On September 20, 2018, the U.S. Food and Drug Administration (“FDA”) released draft guidance “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank” (“Guidance”). The purpose of this Guidance is to explain FDA’s protocol in (1) determining how the centers will identify whether responsible parties failed to comply with submission and certification requirements to the ClinicalTrials.gov or submitted false or misleading documents to the data banks and (2) deciding when, why, and what civil monetary penalties will be assessed against the ...
In a landmark decision, the U.S. Court of Appeals for the Seventh Circuit, sitting en banc, held that discrimination on the basis of sexual orientation is covered under Title VII of the Civil Rights Act’s protections against discrimination on the basis of sex.
In Hively v. Ivy Tech Community College of Indiana, Kimberly Hively, a lesbian part-time professor at Ivy Tech, applied for but was denied several full-time positions with the college. After her employment was later terminated, she filed a lawsuit alleging that she was denied promotion and then terminated because of her ...
Our colleague Marc A. Mandelman, a Member of the Firm at Epstein Becker Green, has a post on the Financial Services Employment Law blog that will be of interest to many of our readers in the health care industry: “8th Circuit Rules Parties to Corporate Transactions Cannot Contract Around the WARN Act Sale of Business Exception ”
Following is an excerpt:
In a rare case interpreting the Worker Adjustment and Retraining Notification (“WARN”) Act “sale of business” exception, the U.S. Court of Appeals for the 8th Circuit recently held in Day v. Celadon Trucking Servs ...
Blog Editors
Recent Updates
- At Long Last, DEA’s Remote Prescribing Rules 2.0 Are (Really) Here! (Pending Further Consideration by the Incoming Administration . . .)
- Massachusetts District Court Applies “But-For Causation” Standard, Dismisses AKS-Based FCA Case After Evaluating Facts and Circumstances of Independent Contractor Arrangements
- DOJ’s False Claims Act Recoveries Top $2.9 Billion in FY 2024, but Health Care Numbers Dip—What Could FY 2025 Hold for Health Care Enforcement?
- Recent Developments in Health Care Cybersecurity and Oversight: 2024 Wrap Up and 2025 Outlook
- Massachusetts Governor Maura Healey Signs into Law a Sweeping Health Care Market Oversight Bill