Alerts

Welcome to the Summer 2025 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.

On June 9, Deputy US Attorney General Todd Blanche issued a memorandum outlining new guidelines for the enforcement of the Foreign Corrupt Practices Act (FCPA).

A recent decision from the US District Court for the Eastern District of New York has significant implications for providers navigating the No Surprises Act (NSA) independent dispute resolution (IDR) process.

In its recent In re Floyd opinion, the US Court of Appeals for the Federal Circuit upheld a decision by Patent Trial and Appeal Board (PTAB) to reject a design applicant’s priority claim to an earlier utility filing for failing to adequately support the claimed design.

Health care organizations are under pressure to shore up their cybersecurity response efforts. Much of this pressure is coming from the US Department of Health and Human Services Office for Civil Rights (OCR), which has made clear through recent enforcement actions that conducting a proper risk assessment under the Health Insurance Portability and Accountability Act (HIPAA) Security Rule is not optional.

It seems like every few months I hear about a situation where a company can’t enforce a forum selection clause as anticipated because of how it was drafted. Recently, an individual named Sidharth Lakhani fell victim to this conundrum when he sought to enforce a forum selection clause that appeared to require all litigation to be brought in the state of New Jersey.

The Robinson-Patman Act (RPA) has been generating a lot of buzz, with private lawsuits and high-profile moves by the Federal Trade Commission (FTC). But two developments last month may signal that the RPA may be slipping back into relative hibernation.

In Ames v. Ohio Department of Youth Services, No. 23-1039 (S. Ct. June 5, 2025), the US Supreme Court unanimously dispelled the concept of “reverse” discrimination, making clear that discrimination on the basis of a protected characteristic is unlawful “discrimination,” no matter the identity of who engaged in the discrimination or which workers were harmed or benefited.

On June 4, President Trump issued a proclamation that fully bans entry into the United States for certain foreign nationals from 12 countries, and partially banning entry from seven more.

Life Sciences Partner Stephanie Trunk and Life Sciences Regulatory and Compliance Attorney Darshan Kulkarni delve into the nuances of direct-to-patient (DTP) and direct-to-consumer (DTC) models in the pharmaceutical industry.

Headlines that Matter for Companies and Executives in Regulated Industries

At a critical stage of the Trump Administration’s aggressive global trade reset, a federal court has struck down a major statutory pylon of the White House trade strategy, potentially depriving President Trump of the most flexible weapon in his trade arsenal and scrambling the calculus for many of the pending negotiations with US trading partners.

On May 27, Blue Cross Blue Shield Healthcare Plan of Georgia, Inc. (BCBSGA) filed a lawsuit in the Northern District of Georgia US District Court, alleging that a group of health care providers, along with their third-party billing agent, manipulated the federal No Surprises Act’s (NSA) independent dispute resolution (IDR) process.

On April 30, the US Food and Drug Administration (FDA), approved the use of a gene-edited pig to confer resistance to Porcine Reproductive and Respiratory Syndrome (PRRS), a devastating swine disease.

The European Union (EU) Intellectual Property Office (EUIPO) has refused to register Thom Browne’s position trademark consisting of four horizontal white stripes placed on the upper left sleeve of garments.

The US Court of Appeals for the Federal Circuit recently affirmed a summary judgment of no design patent infringement in North Star Tech. Int’l Ltd. v. Latham Pool Products, Inc., ruling that the patented and accused pool designs were “plainly dissimilar” despite sharing structural similarities formed by geometric shapes and angular edges common in preexisting pool designs.

On May 12, the Federal Trade Commission’s (FTC) Rule on Unfair or Deceptive Fees took effect. Often referred to as the “Junk Fees Rule,” the Rule targets hidden, misleading, and deceptive charges and fees imposed by live-event ticketing and short-term lodging businesses.

On May 23, the US Department of the Treasury’s Office of Foreign Assets Control (OFAC) issued Syria General License (GL) 25, “Authorizing Transactions Prohibited by the Syrian Sanctions Regulations or Involving Certain Blocked Persons,” following President Trump’s May 13 announcement.

The Make America Healthy Again (MAHA) Commission, chaired by US Health and Human Services Secretary Robert F. Kennedy Jr., has released its long-anticipated report on childhood chronic disease drivers. Although the document is only an assessment and expressly contains no binding policy recommendations, it signals the contours of a federal strategy that officials will draft within 100 days.

On May 22, the US House of Representatives passed H.R. 1, the “One Big Beautiful Bill Act.” This alert highlights the provisions in the Bill that could impact tax-exempt organizations.

Headlines that Matter for Companies and Executives in Regulated Industries

On May 28, a three-judge panel on the US Court of International Trade (CIT) issued a landmark ruling in V.O.S. Selections, Inc. et al. v. United States of America et al. and The State of Oregon et al. v. United States Department of Homeland Security et al.

“Energy security,” the principle that when you flip a light switch the lights will turn on, is something that most Americans take for granted. But the mechanics behind it incorporate both century-old transmission towers and the latest in renewable energy technology.

They say, “timing is everything.” This podcast comes to our listeners as Washington, DC, contemplates next moves on the US tariff front, including new tariffs on products key to the e-mobility sector.

Welcome to “Beyond the Lot,” a podcast series hosted by Kevin Timson that invites industry experts to weigh in on trends and auto retail business topics.