What they admitted in court

The largest health care fraud case in United States history

GSK pleaded guilty and paid $3 billion. Among the charges: promoting paroxetine (Paxil / Seroxat) for children and adolescents, age groups for which it had never been approved, and failing to report safety data to the regulator.

Who wrote the article that presented paroxetine as safe for adolescents — the $17,250 ghostwriting contract and the 22 names on the manuscript — is on the sister site: Part E of psychpractices.org.

[2] United States Department of Justice, Office of Public Affairs, 02.07.2012

An antipsychotic for elderly people with dementia, children and people with disabilities

Janssen, a Johnson & Johnson subsidiary, pleaded guilty and the group paid more than $2.2 billion. The company admitted promoting risperidone (Risperdal) for "controlling aggression and anxiety in elderly dementia patients" and for "behavioural disturbances in children" — uses the FDA had not approved, in populations where the same drug already carried a warning of increased mortality.

[3] United States Department of Justice, 04.11.2013

The same pattern, twice more

Eli Lilly paid $1.4 billion in 2009, admitting it had promoted olanzapine (Zyprexa) for elderly people with dementia. AstraZeneca paid $520 million in 2010 in a civil settlement — no criminal charge, no guilty plea — to resolve allegations that it promoted quetiapine (Seroquel) for aggression, Alzheimer's, "anger management", anxiety and dementia — none of which was an approved use.

In all four cases the target was the same: elderly people in institutions, and children — populations that rarely complain and rarely have anyone to check the prescription on their behalf.

[4] US DOJ · compiled: ProPublica, "Big Pharma's Big Fines"

288 days of hearings, 297 witnesses, 18,714 pages

At the Chelmsford private psychiatric hospital in Sydney, from 1963 to 1979, "deep sleep therapy" was practised: patients were held in a drug-induced coma for days, often with concurrent electroshock. Roughly 1,127 people received it.

By Letters Patent of 14 September 1988, the Governor of New South Wales established a Royal Commission under Supreme Court judge J. P. Slattery. The Commission sat in public for 288 days, examined 297 witnesses under compulsion, received 522 exhibits, produced 18,714 pages of transcript and reported in 15 volumes in December 1990.

What it found, according to the State Archives and Records Authority of New South Wales: no informed consent was obtained; patient records and death certificates were unlawfully falsified by doctors; controlled drugs were administered by nursing staff without lawful authority. The Commissioner described the treatment as unacceptable.

At least 24 patients died in connection with the treatment. Independent accounts give 23 to 27, depending on whether deaths during treatment, immediately afterwards, or after discharge are counted. Many survivors suffered permanent harm — infections, pneumonia, thromboses, fractures, long-term psychological damage. The number of those left permanently harmed was never quantified, and we are not going to invent one.

The treatment had been abandoned at Chelmsford by 1979, before any inquiry was constituted; the hospital continued to operate, renamed from 1980. It is now prohibited by section 83 of the Mental Health Act 2007 of New South Wales, along with insulin coma therapy and psychosurgery. The later proceedings against three doctors were disciplinary, began in 1991, were permanently stayed on grounds of procedural fairness and never led to a trial or a conviction.

Who brought it to light, and why we say so: from 1972 the nurse Rosa Nicholson documented irregularities and passed evidence to the Citizens Commission on Human Rights (CCHR), which kept up the pressure for a decade. I state this explicitly because the distinction is the whole point of this page: the whistleblower is not the source of the proof. The findings were produced by a judge, under oath, with witnesses compelled to testify, and were lodged in the state archives. They would hold just the same had anyone else blown the whistle.

[39] State Archives and Records Authority of NSW, AGY-6764 · NRS-20949 (Royal Commission into Deep Sleep Therapy) · [40] Garton S. "Bailey, Harry Richard", Australian Dictionary of Biography, vol. 17 · [41] Walton M. Australas Psychiatry 2013;21(3):206–212 · [42] Mental Health Act 2007 (NSW), section 83 · [47] CCHR

Rexulti/Abilify: a settlement over behaviour that doesn't feel like a side effect

On 13 November 2025 the Superior Court of Quebec approved a national settlement of CAD 4,750,000 in a class action over brexpiprazole (Rexulti) — a drug in the same D2 partial-agonist family as aripiprazole (Abilify). The suit alleged inadequate research and a failure to warn about compulsive behaviours: pathological gambling, binge eating, compulsive shopping, hypersexuality.

The defendants (Otsuka Canada, Lundbeck Canada) admitted no liability — this is a civil settlement, not a criminal guilty plea, a legally distinct process from the three guilty pleas above. The court's approval itself does not fix a dollar amount per claimant: it allocates the fund by percentage across harm categories from a pool of roughly CAD 2,850,000, subject to pro-rata adjustment depending on how many claims are ultimately approved. Dollar figures that circulated in press coverage (roughly CAD 6,500–102,600 per claim) come from dividing each percentage by an assumed number of claimants — they do not appear that way in the court's own approval.

If since starting aripiprazole or brexpiprazole you've noticed new or escalating urges to gamble, shop, eat, or have sex that feel hard to control — even if they feel like your own desire rather than a side effect — that is exactly what this warning covers, and it's worth telling your prescriber. The FDA issued a comparable warning for aripiprazole back in 2016; the behaviour typically resolves with dose reduction or discontinuation managed by a clinician — not with stopping on your own.

[53] Cour supérieure du Québec, Jugement d'approbation d'un règlement, file no. 500-06-000948-188, 13.11.2025 (Otsuka Canada Pharmaceutical Inc. & Lundbeck Canada Inc.)

Adderall by video call: the first criminal prosecution for telemedicine prescribing, and where it stands today

Done Global is a US digital health company that provided stimulant prescriptions for adult ADHD through telemedicine. The indictment of 12 June 2024 spoke of more than 40 million pills and over $100 million in revenue; the Department of Justice presented it as “the Justice Department's first criminal drug distribution prosecutions related to telemedicine prescribing through a digital health company”, with the mandatory reminder that “an indictment is merely an allegation”. What followed is not an allegation.

On 18 November 2025 a jury found the founder and chief executive guilty on all seven counts — conspiracy to distribute controlled substances, four counts of distribution, conspiracy to commit health care fraud, conspiracy to obstruct justice — and the clinical president on six. The figures that stand after trial, per the sentencing announcement: more than 37 million pills and $12.3 million from insurers. The judgment of 7 July 2026, the court's own document rather than a summary of it, imposes 72 months in prison, a $1 million fine and a forfeiture of $91.3 million; for the clinical president the Department announced 24 months. As of our last verification (September 2026) the conviction is not final: notices of appeal were filed on the case docket in July, August and September 2026, restitution was left “to be determined”, and the company itself has been separately indicted since December 2025 — a pending case, with no plea or verdict. This page will be updated when they are decided.

Cerebral, the largest competitor, never reached trial. Under a non-prosecution agreement dated 1 November 2024 and announced on 4 November by the US Attorney's Office for the Eastern District of New York, it forfeited $3.65 million, with a $2.92 million fine suspended, and — as agreements of this kind provide — admitted that the facts “constitute potential violations of law, specifically attempted distribution of controlled substances”. It had stopped prescribing controlled substances in October 2022 and undertook not to resume.

The context, from the authorities themselves. Both companies operated inside a window: from March 2020 the DEA allowed controlled substances to be prescribed without any in-person examination, and the arrangement, with a fourth extension on 31 December 2025, is still in force. In their joint letter of 1 August 2023 on the stimulant shortage, FDA and DEA wrote that dispensing had increased by 45.5% from 2012 to 2021 — without naming the source of the figure — and that the shortage continued “in combination with record-high prescription rates of stimulant medications”. The same letter adds something rarely mentioned: manufacturers sold only about 70% of the quota they had been allotted. The CDC, among the commercially insured, measured the share of people with at least one stimulant prescription rising from 3.6% in 2016 to 4.1% in 2021, with the largest annual increase among women aged 15–44.

What this exhibit does not say: that telemedicine is fraud, or that people diagnosed with ADHD through an app did not have it. It says that a business model was judged by a jury to be drug distribution — and that the competitor admitted it before getting there.

[70] US DOJ, press release 13.06.2024 · [71] Indictment, US v. He & Brody, N.D. Cal. 3:24-cr-00329, 12.06.2024 · [72] Judgment, 20.07.2026 · [73] US DOJ, press release 07.07.2026 · [74] USAO E.D.N.Y., non-prosecution agreement with Cerebral Inc., 04.11.2024 · [75] Federal Register 88 FR 30037, 10.05.2023 · [96] Federal Register 90 FR 61301, 31.12.2025 · [76] FDA–DEA joint letter, 01.08.2023 · [77] Danielson ML et al. MMWR 2023;72(13):327–332 · [95] Docket US v. He, notices of appeal 07–09.2026

A children's ADHD drug that failed its tests — and $41.5 million to close the lawsuit

Quillivant XR is methylphenidate in an extended-release oral suspension, approved in the United States in September 2012 for ADHD. The regulatory finding came five years before the lawsuit: in its warning letter of 26 March 2018 to the manufacturer Tris Pharma, the FDA recorded that five batches of the drug had failed dissolution testing during 2016, that out-of-specification results were being invalidated, that the test method had been modified “several times” outside the approved application, and that the product was “adulterated” under federal law — the legal term for non-compliance with manufacturing rules, not a finding of harm. Five batches had been recalled in 2017. On 27 December 2021 the FDA closed the file on the letter, judging that the violations had been adequately addressed.

In November 2023 the State of Texas, acting on a complaint by a former head of technology at Tris, sued Pfizer — the licence holder until 2018 — and Tris for Medicaid fraud: that from 2012 to 2018 they changed the test method so that the drug would “pass” while certifying compliance, and that children covered by the programme received an adulterated drug. Those are allegations in a pleading — and allegations they remained: the claim against the chief executive was dismissed in June 2025 for lack of jurisdiction, and on 19 November 2025 the State announced a $41.5 million settlement from the two companies, with no admission of liability. The suit was withdrawn with prejudice the next day. The companies denied any liability. The settlement text and the split of the amount have not been published.

What stands as a finding here is the FDA letter — closed in 2021 — and not the pleading. The pleading alleges that the drug did not work as it should; if that were so, for a child diagnosed with ADHD it would mean a dose increase or a change of drug based on a failure that was not the child's own. That was never adjudicated.

[78] FDA, Warning Letter to Tris Pharma Inc., 26.03.2018 · [97] FDA, Close-Out Letter, 27.12.2021 · [79] Texas Attorney General, press release 20.11.2023 · [80] State of Texas ex rel. Ahmed v. Pfizer Inc., Tris Pharma Inc., Mehta — First Amended Petition, Harrison County, Cause No. 23-1031 · [81] Texas Attorney General, press release 19.11.2025 · [82] Unopposed Motion to Dismiss, 21.11.2025 (nonsuit with prejudice 20.11.2025)