Related insights: Pharmaceutical and Medical Device Litigation

Thumbnail

Making Sense of FDA’s Recent Guidances on Personal Protective Equipment (PPE)

Apr 08 2020
To address the COVID-19 public health crisis, FDA issued two immediately in effect guidance documents: FDA Guidance for Industry (April 2020) Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised), and FDA Guidance for Industry (March 2020) Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency.
Thumbnail

COVID-19 Liability Immunity - What You Need to Know Now

Apr 06 2020
The Secretary of the Department of Health and Human Services issued a declaration providing liability immunity to certain individuals and entities against covered claims of loss relating to the manufacture, distribution, administration, or use of medical countermeasures (“Covered Countermeasures”), except for claims involving “willful misconduct.” The COVID-19 Declaration was issued on March 10, 2020 under the authority of the Public Readiness and Emergency Preparedness Act of 2005 (“PREP Act”), codified at 42 U.S.C. §247d-6d, and is retroactively effective beginning February 4, 2020.

11th Circuit Court of Appeals Mandates Proactive Gathering and Review of SSA Information in Fiduciary’s LTD Benefit Review

Feb 11 2014
Not long ago, the Unites States Supreme Court in MetLife v. Glenn, 128 S. Ct. 2343 (2008) gave a stern warning to plan fiduciaries who required a claimant to apply for disability benefits with the Social Security Administration (SSA) and benefited from an SSA approval because of the offset, and then failed to adequately distinguish its benefit denial from the SSA’s approval: This, the Court declared, not only “suggested procedural unreasonableness,” but also could be important in weighing the factors related to the inherent conflict of interest when the fiduciary was also the payer of benefits. Id. at 2352.