The four cases below are not pending lawsuits. They are closed cases with a guilty plea and a published press release from the United States Department of Justice.
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.
[2] United States Department of Justice, Office of Public Affairs, 02.07.2012Janssen, 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, 04.11.2013Eli Lilly paid $1.4 billion in 2009, admitting it had promoted olanzapine (Zyprexa) for elderly people with dementia. AstraZeneca paid $520 million in 2010 for promoting 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"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 I am 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 I 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