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News Break: New York to Remain the “Big” Apple

Written by Michael A. Walsh on July 2, 2014

Big Apple or Crabapple? The underlying issue In the Matter of New York Statewide Coalition of Hispanic Chambers of Commerce, et al v. New York City Department of Health and Mental Hygiene, et al., was straightforward: If a consumer knows his actions are potentially harmful to his health, but chooses to act against his best Read More…


The Preemption Pendulum: The Supreme Court Punts Stengel v. Medtronic

Written by Michael A. Walsh on June 24, 2014

Drug and Medical Device Manufacturers Beware; State-law Parallel Claims Threaten As failure-to-warn claims, the decades-old staple of medical products liability, are relegated to the trash bin of tort jurisprudence, a new and more potent approach—parallel claims—has emerged. What are parallel claims, where did they come from, why did they emerge, and when will the Supreme Court Read More…


POM v Coca-Cola: The FDA, the Lanham Act and Regulation through Litigation

Written by Michael A. Walsh on June 13, 2014

The Supreme Court decided POM Wonderful LLC v the Coca Cola Company  on June 12, 2014.  If you listened to the oral argument you would have assumed Coke’s chance of success was proportional to the .3% of pomegranate juice in its pomegranate beverage.  POM purported to assert a “classic false advertising case” that the de Read More…


FDA, Social Media & Promotional Labeling: Frees Speech or Freeze Speech

Written by Michael A. Walsh on May 16, 2014

The Food and Drug Administration (FDA) docket recently closed on the “Draft Guidance for Industry on Fulfilling Regulatory Requirements for Post Marketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics” (Social Media Guidance), and the comments are significant. (See our prior post here). Collectively, the comments submitted to the FDA Read More…


FDA & the Lanham Act: Things Did Not Go Better With Coke

Written by Michael A. Walsh on April 29, 2014

On April 21, 2014, the Supreme Court heard oral argument in POM Wonderful LLC v the Coca Cola Company. POM purports to assert a “classic false advertising case” against Coca Cola for pomegranate juice claims. POM alleges that the de minimis amounts of pomegranate juice (.3%) in the Coca Cola pomegranate flavored products are misleading, Read More…