By David Yucht, J.D.
Under federal statute, a manufacturer of a Class III medical device subjected to premarket approval was protected from civil liability if it complied with federal law, according to the U.S. Court of Appeals for the Eleventh Circuit. However, if a patient could prove that he or she was hurt by a manufacturer’s breach of a common-law duty owed to him under state law and that the duty was parallel to the requirements of federal law, there was no preemption (Mink v. Smith & Nephew, Inc., June26, 2017, Martin, B.).
A medical device manufacturer, Smith & Nephew, Inc., developed a metal-on-metal hip replacement system called the Birmingham Hip Resurfacing (BHR) System. This system was a Class III medical device under Food and Drug Administration (FDA) regulations, requiring premarket approval from the FDA before becoming commercially available. The FDA conditionally approved the device requiring the manufacturer to conduct a post-approval safety and efficacy study which included assessing renal function and monitoring metal ion levels in a patient’s blood.
Post-approval study. A Florida patient was advised that he needed a hip replacement. He saw an advertisement for the BHR System and contacted the manufacturer. He was referred to a local orthopedic surgeon who served as a company representative. The patient was advised that he could get the BHR System as a part of the manufacturer’s study and would receive free monitoring and testing for 10 years. Allegedly, he also was advised that the device was more appropriate than others on the market for people his age and that it had been used safely in England for a number of years. The patient signed the consent form to enter the study and was implanted with a BHR.
Patient terminated from study. About seven weeks after the surgery, the doctor representing the manufacturer informed the patient that he could no longer see him. An attempt to substitute another orthopedist to follow up with the patient failed. Thereafter, the manufacturer advised the patient that it could not find a site for him to participate in the study and it removed him from the study.
Device failed. The patient began to experience high metal ion levels and required monitoring at his own expense. He also developed eye problems, and a lymph node near the site of the BHR had to be removed. Metal leaching from the device raised his blood toxicity. After several years, he had the BHR surgically removed.
Patient’s law suit. The patient brought four state law claims against the manufacturer, including negligence, strict product liability, breach of contract, and misrepresentation. His negligence claim alleged a manufacturing defect, inadequate training, and failure to report adverse events. The product liability claim also was based on a manufacturing defect theory asserting that the manufacturer violated FDA manufacturing specifications. His breach of contract claim alleged a breach of the agreement concerning the BHR study. The misrepresentation claim was based on the manufacturer’s alleged misrepresentations about cost and safety.
Summary judgment granted. The district court dismissed the case in its entirety holding that the patient’s claims were barred under Florida law, impliedly preempted by federal law and/or expressly preempted by federal law [see Products Liability Law Daily’s March 15, 2016 analysis]. The patient appealed.
Federal preemption. The Eleventh Circuit opined that to avoid dismissal, a party making a claim against a medical device manufacturer for injuries caused by a Class III device such as the BHR, must sue for conduct that violates a federal requirement (avoiding express preemption), but cannot sue only because the conduct violated that federal requirement (avoiding implied preemption). An injured party may proceed on such a claim so long as the party asserts a breach of a duty owed under state law that was a violation of applicable federal law. Under federal statute, manufacturers of Class III medical devices subjected to premarket approval are protected from civil liability if they comply with federal law. However, where a patient can prove that he or she was hurt by a manufacturer’s breach of a common-law duty owed to him or her and that duty is parallel to the requirements of federal law, there is no preemption.
Negligence-manufacturing defect. The Eleventh Circuit reversed the district court’s dismissal of the manufacturing defect claim. It opined that the patient properly pleaded his manufacturing defect theory under Florida law asserting that the device was defective because it caused toxic levels of metal ions in his blood. According to the appellate court, Florida law recognizes common law negligence claims based on a manufacturing defect theory of liability. This theory was a traditional state tort law that was not impliedly preempted. The duty of a manufacturer to use due care in manufacturing a medical device predated the federal statute concerning Class III devices, and was a duty owed to the patient. Therefore, this theory of liability was not impliedly preempted by federal law. Neither was this theory expressly preempted. The medical device statute did not deny Florida the right to provide a traditional damages remedy for violations of common-law duties when those duties paralleled federal requirements.
Failure to report. However, the appellate court affirmed the dismissal of the negligence claim based upon a failure to report. It opined that although the patient’s "failure to report adverse events" theory was properly pleaded under Florida law, it was impliedly preempted. The theory relied on an allegation that the manufacturer failed to adequately investigate adverse events and complaints and failed to properly report these issues to the FDA. Because this theory of liability was based on a duty to file a report with the FDA, it was very much a "fraud-on-the FDA" claim for which there was no private cause of action.
Learned-intermediary. Based upon state law, the Eleventh Circuit affirmed the lower court’s dismissal of the negligence claim premised on an improper training theory. The patient claimed that the manufacturer had a duty to correctly train the doctor to implant the BHR System. This theory of negligence was barred under the learned-intermediary doctrine. The manufacturer’s duty in this regard, if any, was to the physician, not the patient.
Strict liability. The appellate court reversed the dismissal of the patient’s strict product liability claim. This claim and the court’s analysis was similar to the court’s analysis of the negligence manufacturing defect theory, and the court’s ruling was based on the same reasons.
Breach of contract. Because the patient failed to allege any breach of a written contract, and counsel for the patient conceded during arguments that there was no oral contract, the appellate court affirmed the dismissal of this claim.
Misrepresentation. Finally, the Eleventh Circuit reversed the dismissal of the misrepresentation claim. The patient was allegedly advised that he would receive 10 years of medical monitoring, testing, and examinations for free. He claimed that he was falsely told that the BHR System had been used successfully in England and was a better product for someone his age. He alleged further that these inducements convinced him to use the BHR System which caused him damages. The appellate court noted that this was an appropriate claim under state law. Further, it was not impliedly preempted because the patient was not seeking to enforce FDA requirements. It was not expressly preempted because it was based solely on allegedly fraudulent representations made to the patient by the manufacturer and not on state-law claims based upon safety or effectiveness requirements that were at odds with federal requirements.
The case is No. 16-11646.
Attorneys: Robert E. O'Connell (Robert E. O'Connell, PA) for Joseph Mink. Joseph H. Lang, Jr. (Carlton Fields Jorden Burt, PA) for Smith & Nephew, Inc.
Companies: Smith & Nephew, Inc.
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