Predictive intelligence for product liability

Sovereign and local: data, analysis and forecasts on your own hardware. No cloud required.

Justpoint forecasts regulatory action, recalls and litigation, with every finding cited to the public record.

Exhibit 1HVAD heart pump · the record as a chronologyAs of June 1, 2021

A recordCited by a findingAs of June 1, 2021: the record as it stood that day

Event date	Made public	Record	Cited in
Mar 27, 2011	Made public Apr 14, 2021	Adverse event report (MAUDE)thrombosis/thrombus	·
Dec 27, 2012	Made public May 14, 2013	Recall · Class IIClass II recall: Heartware HVAD…Z-1323-2013	Finding 17
Sep 1, 2014	Made public Dec 3, 2014	Published studyDifferent surgical strategies…PMID 25452906	Finding 4
Aug 5, 2015	—	Safety communicationSerious Adverse Events…	Finding 22
Jan 1, 2016	—	Published studySuccessful use of the Heart Ware HVAD as Bridge…	Finding 3
Mar 10, 2017	Made public May 3, 2017	Recall · Class IClass I recall: HeartWare…Z-1832-2017	·
Sep 15, 2018	—	Published studyThrombus on the inflow cannula…PMID 30399526	·
Feb 21, 2019	—	PMA supplementPMA approvalP100047/S133	·
Feb 21, 2019	—	PMA supplementpost-approval study protocol	·
≈ May 24, 2021	—	PMA supplementmanufacturing process change	·
≈ May 24, 2021	—	PMA supplementPMA approvalP100047/S179	Finding 24
More adverse event reports and other records, up to Aug 2014Cited in finding 2
More recalls, inspections and other records, Aug 2009 to Apr 2021Cited in findings 1, 5 to 16, 18, 19, 26, 27 and 29 to 35
More product and label records, Nov 2012 to Mar 2021

Records from FDA recalls and safety communications, PMA supplements, MAUDE adverse event reports and the scientific literature, as Justpoint links them to one product. Each finding the AI model wrote has a number, and each record it cites carries that number. A dash under Made public: no separate publication date is recorded, and the record’s own date stands in for it.

01 Who it is for

One record, for everyone with a stake in a product

Roundup, PFAS, Takata airbags and Philips CPAP machines each left a public record of reports, recalls, studies and regulatory actions before their MDLs.

Plaintiff firms
“Which product becomes the next mass tort, and when do we start signing clients?”
Screen products early, time your intake, and build the chronology of notice.
Check a suspicion in minutes: name a product and the harm you suspect, and see what the record holds.
Defense firms
“Is our client’s product heading for an MDL?”
Forecast litigation against a client’s product, test the plaintiffs’ chronology against the record, and document the state of the art.
Check a concern about your client’s product, or a competitor’s, before it becomes a claim.
In-house counsel
“What are regulators, courts and the literature saying about our products?”
Track new reports, recalls, studies and rulings on your products.
Check a concern about your product, or a competitor’s, before it becomes a claim.
Litigation funders
“Is this tort worth funding, and how large will it grow?”
Size a tort before you commit capital, with a forecast of the regulatory action and litigation still to come.
Insurers
“What is this maker’s exposure, and which substance becomes the next PFAS?”
Underwrite and set reserves ahead of claims, with every forecast resting on cited findings.
Safety and regulatory teams
“Is a recall, a label change or a warning letter coming for our product, or a competitor’s?”
See a problem build in the record while there is still time to act.
Investors
“Which listed maker faces regulatory action, a recall or a lawsuit next?”
Follow the record behind the makers you hold, with every finding cited.

Across industries

Drugs and medical devices: Zantac, sleep-apnea machines, breast implants
Chemicals and toxic torts: Roundup, PFAS, paraquat
Vehicles: Takata airbags, ignition switches
Consumer products and food: hair relaxers, baby food

02 The sources

Where the records come from

Public records only, from more than 100 sources at home and abroad. Justpoint holds no medical records and no patient files.

U.S. regulators: FDA adverse event reports (MAUDE, FAERS and its predecessor AERS), recalls, warning letters, inspections, approvals, clearances and drug labels; the Federal Register, CMS, HHS-OIG and the FTC; More than 25 milliondevice adverse event reports
Regulators abroad: The European Medicines Agency, the MHRA (UK), BfArM (Germany), Health Canada and the TGA (Australia); More than 40,000alerts and recalls
Courts: Federal dockets and opinions, New York State court dockets, and the orders of the Judicial Panel on Multidistrict Litigation; More than 800,000lawsuits
Science: PubMed, Europe PMC, OpenAlex, ClinicalTrials.gov and Retraction Watch; chemical hazard data from PubChem, IARC, NTP, ECHA and California’s Proposition 65; More than 40 millionPubMed records
Companies: SEC filings (EDGAR) and legal-entity records (GLEIF); More than 300,000SEC filings

As of October 19, 2026, and many other sources.

03 What you can do

Linked records

See a product’s whole record in one place

Every incident report, recall, regulatory action, published study and lawsuit on a product, linked to its makers, brands, components and ingredients.

Exhibit 2Philips CPAP · linked recordsAs of October 19, 2026

Philips CPAP

Its records

Adverse event reports
Recalls
Published studies on its device type
Product-liability MDL

Makers and brands

Koninklijke Philips N.V.
RESPIRONICS INC
Philips Healthcare

REMstar, DreamStation, ComfortGel

Device problems · most reported first

Degraded
Contamination
Corroded
Overheating of Device

Documents

Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating: FDA Safety CommunicationFDA safety communication · Nov 28, 2023
Order Lifting Stay of CTO and Vacating December 4, 2025 Hearing Session OrderU.S. Courts · W.D. Pa. · Oct 16, 2025

Patient problems · most reported first

Unspecified Respiratory Problem
Headache
Dizziness

Regulators abroad

TGA (Australia): Class I recall, product defect correction · Jul 1, 2021Philips Respironics CPAP and Bi-Level PAP Devices
TGA (Australia): safety alert · Jun 18, 2021Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators
Health Canada: recall · Sep 26, 2022Magnets in certain Philips Respironics sleep therapy masks may cause serious injury to some individuals

Also linked: failure modes · components

Philips CPAP as Justpoint links it: kinds of record, makers and brands, problems most reported first, documents and regulators abroad.

Over time

See a pattern build over time

Follow a problem from the first time it appears in the record, and measure how fast its reports grow. Different descriptions of the same failure are grouped together.

How a pattern is charted

Forecasts

Forecast what comes next

Justpoint draws on the total body of knowledge: incident reports, the scientific literature, regulatory actions and court dockets. Each forecast sets out the findings it rests on.

The forecasts can be checked against history: ask the same question as of a past date, with the model given only what was public by then, and compare the forecast with what followed.

How forecasts are checked

Exhibit 3A prescription drug · a forecast, redactedOctober 19, 2026

The forecast, as the AI model wrote it

Forecast from 2026-10-19: label change within 12 months

For a prescription drug; product and maker redacted

Evidence: carries a boxed warning for depression and suicidal ideation in patients, issued in 2023 and updated in 2025.

Chance made public within 6, 12 and 24 months
Event	6 mo	12 mo	24 mo
Class I recall	1%	2%	4%
Any recall	3%	5%	9%
FDA safety communication	10.5%	17.5%	28%
FDA press release	2%	4%	7%
Warning letter	0.7%	1.4%	2.1%
Label change or boxed warningThe forecast	20%	30%	45%
Market withdrawal	0%	0%	1%
MDL petition or creation	1%	2%	3%
New product-liability suits	5%	10%	15%
Rise in adverse event reports	10%	15%	20%

The findings it rests on

Finding 5
2023 Label Update (Supplement )
The label updated on 2023-08 added a Boxed Warning for depression and suicidal ideation in , expanded indications to include , and explicitly warned about Neuroleptic Malignant Syndrome (NMS), QT prolongation, somnolence, parkinsonism, and hypersensitivity.
Cites: Drug label, Aug 2023
Finding 12
2019 Label Update (Supplement )
The label updated on 2019-07 added explicit warnings for parkinsonism, QT prolongation, and somnolence, and included detailed guidance on dose adjustments for strong CYP3A4/CYP2D6 inhibitors, inducers, and MAOIs. Postmarketing hypersensitivity reactions are noted.
Cites: Drug label, Jul 2019
Finding 40
Pooled Long-Term Safety and Tolerability Analysis
Pooled long-term exposure analysis (, happened 2017-08) of 430 subjects across trials demonstrates that was well tolerated over 48 weeks. Treatment-emergent adverse events occurred in 66.5% of subjects, with 14.7% discontinuing due to adverse events. Psychiatric stability was maintained across schizophrenia and mood disorder subgroups, with minimal changes in laboratory parameters, vital signs, and ECGs.
Cites: Published study, Aug 2017
Finding 36
Generic Market Entry and Manufacturing Compliance
Generic approvals for expanded market access: (, approved 2024-04) holds 2 FAERS reports; (, approved 2024-08) holds 1 FAERS report and 5 FDA warning letters regarding manufacturing compliance; holds a tentative approval for (2026-01) with no adverse event reports.
Cites: Generic approval, Apr 2024 · Generic approval, Aug 2024 · Tentative approval, Jan 2026 · Warning letter, Nov 2022 · Warning letter, Aug 2024 · Warning letter, Jun 2026
Finding 19
Absence of Litigation
No multidistrict litigation (MDL) is linked to this product.
Cites: Conclusion

Written by the AI model on October 19, 2026. Words are only dropped, never changed: the product, its makers, trial names, record numbers and the day of each date are redacted.

Citations

Cite-check every finding

A finding is the AI model’s reading of specific documents, and it links to each of them, so you can verify it before you rely on it.

Exhibit 4HVAD heart pump · a finding and the recall it cites

Finding 1, as the model wrote it

The recall document states 17,992 units (8,054 US) distributed worldwide were subject to the recall.[1]

The reason states: ‘There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.’ The firm issued a Medical Device Notice directing physicians to review patient management recommendations on inspecting the HVAD Controller and its cables.

Cites 2 recalls; the first is shown here

[1]Z-1337-2021

Recall · Class I

Class I recall: Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, …

Event date: Feb 26, 2021
Made public: Apr 14, 2021
Source: FDA recalls

Recalls worded most like [1]

Class I recall: Medtronic HVAD…Z-1336-2021 · Feb 26, 2021Closest wording
Class I recall: HeartWare HVAD…Z-1427-2020 · Jan 23, 20202nd closest
Class II recall: Heart Ware…Z-0067-2019 · Aug 28, 20183rd closest

The finding as the model wrote it, the recall it cites, and the recalls worded most like that recall, as Justpoint shows them.

04 Confidentiality

Nothing you ask is sent anywhere

Justpoint works with the network off, so your cases, questions and findings stay with you.

The model’s only tools read documents or write findings, so it cannot act on your systems.

How it runs on your hardware

Your hardwareNo cloud required

The appyour cases, questions and findings
The AI modelfine-tuned for product liability
The recordseach with the date it became public

No outbound connection

Your case

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1Your full name
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3The product your case is about

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