Recently released surveys of nurses and dentists illustrate health care providers continued inability to quickly procure certified and authentic personal protective equipment. (PPE). A survey of more than 1,000 dental practices released earlier in May found that 90% of those surveyed were concerned about procuring PPE.  A survey of over 23,000 nurses found that 87% had to reuse a single-use PPE during the period between April 15-May 10. This shortage corresponds with a high rate of infection for nurses even though only 16 percent of those surveyed had been tested for COVID-19.  Add the demands of nursing homes for PPE and there is an unprecedented supply shortage with no end in sight.

While media coverage of the PPE shortage has subsided, skyrocketing worldwide demand is coupled with significant supply issues. The lack of inventory will certainly escalate in the Fall when most experts agree the number of COVID-19 cases will increase. Even now as elective surgery is gearing up and dentists’ offices are reopening around the country, it remains challenging for providers to procure adequate supplies of PPE.

Compounding the problem is the fact that China, the likely source of the COVID-19 pandemic, has also been the world’s largest exporter of PPE. In the years prior to the pandemic,  Chinese-manufactured PPE will remain a critical part of the U.S. supply chain until a vaccine is universally available. As new U.S. businesses look to enter the market and import PPE in from China to the U.S., stories of fraud and price gouging abound: Health care systems with established vendors importing from China have seen price increases of 500%.

In addition to exercising extreme due diligence to prevent becoming the victim of fraud, anyone seeking to enter this market must be up to date on the most recent U.S. rules and regulations as well as developments in China.  Of course, importers must comply with U.S. Customs requirements and China’s export requirements.   For those considering the importation of PPE, all U.S. Food and Drug Administration (FDA) requirements must be met as well. Under ordinary circumstances, requirements for PPE hinge on the specific type of PPE being imported.  It is more critical than ever to have up to date legal counsel as both FDA’s and China’s requirements have been continually subject to change since the beginning of the pandemic.

Facemasks, face shields and N95 respirators have been in particularly short supply for health care providers in hospital and nursing home settings. In guidance issued in April, the FDA recognized the shortage caused by the pandemic:

[W]hen alternatives, such as FDA-cleared masks or respirators, are unavailable, individuals, including healthcare professionals, might improvise PPE. FDA does not intend to object to individuals’ distribution and use of improvised PPE when no alternatives, such as FDA-cleared masks or respirators, are available.

The myriad and complexity of rules and competing regulatory bodies governing certain types of PPE, such as face masks and respirators, is boundless.  An unsuspecting market participant can quickly run afoul of these often-times confusing regulations without proper guidance.  In this sub-area of PPE alone there are no less than four (4) government agencies including the FDAthe Centers for Disease Control and Prevention (CDC)the Occupational Safety and Health Administration (OSHA) and The National Institute for Occupational Safety and Health (NIOSH), and each provide sometimes contradictory regulation and oversight.

For example, the FDA regulates masks and respirators as devices when they meet the definition of a device set forth in section 201(h) of the Food, Drug and Cosmetic Act (FD&C Act), because they are devices when they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease.  PPE that falls within this definition must follow FDA regulations and meet specific performance standards.  For facemasks, face shields, and N95 respirators that are intended for use by the general public or other industries such as construction, FDA marketing authorization and the FD&C Act do not apply.  However, PPE used in health care and other industries is also subject to guidelines issued by OSHA.  OSHA requires employers to provide PPE to protect against certain hazards at work, including blood or infectious material. NIOSH, housed within the CDC, certifies and approves PPE for occupational use.

To determine whether PPE you may be considering procuring or supplying meets the definition of a device under the FD&C Act, the FDA considers the following three (3) factors:

1) they are labeled or otherwise intended for use by a health care professional;
2) they are labeled or otherwise for use in a health care facility or environment; and
3) they include any drugs, biologics, or anti-microbial/anti-viral agents.

Compounding the complexity in this area even for lawyers let alone “civilian” market participants on the buy or sell side of the PPE transaction, the FDA has issued numerous Emergency Use Authorizations (EUA) designed to mitigate the shortage by altering enforcement or regulatory requirements for equipment used by both health care providers and the general public.  Face masks are either categorized as surgical or non-surgical masks.   Non-surgical masks do not function as PPE as they are designed solely for source control and do not filter particles or provide protection from fluid.  To increase the supply of non-surgical face masks (not to be used as PPE) for the general public pursuant to the CDC guidance, the FDA has stated that regulatory approvals will not be required when the use of the face mask will not create an undue risk in light of the public emergency. The FDA website includes the following statement:

During the COVID-19 public health emergency, a face mask for a medical purpose that is intended for use as source control, is not labeled as a surgical mask, and is not intended to provide liquid barrier protection, may be authorized under the ‘umbrella’ EUA for face masks without submitting documentation to the FDA if the face mask meets the eligibility requirements.  A face mask authorized under this EUA must comply with the Conditions of Authorization (Section IV) of the EUA.  Please note that this EUA does not authorize face masks for use as personal protective equipment.

The FDA has also eased regulatory requirements for surgical face masks which are intended to provide liquid barrier protection as long as certain requirements including designated performance standards and labeling are met.  N95 respirators have been the subject of several EUAs, and the FDA has now allowed previously unauthorized respirators to be used by health care workers.  Respirators are personal protective equipment that tightly fit the face and filter airborne particles to protect health care workers.  They provide a higher level of protection against viruses and bacteria when properly fit-tested.  OSHA mandates that employers “fit test” when an employee is required to wear any tight-fitting respirator on the job.  These types of respirators only perform properly if there is a tight seal around the face and neck. OSHA has also eased its requirements for PPE and fit testing as a result of the shortages.

Along with the FDA, NIOSH also certifies N95 respirators. The FDA has recognized certain NIOSH-approved disposable respirators (Filtering Facepiece Respirators (FFRs), Power Air-Purifying Respirators (PAPRs) and reusable respirators); expired or decontaminated respirators; and certain non-NIOSH-approved respirators, including certain respirators from China.  For each category of respirator, there are different requirements that allow for use in the health care settings.

In addition, the EUAs set forth procedures for additions to the authorized list.  However, on May 6, 2020, in response to concerns about sub-standard products, the FDA had to limit to 14 from 80 previously authorized FFR that were recognized in an April 3rd EUA.  On June 6, 2020 that EUA was updated yet again in response to concerns about which respirators, intended as single-use, could be appropriately decontaminated for additional use.  The National Personal Protective Technological Laboratory of the CDC, which conducted the initial testing, reported in the May 6 EUA that some of the tested devices may have been counterfeit but was unable even to verify the actual manufacturer.  The updated June letter to health care providers states that even the respirators that remain on the approved list cannot be decontaminated for another use.  NIOSH certified N95 respirators, normally single-use PPE, have been approved for additional use if a EUA recognized decontamination process is used.  Accordingly, retaining counsel early to perform careful due diligence and to provide a road map to avoid potential legal issues is strongly recommended if you are or plan to be an importer of N95 respirators into the U.S.

The determination of whether the N95 respirators meet the FDA definition of a medical device is also relevant to compliance with U.S. Customs and Border Protection (CBP) regulations.  CBP requires that all N95 respirators entering the U.S. include the following: 1) the submission of entry documents; 2) payment of estimated duties, including any additional tariffs (determined by the Office of U.S. Trade Representative (USTR)) on the goods; and 3) examination by, and release of, the goods from CBP.

Not surprisingly, the U.S. oftentimes tense relationship with China is adding to the risks associated with importing these items.  As of March 31, China limited the export of PPE to manufacturers that have proper certification by the national medical products registry, including those in the U.S.   In addition, all exports of PPE are subject to inspection for review of proper documentation. While these actions were stated to be a quality control effort after several shipments of defective PPE, critics noted that the majority of the approved manufacturers are Chinese state-owned enterprises (SOE).  These SOEs have limited manufacturing capacity, and while there are other manufacturers who appear to qualify, the certification process routinely takes one year.

To protect any transaction involving the importation of N95 respirators, legal counsel should be engaged early and throughout the entire process. P rior to entering into any agreement to import N95 respirators, legal counsel can assist with due diligence and investigation of potential suppliers.  Once a business supplier has been identified, the contract must address the litany of risks associated with importing these goods. As discussed, there are both substantial commercial and regulatory risks to be identified.  After undertaking extensive due diligence, the agreement can be drafted to mitigate the risk of fraud. On the regulatory side, legal counsel will guide you through compliance with the multitude of enforcement authorities and keep you apprised of the rapidly changing regulatory landscape.  With a huge demand building and supply currently limited, only those with trusted contacts and legal counsel should attempt to import from China during this challenging time.

Contact  Carolyn Kurtz, one of our Partners, to discuss any concerns you may have concerning your current or anticipated PPE business at ckurtz@zplaw.com.

We are proud to announce that our Managing Partner Michael Popok and Senior Partner Mitchell Mandell have both been recognized again by their New York peers as Super Lawyers in the area of Business Litigation.   For Michael and Mitch, that means that they are in the top 5 percent of lawyers in New York.   

Additionally, our Senior Associate Hamutal Lieberman has been recognized as a Rising Star placing her in the top 2.5 percent of her peers under 40 years old or with 10 years of practice or less.  Congratulations to Michael, Mitch and Hamutal.

 

 

As the COVID-19 pandemic continues, so have regulatory actions by the U.S. Food and Drug Administration (FDA) affecting the regenerative medicine industry.  This includes the issuance of agency demand letters also known as “warning” letters that are served on parties for alleged violations of federal law.  Historically, such actions were not rendered until an in-person inspection had taken place, giving a company time to prepare and comply.  However, based on the latest round of warning letters issued in 2020 and the last part of 2019, the FDA has transitioned to issuing these notices based solely on a review of a company’s website and other online materials which can often lead to a company being caught flat-footed and in violation.  This should be a reminder for businesses that offer unapproved stem cell products to immediately conduct a compliance review and determine if premarket review is required.

The FDA regulates the implantation, transplantation, infusion, or transfer of human cells and tissues into the body.  These cells and tissue products have been labeled by the FDA as HCT/Ps (i.e. human cells, tissues, and cellular and tissue-based products).  Usually, these types of products are regulated through the use of licensing applications that require premarket approval.  However, an exception exists for certain products from the review hurdle provided certain requirements are met.

But the guidance provided by the regulations around HCT/Ps have historically been viewed as unclear by the industry, and open to a wide range of interpretations.  This has led to many taking the position that their products fall under the “exception” (given it is the least costly regulatory option) than seeking premarket review which can be costly.  To crackdown on bad actors in the industry and to clear the air on its position, the FDA issued new guidance in November 2017.  In this guidance, the FDA announced a three-year window for businesses to come forward and seek guidance on whether a product requires premarket approval, rather than just make the cheaper assumption that the product falls under the “exception” from regulation.  But this discretionary enforcement period and free pass to the industry ends in less than five (5) months (in November 2020).

A careful review of the latest enforcement letters posted to its website, and a cursory review of company’s websites reveals that manufacturers and providers across the country continue to offer products requiring premarket approval but without having done so.  Many of these products are backed by unsubstantiated claims regarding the potential for these products to prevent, treat or cure various diseases or conditions.  As a result, the FDA continues to step up enforcement including based solely on online content.  As an illustration, on February 10, 2020, the FDA issued a warning letter to RejuvaYou based solely on a review of its website and related advertising.  In April 2020, similar warning letters were issued by the FDA to Dynamic Stem Cell Therapy and Stem Cell Center of New Jersey indicating premarket review was required.  As discussed above, these companies took the position that their products did not fall under the regulatory provisions of the FDA.

Entering the regenerative medicine market requires careful consideration as to the regulatory and legal landscape.  Manufacturers and individual providers need to be aware of the regulations and risks facing the industry.  Unless a product has FDA approval, businesses can face potential criminal and civil exposure.  In order to mitigate such exposure, businesses must first revisit their product designations in consultation with their attorneys to determine whether an exemption actually applies.

A great place to start is with the latest guidance.  Not only does this guidance set forth clarification, but it provides specific examples and a question and answer section explaining the FDA’s approach.  Another good source for insight is from legal filings from the U.S. Department of Justice on behalf of the FDA in the recent federal litigation involving U.S. Stem Cell.  U.S. Stem Cell challenged the regulatory authority of the FDA prompting the agency to a seek a permanent injunction (in which it obtained).  This decision provides valuable information on how the FDA views the current state of the industry.  An opinion should be sought from the FDA itself, even if informal, a step best taken with counsel by your side.  This can be accomplished through contacting the agency’s Tissue Reference Group.  By taking these steps, a business can better manage risk and expectations, and lessen the probability of running afoul of the FDA regulations and civil and criminal penalties.

 

If you have any questions regarding regenerative medicine legal issues, please do not hesitate to contact attorney Matthew M. Fischer (mfischer@zplaw.com).  Matthew is a partner in the Miami office of Zumpano Patricios, P.A.  Matthew specializes in health law related issues and is a former Assistant General Counsel at the FBI and Senior Attorney Advisor at the U.S. Department of Health and Human Services.

Big Banks continue to deny small- and medium-sized Main Street businesses compensation due to them for helping borrowers obtain PPP loans quickly, as intended. But their arguments are thin, and the DOJ is closing in to help as well.  ZPP’s class action suits will solve the problem.

To read more about our class action suits in an article by Kevin Wack for American Banker  featuring our lead attorney and Managing Partner Michael Popok, click here.

We stand in solidarity with the Black community and the peaceful protestors who stand up for civil rights in the name of all those who have died inhumanly at the hands of senseless brutality.

Our continued and unrelenting violent mistreatment of our fellow Americans because of the color of their skin—to deny their most basic civil liberties and human dignity—to make our fellow Americans unsafe and unwelcome in their own country—is a national disgrace.

To be a true American patriot and a lawyer today is to stand up for those that are unrelentingly victimized, oppressed, and murdered, and ensure that their voices are heard and they are protected now.

To stand silently on the sidelines at this moment in our history, is to be complicit.

We the people, indeed.

#blacklivesmatter #blm

The COVID-19 pandemic has brought out the best in many and as with any crisis, it has attracted bad actors looking to capitalize on the situation.  In response, the United States Department of Justice (DOJ) (along with many states) have targeted certain activities to ensure the availability of sufficient personal protection equipment (PPE).  To accomplish this task, the Criminal Division of the DOJ has focused its efforts on price gouging and has weaponized a federal hoarding law, the Defense Production Act (DPA).  But this anti-hoarding provision is not clear as to its boundaries; meaning there is little to no guidance on what is permissible.  This results in companies left with the uncertainty of having to make basic business decisions under the threat of federal prosecution.

The DPA prohibits the accumulation of goods designated as scarce (1) in excess of the reasonable demands of business, personal, or home consumption, or (2) for the purpose of resale at prices in excess of prevailing market prices.  In March, the Department of Health and Human Services (HHS) designated certain categories of products (i.e. PPE) as “scarce” triggering the DPA’s prohibitions.  Pursuant to the DPA, potential criminal exposure includes up to one year of imprisonment and/or a $10,000 fine for a willful violation.  Additionally, the DPA forbids an individual from delivering goods if he or she “knows or has reason to believe that the item will be accepted, redelivered, held, or used in violation of the [DPA].”

To enforce the DPA, the DOJ formed the COVID-19 Hoarding and Price Gouging Task Force, and just this past April, announced the filing of its first criminal complaint against an individual in New York for PPE related price gouging using the DPA.  According to the complaint, Amardeep Singh was charged with accumulating PPE in quantities that far exceeded “reasonable demands” and for selling “scarce” designated items “in excess of prevailing market prices.”  In support of the complaint, authorities indicated that Singh purchased N95 masks at a per unit cost of $2.50 and later resold such masks for between $3.99 and $4.99, which equates to a 59% to 99% markup.  Shortly after, a second criminal complaint was unsealed against two other individuals in New York for conspiring to violate the DPA.  In this case, Kent Bulloch and William Young agreed to sell masks at a 50% markup.  As discussed above, these individuals now potentially face one year in prison and/or a substantial fine.

In addition to the DOJ led task force, the Federal Trade Commission (FTC) has entered the price gouging arena and initiated investigations.  The ramp up of FTC activities was spurred by several members of Congress in April asking the FTC to step up its enforcement efforts.  In addition, Congress also introduced a new bill in the house that would give the FTC and state attorney generals broader powers to go after price gouging.  This proposed bill is entitled the “COVID-19 Price Gouging Prevention Act.”  While previously, price gouging has not been a focus of the FTC, it is anticipated that the FTC will be far more focused given Congress’ outreach.

The DPA provides little to no guidance, and Attorney General William Barr has yet to add much input into what specific conduct the DOJ is targeting.  Enforcement actions such as these lead to a high level of uncertainty and raise many questions for business owners.  The bottom line…business owners need to do as much due diligence as possible and take certain precautions to avoid potential exposure.  This means staying up to date on all federal and state laws.  Notably, in contrast with federal authorities, some states have issued guidance on what is considered excessive.  When contemplating whether to sell “scarce” items, state regulation would be a great barometer and starting point when navigating these waters.  Second, in order to gauge the market for current rates, review bids submitted by other vendors to federal and state governments, which would arguably set the market rates.  Finally, businesses should maintain detailed records for all expenses to be prepared to provide price justification in response to any challenges by government regulators.

 

If you have any questions regarding the DPA, please do not hesitate to contact attorney Matthew M. Fischer (mfischer@zplaw.com).  Matthew is a partner with  Zumpano Patricios, P. A.  resident in its Miami office.  Matthew specializes in health law related issues and is a former Assistant General Counsel at the FBI and Senior Attorney Advisor at the U.S. Department of Health and Human Services.

ZPP Managing Partner Michael Popok and Senior Partner Mitch Mandell lead our team of lawyers in the national class action against banks for failing to pay agent fees under the Federal Paycheck Protection Program for bringing main street borrowers to banks.  Click here for Forbes Magazine’s coverage and click here for Law.com’s  Daily Business Review coverage.  The ZPP team of lawyers is leading the cases in Illinois, Utah, Arizona, New York, and Florida.

On May 7, 2020, the Equal Employment Opportunity Commission (“EEOC”) updated its “Pandemic Preparedness in the Workplace and the Americans with Disabilities Act” guidance (the “Guidance”) by providing a Technical Assistance Questions and Answers sheet (the “Q&A Sheet”).  Together, the Guidance and Q&A Sheet help explain what employers can do during a pandemic, like COVID-19, that they cannot normally do under the Americans With Disabilities Act (“ADA”).  As employers begin tackling the difficult but necessary task of planning to reopen and transitioning from “work from home” (“WFH”) back to physical offices in some capacity, the EEOC has issued instructions and practical tips which, if followed, presumably, will help insulate an employer from future liability.  The Guidance and Q&A Sheet provide employers assistance with balancing workplace safety while continuing to remain compliant with the ADA.  Generally, the ADA regulates (i) inquiries and examinations related to potential and current employees, (ii) whether an employee poses a “direct threat” to the workforce due to a medical condition, and (iii) how to provide “reasonable accommodation” to employees who ask for it.   ZPP has provided an easy to follow set of questions and answers to assist employers in balancing federal laws and requirements with employee rights to both create a safe workplace, and limit liability in the COVID-19 landscape.

HIRING/ONBOARDING PROCESS

 Can I screen employee applicants I am thinking of hiring for COVID-19 symptoms?

Yes, but.  An employer can only screen applicants for COVID-19 or require medical exams after making a conditional offer of employment and then only if all onboarding employees in the same job category are subject to the same screening and examinations.  Additionally, employers can take the temperatures of an applicant as part of a required medical exam or require the candidate to self-report regarding temperature.  However, temperature checks have their limits:  Current medical thinking is that asymptomatic carriers of COVID-19 may not present with a fever, and other symptoms may include a new cough, loss of appetite, and/or loss of smell or taste.   Employers may also inquire of “conditional offer” applicants as to whether they have these other associated symptoms.

Can I refuse employment to a candidate who is in a higher risk category for contracting
COVID-19?

No.  The Center for Disease Control and Prevention (“CDC”) has provided a list of risk factors that may make someone more susceptible to COVID-19.  However, an employer may not unilaterally refuse employment, withdraw an offer, or delay an employee’s start just because a person is deemed to be at a higher risk of becoming infected with COVID-19.  On the other hand, it is acceptable for an employer to generally discuss these issues with a potential hire and to postpone the employee’s start date or to allow WFH measures.

Can I withdraw an offer of employment or delay the start date of an applicant who tested positive for COVID-19, or has reported they have any associated symptoms?

Yes, but.  Based on current CDC guidance, an employer may withdraw an offer if an employer needs the employee to start immediately, but such employee cannot safely enter into the workplace due to having COVID-19 or any associated symptoms.  On the other hand, an employer may also choose to accommodate a delay in the start date for an employee who has tested positive for COVID-19 or has associated symptoms.  Consistency is important here.  Once an employer establishes a policy about immediate start dates, it must apply the policy uniformly to all employees who have the same or similar job description.

CURRENT EMPLOYEES

 Can I require current employees to self-report temperatures on a daily basis during the COVID-19 pandemic?

Yes.  Employers are allowed to require all employees to regularly be tested, or require each employee to self-test for temperature and/or self-report COVID-19-related symptoms, as long as the policy is consistently applied to all employees.

Can I require current employees as a condition of entering the workplace to wear personal protective equipment (“PPE”) either in the office and/or when using mass transit to get to work?

Yes.  Employers may (and probably should) adopt “infection control practices” such as requiring PPE, including, but not limited to, latex gloves, facial masks and/or gowns, and that they be used in the physical workplace and in transit to the office.  In addition, an employer may (and probably should) require regular handwashing, coughing and sneezing etiquette, social distancing protocols, and cleaning and disinfecting policies (i.e., wiping down doors, phones, desks, and commonly used areas) without violating the ADA.  When pandemic planning, it is best practice to establish policies and protocols before returning to the workplace and give all employees advance notice of such policies.  Employers should regularly update their protocols and policies as necessary to comply with federal EEOC and CDC guidelines, as well as state and local mandates and orders.

Another method of initiating “infection control practices” that has gained traction is requiring the use of contact-tracing applications.  These applications are meant to minimize the exposure risk of contracting COVID-19.  While the EEOC has not directly opined on this, the EEOC’s current guidance provides help in navigating the issue if an employer chooses this method.   It is likely that the EEOC will approve of an employer’s mandatory and universal use of contact-tracing applications for employees as long as it is part of a coherent infection control policy, and no more intrusive than necessary.

However, employers should be aware that mandating the use of contact-tracing applications might implicate a variety of other laws, including, but not limited to, state privacy and civil rights laws, and state and federal constitutional laws.  As this is new territory, employers should stay updated on guidance provided by the EEOC or Occupational Safety and Health Administration (“OSHA”), as well as state and local mandates and orders, to ensure compliance with any potential implications these laws might pose.

Can I inquire about an employee’s symptoms if the employee calls in sick or leaves early from work while feeling ill during the COVID-19 pandemic[1]?

Yes.  Employers may inquire about an employee’s symptoms if that employee reports feeling unwell.  The symptoms include fever, chills, shortness of breath, sore throat, and a new persistent cough.  Other possible associated symptoms include loss of taste or smell, loss of appetite, nausea, and vomiting.  It is important to note that as public health authorities learn more about COVID-19 in the coming weeks and months, the symptoms list may expand.  Employers should continue to monitor guidance from the CDC, EEOC, and all public health authorities for the most current information regarding COVID-19 and its associated symptoms.

Can I require employees to stay home or leave the workplace if he or she has COVID-19 associated symptoms?

 Yes.  The ADA does not interfere with an employer’s ability to require its employees to stay home, WFH, and/or leave the workplace if they are experiencing COVID-19 symptoms.

Can I require employees to have a “doctor’s note” certifying fitness for duty during the COVID-19 pandemic?

Yes.  As a practical matter, however, employers should be flexible in relying on local clinics and health care providers and other “first responders” in addition to classic medical doctors to provide such certification, as doctors may be incredibly busy during this time.  Additionally, the employers should be flexible in the types of clearance forms they require, and an email may substitute for a hard-copy.

Can I prohibit a current employee who I know is at a higher risk of contracting COVID-19 from entering the workplace?

No.  You cannot prohibit a current employee from returning to the physical workplace solely because you know he or she is at a higher risk to contract the virus due to his or her medical condition.  However, if the employee’s disability poses a “direct threat” to his or her health that cannot be eliminated or reduced with a reasonable accommodation, then an employer may exclude that employee from returning to the workplace and have them work remotely from home if that is possible given job duties.

The ADA defines “direct threat” as 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.  The Guidance advises an employee to consider four (4) factors when assessing if an employee poses a direct threat: (1) the duration of the risk; (2) the nature and severity of the potential harm; (3) the likelihood that potential harm will occur; and (4) the imminence of the potential harm.  Moreover, an employer must determine if the threat can be reasonably accommodated (i.e., wearing masks, providing protective barriers, teleworking, etc.).

While the CDC has determined the COVID-19 pandemic meets the direct threat standard, the CDC will continue to revise its assessment of the severity and spread of the virus, which could affect whether a direct threat still exists.  Employers should continue to stay updated on guidance from the CDC, as well as public health authorities when assessing whether an employee poses a direct threat.

REASONABLE ACCOMMODATION REQUIREMENTS DURING
A PANDEMIC

 Can I refuse a reasonable accommodation during the COVID-19 pandemic?

No.  Under the ADA, employers must provide reasonable accommodations for employees with disabilities (including having COVID-19) who ask for it unless it poses an undue hardship to the employer.  Undue hardship occurs when the accommodation creates “significant difficulty or expense” for the employer.  An employee’s conclusory statements of undue hardship unsupported by evidence are insufficient.  If an accommodation would impose an undue hardship, the employer is not required to make the accommodation, but the employer is still required to consider any other reasonable accommodation that would not impose an undue hardship.

Can I request information from the employee who requested a reasonable accommodation about why an accommodation is needed, or if the condition is a covered disability during the COVID-19 pandemic?

 Yes.  If it is not obvious or already known, an employer may question, or request medical documentation from, an employee to determine whether the employee has a “disability” as defined by the ADA or whether the employee’s disability requires an accommodation (i.e., how the disability creates a limitation or how the requested accommodation will effectively address the limitation).

EMPLOYEE PERSONAL MEDICAL INFORMATION STORAGE

 Can I store medical information obtained from employees through medical examinations or self-reporting during the COVID-19 pandemic?

 Yes.  An employer is required to treat all disability and medical information obtained from an employee, whether through medical examinations or self-reporting (i.e., symptoms and/or temperature), as confidential medical records.  An employee medical record or log must be separately maintained in an electronic or physical file independent from an employee’s personnel file to ensure confidentiality.  This includes any information provided by the employee that he or she has, or believes he or she has, COVID-19.

 Can I share an employee’s medical information obtained through a medical examination or self-reporting during the COVID-19 pandemic?

 Generally, no.  But if an employer has learned an employee has COVID-19, it can disclose that information to a public health agency.  Additionally, a temporary staffing agency or contractor that places an employee with an employer can notify the employer of the employee who has COVID-19, so the employer can take appropriate precautions to ensure workplace safety.

CONCLUSION

It is undeniable that the COVID-19 pandemic is causing rapid changes in the workplace, which in turn is causing uncertainty for businesses on how to lawfully and efficiently deal with such changes.  However, when pandemic planning in the workplace, continued vigilance in guidance from agencies like the EEOC and CDC, as well as local/state governments and public health authorities, are imperative in order to ensure an environment where employees not only feel safe but also have their rights protected.

If you have any questions about how your business needs to address pandemic planning to return to the workplace or would like to discuss your legal matters further, please do not hesitate to contact our Senior Partner, Mitchell G. Mandell (mmandell@zplaw.com), or Associate, Michelle C. Malone (mmalone@zplaw.com).

 

 

[1]  Outside of a pandemic, the ADA only permits employers to inquire about medical- and disability-related issues when it is “job-related” and “consistent with business necessity.”  This occurs when the employer has a “reasonable belief, based on objective evidence” that the current employee’s “ability to perform essential job functions will be impaired by a medical condition” or if “an employee will pose a direct threat due to a medical condition.”  Americans with Disabilities Act, 42 U.S.C. § 12112(6); U.S. Equal Employment Opportunity Commission, “Pandemic Preparedness in the Workplace and the Americans with Disabilities Act” (March, 21, 2020).

COVID-19 has proved especially troubling for education.  The pandemic challenges every aspect of the educational enterprise and at every level.  Yet decisions have to be made:  should commencement take place?  Should distance learning become the norm?  How do residence halls, dining halls, and athletics operated in “plague years?”  What should institutions do about tuition if it doesn’t pay for exactly what the payer expected?  What are the legal risks if students return to campus and become sick with Covid-19?  Or worse, die?  To chart a course institutions need transparent, inclusive, and collegial decision-making processes.  Leaders frequently cut corners only to pay a high price later.

The pandemic reminds us that traditional educational methods still have merit.  Teachers and students are finding that video classrooms cut out multi-dimensional and multi-sensory aspects of education.  Nuance is gone.  This phenomenon is as true for 7th graders as for college, graduate, and professional students.  At best, remote learning fills a gap.  At the same time, computer interaction between teacher and students can enrich the educational experience so long as it is not all there is.  Of course, distance learning is useful.  Soldiers and sailors on deployment know that.  But it should not be the only or even the best educational model.  But planning how to go forward in anything like the traditional way requires answers to still more questions:

·      What is the appropriate, medically-based, public health response to an ongoing pandemic or the risk of a pandemic in the future?

  • At the moment, there is no consensus about the causes, transmission, and cures, if any.
  • Based on previous experience, a COVID-19 vaccine is months if not more than a year away.
  • An economic deep freeze is unsustainable.

·      Is it possible for dormitories to reopen without creating COVID-19 petri dishes?

  • Is it possible radically to change undergraduate living habits?

·      What are the real legal liabilities?  Can they be limited by contract, behavior, and/or legislation?

The fact these questions remain open could be an excuse for indecision.  But they need not be.  Through a reasonable process, mapping what is and is not known, decisions for the short- and perhaps medium-term can be made that stakeholders will accept.  Such a process must be inclusive, transparent, and collegial or acceptance will be hard to imagine.  Where such a process does not exist, it must be created.  Urgently.

What kind of process is needed?  Certainly not a process for its own sake.  Rather, something that breaks down bureaucratic and institutional habits of isolation and specialization.  Stove-pipes and silos are normal in higher education.  Departments, administrators, and students stick to their knitting.  Interdisciplinary and inter-institutional collaboration is relatively rare, often dependent on personal connections rather than institutional cross-fertilization.  A pandemic demands that these habits end.  The goal of this process must be informed decisions.

Most crises demand a strategic map of assets, liabilities, and risks.  With as full knowledge as possible at a given time, development of strategic goals becomes possible.  A planning process can be implemented.  The results can be the basis for action all the while recognizing that plans change when they confront reality.

Inclusiveness means more than the usual administrative participants.  The general counsel, the public affairs officer, the provost, the dean of students, deans of medical and law schools if they exist are obvious members.  But grounds crews, maintenance, and athletics are essential as well.  In short, the institutional muscle must be brought to bear.  Decision-making processes take time to gel.  In a crisis, trust-building among participants may occur quickly.  If it does not, the process will bog down in disputes about turf.

The process is indispensable for successful navigation, not only of the short-term problems produced by COVID-19; they are essential for institutional health going forward.  Once again, the strategic asset map is essential.  For example, an institution facing severe budget issues, needs to know how best to deploy its people and know what strengths to feed and weaknesses to do without.  Without a strategic map, decisions in the common interest about these important matters are difficult, perhaps impossible, to make.  To govern is to choose a wise politician once said.  That is as true for colleges and universities as governments.  Process is essential to the best-informed decisions, even in a crisis where the instinct is to cut corners.

With process, enter the lawyer as counselor.  Lawyers traditionally are guardians of process, whether in a judicial or decision-making setting.  They help ensure that decision-making processes are inclusive, transparent, collegial, and effective.  They can help institutions “get to yes” in ways all stakeholders can support.  Zumpano, Patricios & Popok are rich in the kind of experience institutions addressing crises can draw on to avoid and overcome obstacles.  They know how to advise and protect higher education leaders and boards of trustees.  And they believe the earlier the consultation the more effective and cost effective the advice will be.