McGUAN

McGUAN v. Endovascular Technologies, Inc.

Good Law
106 Cal. Rptr. 3d 277·182 Cal. App. 4th 974
Court of Appeal of CaliforniaFebruary 9, 2010H033287, H033290California5,652 words

Opinion

Opinion

Mihara, J.

The Food and Drug Administration (FDA) approved the Ancure Endograft System (Ancure Device) for use by surgeons to treat abdominal aortic aneurysms. Plaintiffs Michael J. McGuan and Lillian Johnson, who suffered severe injuries after they were implanted with this device, brought products liability and personal injury actions against defendants Endovascular Technologies, Inc. (EVT), Guidant Corporation (Guidant), Advanced Cardiovascular Systems, Inc., and Origin Medsystems, Inc. The trial court granted defendants’ motions for summary judgment on the ground that plaintiffs’ claims were preempted by federal law. The trial court also denied plaintiffs’ motions to amend their complaints, and granted defendants’ motions to seal portions of the record. Plaintiffs have filed timely appeals from the judgments of dismissal. For the reasons stated below, we affirm.

I. Federal Regulation of Medical Devices

In enacting the Medical Device Amendments of 1976 (MDA) (21 U.S.C. § 360c et seq.) to the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. § 301 et seq.), Congress sought to “ ‘to provide for the safety and effectiveness of medical devices intended for human use.’ ” (Medtronic,…

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