Blanco

Plaintiffs appeal from a judgment after the trial court granted defendants’ motion for summary judgment in a wrongful death action concerning a bileaflet mitral heart valve. The court granted defendants’ motion for summary judgment on the ground the Medical Device Amendments (MDA), title 21 United States Code section 360k(a) (section 360k(a)), preempted plaintiffs’ state common law causes of action. Plaintiffs argue the court erroneously concluded section 360k(a) preempted the state common law causes of action because a state law remedy for a manufacturing defect does not impose a state requirement “different from, or in addition to” a federal requirement relating to a device’s safety or effectiveness. We disagree and affirm the judgment.

FACTS

In 1982, 18-year-old Claudia Blanco (Claudia) was diagnosed with mitral valve stenosis—narrowing/blocking of the heart’s mitral valve that prevents the valve from properly opening and, therefore, obstructs blood flow between the left chambers of the heart. Around the same time, Hemex Scientific, Inc. (Hemex), developed prototypes for new mechanical mitral and aortic heart valves. Hemex subsequently applied for an investigational…