A simple internet search for ketamine will result in multiple stories and headlines ranging from, “Ketamine Might Have Power to Kill Cancer,” to “Ketamine Horror While Youngsters' Use of Dreadful Drug Soars,” and “Mind-Altering Ketamine Becomes New Pain Treatment,” among others. Ketamine is growing in popularity among practitioners and the general population, with patients requesting it for issues such as depression, anxiety, and chronic pain.¹ Ketamine is FDA approved as an anesthetic agent given intravenously and is used in surgical procedures, but is not approved intravenously for any other indications. Despite this, ketamine’s off-label use has grown, with many providers and patients seeing positive results for psychiatric disorders, such as chronic depression, that have been resistant to other treatments.² Yet ketamine’s role in the high-profile passing of actor Matthew Perry again raises questions about its safety and if there is adequate oversight of those who administer it to treat psychiatric illness, even if they do not have any psychiatric training or expertise.³
This Case of the Month further examines this topic and serves as a cautionary tale for providers using ketamine therapy with their patients.
The Case of Valdes v. Brooks
In the case of Valdes v. Brooks,4 a malpractice action was brought against Dr. Brooks, a board-certified anesthesiologist who founded Ketamine Infusions, a medical practice that administered ketamine to patients with treatment-resistant depression.
In 2016, Dr. Kloda sought treatment with Dr. Brooks for his depression. Dr. Kloda shared with Dr. Brooks his desire to try ketamine therapy as he had experienced suicidal ideations in the past and hoped that ketamine would prevent future thoughts. Dr. Kloda also informed Dr. Brooks that he was under the care of a psychiatrist, and “expressly prohibited” Dr. Brooks from contacting his psychiatrist.5 Soon thereafter, Dr. Brooks initiated a ketamine treatment plan for Dr. Kloda.
After the completion of the initial ketamine treatment series, Dr. Kloda indicated to his husband, Mr. Valdes, that he had noted significant improvement in his mood. Mr. Valdes, however, opined that Dr. Kloda’s depression worsened immediately after treatment.
Dr. Brooks recommended that Dr. Kloda return for a booster treatment if he noticed lessening improvement. Within three weeks of his initial treatment Dr. Kloda returned and continued receiving regular infusions. On January 26, 2017, Dr. Kloda saw his psychiatrist, who noted that his depression had returned to "baseline” despite his new treatment but concluded that Dr. Kloda was stable and presented no acute risk.
On January 30, 2017, Dr. Kloda called Dr. Brooks multiple times. When he finally reached him, Dr. Kloda shared that he had experienced several difficult days and wanted to get it under control.
During the visit that same day, Dr. Kloda told Dr. Brooks that he had experienced recent suicidal ideations that had subsided. In response to Dr. Brooks’ question about whether he had any concrete plans to harm himself or weapons at home, Dr. Kloda responded that he did not, but admitted that had begun to prepare prescriptions and transfer notes for his existing patients. At the conclusion of the visit, Dr. Brooks determined that Dr. Kloda was not in imminent danger of self-harm. On February 2, 2017, Dr. Kloda attached several fentanyl patches to his body and died by suicide.
Mr. Valdes filed a lawsuit against Dr. Brooks and Ketamine Infusions alleging negligence, failure to obtain informed consent, failure to report suicidal ideation, wrongful death, and loss of consortium. Following discovery, the defense filed for summary judgment and the Court granted the motion, ending the case.
The Applicable Law
In New York, a plaintiff alleging medical malpractice must prove the following: (1) the standard of care in the locality where the treatment occurred, (2) that the defendant breached that established standard of care, and (3) that the breach was the proximate cause of the injury.6 The plaintiff Mr. Valdes alleged three departures from the standard of care: (a) failure to communicate with Dr. Kloda’s psychiatrist, (b) failure to develop a safety plan of action, and (c) failure to report Dr. Kloda’s suicidal ideations to the authorities.
Failure to Communicate With Dr. Kloda’s Psychiatrist
The Court rapidly disposed of this claim based on the protections afforded by the Health Insurance Portability and Accountability Act of 1996 (HIPAA).7 While HIPAA permits disclosure of protected health information without patient consent under limited circumstances such as preventing serious and imminent harm or an emergency, those did not apply here, and did not allow for Dr. Brooks to communicate with Dr. Kloda’s psychiatrist without his authorization. The plaintiff was also unable to establish that Dr. Kloda’s death could have been prevented even if Dr. Brooks had communicated with his psychiatrist.
Failure to Develop a Plan for Dr. Kloda
The Court noted that in New York, doctors must carefully examine the patient and exercise their medical judgment based on careful evaluation.8 The Court determined that although Dr. Brooks’ notes were “sparse,” this alone was insufficient to negate his claim that he thoroughly examined Dr. Kloda, or to demonstrate that his treatment plan amounted to failure to exercise professional judgment.
Failure to Notify the Authorities
The Court dismissed this claim, again referencing the limitations of HIPAA and that Dr. Brooks made a good faith determination that there was no imminent threat to Dr. Kloda’s life, and thus this HIPAA exception did not apply.
While the outcome of this case was favorable to Dr. Brooks, a slight change in the facts may have rendered a different result. The jury is still out regarding the effective use and clinical impact of ketamine, but if you are using ketamine to treat behavioral health disorders, there are measures you can take to minimize your risk for medical malpractice lawsuits.
The first issue that presented itself was Dr. Kloda’s request that Dr. Brooks not communicate with his psychiatrist. Behavioral health treatments often involve multiple specialists to achieve optimal outcomes, including psychiatrists, psychologists, and other therapists in addition to a primary care provider. Dr. Brooks, an anesthesiologist, could have impressed upon Dr. Kloda the importance of being able to communicate and coordinate with his mental health providers, especially when ketamine was being used to treat his psychiatric illness.
As a provider, you do not want the Court to comment that your documentation was “sparse.” While Dr. Brooks was successful in defending the allegations in this case, it is easy to see how things could have turned out differently. Poor, scant, or careless documentation reflects negatively on the provider, intimating sub-par care and a lack of professionalism.
Off-Label Ketamine Use
The use of ketamine for off-label purposes can pose increased risk of a medical malpractice lawsuit. When assessing the off-label use, consider the following: the benefits of using it versus the risks of not using it all, whether other traditional treatment options have been carefully explored, and what risks the potential side effects pose to the individual patient.9
The Valdes Court stated that, “A physician may be held liable if a mental health treatment decision was ‘something less than a professional medical determination,’ or was ‘not the product of a careful evaluation.’”10 While the United States Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) have extended flexibilities for providers prescribing controlled substances via telemedicine without first performing an in-person visit through 2024,11 providers should keep abreast of these regulations and their locality’s standard of care for treating behavioral health disorders and off-label ketamine use, which may require periodic in-person assessments.
Risk is inherent in the practice of medicine―whether you are administering established treatments and medications or the newest therapies. The deep-rooted risk management strategies of effective communication, medication safety, comprehensive patient education, and thorough documentation remain the best tools for preventing medical malpractice actions and defending your care.
Please call Membership Services at 800-610-6642 if you have questions about coverage for ketamine usage in your practice.
Yvette Ervin is a Senior Risk Management & Patient Safety Specialist. Questions or comments related to this article should be directed to YErvin@CAPphysicians.com.
²Mandal S, Sinha VK, Goyal N. Efficacy of ketamine therapy in the treatment of depression. Indian J Psychiatry. 2019 Sep-Oct; 61(5):480-485. doi: 10.4103/psychiatry.IndianJPsychiatry_484_18. PMID: 31579184; PMCID: PMC6767816; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6767816/; Amit Anand et al., “Ketamine versus ECT for Nonpsychotic Treatment-Resistant Major Depression,” N Engl J Med 2023; 388:2315-2325, https://www.nejm.org/doi/10.1056/NEJMoa2302399
³Leana S. Wen, “Matthew Perry’s Death Offers Tragic Lesson About Ketamine,”(pub. Dec. 18, 2023), www.washingtonpost.com, (Jan. 4, 2024), “https://www.washingtonpost.com/opinions/2023/12/18/matthew-perry-ketami…; Ethan Minkin, “Ketamine Clinics and Malpractice: Recent Litigation,” (pub. Oct. 18, 2023), www.harris-silwoski.com, (Jan.4, 2024), https://harris-sliwoski.com/psychlawblog/ketamine-clinics-and-malpracti…
4Valdes v. Brooks, 19-cv-617 (JGK) (S.D.N.Y. Oct. 13, 2021)
5Ethan Minkin, “Ketamine Clinics and Malpractice: Recent Litigation,” (pub. Oct. 18, 2023), www.harris-silwoski.com, (Jan.4, 2024), https://harris-sliwoski.com/psychlawblog/ketamine-clinics-and-malpracti…
6Nichols v. Stamer, 854 N.Y.S.2d 220, 221-22 (App. Div. 2008)
7United States Department of Health & Human Services, “Summary of the HIPAA Privacy Rule,” www.hhs.gov; (Jan. 4, 2024), https://www.hhs.gov/sites/default/files/privacysummary.pdf
857 N.Y.S.3d at 547 (quoting Ballek v. Aldana-Bernier, 957 N.Y.S.2d 108, 110 (App. Div. 2012)).
9Jackson LLP Healthcare Lawyers, “Legal Issues in Prescribing Ketamine for Depression.”
10Valdes v. Brooks, 19-cv-617
11Federal Register, ”Second Temporary Extension of Covid-19 Telemedicine Flexibilities for Prescriptions of Controlled Substances,” www.federalregister.gov, (Jan. 4, 2023), https://www.federalregister.gov/documents/2023/10/10/2023-22406/second-…