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FDA Releases Guidance on Medical Device Cybersecurity

Written by Debra L. Innocenti and Michael A. Walsh on October 9, 2014

The Food and Drug Administration (FDA) has issued its final guidance on cybersecurity functionality and safety controls, establishing considerations for the design, development and premarket submissions related to medical devices. The FDA issued an earlier draft of the guidance on June 14, 2013. The guidance responds to the rapid evolution of medical devices into special Read More…

Capsule USB

FDA’s “Mid Course Corrections” For Correcting Third-Party Content and Using Twitter

Written by Michael A. Walsh on September 30, 2014

FDA’s Vague Rules Limiting Speech (i.e. Due Process and the First Amendment): On September 29, 2014, the FDA reopened the comment period for two of its Social Media Guidance documents for FDA-regulated industry.  Since the advent of the internet, the FDA has been plagued by its reliance on undefined terms while enforcing vaguely circumscribed regulations Read More…

Truck with Pills

How You Source Drugs and Criminal Liability

Written by Michael A. Walsh on September 12, 2014

In June 2014, the office manager at a hematology and oncology center pleaded guilty to purchasing and selling unapproved and improperly labeled chemotherapy drugs and the center paid $2M to reimburse Centers for Medicare and Medicaid Services for submitting “false claims.” The “crime” was purchasing the drugs from a Canadian supplier whose drug products were sourced from the European Union, Turkey and India.

soft drink

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…