Open Access. Powered by Scholars. Published by Universities.®
- Keyword
-
- 360k(a) (1)
- Amici (1)
- Amici briefs (1)
- Chemical industry (1)
- Common law (1)
-
- Cosmetic (1)
- David Owen (1)
- Drug (1)
- FDA (1)
- Food (1)
- Food Drug and Cosmetic Act (1)
- Food and Drug Administration (1)
- HazCom Standard (1)
- Hazard Communication Standard (1)
- Kathleen O'Malley (1)
- MDA (1)
- Medical Device Amendments (1)
- Medical device (1)
- Medicine (1)
- Notice-and-comment (1)
- OSH (1)
- OSHA (1)
- Occupational Health and Safety Act (1)
- Occupational Health and Safety Administration (1)
- Preempt (1)
- Preemption (1)
- Premarket approval (1)
- Product liability (1)
- Products Liability Law (1)
Articles 1 - 3 of 3
Full-Text Articles in Law
The Welding Fume Case And The Preemptive Effect Of Osha’S Hazcom Standard On Common Law Failure-To-Warn Claims, Richard C. Ausness
The Welding Fume Case And The Preemptive Effect Of Osha’S Hazcom Standard On Common Law Failure-To-Warn Claims, Richard C. Ausness
Law Faculty Scholarly Articles
The Occupational Health and Safety Act (the OSH Act) affects more than ninety million workers in the United States. The OSH Act is administered by the Occupational Health and Safety Administration (OSHA), which promulgates health and safety standards for the workplace. Although OSHA standards do not regulate product manufacturers directly, they may affect liability when manufacturers are sued by workers who are injured by allegedly defective products provided by their employers. With increasing frequency, manufacturers are contending that the OSH Act or OSHA standards preempt these claims. In particular, manufacturers argue that the Hazard Communication Standard (HazCom Standard) should preempt …
“After You, My Dear Alphonse!”: Should The Courts Defer To The Fda’S New Interpretation Of § 360k(A) Of The Medical Device Amendments?, Richard C. Ausness
“After You, My Dear Alphonse!”: Should The Courts Defer To The Fda’S New Interpretation Of § 360k(A) Of The Medical Device Amendments?, Richard C. Ausness
Law Faculty Scholarly Articles
Under the provisions of the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act certain medical devices are subject to premarket approval of the Food and Drug Administration (FDA). Section 360k(a) of the MDA provides that states may not establish “any requirement” which relates to safety or effectiveness of a medical device and "which is different from, or in addition to" any requirement imposed by the FDA. Until recently, the FDA maintained that § 360k(a) did not preempt most common law tort claims; however, in recent amici briefs, the FDA has aggressively asserted that most, if not all, …
Products Liability In The Twenty-First Century: A Review Of Owen’S Products Liability Law, Richard C. Ausness
Products Liability In The Twenty-First Century: A Review Of Owen’S Products Liability Law, Richard C. Ausness
Law Faculty Scholarly Articles
Professor Richard C. Ausness reviews Products Liability Law, a treatise by David Owen.