Companies that buy other companies know perfectly well that they may acquire a few headaches in the process, but recent enforcement trends are making the acquiring companies more careful about acquisitions. Regulatory attorney Jennifer Bragg told an audience at this year’s meeting of the Medical Device Manufacturers Association (MDMA) that the smarter companies are doing their due diligence before approaching the target company, an exercise that could ultimately dissuade the would-be acquirer of the wisdom of the transaction.
The U.S. Department of Justice announced that Keith Berman, formerly the CEO of Los Angeles-based Decision Diagnostics Corp., has received a prison sentence of seven years for misrepresenting the company’s developmental test for the SARS-CoV-2 virus during the height of the COVID-19 pandemic.
U.S. deputy attorney general Lisa Monaco recently outlined some new programs related to federal enforcement across the economy, including some novel elements related to artificial intelligence. However, the more important take-away, according to Preston Pugh of Crowell & Moring LLP, is that the Department of Justice (DOJ) continues to work to make the legal environment more friendly to would-be whistleblowers, thus increasing the risk for companies inside and outside the life sciences.
U.S. deputy attorney general Lisa Monaco recently outlined some new programs related to federal enforcement across the economy, including some novel elements related to artificial intelligence (AI).
Three U.S. federal government agencies announced that their focus on consolidation in health care markets may soon ramp up, given concerns that consolidation may be affecting the cost and quality of patient care.
The U.S. Department of Justice (DOJ) announced in May 2023 that it had obtained a judgment of more than $487 million against the parent company of Precision Lens for alleged violations of the False Claims Act (FCA), but the amount of that decision has been overturned. In a Feb. 8 decision, the U.S. District Court for the District of Minnesota decreed that the judgment be reduced to less than $217 million, an outcome which suggests that some of the more excessive fines levied against health care companies will be viewed with more skepticism upon appeal.
The U.S. Federal Trade Commission (FTC) has drawn blistering criticism over the past couple of years over its handling of merger and acquisition (M&A) activity, criticism that was anything but blunted in a Jan. 31 webinar on the subject.
Royal Philips NV agreed with the U.S. FDA to the terms of a consent decree focused on its Respironics business, following the recall of millions of its devices over the last few years. Although the details of the decree are being finalized, Philips said it will halt the sales of new continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) sleep therapy machines as well as other respiratory care devices in the U.S. until the conditions of the decree are met.
One of the more significant enforcement actions to date in 2024 is the $13 million hit taken by the owner of a clinical lab in New Jersey for allegations of payment of kickbacks for unnecessary testing, suggesting that this new year will be a robust one for federal fraud enforcement in the U.S.
The U.S. Federal Trade Commission (FTC) and the Department of Justice (DOJ) have issued the final version of their updated merger guidelines for corporations, concluding a process that took a scant six months to complete following the issuance of the draft.