Nursing Home Chemical Restraint and Antipsychotic Litigation: What Attorneys Need From Medical Experts
Every long term care attorney has read a chart like this one. A resident with dementia calls out at night, resists bathing, or tries to get out of bed. A PRN order for an antipsychotic or a benzodiazepine appears. The behavior notes stop. The resident sleeps more, eats less, falls, aspirates, or simply declines. Was the drug treating a medical symptom, or was it making the resident easier to manage on a short staffed shift? Federal law calls the second answer a chemical restraint, and it is prohibited. There is no MDL and no bellwether calendar for these claims. They are tried one resident at a time in state court, and the question of purpose is answered almost entirely from records that only clinicians can read.
This is the fifth post in our long term care series, after pressure injuries, sepsis and infection, elopement, and falls. We have already written a close look at the $23.6 million Georgia verdict in a chemical restraint case built on three drugs nobody prescribed. This post steps back to the wider picture: what federal regulators found in 2026, what the current inspection data show, what the science says about these drugs in people with dementia, and which experts each side needs.
The Litigation Landscape
The legal rule is short. A resident has the right to be free from any physical or chemical restraint imposed for purposes of discipline or convenience and not required to treat the resident’s medical symptoms, 42 C.F.R. Sections 483.10(e)(1) and 483.12(a)(2). Separately, each resident’s drug regimen must be free from unnecessary drugs, meaning drugs used in excessive dose, for excessive duration, without adequate monitoring, or without adequate indications, Section 483.45(d). Psychotropic drugs may be started only to treat a specific condition diagnosed and documented in the record, must be paired with gradual dose reductions and behavioral interventions unless clinically contraindicated, and PRN antipsychotic orders are limited to 14 days and cannot be renewed without a prescriber evaluation, Section 483.45(e).3
Surveyor guidance changed in 2025. In Appendix PP revision 229, implemented April 28, 2025, CMS retired tag F758 (unnecessary psychotropic medications) and moved that guidance into F605, the chemical restraint tag. The revised guidance defines convenience to include the unnecessary administration of a medication that causes a change in behavior, intentionally or not, such that the resident is subdued or requires less effort from staff. It also expects documented informed consent before a psychotropic is started or increased, and it adds requirements before schizophrenia can be used as a diagnosis.4 For litigation, the practical effect is that a sedating drug given without a documented medical indication can now be described in the survey record as a chemical restraint whether or not anyone intended to restrain the resident.
What the 2026 federal reports found. In March 2026 the HHS Office of Inspector General issued two companion reports based on a review of 40 focused CMS inspections. The first found that nursing homes gave antipsychotic drugs to residents with dementia to manage behavior for the benefit of staff, including for behaviors the facilities themselves acknowledged were not dangerous or distressing, such as repeatedly asking for help. OIG quoted one nursing home psychiatrist telling a surveyor that the medications were more for the benefit of the staff. It found that medical directors failed to prevent inappropriate use, and that consultant pharmacists failed to identify medical concerns and did not recommend dose reductions. In one example, a medical director gave no rationale after receiving five separate dose reduction recommendations from the pharmacist.5 The second report found that nursing homes inappropriately diagnosed residents with schizophrenia to mask antipsychotic use and inflate their star ratings, because residents with schizophrenia are excluded from the CMS antipsychotic quality measure. OIG described electronic record alerts that prompted nurses to add the diagnosis when an antipsychotic was ordered without one, and one facility whose reported antipsychotic rate fell from more than 80 percent to 5 percent as the diagnoses were added.6 OIG’s examples come from a purposive sample and do not describe every facility, a point defense experts will make, and should.
The measure itself was rebuilt. Effective with the January 2026 Care Compare refresh, CMS replaced the long stay antipsychotic quality measure with a respecified version that supplements the MDS with Medicare and Medicaid claims and Medicare Advantage encounter data, and it corrected the schizophrenia exclusion in April 2026.7,8 CMS also continues offsite audits of schizophrenia coding. A facility found to have miscoded has its overall and long stay quality measure ratings cut to one star for six months.7 In the CMS national average file with a processing date of September 1, 2026, 15.38 percent of long stay residents received an antipsychotic, 19.52 percent received an antianxiety or hypnotic medication, and 1.56 percent of short stay residents newly received an antipsychotic.2 Those figures are not directly comparable to older published rates. CMS’s last National Partnership report put the old MDS based measure at 14.2 percent in the second quarter of 2025, down from 23.9 percent in late 2011.9 Measures that do not exclude anyone run higher: using raw MDS item N0450A, the Long Term Care Community Coalition reported that about 20.4 percent of residents received an antipsychotic in the fourth quarter of 2024.10 An expert who quotes a national rate should name the measure and the period.
What the citation data show. In the CMS health deficiency file with a processing date of September 1, 2026, which covers the most recent inspection cycles for every certified nursing home, there were 418,947 health citations. F605 was cited 1,577 times and the retired F758 tag still appears 4,901 times from surveys before the change. Of those 6,478 combined citations, only 44 were classified at the actual harm level or above (scope and severity G through L), and 16 at immediate jeopardy (J, K, or L). About 99 percent were rated D or E, meaning no actual harm but potential for more than minimal harm.1 Our counts come from querying the CMS dataset directly. LTCCC’s September 2026 report reached a similar conclusion from annual data, counting 2,032 F758 citations in 2024, of which 12 were rated G or above.10 For plaintiffs, this means a facility’s clean or low severity survey history is weak evidence that drugs were used properly. For defendants, it means a D level citation is not a finding of harm, and should not be presented to a jury as one.
Verdicts and enforcement. On August 21, 2026, a Gwinnett County, Georgia jury returned a $23.6 million verdict against PruittHealth-Fitzgerald and two parent entities in Owens. The family alleged that a resident with a traumatic brain injury tested positive for morphine, lorazepam, and hydrocodone, none of them prescribed, and that the drugs were given on a night when two nurses covered 46 residents. The jury found violations of Georgia’s Bill of Rights for Residents of Long-Term Care Facilities. PruittHealth says it strongly disagrees with the verdict and intends to pursue post-trial and appellate options, and it maintained at trial that the resident died of pneumonia and related conditions.11 We did not find a post-trial ruling. On the federal side, in June 2025 the American Health Foundation and three affiliated Ohio and Pennsylvania nursing homes agreed to pay $3.61 million to resolve False Claims Act allegations of grossly substandard care, which the United States alleged included giving residents unnecessary antipsychotic, antianxiety, and hypnotic drugs. As is typical, the settlement resolved allegations only.13 And a September 30, 2026 KFF Health News report described a pending Michigan lawsuit against a senior living community, not a licensed nursing home, in which a memory care resident’s sons, who had resisted sedating drugs for their mother, allege the facility initiated emergency room trips in retaliation for their disagreements about her care. The facility denies the allegations, has called the recommended drugs routine medication, and says it sent her to the hospital because the family refused to allow treatment on site. A judge dismissed the negligence count and the remaining claims are set for trial in 2027 if mediation fails.14 These are allegations and case specific findings, and none establishes liability in any other case.
Who is sued, and under what law, matters. In Frankland v. Etehad, No. B338370 (Cal. Ct. App. Aug. 8, 2025) (certified for publication), the court held that a physician who treated a resident of a skilled nursing facility could not be sued for neglect under California’s Elder Abuse Act based only on negligent medical services, because the physician lacked the robust caretaking or custodial relationship the Act requires.12 The facility, which has custody of the resident, stands in a different position. In chemical restraint cases, where the prescriber, the nurse who gave the dose, the consultant pharmacist, and the facility may each have a different role, an expert’s description of who decided what can determine which claims and damages rules apply.
The Injuries at Issue
The injury claims fall into a few recognizable patterns. The first is sedation and its downstream harms: excessive sleep, reduced intake, dehydration, weight loss, immobility, and pressure injury. The second is acute medical events that the epidemiology links to antipsychotic exposure in dementia: aspiration and other pneumonia, stroke, venous thromboembolism, falls with fracture, and acute kidney injury.19 The third is neurological: drug induced parkinsonism, rigidity and contractures, tardive dyskinesia, and, rarely, neuroleptic malignant syndrome. The fourth is loss of function and personhood that families describe as their mother or father disappearing, which juries hear as a dignity harm separate from any physical injury. Death cases usually follow the pneumonia or fall path, and the defense almost always argues, often with real support, that a frail resident with advanced dementia was dying of the disease.
Unprescribed drug cases, like Owens, are their own category. There the injury theory is opioid or benzodiazepine toxicity, respiratory depression, and the hospitalization that follows, and the central proof is toxicology and the controlled substance chain rather than the care plan.
The Science Behind the Claims
Mortality. The FDA boxed warning on every antipsychotic states that elderly patients with dementia related psychosis treated with antipsychotic drugs are at an increased risk of death.15 The core evidence is a 2005 meta-analysis of 15 placebo controlled trials, mostly 10 to 12 weeks long, in 5,110 patients: deaths occurred in 3.5 percent on drug versus 2.3 percent on placebo, an odds ratio of 1.54 (95% CI 1.06 to 2.23).16 Older conventional drugs such as haloperidol are not safer. In a cohort of 22,890 older adults, conventional agents carried a higher adjusted risk of death than atypicals within 180 days, relative risk 1.37 (95% CI 1.27 to 1.49).17 In 90,786 veterans with dementia, the number needed to harm over 180 days, meaning one additional death for every so many patients treated, was 26 for haloperidol, 27 for risperidone, 40 for olanzapine, and 50 for quetiapine, with higher doses carrying higher risk.18 In the DART-AD withdrawal trial in UK care facilities, residents randomized to continue antipsychotics had lower long term survival than those switched to placebo: 46 versus 71 percent at 24 months and 30 versus 59 percent at 36 months, in a trial of 128 residents who started treatment.21
Other harms. A 2024 BMJ cohort of 173,910 adults with dementia in England found that current antipsychotic use was associated with pneumonia (HR 2.19), acute kidney injury (1.72), venous thromboembolism (1.62), stroke (1.61), fracture (1.43), myocardial infarction (1.28), and heart failure (1.27), with the highest risks soon after the drug was started. In the first 90 days, pneumonia occurred in 4.48 percent of new users versus 1.49 percent of matched non-users.19 These are observational associations, and causation in a single resident still requires a clinician’s analysis of timing, dose, and alternative causes.
Benefit is modest. In the CATIE-AD trial, 421 outpatients with Alzheimer’s disease and psychosis, aggression, or agitation showed no significant difference between olanzapine, quetiapine, risperidone, and placebo in time to discontinuation for any reason.20 The American Psychiatric Association’s 2016 guideline recommends antipsychotics for agitation or psychosis in dementia only when symptoms are severe, dangerous, or cause significant distress, and only after first line nondrug interventions have been tried, at the lowest dose and on a short term basis.5,23 In 2023 the FDA approved brexpiprazole (Rexulti) as the first drug for agitation associated with dementia due to Alzheimer’s disease, based on 12 week trials. In the confirmatory trial, the improvement over placebo on the Cohen-Mansfield Agitation Inventory was 5.32 points (95% CI 1.87 to 8.77).15,24 The label keeps the boxed warning and states the drug is not indicated for PRN use. An FDA approval for one drug and one indication does not make antipsychotic use for dementia behaviors appropriate in general, and it does not make a PRN order appropriate.
Stopping is possible, but not always safe. A 2018 Cochrane review of 10 trials found low quality evidence that antipsychotics can often be withdrawn in older people with dementia without worsening overall behavior. But in two trials limited to residents who had responded to treatment for psychosis or agitation, stopping was associated with relapse, and residents with more severe baseline symptoms may worsen.22 And a 2026 study of 43,668 new antipsychotic episodes in nursing home residents with dementia found that, despite federal initiatives, more than half continued treatment beyond six months.25 The science supports a careful, individualized trial of dose reduction. It does not support either a blanket rule that any antipsychotic in dementia is negligent or a claim that long term use needs no reassessment.
Why Expert Witnesses Are Critical, by Specialty
Geriatric psychiatry. The geriatric psychiatrist is the central expert in most of these cases. The question is whether there was a real psychiatric indication, whether schizophrenia or another diagnosis was supported by a documented evaluation and history or simply added to the record, whether nondrug interventions were tried, and whether dose reduction was attempted. OIG’s finding that schizophrenia diagnoses were added to records to improve star ratings makes the diagnosis itself a contested fact in many charts.6 For the defense, the psychiatrist is the expert who explains when a resident’s distress or danger truly justified medication.
Consultant pharmacy and clinical pharmacology. Pharmacists read the monthly drug regimen reviews, the recommendations made, and the prescriber responses. OIG specifically faulted consultant pharmacists who failed to flag concerns or recommend reductions.5 A pharmacology expert also addresses dose, duplicate therapy, drug interactions, anticholinergic burden, PRN use beyond 14 days, and whether sedation was a predictable effect of the regimen.3
Long term care nursing and Directors of Nursing. Nurses document the behavior that justifies a dose, give the dose, and record its effect. A nurse expert compares behavior logs with PRN administration times, looks for doses clustered on night and weekend shifts, and checks whether the care plan listed person centered interventions and whether anyone tried them. The nurse expert also addresses consent documentation, which the 2025 guidance now expects before a psychotropic is started or increased.4
Nursing administration and staffing. Convenience is a staffing question. The September 1, 2026 national averages show 3.86 total nurse staffing hours per resident day, 3.42 on weekends, and 45.8 percent total nursing staff turnover.2 An administration expert compares payroll based journal data, assignment sheets, and agency use with the times sedating doses were given. In Owens, the two nurses for 46 residents allegation supplied the motive the purpose test asks about.11
Medical directors and geriatric medicine. A geriatrician or certified medical director addresses the attending physician’s examination before ordering, the medical director’s oversight duties, the subject of new 2025 guidance under F841, and whether a change in condition such as infection, pain, constipation, or delirium was the real cause of the behavior.4,5 In death cases, the geriatrician also has to separate the drug’s contribution from the trajectory of advanced dementia.
Forensic toxicology. In unprescribed drug cases, the toxicologist interprets quantitative levels, collection times, half lives, and metabolite ratios to place administration inside a window. In Owens, a morphine level the family’s counsel said was far above any therapeutic range was part of the proof.11 Toxicologists also address whether a level is consistent with prescribed dosing.
Neurology, pulmonology, and infectious disease. Specialists address whether a stroke, parkinsonism, aspiration pneumonia, or fall was more likely than not caused by the drug, using the epidemiology above and the resident’s own timeline.18,19 Defense experts in these fields test the causation chain against the resident’s baseline risks.
Dementia care specialists. Certified dementia practitioners and memory care clinicians explain what nondrug approaches look like in practice, such as consistent caregivers, adjusted bathing routines, pain assessment, and structured activity, and whether the facility had the training and staff to deliver them.
Health information and EHR audit trail experts. Late entries, copied behavior notes, diagnosis codes added the same day across many residents, and MAR changes after the fact are found in metadata. OIG described residents’ names being printed on lists so clinicians could add schizophrenia diagnoses.6 An audit trail expert can show when, and by whom, a diagnosis or order entered the chart.
Forensic pathology and life care planning. Pathologists address cause and manner of death when the certificate lists pneumonia or dementia, and whether drug toxicity contributed. Life care planners and economists address damages for survivors with lasting neurological injury.
What Attorneys Should Look For
Request the full medication administration record and the physician orders, not summaries, for at least 30 days before the first psychotropic order through the injury. Get behavior monitoring flow sheets, PRN effectiveness notes, all monthly pharmacist regimen reviews and prescriber responses, gradual dose reduction history, the consent forms or other consent documentation, the diagnosis list with the date and author of each entry, psychiatric consult notes, and the MDS sections that report antipsychotic use and exclusion diagnoses. Add the controlled substance count sheets and automated dispensing logs, the EHR audit trail, staffing records for the shifts at issue, and the facility’s survey history for F605, F758, F757, and F841. Compare the date any schizophrenia diagnosis appeared with the resident’s psychiatric history before admission and with the facility’s quality measure timeline. For defense counsel, the same list identifies the documentation that supports a legitimate indication, and the earlier it is reviewed, the more options remain.
Key Dates and Authorities
| Date | Authority or event | Why it matters |
|---|---|---|
| June 2008 | FDA extends mortality warning to conventional antipsychotics in elderly patients with dementia | Boxed warning now covers the whole class5 |
| 2012 | CMS launches the National Partnership to Improve Dementia Care in Nursing Homes | Long stay antipsychotic rate was 23.9 percent in late 20119 |
| May 2016 | APA practice guideline on antipsychotics for agitation or psychosis in dementia | Severe, dangerous, or distressing symptoms only; taper attempt23 |
| January 18, 2023 | CMS memo QSO-23-05-NH: offsite schizophrenia coding audits | Miscoding cuts quality ratings to one star for six months6,7 |
| May 11, 2023 | FDA approves brexpiprazole for agitation in Alzheimer’s dementia | First approved drug for this use; boxed warning retained; not for PRN use15 |
| April 28, 2025 | CMS Appendix PP Rev. 229 implemented | F758 moved into F605; consent and schizophrenia diagnosis guidance4 |
| June 3, 2025 | DOJ False Claims Act settlement, American Health Foundation, $3.61 million | Allegations included unnecessary antipsychotic and other drugs13 |
| August 8, 2025 | Frankland v. Etehad, No. B338370 (Cal. Ct. App.) | Elder Abuse Act neglect claim not available against SNF physician for medical care alone12 |
| January 2026 | CMS respecified long stay antipsychotic measure on Care Compare | Claims and encounter data added to MDS7,8 |
| March 16, 2026 | HHS OIG reports OEI-02-23-00200 and OEI-02-23-00201 | Antipsychotics used for staff convenience; schizophrenia diagnoses used to mask use5,6 |
| August 21, 2026 | Owens verdict, Gwinnett County State Court, Georgia, $23.6 million | Unprescribed controlled substances alleged; defendant plans appeal11 |
| September 1, 2026 | CMS processing date for current deficiency and national average files | F605 cited 1,577 times; 15.38 percent long stay antipsychotic rate1,2 |
| September 2026 | LTCCC report, The Accountability Gap | 20.4 percent of residents on an antipsychotic by raw MDS, Q4 202410 |
How Med Legal Pro Helps
Med Legal Pro connects plaintiff and defense attorneys with credentialed experts who read long term care medication records every day: geriatric psychiatrists, consultant pharmacists and clinical pharmacologists, LTC nurses and Directors of Nursing, nursing administration and staffing experts, geriatricians and medical directors, forensic toxicologists, neurology, pulmonary and infectious disease specialists, dementia care specialists, forensic pathologists, and life care planners. We start with the MAR, the orders, and the audit trail, so the opinion on purpose rests on what the record actually shows. Browse our expert witness directory, learn more about our nursing home expert witness services, or read our analysis of the PruittHealth chemical restraint verdict.
Are you a geriatric psychiatrist, consultant pharmacist, toxicologist, or long term care clinician who wants to do expert work? We are adding experts in these specialties now. Med Legal Pro: The Expert for Experts.
Sources
- CMS Provider Data Catalog, Health Deficiencies dataset (r5ix-sfxw), processing date September 1, 2026. Counts by tag and scope and severity queried by Med Legal Pro on October 19, 2026. data.cms.gov
- CMS Provider Data Catalog, State and US Averages dataset (xcdc-v8bm), processing date September 1, 2026. data.cms.gov
- 42 C.F.R. Sections 483.10(e)(1), 483.12(a)(2), and 483.45(d) and (e). ecfr.gov
- CMS, State Operations Manual Appendix PP (Rev. 229, issued April 25, 2025, implementation April 28, 2025), F605 and F841 guidance. cms.gov
- HHS Office of Inspector General, Nursing Homes’ Inappropriate Use of Antipsychotic Drugs Poses a Risk to Residents, OEI-02-23-00200 (March 2026). oig.hhs.gov
- HHS Office of Inspector General, Nursing Homes Inappropriately Diagnosed Residents with Schizophrenia to Mask the Misuse of Antipsychotic Drugs, OEI-02-23-00201 (issued March 16, 2026). oig.hhs.gov
- CMS, Design for Care Compare Nursing Home Five-Star Quality Rating System: Technical Users’ Guide (September 2026), revision notes for January and April 2026 and schizophrenia coding audit adjustments. cms.gov
- CMS, QSO-25-20-NH REVISED, Updates to Nursing Home Care Compare (September 10, 2025). cms.gov
- CMS, National Partnership to Improve Dementia Care in Nursing Homes: Antipsychotic Medication Use Data Report (2025Q2 data). cms.gov
- Long Term Care Community Coalition, The Accountability Gap (2026), Antipsychotic Drugging: Resident Exposure and Regulatory Oversight (September 2026). nursinghome411.org
- Manins R. Family awarded $23M in Georgia nursing home death case. Atlanta Journal-Constitution (September 3, 2026) ajc.com
- Frankland v. Etehad, No. B338370 (Cal. Ct. App., 2d Dist., Div. 5, August 8, 2025) (certified for publication). courts.ca.gov
- U.S. Department of Justice, Ohio Based Nonprofit and Affiliated Nursing Homes Agree to Pay $3.61M to Resolve False Claims Act Liability (June 3, 2025). justice.gov
- Rau J. Drugs Are Widely Used To Sedate Dementia Patients. Her Sons Wanted To Keep Her Off Them. KFF Health News (September 30, 2026). kffhealthnews.org
- FDA, FDA Approves First Drug to Treat Agitation Symptoms Associated with Dementia due to Alzheimer’s Disease (May 11, 2023) fda.gov
- Schneider LS, Dagerman KS, Insel P. Risk of death with atypical antipsychotic drug treatment for dementia: meta-analysis of randomized placebo-controlled trials. JAMA. 2005;294(15):1934-1943. doi:10.1001/jama.294.15.1934
- Wang PS, Schneeweiss S, Avorn J, et al. Risk of death in elderly users of conventional vs. atypical antipsychotic medications. New England Journal of Medicine. 2005;353(22):2335-2341. doi:10.1056/NEJMoa052827
- Maust DT, Kim HM, Seyfried LS, et al. Antipsychotics, other psychotropics, and the risk of death in patients with dementia: number needed to harm. JAMA Psychiatry. 2015;72(5):438-445. doi:10.1001/jamapsychiatry.2014.3018
- Mok PLH, Carr MJ, Guthrie B, et al. Multiple adverse outcomes associated with antipsychotic use in people with dementia: population based matched cohort study. BMJ. 2024;385:e076268. doi:10.1136/bmj-2023-076268
- Schneider LS, Tariot PN, Dagerman KS, et al. Effectiveness of atypical antipsychotic drugs in patients with Alzheimer’s disease (CATIE-AD). New England Journal of Medicine. 2006;355(15):1525-1538. doi:10.1056/NEJMoa061240
- Ballard C, Hanney ML, Theodoulou M, et al. The dementia antipsychotic withdrawal trial (DART-AD): long-term follow-up of a randomised placebo-controlled trial. Lancet Neurology. 2009;8(2):151-157. doi:10.1016/S1474-4422(08)70295-3
- Van Leeuwen E, Petrovic M, van Driel ML, et al. Withdrawal versus continuation of long-term antipsychotic drug use for behavioural and psychological symptoms in older people with dementia. Cochrane Database of Systematic Reviews. 2018;3:CD007726. doi:10.1002/14651858.CD007726.pub3
- Reus VI, Fochtmann LJ, Eyler AE, et al. The American Psychiatric Association practice guideline on the use of antipsychotics to treat agitation or psychosis in patients with dementia. American Journal of Psychiatry. 2016;173(5):543-546. doi:10.1176/appi.ajp.2015.173501
- Lee D, Slomkowski M, Hefting N, et al. Brexpiprazole for the treatment of agitation in Alzheimer dementia: a randomized clinical trial. JAMA Neurology. 2023;80(12):1307-1316. doi:10.1001/jamaneurol.2023.3810
- Shireman TI, Roma C, Zullo AR, et al. Impact of national partnership to improve dementia care on antipsychotic use duration for dementia residents in nursing homes. Journals of Gerontology, Series A. 2026;81(4). doi:10.1093/gerona/glag060
Tracy L. Liberatore Esq, PA-Emeritus, Med Legal Pro. This article is general information for attorneys and is not legal or medical advice. All claims described in pending or recently tried cases are allegations unless and until finally adjudicated.