Tag: CDC

Coronavirus – Further Updates on Travel Impact

As the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO) continue to monitor the current and potential impact of the coronavirus (COVID-19) in the United States and worldwide, the CDC and the Department of State (DOS) have updated their travel guidance by issuing warnings about new countries and raising the threat levels of previously named countries. Further, President Trump has issued a proclamation that temporarily suspends entry to the United States for foreign nationals who have been physically present in Iran within the last 14 days. We outline below the current travel advisories and will continue to provide updates as new information becomes available.

Iran:

The CDC issued a Travel Advisory alert on Iran at the Warning—Level 3 category, recommending that travelers avoid all nonessential travel.

On February 29, 2020, through a Presidential Proclamation, the U.S. government announced that effective today, March 2, 2020, at 5:00 p.m. eastern time, that it was suspending entry of foreign nationals, both immigrants and nonimmigrants, who were physically present in Iran within the last 14 days preceding their entry into the United States.

Italy:

The CDC issued a Travel Advisory alert on Italy at the Warning—Level 3 category, recommending that travelers avoid all nonessential travel. DOS maintains a Level 3 Advisory for Italy as well.

The most affected regions are Lombardy and Veneto (North Italy, Milan consular district). On February 23, 2020, the U.S. Embassy in Rome issued a Health Alert, stating that the U.S. Consulate General in Milan has suspended routine visa services until March 2, 2020. Given the continued health concerns, we expect an updated advisory shortly. However, at this time, full consular services are available at the U.S. Embassy in Rome and the U.S. Consulates General in Florence and Naples.

China:

The CDC has raised the Travel Advisory level for China to a Warning—Level 3 category, recommending that travelers avoid all nonessential travel. DOS has raised the Travel Advisory to Level 4 advising that individuals not travel to China, and to be prepared for the possibility of travel restrictions with little to no advanced notice.

The previous warnings related to China under the Presidential Proclamation, effective February 2, 2020, remain in effect. Foreign nationals who have visited China in the last 14 days may not enter the United States, and American citizens and lawful permanent residents who have been to China in the past 14 days will undergo health screenings at a prescribed list of airports. Depending on their history, individuals may receive additional travel prescriptions.

South Korea:

The CDC has raised the Travel Advisory level for South Korea to a Warning—Level 3 category, recommending that travelers avoid all nonessential travel. DOS maintains a Level 3 Advisory for South Korea as well.

Japan:

The CDC added Japan to the Travel Advisory alerts at Alert—Level 2. The CDC recommends that high-risk travelers practice enhanced precautions. As of February 21, 2020, the U.S. Embassy in Tokyo continues to provide all consular services.

Hong Kong:

The CDC has maintained a Travel Advisory level of Watch—Level 1 (Practice Usual Precautions) for Hong Kong. DOS increased the Hong Kong Travel Advisory to Level 2 (Exercise Increased Caution). Further, the U.S. Consulates in Hong Kong and Macau recommend that anyone with a pending consular appointment who resides in China, has traveled to China recently, or intends to travel to China prior to their planned trip to the United States, postpone their visa interview appointment until 14 days subsequent to their departure from China.

©1994-2020 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

ARTICLE BY Danielle A. Porter of Mintz.
For more on coronavirus developments see the National Law Review Health Law & Managed Care section.

Coronavirus: Employers Should Plan, Not Panic

Coronavirus, whose formal name is COVID-19, has been the subject of much media attention since the first outbreak in Wuhan, China, late last year.  Just like recent outbreaks of the swine flu, the avian flu, SARS and the West Nile virus, each new “bug” creates fear surrounding a previously unknown threat.  While there are tens of thousands of cases in China, as of February 19, 2020, according to the U.S. Centers for Disease Control and Prevention (CDC), there were 15 confirmed cases of coronavirus in the U.S.  The confirmed cases were limited to seven states located on the perimeter of the country.

According to the CDC, coronaviruses are a large family of viruses that are common in many different species of animals, including camels, cattle, cats and bats. Rarely, animal coronaviruses can infect and then spread between people.

To put the current coronavirus outbreak in context, the CDC estimates there have been between 26 MILLION and 36 MILLION cases of flu in the U.S. this season and an estimated 15,000 to 36,000 deaths.  In fact, this year’s flu season is the worst in almost 20 years.  While the majority of these deaths and hospitalizations have occurred in people over age 65, this year’s flu has impacted children and younger adults in greater numbers than usual.

While no one knows for sure the extent to which the coronavirus will take hold in the U.S., employers should take steps now to plan ahead so that they will be able to maintain normal business operations.  The challenges for any business facing coronavirus or any other disease outbreak involve a multitude of conflicting legal obligations.  Under the Occupational Safety and Health Act (OSHA) and similar state laws, employers have a general duty and obligation to provide a safe and healthy work environment, even when the work occurs outside the employer’s physical premises. Furthermore, under these health and safety laws, employers must not place their employees in situations that are likely to cause serious physical harm or death.

Conversely, overreacting by implementing broad-based bans and making business decisions about employees that are not based on statistical realities could get an employer sued under laws that prohibit discrimination based upon disability (perceived or real) and national origin discrimination, among others.

Properly planning for and implementing plans to deal with the coronavirus is legally and operationally complex.  Listing all of the considerations for such plans are too numerous for this brief blog article. By way of example, employers who have operations in Hubei Province in China, the epicenter of the coronavirus outbreak, will face far more difficult and complex challenges than an employer with a single facility in the middle of the U.S.  However, at a minimum here are some things every business should be doing:

  • If you have not already done so, institute a ban on all business travel to China.  This may be a moot point given the cancellation of most flights into and out of mainland China.  Under the circumstances, it is also totally appropriate to require that any of your employees who choose to travel to China for personal reasons notify a designated company official and let the official know of their plans.

  • If employees must use a company-designated travel agent to arrange business travel, get the agent to provide reports on all international business travel.  But don’t overreact and implement a broad-based travel ban to countries that do not pose a risk of harm.  However, if an employee expresses fear of any international travel, have a rational discussion and review the relevant outbreak statistics to see if those fears are real or inflated.  Even if fears are irrational, consider the negative impact on employee morale by forcing someone to travel.

  • Designate a management official to check the CDC website daily to see the latest tracking of the virus’ spread.  This person should be the in-house resource and should be involved in ban or no-ban decisions.

  • If an employee has been to a real coronavirus “hotspot,” consider making him or her stay home for the full 14-day incubation period.  Whether employees work remotely or do not work, the decision whether they should be paid to stay home during this time is an individualized determination.  However, employers need to be flexible and should consider bending the rules if they want to appear humane and seriously concerned about health issues.  If employers force someone to stay home for two weeks without pay or make them use precious PTO, they may push people to hide where they have been, which will defeat planning to ensure that management is taking all reasonable steps to prevent the spread through the workplace.

  • Do not panic or overreact but rather engage in sound business contingency planning.  Begin by developing contingency plans based upon the industry you are in, the size of your business and how you will operate in the event absenteeism rates greatly exceed those of a normal flu season.

  • Use this opportunity to communicate with your employees about seasonal flu prevention strategies, such as minimizing contact and engaging in sound hygiene and sanitation.  As the statistics above demonstrate, seasonal flu poses a far greater and more immediate threat to your employees’ health than does the coronavirus.

  • Develop a plan for communicating with your employees if a major pandemic breaks out, regardless of where they are located, including the workplace, at home or on the road.
    Regardless of how bad things may get, it is important that management not panic or overreact.  Plan for worst case scenarios now so you can effectively respond to what will likely be a rapidly changing situation. To do this, your management should anticipate and prepare for how you will answer the plethora of questions that will almost certainly be raised.

Proper planning for and dealing with individualized employee situations implicates a whole range of employment laws, such as ADA, GINA, OSHA, Title VII, ERISA, as does the nature of your business.  To deal with these legal issues, you should consult with your attorney.

Finally, there are a variety of web-based resources available to assist you in planning, preparation, and monitoring the spread of the coronavirus on a global basis, including the CDC at www.cdc.gov, OSHA at https://www.osha.gov/SLTC/covid-19/, and the World Health Organization https://www.who.int/emergencies/diseases/novel-coronavirus-2019.

© 2020 Foley & Lardner LLP

For more on the coronavirus see the National Law Review Health Law & Managed Care section.

Coronavirus and the Workplace: What Employers Need To Know

News that multiple cases of the newly-identified 2019 Novel Coronavirus have reached the United States have prompted employers to think about employee safety and ways to address disease prevention in the workplace. Although, according to the Occupational Safety and Health Administration (OSHA), “most American workers are not at significant risk of infection” at this time, the situation is evolving, and it is never too early for employers to consider how they can address employee concerns, help prevent an outbreak, or address one if it occurs. Employers should also be aware of legal pitfalls that they may encounter when attempting to protect their employees from the virus.

The following addresses some of the key questions employers may have regarding the Coronavirus threat.

What is the Coronavirus and How Is It Transmitted?

At this point, relatively little is known about the 2019 Novel Coronavirus, more commonly known as the “Coronavirus.” According to the CDC, the initial reports of the illness originated in Wuhan, China, where people likely contracted the virus from animals at a seafood and animal market. Experts now believe that the virus is spreading from human-to-human when an infected person coughs or sneezes, similar to the spread of a cold or flu. However, it is still too early to know how easily the virus is transmitted between people.

What Are the Primary Symptoms of the Coronavirus?

In the confirmed cases of Coronavirus thus far, affected individuals have reported mild to severe respiratory symptoms, fever, cough, shortness of breath, and breathing difficulties. In severe cases, the virus has led to pneumonia, kidney failure, and, in at least 100 deaths (presently, all in China), as of the time of this writing.  The CDC believes at this time that symptoms may appear within two to fourteen days after exposure.  However, some infected individuals have shown little to no symptoms.

How Can Spread of the Coronavirus Be Prevented?

Because there is presently no Coronavirus vaccine available, the CDC is recommending standard precautions to avoid the spread of respiratory viruses, such as washing hands with soap and water for at least 20 seconds, or, if soap is not available, using hand sanitizer; avoiding close contact with people who are sick; staying at home when you are sick; and disinfecting frequently touched objects and surfaces.

What If My Employees Travel to China For Business?

As of January 27, 2020, the CDC has issued a level 3 health travel notice (the highest threat level) recommending that people avoid all nonessential travel to China.

Employers whose employees travel to and from China should keep in mind the following:

  • Consider whether to limit business travel to affected areas. While the current CDC travel notice does not specifically define “nonessential travel,” the General Duty Clause of the Occupational Safety and Health Act (OSHA) requires employers to furnish “employment and a place of employment which are free from recognized hazards that are causing or likely to cause the death or serious physical harm to … employees.”  Although the Occupational Safety and Health Administration (also referred to as OSHA) has not promulgated specific standards covering the Coronavirus, requiring employees to engage in nonessential business travel to China (or any other areas in which the risk of contagion is heightened) could create risk under the General Duty Clause, particularly in light of the CDC warning against nonessential travel.  For that reason, employers whose business may involve travel to China (or other areas that become subject to travel restrictions or otherwise experience an increase in the spread of the virus) should consider other available options for employees for the duration of the threat, such as videoconferencing.

By the same token, employers should also be prepared to respond to employees who may express concerns about traveling to affected areas due to the virus.  While an employer generally has broad discretion to decide the duties and requirements of a job and to discipline employees who fail to fulfill those requirements, as a practical matter employers may wish to consider offering employees reasonable alternatives to such travel.

Finally, while employers may implement restrictions on work-related travel to affected areas, employers should tread more carefully when attempting to police personal, non-work-related travel. That said, recent decisions in the Seventh, Eighth, and Eleventh Circuits have held that the disability discrimination protections of the ADA do not apply where an employer takes an employment action based on the potential for an employee to become ill and disabled in the future.  Specifically, the Eleventh Circuit found no liability under the ADA where an employer terminated an employee who requested time off to travel to Ghana to visit family because of the perceived risk that the employee would contract the Ebola virus, due to recent outbreaks of the disease in neighboring countries.  While courts have tended to take this view, it is worth noting that the EEOC has argued on at least one occasion that an employer acting on a potential future health condition may be viewed as “regarding” an employee as disabled as long as the condition otherwise qualifies as a disability under the law.  For this reason, employers should consider the risks with imposing a ban on personal, non-work-related travel to affected areas.

  • Provide relevant safety information to employees. Employers whose employees travel to affected areas should provide information to their employees about how the Coronavirus is transmitted, its symptoms, and how to avoid exposure – utilizing trusted and reputable sources such as the CDC. Employers would be well advised to also provide these employees with resources and contact information for local health departments and the CDC.
  • Understand that employee travel may be interrupted. The Chinese government has closed transit within and out of Wuhan and certain other areas of the Hubei Province. Hong Kong has also imposed certain restrictions on travel to and from the Chinese mainland. The United States is also re-routing passengers from Wuhan, China to certain designated airports (including Chicago O’Hare, Atlanta, New York JFK, Los Angeles, and San Francisco) for enhanced screening. While screening for common viruses usually takes several hours, officials have indicated that those suspected of having the Coronavirus could be delayed for up to a day if additional screening is needed.

What Should I Do if an Employee Has Recently Traveled to China or Otherwise May Have Been Exposed to the Coronavirus?

Employers should remember that the Americans with Disabilities Act (ADA) places certain restrictions on the kinds of inquiries that can be made into an employee’s medical status. Specifically, the ADA prohibits employers from making disability-related inquiries and requiring medical examinations, unless (1) the employer can show that the inquiry or exam is job-related and consistent with business necessity, or (2) where the employer has a reasonable belief that the employee poses a direct threat to the health or safety of the individual or others that cannot otherwise be eliminated or reduced by reasonable accommodation.

According to Pandemic Preparedness Guidance published in 2009 by the Equal Employment Opportunity Commission (EEOC) in the midst of the H1N1 influenza outbreak, whether a particular outbreak rises to the level of a “direct threat” depends on the severity of the illness.  Employers should look to the most up-to-date assessments being made by the CDC or other public health authorities, as they relate to the employer’s location, to determine the severity level of an illness and, in turn, whether an employee who potentially has been exposed to the illness may constitute a “direct threat.”  Employers should not rely on speculation or unofficial information when making determinations about whether there is a direct threat.  At the moment, the CDC is not classifying the Coronavirus as a pandemic and has not issued a heightened threat level for the United States.  However, the situation continues to rapidly evolve and we will provide updates should additional guidance be released by the CDC or other public health officials on this important issue.

All this being said, employers should keep in mind the following when it comes to employees who have traveled to affected areas:

  • Employers need not wait until an employee returning from travel develops symptoms to inquire about exposure to the Coronavirus. Inquiring about whether an employee has traveled to an affected area or about possible exposure to a contagious illness during such travel would not constitute a disability-related inquiry.  However, as discussed below, the extent to which an employer may act on the information received will depend on the most recent information available from the CDC or other public health officials.  Further, employers inquiring into whether employees have traveled to affected areas should do so of all employees known or believed to have recently traveled, rather than directing such inquiries only to employees of certain races, ethnicities, or national origins. Finally, employers should be mindful to keep confidential all medical-related information received from an employee, in accordance with the ADA.
  • Under certain circumstances, employers may require employees who have traveled to areas affected by serious health threats to stay home. If the CDC or other local public health officials recommend that people who visit specified locations remain at home for several days until it is clear they do not have illness symptoms, an employer may require an employee who traveled to an affected area to remain out of work for the suggested period of time.  While presently the CDC states that individuals who may have been in close contact with someone with the Coronavirus may continue with their daily activities so long as they are not showing any symptoms, employers should continue to monitor the CDC website for further developments. In the absence of a CDC directive that employees who have traveled to affected areas stay at home, an employer who is considering requiring such employees to remain home, they should consult with counsel.

What Other Things Should Employers Be Thinking About When it Comes to the Coronavirus?

  • Employers may – and should – send employees home if they exhibit potential symptoms of contagious illnesses at work. The EEOC has said that sending an employee home who displays symptoms of contagious illness would not run afoul of the ADA’s restrictions on disability-related actions because: (i) if the illness ultimately turns out to be relatively mild or “run of the mill” (such as seasonal influenza), then it would not have constituted a covered disability in the first place; and (ii) if the illness does turn out to be severe (such that it may constitute a disability under the law), then the actions would be warranted under a direct threat analysis. In either case, an employer can send an employee home who is displaying symptoms of contagious illness, even if this is against the employee’s wishes.  Employers should also consider making clear in their policies that employees who have symptoms of a potential contagious illness must not report to work while they are sick.
  • Determine whether the FMLA or other leave laws may apply. An employee who is experiencing a serious health condition or who requires time to care for a family member with such a condition may be entitled to take unpaid leave under the federal Family and Medical Leave Act (FMLA) or state-law analogues.  Employees may also be eligible for leave as a reasonable accommodation under the ADA or related state or local law, if the underlying condition constitutes a qualifying disability.  However, employees generally are not entitled to take FMLA or reasonable accommodation leave to stay at home to avoid getting sick (though an exception may exist where a preexisting medical condition is likely to be worsened by exposure to a contagious disease). Furthermore, employees in certain jurisdictions may be entitled to paid sick leave if needed to care for themselves or a sick family member in the event of an illness, or if their workplace or a child’s school or day care is closed due to a public health emergency.
  • Consider whether OSHA requirements may apply. While, as noted above, OSHA has not promulgated specific standards covering the Coronavirus, it has issued a notice indicating that employers should be aware of the following general standards to which employers may be subject under OSHA:
    • General Duty Clause: As discussed above, the OSHA General Duty Clause requires employers to furnish “a place of employment which [is] free from recognized hazards that are causing or likely to cause the death or serious physical harm to … employees.” To that end, there are some readily achievable steps that employers can take to prevent the spread of the Coronavirus (and other contagious illnesses) within the workplace, such as: providing hand sanitizer to employees, ensuring that surfaces and eating areas are disinfected regularly, and encouraging employees who are sick to stay home. Employers also may start to consider certain policy changes they may wish to implement in response to the Coronavirus should the situation become more severe in the U.S., such as allowing employees to work from home.
    • Personal Protective Equipment: OSHA requires that protective equipment, clothing, and barriers be provided whenever it is necessary to prevent employees from being exposed to environmental hazards. Employers are required to assess the workplace, determine if hazards are present, and if so, select and have employees use protective equipment. Employers whose employees may encounter individuals infected with the Coronavirus, such as those in the healthcare and travel industries, should begin to consider what protective equipment would be necessary to protect its workforce should the virus begin to spread within the United States.
    • Recordkeeping and Reporting Requirements: OSHA requires that certain employers keep a record of certain work-related illness and injuries (often referred to as an OSHA Form 300 log). While there is a regulatory exemption for recording instances of the standard cold and flu, OSHA has deemed the 2019 Novel Coronavirus a recordable illness when a worker is infected on the job. In addition, certain employers may be subject to reporting requirements under state and local law if they have a reasonable belief that a significant disease is present in the workplace.
    • Employers in Higher-Risk Industries: While, again, OSHA has yet to issue any standards or controls specific to Coronavirus, employers operating in industries where employees may be at a potential increased risk of exposure should prepare for the possibility that heightened requirements may be put in place. In the past, OSHA has issued such guidance for employers in industries such as healthcare, airlines, and mortuary services, such as during the MERS outbreak in 2015.

*          *          *

Information about the Coronavirus is constantly developing, so employers also should continue to refer to the CDC, WHO, and OSHA websites for the latest on appropriate precautions, including changes to travel notices.  Of course, we will continue to monitor this situation and report on any updates as they develop.

© 2020 Proskauer Rose LLP.

HHS HIV Drug Lawsuit: Setting Precedent for Other High Priced Medications or Government Collaborations?

On November 6, 2019, the bonds between the U.S. government and pharmaceutical companies were stretched when the U.S. Department of Health and Human Services (“HHS”) filed a patent infringement lawsuit against Gilead Sciences in Delaware federal court regarding Gilead’s popular HIV drugs, Truvada® and Descovy®.  HHS rarely sues for patent infringement.  In fact, the U.S. government and pharmaceutical companies typically have collaborative relationships.  For example, Gilead provided the Center for Disease Control and Prevention (“CDC”) with free drugs for government experiments to expand treatment for certain diseases.  So, what happened?

In 2004, Gilead—after receiving patent protection—began selling Truvada® to treat people already infected with HIV.  The CDC later investigated whether Truvada® could be used as a prophylactic to prevent HIV in monkeys and received patent protection for four key patents that “generally cover processes for protecting a primate or human host from a self-replicating infection by an immunodeficiency retrovirus, including HIV.”  (Complaint, ¶ 196).  Specifically, the claimed inventions provide protection “by a combination of nucleoside reverse transcriptase inhibitor, such as FTC, and a nucleotide reverse transcriptase inhibitor, such as tenofovir, or esters/prodrugs of tenofovir, such as TDF or TAF.” Id. Gilead donated the FTC, TDF, and tenofovir used in the CDC’s research, but its personnel do not appear to have otherwise assisted in the research.

The government alleges that first, it helped develop the drug with Gilead, and second, that Gilead “repeatedly refused to obtain a license from CDC to use the patented regimens” and “profited from research funded by hundreds of millions of taxpayer dollars[,]” without paying any royalties to the CDC.  HHS seeks damages and royalties for Gilead’s alleged infringement.  Many speculate that HHS’s motivation goes beyond royalties to something deeper: to increase access and decrease the price of Truvada® and Descovy® for pre-exposure prophylaxis (“PrEP”).

One goal identified by the Trump administration is to eradicate new cases of HIV and AIDS by 2030.  In fact, the administration requested $291 million for this initiative in May 2019. Truvada® and Descovy® play a critical role in PrEP.  PrEP is stated to be a highly-effective HIV prevention strategy that may play a vital role in ending the global HIV and AIDS epidemic.  However, PrEP is not as widely used as it could be.  Some allege that the limited use is related to limited access to the drugs—which in turn could be due in part to the high cost.  In the United States, Truvada® costs roughly $1,782 a month.[1]  Some have speculated that this suit is part of the Trump administration’s initiative to lower PrEP prices and end the HIV epidemic in the United States.  But is there more?

Political anger and public outcry over drug costs has increased over the years.  Three years ago, a national controversy erupted over the price of EpiPen injectors manufactured by Mylan pharmaceuticals.  In 2008, EpiPens cost about $100.  In 2016, that price rose to $600.  This price increase outraged customers and put the company at the forefront of the debate over drug costs.  Public outrage, coupled with a whistleblower lawsuit, led Mylan to finalize a $465 million settlement with the U.S. Justice Department over claims that it overcharged the government for EpiPens.

The EpiPen controversy, coupled with the HHS lawsuit against Gilead, may signal to pharmaceutical companies across the country that the U.S. government is ready and willing to step in and demand lower drug prices.  Accordingly, this case may be an important bellwether and should be followed by those with interests in these areas.

[1] Descovy® is new to the market, so the average monthly cost is unknown.

©1994-2019 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

ARTICLE BY Aarti Shah and  Kara E. Grogan of Mintz.
For more on drug patents, see the National Law Review Intellectual Property law page.

FDA Works to Find Source of Multi-State Outbreak of E. coli Infections

On November 20, the Centers for Disease Control and Prevention (CDC), in conjunction with the Food and Drug Administration (FDA) and several state agencies, announced that it is currently investigating an outbreak of Shiga toxin-producing E. coli (STEC) O157:H7 infections that has so far impacted at least 17 people across 8 states. The first reported illnesses date back to September 24, 2019. Investigators are looking into a branded chicken Caesar salad as a potential source, after the Maryland Department of Health (MDH) identified E. coli O157 in an unopened package. However, MDH is still conducting a whole genome sequencing (WGS) analysis to determine if it is closely related genetically to the E. coli identified in this outbreak.

As previously reported on this blog, in January 2019, FDA’s Food Safety and Inspection Service (FSIS) transitioned to using only WGS for Shiga toxin-producing E. coli (STEC) in an effort to update its analytical methods to the state of the art. The method of WGS determines the order of all of the DNA building blocks (nucleotides) in an organism’s entire genome in a single laboratory process, and a comparison of the DNA sequence of an isolated bacterial pathogen to the sequences from other samples in a DNA database can pinpoint the source of a foodborne disease outbreak.

The recent outbreak follows a similar outbreak of E. coli 0157:H7 from 2018 that was ultimately traced to romaine lettuce. The 2018 outbreak included 62 cases from 16 states and the District of Columbia, and prompted FDA to issue recommendations for leafy greens growing operations as well as a partnership between FDA and leafy greens stakeholders in Arizona to enhance food safety. Subsequent research from the U.S. Department of Agriculture’s Agricultural Marketing Service found that pest flies were a potential vector in the spread of the E. coli O157:H7 and contamination of leafy greens.

© 2019 Keller and Heckman LLP

For more in food safety, see the National Law Review Biotech, Food & Drug law page.

Mayo Clinic Reports Vaping Injuries Resemble Chemical Burns

The Centers for Disease Control and Prevention (CDC) announced that over 1,000 people became ill from vaping e-cigarettes, including 18 deaths. Now, research by the Mayo Clinic of Arizona suggests the lung damage may be the result of chemical burns.

The CDC announced that 77% of the injured vapers were using e-cigarettes with tobacco and THC products, and 17% were using only nicotine. The CDC partnered with state-based health care services and research hospitals to try to determine the cause of the recent spike in vaping lung damage cases.

The Mayo Clinic of Arizona is one of the first to release data derived from recent cases. The research team tested lung biopsy samples from 17 patients, including two who have since died from the condition. All 17 biopsies suggested that the lung injuries were most likely caused by “direct toxicity or tissue damage from noxious chemical fumes.” These fumes are generated from the vaporized e-cigarette liquids. Researchers said it does not appear that the build-up of lipids, reported earlier as a possible cause of the lung damage, was a factor in these 17 patients.

According to Dr. Larsen, the senior author of the study, “It would seem prudent based on our observations to explore ways to better regulate the industry and better educate the public, especially our youth, about the risks associated with vaping.”

COPYRIGHT © 2019, STARK & STARK

For more on vaping regulation, see the Nationa Law Review Biotech, Food & Drug law page.

Vaping Businesses Catch a Bad Rap: The Recent Ban of ALL Vaping Products in Massachusetts Unfairly Prejudices the Vape Industry and Vape Consumers

Massachusetts has taken a drastic and abrupt step by banning the sale of all vaping products, nicotine and THC, within its state borders for the next four months. This drastic and sweeping prohibition against vaping products will have far-reaching economic consequences for many small businesses that make up the bulk of this new and burgeoning industry. The root cause of the recent vaping-related illnesses appears to be the result of illicit and unregulated THC cartridges from the black market.

Reports and Causes

Dr. Michael Siegal, a professor at Boston University’s School of Public Health, recently stated: “Given the fact that close to 90% of the cases and 100% of the deaths for which products have been reported are associated with marijuana vaping, it is inexcusable that the CDC [Centers for Disease Control and Prevention] fails to distinguish between the products being vaped.” The communications from CDC also have failed to distinguish between vaping oil-based e-liquids − which were used in the illicit THC cartridges that have given rise to multiple arrests in Arizona and Wisconsin and cause lipoid pneumonia − and the water/alcohol-based e-liquids that are used in virtually all e-cigarettes. More troubling is the fact that the media largely has overlooked that the manufacturers of nicotine-containing e-liquids filed their ingredient lists with the FDA years ago.

On September 27, 2019, the CDC released the following information:

  • There are 805 lung injury cases reported from 46 states and 1 U.S. territory. Twelve deaths have been confirmed in 10 states.
  • CDC has received sex and age data on 771 patients.
    • About 69% of patients are male.
    • Nearly two thirds (62%) of patients are 18 to 34 years old; with 22% of patients between 18 and 21.
    • Sixteen percent of patients are under 18 years of age.
  • All reported patients have a history of e-cigarette product use or vaping.
  • The latest findings from the investigation into lung injuries associated with e-cigarette use or vaping suggest products containing THC play a role in the outbreak.
    • CDC has received data on substances used in e-cigarettes or vaping products in the 30 days prior to symptom onset among 514 patients:
      • About 77% reported using THC-containing products; 36% reported exclusive use of THC-containing products.
      • About 57% reported using nicotine-containing products; 16% reported exclusive use of nicotine-containing products.

While some policy makers appear to be confused over the cause of the recent reports of lung disease, there is no coincidence that the recent use of vitamin E acetate and possibly other unapproved thickening agents by the illicit THC manufacturers caused the public health crisis that prompted Massachusetts’s ban of all vapor products. One should ask whether it makes sense that vaping nicotine e-liquids, which have been available since at least 2007, would suddenly cause lipoid pneumonia lung disease (which is a rare condition that occurs when fat particles enter the lung) disproportionately in white males with an average age of 19.

Impact of the Ban

The abrupt action of Massachusetts resembles the witch hunts of that former colony’s past. With a single stroke of a pen on an emergency order from Governor Charlie Baker, Massachusetts has foreclosed the right of its citizens to their freedom of choice, denying them the right to an arguably safer alternative to smoking cigarettes, and caused far-reaching economic harm to many small businesses that manufacture and sell vaping products. Such an action will surely cause many bankruptcies, as these legal businesses can no longer afford to pay rent or buy products made and/or sold by other U.S. companies, pay salaries to employees, or pay taxes to Massachusetts and the federal government.

The economic impact of the vaping industry in the United States in 2018 was almost $24 billion, which means that the impromptu actions of Massachusetts will likely cause a reversing trend and cast a negative shadow over a legitimate and safe industry. The broad scope of the ban smacks of an unconstitutional taking of property without due process. Many affected businesses will have difficulty surviving without four months of revenue, which is why national trade organizations such as The Vapor Technology Association and others are considering legal options.

Call for International Forum on Safety and Health Benefits

Unfortunately, as the witch hunts continue, consumers will not be safer. Any person who was vaping legal nicotine containing e-liquids rather than smoking combustible cigarettes will have to make the choice to return to smoking combustible cigarettes or buy a black market e-liquid product. Citizens of Massachusetts who legally use THC through vaping for medicinal purposes also will be affected by the ban. Since all the data shows the lung disease breakouts were overwhelmingly caused by illicit THC cartridges made with vitamin E acetate or other unregulated thickening agents, the public health ban on legitimate products only increases the black market demand and the risk of illicit THC cartridges finding their way back into the hands of consumers, in addition to creating a black market for nicotine e-liquids while the CDC warns consumers not to buy these products off the street

The manufacturers of both nicotine-containing e-liquids and THC-containing products support meaningful regulation so health problems caused by illicit manufacturers can be prevented. A sensible public health strategy devised by the federal government likely could have prevented many of these illnesses and deaths by stopping unregulated illicit-market THC vape products from getting into the hands of consumers. But the voices of science and good public policy are falling on deaf ears while legitimate small businesses are being harmed and consumer choices for legitimate products are being eliminated.

One can only hope that Massachusetts reconsiders this ban and that other states do not follow this type of overreaching prohibition. Public policy regulators should discuss these issues in an international forum such as The E-Cigarette Summit, where the public health benefits experienced by the UK and other countries as well as the detailed facts of the recent cases of lung disease can be debated before businesses are closed. Until then, the black market profits while legal small businesses are “vaporized.”

© 2019 Wilson Elser

For more on vaping regulation, see the National Law Review Products Liability page.

Long-Term Effects of Nonfatal Drowning Cannot Be Accurately Predicted

According to the Centers for Disease Control and Prevention (CDC), from 2005-2014, an average of 3,536 fatal unintentional drownings occurred per year in the United States. Approximately one in five people who die from drowning are children 14 years old or younger; children one to four years old have the highest drowning rates.

For every death caused by drowning, five children receive emergency room care for nonfatal drowning injuries. Nonfatal drowning can cause hypoxic-ischemic brain injury that may result in long-term disabilities ranging from memory problems and learning disabilities to total loss of basic functioning (persistent vegetative state).

A recent review study found that neurocognitive outcome of children after drowning incidents cannot be accurately predicted from early examinations and treatment. In the study, researchers sought to:  a) report the main factors related to the outcome of drowned children, and b) present existing evidence of long-term neurologic outcome. While some injuries caused by near drownings become evident shortly after the incident, the evidence showed that the initial neurological examination may not reveal all of the long-term effects related to hypoxic brain injury in young children. Skills such as divided attention and executive functions may be negatively affected after a brain injury caused by a nonfatal drowning. Long-term follow-up of drowned resuscitated children should be undertaken.

The review study showed that the long-term outcome of survived drowning victims depends mainly on the severity of the initial ischemic brain insult, the effectiveness of immediate resuscitation with transfer to the ER, and on the post-resuscitation management in the hospital. The study noted that the most susceptible areas to ischemic injury are vascular end zones, hippocampus, insular cortex, and basal ganglia. With greater severity of hypoxic-ischemia, more extensive and global neocortical injury will occur.

Electroencephalograms (EEG) provide useful information to differentiate between patients with good and poor neurological outcome. However, the accuracy in predicting long-term neurological outcome is lacking. The increased use of neuroimaging techniques such as MRIs can add valuable information. The ability to see the degree of edema and brain swelling is better with an MRI than with a CT scan. But the fact remains that data on long-term follow-up and outcome are scarce.

This post was written by Bruce H. Stern of  Stark & Stark.

Employers: How Prepared Are You for Ebola?

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Rapidly changing circumstances raise workplace questions.

The Ebola epidemic in 2014 has already been confirmed by the U.S. Centers for Disease Control (CDC) as the worst in history. The extent of this outbreak is still unknown, as reports of Ebola transmissions continue not only in West Africa but also (for the first time in history) inside U.S. and European borders. Because of the potential risks in a globalized economy, the U.S. government, its various agencies, and employers alike are now scrambling to ensure that appropriate rules and procedures are in place to prevent any further exposure to the disease. Reactions have been swift and fluid as officials learn more about the presence of the virus in West Africa and beyond and as they develop strategies to respond. Among the federal agencies that have already taken action, the CDC has recently issued “tightened” guidance for proper personal protective equipment (PPE) in the healthcare industry, and the Occupational Safety and Health Administration (OSHA) has issued guidance covering a number of workplace safety issues. The situation is changing rapidly and further action is expected by the U.S. government, especially after the White House announced the appointment of an Ebola Response Coordinator (or Ebola Czar).

In the United States, employers are facing challenges and questions on how to best address a wide variety of issues, including workplace safety, travel policies, employee relations, leaves of absence, and refusal to work requests. Whether responding to Ebola or other emergencies, employers should use protocols that include emergency preparedness and response plans, such as assigning responsibilities, assessing the hazard, conveying effective communications, and implementing security measures to address those key issues. In the meantime, here is what you need to know right now.

OSHA’s Interim Guidance

OSHA quickly released interim guidance for workers within the United States that focuses on those in industries most likely to be affected by the Ebola crisis:

  • Healthcare workers

  • Airline and other travel industry personnel

  • Mortuary and death care workers

  • Laboratory workers

  • Border, customs, and quarantine workers

  • Emergency responders

  • Employers in critical infrastructure/key resource sectors, such as bus drivers and pharmacists

Employers in these key industries must evaluate how they currently respond to emergencies and if those preparedness and response plans are adequate or need modification, particularly when assessing hazards specific to their jobsites (OSHA lists industry-specific information on its website). These employers should explore ways to proactively combat and contain the virus, such as obtaining PPE, implementing cleaning and sanitation procedures, and evaluating whether engineering controls, such as pressurized glass, respirators, and decontamination devices, should be used. If an employer happens to be a hospital or similarly licensed accredited facility, state licensing and other laws as well as accreditation bodies may require those organizations to activate emergency preparedness plans. Employers should communicate with their workers and train them about sources of Ebola and any required precautions.

On its newly released website dedicated to Ebola, OSHA has asserted jurisdiction over potential worker exposure via several regulations already in place. Most notably, the Ebola virus has been classified as a “bloodborne pathogen” under OSHA’s Bloodborne Pathogens standard,[1] which explicitly covers pathogens like hepatitis B virus (HBV) and human immunodeficiency virus (HIV). The Bloodborne Pathogens standard imposes a range of requirements on employers whose workers can be reasonably anticipated to contact blood or other potentially infectious materials (OPIM), such as saliva and semen. Covered employers must train employees, prepare exposure control plans, and use “universal precautions,” engineering and work practice controls, PPE, and housekeeping measures to contain the virus. Employers must also offer medical evaluations, blood tests, and follow-up evaluations after any worker is exposed to blood or OPIM. The standard contains many other nuanced requirements, including carefully documenting compliance measures. Given the complexities of the regulation, employers are strongly encouraged to seek legal advice if workers could anticipate exposure and to seek emergency, medical, and legal advice if any work-related exposure to blood or OPIM occurs.

Beyond this standard, OSHA has reminded employers that—when undertaking precautions for contact-transmissible diseases and any bioaerosols containing the Ebola virus—they must comply with OSHA’s (1) Respiratory Protection standard[2] if respirators are used on the job and (2) PPE standard[3] wherever PPE is used as a precaution. Finally, OSHA reiterated that it may issue citations against employers under the General Duty Clause of the Occupational Safety and Health Act of 1970[4]—OSHA’s “catch all” provision, which is used if no other regulation applies and where an employer allegedly fails to keep its workplace free of recognized hazards that can cause death or serious bodily harm to workers.

CDC Involvement

The primary U.S. agency embroiled in the fight against Ebola is the CDC. Of the many steps taken by the CDC in this effort, highlights of the latest guidance and advice are outlined below.

“Tightened Guidance” on PPE for U.S. Healthcare Workers

Following widespread criticism after two nurses contracted Ebola while treating a patient in Dallas, Texas, the CDC released on October 20 “tightened guidance” for PPE used by healthcare workers while caring for patients with Ebola. According to the CDC, three guiding principles control: (1) Employees must receive rigorous and repeated training to fully understand how to use PPE, (2) no skin can be exposed when PPE is worn, and (3) a trained monitor must be present to supervise all workers as they put on or take off PPE. The CDC also described “different options for combining PPE to allow a facility to select PPE for their protocols based on availability, healthcare personnel familiarity, comfort and preference while continuing to provide a standardized, high level of protection for healthcare personnel.” Among the recommendations for monitoring the safe use and removal of PPE, the CDC provides advice on step-by-step PPE removal, as well as disinfection of gloved hands.

In addition to PPE, the CDC further underscored other critical prevention activities to respond to the Ebola risk, including (1) prompt screening and triage of potential patients, (2) designating site managers who have the responsibility to ensure proper implementation of precautions, (3) limiting personnel in the isolation room, and (4) effective environmental cleaning. Employers in the healthcare industry should be aware that the CDC has highlighted management responsibility “to provide resources and support for the implementation of effective prevention precautions” and that management “should maintain a culture of worker safety in which appropriate PPE is available and correctly maintained, and workers are provided with appropriate training.” For more information and advice for healthcare workers, visit the CDC’s website.

Health and Travel Advisories

Given the severity of the risk that Ebola poses, the CDC has issued health and travel alerts, which it will continue to update as the situation develops. In the wake of various governors, particularly those from New York, New Jersey, and Illinois, having announced plans to quarantine health workers traveling from West Africa who treated Ebola patients, the CDC has also updated its guidance on October 27 regarding the monitoring and movement of persons with potential Ebola exposure. The guidance applies to anyone who recently traveled to West Africa and may have been exposed to Ebola and includes newly created tiered categories of risk, ranging from high to no risk and based on exposure to Ebola. Depending on the risk category, the CDC recommends that state and local health authorities isolate travelers who are exhibiting signs of illness or conduct “active” or “direct active” monitoring of signs and symptoms of Ebola for other at-risk individuals.

Health officials will make at least daily contact with these travelers, requiring travelers to disclose (1) temperatures and any other Ebola symptoms, such as headache, diarrhea, and vomiting, and (2) intent to travel out of state. For individuals who are under direct active monitoring, the CDC recommends that discussions with the individual include plans to work, travel, take public transportation, or go to busy public places to determine whether these activities are allowed.

Employers, and particularly employers with an international presence, should closely monitor these CDC travel advisories,[5] as well as advisories published by the World Health Organization (WHO).[6] Employers should evaluate their own travel policies and alerts against those published by the CDC and the WHO.

Protecting Employees from Impacted Regions from Harassment and Protecting the Confidentiality of Medical Information

Like the CDC, employers must respect workers’ privacy—and, particularly, the confidentiality of their medical information pursuant to the Americans with Disabilities Act (ADA)—and they must also comply with rules and guidance from OSHA, the CDC, and other agencies. Employers should balance their need to ensure workplace safety with their obligation to avoid unnecessary or overbroad medical inquiries, which are prohibited by the ADA. Of course, if an employee is exhibiting symptoms of Ebola exposure, it is appropriate to urge him or her to see a doctor. However, the decision to send an employee for a medical exam or to request medical documentation should be based on objective information—not unfounded fears that may or may not be grounded in reality. As an example, without some reason to believe there has been Ebola exposure, it could be risky to request medical information simply because an employee visited an Ebola-impacted region.

Employers should also take caution and consult legal counsel before they send home an employee suspected of Ebola exposure. The decision to remove an employee from the workplace for medical reasons must based on objective belief that the employee may present a direct threat of significant, imminent harm to himself or herself or others. These decisions should not be based on rumor or unfounded concerns.

To address these issues, employers should train human resources employees about the CDC guidance so they can understand the medical and scientific realities of Ebola exposure and, therefore, be prepared to respond appropriately if employees express concern about a coworker believed to be at risk for Ebola exposure. Similarly, employers should take all necessary steps to ensure that employees who are, or who are perceived to be, from regions impacted by Ebola do not experience harassment based on race, national origin, or any perceived medical condition.

HIPAA

The Ebola situation has also introduced some Health Insurance Portability and Accountability Act (HIPAA) interpretation questions for employers that are Covered Entities—such as healthcare providers—but also for those that sponsor a Covered Entity group health plan. HIPAA protects an individual’s protected health information (PHI), which includes, for example, medical, demographic, and other identifying information. HIPAA restricts Covered Entities from disclosing PHI about a worker or plan participant, except in limited circumstances. To date, the U.S. Department of Health and Human Services has not indicated that the Ebola crisis will change its enforcement or interpretation of HIPAA. The HIPAA Privacy Rule and Security Rules, as amended by the Health Information Technology for Economic and Clinical Health Act, will still apply to Covered Entities. Although narrow exceptions exist for use or disclosure for certain public health purposes, this exception will likely only apply in limited situations for limited organizations. Covered Entities should review their policies and procedures to determine if and how infectious diseases, particularly Ebola, are addressed. They should also train their Privacy Employees—workers who act on behalf of the Covered Entity—to continue to protect an individual’s PHI. Before disclosing any PHI, Covered Entities should exercise caution and consult with legal counsel to confirm that a use or disclosure will not constitute a HIPAA violation.

Labor Relations

In light of the media furor from various healthcare and service workers’ unions regarding Ebola risks to workers, employers should also expect to receive collective bargaining demands related to training, adequate safety procedures, and protective equipment and medical services provided to exposed employees, potentially including demands for leave (whether paid or unpaid). Employers should be proactive, therefore, in reaching out to union representatives of healthcare workers to develop protocols on how best to handle these types of issues, and, given the labor laws, should not act unilaterally, even if well intentioned and even if the to-be-implemented protocols are favorable to employees. Employers should also review their current collective bargaining agreements for any clauses or language requiring the employer to implement procedures related to infectious diseases or the safety of their workers. Finally, even nonunion workers can exercise rights under the National Labor Relations Act (NLRA) to engage in concerted activity for their mutual aid and protection if workers fear their safety is not adequately protected. A refusal to work because of safety concerns related to Ebola, therefore, could be protected under the NLRA, and employers should carefully consider this issue prior to implementing discipline to employees for refusing to work.

Immigration

In coordination with the CDC, the Department of Homeland Security (DHS) implemented a set of travel restrictions[7] involving additional screening and protective measures for travelers from Ebola-affected countries at U.S. ports of entry. Travelers to the United States who are arriving directly or indirectly from Liberia, Sierra Leone, or Guinea will undergo enhanced screening that includes the following:

  • Identifying and interdicting travelers from the Ebola-affected countries.

  • Isolating these travelers from the rest of the traveling public while the individual completes a questionnaire and contact information form.

  • Medically trained personnel will take the traveler’s temperature. If the traveler has a fever or other symptoms, or may have been exposed to Ebola, U.S. Customs and Border Protection (CBP) will refer the traveler to the CDC for a public health assessment. The CDC will then determine whether the traveler can continue to travel, should be taken to a hospital for further evaluation, or should be referred to a local health department for further monitoring.

  • Encouraging the traveler to seek healthcare at the first sign of any potential illness.

If CBP discovers that a traveler has been in one of the three countries in the prior 21 days, he or she will be referred for additional screening, and, if necessary, the CDC or other medical personnel in the area will be contacted pursuant to existing protocols. The enhanced screening is in place at the five U.S. airports that account for 94% of travelers flying to the United States from Ebola-affected countries. The airports are John F. Kennedy International, Newark Liberty International, Washington Dulles International, Hartsfield-Jackson Atlanta International, and Chicago O’Hare International. DHS has authority under existing law to deny admission to individuals who represent a public health threat.

Given the rapidly changing circumstances, employers are faced with many labor and employment challenges to consider.

[1]. 29 C.F.R. § 1910.1030.

[2]. 29 C.F.R. § 1910.134.

[3]. 29 C.F.R. 1910.132.

[4]. View the act here.

[5]. View the advisories here.

[6]. View the advisories here.

[7]. View the restrictions here.

ARTICLE BY

Jonathan L. Snare
Joyce A. Cowan
Eric S. Bord
Ross H. Friedman
Michelle Seldin Silverman
Georgina L. O’Hara
OF
Morgan, Lewis & Bockius LLP

A Guide to Dealing with Illnesses in the Workplace

Godfrey Kahn Law Firm

As a result of all of the media coverage surrounding the Ebola issues, many of our clients have wondered whether they need to do anything, as employers, to prepare for similar issues and to address related employment issues. Whether it is the Ebola virus or another virus or pandemic, the general rules for employers remain the same.

The Ebola Virus Basics

The key to contracting the Ebola virus is direct contact (through broken skin or mucous membranes in, for example, the eyes, nose or mouth) with someone who is carrying the virus.  The Centers for Disease Control and Prevention (“CDC”) has a website dedicated to understanding, preparing for and preventing the spread of the Ebola virus.  For additional information regarding the Ebola virus, including symptoms and other useful information, please visit the CDC’s website.

For employers, the key is not to panic.  Given that we are at the early stages of flu season, employers should avoid overreacting at the first sight of an employee with flu-like symptoms.  Employers concerned about particular employees should consult with legal counsel before taking any steps that may lead to liability under various employment laws (more on this below).

Important Employment Issues Each Employer Should Consider

Pandemics (whether the Ebola virus, the 2009 H1N1 virus or influenza) implicate a number of employment laws.  Employers must strike a proper balance between protecting employees from infection and operating within the confines of applicable law.

1. Consider the requirements of the Americans with Disabilities Act before requiring employees to undertake a medical examination.

The Americans with Disabilities Act (“ADA”) prohibits, among other things, medical examinations for applicants and employees.  An employer cannot require a current employee to undergo a medical examination unless the examination is job related and consistent with business necessity.  According to the Equal Employment Opportunity Commission (“EEOC”), medical examinations of an employee are job-related and consistent with business necessity when an employer has a reasonable belief, based on objective evidence, that (1) an employee’s ability to perform essential job functions of his/her job will be impaired by a medical condition; or (2) an employee will pose a direct threat due to a medical condition.  “Direct threat” means “a significant risk of substantial harm to the health or safety of the individual or others that cannot be eliminated or reduced by reasonable accommodation.”  29 C.F.R. § 1630.2(r).  For additional guidance on direct threats, please see the EEOC’s website.

The EEOC’s 2009 guidance specific to the H1N1 virus sheds additional light on how employers should make direct threat assessments before requiring a medical examination.  The EEOC states that whether a pandemic virus rises to the level of a direct threat depends on the severity of the illness.  Helpful data points to determine the severity—and associated direct threat—of a virus are the warnings and guidance from government agencies such as the CDC, state health departments and other recognized authorities on illness and disease.

2. Consider the Occupational Safety and Health Act when accessing your workplace practices.

In addition to the ADA’s medical inquiry restrictions, most employers must follow the safety and health regulations dictated by the Occupational Safety and Health Administration (“OSHA”) under the Occupational Safety and Health Act (“OSH Act”).  Although OSHA does not specifically regulate Ebola or other pandemics, employers may trigger workplace safety violations under OSHA’s General Duty Clause if they do not take proper steps to protect their employees.

Employers run the risk of receiving citations under the General Duty Clause if they expose employees to a hazard that the employer could reasonably have reduced and that the employer recognized would cause or likely would cause serious physical harm to employees.  Employers in industries with a high risk of disease contamination (e.g., healthcare employers) should therefore evaluate potential hazards and determine whether they can take steps to reduce the risk of exposure to employees.

Employers should also keep in mind that an employee who reasonably refuses to report to work because of a dangerous work condition—including contracting a pandemic virus—may be protected from retaliation.

OSHA’s guidance about Ebola and pandemic influenza provides useful information for employers who want to prepare for and respond to contagious disease risks in their workplaces.

3. Employees may be entitled to leave under the Family and Medical Leave Act.

Federal and state (where applicable) family and medical leave laws (“FMLA”) complicate the web of responsibilities an employer has to navigate when it comes to dealing with ill employees.  For employers covered by these laws (generally employers with 50 or more employees under federal law), an eligible employee who has contracted the Ebola virus or another pandemic virus may qualify for leave based on a serious health condition.  Similarly, an eligible employee may qualify for leave if an eligible family member contracts a virus that qualifies as a serious health condition.

If an emergency situation prompts the need for FMLA leave, administering the leave in a lawful manner gets more complicated than under normal circumstances.  For example, it may not be practical to solicit and review medical certification forms.  In these situations, employers must have sufficient information (including the employee’s statements) that the underlying condition qualifies as a serious health condition.  Designating leave as FMLA without sufficient information establishing a serious health condition can result in a retaliation claim.  In emergency situations, employers may also need to exercise forbearance on the return of medical certification forms, particularly if an employee needs to assist a family member who is ill.  For additional FMLA guidance, please visit the United States Department of Labor website.

Steps Employers Should Take to Minimize Workplace Safety and Health Issues

As with any other workplace safety and health issues, the recent Ebola-related news has raised many questions about what employers should do when facing similar situations.  Although each employer is unique and each industry must confront different obstacles and risks, employers should, at a minimum, follow the steps outlined below.

  • Have a plan.  Consult with internal safety experts and review the guidance provided by government agencies regarding specific safety issues.  Create a plan (preferably with the assistance of legal counsel) that addresses issues specific to your workplace and your industry.

  • Communicate your plan to employees.  Your company’s protocols for dealing with safety issues should not be a secret to any of your employees.  Publicize the plan internally and ensure that employees have ready access to the plan.

  • Train your employees.  Train your employees about your company’s safety protocols on a yearly basis.  If you are concerned about a particular risk that is not usually common to your workplace or if you update your plan, provide additional training as needed to address these issues.

  • Supervise implementation of the plan.  Having a plan in place and training your employees to follow certain procedures is meaningless if no one supervises the process.  Designate individuals to review employee actions to ensure that the plan’s protocols are followed and to identify potential shortcomings of/improvements to the plan.  Whenever necessary, update your plan to ensure that it addresses all major safety risks and train employees on the changes made to the plan.

Employers that consult government and other advocacy organization websites to adopt ideas, disseminate information and prepare practices and procedures for addressing workplace safety and health issues will be in a good position to protect against unwanted legal action.

ARTICLE BY

Rufino Gaytán
OF
Godfrey & Kahn S.C.