What do a patent dispute over a CRISPR/Cas system, a rejected whistleblower case involving lab tests and a vaccine injury claim parading as multidistrict tort litigation have in common? All three were denied cert in the U.S. Supreme Court’s latest orders list.
Even though case law has established that 340B-covered providers can’t sue drug companies for overcharging on the steeply discounted drugs, the Adventist Health System of West tried a new door into court – as a whistleblower under the False Claims Act.
The U.S. Department of Justice said recoveries under the False Claims Act in fiscal year 2025 reached a record of more than $6.8 billion, more than 80% of which came from health care cases.
Much has been made of the recent skyrocketing of Medicare spending on skin substitutes, but a new enforcement action by the U.S. Department of Justice might help to explain some of those spending increases.
Aesculap Implant Systems LLC has seen its share of bad news recently, but the company seems to have cleared the legal deck with an agreement to pay $38.5 million per a Nov. 17 announcement by the U.S. attorney’s office for the district of Eastern Pennsylvania.
Exactech Inc., of Gainesville, Fla., decided it will not subject itself to a 10-year corporate integrity agreement with the Office of Inspector General, an understandable move given that the company no longer intends to do business in the U.S. under its old brand.
Bard Peripheral Vascular Inc., agreed to pay $7.2 million to settle allegations that two photoplethysmography products it distributed were the subject of illicit Medicare claims, a problem the company inherited when it decided to do business with Semler Scientific Inc. of Campbell, Calif.
The U.S. Department of Justice announced July 31 that Illumina Inc. agreed to pay $9.8 million to settle allegations it sold genomic sequencing equipment that suffered from cybersecurity problems. The settlement concludes a qui tam lawsuit filed by a former employee and highlights the hazards of poor cybersecurity for med-tech firms.
Janssen Pharmaceutical’s loss in a False Claims Act (FCA) case for the company’s HIV treatments resulted in judgments of roughly $1.6 billion – an outcome the company appealed to the Court of Appeals for the Third Circuit.
The U.S. False Claims Act (FCA) is not the only statute governing the submission of false claims to federal agencies thanks to the more than 30 states with their own versions of the FCA. However, the federal government is providing states with more incentives to amplify their FCA-related activities, a development that raises the stakes for companies in the life sciences.
