Episode 315 - Boeing Pays $51 Million for ITAR Violations
On May 8, the Superior Court of Arizona in Maricopa County ordered a health care company to pay more than $30 million in restitution to the Arizona Health Care Cost Containment System (AHCCCS) due to the company’s alleged...more
State attorneys general (AGs) continue to play a pivotal role as innovators, shaping the regulatory environment by leveraging their expertise and resources to influence policy and practice. The public-facing nature of AG...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
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
On December 8, 2023, New York Attorney General Leticia James penned her approval to an Assurance of Discontinuance with third party dental administrator Healthplex, settling the enforcement action for $400,000 and a litany of...more
Joining every other circuit to address the same issue, the U.S. Court of Appeals for the Eleventh Circuit recently ruled that a consumer does not have to prove actual damages to recover statutory damages for willful...more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...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
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
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
HIPAA penalties vary depending on the type of conduct involved. (45 CFR § 160.404). Under HHS’s prior interpretation, the types of violations were all subject to an annual maximum penalty of $1,500,000 for identical types of...more
We have previously reported on the ongoing cybersecurity issues with St. Jude defibrillators [view related posts here, here, and here]. On June 29, 2018, the Food and Drug Administration (FDA) classified the required firmware...more