By Elena Eyber, J.D.
Injured patient can pursue claims for manufacturing defect, failure to warn, and negligence per se.
In an action brought by an injured patient against a breast implant manufacturer, a California appellate court held that the Medical Device Amendments (MDA) to the federal Food, Drug, and Cosmetic Act (FDC Act) did not preempt the patient’s state law products liability claims and that she sufficiently pleaded causation to survive the manufacturer’s demurrer to those claims. The tort claims survived preemption because they were premised on conduct that both: (1) violated the MDA; and (2) would give rise to a recovery under state law even in the absence of the MDA. Further, the patient pleaded the requisite causal connection between her injuries and the manufacturer’s tortious acts to survive a demurrer (Mize v. Mentor Worldwide LLC, July 2, 2020, Tangeman, M.).
Procedural history. An injured patient filed an action against Mentor Worldwide LLC, a manufacturer of breast implants, alleging negligence and negligence per se based on the manufacturer’s negligent failure to warn and negligent manufacturing; strict products liability for failure to warn; and strict products liability for manufacturing defects. The manufacturer demurred to the complaint, asserting that the patient’s claims were preempted by federal law and insufficiently pleaded. The trial court agreed with the manufacturer and sustained the manufacturer’s demurrer.
Manufacturing defect. On appeal, the patient first contended that the trial court erred when it concluded that: (1) the MDA impliedly preempted her manufacturing defect claims; and (2) the complaint failed to link the alleged defects in her implants to her injuries. The appellate court agreed with the patient.
The patient’s manufacturing defect claims were premised on the manufacturer’s alleged failure to comply with manufacturing requirements imposed by the Food and Drug Administration (FDA). But it did not follow that the claims hinged entirely on conduct that allegedly violated federal law as the trial court had concluded. The patient did not seek to enforce any exclusively federal requirement. Her claims were predicated on violations of state tort law. The manufacturer had a tort duty, under California law, to manufacture its breast implants in compliance with the FDA’s requirements. Thus, the appellate court held that the patient’s claims were not impliedly preempted.
Further, the appellate court held that the patient sufficiently pleaded her manufacturing defect claims. She alleged that in the years leading up to her implant surgery, the manufacturer failed to meet FDA-imposed manufacturing quality standards, destroyed evidence of its implants’ high rupture rates, sold contaminated implants, and failed to comply with FDA-mandated design and materials specifications. She alleged that she later suffered a number of ailments that subsided once her implants were removed. These allegations gave rise to an inference that the manufacturer’s alleged manufacturing defects caused her injuries.
Failure to warn. The patient next contended that the trial court erred when it concluded that: (1) her failure-to-warn claims were expressly preempted; and (2) she did not sufficiently plead that the manufacturer’s failure to report adverse events to the FDA caused her injuries. The appellate court agreed and held that the trial court erroneously sustained the manufacturer’s demurrer to the patient’s failure-to-warn claims.
The patient’s failure-to-warn claims were based on the manufacturer’s breach of its duty to report information about adverse events to the FDA. California law recognizes a manufacturer’s duty to warn the FDA of adverse events. Thus, the appeals court held that the patient’s failure-to-warn claims were not expressly preempted.
At this stage, the patient needed only to allege a causal connection between the manufacturer’s failure to report and her injuries. The patient alleged that if the manufacturer complied with the reporting duties and post-approval studies, a fuller picture of the adverse events associated with its implants would have been available to the FDA, which, in turn, would have made that information available to the patient’s doctors. The patient’s doctors would then have communicated that information to the patient, who would have had her implants removed earlier. The appellate court held that these allegations alleged a sufficient causal connection between the manufacturer’s failure to report and the patient’s injuries.
Negligence per se. The patient also contended that the trial court erred when it dismissed her negligence per se claim since it was based on the same allegations as her manufacturing defect and failure-to-warn claims. The appellate court agreed.
Under the doctrine of negligence per se, negligence will be presumed if: (1) a person violated a statute or regulation; (2) that violation injured another person or their property; (3) the injury was of a type that the statute or regulation was designed to prevent; and (4) the person or property injured was of the class that the statute or regulation was designed to protect. The patient alleged that the manufacturer violated the MDA and FDA-imposed requirements. She also alleged that the company’s manufacturing defects and its failure to properly report adverse events to the FDA caused her injuries. These injuries were clearly those that the MDA and FDA regulations sought to prevent, and the patient was in the class that the FDA sought to protect. Therefore, the appellate court held that the patient could pursue her negligence per se claim.
The case is No. B295829.
Attorneys: Martin N. Buchanan (Law Office of Martin N. Buchanan, APC) for Rexina Mize. Peter L. Choate (Tucker Ellis LLP) for Mentor Worldwide LLC.
Companies: Mentor Worldwide LLC
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