Insights

On June 9, 2025, U.S. Department of Justice (“DOJ”) Deputy Attorney General Todd Blanche issued new Foreign Corrupt Practices Act (“FCPA”) enforcement guidelines (“the Guidelines”). DOJ issued the Guidelines in response to the Trump Administration’s February 2025 Executive Order (“EO”), which paused FCPA enforcement pending the issuance of new guidance from the Attorney General. The new Guidelines resolve lingering doubts about the future of FCPA enforcement under the Trump administration and provide important insights into the key factors DOJ will consider when deciding whether to pursue FCPA investigations or enforcement actions.

On June 5, 2025, the Supreme Court dismissed on procedural grounds the petition for writ of certiorari in Laboratory Corporation of America Holdings, dba Labcorp, v. Luke Davis, et al., No. 22-55873. The Supreme Court had granted the petition on the following question: “[w]hether a federal court may certify a class action pursuant to Federal Rule of Civil Procedure 23(b)(3) when some members of the proposed class lack any Article III injury.” Justice Kavanaugh, writing in dissent, said he would have reached the merits and ruled that federal courts may not certify a damages class that includes uninjured members.

The Supreme Court last week blessed a broad reading of the federal wire fraud statute, resolving a circuit split over whether economic loss is an element of fraudulent inducement and bolstering the Government’s future enforcement of procurement fraud. In Kousisis et al. v. United States (unanimous in judgment), the Court upheld the conviction of a government contractor for falsely representing compliance with disadvantaged business enterprise (DBE) requirements in contracts awarded by the Pennsylvania Department of Transportation (PennDOT), despite completing the contracts to PennDOT’s satisfaction. The Court held that a material misrepresentation used to deceive someone into parting with money or property is sufficient for a federal wire fraud conviction, regardless of whether the victim suffered any economic loss.

On May 12, 2025, President Trump issued an Executive Order titled "Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients," which aims to reduce the costs of prescription drugs and biologics for American consumers and other payers. This Order revives a plan from President Trump’s first term and follows his April Executive Order, “Lowering Drug Prices by Once Again Putting Americans First,” which also sought to reduce drug prices. With drug prices in the United States nearly three times higher than many other countries, this second Order asks drug manufacturers to adopt Most-Favored-Nation (MFN) pricing for drugs sold in the United States or face potential regulation. MFN pricing would tether drug prices offered in the United States to the lower-cost prices offered in other comparably developed nations, such as Canada, Germany, or the United Kingdom.

In a May 12, 2025 speech that signaled both a recalibration of and recommitment to prosecuting white-collar crime, Matthew R. Galeotti, the newly appointed Head of the Department of Justice’s Criminal Division, said that the Division is “turning a new page” and embracing an enforcement approach that aims to elevate efficiency, predictability, and fairness. The changes he outlined aim to incentivize self-reporting, narrow corporate monitorships, and refocus whistleblowers.

On April 29, 2025, the Supreme Court heard oral argument in Laboratory Corporation of America Holdings, dba Labcorp, v. Luke Davis, et al., No. 22-55873. The Supreme Court had granted a petition for writ of certiorari in the case as to the following question: “[w]hether a federal court may certify a class action pursuant to Federal Rule of Civil Procedure 23(b)(3) when some members of the proposed class lack any Article III injury.” The Justices focused much of the oral argument on whether the case was moot, suggesting they may not reach the merits. And when soliciting argument on the merits, the Court appeared divided as to how to answer the question.

In Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., C.A. No. 20-1630 (D. Del.), brand manufacturer Amarin brought an induced infringement claim against Hikma’s generic icosapent ethyl product, which lists Amarin’s Vascepa® as the reference listed drug. Vascepa was originally approved by the U.S. Food and Drug Administration (“FDA”) to treat severe hypertriglyceridemia, and later, Amarin obtained patents and approval for Vascepa as a treatment to reduce cardiovascular risk in certain patient populations. Hikma’s Abbreviated New Drug Application (“ANDA”) for generic icosapent ethyl included a Section viii statement that Hikma was not seeking approval for the patented cardiovascular indication along with a “skinny label” that included only the indication for severe hypertriglyceridemia.

In its first healthcare proposed regulation, the Trump Administration, through the Centers for Medicare & Medicaid Services (CMS), displayed on March 10, 2025, a proposed rule titled, “2025 Marketplace Integrity and Affordability Proposed Rule” (the Proposed Rule), which proposes policy changes for the Health Insurance Marketplaces that impact health plans and insurers offering Affordable Care Act (ACA) coverage to consumers. Specifically, the Proposed Rule shortens the Annual Open Enrollment Period (OEP) for all individual market coverage; proposes standards related to income verification for Health Insurance Marketplaces (Marketplaces); modifies eligibility redetermination procedures; and eliminates eligibility for “Deferred Action for Childhood Arrivals” (DACA) recipients, among other provisions.  

On March 26, 2025, the Department of Justice (DOJ) announced that defense contractor MORSECORP Inc. (MORSE) will pay $4.6 million to settle allegations that MORSE violated the False Claims Act (FCA) by failing to comply with cybersecurity requirements and subsequently submitting false or fraudulent claims for payment in its contracts with the Departments of the Army and Air Force. This is the first FCA settlement that is based on a defense contractor’s failure to reevaluate and promptly update its self-assessment score in the Supplier Performance Risk System (SPRS) after a third-party assessment resulted in a lower score.

On March 12, 2025, the Government of Canada announced plans to launch the Canadian Program for Cyber Security Certification (CPCSC). CPCSC is a cybersecurity compliance verification program that aims to protect sensitive unclassified government information handled by Canadian government contractors and subcontractors within Canada’s defense sector. Canada will roll out CPCSC to contractors in four phases, with the first phase launching this month.

On December 20, 2024, the Federal Circuit affirmed a district court’s holding that five device patents had been improperly listed in the Orange Book by Teva Pharmaceuticals, Inc. as claiming a drug, and ordering that they be delisted.

On October 11, 2024, the Department of Defense (DoD) released a final rule (the “Final Program Rule”) formalizing the requirements, assessment processes, and related governance for its Cyber Maturity Model Certification Program (CMMC).[1] 

On September 10, 2024, the U.S. Securities and Exchange Commission (the “SEC”) announced a settlement with Keurig Dr Pepper Inc (“Keurig”).  The SEC alleged that Keurig made incomplete and inaccurate statements in the Company’s annual reports for fiscal years 2019 and 2020 touting the recyclability of its K-Cup products. Keurig agreed to pay a $1.5 million civil penalty. 

The Securities and Exchange Commission (SEC) has reportedly recently dissolved its Climate and ESG Enforcement Task Force (the Task Force). The Task Force was part of SEC Chair Gary Gensler’s broader push to increase investors’ access to environmental, social, and governance (“ESG”) information about public companies and registered investment companies. The dissolution of the Climate and ESG Enforcement Task Force comes after three years marked by industry resistance and a mixed record in the courts. Prior to the Task Force’s dissolution, the agency removed ESG from its annual Examination Priorities Report, which provides areas of particular focus during SEC examinations. While the Task Force has been dissolved, the SEC is still pursuing a number of its proposed ESG and climate-related rules.

The Texas Supreme Court recently released its decision in In re Dallas County, affirming the constitutionality of the newly-created Fifteenth Court of Appeals. The Fifteenth will be a statewide court of appeals with jurisdiction over Texas’s new business court for disputes valued over $10 million and appeals where the State or a State agency or university is a named party.

On June 17, 2024, the Department of Justice (DOJ) announced a $11.3 million False Claims Act (FCA) settlement that touches on two key enforcement priorities:  the DOJ’s Civil Cyber-Fraud Initiative and pandemic-related fraud.  This settlement, the largest under the Civil Cyber-Fraud Initiative to date, resolved allegations that Guidehouse Inc. (Guidehouse) and its subcontractor, Nan McKay and Associates (Nan McKay), violated the FCA because they failed to conduct pre‑production cybersecurity testing on New York State’s Emergency Rental Assistance Program (ERAP) technology product before public launch, and that Guidehouse used an unapproved third-party data cloud software program to store personally identifiable information (PII).

On May 22, 2024, the U.S. Department of Justice’s National Security Division (NSD) announced its first declination to prosecute a company under its Enforcement Policy for Business Organizations (Enforcement Policy).

The Food and Drug Administration (FDA) has published revised draft guidelines in the Federal Register on promotional labeling and advertising considerations for the biologic and biosimilar industry, updating guidance from 2020. The quick revisions emphasize the fast-changing and rapidly growing nature of this industry.

On May 1, 2024, the Department of Justice (DOJ) announced that Insight Global LLC (Insight), an international staffing and services company, will pay $2.7 million to resolve allegations that it violated the False Claims Act (FCA) by failing to implement adequate cybersecurity measures to protect personal health information (PHI) and personally identifiable information (PII) under its contracts with the Pennsylvania Department of Health (PADOH) to provide staffing for COVID-19 contact tracing services.  Although contracts with state agencies generally fall outside the FCA’s ambit, PADOH paid Insight using funds received from the federal Centers for Disease Control and Prevention (CDC)—bringing the contract within the FCA’s scope. 

As reported in an earlier Client Alert, on November 7, 2023, the Federal Trade Commission challenged 100 patents as improperly listed in the Food and Drug Administration’s “Approved Drug Products with Therapeutic Equivalence Evaluations” publication, commonly known as the Orange Book. The FTC sent warning letters to ten drug and medical device manufacturers identifying patents for inhalers, autoinjectors and anti-inflammatory multi-dose bottles that the FTC believes are improperly listed. In the letters, the FTC indicated it is using the FDA’s regulatory dispute process to challenge the listing of these patents in the Orange Book because improperly listed patents may violate antitrust laws and impede competition.