What to Do if Your Suppliers Are in Distress - Is It Time to Find a New Supplier?
What to Do if Your Suppliers Are in Distress - Candid Conversations with Suppliers in Distress
What to Do if Your Suppliers Are in Distress - Identifying Suppliers in Distress
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
WorldSmart: The Move to Mexico— Why Companies are Setting Sights on Mexico Post COVID
Proposition 65 – Changes That Will Impact the Cannabis Sector
MLM Defense: FTC Earnings Claims and Nonsolicitation Clauses
Supply Chain Disruptions with Special Guest Chris Mills, CEO of Lion Brand Yarn
Law Brief®: Mark Rosenberg and Richard Schoenstein Discuss Online Distribution Leakage
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Business Divorces in the Food and Supplements Space
Nota Bene Episode 135: Europe Q3 Check In: Brexit, Data Protection, and Block Exemption Regulations with Oliver Heinisch
Texas House Passes Pandemic Liability Protection Act
Cannabis Counsel Cast: What Cannabis Companies Need to Know About California’s Prop. 65 (Even if They Aren’t in California)
From Farm to Shelf – COVID’s Impact on Global Supply Chains
Protecting Trade Secrets When Facing Lawsuits or Alternative Dispute Resolution Procedures
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under the Hood
RCG Webinar | Where's the Beef?
Lowndes Client Corner Podcast Episode 1 - DraftLine Technologies, The Business of Beer
Protecting Trade Secrets During Business Collaboration
The Seventh Circuit Court of Appeals recently affirmed a district court’s dismissal of two claims brought by distributors against the medical-device manufacturer Zimmer Biomet. It also affirmed a jury verdict in favor of the...more
This month, our appellate team comprised of Gerry Fornwald, Kyle Kroll, and Cianna Halloran prevailed at the Third Circuit Court of Appeals in obtaining victory for our client, an American distributor. The case involved a...more
In Short - The Situation: The EU Product Liability Directive 85/374/EEC ("PLD") was adopted nearly 40 years ago and has remained almost unchanged since its inception....more
On February 27, 2023, a jury in Minnesota federal court rendered a verdict in favor of the United States and against a surgical product distributor following a False Claims Act jury trial that lasted six weeks. The jury...more
The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued an Advisory Opinion on April 20, 2022, regarding physician ownership in a medical device company. The Advisory Opinion is significant...more
In August 2021, the MDCG issued guidance MDCG 2021-23 for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. The...more
AGG is proud to introduce our newest podcast series titled “I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues.” Each month, we will release a new podcast where different members of our Food and Drug practice...more
Immunity under the Public Readiness and Emergency Preparedness (“PREP”) Act is a moving target for government contractors and other companies manufacturing or distributing personal protective equipment (PPE) in the COVID-19...more
As part of the U.S. government’s response to the COVID-19 pandemic, on March 10, 2020, the Secretary of Health and Human Services (“Secretary”) issued a Declaration pursuant to the Public Readiness and Emergency Preparedness...more
On March 18, 2020, the President signed into law the Families First Coronavirus Response Act, H.R. 6201, Pub. L. No. 116-127 (the “Coronavirus Response Act”). Among other measures in response to the current pandemic, this...more
Since our 2018 year-end post on the busy FDA regulatory agenda, we are nearing the halfway mark of the “grace period” the Agency has extended for certain regenerative medicine product developers to come into compliance by...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
The Situation: In a recent decision, the French Supreme Court clarified the surveillance obligations of notified bodies—independent entities accredited by an EU Member State's national health authority to determine whether a...more
On May 7, 2018, the OIG issued a favorable advisory opinion, No. 18-02, regarding an arrangement that would allow a medical device distributor (Requestor) to provide free sample ostomy products to federal health care program...more
On April 26, 2018, the French administrative Supreme Court (Conseil d'Etat) issued a ruling that annulled Decree 2016-1716 of December 13, 2016 ("2016 Decree") related to the summary of characteristics for medical devices....more
The Irish Health Products Regulatory Authority (HPRA) has published a Guide for Distributors of Medical Devices (“Guide”) in which the HPRA provides useful recommendations concerning the obligations that must be met by...more
On 22 January 2018, the European Commission released a notice to stakeholders concerning the United Kingdom’s (“UK”) possible withdrawal from the European Union (“EU”) and the EU rules in the field of industrial products,...more
Intellirod Spine LLC is, according to its website, a medical device company developing wireless sensing technologies for use in spinal care. According to Orthopedic Design and Technology, Loadpro is the company’s forthcoming...more
Recently, the U.S. Food and Drug Administration (FDA) has issued a flurry of guidance and draft guidance in an effort to better define the types of products that the FDA will choose to actively regulate. In one of these...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
The common industry practice of compensating independent contractor sales representatives on a "percentage of sales" commission basis may be creating an enhanced risk of False Claims Act liability for illegal kickbacks in...more
On July 16, 2013, the U.S. Department of Justice (DOJ) indicted Michael Baker and Michael Gluk, the former CEO and CFO, respectively, of ArthroCare Corp. – a Texas-based publicly traded surgical device company. Baker and...more