Getting Noticed – Receiving FDA-Related Judicial Notice

By Bexis on December 8, 2025

This post sort of got away from us. We started with the proposition that our prescription medical product clients frequently move to dismiss cases, and thus seek to get courts to take judicial notice of FDA-related documents in product liability litigation involving their products. Judicial notice in cases involving FDA regulated products can be of great assistance on pleadings-based motions (Rule 12(b)(6) and judgment on the pleadings) because judicial notice is an exception to the usual limitation of such motions to what plaintiffs plead – or, equally importantly, fail to plead – in their complaints. Not only do judicially noticeable documents fill in facts that plaintiffs deliberately omit, but they can also defeat contrary factual allegations that the documents establish are untrue. This is an important exception to the Rule 12 mantra that challenged allegations are to be taken as true. Instead, allegations in a complaint are not credited where contradicted by judicially noticeable documents. E.g., Fuqua v. Santa Fe County Sheriff’s Office, ___ F.4th ___, 2025 WL 3072794, at *4 (10th Cir. Nov. 4, 2025); Jeffery v. City of New York, 113 F.4th 176, 179 (2d Cir. 2024); Clark v. Stone, 998 F.3d 287, 298 (6th Cir. 2021); Massey v. Ojaniit, 759 F.3d 343, 353 (4th Cir. 2014); Kaempe v. Myers, 367 F.3d 958, 963 (D.C. Cir. 2004); Sprewell v. Golden State Warriors, 266 F.3d 979, 988 (9th Cir. 2001). So judicial notice can overcome contrary pleadings.

FDA (and other government agency) materials are usually “not subject to reasonable dispute” because they “can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned.” Fed. R. Evid. 201. To save everyone time and effort, we intended to compile these FDA-related decisions. We thought they were mostly going to be preemption cases involving premarket-approved medical devices. But it turns out there was a lot more FDA-related judicial noticing going on in cases involving FDA-regulated products than we had expected to find. To save ourselves time and effort, we had to limit our research to decisions involving prescription medical products and OTC drugs – so no decisions involving food, cosmetics, dietary supplements, tobacco, homeopathic products, or anything else that is under the FDA’s regulatory auspices.

At least until recently (preemption has increasingly deterred PMA device litigation), the most common usage of FDA-related judicial notice has been of the fact that a medical device is pre-market approved, and thus entitled to broad preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) – something that plaintiffs almost always omit from their complaints. There are literally dozens of decisions taking judicial notice of FDA PMA status. Take your pick from our compilation for whichever cases will be most persuasive to any given judge in any given jurisdiction.

As one would expect, most of these decisions are by trial courts, however a couple of Fifth Circuit decisions have agreed that an FDA PMA is a judicially noticeable fact in product liability litigation. The plaintiffs in Funk v. Stryker Corp., 631 F.3d 777 (5th Cir. 2011), were unable to hide behind their pleadings, which omitted the fact that the device at issue had received PMA approval:

“A judicially noticed fact must be one not subject to reasonable dispute in that it is either (1) generally known within the territorial jurisdiction of the trial court or (2) capable of accurate and ready determination by resort to sources whose accuracy cannot reasonably be questioned.” Fed. R. Evid. 201(b).

The district court appropriately used judicial notice in accordance with these standards. In the pleadings . . . there was no actual asserted factual dispute. . . . Further, the district court took appropriate judicial notice of publicly-available documents and transcripts produced by the FDA, which were matters of public record directly relevant to the issue at hand. Accordingly, we hold that it was appropriate for the court to take judicial notice, under Rule 12(b)(6), of the PMA the FDA granted to [defendant] for marketing its [device].

Funk v. Stryker Corp., 631 F.3d 777, 783 (5th Cir. 2011) (citations omitted). In Wildman v. Medtronic, Inc., the same court reiterated its holding in Funk. 874 F.3d 862, 866 n.2 (5th Cir. 2017) (“Because the [pre-market] approval process is part of the public record . . ., the court is entitled to take judicial notice of the information presented in the FDA documents.”) (citing Funk).

Not surprisingly, numerous Fifth Circuit district court cases have judicially noticed FDA PMA decisions, in reliance on the Funk precedent. The recent decision in Doucet v. Abbott Laboratories, Inc., 2025 WL 1548534 (E.D. La. May 29, 2025), is a good example:

[T]he Court will take judicial notice of the fact that the [device] was approved by the FDA vis-à-vis the PMA process and received Class III status. The FDA documentation provided by [defendants] in support bears sufficient indicia of reliability, such that its consideration at this stage in the proceedings is fair as to all the parties. Indeed, other courts routinely take judicial notice of PMA approval letters for Class III medical devices when deciding preemption issues at the motion to dismiss stage.

Id. at *7 (citing, inter alia, Funk). See also Armstrong v. ABC Corp., 2023 WL 6063806, at *7 & n.7 (Mag. W.D. La. Aug. 21, 2023) (judicially noticing device PMA), adopted, 2023 WL 6247915 (W.D. La. Sept. 25, 2023); Estate of Comatov v. Medtronic, Inc., 2023 WL 2922830, at *2 n.1 (C.D. Cal. March 16, 2023), (“PMA notices are matters of public record that are judicially noticeable.”) (citations omitted); Richardson v. Tandem Diabetes Care, Inc., 2023 WL 2393692, at *2 & n.7 (W.D. La. March 7, 2023) (judicially noticing device PMA); McGuire v. Abbott Laboratories, Inc., 2022 WL 4295402, at *3 (E.D. Tex. Sept. 15, 2022) (“in view of the fact that [defendant] formally requested the court to take judicial notice of the FDA PMA Letters, and the letters are the type of document of which a court may take judicial notice . . ., the court finds it appropriate to take judicial notice of the FDA letters regarding the pre-market approval”); Celino v. Biotronik, Inc., 536 F. Supp.3d 89, 101 (E.D. La. 2021) (“the Court takes judicial notice . . . that the [devices] underwent the PMA . . . approval process”); Lewis v. Abbott Laboratories, 2021 WL 4448920, at *3 (M.D. La. Sept. 28, 2021) (“the Court takes judicial notice of an FDA document Defendant offers that establishes that the [device] completed the PMA process.”) (footnote omitted); Hawkins v. Abbott Diabetes Care Sales Corp., 2021 WL 795860, at *2 (E.D. La. March 2, 2021) (“the Court sees no merit in refusing Defendants’ request to take judicial notice of [the device’s] premarket approval by the FDA”); Allo v. Allergan USA, Inc., 2020 WL 814855, at *1 n.1 (E.D. La. Feb. 19, 2020) (“A court may take judicial notice of a premarket approval the Food and Drug Administration (FDA) grants to a medical device manufacturer.”) (citation omitted) (“Allo II”); Allo v. Allergan USA, Inc., 2020 WL 32439, at *2 (E.D. La. Jan. 2, 2020) (same) (citation omitted) (“Allo I”); Stampley v. Allergan USA, Inc., 2019 WL 1604201, at *2 (Mag. W.D. La. March 15, 2019) (judicially noticing device PMA), adopted, 2019 WL 1601613 (W.D. La. April 15, 2019); Calloway v. Coloplast Corp., 2019 WL 2169222, at *3 (Mag. W.D. La. Feb. 5, 2019) (“the undersigned, consistent with the practice of other courts, takes judicial notice of the [premarket] approval process for the [device]”), adopted, 2019 WL 2166539 (W.D. La. May 17, 2019); Bryant v. Thoratec Corp., 343 F. Supp.3d 594, 602 (S.D. Miss. 2018) (judicially noticing “that the [device] is a Class III medical device that received pre-market approval”); Ezell v. Medtronic PLC, 2018 WL 6928917, at *5 (Mag. W.D. La. Dec. 19, 2018) (judicially noticing device PMA), adopted, 2019 WL 97041 (W.D. La. Jan. 3, 2019); Parra v. Coloplast Corp., 2017 WL 24794, at *3 (E.D. La. Jan. 3, 2017) (“The Court has taken judicial notice of the FDA’s website, which indicates that the [device] underwent the FDA’s pre-market approval process under the FFDCA.”) (footnote omitted); Yosowitz v. Covidien LP, 182 F. Supp.3d 683, 687-88 (S.D. Tex. 2016) (“tak[ing] judicial notice of” “the fact that the [device] received the FDA’s PMA approval”); Morgan v. Medtronic, Inc., 172 F. Supp.3d 959, 964 (S.D. Tex. 2016) (PMA is a “matter[] of public record of which the Court may take judicial notice”); Spier v. Coloplast Corp., 121 F. Supp.3d 809, 811 n.2 (E.D. Tenn. 2015) (judicially noticing device PMA); Stanfield v. Boston Scientific Corp., 166 F. Supp.3d 873, 879 (S.D. Tex. 2015) (“The FDA’s approval is a matter of public record . . ., and thus the Court may take judicial notice of it as a matter of public record”); Smith v. St. Jude Medical, 2015 WL 9094383, at *3 (S.D. Miss. Dec. 16, 2015) (judicially noticing two device PMAs); Williamston v. Medtronic, Inc., 2014 WL 2042004, at *6 (W.D. La. May 15, 2014) (judicially noticing device PMAs); Scianneaux v. St. Jude Medical, S.C., 961 F. Supp.2d 808, 812 (E.D. La. 2013) (“The Court has taken judicial notice of the FDA’s website, which indicates that the [device] underwent the FDA’s pre-market approval process”); Sons v. Medtronic Inc., 915 F. Supp.2d 776, 781 (W.D. La. 2013) (“The Court takes judicial notice of the FDA Websites stating that the . . . Devices are Class III PMA medical devices”); McBride v. Medtronic, Inc., 2013 WL 3491085, at *2 (W.D. La. July 10, 2013) (“we hereby take judicial notice of the FDA information . . . verifying that the [device] is a Class III PMA device”); Austin v. Medtronic, Inc., 2011 WL 13228412, at *2 (N.D. Tex. Aug. 18, 2011) (judicially noticing device PMA); Lewkut v. Stryker Corp., 724 F. Supp.2d 648, 655 & n.2 (S.D. Tex. 2010) (judicially noticing device PMA); Cenac v. Hubbell, 2009 WL 10678961, at *2 n.4 (E.D. La. July 31, 2009) (judicially noticing device’s “status as a Class III PMA medical device” given “the public records of the FDA”).

Many district courts – and a number of state courts – in other jurisdictions have likewise taken judicial notice of FDA pre-market approval documents or website information:

First Circuit: Summers v. Medtronic, Inc., 2025 WL 863576, at *2 & n.1 (D. Mass. March 18, 2025) (judicially noticing device PMA); Cunningham v. Abbott Vascular, Inc., 2022 WL 2387903, at *1 n.4 (Mag. D. Mass. March 1, 2022) (judicially noticing device PMA), adopted, 2023 WL 6397839 (D. Mass. Sept. 29, 2023).

Second Circuit: Croci v. Zoll Medical Corp., 2025 WL 2307728, at *4 (S.D.N.Y. Aug. 11, 2025) (“Defendants have provided FDA records confirming that [the device] is a Class III medical device that has received a PMA. Courts routinely take judicial notice of FDA records.”) (citations omitted); Dains v. Bayer HealthCare LLC, 2022 WL 16572021, at *2 n.4 (N.D.N.Y. Nov. 1, 2022) (judicially noticing device PMA); Kaemmlein v. Abbott Labortories, 564 F. Supp.3d 58, 63 n.2 (E.D.N.Y. 2021) (judicially noticing device PMA); Moody v. Allergan USA, Inc., 2017 WL 6949742, at *2 (Mag. W.D.N.Y. Dec. 5, 2017) (judicially noticing device PMA), adopted, 2018 WL 451824 (W.D.N.Y. Jan. 17, 2018); Rosen v. St. Jude Medical, Inc., 41 F. Supp.3d 170, 181 n.10 (N.D.N.Y. 2014) (“Because the existence of the PMAs is not in dispute, and its accuracy can be ‘readily determined’ and ‘cannot reasonably be questioned,’ due to its publication on the FDA website, the Court takes judicial notice”); Bloom v. Burwell, 2017 WL 177620, at *1 n.3 (D. Vt. Jan. 17, 2017) (judicially noticing device PMA); Franzese v. St. Jude Medical, Inc., 2014 WL 2863087, at *3 (E.D.N.Y. June 23, 2014) (“Defendants provide accurate documents from the FDA reflecting PMA for the devices at issue. Judicial notice of such facts is consistent with precedent.”); Simon v. Smith & Nephew, Inc., 990 F. Supp.2d 395, 401 nn. 2, 4-5 (S.D.N.Y. 2013) (judicially noticing device PMA); Gale v. Smith & Nephew, 989 F. Supp.2d 243, 246 & n.2 (S.D.N.Y. 2013) (judicially noticing PMA “based on FDA public records”); Desabio v. Howmedica Osteonics Corp., 817 F. Supp.2d 197, 201 n.3 (W.D.N.Y. 2011) (“[t]he Court takes judicial notice” that the device received “PMA” and “was approved”).

Third Circuit: Hollenstein v. St. Jude Medical, Inc., 2025 LX 150897, at *3 n.4 (D.N.J. June 26, 2025) (“[t]his Court may judicially notice the agency’s grant of premarket approval”); Gusky v. Medtronic, Inc., 2025 WL 712967, at *1 (W.D. Pa. March 5, 2025) (plaintiff’s “arguments against taking judicial notice of the FDA premarket approval of Defendants’ product lack merit”); Benn v. Medtronic, Inc., 2023 WL 3966000, at *2 n.3 (D.N.J. June 13, 2023) (“[t]he Court may take judicial notice of published government records such as the FDA’s PMA documents”); Walls v. Medtronic, Inc., 2019 WL 6839942, at *2 (E.D. Pa. Dec. 16, 2019) (“I am satisfied that it is proper for me to take judicial notice of” “FDA records accessible online that demonstrate their products were subject to a full Class III Premarket Approval process”); Freed v. St. Jude Medical, Inc., 2017 WL 4102583, at *2 (D. Del. Sept. 15, 2017) (“FDA approval letters ‘can be accurately and readily determined’ from the FDA’s website, a source ‘whose accuracy cannot reasonably be questioned’”); McLaughlin v. Bayer Corp., 172 F. Supp.3d 804, 810 n.2 (E.D. Pa. 2016) (defendant’s “PMA Letter is referenced in the Complaint and is a matter of public record and, thus, we can consider it”); Becker v. Smith & Nephew, Inc., 2015 WL 4647982, at *2 (D.N.J. Aug. 5, 2015) (“This Court takes judicial notice of the FDA’s website, and holds that it establishes premarket approval of the” device); Clements v. Sanofi-Aventis, U.S., Inc., 111 F. Supp.3d 586, 592 n.2 (D.N.J. 2015) (judicially noticing device PMA; “facts about the FDA approvals of [the device] are also matters of public record, appropriate for judicial notice”); Desai v. Sorin CRM USA, Inc., 2013 WL 163298, at *3-4 (D.N.J. Jan. 15, 2013) (“This Court takes judicial notice of the FDA’s website, and holds that it establishes premarket approval of the [device].”) (footnote omitted); Gross v. Stryker Corp., 858 F. Supp.2d 466, 481 & n.26 (W.D. Pa. 2012) (judicially noticing device PMA).

Fourth Circuit: Mikos v. Abbott Laboratories, 2021 WL 5416534, at *2 n.4 (D. Md. Nov. 18, 2021) (“this Court has also taken judicial notice of a Class III device’s status as a premarket-approved device”) (citation omitted); Hill v. Abbott Laboratories, 2020 WL 4820243, at *1 (D.S.C. Aug. 19, 2020) (judicially noticing device PMAs); Diodato v. Mentor Worldwide LLC, 2020 WL 3402296, at *1 n.1 (D. Md. June 19, 2020) (judicially noticing device PMA); Porter v. Depuy Orthopaedics, Inc., 2019 WL 3979656, at *5 (Mag. E.D. Va. Aug. 6, 2019) (“the Court takes judicial notice that the [device] at issue in this suit constitutes a Class III medical device under the MDA that has received premarket approval”) (citation omitted), adopted, 2019 WL 3978407 (E.D. Va. Aug. 22, 2019); Smith v. St. Jude Medical Cardiac Rhythm Management Div., 2013 WL 1104427, at *3 (D. Md. March 13, 2013) (“This court can take judicial notice . . . that the [device] was approved as a Class III device following the FDA’s pre-market approval (“PMA”) process.”); Ali v. Allergan United States, 2012 WL 3692396, at *1 & n.2 (E.D. Va. Aug. 23, 2012) (judicially noticing device PMA); Covert v. Stryker Corp., 2009 WL 2424559, at *1 & n.2 (M.D.N.C. Aug. 5, 2009) (judicially noticing device PMA); Stevens v. Pacesetter, Inc., 2008 WL 2637417, at *2 n.4 (D.S.C. April 1, 2008) (“the court may take judicial notice of the PMA of the device in question which can be obtained from official federal sources including through an easily accessible government website”).

Fifth Circuit: See above.

Sixth Circuit: Jackson v. Abbott Laboratories, Inc., 2024 WL 4256340, at *2-3 (W.D. Ky. Sept. 20, 2024) (judicially noticing device PMA); Kiser v. Terumo Medical Corp., 2021 WL 4356044, at *1 n.2 (E.D. Tenn. Sept. 23, 2021) (judicially noticing device PMA); Reynolds v. Medtronic, Inc., 2021 WL 1854968, at *4 (S.D. Ohio May 10, 2021) (“the Court will take judicial notice of the approval listings, which are public records available from the FDA’s government database website”); Williams v. Mentor Worldwide LLC, 2019 WL 4750843, at *2 n.2 (N.D. Ohio Sept. 30, 2019) (“Courts regularly take judicial notice of approval letters and other documents on the FDA’s website”) (citation omitted); Kodger v. Zimmer Biomet Holdings, Inc., 2017 WL 4348997, at *1 n.14 (N.D. Ohio Sept. 29, 2017) (“the Court can take judicial notice of these [PMA] facts from the FDA approval letter”); Canary v. Medtronic, Inc., 2017 WL 1382298, at *1 n.2 (E.D. Mich. April 18, 2017) (“although the records evidencing the FDA’s approval of Defendant’s device are not part of the pleadings in this case, the Court may consider public records” under the federal rules); Aaron v. Medtronic, Inc., 209 F. Supp.3d 994, 1014 & n.9 (S.D. Ohio 2016) (“This Court may take judicial notice of [the device’s] receipt of PMA from the FDA”); Potolicchio v. Medtronic, Inc.; 2016 WL 3129186, at *1 n.1 (E.D. Tenn. June 2, 2016) (“Based on documents of which the Court can take judicial notice, the [device] is a PMA-approved medical device.”); Roberts v. Stryker Corp., 2014 WL 12911070, at *3 (W.D. Ky. Aug. 7, 2014) (“The Court takes judicial notice of the [device’s] PMA approval letter.”); Gray v. Stryker Corp., 2013 WL 633120, at *3 (S.D. Ind. Feb. 20, 2013) (“the Court will exercise its discretion and take judicial notice that the . . . Device is a Class III medical device subject to the MDA.”); Cooley v. Medtronic, Inc., 2012 WL 1380265, at *3 n.2 (E.D. Ky. April 20, 2012) (“[a]ll of [defendants] available [devices] have received premarket approval. This information is a matter of public record.”); Phillips v. Stryker Corp., 2010 WL 2270683, at *5 & n.3 (E.D. Tenn. June 3, 2010) (court rejects argument that it could not take judicial notice of PMA).

Seventh Circuit: Bledsoe v. Medtronic, Inc., 2020 WL 43107, at *5 n.3 (N.D. Ind. Jan. 3, 2020) (judicially noticing device PMA); Vincent v. Medtronic, Inc., 221 F. Supp.3d 1005, 1009 (N.D. Ill. 2016) (“approvals by the FDA are subject to judicial notice”); Gray v. Stryker Corp., 2013 WL 633120, at *3 (S.D. Ind. Feb. 20, 2013) (“the Court will exercise its discretion and take judicial notice that the . . . Device is a Class III medical device”); Tillman v. Smith & Nephew, Inc., 2012 WL 6681698, at *1 (N.D. Ill. Nov. 1, 2012) (“despite the fact that [plaintiff] never references the [PMA] letter in his complaint, the court may take judicial notice of the letter”); Heisner v. Genzyme Corp., 2008 WL 2940811, at *1 (N.D. Ill. July 25, 2008) (“this Court takes judicial notice of the fact that [the device] is a Class III device approved by the FDA pursuant to the PMA process”).

Eighth Circuit: Ehlers v. Abiomed, Inc., 792 F. Supp.3d 941, 955 (E.D. Mo. 2025) (judicially noticing device PMA); Welz v. Boston Scientific Corp., 2024 WL 4252817 at *2 (E.D. Mo. Sept. 20, 2024) (“This Court may take judicial notice of the PMA . . . approvals because they can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned.”); Antonacci v. Allergan USA, Inc., 2021 WL 3404024 at *1 n.2 (E.D. Mo. Aug. 4, 2021) (“The Court will take judicial notice of the [device’s] PMA.”); Reed v. St. Jude Medical, 2018 WL 4293146, at *2 (Mag. D. Minn. July 24, 2018) (“the Court takes judicial notice of the FDA’s PMA”), adopted, 2018 WL 4251872 (D. Minn. Sept. 6, 2018); Morton v. Medtronic, Inc., 2015 WL 12778750, at *2 n.2 (Mag. D. Minn. Jan. 5, 2015) (“the Court may properly take judicial notice of the premarket approval for the [device] at issue”), adopted, 2015 WL 12780468 (D. Minn. Feb. 19, 2015); Blankenship v. Medtronic, Inc., 6 F. Supp.3d 979, 983-84 n.1 (E.D. Mo. 2014) (“the Court will take notice of . . . the FDA’s pre-market . . . approval[]”); Arthur v. Medtronic, Inc., 2014 WL 3894365, at *1 n.1 (E.D. Mo. Aug. 11, 2014) (judicially noticing device PMA); Tierney v. AGA Medical Corp., 2011 WL 7400469, at *1 & n.9 (D. Neb. Nov. 18, 2011) (judicially noticing device PMA), amendment denied, 2012 WL 395545 (D. Neb. Feb. 7, 2012).

Ninth Circuit: Stengel v. Medtronic Inc., 676 F.3d 1159, 1167 (9th Cir. 2012) (“Because the accuracy of FDA records cannot reasonably be questioned, the premarket approval status of [defendant’s devide] is a fact subject to judicial notice.”) (citing Funk), reversed on other grounds, 704 F.3d 1224 (9th Cir. 2013) (en banc); Ravindranath v. Purohit, 2025 WL 3527245, at *1 n.3 (D. Nev. Dec. 8, 2025) (judicially noticing device PMA); Gibson v. Advanced Bionics, LLC, 2025 WL 2555237, at *1 & n.2 (C.D. Cal. Sept. 2, 2025) (judicially noticing device PMAs); Skinner v. Small Bone Innovations, Inc., 2023 WL 6318014, at *2 (D. Ariz. Sept. 28, 2023) (“Because [the PMA is a] matter[] of public record and not subject to reasonable dispute, the Court grants Defendant’s request for judicial notice.”) (citations omitted); Tripolskiy v. Boston Scientific Corp., 2023 WL 5440785, at *2 (C.D. Cal. Aug. 18, 2023) (judicially noticing device PMA); Boyd v. Allergan PLC, 2023 WL 4373426, at *3 n.1 (D. Ore. July 6, 2023) (judicially noticing device PMA) (“Boyd II”); Tripolskiy v. Boston Scientific Corp., 2023 WL 5440783, at *1-2 (C.D. Cal. June 23, 2023) (judicially noticing device PMA); Boyd v. Allergan PLC, 2023 WL 2869476, at *3 n.3 (D. Ore. April 10, 2023) (judicially noticing device PMA) (“Boyd I”); Poozhikala v. Medtronic Inc., 2022 WL 610276, at *2 (C.D. Cal. Jan. 31, 2022) (judicially noticing device PMA) (“Poozhikala I”); Hogg-Johnson v. Merz North America, 2020 WL 6826420, at *1 (S.D. Cal. Nov. 18, 2020) (“the Court takes judicial notice of the FDA’s premarket approval”); Titko v. St. Jude Medical, LLC, 2019 WL 13197982, at *2 (D. Ariz. Dec. 13, 2019) (judicially noticing device PMA) (“Titko II”); Titko v. Abbott Laboratories, 2019 WL 13214734, at *2 (D. Ariz. Aug. 28, 2019) (judicially noticing device PMA) (“Titko I”); Soja v. Medtronic, Inc., 2019 WL 2396540, at *2 (E.D. Cal. June 6, 2019) (“numerous courts have taken judicial notice of information from the FDA’s online premarket approval database”) (citations omitted); Shelp v. Allergan, Inc., 2018 WL 5734664, at *2 (W.D. Wash. Nov. 2, 2018) (“The Court takes judicial notice of the fact that the U.S. Food and Drug Administration (FDA) granted premarket approval to [defendant] for the [devices] allegedly at issue in this case”); Ebrahimi v. Mentor Worldwide LLC, 2017 WL 4128976, at *1 (C.D. Cal. Sept. 15, 2017) (judicially noticing device PMA) (“Ebrahimi I”); Paturzo v. Boston Scientific Corp., 2017 WL 8220600, at *3 n.1 (C.D. Cal. April 21, 2017) (judicially noticing device PMA); Brandt v. Medtronic, Inc., 179 F. Supp.3d 963, 965 n.1 (D. Nev. 2016) (judicially noticing device PMA); De La Paz v. Bayer Healthcare LLC, 159 F. Supp.3d 1085, 1089 (N.D. Cal. 2016) (judicially noticing device PMA); Weaver v. Ethicon, Inc., 2016 WL 7098781, at *2 n.1 (S.D. Cal. Dec. 6, 2016) (judicially noticing device PMA) (“Weaver II”); Weaver v. Ethicon, Inc., 2016 WL 4430855, at *2 n.1 (S.D. Cal. Aug. 22, 2016) (judicially noticing device PMA) (“Weaver I”); Money v. Johnson & Johnson, 2016 WL 3055875, at *1 n.5 (N.D. Cal. May 31, 2016) (judicially noticing device PMA); Frere v. Medtronic, Inc., 2016 WL 1533524, at *4 (C.D. Cal. April 6, 2016) (“Premarket Approval Database listings . . . are matters of public record and they can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned”) (citation and quotation marks omitted); Funke v. Sorin Group USA, Inc., 147 F. Supp.3d 1017, 1023 n.1 (C.D. Cal. 2015) (“The Court hereby takes judicial notice of that [PMA] document because it is a public document available on the FDA website, and therefore capable of accurate and ready determination by resort to sources whose accuracy cannot reasonably be questioned.”) (citation and quotation marks omitted); Caton v. Stryker Sustainability Solutions, Inc., 2015 WL 12426110, at *3 (C.D. Cal. May 12, 2015) (“these [PMA] documents are publicly accessible on the FDA website and their authenticity is not subject to reasonable dispute”) (citations and quotation marks omitted); Michajlun v. Bausch & Lomb, Inc., 2015 WL 1119733, at *3-4 (S.D. Cal. March 11, 2015) (judicially noticing device PMA); Hawkins v. Medtronic, Inc., 62 F. Supp.3d 1144, 1151 n.2 (E.D. Cal. 2014) (judicially noticing device PMA); United States ex rel. Modglin v. DJO Global, Inc., 48 F. Supp.3d 1362, 1380, 1382 (C.D. Cal. 2014) (judicially noticing device PMA), aff’d, 678 F. Appx. 594 (9th Cir. 2017); Arvizu v. Medtronic, Inc., 41 F. Supp.3d 783, 785 n.3 (D. Ariz. 2014) (“Because the [PMA-related] documents presented by Defendants are publicly available on the FDA’s website and Plaintiffs do not dispute their authenticity, the Court will take judicial notice of these documents.”); Martin v. Medtronic, Inc., 32 F. Supp.3d 1026, 1031 n.8 (D. Ariz. 2014) (“because these [PMA] documents are publically [sic] available and/or official FDA documents, the court may take judicial notice of these documents”); Beavers-Gabriel v. Medtronic, Inc., 15 F. Supp.3d 1021, 1026 n.1 (D. Haw. 2014) (“Defendants request the court to take judicial notice of certain public documents available on the FDA’s public website regarding premarket approval of the . . . Device. The court grants Defendants’ request − matters of public record such as records and reports of administrative bodies are proper subjects of judicial notice.”) (citation omitted); Herrnandez v. Stryker Corp., 2014 WL 7044171, at *2 (W.D. Wash. Dec. 11, 2014) (judicially noticing device PMA); Johnson v. Hologic, Inc., 2014 WL 2581421, at *1-2 (E.D. Cal. June 6, 2014) (judicially noticing device PMA); Poll v. Stryker Sustainability Solutions, Inc., 2014 WL 199150, at *2 (D. Ariz. Jan. 17, 2014) (judicially noticing device PMA); Eidson v. Medtronic, Inc., 981 F. Supp.2d 868, 879 (N.D. Cal. 2013) (“because all of the [PMA] documents at issue appear on the FDA’s public website, they may be judicially noticed”) (citations omitted); Alton v. Medtronic, Inc., 970 F. Supp.2d 1069, 1075-76 (D. Ore. 2013) (judicially noticing device PMA); Houston v. Medtronic, Inc., 957 F. Supp.2d 1166, 1170 (C.D. Cal. 2013) (“the [PMA] document is judicially noticeable as a public document available on the FDA website, and therefore capable of accurate and ready determination by resort to sources whose accuracy cannot reasonably be questioned.”) (citation and quotation marks omitted); Wilson v. Amneal Pharmaceuticals, L.L.C., 2013 WL 6909930, at *5 (D. Idaho Dec. 31, 2013) (“These documents are taken from the FDA website, are capable of accurate and ready determination, and not subject to reasonable dispute.”) (citations omitted); Knoppel v. St. Jude Medical, Inc., 2013 WL 3803612, at *3 (C.D. Cal. May 7, 2013) (“The Court finds it appropriate to take judicial notice of the fact that the three allegedly defective medical devices are Class III devices that have been approved through the PMA process by the FDA.”); Erickson v. Boston Scientific Corp., 846 F. Supp.2d 1085, 1089 (C.D. Cal. 2011) (judicially noticing device PMA); Norton v. Independence Technology, LLC, 2011 WL 3584491, at *1 n.1 (E.D. Cal. Aug. 15, 2011) (judicially noticing device PMA); In re Thoratec Corp. Securities Litigation, 2006 WL 1305226, at *4 n.3 (N.D. Cal. May 11, 2006) (“The Court may take judicial notice of the FDA preapproval notices as a matter of public record.”) (citations omitted) (pre-Riegel).

Tenth Circuit: Bennington v. Stryker Corp., 2021 WL 8129874, at *5 (Mag. D. Colo. Aug. 16, 2021) (“This Court takes judicial notice that . . ., the [device] . . . was a PMA-approved device.”), adopted, 2021 WL 8129867 (D. Colo. Aug. 31, 2021).

Eleventh Circuit: Walters v. Boston Scientific Corp., 2024 WL 5145958, at *4 (N.D. Ala. Dec. 17, 2024) (“the court takes judicial notice of the fact that [the device] was approved for commercial distribution by the FDA through the PMA process”); Holland v. Abbott Laboratories, Inc., 626 F. Supp.3d 1256, 1260 n.2 (M.D. Fla. 2022) (“the Court will grant Defendant’s request to take judicial notice of the FDA documents that indicate the PMA status of the medical device at issue”); Sullivan v. Boston Scientific Corp., 2020 WL 4558303, at *1 n.3 (Mag. N.D. Fla. June 23, 2020) (“the Court takes judicial notice . . . of the fact that the FDA granted [defendant] premarket approval for commercial distribution of the [device]”) (citation omitted), adopted, 2020 WL 4430392 (N.D. Fla. July 31, 2020); Tinkler v. Mentor Worldwide, LLC, 2019 WL 7291239, at *4 & n.4 (S.D. Fla. Dec. 30, 2019) (“the Court takes judicial notice that the [devices] are Class III medical devices approved through the PMA process”); Angell v. Allergan Sales, LLC, 2019 WL 3958262, at *8 (M.D. Fla. Aug. 22, 2019) (judicially noticing device PMA); Marmol v. St. Jude Medical Center, 132 F. Supp.3d 1359, 1365 (M.D. Fla. 2015) (“judicial notice of the existence of the PMA documents is appropriate”); Ward v. St. Jude Medical, Inc., 2015 WL 12516628 at *1 (S.D. Fla. Nov. 9, 2015) (“the Court has taken judicial notice, that the [devices] are Class III medical devices”); Leroy v. Medtronic, Inc., 2015 WL 4600880, at *5-6 (N.D. Fla. July 29, 2015) (“like other courts faced with this issue, this court should take judicial notice of the PMA Database Listings”); Dixon v. Allergan USA, Inc., 2015 WL 13777064, at *2 (S.D. Fla. April 2, 2015) (PMA document is “readily accessible on the FDA’s website, a source that cannot reasonably be questioned, and the Court will take judicial notice”) (footnote omitted); Stanifer v. Corin USA Ltd., 2014 WL 5823319, at *4 (M.D. Fla. Nov. 10, 2014) (“like other courts faced with this issue, this Court takes judicial notice of the documents that are publicly available on the FDA website which reflect that the [device] is a Class III device that has successfully undergone the PMA process”) (citation omitted); Kaiser v. DePuy Spine, Inc., 944 F. Supp.2d 1187, 1192 n.2 (M.D. Fla. 2013) (judicially noticing device PMA).

A number of state courts have also judicially noticed FDA PMA materials. See Bagumyan v. Medtronic, Inc., 2010 WL 4009891, at *8 (Cal. App. Oct. 14, 2010) (judicially noticing device PMA) (unpublished, non-citable); Bubar v. Medtronic, Inc., 2025 WL 1542353, at *1 (Cal. Super. April 10, 2025); Rieger v. Medtronic MiniMed, Inc., 2025 WL 403801, at *2 (Cal. Super. Jan. 28, 2025); Gurule v. Boston Scientific Corp., 2023 WL 5509070, at *1 (Cal. Super. July 18, 2023); Siordia v. Zoll Medical Corp., 2022 WL 16756576, at *2 (Cal. Super. Oct. 3, 2022); Estate of Comatov v. Kiankhooy, 2022 WL 16575450, at *2 (Cal. Super. Aug. 11, 2022); Pietrowski-Valdez v. Smith & Nephew, 2022 WL 2103125, at *3 (Cal. Super. April 28, 2022); Allergan Implant Cases, 2021 WL 12190293, at *6 & n.2 (Cal. Super. Nov. 23, 2021); Centeno v. Krieff, 2021 WL 3884060, at *3 (N.Y. Sup. Aug. 30, 2021); Hasha v. Padidar, 2020 WL 8371407, at *1-2 (Cal. Super. July 24, 2020); James v. Medtronic, 2020 WL 13310413, at *3 (Cal. Super. July 23, 2020); Fortis Advisors LLC v. Allergan W.C. Holding Inc., 2019 WL 5588876, at *4 (Del. Ch. Oct. 30, 2019); Hasha v. Padidar, 2019 WL 8640460, at *2 (Cal. Super. Oct. 10, 2019); Mize v. Mentor Worldwide LLC, 2018 WL 1364257, at *1 (Cal. Super. March 13, 2018); Golden v. Brown, 2017 WL 3272368, at *2 (Colo. Dist. June 27, 2017); Lutz-Cummings v. Medtronic, Inc., 2016 WL 3082314, at *2 (Minn. Dist. May 31, 2016); Latimer v. Medtronic, Inc., 2015 WL 5222644, at *2 n.1 (Ga. Super. Sept. 4, 2015); Gall v. Stryker Orthopaedics, 2015 WL 12803805, at *3 & n.1 (Cal. Super. Sept. 17, 2015); Morris v. Rotolo, 2014 WL 12618659, at *1 n.3 (Mass. Super. Jan. 15, 2014); David v. Medtronic, Inc., 2014 WL 12626709, at *1 (Cal. Super. Nov. 18, 2014); Glennen v. Allergan, Inc., 2013 WL 8695915, at *1 (Cal. Super. July 9, 2013), aff’d, 202 Cal. Rptr.3d 68 (Cal. App. 2016).

* * * *

But it’s not just PMA that gets judicially noticed. And that’s where this post took on a life of its own. Another large assemblage of decisions supports judicial notice of just about anything that appears on the FDA’s website or that are official FDA publications. Two published circuit court decisions so hold. Generally, a “court is entitled to take judicial notice of the information presented in the FDA documents.” “[P]ublished materials representing the considered views of the FDA,” that “the FDA does not contest their accuracy” are properly the subject of judicial notice. Lotus Vaping Technologies, LLC v. U.S. FDA, 73 F.4th 657, 677 (9th Cir. 2023). Where FDA actions are ”part of the public record, . . . the court is entitled to take judicial notice of the information presented in the FDA documents.” Wildman v. Medtronic, Inc., 874 F.3d 862, 866 n.2 (5th Cir. 2017) (citations omitted). So do many district court decisions from almost every circuit. “FDA publications provide context and a means of measuring defendant’s conduct.” In re Bayer Combination Aspirin Products Marketing & Sales Practices Litigation, 701 F. Supp.2d 356, 368 (E.D.N.Y. 2010). Thus, a court “may, in its discretion, take judicial notice of FDA documents.” Leavitt v. Alnylam Pharmaceuticals, Inc., 525 F. Supp.3d 259, 266 n.1 (D. Mass. 2021).

[S]o long as the documents at issue constitute matters of public record, the Court may consider those documents without converting the instant motion into a motion for summary judgment. The Court is permitted to take judicial notice of documents made publicly available by a government entity. Accordingly, courts have taken judicial notice of documents from the FDA, a government entity, when ruling on a motion to dismiss. . . . [T]he Court concludes that it may consider the documents from the FDA as a matter of public record without converting the instant motion into a motion for summary judgment.

Thomas v. Alcon Laboratories, 116 F. Supp.3d 1361, 1365 (N.D. Ga. 2013) (citations and quotation marks omitted).

A public record is not simply one that is accessible to the public, but rather one to which the public ha[s] unqualified access. . . . Although the Third Circuit has not considered the specific question of whether a court may consider FDA records on a Rule 12(b)(6) motion, other courts in this district have decided they may properly do so, including reports published on the FDA website. In the present case, the public has unqualified access to the [FDA document], which is accessible to the public via the FDA website. Thus, this Court will take judicial notice

In re Egalet Corp. Securities Litigation, 340 F. Supp.3d 479, 496 (E.D. Pa. 2018), aff’d, 802 F. Appx. 738 (3d Cir. 2020). See Kouyate v. Harvard Drug Group LLC, 2025 WL 2773159, at *5 n.4 (S.D.N.Y. Sept. 26, 2025) (“courts routinely take judicial notice of documents which are publicly available on the FDA’s website”) (citation and quotation marks omitted); Cement Masons & Plasterers Local No. 502 Pension Fund v. InMode Ltd., 2025 WL 2658224, at *8 (C.D. Cal. Sept. 12, 2025) (“Courts may take judicial notice of public-facing websites whose accuracy and authenticity are not subject to dispute.”) (citation and quotation marks omitted); Pacira BioSciences, Inc. v. Ventis Pharma, Inc., 2025 WL 576549, at *2 n.4 (C.D. Cal. Jan. 17, 2025) (“the Court takes judicial notice of the publicly available FDA documents”) (citations omitted); Nexus Pharmaceuticals, LLC v. Long Grove Pharmaceuticals, LLC, 2025 WL 81877, at *1 n.1 (D. Mass. Jan. 13, 2025) (“The Court takes judicial notice of this and other cited FDA regulatory materials, which are publicly available.”); Jackson, 2024 WL 4256340, at *3 (“Both the Sixth Circuit and [this court] have on many previous occasions taken judicial notice of facts contained within FDA records and reports because they can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned.”) (citation and quotation marks omitted); Pizzuto v. Homology Medicines, Inc., 2024 WL 1436025, at *2 (D. Mass. March 31, 2024) (“tak[ing] judicial notice of” an “exhibit [that] contains relevant FDA documents proper for consideration at the motion to dismiss stage”); Leung v. bluebird bio, Inc., 599 F. Supp.3d 49, 57 (D. Mass. 2022) (same as Bird); Barry v. Novartis Pharmaceuticals Corp., 2022 WL 2373452, at *5 (E.D. Va. June 30, 2022) (“because these documents constitute FDA publications that the public can access via the FDA website, they satisfy Rule 201, and the Court will judicially notice them”); Whaley v. Merck & Co., 2022 WL 1153151, at *2 (S.D. Cal. April 12, 2022) (“In regard to the first category of FDA records, the Court takes judicial notice of those exhibits as they are government records, and their authenticity is not subject to reasonable dispute.”); Suttman-Villars v. Argon Medical Devices, Inc., 553 F. Supp.3d 946, 953 (D.N.M. 2021) (“It is well-established that courts may take judicial notice of official government publications. Accordingly, the Court will take judicial notice of the FDA documents.”) (citations and quotation marks omitted); Eidmann v. Walgreen Co., 522 F. Supp.3d 634, 642 (N.D. Cal. 2021) (“Documents published on government-run websites are proper for judicial notice given their reliability.”); Sundaramurthy v. Abbott Vascular, Inc., 2021 WL 7542704 at *2 & n.1 (D. Mass. Dec. 6, 2021) (“The Court may consider public documents from the FDA’s website on a Rule 12(b)(6) motion.”); Koublani v. Cochlear Ltd., 2021 WL 2577068, at *4-5 (E.D.N.Y. June 23, 2021) (collecting precedent that “supports” judicial notice of “public FDA records” generally); United States ex rel. Chao v. Medtronic PLC, 2021 WL 4816647, at *5 (C.D. Cal. April 12, 2021) (“The documents on file with the FDA are proper for judicial notice . . . because the accuracy of FDA records cannot reasonably be questioned.”) (citation and quotation marks omitted); Garcia v. Janssen Pharmaceuticals, Inc., 2021 WL 12300189, at *2 (S.D. Tex. March 11, 2021) (“the Court finds it appropriate to take judicial notice of” facts “correlated by information available to the public on the FDA’s official website”) (footnote omitted); Smith v. Zoll Medical Corp., 505 F. Supp.3d 787, 791 n.3 (W.D. Tenn. 2020) (“FDA documents may properly be considered on a motion to dismiss”); Mories v. Boston Scientific Corp., 494 F. Supp.3d 461, 469 (S.D. Ohio 2020) (“grant[ing] Defendant’s request to take judicial notice of public documents, including those filed with the FDA”); Bird v. Globus Medical, Inc., 2020 WL 5366300 at *1 (E.D. Cal. Sept. 8, 2020) (taking judicial notice of various documents “[b]ecause all of defendant’s exhibits are from the FDA’s public website”); Soja v. Medtronic, Inc., 2019 WL 2396540, at *2 (E.D. Cal. June 6, 2019) (“The database documents [here] are publicly available on the FDA website and . . . [a]ccordingly, the court may take judicial notice of them”) (citations omitted); Ezell, 2018 WL 6928917, at *5 n.4 (“[a] court may take judicial notice of the FDA’s public records”); Arbor Pharmaceuticals, LLC v. ANI Pharmaceuticals, Inc., 2018 WL 3677923, at *4 n.3 (D. Minn. Aug. 2, 2018) (“tak[ing] judicial notice of the information contained on the FDA website”); Gustavesen v. Alcon Laboratories, Inc., 272 F. Supp.3d 241, 252-53 (D. Mass. 2017) (“information on the FDA’s website [is] subject to judicial notice and consideration on a motion to dismiss”) (citations omitted), aff’d, 903 F.3d 1 (1st Cir. 2018); Mitchell v. Boehringer Ingelheim Pharmaceuticals, Inc., 2017 WL 5617473, at *2 (W.D. Tenn. Nov. 21, 2017) (“FDA documents may properly be considered on a motion to dismiss.”) (citation omitted); Spier v. Coloplast Corp., 121 F. Supp.3d 809, 811 (E.D. Tenn. 2015) (“[t]he Court here relies upon and takes judicial notice of various publicly-available Food and Drug Administration (‘FDA’) documents”); Modglin, 48 F. Supp.3d at 1381 (“the court can take judicial notice of public records and government documents available from reliable sources on the Internet, such as websites run by governmental agencies”) (citation and quotation marks omitted); Carik v. United States Dept. of HHS, 4 F. Supp.3d 41, 48 & n.4 (D.D.C. 2013) (any “public” FDA document is judicially noticeable); Simon, 990 F. Supp.2d at 401 n.2 (“the Court takes judicial notice of public records contained on the FDA website”), reconsideration denied, 18 F.Supp.3d 423 (S.D.N.Y. 2014); Kaiser v. DePuy Spine, Inc., 944 F. Supp.2d 1187, 1192 n.2 (M.D. Fla. 2013) (“the Court may take judicial notice of public records of the FDA relating to the medical device involved in this case”) (citations omitted); Gale, 989 F. Supp.2d at 246 n.2 (“[t]he Court takes judicial notice of this fact, based on FDA public records”); McClelland v. Medtronic, Inc., 2012 WL 5077401, at *2 (M.D. Fla. Sept. 27, 2012) (“Both [parties] refer to and attach . . . public records of the FDA, which relate to the medical device involved in this case. Because matters in the public record are susceptible to judicial notice and consideration in resolving a motion to dismiss, the Court has considered these public records.”) (citation omitted); Rounds v. Genzyme Corp., 2010 WL 5297180, at *1 (M.D. Fla. Dec. 20, 2010) (public FDA documents generally) (“A matter in the public record is susceptible to judicial notice and consideration in resolving a motion to dismiss. Accordingly, the FDA’s public records and statements about [defendant’s biologic] merit judicial notice.”) (citation omitted); Preston v. Janssen Pharmaceuticals, Inc., 2018 WL 5017045, at *1 n.2 (N.Y. Sup. Oct. 12, 2018) (“[FDA] public records available on its website . . . may be judicially noticed”) (citations omitted).

So here’s everything else. Winning pleading-based motions saves a bundle in discovery costs, so we though it valuable for our defense colleagues to be able to cite to the most persuasive judicial notice decisions in any given jurisdiction, so here is everything we could find that supports judicial notice of every type of FDA document. After reading more FDA-related judicial notice decisions that we knew existed, it’s clear that defendants seek notice far more often than plaintiffs – even of FDA material such as recalls, adverse events, or warning letters that concern product problems. Thus, the remainder of this post presents FDA-related decisions organized by the type of FDA document or website material that the decision held judicially noticed.

Product Labeling: In re Avandia Marketing Sales Practices & Products Liability Litigation, 588 F. Appx. 171, 174 (3d Cir. 2014) (drug labeling); Oxford Asset Management, Ltd. v. Jaharis, 297 F.3d 1182, 1188 (11th Cir. 2002) (drug labeling); True v. Abbvie, Inc., 2025 WL 3560299, at 2 (N.D. Ga. Sept. 3, 2025) (drug labeling); Doyle v. Bayer Corp., 2025 WL 1666261, at *3 n.1 (W.D. Wash. June 12, 2025) (device prescribing information); Glazing Employers & Glaziers Union Local #27 Pension & Retirement Fund v. iRhythm Technologies, Inc., 2025 WL 1569421, at *5 (N.D. Cal. June 3, 2025) (device clinical reference manuals); Tomei v. Wyeth, 2025 WL 1387053, at *1 n.2 (C.D. Cal. March 17, 2025) (drug labeling); Milovich v. Aziyo Biologics, Inc., 2025 WL 864006, at *1 n.1 (Mag. D. Ore. Feb. 24, 2025) (biologic instructions for use), adopted, 2025 WL 861035 (D. Ore. March 19, 2025); In re Gardasil Products Liability Litigation, 724 F. Supp.3d 474, 481 n.4 (W.D.N.C. 2024) (vaccine warnings and prescribing information), aff’d, 151 F.4th 178 (4th Cir. 2025); Fortin v. Abbott Laboratories, Inc., 2024 WL 5147617, at *3 n.1 (E.D. Wash. Dec. 17, 2024) (biologic labeling), reconsideration denied, 2025 WL 383159 (E.D. Wash. Jan. 27, 2025); Sneed v. AcelRx Pharmaceuticals, Inc., 2024 WL 2059121, at *3-4 (N.D. Cal. May 7, 2024) (drug instructions for use), aff’d, 147 F.4th 1123 (9th Cir. 2025); Ganz v. Grifols Therapeutics LLC, 688 F. Supp.3d 1209, 1218, 1226-27 (S.D. Fla. 2023) (drug labeling); Kinnee v. TEI Biosciences Inc., 2023 WL 8191097, at *4 (S.D. Cal. Nov. 27, 2023) (device instructions for use); Sidhu v. Bayer Healthcare Pharmaceuticals, Inc., 2023 WL 6541865, at *2 (N.D. Cal. Oct. 5, 2023) (drug prescribing information); Burton v. Abbvie, Inc., 2023 WL 6396667, at *2 n.3 (C.D. Cal. Sept. 25, 2023) (drug prescribing information); Boyd I, 2023 WL 2869476, at *3 n.3 (device prescribing information); Roshkovan v. Bristol-Myers Squibb Co., 2023 WL 6787444, at *5 (C.D. Cal. Sept. 19, 2023) (drug labeling), aff’d, 2025 WL 972978 (9th Cir. April 1, 2025) (“Roshkovan III”); Polson v. AstraZeneca Limited Partnership, 2023 WL 2770687, at *1 n.2 (D. Conn. April 4, 2023) (drug prescribing information); Roshkovan v. Bristol-Myers Squibb Co., 2023 WL 2626371, at *4 (C.D. Cal. Jan. 13, 2023) (drug labeling) (“Roshkovan II”); Nelson v. F. Hoffmann-La Roche, Inc., 642 F. Supp.3d 1115, 1126 (N.D. Cal. 2022) (drug labeling); MacSwan v. Merck & Co., 602 F. Supp.3d 466, 472 (W.D.N.Y. 2022) (drug labeling); Holcomb v. Pfizer, Inc., 2022 WL 17670003, at *4 n.1 (E.D. Cal. Dec. 14, 2022) (drug labeling); LaTouche v. Merck & Co., 2022 WL 16555263, at *3 n.5 (D.N.J. Oct. 31, 2022) (drug labeling); Frye v. Novartis Pharmaceuticals Corp., 2022 WL 4305656, at *5, 12 (E.D. Ark. Sept. 19, 2022) (drug labeling); Barry, 2022 WL 2373452, at *4-5 (drug labeling); Roshkovan v. Bristol-Myers Squibb Co., 2022 WL 3012519, at *5 (C.D. Cal. June 33, 2022) (drug labeling) (“Roshkovan I”); Johnson v. Ethicon, Inc., 2022 WL 1744697, at *7 (D.N.J. May 31, 2022) (device instructions for use); Whaley, 2022 WL 1153151, at *2 (drug labeling); Watler v. Novartis Pharmaceuticals Corp., 2022 WL 971948, at *2 (M.D. Fla. March 31, 2022) (drug labeling); Colbath v. Merck & Co., 2022 WL 935195, at *2 (S.D. Cal. March 29, 2022) (vaccine labeling); Gioia v. Janssen Pharmaceuticals, 2021 WL 5447330, at *3 n.3 (E.D.N.Y. Nov. 22, 2021) (drug labeling); Silver v. Bayer Healthcare Pharmaceuticals, Inc., 2021 WL 4472857, at *11 (D.S.C. Sept. 30, 2021) (drug labeling; medication guide); Ferraro Family Foundation, Inc. v. Corcept Therapeutics Inc., 2021 WL 3748325, at *8-9 (N.D. Cal. Aug. 24, 2021) (drug labeling) (“Ferraro Family II”); Zamfirova v. AMAG Pharmaceuticals, Inc., 2021 WL 2103287, at *4 n.3 (D.N.J. May 25, 2021) (drug labeling); Morris v. Sun Pharma Global, Inc., 2021 WL 3913191, at *2 (C.D. Cal. May 13, 2021) (drug labeling); In re Amarin Corp. PLC Securities Litigation, 2021 WL 1171669, at *11 (D.N.J. March 29, 2021) (drug labeling), aff’d, 2022 WL 2128560 (3d Cir. June 14, 2022); Spencer v. Bristol-Myers Squibb Co., 2021 WL 864148, at *1 (W.D. Okla. March 8, 2021) (drug labeling); Gioia v. Janssen Pharmaceuticals, 2021 WL 602683, at *4 n.4 (E.D.N.Y. Feb. 16, 2021) (drug labeling); Ferraro Family Foundation, Inc. v. Corcept Therapeutics Inc., 501 F. Supp 3d 735, 752 (N.D. Cal. 2020) (drug labeling) (“Ferraro Family I”); Dye v. Covidien LP, 470 F. Supp.3d 1329, 1339 n.4 (S.D. Fla. 2020) (device instructions for use); Hogg-Johnson, 2020 WL 6826420, at *1 (device labeling); Evans v. Gilead Sciences, Inc., 2020 WL 5189995, at *2 n.6 (D. Haw. Aug. 31, 2020) (drug labeling); Ludy v. Eli Lilly & Co., 2020 WL 3510811, at *2 (S.D. Ind. June 29, 2020) (drug prescribing information); Lewis v. GE Healthcare, Inc., 2020 WL 1490719, at *6 & n.5 (W.D. La. March 25, 2020) (drug labeling); Thomas v. Bracco Diagnostics, Inc., 2020 WL 1016273, at *5 & n.3 (Mag. W.D. La. Feb. 27, 2020) (drug labeling), adopted, 2020 WL 1243389 (W.D. La. March 13, 2020); Allo I, 2020 WL 32439, at *2 (device labeling); Jones v. Medtronic, Inc., 411 F. Supp.3d 521, 533 (D. Ariz. 2019) (device labeling), aff’d, 830 F. Appx. 925 (9th Cir. 2020); Gagnon v. Alkermes PLC, 368 F. Supp.3d 750, 762 (S.D.N.Y. 2019) (drug labeling); Marroquin v. Pfizer, Inc., 367 F. Supp.3d 1152, 1162 n.3 (E.D. Cal. 2019) (drug labeling); Smith v. GE Healthcare, Inc., 2019 WL 4565246, at *6 n.6 (W.D. La. Sept. 4, 2019) (device labeling); Angell, 2019 WL 3958262, at *8 (device labeling); Pierot v. Gilead Sciences, Inc., 2019 WL 1123148, at *3 (Mag. W.D. La. March 11, 2019) (drug labeling); Calloway, 2019 WL 2169222, at *5 (device labeling); A.F v. Sorin Group USA, Inc., 346 F. Supp.3d 534, 538 n.4 (S.D.N.Y. 2018) (device labeling); Chandler v. Janssen Pharmaceuticals, Inc., 322 F. Supp.3d 314, 324 (E.D.N.Y. 2018) (drug labeling); Trisvan v. Heyman, 305 F. Supp.3d 381, 400 (E.D.N.Y. 2018) (drug labeling) (“Trisvan II”); Ebrahimi v. Mentor Worldwide LLC, 2018 WL 6829122, at *1 n.2 (C.D. Cal. Dec. 27, 2018) (device product data sheet) (“Ebrahimi II”), aff’d, 804 F. Appx. 871 (9th Cir. 2020); Trisvan v. Heyman, 2018 WL 6573434, at *4-5 (E.D.N.Y. Dec. 13, 2018) (drug labeling) (“Trisvan I”); Proffitt v. Bristol-Myers Squibb Co., 2018 WL 3318893, at *3 n.1 (S.D.W. Va. July 5, 2018) (drug labeling); Allergan USA, Inc. v. Imprimis Pharmaceuticals, Inc., 2018 WL 5919210, at *3-4 (C.D. Cal. April 30, 2018) (drug labeling) (“Allergan v. Imprimis II”); Aston v. Johnson & Johnson, 248 F. Supp.3d 43, 47 n.1 (D.D.C. 2017) (drug labeling); Westmoreland v. Medtronic, Inc., 2017 WL 5132669, at *1 (E.D. Mo. Nov. 6, 2017) (device instructions for use); McLaughlin v. Bayer Corp., 2017 WL 697047, at *4 n.5 (E.D. Pa. Feb. 21, 2017) (device instructions for use); Pramann v. Janssen Pharmaceuticals, Inc., 2017 WL 58469, at *2 n.3 (E.D. La. Jan. 5, 2017) (generic labeling); Elmazouni v. Mylan, Inc., 220 F. Supp.3d 736, 740 (N.D. Tex. 2016) (generic labeling); Yosowitz, 182 F. Supp.3d at 687-88 & n.11 (device labeling); Martin v. Nebraska, 2016 WL 6993754, at *3 n.3 (D. Neb. Nov. 29, 2016) (indicated drug uses); Andrews v. Target Pharmacy #T-2292, 2016 WL 4250243, at *1 n.2 (D. Mass. Aug. 10, 2016) (indicated drug uses), aff’d, 714 F. Appx. 4 (1st Cir. 2017); Aaron, 209 F. Supp.3d at 1014 & n.9 (device labeling); In re Ariad Pharmaceutical, Inc. Securities Litigation, 98 F. Supp.3d 147, 174 (D. Mass. 2015) (drug prescribing information); Garross v. Medtronic, Inc., 77 F. Supp.3d 809, 818 (E.D. Wis. 2015) (device labeling); Montalbano v. Ariad Pharmaceuticals, Inc., 2015 WL 11198245, at *4 n.2 (S.D. Fla. Aug. 4, 2015) (drug package insert); Carter v. Amgen, Inc., 2015 WL 13388039, at *1 n.1 (C.D. Cal. July 16, 2015) (drug labeling), aff’d, 682 F. Appx. 620 (9th Cir. 2017); In re Celexa & Lexapro Marketing & Sales Practices Litigation, 2015 WL 3751422, at *3-4 (D. Mass. June 15, 2015) (drug labeling); Becker v. Cephalon, Inc., 2015 WL 5472311, at *3 (S.D.N.Y. Sept. 15, 2015) (drug labeling); Brown v. Johnson & Johnson, 2015 WL 12834346, at *3 (E.D. Pa. Aug. 28, 2015) (drug labeling); Cooper v. Pfizer, Inc., 2015 WL 2341888, at *2 n.1 (S.D. Tex. May 13, 2015) (drug labeling); Caton, 2015 WL 12426110, at *3 (device labeling); United States v. Marshall Medical Center, 2015 WL 2235461, at *2 (E.D. Cal. May 12, 2015) (drug labeling); Michajlun, 2015 WL 1119733, at *3-4 (device labeling); Thomas v. Abbott Laboratories, 2014 WL 4197494, at *3 (C.D. Cal. July 29, 2014) (drug labeling); Arthur, 2014 WL 3894365, at *1 n.1 (device labeling); Plumlee v. Pfizer, Inc., 2014 WL 695024, at *4 & n.2 (N.D. Cal. Feb. 21, 2014) (drug labeling, labeling changes); Bartelt v. Affymax, Inc., 2014 WL 231551, at *1 n.3 (N.D. Cal. Jan. 21, 2014) (drug labeling, boxed warning); Poll, 2014 WL 199150, at *2 (device labeling and instructions for use); Ramirez v. Medtronic Inc., 961 F. Supp.2d 977, 984 (D. Ariz. 2013) (device labeling); Chapman v. Abbott Laboratories, 930 F. Supp.2d 1321, 1323 (M.D. Fla. 2013) (drug labeling); Wilson, 2013 WL 6909930, at *6-7 (drug labeling); Weber v. Allergan, Inc., 2013 WL 12177845, at *5 & n.1 (D. Ariz. April 19, 2013) (device labeling); Bryant v. Apotex, Inc., 2013 WL 394705, at *6 (E.D. Cal. Jan. 30, 2013) (drug labeling); Reed v. Pfizer, Inc., 839 F. Supp.2d 571, 575-76 (E.D.N.Y. 2012) (drug labeling); Boston v. Boehringer Ingelheim Pharmaceuticals, Inc., 2012 WL 3021413, at *2 & n.4 (S.D. Ill. July 24, 2012) (drug labeling); Salvio v. Amgen, Inc., 810 F. Supp.2d 745, 750 (W.D. Pa. 2011) (biologic package insert); Tierney, 2011 WL 7400469, at *4 (device instructions for use); Coleman v. State Supreme Court, 697 F. Supp.2d 493, 514 (S.D.N.Y. 2010) (drug labeling); Wendell v. Johnson & Johnson, 2010 WL 2465456, at *4 n.4 (N.D. Cal. June 14, 2010) (biologic labeling); In re Epogen & Aranesp Off-Label Marketing & Sales Practices Litigation, 590 F. Supp.2d 1282, 1286 (C.D. Cal. 2008) (drug labeling); In re Amgen Inc. Securities Litigation, 544 F. Supp.2d 1009, 1023-24 (C.D. Cal. 2008) (drug labeling); Horne v. Novartis Pharmaceuticals Corp., 541 F. Supp.2d 768, 776-77 (W.D.N.C. 2008) (drug package insert); Stuto v. GE Healthcare, Inc., 2023 WL 11780888, at *1 (Cal. Super. Jan. 12, 2023) (drug labeling); Latimer, 2015 WL 5222644 at *2 n.1 (device labeling); Younce v. Glaxosmithkline, LLC, 2022 WL 18359405, at *9 n.115 (Del. Super. Dec. 29, 2022) (drug labeling); Evans v. Genentech, Inc., 2015 WL 310248, at *2 n.6 (Del. Super. Jan. 23, 2015) (drug labeling); Camejo v. Angelini Pharma Inc., 2021 WL 141338, at *2-3 (Del. Super. Jan. 15, 2021) (generic drug labeling); Machala v. Boehringer Ingelheim Pharmaceuticals, Inc., 2017 WL 2814728, at *7 n.69 (Del. Super. June 29, 2017) (drug labeling); Stafford v. Dignity Health, 2015 WL 3833218, at *2 (Ariz. Super. Jan. 5, 2015) (boxed warning); Wieser v. Genentech, Inc., 2014 WL 2453041, at *1 (Cal. Super. March 25, 2014) (drug warnings); Phan v. Fischer, 2012 WL 8260879, at *2 (Cal. Super. Sept. 7, 2012) (medication guide).
Patient Directed Labeling: Boyd II, 2023 WL 4373426, at *3 n.1; Boyd I, 2023 WL 2869476, at *3 n.3; Hill v. Bayer Corp., 485 F. Supp.3d 843, 848 (E.D. Mich. 2020), reconsideration denied, 2020 WL 5903892 (E.D. Mich. Oct. 5, 2020); Allo I, 2020 WL 32439, at *2; Angell, 2019 WL 3958262, at *8; Westmoreland, 2017 WL 5132669, at *1; McLaughlin, 2017 WL 697047 at *4 n.5; Weber, 2013 WL 12177845, at *5 & n.1.
Physician Training Manuals: McLaughlin, 2017 WL 697047 at *4 n.5; De La Paz, 159 F. Supp.3d at 1089, 1096 & n.5.
Non-PMA FDA Product Approval: In re Actos End-Payor Antitrust Litigation, 848 F.3d 89, 96 n.4 (2d Cir. 2017) (generic drug tentative approval); Kos Pharmaceuticals, Inc. v. Andrx Corp., 369 F.3d 700, 728 (3d Cir. 2004) (drug approval); Leonard v. CVS Pharmacy, Inc., 2025 WL 2772598, at *1 & n.2 (N.D. Cal. Sept. 29, 2025) (generic OTC drug approval); True , 2025 WL 3560299, at 2 (drug approval); Cement Masons, 2025 WL 2658224, at *8 (device §510(k) clearances); Barton v. Kimberly-Clark Corp., 2025 WL 2345228, at *3 (S.D. Cal. Aug. 13, 2025) (device §510(k) clearance); Eli Lilly & Co. v. Alderwood Surgical Center LLC, 2025 WL 745670, *1 n.3 (W.D. Wash. March 7, 2025) (drug approval); Brock v. City of Bellingham, 2025 WL 254725, 2 (W.D. Wash. Jan. 21, 2025) (vaccine approval); Argueta v. Walgreens Co., 760 F. Supp.3d 1028, 1034 (E.D. Cal. 2024) (grandfathered §321(p)(1) drug); Krantz v. Regeneron Pharmaceuticals, Inc., 2024 WL 1792769, at *4 (C.D. Cal. April 24, 2024) (drug approvals); Alexandre v. Alcon Laboratories, Inc., 2024 WL 623707, at *3 (S.D.N.Y. Feb. 14, 2024) (OTC drug approval); Curtis v. Inslee, 709 F. Supp.3d 1257, 1264-65 (W.D. Wash. 2023) (vaccine approval), reconsideration denied, 2024 WL 810503 (W.D. Wash. Feb. 27, 2024), aff’d, 154 F.4th 678 (9th Cir. 2025); Ganz, 688 F. Supp.3d at 1218 (drug approval); Hampson v. United States, 2023 WL 3580694, at *8 n.12 (M.D. Ga. March 9, 2023) (drug approvals); Burton, 2023 WL 6396667, at *2 n.3 (drug approval); Pietrantoni v. Corcept Therapeutics Inc., 640 F. Supp.3d 197, 204 (D. Mass. 2022) (drug approval); Kane v. de Blasio, 623 F. Supp.3d 339, 347 n.8 (S.D.N.Y. 2022) (vaccine approval), vacated in part on other grounds, 121 F.4th 448 (2d Cir. 2024); Andre-Rodney v. Hochul, 618 F. Supp.3d 72, 77 n.6 (N.D.N.Y. 2022) (vaccine emergency use authorizations); McArthur v. Brabrand, 610 F. Supp.3d 822, 841 n.12 (E.D. Va. 2022) (vaccine emergency use authorizations); Frye, 2022 WL 4305656, at *5, 12 (drug approval); Lin v. Solta Medical, Inc., 2022 WL 2222987, at *5 (N.D. Cal. June 21, 2022) (device §510(k) clearance) (“Lin II”); Moreland v. Microgenics Corp., 2022 WL 2657287, at *2 n.4 (E.D.N.Y. June 1, 2022) (device §510(k) clearance); Watler, 2022 WL 971948, at *2 (drug approval); Teal v. Argon Medical Devices, Inc., 533 F. Supp.3d 535, 548 (E.D. Mich. 2021) (device §510(k) clearance); Lin v. Solta Medical, Inc., 2021 WL 5771140, at *7 (N.D. Cal. Dec. 6, 2021) (device §510(k) clearance) (“Lin I”); Medford v. Eon Labs, Inc., 2021 WL 5204035, at *1 n.2 (D.N.J. Nov. 9, 2021) (generic drug approval); Bennington, 2021 WL 8129874, at *5 (device §510(k) clearance); Lowe v. Walgreens Boots Alliance, Inc., 2021 WL 477229, at *33 (N.D. Cal. Sept. 23, 2021) (drug approval); Alberici v. Recro Pharma, Inc., 2021 WL 798299, at *5 (E.D. Pa. March 1, 2021) (drug approval after initial rejection); Steele-Warrick v. Microgenics Corp., 2021 WL 1109052, at *2 n.4 (E.D.N.Y. March 22, 2021) (device §510(k) clearance); Morris v. Sun Pharma Global, 2021 WL 687247, at *3 (C.D. Cal. Feb. 19, 2021) (generic drug approval); Itamar Medical, Ltd. v. Ectosense NV, 2021 WL 12095092, at *3 (S.D. Fla. Jan. 4, 2021) (device §510(k) clearance); Frei v. Taro Pharmaceuticals U.S.A., Inc., 443 F. Supp.3d 456, 463 n.1 (S.D.N.Y. 2020) (generic drug approval), aff’d, 844 F. Appx. 444 (2d Cir. 2021); Bird, 2020 WL 5366300, at *2 (device §510(k) clearance); Evans, 2020 WL 5189995, at *1 n.1, *3 n.7 (drug approvals); McDaniel v. Mylan, Inc., 2019 WL 11638407, at *1 n.3 (N.D. Ala. Dec. 16, 2019) (generic drug approval); Kettner v. Cadista Holdings, Inc., 2019 WL 11583314, at *2 (W.D. Tenn. Aug. 12, 2019) (generic drug approval); Allergan v. Imprimis II, 2018 WL 5919210, at *3-4 (drug approval); Patton v. Forest Laboratories, LLC, 2018 WL 5270476, at *4-5 (C.D. Cal. May 10, 2018) (drug and generic drug approvals), aff’d, 793 F. Appx. 608 (9th Cir. 2020); Bell v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 2447788, at *2 (W.D. Pa. May 31, 2018) (drug approval); Nevarez v. Sumavision SFO LLC, 2018 WL 827969, at *2 (N.D. Cal. Feb. 12, 2018) (device §510(k) clearance); Simon, 990 F. Supp.2d at 401 nn. 2-3 (§510(k) clearance); Patton v. Forest Laboratories, LLC, 2017 WL 10439658, at *3 (C.D. Cal. Nov. 1, 2017) (drug and generic drug approvals); United States ex rel Dan Abrams Co., v. Medtronic, Inc., 2017 WL 4023092, at *2 (C.D. Cal. Sept. 11, 2017) (device §510(k) clearance); Mitchell v. Qualitest Pharmaceuticals, 187 F. Supp.3d 831, 832-33 n.2 (W.D. Ky. 2016) (drug approval); Laxton v. Teva Pharmaceuticals USA, Inc., 2016 WL 6947487, at *2 (E.D. Mo. Nov. 28, 2016) (generic drug approval); Elmazouni, 220 F. Supp.3d at 740 (generic drug approval); Otsuka Pharmaceutical Co. v. Torrent Pharmaceuticals Ltd., 118 F. Supp.3d 646, 655 & n.7 (D.N.J. 2015) (generic drug approval); Bertini v. Smith & Nephew, Inc., 8 F. Supp.3d 246, 250 n.1 (E.D.N.Y. 2014) (device §510(k) clearance); Ossim v. Anulex Technologies, Inc., 2014 WL 4908574, at *2 (S.D. Ind. Sept. 30, 2014) (device §510(k) clearances); Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc., 930 F. Supp.2d 808, 811 (S.D. Tex. 2013) (drug approval); Wilson, 2013 WL 6909930, at *5-7 (drug approval); Porter v. Wetzel, 2012 WL 4442792, at *1 n.3 (Mag. W.D. Pa. Aug. 24, 2012), adopted, 2012 WL 4378116 (W.D. Pa. Sept. 25, 2012) (drug approval); Jones v. Hall, 2012 WL 2003574, at *1 n.1 (M.D. Tenn. June 5, 2012) (drug approval); United States ex rel. Bennett v. Medtronic, Inc., 747 F. Supp.2d 745, 756 n.9 (S.D. Tex. 2010) (device §510k clearances); In re Wellbutrin SR/Zyban Antitrust Litigation, 281 F. Supp.2d 751, 755 n.2 (E.D. Pa. 2003) (generic drug approval); Lamkin v. Cockrell, 2003 WL 22244962, at *3 n.1 (W.D. Tex. Sept. 30, 2003) (drug approval); In re Amylin Pharmaceuticals, Inc., Securities Litigation, 2002 WL 31520051, at *2 (S.D. Cal. Oct. 10, 2002) (FDA drug approvable letter), amended on other grounds, 2003 WL 21500525 (S.D. Cal. May 1, 2003); Baylis v. Wilmington Medical Center, Inc., 477 A.2d 1051, 1053 n.1 (Del. 1984) (drug approval); Boyle v. Meyer, ___ A.3d ___, 2025 WL 2599782, at *4 n.7 (Pa. Super. Sept. 9, 2025) (vaccine emergency use authorizations); Baker v. Smith & Nephew Richards, Inc., 1999 WL 811334, at *7 n.23 (Tex. Dist. June 7, 1999) (device reclassification), aff’d, 2000 WL 991697 (Tex. App. July 20, 2000). Cf. Denis v. Ige, 557 F. Supp.3d 1083, 1094 (D. Haw. 2021) (revocation of drug emergency use authorization); Montero v. Teva Pharmaceuticals USA Inc., 2019 WL 6907467, at *1 n.1 (S.D.N.Y. Dec. 4, 2019) (absence of generic drug approval).

PMA Supplements: Gibson, 2025 WL 2555237, at *1 & n.2; Keim-Bacon v. Stryker Corp., 2024 WL 4886051, at *6 (N.D. Okla. Nov. 25, 2024); Jackson, 2024 WL 4256340, at *2-3; Welz, 2024 WL 4252817, at *2; Skinner, 2023 WL 6318014, at *2; Benn, 2023 WL 3966000, at *2 n.3; Poozhikala I, 2022 WL 610276, at *2; Celino, 536 F. Supp.3d at 101; Titko II, 2019 WL 13197982, at *2; Titko I, 2019 WL 13214734, at *2; Bryant, 343 F. Supp.3d at 601-02; Ezell, 2018 WL 6928917, at *5; Parra, 2017 WL 24794, at *3 & n.18; Vincent, 221 F. Supp.3d at 1009 & n.4; Frere, 2016 WL 1533524, at *4; Stanfield, 166 F. Supp.3d at 879; Smith, 2015 WL 9094383, at *3; Modglin, 48 F. Supp.3d at 1380, 1382; Blankenship, 6 F. Supp.3d at 983-84 n.1; Eidson, 981 F. Supp.2d at 878-79; Alton, 970 F. Supp.2d at 1075-76; Ali, 2012 WL 3692396, at *1 & n.2; Erickson, 846 F. Supp.2d at 1089. Cf. Rivelli v. MH & W Corp., 890 A.2d 978, 982 (N.J. Super. App. Div. 2006) (judicially noticing supplemental drug approval).
FDA Product Development Protocols: Stanfield, 166 F. Supp.3d at 879; Erickson, 846 F. Supp.2d at 1089.
OTC Monographs: Pineda v. Lake Consumer Products, Inc., 2025 WL 2698991, at *6 n.1 (E.D. Pa. Sept. 22, 2025) (final); Hayde v. Arcadia Consumer Healthcare Inc., 2025 WL 1386779, at *3 (C.D. Cal. March 28, 2025) (final); Lester v. CVS Pharmacy, Inc., 2024 WL 1312935, at *4 (S.D.N.Y. March 27, 2024) (final); Hwang v. Ohso Clean, Inc., 2013 WL 1632697, at *2 n.2 (N.D. Cal. April 16, 2013) (tentative).
“Orange Book”: Teva Pharmaceuticals USA, Inc. v. Eli Lilly & Co., 2025 WL 1826058, at *1 n.2 (S.D. Ind. June 30, 2025); Hernandez v. Aurobindo Pharma USA, Inc., 582 F. Supp.3d 1192, 1201 (M.D. Fla. 2022); Takeda Pharmaceutical Co. v. Norwich Pharmaceuticals, Inc., 2022 WL 17959811, at *46 (D.N.J. Dec. 27, 2022), aff’d, 2023 WL 3244022 (Fed. Cir. May 4, 2023); Allergan v. Imprimis II, 2018 WL 5919210, at *3-4; Bell, 2018 WL 2447788, at *1; Warren v. Boehringer Ingleheim Pharmaceuticals, Inc., 2017 WL 3970666, at *16 (S.D. Ind. Sept. 8, 2017); In re Thalomid & Revlimid Antitrust Litigation, 2015 WL 9589217, at *13 n.11 (D.N.J. Oct. 29, 2015); Morris v. Wyeth, Inc., 2012 WL 601455, at *5 n.4 (W.D. La. Feb. 23, 2012), aff’d, 713 F.3d 774 (5th Cir. 2013).
Summary of Safety & Effectiveness: Sheinfeld v. B. Braun Medical, Inc., 2024 WL 635483, at *4 n.3 (Mag. S.D.N.Y. Feb. 1, 2024), adopted, 2024 WL 691415 (S.D.N.Y. Feb. 20, 2024), adoption vacated on procedural grounds, 2024 WL 714686 (S.D.N.Y. Feb. 21, 2024); Allo I, 2020 WL 32439, at *2; Angell, 2019 WL 3958262, at *8; Yosowitz, 182 F. Supp.3d at 687-88 & n.11; Smith, 2015 WL 9094383, at *3; Caton, 2015 WL 12426110, at *3; Dixon, 2015 WL 13777064, at *2; Roberts, 2014 WL 12911070, at *3 & n.1; Herrnandez, 2014 WL 7044171, at *2; Johnson, 2014 WL 2581421, at *1-2; Poll, 2014 WL 199150, at *2; Eidson, 981 F. Supp.2d at 878-79; Alton, 970 F. Supp.2d at 1075-76; Gross, 858 F. Supp.2d at 481 n.26; Ali, 2012 WL 3692396, at *1 & n.2; White v. Stryker Corp., 818 F. Supp.2d 1032, 1035-36 & n.7 (W.D. Ky. 2011); Tierney, 2011 WL 7400469, at *4; Rieger, 2025 WL 403801, at *3; Fuchs v. Allergan, Inc., 2019 WL 13411864, at *1, 3 (Cal. Super. Oct. 2, 2019).
FDA Adverse Event Databases: Lawrence v. Medtronic, 791 F. Appx. 679, 680 (9th Cir. 2020) (device); Krantz, 2024 WL 1792769, at *4 (drug); Pietrantoni v. Corcept Therapeutics Inc., 640 F. Supp.3d 197, 204-05 (D. Mass. 2022) (drug); Ferraro Family II, 2021 WL 3748325, at *8-9 (drug); Bird, 2020 WL 5366300, at *2, 8 (device); Bell v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 2447788, at *3 (W.D. Pa. May 31, 2018) (drug); Funke, 147 F. Supp.3d at 1025 (device); Rollins v. St. Jude Medical, 583 F. Supp.2d 790, 804-05 (W.D. La. 2008) (ADE concerning the plaintiff); Gaines v. Guidant Corp., 2004 WL 2538374, at *9 n.20 (S.D. Ind. Nov. 8, 2004) (device); but see Bryant, 343 F. Supp.3d at 603 (refusing to take notice of “facts” in device ADEs).
Recalls: Christian v. Altaire Pharmaceuticals, Inc., 2021 WL 3578812, at *3 (6th Cir. Aug. 10, 2021), aff’g, Christian v. Altaire Pharmaceuticals, Inc., 2020 WL 6051255, at *4 (E.D. Ky. Oct. 13, 2020); In re Chantix (Varenicline) Marketing, Sales Practices & Products Liability Litigation (No. II), 735 F. Supp.3d 352, 369 (S.D.N.Y. 2024); Rice v. DCI Donor Services, 2024 WL 2646668, at *3 (N.D. Fla. March 25, 2024); Ganz, 688 F. Supp.3d at 1228; Tripolskiy, 2023 WL 5440785, at *2; Tripolskiy, 2023 WL 5440783 at *1-2; Harris v. Pfizer Inc., 586 F. Supp.3d 231, 245 & n.3 (S.D.N.Y. 2022); Poozhikala v. Medtronic, Inc., 2022 WL 1076173, at *1 n.2 (C.D. Cal. April 7, 2022) (“Poozhikala II”); Morris, 2021 WL 687247, at *3; Noordhof v. Howmedica Osteonics Corp., 2019 WL 10301741, at *2 (N.D. Ill. April 8, 2019); Bryant, 343 F. Supp.3d at 601-02; Weaver v. Ethicon, Inc., 2017 WL 680725, at *5 & n.3 (S.D. Cal. Feb. 21, 2017) (“Weaver III”), aff’d, 737 F. Appx. 315 (9th Cir. 2018); Frere, 2016 WL 1533524, at *4; Shields v. Alere Home Monitoring, Inc., 2015 WL 7272672, at *1-2 & n.1 (N.D. Cal. Nov. 18, 2015); Leroy, 2015 WL 4600880, at *5-6; Trahan v. Sandoz, Inc., 2015 WL 2365502, at *1 & n.3 (M.D. Fla. March 26, 2015); A.B. v. Coopersurgical, Inc., 2024 WL 4700355, at *2 (Cal. Super. Oct. 9, 2024). Cf. Leake v. Raytheon Technologies Corp., 2023 WL 2242857, at *1 n.2 (D. Ariz. Feb. 27, 2023) (judicially noticing lack of recalls), aff’d, 2024 WL 1854287 (9th Cir. April 29, 2024).
Warning Letters: Eli Lilly & Co. v. Willow Health Services, Inc., 2025 WL 2631620, at *3 (C.D. Cal. Aug. 29, 2025); Silva v. Haleon US, Inc., 758 F. Supp.3d 1082, 1086-87 (N.D. Cal. 2024); Morgan v. Albertsons Cos., 2023 WL 3607275, at *1 n.1 (N.D. Cal. March 13, 2023); ImprimisRx, LLC v. OSRX, Inc., 2022 WL 3371343, at *6 (S.D. Cal. Aug. 15, 2022); United States v. Orthopedic Alliance, LLC, 2020 WL 6151084, at *4 (C.D. Cal. July 13, 2020); Franz v. Beiersdorf, Inc., 2019 WL 2192635, at *2 n.2 (S.D. Cal. May 21, 2019); Allergan v. Imprimis II, 2018 WL 5919210, at *3-4; Bell v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 2447788, at *1 (W.D. Pa. May 31, 2018); Grivas v. Metagenics, Inc., 2016 WL 11266835, at *2 (C.D. Cal. March 31, 2016); Modglin, 48 F. Supp.3d at 1384; Herrnandez, 2014 WL 7044171, at *2; Lederman v. Howmedica Osteonics Corp., 950 F. Supp.2d 1246, 1251 (M.D. Fla. 2013); Gall, 2016 WL 7011530, at *2.
Absence of Warning Letters: Keim-Bacon, 2024 WL 4886051, at *6 (device); Oklahoma Police Pension Fund & Retirement System v. Teligent, Inc., 2020 WL 3268531, at *13 n.7 (S.D.N.Y. June 17, 2020) (generic drug).
Forms 483: Eli Lilly v. Willow Health, 2025 WL 2631620, at *3; De La Paz, 159 F. Supp.3d at 1089, 1095; Frere, 2016 WL 1533524, at *4; Mallon v. Hologic, Inc., 2023 WL 12082524, at *5 (Cal. Super. Feb. 22, 2023), aff’d, 2025 WL 482652 (Cal. App. Feb. 13, 2025).
FDA Establishment Inspection Reports: Connelly v. St. Jude Medical, Inc., 2018 WL 732734, at *3 n.2 (N.D. Cal. Feb. 6, 2018); Frere, 2016 WL 1533524, at *4; Mallon, 2023 WL 12082524, at *5.
FDA Proposed Rules: Allergan USA, Inc. v. Imprimis Pharmaceuticals, Inc., 2017 WL 10526121, at *3-4 (C.D. Cal. Nov. 14, 2017) (“Allergan v. Imprimis I”); Veil v. Vitek, Inc., 803 F. Supp. 229, 232 (D.N.D. 1992).
Guidance Documents: Apotex Inc. v. Acorda Therapeutics, Inc., 823 F.3d 51, 60 (2d Cir. 2016); Leonard, 2025 WL 2772598, at *1 n.2; Sneed v. Procter & Gamble Co., 779 F. Supp.3d 1025, 1031-32 (N.D. Cal. 2025); Laucella v. Medtronic, Inc., 2025 WL 2078269, at *4 n.3 (C.D. Cal. June 6, 2025); Aramic LLC v. Revance Therapeutics, Inc., 2025 WL 240796, at *3 (N.D. Cal. Jan. 17, 2025); Chantix, 735 F. Supp.3d at 369; Langara v. Bayer Corp., 2024 WL 5186723, at *9 & n.6 (D. Conn. Dec. 20, 2024), aff’d, 2025 WL 3022438 (2d Cir. Oct. 29, 2025); Aramic LLC v. Revance Therapeutics, Inc., 2024 WL 1354503, at *4 (N.D. Cal. April 2, 2024); Holloway v. AbbVie, Inc., 2024 WL 477523, at *3 (M.D. La. Feb. 7, 2024); Bischoff v. Albertsons Cos., 678 F. Supp.3d 518, 524 & n.1 (S.D.N.Y. 2023); United States ex rel. Jackson v. Ventavia Research Group, LLC, 667 F. Supp.3d 332, 340 n.4 (E.D. Tex. 2023); In re Ocugen, Inc. Securities Litigation, 659 F. Supp.3d 572, 587 n.13 (E.D. Pa. 2023), aff’d, 2024 WL 1209513 (3d Cir. March 21, 2024); Morgan, 2023 WL 3607275, at *1 n.1; Barry, 2022 WL 2373452, at *4-5; America’s Frontline Doctors v. Wilcox, 2022 WL 1514038, at *4 (C.D. Cal. May 5, 2022); Block Scientific, Inc. v. True Diagnostics, Inc., 2022 WL 485010, at *2 (S.D. Cal. Feb. 16, 2022); Suttman-Villars, 553 F. Supp.3d at 952-53; Teal, 533 F. Supp.3d at 548; Eidmann, 522 F. Supp.3d at 642; Inchen Huang v. Higgins, 443 F. Supp.3d 1031, 1048 (N.D. Cal. 2020) (also draft guidance); Prescott v. Bayer HealthCare LLC, 2020 WL 4430958, at *2 n.2 (N.D. Cal. July 31, 2020); Lake v. Zogenix, Inc., 2020 WL 3820424, at *5 (N.D. Cal. Jan. 27, 2020); Bennett v. Medtronic 747 F. Supp.2d at 756 n.9; Allergan USA, Inc. v. Prescribers Choice, Inc., 364 F. Supp.3d 1089, 1095 (C.D. Cal. 2019); Franz, 2019 WL 2192635, at *2 n.2; Allergan v. Imprimis I, 2017 WL 10526121, at *3-4; Grivas, 2016 WL 11266835, at *2 (draft guidances); Tawfilis v. Allergan, Inc., 157 F. Supp.3d 853, 861 (C.D. Cal. 2015); Modglin, 48 F. Supp.3d at 1379-80, 1382; In re XenoPort, Inc. Securities Litigation, 2011 WL 6153134, at *3 (N.D. Cal. Dec. 12, 2011); In re Nuvelo, Inc. Securities Litigation, 668 F. Supp.2d 1217, 1220 (N.D. Cal. 2009); Construction Laborers Pension Trust v. Neurocrine Biosciences, Inc., 2008 WL 2053733, at *7 (S.D. Cal. May 13, 2008); Sykes v. Glaxo-SmithKline, 484 F. Supp.2d 289, 293 n.4, 310 (E.D. Pa. 2007); In re Intrabiotics Pharmaceuticals, Inc. Securities Litigation, 2006 WL 708594, at *9 (N.D. Cal. Jan. 23, 2006); Noble Asset Management v. Allos Therapeutics, Inc., 2005 WL 4161977, at *2 (D. Colo. Oct. 20, 2005); In re Empyrean Biosciences, Inc. Securities Litigation, 219 F.R.D. 408, 410 (N.D. Ohio 2003).
FDA Policy Statements: Allergan v. Imprimis I, 2017 WL 10526121, at *3-4 (interim policy); Kader v. Sarepta Therapeutics, Inc., 2017 WL 72396, at *2 n.3 (D. Mass. Jan. 6, 2017), aff’d, 887 F.3d 48 (1st Cir. 2018); Sykes, 484 F. Supp.2d at 293 n.4, 310; In re Vertex Pharmaceuticals, Inc., Securities Litigation, 357 F. Supp.2d 343, 352 n.4 (D. Mass. 2005).
Citizen’s Petitions/FDA Responses: Kouyate, 2025 WL 2773159, at *5 n.4; Bodunde v. Walgreens Boots Alliance, Inc., 2025 WL 1411306, at *3 n.5 (E.D. Cal. May 15, 2025); Dains, 2022 WL 16572021, at *7; Aquino v. C.R. Bard, Inc., 413 F. Supp.3d 770, 781 & n.5 (N.D. Ill. 2019); In re Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litigation, 333 F. Supp.3d 135, 152 (E.D.N.Y. 2018); Kripke v. Safeway, Inc., 2018 WL 3491903, at *3 (N.D. Cal. July 20, 2018); United Food & Commercial Workers Local 1776 v. Teikoku Pharma USA, Inc., 74 F. Supp.3d 1052, 1062 n.14 (N.D. Cal. 2014); Novartis Pharmaceuticals Corp. v. Wockhardt, 2013 WL 5770539, at *4 (D.N.J. Oct. 23, 2013).
FDA Manuals: In re Zantac (Ranitidine) Products Liability Litigation, 510 F. Supp.3d 1141, 1163 n.8 (S.D. Fla. 2020) (guidance); Allergan v. Imprimis II, 2018 WL 5919210, at *3-4 (regulatory procedures); Plumbers & Pipefitters Local Union v. Zimmer, 673 F. Supp.2d 718, 736 n.18 (S.D. Ind. 2009) (investigations), aff’d, 679 F.3d 952 (7th Cir. 2012); Noble Asset, 2005 WL 4161977, at *2 (policies and procedures).
FDA Safety Alerts/Announcements: Timothy v. Boston Scientific Corp., 665 F. Appx. 295, 298 n.4 (4th Cir. 2016); Anspach v. City of Philadelphia, 503 F.3d 256, 272-73 & n.11 (3d Cir. 2007); Barton v. Procter & Gamble Co., 766 F. Supp.3d 1045, 1057 (S.D. Cal. 2025); Ganz, 688 F. Supp.3d at 1229; Foti v. EzriCare, LLC, 2023 WL 11117028, at *8 (C.D. Cal. Nov. 22, 2023); Monroe v. Kirby, 2023 WL 3331057, at *2 n.4 (C.D. Cal. April 11, 2023); Cloutier v. Ethicon, Inc., 2022 WL 17885682, at *2 (C.D. Cal. Nov. 3, 2022); Thompson v. Boston Scientific Corp., 2022 WL 4593086, at *7-8 (M.D. La. Sept. 29, 2022); Hutchinson v. Boston Scientific Corp., 2020 WL 5752393, at *4 n.3 (D. Del. Sept. 25, 2020); Mecham v. C.R. Bard, Inc., 2020 WL 2768997, at *8 (D. Utah May 27, 2020); Klein v. Bayer Healthcare Pharmaceuticals, Inc., 2019 WL 3945652, at *1 n.1 (D. Nev. Aug. 21, 2019); Bryant, 343 F. Supp.3d at 601-02; Pernix Ireland Pain DAC v. Alvogen Malta Operations Ltd., 323 F. Supp.3d 566, 609 n.12 (D. Del. 2018), aff’d, 945 F.3d 1184 (Fed. Cir. 2019); Prendergast v. Secretary, DOC, 2015 WL 7450107, at *9 n.11 (M.D. Fla. Nov. 24, 2015); Horne, 541 F. Supp.2d at 776-77; Rozzelle v. Rossi, 2007 WL 2571935, at *6-7 & n.9 (W.D. Pa. Aug. 31, 2007).
FDA Important Medical Information Statement: Scanlon v. Medtronic, Inc., 61 F. Supp.3d 403, 413 n.16 (D. Del. 2014); Eidson, 981 F. Supp.2d at 878-79; Alton, 970 F. Supp.2d at 1075-76.
FDA Import Alerts: Ashlynn Marketing v. Pan, 2025 WL 1953229, at 6 n.2 (S.D. Cal. July 16, 2025); J.J. v. Ashlynn Marketing Group, Inc., 2025 WL 1811854, at *4 (S.D. Cal. July 1, 2025), reconsideration denied,2025 WL 2939532 (S.D. Cal. Oct. 16, 2025); In re Mylan N.V. Securities Litigation, 2020 WL 1673811, at *5 (S.D.N.Y. April 6, 2020).
Transcripts of FDA Proceedings: Funk, 631 F.3d at 783; Alger Dynamic Opportunities Fund v. Acadia Pharmaceuticals, Inc., 756 F. Supp.3d 852, 861 (S.D. Cal. 2024) (meeting minutes); United States ex rel. Bennett v. Bayer Corp., 2022 WL 970219, at *10 (D.N.J. March 31, 2022); United States v. Medtronic, Inc., 2019 WL 12536543, at *1 n.1 (C.D. Cal. July 23, 2019), aff’d in part & rev’d in part on other grounds, 850 F. Appx. 508 (9th Cir. 2021); Allergan v. Imprimis I, 2017 WL 10526121, at *3-4; Dan Abrams, 2017 WL 4023092, at *2; Frater v. Hemispherx Biopharma, Inc., 996 F. Supp.2d 335, 338 n.1, 341 n.5 (E.D. Pa. 2014) (meeting minutes); Plumlee, 2014 WL 695024, at *4 & n.2; Noble Asset, 2005 WL 4161977, at *2; In re CV Therapeutics, Inc., 2004 WL 1753251, at *12 (N.D. Cal. Aug. 5, 2004).
FDA Reports: Barton, 2025 WL 2345228, at *3; Kinnee, 2023 WL 8191097, at *3; Allergan USA Inc. v. Imprimis Pharmaceuticals, Inc., 2019 WL 3029114, at *10 n.4 (C.D. Cal. July 11, 2019) (“Allergan v. Imprimis III”); Starks v. Coloplast Corp., 2014 WL 617130, at *2 (E.D. Pa. Feb. 18, 2014); Menn v. ConMed Corp., 2022 WL 2387802, at *29 n.378 (Del. Ch. June 30, 2022).
FDA Definitions of Terms: Keim-Bacon, 2024 WL 4886051, at *6; Homyk v. ChemoCentryx, Inc., 2023 WL 3579440, at *4 (N.D. Cal. Feb. 23, 2023); United Therapeutics Corp. v. Liquidia Technologies, Inc., 2025 WL 2157516, at *2 n.4 (N.C. Super. July 29, 2025).
FDA Public Letters: Aquino, 413 F. Supp.3d at 781 & n.5; Becker 2015 WL 5472311, at *3.
FDA Questions & Answers: Frye, 2022 WL 4305656, at *5, 12; Watler, 2022 WL 971948, at *2; Margulis v. Stryker Corp., 2019 WL 6830209, at *1 n.2 (Mag. D.N.J. Nov. 12, 2019), adopted, 2019 WL 6828175 (D.N.J. Dec. 12, 2019); Allergan v. Prescribers Choice, 364 F. Supp.3d at 1095; Allergan v. Imprimis II, 2018 WL 5919210, at *3-4; Grivas v. Metagenics, Inc., 2018 WL 6185977, at *2-3 (C.D. Cal. Jan. 4, 2018); Allergan v. Imprimis I, 2017 WL 10526121, at *3; PhRMA v. United States Dept. of HHS, 43 F. Supp.3d 28, 33 (D.D.C. 2014).
FDA Product Information: Bond v. Johnson & Johnson, 2021 WL 6050178, at *1 n.1 (D.N.J. Dec. 21, 2021), aff’d, 2022 WL 4594185 (3d Cir. Sept. 30, 2022); Sparks v. Medtronic, Inc., 2021 WL 2649235, at *2 n.2 (M.D. Fla. June 28, 2021); Loomis v. Slendertone Distribution, Inc., 420 F. Supp.3d 1046, 1062 (S.D. Cal. 2019); Rhodes v. Covidien LP, 2019 WL 2162845, at *3 n.30 (E.D. La. May 17, 2019); Reeves v. PharmaJet, Inc., 846 F. Supp.2d 791, 794 & n.1 (N.D. Ohio 2012).
FDA List of Covered Countermeasures: Sorace v. Orinda Care Center, LLC, 2021 WL 5205603, at *11-12 (N.D. Cal. Nov. 9, 2021), aff’d, 2023 WL 4105217 (9th Cir. June 21, 2023); Burton v. Silverado Escondido, LLC, 2021 WL 5087259, at *4 (S.D. Cal. Nov. 2, 2021), aff’d, 2025 WL 2158805 (9th Cir. Feb. 21, 2025).
FDA Press Releases: Lotus Vaping, 73 F.4th at 677; McMahon v. City of Los Angeles, 2025 WL 3125938, at *3 (C.D. Cal. Sept. 30, 2025); Gieser v. Moderna Corp., 2024 WL 3077100, at *2 (Mag. E.D. Cal. June 20, 2024), adopted in pertinent part, rejected in part on other grounds, 2024 WL 4190086 (E.D. Cal. Sept. 13, 2024); Marquez v. Nutek Disposables, Inc., 2017 WL 5071335, at *6 (W.D. Tex. Sept. 27, 2017); Kiker v. SmithKline Beecham Corp., 2016 WL 8189286, at *4 n.3 (S.D. Ohio Dec. 15, 2016); Jones v. Jones, 2023 WL 2625862, at *9 (Ill. App. March 24, 2023); Galindo v. Corona Regional Medical Center, 2024 WL 6112704, at *2 (Cal. Super. March 7, 2024).
FDA Federal Register Materials: We don’t list these cases separately. The Federal Register must, by statute, be judicially noticed by all federal and state courts. See 44 U.S.C. §1507 and our prior post, here, discussing §1507.
Miscellaneous FDA Documents/Website Material: Brod v. Sioux Honey Assn. Co-op., 609 F. Appx. 415, 416 (9th Cir. 2015) (FDA letter); Haney, Inc. v. Axium BioResearch, 2025 WL 2734218, at *6 (S.D. Cal. Sept. 25, 2025) (Clinical Laboratory Improvement Amendments certifications); Cement Masons, 2025 WL 2658224, at *3, 8 (FDA investigatory letter); Hills v. BioXcel Therapeutics, Inc., 2024 WL 3374145, at *5 (D. Conn. July 11, 2024) (FDA statistics); EmCyte Corp. v. XLMedica, Inc., 2024 WL 2853705, at *1 (M.D. Fla. May 22, 2024) (website documents); United States v. Medtronic PLC, 2024 WL 1363644, at *2 (C.D. Cal. March 28, 2024) (summary of substantial equivalence); Strezsak v. Ardelyx, Inc., 2024 WL 1160900, at *4 (N.D. Cal. March 18, 2024) (FDA briefing document, FDA surrogate endpoint resources, FDA table of surrogate endpoints); Eisai R&D Management Co. v. Dr. Reddy’s Laboratories, Inc., 2023 WL 7331272, at *6 (D.N.J. Nov. 7, 2023) (drug patent exclusivity list); Tripolskiy, 2023 WL 5440785, at *2 (device lookup information); Tripolskiy, 2023 WL 5440783, at *1-2 (device lookup information); City of Birmingham Relief & Retirement System v. Acadia Pharmaceuticals, Inc., 2022 WL 4491093, at *2 (S.D. Cal. Sept. 27, 2022) (breakthrough therapy designation); Jacksonville Police Officers & Fire Fighters Health Insurance Trust v. Gilead Sciences, Inc., 2022 WL 3579881, at *5 (N.D. Cal. Aug. 19, 2022) (FDA documentation of start-selling dates); Suttman-Villars, 553 F. Supp.3d at 952-53 (“website publication”); Allergan v. Prescribers Choice, 364 F. Supp.3d at 1095 (various FDA publications); Combs v. Bayer Healthcare Pharmaceuticals, Inc., 2019 WL 2124518, at *2-3 (N.D. Ohio May 15, 2019) (plaintiff’s personal submission to FDA); Egalet Corp., 340 F. Supp.3d at 496 (FDA public memorandum); Allergan v. Imprimis III, 2018 WL 5919210, at *3-4 (FDA webpages); Allergan v. Imprimis I, 2017 WL 10526121, at *3-4 (FDA webpages, dear colleague letter, commissioner’s statement, §503B manufacturers list); KB Partners I, L.P. v. Pain Therapeutics, Inc., 2015 WL 7760201, at *3 n.2 (W.D. Tex. Dec. 1, 2015) (discipline review letter); Modglin, 48 F. Supp.3d at 1379-80, 1382, 1384 (device reclassification materials, interagency agreement, website documents); Johnson, 2014 WL 2581421, at *1-2 (product classification listing); Ali, 2012 WL 3692396, at *1 & n.2 (FDA executive summary memorandum); In re Digitek Products Liability Litigation, 821 F. Supp.2d 822, 826 n.4, 828 n.8 (S.D.W. Va. 2011) (FDA “resources”); Colacicco v. Apotex, Inc., 432 F. Supp.2d 514, 526-27 n.10 (E.D. Pa. 2006) (FDA rejections of proposed label changes), aff’d, 521 F.3d 253 (3d Cir. 2008), vacated on other grounds, 556 U.S. 1101 (2009); Femrite v. Abbott Northwestern. Hospital, 568 N.W.2d 535, 541 (Minn. App. 1997) (FDA regulatory updates).

There you have it. After much more work than we anticipated, this post contains a complete list of the judicial decisions that have judicially noticed FDA prescription medical product (and OTC drug) materials, divided by the type of material that each decision has judicially noticed. We don’t think that this precedent has ever been compiled in this fashion before. We hope our defense colleagues put this to good use.

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