Law and case law
Kelsey holds US court decisions and 21 CFR by date: eCFR's point-in-time text[1] from 23 December 2016, and the annual CFR edition for earlier dates, which the card says it is. The Federal Food, Drug, and Cosmetic Act is held as current text only. FDA guidance and rule preambles are held as well.
A ruling in the answer, with its passage
Does federal preemption bar a state-law failure-to-warn claim against the maker of a generic drug, and what is the Zofran generic maker's argument?
What comes back: The rule from PLIVA, Inc. v. Mensing, cited 564 U.S. 604, and a correction of the question: "The Zofran decisions available here do not establish that a Zofran generic manufacturer made that argument: the preemption motion in the 2019 Zofran decision was GSK's, and the First Circuit's 2023 appeal was also against GSK" (368 F. Supp. 3d 94; 57 F.4th 327). On the right, the Mensing syllabus under US COURT DECISIONS · Court decision · 2011-06-23, with the holding highlighted.
A memo, and what it could not find
A legal question gets a memo with an ON THIS PAGE bar: Issue, Rule, Exceptions and arguments considered, Other courts, Statute, Practical consequence. This Texas memo names its controlling authority, the Texas Supreme Court's decision in Centocor. Under Statute: "A targeted search did not retrieve the text of a Texas statutory provision relevant to this question. This answer therefore states the case-law rule and does not assess any statutory presumption or defense."
State product-liability statutes
Kelsey holds the current text, section by section, of four state statutes:
| State | Statute |
|---|---|
| Texas | Civil Practice and Remedies Code ch. 82 |
| Michigan | MCL 600.2945 to 600.2949a |
| New Jersey | Product Liability Act, N.J.S.A. 2A:58C |
| Louisiana | Products Liability Act, La. R.S. 9:2800.51 to .59 |
Each section is dated "as retrieved on" the day it was read. Earlier versions of these statutes are not held.
A state-by-state table of product-liability rules in drug and device cases quotes each cell from an opinion. Its limitation and repose periods come from the state's statute, kept only when the quoted passage is found on the page it cites, with the retrieval date and the URL.
The same rules in the evidence cards
The Evidence assessment cites 21 CFR 314.70(c)(6)(iii) and 21 CFR 314.3 in its row "Ability to change the label". The device approval route card cites Riegel v. Medtronic and Medtronic v. Lohr under each route. Court decision cards give each case's caption, court and date, and a "Read by AI" box quotes the passage a holding rests on.
Example questions
Which Rule 702 rulings accepted or rejected FAERS disproportionality?
What comes back: The rulings, with court, date and the passage on the method, for both outcomes.
What did 21 CFR 314.70 say on the date the label was approved?
What comes back: The section as in force on that date, cited to eCFR.
Sources
- eCFR, 21 CFR 10.30, as of 2026-10-01 (an example of eCFR's point-in-time text), https://www.ecfr.gov/api/versioner/v1/full/2026-10-01/title-21.xml?part=10§ion=10.30