What you can ask, and who asks
Plain-English questions about any drug or device. Each answer is cited to the original documents. See who uses Kelsey for the work each group does.
Questions, and what comes back
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A plaintiff firm
“Which drugs are most often reported with this injury, and did their labels warn before my client started in March 2019?”
What comes back: The drugs, the label in force on 1 March 2019 for each, and the date each warning appeared
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A defense team
“What did FDA’s reviewers say about this risk at approval, and did the company later propose a warning FDA declined?”
What comes back: The reviewers’ passages, the company’s submissions and FDA’s response, quoted and dated
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A pharma safety team
“For every side effect of Ozempic, which appeared in published studies before the label warned, and how long before?”
What comes back: For each side effect: first publication, first label mention, first warning, and the months between
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An insurer
“Which GLP-1 drugs gained new evidence of pancreatitis in the last 90 days, and did any foreign regulator act first?”
What comes back: Each drug’s new dated items, with EMA, MHRA, Health Canada and Swissmedic actions and their dates
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A litigation funder
“Does the reporting signal hold with lawyer-filed reports removed, and is there a trial or meta-analysis against it?”
What comes back: The four measures computed both ways, and the studies on each side
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A diligence team
“Across the drugs this company holds, where did evidence build up before any public safety action?”
What comes back: Drug by drug, the dated evidence ahead of the first FDA action
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An expert witness
“Which terms make up ‘eye damage’, and which query and data version sit behind each number?”
What comes back: The term list, the query run and the data snapshot behind each calculated figure
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A journalist
“Which 2025 safety label changes came without an FDA safety communication?”
What comes back: Each change, its date, and the label text before and after
More questions, by task
1What was known, and when
- “Was eye damage from Elmiron knowable before the label warned of it?”What comes back: A 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.”Asked by: plaintiff trial team
- “When could a patient first have known that Ozempic is linked to gastroparesis?”Asked by: intake
2Devices
- “Did the earlier devices this one was cleared against have the same failure, and does this recall cover my client’s model?”Asked by: device litigation
3One drug, or many at once
- “Was the warning strengthened, moved up a section or boxed, and when?”Asked by: regulatory affairs
- “Did regulators in Europe, the UK or Canada warn before FDA, and by how long?”Asked by: both sides, journalists
4Your client’s facts and FDA’s decisions
- “Which label version was in force when my client started in March 2019, and did it warn?”Asked by: plaintiff firm
- “What did FDA consider about this risk before the prescription, and what did it decide?”Asked by: defense team
- “Did FDA reject or reword the warning now demanded?”Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019)Asked by: defense team
5Is the signal real, and what do the courts say
- “Give me the general-causation table: studies from PubMed and ClinicalTrials.gov with design, size and date, and the effect where the abstract reports it.”Asked by: plaintiff experts
- “Is there a randomized trial or meta-analysis that cuts against the association?”What comes back: The studies on both sides.Asked by: litigation funders
- “Which rulings on expert testimony accepted or rejected statistical analysis of FDA adverse-event reports?”Asked by: both sides
Emerging evidence
Choose a drug or a condition, optionally a side effect, and a look-back window, then press Start watching. Each check compares the result with the previous one and adds one alert listing the evidence added or removed, linked to its source. The first check sets the baseline.