Jeffrey Connell v. Lima Corporate

FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

JEFFREY D. CONNELL; JANET No. 19-35797

CONNELL,

Plaintiffs-Appellants, D.C. No.

1:16-cv-00456-

v. CWD

LIMA CORPORATE; LIMA USA, INC.,

an Indiana corporation, OPINION

Defendants-Appellees,

DJO GLOBAL, INC., a Delaware

corporation; ENCORE MEDICAL LP, a

Delaware corporation,

Defendants-Intervenors.

Appeal from the United States District Court

for the District of Idaho

Candy W. Dale, Magistrate Judge, Presiding

Argued and Submitted August 10, 2020

Anchorage, Alaska

Filed February 17, 2021

Before: Johnnie B. Rawlinson, Mary H. Murguia, and

Ryan D. Nelson, Circuit Judges.

Opinion by Judge R. Nelson

2 CONNELL V. LIMA CORPORATE

SUMMARY *

Biomaterials Access Assurance Act

The panel affirmed the district court’s summary

judgment in favor of Lima Corporate in a diversity action

alleging product liability and negligence claims relating to a

hip implant.

The panel held that in light of the statutory text, context,

and stated purpose, Lima Corporate was a biomaterials

supplier of its Hip Stem – a “component part” supplied “for

use in the manufacture of an implant.” See the Biomaterials

Access Assurance Act (“BAAA”), 21 U.S.C. § 1602(1)(A).

The panel concluded that Lima Corporate was immune from

liability under the BAAA and, under the circumstances of

this case, could not be impleaded under 21 U.S.C. § 1606.

COUNSEL

Eric S. Rossman (argued) and Erica S. Phillips, Rossman

Law Group PLLC, Boise, Idaho; George E. McLaughlin,

Warshauer McLaughlin Law Group, Denver, Colorado; for

Plaintiffs-Appellants.

Stephen R. Thomas (argued) and Andrew J. Rosholt,

Hawley Troxell Ennis & Hawley LLP, Boise, Idaho; Brian

J. Hurst, Baker McKenzie, Dallas, Texas; for Defendants-

Appellees.

*

This summary constitutes no part of the opinion of the court. It

has been prepared by court staff for the convenience of the reader.

CONNELL V. LIMA CORPORATE 3

OPINION

R. NELSON, Circuit Judge:

We are presented with a question of first impression:

who qualifies as a biomaterials supplier under the

Biomaterials Access Assurance Act (“BAAA”), 21 U.S.C.

§ 1601 et seq. We conclude, in light of the statutory text,

context, and stated purpose, that Lima Corporate (“Lima”) is

a biomaterials supplier of its Hip Stem—a “component part”

supplied “for use in the manufacture of an implant.” See id.

§ 1602(1)(A). Therefore, Lima is immune from liability

under the BAAA and, under the circumstances here, cannot

be impleaded under § 1606.

I

A

Encore Medical L.P., doing business as DJO Surgical

(“DJO”), manufactures and sells orthopedic hip, knee, and

shoulder devices. DJO purchases medical devices from

suppliers such as Lima, an Italian company, to sell in the

United States. One of Lima’s products is a modular revision

hip stem (“Hip Stem”) which consists of: (1) a femoral stem,

which the surgeon inserts into a channel in the patient’s

femoral canal; (2) an angled neck, also called a proximal

body; and (3) a set screw, which holds the stem and neck

together.

Lima supplied the Hip Stem to DJO for sale in the United

States. The Supply Agreement between Lima and DJO

described the Hip Stem (referred to as the “Revision Femoral

Stem”) as comprising two parts—the stem and the neck—

but included pictures of the screw holding them together.

The Supply Agreement also mentioned compatible hip

4 CONNELL V. LIMA CORPORATE

implant product components not included in the Hip Stem,

such as acetabular plates, acetabular cups, polyethylene

liners, femoral heads, and bone screws. DJO agreed to

obtain regulatory certifications permitting sale of the Hip

Stem, such as the required United States Food and Drug

Administration (“FDA”) clearance letters and 510(k)

notifications, in DJO’s name. Lima agreed to produce the

Hip Stem according to DJO’s specifications.

Image 1. Image of the Hip Stem.

DJO submitted a 510(k) notification to the FDA seeking

preclearance for the Hip Stem (calling it the “Modular

Revision Hip Stem”). DJO described its methods for

“steriliz[ing] and packaging” the Hip Stem before labeling

and redistribution. DJO also developed and provided

instructions for use of the Hip Stem. Lima had provided

DJO with access to testing data and results from its European

operations and a copy of Lima’s “Instructions for Use” for

CONNELL V. LIMA CORPORATE 5

the Hip Stem used in other countries. Lima was not required

by law to register or list the Hip Stem it sold to DJO. DJO

obtained clearance from the FDA to market the Hip Stem in

the United States.

The Hip Stem sold by DJO was essentially identical to

the Hip Stem supplied by Lima. DJO’s 510(k) notification

specified a list of separate “Compatible Components”

previously cleared by the FDA, including various femoral

heads, acetabular shells, and liners. DJO’s “Instructions for

Use” noted the Hip Stem may be used with DJO’s “CoCr”

brand of femoral heads or ceramic heads, separate pieces that

could be paired with the Hip Stem but were not

manufactured or supplied by Lima and approved under

separate 510(k) notifications. DJO’s surgical technique

specified that the Hip Stem cannot be implanted or function

without a separate compatible femoral head. The surgeon

was instructed to attach various component parts with the

Hip Stem “in situ,” meaning inside the patient’s body during

surgery.

B

In 2011, Jeffrey Connell underwent left hip revision

surgery in Boise, Idaho. The orthopedic surgeon implanted

a dual mobility acetabular shell, polyethylene liner, and a

DJO CoCr metal femoral head connected to the Hip Stem.

6 CONNELL V. LIMA CORPORATE

Image 2. A dual mobility acetabular shell, liner, and

ceramic femoral head.

Image 3. The Hip Stem attached to a shell, liner, and

ceramic femoral head.

Three years after surgery, Mr. Connell had gained weight

and the femoral stem portion of Mr. Connell’s implant

fractured. The failed hip prosthesis was removed, discarded,

and replaced. Because the explanted products were not

returned, DJO did not determine a definitive root cause for

the fracture.

Mr. Connell and his wife filed this action against DJO

and Lima for product liability, negligence, breach of

warranties, and negligent infliction of emotional distress.

CONNELL V. LIMA CORPORATE 7

After discovery, DJO and the Connells settled and the

district court dismissed the claims against DJO with

prejudice on November 16, 2018.

Lima then moved for summary judgment as a

“biomaterials supplier” entitled to immunity under the

BAAA. The district court held the Connells’ claims against

Lima were preempted by the BAAA and granted summary

judgment on January 30, 2019. The district court reasoned

that the pieces supplied by Lima were not ready for

implantation when they arrived at DJO’s facility and thus

were not an implant under the BAAA. The district court also

noted, incorrectly as it turned out, that the screw used in the

Hip Stem was not provided by Lima and, therefore, Lima

supplied only two of the three pieces of the Hip Stem.

The Connells timely requested reconsideration under

Rule 59(e) noting the district court’s misunderstanding that

Lima did not provide the screw and arguing the district court

erroneously interpreted the BAAA. The Connells separately

sought to implead Lima back into the action pursuant to

21 U.S.C. § 1606(a)(2), which provides that under specific

circumstances a claimant may implead a dismissed

biomaterials supplier within 90 days after a “final judgment

in an action by the claimant against a manufacturer.”

The district court denied reconsideration, explaining that

who manufactured the screw was not dispositive because the

Hip Stem was not ready for implantation when DJO received

it. DJO still had to complete several steps before the Hip

Stem was ready for commercial distribution. The district

court also held that Lima was not a manufacturer of the Hip

Stem under the BAAA given the FDA’s determination

pursuant to 21 C.F.R. § 807.20 that Lima “was exempt from

FDA’s registration and listing requirements as an entity that

manufactured ‘devices for another party who both initiates

8 CONNELL V. LIMA CORPORATE

the specifications and commercially distributes the device.’”

The district court declined to consider new arguments or

evidence regarding the other two exceptions to preemption

of liability for a biomaterials supplier under the BAAA,

which the Connells had not previously raised.

The district court also denied the Connells’ motion to

implead Lima under 21 U.S.C. § 1606(a), because there was

no “final judgment” against DJO, the “manufacturer.” The

district court held that the settlement agreement resulting in

a voluntary dismissal with prejudice of the claims against

DJO was not an adjudication on the merits and thus not an

appealable judgment. The Connells timely appealed the

district court’s grant of summary judgment and denial of the

Connells’ motions for reconsideration and impleader, and

we have appellate jurisdiction under 28 U.S.C. § 1291.

II

“We review the district court’s order granting summary

judgment de novo.” Guenther v. Lockheed Martin Corp.,

972 F.3d 1043, 1052 (9th Cir. 2020) (citation omitted). A

party is entitled to summary judgment only when “there is

no genuine dispute as to any material fact and the movant is

entitled to judgment as a matter of law.” Fed. R. Civ. P.

56(c). 1 We view all facts in the light most favorable to the

non-moving party. Guenther, 972 F.3d at 1052.

1

Lima argues that Congress provided for an alternative standard to

Rule 56 in the BAAA. Under the BAAA, a “biomaterials supplier shall

be entitled to entry of judgment without trial if the court finds there is no

genuine issue of material fact for each applicable element set forth in

paragraphs (1) and (2) of section 1604(d).” 21 U.S.C. § 1605(d)(1)(A).

The statutory language limits the BAAA’s standard for summary

judgment to cases dealing with § 1604(d). Because § 1604(d) is not at

CONNELL V. LIMA CORPORATE 9

The denial of a Rule 59(e) motion is reviewed for abuse

of discretion. 389 Orange St. Partners v. Arnold, 179 F.3d

656, 661 (9th Cir. 1999). We review the denial of a motion

to implead under Federal Rule of Civil Procedure 14 for

abuse of discretion, Stewart v. Am. Int’l Oil & Gas Co.,

845 F.2d 196, 199 (9th Cir. 1988), and assume the same

standard of review applies by analogy to impleader under

§ 1606, which is permissive. See 21 U.S.C. § 1606(a) (“A

court . . . may implead a biomaterials supplier who has been

dismissed from the action . . .” (emphasis added)). Lastly,

we review issues of statutory interpretation de novo. United

States v. Schmidt, 947 F.2d 362, 370 (9th Cir. 1991).

III

We begin by interpreting the language of the BAAA.

Whether a company like Lima is immune from liability as a

“biomaterials supplier” under the BAAA is a question of

first impression in the courts of appeal. But our de novo

review is guided by well-established rules of statutory

interpretation. We “begin[] with the statutory text, and end[]

there as well if the text is unambiguous.” BedRoc Ltd., LLC

v. United States, 541 U.S. 176, 183 (2004). “[W]hen the

statute’s language is plain, the sole function of the courts . . .

is to enforce it according to its terms.” Lamie v. U.S. Tr.,

540 U.S. 526, 534 (2004) (citations omitted). “[U]nless

otherwise defined, words will be interpreted as taking their

ordinary, contemporary, common meaning” existing “at the

time Congress enacted the statute.” Perrin v. United States,

444 U.S. 37, 42 (1979) (citation omitted).

issue in this appeal, the BAAA’s standard for summary judgment does

not apply.

10 CONNELL V. LIMA CORPORATE

“[B]ecause the statute contains an express pre-emption

clause, we do not invoke any presumption against pre-

emption but instead focus on the plain wording of the clause,

which necessarily contains the best evidence of Congress’

pre-emptive intent.” Puerto Rico v. Franklin Cal. Tax-Free

Tr., 136 S. Ct. 1938, 1946 (2016) (internal quotation marks

and citations omitted). We also analyze the scope of a

preemption statute using a “fair understanding of

congressional purpose,” see Medtronic, Inc. v. Lohr,

518 U.S. 470, 485–86 (1996) (citation and emphasis

omitted), and using “the ordinary meaning of the words

used,” Richards v. United States, 369 U.S. 1, 9 (1962).

We determine if a statute’s meaning is plain or

ambiguous by looking to “the language itself, the specific

context in which that language is used, and the broader

context of the statute as a whole.” Robinson v. Shell Oil Co.,

519 U.S. 337, 341 (1997). “In construing a statute we are

obliged to give effect, if possible, to every word Congress

used,” Reiter v. Sonotone Corp., 442 U.S. 330, 339 (1979),

without rendering words “superfluous, void, or

insignificant,” Young v. United Parcel Serv., Inc., 135 S. Ct.

1338, 1352 (2015) (internal quotation marks and citations

omitted). If we find the language ambiguous, “we are left to

resolve that ambiguity” and find the interpretation that is

“more consistent with the broader context” and “primary

purpose” of the statute. Robinson, 519 U.S. at 345–46.

A

We begin, as we must, with the text of the Biomaterials

Access Assurance Act. Pub. L. No. 105-230, 112 Stat. 1519

(1998) (codified at 21 U.S.C. §§ 1601–06). At its core, the

BAAA preempts liability for “biomaterials supplier[s]” with

CONNELL V. LIMA CORPORATE 11

certain exceptions. 21 U.S.C. § 1604(a). 2 This liability

preemption “applies to any civil action brought by a

claimant, whether in a Federal or State court, on the basis of

any legal theory, for harm allegedly caused, directly or

indirectly, by an implant.” Id. § 1603(b)(1). It “supersedes

any State law regarding recovery for harm caused by an

implant and any rule of procedure applicable to a civil action

to recover damages for such harm only to the extent that [the

BAAA] establishes a rule of law applicable to the recovery

of such damages.” Id. § 1603(c)(1). Thus, if a defendant

satisfies the definition of a biomaterials supplier, it may

“raise any exclusion from liability” as provided in the statute

and move for dismissal or summary judgment. Id.

§ 1603(a)(1).

Congress included a statement of findings in the BAAA

that clarified its purpose in immunizing biomaterials

suppliers. Id. § 1601; see United States v. Turkette, 452 U.S.

576, 589 (1981) (applying the statutory statement of findings

as “the declared purpose of Congress”). It sought to “assure

the continued supply of materials for lifesaving medical

devices” without protecting “negligent suppliers.”

21 U.S.C. § 1601(17). Though “raw materials and

component parts suppliers d[id] not design, produce, or test

a final medical device,” id. § 1601(7), they were

nevertheless targeted by costly and often meritless litigation

deterring them from providing component parts for use in

2

Three exceptions exist under which biomaterials suppliers may be

held liable: if the supplier (1) is a “manufacturer” as defined in

§ 1604(b); (2) is a “seller” as defined in § 1604(c); or (3) “furnish[es]

raw materials or component parts for the implant that fail[] to meet

applicable contractual requirements or specifications,” as described in

§ 1604(d). 21 U.S.C. § 1604(a). On appeal, the Connells only argue that

Lima is not a “biomaterials supplier,” not that any of these exceptions

apply.

12 CONNELL V. LIMA CORPORATE

medical devices, id. § 1601(8); see also id. § 1601(11). This

“unavailability of raw materials and component parts”

would “lead to unavailability of lifesaving and life-

enhancing medical devices.” Id. § 1601(9). Of particular

concern was that “suppliers . . . in foreign nations [were]

refusing to sell raw materials or component parts” in the

United States. Id. § 1601(10). Thus, Congress enacted the

BAAA “to clarify the permissible bases of liability for

suppliers of raw materials and component parts for medical

devices” and “provide expeditious procedures to dispose of

unwarranted suits against the suppliers . . . to minimize

litigation costs.” Id. § 1601(15).

Whether Lima is immune from liability hinges on the

BAAA’s definition of “biomaterials supplier,” defined as

“an entity that directly or indirectly supplies a component

part or raw material for use in the manufacture of an

implant.” Id. § 1602(1)(A) (emphases added). We turn to

whether Lima met these elements of (1) supplying a

“component part” (2) “for use in the manufacture of an

implant.” Id. The definition of “component part” in the first

element incorporates the definition of “implant,” contained

in the second element. As discussed below, the definition of

“implant” is key to our holding that Lima is immune as a

“biomaterials supplier.”

B

1

We first analyze whether Lima’s Hip Stem was a

component part. The BAAA defines a “component part” as

“a manufactured piece of an implant.” Id. § 1602(3)(A). We

hold the Hip Stem meets the definition of a component part

under the BAAA.

CONNELL V. LIMA CORPORATE 13

The Hip Stem meets the first element of the definition of

“component part” according to the plain, ordinary meaning

of “manufactured.” Congress did not define the word

“manufactured” in the BAAA, though it defined

“manufacturer” in great detail as:

any person who, with respect to an implant—

(A) is engaged in the manufacture,

preparation, propagation, compounding,

or processing (as defined in section

360(a)(1) of this title) of the implant; and

(B) is required—

(i) to register with the Secretary pursuant

to section 360 of this title and the

regulations issued under such section;

and

(ii) to include the implant on a list of

devices filed with the Secretary

pursuant to section 360(j) of this title

and the regulations issued under such

section.

Id. § 1602(6). A “manufacturer” explicitly engages in

activities beyond just the “manufacture” of the implant:

specifically, “preparation, propagation, compounding, or

processing.” Id. This statutory distinction suggests

“manufacturer” and “manufactured” are not mere variations

of the same definition. If Congress had intended the

meaning of “manufactured” to be the same as its definition

of “manufacturer,” it could have easily done so by defining

the term “manufactured.” It did not. We read this omission

to be intentional. See Barnhart v. Sigmon Coal Co., 534 U.S.

14 CONNELL V. LIMA CORPORATE

438, 452–54 (2002). Since the statute does not “clearly

express[] an intention to the contrary,” we read

“manufactured” according to its “ordinary meaning.” See

United States v. Price, 980 F.3d 1211, 1218 (9th Cir. 2019)

(as amended) (internal quotation marks and citation

omitted). And the Hip Stem satisfies the first element of a

component part under the ordinary meaning of

“manufactured.” See Manufacture, Black’s Law Dictionary

964–65 (6th ed. 1990) (defining “manufactured” items as

“nearly all such materials as have acquired changed

conditions or new and specific combinations . . . from . . .

direct action of the human hand, . . . chemical processes . . . ,

or . . . machinery”).

Moreover, the Hip Stem is a “piece” of an implant as a

separate part of a larger whole, unable to function on its own.

See Piece, Oxford English Dictionary (2d ed. 1989)

(defining “piece” as a “separate or detached portion, part, bit,

or fragment of anything”); see also Part, Black’s Law

Dictionary 1117 (6th ed. 1990) (defining “part” as “[a]n

integral portion, something essentially belonging to a larger

whole”). The Connells acknowledge that the Hip Stem

cannot be implanted or function without a separate

compatible femoral head. DJO’s 510(k) notification,

surgical technique for inserting the Hip Stem, and

Instructions for Use all clarify that the Hip Stem cannot be

implanted alone. To function, it must be combined with a

separate compatible femoral head, acetabular shell, and

liner—all separate parts not supplied by Lima. See, e.g.,

Image 1, supra at 4; Image 2, supra at 6; Image 3, supra at 6.

Thus, the Hip Stem is a “manufactured piece” of the larger

whole of Mr. Connell’s hip implant, which also incorporates

a shell, liner, and DJO CoCr femoral head.

CONNELL V. LIMA CORPORATE 15

Finally, the Hip Stem is a manufactured piece of an

“implant” and therefore a “component part.” The definition

of “implant” is the crux of the determination that Lima

constitutes a biomaterials supplier. The Connells contend

that the Hip Stem cannot be a component part because it is

itself an implant. But the BAAA’s definition of “implant”

clarifies the difference between an implant and a component

part.

The BAAA defines “implant” as:

(A) a medical device that is intended by the

manufacturer . . .

(i) to be placed into a surgically or

naturally formed or existing cavity of

the body for a period of at least

30 days; or

(ii) to remain in contact with bodily fluids

or internal human tissue through a

surgically produced opening for a

period of less than 30 days; and

(B) suture materials used in implant

procedures.

21 U.S.C. § 1602(5) (emphases added). There are two major

elements to the definition of implant: “medical device” and

“intended by the manufacturer . . . to be placed” in a body

cavity. The parties both conflate “medical device” with

“implant,” likely because of the BAAA’s circular definition

of “device.” But the definition of “implant” hinges

decisively on the second element of “intended by the

manufacturer . . . to be placed” in a body cavity. And the

complete hip implant (not the Hip Stem) was the only

16 CONNELL V. LIMA CORPORATE

medical device intended to be implanted by DJO, the

manufacturer, into Mr. Connell. Thus, the Hip Stem was

only a component part comprising “a manufactured piece”

of the complete hip implant.

It is true that both the Hip Stem component part and Mr.

Connell’s complete hip implant satisfy the first element of

the “implant” definition—a “medical device.” A “medical

device” is “a device, as defined in section 321(h) of this title,

and includes any device component of any combination

product as that term is used in section 353(g) of this title.” 3

Id. § 1602(7). Section 321(h) broadly and circularly defines

“device” as “an instrument, apparatus, implement, machine,

contrivance, implant, in vitro reagent, or other similar or

related article, including any component, part, or accessory,

which is . . . intended to affect the structure or any function

of the body of man or other animals.” Id. § 321(h). The Hip

Stem is a device or “similar or related article” “intended to

affect the structure” of the human body. And Mr. Connell’s

complete hip implant (incorporating the Hip Stem, shell,

liner, and femoral head) is also a medical device under this

definition. Therefore, the broad definition of “medical

device” is not determinative.

The Hip Stem can be both a “medical device” and a

“component part” because these statutory definitions are not

mutually exclusive. The definition of “medical device”

cross-referenced in § 1602(7) includes “any component,

part, or accessory.” Id. § 321(h). Though Congress chose

an inartful and circular definition of “medical device,” its

expansive choice of wording is clear. Lamie, 540 U.S.

at 534 (“The statute is awkward . . . but that does not make

3

21 U.S.C. § 353(g) does not provide any additional relevant

definitions.

CONNELL V. LIMA CORPORATE 17

it ambiguous on the point at issue.”). The definition of

“medical device” “is worded broadly” and “[i]ts plain text

prevents us from reading it” to mean that a component part

cannot also be a medical device. See United States v. Nader,

542 F.3d 713, 721 (9th Cir. 2008).

Instead, the parties’ main disagreement, and the key to

defining “implant,” centers on the second element of the

definition: “intended by the manufacturer . . . to be placed”

in a body cavity. 21 U.S.C. § 1602(5). This phrase could be

read in one of two ways. It could be read to apply only when

the device is ready to be placed into a body cavity by itself.

Alternatively, it could be read to apply when a manufacturer

anticipates that an item could ever be inserted into a body,

even if it must first be combined with other items to become

implant-ready. Here, Lima argues that the Hip Stem was not

intended to be implanted by itself; thus, it was a component

part. But the Connells assert that because the Hip Stem was

intended to be inserted into a body at some point (albeit with

other parts attached), it is more properly classified as an

implant, not a component part. Lima’s interpretation is

better supported by the statutory context and stated purpose.

The text of the BAAA differentiates a component part

from the final implant. See, e.g., id. § 1601(2)–(5); id.

§ 1602(3), (5). If an “implant” were anything that could

eventually make its way into a body in some form or another,

then every component part of a final implant would be an

implant. The Connells’ interpretation of “implant” ignores

the statutory distinction between “component part” and

“implant,” rendering it superfluous. See Young, 135 S. Ct.

at 1352. Further, Congress’s statement of findings states the

BAAA’s overriding purpose is to preclude liability for

suppliers of component parts that did not manufacture the

final implant. See generally id. § 1601. Both Lima and the

18 CONNELL V. LIMA CORPORATE

Connells agree, as do we, that the BAAA is meant to

immunize those lacking control over the final implant. Thus,

it makes more sense to read “implant” as the final device

ready and intended for implantation, not as a device merely

intended to form a piece of some broader implant.

In light of the statutory context and purpose, we read the

words “intended . . . to be placed” in § 1602(5) to mean

intended for implantation by itself, according to the

limitations in § 1602(5)(A)(i)–(ii). See Robinson, 519 U.S.

at 345–46; Antonin Scalia & Bryan A. Garner, Reading

Law: The Interpretation of Legal Texts 63 (2012) (“A

textually permissible interpretation that furthers rather than

obstructs the document’s purpose should be favored.”). A

“component part” is not an “implant” because it does not

meet the second element of the definition, being intended for

implantation by itself, even if it meets the first element,

being a medical device.

Whether the manufacturer DJO intended the Hip Stem to

be implanted as it was received from Lima is therefore

determinative. DJO is indisputably the statutory

“manufacturer” of the Hip Stem under § 1602(6) of the

BAAA because DJO, not Lima, was required to register with

the FDA. And DJO made clear that the Hip Stem, as

supplied by Lima, could not be implanted and function by

itself. In fact, DJO processed, sterilized, labeled, and

packaged the Hip Stem and included Instructions for Use

requiring it to be combined with other component parts

before implantation. DJO did not intend the Hip Stem to be

implanted by itself when it was received from Lima.

Therefore, the Hip Stem was not an implant under the

BAAA. It was instead a component part. Common parlance

might refer to any item inserted into a body as an implant.

But the BAAA lays out a specific two-part definition for our

CONNELL V. LIMA CORPORATE 19

purposes here—medical device, and manufacturer’s intent

for implant. 21 U.S.C. § 1602(5). A device not intended to

be implanted by itself would not be an “implant” under the

BAAA, even if a supplier may intend it to be part of an

implantable medical device sometime down the road. The

hip implant, complete with all component parts including the

Hip Stem, femoral head, shell, and liner, was the only device

intended to be placed in a body cavity alone as-is. 4

2

Besides their main argument regarding the definition of

“implant,” the Connells cursorily assert that a component

part must have “significant non-implant applications” if it

has no implant value in itself, citing § 1602(3)(B). Section

1602(3)(B) states under the subheading “Certain

components” that “[s]uch term includes a manufactured

piece of an implant that . . . has significant non-implant

applications; and . . . alone, has no implant value or purpose,

but when combined with other component parts and

materials, constitutes an implant.” The Connells’ argument

would require § 1602(3)(A) to generally define “component

part,” and for § 1602(3)(B) to narrow the definition to only

include “certain components.” However, the alternative

reading that § 1602(3)(B) merely lists a nonexclusive

example additionally defining “certain components” is the

only reading that makes sense in light of the statutory text,

context, and purpose.

4

The manufacturer’s intent requirement in the component part

definition addresses any concerns that companies could “launder” a final

medical device to achieve immunity. A company could not be immune

as a biomaterials supplier by merely sending a final medical device to a

third party for repackaging because the manufacturer would intend it to

be inserted without combination with other component parts.

20 CONNELL V. LIMA CORPORATE

Section 1602(3)(B)’s choice of wording is key. After

component part is defined, § 1602(3)(B) states “[s]uch term

includes” parts of implants with “significant non-implant

applications” and no implant value alone. The word

“includes” shows § 1602(3)(B) is illustrative and a non-

exclusive listing of one type of component part, not defining

all parts. See Fed. Land Bank of St. Paul v. Bismarck

Lumber Co., 314 U.S. 95, 100 (1941) (“[T]he term

‘including’ is not one of all-embracing definition, but

connotes simply an illustrati[on.]”). So § 1602(3)(A)

defines “component part,” whereas § 1602(3)(B) clarifies

that definition to expansively also include “certain

components” with non-implant applications and no separate

implant value or purpose.

The statutory context reinforces this interpretation. See

United States v. Morton, 467 U.S. 822, 828 (1984) (“We do

not . . . construe statutory phrases in isolation; we read

statutes as a whole.”). Congress could have written a limited

definition in the same way it wrote limited definitions

elsewhere in § 1602, but did not. See, e.g., 21 U.S.C.

§ 1602(2)(D) (titled “Exclusions” and stating “[s]uch term

does not include” certain items); see also United States v.

Philip Morris USA Inc., 566 F.3d 1095, 1115 (D.C. Cir.

2009) (holding that the verb “include” is non-limiting where

the “most obvious way” to limit a definition would be to

write it the way Congress wrote other limited definitions

nearby). Congress did not title § 1602(3)(B) “Exclusions,”

as it did § 1602(2)(D). Nor did Congress state that the

component part definition is limited to items with significant

non-implant applications and no implant value or purpose

alone. Instead, it titled § 1602(3)(B) “Certain components,”

defining that term, not “component part,” with the text in

§ 1602(3)(B). See Almendarez-Torres v. United States,

523 U.S. 224, 234 (1998) (“[T]he title of a statute and the

CONNELL V. LIMA CORPORATE 21

heading of a section are tools available for the resolution of

a doubt about the meaning of a statute.” (internal quotation

marks and citations omitted)). Thus, we read § 1602(3)(B)

as non-limiting; it does not require component parts to have

“significant non-implant applications.”

Moreover, the Connells’ interpretation of § 1602(3)(B)

raises superfluity problems, as little would differentiate the

definitions of “component part” and “raw material.” If a

component part requires significant non-implant

applications, it would be virtually identical to a raw material,

which is a “substance or product that . . . has a generic use;

and . . . may be used in an application other than an implant.”

21 U.S.C. § 1602(8). Yet “raw material” and “component

part” are used distinctively throughout the entire BAAA;

reading them similarly means reading them impermissibly

as “superfluous.” See Young, 135 S. Ct. at 1352.

The Connells argue, though, that Congress’s statement

of findings dictates that most medical devices be “made with

raw materials and component parts that . . . are not designed

or manufactured specifically for use in medical devices.”

21 U.S.C. § 1601(3). They note that the statement of

findings states that “raw materials and component parts also

are used in a variety of nonmedical products” and only

“small quantities of the raw materials and component parts

are used for medical devices . . . .” Id. § 1601(4)–(5). This,

they urge, means the Hip Stem cannot be a component part

because it was designed for exclusive use in a medical

device.

This argument fails for two reasons. First, when reading

a preemption statute, we rely on its “plain wording” which

“necessarily contains the best evidence of Congress’ pre-

emptive intent.” Puerto Rico, 136 S. Ct. at 1946 (cleaned

up). Immunity under BAAA preemption hinges on the

22 CONNELL V. LIMA CORPORATE

statutory definition of “biomaterials supplier.” 21 U.S.C.

§ 1604. And we have explained how the operative language

here—the definition of “biomaterials supplier”—covers

those who supply component parts for manufacture in an

implant, regardless of whether those parts are also used in

nonmedical products. Though the statement of findings may

explain the impetus for the BAAA, we analyze Lima’s status

and the Hip Stem according to the BAAA’s substantive

provisions. See District of Columbia v. Heller, 554 U.S. 570,

578 n.3 (2008) (“[T]he preamble cannot control the enacting

part of the statute in cases where the enacting part is

expressed in clear, unambiguous terms.” (citation omitted)).

Second, even if considered, the statement of findings

does not support the Connells’ argument. The findings

explain the facts that existed at the time of enactment; they

do not limit the scope of preemption. When Congress passed

the BAAA, it was concerned precisely because “small

quantities of the raw materials and component parts are used

for medical devices.” 21 U.S.C. § 1601(5). Congress sought

to fix the problem of this dwindling market for raw materials

and component parts in medical devices. Id. § 1601(5)–(17).

Indeed, the fact that entities such as Lima are creating

component parts specifically for use in the manufacture of

implants evidences the BAAA’s success in encouraging the

component part market. Accepting the Connells’ reading

would punish those suppliers like Lima that undertake the

very thing Congress meant to encourage—providing

“sources of supply for the full range of threatened raw

materials and component parts for medical devices.” Id.

§ 1601(10). The Connells’ selective quotations of isolated

findings do not square with the overall substance of the

findings. See, e.g., id. § 1601(10)–(11) (highlighting the

need to convince foreign suppliers to export component parts

to the United States).

CONNELL V. LIMA CORPORATE 23

The Connells concede that the statute immunizes a

supplier who supplies a component part, such as a screw or

stem. That is the case here. The level of processing, testing,

advertising, and assembly needed to produce Lima’s

component part is irrelevant. Lima supplied a component

part—the Hip Stem—and did not supply the other required

shell, liner, and femoral head component parts. It matters

not that Lima’s component part itself comprised three

divisible pieces (the femoral neck, stem, and attachment

screw). Whether Lima provided one or three component

parts, Lima’s Hip Stem could not function alone and was not

intended to be implanted alone. It was not an entire hip

implant as the Connells claim. The final medical device—

Mr. Connell’s entire hip implant—necessarily combined a

shell, liner, and femoral head in addition to the Hip Stem. 5

5

Various district courts addressing component parts of hip implants

under the BAAA have come to similar conclusions. A femoral head was

held to be a component part where, as here, it was used in a broader final

hip implant consisting of several components: a “femoral sleeve,” a

“femoral stem,” a “femoral hip head,” an “acetabular cup,” and a “liner.”

Whaley v. Morgan Advanced Ceramics, Ltd., No. 07-cv-00912, 2008

WL 901523, at *2 (D. Colo. Mar. 31, 2008). A defendant was held to be

a biomaterials supplier because it made “femoral necks” that “were not

completed medical devices and could not be implanted into a human

being without additional components and numerous other manufacturing

steps and quality checks . . . .” Daley v. Smith & Nephew Inc., 321 F.

Supp. 3d 891, 897–98 (E.D. Wis. 2018). And a biomaterials supplier

providing a hip stem for use in a hip implant, Def.’s Mem. Opp. Pl.’s

Mot. Am. Compl. 5, was held likely immune under the BAAA, Marshall

v. Zimmer, No. 99-0973-E, 1999 WL 34996711, at *3 (S.D. Cal. Nov. 4,

1999).

District courts addressing other types of implants have reached

similar conclusions. See, e.g., Cavanaugh v. Ethicon Inc., No. 19-2014,

2019 WL 6883752, at *2–3 (E.D. Pa. Dec. 16, 2019) (holding defendants

were “biomaterials suppliers” because “the mesh they created was a

24 CONNELL V. LIMA CORPORATE

C

Lima must also meet the second element of the definition

of “biomaterials supplier” to be immune under the BAAA.

That is, Lima must have supplied the Hip Stem component

part “for use in the manufacture” of an implant. 21 U.S.C.

§ 1602(1). We hold that Lima satisfies this element under

the plain, ordinary meaning of “manufacture.”

First, as explained above, we read the phrase “for use in

the manufacture” by its ordinary meaning. “Use” means

“application” or “employ[ment] for . . . a given purpose.”

Use, Black’s Law Dictionary 1541 (6th ed. 1990). The noun

“manufacture” means “[t]he production of articles for use

from raw or prepared materials by giving such materials new

forms, qualities, properties or combinations.” Manufacture,

Black’s Law Dictionary 965 (6th ed. 1990). Putting these

two together, Lima needs only to have supplied the Hip

Stem, a prepared material, to be applied in a new form,

quality, or combination to produce a complete hip implant.

This it did. After Lima supplied the Hip Stem, it was then

sterilized, packaged, and combined with other component

parts to form a complete hip implant. Thus, Lima meets the

second element of the definition of “biomaterials supplier.”

component part used in the manufacture of the pelvic mesh devices

underlying th[e] litigation”); Mattern v. Biomet, Inc., No. 12-4931, 2013

WL 1314695, at *2 (D.N.J. Mar. 28, 2013) (holding supplier who shaped

metal for implants was a biomaterials supplier because “[t]he castings

. . . are not completed medical devices and could not be implanted into a

human being without additional manufacturing steps and quality

checks”); Jones v. Blackstone Med., Inc., No. 6:07-cv-455, 2009 WL

10677484, at *2 (E.D. Tex. Apr. 13, 2009) (“[T]he literal language of

[§ 1604(a)(3)] envisions the situation where a manufacturer of a medical

device contracts with another manufacturer to produce a specific

component part that will be incorporated into a medical device.”).

CONNELL V. LIMA CORPORATE 25

Note that if the Hip Stem had only been sterilized and

packaged before being implanted by itself into a body, that

may not have been enough to give it “new forms, qualities,

properties or combinations.” As we have explained,

Congress evidently chose to list “manufacture” as a noun

distinguished from “preparation, propagation,

compounding, or processing.” 21 U.S.C. § 1602(6). Thus,

merely sterilizing and packaging an item might not

necessarily cause it to be supplied for “use in the

manufacture” of an implant. But here the Hip Stem was

given a “new . . . combination[]” by being assembled with

other component parts, in addition to being sterilized and

packaged with instructions created by DJO. Together, this

was enough to cause the Hip Stem to be “use[d] in the

manufacture” of the final complete hip implant.

***

Altogether, Lima meets the elements of the definition of

a biomaterials supplier under § 1602(1) by (1) supplying a

“component part”—the Hip Stem—(2) “for use in the

manufacture of”—the sterilizing, packaging, and combining

the Hip Stem with three other component parts—(3) “an

implant”—the final complete hip implant. 6

We recognize that defining “biomaterials supplier”

expansively may limit recovery for plaintiffs like the

Connells. But given the limited case law and the strong

statutory indications that Congress intended to broadly

preempt liability for those supplying raw materials and

6

Because we affirm the grant of summary judgment de novo, we

also affirm the denial of the Rule 59 motion. The district court did not

abuse its discretion in denying reconsideration because the district court

properly determined that Lima is immune from liability as a biomaterials

supplier.

26 CONNELL V. LIMA CORPORATE

component parts, we believe this result is consistent with

both the text and purpose of the BAAA. In addition, this

expansive definition of “biomaterials supplier” has the

benefit of providing a clearer rule to litigants—if an entity

has provided a part that must be combined with other items

to create a final, independently functional “implant,” that

entity is a “biomaterials supplier” and only liable according

to the exceptions in 21 U.S.C. § 1604(b)–(d). In such a case,

it appears that Congress meant for plaintiffs to recover from

either the statutory manufacturer or the direct seller of an

implant instead. Although the Connells settled previously

with the statutory manufacturer here, DJO, future plaintiffs

are now on notice that absent negligence or intentionally

tortious conduct, recovery from an entity that provides part

of an implant will not be available. Further, the statute

provides a safety valve by which either manufacturers or

claimants may implead negligent suppliers who have been

dismissed back into the action. See 21 U.S.C. § 1606. We

now turn to the contours of this particular statutory

provision.

IV

Even if a defendant has immunity as a “biomaterials

supplier,” a complainant may implead a dismissed

biomaterials supplier as follows:

A court, upon motion by a manufacturer or a

claimant within 90 days after entry of a final

judgment in an action by the claimant against

a manufacturer . . . may implead a

biomaterials supplier who has been dismissed

from the action . . . if . . .

(2) the claimant has moved to implead the

supplier and the court finds . . .

CONNELL V. LIMA CORPORATE 27

(A) the negligence or intentionally

tortious conduct of the dismissed

supplier was an actual and proximate

cause of the harm to the claimant; and

(B) the claimant is unlikely to be able to

recover the full amount of its

damages from the remaining

defendants.

Id. § 1606(a) (emphases added).

Prior to the district court’s order, no court had interpreted

§ 1606(a). The district court concluded impleader was not

available because there was no “final judgment” against the

manufacturer—DJO—after DJO’s voluntary settlement

with the Connells. According to the district court, the

voluntary dismissal entered after that settlement was not a

“judgment” under Federal Rule of Civil Procedure 54

because a voluntary settlement is not appealable. Because

we “affirm the district court’s decision on [an] alternative

ground,” Myers v. U.S. Parole Comm’n, 813 F.2d 957, 959

(9th Cir. 1987), we do not decide whether a voluntary

dismissal pursuant to a mutual settlement agreement is

appealable. Instead, the statutory text, context, and purpose

support reading § 1606(a) to foreclose impleader here

because there were no “remaining defendants” besides Lima,

the biomaterials supplier, when Lima was dismissed from

the action.

As a threshold matter, the grant of summary judgment

for Lima qualifies as an “entry of a final judgment in an

action by the claimant against a manufacturer,” 21 U.S.C.

§ 1606(a). The limiting phrase “against a manufacturer”

applies to the “action by the claimant,” not the “entry of final

judgment.” See Barnhart v. Thomas, 540 U.S. 20, 26 (2003)

28 CONNELL V. LIMA CORPORATE

(“[A] limiting clause or phrase . . . should ordinarily be read

as modifying only the noun or phrase that it immediately

follows.”).

And “an action by the claimant against a manufacturer”

refers to the action as a whole, not a subsidiary claim.

Compare Action, Black’s Law Dictionary 28 (6th ed. 1990)

(defining “action” as “all the formal proceedings in a court

of justice attendant upon the demand of a right”), with Claim,

Black’s Law Dictionary 247 (6th ed. 1990) (defining “claim”

as a “cause of action”); see also Fed. R. Civ. P. 54(b) (“[A]ny

order . . . that adjudicates fewer than all the claims . . . does

not end the action.”) (emphases added). 7 The language in

§ 1606 contemplating a separate “entry of judgment on the

claim” against the biomaterials supplier underlines these

distinct concepts. 21 U.S.C. § 1606(b)(1) (emphasis added).

Thus, there is “an action by the claimant against a

manufacturer” under the BAAA if the manufacturer was

7

In Pedrina v. Chun, we discussed the “interpretation of the word

‘action’ in Rule 41(a)(1), and whether it refers to the entire controversy

against all the defendants, or to the entirety of claims against any single

defendant.” 987 F.2d 608, 609 (9th Cir. 1993). We concluded that Rule

41(a)(1), which provides for dismissal of an “action,” “[p]ermitt[ed] a

plaintiff to dismiss fewer than all of the named defendants” because it

was “consistent with th[e] purpose” of Rule 41(a)(1). Id. at 610. That

interpretation of “action” as the claims against a particular defendant was

cabined to Rule 41(a)(1). See id.; see also 9 Charles Alan Wright &

Arthur R. Miller, Federal Practice and Procedure § 2362 (4th ed. 2008,

October 2020 Update) (stating it is “unnecessary” to read Rule 41(a)(1)

literally because “[t]he power to drop some plaintiffs or defendants from

the suit plainly exists, either explicitly in the Federal Rules or in the

district court’s inherent power”). Pedrina does not govern our reading

of “action” as used in § 1606(a).

CONNELL V. LIMA CORPORATE 29

ever a defendant in the lawsuit. Here, the action was brought

against the manufacturer, DJO.

We now move on to “final judgment.” The “final

judgment” must be the judgment disposing of the claimant’s

entire action brought against a manufacturer. See Riley v.

Kennedy, 553 U.S. 406, 419 (2008) (“A final judgment is

‘one which ends the litigation on the merits and leaves

nothing for the court to do but execute the judgment.’”

(quoting Catlin v. United States, 324 U.S. 229, 233 (1945))).

The voluntary settlement and dismissal of DJO with

prejudice was not a final judgment on the action as a whole,

because the action continued with Lima as a defendant. 8

Thus, before us is “an action by the claimant [the Connells]

against a manufacturer [DJO],” and a “final judgment” was

entered upon summary judgment for Lima disposing of the

action as a whole. So far, so good for the Connells.

But the crux of the motion to implead here turns on the

language, context, and purpose of § 1606(a). Starting with

the statutory language, a claimant’s motion to implead a

biomaterials supplier back into the action is permitted only

when it is “unlikely to be able to recover the full amount of

its damages from the remaining defendants.” 21 U.S.C.

§ 1606(a)(2)(B) (emphasis added). Lima argues that there

were no “remaining defendants” at the time Lima was

dismissed, because DJO had already been dismissed from

the action months earlier. The Connells do not address

8

Were the voluntary settlement a final judgment, the motion to

implead would have been untimely. The settlement was signed July 13,

2018, and effective June 29, 2018, and the order dismissing DJO with

prejudice was entered November 16, 2018. The motion to implead was

filed April 29, 2019—well beyond the statutorily permitted 90 days of

either the settlement’s effective date or the order dismissing DJO with

prejudice.

30 CONNELL V. LIMA CORPORATE

Lima’s statutory argument, instead urging us to treat DJO as

a remaining defendant notwithstanding the statutory

language. The statutory language is imprecise to be sure and

either interpretation is plausible. The statutory text, context,

and purpose, however, better support interpreting § 1606 to

require a defendant—other than the biomaterials supplier—

to remain in the litigation after the biomaterials supplier is

dismissed.

The plain text of § 1606(a)(2)(B) connotes there must be

defendants remaining in the action for a claimant to implead

a dismissed biomaterials supplier. Congress specified the

claimant may implead only if “the remaining defendants” are

unlikely to provide the full amount of damages, requiring

there be defendants remaining. Qualifying “defendants

remaining” with the article “the,” as opposed to “any” or “if

any,” suggests there must be at least one defendant

remaining. See Hernandez v. Williams, Zinman & Parham

PC, 829 F.3d 1068, 1074 (9th Cir. 2016) (“[T]he definite

article ‘the’ ‘particularizes the subject spoken of’ . . . .”

(quoting The, Black’s Law Dictionary 1647 (4th ed. 1968)));

see also Gates & Fox Co. v. Occupational Safety & Health

Rev. Comm’n, 790 F.2d 154, 156 (D.C. Cir. 1986) (“[T]he

definite article suggest[s] that some specific [item] is

referred to . . . .”); Scalia & Garner, supra, at 122–23

(explaining the “wording of the lead-in may be crucial to the

meaning” by distinguishing the phrases “the following” and

“any . . . of the following” (emphases added)).

And “remaining” requires that other defendants continue

in the action after the biomaterials supplier is dismissed. See

Remaining, Oxford English Dictionary (1989) (defining

“remaining” as “[t]hat remains, in various senses”); see also

Remain, Oxford English Dictionary (1989) (defining

CONNELL V. LIMA CORPORATE 31

“remain” as “[t]o be left after the removal or appropriation

of some part, number or quantity”).

The Connells essentially urge this court to read the

statute as “remaining defendants, if any” and add an implied

exception. Cf. Ali v. Fed. Bureau of Prisons, 552 U.S. 214,

227–28 (2008) (contrasting the “unmodified, all-

encompassing” use of the word “any” with other more

limited modifiers). Yet “[a] casus omissus does not justify

judicial legislation.” Ebert v. Poston, 266 U.S. 548, 554

(1925). “It is our judicial function to apply statutes on the

basis of what Congress has written, not what Congress might

have written.” Hooks v. Kitsap Tenant Support Servs., Inc.,

816 F.3d 550, 562 (9th Cir. 2016) (quoting United States v.

Great N. Ry. Co., 343 U.S. 562, 575 (1952)) (alteration

removed).

Congress could have written § 1606(a)(2)(B) to

explicitly allow a claimant to implead a dismissed

biomaterials supplier when there are no remaining

defendants. But “Congress did not write the statute that

way,” which is “strong affirmative evidence” supporting our

interpretation of § 1606. See United States v. Naftalin,

441 U.S. 768, 773 (1979). Reading “the remaining

defendants” to require other defendants to be remaining thus

gives “effect . . . to all [§ 1606’s] provisions, so that no part

will be inoperative or superfluous, void or insignificant.”

Corley v. United States, 556 U.S. 303, 314 (2009) (citation

omitted).

Acknowledging that the statutory text supports a

requirement that defendants must be remaining then raises

the question of precisely at which point there must be

defendants remaining. We see three potential ways to read

this provision: that there must be defendants remaining at

(1) the time of the biomaterials supplier’s dismissal; (2) the

32 CONNELL V. LIMA CORPORATE

time of final judgment; or (3) the time the motion to implead

is filed. We conclude that the statutory text, context, and

purpose support reading “the remaining defendants” to

require defendants to be remaining at the time of the

biomaterials supplier’s dismissal.

The use of the word “remaining” refers directly to the

point in time when there was “removal or appropriation of

some part, number or quantity”—i.e., when the biomaterials

supplier was dismissed. See Remaining, Oxford English

Dictionary (1989); Remain, Oxford English Dictionary

(1989). Congress did not use a different qualifying phrase,

such as “any other” defendants, which would suggest that

other defendants only had to be part of the action at some

prior point. Rather, Congress specifically used “remaining,”

which by its own terms ties directly to the point in time of

“removal” of the biomaterials supplier. This “strong

affirmative evidence” supports our interpretation of

§ 1606(a). Naftalin, 441 U.S. at 773.

And the text of § 1606(a) explicitly states that a

manufacturer or claimant may only implead a biomaterials

supplier “who has been dismissed from the action.”

§ 1606(a)(2) (emphasis added). This language suggests that

an action continues to exist after the biomaterials supplier

has been dismissed. The action itself cannot have been

disposed of in the dismissal. Thus, the biomaterials supplier

must first be dismissed from the action, which then continues

to be litigated between at least two other parties until the

action has been resolved in a final judgment. Reading “the

remaining defendants” to apply at time of final judgment or

when the motion was filed would not be possible because

there would be no action continuing after dismissal. Thus,

the statutory language points us towards reading § 1606(a)

CONNELL V. LIMA CORPORATE 33

to require at least one other defendant to be remaining at the

time of the biomaterials supplier’s dismissal.

Applying “the remaining defendants” at the time the

impleader motion is filed may seem to be a more natural

reading, but in context it would read the phrase to be “void,”

Young, 135 S. Ct. at 1352. Filing a motion after final

judgment necessarily means there are no remaining

defendants—the action has already been finally resolved.

Thus, in cases where a plaintiff moves to implead after a

judgment with respect to the manufacturer, it is impossible

to read “remaining defendants” to apply at the time the

impleader motion is filed without violating the “cardinal rule

of statutory interpretation that no provision should be

construed to be entirely redundant.” Brewster v. Sun Tr.

Mortg., Inc., 742 F.3d 876, 879 (9th Cir. 2014) (internal

quotation marks and citation omitted). The only way to

salvage reading “the remaining defendants” to apply at the

time the impleader motion is filed is by reading the provision

as “any other defendants” instead, which we have already

rejected. See supra, at 31–32. Our reading applying “the

remaining defendants” to apply at the time of the

biomaterials supplier’s dismissal makes more sense in light

of the statutory context and purpose.

Sections 1606(b) and (c) further support requiring

“remaining defendants” at the time the biomaterials supplier

is dismissed, not at final judgment or when the motion to

implead is filed. Section 1606(b)(1) allows an impleaded

biomaterials supplier to “supplement the record of the

proceeding that was developed prior to the grant of the

motion for impleader.” And § 1606(c) clarifies that nothing

in § 1606 “shall give a claimant or any other party the right

to obtain discovery from a biomaterials supplier at any time

prior to grant of a motion for impleader beyond that allowed

34 CONNELL V. LIMA CORPORATE

under section 1605” of the BAAA. Section 1606 thus

explicitly contemplates that the biomaterials supplier was

dismissed at an early stage before the record of the

proceeding had been developed or discovery had occurred.

Section 1606 does not similarly address the situation here,

where the manufacturer has been dismissed and the

biomaterials supplier has undergone full discovery, won on

final judgment, and then is impleaded back into the case.

This statutory presumption that the biomaterials supplier

was dismissed at an early stage further supports our

interpretation of § 1606.

The BAAA’s statutory context reinforces our

interpretation. Permitting a motion to implead in this case

would effectively insert an unwritten third ground for

finding a biomaterials supplier liable into § 1604(d), as the

Connells essentially urge. As written, § 1604(d) includes

only two exceptions to biomaterials supplier immunity for

failure to meet contractual requirements or specifications.

Congress could have written the provisions of § 1606(a)(1)

and (2) regarding negligent or intentionally tortious harmful

conduct and damages into § 1604(d), but did not. Thus, we

assume that Congress intended only the two exceptions

listed in § 1604(d) to exist and the impleader section to

function as a process different from a third exception. See

Duncan v. Walker, 533 U.S. 167, 173 (2001) (“[W]here

Congress includes particular language in one section of a

statute but omits it in another section of the same Act, it is

generally presumed that Congress acts intentionally and

purposely in the disparate inclusion or exclusion.” (citations

omitted)).

Moreover, § 1605 imposes strict limitations on

discovery regarding biomaterials suppliers. For summary

judgment motions, discovery is “limited solely to

CONNELL V. LIMA CORPORATE 35

establishing whether a genuine issue of material fact exists”

as to the § 1604(d) exceptions for biomaterials supplier

immunity. 21 U.S.C. § 1605(d)(2). And any discovery

permitted is cabined “solely to the extent permitted by the

applicable Federal or State rules for discovery against

nonparties.” Id. § 1605(d)(3). As with §§ 1606(b) and (c),

§ 1605 allows limited discovery with the presumption that

the biomaterials supplier will be dismissed early, unless it is

liable under §§ 1604(b), (c), or (d). The BAAA does not

contemplate the situation here where a biomaterials supplier

not liable under § 1604 undergoes full discovery, is

dismissed, and then is immediately impleaded back.

The BAAA also generally requires a claimant to name

the manufacturer as a party. Id. § 1605(b); see also id.

§§ 1605(a)(4), (c)(3)(C). In only two limited scenarios, a

manufacturer need not be a party: (1) where the

manufacturer was not subject to service of process where the

biomaterials supplier was domiciled or subject to service of

process, and (2) where an “applicable law or rule of practice”

bars a claim against the manufacturer. Id. § 1605(b). So

Congress knew how to specify when an action could proceed

without a manufacturer in § 1605(b), but chose not to do so

in § 1606(a). See Sigmon Coal Co., 534 U.S. at 452–54.

And even if § 1606(a) could apply in the two limited

scenarios listed in § 1605(b) where the manufacturer is not a

party, neither scenario is present here where the Connells

and DJO entered a voluntary settlement to dismiss DJO with

prejudice. Thus, impleader is not available.

To the extent this result might be seen to permit

biomaterials suppliers to insulate themselves from liability

by waiting until the claimant reaches a settlement with a

manufacturer to assert immunity under the BAAA, as the

Connells suggest, it seems unlikely that suppliers who are

36 CONNELL V. LIMA CORPORATE

potentially immune under the BAAA would persist in costly

litigation and discovery with the aim to avoid liability later.

Finally, the statutory purpose also supports our reading

of § 1606. Congress created “expeditious procedures to

dispose of unwarranted suits against the suppliers in such

manner as to minimize litigation costs.” 21 U.S.C.

§ 1601(15)(B). These procedures were meant to protect

biomaterials suppliers. And though the BAAA’s

“protections do not protect negligent suppliers,” id.

§ 1601(17), the BAAA does “clarify the permissible bases

of liability for suppliers of raw materials and component

parts for medical devices,” id. § 1601(15)(A). These bases

of liability apply only through certain procedural processes.

Claimants must first show a biomaterials supplier is

liable under one of the bases of liability in §§ 1604(b), (c),

or (d). If not, a biomaterials supplier is dismissed and the

action proceeds against “the remaining defendants.” The

claimant can only implead a biomaterials supplier back into

the action if the biomaterials supplier was negligent or

intentionally tortious and “the remaining defendants” still in

the action are unable to cover the full amount of damages.

Id. § 1606.

Reading § 1606(a)’s plain text, together with its statutory

context and purpose, leads to the conclusion that a motion to

implead under § 1606(a) is permitted only when there is a

defendant, other than the biomaterials supplier, remaining in

the action after the biomaterials supplier is dismissed.

Although this result could limit plaintiffs’ recovery in some

cases, we understand this result to be consistent with

Congress’s purpose in enacting the BAAA—broadly

limiting liability for biomaterials suppliers while

maintaining avenues for plaintiffs to recover from the

statutory manufacturer. Here, after the manufacturer, DJO,

CONNELL V. LIMA CORPORATE 37

was dismissed with prejudice from the lawsuit, § 1606(a) did

not permit the Connells to implead Lima after Lima, the only

defendant, was later dismissed on summary judgment.

V

We hold Lima is a biomaterials supplier of the Hip Stem

under the BAAA and thus immune from liability. We also

hold that § 1606(a) does not permit the Connells to implead

Lima here.

AFFIRMED.