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Here at the Blog, we love the learned intermediary rule.  We’ve chronicled the rule’s steady expansion as it now has precedential support in all fifty states.  “Every state in the country, along with the District of Columbia and Puerto Rico, has adopted the learned intermediary doctrine in some iteration.”  Dearinger v. Eli Lilly & Co., 510 P.3d 326, 329 (Wash. 2022). We’ve discussed how it applies to all types of prescription medical products (specifically, medical devices as well as drugs).  We’ve pointed out that it protects pharmacies as well as product manufacturers.  We have headcounts and 50-state surveys.  In fact, it’s gotten to the point that we’ve discussed the learned intermediary rule so many times from so many angles, that there are probably too many places to look efficiently.

We’re hoping to address the problem of too much information in too many places with this post.  Here, we’re combining in one place the jurisdictional information about the rule from our headcounts with the substantive information from our 50-state surveys.  This post, on a state-by state basis, not only provides the decisions from highest-level courts to adopt the learned intermediary rule itself, but also the best precedents for its application to medical devices, biologics (fewer cases after the Vaccine Act), and pharmacists.

One final note before getting to the meat of this quite long (81+ pages in Word) post − obviously, we believe the rationale for the rule would support its application in all of these contexts, even if a particular state doesn’t have authority in each area, so don’t let lack of directly on-point precedent in any particular state stop you from arguing for the learned intermediary rule.  This post is intended to help defense counsel do just that.  So, fill in those holes.

What we’re doing initially is what the Blog did with the failure to report 50-state survey, which was of similar length.  We’re going to break it into three posts over three weeks, so people who want to read them can do so without spending all day.  When that’s done, behind the scenes, we will add the three pieces back together so that our users can find everything in one place – our original goal.

Here goes.  Part 1 (and what will eventually become the full post).

Alabama

We don’t have to go past supreme court decisions in Alabama.  This state was a relatively early adopter of the learned intermediary rule in Stone v. Smith, Kline & French Laboratories, 447 So.2d 1301, 1305 (Ala. 1984).

We cannot quarrel with the general proposition that where prescription drugs are concerned, the manufacturer’s duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the drug’s use.  This special standard for prescription drugs is an understandable exception to the . . . general rule that one who markets goods must warn foreseeable ultimate users of dangers inherent in his products.

Id. at 1304-05 (citation and quotation marks omitted).  Other Alabama Supreme Court cases applying the learned intermediary rule to prescription drugs are Blackburn v. Shire U.S., Inc., 380 So.3d 354, 359 (Ala. 2022) (“The learned-intermediary doctrine recognizes the role of the physician as a learned intermediary between a drug manufacturer and a patient.”) (citation and quotation marks omitted); and Wyeth, Inc. v. Weeks, 159 So.3d 649, 672-74 (Ala. 2014), but read them before citing.

The Alabama Supreme Court applied the learned intermediary rule to medical devices in Morguson v. 3M Corp., 857 So.2d 796, 801-02 (Ala. 2003) (defendant “had no duty to provide warnings to [plaintiff] rather, [defendant’s] duty was to warn the physicians and perfusionists . . . who used the [device]”).

The Alabama Supreme Court has also repeatedly recognized that the learned intermediary rule protects pharmacists.  Nail v. Publix Super Markets, Inc., 72 So.3d 608, 616 (Ala. 2011) (“the pharmacist does not have a duty to warn customers of the hazardous side effects either orally or by way of the manufacturer’s package insert”; but finding an exception); Springhill Hospitals, Inc. v. Larrimore, 5 So.3d 513, 518 (Ala. 2008) (“The learned-intermediary doctrine is more than just a narrow rule of law regarding a manufacturer’s or pharmacist’s limited duty to warn.  It addresses questions of liability in light of the relationships between the parties involved in the distribution, prescribing, and use of prescription drugs.”); Walls v. Alpharma USPD, 887 So.2d 881, 886 (Ala. 2004) (“The learned-intermediary doctrine forecloses any duty upon a pharmacist filling a physician’s prescription, valid and regular on its face, to warn the physician’s patient, the pharmacist’s customer, or any other ultimate consumer of the risks or potential side effects of the prescribed medication”).

The only thing we haven’t found in Alabama is a biologic case involving the learned intermediary rule.

Alaska

In Shanks v. Upjohn Co., 835 P.2d 1189 (Alaska 1992), the Alaska Supreme Court followed the learned intermediary rule.  “In determining the adequacy of the warnings and directions in the context of typical prescription drugs, it is appropriate for the trier of fact to consider that the warnings and directions were directed to the prescribing physician rather than to the patient.”  Id. at 1200 & n.17.  We have not seen any Alaska law precedent involving application of the learned intermediary rule in the context of medical devices, biologics, or pharmacists.

Arizona

Arizona adopted the learned intermediary rule in Watts v. Medicis Pharmaceutical Corp., 365 P.3d 944 (Ariz. 2016), a prescription drug case.  “In our view, the Third Restatement properly states the [learned intermediary rule], and therefore we adopt §6(d) as our expression of it.”  Id. at 949.  Conklin v. Medtronic, Inc., 431 P.3d 571 (Ariz. 2018), extended the learned intermediary rule to manufacturers of medical devices – pointing out that the Third Restatement version of the learned intermediary rule expressly applied to both drugs and medical devices.  Id. at 577.

In Lasley v. Shrake’s Country Club Pharmacy, Inc., 880 P.2d 1129 (Ariz. App. 1994), the court rejected the learned intermediary rule in a pharmacy context, but for an unusual reason – “us[ing] details of the standard of conduct to determine whether a duty exists.”  Id. at 1134.  Whether Lasley survives Watts and Conklin is questionable, but undecided.

No Arizona case that we know of has applied learned intermediary rule in litigation involving a biologic.

Arkansas

In West v. Searle & Co., 806 S.W.2d 608, 613 (Ark. 1991), the Arkansas Supreme Court adopted the learned intermediary rule in a prescription drug case.  The rule was “almost universally applied” and “provides that a drug manufacturer may rely on the prescribing physician to warn the ultimate consumer of the risks of a prescription drug.”  Id. at 613.  In Kowalski v. Rose Drugs of Dardanelle, Inc., 378 S.W.3d 109, 120 (Ark. 2011), that court extended the rule to pharmacists:

[W]e believe the more reasoned analysis is that followed by the majority of jurisdictions that there is no general duty to warn, counsel, or refuse to fill prescriptions. . . .  The relationship between the physician-patient-manufacturer applies equally to the relationship between the physician-patient and pharmacist.  In both circumstances the patient must look to the physician.

Id. at 120 (citation and quotation marks omitted).

There is no appellate precedent, but Arkansas federal courts have repeatedly utilized the learned intermediary rule in medical device cases.  Meade v. Ethicon, Inc., 2021 WL 4302252, at *3 (E.D. Ark. Sept. 21, 2021); Kendrick v. Wright Medical Technology, Inc., 2021 WL 3516663, at *6 (E.D. Ark. Aug. 10, 2021) (agreeing that the learned intermediary rule “is just as applicable to medical devices” as it is to drugs); Wilichowski v. Boston Scientific Corp., 2021 WL 798869, at *3 (W.D. Ark. March 2, 2021); Sharp v. Ethicon, Inc., 2020 WL 1434566, at *3 (W.D. Ark. March 24, 2020).

We are unaware of any Arkansas learned intermediary rule biologic cases.

California

California is another state where it is not necessary to go beyond the state’s highest court.  The California Supreme Court first recognized the learned intermediary rule in Stevens v. Parke, Davis & Co., 507 P.2d 653 (Cal. 1973), a prescription drug case.  Id. at 661 (“In the case of medical prescriptions, if adequate warning of potential dangers of a drug has been given to doctors, there is no duty by the drug manufacturer to insure that the warning reaches the doctor’s patient for whom the drug is prescribed.”) (citation and quotation marks omitted).  “[I]n the case of prescription drugs, the duty to warn runs to the physician, not to the patient.”  Carlin v. Superior Court, 920 P.2d 1347, 1354 (Cal. 1996) (emphasis original) (citations omitted).  Thus, “[i]t is well established that a manufacturer fulfills its duty to warn if it provides adequate warning to the physician.”  Brown v. Superior Court, 751 P.2d 470, 477 n.9 (Cal. 1988).  See also T.H. v. Novartis Pharmaceuticals Corp., 407 P.3d 18, 28 (Cal. 2017) (“In the context of prescription drugs, a manufacturer’s duty is to warn physicians about the risks known or reasonably known to the manufacturer.”) (paraphrasing Carlin).

Himes v. Somatics, LLC, 549 P.3d 916, 922-25 (Cal. 2024), explicitly recognized the learned intermediary rule as extending to medical devices as well.

As long as the manufacturer has adequately warned the patient’s physician of the non-negligible risks of its prescription drug or medical device, the manufacturer has fulfilled its duty to warn. . . .  The learned intermediary doctrine recognizes that, while the ordinary consumer may have a reasonable expectation that a product such as a machine . . . will operate safely when used as intended, a patient’s expectations regarding the effects of a prescription drug or medical device are those related . . . by [the] physician, to whom the manufacturer directs the warnings regarding the drug’s or medical device’s properties.

Id. at 923 (citations and quotation marks omitted).  Furthermore, Himes did so in a case that did not involve an implant, but instead “electroconvulsive therapy” device, id. at 921, thereby establishing that the rule is not limited to implants.

California’s adoption of the learned intermediary rule was also noted in Webb v. Special Electric Co., 370 P.3d 1022, 1034 n.10 (Cal. 2016), a non-prescription medical product case.

In Murphy v. E.R. Squibb & Sons, Inc., 710 P.2d 247, 250-53 (Cal. 1985), the same court exempted pharmacists from duty to warn liability, but without specifically mentioning the rule.  Murphy has been recognized as an application of the learned intermediary rule.  E.g., Lacesa v. Walgreen Co., 2022 WL 19240778, at *2 (C.D. Cal. Sept. 22, 2022).

Precedent also applies the learned intermediary rule to biologics in California law cases.  Plummer v. Lederle Laboratories, 819 F.2d 349, 356-57 (2d Cir. 1987) (applying California law); Garcia v. Sanofi Pasteur Inc., 2023 WL 6387171, at *5 (E.D. Cal. Sept. 29, 2023); In re Zostavax Zoster Vaccine Live Products Liability Litigation, 2023 WL 2562981, at *2 (E.D. Pa. March 16, 2023) (applying California law); Colbath v. Merck & Co., 2022 WL 935195 at *6 (S.D. Cal. March 29, 2022) (vaccine); In re Zoster, 2021 WL 3423361, at *5 (E.D. Pa. Aug. 4, 2021) (applying California law).

Colorado

Colorado is one of four remaining states where an intermediate appellate court, but not the state’s high court, has followed the learned intermediary rule.  In Hamilton v. Hardy, 549 P.2d 1099, 1110 (Colo. App. 1976) (“the drug manufacturer’s duty, owed to the public, is the duty to warn the medical profession”) (footnote omitted), overruled on other grounds, State Board of Medical Examiners v. McCroskey, 880 P.2d 1188 (Colo. 1994).  A quarter century later, the same court held that the learned intermediary rule also applied in medical device cases.

[T]he learned intermediary rule is generally accepted, and . . . a manufacturer “fulfills its legal obligation to warn by providing adequate warnings to the health-care provider.  Courts in other jurisdictions have applied the learned intermediary doctrine in cases involving medical devices.  Based on the above authorities, we are persuaded that the learned intermediary doctrine should apply to failure to warn claims in the context of a medical device installed operatively when it is available only to physicians and obtained by prescription, and the doctor is in a position to reduce the risks of harm in accordance with the instructions or warnings.

O’Connell v. Biomet, Inc., 250 P.3d 1278,1281-82 (Colo. App. 2010) (citations and quotation marks omitted).  No Colorado decision has addressed the application of the learned intermediary rule to pharmacies, however language in Thornton v. DaVita Healthcare Partners, Inc., 2014 WL 1389958 (D. Colo. April 9, 2014) (citing pharmacy case from Arkansas), recognizes that it does elsewhere.

We have not found a learned intermediary rule case about a biologic under Colorado law.

Connecticut

In Vitanza v. Upjohn Co., 778 A.2d 829, 836-38 (Conn. 2001), the Connecticut Supreme Court adopted the learned intermediary rule in a prescription drug case.

The learned intermediary doctrine provides that adequate warnings to prescribing physicians obviate the need for manufacturers of prescription products to warn ultimate consumers directly. The doctrine is based on the principle that prescribing physicians act as “learned intermediaries” between a manufacturer and consumer and, therefore, stand in the best position to evaluate a patient’s needs and assess the risks and benefits of a particular course of treatment.

Id. at 836-37 (citation and quotation marks omitted).  The learned intermediary rule was extended to medical devices in the Hurley litigation.  Hurley v. Heart Physicians, P.C., 898 A.2d 777, 783-84 (Conn. 2006) (“Although we adopted the learned intermediary doctrine in the context of prescription drugs [in Vitanza], we did not decide whether the policies behind the rule equally were applicable to prescription medical device cases.  Numerous courts have determined that they are applicable to prescription medical device cases.”) (citations and footnote omitted); Hurley v. Heart Physicians, P.C., 3 A.3d 892, 900 (Conn. 2010) (“we would agree with the defendant that the trial court properly rendered judgment in its favor on the learned intermediary doctrine”).

A combination of state and federal trial courts has applied the learned intermediary rule to pharmacists.  DiVincenzo v. Molinaro, 2022 WL 17102332, at *3 (Conn. Super. Nov. 2, 2022); Levesque v. Cluett, 2007 WL 4305676, at *3 (Conn. Super. Oct. 16, 2007); Deed v. Walgreen Co., 927 A.2d 1001, 1003-04 (Conn. Super. 2007); Plante v. Lomibiao, 2005 WL 1090180, at *3-4 (Conn. Super. March 31, 2005); Deed v. Walgreen Co., 2004 WL 2943271, at *5 (Conn. Super. Nov. 15, 2004); White v. Stop & Shop Cos., 1998 WL 559730, at *2 (D. Conn. Aug. 17, 1998).

Delaware

In Lacy v. G.D. Searle & Co., 567 A.2d 398 (Del. 1989), the Delaware Supreme Court adopted the learned intermediary rule in a case involving an intrauterine device, and held that the rule applied to both prescription drugs and medical devices.

We hold that it was appropriate . . . to apply the theory of the learned intermediary in this case.  A patient obviously is unable to obtain a prescription drug (or a device of this type) unless his physician orders it.  When a patient consults with a physician seeking a prescription drug or restricted device, the patient also expects the physician to use his informed independent judgment to advise the patient and to prescribe the most appropriate use of the drug or device, based on his professional judgment.  In the final analysis it is the physician who ultimately prescribes the drug or device.  Thus, if the manufacturer of prescription products provides the physician with the legally appropriate information, it has satisfied its duty to warn.

Id. at 400 (emphasis added).

Numerous state and federal trial courts have applied the Delaware learned intermediary rule to both drugs and devices.  Godreau-Rivera v. Coloplast Corp., 598 F. Supp.3d 196, 216-217 (D. Del. 2022) (device); Evans v. Johnson & Johnson Co., 2020 WL 616575 at *4 (D. Del. Feb. 10, 2020) (drug); Green v. Janssen Pharmaceuticals, Inc., 2019 WL 1567841, at *2 (D. Del. April 11, 2019) (drug); Hopkins v. Janssen Pharmaceuticals, Inc., 2019 WL 1567840, at *3 (D. Del. April 11, 2019) (drug); Trower v. Janssen Pharmaceuticals, Inc., 2019 WL 1571834, at *4 (D. Del. April 11, 2019) (drug); Guinan v. A.I. Dupont Hospital for Children, 597 F. Supp.2d 485, 497-98 (E.D. Pa. 2009) (investigational device), rev’d on other grounds, 393 F. Appx. 884 (3d Cir. 2010); Boros v. Pfizer, Inc., 2019 WL 1558576, at *3 (Del. Super. March 25, 2019) (drug); Barba v. Carlson, 2014 WL 1678246 at *2 (Del. Super. April 8, 2014) (device); Crookshank v. Bayer Healthcare Pharmaceuticals, 2009 WL 1622828, at *3 (Del. Super. May 22, 2009) (device); O’Brien-Hastings v. Howmedica Corp., 1996 WL 944855, at *4 (Del. Super. May 15, 1996) (device).

We have not seen any Delaware law learned intermediary decisions concerning pharmacists or biologics.

District of Columbia

In the District of Columbia, Mampe v. Ayerst Laboratories, 548 A.2d 798 (D.C. 1988), recognized that in prescription drug cases, “the user” is “the prescribing physician.”  Id. at 801.  “When the purchase of the product is recommended or prescribed by an intermediary who is a professional, the adequacy of the instructions must be judged in relationship to that professional.”  Id. at 802 n.6 (citation and quotation marks omitted).  The rule’s applicability to medical devices was recognized in Kubicki v. Medtronic, Inc., 293 F. Supp.3d 129, 188-89 (D.D.C. 2018).

[T]he learned intermediary doctrine . . . holds that, because prescription devices are available to the public only through a physician and are to be administered only under a physician’s supervision, the device manufacturer’s duty is to adequately inform the physician, who is expected to function as a “learned intermediary” between the company and the patient in protecting the patient and providing direct information about the device to the patient.

Id. at 188 (citation and quotation marks omitted).

The learned intermediary rule has also been applied in D.C. pharmacy cases.  Ealy v. Richardson-Merrell, Inc., 1987 WL 159970, at *2-3 (D.D.C. Jan. 12, 1987) (following Raynor); Raynor v. Richardson-Merrell, Inc., 643 F. Supp. 238, 246-47 (D.D.C. 1986) (refusing “to impose a duty to warn on pharmacies,” because “such a duty would, in effect, require a pharmacy to substitute its judgment for that of the prescribing physician”).

We are unaware of a biologic learned intermediary rule decision under DC law.

Florida

The Florida Supreme Court has repeatedly followed the learned intermediary rule, beginning with Felix v. Hoffmann-LaRoche, Inc., 540 So.2d 102, 104 (Fla. 1989).

[I]t is clear that the manufacturer’s duty to warn of [the drug’s] dangerous side effects was directed to the physician rather than the patient.  This is so because the prescribing physician, acting as a “learned intermediary” between the manufacturer and the consumer, weighs the potential benefits against the dangers in deciding whether to recommend the drug to meet the patient’s needs.

Id. at 104 (citation omitted).  Accord Upjohn Co. v. MacMurdo, 562 So. 2d 680, 683 (Fla. 1990) (“The manufacturer’s duty to warn of the drug’s dangerous side effects is directed to the physician rather than the patient.”) (citation omitted).

In E.R. Squibb & Sons, Inc. v. Farnes, 697 So.2d 825, 827 (Fla. 1997), the court affirmed application of the learned intermediary rule in the vaccine (biologics) context.  Accord Guarino v. Wyeth, LLC, 719 F.3d 1245, 1250 (11th Cir. 2013) (“Pharmaceutical manufacturers discharge their duty to warn the learned intermediary by way of a package insert which accompanies each vial of vaccine.”) (citation and quotation marks omitted); Christopher v. Cutter Laboratories, 53 F.3d 1184, 1192-93 (11th Cir. 1995) (also applying learned intermediary rule in biologic case).

While the Florida Supreme Court has not addressed the learned intermediary rule in a medical device case, other appellate courts, both federal and state have applied it.  Cavanaugh v. Stryker Corp., 308 So.3d 149 (Fla. App. 2020), held:

Even assuming that some version of the consumer expectations test should apply to complex medical products which are provided to a consumer through a learned intermediary, the standard instruction would need to be modified in order to inform the jury that the relevant expectations are those of the health care professional.  The Plaintiff’s proposed instruction as written would have been misleading to the jury because it failed to inform the jury that the relevant expectations are those of the medical professional, not the ordinary consumer.

Id. at 156 (citations omitted).  The Eleventh Circuit has agreed:

[I]n cases involving medical products . . . the duty of a device manufacturer to warn of dangers involved in the use of a device is satisfied if it gives adequate warning to the physician who prescribes the device.  The physician acts as a “learned intermediary” between the manufacturer and the patient, weighing the potential benefits of a device against the dangers in deciding whether to recommend it to meet the patient’s needs.  Thus, in order to satisfy the causation requirement in a medical device failure-to-warn claim, a plaintiff must show that her treating physician would not have used the product had adequate warnings been provided.  The learned intermediary doctrine is a longstanding feature of Florida law.

Salinero v. Johnson & Johnson, 995 F.3d 959, 964-65 (11th Cir. 2021) (citations and quotation marks omitted).  Accord Cates v. Zeltiq Aesthetics, Inc., 73 F.4th 1342, 1347 (11th Cir. 2023) (“We must first address whom a product manufacturer must warn.  In cases involving medical devices . . ., the device manufacturer has a duty to warn the physician who prescribes the device.) (citation and quotation marks omitted); Eghnayem v. Boston Scientific Corp., 873 F.3d 1304, 1321 (11th Cir. 2017) (“For medical products like [this device], the duty to warn is directed to physicians rather than patients under the ‘learned intermediary’ doctrine.”) (citation omitted); Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1330 (11th Cir. 2017) (“[Defendant’s] duty . . . if any, was to the physician, not [plaintiff].  We therefore affirm . . . dismissal of [plaintiff’s] negligence claim to the extent it was premised on an improper training theory.”) (citation omitted).  In addition, Beale v. Biomet, Inc., 492 F. Supp.2d 1360, 1367-68 (S.D. Fla. 2007), has been particularly influential in the medical device context.

In McLeod v. M.S. Merrell Co., 174 So.2d 736, 738-39 (Fla. 1965), the Florida high court also exempted pharmacists from duty to warn liability, but without specifically mentioning the rule.  Another Florida case reaching the same result is Estate of Johnson v. Badger Acquisition of Tampa LLC, 983 So.2d 1175, 1186 n.4 (Fla. App. 2008) (“imposing a duty to warn on the pharmacist would intrude on the doctor-patient relationship and would force the pharmacist to practice medicine without a license”) (citation and quotation marks omitted).

Georgia

In McCombs v. Synthes (U.S.A.), 587 S.E.2d 594, 595 (Ga. 2003), the Georgia Supreme Court recognized the learned intermediary rule in a medical device case, and also held that it applied to prescription drugs.

Under the learned intermediary doctrine, the manufacturer of a prescription drug or medical device does not have a duty to warn the patient of the dangers involved with the product, but instead has a duty to warn the patient’s doctor, who acts as a learned intermediary between the patient and the manufacturer.  The rationale for the doctrine is that the treating physician is in a better position to warn the patient than the manufacturer, in that the decision to employ prescription medication or medical devices involves professional assessment of medical risks in light of the physician’s knowledge of a patient’s particular need and susceptibilities.

Id. at 595 (footnotes and quotation marks omitted).  See In re Bard IVC Filters Products Liability Litigation, 969 F.3d 1067, 1076 (9th Cir. 2020) (quoting and following McCombs) (applying Georgia law).

Georgia appellate courts have also barred claims against pharmacists.  Nail v. State, 686 S.E.2d 483, 485-86 (Ga. App. 2009) (quoting and following Chamblin); Chamblin v. K-Mart Corp., 612 S.E.2d 25, 28 (Ga. App. 2005) (McCombs’ “reasoning that the treating physician is in a better position to warn a patient of the dangers associated with a drug or medical device would seem to apply in the case of a pharmacist as well”).

We have not seen a Georgia biologic case involving the learned intermediary rule.

Hawai’i

Similarly to Georgia, the Hawai’i Supreme Court adopted the learned intermediary rule in a medical device (breast implant) case.

The learned intermediary rule assumes that it is reasonable for a manufacturer to rely on the prescribing physician to forward to the patient, who is the ultimate user of the drug products, any warnings regarding their possible side effects.  The rule does not alter the duty of a manufacturer to provide adequate warnings rather, the doctrine simply substitutes the physician for the consumer as the person to receive those warnings.  Because the manufacturer has little or no contact with the ultimate consumer and the treating physician makes the purchasing decisions and judgments concerning medical products, the warnings are better conveyed to the physician user.

Craft v. Peebles, 893 P.2d 138, 155 (Haw. 1995) (citations and quotation marks omitted).  Of course, Hawai’i courts have applied the learned intermediary rule in prescription drug cases as well.  Evans v. Gilead Sciences, Inc., 2020 WL 5189995, at *12 (D. Haw. Aug. 31, 2020) (“Hawai’i adheres to the ‘learned intermediary’ rule in the the prescription drug arena.”) (citation and quotation marks omitted); Forsyth v. Eli Lilly & Co., 1998 WL 35152135, at *6 (D. Haw. Jan. 5, 1998) (“a drug manufacturer can presume that its warnings will be passed on from the prescribing physician to the ultimate patient/consumer under the ‘learned intermediary’ doctrine”) (citation omitted); Yamane v. Wyeth, 2012 WL 1120367 ¶23 (Haw. Cir. Jan. 3, 2012) (“conclud[ing] that plaintiffs’ state-law tort claims are also barred as a matter of law by the learned intermediary doctrine”).

We were unable to find any biologic or pharmacy liability cases out of Hawai’i.

Idaho

Idaho is an odd duck.  Idaho’s highest court has adopted the learned intermediary rule, but not in the prescription medical product context.

[I]n some circumstances a supplier positioned on the commercial chain remote from the ultimate consumer may fulfill its duty to warn by adequately warning an intermediary. . . .  [T]he first [of these] being when a drug manufacturer properly warns a prescribing physician of the dangerous propensities of its product.  The doctor stands as a learned intermediary between the manufacturer and the ultimate consumer. Generally, only the doctor could understand the propensities and dangers involved in the use of a given drug.

Sliman v. Aluminum Co. of America, 731 P.2d 1267, 1270 (Idaho 1986) (citations and quotation marks omitted).

An early vaccine/biologic case under Idaho law held, “Ordinarily in the case of prescription drugs warning to the prescribing physician is sufficient,” but created an exception for mass immunizations.  Davis v. Wyeth Laboratories, Inc., 399 F.2d 121, 130-31 (9th Cir. 1968).  The only other learned intermediary rule decision under Idaho law is a medical device decision, In re Zimmer M/L Taper Hip Prosthesis or M/L Taper Hip Prosthesis with Kinectiv Technology & Versys Femoral Head Products Liability Litigation, 2021 WL 3475681, at *11 (S.D.N.Y. Aug. 6, 2021) (“the learned intermediary doctrine applies, so that [defendant’s] duty to warn ran to [the] surgeon”), reconsideration denied, 2021 WL 4251906 (S.D.N.Y. Sept. 17, 2021) (applying Idaho law).

No Idaho law pharmacy learned intermediary rule cases turned up.

Illinois

Illinois, by contrast, has a plethora of learned intermediary rule precedent.  The Illinois Supreme Court first followed the rule in Kirk v. Michael Reese Hospital & Medical Center, 513 N.E.2d 387 (Ill. 1987), involving prescription drugs:

[A]dequate warnings are to be given to physicians only and not to the public generally. . . .  The rule, as adopted in numerous jurisdictions, provides that manufacturers of prescription drugs have a duty to warn prescribing physicians of the drugs’ known dangerous propensities, and the physicians, in turn, using their medical judgment, have a duty to convey the warnings to their patients.  We cannot quarrel with the general proposition that where prescription drugs are concerned, the manufacturer’s duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the drug’s use. . . .  The doctor, functioning as a learned intermediary between the prescription drug manufacturer and the patient, decides which available drug best fits the patient’s needs and chooses which facts from the various warnings should be conveyed to the patient, and the extent of disclosure is a matter of medical judgment.  As such, we believe the learned intermediary doctrine is applicable here and that there is no duty on the part of manufacturers of prescription drugs to directly warn patients.

Id. at 392-93 (citations and quotation marks omitted).  Accord Martin v. Ortho Pharmaceutical Corp., 661 N.E.2d 352, 356 (Ill. 1996) (“We agree with those decisions which have declined to recognize an exception to the learned intermediary doctrine for manufacturers of contraceptive pharmaceuticals.”)

The Illinois high court applied the learned intermediary rule in the medical device context in Hansen v. Baxter Healthcare Corp., 764 N.E.2d 35 (Ill. 2002):

Generally, the manufacturer of a prescription medical device has a duty to warn prescribing physicians or other health professionals who may prescribe the device of the product’s known dangerous propensities.  Likewise, physicians, using their medical judgment, have a duty to convey the warnings to their patients.  The duty to warn the health-care professional, rather than the ultimate consumer or patient, is an expression of the “learned intermediary” doctrine.

Id. at 42.

The Illinois Supreme Court has likewise recognized that the learned intermediary rule precludes pharmacists from owing generalized warning duties:

[W]e think that it is unreasonable to argue that by placing only the [one] label on the prescription container, a pharmacist might mislead a consumer into believing that [the labeled risk] is the only side effect of [the drug].  In our opinion, consumers should principally look to their prescribing physician to convey the appropriate warnings regarding drugs, and it is the prescribing physician’s duty to convey these warnings to patients.

Frye v. Medicare-Glaser Corp., 605 N.E.2d 557, 561 (Ill. 1992) (citation omitted).  See also Happel v. Wal-Mart Stores, Inc., 766 N.E.2d 1118, 1127 (Ill. 2002) (“[P]harmacists should not have a duty to warn a patient or physician of the adverse side effects of prescription drugs [because i]mposing such a duty . . . would require the pharmacist to learn the customer’s condition and monitor his drug usage. To accomplish this, the pharmacist would have to interject himself into the doctor-patient relationship and practice medicine without a license.”).  Indeed, the Seventh Circuit considered pharmacy non-liability so well established in Illinois that it held joining pharmacies to be fraudulent joinder.  Walton v. Bayer Corp., 643 F.3d 994, 1001 (7th Cir. 2011).

The learned intermediary rule was applied to a biologic in Tongate v. Wyeth Laboratories, 580 N.E.2d 1220, 1224-55 (Ill. App. 1991).  Accord Mohr v. Targeted Genetics, Inc., 690 F. Supp.2d 711, 719-20 (C.D. Ill. 2010); Erickson v. Baxter Healthcare, Inc., 151 F. Supp.2d 952, 962 (N.D. Ill. 2001).

Indiana

Indiana is another state, like Colorado, where the learned intermediary rule has been adopted by the state’s intermediate appellate court.  That first happened in a decision involving a prescription contraceptive drug.  An “important limitation on liability in [the prescription drug] context . . . applies to manufacturers of ethical drugs.  Since such drugs are available only by prescription, a manufacturers duty to warn extends only to the medical profession, and not the ultimate users.”  Ortho Pharmaceutical Corp. v. Chapman, 388 N.E.2d 541, 548 (Ind. App. 1979) (citations and footnote omitted).  See also Ziliak v. AstraZeneca LP, 324 F.3d 518, 521 (7th Cir. 2003) (defendant “is absolved of strict liability so long as it has imparted adequate warnings to treating physicians”) (citation omitted).

Several intermediate Indiana appellate decisions have since recognized the rule’s applicability in pharmacy liability cases.  Ingram v. Hook’s Drugs, Inc., 476 N.E.2d 881 (Ind. App. 1985), held:

[T]he duty to warn of hazards associated with prescription drugs is part and parcel of the physician-patient relationship. . . .  The decision of weighing the benefits of a medication against potential dangers that are associated with it requires an individualized medical judgment.  This individualized treatment is available in the context of a physician-patient relationship which has the benefits of medical history and extensive medical examinations.  It is not present, however, in the context of a pharmacist filling a prescription for a retail customer.  The injection of a third-party in the form of a pharmacist into the physician-patient relationship could undercut the effectiveness of the ongoing medical treatment.  We perceive the better rule to be one which places the duty to warn of the hazards of the drug on the prescribing physician and requires of the pharmacist only that he include those warnings found in the prescription.

Id. at 886-87 (“concur[ing]” with Chapman).  Accord Allberry v. Parkmor Drug, Inc., 834 N.E.2d 199, 202 (Ind. App. 2005) (“imposing such a [warning] duty on the pharmacist would place the pharmacist between the physician − who knows the patient’s physical condition − and the patient and could lead to harmful interference in the patient-physician relationship”); Peters v. Judd Drugs, Inc., 602 N.E.2d 162, 165 (Ind. App. 1992) (“a pharmacist had no duty to warn a consumer of the possible side effects of a prescription drug prescribed by a physician”).

Oddly, there is no Indiana state appellate precedent applying the learned intermediary rule in the medical device context.  Federal appellate authority fills this gap.  Kaiser v. Johnson & Johnson, 947 F.3d 996, 1015 (7th Cir. 2020) (“Under Indiana’s learned-intermediary doctrine, a medical-device manufacturer can discharge this duty by providing adequate warnings to physicians.”); Phelps v. Sherwood Medical Industries, 836 F.2d 296, 303 (7th Cir. 1987) (“This ‘learned intermediary’ exception has equal application to those cases concerning medical devices.”).  See Hammons v. Ethicon, Inc., 190 A.3d 1248, 1270 (Pa. Super. 2018) (“Indiana follows the learned intermediary doctrine, under which [defendant’s] duty to warn for a prescription-only product like [this device] ‘extends only to the medical profession, and not the ultimate users.’”) (quoting Chapman), aff’d, 240 A.3d 537 (Pa. 2020) (applying Indiana law).

The only cases applying the Indiana learned intermediary rule to biologics are outside Indiana.  See Juday v. Sadaka, 2023 WL 6520487, at *2 (E.D. Pa. Oct. 5, 2023) (“Under Indiana law, the learned intermediary doctrine applies to this claim.”); Cleary v. Biogen, Inc., 2017 WL 8226624, at *8-12 (Mass. Super. Sept. 8, 2017) (“The learned intermediary doctrine applies to failure to warn claims in Indiana.”) (citation omitted).

Iowa

While the Iowa Supreme Court never directly addressed the learned intermediary rule, it “recognize[d]” the rule as an example of a “‘no duty’ rule[] in the warning area based on . . . lack of control” in McCormick v. Nikkel & Associates, Inc., 819 N.W.2d 368, 375 (Iowa 2012).

The only Iowa law decisions directly applying the learned intermediary rule in prescription medical product liability litigation are federal.  Petty v. United States, 740 F.2d 1428 (8th Cir. 1984), applied the rule – and its mass-immunization exception − in a vaccine (biologic) case.  “[I]n a mass immunization context, where there is no learned intermediary, the duty extends to the ultimate recipient of the vaccine.”  Id. at 1440.

Several federal district court decisions have applied the rule.  Kelly v. Ethicon, Inc., 2020 WL 6120155, at *7 (N.D. Iowa Oct. 16, 2020) (following Willet; medical device case), reconsideration denied, 2021 WL 7185090 (N.D. Iowa, March 9, 2021); Kelly v. Ethicon, Inc., 2020 WL 4572348, at *4 (N.D. Iowa Aug. 7, 2020) (“Under the learned intermediary doctrine, a manufacturer of prescription drug or medical device need not provide warnings directly to patients using its products so long as adequate warnings were given to the health care provider supplying the products to patients.”) (citations omitted); Wessels v. Biomet Orthopedics, 2020 WL 3421478, at *14 (N.D. Iowa June 22, 2020) (“Under [the learned intermediary] rule, [defendant] need only have adequately warned [the implanter] about the risks of the [medical device], not [plaintiff] himself.”); Nicholson v. Biomet, Inc., No. 18-CV-3057-CJW-KEM, 2020 WL 3399899 at *19 (N.D. Iowa March 6, 2020) (citing McCormick and Petty medical device case); Willet v. Johnson & Johnson, 2019 WL 7500524, at *2 (S.D. Iowa Sept. 30, 2019) (“in the context of prescription medical devices and drugs, Iowa follows the learned intermediary doctrine”); Gilliland v. Novartis Pharmaceuticals Corp., 34 F. Supp.3d 960, 969 (S.D. Iowa 2014) (“manufacturers of prescription drugs discharge their duty of care to patients by warning the health-care providers who prescribe and use the drugs to treat them”); Madsen v. American Home Products Corp., 477 F. Supp.2d 1025, 1033-34 (E.D. Mo. 2007) (“the Court believes that Iowa would adopt the doctrine”) (citing Petty) (applying Iowa law); Doe v. Baxter Healthcare Corp., 2003 WL 27384538, at *4 (S.D. Iowa June 3, 2003) (the learned intermediary rule “has been recognized by the Eighth Circuit, applying Iowa law”; biologic case) (following Petty), aff’d, 380 F.3d 399 (8th Cir. 2004).

We don’t know of any pharmacist cases from Iowa.

Kansas

In Wooderson v. Ortho Pharmaceutical Corp., 681 P.2d 1038, 1052 (Kan. 1984), the Kansas Supreme Court “conclude[d]” that the defendant “had a duty to warn the prescribing physician” and “h[e]ld that the manufacturer of an ethical drug has a duty to warn the medical profession of dangerous side effects of its products.”  Id. at 1057.  Wooderson did so after a lengthy discussion of learned intermediary cases from other jurisdictions.  Id. at 1049-56.  Accord Humes v. Clinton, 792 P.2d 1032, 1042-43 (Kan. 1990) (“under the learned intermediary rule drug manufacturers are not liable for failure to directly warn patients of risks and side effects”); Savina v. Sterling Drug, Inc., 795 P.2d 915, 929 (Kan. 1990) (“This case involves an individualized medical decision and the learned intermediary rule applies.”) (prescription drug case).

In Johnson v. American Cyanamid Co., 718 P.2d 1318 (Kan. 1986), the court extended the rule to vaccines/biologics:

As in the case before us, the drug in Wooderson was sold to a physician who, in turn, prescribed/administered the drug to the patient.  As recognized in Wooderson, under such circumstances the “learned intermediary” concept comes into play. The manufacturer’s duty is to adequately warn the physician of a known risk.

Id. at 1324.

Also, in Tetuan v. A.H. Robins Co., 738 P.2d 1210 (Kan. 1987), the court applied the learned intermediary rule to a medical device.  Such devices “are ethical products − that is, they are available only through licensed medical care providers.”  Id. at 1227.

[T]he patient is expected to look to the physician for guidance and not to the manufacturer of the products which he may use or prescribe in the course of treatment.  We apply that same rationale to plaintiff’s action for fraud . . ., and we hold that, where a patient relies on a physician for treatment or advice as to an ethical or prescription device, justifiable reliance by the physician . . . constitutes justifiable reliance by the patient.

Id. at 1228 (citation and quotation marks omitted).  Accord Ralston v. Smith & Nephew Richards, Inc., 275 F.3d 965, 974-75 (10th Cir. 2001) (applying learned intermediary rule in medical device case).

In Nichols v. Central Merchandise, 817 P.2d 1131, 1133 (Kan. App. 1991), the court barred pharmacist claims.  Id. at 1133 (“because the doctor is the learned intermediary between the manufacturer and the patient, the patient should rely on the doctor; the pharmacist . . . has no legal duty to warn the patient of potential consequences from the use of the drug prescribed by the doctor”).

This is the end of Part 1.  Look for Part 2 next week.

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We observed arguments last week in the California Supreme Court in Gilead Tenofovir Cases, and quality advocates on both sides put on a great performance.  As we previewed last week, the case presents a question with potentially sweeping consequences for product liability law: Does a pharmaceutical manufacturer owe a duty of reasonable care to users of a non-defective medicine when making decisions about the development of an allegedly safer and equally effective alternative compound?

In other words, when a patient experiences an alleged side effect when using a non-defective medicine, can the patient sue anyway and claim the manufacturer should have developed an allegedly safer alternative faster than it actually did?  In an unprecedented ruling, the California Court of Appeal recognized this novel claim. 

The plaintiffs in these cases allege injuries from taking TDF-based HIV antiretroviral medications, but they concede that their TDF meds are not defective.  They allege instead that the manufacturer unreasonably delayed developing an alternative that plaintiffs allege was safer—TAF-based medications.   

As expected, the advocacy on both sides was top notch.  For the pharmaceutical manufacturer, counsel followed three themes.  First, the manufacturer’s development of TDF-based drugs saved thousands of lives, and the Court of Appeal’s new duty purporting to regulate pharmaceutical development would impose an unacceptable social cost for multiple reasons.  Second, the existence of an allegedly safer alternative certainly could be relevant to whether TDF medicines were defective—but not to create new tort duty.  Third, the Court of Appeal’s new duty is unnecessary.  Manufacturers do not delay the commercialization of good products, and the existing duty under California law to produce reasonably safe, non-defective products already protects consumers. 

So off they went.  Counsel noted at the outset that when suing for a personal injury allegedly caused by a product, the plaintiff needs to prove a product defect.  This is a sound argument based on decades of California law, and it is enough here to win.

Counsel, however, immediately pivoted to explain why the Supreme Court should reject the Court of Appeal’s new duty, and it was a compelling introduction.  To start, no other court has ever recognized such a duty, and doing so would be costly to public health.  Indeed, this is the only duty in history where the development of an allegedly safer product resulted in a new duty of care.  Moreover, imposing this duty to innovate will redirect scarce resources from beneficial development in existing products to alternative development pathways.  That is particularly poignant here because the pharmaceutical manufacturer invested in developing a single, combined TDF-based medicine at the FDA’s urging, resulting in a combination medicine that saved lives.  Under the Court of Appeal’s new duty, the manufacturer had a legal duty to spend its scarce development resources on something else.  The Court of Appeal’s new duty also creates a new plaintiff class for the path not taken, and it places manufacturers in a position where learning a little bit about the safety of a back-up molecule will now require pushing further, thus slowing the development of an existing better medicine.  This is not a good outcome. 

Importantly, counsel acknowledged that it would be relevant if a plaintiff could show that a manufacturer delayed the release of an alternative product with full knowledge of potential harm and for the sole purpose of profit.  Even though no one has explained why a manufacturer would ever do that, there might well be a duty there because those circumstances could show a safer feasible alternative—and that is a factor in determining whether a product is defective. 

This is a key point.  Hyperbolic allegations of intentional wrongdoing and hypothetical evidence of companies rejecting “safer” alternatives because they are “too expensive” grab the attention.  But the concept of a safer alternative design is already embedded in the existing duty.  In other words, allegations of a safer alternative can be relevant to defect, but not a new tort. 

Yes, there is a general duty to avoid unreasonably doing harm to others, but juries should not weigh social costs twenty years after the fact, and the Court should not create duties unless there is evidence of a problem requiring a solution.  Product manufacturers do not delay the commercialization of good products, and patients are already protected by the duty to make reasonably safe, non-defective products.  They are also protected by the FDA.  In the end, the Court of Appeal’s new duty imposes an unacceptable social cost will stifle innovation. 

Plaintiffs’ counsel countered with plaintiffs’ own three themes.  First, this is not new—it is “bedrock” principle that everyone is responsible for the failure to exercise reasonable care.  Second, this case is not about a product defect; it is about the manufacturer’s unreasonable conduct in delaying development of an allegedly safer product for the sake of profit, resulting in harm to TDF patients.  Third, public policy does not justify creating an exemption for pharmaceutical manufacturers.

In our biased view, it was startling that plaintiffs’ counsel referred to harm to “thousands” without once acknowledging that TDF-based drugs have indisputably saved thousands of lives, including probably many of the plaintiffs.  When asked directly, “What is the duty,” counsel echoed the Court of Appeal’s tortured attempt to limit the duty to the allegations of these cases:  The duty arises when a manufacturer is currently selling a drug, which is not defective, but the manufacturer has decided to delay commercialization of an alternative that it knows to be safer and more effective.  The alleged breach is the decision to “press pause.” 

Here more than one justice tried to steer plaintiffs back into traditional tort duties and the law of product defect.  In other words, if the plaintiffs’ allegations are that the manufacturer is selling a product that made them sick, why not just plead it that way?  And why is the manufacturer’s knowledge of a safer alternative not relevant to a defect in TDF-based medicines?  Counsel resisted taking this offramp (which she also did in the Court of Appeal) and repeated that the duty is based on the manufacturer’s decision to delay development of TAF under its own timeline. 

Which provoked another round of questioning on what the duty is and when it arises.  One justice noted that a patient on TDF-based medicine might suffer from kidney injury, but without the medicine, the patient might not have lived long enough to experience that alleged complication.  Moreover, product development “does not happen overnight or for free.”    

The panel continued to question the details.  When asked whether a duty could arise based on the study of 30 patients, with no Phase III clinical trial, counsel replied (again) that the breach is the failure to act reasonably.  When asked about whether the company should have proceeded to later-phase clinical trials and whether it mattered that the manufacturer has limited resources, counsel replied that the jury can decide. 

One justice noted that counsel kept coming back to reasonableness and wondered whether this is a problem for the legislature.  The law does not prevent profit from innovation, and it is uncomfortable to allow a court or jury to determine whether a company should lose profit because it innovated more and innovated better.  Counsel replied that the opposite is uncomfortable too—giving a company special treatment, when pharmaceutical companies already make lots of money.  The duty of reasonable care does not impact innovation.  

Counsel for the manufacturer made several points in rebuttal, but the most powerful was that plaintiffs’ expansive duty to “be reasonable” is not workable.  The struggle to articulate precisely what this duty is demonstrates why we have the requirement to prove a product defect.  In the end, this appeal is about life-and-death decisions and developing drugs that save lives.  The Supreme Court should embrace the duty to make a non-defective product, not an expansion of tort law that is unnecessary and unwarranted. 

We will not hazard a guess at the likely outcome.  One justice was clearly on the plaintiff’s side.  Another showed a willingness to engage the issues outside the framework of tort law.  Multiple justices tested what the duty should be and when it ought to arise, whether within the framework of existing tort law or not.  We know where we stand:  The Court of Appeal’s new duty is gratuitous.  If these plaintiffs have experienced alleged complications from their treatment, they have a remedy—so long as they can prove a product defect.  The opinion should come out within 90 days.

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This post is from the non-RS side of the Blog.

Consider the following scenario.  A fifty-two-year-old woman has end-stage left ventricular heart failure despite medical care and the latest medications.  Her prospects for a heart transplant or the implantation of a left-ventricular assist device to prolong her life are limited, including by financial considerations.  She chooses to enroll in a clinical trial for people like her, is accepted after a rigorous informed consent process, and is randomly allocated to the investigational device group in the study.  The investigational device is a cutting-edge magnetically levitated centrifugal-flow left ventricular assist device, whereas the other option in the study is a mechanical-bearing axial-flow left ventricular assist device.  Her investigational device is implanted at a premier medical institution.  All the costs of her care in connection with the study are borne by the sponsor of the study, a medical device company that also makes some of the axial-flow devices on the market.  A few years before her enrollment, FDA approved an Investigational Device Exemption for her clinical trial.  Even though the new device is intended for short-term use in a heart failure patient or as a short-term bridge to a heart transplant, the woman lives another three years with the magnetically levitated centrifugal-flow left ventricular assist device keeping her heart functioning.  Along the way, FDA approves the device’s Premarket Market Approval application, including the device’s design, warnings, and other labeling.  Yet the study continues to provide the woman with free medical care related to her implanted device.  Also, the results of the clinical study are published three times in the New England Journal of Medicine, with the third publication noting that “a fully magnetically levitated centrifugal-flow left ventricular assist device was associated with less frequent need for pump replacement than an axial-flow device and was superior with respect to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device.”  In laymen’s terms, the investigational device was a great success.  About a month after that third article, the woman was alerted to a malfunction in her implanted device, so she called the number she had from her investigators/providers at this premier medical institution.  Unfortunately, the woman died that day, which her daughters blamed on the level of training of the provider with whom the woman spoke on the day she died.  Instead of being thankful for the three extra years with their mother and the free care she had received, the daughters sued.  In addition to the hospital and investigator, they sued the manufacturer/sponsor in California state court under a number of product liability theories.

This is what happened in Galdamez v. Abbott Cardiovascular Sys., Inc., No. CGC-21-591082, 2026 WL 1303411 (Cal. Super Ct. May 7, 2026), slip op., with a little color added from a few minutes of fishing around on reputable sites on the internet.  It should be obvious to Blog readers and anyone knowledgeable about preemption, that most of the plaintiffs’ claims would be preempted.  Design and warnings claims against devices with a PMA or IDE approval at a relevant time are preempted.  Parallel claims are an overblown fallacy.  Plaintiffs will almost never have the device- or lot-specific evidence to sustain a manufacturing defect claim, generally making design arguments and labeling them manufacturing arguments.  We saw all of that in Galdamez.  We also saw that the plaintiff failed to dispute any of the manufacturer’s facts according to the California summary judgment procedure and failed to respond to some of the manufacturer’s arguments at all.  By the time the court ruled on the manufacturer’s motion for partial summary judgment, about five years had passed since the case was filed.  Regardless of why it took so long or why defendants held off on seeking complete summary judgment—the court even said the express preemption claim that was not raised in the motion would be preempted once challenged—the remnants of the case limp along when the case never should have been brought against the manufacturer/sponsor in the first place.  (The decision does not provide enough information to weigh in on whether plaintiffs could show substandard care by the decedent’s healthcare providers, but that would not create liability for the manufacturer/sponsor anyway.)

So why are we discussing a state court partial summary judgment ruling?  We certainly do pay attention to cases addressing the liability of clinical trial sponsors.  That has been an interest since the Blog’s infancy.  We also like to see what wacky arguments plaintiffs make as they try to dance between express and implied preemption.  We also think this is a good example of what is wrong with the “duty to innovate” claim presently before the California Supreme Court.  Taking the last first, the plaintiffs did not assert that the manufacturer/sponsor has breached a supposed “duty to innovate” and the court did not address it.  After all, this device was the first of its kind.  Pretend, though, that a different plaintiff was suing over one of this defendant’s marketed axial-flow devices that was implanted at the same time as the implant in the Galdamez plaintiffs’ decedent.  It could even have been implanted within the Galdamez plaintiffs’ decedent’s clinical trial as part of the established therapy arm of the trial; this was a non-inferiority trial with, of course, no ethical possibility for a placebo comparator.  At what point in time—interim results, PMA submission for the new device, PMA approval, or two years after PMA approval, to name four options—would the ludicrous “duty” require the manufacturer to pull its axial flow devices in favor of the centrifugal flow device?  Given the position of the Bartlett court (and, apparently, the Galdamez court) that any stop selling theory for an FDA-approved medical product would be preempted, why would any court entertain creating a novel but invariably preempted claim?  As we run through what plaintiff threw at the innovative device in Galdamez, we suggest keeping in mind how other plaintiffs would use the innovative device in a suit over an older device that was still marketed and widely used.

First up were plaintiffs’ design defect claims.  Plaintiffs contended that the design approved as part of the IDE and later the PMA was defective because of its purported propensity to blow a fuse.  Because of the timing, the preemptive effect would have come from the IDE approval, so plaintiffs contended that IDEs should be treated like 501(k)s under Lohr and have no preemptive effect.  The court disagreed based on a California case, Robinson v. Endovascular Techs., Inc., 190 Cal.App.4th 1490 (Cal. Ct. App. 2010), and two federal appellate decisions, Slater v. Optical Radiation Corp., 961 F.2d 1330 (7th Cir. 1992), and Martin v. Telectronics Pacing Sys., Inc., 105 F.3d 1090 (6th Cir. 1997).  We could quibble with the court saying it was bound by California authority on a Supremacy Clause issue and its omission of plenty of additional authority supporting IDE preemption of design claims, but the best plaintiffs could do was complain that the California case is old and an outlier—which it is not.

Next up was a claim for failure to recall, which is pretty silly in the context of a pre-market clinical trial.  During briefing, Plaintiffs tried to shift to a “failure to report to FDA” theory based on the horrible Stengel decision (that turns on a non-existent state law claim).  The original claim was both abandoned and also preempted under Buckman, both because FDA has exclusive enforcement over withdrawing an IDE or recalling a marketed device.  During argument, Plaintiffs tried to shift to a failure to warn the clinical trial investigators and participants theory not asserted in their live complaint, but that also would have been preempted.

Plaintiffs also offered implied warranty theories, which failed under state law for lack of privity and were preempted for the same reasons that the design defect claims were.  We pause to ponder the assertion that a free, life-prolonging device received in connection with a randomized clinical trial where the patient knew in advance that she had a 50% chance of getting an investigational device could ever breach an implied warranty of merchantability.

Plaintiffs also tried to make the sponsor liable for the alleged wrong emergency number provided to plaintiffs’ decedent by the medical institution where she got her three years of free care in connection with the clinical trial.  Lacking any “authority for the proposition that a device manufacturer . . . owes a duty to a patient in a clinical trial to provide her with an emergency number,” plaintiffs were left to argue that the clinical trial was a joint venture under California law.  The clinical trial documents said that it was not and there were no other features of a joint venture, such as shared profits.

While it is possible that a clinical trial subject could receive substandard medical care in connection with her voluntary participation in a clinical trial that might lead to liability for treaters, when the trial involves an IDE device, the sponsor is almost never going to have liability.  After five years on the docket, there is no indication that Galdamez is the rare exception, and it is time for the sponsor of a trial that helped bring an innovative device to market to be out of the case.

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Today’s guest post from Justin Kadoura, a Holland & Knight product liability and toxic tort litigator, concerns a Supreme Court decision on an issue that might seem unrelated to the sort of case we cover at the DDL Blog.  However, federal officer removal does come up in our cases and we have covered it before.  As always, all credit and blame for a guest post goes to the guest poster.

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Before 2011, the federal officer removal statute allowed removal to federal court of any action that is (1) against “[t]he United States or any agency thereof or any officer (or any person acting under that officer) of the United States or of any agency thereof, sued in an official or individual capacity” and (2) “for any act under color of such office or on account of any right.”  28 U.S.C. § 1442 (a)(1) (1996).  In 2011, Congress amended the statute, expanding the second element to include suits “for or relating to any act under color of such office.”  Unlike most removal statutes, the federal officer removal statute is interpreted broadly in favor of removal.  Last month, in Chevron USA Inc. v. Plaquemines Parish, 608 U.S. __, 146 S. Ct. 1052 (2026), the Supreme Court held the “ordinary meaning” of Congress’s 2011 amendments continued that tradition of expansive federal officer jurisdiction.  Although the ultimate reach of the Court’s decision is unclear, it will likely open new doors to removal in environmental and toxic tort actions.

The Supreme Court’s decision is preceded by a long procedural history.  In 2013, several Louisiana parishes filed forty-two actions in state court against various oil and gas companies, including Chevron, for alleged violations of Louisiana’s 1978 State and Local Coastal Resources Management Act (the “Act”).  The Act created permitting requirements for use of Louisiana’s coastal zones, with exceptions for “individual specific uses legally commenced or established prior to” 1980.  La. Rev. Stat. Ann. § 49:214.34(C)(2).  The parishes alleged that the defendants used the coastal zones for oil drilling and exploration without meeting the permit requirements.  The defendants initially removed the actions to federal court in 2013, but the cases were remanded to state court for lack of jurisdiction.  Plaquemines Parish v. BP Am. Prod. Co., 103 F.4th 324, 330 (5th Cir. 2024).  In 2018, following remand, the parishes produced an expert report opining that the defendants’ pre-1980 uses of the coastal zones included, among other things, defendants’ crude oil production in during World War II, and that those uses were not “legally commenced or established” for purposes of the Act’s permitting exception because of defendants use of “vertical drilling,” earthen pits instead of steel tanks, and canals instead of roads.  Relying on the report, the defendants again removed the cases to federal court, asserting federal officer jurisdiction, which set off additional remand orders and two Fifth Circuit appeals.  Id. at 330–31.

In 2023, Plaquemines Parish moved to remand one of the other actions that had been stayed pending the second Fifth Circuit appeal.   Chevron argued that the Texas Company’s (Chevron’s predecessor) crude oil production in the coastal zones during WWII was connected with its refinement of crude oil to create “avgas” (aviation fuel used in the war effort) for the government at its refineries in Texas, and the challenged conduct was thus “in relation to” actions taken under color of federal law.  The district court and Fifth Circuit rejected Chevron’s argument, holding that although Chevron was a “person acting under [a federal] officer” vis-à-vis is oil its refining efforts during WWII, the parishes’ claims did not “relate to” those refining efforts.  Relying on Latiolais v. Huntington Ingalls, Inc., 951 F.3d 286 (5th Cir. 2020), the Fifth Circuit acknowledged that under the 2011 amendments to the statute, an action can “relate to” actions of a federal officer so long as the suit “is connected or associated with an act under color of federal office,” rejecting the pre-2011 requirement that there be a “causal nexus” between the two.  Id. at 335–36.  But the Fifth Circuit held that because the Texas Company’s federal contacts did not specify how it had to obtain the crude oil for use in its refinery operations, the Texas Company’s oil production did not “relate to” its avgas refining for the government.  “Although Defendants need not show that a federal officer directed the specific oil production activities being challenged, they still must show these activities had a sufficient connection with directives in their federal refinery contracts.”  Id. at 341 (footnote omitted).  The Fifth Circuit also found that the government had allocated crude oil to specific refineries, severing any relation between the crude oil production and the government contracts.

The Supreme Court disagreed.  Justice Thomas, writing for the majority, explained that “[t]he phrase ‘relating to’ sweeps broadly. It means ‘to stand in some relation; to have bearing or concern; to pertain; refer; to bring into association with or connection with.’”  Chevron, 146 S. Ct. at 1060.  (Six other justices joined Justice Thomas’s opinion, with Justice Alito recusing himself, and Justice Jackson concurring.)  A suit can be sufficiently connected to the act taken under color of federal law even if it is “not specifically designed to affect” it, there is not a “strict causal relationship,” and the connection is “indirect.”  Id.  In the context of the “all-hands-on-deck” approach that the government took to avgas production, the Court held that “Chevron’s case fits comfortably within” this definition.  Id. at 1061.

This suit implicates Chevron’s wartime efforts to produce and supply avgas’ essential feedstock, so it is closely connected to Chevron’s wartime avgas refining for the military. Much of the crude oil that Chevron produced in the Delta Duck Club field was ultimately used for its own avgas refining. [T]his suit will challenge Chevron’s actions that allowed it to increase its production of crude oil in the Delta Duck Club field during wartime. . . . The parish’s report alleged that Chevron’s use of the coastal zone had been illegally commenced because of its reliance on vertical-drilling methods, canals, and earthen pits. . . . But, using vertical-drilling methods “maximize[d] production” of crude oil. . . . Using canals instead of building roads saved “time, materials, and manpower,” resulting in more “timely oil production.” . . . And, using earthen pits complied with the P.A.W.’s directive to preserve steel. . . . If Chevron had refrained from these actions and produced less crude oil as a result, its avgas refining for the military may have suffered.

Id.  “Moreover, the Government emphasized the importance of increasing Chevron’s crude-oil production to support avgas refining as part of the war effort,” including by (1) designating the particular coastal zone at issue as “essential” to the war effort because it produced better oil for avgas; (2) paying more for avgas when the price of obtaining crude oil increased; (3) developing plans to produce as much avgas as possible “in the shortest possible time”; and (4) requiring “the vertical-drilling methods challenged by the parish.”  Id. at 1061–62.  And the Court held that the government’s failure to specify how to obtain the crude oil and its allocation of crude oil to specific refineries were irrelevant:  A defendant need not “show that his federal duties specifically invited his challenged conduct” and “an act can relate to its consequences even when the causal chain includes actions by intermediaries” such as the government.  Id. at 1062.

Although it is unclear the degree to which WWII played some special role in the Court’s decision, the Court’s interpretation of the second prong of the federal removal statute appears to be very broad.  In context, the plaintiffs included the State of Louisiana and parishes located in that state, alleging claims relating to decades of oil production activity in that state, under a state statute that applies only to conduct in and relating to that state’s coastal zones.  Yet, the Chevron Court held that the claims did not belong in state court because a state statutory defense implicated Chevron’s contracts with the government relating to avgas refining for a four-or-five-year period out of the decades of alleged conduct—contracts that did not reference oil production at all, did not require any specific methods for producing oil, and in fact allowed Chevron to obtain crude oil from others to meet its refining commitments.  In doing so, the Court affirmed that the statute means what it says:  the challenged conduct need only “relate to” actions taken under color of federal law in some amorphous way.  Indeed, despite the Court cautioning that the “ordinary meaning of ‘relating to’ . . . is not ‘so broad that it is meaningless,” it is unclear what degree of connection would be beyond the reach of the Court’s test.  The Court merely hinted that some cases involving federal contracts might not satisfy this broad test, pointing to a D.C. Circuit decision holding that “a false-advertising suit targeting an oil company’s statements to consumers about the future effects of fossil fuels on climate change did not relate to its decades-earlier production for the Government.”  Chrevon, 146 S. Ct. at 1061.

Despite this breadth, it is important to remember that Chevron specifically dealt with the second prong of the federal officer removal statute, and a defendant must still show that it is a person acting under color of federal law under the first prong.  The Texas Company satisfied both prongs of the test in part because it was vertically integrated—i.e., it both sourced the crude oil and refined it to fabricate avgas.  If it was not involved in the fabrication side of the equation, the Texas Company might not have had relevant government contracts that related to its challenged sourcing activities.  In other industries where vertical integration is rarer and government contracts tend to focus on the industry’s fabrication activities, we will have to see the degree to which Chevron will open the door to removal of suits that challenge sourcing activities alone.

Nonetheless, courts have already begun applying Chevron to cases involving other industries, and that trend is likely to continue.  See Griffin v. OptumRx, Inc., No. 25-1165, 2026 WL 1239289 (9th Cir. May 6, 2026) (involving pharmacy benefits managers).  Indeed, the Supreme Court’s decision appears to expand the decision in Latiolais, an asbestos case to which the Fifth Circuit compared Chevron’s arguments in the third appeal.  In Latiolais, the plaintiff brought tort claims based on asbestos exposure while refurbishing a naval vessel for Avondale.  The Fifth Circuit held that the claims were removable because Avondale’s ship-refurbishment contracts with the Navy specifically required the use of asbestos for thermal insulation, even though they did not say anything about safety practices or warnings.  In Plaquemines Parish, the Fifth Circuit held that “[t]he lack of any contractual provision pertaining to oil production or directing Defendants to use only oil they produced is what distinguishes these cases from Latiolais.”  Plaquemines Parish, 103 F.4th at 341.  Following Chevron, this distinction appears to be irrelevant, and some asbestos liability cases thus might satisfy the second prong of the removal statute regardless of whether a federal contract specifically required the use of asbestos.  

The Chevron case also creates interesting implications for the role that federal regulations could play in federal officer removal going forward.  Some courts have held that compliance with federal regulations generally does not satisfy the first prong of the federal officer removal statute.  See Attorney General of N.J. v. Dow Chem. Co., 140 F.4th 115, 120 (3d Cir. 2025); Schleider v. GVDB Ops., LLC, 121 F.4th 149, 159 (11th Cir. 2024). But the Chevron Court’s reliance on federal regulations relating to vertical drilling suggests that even in jurisdictions where compliance with federal regulations alone usually does not satisfy the first prong, it can be significant under the second prong. 

Finally, the Chevron case should encourage defendants in all industries to think carefully and creatively throughout the case about their contractual arrangements with the government and how those may “relate to” the plaintiff’s claims.  The Chevron action had been pending for five years before Chevron first asserted federal officer removal in response to the parishes’ 2018 expert report, and for over a decade before the Supreme Court finally resolved the issue of removability.  When the basis for removal is not clear on the face of a complaint, we can expect to see defendants trying to drive discovery and motions practice in a direction that might reveal a sufficient connection to the government.

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Back in 2006, people were still carrying around Motorola Razrs, “YouTube” was barely a year old, and nobody had heard of an iPhone. That is when the device in Aceste v. Stryker Corp., 2026 Ohio Misc. LEXIS 1215 (Lucas Cty. C.P. Feb. 4, 2016),was implanted. By the time the case was filed in 2015, smartphones were ubiquitous and people were binge-watching Making a Murderer on Netflix. Now here we are in 2026, and after all that time, plaintiff has accomplished almost nothing. Summary judgment was a complete defense victory on every claim and on multiple independent grounds—causation, preemption, and statute of limitations.

The case involved an investigational spinal implant device subject to an IDE (investigational device exemption). Plaintiff alleged two injuries: (1) excessive wear debris allegedly causing metallosis or metal poisoning, and (2) fusion of the device that prevented it from articulating as designed and caused pain. Id. at *6-7.

Oddly, an Ohio trial court was applying Florida law to the substantive claims, but its causation analysis was spot on. And plaintiff’s proof problems were glaring. Plaintiff had no evidence whatsoever that he suffered metallosis or metal poisoning. Id. at *6. Medical records did show that the device had fused. Id. at *7. But identifying an injury is only half the causation equation. Plaintiff still had to prove that a defect in the device caused that injury.

That is where the case fell apart. Plaintiff offered testimony from a metallurgical engineer opining that the device suffered from manufacturing defects that could increase the production of metal debris inside the body. But the expert said nothing about whether those alleged defects could cause the device to fuse or fail to articulate. Id. at *7-8. In other words, plaintiff had evidence of a defect that could cause an injury he did not have, but no evidence of a defect that could cause the injury he did have. That mismatch proved fatal. Without evidence either that plaintiff suffered from excessive metal debris or that the fusion/non-articulation was caused by a manufacturing defect, there was no triable causation issue.

Plaintiff tried to bridge the evidentiary gap with a res ipsa loquitur argument. The device was explanted, therefore it must have been defective. The court rejected that theory outright as plaintiff’s statements were simply argument. Id. at *8. “[T]he fact that a course of treatment was unsuccessful does not alone prove a manufacturing defect.” Id. at *9. Even assuming counsel was correct that “many” of these devices allegedly failed to meet specifications (counsel claimed to have other clients with the same device), plaintiff still lacked evidence that his particular device deviated from specifications or that any such deviation caused his injuries. Res ipsa could not substitute for proof.

Even though the causation ruling alone disposed of the case, the court went on to address preemption—and delivered another sweep for defendants.

Plaintiff relied heavily on Mink v. Smith & Nephew, Inc., where the Eleventh Circuit allowed the plaintiff’s manufacturing defect claims to proceed as “parallel claims” because Florida recognizes a strict product liability claim based on a manufacturing defect and the plaintiff alleged that the defendant “violated the Florida common law duty to use due care in manufacturing a medical device.” Now, we think the Eleventh Circuit got it wrong because the supposed “parallel” duty in that case boiled down to allegations that the manufacturer violated FDA requirements—a classic attempt at private FDCA enforcement dressed up as state tort law. But that’s neither here nor there for Aceste because Mink was about a PMA medical device and Aceste involves an IDE device. That distinction mattered. IDE devices are still in the clinical trial phase gathering data for the PMA process. As the court recognized, IDE devices are not subject to the same sort of detailed, device-specific federal requirements that plaintiffs often try to use as the basis for parallel claims. And even if Mink applied, plaintiff here never identified any specific federal requirement that defendants allegedly violated. Without an identified federal requirement to parallel, there was no escaping preemption. The court therefore held all claims preempted. Id. at *15-16.

The component supplier defendants had an additional layer of protection. Claims against them were barred by the Biomaterials Access Assurance Act (“BAAA”), which generally shields component suppliers where the manufacturer accepted the component parts. Yet another dead end for plaintiff. Id. at *16-19.

Finally, the court addressed statute of limitations. There was evidence plaintiff knew as early as January 2007 that the device had fused and was causing him pain. Plaintiff nevertheless argued that the statute should not begin running until 2015, when he allegedly first learned of a potential manufacturing defect. But Ohio’s discovery rule applies to latent injuries, not latent defects. The relevant inquiry was when plaintiff had constructive knowledge of the injury and its factual cause—not when he later learned of a possible legal theory. Id. at *20-23. Once plaintiff knew the device had fused and was allegedly causing pain, the clock started ticking. By the time suit was filed, Ohio’s two-year statute of limitations had long expired.

After more than ten years of litigation over a device implanted nearly twenty years ago, plaintiff still could not produce evidence tying any alleged manufacturing defect to his actual injuries, could not avoid preemption, and could not overcome the statute of limitations. The result was a clean sweep for defendants across the board.

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In the drug and device product liability world, we love our acronyms and our short-hand phrases.  The MDAs to the FDCA.  Class III.  PMA.  510(k).

Today’s acronym is CGMP, which sometimes you will see written as “cGMP”.  The GMP stands for Good Manufacturing Practices, and the “C” (or “c”) has, since a 1996 Final Rule—and until recently—stood for Current. 

These CGMPs have been housed in the Code of Federal Regulations, 21 C.F.R. 820, et seq. (which, to add to the acronyms, are sometimes called “QSRs” for Quality System Regulations or “QMSR” for Quality Management System Regulations).

Although the CGMPs were meant to “govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use” and “intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act)” [21 C.F.R. § 820.1(a) (1996)], they were never prescriptive.

They were meant to be tailored by manufacturers to the particular device at issue, and they were meant to evolve and adapt to fit the circumstances.  

For example, 21 C.F.R. § 820.22 (available at https://www.govinfo.gov/content/pkg/FR-1996-10-07/pdf/96-25720.pdf) required device quality checks, but it provided:

Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system.

Similarly, 21 C.F.R. § 820.70 required manufacturing processes that would prevent non-conforming products, but stated:

Each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications.

Design, manufacture, labeling, adverse event reporting—all the regulations followed the same pattern.  Manufacturers need to have processes covering these areas, but those processes are not “one size fits all.”

Over the years, many plaintiffs have tried to plead around express preemption for Class III, PMA devices [21 U.S.C. § 360k(a) as interpreted in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)] by citing a laundry list of allegedly-violated CGMPs.  

The courts that have properly understood the non-prescriptive aspect of alleged CGMP violations have found such allegations insufficient to support a claim that escapes preemption because these CGMPs always have been “intentionally vague and open-ended.” Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582, 588 (E.D.N.Y. 2009); see also In re Medtronic, Inc. Sprint Fidelis Leads Prod. Liab. Litig., 592 F. Supp. 2d 1147, 1157 (D. Minn. 2009) (CGMPs “are inherently flexible” and “require manufacturers to develop their own quality-system controls”).

A more compelling reason exists for preemption of CGMP-based claims, however.  For devices approved through the PMA process, the FDA actually reviews and approves the manufacturer’s quality management system processes as part of the PMA process and the FDA then is charged with enforcing what has been transformed into device-specific federal requirements.

As the FDA explained in “Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff” (available at https://www.fda.gov/media/71083/download),

A Premarket Approval Application (PMA) is required to include a complete description of the methods, facilities, and controls, in sufficient detail so that FDA can make a knowledgeable assessment of the quality control used in producing the medical device (21 U.S.C. 515(c)(1)(C)).

Not enough?  See also FDA’s Compliance Program Guidance Manual related to Medical Device PMA Preapproval and PMA Postmarket Inspections, at Part I, p. 1-2:

PMA applications “are required to include” descriptions of their compliance with Current Good Manufacturing Practices (“CGMP”) requirements, which are promulgated in the Quality System Regulation (“QSR”), and “approval of a PMA application for a device can be denied if a manufacturer does not conform to the QS regulation requirements.”  

In other words, although all devices have to have tailor-made quality processes as outlined in the otherwise vague regulations at  21 C.F.R. § 820 et seq., for PMA devices, the FDA always has had the last word on whether those processes were appropriate and adequate—and once the FDA mandated those processes by granting premarket approval, changes to those devices that might affect safety or effectiveness had to be approved by the FDA as well.  

Accordingly, although we certainly agree that superficial citations to various CGMP regulations have always failed to assert a non-preempted claim because the regulations themselves are too vague and open-ended, that is not even half of the preemption story.  

The rest of the preemption story is that, as part of the PMA process, the FDA actually examines the manufacturer’s proposed processes and then mandates (through premarket approval) what those processes must entail.  A tort plaintiff who tries to use state law to fault the FDA-required process and suggest that a different one should have been used is, by definition is seeking to enforce a state law requirement that is different from, or in addition to, what the FDA itself required as a matter of federal law.   

The reality of the FDA’s regulatory processes matter to preemption, and it is important to inform courts about those processes because they are not well-developed in the preemption case law.  

Please also note that the CGMPs of 21 C.F.R. 820 et seq. themselves recently underwent a significant change, effective February 2, 2026.  In 89 Fed. Reg. 7496, the FDA issued

a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation. We are harmonizing to align more closely with the international consensus standard for devices by converging with the quality management system (QMS) requirements used by other regulatory authorities from other jurisdictions (i.e., other countries). We are doing so by incorporating by reference an international standard specific for device quality management systems.

The main international standard:  ISO 13485 (2016), Medical Devices—Quality Management System Requirements for Regulatory Purposes.  (Users who register can download a read-only version of ISO 13485 at https://ibr.ansi.org/Standards/iso2.aspx ).

This change-over—from federal regulations covering the various quality system topics to incorporation of ISO 13485 which does much the same thing—should not alter the preemption arguments.  

Like the CGMPs before it, ISO 13485 requires the development of device-appropriate design, manufacture, labeling, and other processes, and relevant for preemption purposes, those will still require FDA review and approval through the PMA process, and that should mean preemption is the result.  

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About a year ago we blogged about a strong preemption decision from the Eastern District of New York, Gallego v. Tandem Diabetes Care, Inc., 2025 WL 948282 (E.D.N.Y. March 28, 2025). Gallego involved a Class III insulin injection pump that sent a warning alarm to its user that insulin was no longer being delivered. The diabetic using the pump then spoke with a representative of the manufacturer who confirmed that the pump was not delivering insulin and that the user should replace the insulin cartridge. The user of the pump died later the same day, and his estate filed a lawsuit. As discussed in our prior post, the court dismissed with prejudice most of the estate’s claims, but it granted plaintiff leave to file a second amended complaint (SAC) that included a claim for negligent defective design and wrongful death. Today’s decision, Gallego v. Tandem Diabetes Care, Inc., 2026 WL 1130316 (E.D.N.Y. Apr. 27, 2026), applies another robust preemption analysis and dismisses the plaintiff’s remaining claims with prejudice.

Continue Reading Preemption Round Two in the Eastern District of New York
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Bexis has been working with Lawyers for Civil Justice on a number of projects, including the currently pending initiative to enact a federal rules amendment that requires meaningful disclosure of third-party litigation funding (“TPLF”) on essentially the same rationale that insurance policies are routinely disclosed under Fed. R. Civ. P. 26 (a)(1)(A)(iv).  As part of this project, LCJ has its own initiative – “Ask About TPLF” – to encourage defendants, including defendants in prescription medical product liability litigation, to seek discovery of TPLF.

If you or your clients are participating in this LCJ initiative, or otherwise involved in seeking TPLF discovery, then you know that the other side almost always seeks to impede TPLF discovery with questionable claims of attorney/client privilege or work product protection.  Well, here’s something new that can help overcome such objections.

On April 7, 2026, Todd Presnell, a partner at Bradley Arant, submitted a comment to the Committee on Rules of Practice and Procedure (the judicial committee considering the TPLF rules change), which “conclude[d] that mandating disclosures will not adversely affect a party’s attorney-client privilege shield for communications or that party’s or her lawyer’s work-product.”  Presnell comment at 1.

Why should we care?

Because Presnell has probably forgotten more about attorney/client privilege/work product protection than any of us here on the Blog know.  As stated in the comment:

I have devoted a substantial amount of my practice to the study and analysis of . . . the attorney-client privilege and work-product doctrine. . . .  I have published over 40 articles in various journals on privilege-related issues. . . .  Separately, I am the sole creator and author of the legal blog Presnell on Privileges . . . and the lead author of the legal treatise Privileges and Protections: Tennessee and Sixth Circuit Law. . . .  I have given over 100 legal-education presentations or client-focused privilege training sessions, been retained to author and file several amicus briefs on privilege issues, . . . and been retained by law firms to serve as a legal expert witness in the area of evidentiary privileges.

Id. at 1-2.  This guy knows of what he speaks.

And what did he have to say?

In general, and with plenty of citations to back it up, that neither the attorney/client privilege nor the work product protection is an impediment to a rule requiring the general disclosure of TPLF contracts.  Id. at 2.  Other documents, maybe, but not the TPLF contracts themselves.  Why?

A TPLF Agreement between a party, or that party’s counsel, and a non-party funding entity is not a communication, not a communication between a client and her lawyer, and does not pertain to the request for or provision of legal advice. . . .  A TPLF Agreement arises in the ordinary course of a non-party funding entity’s business.

Id. 2.  In short, privilege-based objections to the proposed TPLF disclosure rule are overblown and should be limited to “putatively protected portions” of the actual contracts.  Id.

Here is an outline of the rest of the privilege argument:

  • Because privileges preclude discovery of otherwise relevant information, they are interpreted narrowly.  Id. at 3.
  • The attorney/client privilege is limited to confidential communications between clients and attorneys for the purpose of obtaining legal advice.  Id. at 3-4.
  • Even where applicable, the privilege can be waived.  Id. at 4.
  • A TPLF agreement is a contractual agreement, not a communication.  Id.
  • A TPLF contract cannot be confidential because it necessarily involves a third-party funder.  Id.
  • A TPLF contract does not involve provision of legal advice.  Id.
  • If a TPLF contract includes an otherwise privileged communication, that is a waiver of confidentiality.  Id.

The work product doctrine is different.  It protects information an attorney uses in anticipation of litigation that either the attorney or the client prepares.  It does not extend to material prepared in the attorney’s ordinary course of business.  Id. at 5-6.  The work product protection does not extend to a TPLF contract because that kind of agreement “arises [from] the funder’s decision to invest capital as part of its ordinary business and [the] attorney’s need for business financing.”  Id. at *7.  This section is notable for its comprehensive discussion of relevant precedent, as to both TPLF contracts and “other litigation-related agreements” such as contingent fee documents, invoices, and billing statements.  Id. at *7-8.  It concludes that “[a] TPLF Agreement does not warrant work-product protection because, while related to litigation, it is a [contract] created in the ordinary course of the non-party funder’s business for the purpose of memorializing a financing arrangement.”  Id. at *8.

So if you’re involved in motion practice concerning production of TPLF agreements, take a look at Presnell’s public comment.  Unless and until the rules committee acts, it can save time and money while increasing your understanding of why the other side’s privilege arguments can’t hold water.

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If Rule 702 is supposed to keep unreliable expert opinions out, this decision raises a fair question: how many gaps are too many? In In re Covidien Hernia Mesh Products Liability Litigation, 2026 WL 1129617 (D. Mass. Apr. 27, 2026), the court considered a familiar lineup of expert opinions—general causation, specific causation, alternative design, and warnings. The outcome is mixed. Most of plaintiff’s expert’s opinions survive. But not all.

Plaintiff underwent emergency hernia repair surgery and received defendant’s surgical mesh, a polyester textile with a porcine collagen and glycerol coating designed to prevent tissue attachment during healing. Three years later, plaintiff required another surgery to repair a recurrent hernia and bowel obstruction. During that procedure, the surgeon found a portion of plaintiff’s bowel “stuck tightly” to the prior mesh. Id. at *3.  Plaintiff’s theory, offered via a general surgery expert, is that the polyester triggers a chronic inflammatory response, and the collagen barrier—represented to last “less than 1 month”—actually degrades too rapidly, allowing adhesions to form and leading to complications like obstruction and recurrence. Id. at *2-3.

The primary attack on general causation focused on the expert’s reliance on animal studies while largely excluding human clinical data. And while the court acknowledged that opinions that rely on animal studies should be “scrutinized” due to the difficulty in extrapolating to humans, it allowed it here, especially given the ethical limitations on conducting human studies:

testing the barrier’s resorption in humans in the period immediately following a hernia repair would require reopening patients. Given this ethical limitation, animal studies and anecdotal case reports are a reliable basis for reaching a scientific conclusion about the resorption period of the barrier.

Id.  at *8.

That’s a fairly narrow, case-specific ruling which was bolstered in the court’s opinion by the fact that the studies the expert relied on were conducted by the defendant itself. Even though that says little about whether the expert reliably extrapolated from those studies to his ultimate conclusions.

The more notable move comes next. The court admitted that plaintiff’s expert lacked human clinical data on inflammatory response and could not clearly explain how his animal-based conclusions translated to humans. Id. at *9. Ordinarily, that would be a problem for the proponent of the testimony. Here, it wasn’t. Because defendant did not cite product-specific clinical studies affirmatively disproving the expert’s theory, the court allowed the opinion to stand. Id. That framing effectively flips the burden. Instead of requiring plaintiff to demonstrate reliability, the court faulted defendant for not filling the gaps.

The same dynamic appears in the court’s treatment of contrary clinical data. Defendant argued the expert cherry-picked his data by ignoring product-specific studies that showed no increased rate of relevant complications. Because plaintiff’s expert dismissed those studies as having “limitations,” the court found defendant’s argument went to weight, not admissibility. Leaving cross-examination—rather than Rule 702—to do the work. Id.

The court also admitted the expert’s specific causation opinion based on a differential diagnosis. On the “rule in” side, the expert pointed to the presence of “dense” adhesions observed during the explant surgery years later as support for his theory that adhesions began forming shortly after implantation due to premature barrier degradation. That was enough for the court. Id. at *10.

On the “rule out” side, the burden of proof was again flipped. Defendant identified two obvious alternative causes: the urgent nature of the surgery and the surgical technique used—both known risk factors for recurrence. But instead of requiring the expert to meaningfully rule them out, the defendant was required to “offer data” to rule them in.  Id. at *11. The result is a differential diagnosis that does not do much ruling out, yet still survives.

If the court was permissive on causation, it was not on design defect. Plaintiff’s expert offered two purported safer alternatives: a different material and a different product. That was essentially it. No comparative analysis. No discussion of risks and benefits. No methodology tying the alternatives to a safer outcome. That, the court held, is classic ipse dixit—and inadmissible. Plaintiff’s attempt to rehabilitate the opinion through attorney argument in briefing came too late and in the wrong form. Without support in an expert report, deposition, or affidavit, the expanded theories could not be considered. Id. at *12-13.

Finally, the court allowed the expert to testify about warning adequacy from a surgeon’s perspective. A practicing physician can opine on whether warnings communicate sufficient information for clinical decision-making. But the expert cannot offer legal conclusions about adequacy under the law. Nor is he required to opine on warning causation—that is, whether a different warning would have changed the treating surgeon’s conduct. Id. at *13-14.

Taken as a whole, the decision reads less like strict gatekeeping and more like gap tolerance. The court repeatedly acknowledges analytical shortcomings—missing data, unexplained extrapolations, incomplete differential diagnosis—but treats them as fodder for cross-examination rather than grounds for exclusion. In doing so, it edges toward placing the burden on defendants to disprove opinions that plaintiffs have not fully substantiated. Fortunately, the alternative design ruling cuts the other way. However far plaintiff’s causation opinions are allowed to go, design defect claims still require evidence of a feasible, safer alternative supported by a reliable methodology. Without that cornerstone, plaintiff’s design defect theory may have a short shelf life.

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We’ve never done a cross-post before with any other Reed Smith (or any other firm’s) blogs, but the recent decision, Louisiana v. FDA, ___ F.4th ___, 2026 WL 1194924 (5th Cir. May 1, 2026), justifies this unprecedented action. Essentially, the Fifth Circuit, ordered a nationwide injunction against the FDA’s 2003 REMS amendments that authorized prescription of mifepristone by telemedicine – thereby requiring in person prescriptions that the FDA had determined were unnecessary, given the drug’s safety. With the change of administrations, the FDA is now controlled by RFK Jr. and has switched sides, with little scientific explanation, and no longer defends the REMS. As we know, the Supreme Court frowned on nationwide injunctions in Trump v. CASA, 606 U.S. 831 (2025). That proved of little consequence to the Fifth Circuit, which disposed of that argument in a single sentence, that the Supreme Court didn’t prohibit such injunctions under the Administrative Procedure Act. La. v. FDA, 2026 WL 1194924, at *9. So that means, in the Fifth Circuit, the APA now enjoys a more exalted position than the US Constitution itself, since CASA involved constitutional issues. That’s one of many topsy-turvy things about this ideologically driven decision.

Without further ado, here is the cross post from Reed Smith’s Health Industry/Washington Watch blog, authored by Scot Hasselman, Lesley Reynolds, Sarah Cummings Stewart, Allie Klimkiewicz, Alexa Chronister, and Matt Loughran reprinted in full.

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On Friday, May 1, 2026, a unanimous three-judge panel of the U.S. Court of Appeals for the Fifth Circuit granted the State of Louisiana’s emergency motion for a stay pending appeal in State of Louisiana v. FDA, No. 26-30203. The order immediately reinstated the in-person dispensing requirement for mifepristone, which was previously rolled back in 2021 (and formalized in 2023) by the FDA’s Risk Evaluation and Mitigation Strategy (REMS). In plain English: health care providers can now only prescribe mifepristone in-person and may no longer prescribe it virtually via telehealth. However, early on Monday, May 4, 2026, the Supreme Court issued an administrative stay of the Fifth Circuit’s order until May 11, effectively restoring the status quo for at least a week. This blog post analyzes the Fifth Circuit’s order and actions companies should consider during this interim time.

Mifepristone is used in most medication abortions in the United States (in a regimen with misoprostol); it is also widely used in miscarriage care. This ruling does not impact the FDA’s approval of mifepristone, though it may create legal and practical obstacles to accessing mifepristone. For example, patients may face barriers and longer wait times to pick up the medication in person, even in states where abortion remains legal, and even when mifepristone is being used for non-abortion purposes, like miscarriage management. This case is one of several actions brought by states seeking to prohibit telehealth and remote dispensing of mifepristone to patients in states with abortion bans, and the outcome here may influence those parallel proceedings. 

Friday’s ruling overturned the Western District of Louisiana’s April 2026 decision, which refused to stay the 2023 REMS requirements. There, the district court held that while the State of Louisiana demonstrated standing, a strong likelihood of success, and irreparable harm, the balance of equities and public interest weighed against Louisiana. Instead, the Western District of Louisiana stayed the entire case to allow FDA to complete its ongoing comprehensive review of the mifepristone REMS. On appeal, the Fifth Circuit held that the district court abused its discretion when balancing the equities and public-interest, as the Fifth Circuit emphasized that the likelihood of success and irreparable harm factors are the most critical factors upon which to focus.

In granting the administrative stay, Justice Alito did not evaluate the merits of either the district court’s or the Fifth Circuit’s holdings. Rather, the 7-line Order merely granted the stay and set deadlines for a response and expiration of the stay.

Background

Mifepristone was approved by FDA in 2000 for use in combination with misoprostol to end early pregnancy and for early miscarriage management, and has been subject to successive REMS modifications. A REMS is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

When initially approved, the REMS imposed significant access restrictions, which included three in-person visits and mandatory reporting of serious adverse events. Over time, the barriers to access mifepristone were progressively lowered. In 2016, the FDA allowed nurse practitioners to prescribe mifepristone after one in-person visit and limited reporting to only fatalities. During the COVID-19 pandemic, the FDA issued a Non-Enforcement Decision, by which FDA removed the in-person dispensing requirement entirely, permitting mail-order and pharmacy dispensing without an in-person visit, which were later formalized in the 2023 REMS.

In October 2025, Louisiana challenged the 2023 REMS under the Administrative Procedure Act (APA), arguing that FDA’s justifications for permitting remote dispensing relied on flawed or nonexistent data and that the 2023 REMS changes led to illegal abortions in Louisiana and unrecoverable Medicaid costs for alleged complications. Danco Laboratories and GenBioPro (the brand and generic manufacturers of mifepristone) intervened as defendants. The district court denied Louisiana’s motion for preliminary relief and stayed the litigation pending FDA review. Louisiana then appealed to the Fifth Circuit. 

The Fifth Circuit’s opinion begins by invoking the post-Dobbs landscape of state-level regulation and noting that President Biden’s Executive Order No. 14076 directed federal agencies to expand access to medication abortion. The Court also highlights FDA’s own recent concession—made when it announced its comprehensive review of mifepristone late last year—that the prior REMS approvals suffered from a “lack of adequate consideration.” Together, this contextual framing sets the stage for the Court’s decision to grant Louisiana’s emergency motion for a stay pending appeal, discussed further below. 

Key Holdings on the Stay Factors Under 5 U.S.C. § 705

Louisiana sought a stay of the 2023 REMS under 5 U.S.C. § 705, which authorizes courts to “postpone the effective date of an agency action or to preserve status or rights pending conclusion of the review proceedings.” The Court applied the standard four-factor test as follows:

  1. Strong Likelihood of Success. The Court held Louisiana is likely to prevail on its APA claim, calling the scientific literature supporting the 2023 REMS modification inadequate and a “textbook example of arbitrary and capricious agency action.” 
  2. Irreparable Harm. The Court held Louisiana has shown that it is irreparably harmed without a stay, pointing to Louisiana’s argument that the 2023 REMS undermines Louisiana’s abortion laws and causes financial harm to Louisiana from Medicaid expenditures.
  3. Equities and Public Interest. The Court agreed with Louisiana that the district court erred by finding Louisiana’s irreparable harms are outweighed by FDA’s interest in continuing its review and Danco’s financial interests in selling mifepristone. The Court held that “[n]either the FDA nor the public has any interest in enforcing a regulation that violates federal law,” noting this was the third time the Fifth Circuit has found that FDA’s relaxation of mifepristone’s safeguards “likely lacked a basis in data and scientific literature.” The Court emphasized that FDA itself concedes the 2023 REMS was marred by “procedural deficits” and a “lack of adequate consideration,” and that “the public interest is not served by perpetuating a medical practice whose safety the agency admits was inadequately studied.”

The Fifth Circuit’s order is applied nationwide, goes into effect immediately (subject to the Supreme Court’s temporary administrative stay), and does not disturb the underlying FDA approval of mifepristone itself or the continued review that the FDA is conducting. The Court cautioned that while this ruling has nationwide effect, it should not be construed through the same lens as other nationwide injunctions given that this is a remedy of the Administrative Procedure Act, and therefore appropriate. In other words, though this ruling functions practically as a nationwide injunction, it does not violate the Supreme Court’s 2025 limitations on universal injunctions, as the § 705 stay “temporarily voids the challenged authority,” and here, the challenged authority is a nationwide regulator action.

Key Implications

For pharmaceutical manufacturers, pharmacies, telehealth platforms, health systems, distributors, and other stakeholders, Friday’s order creates immediate compliance and operational obligations under the reinstated, pre-2023, REMS. Though the Supreme Court has temporarily issued an administrative stay, companies should nonetheless consider the below recommendations in the event the stay is soon lifted:

  • REMS Compliance and Enforcement Risk: Unless the Supreme Court’s administrative stay is extended, certified pharmacies and distributors will need to immediately revert to in-person-only dispensing protocols for mifepristone. Mail-order and telehealth-based fulfillment of mifepristone prescriptions would be prohibited. Manufacturers should be prepared to promptly update REMS materials, labeling, distribution agreements, and training to reflect the pre-2023 framework. 
  • Telehealth and Virtual Care Disruption: Unless the Supreme Court’s administrative stay is extended, providers and platforms offering medication abortion or miscarriage management involving mifepristone via telehealth must require in-person evaluations or clinic-based dispensing. This will disproportionately impact access in rural or restrictive jurisdictions and may create tension with state shield laws in permissive states. 

What’s Next?

On Friday night, mere hours after the Fifth Circuit issued its decision, Danco Laboratories, filed for an emergency one-week administrative stay of the Fifth Circuit’s order to allow Danco time to seek relief in the United States Supreme Court. The motion requested a decision by the Fifth Circuit by 9 pm on Friday. Shortly after that deadline passed, Danco then filed an application for an emergency stay to the Supreme Court. Applications from the Fifth Circuit go to Justice Samuel Alito for initial review, who can then either rule on the application individually or refer it to the full court for review. As of Monday morning, Justice Alito administratively stayed the Fifth Circuit’s order until 5:00 pm EDT on Monday, May 11, 2026. A response to the manufacturers’ application for a stay is due by 5:00 pm EDT on Thursday, May 7, 2026. 

Meanwhile, FDA’s comprehensive review of mifepristone, which began in September 2025 and will include consideration of the 2023 REMS, continues in the background, though the agency has not committed to a timeline for completing its review. The results of that review could also influence the ongoing proceedings in this and other cases.

While the Supreme Court’s temporary administrative stay has restored the status quo, within weeks it could lift that say, reinstating the in-person dispensing requirement in full effect. Notwithstanding the administrative stay, manufacturers, pharmacies, telehealth providers, and health systems should evaluate immediate operational changes and consider strategic engagement with FDA where appropriate. 

Reed Smith will continue to track developments in the post-Dobbs abortion landscape and the regulation of mifepristone in particular. If you have questions about how this decision affects your REMS compliance program, distribution practices, or telehealth operations, please reach out to the health care lawyers at Reed Smith. 

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