In the first challenge ever brought against FDA’s rarely used power to ban a medical device, a court found FDA overstepped its authority and overturned the ban. In March 2020, FDA issued a final rule that banned the use of Graduated Electronic Decelerators (GEDs) to …
On April 2, 2021, the Ninth Circuit issued a decision in a False Claims Act (FCA) case against Medtronic. The Dan Abrams Co. LLC v. Medtronic Inc., No. 19-56377, 2021 U.S. App. LEXIS 9637 (9th Cir. Apr. 2, 2021). Relator appealed the U.S. District Court …
It’s not just drug companies that push the limit on marketing their products – see our posts about recent OPDP warning letters. Medical device companies are fighting for any edge to differentiate their products too. Even before COVID-19 brought an onslaught of new players to …
It’s a burning question: when will we return to normal? And although the answer is hugely subjective, this post focuses on the date the official emergency declaration for COVID-19 will terminate. Despite the general sentiment that we want to be back to normal sooner rather …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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. …
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 …
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 …
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 …
