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Volume 39: Issue 4

Medical Device Law

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Medical Device Law

Brian P. Wallenfelt, Foreword: Is It Time for an Abbreviated Premarket Approval for Medical Devices?

J. David Prince, The Puzzle of Parallel Claims, Preemption, and Pleading the Particulars

Christiana C. Jacxsens, Sara E. Deskins, and Sean P. Jessee, Beyond the Basics: Expanding Theories of Liability and Defenses for Claims Involving Medical Device Sales Representatives

David T. Schultz and D. Scott Aberson, Be Careful What You Ask for: The FDA’s Denials of Citizen Petitions Confirms There Is No Such Thing as a Limited Premarket Approval

Suneel Arora, Timothy J. Christman, Ashley N. Mays, PhD, and Andrew Schmidt, The Interplay Between FDA and Patent Law: Infusing Organizational Knowledge for Medical Device Companies

Bruce Patsner, Direct-to-Consumer Advertising of Restricted, Surgically Implanted Medical Devices: What Does the Advertising Arena Look Like, and Whose Regulatory Problem Is It?

Lars Noah, Turn the Beat Around?: Deactivating Implanted Cardiac-Assist Devices

David Orentlicher, Deactivating Implanted Cardiac Devices: Euthanasia or the Withdrawal of Treatment?

Student Notes

Jevon C. Bindman, The Spam Filter Ate My E-mail: When Are Electronic Records Received?

Brandon L. Boese, The Controversy of Redistricting in Minnesota

Deborah Prokopf, Public Employees at the School of Hard Knox: How the Supreme Court Is Turning Public-Sector Unions into a History Lesson

Frederik W. Struve, Ending Unnecessary Novelty Destruction: Why Europe Should Adopt the Safety-Net Grace Period as an International Best Practice


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