Litigation Archives - Page 3 of 107 - The National Law Forum

Supreme Court Declines to Hear “Willfulness” Case

On Monday, October 7, 2024, the U.S. Supreme Court declined to consider a petition for certiorari in United States ex rel. Hart v. McKesson Corp., Case No. 23-1293, where relator, Adam Hart (“Relator”), sought review of a Second Circuit decision upholding the dismissal of Relator’s complaint against pharmaceutical distributor, McKesson Corporation (“McKesson”).

The case involved allegations that McKesson violated the Anti-Kickback Statute (“AKS”), which prohibits offering, paying, soliciting, or receiving remuneration to induce the purchase of goods and services paid for by a federal health program. Relator, a former McKesson employee, filed a qui tam action, claiming McKesson provided valuable business management tools—valued at over $150,000—to oncology practices at no cost, in order to induce them to purchase oncology pharmaceuticals from McKesson.

The Second Circuit dismissed Relator’s federal claims, reasoning that the allegations failed to meet the mens rea (intent) element under the AKS. The Court held that, to act willfully under the AKS, a defendant must know that its conduct is unlawful, either under the AKS or other law. Since Relator’s allegations did not plausibly suggest McKesson acted with knowledge of illegality, his federal False Claims Act claims based on the federal AKS were dismissed.

The Supreme Court’s refusal to hear Relator’s case preserves the existing circuit split regarding the interpretation of “willfulness” under the AKS. The Second Circuit, along with the Eleventh Circuit, has adopted the view that the AKS is violated when a defendant intends to violate a legal standard. This contrasts with the Fifth Circuit, which interprets the mens rea element to prohibit acts done knowingly and willfully, as opposed to by mistake or accident, and the Eight Circuit, which requires intent to commit an act known to be wrongful, but not necessarily known to be unlawful.

As it stands, the unresolved split among the circuits on this critical issue remains, and providers should be mindful that, at least in the Second and Eleventh Circuits, the stricter interpretation of “willfulness” under the AKS will continue to apply.

Is It the End of the False Claims Act As We Know It? District Court Rules Qui Tam Provisions Unconstitutional

In a first-of-its-kind ruling on 30 September 2024, Judge Kathryn Kimball Mizelle of the US District Court for the Middle District of Florida held in United States ex rel. Zafirov v. Florida Med. Assocs., LLC that the qui tam provisions of the False Claims Act (FCA) are unconstitutional. No. 19-cv-01236, 2024 WL 4349242, at *18 (M.D. Fla. Sept. 30, 2024). Specifically, Judge Mizelle found that qui tam relators in FCA actions qualify as executive branch “Officers” who are not properly appointed, thereby violating the Appointments Clause of Article II of the US Constitution.

The holding adopts Appointments Clause arguments that have been gaining traction in recent Supreme Court opinions. It also addresses some of the “serious constitutional questions” that Justice Clarence Thomas had raised regarding the FCA’s qui tam provisions in his dissent in the Supreme Court’s June 2023 decision in United States ex rel. Polansky v. Exec. Health Res., Inc., 599 U.S. 419, 449 (2024) (Thomas, J., dissenting). Notably, Judge Mizelle’s decision in Zafirov is contrary to a number of other decisions post-Polansky that rejected similar constitutional arguments.

The decision is sure to be appealed to the Eleventh Circuit and it remains to be seen whether Judge Mizelle’s rationale will withstand appellate scrutiny. In any event, for the time being, the defense bar has a new tool in its arsenal to seek dismissal of qui tam FCA actions. Moreover, if the decision stands, it will have broad ramifications on the FCA, which has provided for qui tam actions (a form of “whistleblower” activity) since the FCA’s enactment in 1863. Cases filed by qui tam relators have comprised the largest portion of overall FCA recoveries for years, accounting for 87% of FCA recoveries in the most recent fiscal year. For additional data on qui tam cases, see our firms’ recent white paper here.

Summary of the Decision

In 2019, the relator, a board-certified family care physician, filed a qui tam FCA action against her employer and several other providers, as well as Medicare Advantage Organizations (MAOs). The relator alleged that the providers acted in concert with the MAOs to artificially increase the risk adjustment scores of Medicare Advantage enrollees, in turn increasing the defendants’ capitated payments from the government.

After a lengthy procedural history involving multiple rounds of motions to dismiss, in February 2024, the defendants sought judgment on the pleadings, arguing that the FCA’s qui tam provisions violate the Appointments, Vesting, and Take Care Clauses of Article II of the US Constitution. The defendants also argued that historical practice does not cure the qui tam provisions’ constitutional defects. The United States intervened solely to defend the constitutionality of the FCA’s qui tam provisions, with several amici curiae also filing briefs.

The court did not reach the Vesting and Take Care Clause arguments but agreed with defendants that the qui tam provisions violate the Appointments Clause. Analyzing that question, the court first found that qui tam relators are “Officers of the United States” because: (1) relators exercise significant authority by possessing civil enforcement authority on behalf of the United States; and (2) relators occupy a “continuing position” established by law given that the FCA prescribes their statutory duties, powers, and compensation and the position is analogous to other temporary officials that wield core executive power, such as bank receivers and special prosecutors. Second, the court found that Article II of the US Constitution contains no qui tam exception, rejecting arguments that historical practice confirms the qui tam provisions’ constitutionality. The court stated that “[w]hen the Constitution is clear, no amount of countervailing history overcomes what the States ratified.” Third, the court found that because a relator is an Officer, the relator must be appointed by the president, the head of an executive department, or a court. Because relators are self-appointed by initiating their own FCA actions, the court held that the qui tam provisions violate the Appointments Clause and dismissed the action.

Key Takeaways

Although noteworthy, Zafirov is an outlier among the multiple decisions pre- and post-Polansky that have addressed the qui tam provisions’ constitutionality. The case is also expected to be appealed by both the relator and the United States to the Eleventh Circuit. Of note, the Eleventh Circuit is currently considering an appeal of a separate Appointments Clause ruling that found a special counsel was improperly appointed in United States v. Trump.
This issue could also make its way to the Supreme Court. In addition to Justice Thomas’ comments noted above, Justices Brett Kavanaugh and Amy Coney Barrett (in a concurrence in Polansky) acknowledged that “[t]here are substantial arguments that the qui tam device is inconsistent with Article II” and suggested that the Court consider those arguments in an “appropriate case.” Time will tell whether Zafirov is that case.
The anti-whistleblower holding in Zafirov stands in sharp contrast to other recent notable developments that encourage whistleblower activity, including the US Department of Justice’s Corporate Whistleblower Awards Pilot Program and similar initiatives, as well as recent US Securities and Exchange Commission enforcement actions.
Despite the expected appeals, the success in Zafirov raises important issues for FCA defendants and the defense bar to evaluate, and the decision may open the door to similar arguments in other FCA qui tam actions. For one, it remains to be seen what impact Zafirov should have where a defendant is considering settling in a nonintervened case and whether a conditional settlement that preserves the right to appeal the constitutional issue is appropriate. Other courts may also draw different lines, including if and how the government’s decision to intervene impacts the constitutional analysis. These will all be important issues for affected companies and FCA practitioners to consider and keep an eye on.

Our Firm’s FCA lawyers will continue to closely monitor these developments.

A Guidebook to Lawsuits Over PFAS, or Forever Chemicals

Lawsuits over the effects of per and polyfluoroalkyl substances (PFAS) have become some of the most momentous legal battles since the Big Tobacco lawsuits. PFAS compounds, also known as “forever chemicals,” are used in so many different products that you are almost guaranteed to have one in your home. Since 2000, it has been discovered that these chemicals do not break down, have contaminated numerous water sources in America, that virtually everyone has been exposed to them, and that they carry serious health risks, including several types of cancer.

Already, PFAS manufacturers and other companies that use PFAS in the course of their daily business have paid over $11 billion in PFAS lawsuits, and that is just to mitigate the damage of PFAS exposure by cleaning up contaminated soils and waters. The lawsuits to compensate victims of PFAS exposure are just beginning, and may eclipse this massive total.

What are PFAS Chemicals?

PFAS chemicals are synthetic compounds that have multiple fluorine atoms attached to a chain of alkyl, which includes carbon atoms. There are thousands of different compounds that fall into the category of PFAS chemicals. Importantly, though, the fluorine-carbon bond that is present in all of them is one of the strongest in organic chemistry, with no natural processes for breaking it down. As a result, once a PFAS compound is created, it will continue to be a PFAS compound until something is done to it to break down its chemical structure, like superheating it when it is in water.

What are They Used For?

PFAS chemicals have been used by several major corporations for a variety of applications since they were first used to invent Teflon in 1938. Broadly speaking, PFAS chemicals are extremely useful at resisting, cleaning, or preventing:

Heat
Water
Stains
Grease
Oil

These broad applications, however, have meant that they have been used in a huge number of specific ways. For example, PFAS chemicals are included in the following products to resist water:

Paint
Clothing
Raincoats
Tents
Shoes
Personal care products, like mascara and sunscreen

As a heat resistant chemical, PFAS compounds are frequently used in:

Non-stick cookware
Electrical wire insulation
Firefighting foam
Building materials, including adhesives and insulation

As a stain resistant material, PFAS chemicals have been used in:

Carpeting
Stain-resistant clothing
Window curtains
Furniture and varnishing
Dental floss
Food packaging

PFAS chemicals have also been used as oil- and grease-resistant products, like:

Lubricants
Hydraulic fluids
Pizza boxes and microwave popcorn bags

The practical effect of all of this is that PFAS chemicals are everywhere. There are very few days that you do not interact with one. Worse, because the chemical structure of PFAS compounds do not break down, when they are used or discarded they can contaminate the area around them.

What Have PFAS Chemicals Contaminated?

Virtually everything.

In the early days after PFAS chemicals started to get used for a variety of consumer products, the public and the companies behind the compounds disposed of them with no regard or understanding for the dangers that they were causing.

That lack of understanding by the corporations behind PFAS chemicals, however, began to disintegrate in the 1970s. It was around then that 3M, one of the leading PFAS manufacturing companies, discovered its PFAS chemicals inside fish in local waterways.

Rather than sound the alarm, though, 3M and its competitors continued to dispose of used or unwanted PFAS materials in whatever means they wanted or were most convenient at the time. They burned them, buried them, or dumped them into the water. Some PFAS manufacturers even developed a new firefighting foam, aqueous film forming foams (AFFFs), that relied heavily on PFAS chemicals to put out fires involving airplane jet fuel. Firefighters used this PFAS containing firefighting foam on actual fires at airports and trained with it on controlled fires at airports across the country.

The PFAS chemicals in the foam leeched into the soil and waterways near these airports for decades.

The problem was not discovered, at least not by regulators from the federal government, until 1998. That was when the U.S. Environmental Protection Agency (EPA) learned of an internal study by 3M. In that study, researchers exposed pregnant rats to PFAS materials. Inevitably, the newborn rats died within a few days. Alarmed by the news, the EPA began to investigate in an effort to regulate PFAS.

It was also at this time that a cattle farmer in West Virginia lost his animals to a mysterious health condition. Suspecting that the culprit was a major chemical plant upriver that was owned by PFAS manufacturer DuPont, the farmer sued. Over the next couple of years, the PFAS litigation expanded into a class action of over 3,500 plaintiffs and multiple water districts in the West Virginia region. A temporary settlement was reached in which DuPont would provide $30 million of funding for an independent health and environmental study to address PFAS contamination in the soil and water, the C8 Science Panel.

The findings of this Panel and subsequent studies were dire: There was PFAS contamination virtually everywhere. It was in the soil. It was in the water. It was in the animals that ate plants from the soil and that drank the water. Fish from contaminated waterways had especially high levels of PFAS chemicals in them. And PFAS chemicals were in human beings.

Who Has Been Exposed to Them?

According to one study, 95 percent of Americans had a detectable amount of PFAS chemicals in their blood.

Anyone who is exposed to PFAS chemicals has a risk of ingesting it or it getting into their body some other way – PFAS chemicals are readily absorbed through the skin, and can even get inside your body through your tear ducts. The most common way for your PFAS exposure to become PFAS contamination are:

Eating contaminated food or drinking contaminated water
Touching anything with PFAS chemicals in it, including clothing and soil
Inhaling contaminated dust or air
Swallowing anything that has PFAS chemicals in it, like makeup or lipstick
Being in contaminated air, which can get into your body through your skin pores and sweat

This means different people are at higher risk of PFAS exposure and contamination than others.

For example, people who live in or near communities that have PFAS industries that emit the chemical into the air are likely to get exposed to the dangerous chemical every single day. Firefighters who use or train with PFAS-heavy AFFF are likely to get severe exposure to the chemical whenever they use the foam, but especially when they use it on a real fire, which burns the chemical and releases it into the air where it is more easily inhaled or absorbed through the skin.

Once they are in your body, PFAS chemicals work their way into your bloodstream. Once there, they pass through your body as your blood circulates. This takes them through all of the organs that handle your blood, including your kidneys and liver. While these organs are responsible for breaking down toxins in your blood, they cannot handle PFAS chemicals. Unless PFAS chemicals are excreted somehow, they will continue to pass through your organs, causing harm to them each time they go by.

Excreting PFAS chemicals seems to be difficult. Studies have found that many people do not excrete PFAS chemicals in their urine very well, though others can do it better. These variations in excretion mean that similar people with similar exposures to PFAS chemicals may have different levels of contamination.

Aside from urinating, the only ways to get PFAS chemicals out of your body are to bleed out contaminated blood and to breastfeed, though breastfeeding just gives the contamination to the newborn child who drinks the milk.

What Health Risks Come With PFAS Contamination?

It is important to know that there is still a lot that researchers have to learn about the health conditions caused by PFAS contamination. Collecting more data may connect new health conditions to high levels of exposure to the chemical, or may even undermine what we think we know at this point.

Right now, though, medical research has found that exposure to toxic PFAS chemicals and high levels of PFAS contamination are associated with higher risks of:

Liver damage and cancer
Kidney cancer
Prostate cancer
Testicular cancer
Thyroid Disease
Fertility problems
Pregnancy issues, including:
- Fetal death
- Low birth weight
- Developmental delays in newborns
- Preeclampsia
- Hypertension
Obesity
Hormonal disruption and irregularities
Dysfunction in the immune system
High cholesterol

Some of these conditions are debilitating. Others may prove to be fatal.

Have There Been Any Settlements?

At this point, the only lawsuits that have been settled by PFAS manufacturers have been those brought by public municipalities and water districts. These class actions and multidistrict litigation (MDL) cases demanded compensation from these companies for the costs of decontaminating soil and upgrading water filtration system to eliminate PFAS from the drinking water.

Already, though, these lawsuits have recovered over $11 billion in settlements.

The first settlement is probably the most telling. This was the West Virginia case that led to the creation of the C8 Science Panel. In 2005, the Panel was created as a part of a temporary settlement that also required DuPont and its spin-off company, Chemours, to pay $71 million and cover the costs of fixing local water treatment facilities.

After the C8 Science Panel began publishing its findings, though, DuPont and Chemours reached a final settlement agreement of $671 million.

Both the settlement and the Panel’s findings led to numerous other studies, as well as to lawsuits by water districts against PFAS manufacturers.

The biggest of these has proven to be the MDL consisting of claims of over 300 water municipalities against the company 3M. This one nearly went to a bellwether trial, settling at the last moment in June, 2023, for between $10.3 billion and $12.5 billion, with the final amount depending on the amount of PFAS contamination that is found in the water. A similar lawsuit against DuPont and its subsidiaries and spin-offs settled soon thereafter for $1.185 billion. More recently, the MDL against Tyco Fire Products, one of the companies behind the firefighting foam AFFF, settled in April, 2024, for $750 million, and the one against BASF settled in May for $316.5 million.

What About Mass Tort Claims?

These massive settlements, totaling over $11 billion, are just to cover the costs of cleaning up the soil and water of the plaintiff municipalities. We have not even begun to recover compensation for the individual victims who have suffered the healthcare issues connected to PFAS exposure and contamination.

Several of these cases are ongoing, though.

Some are being pursued by small groups of plaintiffs against smaller PFAS businesses, like this Connecticut community that is suing a local paper company for contaminating local waterways with PFAS chemicals.

Many more, however, have been consolidated into an MDL in South Carolina. As of July, 2024, it had more than 9,000 claims in it. This MDL, though, is strictly concerned with PFAS exposure from AFFF firefighting foam. However, it does include individual plaintiffs who have suffered actual harm from PFAS exposure, rather than public municipalities. These individual plaintiffs are demanding compensation for their adverse health conditions, medical monitoring, and even for the costs of cleaning up contaminated private property or for the reduction in property values caused by the contamination.

According to PFAS mass tort lawyer Dr. Nick Oberheiden, founding partner of the national law firm Oberheiden P.C., “It seems safe to say that these individual claims for compensation related to PFAS exposure and contamination are going to continue to get filed for decades into the future. One likely outcome is that an MDL will form for non-AFFF specific claims related to medical conditions and property value loss due to PFAS contamination. Victims who have been exposed to PFAS chemicals could then join the MDL and benefit from the expedited process that it entails. If PFAS manufacturers and defendants go bankrupt, we will likely see a trust fund being created, similar to how asbestos manufacturers handled the thousands of cases against them.”

Prayers for Religious Holiday Time Off May Need to be Accommodated by Employers

Knowing several religious holidays are coming up soon, employers can take steps to avoid triggering religious discrimination and reasonable accommodation lawsuits. Consistently applying paid time off rules can help to prevent discrimination, retaliation, and religious reasonable accommodation claims.

Quick Hits

Private and public employers with fifteen or more workers must accommodate reasonable requests from workers to observe religious holidays (pursuant to federal law; however, state law coverage varies and might only require one or more workers).
Employers may avoid confusion by clearly stating leave policies and company holidays in the employee handbook.
Employers can use online systems or software to detect patterns in approving or denying requests for leave on religious holidays.

With many religious holidays taking place in the next two months, employers are likely to see many requests for time off for religious celebrations.

Title VII of the Civil Rights Act of 1964 prohibits employers from discriminating against workers for practicing their religion unless the worker’s religious practice cannot reasonably be accommodated without an undue hardship to the business. If a manager approves holiday leave requests from Christian employees, but rejects holiday leave requests from Muslim or Jewish employees, that could raise the risk of religious discrimination lawsuits. Additionally, some states, including California, also prohibit religious discrimination and require reasonable accommodation.

In June 2023, in Groff v. DeJoy, the Supreme Court of the United States ruled that employers cannot legally deny a valid religious accommodation request, unless they can show a substantial burden from a proposed religious accommodation. In Groff, an evangelical Christian postal worker sued the U.S. Postal Service for failing to accommodate his request to not work on Sundays for religious reasons. The Supreme Court held in favor of the postal worker and remanded the case to lower courts.

This decision raised the bar for employers to invoke an undue hardship defense. A de minimiscost is no longer enough to demonstrate an undue burden. If an employee holds a sincere religious belief or practice that conflicts with a workplace policy or staffing schedule, then the employer must engage in an interactive process to see whether an accommodation can be made without substantially interfering with its overall business operations.

Some workplaces, including in the healthcare, hospitality, and transportation industries, require staffing 24/7 every day. In that situation, it may be possible to coordinate schedules so that leave requests can be honored for religious holidays. For example, non-Jewish employees may agree to work during Jewish holidays, and non-Muslim workers may agree to work during Muslim holidays. And, then, those employees might cover gaps in staffing caused by time off for Christian holidays. Compliance with the religious accommodation laws contemplates this type of interactive process and teamwork to find an appropriate solution.

If this type of shift-swapping is not possible or practical, it may be helpful for an employer to document why that is the case.

Next Steps

Employers may wish to review their religious accommodation request procedures, leave policies, scheduling process, and related practices to ensure that managers do not engage in religious discrimination when they approve or deny leave requests. In addition, employers may wish to train managers to apply all of the time off rules consistently.

These holidays are upcoming:

The Jewish holidays Rosh Hashanah and Yom Kippur fall on October 3, 2024, and October 12, 2024, respectively. Hanukkah will be celebrated December 25 through January 2, 2025.
The Hindu holiday Diwali falls on November 4, 2024.
The Buddhist holiday Bodhi Day falls on December 8, 2024.
The Christian holiday Christmas Day falls on December 25, 2024.

The Fifth Circuit Confirms the DOL’s Authority to Use Salary Basis Test for FLSA Overtime Exemptions

On September 11, 2024, the U.S. Court of Appeals for the Fifth Circuit in Mayfield v. U.S. Department of Labor confirmed that the United States Department of Labor (“DOL”) has the authority to use a salary basis to define its white-collar overtime exemptions. This is a significant win for the DOL as it is presently defending its latest increase to the minimum salary thresholds for executive, administrative, and professional exemptions under the Fair Labor Standards Act (“FLSA”), also known as the FLSA’s “white-collar exemptions,” in litigation pending in the U.S. District Courts for the Eastern and Northern Districts of Texas.

The Mayfield Decision

In Mayfield, a unanimous three-judge panel of the Fifth Circuit provided that the DOL has the authority to “define and delimit” an exemption from overtime pay under the FLSA. In so ruling, the Court affirmed the dismissal of a lawsuit initiated by a Texas fast-food operator, Robert Mayfield, who claimed Congress never authorized the DOL to use salaries as a test for whether workers have managerial duties.

The Court rejected Mayfield’s argument. In response, the Fifth Circuit wrote that “[d]istinctions based on salary level are… consistent with the FLSA’s broader structure, which sets out a series of salary protections for workers that common sense indicates are unnecessary for highly paid employees.” Upon issuing the Mayfield decision, the Fifth Circuit joined the four other federal appeals courts that have considered this issue previously (including the D.C. Circuit, Second Circuit, Sixth Circuit, and the Tenth Circuit).

2024 DOL Rule

The 2024 DOL rule effectively focused on three main points. First, it raised the minimum weekly salary to qualify for the FLSA’s white-collar exemptions from $684 per week to $844 per week (equivalent to a $43,888 annual salary) on July 1, 2024. Second, it called for another increase of the minimum weekly salary to $1,128 per week (equivalent of a $58,656 annual salary) on January 1, 2025. Third, under the 2024 DOL rule, the above salary threshold would increase every three years based on recent wage data.

As mentioned above, the Mayfield decision comes at a time when the DOL is defending its recent 2024 rule increasing the salary thresholds for white-collar exemptions in both the Eastern and Northern Districts of Texas. Indeed, the Mayfield decision’s timing could not have come at a more opportune time for the DOL because it supplies these Texas federal judges with new direction from the Fifth Circuit to consider when making their rulings.

What Does This Mean for Employers?

The Mayfield decision bolsters the DOL in its bid to set and increase the minimum salary requirements for its white-collar overtime exemptions, which will certainly pose challenges for employers in creating compliant employee compensation structures. In short, if the 2024 DOL rule goes into effect, employers will have to substantially raise their employees’ salaries to ensure they remain properly exempt from the overtime provisions of the FLSA.

by: Derek A. McKee of Polsinelli PC

For more news on Overtime Exemption Litigation, visit the NLR Labor & Employment section.

Former Acadia Employees Received Reward for Blowing the Whistle on Healthcare Fraud

The United States Department of Justice settled a False Claims Act qui tam whistleblower lawsuit against inpatient behavioral health facilities operator Acadia Healthcare Company, Inc. Under the terms of the settlement, the operator paid almost $20 million to the United States and the States of Florida, Georgia, Michigan, and Nevada. The relators, or whistleblowers, who filed suit in 2017, received a reward of 19% of the government’s recovery of misspent Medicare, TRICARE, and Medicaid funds. According to one of the Relators, Jamie Clark Thompson, a former Director of Nursing at Acadia’s Lakeview Behavioral Health facility, “I am passionate about advocating for improved and quality services for individuals living with mental illness. Unfortunately, our communities have seen the devastating impact when this vulnerable population receives inadequate care. I firmly believe that by continuously working to improve our mental health system, we can support recovery and well-being, benefiting our entire community. I hope that my actions have made a difference, and I know that properly allocating funds is crucial to supporting behavioral health services and those working tirelessly to improve them.”

Medicare, TRICARE, and Medicaid Fraud Allegations

According to the settlement agreement, the whistleblowers alleged Acadia and certain of its facilities submitted false claims to Medicare, TRICARE, and Medicaid. Specifically, the facilities allegedly admitted ineligible patients, provided services for longer than was medically necessary or did not provide treatment at all (but still billed the healthcare programs for it), did not provide sufficient care for those who needed acute care or individualized care plans, and hired the wrong people or failed to train their staff to “prevent assaults, elopements, suicides, and other harm resulting from staffing failures.”

Behavioral Health Facility Fraud

Behavioral healthcare facilities provide inpatient, outpatient, and residential care for adolescents, adults, and seniors for mental health conditions. As taxpayer-funded healthcare programs, Medicare, Medicaid, and TRICARE cover behavioral healthcare. Treating mentally ill Medicare, Medicaid, or TRICARE beneficiaries as cash cows, and either under-treating, over-treating, or not treating them at all both robs the individuals of the chance to recover, wastes taxpayer resources, and may even jeopardize their safety and well-being.

The Importance of Medicare, Medicaid, and TRICARE Whistleblowers

Whistleblowers who report behavioral health facility fraud are not only protecting vulnerable patients but also making sure federally funded healthcare dollars are being spent to properly treat adolescent, adult and older patients with significant behavioral health conditions. Three employees at different Acadia facilities came forward, faced retaliation for speaking up, and are now being rewarded for helping to fight fraud and abuse and for their courage.

Read the Department of Justice’s Press Release

by: Tycko & Zavareei Whistleblower Practice Group of Tycko & Zavareei LLP

Sixth Circuit Explicitly Sidesteps the NLRB’s McLaren Macomb Decision

The Sixth Circuit Court of Appeals recently declined to comment on the National Labor Relations Board’s (the “Board”) McLaren Macomb decision which took aim at overbroad non-disparagement and non-disclosure agreements.

We first reported in February 2023, on the significant decision by the Board in McLaren Macomb, 372 NLRB No. 58 (Feb. 21, 2023), which concluded, among other things, that proffering a severance agreement with broad confidentiality and non-disparagement provisions could violate Section 7 of the National Labor Relations Act (“NLRA”) – a decision and rationale we wrote about in depth here. The decision drove employers to reevaluate existing severance agreements with such provisions.

On appeal, the Sixth Circuit sidestepped the most salient aspects of the Board’s McLaren Macomb decision, namely those portions addressing the lawfulness of confidentiality and non-disparagement provisions in severance agreements, writing, “we do not address [the Board’s] decision to reverse Baylor [Univ. Med. Ctr., 369 NLRB No. 43 (2020)] and IGT[, 370 NLRB No. 50 (Nov. 4, 2020)], or whether it correctly interpreted the NLRA in doing so.” In other words, the Sixth Circuit did not offer any insight or pass judgment one way or another on the Board’s ruling that broad-based non-disparagement and confidentiality provisions are unlawful under NLRA. Indeed, while the Sixth Circuit did find the specific severance agreements at issue unlawful, it did so under previous Board precedent (not for the reasons articulated in McLaren Macomb), further reinforcing the Court’s unwillingness to address this critical issue directly.

What does this mean for employers? While there is lingering uncertainty for employers, it reinforces, at least for now, that the Board may continue to find severance agreements offered to non-supervisory employees that include broad-based confidentiality and non-disparagement provisions as unlawful. Consequently, employers should continue to review their existing severance agreements with the assistance of employment counsel to determine whether, when, and to what extent they may include appropriately crafted non-disparagement and confidentiality clauses.

Temporary Injunctive Relief for Nondebtors in Bankruptcy Court Post-Purdue Pharma

In June, in Harrington v. Purdue Pharma L.P., 144 S. Ct. 2071 (2024), the Supreme Court held that the Bankruptcy Code does not, as part of a bankruptcy plan, allow nondebtors to receive permanent injunctive relief through nonconsensual releases. Less than a month later, two U.S. bankruptcy courts addressed whether Purdue Pharma bars bankruptcy courts from issuing temporary injunctive relief for the protection of nondebtors, and both courts determined that it does not. And just a couple of weeks ago, a third U.S. bankruptcy court reached the same conclusion.

The Supreme Court clearly limited the scope of its Purdue Pharma ruling to the permanent releases before it. In July, the U.S. Bankruptcy Court for the District of Delaware tackled a precise question left unresolved by Purdue Pharma: Can a bankruptcy court issue a preliminary injunction to stay claims against nondebtors? Yes, the court held in Parlement Technologies.

The facts of Parlement Technologies are straightforward. The debtor, Parlement Technologies, and several of its former officers were sued in Nevada state court. While section 362(a) of the Bankruptcy Code automatically stayed the Nevada action against Parlement Technologies, it did not stay claims against the former officers, and Parlement Technologies therefore sought a temporary stay of those claims. Faced with whether it could temporarily stay an action against nondebtors in light of the Supreme Court’s Purdue Pharma ruling, the court concluded: “Purdue Pharma does not preclude the entry of such a preliminary injunction.” In re Parlement Techs., 24-10755 (CTG) (Bankr. D. Del. Jul. 15, 2024).

The court went on to describe the four-factor test for granting a preliminary injunction: (1) likelihood of success on the merits, (2) irreparable injury to plaintiff or movant absent an injunction, (3) harm to defendant or nonmoving party brought about by the injunction, and (4) public interest. In addressing the likelihood of success on the merits, the court considered how Purdue Pharma altered the traditional “success on the merits” calculation. Given the Purdue Pharma holding – that nondebtors may not receive permanent injunctive relief in the form of nonconsensual third-party releases – success on the merits in a temporary stay determination cannot be based on the likelihood that the nondebtors would be entitled to a nonconsensual third-party release. Clearly, that factor would never be met.

Instead, a court should find a likelihood of success on the merits when it concludes that (1) a preliminary injunction is necessary to permit debtors to focus on reorganization, or (2) the parties may ultimately negotiate a plan that includes resolution of the claims against nondebtors. After focusing primarily on the debtor’s failure to meet this first element of the four-factor test – success on the merits – the court declined to issue the preliminary injunction.

The same week that the Parlement Technologies court denied the temporary injunction, the U.S. Bankruptcy Court for the Northern District of Illinois – in Coast to Coast Leasing – granted a preliminary injunction staying state court litigation against nondebtors. Coast To Coast Leasing, LLC v. M&T Equip. Fin. Corp. (In re Coast to Coast Leasing), No. 24-03056 (Bankr. N.D. Ill. Jul. 17, 2024). The Illinois court addressed both the Purdue Pharma and Parlement Technologies decisions, and relied on a three-factor Seventh Circuit test used to determine whether a bankruptcy court may enjoin proceedings in another court: (1) those proceedings defeat or impair its jurisdiction over the case before it, (2) the moving party established likelihood of success on the merits, and (3) public interest.

The Coast to Coast court issued the temporary injunction. The court stressed that unlike Purdue Pharma, where the nondebtors sought to release and enjoin claims, the case before it involved only a temporary injunction (of two weeks). And unlike in Parlement Technologies, there was a likelihood of success on the merits based on both of the above-noted measures set forth in the Parlement Technologies decision ((1) a preliminary injunction is necessary to permit debtors to focus on reorganization, or (2) the parties may ultimately negotiate a plan that includes resolution of the claims against nondebtors).

These two cases point to the conclusion that Purdue Pharma does not preclude bankruptcy courts from temporarily staying claims against nondebtors. On September 13, the U.S. Bankruptcy Court for the Eastern District of Louisiana similarly stated, “under certain circumstances, a bankruptcy court may issue a preliminary injunction that operates to stay actions against nondebtors.” La. Dep’t of Envtl. Quality v. Tidewater Landfill, LLC (In re Tidewater Landfill LLC), No. 20-11646 (Bankr. E.D. La. Sep. 13, 2024). That court cited both Parlement Technologies and a pre-Purdue Pharma Fifth Circuit case, Feld v. Zale Corp. (In Re Zale Corp.), 62 F.3d 746 (5th Cir. 1995), suggesting that preliminary relief should not be treated differently after Purdue Pharma.

That court did not reach the relevant motion, but its clear statement of the law is instructive. Together this trio of cases provides guidance to debtors seeking temporary stays for nondebtors in the wake of Purdue Pharma.

A Study in THC-O: Unpacking the Recent Anderson Case

Recently, the United States Court of Appeals for the Fourth Circuit handed the Drug Enforcement Administration (“DEA”) a big loss when it comes to hemp. In Anderson v. Diamondback Investment Group, LLC, the court ruled that the DEA’s interpretation, which classified a host of hemp-derived products as illegal, was incorrect.

I’ve previously written about the impact of Loper Bright Enterprises v. Raimondo on cannabis and hemp in this blog, and Anderson is one of the first cases to show how courts will handle cannabis law post-Chevron. In Loper, the Supreme Court ended the long-standing doctrine of Chevron deference. That doctrine required federal courts to defer to an agency’s interpretation of an ambiguous statute, so long as it was “reasonable,” even if the court didn’t agree with it. Now, courts don’t have to give the DEA (or any agency) that kind of leeway. If the agency’s interpretation isn’t the best reading of the statute, it is merely persuasive material at best.

This reminds me of my days of clerking on the Court of Common Pleas. Oftentimes, lawyers would cite other non-binding Common Pleas decisions, and the judge would merely say he would consider them but did not view them as binding. It’s almost like déjà vu for me now with Loper, on a grander scale.

Since Loper was decided, everyone has had theories about how it could impact things like cannabis rescheduling or the legality of hemp-derived cannabinoids. In particular, the DEA has been flexing its muscles with opinion letters about what it considers to be legal or illegal cannabinoids. This is where Loper comes into play. In theory, the DEA can still issue its opinions, but the courts aren’t going to roll over and accept those interpretations without question anymore. That’s exactly what happened in Anderson.

Without getting into the weeds of the case too much, here’s the gist: an employee was fired after drug tests allegedly showed cannabis use. She sued her employer, claiming she was using legal hemp-derived products. The court said she didn’t provide enough evidence to prove those products contained less than 0.3% Delta-9 THC—the magic number that separates hemp from cannabis under federal law. So, in the district court’s view, she did not have a case.

But the important part for us is what the court said about the 2018 Farm Bill and the DEA’s interpretation of cannabinoids like THC-O. THC-O is a synthetic compound made from hemp derivatives, and there’s been a long debate about whether products like THC-O or Delta-8 THC fall under the “hemp” umbrella.

The DEA considers synthetic cannabinoid-controlled substances, and they’ve argued that products like THC-O are illegal. The Ninth Circuit took on this issue a few years ago in AK Futures LLC v. Boyd Street Distro, LLC, where they ruled that Delta-8 THC products derived from hemp with less than 0.3% Delta-9 THC were legal under the 2018 Farm Bill.

In Anderson, the Fourth Circuit agreed with the Ninth Circuit’s logic, holding that “we think the Ninth Circuit’s interpretation of the 2018 Farm Act is the better of the two.” The court went even further, rejecting the DEA’s argument outright, thanks to the post-Loper world we now live in, where the DEA’s interpretation no longer gets automatic deference.

Here’s the key takeaway: according to the Fourth Circuit, if a product is derived from hemp and doesn’t contain more than 0.3% Delta-9 THC, it’s legal—even if it’s been processed into something like Delta-8 THC. But if a cannabinoid is made entirely from synthetic materials, it’s not hemp, and it’s not protected by the 2018 Farm Bill.

Now, before anyone starts thinking this is an all-clear for hemp products, there’s still a lot to unpack. While Anderson pushes back against the DEA’s overreach, it doesn’t mean every hemp-derived product is automatically legal. The 0.3% Delta-9 THC threshold is still critical, and businesses need to make sure they’re playing by the rules. Plus, this ruling doesn’t mean states won’t have their own say about what’s legal within their borders.

To sum it all up, the Anderson decision is important because it reinforces that courts are not bound by the DEA’s interpretations, especially post-Loper. This decision helps the hemp-derived cannabinoid market. As always, businesses must stay compliant with both federal and state laws to avoid legal headaches.

For more news on Hemp Classification Litigation, visit the NLR Biotech, Food, and Drug section.

EVERYTHING’S FINE: Big TCPA Win For Medical Debt Collector Suggests FCC Rulings Still Binding After Loper Bright–Let’s Hope it Stays That Way

Fascinating little case for you all today.

Consumer visits hospital for treatment. Provides phone number at admission. Receives treatment and is discharged.

Consumer fails to pay resulting invoices. Hospital and provider network turn account over to collections. Debt collector allegedly uses an ATDS to call consumer on the number she provided.

What result?

Prior to the Supreme Court’s Loper Bright decision the determination would be easy. The FCC held back in 2009 that providing a number in connection with a transaction permits autodialed calls to a consumer in connection with that transaction. And the Sixth Circuit Court of Appeals has directly held that providing a phone number on hospital intake documents permits later debt collection activity at that number–including via autodialer.

But the Loper Bright decision recently destroyed Chevron deference–meaning courts no longer have to yield to agency determinations of this sort. And while the Hobbs Act affords extra protections to certain FCC rulings, those protections only apply where certain procedural requirements were met by the Commission in adopting the rule.

So does the FCC’s rule from 2009 permitting informational calls to numbers provided in connection with a transaction still bind courts? According to the decision in Woodman v. Medicredit, 2024 WL 4132732 (D. Nv Sept. 9, 2024) the answer is yes!

In Woodman the defendant debt collector moved for summary judgment arguing the Plaintiff consented when she provided her number to the hospital. The Court had little problem applying the FCC’s 2009 order and precedent that came before Loper Bright to grant summary judgment to he defense. So just like that case is gone.

Great ruling for the defense, of course, and it makes me feel a bit better about the whole “no one knows what the law is anymore” thing, but the Woodman court didn’t really address the core issue– was the 2009 ruling enacted with sufficient APA pop and circumstance to merit Hobbs Act deference under PDR Resources.

Really interesting question and one folks should keep in mind.

Category: Litigation

Supreme Court Declines to Hear “Willfulness” Case

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