Tag: healthcare

New Tools in the Fight Against Counterfeit Pharmaceuticals

The explosive growth of internet pharmacies and direct-to-consumer shipment of pharmaceuticals has provided increased access to, and reduced the cost of, important medications. Unfortunately, these same forces have increased the risks that counterfeit medicines will make their way to consumers, endangering patient safety and affecting manufacturers’ reputation in the public eye.

While the Food and Drug Administration attempts to police such misconduct through enforcement of the Food, Drug, and Cosmetics Act (FDCA), the resources devoted to enforcement are simply no match for the size and scope of the counterfeiting threat. Fortunately, pharmaceutical manufacturers are not without recourse, as several well-established tools may be used in the right circumstances to stop counterfeiters from profiting from the sale of knock-offs.

Experienced litigators can use the Lanham Act and the Racketeer Influenced Corrupt Organizations (RICO) Act to stop unscrupulous individuals and organizations from deceiving customers with counterfeit versions of trademarked drugs. Until recently, these legal weapons – including search warrants, seizures, forfeitures, and significant penalties – were typically wielded only by the government and only in criminal prosecutions.

As one recent case demonstrates, however, many of the tools that law enforcement has used for years to combat counterfeiters are also available to pharmaceutical manufacturers. In Gilead Sciences, Inc. v. Safe Chain Solutions, LLC, et al., the manufacturer of several trademarked HIV medications filed a civil complaint, under seal, alleging violations of the Lanham Act and RICO against scores of individuals and companies that were allegedly selling counterfeit versions of these drugs to patients across the country.

By deploying private investigators and techniques typically used by law enforcement, Gilead was able to gather a substantial amount of evidence before even filing the case. The company then used this evidence to secure ex parte seizure warrants and asset freezes, allowing it to locate and seize thousands of counterfeit pills and packaging before they could be shipped to unsuspecting consumers. Through the seizure of the financial proceeds of the alleged counterfeiting, Gilead prevented the dissipation of assets. If the company can successfully prove its RICO case, it stands to recover treble damages and attorneys’ fees as well.

Manufacturers of trademarked pharmaceuticals may consider using these and other tools to tackle the threat posed by counterfeiters. By drawing upon the experience and skills of trained litigators – particularly counsel who previously deployed these tools on behalf of the government while serving as federal prosecutors – companies can proactively protect their intellectual property and the consumers who depend on their products.

Article By Eric J. Beste, Anthony J. Burba and Heather F. Delgado of Barnes & Thornburg LLP

For more health law legal news, click here to visit the National Law Review.

© 2022 BARNES & THORNBURG LLP

U.S. Supreme Court Lifts Preliminary Injunctions on Healthcare Worker Vaccine Mandate

On January 13, 2022, the United States Supreme Court upheld the Centers for Medicare & Medicaid Services (“CMS”) Interim Final Rule (the “Rule”) in a 5-4 decision, staying the preliminary injunctions issued for 24 states by the District Courts for the Eastern District of Missouri and the Western District of Louisiana.  Therefore, the CMS vaccine mandate is in full effect for all states except Texas, which was not part of the cases before the Court.  The Rule requires nearly all workers at Medicare- and Medicaid-certified facilities—whether medical personnel, volunteers, janitorial staff, or even contractors who service the facilities—to be fully vaccinated against COVID-19 unless they qualify for a medical or religious exemption.

The Court based its holding on two main points.  First, the Court held that Congress clearly authorized CMS to put conditions on funding it provides to the Medicare and Medicaid certified facilities.  The Court opined that perhaps CMS’s “most basic” function is to ensure that regulated facilities protect the health and safety of their patients, noting that Medicare and Medicaid patients are often some of the most vulnerable to infection and death from COVID-19.  Because CMS determined that a vaccine mandate is necessary to protect patient health and safety, the Court held the mandate “fits neatly within the language of the [authorizing] statute.”  The Court acknowledged that CMS has never required vaccinations in the past, but attributed this in part to the fact that states typically already require necessary vaccinations like hepatitis B, influenza, and measles for healthcare workers.

Second, the Court held that the mandate is not arbitrary and capricious, and cautioned the district courts that their role is merely to make sure an agency acts within the “zone of reasonableness.”  The Court found the administrative record sufficient to explain CMS’s rationale for the mandate and also accepted that getting the vaccine mandate in place ahead of winter and flu season satisfied the “good cause” standard for skipping the notice and comment period.

Healthcare employers subject to the Rule should immediately start implementing vaccine requirements if they have not already.  It is anticipated that in all states but Texas, CMS will likely begin enforcement of the vaccine mandate in approximately 30 days.  On December 28, 2021, CMS released guidance to state surveyors with enforcement standards to use starting 30 days from the memo, though at the time the memo only applied to the 25 states that were not enjoined.  Healthcare employers should also keep in mind that this is not the end of the road: the Court’s holding only means that the CMS vaccine mandate is in force while the 5th and 8th Circuits complete their review of the underlying state challenges to the mandate.  While the Supreme Court’s opinion sends a strong message that lower courts should uphold the mandate, there is no guarantee they will do so.

The legal landscape continues to evolve quickly and there is a lack of clear-cut authority or bright line rules on implementation.  This article is not intended to be an unequivocal, one-size-fits-all guidance, but instead represents our interpretation of where applicable law currently and generally stands.  This article does not address the potential impacts of the numerous other local, state and federal orders that have been issued in response to the COVID-19 pandemic, including, without limitation, potential liability should an employee become ill, requirements regarding family leave, sick pay and other issues.

Article By Keeley A. McCarty and Ashley T. Hirano of Sheppard, Mullin, Richter & Hampton LLP

For more health law legal news, click here to visit the National Law Review.

Copyright © 2022, Sheppard Mullin Richter & Hampton LLP.

Study Demonstrates Earlier Physician Retirement Overall and Increased Pay Equity Concerns for Female Doctors During the Pandemic

This month, Doximity issued its Fifth Annual 2021 Physician Compensation Report. With the continued strain of the pandemic spanning 2021, the self-reported physician data reflected widespread burnout and early retirement, especially by female physicians. With respect to physician compensation, Doximity findings demonstrated:

  • While average doctor pay increased 3.8 percent between 2020 and 2021, there was a decline of real income compared to 2020 given the CPI 6.2% rate of inflation in 2021.
  • The top five metro areas with the highest physician pay were Charlotte, NC; St. Louis, MO; Buffalo, NY; Jacksonville, Florida; and, Orlando, Florida.
  • The top five metro areas with the lowest physician pay were Baltimore, MD; Providence, RI; San Antonio, TX; Washington, D.C.; and Boston, MA.
  • A widening gender pay gap of 28.2% this year, with female physicians making $122,000 less than male physicians in 2021.
  • Based on 2014-2019 data, Doximity estimates that over the course of a career, female physicians will earn over $2 million less than male physicians.

Specialties with the largest pay equity gaps between men and women are oral & maxillofacial surgery; allergy and immunology; ENT; pediatric nephrology; and thoracic surgery. Significantly, there is no one medical specialty where women earned the same or more than men in 2021. All specialties had a pay gap over 10%, except Pediatric Rheumatology (which had a gap of 7.9%). To compound matters, a recent Jama Network Open research letter found that physician residents who were mothers – compared to physician residents who were fathers – were more likely to be responsible for childcare or schooling (24.6% v. .8%), household tasks (31.4% v. 7.2%), to work primarily from home (40.9% to 22%), and to reduce their work hours (19.4% to 9.4%). The study reflected the significant concern that these “short-term adjustments can have serious long-term repercussions as they may lead to lower earnings and negatively impact advancement.”

Doximity’s research also revealed that due to the pandemic, over 1% of physicians retired before expected, which is feared to strain an already tight labor market. The report also highlighted studies suggesting about half of doctors are considering an employment change due to the “COVID-related overwork.” The overwork also had a disproportionate impact on women physicians, with 25% of them reporting they are “considering early retirement” due to increased work during the pandemic.

This research reflects the importance of a physician/employer in any setting reflecting on the impact of the pandemic on its healthcare team. Moreover, the research shows continued pay equity deficits between female and male physicians, which may be exacerbated by the pandemic. Internal reflection on current pay practices to identify the factors contributing to it are critical to maintain top talent, improve morale amidst very difficult times and avoid wage and hour litigation.

Article By Dorothy Parson McDermott of Jackson Lewis P.C.

For more healthcare and health law legal news, click here to visit the National Law Review.

Jackson Lewis P.C. © 2021

CMS Removes All Nursing Home Visitation Restrictions as COVID-19 Cases Decrease

In order to continue addressing the impacts of COVID-19 on nursing home residents, the Centers for Medicare & Medicaid Services (CMS) recently issued a memo updating guidance for nursing home visitation. You can read the full memo here.

Early in the pandemic, CMS implemented visitation restrictions to mitigate the risk of visitors introducing COVID-19 to nursing homes. Now, CMS is updating its guidance and allowing visitation for residents at all times. CMS explained its decision to allow visitation is based upon data which shows approximately 86% of residents and 74% of staff are fully vaccinated, and the number of new COVID-19 cases each week in nursing homes has dramatically decreased.

Under the new guidance, nursing homes cannot limit the frequency and length of visits for residents, the number of visitors, or require advance scheduling of visits as mandated under the previous guidance. However, CMS is still directing nursing homes to follow infection-control policies and procedures. Visitors who have tested positive for COVID-19, have symptoms of COVID-19, or currently meet the criteria for quarantine, should not enter the facility. Nursing homes should still screen all visitors before entry.

Although not required, CMS is encouraging nursing homes in counties with substantial or high levels of community transmission to offer testing to visitors, if feasible. Nursing homes should also educate and encourage visitors to become vaccinated. Visitors should still wear face coverings and social distance at all times while in the nursing home. Nursing homes should stay diligent in their infection-control efforts.

Article By Sydney N. Pahren and Timothy Cahill of Dinsmore & Shohl LLP

© 2021 Dinsmore & Shohl LLP. All rights reserved.

Health Care Settings Subject to New COVID-19 Requirements Issued by New Jersey and OSHA

Health care settings continue to be at the center of testing and treatment for COVID-19 and are the focus of new safety requirements implemented to minimize risks of transmission. Last month, Governor Murphy issued an Executive Order related to vaccination management, COVID-19 testing, and data collection, which mandates “covered health care and high-risk congregate settings” to establish a policy requiring “covered workers” to either submit proof of full vaccination or to submit to weekly COVD-19 testing. This requirement goes into effect on September 7, 2021.

In addition, the Occupational Health and Safety Administration (OSHA) has implemented an emergency temporary standard (ETS) applicable to certain health care settings, which includes extensive safety and health measures. The ETS provides for certain exceptions for coverage, and while the precise definitions are complicated and must be consulted, the focus appears to be on those settings where employees are interacting with patients who are suspected or confirmed for COVID-19. Unlike the Executive Order, the OSHA ETS does not include vaccine or testing requirements; however, certain New Jersey health care providers will be covered by both measures.

Which health care and high-risk congregate settings must comply with the Executive Order?

The scope of this Executive Order is quite broad and will impact most health care settings across New Jersey, both in terms of the covered health care settings and the covered workers to which the vaccine or testing requirements will apply.

The Executive Order defines “health care facility” extremely broadly as including:

acute, pediatric, inpatient rehabilitation, and psychiatric hospitals, including specialty hospitals, and ambulatory surgical centers; long-term care facilities; intermediate care facilities; residential detox, short-term, and long-term residential substance abuse disorder treatment facilities; clinic-based settings like ambulatory care [which would include all private medical offices], urgent care clinics, dialysis centers, Federally Qualified Health Centers, family planning sites, and Opioid Treatment Programs; community-based healthcare settings including Program of All-inclusive Care for the Elderly, pediatric and adult medical day care programs, and licensed home health agencies and registered health care service firms operating within the State.

High-risk congregate settings under the Executive Order include:

State and county correctional facilities; secure care facilities operated by the Juvenile Justice Commission; licensed community residences for individuals with intellectual and developmental disabilities (“IDD”) and traumatic brain injury (“TBI”); licensed community residences for adults with mental illness; and certified day programs for individuals with IDD and TBI.

“Covered workers” is defined to include full and part time employees and independent contractors, as well as individuals with operational, custodial and administrative support roles.

How to Comply and Penalties for Violations

Covered workers are not required to provide proof of having been fully vaccinated under the Executive Order, but those who do not submit proof of full vaccination must submit to COVID-19 testing one to two times per week. The settings covered by this Executive Order may choose to impose more frequent testing as well. A covered worker will not be considered fully vaccinated until two weeks have elapsed since receipt of the second dose of a two-dose series, or a single dose of a one-dose.

Acceptable proof of full vaccination includes: (1) CDC COVID-19 Vaccination Card; (2) Official record from the New Jersey Immunization Information System or other State immunization registry; (3) Record from a health care provider portal/medical record system on official letterhead signed by a physician, nurse practitioner, physician’s assistant, registered nurse or pharmacist; (4) Military immunization or health record from the U.S. Armed Forces; or (5) Docket® mobile phone application record or any state specific application that produces a digital health record. Records of such proofs must be maintained confidentially.

Those employees who do not submit proof of vaccination must submit to weekly testing, which can be either antigen or molecular tests with Emergency Use Authorization from the Food and Drug Administration or operating pursuant to the Laboratory Developed Test requirements by the U.S. Centers for Medicare and Medicaid Services. Covered settings may provide onsite COVID-19 tests, which can be either an antigen or molecular test. Covered settings must have a policy for tracking test results and are required to report results to the local public health department. However, in all other respects, vaccination and testing information must be kept confidential and separate from the employees’ personnel records.

The penalties for violations are stringent. Pursuant to N.J.S.A. 9:49, a violation may be considered a disorderly conduct offense, which can carry a penalty of a fine of up to $1,000 or 6 months imprisonment.

It should be noted that the requirements of the Executive Order with respect to screening and testing of unvaccinated workers do not override any requirement imposed by the covered setting regarding the testing and screening of symptomatic workers or vaccinated workers.

OSHA’s COVID-19 Emergency Temporary Standard (ETS) for Health Care Settings

Published on June 21, 2021[1] and in further effort to ensure the safety of health care workers, the OSHA ETS for health care and related industries provides that, unless an exception applies, in settings where employees provide health care services or health care support services, employers must develop and implement COVID-19 plans.

The analysis to determine whether an exception applies is complicated, and OSHA offers a flowchart to assist with this analysis. Among these exceptions are:

  • Private medical practices, where (i) the office is in a non-hospital setting, (ii) ALL non-employees are screened prior to entry, and (iii) anyone with suspected or confirmed COVID-19 is not permitted to enter the premises.
  • Well-defined hospital ambulatory care settings where all employees are fully vaccinated and all non-employees are screened prior to entry and people with suspected or confirmed COVID-19 are not permitted to enter those settings.
  • Home health care settings where all employees are fully vaccinated, all non-employees are screened prior to entry, and people with suspected or confirmed COVID-19 are not present.
  • Well-defined areas where there is no reasonable expectation that any person with suspected or confirmed COVID-19 will be present, the requirements in the ETS for personal protective equipment (PPE), physical distancing, and physical barriers do not apply to employees who are fully vaccinated.

For those covered health care settings with more than 10 employees, the COVID-19 plan must be in writing. It is not practicable to list every requirement in this alert without making it quite lengthy, but the following will highlight some of the notable plan requirements:

  • A designated safety coordinator who understands and is able to identify COVID-19 hazards in the workplace, is knowledgeable in infection control and has the authority to ensure compliance with the COVID-19 plan
  • A workplace hazard assessment (including involvement of non-managerial employees)
  • Policies and procedures to minimize the risk of transmission of COVID-19 to employees, which are extensive and include but are not limited to:
  • Limiting points of entry for patients and screening patients, clients and visitors at entry
  • Social distancing when indoors
  • Physical barriers between fixed work stations in non-patient areas
  • Cleaning and disinfecting surfaces and equipment in patient areas and in high touch areas at least once per day
  • Providing hand sanitizer with a minimum of 60% alcohol or easily accessible handwashing facilities
  • Providing Personal Protective Equipment (PPE) to employees with close contact exposure (within six feet in same room) to a person with suspected of confirmed COVID-19
  • Ensuring HVAC systems are used per manufacturer instructions and utilize Minimum Efficiency Reporting Value of 13 or higher if the system permits
  • Screening employees each workday/shift
  • Employees required to promptly notify employer of positive COVID-19 test, a suspected COVID-19 case or of COVID-19 symptoms

When an employee who has been physically present in the workplace tests positive, that employee must notify a designated employee within 24 hours

Employees should be trained on COVID-19 transmission and informed of their right not be retaliated against for exercising their rights under this ETS. Finally, health care settings with more than 10 employees must retain records of positive COVID-19 cases and all covered health care settings must report any COVID-19 fatalities and in-patient hospitalizations to OSHA.

ETS Requires Employers Pay Employees Forced to Quarantine or Isolate Under Defined Circumstances

Significantly, the ETS requires covered employers with ten or more employees to provide employees with substantial “medical removal protection benefits” if the employee must be removed from the workplace when the employer knows that the employee:

  1. Is COVID-19 positive, meaning that the employee was confirmed positive for or was diagnosed by a licensed health care provider with COVID-19;
  2. Has been told by a health care provider that they are suspected to have COVID-19;
  3. Is experiencing recent loss of taste and/or smell, with no other explanation; or is experiencing both fever (≥100.4° F) and new unexplained cough associated with shortness of breath; or
  4. Is required to be notified by the employer of close contact in the workplace to a person who is COVID-19 positive, UNLESS the employee has been fully vaccinated against COVID-19 (i.e., 2 weeks or more following the final dose), or had COVID-19 and recovered within the past 3 months, AND the employee does not experience the symptoms listed in item 3.

When an employee must quarantine or isolate under the aforementioned circumstances, medical removal benefits entitle the employee to regular pay the employee would have received had the employee not been absent from work, up to $1,400 per week until the employee is able to return to work. After three weeks of this leave, employers with 500 or less employees may reduce the benefits paid to two thirds of the employee’s regular rate of pay (up to $200 per day). If an employee removed from the workplace is too ill to work remotely, OSHA directs the employer to provide the employee with sick leave or other leave in accordance with the employer’s policies and applicable law. The employer’s payment obligation is reduced by the amount of compensation the employee receives from any other source, such as a publicly or employer-funded compensation program. Employers may also be entitled to an American Rescue Plan tax credit if they pay sick and family leave for qualified leave from April 1, 2021, through September 30, 2021. More information on the tax credit is available from the IRS.

Resources for Compliance

OSHA provides a lengthy COVID-19 plan template to assist health care providers, which may be customized for each workplace. There are additional resources available to health care providers including worksite checklists, sample employee screening questionnaires, an employee training presentation on the Health care ETS and a sample COVID-19 log. OSHA also offers an FAQ on the ETS standard.

Enforcement and Penalties

Violations of the OSHA ETS may carry a maximum penalty of $13,653 per serious violation or per day for failure to abate beyond the abatement date. Willful or repeated violations carry a penalty of $136,532 per violation. OSHA will use its discretion to determine whether an entity’s failure to comply with the ETS standard despite its best efforts warrants relaxation of the enforcement penalties. However, the agency expects that most employers should be able to achieve compliance within the stated deadlines. When addressing penalties for violations, the agency will also consider the size of the company and any past violations.

Takeaways

Health care settings continue to be at the frontline as we battle COVID-19. State and Federal guidelines and mandates are evolving, extremely complicated and can be difficult to navigate. As a threshold matter, it is critical to determine which measures apply to the health care setting. Compliance is critical to minimize the risks to patients and employees and to avoid penalties for non-compliance. Clear communication with employees is crucial to ensure that they are familiar with the requirements and expectations, as well as to understand the employer’s efforts to keep them safe.

[1] Covered health care employers must comply with all provisions in the ETS as of July 6, 2021  except those requirements related to ventilation, physical barriers, and training, which had a  compliance deadline of July 21, 2021

© Copyright 2021 Sills Cummis & Gross P.C.

Article By Jill Turner Lever, Stacy L. Landau, Patricia M. Prezioso, and Charles H. Newman with Sills, Cummis & Gross PC.

For more COVID-19 updates, visit the NLR Healthcare Law section.

Asset Protection for Doctors and Other Healthcare Providers: What Do You Need to Know?

As a doctor or other healthcare professional, you spend your career helping other people and earning an income upon which you rely on a daily basis—and upon which you hope to be able to rely in your retirement. However, working in healthcare is inherently risky, and a study published by Johns Hopkins Medicine which concluded that medical malpractice is the third-leading cause of death in the United States has led to a flood of lawsuits in recent years. As a result, taking appropriate measures to protect your assets is more important now than ever, and physicians and other providers at all stages of their careers would be well-advised to put an asset protection strategy in place.

What is an asset protection strategy? Simply put, it is a means of making sure that you do not lose what you have earned. Medical malpractice lawsuits, federal healthcare fraud investigations, disputes with practice co-owners, and liability risks in your personal life can all put your assets in jeopardy. While insurance provides a measure of protection – and is something that no practicing healthcare professional should go without – it is not sufficient on its own. Doctors and other healthcare providers need to take additional steps to protect their wealth, as their insurance coverage will either be inadequate or inapplicable in many scenarios.

“In today’s world, physicians and other healthcare providers face liability risks on a daily basis. In order to protect their assets, providers must implement risk-mitigation strategies in their medical practices, and they must also take measures to shield their wealth in the event that they get sued.”

What Types of Events Can Put Healthcare Providers’ Assets at Risk?

Why do doctors and other healthcare providers need to be concerned about asset protection? As referenced above, medical professionals face numerous risks in their personal and professional lives. While some of these risks apply to everyone, it is doctors’ and other medical professionals’ additional practice-related risks – and personal wealth – that makes implementing an asset protection strategy particularly important. Some examples of the risks that can be mitigated with an effective asset protection strategy include:

  • Medical Malpractice Lawsuits – All types of practitioners and healthcare facilities face the risk of being targeted in medical malpractice litigation. From allegations of diagnostic errors to allegations of inadequate staffing, plaintiffs’ attorneys pursue a multitude of types of claims against healthcare providers, and they often seek damages well in excess of providers’ malpractice insurance policy limits.
  • Contract Disputes and Commercial Lawsuits – In addition to patient-related litigation, medical practices and healthcare facilities can face liability in other types of civil lawsuits as well. By extension, their owners’ assets can also be at risk, as there are laws that allow litigants to “pierce the corporate veil” and pursue personal liability in various circumstances.
  • Federal Healthcare Fraud Investigations – Multiple federal agencies target healthcare providers in fraud-related investigations. From improperly billing Medicare or Medicaid to accepting illegal “kickbacks” from suppliers, there are numerous forms of healthcare fraud under federal law. Healthcare fraud investigations can either be civil or criminal in nature, and they can lead to enormous fines, recoupments, treble damages, and other penalties.
  • Drug Enforcement Administration (DEA) Audits and Inspections – In addition to healthcare fraud investigations, DEA audits and inspections present risks for healthcare providers as well. If your pharmacy or medical practice is registered with the DEA, any allegations of mishandling, diverting, or otherwise unlawfully distributing controlled substances can lead to substantial liability.
  • Liability for Personal Injury and Wrongful Death in Auto and Premises-Related Accidents – In addition to liability risks related to medical practice, doctors, other practitioners, and healthcare business owners can face liability risks in their personal lives as well. If you are involved in a serious auto accident, for example, you could be at risk for liability above and beyond your auto insurance coverage. Likewise, if someone is seriously injured in a fall or other accident while visiting your home (or office), you could be at risk for liability in a personal injury lawsuit in this scenario as well.

To be clear, an asset protection strategy mitigates the risk of losing your wealth as a result of these types of concerns—it does not mitigate these concerns themselves. The means for addressing medical practice-related concerns is through the adoption and implementation of an effective healthcare compliance program.

Are Asset Protection Strategies Legal?

One of the most-common misconceptions about asset protection is that it is somehow illegal. However, there are various laws and legal structures that are designed specifically to provide ways for individuals and businesses to protect their assets, and it is absolutely legal to use these to your full advantage. Just as you would not expect your patients to ignore treatment options that are available to them, you are not expected to ignore legal tools and strategies that are available to you.

What are Some Examples of Effective Asset Protection Tools for Doctors and Other Healthcare Providers?

Given the very real liability risks that doctors and other healthcare providers face, for those who do not currently have an asset protection strategy in place, implementing a strategy needs to be a priority. With regard to certain issues, asset protection measures need to be in place before a liability-triggering event occurs. Some examples of the types of tools that physicians, healthcare business owners, and other individuals can use to protect their assets include:

1. Maximizing Use of Qualified Retirement Plans

Qualified retirement plans that are subject to the Employee Retirement Income Security Act (ERISA) can offer significant protection. Of course, obvious the limitation here is that these assets placed in a qualified plan will only be available to you in retirement. However, by maximizing your use of a qualified retirement plan to the extent that you are preserving your assets for the future, you can secure protection for plan assets against many types of judgments and other creditor claims.

2. Utilizing Nonqualified Retirement Plans as Necessary

If you operate your medical practice as a sole proprietor, then you are not eligible to establish a qualified retirement plan under ERISA. However, placing assets into a nonqualified retirement plan can also provide these assets with an important layer of protection. This protection exists under state law, so you will need to work with your asset protection attorney to determine whether and to what extent this is a desirable option.

3. Forming a Trust

Trusts are the centerpieces of many high-net-worth individuals’ asset protection strategies. There are many types of irrevocable trusts that can be used to shield assets from judgment and debt creditors. When you place assets into an irrevocable trust, they are no longer “yours.” Instead they become assets of the trust. However, you will still retain control over the trust in accordance with the terms of the trust’s governing documents. Some examples of trusts that are commonly used for asset protection purposes include:

  • Domestic asset protection trusts (DAPT)
  • Foreign asset protection trusts (FAPT)
  • Personal residents trusts
  • Irrevocable spendthrift trusts

4. Offshore Investing

Investing assets offshore can offer several layers of asset protection. Not only do many countries have laws that are particularly favorable for keeping assets safe from domestic liabilities in the United States; but, in many cases, civil plaintiffs will be deterred from pursuing lawsuits once they learn that any attempts to collect would need to be undertaken overseas. Combined with other asset protection strategies (such as the formation of a trust or limited liability company (LLC)), transferring assets to a safe haven offshore can will provide the most-desirable combination of protection and flexibility.

5. Forming a Limited Liability Company (LLC) or Other Entity

If you are operating your medical practice as a sole proprietor, it will almost certainly make sense to form an LLC or another business entity to provide a layer of protection between you and any claims or allegations that may arise. However, even if you have a business entity in place already—and even if you are an employee of a hospital or other large facility—forming an LLC or other entity can still be a highly-effective asset protection strategy.

6. Utilizing Prenuptial Agreements, Postnuptial Agreements, and Other Tools

Depending on your marital or relationship status, using a prenuptial or postnuptial agreement to designate assets as “marital” or “community” property can help protect these assets from your personal creditors (although debts and judgments incurred against you and your spouse jointly could still be enforced against these assets). Additionally, there are various other asset protection tools that will be available based on specific personal, family, and business circumstances.

7. Gifting or Transferring Assets

If you have assets that you plan to give to your spouse, children, or other loved ones in the future, making a gift now can protect these assets from any claims against you. Likewise, in some cases it may make sense to sell, transfer, or mortgage assets in order to open up additional opportunities for protection.

Ultimately, the tools you use to protect your assets will need to reflect your unique situation, and an attorney who is familiar with your personal and professional circumstances can help you develop a strategy that achieves the maximum protection available.

Oberheiden P.C. © 2020  

ARTICLE BY Dr. Nick Oberheiden of Oberheiden P.C.

For more articles on healthcare providers, see the National Law Review Health Law & Managed Care section.

Return to Work COVID-19 Testing Considerations

As employees increasingly transition back into the physical workplace, employers have begun to grapple with whether and how to deploy COVID-19 diagnostic testing as a return-to-work solution.  Many employers want to avoid extended employee quarantine or isolation requirements that prevent their employees from returning to the office for weeks and disrupt their operations.  But is this potential solution legal?  And is it effective?  Below we discuss practical considerations for employers considering a return to work COVID-19 testing strategy.

Is it Legal?

For the most part, yes.  While the Equal Employment Opportunity Commission (“EEOC”) has approved of COVID-19 diagnostic testing in the workplace generally, it has, as explained further below, recently modified its guidance to discourage its use as a return to work strategy.  Further, approaches vary widely across the states and localities that have taken a position on return to work testing.  For example, while Illinois permits its use, an ordinance in Dallas, Texas prohibits return to work testing.

Is it Effective?  

It depends.  Before mandatory vaccination becomes an option (which we wrote about here), requiring employees to test negative for COVID-19 before returning to work may at first glance seem like a reasonable way to ensure employee attendance while keeping the workplace safe.  For some employers, particularly those that are able to test frequently, quickly and accurately, this may be a sound approach.  But for other employers, they will have to weigh their options carefully.  Recent updated guidance from the CDC, employee complaints about the invasiveness of testing, and very real ongoing concerns about testing availability and accuracy may militate against pursuing a testing strategy at this time.

More specifically, recent guidance from the CDC discourages a test-based strategy as a primary solution finding that a symptom-based screening strategy is sufficient to identify when an individual with symptoms may return to work.  However, if an employer nevertheless decides to proceed with diagnostic testing as part of their COVID-19 mitigation strategy, the CDC recommends having employees test negatively twice with the two consecutive tests coming at least 24 hours, before returning to work.

State and local guidance does not necessarily provide additional clarity on how best to proceed.  For example New York State’s guidance only addresses situations where an employee experiences symptoms upon arrival at work or while at the office, advising that in those instances an employee may return to work with a single negative COVID-19 test (in contrast to the CDC’s recommended two consecutive negative tests).  But New York’s guidance does not currently address whether testing is a solution to a host of other scenarios – for instance, where an employee’s remote screening indicates recent symptoms, known exposure, or where an employee traveled to a place with significant community spread.  In those instances, the New York guidance does not incorporate testing as a return to work solution, instead asserting that individuals who have had known close contact with someone who has COVID-19 (i.e. within 6 feet of someone for ten or more minutes) should (1) isolate for 10 days from the onset of symptoms (if the individual has symptoms); or (2) isolate for 14 days from the date of exposure (if the individual does not have symptoms).  New York’s guidance also states that employees who test positive for COVID-19 must complete at least 10 days of isolation from the onset of symptoms or 10 days of isolation after the first positive test if they remain asymptomatic.

Putting all the guidance aside for the moment, testing may prove futile in many cases regardless.  First, COVID-19 reportedly can take 2-14 days after exposure to become identifiable in a diagnostic test, and thus, employees who test negative may return to work and later discover they have indeed been infected.  And in other cases, testing may prove futile if an employee cannot access a test readily, and thereafter receive their results in a timely manner, which effectively sidelines them from returning to the office anyway.  Further, there is also the possibility of a false negative, particularly when an employee takes a rapid test.  Other employer considerations include how COVID-19 testing, and the resulting disciplining of employees if they refuse to be tested, might affect overall employee morale.

Employers should consider these issues and weigh them against the vitality of other preventative measures such as whether an employee can telework or take a paid or unpaid leave in lieu of returning to work.  If the employee must return to work, employers should consider using other safety measures (whether in lieu of or in addition to testing), such as symptom/exposure questionnaires, temperature checks and workplace social distancing requirements.

What if an Employee Refuses to Take a Diagnostic Test? 

In selecting any of these options, employers should consider creating a policy or procedure that, among other things, discloses the circumstances under which an employee must take a test, the specific test or tests that the employer will accept, and the consequences of an employee’s refusal to be tested prior to returning to work.  Employers should also consider whether they will afford an employee the opportunity to take an unpaid leave of absence where they refuse to take a test in lieu of a disciplinary action.

Further, before resorting to disciplinary measures, employers should first consider the nature of the employee’s objection.  If the employee is simply annoyed or frustrated about the testing policy, disciplinary measures may be appropriate as the employees is failing to adhere to a company safety policy.  However, employers should evaluate whether the employee is asking for a disability accommodation, and if so, should consider alternative options to testing.

A Note about Isolation Practices and Employee Abuses.

In jurisdictions that do not require employees to isolate after potential symptoms or exposure, employers that need employees to work in the office may be turning to COVID-19 diagnostic testing as an alternative or supplement to isolation practices they consider impractical or prone to abuse.  Indeed, some employers are facing scenarios in which employees attempt to take advantage of company isolation policies in an effort to take extended time away from the workplace.

Employers facing this situation may consider implementing a diagnostic testing strategy (where permitted and feasible), but should also consider addressing the various employee abuse scenarios that might unfold and provide cautionary warnings to employees.  For example, New York, New Jersey, Massachusetts, and some other jurisdictions are requiring individuals who travel to certain states with troublesome COVID-19 metrics to quarantine for 14 days upon their reentry.  If an employee is planning travel to a “hot spot” on vacation to avoid returning to work, the employer should consider warning the employee that if they are unable to telework upon their return, they may be required to take additional paid time off or even unpaid leave.  Alternatively, employers facing operational difficulties if employers are away for multiple weeks may wish to revisit paid time off approval processes or condition approval of company-provided vacation time on an employee’s ability to return to work promptly after traveling.  In short, employers may have several options to address employees’ abuse of isolation rules that do not necessarily have to involve the implementation of diagnostic testing.

Final Considerations.

If an employer does decide to implement a testing strategy, it should ensure that its COVID-19 testing and screening protocols and policies adhere to relevant state and local guidelines, which vary greatly by jurisdiction.  Employers should further ensure they are tracking other practical aspects of testing.  For example, employers must safeguard employee medical records in accordance with Americans with Disabilities Act (“ADA”) requirements and the privacy requirements of various states and localities, which we discussed here.  When choosing a diagnostic test, employers must also ensure that the test is reliable and accurate – for instance, some rapid testing kits now entering the market may not meet the EEOC’s reliability and accuracy standards.  Similarly, any testing strategies must be uniformly applied so as not to cause disparate treatment amongst employees.  Employers should refer to the EEOC’s ADA guidance, which we discussed here, to ensure non-discriminatory application of testing policies.

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

For more on COVID-19 Testing see the National Law Review Coronavirs News 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.

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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.

Emerging Cyber-Security Threats for 2020: The Rise of Disruptionware and High-Impact Ransomware Attacks

Disruptionware is defined by the Institute for Critical Infrastructure Technology (ICIT) as a new and “emerging category of malware designed to suspend operations within a victim organization through the compromise of the availability, integrity and confidentiality of the systems, networks and data belonging to the target.”  New forms of disruptionware can be a more crippling form of cyber-attack than other more “garden-variety” malware and ransomware attacks. This is the case since, as the ICIT notes, disruptionware not only attempts to encrypt and deny users access to their data, but works as a “layered attack” designed to “disrupt operations and production in manufacturing or industrial environments (as well as infrastructure) in order to achieve some other strategic goal.”

Disruptionware has “consumed” many traditional cyber-attacks, making them part of the disruptioware “toolkit.” These techniques include cyber-attacks such as ransomware, “wipers,” “bricking capabilities,” automated components, data exfiltration tools and network reconnaissance tools. (See ICIT report for further definitions.) Today, the rise of disruptionware is a new and even more chaotic form of cyber warfare attack – it not only attempts to encrypt and deny users access to their data, but disruptionware works to “disrupt operations and production in manufacturing or industrial environments (as well as infrastructure) in order to achieve some other strategic goal.”

Additionally, generalized forms of ransomware attacks – designed to block access to the victim’s computer systems until money is paid – are continuing to represent a more prevalent threat to government agencies, healthcare providers and educational institutions. Ransomware was so destructive on its own that the FBI recently issued a Public Service Announcement (PSA) warning about such “high-impact” attacks on critical private and public sector institutions. Underscoring the FBI’s announcement, another publication has noted the rise of ransomware attacks since the beginning of 2019 finding that there have been at least 621 reported successful ransomware attacks against U.S.-based corporations. Of these attacks, at least 491 were targeted against healthcare providers, while another 68 of the attacks were directed at county and municipal institutions, and 62 of the attacks were focused on school districts.

According to the FBI, hospitals and health care institutions are the primary targets of these high-impact ransomware attacks because of the critical role they play in providing lifesaving services, and the fact that these institutions usually do not have the luxury of taking time to restore backups in order to get their networks working again and running safely and securing after an attack. Above and beyond the costs associated with paying the ransom and restoring computer networks and systems, ransomware attacks on hospitals and health care providers have proven especially damaging because they affect the ability of the targeted healthcare providers to deliver critical health care services to patients. Perhaps even more disturbingly, many of the victim companies reported losing data even when they paid the ransom demanded by the hackers. Nevertheless, according to the blog “knowbe4,” it was predicted that ransomware payments alone by victim companies will have exceeded $11.5 billion in 2019 – representing an increase of almost 30% over the approximately $8 billion paid in 2018.

Along with the rise of disruptionware and high-impact ransomware, hackers are also now using new and diverse techniques to launch multiple forms of cyber-attacks including, among other things, an increased use of new Remote Desktop Protocol (RDP) attacks, as well as leveraging various software vulnerabilities to infect organizations through backdoor channels. Unfortunately, few businesses are hardening their IT infrastructure against these new types of extremely damaging cyber-attacks. RDP attacks are becoming far more common because of the simplicity of many users’ login credentials, while companies are not doing enough to “whitelist” exclusively acceptable computer software and applications to prevent security holes caused by numerous software vulnerabilities in unsecured and sometimes untested software applications.

The FBI’s PSA serves as a warning to businesses that they should have a plan in place to respond efficiently and appropriately in the event of high impact ransomware and disruptionware attacks. Such plans should include, among other things, clear designations of responsible individuals (both inside and outside the company), procedures for contacting law enforcement, and the business having a firm understanding of what their data is as well as a good understanding of its importance in the overall business plan. Finally, businesses need a current and workable Disaster Recovery Plan for getting the organization up and running again as quickly as possible if there is a cyber-attack. Businesses would be wise to review how their systems are backed up, as reliable and readily accessible backups are often critical in allowing ransomware or disruptionware victims to try and resume normal business operations as quickly as possible.

©2020 Drinker Biddle & Reath LLP. All Rights Reserved

For more on ransomware and other cyberthreats, see the Communications, Media & Internet section of the Nationa Law Review.

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.