Most experienced False Claims Act (FCA) practitioners are all too familiar with the statutory provision requiring defendants to pay whistleblowers’ attorneys’ fees at the end of FCA cases. What is less commonly known is the provision that grants defendants their attorneys’ fees in certain circumstances.

One whistleblower learned about that provision the hard way, when on March 14, 2024, a Mississippi federal judge ordered that he pay over $1 million to cover the defendants’ attorneys’ fees, following grant of summary judgment to defendants in what the judge labeled a “frivolous” qui tam. This blog post looks at the case that led to such a large attorneys’ fees award and considers the types of cases in which these efforts are wise.

Continue Reading Federal Judge Orders Whistleblower Who Filed a “Frivolous” Qui Tam to Pay Over $1 Million for Defendants’ Attorneys’ Fees

U.S. Senators Angus King (I-ME) and Marco Rubio (R-FL) recently introduced a bill addressing cybersecurity protections and oversight in the healthcare industry. The Strengthening Cybersecurity in Health Care Act, introduced on February 8, 2024, aims to bolster a vulnerable and often-targeted industry against cyberattacks. The proposal follows a number of significant cyberattacks on healthcare organizations in recent years; Senator King noted that approximately 133 million people, or nearly one in three Americans, had their personal information compromised in 2023 alone.

Continue Reading Cybersecurity in Healthcare: Pending Bill Calls for Tougher Protections

In the United States, mental health (“MH”) and substance use disorder (“SUD”) (collectively “MH/SUD”) have continued to represent areas of intense concern. During the COVID-19 pandemic, the MH struggles of essential workers and health care professionals were pushed to the forefront. However, issues related to MH/SUD have continued to escalate.

Continue Reading Mental Health Parity and Addiction Equity Act: Comprehensive Final Rule Expected in 2024

Every year, I look forward to the SXSW Interactive Health & MedTech Track, which showcases and explores the future of healthcare technology being created by innovators, entrepreneurs, and tech enthusiasts. This year is no different!

Continue Reading Avoiding the Landmines on the Path to HealthTech Innovation

The recent, rapid advancement of the development of artificial intelligence and machine learning (AI) has revolutionized various industries. It is unsurprising then, that at this year’s South by Southwest Conference (SXSW), there are more AI related panels than any other subject — by far.

Continue Reading Closing the Gap: Medical Device Innovation, Frontline Healthcare Workers, and the Role of AI

Corporate defendants are frequently faced with a quandary—is the company’s highly sophisticated professional employee simply a fact witness or does their anticipated testimony propel them into the world of expert discovery? The individual knows the business inside and out, and typically has a comprehensive understanding of the entire industry, but the legal parameters of whether they qualify as a lay witness or expert witness in this context is not always clear. And either designation presents potentially significant risks. Companies must proceed with caution and consider the following before proceeding.

Continue Reading A Non-Expert with Expertise: Navigating the Risks and Rewards of Testimony from Highly Sophisticated Professional Employees in Federal Court

Husch Blackwell’s False Claims Act team previously covered the results of a rare False Claims Act (FCA) trial in which a federal jury found that a surgical product distributor was liable for paying kickbacks to physicians. The federal judge overseeing that trial initially entered judgment against the distributor defendants for $487 million after trebling the government’s actual damages and then adding penalties for each kickback-tainted claim.

On February 8, 2024, however, that same federal judge amended the judgment over concerns that the statutory penalties were unconstitutionally excessive. This article highlights the issue and explains what those accused of violating the FCA can learn from this decision.

Continue Reading Federal Court Reduces FCA Penalties by 82 Percent Because of Excessive Fines Clause Concerns

Research into psychedelic-assisted therapy receives funding in the National Defense Authorization Act for Fiscal Year 2024.

In an epoch marked by rapid innovation in mental health treatments, a paradigm shift is on the horizon for the well-being of our armed forces personnel. Psychedelic-assisted therapy has surfaced as an innovative intervention for ailments such as depression, traumatic brain injury (TBI), and—perhaps most widely applicable to military personnel—post-traumatic stress disorder (PTSD). Combat veterans are significantly susceptible to PTSD, and the debilitating impact of PTSD can last a long time.

Continue Reading Advancing Military Mental Health

Psychedelics have the potential to treat chronic conditions such as post-traumatic stress disorder (PTSD), depression, obsessive-compulsive disorder (OCD), fibromyalgia, and various behavioral health conditions, yet psychedelics are not like traditional pharmaceuticals. The mode of administration often involves a psychotherapy component, necessitating a closer patient-physician relationship and making risk management crucial. In this post, we delve into the critical legal factors that researchers and practitioners must consider before embarking on psychedelic clinical trials. From the intricacies of Food and Drug Administration (FDA) approval for Investigational New Drug (IND) applications to the imperative Drug Enforcement Administration (DEA) registration, site selection criteria, harnessing digital health technologies, and the ongoing and essential nature of informed consent, each factor plays a pivotal role in ensuring the ethical, legal, and safe exploration of psychedelics in the clinical realm. Let’s unravel these legal considerations that pave the way for responsible and groundbreaking advancements in psychedelic medicine.

Continue Reading Psychedelic Breakthroughs: Key Considerations for Clinical Trials

In response to the COVID-19 pandemic, pharmaceutical companies like Pfizer worked diligently to develop safe and effective vaccines. Following the FDA’s approval of these vaccines, many state governments and private employers—including those in the educational and medical fields—implemented policies requiring certain individuals obtain them. Some individuals subject to these policies have been challenging them in court ever since under a variety of constitutional and statutory arguments, largely without success. These cases typically alleged that government mandates violated the right to bodily integrity under the Fourteenth Amendment and that private employer mandates violated laws that prohibit discrimination based on disability and/or religious beliefs.

Continue Reading Wash. Federal Judge Pokes Hole in New Wave of Vaccine Mandate Challenges