Medical & Professional Malpractice Investigations, Defense, Litigation & ADR
At the Law Office of Kevin O’Mahony, we serve as outside counsel for hospitals, health systems and other healthcare entities, conducting investigations of unanticipated adverse patient outcomes and medical malpractice claims. We also represent and defend hospitals, physicians, physician assistants, nurse practitioners, nurses, and other healthcare entities and staff in medical malpractice lawsuits in both state and federal courts, arbitration, mediation and other alternative dispute resolution (“ADR”) proceedings. Additionally, we serve as personal counsel for physicians facing medical malpractice claims or lawsuits in which liability exposure may exceed their malpractice insurance policy limits.
Internal Investigations & Outside Counsel’s Role
Every safety-critical industry devotes considerable time and resources to investigating and analyzing accidents, incidents and near misses. Systematic analysis of incidents has expanded understanding of both the causes and prevention of harm. These methods have been widely employed in healthcare for many years, and most healthcare organizations have their own internal systems and processes for reporting and responding to incidents.
However, it is also important – at least in some cases – to engage independent, outside counsel to investigate unexpected adverse outcomes. Such investigations are conducted in an effort to strengthen processes of care and improve the quality of care afforded patients, as well as minimize potential legal liability.
Expertise in conducting internal investigations cannot be found in case law or “how to” books. It comes through years of practice. We have many years’ experience working as outside counsel for both large and small healthcare organizations, conducting investigations of unanticipated adverse outcomes and incidents.
The following outlines some of the reasons for conducting internal investigations (even if no claim or suit is anticipated), why it is important to conduct an internal investigation as soon as possible after an unexpected adverse outcome or incident is discovered, and why it is wise to retain outside counsel to conduct investigations.
What is an internal investigation?
- A factual review and legal analysis of potential problems or issues.
- Often conducted by compliance officers, internal audit departments, outside counsel, or all of them.
- Usually independent of a government investigation.
When may an internal investigation be warranted or necessary?
- Patient’s or patient family member’s complaints.
- Reasonable belief that a problem exists.
- Discovery of potential error through a routine audit or by chance.
- Receipt of actual notice of potential violation of law or regulation from employees or third parties.
- Learning of departure from, violation or material breach of, standard of care, compliance program or organization policy.
- Notification from a governmental agency (i.e., request for documents, subpoena or search warrant).
- Learning that the government has begun an investigation.
- Learning that your carrier or fiscal intermediary is conducting an audit.
- Annual OIG Work Plan, OIG Audit Reports, new regulations or revisions to existing regulations identify risk areas.
- Reports received from your Compliance Hotline.
Why do an internal investigation?
- Provide insight into problematic practices within your organization.
- Determine if there has been any wrongdoing.
- Stop any wrongdoing and implement corrective action immediately.
- Gather information for developing appropriate responses to the government or claimants.
- Learn about the strengths and weaknesses of your current control processes.
- Provide your attorney with the information necessary to counsel you about potential legal pitfalls, defenses and options on how to proceed with your case.
- Minimize any potential civil or criminal liabilities.
- Determine whether to make a voluntary disclosure or payment.
Who should conduct an internal investigation?
- Compliance Officer, if he or she can effectively conduct objective, independent investigation.
- Outside counsel (working collaboratively with Compliance Officer and/or in-house counsel) because they can more effectively assert the attorney-client privilege and work product exception to discovery, and maintain independence and credibility with outside parties, including the government.
- Independent auditors and experts, but only if retained through, and directed by, an attorney so that their communications and work product can remain privileged.
- The Compliance Officer or in-house counsel should work with outside counsel to determine when it is appropriate to conduct an investigation under attorney-client privilege.
Attorney vs. non-attorney directed investigations – what difference does it make?
- Only attorneys can conduct privileged investigations and assert the attorney-client privilege and the work product immunity protection.
- Experts retained by, and working at or by the attorney’s direction, normally fall under the attorney’s privilege umbrella and their reports will be (or at least have a better chance of being) shielded from discovery via the attorney-client privilege and work product exception to discovery.
- Attorneys are better suited to analyze legal issues, examine legal consequences, and render legal advice regarding potential defenses, liabilities and corrective actions.
- Potential for waiver (i.e., inadvertent disclosures) is greater when a non-attorney is leading an investigation.
- In all instances, the complexity and materiality of the issue should be considered in determining who should conduct the investigation.
Internal Compliance Officer, In-House Counsel or Outside Counsel – what’s the difference?
Internal Compliance Officer or In-House Counsel – Advantages
- Often more knowledgeable about the organization, its business operations and policies.
- Has working knowledge of the organization’s compliance program.
- May be more cost-efficient because investigation may proceed more quickly, and because he or she is already on the organization’s payroll.
Internal Compliance Officer or In-House Counsel – Disadvantages
- Government and other outside parties’ potential perception of lack of objectivity and independence.
- Internal conflicts of interest can arise if a wrongdoer is a high-level employee or official.
Outside Counsel – Advantages
- Government and other outside parties often view outside counsel as independent of the organization.
- Can more effectively maintain the attorney-client privilege and work product immunity protection.
- Provides more objectivity in assessing legal issues and liabilities relating to the investigation.
- Often has more experience in dealing with potential plaintiffs’ counsel and government agents in connection with governmental investigations.
- May be able to avoid lawsuit or formal government action.
- Usually is exposed to other areas of law and may have a broader knowledge of administrative, civil and criminal issues relating to fraud, etc.
Outside Counsel – Disadvantages
- Scope and complexity of investigation may not warrant outside involvement.
- Relative unfamiliarity with the client’s organizational structure, players and internal dynamics.
What do the attorney-client privilege and work product discovery exception protect?
- Attorney-client privilege covers the communications between an attorney and the client. It generally attaches to the complete communication, including legal advice and facts. But pre-existing documents, non-confidential matters of employment, or communications made in furtherance of a crime or fraud are usually not protected.
- Work product immunity covers work relating to the preparation of the client’s case. It protects the materials prepared, the mental impressions developed, legal theories and conclusions made by an attorney, and communications made in anticipation of litigation or for trial.
How do we preserve privileges?
- Identify who the attorney represents.
- Obtain only legal advice from the attorney because business advice by itself is not privileged.
- Clearly designate all covered written materials as being privileged.
- Limit the number of persons who have access to privileged information and communications to those with genuine need “need to know.”
- Avoid conflicts of interest.
What happens after we investigate?
- Assess whether a written report outlining the investigative results is necessary and, if so, what it will cover.
- Assess whether you should make a formal self-disclosure to the government, patient or patient’s representative, or an informal self-disclosure to your fiscal intermediary or insurance carrier.
- If credible evidence of wrongdoing is uncovered, explore the advantages and disadvantages of self-reporting to the government or other parties.
- Keep in mind that any information provided to the government via voluntary disclosure could result in a waiver of the attorney-client privilege and work product immunity, and could become discoverable by private third-party litigants.
- Consider re-evaluating your compliance program to ensure its effectiveness and make any necessary and appropriate changes.
What are some of the advantages and disadvantages of self-reporting?
- Disclosure demonstrates that you have an effective compliance program that detected an incident of potential non-compliance.
- Disclosure allows you to voluntarily enact measures to detect, reduce and eliminate future problems.
- Disclosure may actually prevent a civil lawsuit and lead to a more favorable, less expensive resolution/outcome.
- Disclosure helps prevent or reduce the number of potential whistleblower actions.
- If potential criminal conduct is involved, entities or individuals who cover-up misconduct expose themselves to harsher criminal penalties and fines.
- Federal Sentencing Guidelines for Organizations provides for leniency for those organizations that self-report, have no high level of involvement in the misconduct, and cooperate with the government’s prosecution.
- Voluntary disclosure could result in a potential waiver of privileges.
- Adverse publicity may result from the disclosure.
- Voluntary disclosure alerts the government and other parties of potential wrongdoing and may invite legal and punitive action.
- The government and other litigants may use your voluntary disclosure against you if they decide to prosecute or sue.
If we decide to self-report, what information should our report contain?
- Circumstances that led to the investigation.
- Investigative process and methodology.
- Facts disclosed by your investigation.
- Discussion of applicable laws or regulations.
- Reason for violation.
- Liability assessment, including arguments for and against healthcare organization’s position.
- Recommended or actual corrective and remedial actions.
In-House Counsel and Outside Counsel’s Perspectives on Internal Investigations
- Self-serving as it may sound coming from lawyers, we should be involved in the process as early as possible because we can be more objective and bring other advantages as well.
- The provider needs to preserve privilege during this process; we can help.
- We know the law and can best evaluate the provider’s civil and criminal liability exposure.
- It’s better to know about potential problems than not know and pay a greater price later.
Defense of Medical Malpractice Claims & Lawsuits
Besides conducting investigations of adverse outcomes (which may or may not result in claims, demands for payment or lawsuits), we also assist in responding to settlement demands, and defend medical malpractice claims and lawsuits filed in state or federal court.
Medical professionals have much at stake in malpractice cases. Adverse patient outcomes – even unexpected ones — are not always caused by negligence or medical error. And difficult and complicated cases often result in less than ideal outcomes or results. But even in cases where negligence did not occur, a medical malpractice claim or lawsuit may ensue, which can have a drastic effect on a healthcare professional’s license, credentials, privileges and reputation.
While your financial exposure may be mitigated by malpractice insurance, you still may suffer professional licensing consequences and damage to your reputation based on the amount of a settlement or if you are found liable for malpractice. Medical facilities and entities also may have much at stake due to possible licensing implications, negative publicity and other issues.
We understand the strain a professional negligence investigation, claim or lawsuit can put on an individual professional and everyone else involved in the process. We therefore strive to make the process as painless as possible, by handling it professionally — from initiation of an investigation, to defense of a claim or suit, final decision or resolution, and dealing with the consequences afterward.
We have developed close working relationships with numerous medical experts in virtually every specialty. We also employ legal nurse consultants and have access to the most highly-respected and relevant medical resources, to assist in defending malpractice cases and achieving the best possible outcomes. And we understand the importance of consistently advocating for our clients’ best interests, while at the same time complying with budgetary, billing and reporting guidelines.
We have defended a broad range of medical malpractice claims and lawsuits (including many alleging wrongful death), involving allegations such as:
- Diagnostic errors or omissions
- Failure to obtain informed consent
- Failure to timely assess, diagnose or treat a condition, illness or complications
- Failure to recognize and treat significant changes in a patient’s condition
- Failure to communicate critical information to other healthcare professionals
- Failure to properly monitor and supervise
- Failure to report to regulatory agencies or boards
- Improper charting or failure to document medical records appropriately
- Improper testing
- Improper wound care, pressure and decubitus ulcers prevention and treatment
- Medication errors
- Negligence, abuse, exploitation or improper relationships
- Recommending or providing an improper form of treatment
- Surgical and post-op errors
- Violations of standard of care, statutes, regulations or policies
In addition to trials and appeals, we have achieved many favorable, cost-effective outcomes through motions to dismiss and for summary judgment, alternative dispute resolution proceedings, and pretrial settlements. We also work with clients to manage sensitive communications and negotiations with patients, their families and legal counsel, to properly handle staffing or administrative issues, and to address concerns related to the media or public.
Providing Liability Protections to Healthcare Workers During Coronavirus Pandemic
The COVID-19 pandemic created a public health emergency that has quickly changed the provision of healthcare services across the country based on guidance and recommendations from the Centers for Disease Control and Prevention and other federal, state and local government directives. Although necessary, these measures have raised concern about the potential liability of physicians and other healthcare professionals who are responding to the pandemic and continue to provide high-quality patient care while adhering to these guidelines and recommendations.
Also, in an effort to extend and expand the capacity of our nation’s healthcare workforce to provide care on the frontlines of the COVID-19 crisis, the Secretary of Health and Human Services issued a letter on March 24, 2020 and associated guidance urging all state governors to take a number of immediate actions, including shielding healthcare professionals from medical liability. Below is a summary of some of the liability protections for healthcare professionals that are in effect as of this writing, as well as other activities currently underway.
On March 27, 2020, President Donald Trump signed into law H.R. 748, the “Coronavirus Aid, Relief and Economic Security Act” (“CARES” Act). This new law includes Good Samaritan language that provides additional federal liability protections for volunteer healthcare professionals during the COVID-19 emergency response (see section 3215).
The law clarifies that physicians and other healthcare professionals who provide volunteer medical services during the public health emergency related to COVID-19 shall not be liable for providing such services that relate to the diagnosis, prevention or treatment of COVID-19 or the assessment or care of a patient related to an actual or suspected case of COVID-19. Limited exceptions apply for such things as gross negligence, criminal misconduct and providing care while intoxicated. These protections preempt state and local laws that are inconsistent with the CARES Act. However, state laws that provide greater liability protections are not preempted.
The Public Readiness and Emergency Preparedness Act (“PREP” Act) provides broad immunity protections to health care professionals who administer or use countermeasures covered by declarations issued by the Secretary of HHS. On March 17, 2020, the Secretary issued such a declaration, applying immunity protections to physicians and other healthcare professionals who administer or use such countermeasures as antiviral medications, other drugs, biologics, vaccines, diagnostics and/or devices (e.g., COVID-19 testing and respiratory therapy) to treat, diagnose, cure, prevent or mitigate COVID-19 or the transmission of SARS-CoV-2 or a virus mutating therefrom.
The Volunteer Protection Act of 1997 (“VPA”) provides liability protections to volunteers, including physicians, who are performing services for nonprofit organizations or government entities. A public health emergency or national emergency declaration is not required for these protections to apply. The protections apply to an uncompensated volunteer for acts of ordinary negligence committed within the scope of the volunteer’s responsibilities. Physician volunteers are not liable for economic damages caused when they provide medical care within their scope of practice.
The volunteer must be properly licensed, certified or authorized by the appropriate authorities as required by the law in the state in which the harm occurred. Limited exceptions apply for such things as gross negligence and reckless misconduct. These protections preempt state and local laws that are inconsistent with the VPA. However, state laws that provide greater liability protections are not preempted.
Section 194 of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) extends eligibility for Federal Tort Claims Act liability protections to volunteer health professionals at qualifying free clinics, provided that the clinic sponsors the physician by submitting an application to the Health Resources and Services Administration.
HHS has also published a “COVID-19 Workforce Virtual Toolkit,” containing a set of resources and tools for decision-makers managing healthcare workforce challenges in response to the COVID-19 emergency. That toolkit includes a separate webpage providing resources on various liability protections for healthcare professionals assisting with the COVID-19 response.
In a letter to the nation’s governors on workforce solutions to address COVID-19, HHS Secretary Alex Azar encouraged governors to develop a list of liability protections for in-state and out-of-state physicians, including volunteers, relicensed or recently licensed medical professionals, services provided through telehealth, and services consistent with expanded scopes of practice. The National Governors Association website is tracking state declarations and other COVID-19 responses at https://www.nga.org/coronavirus/#states. And the AMA has issued COVID-19: Recommendations for pursuing liability protections through state action and policy options for states to address COVID-19, containing guidance on how states may provide additional liability protections for physicians and other providers in response to COVID-19.
PREP Act Application & Scope of Preemption
On January 8, 2021, HHS’s Office of General Counsel (the “OGC”) issued an Advisory Opinion addressing the scope of the Public Readiness and Emergency Preparedness Act’s (the “PREP Act’s”) preemption provision. The OGC issued this Opinion in response to recent lawsuits where patients or their estates allege that patients contracted COVID-19 because a facility, among other things, failed to provide its staff with personal protective equipment (“PPE”), failed to teach the staff how to properly use that equipment, or failed to ensure that its staff used the PPE that it had been given. Defendants in these cases will often argue that the PREP Act applies to these cases and that the defendants are immune from liability under the PREP Act.
In its Opinion, the OGC analyzed the issue of when certain cases should be removed to federal court. The recent cases in which plaintiffs allege that a facility failed to provide staff with PPE, train staff on the use of PPE, or ensure that PPE was used are often filed in state courts alleging a variety of state law-based torts. Courts have subsequently grappled with the issue of whether such cases should proceed in state court or be removed to federal court because the PREP Act may apply. In its Opinion, the OGC indicates that cases seeking to determine the “metes and bounds” of the PREP Act during a national public health emergency belong in federal court. To support its conclusion, the OGC cites to the case of Grable & Sons v. Darue in which the U.S. Supreme Court indicated that “a federal court ought to be able to hear claims recognized under state law that nonetheless turn on substantial questions of federal law[.]” The OGC therefore concludes that the Grable doctrine should be invoked for all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure.
The OGC also addressed the issue of when the PREP Act is triggered. In rejecting the idea that the PREP Act automatically does not apply to the non-use of a covered countermeasure, the OGC indicates that the PREP Act extends immunity to anything “relating to” the administration of a covered countermeasure. To illustrate this argument, the OGC provided an example in which a facility only has one dose of a COVID-19 vaccine and decides to administer it to an individual who is more vulnerable to COVID-19 rather than to another individual who is less vulnerable to COVID-19. In this circumstance, the OGC contends that the PREP Act could apply to the decision to not administer the COVID-19 vaccine to the less vulnerable individual. The OGC contrasts this example with a situation in which a facility fails to purchase any PPE, which may not be sufficient to trigger the PREP Act.
In another recently issued Advisory Opinion, the OGC further explored the issue of PREP Act coverage and its relationship with vaccine recommendations issued by the Advisory Committee on Immunization Practices (“ACIP”). And effective February 10, 2021, HHS amended its declaration providing liability protection under the PREP Act to include federal government employees, contractors and volunteers authorized to prescribe, administer, deliver, distribute or dispense COVID-19 medical countermeasures.
On September 14, 2021, HHS issued an amendment to the PREP Act Declaration that expands the pool of professionals now covered under the Act for the administration of COVID-19 monoclonal antibody therapeutics. Specifically, the amendment includes coverage of licensed pharmacists, pharmacy technicians, and pharmacy interns when administering COVID-19 monoclonal antibody therapeutics orally, through intramuscular injection, or through subcutaneous injection. Additional information about the PREP Act and additional Advisory Opinions issued by the OGC can be found at: HHS’s Public Readiness and Emergency Preparedness Act Webpage.
Vaccine Adverse Events Reporting Requirements for Providers
Vaccination providers are required by the FDA to report vaccination administration errors, serious adverse events, cases of Multisystem Inflammatory Syndrome, and cases of COVID-19 that result in hospitalization or death following COVID-19 vaccination under Emergency Use Authorization. Reporting is encouraged for any other clinically significant adverse event even if it is uncertain whether the vaccine caused the event. Providers can submit a report to the Vaccine Adverse Event Reporting System (VAERS) or call 1-800-822-7967.
States have a number of liability protections that could apply to a physician or other provider providing care in an emergency, particularly those serving as a volunteer. For instance, 50 states have Good Samaritan statutes which provide immunity to licensed physicians acting in good faith who provide gratuitous care at the scene of an accident.
Some states extend these protections to care provided by volunteer physicians, often as part of an official response team, in a public health emergency, state of emergency or other state declared disaster proclamation issued by governors. State laws also provide liability protections for volunteer physicians providing care in a free clinic, non-profit hospital, nonprofit organization or as part of a government organization.
States also have enacted Compacts or Uniform Laws, which include liability protections for volunteers responding to a declared emergency. However, these protections are not automatic and are limited in their applicability. For example, the Emergency Management Assistance Compact (“EMAC”), which has been enacted by all 50 states, provides immunity to officers or employees from the rendering state to the state requesting aid, in which officers or employees are considered agents of the requesting state for tort liability and immunity purposes. For EMAC protections to apply, however, a state must make a request to another state(s) though the Compact and such request must be formally accepted by the rendering state.
The Uniform Emergency Volunteer Health Practitioners Act (“UEVHPA”), grants immunity of civil liability to out-of-state licensed health professionals for gratuitous care provided in a declared emergency. There are, however, limitations to whom the UEVHPA applies, including only out-of-state physicians who have registered in advance or during an emergency. According to the National Conference of Commissioners on Uniform State Laws, the UEVHPA has been enacted in 17 states, D.C. and U.S. Virgin Islands since 2007. Georgia is among those states (with AR, CO, IL, IN, KY, LA, ME, NV, NM, ND, OK, TN, TX, UT, WA, WV currently the others). It is important to keep in mind, however, that practically all the laws described above typically include exceptions for gross negligence or reckless or intentional misconduct.
In response to COVID-19, states are considering ways to extend liability protections for physicians and other healthcare professionals. For example, on March 23, 2020, New York Governor Andrew Cuomo issued an executive order amending New York’s Good Samaritan statute to provide broad civil immunity to healthcare professionals for any injury or death alleged to have been sustained directly as a result of an act or omission by such medical professional in the course of providing medical services in support of the state’s response to the COVID-19 outbreak, unless it is established that such injury or death was caused by the gross negligence of such medical professional. New York’s legislature then took the next step in codifying these immunities in New York’s Public Health Law.
Notably, however, with the virus surge in New York reduced as of July 2020, and the state coping with the nation’s highest death toll (more than 25,000 confirmed coronavirus fatalities statewide, including over 6,500 in nursing homes and other long-term care facilities), lawmakers voted on July 23rd to narrow its legal immunity provisions. And on August 3, 2020 and April 6, 2021, Gov. Cuomo signed legislation scaling back civil liability protections provided to nursing home and other healthcare workers and facilities during the pandemic. So, the pendulum can swing back as conditions change.
In Georgia, on April 14, 2020, Governor Brian Kemp issued an Executive Order designating employees of hospitals, nursing homes and other specified entities as emergency management workers, precluding them from personal injury or property damage liability under O.C.G.A. §38-3-35 when acting in that capacity during the current Public Health State of Emergency. For the duration of the Public Health State of Emergency, this order will limit the civil liability of “auxiliary emergency management workers” engaging in “emergency management activities” while providing patient care if such care results in the death or injury of a patient. “Healthcare institutions” and “medical facilities” include, but are not limited to, hospitals, ambulatory surgical centers, nursing homes, assisted living communities, personal care homes, health testing facilities, infirmaries, diagnostic and treatment centers, and public health centers. Note, however, that physicians’ and dentists’ private offices and treatment rooms in which such physicians or dentists primarily see, consult with, or treat patients were not covered by these protections. Governor Kemp’s Executive Order 04.14.20.01 can be read here. (See also O.C.G.A. §31-7-1(4)(A) and (C)-(G), and (5); and O.C.G.A. §38-3-35.)
Another Executive Order issued on April 20, 2020 (combined with the April 14 order) protects healthcare facilities and their employees, staff and contractors from liability for services that they provide during the COVID-19 public health emergency, except in cases of willful misconduct, gross negligence or bad faith. And on May 12, 2020, Gov. Kemp issued yet another Executive Order, extending the same classification and liability protection to physicians, physician assistants, nurses and other providers whose practices are affected by COVID-19, as well as employees and independent contractors of dialysis treatment facilities. Nonetheless, plaintiffs’ attorneys still may contend that such executive orders are insufficient to override duly-enacted legislation passed by both houses of the legislature and signed by a governor.
On June 22, 2020, the Senate Committee on Rules adopted a new substitute for HB 167 by Rep. Darlene Taylor (R-Thomasville) before adding it to the Senate Floor Calendar. The next day HB 167 passed the Senate with substitute language containing COVID-19 liability protections for healthcare facilities and individual providers. The new substitute included technical changes and clarification that liability protections would apply to services provided in temporary or expanded facilities outside a healthcare facility’s normal service area. These proposed protections would supplement the protections providers have during the Public Health State of Emergency under Governor Kemp’s Executive Orders 04.14.20.01 and 05.12.20.02. But the House still had to agree to the Senate changes for final passage.
On June 23, 2020, the House Special Committee on Access to the Civil Justice System met to discuss a substitute to SB 359, which originally dealt with surprise billing. The Committee proposed changes to address liability protection for businesses, healthcare facilities and providers related to COVID-19 claims. The Committee heard from multiple stakeholders, met again on June 24 to consider further changes to the proposed substitute, and passed it on June 25. On June 26, SB 359 received final passage.
The limited liability protection offered in SB 359 (the “Georgia COVID-19 Pandemic Business Safety Act“) allows businesses and healthcare providers to continue navigating the COVID-19 response without fear of frivolous lawsuits. The bill shields companies from legal liability unless claimants or plaintiffs show “gross negligence, willful and wanton misconduct, reckless infliction of harm, or intentional infliction of harm.” The bill limits protection to cases where COVID-19 interfered with care, but it does not impact employee claims for workers’ compensation during the pandemic. Additionally, this legislation encourages businesses and other entities to notify the public about risks associated with COVID-19 so that consumers can make cautious and educated decisions as they relax social isolation practices.
Specifically, the legislation amends Georgia tort law to provide immunities from liabilities regarding COVID-19, and to provide assumption of risk presumptions as defenses to tort claims alleging a claimant or plaintiff contracted COVID-19 because of negligence by a health facility, health worker, or other business. It will add O.C.G.A. § 51-16-1, et seq. to the Georgia Code’s provisions relating to torts.
O.C.G.A. § 51-16-1 broadly defines healthcare provider, healthcare facility and other business entities able to assert immunities from liability relating to COVID-19. O.C.G.A. § 51-16-2 provides comprehensive immunity from tort liability relating to COVID-19 for a healthcare facility, healthcare provider, entity or individual. The only exception is for “gross negligence, willful or wanton misconduct, reckless infliction of harm or intentional infliction of harm.”
This heightened standard applies to any “COVID-19 liability claim,” which is a defined term in the statute that includes any transmission claim, malpractice claim, or PPE-related claim. Specifically with regard to medical malpractice claims, the increased standard applies to treatment “for COVID-19 or where the response to COVID-19 reasonably interfered with the arranging for or providing of healthcare services” to a claimant or plaintiff. In other words, any treatment of a COVID-19 patient is subject to an enhanced standard of gross negligence. Similarly, any non-COVID treatment of a patient which was “reasonably interfered with” by the response to COVID-19 also receives a higher gross negligence standard.
O.C.G.A. § 51-16-3 provides an “assumption of risk” presumption as a defense to any COVID-19 claim against an individual or entity because the plaintiffs allege they contracted, or were exposed to, COVID-19 while on the premises of the defendant individual or entity. The “assumption of risk” presumption applies if the individual or entity has provided an “assumption of risk” warning to the plaintiff(s) before they enter the premises. The warning can be on a ticket, receipt or wristband issued to allow entry on premises, or posted on signage at a point of entry. O.C.G.A. § 51-16-3 describes the warning that must be provided and the size and type of font required, and it includes an explicit warning that injury or death is an inherent risk of contracting COVID-19. Again, the only exception is for “gross negligence, willful or wanton misconduct, reckless infliction of harm or intentional infliction of harm.”
O.C.G.A. § 51-16-4 also provides an assumption of risk presumption relating to COVID-19 related claims for healthcare providers and healthcare facilities when an assumption of risk warning is posted at a point of entry to premises. The specific warning must include a warning that injury or death is an inherent risk of contracting COVID-19, as in § 51-16-3. The only exception (again) is for “gross negligence, willful or wanton misconduct, reckless infliction of harm or intentional infliction of harm.”
This legislation provides Georgia healthcare providers and businesses with strong protections against tort claims related to COVID-19. But to obtain these protections, healthcare providers and businesses must implement appropriate safety measures, and they should provide the requisite notices and signage to receive maximum protection.
Healthcare providers and businesses should therefore take recommended safety steps, such as masks and social distancing, to protect their employees, patients and customers. And, as always, employers should consider their obligations to maintain a safe and healthy workplace under the Occupational Safety and Health Act and other state and federal laws.
For example, in early July 2020, the federal Occupational Safety and Health Administration (“OSHA”) issued new guidance recommending that employers require masks to be worn by employees. The guidance was part of a revised “Frequently Asked Questions” section that is included in OSHA’s COVID-19 resource materials. The new guidance states: “OSHA generally recommends that employers encourage workers to wear face coverings at work. Face coverings are intended to prevent wearers who have Coronavirus Disease 2019 (COVID-19) without knowing it (i.e., those who are asymptomatic or pre-symptomatic) from spreading potentially infectious respiratory droplets to others. This is known as source control.”
OSHA went on to explain circumstances where mask wearing might not be appropriate in the workplace. These include situations where a mask could become contaminated with chemicals used in the workplace, or where use of a cloth mask would interfere with the performance of a mandated respirator. OSHA then refers employers to the CDC website for additional information.
OSHA’s guidance is not mandatory, meaning that it will not cite employers just because they fail to implement a mask requirement. However, companies that fail to take steps designed to lower the risk of COVID-19 transmission in the workplace face possible “General Duty Clause” citations. And OSHA reports that it has received a growing number of complaints from employees concerned over the potential for infection from third parties not subject to control measures imposed on employees. So employers may want to consider expanding mask requirements to customers and visitors anyway.
Then on June 10, 2021, OSHA announced a rule outlining steps that employers must take to protect workers from the risk of COVID-19 that will apply only to the healthcare industry. The rule (called an emergency temporary standard) requires healthcare employers to provide protective equipment like masks, to screen and triage patients for the risk of COVID-19, and to ensure adequate ventilation and distancing, among other measures. Other businesses will have to follow less stringent safety guidelines, particularly where there is no reasonable expectation that any person with suspected or confirmed COVID-19 will be present or everyone is fully vaccinated. OSHA also posted related summaries, fact sheets, and compliance assistance materials and tools.
Under the emergency temporary standard (“ETS”), nonexempt facilities are required to conduct a hazard assessment and have a written plan to mitigate the spread of COVID-19. The rules also require healthcare employers to provide and ensure workers wear facemasks when indoors and when occupying a vehicle with other people for work purposes; provide and ensure workers use respirators and other personal protective equipment for exposure to people with suspected or confirmed coronavirus; and ensure social distancing between workers, or place physical barriers between employees in non-patient care areas where employees are not socially distanced, according to a fact sheet.
The rules also require healthcare employers to provide workers with paid time off to get inoculated and to recover from side effects. Healthcare employees who are infected or may be contagious must work remotely or otherwise be separated from other workers if possible or be given paid time off up to $1,400 weekly. Tax credits in the American Rescue Plan may be paid back through these provisions for most businesses with fewer than 500 employees.
On September 9, 2021, President Biden announced a “Path Out of the Pandemic” plan. The plan, among other things, creates new obligations for healthcare providers and many other private employers, including:
- The Centers for Medicare & Medicaid Services (“CMS”) will be taking action to require vaccination for workers in most healthcare settings that receive Medicare or Medicaid reimbursement. The requirement applies to hospitals, dialysis facilities, ambulatory surgical centers, home health agencies, and other healthcare settings. It expands on the CMS announcement Aug. 18 that nursing homes must have staff vaccinated against COVID-19 as a condition for receiving federal funds.
- OSHA will be issuing a new ETS that will require employers with 100 or more employees to ensure that all employees either (a) are vaccinated against COVID-19 or (b) produce a negative COVID-19 test result on at least a weekly basis.
- OSHA’s ETS will also require employers with 100 or more employees to provide paid time off for the time it takes employees to get vaccinated (or to recover from post-vaccination side effects).
- The Safer Federal Workforce Task Force will be issuing guidance that is expected to require certain federal contractors (and subcontractors) to ensure that their employees who “work on or in connection with” certain federal government contracts be vaccinated. Notably, this requirement is not expected to be limited to employees who physically perform work at a federal site, nor is it expected to have a weekly testing option in lieu of vaccination.
On November 5, 2021, CMS issued an interim final rule requiring COVID-19 vaccinations for workers in most healthcare settings that participate in the Medicare and Medicaid programs, including hospitals and health systems. The rule requires all eligible workers to be fully vaccinated by Jan. 4, 2022. However, the regulation allows exemptions based on religious beliefs or recognized medical conditions.
On November 12, 2021, the U.S. Court of Appeals for the Fifth Circuit granted a motion to stay OSHA’s COVID-19 Vaccination and Testing Emergency Temporary Standard, published on November 5, 2021 (“ETS”). The court ordered that OSHA “take no steps to implement or enforce” the ETS “until further court order.” While OSHA remains confident in its authority to protect workers in emergencies, OSHA has suspended activities related to the implementation and enforcement of the ETS pending future developments in the litigation. Since similar challenges were filed in other courts, the 6th U.S. Circuit Court of Appeals was randomly selected to hear a consolidated action. Ultimately, the U.S. Supreme Court could decide whether to uphold OSHA’s ETS. In the meantime, even though OSHA has indicated it will suspend its mandate rule, the CMS vaccine mandate for hospitals and other healthcare providers remained in effect.
However, on November 30, 2021, federal judges in Kentucky and Louisiana issued preliminary injunctions, temporarily blocking CMS from enforcing its vaccination mandate for healthcare workers until legal challenges are resolved. The orders halted implementation and enforcement of CMS’s interim final rule requiring hospitals and other healthcare facilities to establish COVID-19 vaccination requirements for virtually all staff in the form of new Medicare Conditions of Participation (“CoPs”). The injunctions effectively expanded a separate order issued Nov. 29 by a federal court in Missouri that temporarily blocked the vaccine rules for healthcare workers in ten states. Unlike previous orders, the Louisiana federal court’s preliminary injunction applies to hospitals and other healthcare providers in Georgia. But hospitals, health systems and other providers are still able implement their own vaccination requirements for staff if they choose to do so.
CMS suspended implementation and enforcement of its COVID-19 vaccination mandate for healthcare workers pending developments in litigation, the agency said in a Dec. 2 memorandum. But the federal government has appealed the preliminary injunction decisions. So, healthcare providers should remain ready to resume implementation of policies and procedures to comply with the CMS vaccine mandate if it is reinstated. And providers that have federal contracts may also be subject to the vaccine mandate for federal contractors, which remains in effect in Georgia. Since this situation continues to evolve, please stay tuned for new developments.
Georgia healthcare providers and businesses should also review the signage requirements and post signage that meet the requirements of O.C.G.A. § 51-16-1, et seq. at their premises’ entry points. Providing appropriate signage will lead to the presumption of an assumption of risk defense against tort claims relating to COVID-19. The combination of protective actions and posted warnings should reduce the likelihood that gross negligence or recklessness will be found if a claim or lawsuit is filed.
On August 5, 2020, Gov. Kemp signed Senate Bill 359, the Georgia COVID-19 Pandemic Business Safety Act, into law. The new law thus became effective on August 5, 2020, and protects providers from liability in three circumstances:
- Transmission of COVID-19 (where a patient or visitor claims they were infected with COVID at the hospital or healthcare facility);
- Treatment of a COVID-19 patient; and
- A provider’s response to COVID-19 reasonably interfered with the patient’s treatment regardless of whether the patient has COVID-19.
But, again, the 2020 law does not provide blanket immunity. Healthcare providers may still be liable for injuries resulting from gross negligence, willful and wanton misconduct, reckless infliction of harm, or intentional infliction of harm. This “gross negligence standard” does, however, provide meaningful protection similar to the heightened standard that applies to emergency services under the tort reform law enacted in 2005.
Importantly, these new protections are in addition to any immunities that may also be available to healthcare providers under state or federal law, including the liability protections put in place by Gov. Kemp via Executive Orders issued on April 14, April 20 and May 12, 2020. The orders designate certain healthcare facilities, including hospitals, and individual healthcare providers as “auxiliary emergency management workers” under the Georgia Emergency Management Act. (O.C.G.A. § 38-3-1, et seq.) This designation protects healthcare providers from liability for emergency management activities, like the treatment of COVID-19 patients or temporary expansion of hospital facilities, unless there is gross negligence, willful misconduct or bad faith. (O.C.G.A. § 38-3-35(b).) These protections are in effect until the Public Health Emergency expires.
SB 359 originally was only to remain in effect for claims that accrued prior to July 14, 2021, when it was supposed to be repealed, unless extended by additional legislation. But prior to the automatic repeal, the General Assembly had the opportunity extend the protections during the 2021 legislative session, if deemed necessary. In January 2021, HB 112 was introduced by Rep. Trey Kelley (R-Cedartown). That bill extended for another year (until July 14, 2022) the liability protections from COVID-19 lawsuits that were given to hospitals, other healthcare providers and businesses in SB 359, the Georgia COVID-19 Pandemic Business Safety Act. The 2021 bill was intended to allow providers and businesses to continue navigating the COVID-19 response without the fear of frivolous lawsuits targeting them. The House passed HB 112 on February 9, 2021, and the Senate passed it on March 17, 2021. And Gov. Kemp signed the extension into law on May 4, 2021.
Reporting Test Results
On June 4, 2020, HHS established a list of data elements that must be reported to state or local public health departments for each COVID-19 test performed by a healthcare facility or provider, as well as a number of requested data elements. All physicians, laboratories, and other health providers are legally required to report an actual or suspected case of a notifiable disease in Georgia, including COVID-19. The legal authority for notifiable disease reporting is in both Georgia law (O.C.G.A. § 31-12-2(a); Ga. Comp. R. & Regs. 511-2-1-.01(h), -.02(1)) and federal law. That legal authority has been expanded for the COVID-19 pandemic to include reporting of negative test results and includes any individual, organization, or agency facilitating specimen collection and/or testing, including a specimen collection site or event. (See Public Law 116-136, § 18115(a), the Coronavirus Aid, Relief, and Economic Security (CARES) Act; Department of Health and Human Services, COVID-19 Pandemic Response, Laboratory Data Reporting: CARES Act Section 18115, June 4, 2020.)
In addition to traditional reporters to Public Health such as healthcare providers and laboratories, non-traditional reporters including, but not limited to, schools and universities, long-term care and assisted living facilities, Emergency Medical Services (“EMS”) and other first responder agencies, employers, and worksites must also report these test results. Healthcare providers and other individuals, organizations, and agencies do not incur liability for reporting to the Georgia Department of Public Health (“DPH”), as Georgia law specifically states that “[a]ny person . . . submitting in good faith reports or data to the department or county boards of health in compliance with the provisions of this Code section shall not be liable for any civil damages therefor.” O.C.G.A. § 31-12-2(d). DPH’s COVID-19 Test Reporting Guidance, which contains additional important details, can be viewed here.
Providing Non-COVID-19 Care During the Pandemic
At the onset of the COVID-19 pandemic, CDC recommended that healthcare systems prioritize urgent visits and delay elective care to mitigate the spread of COVID-19 in healthcare settings. A consequence of the pandemic has been the under-utilization of important medical services for patients with non-COVID-19-related urgent and emergent health needs.
On May 20, 2020, CDC issued a framework for healthcare providers to follow in providing non-COVID-19 care during the pandemic. The framework weighs the potential for patient harm in delaying care against the degree of local transmission (substantial, moderate, or minimal to none).
But with the exception of the CARES Act protections for volunteers, none of the immunities enacted into law to date would protect a provider from a claim that the provider neglected the proper care and treatment of a non-COVID-19 patient. There have been, and will continue to be, many of these patients. And the circumstances involving their care during the pandemic and any COVID-19 patient surges have been, and will continue to be, challenging.
A bill sponsored by Senator Ben Sasse (R-Nebraska) would plug a gaping hole in liability protections for healthcare providers regarding such patients during this crisis. And some states have taken similar actions to immunize providers caring for non-COVID-19 patients. For example, legislation in New York enacted in April 2020, includes broad language that appears to establish protections for providers caring for all patients during the public health emergency, including non-COVID-19 patients. And the Georgia COVID-19 Pandemic Business Safety Act enacted in June and effective August 5, 2020, appears to do the same. But more may be needed, given the staffing, equipment and supply shortages caused by the pandemic.
Telehealth – Malpractice Liability Considerations
As the use of telehealth and telemedicine continue to increase, providers need to be aware of the liability laws in the jurisdictions in which they practice remotely. Similar to in-person medical practices, telehealth services carry substantial malpractice liability risks. Once a provider virtually crosses a state line via an electronic or digital device, he or she becomes subject to the liability laws of the other state.
Many states, including Georgia, have enacted medical malpractice liability reform acts to limit providers’ potential liability. Most notably, laws have been passed to limit or place caps on certain non-economic and punitive damages in medical malpractice cases. Non-economic damages include claims for pain and suffering, mental anguish, anxiety, loss of companionship, and all other losses that do not directly relate to economic losses, such as medical expenses and lost wages. While such limits or caps can reduce providers’ potential liability, telehealth providers who virtually leave Georgia, for example, may find that they are subject to increased liability exposure.
Although the majority of states currently have some form of cap on non-economic damages in medical malpractice cases, many do not, or do not provide the same limits that Georgia does. For example, Hawaii’s cap on non-economic damages is set at $375,000, and South Dakota’s cap is set at $500,000. And several states, such as Arizona, Connecticut and New York, have no cap on non-economic malpractice damages.
Georgia providers rendering telehealth services to patients in other states need to understand that Georgia’s liability limits or protections will not necessarily travel with them. Telehealth providers are normally subject to the liability laws of the state in which the patient is located. It therefore is critical that providers do not render services outside their home state without first making sure they have adequate malpractice insurance coverage for their expanded activities.
CDC Updates its Mask & Testing Guidance for Fully Vaccinated People
On May 13, 2021, the CDC updated its interim guidance stating that fully vaccinated people no longer need to wear a mask or physically distance for their own protection in most settings, indoors or outdoors. However, the CDC continues to recommend masks be worn where required by federal, state, local, tribal or territorial laws, rules or regulations, including local businesses and workplaces. And the new guidance still calls for wearing masks in crowded indoor settings like buses, trains, planes, hospitals, prisons and homeless shelters.
The CDC emphasized that its new masking recommendations for people fully vaccinated against COVID-19 do not apply to healthcare settings, stating that staff, patients, residents and visitors should continue to wear masks as recommended in all healthcare facilities. CDC said healthcare facilities should continue to refer to CDC’s infection prevention and control guidance for recommendations regarding source control and physical distancing in health care settings.
Because unvaccinated and immunocompromised persons remain at significant risk (at least until herd immunity is achieved), healthcare providers and businesses still may require masks, even under the recent change in federal guidance. There is no easy way to determine who has been vaccinated and who hasn’t. And the new guidelines essentially leave it up to people to do the right thing. Generally, masks should continue to be worn by all in settings where the vaccination status of participants is unknown, according to the guidance.
Additionally, the CDC said fully vaccinated people can refrain from testing following known COVID-19 exposures unless they are residents or employees of correctional facilities or homeless shelters. For additional information, please see the following links:
- New CDC Mask Guidance – Note that this guidance specifically states it is not intended for healthcare settings.
- CMS Survey Guidance for Hospitals on Infection Control (including PPE)
- CDC Guidance for Health Care Facilities as a Result of COVID-19 Vaccination – Note that PPE guidance remains unchanged.
- CDC Infection Control Guidance for Health Care Providers
On August 13, 2021, OSHA updated its COVID-19 guidance for employers with vaccinated, unvaccinated, and otherwise at-risk employees. OSHA previously released guidance on June 10, 2021, which focused primarily on unvaccinated workers. OSHA’s August 2021 guidance discusses vaccinated workers and is intended to address the CDC’s updated recommendations issued a result of the Delta variant. OSHA’s August 2021 guidance is intended to assist employers and workers in “areas of substantial or high community transmission,” per the CDC. Consistent with the CDC, OSHA now recommends the following even for fully vaccinated workers:
- wear a mask in public indoor settings in areas of substantial or high transmission;
- wear a mask regardless of level of transmission, if individuals are at risk or have someone in their household who is at increased risk of severe disease or not fully vaccinated;
- get tested 3-5 days following a known exposure to someone with suspected or confirmed COVID-19; and
- wear a mask in public indoor settings for 14 days after exposure or until a negative test result.
As noted above, OSHA released a COVID-19 Emergency Temporary Standard (“ETS”) for employers in healthcare settings in June 2021. Compliance was required by July 6, 2021. Unlike the ETS, however, OSHA’s latest COVID-19 guidance is merely advisory. Nonetheless, employers will be in a much stronger position from a liability perspective if they follow even OSHA’s advisory guidance as much as possible.
To promote the public health, safety and welfare of everyone, hospitals and medical providers need to be able to make treatment, staffing and resource allocation decisions during the crisis without undue concerns about future litigation. Despite all of the above emergency measures, providers (including those who volunteer their services during the COVID-19 pandemic) do not have absolute liability protection. Therefore, providers should still take certain steps to help protect themselves from liability claims.
For instance, providers – particularly those who may be granted special certifications to work across state lines, or those who may be asked to care for patients outside of their core competencies – should ensure that they have adequate medical malpractice insurance coverage. Retired providers returning to assist in the pandemic response should check with the insurance company with which they previously had coverage, as some carriers are offering coverage at no cost for physicians returning to practice as volunteers during the emergency time period. Hospitals and other healthcare entities should also ensure that the individual providers working in their facilities have proper insurance coverage under the entity’s policy, individually, or both.
It also will be very important for providers to carefully document their thought processes and actions – even in an environment that may be highly stressful and chaotic – in the event their decisions, care or treatment are later questioned or challenged. Providers should also bear in mind that legal claims often arise from miscommunications or failures to communicate in a sufficiently caring or adequate manner with patients or their family members. Although face-to-face communications may by necessity be more limited during the pandemic, whatever communications do occur will remain extremely important.
Finally, if governmental actions allow for hospitals or other healthcare entities to implement policies or guidelines allocating scarce medical resources, individual providers and healthcare entities should work together to implement those policies or guidelines in as effective a manner as possible under the circumstances. Healthcare entity or hospital-specific guidelines involving allocation of possibly scarce resources during a COVID-19 surge are intended to take into account the urgency and extraordinary circumstances caused by the pandemic. Properly carrying out such policies or guidelines will not only help insulate providers from claims alleging they should have taken extraordinary steps to provide levels of care that may simply be impossible in the event of a surge of patients and limited medical resources, it will best serve patients.
Taking such practical steps will help healthcare providers better focus on the care they provide, without (hopefully) having to worry about the potential for medical malpractice claims down the road. Fewer malpractice lawsuits were filed in 2021 according to Medscape’s 2021 malpractice report [login required]. The report suggests that the decline may be due to a smaller number of procedures being done, and plaintiffs being less likely to visit lawyers and file lawsuits during the pandemic. The report did not reveal many COVID-19-related lawsuits reported to date. The report suggested that the number of COVID-19-related suits might be limited due to grants of immunity for COVID-related treatment issues by many states. But that could change in 2022 and beyond.
We will continue to monitor developments in this area. Please stay tuned for additional updates as the pandemic continues to develop. If you are a healthcare provider and have questions or need information or assistance regarding potential liability for actions taken during the COVID-19 pandemic, please do not hesitate to contact us.
How We Can Help
At the Law Office of Kevin O’Mahony, we serve as outside counsel for healthcare clients investigating unanticipated adverse outcomes and incidents. We assist healthcare organizations in conducting root cause analyses, error reporting and disclosure, implementing corrective action plans, and managing and minimizing risks their patients and providers face.
We also represent and defend healthcare clients in medical malpractice pre-suit claims and lawsuits, mediations and arbitrations. And we handle, investigate and have successfully prosecuted and defended numerous medical device and pharmaceutical product liability claims. Additionally, we serve as personal counsel for physicians facing medical malpractice claims or lawsuits in which liability exposure may exceed their malpractice insurance policy limits. Please call or email us if you need legal assistance in any of these areas.