Analyses
Each analysis sets out, from public documents only, what was known about a drug or device risk and when: a dated chronology table, then a short reading of what the record shows and what it leaves open. The articles draw no legal conclusions and take no position on any pending case.
Date types, sources and the limits of a record
Dates. Every row carries a date and a date type. Published: a document or article became public. Submitted: a company filed something with a regulator. Approved: a regulator acted on a filing. Announced: a company or agency told the public. These often sit months apart. Where a date comes from a later letter or page, the row says so. Where a source gives only a month, the row shows only a month.
Sources. Every claim about a drug, device, regulator or event is footnoted to a primary source we fetched and read: FDA pages and approval packages, Drugs@FDA label versions and approval letters, journal articles with their identifiers, company press releases and Judicial Panel on Multidistrict Litigation orders. Panel orders are cited only to show that a proceeding exists. A key fact we could not confirm in a primary source is left out.
What a record can show. The order of events; what a company filed; what an agency wrote; what a label said on a given date; how an agency described its own reasoning.
What a record cannot show. What was known inside a company, unless the company published it. That a drug or device caused a particular harm: label sections that list postmarketing reports, and adverse event databases, say so themselves: a report does not establish causation, and its contents are not verified. A regulator's statement about an impurity or a test result is no finding about any patient. Missing documents are evidence of nothing, and a redacted page is a limit of the record, marked as one.
The four analyses
Elmiron and retinal pigmentary maculopathy
From a 2018 case series to the June 16, 2020 FDA approval of a revised Warnings section, including the manufacturer's June 24, 2019 supplement and the FDA review file.
Ranitidine (Zantac) and NDMA
FDA's statements from the September 13, 2019 alert, through its testing updates, to the April 1, 2020 request that manufacturers withdraw all ranitidine products.
GLP-1 receptor agonists and ileus
Which semaglutide, liraglutide and dulaglutide labels added ileus and intestinal obstruction, when, and what FDA's letters say about why.
The Philips Respironics PE-PUR foam recall
The 2021 recall of CPAP, BiPAP and ventilator devices, FDA's Class I identification, and FDA's later actions through the April 2024 consent decree.