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:

Baker, 7:20-cv-39

Judge M. Casey Rodgers

Magistrate Judge Gary R. Jones

ORDER

This matter is before the Court on the parties’ Motions for Judgment as a Matter 

of Law (“JMOL”) under Federal Rule of Civil Procedure 50(a). Defendants move for 

JMOL on all of Plaintiff Lloyd Baker’s claims. Baker moves for JMOL on Defendants’ 

intermediary defenses under Washington law,

1 Defendants’ superseding cause defense, 

and Defendants’ avoidable consequence/failure to mitigate affirmative defense. Both 

sides submitted briefs on Defendants’ intermediary defenses and oral argument on the 

motions was heard on June 17, 2021. Having now fully considered the parties’ 

arguments and the applicable law, the Court concludes that Defendants’ motion is due 

to be denied and that Baker’s motion is due to be granted, in part, and denied, in part.

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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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 

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. Defendants’ Motion for JMOL

For the reasons stated on the record, the Court finds that there is a sufficient 

evidentiary basis for a reasonable jury to find for Baker on each of his claims. 

Accordingly, Defendants’ motion for JMOL is DENIED.

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B. Baker’s Motion for JMOL

1. Intermediary Defenses

i. Sophisticated Intermediary Doctrine

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

known dangers inherent in their products. See Campbell v. ITE Imperial Corp., 733 

P.2d 969, 973 (Wash. 1987) (en banc). 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). Washington has 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 Terhune v. A.H. Robins Co., 577 P.2d 975, 978–79

(Wash. 1978) (en banc). Physicians serve as “learned intermediar[ies]” 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 

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drug or medical device, and to advise their patients accordingly. See Taylor v. Intuitive 

Surgical, Inc., 389 P.3d 517, 525 (Wash. 2017).

A small number of states—at least nine—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 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 end-users. See, e.g., Webb, 370 P.3d at 

1033–38.

“Washington case law on the [sophisticated intermediary] doctrine centers 

almost exclusively on the pharmaceutical context.” See Jack v. Borg-Warner Morse 

Tec, LLC, No. C17-0537, 2018 WL 4409800, at *27 (W.D. Wash. Sept. 17, 2018); see 

also Rublee v. Carrier Corp., 428 P.3d 1207, 1216 (Wash. 2018) (“The only scenario 

in which we differentiate between types of users or consumers is in the pharmaceutical 

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or medical device context, where the ‘learned intermediary’ doctrine applies.”);

Headley v. Ferro Corp., 630 F. Supp. 2d 1261, 1272 (W.D. Wash. 2008) (“[T]his Court 

cannot find[] a single Washington case adopting or applying the Sophisticated User

Doctrine.”).2 Nevertheless, Defendants insist that Washington courts would apply the 

sophisticated intermediary defense in the instant case. The Court disagrees.

It is true, as Defendants point out, that “Washington courts have recognized a 

variant of the sophisticated purchaser doctrine in toxic tort claims, where a 

manufacturer or supplier of the products alleged to have caused the plaintiff’s injuries 

warns the plaintiff’s intermediary or employer of the products’ dangerous 

propensities.” See Jack, 2018 WL 4409800, at *27 (citing Reed v. Pennwalt Corp., 591 

P.2d 478 (Wash. Ct. App. 1979), appeal dismissed, 604 P.2d 614 (Wash. 1979)). But 

Reed and the other case cited by Defendants, Lunt v. Mount Spokane Skiing Corp., 814 

P.2d 1189 (Wash. Ct. App. 1991), are readily distinguishable because neither case

applied the doctrine to an ordinary consumer product marketed and sold directly to the 

general public. See Reed, 591 P.2d at 482 (caustic soda manufacturer not required to 

warn employees of a food processing plant of the product’s hazards where the 

manufacturer had warned the plaintiff’s employer); Lunt, 814 P.2d at 1194 (ski binding 

2 While the Headley court used the term “Sophisticated User Doctrine,” a close reading of the 

case makes clear that the court was referring instead to the sophisticated intermediary doctrine. See 

Headley, 630 F. Supp. 2d at 1272 (“Ferro’s second causation argument attempts to shift the burden 

of warning those exposed to silica to A.O. Smith, which it contends failed miserably in this role by 

neglecting to properly train, supervise, and care for its employees.”).

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manufacturer fulfilled its duty to warn by warning ski resort because “a ski binding 

manufacturer who makes bindings for rental use . . . has limited opportunities to 

communicate directly with the consumer”).

3 Defendants cite no authority that would

support a conclusion that Washington courts would expand the bounds of the 

sophisticated intermediary doctrine to encompass ordinary consumer products 

marketed and sold directly to the general public.

4 See Rublee, 428 P.3d at 208 (“We 

have long recognized that consumer protection is the touchstone of Washington’s 

product liability law. . . . we do not differentiate between types of users or consumers 

3 Indeed, the Court has not found a single case—anywhere—in which the sophisticated 

intermediary doctrine was applied to an ordinary consumer product marketed and sold directly to the 

general public, like the CAEv2. 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 a licensed plumber); Swan 

v. I.P., Inc., 613 So. 2d 846 (Miss. 1993) (polyurethane roofing materials installed by polyurethane 

roofing contractor); 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); 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); 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). In other words, 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.

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

to the Washington Supreme Court. However, there being no indication in Washington 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.

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for purposes of liability.”); 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).

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. 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). Indeed, the Lunt court noted—without deciding—that “a 

different duty” may “be imposed on a manufacturer who sells products directly to 

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consumers.” See 814 P.2d at 1194 n.5. 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 Washington 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.5

ii. Bulk Supplier Doctrine

Defendants further argue that “[t]he related bulk supplier doctrine is also 

applicable.”6 The Court is not persuaded. “Under the bulk supplier doctrine, ‘[b]ulk 

suppliers of products to manufacturers, who are sophisticated users, have no duty in 

negligence, strict liability, or breach of warranty to warn ultimate purchasers of the 

5 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.

6 The bulk supplier doctrine is an affirmative defense. See Little v. Liquid Air Corp., 952 F.2d 

841, 851 (5th Cir. 1992).

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manufacturer’s product.’ ” Kealoha v. E.I. du Pont de Nemours & Co., Inc., 82 F.3d 

894, 901 (9th Cir. 1996). “The doctrine is a recognition of the difficulties peculiar to 

suppliers of raw materials and component parts, in discharging their duty to warn those 

ultimately exposed to the hazards posed by their products.” See Am. L. Prod. Liab. 3d 

§ 33:26; see also Genereux v. Am. Beryllia Corp., 577 F.3d 350, 374 (1st Cir. 2009) 

(explaining that “products delivered in bulk are often reformulated and repackaged by 

an intermediary, making it unlikely that the supplier could provide a warning that 

would reach end users; and that bulk supplies are often put to ‘multitudinous 

commercial uses,’ making it unduly burdensome to require the supplier to warn all 

foreseeable end users” (citation omitted)); Forest v. E.I. DuPont de Nemours & Co., 

791 F. Supp. 1460, 1465 (D. Nevada 1992) (explaining that “there are duties elsewhere 

in the law that require the intermediary [who actually manufacturers the finished 

product] as a manufacturer and retail marketer to safely design the product, test it, and 

provide its own adequate warning of any unavoidable inherent dangers” and that “[i]t 

would be wasteful, and at times counter-productive, for courts to require the bulk 

supplier to duplicate these efforts”). Courts in numerous states have adopted the 

doctrine and applied it to bulk suppliers of raw materials and manufacturers of 

non-defective component parts. See In re Silicon Gel Breast Implants Prods. Liab. 

Litig., 887 F. Supp. 1463, 1467–68 (N.D. Ala. 1995) (collecting cases); see also

Hoffman v. Houghton Chem. Corp., 751 N.E.2d 848, 852 (Mass. 2001) (applying the 

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doctrine to bulk suppliers of chemical products); Sara Lee Corp. v. Homasote Co., 719 

F. Supp. 417, 419 (D. Md. 1989) (applying the doctrine to bulk suppliers of expandable 

polystyrene beads). The Washington Supreme Court has applied the doctrine to a bulk 

supplier of propane gas where the defendant supplier bought the propane from a 

manufacturer and sold it to a retailer “completely as a paper transaction” and therefore 

“never had possession or control of the propane.” See Zamora v. Mobil Corp., 704 P.2d 

584, 586, 588 (Wash. 1985) (en banc); see also Braaten v. Saberhagen Holdings, 198 

P.3d 493, 383 (Wash. 2008) (en banc) (“[A] ‘manufacturer’s duty to warn is restricted 

to warnings based on the characteristics of the manufacturer’s own products’; ‘[t]he 

law generally does not require a manufacturer to study and analyze the products of 

others and warn users of the risks of those products.’ ” (citations omitted)).

As illustrated by these cases, the “[j]ustification for absolving a supplier from 

liability to ultimate users of the end-product is strongest . . . when a supplier sells to a 

knowledgeable manufacturer raw materials in bulk, which are not themselves 

inherently dangerous and which are substantially changed during the manufacturing 

process before resale to consumers, and when the supplier has little to no role in the 

design of the end product.” See In re Silicone Gel Breast Implants Prods. Liab. Litig., 

996 F. Supp. 1110, 1114 (N.D. Ala. 1997). In this case, Defendants, unlike the 

defendant propane supplier in Zamora and the defendant bulk suppliers in cases from 

other jurisdictions applying the doctrine, did not merely supply bulk raw materials or 

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component parts to another retailer or manufacturer. Rather, Defendants designed,

manufactured, and marketed the end product at issue in this case—the CAEv2. Thus, 

the bulk supplier doctrine is inapplicable. See Ramos v. Brenntag Specialties, Inc., 372 

P.3d 200, 275 (Cal. 2016) (“[T]he protection afforded to defendants by the component 

parts doctrine does not apply when the product supplied has not been incorporated into 

a different finished or end product but instead, as here, itself allegedly causes injury 

when used in the manner intended by the product supplier.”).

For these reasons, the Court concludes as a matter of law that neither the 

sophisticated intermediary doctrine nor the bulk supplier doctrine apply in this case.

Accordingly, Plaintiff’s motion for judgment as a matter of law on Defendants’ 

defenses based on the sophisticated intermediary doctrine and the bulk supplier 

doctrine is GRANTED.

2. Superseding Cause

For the reasons stated on the record, the Court finds that there is a sufficient 

evidentiary basis for a jury to find that the Army’s failure to ensure Baker’s CAEv2 

earplugs were properly fitted or to provide Baker with adequate instruction in proper 

use of the CAEv2 is a superseding cause of Baker’s injuries. See Sluman v. State, 418 

P.3d 125, 150 (Wash. Ct. App. 2018) (“Whether an intervening act constitutes a 

superseding cause is generally a question of fact for the jury.”). Accordingly Baker’s 

motion for JMOL on Defendants’ superseding cause defense is DENIED.

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3. Avoidable Consequences/Failure to Mitigate

Defendants argue that Baker has failed to avoid consequences and mitigate 

damages because he does not use hearing aids. Under Washington law, a jury may not 

base its decision to allocate a portion of damages to the plaintiff for failure to mitigate 

based on speculation. See Fox v. Evans, 111 P.3d 267, 271 (Wash. Ct. App. 2005). For 

this reason, “expert testimony is required to show that reasonable alternatives were 

available,” the “expert testimony must establish that the alternative treatment would 

more likely than not improve or cure the plaintiff’s condition,” and “[t]he evidence 

must also allow a jury to segregate the damages.” Id. at 270–71. The Court finds that 

there is not a sufficient evidentiary basis for a reasonable jury to find that Baker failed 

to mitigate his damages by not using a hearing aid. For one, there is no expert testimony 

in this case establishing that the alternative treatment at issue here—hearing aids—

would “more likely than not improve or cure” Baker’s condition. See Fox, 111 P.3d at 

271; Trial Tr. (6/14/2021) at 178, 299 (Dr. Mark Packer testifying that “a hearing aid 

may or may not help his hearing right now” and that “I don’t know that it would help 

him overcome some of his hearing difficulties based on the configuration of his 

profile”); Trial Tr. (6/16/2021) at 327 (Dr. Greg Flamme testifying that “it would be 

well worth looking into the possibility of fitting [Baker] with a hearing aid and trying 

that out to see how it works” and that “[h]e would be a suitable candidate for that”

(emphasis added)). Moreover, there is no evidence that would allow the jury to 

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segregate the damages because there is no evidence of what a hearing aid would have 

cost or how much it would have mitigated Baker’s injuries. Additionally, while there 

is evidence that hearing aids may have helped mask Baker’s tinnitus, there is also 

evidence that a hearing aid could have exacerbated Baker’s hyperacusis by painfully 

amplifying sound. See Trial Tr. (6/14/2021) at 178 (Dr. Packer testifying that 

“[s]omebody with significant tinnitus can be helped by hearing aids as a masking 

device. . . . But when you put a hearing aid on somebody with hyperacusis, that’s 

sometimes a problem because now you have amplified sound which is painful.”). 

Washington law does not force Baker to face a Hobson’s choice between masking his 

tinnitus and painfully amplifying sounds. See Hogland v. Klein, 298 P.2d 1099, 1102 

(Wash. 1956) (“A wide latitude of discretion must be allowed to the person who by 

another’s wrong has been forced into a predicament where he is faced with a probability 

of injury or loss. . . . If a choice of two reasonable courses presents itself, the person 

whose wrong forced the choice cannot complaint that one rather than the other is 

chosen.” (citation omitted)). Accordingly, Baker’s motion for JMOL on Defendants’ 

avoidance of consequences/failure to mitigate affirmative defense is GRANTED.

SO ORDERED, on this 17th day of June, 2021.

M. Casey Rodgers

M. CASEY RODGERS

UNITED STATES DISTRICT JUDGE

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