Food & Drug Law Blog


Sanitary Food Transportation: New Rules May Require a Fresh Look

Written by Michael A. Walsh on April 25, 2016

Prompted by the Sanitary Food Transportation Act of 2005 and the Food Safety Modernization Act of 2011 (FSMA), the Food and Drug Administration (FDA) issued a new rule entitled “Sanitary Transportation of Human and Animal Food” (the SFT Rule). The SFT Rule establishes the requirements for sanitary transportation practices that will apply beginning April 6, Read More…


Two Cases: Wineries and Regulators Are a Unique Blend

Written by Michael A. Walsh on April 19, 2016

Regulatory enforcement can threaten the existence of wineries and small producers. First, the financial costs of regulatory inspection can be high, and new laws and regulations have given the government significant new authority. Further, when the regulator determines that a winery’s products are “adulterated,” the specter of civil and criminal penalties is significant. Governmental inspections Read More…

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$500 Million Verdict in J&J Ultamet Case: Too Much Green, Even For St. Patrick’s Day

Written by Michael A. Walsh on March 22, 2016

On March 17, 2016, St. Patrick’s Day, a Dallas federal court jury saw green, awarding almost $500 million to five plaintiffs in a consolidated trial against DePuy Orthopedics and J&J over the Ultamet hip implant. There will be plenty for the trial court to (re)consider in reducing the verdict and even more for the Fifth Read More…

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Restaurant Menu Calorie Count Compliance Stayed Indefinitely

Written by Michael A. Walsh on March 18, 2016

Section 747 of the Consolidated Appropriations Act of 2016 has effectively stayed the requirements for nutrition labeling of standard menu items in restaurants and similar establishments. The Act states that None of the funds made available by this Act may be used to implement, administer, or enforce the final rule entitled ‘Food Labeling; Nutrition Labeling Read More…

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Conte Revisited: Innovator Liability for A Generic Manufacturer’s Product

Written by Michael A. Walsh on March 14, 2016

On March 9, 2016, in T.H. v. Novartis 2016 Cal. App. LEXIS 179 (CA 4th App. Dist. March 9, 2016), a California Court of Appeals rejected what every other court in the union has ruled, reversed the lower court, and will permit plaintiffs to sue a brand drug manufacturer for a product it did not manufacture. Read More…