Carol Jean Brooks, St. Luke's Hospital, Intervenor Below v. Howmedica, Inc., a Delaware Corporation, Division of Pfizer Hospital Products Group, Inc. Pfizer, Inc. Howmedica International, Ltd.
Docket: 00-1188
Court: Court of Appeals for the Eighth Circuit; January 9, 2001; Federal Appellate Court
The case involves Carol Jean Brooks as the appellant against Howmedica, Inc., Pfizer, Inc., and Howmedica International, Ltd. as appellees, concerning the preemptive effect of the Medical Device Amendments of 1976 (MDA) in light of the Supreme Court's ruling in Medtronic, Inc. v. Lohr. Howmedica developed 'surgical Simplex (r) P Radiopaque bone cement' in the late 1960s for orthopedic surgeries, which consists of a liquid and powder mixed to form a hardening cement. The mixing process emits harmful methyl methacrylate vapors, posing inhalation risks for healthcare personnel.
Howmedica submitted Simplex for FDA marketing approval in February 1971, providing extensive safety data, including animal studies, clinical trials, and manufacturing protocols. The FDA subjected Simplex to the New Drug Application (NDA) process, carefully reviewing and modifying the product's labeling and packaging. The FDA approved Simplex on October 7, 1971, but continued to mandate label updates in response to emerging safety data and studies regarding its use.
Carol Brooks, a licensed practical nurse since 1965, worked with bone cement at St. Mary’s Hospital and later at St. Luke’s Hospital, where she regularly mixed Simplex for surgical procedures. The case is being heard by the United States Court of Appeals for the Eighth Circuit.
Brooks worked primarily in the orthopedic surgery department at St. Luke's, where her responsibilities included mixing bone cement. Initially mixing for four cases per week, her duties escalated to assisting in approximately ten surgeries weekly by 1992, during which she mixed the cement herself or was present while another nurse did so. In 1989, Brooks began experiencing a persistent cough, which led to a diagnosis of asthma in 1991. Despite efforts to determine the cause, her doctor could not identify it, although he limited her exposure to Simplex, a bone cement product. In 1992, following an acute asthma attack, Brooks was further restricted from exposure and ultimately left her job in 1995 due to her condition, which was later attributed to methyl methacrylate vapors from Simplex.
On March 19, 1997, Brooks filed a products liability lawsuit against Howmedica, alleging negligence for failing to warn her about the risks of occupational asthma from inhaling vapors during the cement mixing process and noncompliance with FDA labeling regulations. Following extensive discovery, Howmedica sought summary judgment, which the district court granted, ruling against Brooks. Brooks appealed the judgment.
The appellate court reviews the summary judgment de novo, examining if there are any disputed material facts favoring the nonmoving party. Brooks's failure-to-warn claim was deemed preempted by federal law, specifically the Medical Device Amendments (MDA), which prohibits state requirements that differ from federal standards concerning medical devices. The court referenced a recent Supreme Court decision in Lohr, which clarified that state law claims were not necessarily preempted under similar circumstances.
Lohr clarified the complexities surrounding the preemption provision under 360k of the Medical Device Amendments (MDA), leading to confusion among lower federal courts despite a lack of consensus from the Supreme Court. Justice Stevens supported a narrow interpretation of preemption, while Justice O'Connor advocated for a broader approach, resulting in a plurality opinion from Stevens and a partial concurrence/dissent from O'Connor. All Justices agreed that 360k encompasses common law tort actions, but differed on the relevance of FDA regulations in interpreting preemption. The FDA's preemption regulation specifies that state requirements are only preempted when the FDA has established specific counterpart regulations for a device, and does not intend to preempt general state requirements related to other products or unfair trade practices.
Stevens, supported by Breyer, proposed a three-step analysis for preemption:
1. Identify the state requirement in question, which must relate to the safety or effectiveness of the specific medical device.
2. Determine if a specific federal requirement governs the device, with preemption applying only to specific counterpart regulations.
3. Compare the state and federal requirements to assess whether compliance with both is impossible, which would result in federal preemption. This comparative analysis is crucial, as 360k aims to protect federal regulations from conflicting state requirements.
If state law obstructs Congressional objectives, federal law preempts state law. A careful comparison is necessary between federal and state requirements to assess preemption. Brooks alleged that Howmedica did not adequately warn her about the dangers of methyl methacrylate vapors during the mixing of Simplex, arguing that a common law failure-to-warn claim is generic and not a specific state requirement subject to preemption. The court recognizes Minnesota failure-to-warn claims as generic but must address whether such claims can function as device-specific requirements when applied to a particular product.
In the case of Lohr, five Justices indicated that generic common law claims could be preempted, as they may compel compliance similar to specific state regulations. Justices Breyer and O'Connor noted that a common law judgment against a medical device manufacturer could impose state requirements akin to formal regulations. A judgment favoring Brooks would impose a specific state law mandate, as it would necessitate expanded labeling for Simplex regarding asthma risks associated with chemical exposure. Thus, the court concludes that Brooks's claim represents a specific state law requirement, aligning with the criteria for preemption.
The analysis addresses the federal requirement regarding the premarket approval (PMA) process for medical devices, affirming its status as a specific federal requirement under 21 U.S.C. 360k(a) and 21 C.F.R. 808.1(d). It references Martello v. Ciba Vision Corp. to support the argument that the PMA process retains its preemptive power despite the Supreme Court's decision in Lohr, which focused on the less rigorous 510(k) approval process. The FDA has explicitly expressed concerns regarding the device Simplex, indicating that the PMA process imposes strict FDA requirements on the manufacturer.
The excerpt further cites opinions from the Sixth and Seventh Circuits, affirming that the PMA process constitutes specific federal regulation that may have a preemptive effect. Although Simplex was not reviewed under the PMA process, it underwent scrutiny under the New Drug Application (NDA) process, which preceded the PMA framework. The FDA meticulously reviewed and approved the labeling and packaging of Simplex, demonstrating a thorough federal regulatory process.
The text notes that while the PMA process may be more stringent than the NDA process, both aim to ensure the safety of medical devices before market release. It concludes that, by operation of law, Simplex is considered PMA-approved due to its classification and regulatory history, which counters the argument made by Brooks disputing the equivalence of the two processes.
Martello establishes that a PMA-compliant medical device like Simplex has undergone specific federal regulation, as Simplex is considered PMA-compliant through an NDA equivalent approval process. A comparison of state and federal requirements is necessary, focusing on (1) potential incompatibility and (2) whether state laws undermine federal objectives. Justice Stevens emphasizes that state regulations that support federal regulations do not trigger preemption. He likens these complementary state requirements to local fire codes, which do not conflict with federal health standards. State requirements duplicating federal standards also do not threaten federal law and will not be preempted. Only divergent state requirements necessitate preemption under 21 U.S.C. 360k(a)(1) and 21 C.F.R. 808.1(d).
Howmedica argues that federal labeling requirements for Simplex conflict with a hypothetical adverse judgment on a state-law failure-to-warn claim, claiming it cannot meet both federal and state obligations. However, this argument is flawed because FDA regulations do not restrict Simplex's labeling to its 1971-approved state. The FDA allows manufacturers to enhance warnings and information on labels. Howmedica's assertion that it cannot change the labeling is incorrect, as the FDA encourages the addition of warnings regarding adverse outcomes, which means an adverse judgment on the state failure-to-warn claim would not force a conflict between compliance with federal regulations and state law.
A judgment against Howmedica regarding Brooks's failure-to-warn claim would not conflict with Congressional intent or FDA policy, as the FDA's primary role is to ensure the safety of medical devices before market release. The claim for enhanced warnings does not contradict FDA regulations, which establish minimum requirements, allowing for additional state law claims that could raise warning standards without conflicting with federal law. Howmedica could comply with both an adverse state-law ruling and FDA regulations, making preemption inappropriate in this case. The district court mistakenly granted summary judgment to Howmedica on Brooks's claim.
Although there may appear to be a conflict with 21 U.S.C. § 360k, which prohibits state requirements that differ from federal law, this tension is superficial. Supreme Court interpretations suggest that § 360k requires analysis beyond its literal wording. Justices Breyer and Stevens emphasized the importance of conflict preemption, indicating that a state law would only be preempted if it directly conflicts with a federal requirement for the specific device. Justice O'Connor's dissent, which would interpret § 360k literally, did not receive sufficient support, indicating that a majority of Justices preferred a conflict preemption approach. In Brooks's case, the conflict preemption analysis demonstrates no inconsistency between the failure-to-warn claim and FDA labeling requirements.
Brooks asserted that Howmedica violated FDA regulations after the pleadings were filed, which led to the construction of her claim as a 'negligence per se' based on alleged FDA noncompliance. U.S. Supreme Court precedent in Lohr indicates that such state-law claims are not preempted when related to medical device manufacturers. Under Minnesota law, to succeed in a negligence per se claim, a plaintiff must demonstrate that they belong to a protected class and that the defendant violated relevant FDA regulations. Brooks was recognized as part of the protected class intended to be safeguarded by FDA labeling regulations, having been regularly exposed to Simplex and its byproducts.
However, Brooks's claim failed on the second element, as Howmedica was found to have complied with FDA labeling requirements since Simplex's approval in 1971. The company made necessary adjustments to its packaging as recommended by the FDA, and all labeling was formally approved. The court determined that Brooks did not provide sufficient evidence to show that Howmedica violated FDA regulations, leading to the failure of her negligence per se claim. The district court's summary judgment in favor of Howmedica regarding Brooks's failure to comply with federal regulations was affirmed, while the judgment that her state-law failure-to-warn claim was preempted by federal law was reversed, with the case remanded for further proceedings.
Conflict preemption principles are significant in the Court's analysis; however, field preemption is not relevant in the context of 360k preemption analysis. Five Justices determined that Congress did not intend to create a comprehensive federal regulation scheme that would entirely replace state tort law. There is no evidence from legislative hearings or reports indicating an intention to broadly preempt traditional common-law remedies for defective devices.
Brooks presents affidavits and expert reports alleging Howmedica's violation of FDA regulations, but these are insufficient for her claim. Even if the experts were qualified, they did not provide opinions on violations of specific FDA regulations, which are necessary under the Daubert standard for expert testimony.
Judge Murphy dissents on the issue of Brooks' failure to warn claim, arguing that the product Simplex is subject to extensive federal regulations, unlike the pacemaker in Lohr. The FDA evaluated and approved all labeling for Simplex, which cannot be altered without federal consent. A state requirement that adds to federal requirements can be preempted under the Medical Device Amendments (MDA). Brooks' claim seeks additional warnings not included in the FDA-reviewed labeling, thereby imposing a different substantive requirement. This preemption aligns with rulings from other federal circuits where common law failure to warn claims are preempted when the device has undergone PMA or NDA review.
The statute 21 U.S.C. 360k(a) explicitly preempts any state requirements that differ from or add to federal regulations related to medical devices. Despite the court's assertion that Congress did not intend for this language to be interpreted literally due to safety concerns, legislative history indicates that the preemption was included in the Medical Device Amendments (MDA) to prevent burdens on interstate commerce from varying state requirements. The FDA's close collaboration with Howmedica on the approval of Simplex's warning labels further supports this preemption. Allowing state-level requirements could lead to inconsistent labeling, confusion, and increased costs for manufacturers, undermining congressional intent. Therefore, the failure to warn claim is subject to this preemption, warranting affirmation of the district court's judgment.
