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The Briefing: Are LEGO Creations Based on Religious Texts Eligible for Copyright Protection?
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The Labor Law Insider: Union Activity, Employment Engagement, and Changes in the Manufacturing Industry
WorldSmart: The Move to Mexico— Why Companies are Setting Sights on Mexico Post COVID
Proposition 65 – Changes That Will Impact the Cannabis Sector
Five Questions, Five Answers: Driving the I-75 with Rick Walker of GAMA Georgia
Medical Device Manufacturer THD Pays $700,000 to Resolve FCA Allegations - On September 6, the US Attorney’s Office for the District of Maryland announced that THD America, Inc., and its parent company, THD SpA of Italy,...more
On May 29, 2024, the U.S. Department of Health and Human Services’ Office of Inspector General (HHS OIG) announced a $12 million settlement with Innovasis Inc., a medical device manufacturer, and two of its senior executives...more
There are many junctures in the U.S. healthcare system that enable fraudulent activities, and one of the biggest has to do with pharmaceutical companies. The U.S. Food and Drug Administration (FDA) and the Department of...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for August 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more
On February 7, the Department of Justice (DOJ) issued a press release indicating that settlements and judgments under the False Claims Act (FCA) exceeded $2.2 billion in the fiscal year ending September 30, 2022. Of this...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more
On February 7, 2023, the Department of Justice (DOJ) announced its annual False Claims Act (FCA) recoveries for fiscal year 2022. DOJ recovered $2.2 billion from a total of 351 settlements and judgments—the second-highest...more
The medical product and healthcare service industry is one of the most closely regulated sectors in the U.S. Several agencies actively exercise authority with constantly changing legislation and policies to keep pace with...more
On January 4, 2023, the Department of Justice issued a press release stating that Jet Medical Inc. has agreed to pay $200,000 to resolve criminal allegations relating to a migraine headache treatment. Jet Medical and two...more
The third quarter of 2022 brought a number of noteworthy False Claims Act (FCA) settlements, including several over $20 million and one in the high nine figures. This post summarizes key settlements of interest to healthcare...more
The United States’ recent False Claims Act (“FCA”) prosecution in United States v. Prometheus Group, et al., is a reminder that the government will use the FCA to target medical device manufacturers for off-label use of...more
After years of government skepticism and enforcement activity targeting physician-owned medical device companies, a recent favorable advisory opinion by the Office of Inspector General for the U.S. Department of Health &...more
Last month, we had an engaging Fast Break session covering compliance topics regarding healthcare professionals’ relationships with pharmaceutical and medical device manufacturers. We were joined by Terrence Burek, senior...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
On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, marking the end of an effort FDA began in 2015. While the...more
St. Jude Medical Inc. (“St. Jude”), which was acquired by Abbott Laboratories in 2017, entered into a settlement last week with the United States Department of Justice (“DOJ”) for $27 million to resolve allegations it had...more
Senior DOJ Official Michael Granston Discusses COVID Relief Enforcement, Granston Memo, and other FCA Issues - Michael Granston, the Deputy Assistant Attorney General of the DOJ Civil Division, sat down this week with Jody...more
On October 29, 2020, the U.S. Department of Justice (“DOJ”) announced a unique False Claims Act (“FCA”) settlement with medical device manufacturer Medtronic USA Inc. (“Medtronic”) for $9.2 million to resolve allegations...more
A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more
In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more
The lure of significant monetary awards continues to stimulate high-risk whistleblower actions under the False Claims Act (FCA), and these claims are increasingly common in the pharmaceutical and medical device industry. The...more
The Department of Justice (DOJ) recently announced that ev3 Inc. (which acquired Fox Hollow Technologies, Inc. (“Fox Hollow”), a medical device manufacturer, in late 2007) agreed to pay $1.25 million to resolve allegations...more
The United States Court of Appeals for the District of Columbia Circuit recently upheld a District Court's dismissal of a False Claims Act (FCA) complaint against a federal government contractor in a case that will be of...more
In This Issue: - Export-Import Bank Is Reauthorized Through June 2015 - Roadblocks to Bali Package Implementation Remain As Summer Deadline Passes Without A Clear Path Forward - Customs Litigation: Federal...more
Last week, a New Jersey federal court allowed medical device maker Boston Scientific Neuromodulation Corp. (“Boston Scientific”) to proceed with counterclaims against two of its former employees for violating their contracts...more