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Victory and Setback for Medical Device Manufacturers


Medical device manufacturers have another case they can rely upon to strengthen their argument that any strict liability design defect claims involving implantable medical devices should be dismissed.  Garrett v. Howmedica Osteonics Corp. (2013) 214 Cal.App.4th 173, a recent California Court of Appeal decision out of the Second District, joins a line of appellate decisions throughout California excluding strict liability design defect claims for implantable medical devices.

The Garrett Court held that “the doctrine of strict products liability based on a design defect is inapplicable to implanted medical devices available only through the services of a physician . . . .”  (Id. at p. 178.)  The Court further stated that the design defect exemption applies to an implanted medical device regardless of whether it was available only by prescription and regardless of whether it is properly characterized as a “prescription” device.  (Id. at p. 184.)  Consequently, a court need not apply the risk-benefit test or the consumer expectations test; rather, the appropriate test for determining whether a manufacturer is liable for a design defect in an implantable medical device involves the application of the ordinary negligence standard.

Ninth Circuit Adds to Circuit Split on Preemption Issue in Medical Device Litigation

A recent Ninth Circuit ruling for plaintiffs could expose manufacturers of hundreds of high-risk medical devices to significant state tort damages.  In Stengel v. Medtronic Inc. (2013) 704 F.3d 1224, the Court held that a state law tort claim for failure to warn about risky medical devices was not preempted by the Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act.  (Id. at p. 1226.)  The Ninth Circuit described the central issue as “whether the MDA preempts a state-law claim in which the state-law duty of care ‘parallels’ a federal-law duty imposed by the MDA.”  (Ibid.)

Plaintiffs brought their claim under “settled Arizona law that protects the safety and health of Arizona citizens by imposing a general duty of reasonable care on product manufacturers.”  (Id. at p. 1233.)  The Court concluded that Plaintiffs’ state-law claim was not preempted because that same duty of care is included in the MDA, albeit with lesser remedies.  In so holding, the Ninth Circuit joins the Fifth and Seventh Circuits, “which reached the same conclusion with respect to comparable state-law claims.”  (Ibid.)