UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF FLORIDA

PENSACOLA DIVISION

IN RE: 3M COMBAT ARMS 

EARPLUG PRODUCTS

Case No. 3:19md2885

LIABILITY LITIGATION

This Document Relates to:

Estes, 7:20cv137

Keefer, 7:20cv104

Hacker, 7:20cv131

Judge M. Casey Rodgers

Magistrate Judge Gary R. Jones

ORDER

This matter is before the Court on Plaintiffs’ Motion for Judgment as a Matter 

of Law under Federal Rule of Civil Procedure 50(a) on the applicability of the 

sophisticated intermediary defense under Georgia and Kentucky law, respectively.

1

 

Both sides submitted briefs on the issue and oral argument was heard on April 26, 2021. 

Having now fully considered the parties’ arguments and the applicable law, the Court 

concludes the sophisticated intermediary defense is not a legally viable defense in these 

cases.

1 Contrary to Defendants’ assertions during oral argument, the intermediary doctrine is an

affirmative defense—and not merely an evidentiary standard—in Georgia. See Freeman v. United 

Cities Propane Gas of Ga., Inc., 807 F. Supp. 1533 (M.D. Ga. 1992) (“The suppliers have the burden 

of proof on [the intermediary doctrine]. It is, after all, an affirmative defense to the assertion that 

[they] failed to warn [plaintiff].”). Kentucky does not appear to have taken a position on the issue. 

Of note, Defendants pled the sophisticated intermediary doctrine as an affirmative defense in their 

Amended Answer to Master Long Form Complaint. See ECF No. 959 at 99-100.

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I. Legal Standard

Judgment as a matter of law is appropriate where a party has been fully heard on 

an issue and there is no legally sufficient evidentiary basis for a reasonable jury to find 

for the party on that issue. Ledbetter v. Goodyear Tire & Rubber Co., Inc., 421 F.3d 

1169, 1177 (11th Cir. 2005) (citing Fed. R. Civ. P. 50(a)). When considering such a 

motion, a court must “review the entire record, examining all the evidence, by 

whomever presented, in the light most favorable to the nonmoving party, and drawing 

all reasonable inferences in the nonmovant’s favor.” Id. In doing so, the court may 

not make credibility determinations or weigh the evidence, as those are solely functions 

of the jury. Reeves v. Sanderson Plumbing Products, Inc., 530 U.S. 133, 150 (2000). 

A motion for judgment as a matter of law should be granted “only if the facts and 

inferences point so overwhelmingly in favor of the [moving party] that [a] reasonable 

[jury] could not arrive at a contrary verdict.” Bogle v. Orange County Bd. of County 

Comm’rs, 162 F.3d 653, 656 (11th Cir. 1998).

II. Discussion

Manufacturers generally owe a “non-delegable” duty to warn foreseeable users 

of known dangers inherent in their products. Larkin v. Pfizer, Inc., 153 S.W.3d 758, 

768 (Ky. 2004). Most jurisdictions have carved out one or more limited exceptions to 

the rule, which allow a manufacturer to “discharge” its duty to warn by adequately 

warning a sufficiently knowledgeable or sophisticated intermediary who purchases the 

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product and/or controls its availability to the ultimate users. See, e.g., Webb v. Special 

Elec. Co., Inc., 370 P.3d 1022, 1027 (Cal. 2016) (discussing various intermediary

defenses). Georgia and Kentucky have explicitly adopted the most commonly invoked 

intermediary exception—the learned intermediary doctrine—which enables 

manufacturers of prescription drugs and medical devices to adequately inform 

prescribing physicians, as opposed to patients directly, of any risks associated with 

their drugs and devices. See McCombs v. Synthes (U.S.A.), 587 S.E.2d 594, 595 (Ga. 

2003); Larkin, 153 S.W.3d at 761-63. Physicians serve as “learned intermediaries” 

between manufacturers and patients, as patients can only obtain prescription products 

through their physicians, and physicians, through specialized education and 

experience, are generally in the best position to evaluate the potential risks and benefits 

of a particular drug or medical device, and to advise their patients accordingly. See 

McCombs, 587 S.E.2d at 595; Larkin, 153 S.W.3d at 763-64. 

A small number of states—at least nine, according to Defendants—have also 

adopted another variant of the intermediary exception, the so-called “sophisticated 

intermediary” doctrine, which enables a manufacturer to warn certain intermediate 

purchasers of its product of the known and knowable hazards in the product’s use, and 

to rely on those purchasers to pass on adequate warnings to end users. See, e.g., Webb, 

370 P.3d at 1027. Where available, the sophisticated intermediary doctrine generally 

has been extended in circumstances where: (1) the manufacturer lacked knowledge 

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and/or control over how their product would be used or what the product might

ultimately become; (2) the manufacturer had little ability to reasonably predict who 

potential end-users would be; and/or (3) the form or nature of the product—particularly 

raw materials and industrial products, such as chemicals, metals or sand—made it 

impossible or impractical for the manufacturer to provide effective warnings to endusers. See, e.g., Webb, 370 P.3d at 1033-38. Significantly, neither Georgia nor 

Kentucky has expressly adopted or applied the sophisticated intermediary doctrine. 

Nevertheless, Defendants insist “there is no doubt they would do so in an appropriate 

case” and, in their view, the instant cases are precisely that. The Court disagrees.

To begin with, it is not at all clear that either Georgia or Kentucky would adopt 

the sophisticated intermediary doctrine as a general proposition. As Defendants 

themselves observe, “the Restatement of Torts has recognized the defense for nearly 

sixty years.” See Def. Brief, ECF No. 100 at 6. However, in that time, there has not

been a single reported decision in either jurisdiction doing the same. As already 

discussed, both states have explicitly adopted the learned intermediary doctrine with 

respect to prescription drugs and medical devices. See McCombs, 587 S.E.2d at 595; 

Larkin, 153 S.W.3d at 761. Notably, Kentucky has never applied that doctrine outside 

of prescription products. See Roberts v. Stryker Corp., 2014 WL 12911070, *10 (W.D. 

Ky. Aug. 7, 2014) (“[T]he Court can find no instance in which Kentucky courts have 

described [the intermediary] doctrine with regard to anyone other than physicians.”); 

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id. (“Not once does Larkin mention a potential application to a third party who is not a 

medical provider.”); see also Larkin, 153 S.W.3d at 761-63. And Georgia has declined 

to extend the learned intermediary doctrine beyond the prescription context except in

very limited circumstances involving specialized industrial products supplied to 

members of a “particular trade or profession” charged with knowledge of the dangers 

associated with such products. Compare Eyster v. Borg-Warner Corp., 206 S.E.2d 

668, 670 (Ga. App. 1974) (doctrine applied for home air conditioner with copper 

terminal connected using aluminum wire by distributor charged with generally 

accepted trade knowledge of the dangers of copper-aluminum connections, and with 

installing in accordance with electrical codes that warned against improper copperaluminum connections), and Stiltjes v. Ridco Exterminating Co., 343 S.E.2d 715 (Ga. 

App. 1986) (doctrine applied for pesticides sold only to licensed commercial 

applicators and not to individuals, and all commercial applicators were charged by 

federal law with knowledge of the dangers of the use of pesticides), with Dozier Crane 

& Mach., Inc. v. Gibson, 644 S.E.2d 333 (Ga. App. 2007) (declining to treat crane and 

rigging company that purchased used crane as a learned intermediary in case against 

seller and refurbisher of the crane for injuries resulting from accident involving the 

crane), Hill v. Konecranes, Inc., 2020 WL 3259178 (S.D. Ga. June 16, 2020) (declining 

to treat crane owner as learned intermediary in case against manufacturers and servicers 

contracted to inspect, repair, and maintain the crane), and Long v. Amada Mfg. Am., 

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Inc., 2004 WL 5492705 (N.D. Ga. Mar. 31, 2004) (declining to extend intermediary 

doctrine to equipment manufacturing cases). These authorities, which explicitly and 

narrowly cabin the bounds of the intermediary rule in Kentucky and Georgia, do not 

support a conclusion that either jurisdiction would recognize a variant of that rule, like 

the sophisticated intermediary doctrine, which greatly expands those bounds.2

 See 

Combs v. Int’l Ins. Co., 354 F.3d 568, 578 (6th Cir. 2004) (“Federal courts hearing 

diversity matters should be extremely cautious about adopting ‘substantive innovation’ 

in state law.”); Pincus v. Am. Traffic Solutions, Inc., 986 F.3d 1305, 1310 (11th Cir. 

2021) (federal courts in diversity cases must determine issues of state law in “the way 

it appears the state’s highest court would” decide them based on relevant state law 

precedents).

Even assuming theoretically that Kentucky and Georgia would adopt the 

sophisticated intermediary doctrine, it would not be available here. Indeed, the Court 

has not found a single case—anywhere—in which the doctrine was applied to an 

ordinary consumer product marketed and sold directly to the general public, like the 

CAEv2.3

 None of the sophisticated intermediary cases identified by Defendants 

2 Perhaps the Eleventh Circuit, in its discretion, will find it appropriate to certify this question 

to the Kentucky and Georgia Supreme Courts. However, there being no indication in these states’ 

jurisprudence that either would adopt the sophisticated intermediary doctrine and, in fact, undeniable

indications that both would reject the doctrine, this Court will not certify the question.

3 In other words, as Plaintiffs observed during oral argument, if the sophisticated intermediary 

doctrine were made available here, it would be the first and only case in the country where the doctrine 

was applied to an ordinary consumer product marketed and sold directly to the general public. 

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involved such a product. See, e.g., Parker v. Schmiede Mach. & Tool Corp., 445 F. 

App’x 231 (11th Cir. 2011) (beryllium-containing products supplied to aircraft 

manufacturing plant); Freeman v. United Cities Propane Gas of Ga., Inc., 807 F. Supp. 

1533 (M.D. Ga. 1992) (chemical odorant added to propane gas); Webb, 370 P.3d at 

176 (crocidolite asbestos used in manufacturing transite pipe); Gray v. Badger Mining 

Corp., 676 N.W.2d 268 (Minn. 2004) (silica sand supplied to foundry for use in 

creating molds for shaping metal); Nat. Gas Odorizing, Inc. v. Downs, 685 N.E.2d 155 

(Ind. App. 1997) (chemical odorant added to natural gas supply); Gajewski v. Pavelo, 

670 A.2d 318 (Ct. 1996) (gas fired boiler installed by a licensed plumber); Alm v. 

Aluminum Co. of Am., 717 S.W.2d 588 (Tex. 1986) (closure system for applying 

aluminum caps to carbonated soft drink bottles); Jones v. Hittle Serv., Inc., 549 P.2d 

1383 (Kan. 1976) (chemical odorant added to propane gas supply); Schmeiser v. Trus 

Joist Corp., 540 P.2d 998 (Or. 1975) (truss joists used in roof construction); Morris v. 

Shell Oil Co., 467 S.W.2d 39 (Mo. 1971) (industrial use petroleum solvents); see also 

Gajewski v. Pavelo, 670 A.2d 318 (Ct. 1996) (gas fired boiler installed by a licensed 

plumber); Persons v. Salomon N. Am., 265 Cal. Rptr. 773 (Cal. App. 3d 1990) (ski 

bindings supplied to shop that selected and rented skis and bindings). And even in 

cases where an intermediary was implicated—a sophisticated intermediary purchaser 

of a chemical product, or a learned intermediary physician recommending a 

nonprescription medical product to a patient—courts have consistently refused to 

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extend the intermediary doctrine to products available both directly to the intermediary 

and over-the-counter to ordinary consumers. See, e.g., Hall v. Ashland Oil Co., 625 F. 

Supp. 1515, 1519 (D. Conn. 1986) (benzene sold both to large industrial purchaser and 

ordinary consumers); Mitchell v. VLI Corp., 786 F. Supp. 966, 970 (M.D. Fla. 1992) 

(nonprescription contraceptive sponge given to patient by her physician); Prager v. 

Allergan, Inc., 1990 WL 70875 (N.D. Ill. 1990) (contact lens solution recommended 

by physician but available over-the-counter without prescription); Torsiello v. 

Whitehall Lab’ys, Div. of Home Prods. Corp., 398 A.2d 132 (N.J. Super. Jan. 23, 1979) 

(over-the-counter drug containing aspirin recommended by physician). Georgia and 

Kentucky jurisprudence reflect a similarly unequivocal stance that the learned 

intermediary doctrine “obviously” does not apply “to over-the-counter products” and 

“normal consumer item[s].” See Larkin, 153 S.W.3d at 762-63; Hawkins v. Greenberg, 

283 S.E.2d 301, 307 (Ga. App. 1981) (learned intermediary does not apply to “drugs 

sold over the counter”). Reading these authorities together, the basis for distinguishing 

ordinary consumer products is clear—“the underlying rationale for the intermediary

defense is lost where . . . users could purchase and use the product without an 

intermediary.” See Pl. Brief, ECF No. 102 at 7; see also Hall, 625 F. Supp. at 1519; 

Mitchell, 786 F. Supp. at 970 (“Considering that [plaintiff] could have obtained the 

[product] over-the-counter, it would be illogical to treat her differently based on the 

mere fortuity that she obtained a sample of the [product] from her physician.”). No 

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authority has been cited or found that would support a different conclusion. Consistent 

with that conclusion, the Court finds that neither Georgia nor Kentucky would extend 

the sophisticated intermediary doctrine to a product like the CAEv2, which was 

marketed and sold both to the military and directly to the general public, and declines 

to extend the doctrine here.4

 

For these reasons, the Court concludes as a matter of law that the sophisticated 

intermediary doctrine does not apply in these cases. Neither Georgia nor Kentucky 

recognizes the doctrine, and even if they did, it would not be available in this context. 

Accordingly, Plaintiffs’ motion for judgment as a matter of law on the sophisticated 

intermediary defense is GRANTED. 

SO ORDERED, on this 27th day of April, 2021.

M. Casey Rodgers

M. CASEY RODGERS

UNITED STATES DISTRICT JUDGE

4 It is worth noting that even within the military, the CAEv2 was but one of numerous hearing 

protector options approved for use by service members, who could (and, sometimes, did) obtain the 

CAEv2 either directly from the military or by purchasing it in a retail store. 

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