requirement and the Riegels' state-law tort claims. The consensus among circuits is that PMA-approved devices are subject to federal requirements, unlike 510(k)-cleared devices, which focus on equivalence rather than safety. The distinction is significant; PMA approval necessitates assurance of safety and effectiveness, whereas 510(k) clearance does not equate to official FDA approval and involves a simpler review process. Consequently, liability implications differ, leading to the conclusion that the Riegels' claims regarding the Evergreen Balloon Catheter are preempted by federal law. The district court's summary judgment in favor of Medtronic is affirmed, as no genuine issues of material fact were found regarding the claims dismissed on preemption grounds. The applicable legal standard for summary judgment requires the absence of material fact disputes, allowing the court to determine if the law was correctly applied. The December 2, 2003 dismissal of the Riegels' negligent manufacturing claim necessitates an analysis of whether genuine issues of material fact exist, evaluated in favor of the non-moving party. Central to this evaluation is the preemption issue, informed by the Medical Device Amendments (MDA) of 1976, which amended the 1938 Food, Drug, and Cosmetic Act to ensure the safety and effectiveness of medical devices. The MDA categorizes devices into three classes based on risk: 1. **Class I** - Low-risk devices (e.g., elastic bandages) that do not require premarket approval, only general controls. 2. **Class II** - Moderate-risk devices (e.g., powered wheelchairs) that may require special controls in addition to general controls. 3. **Class III** - High-risk devices (e.g., the Evergreen Balloon Catheter at issue) that necessitate rigorous premarket approval (PMA) to demonstrate safety and effectiveness before marketing. The PMA process is described as lengthy and detailed, requiring comprehensive data on safety, effectiveness, manufacturing methods, and labeling, with substantial interaction expected between the FDA and manufacturers throughout the process. The FDA typically mandates that initial PMA applications include clinical investigation data, which cannot commence without FDA permission. Manufacturers must include the results of clinical investigations in their Premarket Approval (PMA) applications as mandated by 21 C.F.R. 814.20 and 21 U.S.C. 360e(c). The FDA reviews these submissions for completeness; incomplete applications will be refused for filing under 21 C.F.R. 814.42. Once accepted, the FDA may refer the PMA to an advisory committee and will meet with the applicant on the 100th day to discuss the application’s status and deficiencies (21 U.S.C. 360e(d)(3)). Upon completion of its review, the FDA can either approve the device, issue an "approvable letter" indicating conditions for potential approval, or send a "not approvable letter" detailing deficiencies (21 C.F.R. 814.44(e) and 814.44(f)). Once approved, the applicant must adhere to the conditions specified in the PMA approval order (21 C.F.R. 814.80). Any changes affecting the safety or effectiveness of the device require a PMA supplement for FDA approval (21 C.F.R. 814.39(a)). Such changes include new indications for use, labeling modifications, alterations in manufacturing facilities, sterilization procedures, packaging adjustments, design or specification changes, and expiration date extensions. Additionally, the PMA's continued approval is contingent on annual postapproval reports (21 C.F.R. 814.84), which must identify all changes made to the device, regardless of their impact on safety or effectiveness. 21 C.F.R. 814.84(b)(1) and (2) require applicants to provide summaries and bibliographies of unpublished clinical and nonclinical studies related to their devices, along with known scientific literature. Additionally, manufacturers must submit an "Adverse Reaction Report" or "Device Defect Report" to the FDA within ten days of learning about significant issues, including mix-ups, unexpected adverse reactions, and serious device deterioration that cannot be corrected through standard maintenance. The FDA has the authority to impose further conditions on PMA approval, such as restrictions on sales, ongoing evaluations, record maintenance, and batch testing, either at the time of approval or subsequently. Most Class III medical devices do not undergo the PMA process due to a "grandfathering" provision that allows devices marketed before 1976 to remain available without FDA approval until a PMA is completed. Additionally, new devices deemed "substantially equivalent" to these older devices can market through the 510(k) premarket notification process, bypassing PMA requirements. The Lohr Court recognized that the 510(k) process is the primary route for new medical devices, evidenced by data from 2005 showing that 99% of new Class III devices were cleared through the 510(k) process, while only 1% underwent PMA. The stark contrast between the two processes is highlighted by their differing regulatory requirements. The PMA process mandates that manufacturers provide reasonable assurance of a new device's safety and effectiveness, leading to FDA approval. In contrast, the 510(k) process requires only that a manufacturer demonstrate substantial equivalence to an existing device that has not undergone PMA. The Supreme Court noted that the 510(k) process aims to maintain the marketing status quo of existing devices and their equivalents. The review time for a 510(k) averages around 20 hours, significantly shorter than the 1,200 hours needed for PMA reviews. FDA regulations clarify that substantial equivalence does not imply official approval of the device; any misleading representation suggesting approval constitutes misbranding. Once a device is cleared through the 510(k) process, manufacturers can independently make changes without FDA approval, provided the device remains substantially equivalent to its predicate. In contrast, PMA-approved devices require FDA review for any changes affecting safety or effectiveness. Section 360k(a) of the MDA introduces an express preemption provision, prohibiting states from imposing requirements on devices that differ from or add to federal regulations concerning safety or effectiveness. This preemption aspect is central to the case at hand. The 1976 Medical Device Amendments (MDA) led to judicial inquiries regarding the scope of Section 360k(a)'s preemption of conflicting state requirements. Courts debated whether state requirements could arise from common law or only from statutes. A significant case, Becker v. Optical Radiation Corp., clarified that state common law claims alleging defects in a PMA-approved device are preempted by Section 360k(a), as allowing such claims would impose additional requirements beyond those assessed by the FDA through the PMA process. The FDA evaluates safety and effectiveness based on testing, design, and other standards. Conversely, the Supreme Court case Lohr examined whether state tort claims regarding 510(k)-cleared devices were similarly preempted. The Court found that the 510(k) process does not establish federal requirements for device design, as it only assesses substantial equivalence to existing devices. Consequently, design defect claims for 510(k)-cleared devices are not preempted by federal law, as no federal requirements exist to conflict with state law. The justices faced a split decision regarding the interpretation of Section 360k(a) of the Medical Device Amendments (MDA) concerning the preemption of state requirements. Five justices (Stevens, Kennedy, Souter, Ginsburg, and Breyer) argued that only device-specific federal requirements could lead to preemption, concluding that the general FDA manufacturing and labeling requirements applicable to the pacemaker did not preempt the plaintiffs' claims. Conversely, four justices (Rehnquist, O'Connor, Scalia, and Thomas) contended that general FDA requirements could also result in preemption, dissenting on the grounds that the plaintiffs' claims were thus preempted. Additionally, the justices were divided over whether state "requirements" under Section 360k(a) could arise from common law or only from state statutes and regulations. The majority (Stevens, Kennedy, Souter, and Ginsburg) maintained that the MDA was primarily concerned with conflicting state statutes and regulations, suggesting that common-law duties were rarely preempted. Justice Breyer, while concurring in part, expressed skepticism regarding the rarity of future preemption of common-law claims and indicated that the term "requirement" could encompass legal obligations stemming from state tort law. He provided a hypothetical scenario to illustrate this point, contrasting federal and state regulatory requirements for a hearing aid component. Federal law, specifically the "2-inch" Medical Device Amendments (MDA) regulation, pre-empts state regulations and tort actions that impose different requirements on medical devices. If the MDA pre-empts state agency regulations, it logically follows that it should also pre-empt state tort actions based on the failure to meet those regulations, such as a claim that a manufacturer was negligent for using a 1-inch wire instead of a 2-inch wire. The effects of both the state regulation and the tort action are essentially the same. Five justices have indicated that state "requirements" under the MDA can emerge from both state statutes and common law tort actions. The two main principles arising from the Lohr case involve first assessing whether there are device-specific federal requirements, and then examining if those requirements conflict with the premises of the state tort claim. Most circuits have determined that common law tort actions related to devices approved through the Pre-Market Approval (PMA) process are pre-empted by the MDA, as PMA approval constitutes a specific federal requirement. In contrast, only the Eleventh Circuit has ruled that PMA approval does not equate to a federal device-specific requirement. The current appeal reviews the district court's dismissal of several claims based on these preemption grounds, reaffirming the precedent that tort claims regarding PMA-approved devices are generally pre-empted by the MDA. Becker's precedent regarding the preemptive scope of Section 360k(a) must be reassessed in light of the Supreme Court's ruling in Lohr. The analysis is divided into two parts: first, determining if a PMA-approved device, like the Evergreen Balloon Catheter, is subject to federal device-specific requirements; second, examining the Riegels' tort claims for any conflicts with these requirements. The majority of circuits concur that PMA-approved devices are indeed subject to such requirements, unlike 510(k)-cleared devices, which do not establish federal device-specific mandates. The Lohr decision emphasized significant distinctions between the two processes: 510(k) clearance is based on equivalence, not safety; it does not denote official FDA approval; and it aims to maintain the status quo regarding existing devices. In contrast, PMA approval necessitates evidence of a device's safety and effectiveness, represents official FDA approval, and allows for the FDA to mandate specific forms for device approval. The PMA process was designed for devices that are not substantially equivalent to older models, contrasting with the 510(k) process's focus on equivalence. Overall, the PMA process embodies a more rigorous regulatory framework compared to the 510(k) pathway. An applicant can receive a "not approvable" letter from the FDA detailing deficiencies in a Premarket Approval (PMA) application and suggesting corrective measures. Once a device is approved under PMA, any changes affecting its safety or effectiveness require FDA approval; this contrasts with the broader flexibility allowed for manufacturers of 510(k)-cleared devices, where only significant changes necessitate further approval. The distinction lies in the nature of 510(k) clearance, which focuses on substantial equivalence to existing devices, while PMA signifies the FDA's endorsement of a device's safety and effectiveness as presented. Consequently, the Evergreen Balloon Catheter, being PMA-approved, is obligated to comply with specific standards outlined in its PMA application. Although the FDA approved the Evergreen Balloon Catheter without requiring modifications, this does not diminish its regulatory obligations. The FDA's acceptance indicates that the device was deemed safe and effective as submitted. Therefore, all PMA-approved devices uniformly adhere to the regulations set forth in their respective PMA applications after the approval process is finalized. The Riegels contend that their failure-to-warn claim concerning the Evergreen Balloon Catheter's labeling is not subject to federal preemption because: (1) the only applicable federal regulation is 21 C.F.R. 801.109, which the Supreme Court in Lohr deemed insufficiently device-specific to preempt labeling claims for a 510(k)-cleared device, and (2) under 21 C.F.R. 814.39(d)(1)(2), manufacturers of PMA-approved devices can make certain labeling changes without FDA pre-approval. However, the court finds this argument flawed since the FDA explicitly approved the catheter's labeling through the PMA process. Medtronic submitted PMA supplements for label revisions, which the FDA approved, indicating that no label changes were made outside this process. The court does not need to explore the potential preemption of claims based on changes made under 814.39(d) because no such changes occurred. Additionally, while the dissent raises concerns about the FDA's effectiveness in ensuring medical device safety, the court emphasizes that these concerns are policy issues for Congress and the Executive, not legal questions regarding federal requirements. The court ultimately concludes that the Riegels' claims, if successful, would impose state requirements that differ from the federal standards established in the approved PMA application, referencing the Supreme Court's ruling in Cipollone v. Liggett Group, which affirmed that state common law tort suits are included under preemption provisions. The phrase "no requirement or prohibition" is interpreted broadly, encompassing both statutory and common-law obligations. Common-law damages actions, such as those presented by the petitioner, are based on the existence of a legal duty, which inherently imposes requirements or prohibitions. The Supreme Court has previously established in Cipollone that state regulations can manifest through tort actions, indicating that such actions create requirements. In Lohr, justices confirmed that the term "requirements" includes state common law tort lawsuits. The recent case Bates v. Dow Agrosciences LLC reaffirmed this interpretation, stating that "requirements" under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) extend beyond statutory enactments to common-law duties. Consequently, the Riegels' claims of strict liability, breach of implied warranty, and negligent design are seen as imposing state requirements that differ from the standards set by the Premarket Approval (PMA) for the Evergreen Balloon Catheter. These claims are based on the assertion that the catheter, even in its approved form, is defective and necessitates modification, rather than alleging a deviation from the PMA standards. The Riegels argue that a favorable verdict would arise from general state common law duties, such as the duty to exercise due care and inform users of risks. A verdict in favor of the Riegels on their claims against the Evergreen Balloon Catheter would imply that the device violated state common law duties, such as the duty of due care in its design or adequate warning in its labeling. This finding would conflict with the FDA’s determination that the device, having received premarket approval (PMA), is reasonably safe and effective. The document cites Supreme Court cases—Cipollone, Lohr, and Bates—indicating that common law actions impose requirements that can differ from federal standards. It draws a parallel to Justice Breyer’s hypothetical scenario where a tort claim against a medical device manufacturer could be preempted due to a federal requirement. The Riegels’ claims would suggest that the manufacturer failed to comply with a standard other than the PMA-approved criteria, complicating compliance for manufacturers who cannot modify the device without further FDA approval. This situation raises concerns about inconsistent jury verdicts across jurisdictions, which could impede compliance with federal PMA requirements and disrupt interstate commerce, aligning with the intent of the Medical Device Amendments (MDA) to prevent burdensome state regulations on medical device innovation. The excerpt addresses the interpretation of Section 360k(a) of the Medical Device Amendments (MDA) concerning preemption of state tort claims. It acknowledges a general presumption against preemption and notes that the legislative history of the MDA does not explicitly mention preemption of state tort liability. However, it asserts that Supreme Court precedent indicates that the term "requirements" in Section 360k(a) includes state common law actions. The distinction is made between 510(k)-cleared devices, which were meant to maintain existing marketing practices and could be subject to state tort claims, and PMA-approved devices, which are under stricter federal oversight and thus less likely to allow for state tort remedies. The PMA process is seen as a comprehensive federal regulation approach, inherently preemptive. The court holds that the Riegels' claims related to strict liability, breach of implied warranty, and negligent design are preempted by Section 360k(a), affirming the district court's summary judgment in favor of Medtronic. Conversely, the negligent manufacturing claim is not preempted, as it alleges a failure to comply with PMA-approved standards, which aligns with federal requirements. The conclusion emphasizes that state tort claims can coexist with federal standards if they do not impose differing requirements. The analysis concludes that the decision's impact is limited, countering dissenting concerns about a lack of remedies for injuries caused by dangerous medical devices. Most Class III medical devices are approved through the 510(k) process, not the PMA process, and the Supreme Court's ruling in Lohr established that tort claims for 510(k)-cleared devices are not preempted. The current decision does not preempt all state tort claims related to PMA-approved devices; claims based on a manufacturer's deviation from PMA standards, such as negligent manufacturing, are still permissible. Only claims asserting liability despite compliance with PMA standards are preempted, which represents a narrow category of cases. The dissent's argument suggesting that preemption will discourage manufacturers from improving safety is questioned; PMA manufacturers are already required to submit annual reports to the FDA and notify it of adverse events, maintaining safety standards. Furthermore, competition among manufacturers serves as an additional incentive for product improvement. The analysis views the preemption issue more as a policy matter for Congress than a legal one, indicating that Congress could amend Section 360k(a) to clarify that state tort actions are not included under "requirements." Lastly, the FDA supports the conclusion that preemption is warranted, as expressed in its amicus brief related to the Horn case, which aligns with the view that state law claims impose different requirements than those established by the FDA during the PMA process. The majority opinion in Lohr noted the FDA's unique expertise in determining the appropriateness of state law preemption. The FDA's change in stance regarding medical device regulations is permissible if supported by a reasoned analysis, as established in the case of Horn. The December 2, 2003 order granted summary judgment to Medtronic on the Riegels' negligent manufacturing claim, which hinges on circumstantial evidence due to the absence of the actual Evergreen Balloon Catheter used in Mr. Riegel's angioplasty. The Riegels must demonstrate that the catheter was defective by proving it did not function as intended and ruling out other potential causes. Medtronic contends that the catheter burst due to improper inflation to 10 atmospheres, the catheter's use in a heavily calcified artery, and the potential puncturing by metal stents. To counter Medtronic's arguments and avoid summary judgment, the Riegels needed to provide credible evidence excluding these alternative explanations. The district court concluded that the Riegels failed to present sufficient evidence to eliminate these alternative causes, as Dr. Roccario acknowledged inflating the catheter beyond the recommended limit and that the use of the catheter in calcified arteries was contraindicated, despite asserting it was a common practice at the time. This acknowledgment does not absolve the inflation or the artery condition as potential causes of the rupture. Dr. Roccario stated that his medical procedures and decisions on May 10, 1996, did not contribute to the catheter's bursting. However, he did not assert that the rupture was due to a manufacturing defect. The Riegels' only evidence for a manufacturing defect was engineer Ted Milo’s opinion, which claimed the catheter burst radially rather than longitudinally, indicating a defect. The district court deemed Milo's conclusion to be speculative and lacking scientific foundation, thus ruling it inadmissible as expert testimony. The court highlighted shortcomings in Milo’s reasoning, noting he did not clarify why a radial failure was more indicative of a defect or address alternative causes, such as overinflation or punctures. Additionally, Milo did not express an opinion regarding another expert's view that the rupture might result from external factors rather than a manufacturing defect. The Riegels contended that a jury should evaluate Milo's theories, but the court asserted that it was appropriate for the district court to assess the admissibility of scientific evidence before summary judgment. The court concluded that Milo's opinion lacked sufficient explanation and methodology to be considered admissible, thus it could not substantiate a claim of manufacturing defect. Under R.Evid. 702, expert testimony is admissible if it aids the trier of fact, provided the witness is qualified and the testimony is based on sufficient facts, reliable principles, and their application to the case's facts. The district court excluded Milo's opinion on the cause of a catheter rupture due to a lack of explanation and inconsistency in his deposition. Consequently, without competent evidence to rule out other possible causes—specifically, interaction with a calcium spicule or catheter over-inflation—there were no material facts in dispute regarding the Riegels' claim. The court affirmed the dismissal of their negligent manufacturing claim and the summary judgment in favor of Medtronic on all claims, confirming jurisdiction based on diversity as the Riegels are New York residents and Medtronic is based in Minnesota. The court noted that while a loss of consortium claim was allowed, the Riegels did not contest the dismissal of their breach of express warranty claim. The excerpt includes details about FDA regulations relevant to medical devices, specifically regarding reporting malfunctions and the classification process under the 510(k) and PMA systems. Calculations referenced in the document are based on the 2005 monthly listings of 510(k)-cleared and PMA-approved devices. The FDA identifies "significant changes or modifications" that could impact device safety or effectiveness, as well as "major changes" in intended use, under 21 C.F.R. 807.81. Section 360k(b) of the MDA allows the Secretary to exempt certain state regulations from preemption upon request, although this section has not been argued by either party. The preemption doctrine is clarified by 21 C.F.R. 808.1(d), which states that state and local requirements are only preempted when the FDA has established specific counterpart regulations for particular devices. Manufacturers must adhere to labeling regulations in 21 C.F.R. 801.109 that specify required information for safe device use, and must comply with "Good Manufacturing Practices" as outlined in the Code of Federal Regulations. The discussion of the Cipollone decision indicates a nuanced view of preemption, particularly concerning state common-law requirements, which are not necessarily developed specifically for medical devices and therefore may avoid preemption. Justice Breyer's separate concurrence highlights his belief that MDA preemption of state-law tort suits could occur more frequently than suggested, indicating that if a state requirement is preempted by MDA, a similar requirement from a tort action would also be preempted. Breyer expressed agreement with Justice O'Connor's analysis while maintaining a distinct stance on the implications of MDA preemption. Justice Breyer's fifth vote indicates that state requirements may arise from common law tort actions based on a breach of the standard of care. The Seventh Circuit reaffirmed this view in McMullen v. Medtronic, while the Tenth Circuit, in a non-PMA context, agreed that state common law actions based on a general duty of care are not preempted by the Medical Device Amendments (MDA). However, state courts are divided on this matter. Some, like the Texas and California courts, have held that common law claims alleging liability despite adherence to PMA standards are preempted. In contrast, other jurisdictions, such as Illinois and New York, have ruled that such claims are not preempted. The Court clarified that claims for defective design, manufacture, and negligent testing are not preempted, as they do not pertain to labeling or packaging, which are the focus of FIFRA's preemption provision. The Court also stated that a claim for breach of express warranty is not preempted, as it merely requires the manufacturer to fulfill its contractual obligations. Additionally, a judge noted that a physician's assumption regarding the relevance of contraindications in a specific medical procedure was inadequately addressed. The majority opinion determined that once a device undergoes the PMA process, all state tort claims concerning its design or labeling are preempted. The dissenting opinion highlights two crucial factors in the preemption analysis: the presumption against preemption and the intent of Congress. These factors, according to the dissent, argue against preemption, leading to the conclusion that the PMA process does not constitute a device-specific federal requirement and that Riegel's tort claims should not be preempted. The dissent references Supreme Court precedents emphasizing that state regulations concerning health and safety are generally not overridden by federal law unless Congress's intent is explicit. It notes the strong presumption against preemption is particularly relevant given states' historical role in providing tort remedies for defective products. The Medical Device Amendments (MDA) were enacted primarily to enhance consumer safety following issues with medical devices like the Dalkon Shield, reflecting Congress's intent to prioritize consumer protection over concerns about regulatory burdens. The legislative history of the Medical Device Amendments (MDA) does not suggest that Congress intended to preempt state tort liability concerning medical devices. There is no evidence that Congress was concerned about litigation affecting the development of medical devices, nor is there any mention of preemption of state tort claims in contemporaneous analyses. If Congress had aimed to eliminate all state tort claims for defective devices, such a substantial shift from existing law would likely have been explicitly noted, especially given the ongoing litigation surrounding devices like the Dalkon Shield. The available discussions on the preemption provision indicate it was primarily designed to prevent conflicting state regulatory schemes. State tort remedies are notably absent from these discussions, which is significant given that Congress did not establish a federal remedy for individuals harmed by medical devices. This raises doubts about the intention to preempt state tort claims, particularly since such a decision would adversely affect consumers. Furthermore, the Supreme Court has ruled that claims involving fraud on the FDA are impliedly preempted, meaning that even if a manufacturer obtained premarket approval through deceitful means, injured consumers would be unable to seek compensation. The absence of a clear intent from Congress to deny injured parties a long-standing method of compensation is emphasized. The assertion that all state tort claims are unequivocally preempted is questioned, as it appears that until recently, neither the medical device industry nor the FDA believed such claims were preempted. It was only about fifteen years post-MDA enactment that the industry started to use FDA approval as a defense against state tort claims. The FDA's stance as of 1997 was that common law duties would only be preempted when the FDA explicitly imposed a specific substantive requirement that differed from state law. State tort claims for negligent design or labeling aim to compensate consumers for injuries caused by products manufacturers knew or should have known posed unreasonable risks. Strict product liability typically holds manufacturers responsible for compensating injured users, as they can better manage risks and distribute costs among product beneficiaries. However, a finding of federal preemption in cases involving defective medical devices could shift this burden entirely onto injured consumers, diminishing manufacturers' incentives to enhance product safety after obtaining Premarket Approval (PMA). Concerns arise regarding the FDA's ability to ensure medical device safety, as its resources may be inadequate for effective oversight, and its relationship with the regulated industry could compromise its effectiveness. Historical evidence, including a 1993 House subcommittee report, highlights instances where the FDA approved unsafe devices, often due to insufficient data from manufacturers and inadequate evaluation processes. For example, the FDA's approval of bovine collagen in 1981 occurred despite serious flaws in clinical data and delayed responses to adverse reaction reports, reflecting systemic issues in the agency's oversight capabilities. In 1991, the FDA acknowledged a link between bovine collagen use and autoimmune responses, indicating serious health risks. This acknowledgment raises concerns about relying solely on FDA oversight for medical device safety. The majority opinion views these concerns as legislative issues, irrelevant to preemption analysis, but the dissent argues that they reflect Congress's intent to protect consumers. The dissent emphasizes that preemption should not eliminate all state tort claims related to design or labeling defects, especially since Congress aimed to safeguard consumers when enacting the Medical Device Amendments (MDA). The dissent asserts a strong presumption against preemption, stating that a thorough comparison of federal and state requirements is essential to determine preemption under Section 360k(a). It highlights that without a specific federal requirement for the Evergreen Balloon Catheter, the Riegels' state tort claims should not be preempted. The dissent agrees that the PMA process must impose device-specific federal requirements, referencing the Supreme Court's mandate for careful comparisons between federal and state regulations. Despite the rigorous nature of the PMA review, it concludes that no specific federal requirements are established that could be compared to state law, thus supporting the argument against preemption. FDA approval indicates that a manufacturer has met the agency's minimum safety and effectiveness standards, but it does not imply a thorough evaluation or rejection of alternative, safer designs. The FDA’s issuance of a generic approval letter does not suggest that it has denied any design improvements proposed by the Riegels through their tort claims. The FDA has the authority to establish performance standards that would impose specific federal requirements with preemptive effects, but this was not the case here. The majority opinion erroneously asserts that compliance with the standards in the approved PMA application constitutes a specific federal requirement. Although manufacturers must seek FDA approval for changes affecting safety and effectiveness post-PMA, they can request PMA supplements for changes. Therefore, the FDA is not seen as prohibiting manufacturers from making specific improvements until a request is made and potentially denied. Additionally, manufacturers can implement certain safety enhancements without prior FDA approval. The idea that manufacturers are incentivized to promptly notify the FDA about necessary changes based on new safety data is supported by the potential for damage actions, which may encourage proactive product improvements. The majority's distinction regarding changes post-Section 510(k) approval lacks merit, as the requirement for FDA approval after PMA does not create a specific federal requirement. Consequently, the PMA process does not impose any federal device-specific requirements, negating the need to assess whether state tort claims are preempted by such a requirement. The majority opinion asserts that the Riegels' claims, including negligent design, strict product liability, breach of implied warranty, and loss of consortium, are preempted due to the federal requirements of the Premarket Approval (PMA) process, which prohibits alterations to the design, manufacturing, or labeling of the Evergreen Balloon Catheter. The dissenting opinion agrees that some state tort claims could be preempted as they may impose additional requirements beyond federal standards, referencing the Supreme Court's decision in Bates. However, it argues against the preemption of the Riegels' claims since there is no specific federal requirement to compare against the state claims, and the manufacturer, Medtronic, is not barred from improving the device. The dissenting judge concurs with the majority regarding the summary judgment on the negligent manufacturing claim but disagrees with the overall finding of preemption. Furthermore, the dissent highlights that while the FDA is required to be informed of new safety information by manufacturers, this does not necessitate proactive efforts to enhance safety unless mandated by the FDA. The dissent also notes that the FDA's long-standing position has been that PMA criteria establish minimum standards, which do not eliminate state law standards of care.