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On August 7, 2024, the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) issued a final procedural notice (“Notice”) outlining a new Medicare coverage pathway, aimed at achieving timelier and predictable access...more
On Thursday, June 13, the Supreme Court of the United States issued three decisions: FDA v. Alliance for Hippocratic Medicine, No. 23-235: This case involves an attempt to rescind the Food and Drug Administration’s...more
On April 26, the US Department of Health and Human Services Office for Civil Rights (OCR) published a Final Rule that adds protections under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule...more
...NLRB Issues Final Rule on ‘Joint Employer’ Standard On - October 26, 2023, the National Labor Relations Board (NLRB) issued a final rule titled “Standard for Determining Joint Employer Status,” which rescinds and...more
In a rare unanimous opinion, the U.S. Supreme Court recently confirmed that existing law allows the IRS to probe your bank records, without ever notifying you. Under the applicable statute, the Court concluded the IRS is not...more
The Supremes- The Constitution has figured prominently in the news of late. In the days preceding the initial discussions among members of the Administration and the Congressional leadership regarding the debt ceiling,...more
The National Labor Relations Board (Board) continues to expand its authority to impose remedies on employers in its decision in Noah’s Ark Processors, LLC; rendering an unusual advisory opinion on the extent of the remedies...more
The widely publicized U.S. Supreme Court case addressing Harvard University’s (Harvard) admissions practices not only concerns a significant constitutional issue but also serves as a cautionary tale for businesses and...more
The United States Supreme Court held in BFP v. Resolution Trust, that properties sold at “force-sale” mortgage foreclosure sales properly conducted pursuant to a state’s foreclosure statute are presumed to have been sold for...more
Niz-Chavez v. Garland, No. 19-863: Congress has given the Attorney General discretion to allow qualifying nonpermanent resident aliens ordered to be removed from the United States, to instead remain in the country. One of the...more
It’s hard to keep up with all the recent changes to labor and employment law. While the law always seems to evolve at a rapid pace, there have been an unprecedented number of changes for the past few years—and this past month...more
This edition of Employment Flash summarizes key employment law issues related to COVID-19 as well as two seminal U.S. Supreme Court rulings that protect gay and transgender employees from discrimination, and clarify the...more
On March 30, 2020, the U.S. Supreme Court declined to review a decision from the Seventh Circuit in Leeper v. Hamilton County Coal, LLC, No. 19-1109, which held that a layoff was temporary, and thus did not trigger the 60-day...more
On June 26, 2018, the United States Supreme Court decided National Institute of Family and Life Advocates v. Becerra, No. 16-1140, holding that the petitioners were likely to succeed on their claim that California’s...more
Chevron deference is increasingly coming under fire from the justices of the Supreme Court of the United States. That came through loud and clear in Pereira v. Sessions, issued on June 21, 2018....more
Parties have long argued over whether the filing of a class action tolls the statute of limitations for absent class members so that they can pursue a separate class action if the initial action fails to be certified for any...more
In an opinion issued on December 14, 2017, the United States Court of Appeals for the Federal Circuit held that the 2010 Biologics Price Competition and Innovation Act (“BPCIA”) preempts the use of state law to penalize...more
District Court Abused Discretion in Not Finding Case Exceptional - In Rothschild Connected Devices v. Guardian Protection Services, Appeal No. 2016-2521, the Federal Circuit held that a district court abused its discretion...more
In borrowing a page from the '80s band "Men Without Hats," on June 12, 2017, the U.S. Supreme Court brought greater certainty for both biosimilar applicants and originator companies. In Sandoz Inc. v. Amgen Inc., the Supreme...more
On Monday, June 12, 2017, the United States Supreme Court in a unanimous decision held that manufacturers making biosimilars of biologic drugs did not have to wait until after gaining federal approval of the biosimilar to...more
On June 12, 2017, the Supreme Court issued a unanimous opinion in Sandoz v. Amgen, interpreting key provisions of the Biologics Price Competition and Innovation Act (BPCIA) in favor of biosimilar manufacturers...more
The Supreme Court handed down its opinion in Sandoz Inc. v. Amgen Inc., marking the first time the Court has interpreted the Biologics Price Competition and Innovation Act (“BPCIA”) for the approval of biosimilar drugs. On...more
On June 12, 2017, the U.S. Supreme Court decided two important questions under the Biologics Price Competition and Innovation Act ("BPCIA"), which provides an abbreviated pathway for the approval of generic biologics: (i) the...more
On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral...more
In a unanimous decision issued on June 12, 2017, the Supreme Court for the first time interpreted key provisions of the 2010 Biologics Price Competition and Innovation Act (“BPCIA”). See Sandoz Inc. v. Amgen Inc., No. 15-1195...more