On July 20, 2020, the United States Food and Drug Administration (FDA) announced a six-month extension of its enforcement discretion policy for certain regenerative medicine products requiring pre-market review due to the COVID-19 pandemic. Included in a final guidance document entitled, “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use,” this extension will give manufacturers additional time to determine whether they need to submit an investigational new drug (IND) or marketing application and to prepare and submit to FDA any required IND or marketing application before the enforcement discretion period expires on May 31, 2021. This extension should come as a welcome reprieve to manufacturers of affected products, many of which delayed seeking FDA approval of their products following release of the enforcement discretion policy guidance in November 2017.
In Response to COVID-19, FDA Extends Enforcement Discretion for HCT/Ps Requiring Pre-Market Review
EMPLOYMENT CONTRACT OF THE SPORTSPERSON & COVID-19 – THE IMPACT OF THE NEW CORONAVIRUS ON THE DURATION OF THE EMPLOYMENT BOND AND RETRIBUTION OF THE SPORTSPERSON
The sports phenomenon, with particular emphasis on professional sport, especially the legal-labour relationship of the sports practitioner, has special and complex specificities based on the axis of the mandatory labour relationship between the athlete and his employer. Read more…
Video: First Workplace Safety Mandates, COVID-19 Employee Training, Masks Required at Major Retailers – Employment Law This Week
Featured in #WorkforceWednesday: This week, Virginia became the first state to issue workplace safety standards, but with guidance still varying widely, many nationwide businesses have begun requiring masks.
The Board Brings the NLRA Into the Modern Era of Discipline for Abusive Conduct, and Union Leaders Lament “Guys Like Us, We Had It Made. Those Were the Days.”
On Tuesday, the three-member, all Republican, National Labor Relations Board (the “Board”) issued a 3-0 decision in General Motors LLC and Charles Robinson, 369 NLRB No. 127 (July 21, 2020), reversing its longstanding standard for determining when employers violate the National Labor Relations Act (the “Act”) by disciplining employees who, while engaged in activity protected under Section 7 of the Act, use profanity-laced speech, as well as racial, ethnic or sexist slurs, or other abusive conduct toward or about management or other employees. Going forward, including to any unfair labor practice case currently pending, the Board will apply its familiar burden-shifting standard under Wright Line, pursuant to which a charging party must show through evidence that the employer would not have disciplined the employee but for his or her engaging in the protected activity, and the employer will not violate the Act where it shows the employee would have been disciplined because of the abusive speech or conduct regardless of any involvement in protected activity. The Board will no longer treat the engagement in the protected activity and the abusive conduct as being analytically inseparable. Nor will the Board any longer presume in such circumstances the issue of causation between the employee’s discipline and his or her involvement in protected activity. In so doing, the Board has brought the Act into the modern era so as to be consistent with current workplace standards of decorum and employers’ legal obligations under antidiscrimination laws. To those union leaders and employees who engage in abusive and offensive language or other conduct, similar to that old television dinosaur Archie Bunker, they may well reminisce about the old days when guys like them had it made and they were protected from discipline.
The U.S. Department of Labor Issues New Guidance on Leave and Wage & Hour Issues Confronting Employers as They Reopen for Business
On July 20, 2020, the Wage and Hour Division (“WHD”) of the U.S. Department of Labor (“DOL”) published new guidance for businesses reopening amid the COVID-19 pandemic. The guidance is in the form of additions to the WHD’s existing Frequently Asked Questions (“FAQs” or “Guidance”) and addresses issues arising under two leave laws—the Family and Medical Leave Act (“FMLA”), and the Families First Coronavirus Response Act (“FFCRA”)—and wage and hour matters governed by the Fair Labor Standards Act (“FLSA”).
A Snapshot of our Recent Activity — Insurance Law
July 24, 2020 — A brief portrait of cases and activities of RSS’s Insurance Law Practice Group over the past few months
Active Despite the Coronavirus
The pandemic has not spared the legal community. However, as legal services were quickly declared essential services by the Quebec government, we were able to maintain our activities.
U.S. Supreme Court Lets Stand Ninth Circuit Ban on ‘Salary History’ Defense to an Equal Pay Act Claim
In recent years, wage discrimination has been a hot topic and with it, the question of whether employers may rely on a worker’s salary history to justify a pay disparity between male and female employees. In a 2018 case involving the federal Equal Pay Act (“EPA”), Rizo v. Yovino, (about which we wrote here), the U.S. Court of Appeals for the Ninth Circuit (“Ninth Circuit”) ruled that employers may not rely on prior salary to excuse unequal pay. On petition, the Supreme Court vacated the decision and remanded the case on a technical ground (i.e., because the judge who authored the opinion died before release of the decision). On remand, the Ninth Circuit ruled as it had before. On July 2, 2020, the Court declined review, thereby leaving the Ninth Circuit’s ruling in place.
Third Circuit: Provider’s Out-of-Network Claims not Pre-empted by ERISA
In an important win for healthcare providers, on July 17, 2020, the Third Circuit determined in a published opinion that an out-of-network provider’s direct claims against in insurer for breach of contract and promissory estoppel are not pre-empted by ERISA. In Surgery Ctr., P.A. v. Aetna Life Ins. Co.[1] In an issue of first impression, the Third Circuit addressed the question of what remedies are available to an out-of-network provider when an insurer initially agrees to pay for the provision of out-of-network services, and then breaches that agreement.
Clarifications of the Constitutional Court on the participation of representatives without law degree in commercial procedure
The Constitutional Court and Supreme court continue to clarify the novels in procedural codes on professional judicial representatives. Recall that earlier, in June, the Supreme Court in the Review of Judicial Practice No. 1 dated 06/10/20201 indicated that the law degree requirements do not relate to representatives in bankruptcy cases. Recently, the Constitutional Court in its decision2 ruled that the interests of legal entities can be represented by employees, founders (shareholders) and other persons without a law degree.
Global Diversity: A Practical Approach
Tracking diversity and inclusion efforts on a global basis is often a challenging task for in-house legal, human resources, and diversity and inclusion teams. While employers may be interested in collecting applicants’ and/or employees’ diversity information for worthy reasons, such an effort is a fertile ground for potential litigation involving data privacy violations and discrimination claims.
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