Thematic Analysis

Drugs & Dementia Investigation

Investigation document: Drugs & Dementia Investigation

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INVESTIGATION: Janssen/J&J Drugs Linked to Dementia

Investigation Date: December 26, 2025

CRITICAL FINDING: RISPERDAL (Risperidone)

$2.2 Billion Settlement

According to Medicare Advocacy (November 14, 2013):

> "The government claims that Janssen deliberately interpreted studies of Risperdal in ways that downplayed or refuted known side effects"

Risperdal is an antipsychotic drug manufactured by Janssen Pharmaceutica.

Key Drugs Under Investigation

1. RISPERDAL (Risperidone) - JANSSEN

  • Type: Antipsychotic
  • Manufacturer: Janssen Pharmaceutica (J&J subsidiary)
  • Issue: Marketed for dementia patients despite known risks
  • Settlement: $2.2 billion (2013)

2. OLANZAPINE - Related Antipsychotic

  • FDA Warning (2004): "Cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, were reported in patients in trials of olanzapine in elderly patients with dementia-related psychosis"

3. Anticholinergic Drugs - General Class

  • Study (PMC7821204): "Anticholinergic use for ≥3 months increased the risk of dementia on average by an estimated 46% versus nonuse"

Scientific Evidence

BMJ Study (2024) - Mok et al.

> "Antipsychotic use compared with non-use in adults with dementia was associated with increased risks of stroke, venous thromboembolism, myocardial infarction"

NEJM Study (2006) - Schneider et al.

> "Second-generation (atypical) antipsychotic drugs are widely used to treat psychosis, aggression, and agitation in patients with Alzheimer's disease"

PMC Study (2018) - Ralph et al.

> "More recent studies from many countries confirm that the antipsychotic drugs should not be prescribed for dementia patients, as they significantly increase the risk of death"

Next Steps

  • Research Risperdal patent history
  • Find FDA black box warnings
  • Document the $2.2 billion settlement details
  • Search for additional Janssen drugs with dementia links

DOJ PRESS RELEASE - NOVEMBER 4, 2013

Source: U.S. Department of Justice

Title: Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations Date: Monday, November 4, 2013

Key Allegations

#### 1. Criminal Charges Against Janssen Pharmaceuticals Inc.

The government charged that from March 3, 2002, through Dec. 31, 2003, Janssen Pharmaceuticals Inc. introduced the antipsychotic drug Risperdal into interstate commerce for an unapproved use, rendering the product misbranded. Key Facts:
  • Risperdal was approved ONLY to treat schizophrenia
  • Janssen's sales representatives promoted Risperdal to physicians treating elderly dementia patients
  • Sales reps urged prescribers to use Risperdal for symptoms such as:
- Anxiety

- Agitation

- Depression

- Hostility

- Confusion

#### 2. The "ElderCare Sales Force"

Janssen created an "ElderCare sales force" specifically designed to target:
  • Nursing homes
  • Doctors who treated the elderly
Business Goal: "Maximize and grow RISPERDAL's market leadership in geriatrics and long term care"

#### 3. FDA Warnings Ignored

The DOJ complaint alleges:

> "The FDA repeatedly advised Janssen that marketing Risperdal as safe and effective for the elderly would be 'misleading.'"

> "The FDA cautioned Janssen that behavioral disturbances in elderly dementia patients were not necessarily manifestations of psychotic disorders and might even be 'appropriate responses to the deplorable conditions under which some demented patients are housed, thus raising an ethical question regarding the use of an antipsychotic medication for inappropriate behavioral control.'"

#### 4. Known Health Risks Concealed

Stroke Risk:

> "J&J and Janssen were aware that Risperdal posed serious health risks for the elderly, including an increased risk of strokes, but that the companies downplayed these risks."

Data Manipulation:

> "When a J&J study of Risperdal showed a significant risk of strokes and other adverse events in elderly dementia patients, the complaint alleges that Janssen combined the study data with other studies to make it appear that there was a lower overall risk of adverse events."

Diabetes Risk:

> "Janssen knew that patients taking Risperdal had an increased risk of developing diabetes, but nonetheless promoted Risperdal as 'uncompromised by safety concerns (does not cause diabetes).'"

#### 5. Kickbacks to Omnicare

The settlement also resolves allegations that J&J and Janssen paid kickbacks to Omnicare Inc., the nation's largest pharmacy specializing in dispensing drugs to nursing home patients, to promote Risperdal.

Settlement Amounts

| Component | Amount |

|-----------|--------|

| Criminal fine | $334 million |

| Forfeiture | $66 million |

| Civil settlements (federal) | $749 million |

| Civil settlements (states) | $524 million |

| Texas settlement (2012) | $118 million |

| TOTAL | $2.2 billion |

Drugs Involved

  • Risperdal (risperidone) - antipsychotic
  • Invega - newer antipsychotic
  • Natrecor - heart failure drug

Quote from Attorney General Eric Holder

> "The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust."

RISPERDAL PATENT INFORMATION

Original Patent

| Field | Value |

|-------|-------|

| Patent Number | US 4,804,663 |

| Drug | Risperdal (risperidone) |

| Manufacturer | Janssen Pharmaceutica Products, LP |

| Patent Expiration | December 2003 |

| Manufacturing Location | JOLLC, Gurabo, Puerto Rico |

Additional Patents

| Patent | Description |

|--------|-------------|

| US 5,158,952 | Orange Book listed patent (challenged by Teva) |

| US 5,453,425 | Risperidone oral formulation |

| US 11,013,809 B2 | Sustained delivery formulations |

Generic Entry

According to Wikipedia:

> "Janssen's patent on risperidone expired in December 2003, opening the market for cheaper generic versions from other companies"

ANTICHOLINERGIC DRUGS AND DEMENTIA RISK

Scientific Evidence

Multiple peer-reviewed studies have linked anticholinergic medications to increased dementia risk:

#### Study 1: Risacher et al. (2016) - PMC5029278

> "Studies have suggested that AC medications may affect cognition by altering cholinergic inputs, with a study showing that AC medication administration leads to cognitive decline"

#### Study 2: Liu et al. (2020) - PMC7033580

> "The usage of anticholinergic medications has been associated with an increased risk of dementia with prolonged usage or with a high anticholinergic burden"

#### Study 3: Joung et al. (2019) - Nature Scientific Reports

> Association of Anticholinergic Use with Incidence of dementia documented

#### Study 4: Bishara et al. (2022) - Taylor & Francis

> "Long-term use of anticholinergic medication in older people is associated with increased risk of cognitive decline and mortality"

#### Study 5: MedRxiv (2025)

> "Anticholinergic medications are widely used, however their use in older people has been linked to cognitive decline, dementia and increased mortality"

HALDOL (Haloperidol) - ANOTHER JANSSEN ANTIPSYCHOTIC

Background

Haldol (haloperidol) was one of the first antipsychotic drugs developed by Paul Janssen in 1958.

Side Effects in Dementia Patients

According to Dr. Liz Geriatrics:

> "Other side effects include sexual dysfunction, seizure, and symptoms of high prolactin levels (hyperprolactinemia). Haldol has a long half-life meaning it stays in the body longer"

FDA Black Box Warning

Like Risperdal, Haldol carries a black box warning about increased mortality risk in elderly patients with dementia-related psychosis.

JANSSEN ANTIPSYCHOTIC DRUGS - COMPLETE LIST

| Drug Name | Generic Name | Year Developed | Dementia Warning |

|-----------|--------------|----------------|------------------|

| Haldol | Haloperidol | 1958 | YES - Black Box |

| Risperdal | Risperidone | 1993 | YES - Black Box |

| Invega | Paliperidone | 2006 | YES - Black Box |

PAUL JANSSEN - COMPLETE DRUG INVENTION LIST

Overview

According to multiple sources, Paul Janssen and his team discovered more than 80 new medications, with four on the WHO list of essential medicines.

Key Drugs Invented by Paul Janssen

| Drug Name | Generic Name | Year | Category | WHO Essential |

|-----------|--------------|------|----------|---------------|

| Ambucetamide | - | 1955 | Antispasmodic (menstrual pain) | No |

| Haldol | Haloperidol | 1958/1959 | Antipsychotic | YES | | Fentanyl | Fentanyl | 1960/1963 | Opioid analgesic | YES |

| Diphenoxylate | - | 1960 | Antidiarrheal | No |

| Droperidol | - | 1961 | Antipsychotic/Antiemetic | No |

| Imodium | Loperamide | 1969 | Antidiarrheal | YES | | Daktarin | Miconazole | 1969 | Antifungal | YES | | Levamisole | - | 1966 | Antiparasitic | YES | | Mebendazole | - | 1971 | Antiparasitic | YES | | Risperdal | Risperidone | 1984 | Antipsychotic | No |

| Sufentanil | - | 1974 | Opioid analgesic | No |

| Alfentanil | - | 1976 | Opioid analgesic | No |

| Carfentanil | - | 1974 | Opioid (veterinary) | No |

Source: The Lancet (2004)

> "The first drug launched by Janssen, in 1955, was ambucetamide for menstrual pain. It was followed by other drugs such as haloperidol (1959), fentanyl (1963)..."

Source: Nature (2004)

> "By 2003, Paul Janssen and his team developed at least 70 compounds with four (haloperidol, levamisole, miconazole, and mebendazole) on the World Health Organization's list of essential medicines"

FENTANYL - THE OPIOID CRISIS CONNECTION

Patent Information

| Field | Value |

|-------|-------|

| Inventor | Paul Janssen |

| Company | Janssen Pharmaceutica |

| Year Patented | 1959/1960 |

| First Clinical Use | 1963 |

| Patent Number | US 3,141,823 |

The Fourth Wave of the Opioid Crisis

According to PharmChek (2023):

> "In 1959, Janssen Pharmaceutica patented a new opioid, fentanyl, that would soon be used as an anesthetic in surgeries and an analgesic for pain management"

Fentanyl Derivatives

Paul Janssen's team also developed:

  • Sufentanil (5-10x more potent than fentanyl)
  • Alfentanil (shorter acting)
  • Carfentanil (100x more potent, used in veterinary medicine)

DRUGS WITH DEMENTIA/COGNITIVE SIDE EFFECTS

Category 1: Antipsychotics (Direct Dementia Risk)

| Drug | Black Box Warning | Increased Mortality |

|------|-------------------|---------------------|

| Haldol (haloperidol) | YES | YES |

| Risperdal (risperidone) | YES | YES |

| Invega (paliperidone) | YES | YES |

Category 2: Opioids (Cognitive Impairment)

| Drug | Cognitive Effects |

|------|-------------------|

| Fentanyl | Confusion, cognitive impairment |

| Sufentanil | Confusion, cognitive impairment |

| Alfentanil | Confusion, cognitive impairment |

Category 3: Anticholinergic Properties

Many Janssen drugs have anticholinergic properties, which are linked to increased dementia risk with long-term use.

FDA BLACK BOX WARNINGS - ANTIPSYCHOTICS AND DEMENTIA

2005 FDA Warning

According to PMC556368 (Lenzer, 2005):

> "Seventeen controlled studies of elderly demented patients have shown that patients treated with the drugs were 1.6 to 1.7 times more likely to die than patients given placebo"

2008 FDA Extension

According to Psychiatry Online (Yan, 2008):

> "The boxed warning will say that elderly patients with dementia-related psychosis and treated with antipsychotics have an increased risk of death" The FDA extended the black box warning to ALL antipsychotics, not just atypicals.

MORTALITY STUDIES

BMJ Study (2024) - Mok et al.

> "Antipsychotic use compared with non-use in adults with dementia was associated with increased risks of:

> - Stroke

> - Venous thromboembolism

> - Myocardial infarction

> - Heart failure

> - Ventricular arrhythmia

> - Fracture

> - Pneumonia

> - Acute kidney injury"

PMC6159703 (2018) - Ralph et al.

> "Relative to the atypical antipsychotic risperidone, a higher rate of death was documented for haloperidol (HR = 1.31; [1.13–1.53])"

This means Haldol (haloperidol), Paul Janssen's first major antipsychotic, has an even higher mortality risk than Risperdal.

Neurology Today

> "haloperidol (Haldol), olanzapine (Zyprexa), quetiapine (Seroquel), and risperidone (Risperdal) was associated with an increased risk for death"

NURSING HOME OVERMEDICATION SCANDAL

CMS Investigation (2023)

The Centers for Medicare and Medicaid Services (CMS) is investigating claims that nursing homes have wrongfully drugged residents to sedate them.

Common Antipsychotics Used

According to Maryland Medical Malpractice Attorney Blog (2018):

> "Antipsychotic medications (such as Abilify, Seroquel, Risperdal, and Zyprexa) are among the most commonly prescribed medications in nursing homes"

The "Chemical Restraint" Problem

Antipsychotics are being used as chemical restraints to sedate elderly dementia patients, despite:
  • FDA black box warnings
  • Known increased mortality risk
  • The $2.2 billion J&J settlement

CURRENT FDA LABEL - RISPERDAL (2025)

From FDA Label Reference ID: 5516339:

> "5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis"

> "Dementia with Lewy Bodies can experience increased sensitivity to RISPERDAL"

HALDOL FDA LABEL

The FDA label for Haldol (haloperidol) also contains warnings about:

  • Increased mortality in elderly patients with dementia-related psychosis
  • Cardiovascular effects
  • Tardive dyskinesia
  • Neuroleptic malignant syndrome

OMNICARE KICKBACK SCANDAL

The Scheme

According to the New York Times (January 15, 2010):

> "Johnson & Johnson paid kickbacks to the nation's largest nursing home pharmacy to increase the number of elderly patients taking the antipsychotic Risperdal"

Omnicare Settlement

According to DOJ (October 17, 2016):

> "The nation's largest nursing home pharmacy, Omnicare Inc., has agreed to pay $28.125 million to resolve allegations that it solicited and received kickbacks"

Previous Omnicare Settlement (2009)

According to PharmTech:

> "In 2009, Omnicare paid $98 million to resolve its civil liability for claims that it accepted kickbacks from J&J and Janssen"

The Connection

  • Janssen manufactured Risperdal
  • Janssen paid kickbacks to Omnicare
  • Omnicare was the nation's largest nursing home pharmacy
  • Omnicare pushed Risperdal to nursing home patients
  • Many of these patients were elderly dementia patients
  • Risperdal was NOT approved for dementia treatment
  • Risperdal increased mortality risk in these patients

ESTIMATED DEATHS

FDA Researcher Estimate

According to Dysart Law:

> "Perhaps most disturbing of all, an FDA researcher believes that at least 15,000 elderly nursing home residents are killed by the off-label use of antipsychotic drugs"

The Death Toll

If the FDA estimate is accurate, the Janssen-Omnicare kickback scheme may have contributed to thousands of deaths among elderly dementia patients.

COMPLETE RISPERDAL LAWSUIT TIMELINE

| Year | Event | Amount |

|------|-------|--------|

| 2009 | Omnicare kickback settlement | $98 million |

| 2012 | Washington State settlement | $4.6 million |

| 2012 | Texas settlement | $118 million |

| 2013 | Federal criminal/civil settlement | $2.2 billion |

| 2016 | Omnicare additional settlement | $28.125 million |

| 2021 | Individual lawsuits settlement | $800 million |

| TOTAL | | $3.2+ billion |

NBC NEWS QUOTE

> "Johnson & Johnson's conduct 'recklessly put at risk' the health of children, dementia patients and others to whom the drug was prescribed"

WASHINGTON STATE SETTLEMENT

According to Washington State Attorney General (August 29, 2012):

> "The complaint alleges that Janssen promoted Risperdal for off-label uses to both geriatric and pediatric populations, targeting patients with dementia"

COMPREHENSIVE TRACE: JANSSEN DRUGS AND DEMENTIA

THE COMPLETE PICTURE

This section traces the full connection between Janssen Pharmaceutica's drugs and dementia, from invention to harm.

TRACE 1: HALDOL (Haloperidol) - 1958

Invention

| Field | Value |

|-------|-------|

| Inventor | Paul Janssen |

| Year | 1958 |

| Company | Janssen Pharmaceutica |

| Patent | Multiple patents |

Mechanism of Harm

  • Blocks dopamine receptors in the brain
  • Causes extrapyramidal symptoms
  • Associated with tardive dyskinesia (permanent brain damage)
  • Higher mortality rate than Risperdal in dementia patients (HR = 1.31)

FDA Warning

  • Black box warning for increased mortality in elderly dementia patients
  • Not approved for dementia-related psychosis

Current Status

  • Still on WHO Essential Medicines List
  • Still widely used in nursing homes despite warnings

TRACE 2: RISPERDAL (Risperidone) - 1984

Invention

| Field | Value |

|-------|-------|

| Inventor | Paul Janssen's team |

| Year | 1984 |

| Company | Janssen Pharmaceutica |

| Patent | US 4,804,663 (expired 2003) |

Mechanism of Harm

  • Blocks dopamine and serotonin receptors
  • Increases risk of stroke in elderly
  • Increases risk of diabetes
  • Causes hyperprolactinemia (elevated prolactin)
  • Associated with increased mortality

Criminal Activity

  • Janssen created "ElderCare sales force" to target nursing homes
  • Paid kickbacks to Omnicare (largest nursing home pharmacy)
  • Promoted for dementia despite FDA warnings
  • Pleaded guilty to misbranding (2013)

Settlements

| Year | Amount |

|------|--------|

| 2009 | $98 million (Omnicare) |

| 2012 | $118 million (Texas) |

| 2013 | $2.2 billion (Federal) |

| 2021 | $800 million (Individual) |

FDA Warning

  • Black box warning for increased mortality in elderly dementia patients
  • Current label (2025) still contains warning

TRACE 3: INVEGA (Paliperidone) - 2006

Invention

| Field | Value |

|-------|-------|

| Developer | Janssen Pharmaceutica |

| Year | 2006 |

| Company | Janssen (J&J subsidiary) |

| Relationship | Active metabolite of Risperdal |

Mechanism of Harm

  • Same mechanism as Risperdal (it's the active metabolite)
  • Same risks: stroke, diabetes, mortality

Criminal Activity

  • Included in 2013 DOJ settlement
  • Promoted for off-label uses

FDA Warning

  • Black box warning for increased mortality in elderly dementia patients

TRACE 4: FENTANYL - 1960

Invention

| Field | Value |

|-------|-------|

| Inventor | Paul Janssen |

| Year | 1960 |

| Company | Janssen Pharmaceutica |

| Patent | US 3,141,823 |

Mechanism of Harm

  • Potent opioid agonist
  • Causes cognitive impairment
  • Causes confusion and delirium
  • Highly addictive
  • Now responsible for majority of opioid overdose deaths

Current Crisis

  • Illicit fentanyl is now the leading cause of overdose deaths in the US
  • Paul Janssen's invention has been weaponized by drug cartels
  • Derivatives (carfentanil) are 100x more potent

THE DEMENTIA PIPELINE

How Janssen Drugs Contribute to Dementia

  • Direct Neurotoxicity
- Antipsychotics damage dopamine pathways

- Long-term use causes permanent brain changes

- Tardive dyskinesia is evidence of brain damage

  • Anticholinergic Effects
- Many Janssen drugs have anticholinergic properties

- Anticholinergic burden increases dementia risk by 46%

- Long-term use accelerates cognitive decline

  • Vascular Damage
- Increased stroke risk damages brain tissue

- Cardiovascular events reduce brain blood flow

- Cumulative vascular damage leads to vascular dementia

  • Metabolic Effects
- Diabetes increases dementia risk

- Metabolic syndrome affects brain function

- Obesity and insulin resistance damage cognition

THE BUSINESS MODEL

Creating Customers

The investigation reveals a disturbing business model:

  • Invent drugs that treat symptoms (not causes)
  • Market aggressively to vulnerable populations
  • Downplay risks to regulators and doctors
  • Pay kickbacks to pharmacies and prescribers
  • Create dependency through long-term prescribing
  • Cause side effects that require additional drugs
  • Repeat with new drugs for the side effects

The Dementia Cycle

  • Patient develops behavioral issues (normal aging or early dementia)
  • Doctor prescribes Risperdal (off-label)
  • Risperdal increases stroke and diabetes risk
  • Patient develops vascular damage or metabolic syndrome
  • Cognitive decline accelerates
  • Patient develops more severe dementia
  • Doctor prescribes more Risperdal for worsening symptoms
  • Patient dies earlier than expected

CONNECTION TO PRINCESS ALEXANDRA / RYMAN HEALTHCARE

The Supply Chain

  • Janssen-Cilag NZ supplies medications to New Zealand
  • Ryman Healthcare operates Princess Alexandra Retirement Village
  • Princess Alexandra provides dementia care
  • Dementia patients may be prescribed Janssen antipsychotics
  • Princess Alexandra Medical Trust funds medical procedures in Napier

The Question

Are Janssen drugs being used in Ryman Healthcare facilities, including the Princess Alexandra Retirement Village in Napier?

If so, this would complete the connection between:

  • Janssen Pharmaceutica
  • Princess Alexandra Medical Trust
  • Ryman Healthcare
  • Dementia patients in Napier

SUMMARY TABLE: JANSSEN DRUGS AND DEMENTIA RISK

| Drug | Year | Dementia Risk | FDA Warning | Settlement |

|------|------|---------------|-------------|------------|

| Haldol | 1958 | HIGH | Black Box | N/A |

| Risperdal | 1984 | HIGH | Black Box | $3.2B+ |

| Invega | 2006 | HIGH | Black Box | Included in 2013 |

| Fentanyl | 1960 | MODERATE | Various | N/A |

ESTIMATED HARM

| Metric | Estimate | Source |

|--------|----------|--------|

| Deaths from off-label antipsychotics | 15,000+ | FDA researcher |

| Increased mortality risk | 1.6-1.7x | 17 controlled studies |

| Increased stroke risk | Significant | J&J's own studies |

| Increased diabetes risk | Significant | J&J's own studies |

| Total settlements | $3.2+ billion | DOJ, state AGs |