What you can ask
Ask about any drug or device, by task.
Questions by the work they do. Each answer is cited to the original documents.
Task
What was known, and when
The question every drug and device case turns on.
- “Was eye damage from Elmiron knowable before the label warned of it?”What comes backA dated chronology with the original passage behind each statement.Worked example
- “Build a chronology of everything that was public about drug X and injury Y before the label warned.”Plaintiff trial team
- “When could a patient first have known that Ozempic is linked to gastroparesis?”Intake
Task
One drug, every side effect
- “For every side effect of Ozempic, which appeared in published studies before the label warned, and how long before?”What comes backEach side effect, its first study, the first label to name it, and the gap.Pharma safety team
- “Was the warning strengthened, moved up a section or boxed, and when?”Regulatory affairs
Task
Many drugs at once
Scan across drugs and classes, then watch what you find.
- “Which GLP-1 drugs gained new evidence of pancreatitis in the last 90 days, and did any foreign regulator act first?”What comes backA watch list, with foreign warnings and their dates.Insurers, pharma safety
- “Which 2025 safety label changes came without an FDA safety communication?”What comes backEach change with its date and the label text before and after.Journalists
- “Across the drugs this company holds, where did evidence build up before any public safety action?”What comes backProduct by product, the evidence and its dates.Due diligence
Task
Your client’s facts
From an injury to the drugs, and from the drugs to the dates.
- “Which drugs are most often reported with this injury, and did their labels warn before my client started in March 2019?”What comes backThe candidate drugs, the label in force on that date, and when each warning appeared.Plaintiff firm screening a new injury
- “Which label version was in force when my client started in March 2019, and did it warn?”Plaintiff firm
- “When we prescribed it in 2021, what did the label and FDA say about this risk?”Physician · Learned intermediary
Task
What FDA reviewed and decided
- “What did FDA’s reviewers say about this risk at approval, and did the company later propose a warning FDA declined?”What comes backThe reviewers’ passages, the company’s submissions and FDA’s response, quoted and dated.Defense team
- “What did FDA consider about this risk before the prescription, and what did it decide?”Defense team
- “Did FDA reject or reword the warning now demanded?”Defense team · Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019)
Task
Is the signal real
Check a pattern in the reports from several directions.
- “Does the signal hold with lawyer-filed reports removed, and after duplicates are removed?”What comes backThe signal recomputed each way.Defense experts
- “Give me the general-causation table: every study with design, size, effect and date.”Plaintiff experts
- “Is there a randomized trial or meta-analysis that cuts against the association?”What comes backThe studies on both sides.Litigation funders
- “How many US patients took this drug each year, and what share was generic?”Funders, insurers
Task
The law and regulators abroad
- “Which rulings on expert testimony accepted or rejected statistical analysis of FDA adverse-event reports?”Both sides
- “Did regulators in Europe, the UK or Canada warn before FDA, and by how long?”Both sides, journalists
Task
Devices
- “Did the earlier devices this one was cleared against have the same failure, and does this recall cover my client’s model?”Device litigation
Task
For experts under cross-examination
- “Which terms make up ‘eye damage’, and which query and data version sit behind each number?”What comes backThe term list, the method and the data version behind every figure.Expert witnesses
Watch lists
Emerging Evidence
See risks build up across drugs and classes before they become cases.
Kelsey scans across drugs, classes and conditions for evidence building up: new reporting signals, new studies, regulators acting abroad and label changes.
Put a drug, a class or a portfolio on a watch list. You get an alert, with its source, when new evidence appears.
Exploration, not prediction. Kelsey shows the evidence. It never forecasts lawsuits or outcomes.
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Working product. Test links upon request.
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