Photo of Bexis

We could care less about almost everything in Driver v. Naranjo, 2024 WL 2869367 (S.D. Cal. June 6, 2024), which dismissed an overly litigious pro se prisoner’s product liability and other claims involving his purportedly forced use of a prescription drug.

But Driver’s first footnote raises an interesting question of judicial notice – whether notice can extend to the “characteristics” of prescription medical products. Driver held that “[t]he Court may take judicial notice of medical facts regarding prescription drugs, their active ingredients and effects.”  2024 WL 2869367, at *1 n.1.  The opinion cited two cases for that proposition, United States v. Howard, 381 F.3d 873, 880 & n.7 (9th Cir. 2004) (taking judicial notice of certain effects of a drug listed in the product warnings reprinted in the Physician’s Desk Reference (“PDR”)); and Lolli v. County of Orange, 351 F.3d 410, 419 (9th Cir. 2003) (“Well-known medical facts are the types of matters of which judicial notice may be taken.”) (citation omitted).

Since judicial notice of this nature would make it easier for defendants to “fill in the blanks” in often intentionally vague complaints and when we move to dismiss them on the pleadings, we decided to take a look at this subject.  Howard took judicial notice that two drugs the criminal defendant had used “contain the active ingredient oxycodone, an opioid with attributes similar to morphine and which may impair [a person’s]  mental and physical abilities,” citing the PDR.  381 F.3d at 880.  The PDR, however, is simply a collection of FDA-approved drug warnings.  See, e.g., Libertelli v. Hoffman-La Roche, Inc., 1981 WL 714285, at *2 (S.D.N.Y. Feb. 23, 1981) (“The material published by PDR is all approved verbatim by the federal Food and Drug Administration, and published by PDR pursuant to 21 C.F.R. §202.1).”  Lolli, followed in Howard, involved judicial notice of the symptoms of a disease, not anything having to do with a prescription medical product.  351 F.3d at 419.  Between the two of them, it would appear that substantive information appearing in FDA-approved product labels is judicially noticeable in the Ninth Circuit, at least when that information is “well-known.”

That is probably the rule elsewhere as well.  The relevant headnote in Howard, on judicial notice, has been cited by no less than 315 cases.  In a number of them, like Driver, courts took judicial notice of drug facts from product labeling.  See Arellano v. Guldseth, 2023 WL 3296154, at *3 nn.3, 5 (S.D. Cal. May 5, 2023) (drug indications and precautions); Turner v. Williams, 2022 WL 4125224, at *4 n.5 (S.D. Cal. Sept. 9, 2022) (drug classification); Rapinoe v. Gore, 2022 WL 686461, at *3 nn. 2-3 (S.D. Cal. March 8, 2022) (drug indications and composition); Arellano v. Santos, 2021 WL 5140187, at *3 n.3 (S.D. Cal. Nov. 4, 2021) (drug classifications and indications); O’Brien v. Saha, 2021 WL 321971, at *6-7 nn. 6-7 (Mag. S.D. Cal. Jan. 30, 2021), adopted, 2021 WL 960693 (S.D. Cal. March 15, 2021) (classifications and indications of two prescription drugs), aff’d, 2022 WL 16945892 (9th Cir. Nov. 15, 2022); Arellano v. Santos, 2020 WL 1275650, at *4 n.2 (S.D. Cal. March 16, 2020) (drug indications and precautions); Joseph v. Clayton, 2020 WL 804863, at *1 n.2 (S.D. Cal. Feb. 18, 2020) (drug characteristics and risks); Tortolano v. Poulsen, 2014 WL 4384341, at *5 n.5 (D. Idaho Sept. 3, 2014) (drug mechanism of action); Cutler v. Corrective Medical Services, 2011 WL 4479025, at *7 (D. Idaho Sept. 26, 2011) (drug characteristics; it is “appropriate to take judicial notice of well-known medical facts, such as those contained in the Physician’s Desk Reference”); Bates v. Dura Automotive Systems, Inc., 2011 WL 2618235, at *9 (M.D. Tenn. July 1, 2011) (drug adverse effects and warnings).  We note that most of these cases – and all the California ones − involve pro se prisoner litigation.

Other cases in other jurisdictions that don’t involve prison inmates have reached the same result.  Judicial notice of medical facts is frequently encountered in vaccine litigation.  Most recently the Ninth Circuit indicated that a statement by the Centers for Disease Control (“CDC”) that “COVID-19 vaccines are safe and effective” could be judicially noticed.  Health Freedom Defense Fund, Inc. v. Carvalho, ___ F.4th ___, 2024 WL 2873372, at *8 (9th Cir. June 7, 2024) (noting, however, that the statement begged the question “safe and effective for what?”).  Refusal to take judicial notice of “safety and efficacy of vaccines” a stated by the CDC was reversible error in Seymour v. Seymour, 263 A.3d 1079, 1084 (Me. 2021).  The Nevada Supreme Court likewise affirmed the taking of judicial notice “of the CDC and AAP guidelines and the research from those organizations regarding the safety of the vaccines.”  Kelley v. Kelley, 535 P.3d 1147, 1153 (Nev. 2023).  See also Pietrangelo v. Sununu, 15 F.4th 103, 106 n.1 (1st Cir. 2021) (“[t]he accuracy of state and federal vaccine distribution data cannot be reasonably questioned, and we take judicial notice”); Krewionek v. McKnight, 217 N.E.3d 424, 433 (Ill. App. 2022) (“tak[ing] judicial notice . . . that the COVID-19 vaccines are intended to prevent the contraction and transmission of COVID-19”), appeal denied, 210 N.E.3d 774 (Ill. 2023); Lippert v. Lippert, 2022 WL 18000080, at *5 (Ill. App. Dec. 30, 2022) (“we find it was appropriate for the trial court to take judicial notice of the CDC’s . . . recommendations that healthy children should receive the COVID-19 vaccination”); Mollett v. Pennsylvania Dept. of Corrections, 2024 WL 232164, at *3 (M.D. Pa. Jan. 22, 2024) (taking judicial notice “that vaccination against COVID-19 is recommended for people with diabetes”); cf. United States v. Paige, 2022 WL 704200, at *3 (E.D. Pa. March 9, 2022) (taking judicial notice of various COVID-19 statistics from CDC website).

Over objection, Hines v. Secretary of HHS, 940 F.2d 1518 (Fed. Cir. 1991), took judicial notice of “the incubation period of measles” as a medical fact “not subject to reasonable dispute.”  Id. at 1526.  In one of the earliest relevant appellate decisions, Franklin Life Insurance Co. v. William J. Champion & Co., 350 F.2d 115, 130 (6th Cir. 1965), took judicial notice of “common knowledge that cancer often does not manifest itself . . . for a considerable time[].”  Id. 130.

The adverse effect of a drug on a user’s ability to drive was judicially noticed in United States v. Dillavou, 2009 WL 230118, at *1 (S.D. Ohio Jan. 30, 2009) (also finding no precedent “disapproving judicial notice of the PDR”).  In a product liability case, the function of a vaccine preservative was granted judicial notice.  Sykes v. Glaxo-SmithKline, 484 F. Supp.2d 289, 293 (E.D. Pa. 2007).  More recently, the generic status of a drug was judicially noticed in Hernandez v. Aurobindo Pharma USA, Inc., 582 F. Supp.3d 1192, 1202 (M.D. Fla. 2022).  There may well be more such decisions out there, but that’s enough.

On the other end, how far is too far for judicial notice?  We offer Allen v. Secretary of HHS, 2007 WL 6011762 (Fed. Cl. Feb. 1, 2007), as an example of judicial notice taken too far.  There a claimant contended that causation – that the vaccine in question caused the injury at issue − was a judicially noticeable “medical fact.”  Id. at *2.  Allen, however, disagreed:

[The government] reasons that a legal conclusion on the issue of whether [a] vaccine can cause [a medical condition] result[s] from the weighing, inter alia, of competing medical opinions, and a medical opinion is not a fact of which judicial notice may be taken.  The court agrees. . . .  [W]hether [a] vaccine can cause [a condition], is a legal question informed by a factual investigation of a sequence of events and by offered medical opinions that address the significance of the ascertained facts.

Id. (citations and quotation marks omitted).  See also Hardy v. Johns-Manville Sales Corp., 681 F.2d 334, 347-48 (5th Cir. 1982) (“The proposition that asbestos causes cancer, because it is inextricably linked to a host of disputed issues . . . is not at present so self-evident a proposition as to be subject to judicial notice.”); United States ex rel. Dingle v. BioPort Corp., 270 F. Supp.2d 968, 973 (W.D. Mich. 2003) (medical information on websites that “could not [be] verif[ied]”could not be judicially noticed), aff’d, 388 F.3d 209 (6th Cir. 2004).

Thus, defendants have good reason to seek judicial notice of authoritatively established medical facts about prescription medical products, particularly medical information found in the PDR and CDC websites.