The Presumption of Innocence Podcast: Episode 45 - The Grit, Grace and Gift of Second Chances
The Justice Insiders Podcast - The Ever-Expanding Net: Corporate Compliance in an Era of Increasing Trade Sanctions and Restrictions
False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Episode 333 -- The Boeing Proposed Plea Agreement
DOJ’s New Self-Disclosure Policy and Corporate Whistleblower Awards Pilot Program
False Claims Act Insights - Assessing the Fallout from a Thermonuclear FCA Verdict
FCPA Survival Guide - Step 8 - Investing in Compliance
Exploring the AI and Crypto Intersection
The Justice Insiders Podcast: Jarkesy’s Implications for the Administrative State
The Presumption of Innocence Podcast: Episode 41 - The Dynamics of Decision-Making: Psychology and the Criminal Justice System
INTERPOL and Child Kidnapping Cases. What are INTERPOL’s Abilities and Limitations?
False Claims Act Insights - Eureka! Government Investigators Seek Out Research Misconduct
The Justice Insiders Podcast - AI-Washing: Everything Old Is New Again
The CFPB and State AGs Act Jointly Against Online Educational Company
Will the U.S. Have a GDPR? With Rachael Ormiston of Osano
Episode 328 -- Sanctions Enforcement Risks and Redlines
FCPA Survival Guide: Step 3 - Extensive Remediation
Episode 324 -- Third-Party Risks and Sanctions Compliance
Compliance Tip of the Day – Compliance Lessons from the Albemarle FCPA Enforcement Action
The Presumption of Innocence Podcast: Episode 38 - A Blueprint for Compliance: The Fraud Pentagon Theory
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more
In June 2021, Philips notified the ANSM of a field safety action that related to the potential risk of degradation and inhalation of carcinogenic compounds from the sound-absorbing foam used in its ventilation devices for...more
Earlier this year, the US Center for Disease Control and Prevention (“CDC”) spotted an outbreak of a rare bacterial infection in 11 (now 16) different states, associated with multiple different infection types, particularly...more
As 2022 came to a close, the U.S. Consumer Product Safety Commission (CPSC) had one last order of business. On December 28, 2022, the CPSC provisionally accepted a settlement agreement with Peloton Interactive, Inc....more
On May 16, President Biden signed the Safe Sleep for Babies Act into law, less than two weeks after being passed by Congress. The Act addresses the controversy around inclined sleepers and crib bumpers for infants by banning...more
Manufacturer Has Ceased Sales and Issued Urgent Letter Warning Physicians to “Stop Using” Unused Implants - Medtronic, the manufacturer of a medical implant that is alleged to have led to more than a dozen deaths,...more
Three recent settlements demonstrate the U.S. Department of Justice’s (DOJ’s) continued scrutiny of product quality and manufacturing issues in the medical device industry. Using the civil False Claims Act (FCA) and the...more
Alere, Inc. and its San Diego subsidiary, agreed to pay $38.75 million to resolve False Claims Act charges for billing the Medicare program for defective rapid point-of-care testing devices. ...more
In early January, after referral by the CPSC to the Department of Justice (and probably the subject of an Acting Chair Adler public comment), fire extinguisher manufacturer Kidde reached a settlement with the government to...more
Health care fraud continues to be a top enforcement priority for U.S. prosecutors, and nowhere is this more true than for the medical technology sector. From 2014-2019, the U.S. Department of Justice (DOJ) brought enforcement...more
Recent FDA Recall Highlights & Developments - • The agency finalized Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Guidance for Industry and FDA Staff, providing recommendations regarding the...more
CBS isn’t the only large company with insider trading worries. In complaints made public yesterday, the SEC has accused Gene Levoff, Apple’s former senior director of corporate law and corporate secretary, of “repeatedly”...more
On Friday, October 5, 2018, the U.S. Consumer Product Safety Commission (“CPSC”) announced that Costco Wholesale, Corp. (Costco) entered into a settlement agreement with the CPSC to pay a $3.85 million civil penalty for its...more
Product recalls are critical events for firms that produce food and medical products. The lives and health of patients and consumers can be at stake. Companies risk enforcement action by the Food and Drug Administration...more
The U.S. Consumer Product Safety Commission (CPSC) is set to announce yet another civil penalty settlement. Sunbeam Products d/b/a Jarden Consumer Solutions (Sunbeam or the Company) has agreed to pay a $4.5 million civil...more
"Wherefore Art Thou Due Process?" Part III - Why it matters: It is time for another installment in our continuing "Wherefore Art Thou Due Process?" coverage into the ongoing constitutional challenges to the SEC's...more
At the very beginning of this year, we wrote that we expected the CPSC to remain active in bringing enforcement actions against companies for violations of the Consumer Product Safety Act (CPSA). About one month later, CPSC...more
The U.S. Consumer Product Safety Commission continues to escalate its enforcement efforts. Recently, the U.S. Department of Justice, on behalf of the CPSC, filed suit against Spectrum Brands Inc. See United States v. Spectrum...more
The United States Consumer Product Safety Commission (CPSC) continues to escalate its enforcement efforts. Last week, the United States Department of Justice, on behalf of CPSC, filed suit against Spectrum Brands, Inc....more