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Medical Malpractice Law & Strategy
Exclusion of Evidence: The FDA’s 510(k) Process
Janice G. Inman
In a drug or medical device injury case, one of the defense’s most potent arguments is often that the product in question underwent FDA approval, so the balance of its safety and efficacy has already been determined. But when a device is approved for sale to the public through the FDA’s 510(k) process, the rigorous safety and efficacy analysis required of new and unique medical devices has not been undertaken.
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Product Liability Law & Strategy
Genetic Labeling: Legal Uncertainty for Pharma Product Liability
Shannon E. McClure and Whitney Mayer
The FDA’s recent approval of 23andMe’s direct-to-consumer genetic test to identify genes associated with 10 common diseases and disorders could result in a widespread expansion of patients armed with individualized health information. This expansion of genetic information in the hands of consumers potentially impacts regulatory and litigation issues for pharmaceutical companies.
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Product Liability Law & Strategy
Exclusion of Evidence: The FDA's 510K Process
Janice G. Inman
In a drug or medical device injury case, one of the defense's most potent arguments often is that the product in question underwent FDA approval. But when a device is approved for sale to the public through the FDA's 510(k) process, the rigorous safety and efficacy analysis required of new and unique medical devices has not been undertaken.
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Product Liability Law & Strategy
The Food Safety Modernization Act
Michael A. Leichtling
Part Two of a Two-Part Article
Last month, the author began discussion of the Food Safety Modernization Act (FSMA), which will have a large impact on the food and feed industry in the coming years. The author continues here with an explanation of some of the effects the FSMA is expected to have on equipment manufacturers and on lenders and lessors.
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Product Liability Law & Strategy
The Food Safety Modernization Act
Michael A. Leichtling
Part One of a Two-Part Article
By being proactive in adopting safe food processing operations, such companies hope to protect their reputation and business from the negative publicity and possible financial disaster arising from the sale of contaminated food and non-compliance with the Food Safety Modernization Act (FSMA).
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Product Liability Law & Strategy
Benjamin R. Dwyer and Vivian Quinn
In 2017-2018, the food industry can expect to see fundamental change in the regulations regarding use of the word "healthy" in food packaging, and showdowns over class actions challenging food label claims.
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Product Liability Law & Strategy
The Responsible Corporate Officer Doctrine
Joseph F. Savage, Jr. and Kate E. MacLeman
Briseno v. ConAgra
The Food, Drug, and Cosmetic Act (FDCA) has historically allowed prosecutors to charge corporate employees with misdemeanors without having to prove personal participation or wrongful intent. But, as the use of the statute has become more frequent and penalties have gotten more severe, the constitutionality of such an application of the FDCA has come under heightened scrutiny.
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