testing – Page 2 – Coronavirus (COVID-19)

April 9, 2020August 31, 2020 by Duane Morris

What Companies Are Looking for Before You Can Come Back to Work

At some point, the biggest American companies are going to tell their employees it’s time to leave home and return to work.

That decision will be fraught with risk without widespread testing for the COVID-19 virus. For some industries, such as Wall Street banks, ubiquitous testing is essential to bringing back their workforce to offices around the globe. For other industries, such as automakers, plans are already being made to open factories as early as May.

The tension between getting up and running as soon as possible versus taking chances with the health of employees is both a moral and a legal quandry. Employers have a relatively low legal risk, but a high reputational one, if they rush people back to the office, said Jonathan Segal, an employment attorney at law firm Duane Morris who specializes in human resources and minimizing companies’ legal and business risks.

To read more of Mr. Segal’s comments, please visit the firm website. To read the full text of the article, please visit the CNBC website.

April 1, 2020August 31, 2020 by Duane Morris

FDA Unveils Program to Expedite Coronavirus Treatments

On March 31, 2020, the U.S. Food & Drug Administration (FDA) introduced a specially designed “emergency program”—dubbed the Coronavirus Treatment Acceleration Program (CTAP)—to provide patients with faster access to new COVID-19 treatments. The CTAP allows FDA to “move new therapies to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.”

Given the rapidly increasing rate of COVID-19 confirmed cases and fatalities in the United States, efforts to streamline FDA processes may prove crucial to uncovering and delivering viable treatments.

To read the full text of this Duane Morris Alert, please visit the firm website.

March 31, 2020August 31, 2020 by Duane Morris

FDA Virtual Town Hall for Laboratories and Manufacturers Developing Diagnostics Tests for COVID-19

FDA is hosting a virtual town hall April 1, 2020, at 12:15 p.m. Eastern for clinical laboratories and commercial manufacturers developing diagnostic tests for the COVID-19 virus. FDA intends to help answer technical questions about validation and development of tests and FDA’s recently issued Guidance from March 16, 2020 outlining FDA policy for development of diagnostic tests during the COVID-19 public health emergency. FDA will host subsequent virtual town halls for clinical laboratories and commercial manufacturers each Wednesday of April at 12:15 p.m. Eastern. Registration not required. Details to join the call are available on the event page.

For additional information, please contact Dana J. Ash, Frederick R. Ball, Patrick C. Gallagher, Ph.D., Jonathan Lourie, Vicki G. Norton, Ph.D., or Sandra G. Stoneman of Duane Morris’ LIfe Sciences Industry Group.

March 31, 2020September 1, 2020 by Duane Morris

Federal Prosecutors Begin Charging COVID-19 Fraud in California and New Jersey

By Jovalin Dedaj

Yesterday, federal prosecutors in the District of New Jersey charged a Georgia man for his alleged role in a conspiracy to defraud federally funded and private health care benefit programs by submitting fraudulent testing claims for COVID-19 and genetic cancer screenings. It follows a criminal complaint announced last week by the U.S. Attorney’s Office for the Central District of California against a Southern California man on a federal fraud charge alleging he solicited investments in a company he claimed would be used to market pills that would prevent coronavirus infections and an injectable cure for those already suffering from COVID-19. These cases are among the first criminal actions in the ongoing public health crisis and come on the heels of the first civil enforcement action by the Department of Justice against a COVID-19 related fraud.

Continue reading “Federal Prosecutors Begin Charging COVID-19 Fraud in California and New Jersey”

March 25, 2020August 31, 2020 by Duane Morris

COVID-19 Prompting Significant Action by State and Federal Prison Authorities

This past week, federal and state correctional facilities across the country have confirmed outbreaks of COVID-19 infections among inmates and staff. New York City’s primary jail, Riker’s Island, currently has the most confirmed cases, with 52 inmates and 30 employees testing positive. As this blog and other outlets have reported, crowded conditions, limited access to healthcare, and a high-risk population mean those incarcerated are particularly vulnerable to the disease.

To read the full text of this post by Duane Morris attorney Jovalin Dedaj, please visit the Duane Morris White-Collar Criminal Law Blog.

March 18, 2020August 31, 2020 by Duane Morris

FDA Guidance Aims to Accelerate Availability of COVID-19 Tests

On March 16, 2020, the U.S. Food & Drug Administration (FDA) issued new guidance aimed at accelerating the availability of COVID-19 diagnostic tests developed by laboratories and commercial manufacturers. The guidance, which took immediate effect upon release, contains recommendations for clinical laboratories and commercial manufacturers regarding development of diagnostic tests for COVID-19 during the current public health emergency.

To read the full text of this Duane Morris Alert, please visit the firm website.

March 18, 2020August 31, 2020 by Duane Morris

Declaration Provides Immunity for Certain COVID-19 Pandemic Medical Countermeasure Activities

In an effort to encourage development of drugs, devices and biologics useful for the treatment, diagnosis, and prevention of COVID-19 respiratory illness, the Secretary of Health and Human Services has issued a declaration providing statutory immunity under the Public Readiness and Emergency Preparedness (PREP) Act. This declaration is separate from the Public Health Emergency declared under Section 319 of the Public Health Service Act on January 31, 2020, and is a part of the continued effort by the federal government to expedite development and distribution of medical products that can address the COVID-19 pandemic.

To read the full text of this Duane Morris Alert, please visit the firm website.

March 11, 2020August 31, 2020 by Duane Morris

Coronavirus Testing—Issues for Employers Reaching for Thermometer

By Jonathan Segal

Employers need to apply a measured approach to the new coronavirus. Some employers are considering measuring the temperatures of their employees before they report to work, since a fever may be a symptom of the coronavirus.

The Centers for Disease Control and Prevention defines a fever as 100.4°F/38°C or higher.

The following is a checklist of some of the more salient issues employers need to consider in determining whether to temperature test their employees. Continue reading “Coronavirus Testing—Issues for Employers Reaching for Thermometer”

March 5, 2020September 1, 2020 by Duane Morris

Coronavirus and the Workplace: A Quick Reference Guide for Employers

With no signs of slowing down, the coronavirus, or COVID-19, presents a potentially serious risk to the safety and welfare of employees and the financial health of companies. Employers must be prepared to address COVID-19 related issues in the workplace without violating employees’ rights and without causing unnecessary confusion.

What Should Employers Do to Protect Their Workforce?

There is no known vaccine or treatment for COVID-19, and thus the best way to protect the workplace is to avoid exposure to the virus. Based on the Centers for Disease Control and Prevention’s (CDC) recommendations, employers should:

Encourage employees to cleanse their hands regularly and thoroughly with soap and water or with an alcohol-based rub, avoid touching their eyes, nose and mouth, and cover their coughs or sneezes with a tissue.
Review cleaning operations to ensure frequently touched surfaces are disinfected regularly.
Encourage employees to avoid contact with sick people and to stay home if they are sick.

Personal protective equipment is a must for healthcare workers, however, it is not likely necessary for employees who are well, according to the CDC. If an employer receives a request from an employee to wear masks or gloves, employers should consider the requests with three issues in mind: whether the employee (1) has traveled to or from an area where COVID-19 is prevalent; (2) is exhibiting symptoms of the virus or has an underlying health condition; or (3) has been in close contact with someone who has COVID-19. The employer may also consider directing such employee not to report to work for a period of at least 14 days or longer, based on current CDC advice.

View the full Alert on the Duane Morris LLP website.

March 3, 2020September 1, 2020 by Duane Morris

During Coronavirus Outbreak, Should Employers Check Workers’ Temperatures?

Infrared forehead thermometers—so-called thermometer guns—are “notoriously unreliable,” according to medical experts quoted in an article in The New York Times, but that hasn’t kept the devices from flying off store shelves as coronavirus cases pop up around the world. Some employers are using them to take workers’ temperatures, then sending the workers home if they have a fever.

[…]

Is it legal for employers to take workers’ temperatures? If the Centers for Disease Control and Prevention (CDC) or a state or local health authority proclaims a pandemic has spread in an area, then yes, it is; otherwise, it is not, according to Equal Employment Opportunity Commission (EEOC) guidance.

[…]

“Employers are doing the right thing by considering all options potentially available to them in the event of a pandemic, including temperature testing,” said Jonathan Segal, an attorney with Duane Morris in Philadelphia and New York City.

[…]

To read the full article, visit the SHRM website.