COMMENTARY

7 Legal Risks of Promoting Unproven COVID Treatments

Brian W. Whitelaw, JD; Julie M. Janeway, JD

Disclosures

December 06, 2021

What Are the Legal Consequences?

Medical Malpractice

The first consequence to consider is professional liability or medical malpractice. This applies if a patient claims harm as a result of the healthcare practitioner's recommendation of an unproven treatment, product, or protocol. For example, strongly discouraging vaccination can result in a wrongful death claim if the patient follows the doctor's advice, chooses not to vaccinate, contracts COVID-19, and does not recover. Recommending or providing unproven approaches and unapproved treatments is arguably a violation of the standard of care.

The standard of care is grounded in evidence-based medicine: It is commonly defined as the degree of care and skill that would be used by the average physician, who is practicing in their relevant specialty, under the same or similar circumstances, given the generally accepted medical knowledge at the time in question.

By way of example, one can see why inhaling peroxide, drinking bleach, or even taking US Food and Drug Administration–approved medications that have little or no proven efficacy in treating or preventing COVID-19 is not what the average physician would advocate for under the same or similar circumstances, considering available and commonly accepted medical knowledge. Recommending or providing such treatments can be a breach of the standard of care and form the basis of a medical malpractice action if, in fact, compensable harm has occurred.

In addition, recommending unproven and unapproved COVID-19 preventives and treatments without appropriate informed consent from patients is arguably also a breach of the standard of care. The claim would be that the patient has not been appropriately informed of the all the known benefits, risks, costs, and other legally required information such as proven efficacy and reasonably available alternatives.

In any event, physicians can rest assured that if a patient is harmed as a result of any of these situations, they'll probably be answering to someone in the legal system.

Professional Licensing Action

Regardless of whether there is a medical malpractice action, there is still the potential for a patient complaint to be filed with the state licensing authority on the basis of the same facts and grounds. This can result in an investigation or an administrative complaint against the license of the healthcare provider.

This is not a mere potential risk. Licensing investigations are underway across the country. Disciplinary licensing actions have already taken place. For example, a Washington Medical Commission panel suspended the license of a physician assistant (PA) on October 12, 2021 after an allegation that his treatment of COVID-19 patients fell below the standard of care. The PA allegedly began a public campaign promoting ivermectin as a curative agent for COVID-19 and prescribed it without adequate examination to at least one person, with no evidence from reliable clinical studies that establish its efficacy in preventing or treating COVID-19.

In licensing claims, alleged violations of failing to comply with the standard of care are usually asserted. Such claims may also cite violations of other state statutes that encompass such concepts as negligence; breach of the duty of due care; incompetence; lack of good moral character; and lack of ability to serve the public in a fair, honest, and open manner. A licensing complaint may also include alleged violations of statutes that address prescribing protocols, reckless endangerment, failure to supervise, and other issues.

The filing of an administrative complaint is a different animal than a medical malpractice action — they are not even in the same system or branch of government. The focus is not just about what happened to the one patient who complained; it is about protection of the public.

The states' power to put a clinician on probation, condition, limit, suspend, or revoke the clinician's license, as well as issue other sanctions such as physician monitoring and fines), is profound. The discipline imposed can upend a clinician's career and potentially end it entirely.

Administrative discipline determinations are usually available to the public and are required to be reported to all employers (current and future). These discipline determinations are also sent to the National Practitioner Data Bank; other professional clearinghouse organizations (such as the Federation of State Medical Boards); state offices; professional liability insurers; to payers with whom the clinician contracts; accreditation and certification organizations; and the clinician's patients.

Discipline determinations must be promptly reported to licensing agencies in other states where the clinician holds a license, and often results in "sister state" actions because discipline was issued against the clinician in another state. It must be disclosed every time a clinician applies for hospital privileges or new employment. It can result in de-participation from healthcare insurance programs and affect board certification, recertification, or accreditation for care programs in which the clinician participates.

In sum, licensing actions can be much worse than medical malpractice judgments and can have longer-term consequences.

Peer Review and Affected Privileges

Recommending, promoting, and providing unapproved or unproven treatments, cures, or preventives to patients may violate hospital/health system, practice group, or surgical center bylaws. This can trigger the peer review process, which serves to improve patient safety and the quality of care.

The peer review process may be commenced because of a concern about the clinician's compliance with the standard of care; potential patient safety issues; ethical issues; and the clinician's stability, credibility, or professional competence. Any hospital disciplinary penalty is generally reported to state licensing authorities, which can trigger a licensing investigation. If clinical privileges are affected for a period of more than 30 days, the organization must report the situation to the National Practitioner Data Bank.

Criminal Charges

Depending on the facts, a physician or other healthcare professional could be charged with reckless endangerment, criminal negligence, or manslaughter. If the clinician was assisting someone else who profited from that clinician's actions, then we can look to a variety of potential federal and state fraud charges as well.

Conviction of a fraud-related felony may also lead to federal healthcare program and Centers for Medicare & Medicaid Services (CMS) exclusion for several years, and then CMS preclusion that can be imposed for years beyond the conclusion of the statutorily required exclusion.

Breach of Contract

Some practice groups or other organizational employers have provisions in employment contracts that treat discipline for this type of conduct as a breach of contract. Because of this, the clinician committing breach may be subject to liquidated damages clauses; forfeiture of monies (such as bonuses or other incentives or rewards); termination of employment; forced withdrawal from ownership status; and being sued for breach of contract to recover damages.

Reputation/Credibility Damage and the Attendant Consequences

In regard to hospitals and healthcare system practice groups, another risk is the loss of referrals and revenue. Local media may air or publish exposés. Such stories may widely publicize the media's version of the facts — true or not. This can cause immediate reputation and credibility damage within the community and may adversely affect a clinician's patient base. Any information that is publicly broadcasted might attract the attention of licensing and law enforcement authorities and taint potential jurors.

Hospitals and healthcare systems may pull privileges; post on websites; make official statements about the termination of affiliation; or denounce the clinician's behavior, conduct, and beliefs as being inconsistent with quality care and patient safety. This causes further damage to a physician's reputation and credibility.

In a group practice, accusations of this sort, licensing discipline, medical malpractice liability, investigations, loss of privileges, and the other sequelae of this conduct can force the withdrawal of the clinician as a member or shareholder in multiprovider groups. Adverse effects on the financial bottom line, patient referrals, and patient volume and bad press are often the basis for voting a clinician out.

Violation of the COVID-19 Consumer Protection Act of 2020

For the duration of the COVID-19 public health emergency, the FTC COVID-19 Consumer Protection Act makes it unlawful for any person, partnership, or corporation (as those terms are defined broadly in the act) to engage in a deceptive act or practice in or affecting commerce associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19 or a government benefit related to COVID-19.

The first enforcement action authorized by this act took place in April 2021 against a chiropractor who promised vitamin treatments and cures for COVID-19. The act provides that such a violation shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under the FTC Act.

Under the act, the FTC is authorized to prescribe "rules that define with specificity acts or practices which are unfair or deceptive acts or practices in or affecting commerce." Deceptive practices are defined as involving a material representation, omission, or practice that is "likely to mislead a consumer acting reasonably in the circumstances." An act or practice is unfair if it "causes or is likely to cause substantial injury to consumers which is not reasonably avoidable by consumers themselves and not outweighed by countervailing benefits to consumers or to competition."

After an investigation, the FTC may initiate an enforcement action using either an administrative or judicial process if it has "reason to believe" that the law has been violated. Violations of some laws may result in injunctive relief or civil monetary penalties, which are adjusted annually for inflation.

In addition, many states have deceptive and unfair trade laws that can be enforced in regard to the recommendation, sale, or provision of unproven or unapproved COVID-19 treatments, cures, and preventives as well.

Conclusion

It is difficult even for intelligent, well-intentioned physicians to know precisely what to believe and what to advocate for in the middle of a pandemic. It seems as though new reports and recommendations for preventing and treating COVID-19 are surfacing on a weekly basis. By far, the safest approach for any medical clinician to take is to advocate for positions that are generally accepted in the medical and scientific community at the time advice is given.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.

processing....