Episode 315 - Boeing Pays $51 Million for ITAR Violations
Illumina, Inc., a publicly-traded biotechnology company, agreed to a $9.8 million settlement with the U.S. Department of Justice (DOJ) in response to alleged violations of the False Claims Act (FCA). DOJ alleged that Illumina...more
Despite the recent downward trend in DOJ healthcare industry settlements, the first quarter of 2024 saw many noteworthy False Claims Act (FCA) and civil healthcare fraud settlements related to alleged kickbacks, medically...more
The United States notified the U.S. District Court for the Northern District of Georgia that it plans to intervene in a False Claims Act case filed against Georgia Tech Research Corporation (Georgia Tech) by its Associate...more
Fiscal year 2023 saw record recoveries and the highest number of settlements and judgments ever under the Federal False Claims Act. According to a new report released by the United States Department of Justice (“DOJ”), the...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for December 2023. We discuss several civil and criminal enforcement actions that involve alleged violations of the False...more
We always focus on foreign bribery — the FCPA and corporate bribery of foreign officials. It is certainly a problem that undermines economic development and human rights. ...more
Recently the Federal Trade Commission entered into a settlement under which Patriot LED must pay civil damages of nearly $158,000, plus a penalty of $2.96 million, for its alleged false marketing of lighting products as...more
The Federal Government continues ramping up enforcement of data security requirements by deploying significant new enforcement theories and tools in support of cyber and data security controls required by federal law....more
On February 9, 2022, the United States Department of Justice (DOJ) announced a $3.8 million settlement with Catholic Medical Center (CMC) of Manchester, New Hampshire. This settlement resolves allegations that CMC violated...more
Health care industry participants frequently operate under nuanced legal frameworks that apply to the receipt of government funds. A breach of these regulations can open the door to draconian liability under the FCA even when...more
Worth the Wait? DOJ finally released its Fraud Statistics for FY 2021 and announced the “second largest amount recorded” since 1986: FCPA Settlement and judgment exceed $5.6 billion...more
The healthcare industry faces cascading risks – one risk flows to another with compounding financial results. Three generic drug companies just experienced this cascading liability. ...more
Liability under the False Claims Act (FCA) can result in potentially enormous payouts to individuals, and sometimes to companies, who alert the government to allegations of healthcare fraud. The payouts to the whistleblower...more
The Situation: Manufacturers of allergenic extracts that are injected into a patient must obtain a Food and Drug Administration ("FDA") approved license in order to ensure their products are safe for consumption. Until the...more
On January 8, 2021, in the first appellate decision of the year addressing a False Claims Act case, the Fourth Circuit affirmed the summary judgment dismissal of relators’ claims that a manufacturer of allergenic extracts...more
Last week FDA published a proposed rule that would revise the agency’s “intended use” regulations to clarify that a manufacturer’s knowledge of off-label use of its drug or device is, by itself, not sufficient to establish a...more
Earlier this month, the California Insurance Commissioner announced that AbbVie had entered into a settlement agreement with the California Department of Insurance (CDOI) to resolve allegations that the pharmaceutical...more
In this installment of the Healthcare Enforcement Quarterly Roundup we cover several topics that have persisted over the past few years and identify new issues that will shape the scope of enforcement efforts in 2020. In this...more
On October 28, 2019 the U.S. Department of Housing and Urban Development (HUD) and the U.S. Department of Justice (DOJ) released a Memorandum of Understanding (MOU) announcing their joint approach to False Claims Act (FCA)...more
On September 17, 2019, the Third Circuit Court of Appeals issued a decision with potentially far-reaching consequences involving the Stark Act. The case, United States ex rel. Bookwalter v. UPMC, involves allegations that a...more
On Thursday, August 8, 2019, the Department of Justice (“DoJ”) announced that Danish medical device company Ambu, Inc. (“Ambu”) will pay $3.3 million to settle False Claims Act (“FCA”) allegations that it violated the Trade...more
On November 30, 2018, the Solicitor General of the United States filed a long-awaited amicus brief in response to the U.S. Supreme Court’s request for the government’s view of the False Claims Act (FCA) case U.S. ex rel....more
A United States District Court (Eastern District-Pennsylvania) (“Court”) addressed a qui tam action filed by Gary Cressman (“Cressman”) under the federal False Claims Act (“FCA”) in connection with an alleged environmental...more
Few, if any, in the medical industry are unfamiliar with the federal Anti-Kickback Statute (“AKS”). Under AKS, those giving or receiving compensation for referrals for items or services reimbursed by the federal healthcare...more