Fender

MEMORANDUM OF OPINION AND ORDER

This case presents difficult questions as to the scope of preemption under the Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 321-394 . The devices particularly at issue — pacemaker leads — are Class III devices, the most sensitive classification, but were not required to go through the Food and Drug Administration’s (“FDA”) exacting premarket approval process. The scope of preemption in this context is unresolved in the Ninth Circuit. In bringing this summary judgment motion, defendant Medtronic seeks a ruling that the FDA’s regulations governing the substantial equivalence process, 21 C.F.R. §§ 807.81-807.100 , and good manufacturing practices, 21 C.F.R. §§ 801 & 820, preempt plaintiff Fender’s personal injury and liability claims.

I

On October 28, 1985, due to his symptomatic radial arrhythmia, plaintiff Duane Fender received a Medtronic dual chamber Model 7006 implantable pulse generator, a Model 4012 ventricular lead, and a Model 4512 atrial J-lead. In late September 1991, Medtronic began contacting physicians, including Fender’s surgeon, about performance problems with the Model 4012 lead. Fender met…