Jeffrey Connell v. Lima Corporate ( 2021 )

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.