Section 510

News & Analysis as of

FDA Regulatory and Compliance Monthly Recap — September 2016

FDA issues final rule modifying regulations for drug establishment registration, listing requirements - The final rule, which comes nearly 10 years after changes were initially proposed, updates the regulations to...more

10 Key Takeaways from FDA’s Draft Guidance on 510(k) Modifications

The Draft Guidance may not significantly increase the number of 510(k)s filed, but likely would increase manufacturers’ procedural and documentation burdens. The US Food and Drug Administration (FDA or the Agency) issued...more

The ERISA Litigation Newsletter - September 2016

Editor's Overview - This month, we have re-published an interview of our colleague Seth Safra discussing the Department of Labor’s final regulation concerning fiduciaries and conflicts of interest. In this interview,...more

ERISA Section 510 Interference Claim Time Barred

A federal magistrate judge in Pennsylvania recommended that a class action complaint claiming that AlliedBarton terminated certain employees to prevent them from reaching eligibility for vacation benefits be dismissed as...more

The ERISA Litigation Newsletter - June 2016

Editor's Overview - In this month’s newsletter, our colleagues focus on two sets of legislative updates. First is a discussion of the IRS’s proposed Treasury Regulations prescribing rules under Section 457 of the...more

Court Declines to Decide Whether ERISA Protects Employee From Reprisal For Informal Complaint

A federal court in Missouri was asked to determine whether a former employee proved a viable claim for retaliation under ERISA Section 510 by virtue of being terminated after she sent emails disparaging the company’s owner...more

Employer Facing Potential Liability For Allegedly Reducing Worker Hours To Avoid Affordable Care Act Penalties

The Affordable Care Act’s (ACA) employer shared responsibility mandate requires large employers to offer certain minimum health coverage to substantially all of their full-time employees, or potentially pay significant...more

'Right-Sizing' Full-Time Employees to Reduce ACA Obligations May Lead to ERISA Class Action Exposure

Compliance with the Affordable Care Act (ACA) has resulted in increased health benefit costs for many employers. A recent court decision demonstrates that while programs to reduce the number of full-time employees may lower...more

Gaming the System? ERISA Interference Lawsuit Targets ACA-Driven Reduction of Hours Strategy

In a case believed to be the first of its kind, a recent class action claim has accused an employer of reducing hours of employees to avoid having to provide health coverage as required under the Patient Protection and...more

The ERISA Litigation Newsletter - August 2015

Editor's Overview - As the summer draws to a close, this month's Newsletter previews three cases that the U.S. Supreme Court already has agreed to hear that ought to be of particular interest to ERISA plan sponsors and...more

Ninth Circuit Affirms Dismissal of ERISA Section 510 Claim

The Ninth Circuit affirmed the dismissal on summary judgment of Plaintiff Rosemarie Cole’s claim that her employer, Permanente Medical Group, interfered with her receipt of pension benefits in violation of ERISA § 510....more

Class Action Suit Alleges Dave & Buster’s Cut Employee Work Hours to Skirt ACA Obligation to Offer Health Coverage

In the first lawsuit of its kind, a purported class of approximately 10,000 workers at Dave & Buster’s, the restaurant chain, filed a lawsuit in the Southern District of New York (Marin v. Dave & Buster’s, Inc., S.D.N.Y., No....more

Mortgage-Backed Securities: “It Is The Rare Ordinary Human Being Who Understands Them”

In re Lehman Bros. Holdings Inc., 513 B.R. 624 (Bankr. S.D.N.Y. 2014) – A purchaser of residential mortgage-backed securities filed proofs of claim based on alleged misrepresentations by the debtors in offering...more

Medical Device Update: FDA Issues Final Guidance on 510(k) Determinations, Use of “Split” Predicates Strongly Discouraged

On July 28, the Food and Drug Administration (FDA) issued a final guidance titled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” Device manufacturers should be aware of key...more

Sixth Circuit: ERISA’s Whistleblower Provision Doesn’t Protect Giving Information

The Sixth Circuit (in a 2-1 decision) recently held that ERISA Section 510 does not protect unsolicited employee complaints. See Sexton v. Panel Processing, Inc., 2014 U.S. App. LEXIS 8752 (6th Cir. May 9, 2014). Plaintiff...more

Employment Relationship Not Required For Claim Of ERISA Violation For Benefit Rights

In a recent Seventh Circuit Court of Appeals decision successfully litigated by Laner Muchin, the Court addressed novel aspects of whether an employer interfered with employees’ benefit rights in violation of ERISA. The case...more

Seventh Circuit Resolves Question of Whether Informal Complaints Can Provide the Foundation for Retaliation under ERISA

Section 510 of the Employee Retirement Income Security Act (ERISA) prohibits retaliation “against any person because he has given information or has testified or is about to testify in any inquiry or proceeding related to...more

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