Michael J. Malinowski

Biography

Professor Malinowski is a member of Phi Beta Kappa and Oxford University’s 21st Century Trust, and he is a past Chair of the Health and Human Services Committee, Administrative Law Section, of the American Bar Association and member of the ABA President’s Special Committee on Bioethics. He received a B.A. summa cum laude from Tufts University and a J.D. from Yale Law School, where he was Articles Editor for the Yale Law Journal. Upon graduating from Yale, Professor Malinowski clerked first for Judge Emilio M. Garza and then for Chief Judge Carolyn Dineen King, U.S. Court of Appeals for the Fifth Circuit. He has published extensively on the commercialization of biotechnology and related health care and bioethics issues, and frequently lectures on these topics throughout the United States and abroad.

Courses Taught

• Biotechnology
• Law, Business, and Policy
• Health Law Survey
• Bioethics Law and Policy
• Comparative Health Law
• Food and Drug Law
• Health Care Finance

Selected Publications

Books

How To Regulate a Medical Revolution: The Law and Ethics of Personal Genome Medicine, (Cambridge University Press) (forthcoming).

Handbook on Biotechnology Law, Business, and Policy: Human Health Products from the Laboratory Bench to Market Approvals (West Academic Publishers, 2016).

Biotechnology: Law, Business, and Regulation (Aspen Law and Business/Little Brown, 1999 & Supps. 2000, 2001, 2002, 2003, 2004).

Articles

The U.S. Science and Technology “Triple Threat”: A Regulatory Treatment Plan for the Nation’s Addiction to Prescription Opioids, 48 Univ. Memphis L. Rev. 1027 (lead presentation and article for live and published symposium, “The American Addiction: Pathways to Address the Opioid Crisis” (Mar. 16, 2018).

Biting the Hands that Feed ‘the Alligators: A Case Study in Morbid Obesity Extremes, End-of-Life Care, and Prohibitions on Harming and Accelerating the End of Life, 44 Am. J. l. & Med. 23 (2018).

Throwing Dirt on Doctor Frankenstein’s Grave:  Access to Experimental Treatments at the End of Life, 65 Hastings L.J. 615 (2014).

Government RX—Back to the Future in Science Funding?  The Next Era in Drug Development, 51 U. Louisville L. Rev. 101 (2012).

All that is Gold Does Not Glitter in Human Clinical Research: A Law-Policy Proposal to Brighten the Global “Gold Standard” for Drug Research and Development, 45 Cornell J. Int’l Law 185 (2012) (co-author Grant G. Gautreaux).

Drug Development—Stuck in a State of Puberty?  Regulatory Reform of Human Clinical Research to Raise Responsiveness to the Reality of Human Variability, 56 St. Louis U. L.J. 363 (2012) (co-author Grant G. Gautreaux).

Doctors, Patients, and Pills—A System Popping under Too Much Physician Discretion?  A Law-Policy Prescription to Make Drug Approval More Meaningful in the Delivery of Health Care, 33 Cardozo L. Rev. 1085 (2012).