• where experts go to learn about FDA
  • Anne K. Walsh

    • Lemonade from Lemons: Fairness in FDA Enforcement ActionsOctober 20th, 2020

      Although it is difficult to glean much positive during these COVID-times, particularly if you are (or could be) the subject of a government enforcement action, this post attempts to provide a possible silver lining.  As part of an effort to support economic recovery during this …

    • Courts Reject Demands to Force FDA to Approve Hydroxychloroquine for COVID-19October 1st, 2020

      Two federal courts, in unrelated cases, separately rejected plaintiffs’ attempts to force FDA to authorize the use of hydroxychloroquine to treat or prevent COVID-19.  Hydroxychloroquine, a drug that has been used for over 60 years, has been touted by President Trump as an effective treatment …

    • A Couple of Firsts in Food EnforcementSeptember 22nd, 2020

      Last week brought a reminder that the government can bring to bear a range of legal theories – some old, some new – in pursuing alleged violations of food safety requirements. The U.S. Department of Justice (DOJ) announced a sentence levying $17.25 million in criminal penalties …

    • Much-Needed Clarity on Disgorgement from the Supreme CourtJune 24th, 2020

      A Supreme Court decision this week shows good potential to upend FDA and FTC’s claim that they can without limits seek disgorgement of “profits” from defendants who engage in unlawful activities.  In Liu v. Securities and Exchange Commission, the question was whether the SEC could …

    • Swift Enforcement Against COVID FraudstersMay 1st, 2020

      Since HHS declared a public health emergency caused by COVID-19 in February 2020, there has been an overwhelming response to develop and market products to treat or mitigate the effects of the virus.  Unfortunately, bad apples still are out there preying upon consumer fears and …

    • HHS Broadly Interprets PREP Act Immunity: Reasonable Belief is Good EnoughApril 23rd, 2020

      Under the Public Readiness and Emergency Preparedness Act (“PREP Act”), manufacturers, distributors, and health care providers acting to address the COVID-19 crisis can be protected from products liability suits related to the use of certain products.  The Act provides immunity “from suit and liability under …

    • Court Vacates USDA Rule Citing APA ViolationsApril 20th, 2020

      Given the broad deference afforded to federal agencies, it is rare when a court overturns an agency action challenged under the Administrative Procedure Act (APA).  In a recent decision, however, a court found that a regulation issued by the U.S. Department of Agriculture (USDA) violated …

    • FDA Relaxes Postmarketing Reporting Requirements During a PandemicApril 1st, 2020

      As noted in our blog post last week, FDA has issued several guidance documents authorizing the emergency use of medical devices and drugs to address the COVID-19 outbreak.  These EUAs provide a streamlined approach for selling otherwise unapproved products intended to alleviate the national emergency.  …

    • The High Costs of “Weaponizing” Discovery StrategiesOctober 25th, 2019

      What do you get when you “cross an approach to discovery à la Inspector Clouseau with a corporate lawyer caricature found in cartoon caption contests?” According to Judge Steven Rau of the District of Minnesota in a 32-page order that required an “exhaustive” 15-page factual …

    • Think Twice Before Sharing: Court Compels Disclosure of Settlement Presentations in Relator’s Qui Tam SuitOctober 7th, 2019

      In a decision that could dramatically change the course of how defendants conduct discussions with the government, a district court judge in the District of Minnesota required a defendant in a False Claims Act (FCA) case to turn over to a qui tam relator the …

    • Deference to Agency DeferenceAugust 27th, 2019

      Companies challenging FDA in court typically face a steep uphill battle given the long-standing doctrine known as Auer deference, which (in simplified terms) requires courts to defer to FDA’s interpretation of its own regulations if they are ambiguous.  The recent Supreme Court ruling in Kisor …

    • The FTC Loses Big in the Seventh CircuitAugust 26th, 2019

      In the August 21 split panel decision issued in Federal Trade Commission v. Credit Bureau Center LLC, the Seventh Circuit held that section 13(b) of the Federal Trade Commission Act (“FTCA”), 15 U.S.C. § 53(b), does not authorize an award of restitution.  In overturning its …

    • “Wine-ing” about FDA Involvement in Regulating Alcohol LabelsAugust 21st, 2019

      This case caught our eye for a few reasons, none of which directly relates to the business activities of most of our blog readers but may relate to their happy-hours activities.  As most know, FDA regulates foods, including beverages, but Congress delegated most of the …

    • Device Manufacturer’s Criminal and Civil Penalties Deserve Closer AttentionJuly 2nd, 2019

      Today’s blog post illustrates how a company’s problems can escalate rapidly from an administrative warning letter to the full weight of the criminal system.  The unfortunate subject is ACell, a manufacturer of medical devices derived from porcine urinary bladder material.  ACell received a Warning Letter …

    • SCOTUS Makes it Easier for Government to Withhold Commercial or Financial InformationJune 26th, 2019

      In a 6-3 decision, the U.S. Supreme Court reversed and remanded the lower courts’ decision to publicly disclose commercial information that previously had been submitted to the government.  Given that FDA-regulated entities often submit to FDA commercial or financial information that those entities regard as …