Tag: Litigation

FCA Enforcement & Compliance Digest — Fall 2024 False Claims Act Newsletter

Welcome to the Fall 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance tips. We bring you the most recent and significant insights in an accessible format, concluding with our main takeaways — aka “And the Fox Says…” — on what you need to know.

In this Fall 2024 edition, we cover:

  1. Enforcement Trends: Manufacturers challenge AKS intent requirement as reflected in recent denials of OIG Advisory Opinion requests.
  2. Litigation Developments: Implications of Florida judge’s ruling that the FCA qui tam provision is unconstitutional.
  3. Compliance Corner: What health care companies need to know about AI.
  4. ICYMI: Federal Court Permits Investors to Resume Kickback Suit Against Teva

1. Enforcement Trends

Do Violations of the AKS Require a ‘Corrupt’ Intent? Manufacturers Challenge the OIG’s Interpretation of the Statute

In a series of recent lawsuits filed by the pharmaceutical industry against the US Department of Health and Human Services (HHS) Office of the Inspector General (OIG), manufactures are challenging the OIG’s interpretation of the Anti-Kickback Statue (AKS), arguing that violations of the statute require a corrupt intent. While courts have so far ruled in OIG’s favor, should a court accept this argument, the AKS regulatory landscape could be upended, providing health care providers and suppliers the opportunity to develop and implement arrangements that have historically been prohibited by the OIG.

The challenges to OIG’s interpretation of the AKS come in the context of OIG Advisory Opinion requests submitted by the manufacturers (or a related charity) proposing various forms of patient assistance programs under which the manufacturers or their related charities offer financial assistance to patients on the manufacturers’ products. The OIG denied each of the Advisory Opinion requests, finding that the proposed forms of patient assistance would constitute remuneration intended to induce patients to purchase the manufacturers’ drugs in violation of the AKS.

The OIG has consistently reiterated its opposition to manufacturer-operated patient assistance programs, with both the OIG’s 2005 Special Advisory Bulletin: Patient Assistance Programs for Medicare Part D Enrollees and the 2014 Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs noting that manufacturers cannot provide co-pay assistance to federal health care program beneficiaries, as doing so would constitute a kickback. However, the guidance also described the parameters under which independent charities can provide co-pay assistance, including assistance to federal health care program beneficiaries (i.e., Medicare beneficiaries). One of the key factors with respect to the operation of charitable patient assistance programs, is the independence of the charities operating the programs. While the independent charities are primarily funded by manufacturers, to be considered independent for OIG’s purposes, the charities must retain independence from donors. This means the donors cannot influence the design or operation of the patient assistance programs, and the programs cannot favor patients on the donor’s drug (e.g., assistance cannot be contingent upon the patient being prescribed a donor’s drug).

In three separate litigations, Pfizer Inc. v. United States Department of Health and Human Services, Vertex Pharmaceuticals Incorporated v. United States Department of Health and Human Services et al., and Pharmaceutical Coalition for Patient Access v. United States of America et al., manufacturers are challenging OIG’s long-held position that manufacturers cannot provide patient assistance, including co-pay assistance, to federal health care program beneficiaries. In doing so, the goal of the manufacturers is to provide assistance to patients, including co-pay support, either directly or through a charity that is not considered independent by OIG’s standards due to the relationship of the proposed charities to the manufactures and the level of influence by the manufacturers over the proposed charities. In each litigation, the manufacturer or, in the case of the Pharmaceutical Coalition for Patient Access (PCPA), the charity controlled by the manufacturers, is challenging an unfavorable Advisory Opinion issued by OIG concluding that the proposed patient assistance programs would constitute remuneration intended to induce patients to use a particular manufacturer’s products.

Under the arrangements proposed by Pfizer and PCPA, the proposed charities would be funded exclusively by manufacturers and would only provide support to patients on those funders’ drugs. In Pfizer’s Advisory Opinion request, the company proposed two potential co-pay assistance programs: (1) a direct co-pay assistance program and (2) a Pfizer-supported charity co-pay assistance program. Similar to the proposed Pfizer-supported charity co-pay assistance program, PCPA, an organization funded by manufacturers of Part-D-covered oncology drugs, proposed to create its own patient assistance program that would provide co-pay assistance to patients who meet certain qualifying criteria and then invoice each participating manufacturer for “the total amount of cost-sharing subsidies provided to eligible Part D enrollees.”

Vertex’s Advisory Opinion request focused on a proposed “Fertility Preservation Program” under which Vertex would pay fertility providers through a third-party vendor for the treatments provided to patients enrolled in the program. While this proposed program involved coverage of related treatment costs (i.e., the costs of the fertility treatments) rather than coverage of the co-pay costs associated with the Vertex drug itself, OIG nonetheless applied the same reasoning as in the Pfizer and PCPA opinions, concluding that the program would constitute remuneration to the patients in violation of the AKS.

In each litigation, the manufacturer (or, in the case of PCPA, the manufacturer-related charity) is challenging OIG’s position that the manufacturer’s subsidies constitute “remuneration” meant “to induce” patients to purchase manufactures’ products. The manufacturers argue that the AKS criminalizes conduct that “leads or tempts to the commission of crime” through “remuneration” that corrupts medical decision-making, as part of a quid pro quo transaction. In other words, according to the manufacturers, “to induce” requires a corrupt intent. Therefore, because the manufactures’ efforts to assist patients with meeting Medicare co-pay obligations or gaining access to Medicare-covered treatments (or treatments otherwise covered by the federal health care programs) are not done with malice or corrupt intent, such programs would not violate the AKS.

To date, no court has agreed with the manufacturers’ position. While Vertex is still pending trial in the District Court for the District of Columbia, the District Court for the Southern District of New York ruled against Pfizer, noting that “the law is clear that absent an express carve-out, the Anti-Kickback Statute prohibits any remuneration intended to induce someone to purchase or receive a drug or medical service.” Similarly, the District Court for the Eastern District of Virginia ruled against PCPA, concluding that HHS OIG’s “interpretation of the AKS adheres faithfully [to] the statute’s plain text, comports with its context, and does not offend its history.” On appeal, the Second Circuit affirmed the District Court’s decision in Pfizer, finding that an AKS violation does not require “corrupt intent.” Pfizer then appealed to the US Supreme Court, which denied certiorari. PCPA’s case is currently on appeal with the Fourth Circuit.

Should the Vertex court or a court of appeals agree that the statutory terms “induce” and “remuneration” should be construed more narrowly and require a corrupt intent to violate the AKS, AKS regulatory interpretation and much of OIG’s guidance could be called into question. Arrangements that have historically been viewed as suspect by the OIG could be considered compliant to the extent the parties lacked a corrupt intent to violate the law.

And the Fox Says… Ongoing efforts challenging OIG’s statutory interpretation of the AKS demonstrate manufacturers’ interests in narrowing the scope of prohibited activities under the law. Providers and suppliers should continue monitoring the ongoing litigation and any future efforts to challenge OIG’s interpretation of the AKS, as any judicial narrowing of the interpretation could provide opportunities to develop innovative arrangements that may be beneficial to patients. Regardless, developing compliant arrangements to benefit patients can be complicated, and legal counsel can help to ensure you remain apprised of all relevant developments and assist in structuring compliant arrangements.

2. Litigation Developments

What Is the FCA Without Its Qui Player? A Look Into Zafirov’s Future Implications and the Enforceability of the FCA Without a Qui Tam Device

As we previously discussed, a Florida federal district court recently held in Zafirov v. Florida Medical Associates LLC that the FCA qui tam provision is unconstitutional. The court reasoned that a relator who litigates an FCA lawsuit on behalf of the United States is not a properly appointed “officer” under Article II of the US Constitution and, thus, does not have the authority to serve in that position. This article examines several questions: What does FCA enforcement look like without a qui tam device? What questions did Zafirov leave unresolved? And what should one expect in the coming years as this issue is litigated on appeal and among other courts?

Can the government successfully enforce the FCA without a qui tam device? If, in the end, the qui tam provision is voided, that does not spell doom for the FCA. This is because the government still has the authority to file FCA actions itself and could hire many more attorneys to investigate and prosecute them. The government also has other mechanisms to entice whistleblowers to come out of the woodwork and inform it of wrongdoing. For example, recently, the US Department of Justice (DOJ) announced the “Corporate Whistleblower Awards Pilot Program.” This enforcement program compensates whistleblowers who inform the DOJ of original and truthful information concerning corporate misconduct. If the information leads to a successful forfeiture of over $1 million, the whistleblower is compensated. Currently, however, the program does not cover FCA claims. But the DOJ or US Congress could theoretically expand this program, or create a new one, to attract whistleblowers who have information concerning FCA violations. Under such a program, the government’s litigation of FCA claims would not be all that different from what happens currently. Rather than intervene in a meritorious FCA case brought by a relator, the government would file its own case based on information provided by a whistleblower. This would avoid the constitutional pitfalls identified in Zafirov. A post-qui tam landscape will certainly see fewer FCA claims being filed overall, but the government would likely file more FCA claims than it does now.

Still, many questions remain unresolved under Zafirov concerning the extent to which relator suits are constitutionally permissible. In Zafirov, the relator was litigating an FCA suit in which the United States declined to intervene. But what happens if the United States does intervene and takes over the case? Are those suits permissible? Does the relator act as an “officer” if her role is just limited to filing a lawsuit? Could the government get around Zafirov by intervening in more cases? Or are all FCA lawsuits filed by a relator invalid ab initio even if the government intervenes? If so, would Congress have to create a mechanism to appoint a relator as an officer for FCA purposes? In short, it is unclear how broadly Zafirov will be read. On one hand, it could be read to only apply to non-intervened cases. On the other hand, the very act of filing a complaint on behalf of the United States may require a constitutional appointment, and the government’s intervention would not cure that taint. These questions will remain unresolved until they are addressed by the Supreme Court.

Only time will tell what will happen as this issue percolates in the courts. Already, several circuit courts have upheld the constitutionality of the qui tam provisions. In the district courts located in circuits that have not yet addressed this issue, defendants are filing dispositive motions arguing that the relator’s appointment is unconstitutional. Though the decision in Zafirov is currently an outlier, it soon may not be as more courts consider arguments that rely on Zafirov’s reasoning.

And the Fox Says… Zafirov is significant because it may be the first blow to a significant enforcement mechanism on which the government heavily relies. But the qui tam provision’s fate is not set in stone. The relator in Zafirov will almost certainly appeal the decision to the Atlanta-based Eleventh Circuit Court of Appeals. That court’s decision may then be appealed to the Supreme Court. The appeals process for Zafirov may take years before the Supreme Court grants certiorari on the issue (if it does at all). In the meantime, the issue is not going away, and Zafirov is unlikely to be a one-off case. Those who are in the throes of an FCA investigation or litigation should raise this issue as a possible litigation risk or as an affirmative defense. The best possible time to raise this issue amid litigation is on a Rule 12(b)(6) motion to dismiss. Even if a case is past this point, Zafirov supports the position that such an argument is not waived, given that the issue goes to the relator’s very authority to bring the suit. So, defendants litigating a case brought by a relator should raise this issue as soon as possible. We at ArentFox Schiff will continue to monitor developments to help our clients navigate this ever-changing legal landscape.

3. Compliance Corner

AI Under the DOJ Microscope: How Health Care Companies Should Respond

Many companies, including health care companies, have incorporated artificial intelligence (AI) into their business practices. While historically, AI has largely been unregulated, that is starting to change. Recently, state governments have begun regulating the use of AI in the health care setting, as our colleagues summarized here regarding recently passed California legislation requiring health care facilities, clinics, and physician practices in the state to disclose the use of AI in communications regarding patient clinical information. Now, AI has the attention of the DOJ.

This past March, Deputy Attorney General Lisa Monaco indicated the DOJ’s interest in AI, stating at the American Bar Association’s 39th National Institute on White Collar Crime that “fraud using AI is still fraud.” Following Monaco’s statement, in September, the Criminal Division of the DOJ updated its Evaluation of Corporate Compliance Programs (ECCP) guidelines to require DOJ prosecutors to consider whether a company’s compliance program safeguards against misuse of AI or other emerging technologies. As a brief primer, the ECCP is a DOJ document that prosecutors use to evaluate the effectiveness of a corporate compliance program in determining whether to criminally charge a company. The document is published publicly and provides helpful insight into the DOJ’s expectations for companies as they build and implement their corporate compliance programs.

Under the updated guidance, the DOJ emphasizes that companies need to assess AI-related risks as part of their overall enterprise risk management systems. Specifically, a corporate compliance program must consider whether it has specific policies and procedures to prevent “any potential negative or unintended consequences” resulting from the use of AI in its business practices and compliance program. Additionally, a company should proactively conduct risk analyses of its use of AI and mitigate the potential for “deliberate or reckless misuse of technologies” by company insiders. Other key considerations are whether the company trains its employees on the use of AI, whether there is a baseline of human decision-making used to assess AI-generated content, and how the company implements accountability over the use of AI.

In its September update, the DOJ also revised a section of the ECCP, asking whether compliance personnel have access to relevant data sources to allow for “timely and effective monitoring and/or testing” of policies, controls, and transactions. A key consideration is whether the assets, resources, and technology available to compliance programs are comparable to those available elsewhere in the company. An imbalance in access to technology and resources may indicate a compliance program’s inability to detect and mitigate risks, particularly if a business unit is given unfettered access to AI tools while compliance lags behind.

Compliance officers at health care companies should take steps now to ensure that the implementation and use of AI within their organizations do not raise any compliance red flags. Consider the recent Texas Attorney General settlement with Pieces Technologies, a company that markets generative AI products, which resolved allegations that the company made misleading statements regarding the accuracy of its products. As part of the settlement, Pieces agreed to provide more explicit disclosures to customers related to how the company’s products should be used and the potential harm that could result from the products.

Providers using such technologies may encounter data privacy and security risks, including cybersecurity risks such as ransomware and malware attacks, bias and fairness concerns with respect to the training of the AI systems that may result in preference for a particular drug or treatment, and reliability and accountability concerns affecting a health care professional’s ability to provide patient care. With that being said, the DOJ could conduct investigations similar to the Pieces investigation against health care providers that use AI without considering these risks.

To help mitigate the risks associated with AI, including in the event of a DOJ investigation, compliance officers should be involved during all stages of discussions around AI initiatives, including through implementation and use. Compliance officers should ensure their companies have appropriate policies and procedures governing the use of AI once it is introduced to their organizations and provide training to employees both on the AI technology and on the policies governing its use. Finally, compliance officers should ensure they have the necessary access to AI systems to conduct compliance oversight measures. Such oversight measures may include assessing AI-related risks as part of their organization’s annual risk assessment, conducting AI-related auditing, and monitoring to help identify potential issues with the technology as they arise.

And the Fox Says… The DOJ’s AI-focused compliance guidance is a call to action for companies to proactively address the legal and regulatory implications of AI technologies, reminding them that the age of AI requires more than just innovation — it demands robust compliance strategies. Companies that conduct regular risk assessments of their practices must consider the use of AI, update policies and procedures to address its use, provide compliance teams with equal data access, and regularly update training on the lawful use of these technologies. Empowering compliance personnel and working with outside compliance experts to make these regular updates will put a company in a good position to meet these new standards. By embracing these guidelines, companies can mitigate legal and regulatory risks while leveraging the capabilities of AI technologies.

4. In Case You Missed It

Our most popular blog post from the last quarter: Federal Court Permits Investors to Resume Kickback Suit Against Teva.

© 2024 ArentFox Schiff LLP
For more on the FCA, visit the NLR Criminal Law Business Crimes section

8 Things to Know About AFFF Lawsuits

Thousands of individual lawsuits have been consolidated into multidistrict litigation (MDL) against the corporations that make aqueous film forming foam (AFFF), a type of firefighting foam that was filled with per- and poly-fluoroalkyl substances (PFAS), synthetic chemicals that are now known to be dangerous to human health.

Here are 8 things that you should know about the AFFF firefighting foam lawsuits, according to mass tort lawyer Dr. Nick Oberheiden.

1. AFFF Caused Lots of Chemical Contamination

AFFF is one of the types of foam that firefighters use to put out flames. There are two classes of AFFF firefighting foam:

  1. Class A, which is used for combustible fires, like for wood or paper
  2. Class B, which is used for ignitable liquids like oil, gas, or jet fuel

Class A firefighting foams rely primarily on the water in the foam to put out the flames, though they are still substantially more effective than just using straight water. They have far fewer chemicals in them and are used more often than Class B foams.

Of Class B foams, there are two types:

  1. Foams that have fluorine in them
  2. Foams that do not have fluorine in them

Both foams work the same basic way: By blanketing flammable liquids, they prevent the fuel from catching fire and extinguish any lit fuels by suffocating the flames of the oxygen that they need in order to keep burning. This works far better than water for these types of fires, as the flaming liquids are lighter than water and would float on its surface and continue to burn.

AFFF, however, is a fluorinated type of foam. That fluorine comes in the form of a PFAS compound. There are hundreds of types of these compounds, but they are all based on one of the strongest chemical bonds in organic chemistry; the one between fluorine and carbon.

2. PFAS Chemicals are Everywhere

While PFAS chemicals have been used in firefighting foam since the 1970s, when the U.S. Navy worked in collaboration with the giant chemical corporation 3M to produce a foam that could quickly put out fires on vessels, PFAS compounds have been used in a wide variety of other capacities since the 1940s. A very versatile chemical compound, PFAS chemicals were used to:

  • Prevent or remove stains
  • Suppress or resist heat
  • Waterproof materials or make them water resistant
  • Contain grease or oil

As a result, PFAS chemicals have been added to a huge array of consumer products that span nearly every industry, including:

  • Food packaging and wrapping
  • Pizza boxes
  • Raincoats
  • Water resistant clothing and shoes
  • Non-stick cookware
  • Carpeting
  • Paint
  • Wood stain, varnish, and lacquer

In recent decades, though, researchers have noticed that the sheer ubiquity of these chemicals could pose a threat: The carbon-fluorine bond that these synthetic compounds are based on does not break down naturally, leading to PFAS being dubbed “forever chemicals.” Every piece of PFAS that is produced will continue to be a PFAS until something is done to break it down artificially, like putting the chemical into water and then superheating the water well past its boiling point.

3. PFAS Chemicals are Dangerous

It was not until relatively recently that the public learned two things about these PFAS chemicals:

  1. They had contaminated soil and groundwater across the country, and
  2. They were connected to numerous different medical conditions, including several types of cancers.

The strong chemical bond between carbon and fluorine that was fundamental to PFAS meant that, as it was used or disposed of, it would not break down. Instead, PFAS chemicals would just build up in the soil where they were dumped or would contaminate the groundwater in that soil. Eventually, PFAS chemicals found their way into drinking water and water for crops and animals. From there, it got into the food system.

It was not until the 2000s that this became apparent to the public. By then, there had been nearly 60 years of PFAS buildup.

Around this time, medical researchers also discovered that exposure to PFAS chemicals could lead to PFAS contamination in the bloodstream, which could cause a host of serious medical conditions. While research is still being done to find out what, exactly, PFAS chemicals does in the human body and which medical conditions it can cause, PFAS contamination has been linked to increased risks for:

  • Pregnancy issues, including:
    • Fetal death
    • Birth deformities
    • Hypertension
    • Preeclampsia
    • Low birth weight
    • Developmental delays in young children
  • Liver damage
  • Liver cancer
  • Testicular cancer
  • Thyroid cancer
  • Kidney cancer
  • Prostate cancer
  • Fertility problems
  • A dysfunctional immune system, including decreased effectiveness of vaccines
  • Hormonal imbalances
  • Obesity
  • High cholesterol

These are some serious medical conditions that could end up being fatal. Anyone who was exposed to PFAS chemicals, including those in AFFF, are at risk of developing them and can talk to an AFFF lawyer about filing an AFFF firefighting foam lawsuit.

4. These Cases Involve Yet Another Corporate Cover-Up

As lawsuits over PFAS exposure started to get filed in the 2000s, it quickly became clear that the large corporations who had filled our world with PFAS-heavy products had long known the risks associated with them.

PFAS manufacturer DuPont, one of the largest chemical producers on the planet, instructed its workers to only handle PFAS chemicals with extreme care as early as 1961. PFAS manufacturer 3M had discovered that the company’s PFAS chemicals were inside fish that swam in the water near one of its plants in the 1970s. In the 1980s, DuPont suddenly moved all of its female employees out of the production facility that handled PFAS chemicals – several female DuPont employees in the facility had given birth to children with serious deformities.

In spite of these warning signs, these major corporations continued to dispose of PFAS materials however they wanted to – whether that meant dumping it into the water, burying it in the ground, or burning it into the air. They also continued making new products with PFAS chemicals in them, including AFFF firefighting foam in the 1970s, which was then used by military and civilian firefighters both to put out real fuel fires and to train in putting them out. This continued for three decades, with firefighters pumping PFAS-heavy foam onto airport tarmacs and training areas on military bases across the country, deeply contaminating the soil and nearby waterways and exposing the firefighters to dangerous amounts of PFAS chemicals.

The corporate cover-up would have continued, if it were not for two things. First, in 1998, the U.S. Environmental Protection Agency (EPA) learning of an internal study at one of the major PFAS manufacturers that had found that the offspring of pregnant lab rats who had been exposed to PFAS chemicals were almost guaranteed to die within days. Second, the first class action against the PFAS manufacturer Chemours reached a temporary settlement for $71 million and funding for the C8 Science Panel to research the dangers posed by PFAS chemicals. When the Panel started to publish its findings, Chemours quickly settled the case permanently for $671 million.

5. Other PFAS Lawsuits Have Recovered Billions, and That is Just for Clean Up 

Since that first class action settled, many, many more lawsuits have been filed over PFAS contamination. These lawsuits have targeted the major corporations that have manufactured PFAS products, including:

  • 3M
  • DuPont
  • Chemours
  • BAFS

All told, these MDLs and class actions have settled for over $11 billion. There are two things about these PFAS lawsuits are important to know:

  1. They are confined to compensating for cleanup and decontamination costs, and
  2. They apply to general PFAS products, not specifically to AFFF.

This first point is crucial. The plaintiffs in these huge lawsuits have been water districts that have demanded compensation for the costs of upgrading their filtration equipment and the decontamination of their water and soil. None of the $11 billion is earmarked for the inevitable medical conditions that all of that prior PFAS contamination will cause.

6. AFFF Firefighting Foam: Class Action or MDL? AFFF Lawsuits the First to Allege Personal Injuries and Losses

Now, though, an AFFF firefighting foam MDL includes personal injury claims for medical and financial losses by victims of AFFF exposure for the first time. So you have time to file an AFFF lawsuit and join the MDL.

MDL No. 2873 consolidated hundreds of these AFFF firefighting foam cases in the U.S. District Court for South Carolina in January, 2019. This MDL covers individual victims who have suffered from one of the medical conditions associated with PFAS exposure, who need medical monitoring after being exposed to the chemicals, or who have suffered a financial loss for the diminution in the value of their property due to PFAS contamination. The cases are limited to PFAS exposure from contaminated groundwater near military bases, airports, and other industrial sites due to the use of AFFF that contain either of the two main types of PFAS chemicals used in AFFF:

  1. Perfluorooctanoic acid (PFOA)
  2. Perfluorooctane sulfonate (PFOS)

When it was first consolidated into an MDL, there were around 500 cases. Since then, it has exploded to over 9,000 claims by July, 2024, with much of the growth coming in recent months.

7. Status and Future of the AFFF MDL

MDLs like this one have become the preferred way to handle mass tort situations: Cases where the misconduct of one or a small handful of companies have led to hundreds or thousands of people suffering in similar or identical ways. By consolidating all of the cases together for pre-trial procedures, like the gathering of evidence and summary judgment motions, the cases can move forward far more efficiently than if they were all on their own.

Even though the MDL was formed over two years ago now, the AFFF litigation is still in its early stages. The defendant corporations, all of whom manufactured and sold AFFF firefighting foams, will advance numerous legal defenses to avoid accountability for their conduct or to at least mitigate the damage of a judgment or the amount of a settlement. Some of the defenses that we will likely hear are:

  • The medical condition a particular person suffered was caused by something else
  • Some other AFFF manufacturer was responsible for a particular area of contamination
  • Plaintiffs waited too long to file their claims and the statute of limitations has expired
  • The company’s version of AFFF has less PFAS chemicals in it than others

In the meantime, a growing body of medical literature is connecting PFAS exposure and contamination to serious medical issues. We may even see new medical conditions getting linked to AFFF and the toxic chemicals in it.

As evidence is gathered, settlement talks will begin. If these prove to be fruitless, the court will schedule bellwether trials. These are individual cases that are representative of the rest of the cases in the MDL that are brought through a jury trial. The outcome of those trials are then used to inform further settlement discussions, which nearly always resolve the MDL outside of the courtroom.

8. How This Will Likely End

PFAS lawsuits have been equated to the Big Tobacco Settlement, when cigarette companies settled a class action against them for huge sums. In both cases, the large corporations knew that the products that they were selling were likely to cause life-threatening medical conditions, but continued to sell them and took affirmative actions to cover up evidence that there was any risk.

In the end, though, the most important factor will be the solvency of the defendant corporations that make AFFF. Some of them are substantially larger than others and will be better able to pay the huge settlements that we are likely to see. According to mass tort lawyer Dr. Nick Oberheiden, founding partner of the national law firm Oberheiden P.C. and leading attorney on AFFF cases, “As evidence is gathered, it will become more and more clear what the defendant corporations owe. If they are not able to pay it, they are more likely to extend this MDL to the bellwether trial stage in a risky attempt to avoid settling and try to beat it, altogether. Another option that they would have in this situation is to file for bankruptcy and create a victim’s trust fund, much like asbestos companies did in order to resolve the class action against them for causing mesothelioma.”

Oberheiden P.C. © 2024
For more news on Aqueous Film Forming Foam Litigation, visit the NLR Health Law & Managed Care  section.

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.

© Polsinelli PC, Polsinelli LLP in California
For more news on Anti-Kickback Litigation, visit the NLR Health Law & Managed Care section.

APPARENTLY NOT AN INDEPENDENT CONTRACTOR: Summary Judgment Denied Because Third Party Vendor May Have Had Apparent Authority To Make Calls Without Consent

Hi TCPAWorld! The Baroness here and I have a good case today.

Dickson, v. Direct Energy, LP, et al., No. 5:18-CV-00182-JRA, 2024 WL 4416856 (N.D. Ohio Oct. 4, 2024).

Let’s dive in.

Background

In this case, the plaintiff Dickson alleges the defendant Direct Energy sent him ringless voicemails (RVMs) in 2017 without consent.

Direct Energy filed a motion for summary judgment arguing that it cannot be held liable under the TCPA because it did not directly make the calls to Dickson (a third-party vendor did) and it cannot be held vicariously liable for the calls under agency principals.

More specifically, Direct Energy argues that Total Marketing Concepts (TMC) was an independent agent and was not acting with actual or apparent authority when it violated the TCPA and Direct Energy did not ratify the illegal acts of TMC.

Law

For those of you not familiar, a motion for summary judgment is granted when there is no genuine dispute as to any material facts and the movant is entitled to judgment as a matter of law.

Under the TCPA, a seller can be held either directly or vicariously liable for violations of the TCPA.

As noted above, Direct Energy did not directly deliver any RVMs to Dickson. So it cannot be directly liable for the calls. Dickson instead seeks to hold Direct Energy vicariously liable for the acts of TMC and TMC’s subvendors.

Let’s first look at the principal/agent relationship.

Direct Energy primarily argued that TMC was NOT its agent because of the terms of their agreement. Specifically, Direct Energy identified TMC as an “independent contractor.” Moreover, TMC was “expressly instructed to send RVMs only with TCPA-compliant opt-in consent.”

Importantly, however, whether an agency relationship exists is based on an assessment of the facts of the relationship and not on how the parties define their relationship.

Listen up folks—contractual terms disclaiming agency will not cut it!

While Direct Energy and TMC did have a provision in their contract which expressly disclaimed any agency relationship, the Court highlighted that the parties entered into an amended agreement which expressly authorized TMC to (among other things) close sales on Direct Energy’s behalf and thereby bind Direct Energy in contracts with customers. In other words, Direct Energy authorized TMC to enter into agreements on its behalf.

The Court also found Direct Energy exerted a high level of control over TMC:

  • Direct Energy had the ability to audit TMC’s records to ensure compliance with its contractual obligations
  • Direct Energy could audit TMC’s subcontractors in the same manner
  • Direct Energy had access to TMC facilities to ensure compliance
  • Direct Energy had the ability to terminate the contract with or without cause
  • Direct Energy authorized TMC to telemarket on its behalf using the Direct Energy trade name as if Direct Energy was making the telemarketing call

Therefore, the Court found Dickson produced evidence which a reasonable jury could find that Direct Energy exerted such a level of control over TMC such that there was a principle/agent relationship, despite their contract expressly providing otherwise.

ACTUAL AUTHORITY

Actual authority exists when a principal explicitly grants permission to an agent to act on their behalf, whether through express or implied means.

Express authority

Pursuant to the Teleservices Agreement, TMC was responsible for complying with the TCPA. Thus, there was no evidence that TMC had express actual authority to contract individuals who had not given consent.

Implied authority

Dickson argued that Direct Energy nonetheless led TMC to reasonably believe it should make telemarketing calls that violate the TCPA. However, the Court found that TMC’s authority was expressly limited to opt-in leads. So, Dickson failed to demonstrate a genuine issue of material facts showing that TMC acted actual authority—either express or implied—when it contracted potential customers who had not opted in to receiving such calls.

APPARENT AUTHORITY

Apparent authority arises when a principal’s conduct leads a third party to reasonably believe that an agent has the authority to act on the principal’s behalf, even if such authority has not been explicitly granted.

Here’s where it gets interesting.

Dickson presented evidence that Direct Energy received several thousand complaints regarding the RVMs but did not stop the conduct.

That’s a lot of complaints..

Moreover, Direct Energy authorized TMC to use its trade name and approved the scripts. Thus, Dickson argued Direct Energy allowed third-party recipients of the RVMs to reasonably believe the RVMs were from Direct Energy.

And even though TMC used other third-party telephony services, this was expressly authorized by the agreement between Direct Energy and TMC.

Therefore, the Court found that Dickson demonstrated that Direct Energy authorized and instructed TMC to use its tradename in its RVMs, approved the scripts used by TMC, and knew or should have known of TMC’s improper conduct and that did not take action to prevent that conduct from continuing.

As such, the Court found a genuine issue of material fact existed that TMC acted with apparent authority when it contracted potential customers who had not opted in to receiving such calls.

RATIFICATION

Ratification occurs when an agent acts for the principal’s benefit and the principal does not repudiate the agent’s actions.

A plaintiff must present some evidence that a principal benefitted from the alleged unlawful conduct of its purported agent to hold the principal liable for the acts of the agent under the theory of ratification.

Here, Dickson failed to produce evidence that Direct Energy received any benefit from TMC’s unlawful telemarketing acts. For example, Dickson produced no evidence of any contracts that Direct Energy secured as a result of TMC contacting potential consumers who had not given opt-in consent. Importantly, the Court stated “[p]ure conjecture that Direct Energy must have benefitted in some way because of the volume of calls made by TMC on its behalf is simply not enough to survive summary judgment.”

Therefore, the Court found Dickson failed to demonstrate the existence of a material fact as to whether Direct Energy ratified TMC’s violations of the TCPA.

In light of the above, the Court recommended denying Direct Energy’s motion for summary judgment. Although there was no genuine issue of material fact related to actual authority and ratification, the Court determined that a genuine issue of material fact does exist concerning whether TMC acted with apparent authority.

This case highlights the complexities of agency relationships in TCPA cases and serves as a reminder for companies: mere contractual disclaimers of agency will not suffice. Courts can still hold you vicariously liable for the actions of third parties acting on your behalf! Choose the companies you are working with wisely.

© 2024 Troutman Amin, LLP
For more news on Independent Contractor TCPA Liability, visit the NLR Communications, Media, & Internet section.

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.”

Oberheiden P.C. © 2024
by: Dr. Nick Oberheiden of Oberheiden P.C.
For more news on PFAS Litigation, visit the NLR Environmental, Energy, & Resources 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

© 2024 by Tycko & Zavareei LLP

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.

©1994-2024 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.
 For more news on the Sixth Circuit NLRB Ruling, visit the NLR Labor & Employment section.

Arguing Internet Availability to Establish Copyright Infringement Is Bananas

In an unpublished opinion, the US Court of Appeals for the Eleventh Circuit affirmed a district court’s decision finding that a pro se Californian artist failed to establish that an Italian artist had reasonable opportunity to access the copyrighted work simply because it was available to view on the internet. Morford v. Cattelan, Case No. 23-12263 (11th Cir. Aug. 16, 2024) (Jordan, Pryor, Branch, JJ.) (per curiam).A plaintiff alleging copyright infringement may show factual copying by either direct or indirect evidence showing “that the defendant had access to the copyrighted work and that there are probative similarities between the allegedly infringing work and the copyrighted work.” To do so, however, the copyright owner must establish a nexus between the work and the defendant’s alleged infringement. Mere access to a work disseminated in places or settings where the defendant may have come across it is not sufficient.

Joe Morford’s Banana and Orange and Maurizio Cattelan’s Comedian both “involve the application of duct tape to a banana against a flat surface” (see images below from the court decision’s appendix). Cattelan’s Comedian went viral and sold for more than $100,000 at Miami’s Art Basel. Morford claimed that Comedian was a copy. The district court found that Morford failed to show that Cattelan had reasonable opportunity to access Banana and Orange and thus could not establish a copyright claim. Morford appealed.

Orange and Banana, Comedian

On appeal, Morford argued that because he could show striking similarity between Banana and Orange and Comedian, he was not required to proffer evidence of access to show copyright infringement. In the alternative, he argued that he could show substantial similarity and that Cattelan had reasonable opportunity to access Banana and Orange as it was widely disseminated and readily discoverable online.

The Eleventh Circuit explained that in circuits adopting a widespread dissemination standard, that standard requires showing that the work enjoyed “considerable success or publicity.” Morford showed that Banana and Orange was available on his public Facebook page for almost 10 years and featured on his YouTube channel and in a blog post, with views in more than 25 countries. But Banana and Orange’s availability on the internet, without more, was “too speculative to find a nexus” between Cattelan and Morford to satisfy the factual copying prong of a copyright infringement claim, according to the Court.

The Eleventh Circuit also found that Morford failed to meet the high burden of demonstrating that the original work and accused infringement were so strikingly similar as to establish copying. Such similarity exists if the similarity in appearance between the two works “is so great that [it] precludes the possibility of coincidence, independent creation or common source,” but identical expression does not necessarily constitute infringement. In this analysis, a court addresses the “uniqueness or complexity of the protected work as it bears on the likelihood of copying.” Morford argued that he established striking similarity based on the “same two incongruous items being chosen, grouped, and presented in the same manner within both works.” Although the two incongruous items in both works were similar (i.e., a banana and duct tape), the Court decided that there were sufficient differences between Banana and Orange and Comedian to preclude a finding of striking similarity. Banana and Orange had both a banana and an orange held by duct tape, while Comedian only contained a banana.

© 2024 McDermott Will & Emery
For more news on Copyright Infringement Litigation, visit the NLR Intellectual Property section.

Federal Circuit Weighs in on Exceptional Case Determinations in Realtime Adaptive Streaming v. Sling TV and Dish

A recent Federal Circuit decision provided some additional insight into exceptional case determinations in patent infringement disputes. In Realtime Adaptive Streaming v. Sling TV, the Federal Circuit reviewed an award of attorneys’ fees granted to DISH and related Sling entities (collectively, DISH) by the United States District Court for the District of Colorado. Realtime Adaptive Streaming LLC v. Sling TV, L.L.C. , Fed. Cir., 23-1035, vacated 8/23/24.

History of Events

On August 31, 2017, Realtime Adaptive Streaming LLC sued DISH and related Sling entities for alleged infringement of U.S. Patent Nos. 8,275,897; 8,867,610; and 8,934,535. Early in the case, the Defendants filed motions to dismiss and motions for judgment on the pleadings, asking the district court to find the asserted claims invalid under § 101. The district court denied these motions.

In October 2018, the Central District of California issued an order finding Claims 15-30 of the ‘535 patent ineligible under § 101 (Google decision). In December 2018, a magistrate judge in the District of Delaware found Claim 15 of the ‘535 patent ineligible (Netflix decision). Shortly after that, the district court stayed the infringement litigation pending IPR proceedings.

During the IPR proceedings claims 1-14 of the ‘535 patent were found to be unpatentable on obviousness grounds. Realtime then withdrew its claims under the ‘535 patent.

The district court lifted the stay on January 15, 2021. Shortly after stay was lifted the USPTO rejected claim 1 of the ‘610 patent as obvious as part of an ex parte reexamination.

In February 2021, DISH sent Realtime a letter conveying its belief the ‘610 patent was invalid and expressing its intention to seek attorneys’ fees.

On July 31, 2021, the district court granted DISH’s motion for summary judgment of invalidity, finding Claims 1, 2, 6, 8-14, 16, and 18 of the ‘610 patent directed to ineligible subject matter under § 101 and ultimately granted DISH’s Motion for Attorneys’ Fees, highlighting six “red flags” that Realtime’s case was fatally flawed.

On May 11, 2023, the Federal Circuit affirmed the district court’s order concluding that the asserted claims of the ‘610 patent are directed to ineligible subject matter under § 101. On August 23, 2024, it issued its opinion on the appeal of the attorneys’ fees award under 35 U.S.C. § 285, vacating the district court’s opinion and remanding for further consideration.

Federal Circuit’s Analysis of the District Court’s Red Flags

The Federal Circuit reviewed each of the six red flags identified by the district court:

a) Google and Netflix decisions: The Federal Circuit agreed that these decisions, which found claims of a related patent ineligible, were significant red flags.

b) Adaptive Streaming decision: The Federal Circuit found that the district court erred in treating this as a red flag, as it involved different technology and lacked sufficient analysis to show the patent infringement claim was exceptionally meritless.

c) Board’s invalidation of the ‘535 patent: The Federal Circuit found that the district court failed to adequately explain how these decisions supported a finding of exceptionality.

d) Reexamination of the ‘610 patent: The Federal Circuit found that the district court’s analysis was lacking and failed to adequately explain how these decisions supported a finding of exceptionality.

e) DISH’s notice letter: The Federal Circuit found that the letter alone was not sufficient to trigger § 285 and support an exceptionality finding.

f) Expert analysis evidence: The Federal Circuit found that the district court erred in its justification of Dr. Bovik’s opinions as a red flag.

Notice Letter Insufficient

The notice letter from DISH was not considered sufficient to trigger § 285 and support an exceptionality finding for several reasons:

  1. Limited analysis: The letter contained only two paragraphs dedicated to discussing the ineligibility of the asserted claims of the ‘610 patent. These paragraphs were described as “conspicuously short” and “riddled with conclusory statements” asserting similarities between the ‘610 patent claims and those of the ‘535 patent and the Adaptive Streaming patent.
  2. Lack of specific comparisons: The letter did not provide any further analysis or specific comparisons to support its assertions about the similarities between the patents.
  3. Insufficient notice: The court found that simply being on notice of adverse case law and the possibility that opposing counsel would pursue § 285 fees does not amount to clear notice that the ‘610 claims were invalid.
  4. Potential for abuse: The court noted that if such a notice letter were sufficient to trigger § 285, then every party would send such a letter setting forth its complaints at the early stages of litigation to ensure that—if it prevailed—it would be entitled to attorneys’ fees.
  5. Lack of follow-up: DISH did not follow up regarding its allegations after Realtime responded to the notice letter eleven days later.

The Federal Circuit concluded that without more substantive analysis or specific comparisons, the notice letter alone was not enough to put the patentee on notice that its arguments regarding ineligibility were so meritless as to amount to an exceptional case.

Conclusion

In conclusion, while the Federal Circuit agreed that some of the red flags identified by the district court were valid considerations, it found that others were not properly justified or explained. As a result, the court vacated the attorneys’ fees award and remanded the case for reconsideration consistent with its opinion.

The findings regarding the notice letter are not surprising. Patent cases may take a long time to develop and typically include an enormous amount of information. Both parties have a limited amount of information early in the case and so positions are staked out carefully. The court did not give an indication of what would be necessary to serve as adequate notice of the defects of a plaintiff’s patent assertion. It remains to be seen how the court treats the exceptional case analysis in light of the remand guidance from the Federal Circuit.

© 2024 Schwegman, Lundberg & Woessner, P.A. All Rights Reserved.
For more news on Federal Patent Litigation, visit the NLR Intellectual Property section.

Deep in the Heart of Texas: Court Blocks FTC Non-Compete Rule

On August 20, 2024, the United States District Court for the Northern District of Texas invalidated the FTC’s rule banning most non-compete agreements.  Ryan LLC et al v. Federal Trade Commission, WL 3297524 (08/20/2024). In its highly anticipated opinion, the Court determined the FTC exceeded its authority in promulgating the rule and that the rule is arbitrary and capricious.  This decision was not limited to the parties before the Court and blocks the rule from becoming effective nationwide on September 4, 2024.  As a result, existing non-compete agreements may still be valid and enforceable when permitted under applicable law.

Ryan, LLC (“Ryan”) filed its lawsuit on April 23, 2024, arguing the FTC did not have rulemaking authority under the Federal Trade Commission Act, that the rule is the product of an unconstitutional exercise of power, and that the FTC’s acts and findings were arbitrary and capricious.  Several plaintiffs, including the U.S. Chamber of Commerce, intervened in the lawsuit to challenge the rule.

In July, the Court enjoined the FTC from implementing or enforcing the rule.  That ruling, however, was limited in scope and only applied to Ryan and the intervening plaintiffs.  Shortly thereafter, all parties filed motions for summary judgment.  Plaintiffs asked the Court to invalidate the FTC’s rule, and the FTC sought dismissal under the theory it has express rulemaking authority under the FTC Act.

The Court first examined the FTC’s statutory rulemaking authority and determined the rulemaking provisions under the FTC Act do not expressly grant the FTC authority to promulgate substantive rules.  The Court reasoned that although the Act provides some rulemaking authority, that authority is limited to “housekeeping” types of rules.  The Court concluded “the text and the structure of the FTC Act reveal the FTC lacks substantive rulemaking authority with respect to unfair methods of competition…”  As a result, the Court held the FTC exceeded its statutory authority in promulgating the rule.

Next, the Court considered whether the rule and the promulgation procedure was arbitrary and capricious.  The Court was unconvinced by the studies and other evidence relied on by the FTC in promulgating the rule and found that the FTC failed to demonstrate a rational basis for imposing the rule.  The Court also noted that the FTC was required to consider less disruptive alternatives to its near complete ban on non-compete agreements.  Although the FTC argued it had “compelling justifications” to ignore potential exceptions and alternatives, the Court concluded the rule was unreasonable and the FTC failed to adequately explain alternatives to the proposed rule.  Ultimately, the Court opined the rule was based on flawed evidence, that it failed to consider the positive benefits of non-compete clauses and improperly disregarded substantial evidence supporting non-compete clauses.

As a result of this ruling, the FTC’s rule will not become effective on September 4, 2024, short of any additional orders or rulings from a higher court reversing or staying the decision.  For the time being, the existing laws governing non-compete agreements will remain in place.  In Michigan, employers may enforce non-compete agreements that are reasonable in duration, geographical area and type of employment or line of business. In Illinois, they are regulated by the Illinois Freedom to Work Act, which imposes a stricter regulatory scheme. This should come as a relief for employers who can generally avoid—at least for now—analyzing complex issues regarding the impact that the FTC’s rule would have had on executive compensation arrangements tied to compliance with non-compete agreements, especially in the tax-exempt organization context.

© 2024 Miller, Canfield, Paddock and Stone PLC

by: D. Kyle Bierlein, Brian T. Gallagher, Barry P. Kaltenbach, Brian Schwartz of Miller Canfield

For more news on the Federal Court Ruling Against the FTC’s Non-compete Rule, visit the NLR Labor & Employment section.