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Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget Oct 2014

Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget

Seattle University Law Review

Since Congress amended the False Claims Act (FCA) in 1986, the statute has evolved into a seemingly boundless weapon for enforcing other statutes and regulations applicable to every industry that accepts any form of government funding. Use of the FCA by the Department of Justice (DOJ) and by private citizens bringing actions on behalf of the U.S. government to enforce other statutes and regulations is particularly evident in the field of health care. The FCA has been utilized in actions where the allegations include off-label promotion of drugs, kickbacks, and violations of current good manufacturing practices (cGMPs) by linking the …


Why Don't Doctors & Lawyers (Strangers In The Night) Get Their Act Together?, Frances H. Miller May 2004

Why Don't Doctors & Lawyers (Strangers In The Night) Get Their Act Together?, Frances H. Miller

Michigan Law Review

Health care in America is an expensive, complicated, inefficient, tangled mess - everybody says so. Patients decry its complexity, health care executives bemoan its lack of coherence, physicians plead for universal coverage to simplify their lives so they can just get on with taking care of patients, and everyone complains about health care costs. The best health care in the world is theoretically available here, but we deliver and pay for it in some of the world's worst ways. Occam's razor ("Among competing hypotheses, favor the simplest one") is of little help here. There are no simple hypotheses - everything …


How The Tobacco Industry May Pay For Public Health Care Expenditures Caused By Smoking: A Look At The Next Wave Of Suits Against The Tobacco Industry, Mark D. Fridy Jan 1996

How The Tobacco Industry May Pay For Public Health Care Expenditures Caused By Smoking: A Look At The Next Wave Of Suits Against The Tobacco Industry, Mark D. Fridy

Indiana Law Journal

No abstract provided.