23.22 Preemption

• Jurisdiction: Arizona

23.22 Preemption. Certain federal statutes may preempt state court product liability actions under the theories of express, field, or implied preemption.⁵¹⁰ In determining whether a particular claim has been preempted, the courts have held that “Federal law preempts state law under the Supremacy Clause when Congress expressly so provides, the federal law so thoroughly occupies the field that it leaves no room for state law, or state law actually conflicts with federal law.”⁵¹¹ An actual conflict occurs when it is impossible to comply with both state and federal law or where state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.⁵¹²

The Federal Motor Vehicle Safety Standards, for example, impliedly preempt certain product liability actions against vehicle manufacturers.⁵¹³ Similarly, the 1969 amendment to the Federal Cigarette Labeling and Advertising Act partially preempts state failure-to-warn claims against cigarette manufacturers.⁵¹⁴

In a 2013 case, the Ninth Circuit Court of Appeals specifically held that, Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”) do “not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty under the MDA.”⁵¹⁵ The United States District Court for the District of Arizona has, however, issued a series of disparate rulings in applying the preemption analysis to medical devises that have secured Premarket Approval (PMA) from the Federal Drug Agency (FDA). In July 2014, the district court stated that “[t]his court joins the majority of other courts” to hold that “the preemption analysis does not apply to claims based on off-label promotion.”⁵¹⁶ Just one month later, the court reversed itself to hold that the MDA will effectively preempt claims where an FDA approved a product is used in an off-label application.⁵¹⁷ As the court stated, “where the FDA imposes requirements on a ‘device,’ not specific uses of the device, and off-label uses remain subject to federal regulation and therefore to preemption.”

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Notes:

^[510] See Hutto v. Francisco, 210 Ariz. 88, 107 P.3d 934 (App 2005). For examples of preempted claims, see also Talbott v. C.R. Bard, Inc., 63 F.3d 25 (1st Cir.1995) (all state law product liability and breach of warranty claims preempted); Mendes v. Medtronic, Inc., 18 F.3d 13 (1st Cir.1994) (negligence and breach of warranty claims based on failure to warn and manufacturing defect...