A federal judge has ordered Johnson & Johnson’s Janssen unit to pay $1.64 billion for illegally promoting HIV drugs Prezista and Intelence. U.S. District Judge Zahid Quraishi imposed a $360 million penalty and $1.28 billion in civil fines, to be…
Legal & Regulatory Issues
A federal judge has dismissed Amgen’s lawsuit against Colorado’s Prescription Drug Affordability Board, allowing the state to move forward with setting price ceilings on prescription drugs, The Denver Post reported March 31. U.S. District Judge Nina Wang ruled March 28…
A federal judge in Texas has ruled that the FDA does not have the authority to regulate laboratory developed tests as medical devices, striking down the agency’s recently finalized rule. The decision, issued in the U.S. District Court for the…
New era of anti-corruption enforcement The second Trump administration has issued executive orders (EO) to quickly shift enforcement priorities, including anti-bribery and anti-corruption (ABAC) laws. In a recent EO, President Trump paused Foreign Corrupt Practices Act (FCPA) enforcement for a…
The Justice Department has launched an anticompetitive regulations task force, aimed at identifying and eliminating federal and state regulations that hinder market competition — including in healthcare. The initiative will operate within the DOJ’s antitrust division and expand ongoing efforts…
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The U.S. government has reached a $550,000 settlement with the Prometheus Group, a New Hampshire-based manufacturer of rectal therapeutic systems, and its president, Richard Poore, over allegations that they violated the False Claims Act. The lawsuit alleged Prometheus and Mr.…
HonorBridge, an organ procurement organization in Chapel Hill, N.C., is suing the federal government over its decision to allow Atrium Health Wake Forest Baptist to switch to a new transplant partner, according to court documents obtained by Becker’s. CMS granted…
On March 25, a jury handed down a $48 million verdict against St. Louis-based Mercy Hospital, Mercy Clinic and an obstetrician, siding with the family of a child left with brain damage after his birth at the hospital. The case…
Carmichael, Calif.-based Mercy San Juan Medical Center is under scrutiny after numerous deceased patients were transported to an off-site morgue without next of kin being notified, Medpage Today reported March 25. The issue has spanned the last three years, according…
Fort Myers, Fla.-based Lee Health has filed a lawsuit against Nicklaus Children’s Hospital in an effort to block its eviction from the Golisano Children’s Health Center in Naples — a move that could shut down a facility that serves about…