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:

McCombs, 7:20-cv-94

Judge M. Casey Rodgers

Magistrate Judge Gary R. Jones

ORDER

This matter is before the Court on Plaintiff Dustin McCombs’ Motion for 

Judgment as a Matter of Law (“JMOL”) under Federal Rule of Civil Procedure 50(a)

on the duty and breach elements of his negligence per se claim, Defendants’ “excuse” 

defense to his negligence per se claim, Defendants’ superseding cause defense, and 

Defendants’ affirmative sophisticated intermediary defense.1 Oral argument was heard 

on May 27, 2021. Having now fully considered the parties’ arguments and the

applicable law, the Court concludes that McCombs’ motion is due to be granted, in 

part, and denied, in part.

I. Legal Standard

JMOL 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 

1 Defendants pled the sophisticated intermediary doctrine as an affirmative defense in their 

Amended Answer to Master Long Form Complaint. See MDL Dkt. No. 959 at 99–100.

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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 Prods., Inc., 530 U.S. 133, 150 (2000). A motion for JMOL

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

II. Discussion

A. Duty & Breach Elements of Negligence Per Se Claim

For the reasons stated in the Court’s Order denying Defendants’ motion for 

summary judgment on McCombs’ negligence per se claim, see ECF No. 64 at 13–16, 

the Court finds that the Environmental Protection Agency’s (“EPA”) regulations 

governing the labeling of hearing protection devices and the Noise Control Act 

(“NCA”) establish the applicable duty and standard of care. However, the Court finds 

that there is a sufficient evidentiary basis for a reasonable jury to find that Defendants 

did not violate the EPA regulations or the NCA. Accordingly, McCombs’ motion for 

JMOL on the duty element of McCombs’ negligence per se claim is GRANTED. 

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McCombs’ motion for JMOL on the breach element of McCombs’ negligence per se 

claim is DENIED.

B. “Excuse” Defense to Negligence Per Se Claim

The Court finds McCombs is entitled to JMOL on Defendants’ “excuse” defense 

to his negligence per se claim. As a threshold matter, the Court is persuaded by 

McCombs’ argument that Defendants waived the defense because Defendants did not

give at least reasonable notice in their pleadings of both their intent to assert the defense 

and of the specific excuses they intended to rely on.

2 Alaska Pattern Jury Instruction 

3.04(A) enumerates six excuses, and the parties agree that this list is not exhaustive. 

Even if the defense is not an affirmative defense, it would be a strange feature of Alaska 

law if a defendant was not required to provide at least reasonable notice in its pleadings 

to a plaintiff as to which of the numerous excuses—whether enumerated in Pattern Jury 

Instruction 3.04(A) or not—it intends to assert at trial. 

But even if this were not the case, the Court would still find that McCombs is 

entitled to JMOL on Defendants’ “excuse” defense. First, Defendants, relying solely 

on Elliot Berger’s testimony that he did not believe that the EPA regulations or NCA 

applied to the CAEv2, assert the second enumerated excuse in Pattern Instruction 

3.04(A): that they “did not know and should not have known that [they] needed to 

2 Defendants’ inclusion of Pattern Jury Instruction 3.04(A) in their proposed jury instructions 

does not constitute reasonable notice.

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follow the law.” (emphasis added). While Berger’s testimony provides a sufficient 

evidentiary basis to support a jury finding that Defendants did not believe that the EPA 

regulations or NCA applied to the CAEv2, there is no evidence—zero—from which a 

reasonable jury could find that Defendants should not have known that the EPA 

regulations or NCA applied to the CAEv2. In fact, the evidence is to the contrary. See 

Trial Tr. (5/26/2021) at 217 (John Casali testifying that Berger “has some significant 

leadership roles – with ANSI standards committees”); Unofficial Trial Tr. (5/27/2021) 

at 55 (Casali testifying that Berger “testif[ied] in front of the EPA”). Second, 

Defendants assert the sixth enumerated excuse in Pattern Instruction 3.04(A): that “the 

meaning of the law was obscure or unreasonable and the defendant acted with 

reasonable care in attempting to obey it.” However, there is no evidence in the record 

from which a reasonable jury could find that the EPA regulations or NCA were 

“obscure or unreasonable.” Indeed, the case cited by Defendants in support of their 

argument, HDI-Gerling Am. Ins. Co. v. Carlile Transp. Sys., Inc., 426 P.3d 881 (Alaska 

2018) is readily distinguishable on this basis. In Carlile, “the evidence at trial showed 

without contradiction drivers, experts, and regulators” did not understand the 

regulation at issue. See 426 P.3d at 888. There is no such evidence in the record here. 

Accordingly, McCombs’ motion for JMOL on Defendants’ “excuse” defense to his 

negligence per se claim is GRANTED.

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C. Superseding Cause Defense

After considering both the Restatement and the law cited by the parties during 

oral argument, the Court finds that there is jury question as to whether, in hindsight, it 

is highly extraordinary that Defendants’ conduct would have brought about McCombs’ 

harm. Accordingly, McCombs’ motion for JMOL on Defendants’ superseding cause 

defense is DENIED.

D. Affirmative Sophisticated Intermediary Defense

Manufacturers generally owe a duty to warn foreseeable users of known dangers 

inherent in their products. See Robles v. Shoreside Petroleum, Inc., 29 P.3d 838, 842 

(Alaska 2001); Prince v. Parachutes, Inc., 685 P.2d 83, 87 (Alaska 1984). 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 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). Alaska

has explicitly adopted the most commonly invoked intermediary exception—the 

learned intermediary doctrine—which gives manufacturers of prescription drugs a 

defense if they have adequately informed prescribing physicians, as opposed to patients 

directly, of risks associated with their drugs. See Shanks v. Upjohn Co., 835 P.2d 1189, 

1194 n.6, 1200 (Alaska 1992); Specter v. Tex. Turbine Conversions, Inc., No. 3:17-cvCase 7:20-cv-00094-MCR-GRJ Document 150 Filed 05/27/21 Page 5 of 11
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194, 2021 WL 218720, at *6 & n.47 (D. Alaska Jan. 21, 2021). Physicians serve as 

“learned intermediaries” between drug 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, and to advise their patients accordingly. 

See Shanks, 835 P.2d at 1195 (“In a sense, prescribing doctors are the consumers of 

prescription drugs. It is the doctor’s evaluation of the patient’s condition and 

consideration of the available treatment alternatives which leads to the choice of a 

specific prescription drug product.”).

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 gives a manufacturer a defense if it warned certain 

intermediate purchasers of its product of the known and knowable hazards in the 

product’s use, and reasonably relied 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 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, 

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metals or sand—made it impossible or impractical for the manufacturer to provide 

effective warnings to end-users. See, e.g., Webb, 370 P.3d at 1033–38.

Alaska has not expressly adopted or applied the sophisticated intermediary 

doctrine. Nevertheless, Defendants insist that “[i]f confronted with a case that 

presented facts for which the sophisticated intermediary defense would actually apply, 

Alaska courts would readily adopt the doctrine” and, in their view, the instant case is

precisely that. The Court disagrees.

To begin with, it is not at all clear that Alaska 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. 74 at 3. However, in that time, there has not been a single reported decision 

in Alaska doing the same. As already discussed, Alaska has explicitly adopted the 

learned intermediary doctrine with respect to prescription drugs, see Shanks, 835 P.2d 

at 1194 n.6, 1200, but “the Shanks Court made clear that the learned intermediary 

defense has a limited application” and “Alaskan courts have not expanded the defense 

in the nearly thirty years since Shanks was decided,” see Specter, 2021 WL 218720, at 

*9.3

 Defendants cite no authority that would support a conclusion that Alaskan courts

would recognize a variant of that rule, like the sophisticated intermediary doctrine, 

3 The Court is not persuaded by Defendants’ argument that Specter supports their position.

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which greatly expands those bounds.4 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 Sols., 

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 Alaska 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 CAEv2.5

 None of the 

sophisticated intermediary cases identified by Defendants involved such a product. 

See, e.g., 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. Ct. App. 1997) (chemical odorant added to natural 

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

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

to the Alaska Supreme Court. However, there being no indication in Alaskan jurisprudence that it 

would adopt the sophisticated intermediary doctrine and, in fact, undeniable indications that it would 

reject the doctrine, this Court will not certify the question.

5 If the sophisticated intermediary doctrine were recognized 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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a licensed plumber); Swan v. I.P., Inc., 613 So. 2d 846 (Miss. 1993) (polyurethane 

roofing materials installed by polyurethane roofing contractor); 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 Parker v. 

Schmiede Mach. & Tool Corp., 445 F. App’x 231 (11th Cir. 2011) (berylliumcontaining 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); Persons v. Salomon N. Am., 265 Cal. Rptr. 773 (Cal. Ct. App. 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 

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. 

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Allergan, Inc., 1990 WL 70875 (N.D. Ill. May 2, 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. 

Ct. App. Div. 1979) (over-the-counter drug containing aspirin recommended by 

physician). The Shanks court similarly indicated that the learned intermediary doctrine 

would not apply to “drugs typically administered in a clinical setting with little or no 

physician involvement, or drugs marketed under a strategy designed to appeal directly 

to the consuming public.” See Shanks, 835 P.2d at 1195 n.7. 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 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 authority has 

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

conclusion, the Court finds that Alaska would not 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.6

 

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

intermediary doctrine does not apply in this case. Alaska does not recognize the 

doctrine, and even if it did, it would not be available in this context. Accordingly, 

McCombs’ motion for judgment as a matter of law on the sophisticated intermediary 

defense is GRANTED. 

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

M. Casey Rodgers 

M. CASEY RODGERS

UNITED STATES DISTRICT JUDGE

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