Category: Legal & Regulatory Issues

Court orders FDA to release more COVID-19 vaccine records

A federal judge in the Northern District of Texas has ruled that the FDA must release key documents related to the emergency use authorization of the Pfizer-BioNtech COVID-19 vaccine, according to court documents obtained by Becker’s. 

California officials probe system in human tissue, patient data dumping case

Local law enforcement officials are investigating Santa Clara (Calif.) Valley Healthcare after finding evidence that its hospitals have been illegally dumping biohazardous waste including human tissue, vials of prescription drugs and unredacted documen…

Former medical director sues New York system for wrongful termination

A former director of medical staff services at Utica, N.Y.-based Mohawk Valley Health System is suing the system, claiming her termination was retaliation for whistleblowing, the Observer-Dispatch reported Dec. 6.

10 recent healthcare industry lawsuits, settlements

From a judge dismissing a class-action lawsuit against CommonSpirit to a former employee suing Lurie Children’s for alleged retaliation, here are 10 healthcare industry lawsuits, settlements and legal developments that Becker’s has reported since Nov. …

UC Regents reaches $15M settlement over medication error: 5 things to know

The Regents of the University of California, the governing board that oversees the University of California system, has reached a $15 million settlement in a lawsuit alleging medical battery and negligence that was brought forth by a patient’s family a…

2 healthcare staffing agencies to pay $2.4M in back wages

Healthcare staffing companies in Massachusetts and Pennsylvania will pay 341 employees more than $2.4 million in back wages and liquidated damages, according to a recently filed consent judgment and order. 

Healthcare billing fraud: 10 recent cases

Here are 10 healthcare billing fraud cases that Becker’s has reported since Nov. 15: 

Supreme Court to consider gender-affirming care

For the first time, the Supreme Court will hear arguments about whether states can ban gender-affirming care for youths. 

CMS updates immediate jeopardy guidance: 4 key changes

In late November, CMS  revised guidance for surveyors and healthcare providers regarding immediate jeopardy, the most serious type of warning for noncompliance deficiencies that place organizations at risk of losing federal funding. 

4th drugmaker seeks 340B changes

As several pharmaceutical companies challenge their role in the 340B drug pricing program, Bristol Myers Squibb filed a lawsuit Nov. 26 against the HHS agency that oversees the federal program.