On April 13, the Federal Trade Commission (“FTC” or “Commission”) issued a press release that it had sent letters to “almost 700 marketing companies that they could face civil penalties if they can’t back up their product claims.” FTC indicates that the notices were sent to companies …
On April 18, the Supreme Court will hear oral argument in two consolidated cases that present the question of whether a defendant can “knowingly” submit a false claim under the Federal False Claims Act when the alleged falsity is based on an objectively reasonable legal …
Earlier this year, we posted on the still unsettled state of the law regarding whether “FDCA violations may, in certain circumstances, be material to the government’s decision whether to pay for the affected product, and thus relevant in an FCA case.” In particular, we noted …
In a recent JAMA editorial (unfortunately behind a paywall), three authors called for increased use of the Park Responsible Corporate Officer doctrine, under which senior level officials at a company can be held liable under a strict liability theory even if they were not involved …
In a speech last week, Deputy Attorney General Lisa Monaco touched on a number of topics that should interest readers of this blog. First, although the topic of her speech was corporate criminal enforcement, DAG Monaco stressed that DOJ’s “number one priority is individual accountability.” …
It may be just a coincidence that DOJ released its latest policy pronouncement at the same time as the final “Daniel Craig as James Bond” movie. But like James Bond, companies in the crosshairs of a government investigation have No Time to Die, as they …
The adage that “no one is perfect” applies as equally to companies as it does to people. Before committing to a merger or acquisition with another company, a potential Buyer must conduct due diligence to identify the imperfections of a target company so the Buyer …
Companies often use rebranding to reposition and refocus their business. Sometimes they do it with great fanfare; sometimes it is done quietly and incrementally. The federal government does its own version of rebranding with each change in administration. Just before the July 4 holiday weekend, …
It is a well-accepted fact that even well run ethical and compliant organizations can have serious problems. The Sentencing Guidelines, the DOJ Manual, and the HHHS OIG–among others–all recognize that reality. In its Compliance Guidance for Pharmaceutical Manufacturers, the HHS OIG notes: The OIG recognizes that …
As has been widely covered in local and national press in and around the Washington, DC area, this month marks the once every seventeen year emergence of the Brood X cicadas. These insects are so plentiful in local areas with trees, including FDA’s aptly named …
Earlier this month, the Department of Justice announced another settlement in a Medicaid Rebate False Claims Act (FCA) case. In this case, United States ex rel. Streck v. Bristol-Myers Squibb Co., Civil Action No. 2:13-CV-7547 (E.D. Pa) Bristol Myers Squibb (BMS) agreed to pay $75 …
On December 19, 2019, the Federal Trade Commission (“FTC” or the “Agency”) filed a petition for writ of certiorari in the Supreme Court seeking review of a ruling by the Seventh Circuit case FTC v. Credit Bureau Center, LLC. A detailed overview of the background …
In the August 21 split panel decision issued in Federal Trade Commission v. Credit Bureau Center LLC, the Seventh Circuit held that section 13(b) of the Federal Trade Commission Act (“FTCA”), 15 U.S.C. § 53(b), does not authorize an award of restitution. In overturning its …
Hi-Tech Pharmaceuticals, Inc. (Hi-Tech) and its President and Chief Operating Officer filed suit in the U.S. District Court for the District of Columbia to enjoin FDA from continuing to seek removal of DMHA products from commerce through the issuance of warning letters and “pressure… to …
We have long posted about the government’s threats to hold individuals liable for actions taken on behalf of their companies, for example here, but these actions remain rare and typically are reserved for egregious, repeated, and intentional criminality. A recent indictment against two former executives, …
