The Role of the Certified Legal Nurse Consultant in COVID-19 Lawsuits

COVID-19, the coronavirus disease that originated in 2019, has created a global pandemic the size of which none of us has seen in our lifetime.

Lawsuits related to COVID-19 are one of the newest and most emerging areas of litigation. They have the potential to be one of the largest areas of litigation in your career as a CLNC® Consultant. It will pay to decide if, and how, you will participate and to start researching and marketing to law firms involved in COVID-19 litigation.

Vickie L. Milazzo
RN, MSN, JD

As the COVID-19 pandemic continues, it’s obvious that there will be myriad COVID-19 related lawsuits on the horizon. Thousands of COVID-19 related lawsuits have already been filed. Certified Legal Nurse Consultants are pivotal to attorneys understanding the complexities of COVID-19. As a CLNC® consultant you will want to position yourself for this new and emerging litigation which could conceivably last a decade or more.

Types of COVID-19 Lawsuits

The Certified Legal Nurse Consultant focuses on all four legal elements (duty, breach of duty, damages and causation) in medical malpractice cases. In non-medical malpractice cases, the CLNC consultant focuses primarily on damages and causation.

Medical Malpractice

These cases involve the professional negligence of a healthcare provider or the negligence of a healthcare facility. Hospitals, long term care facilities, home healthcare agencies, emergency medical services, urgent care centers and individual RNs, respiratory therapists and MDs are most vulnerable to the allegations of negligent management and treatment of COVID-19 patients or residents.

The focus is on the Certified Legal Nurse Consultant’s role. Addressing legal allegations (e.g. breach of fiduciary duty) and legal defenses (e.g. consent) are the role of the attorney and are not addressed in this article.

Possible Allegations

Allegations are asserted by the plaintiff. The allegations addressed in this medical malpractice section are examples of deviations from the Standards of Care (SOC) that the Certified Legal Nurse Consultant addresses with the attorney from a nursing or medical perspective. The plaintiff also asserts allegations that are not within the scope of the CLNC consultant’s role.

  • Failure to timely diagnose COVID-19.
  • Failure to institute appropriate nursing (medical) interventions. An example of a negligent medical intervention is negligently prescribing hydroxychloroquine for off-label use. Note, physicians are free to prescribe FDA-approved drugs for any scientifically supported use, whether on- or off-label, however they are potentially liable for adverse events from the prescribed drug, especially if there is no scientific support for off-label use.

    In June 2020, the FDA revoked the emergency use authorization (EUA) for use of hydroxychloroquine to treat COVID-19 patients outside of a clinical trial. The FDA determined the drug is not effective and had the potential to cause cardiac adverse events and other serious side effects. A plaintiff attorney would use the FDA revocation of the EUA as proof of negligence if the drug was used after that date.


    Another example of negligent medical intervention is a physician’s failure to order remdesivir and dexamethasone, which the plaintiff alleges are the SOC for COVID-19.

  • Failure to assess and perform appropriate tests and diagnostic studies. This includes the failure to assess and perform appropriate tests and diagnostic studies relevant to systemic complications of COVID-19.
  • Failure to respond timely and appropriately to the patient’s deteriorating condition (e.g. severe respiratory distress).
  • Negligent staffing and supervision. For example, a specific RN in the ICU was not experienced and qualified to treat the patient. With hospitals having to tap into surge capacity ICU beds, resources were strained and the RNs called upon to treat critical COVID-19 patients might not have been experienced and qualified.

    Another example of an allegation is negligent implementation of infection control by management.

  • Negligent lack of preparedness. Failure to provide adequate personal protective equipment (PPE) and adequate supplies of ventilators. Lack of preparedness was a big issue in some areas (e.g. New York City) at the beginning of the pandemic and then again later in areas where COVID-19 spiked, therefore straining the healthcare system.
  • Failure to provide policies and procedures regarding screening, infection control, containment, use of PPE (N95 respirators, masks, eye protection, face shields, gloves and gowns, etc.) and treatment of patients with COVID-19.
  • Failure to provide adequate training to personnel treating possible COVID-19 infections regarding PPE, the preparedness plan, infection control and management of COVID-19.
  • Violated state and/or federal regulations.
  • Abuse and neglect.
  • Failure to diagnose non-COVID-19 medical issues due to physicians practicing telemedicine.

Possible Defenses

The defense will assert defenses responsive to the allegations asserted by the plaintiff, plus additional damage and causation defenses.

  • Adhered to recognized standards regarding diagnosis, testing, nursing and medical interventions and/or response to the patient’s deteriorating condition. An example is “The use of hydroxychloroquine was appropriate.” In July 2020, a study suggested that use of the drug in patients with minimal cardiac risk factors reduced mortality. The validity of that study is being challenged.
  • The SOC evolved for this new disease and were being developed in real time. There were no actual SOC at the time of the incident. For example, ventilator use for patients who are hypoxic and not in true respiratory distress was recognized as harmful to COVID-19 patients in April 2020. Some medical professionals have acknowledged they were treating the wrong disease initially and jumping to ventilators too quickly.

    In April 2020, remdesivir was considered the Standard of Care (SOC). In June 2020, a trial reported that dexamethasone (steroid) reduced death rates by approximately one third among severe COVID-19 patients. This is not surprising considering that COVID-19 causes inflammation and catastrophic systemic issues. A physician treating a severe COVID-19 patient in July 2020 had a more accurate understanding of COVID-19 than one treating the same patient in March 2020 and would therefore be held to higher or different standards. For example, a defense of a physician in March 2020 would be that remdesivir and dexamethasone were not the SOC at the time of the incident. An additional defense related to remdesivir is the unavailability of the drug due to a supply shortage.

  • Adhered to crisis standards of care (CSC) implemented by the state government. CSC are based on the substantial change in usual healthcare operations and the level of care it is possible to deliver in the absence of necessary equipment, ICU beds, medications, personnel or experience. CSC might apply to the peak of the pandemic in New York City v to a city with a controlled number of cases and available resources.
  • Reliance upon junk science and/or no scientific support for allegations. For example, use of convalescent plasma in July 2020 was still investigational and there is no proven safety and effectiveness at this time. If the plaintiff asserts the physician was negligent for failing to administer convalescent plasma, the defense would argue there is no scientific support for this allegation.
  • The RNs and MDs on the frontlines are the heroes of the COVID-19 pandemic. They risked their own lives and potentially the lives of their families. Because jurors might not be willing to hold healthcare providers accountable for negligent actions, plaintiff attorneys may prefer to pursue healthcare facilities for systemic issues rather than sue the heroes on the frontlines for individual negligence.
  • Reliance upon an immunity defense. Possible state immunity granted to some (e.g. out-of-state volunteers, retired professionals) or all healthcare providers treating COVID-19 patients. Some states have granted immunity to long term care facilities. If immunity applies, the plaintiff would have to prove gross negligence or intentional misconduct, both of which are difficult to prove.
  • Staffing and supervision were consistent with the recognized SOC.
  • Was adequately prepared. Or the lack of preparedness and shortage of PPE is not the fault of the provider and/or facility given the magnitude of the pandemic and the global emergency. No one could have been prepared. If anyone is at fault, it is the state and federal governments and the CDC who failed the healthcare system and the American public.
  • Did have adequate policies and procedures given the magnitude of the pandemic and the global emergency and continued to update in real time.
  • Did provide adequate training for personnel given the magnitude of the pandemic and the global emergency and continued to update in real time.
  • Adhered to state and federal regulations.
  • No proof of abuse or neglect.
  • Limited or no damages.
  • The actions did not cause the patient’s death or injuries. For example, the defense will argue that the death or injuries are acceptable side effects of COVID-19 and were not preventable due to the severity of COVID-19 at the time of presentation. Additional causation defenses include that the plaintiff had preexisting conditions which made him high risk and/or that the plaintiff was also negligent (comparative negligence). For example, the plaintiff delayed seeking treatment. Finally, the defense might argue that the damages are acceptable complications of treatment necessary to save the patient’s life.

It’s important for the Certified Legal Nurse Consultant to address both allegations and defenses when consulting for either plaintiff or defense attorneys.

General Negligence

These cases can involve a wide range of negligence claims against a variety of businesses, corporations and individuals.

Examples of corporations that will potentially face COVID-19 litigation include long term care facilities (e.g. nursing homes and assisted living facilities), airlines, cruise lines, ride share companies, hotels and casinos. Day care centers, gyms, nail and hair salons, bars and restaurants are also potential defendants. Businesses that remained open or failed to cancel events during the public health crisis are also at risk.

Examples of individuals include employees of long term care facilities, massage therapists, chiropractors, hair stylists and other personal service providers.

Individuals are also potentially liable for negligently transmitting the virus after notice of infection. Once a person has been diagnosed as infected, it’s arguable that they have a duty to self-quarantine from family, friends, coworkers, clients and the public at large.

Possible Allegations

  • Failure to properly screen employees for COVID-19.
  • Failure to inform customers of possible exposure to COVID-19.
  • Failure to provide PPE.
  • Failure to provide safe air quality.
  • Failure to implement safety policies such as social distancing, mask requirements, workplace sanitation, etc.
  • Failure to cleanse and sanitize the workplace. Surface transmission is low risk compared to the risk of airborne transmission. The Certified Legal Nurse Consultant might steer the attorney away from this allegation toward more effective allegations related to air quality, mask requirements and social distancing.
  • Failure to implement state or federal regulations. For example, a long term care facility may be sued for failing to implement infection control regulations. A long term care facility may be sued for elder abuse resulting from failure to adhere to state and federal regulations regarding hiring, retention and supervision of employees. The plaintiff attorney wants elder abuse to be a management issue, not a case about an individual employee.
  • For long term care facilities, also refer to Medical Malpractice allegations.

Possible Defenses

  • Did provide adequate and appropriate protection for clients through screening, informing customers of possible exposure, PPE, safe air quality and safety policies and procedures.
  • Adhered to state and federal regulations (e.g. no proof of abuse and neglect).
  • Reliance upon junk science and/or no scientific support for allegations.
  • Limited or no damages.
  • Did not cause the plaintiff to contract COVID-19. Given that the incubation period is up to 14 days, it will be difficult to prove when and where the plaintiff contracted COVID-19. If someone gets symptoms 13 days after exposure, a lot could have happened in those 13 days.

    Causation will be easier to prove when a large number of individuals are infected (e.g. nursing home residents, staff and visitors, cruise ship passengers, hotel guests and casino visitors) than a single case.

  • The actions did not cause the patient’s death or injuries. The defense will also potentially argue that the incident did not cause the alleged death or injuries. Damages are due to the severity of COVID-19 at the time of presentation, preexisting conditions which made the patient high risk and/or comparative negligence (e.g. Plaintiff delayed seeking treatment.).
  • Plaintiff signed a waiver agreeing not to sue. Whether waivers will hold up in court is unknown at the time of this writing. Government waivers (e.g. attending legislative session or hearing) are likely to be upheld, while private event waivers (e.g. campaign rallies, concerts, sporting events, auto races, conventions, exhibitions, etc.) may face stricter scrutiny.
  • For long term care facilities, also refer to Medical Malpractice defenses.

Products Liability

These cases involve injury as a result of a defective product. There are a large number of products related to COVID-19 that are already known to be defective. Examples include defective COVID-19 virus tests with high false negative rates, defective COVID-19 antibody tests with false positive rates, defective hand sanitizers and defective and counterfeit PPE. Ultimately there will be vaccines and potentially there could be issues of effectiveness and deaths or serious side effects resulting from vaccines.

Possible Allegations

  • Design defect – the entire line of products is defective. For example, the entire line of a specific antibody test produced by a specific manufacturer is only 50% accurate and therefore defective.
  • Manufacturing defect – a single product in the line of products is defective. For example, a specific antibody test is generally 95% accurate, but one batch of the antibody test is only 50% accurate.
  • Failure to warn of defects, foreseeable risks or known defects. For example, there is a failure to warn that an antibody test has a 20% inaccuracy rate. That inaccuracy rate may be acceptable given the pandemic, as long as a warning is provided.
  • Fraudulent misrepresentation for holding out that a product meets standards, which it does not. For example, an N95 respirator does not meet the NIOSH filtration standards of filtering at least 95% of airborne particles.

Possible Defenses

  • The product is not defective (design or manufacturing). In a pandemic, a higher inaccuracy percentage of COVID-19 and antibody tests will be accepted than would be outside of a pandemic.
  • Appropriate warnings were given and/or not indicated.
  • All representations were accurate based on what was known at the time.
  • Reliance upon junk science and/or no scientific support for allegations.
  • Immunity defenses for manufacturers of vaccines, testing and treatment products. If applicable, immunity defenses would probably only apply to FDA approved products and drugs.

    Title 42 of the U.S. Code protects vaccine manufacturers from liability for state lawsuits for injuries from vaccines. The U.S. Supreme Court has upheld the National Childhood Vaccine Injury Act (NCVIA), which preempts all design defect claims against vaccine manufacturers. The National Vaccine Injury Compensation Program (NVICP), compensates parties injured by vaccines on a no-fault basis which limits damages. Given these hurdles, it is unlikely that there will be large-scale litigation over vaccine-related deaths or injuries.

  • Limited or no damages.
  • The product did not cause the patient’s COVID-19 infection. The plaintiff contracted COVID-19 from another cause. It will be difficult to prove when and where the plaintiff contracted COVID-19. The defense will also potentially argue that the product did not cause the alleged death or injuries. Damages are due to the severity of COVID-19 at the time of presentation, preexisting conditions which made the patient high risk and/or comparative negligence (e.g. Plaintiff delayed seeking treatment.).

Workers’ Compensation

These cases involve job-related injuries. Workers’ compensation laws vary from state to state. Whether contracting COVID-19 from work-related activities is compensable will vary from state to state. If applicable, workers’ compensation applies to any worker (healthcare providers and other ancillary workers, meatpacking plant employees, flight attendants, office workers, etc.) who can prove they contracted COVID-19 at work.

If an employer is workers’ compensation insured, this system is usually the employee’s sole remedy. In some states employees can sue employers outside of workers’ compensation if the employee can prove an intentional act or gross negligence on the part of the employer, both of which are difficult to prove.

Proof of fault is not required. The employee has to prove that they contracted COVID-19 on the job. Some states have already enacted legislation providing a presumption of causation, while others may treat COVID-19 as a common disease of life like a cold or flu and, therefore, not compensable.

Possible Defenses

  • Limited or no damages.
  • In some states the plaintiff will have to prove that the actual COVID-19 infection occurred on the job site and not elsewhere. With America’s return to work, commuting, traveling, restaurants, bars, beaches, gyms, worship services, casinos and general disregard for wearing masks and social distancing, proving causation could be a difficult hurdle.

Workplace Safety

These cases involve lawsuits by employees or unions against employers seeking injunctive relief from employers to ensure a safe working environment. Plaintiffs may include almost any worker (healthcare providers and other ancillary workers, meatpacking plant employees, flight attendants, office workers, etc.).

Possible Allegations

  • Failure to properly screen employees for COVID-19.
  • Failure to inform employees of possible exposure to COVID-19 in the workplace.
  • Failure to provide PPE.
  • Failure to provide safe air quality.
  • Failure to implement safety policies such as social distancing, mask requirements, workplace sanitation, etc.
  • Failure to cleanse and sanitize the workplace.
  • Failure to implement state or federal regulations.

Possible Defenses

  • Adhered to standards and regulations and did provide adequate and appropriate protection for employees through screening, informing employees of possible exposure, PPE, safe air quality and safety policies and procedures.
  • The lack of preparedness and shortage of PPE is not the fault of the employer given the magnitude of the pandemic and global emergency.

Wrongful Termination, Employment Discrimination and Constructive Discharge

Healthcare providers and other relevant workers may sue employers for wrongful termination for insisting on adequate PPE, reporting employer/employee misconduct or unsafe working conditions or wearing their own PPE against company policy.

Employment discrimination can take place when employees are terminated, passed over for promotion or not hired based on age, sex, race/ethnicity or disability, etc.

Constructive discharge cases involve employees forced to quit their jobs due to intolerable workplace conditions. For example, when bars first opened, many of them were out of control regarding crowd size, lack of social distancing and failure to wear masks. Security staff, bartenders and other service staff may have been forced to quit their job due to intolerable workplace conditions.

Intentional Torts

These cases could include assault, battery and intentional infliction of emotional distress for volitional acts that intend to bring about actual or threatened transmission of COVID-19. For example, a non-masker intentionally coughs in an employee’s face for insisting the customer wear a mask.

Criminal

These cases involve acts that society has deemed contrary to the public good. According to the CDC, transmission of HIV and STDs has been criminalized to varying degrees in at least 34 states. It’s possible that COVID-19 may receive similar treatment if the person knows they have COVID-19 and acts without regard for the safety and well-being of others. As of the date of this article, there are no states that criminalize transmission of COVID-19, but there are states that do criminalize threats of transmission of COVID-19.

Individuals, online resellers and companies may also be criminally prosecuted for fraudulently deceiving the public regarding representations of quality and/or effectiveness of products such as masks, other PPE, supplements, alternative therapy remedies, etc. For example, a Chinese company faces federal charges for selling fake N95 respirators to American healthcare facilities.

Businesses could be charged for refusing to close when mandated by law.

Criminal cases also include elder abuse in long term care facilities.

Miscellaneous

There are additional potential and actual lawsuits relevant to COVID-19:

  • Lawsuits against the federal, state and local governments for negligently handling COVID-19 (arguably unlikely to be successful). For example, there is a lawsuit against one state’s department of health over nursing home inspection procedures in a nursing home that had a large number of residents infected with COVID-19.
  • Lawsuits against the federal, state and local governments for required business closures during the pandemic.
  • Actions by regulatory agencies against corporations for failing to adhere to regulations.
  • Lawsuits by businesses against insurance companies for economic losses due to COVID-19.
  • Lawsuits (class actions) against China for negligently failing to contain COVID-19.
  • Lawsuits for failing to comply with state, local or business mask policies. Examples include airline passengers placed on “do not fly” lists and customers barred from business establishments or public events.
  • Lawsuits brought under the Americans with Disabilities Act (ADA) by parties with asthma or other disabilities who cannot wear a mask and parties refused reasonable accommodations due to disabilities.
  • Lawsuits involving exemptions from mandatory COVID-19 vaccines due to medical exemptions and religious, personal, moral or other beliefs.
  • Lawsuits regarding failure to provide leave under either the Family and Medical Leave Act (FMLA) or Families First Coronavirus Response Act (FFCRA) where applicable.

What Interested CLNC® Consultants Should Do

Lawsuits related to COVID-19 are one of the newest and most emerging areas of litigation. They have the potential to be one of the largest areas of litigation in your career as a CLNC Consultant. It will pay to decide if, and how, you will participate and to start researching and marketing to law firms involved in COVID-19 litigation.

Certified Legal Nurse Consultants: Go to Part 2 of The Role of the Certified Legal Nurse Consultant in COVID-19 Lawsuits to learn more about the specific services Certified Legal Nurse Consultants provide and factors that will affect COVID-19 litigation. Go also to the presentation How to Market to Attorneys Handling COVID-19 Cases.

Vickie

Vickie L. Milazzo, RN, MSN, JD
The Pioneer of Legal Nurse Consulting

Updates

8/23/20 – FDA Issues Emergency Use Authorization (EUA) for Convalescent Plasma as Potential COVID–19 Treatment

The U.S. Food and Drug Administration (FDA) issued an EUA for investigational use of COVID-19 Convalescent Plasma (CCP) for treatment of COVID-19 in hospitalized patients. The FDA decision memorandum states “CCP may be effective in the treatment of COVID-19 and it is reasonable to believe the known and potential benefits of CCP outweigh the known and potential risks.” Randomized control trials will be required to show definitive evidence of safety and efficacy. Usage limitations and additional information can be found in the FDA’s decision memorandum located at https://www.fda.gov/media/141480/download.

9/1/20 – COVID-19 Treatment Guidelines Panel at the National Institutes of Health (NIH) Issues Statement on the Emergency Use Authorization of Convalescent Plasma for Treatment of COVID-19

The COVID-19 Treatment Guidelines Panel at the National Institutes of Health (NIH) issued a statement on the Food and Drug Administration’s (FDA) Emergency Use Authorization of Convalescent Plasma for the Treatment of COVID-19 stating, “There are insufficient data to recommend either for or against the use of convalescent plasma for the treatment of COVID-19” The statement further emphasized, “Convalescent plasma should not be considered standard of care for the treatment of patients with COVID-19.” It also reinforced the FDA’s August 23, 2020 recommendation that randomized control trials are needed to determine whether convalescent plasma is effective and safe for treatment of COVID-19. Finally, NIH attached a footnote stating, “The criteria for issuance of an EUA are not the same as the standards for FDA approval. There are currently no FDA-approved therapies for the treatment of COVID-19.” Additional information can be found in the NIH’s statement located at https://www.covid19treatmentguidelines.nih.gov/statement-on-convalescent-plasma-eua/

10/9/20 – NIH Update: Therapeutic Management of Patients with COVID-19

NIH published updated guidelines for therapeutic management of patients with COVID-19. Protocols for pharmacologic management and treatment are broken down by disease severity as follows:

  1. Not hospitalized or hospitalized but does not require supplemental oxygen,
  2. Hospitalized and requires supplemental oxygen,
  3. Hospitalized and requires oxygen delivery through a high-flow device or noninvasive ventilation, and
  4. Hospitalized and requires invasive mechanical ventilation or ECMO.

You can download the updated guidelines at: https://www.covid19treatmentguidelines.nih.gov/therapeutic-management/

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