Connell et al v. Lima Corporate et al

Filing 134

MEMORANDUM DECISION AND ORDER. IT IS HEREBY ORDERED: Defendants' Motion for Summary Judgment (Dkt. 104 ) is GRANTED. Defendants' Motion to Exclude Sharlin "Rebuttal" (Dkt. 97 ) is DENIED as MOOT. Defendants' Motion to Excl ude Burns Explant Evidence (Dkt. 106 ) is DENIED as MOOT. Plaintiffs' Motion for Partial Summary Judgment (Dkt. 98 ) is DENIED as MOOT. Plaintiffs' Motion to Amend (Dkt. 99 ) is DENIED as MOOT. Plaintiffs' Motion to Exclude Expert T estimony of Dr. Timothy Wright (Dkt. 73 ) is DENIED as MOOT. Signed by Judge Candy W. Dale. (caused to be mailed to non Registered Participants at the addresses listed on the Notice of Electronic Filing (NEF) by (km) Modified on 1/31/2019 to correct filing date (km).

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF IDAHO

JEFFREY D. CONNELL and JANET
CONNELL, husband and wife,
Plaintiffs,

Case No. 1:16-CV-00456-CWD
MEMORANDUM DECISION AND
ORDER

v.
LIMA CORPORATE; LIMA USA,
INC., an Indiana corporation; and
JOHN DOE CORPORATIONS I
through V,
Defendants.

INTRODUCTION
Six motions are pending before the Court: Lima Defendants’1 two motions to
exclude certain evidence (Dkts. 97 and 106), and motion for summary judgment (Dkt.
104), as well as Connell Plaintiffs’ motion to exclude certain evidence (Dkt. 73), motion
for partial summary judgment (Dkt. 98), and motion for leave to amend the complaint to
add a claim for punitive damages. (Dkt. 99.) All six motions are fully briefed, and the
Court heard oral argument on each motion from the parties on January 22, 2019. After
careful consideration of the record, the parties’ briefing and oral argument, as well as
relevant authorities, the Court will grant Defendants’ motion for summary judgment.

The Court’s discussion and decision applies only to Lima Corporate S.p.a. Lima USA, Inc. was dismissed
from the case via previous order of the Court. (See Dkt. 132.)
1

MEMORANDUM DECISION AND ORDER - 1

BACKGROUND
In April of 2011, Plaintiff Jeffrey Connell underwent a total hip revision surgery at
Saint Alphonsus Medical Center in Boise, Idaho. (Dkt. 1-6 at 3.) Plaintiff Janet Connell is
his wife. Id. at 1. During the surgery Dennis McGee, M.D. implanted a femoral stem
prosthesis. Id. at 3. The device implanted in Mr. Connell was sold to St. Alphonsus by
Rose & Associates, a medical device distribution company. (Dkt. 59 at 4.) Rose &
Associates contracted with DJO Surgical to distribute hip prosthesis systems in Idaho and
other states. Id. at 3. The hip system implanted into Mr. Connell consisted of three parts:
a revision hip stem, a femoral neck, and a safety screw. (Dkt. 113-3.) As discussed in
detail below, the two main parts of the hip system, the stem and the neck, were
manufactured in Italy by Defendant Lima Corporate S.p.a. (Lima). (Dkt. 112-1 at 3.)
At the time of his revision surgery, Mr. Connell was 49 years of age,
approximately 6 feet tall, weighed 217 pounds, and had a Body Mass Index (BMI) in
excess of 28. (Dkt. 59 at 5.) X-rays of Mr. Connell taken prior to his revision surgery
showed he had proximal bone loss in his femur. (Dkt. 104-22 at 2).
In October of 2014, the femoral stem portion of Mr. Connell’s hip prosthesis
fractured while he was performing his work as a plumber—just three and one half years
after implantation. (Dkt. 1-6 at 3.) Doctors at the University of Utah removed the failed
hip prosthesis and implanted a different type of hip system. Id. at 3-4. The failed hip
prosthesis was discarded after it was removed. (Dkt. 104-2 at 7.)

MEMORANDUM DECISION AND ORDER - 2

DJO produced a Product Complaint Report after investigating the fracture
incident. (March 26, 2015 report, Dkt. 113-5.) According to DJO’s report, the definitive
root cause of the stem fracture could not be determined at that time because the hip stem
was discarded and thus not available for inspection or testing. Id. at 3.
On August 9, 2016, Jeffery and Janet Connell filed a complaint against Lima
Corporate, Lima USA, Inc., and the DJO entities. (Complaint, Dkt. 1-6.) Plaintiffs
asserted product liability claims under Idaho law based in strict liability, negligence, and
breach of warranty, as well as a claim of negligent infliction of emotional distress against
all defendants. Id. In July of 2018, the DJO entities and Plaintiffs reached a settlement
and filed a joint motion to dismiss all claims against the DJO entities. (Dkt. 62.) The
settlement prompted a period of hard-fought discovery, concluding with the Court
granting Plaintiffs’ and DJO entities’ motion to dismiss in November of 2018. (Dkt. 95.)
As a result, the Lima entities became the only remaining defendants in this matter.
On November 19, 2018, Lima filed the present motion for summary judgment,
arguing, primarily that, because it was a component supplier of medical device parts for
DJO’s hip system, all claims against Lima are preempted by the Biomaterials Access
Assurance Act (BAAA). 21 U.S.C. Section 1604 et seq. However, as noted above,
numerous motions are currently pending before the Court. The motions include Plaintiffs’
motion for partial summary judgment on Lima’s affirmative defense of comparative fault
as to Dr. McGee and DJO (Dkt. 98), as well as a motion to amend the complaint to add a
claim for punitive damages. (Dkt. 99.) The other motions are evidentiary in nature
MEMORANDUM DECISION AND ORDER - 3

whereby the parties seek to exclude certain evidence from trial. (Dkts. 73, 97, and 106.)
Although the Court carefully considered the parties’ briefing and arguments on all of
these motions, the Court will first analyze the merits of Lima’s motion for summary
judgment based on BAAA preemption. As such, the facts that follow relate specifically to
whether the BAAA so applies.
1.

2009 Supply Agreement
In April of 2009, Encore Medical, doing business as DJO Surgical, entered into a

written supply agreement with Lima. (Dkt. 103-3.) According to the agreement’s terms,
as the “Seller,” Lima agreed to supply to DJO, the “Purchaser,” with “parts … used in or
incorporated into a joint prosthesis system, including without limitation, the Components
and Instruments, all in accordance with the terms and conditions” of the agreement. Id. at
4. The agreement described the Seller as being “engaged in the design, development,
manufacture, distribution and sale of, among other things, the Components … for use in,
among other things, total joint replacement systems.” Id. Whereas the agreement
described the Purchaser as being, “engaged in the design, development, manufacturing,
distribution and sale of, among other things, joint prosthesis systems.” Id.
The agreement defines Components as “parts developed and/or manufactured by
Seller and designed for incorporation into joint prosthesis systems.” Id. at 27. “Revision
Modular Stems” are included within the agreement’s list of Components. Id. at 36. The
agreement describes a revision stem as being “made up of two components, a diaphyseal
stem and a femoral neck.” Id. at 31. The agreement provided that Lima was to
MEMORANDUM DECISION AND ORDER - 4

manufacture stems in six different diameters and two different lengths. Id. Likewise,
Lima was to manufacture the neck portion in varying specified sizes. Id. Lima was also to
“manufacture the Components […] in accordance with the applicable current Purchaser
approved drawings […] and the applicable delivery specifications.” Id. at 5.
The Supply Agreement specified other details pertinent to the question before the
Court, including that Lima granted to DJO a non-exclusive license and right to use
Lima’s trademarks in marketing materials. Id. at 14. Title to the Components passed to
DJO at the place of shipment, and DJO assumed all risk of damage to such Components.
Id. at 9. Accordingly, the agreement provided that all Components received by DJO were
“subject to inspection and performance testing, if any, to determine the Components’…
conformity to the … Specifications.” Id., Section 4.01.
The Supply Agreement also set forth terms to govern regulatory matters related to
the Components. Id. at 10. Both Lima and DJO agreed to “comply in all material respects
with all applicable Laws that pertain[ed] to the activities for which Seller and Purchaser
[were] each responsible under [the] Agreement.” Id. However, the agreement also
assigned DJO the responsibility for obtaining, in DJO’s name, all regulatory certifications
to allow “Purchaser and Seller to sell the Product and all Components” in the United
States, “including all FDA clearance letters and 510(k)s.”2 Id. The agreement required
Lima to “assist” DJO in obtaining the certifications by providing declarations of

Product is defined as “any part of a joint prosthesis system designed, developed, manufactured, marketed or
distributed by Purchaser that mates with the Components.” (Dkt. 103-3 at 28.)
2

MEMORANDUM DECISION AND ORDER - 5

conformity and certification, technical files, licenses and registrations, and specifications.
Id. Lima agreed also to provide DJO with immediate notice should it obtain information
that indicated a material defect that could affect the safety or efficacy of any of the
Components. Id.
DJO further agreed to comply with the FDA’s Medical Device Reporting
requirements, as set forth in 21 C.F.R., Part 803. Id. Again, Lima agreed to assist DJO by
providing information necessary for compliance with the reporting requirements. Id.
Finally, among these terms of the agreement related to regulatory responsibilities, Lima
and DJO both agreed to submit to the United States Food and Drug Association (FDA)
“any necessary reports of removals, corrections, or other field actions” respecting “the
Product and Product’s Labeling” and “the Components.” Id. at 12.
2.

DJO’s 510(k) Application to the FDA
With the Supply Agreement in place, on July 31, 2009, DJO submitted a 510(k)

application to the FDA. (Dkt. 113-2.) The application requested FDA clearance for use of
a new hip stem. Id. at 2. In the application, “DJO Surgical” was identified as
manufacturer of the “DJO Modular Revision Femoral Hip Stem,” which the application
described as being “made up of a modular stem coupled with a proper neck by means of a
‘Morse’ taper stabilized during the implantation phase by a safety screw.” Id. DJO’s
application referred to the three parts as a “system.” Id.
Of particular note, DJO’s 510(k) application included a section titled, “Packaging
and Sterilization.” Id. at 8. Therein, DJO described the process by which it would
MEMORANDUM DECISION AND ORDER - 6

package, label, and sterilize the parts of the hip system to ready them for commercial
distribution. Id. The process involved DJO completing the following; First, DJO placed
each component into multiple polyethylene peel pouches. Id. Next, DJO air vacuumed
and heat sealed each pouch. Id. DJO then placed the components in a container, separated
by protective packaging, including die cut paperboard and foam pads to restrict
movement. Id. DJO affixed product labeling to each portion of the packaging, from the
innermost pouch to the outer container. Id. DJO included its Instructions for Use and
tracking labels inside the carton. Id. Next, DJO shrink-wrapped “[t]he entire packaged
assembly.” Id. According to the application, DJO sterilized the product “after the implant
[was] packaged and labeled.” Id. The labels affixed by DJO stated that all of the metal
components had a six (6) year expiration date.3 Id. In March of 2010, the FDA approved
DJO’s application for the “DJO Surgical Revision Femoral Hip System.”4 (Dkt. 105-4.)
A.

Surgical Brochures and Instructions for Use

Consistent with its regulatory obligations as the manufacturer of record, DJO
drafted the surgical technique brochures and Instructions for Use (IFU) that accompanied
the DJO Surgical Revision Femoral Hip System when it was marketed and sold in the
United States. (Brochure, Dkt. 113-2 at 8); (DJO IFU, Dkt. 104-10.) Also consistent with

According to FDA guidance, “final labeling is not required for 510(k) clearance, final labeling must
comply with the requirements of 21 CFR 801 before introducing a medical device to interstate commerce.” (U.S.
DEPT. OF HEALTH AND HUMAN SERV., FOOD AND DRUG ADMIN., GUIDANCE FOR INDUSTRY AND FDA
STAFF (2007), Dkt. 104-9 at 15 n. 8.)
3

4

Within its letter approving the application, the FDA directed DJO to existing major regulations affecting
the device. (C.F.R., Title 21, pts. 800 to 898.) The letter also included a paragraph regarding device labeling
regulation. (Dkt. 105-4 at 2-3.)

MEMORANDUM DECISION AND ORDER - 7

the Supply Agreement, Lima provided DJO technical information to draft the documents.
Notably, in 2010, Lima sent DJO the IFU Lima produced and included with the modular
revision femoral hip stem systems for which Lima obtained license to prepare, market,
and sell throughout Europe. (Lima’s IFU, Dkt. 105-6 at 3.)
Consideration of the content of the brochure and IFU is also helpful to the Court’s
determination of whether the BAAA applies to preempt Plaintiffs’ claims against Lima.
For example, DJO Surgical’s name and address appear on the front and final pages of its
surgical technique brochure. (Dkt. 113-4 at 4; 16.) Also on the front page is the following
language: “This brochure is presented to demonstrate a surgical technique. DJO Surgical,
as the manufacturer of this device, does not practice medicine and cannot recommend
this or any other surgical technique for [unreadable].” Id. at 4 (emphasis added).
However, the brochure also referred to the hip as the “Lima Modular Revision Hip” on
the top of the second page and throughout the document. Id. at 5-16. DJO’s use of Lima’s
name in the brochure is consistent with the limited license granted by Lima in the Supply
Agreement. (See Dkt. 103-3 at 14.)
As with the surgical brochure, DJO Surgical’s name appears throughout its
Instructions for Use. (Dkts. 104-10; 104-11.) The IFU describe the product as the
“Modular Revision Hip Stem” and the “DJO Modular Revision hip stem” and indicate
that the “stem can be used with either DJO Surgical CoCr or Ceramic femoral heads.”
(Dkt. 104-10 at 2.) Consistent with DJO’s 510(k) application to the FDA, the IFU
indicate that the “DJO Surgical Modular Revision Hip Stems are supplied sterile…” and
MEMORANDUM DECISION AND ORDER - 8

that sterilization “is performed by gamma radiation….” Id. The IFU state that “DJO
Surgical has validated sterilization cycle data on file.” Id. at 4. Finally, and notably, the
DJO IFU state that, “DJO Surgical Hip systems are manufactured by Encore Medical,
L.P. 9800 Metric Blvd., Austin, TX 78758 USA (Made in the USA).” Id.
DISCUSSION
1.

Summary Judgment under the Biomaterials Access Assurance Act
In 1998, Congress enacted the Biomaterials Assurance Act (BAAA) with the aim

of assuring “the continued supply of materials for lifesaving medical devices” through
provisions insulating the suppliers of raw materials or component parts of medical
devices from litigation. 21 U.S.C. § 1601 et seq. The Act 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.” 21 U.S.C. §
1603(b)(1). In effect, the BAAA “provides immunity to biomaterials suppliers who
provide component parts to manufacturers of medical devices.” Wilson v. Ethicon
Women’s Health & Urology, WL 1900852, at *2 (S.D.W. Va. May 13, 2016).
The BAAA permits a biomaterials supplier to file a motion for summary judgment
on the basis that the claims against it are preempted by the Act. 21 U.S.C. § 1605. A
court must grant summary judgment if there are no genuine issues of material fact as to
(1) whether the biomaterials supplier acted as manufacturer of the implant; acted as seller
of the implant; or furnished raw materials or component parts for the implant that failed
to meet applicable contractual requirements or specifications; or (2) whether the
MEMORANDUM DECISION AND ORDER - 9

biomaterials supplier can be considered the manufacturer of the implant that caused harm
to a claimant because: it was required to register with the Secretary of Health and Human
Services; or was the subject of a declaration issued by the Secretary that stated the
supplier, with respect to the implant, was required to register or to include the implant on
the list of devices and failed to do so. Id. at § 1604(a-b).
A.

Preemption under the BAAA

Lima argues Plaintiffs’ claims are pre-empted by the BAAA, because Lima was a
biomaterials supplier of component parts for the DJO Surgical Revision Femoral Hip
System. Plaintiffs assert Lima was the manufacturer of the hip system and that DJO was
merely a distributor or seller. Plaintiffs assert that DJO is an orthopedic medical device
company that provides hip, knee, and shoulder devices. (Plaintiffs’ SOF, Dkt. 1121(emphasis added)). Plaintiffs point to a press release jointly issued by DJO and Lima in
announcing the partnership formalized in the 2009 Supply Agreement. The release
described a “strategic partnership” allowing “Lima Corporate to distribute select DJO
Surgical products in Europe, while Lima Corporate will provide products for sale in the
US through DJO Surgical.” (Dkt. 112-1 at 2.)
In turn, Lima argues DJO is an orthopedic medical device company that
manufactures hip, knee, and shoulder devices. (Dkt. 104-2 at 2 (emphasis added)). Lima
points to the terms of the Supply Agreement whereby Lima agreed to manufacture and

MEMORANDUM DECISION AND ORDER - 10

deliver component parts “to be incorporated into a DJO prosthesis system (ultimately
cleared by the FDA as the ‘DJO Modular Hip Revision System’).”5 Id.
The BAAA defines a “biomaterials supplier” as “an entity that directly or
indirectly supplies a component part […] for use in the manufacture of an implant.” 21
U.S.C. § 1602(1)(A). For this definition to apply to Lima, the Court must find that there
is no genuine issue of material fact that the hip stem and neck were two separate
component parts of the hip system implanted in Mr. Connell.6 (Dkt. 104-1 at 8.)
Under the BAAA, a “component part” is “a manufactured piece of an implant.” 21
U.S.C. § 1602(3)(A). An “implant” is “a medical device that is intended by the
manufacturer of the device to be placed into a surgically or naturally formed or existing
cavity of the body for a period of at least 30 days.” Id. at 1602(5)(A)(i). And a
“manufacturer” is “any person who, with respect to an implant is engaged in the
manufacture, preparation, propagation, compounding, or processing of the implant; and is
required to register with the Secretary [of Health and Human Services]” … “and include
the implant on a list of devices filed with the Secretary.” Id. at 1602(6). Further, under
the Act, the term “manufacture, preparation, propagation, compounding, or processing”

In its March 2010 510(k) application approval letter, the FDA identified the system as the “DJO Surgical
Revision Femoral Hip System.” (Dkt. 105-4.) This specific language is not used throughout the briefing or even
throughout the record evidence. However, the Court finds the variations result in slight differences that are not
material to disposition of the motion.
5

6

At the January 22, 2019 hearing on the motions, Plaintiffs reiterated the argument that, if the Court found
that Lima is a manufacturer under the BAAA, such finding would preclude the Court finding Lima was a
biomaterials supplier under the BAAA. However, Plaintiffs conceded that, if Lima made and supplied only one
component of the hip system, for example just the head, or just the stem, Lima would, in fact, be a biomaterials
supplier for purposes of the BAAA and Plaintiffs could not proceed in asserting their claims in this action.

MEMORANDUM DECISION AND ORDER - 11

of the implant, “shall include” entities engaged in “repackaging or otherwise changing
the container, wrapper, or labeling of any […] device package in furtherance of the
distribution of the […] device from the original place of manufacture to the person who
makes final delivery or sale to the ultimate consumer or user.” 21 U.S.C. § 360(a)(1).
The distinction between component parts and biomaterials suppliers and implants
and manufacturers has been discussed by federal courts throughout the country. For
instance, a court in the Eighth Circuit found that “a Section 510(k) device… is an
‘implant’ and is therefore governed by the BAAA.” Daley v. Smith & Nephew, Inc., 321
F. Supp.3d 891, 897-98 (E.D. Wis. 2018).7 A court in the Third Circuit found that, when
a component is unable to be implanted into a human being without additional
components, manufacturing steps, and quality steps, it is not an implant for purposes of
the BAAA. Id. at 896-97; Mattern v. Biomet, Inc., 2013 WL 1314695 (N.D.J. March 29,
2013). Additionally, a court in the Tenth Circuit found that, when a company supplies a
component for a hip system, such as a finished femoral head, but does not supply all of
the components, the company is likely a biomaterials supplier and not a manufacturer.
Whaley v. Morgan Advanced Ceramics, Ltd., 2008 WL 901523 (D. Col., March 31,
2008). The court held this is true even if the company that manufactures the component

7

Defendant company machined femoral neck components pursuant to a contract with another company. The
neck components be fashioned from a raw titanium, as specified by the other company per the contract terms. 321 F.
Supp.3d at 897-98 The court found the defendant company qualified as a biomaterials supplier because the facts
showed the machined necks were not completed medical devices as they could not be implanted into a human being
without additional components and numerous other manufacturing steps and quality checks performed by others. Id.
at 898.

MEMORANDUM DECISION AND ORDER - 12

also helps with the premarket approval process by providing necessary information yet
does not conduct the regulatory submissions itself. Id.
This guiding case law and the following facts support the finding that Lima was a
biomaterials supplier of component parts for the DJO Surgical Revision Femoral Hip
System. Lima provided two pieces of the three-part hip system—a distal stem and a
femoral neck. Lima did not manufacture or provide the safety screw. Lima fashioned the
stem and the neck out of a raw titanium. Lima also provided DJO with information
necessary for DJO to complete the FDA premarket approval process but did not conduct
any regulatory submissions itself.
A close review of the Supply Agreement’s terms and conditions shows that Lima
was characterized as a seller of the component parts that would be used by DJO in joint
prosthesis systems that DJO owned, licensed, marketed, and sold throughout the United
States. For example, as set forth in the facts above, DJO is defined in the agreement as
the Purchaser—an entity “engaged in the design, development, manufacturing,
distribution and sale of, among other things, joint prosthesis systems.” (Dkt. 103-3 at 4.)
Lima, on the other hand, is described as the Seller—an entity “engaged in the design,
development, manufacture, distribution and sale of, among other things, the Components
… for use in, among other things, total joint replacement systems.” Id.
According to the Supply Agreement, Lima was responsible for manufacturing the
Components in accordance with specification drawings approved by DJO. Title to the
Components passed to DJO at the place of shipment and DJO was responsible for
MEMORANDUM DECISION AND ORDER - 13

inspecting and conducting performance testing to ensure the Components were in
conformity with its specifications. Furthermore, under the agreement DJO had sole
responsibility for obtaining all FDA clearances to sell its products in the United States.
Relatedly, DJO identified and held itself out as the manufacturer of the “DJO Modular
Revision Femoral Hip Stem” in its 510(k) application to the FDA. (Dkt. 113-2.) Lima’s
name does not appear anywhere within the application. In the application, DJO described
the stem as being composed of three parts—a stem, a neck, and a safety screw.
Additionally, undisputed facts show that, when DJO received the two pieces from
Lima, they were not yet ready for implantation into a human being. First, the pieces
underwent inspection by DJO. Second, the pieces were packaged by DJO to prevent
damage while in transit and storage. Third, the pieces were labeled with DJO-specific
product numbers that corresponded to the licensure DJO obtained from the FDA. Fourth
and finally, DJO performed sterilization of each component prior to final packaging and
marking the system with an expiration date.
Part and parcel to readying the components of the hip system for human
implantation was including the FDA-mandated Instructions for Use. The IFU included
with the hip stem implanted in Mr. Connell were drafted by DJO. In content, the IFU
state that DJO Surgical was the manufacturer of the hip system and should be contacted
in the event of any questions, including those regarding its labeling or sterilization.
In sum, when the distal stem and femoral neck arrived from Italy in Austin, Texas,
at DJO’s facility, the parts were not ready for implantation into a human being—a crucial
MEMORANDUM DECISION AND ORDER - 14

characteristic of an implant under the BAAA. The two pieces supplied by Lima, though
integral, were not yet an implant. As fully set forth above, DJO, as the FDA-approved
manufacturer of the “DJO Surgical Revision Hip System” performed the numerous
additional steps necessary to ready all three components of the hip system for commercial
distribution. Plaintiffs have failed to present evidence that raises a genuine issue of
material fact as to that conclusion. Therefore, for purposes of the BAAA, these
undisputed facts lead the Court to conclude that Lima was a biomaterials supplier of
components parts used by DJO for its Revision Femoral Hip System.
The inquiry does not end here, however, as it is possible that one of the exceptions
to the BAAA’s shield of liability for biomaterial suppliers applies to Lima. As set forth
above, Plaintiffs’ product liability claims are not pre-empted by the BAAA if Lima acted
(1) as manufacturer of the implant; (2) as seller of the implant; or (3) furnished raw
materials or component parts for the implant that failed to meet applicable contractual
requirements or specifications. 21 U.S.C. § 1604(a). Thus, the Court must determine
whether a genuine issue of material fact exists regarding one or more of these three
exception categories.8
First, there is no evidence showing or supporting the conclusion that Lima was the
seller of Mr. Connell’s implant. Rather, undisputed facts show Lima did not hold title to
the modular hip system implanted in Mr. Connell, nor did Lima act under contract as a

8

Of note, Plaintiffs do not provide argument regarding whether Lima, as a biomaterials supplier, acted as
seller of the implant or failed to meet applicable contract requirements or specifications. (See Memorandum in
Opposition, Dkt. 112 at 3-11.)

MEMORANDUM DECISION AND ORDER - 15

seller, or arrange transfer of the implant directly to St. Alphonsus or Mr. Connell. See 21
U.S.C. § 1604(c). Therefore, no genuine issue has been raised that would support the
conclusion Lima acted as seller of the implant.
Second, there is no evidence showing or supporting the conclusion the component
parts provided by Lima to DJO failed to meet specifications of the 2009 Supply
Agreement. Rather, Lima provides evidence in the form of quality assurance records
from its factory that no abnormalities were noted for the production lot of stems including
the stem eventually implanted in Mr. Connell. There is also no evidence that DJO’s
inspection upon receipt noted any deviation or that the stems in the shipment failed to
meet the specifications set in the Supply Agreement. Plaintiffs have failed to raise
conflicting evidence as to these facts. Therefore, no genuine issue has been raised that
would support the conclusion that Lima failed to meet applicable contractual
requirements or specifications.
As such, the Court’s final inquiry is whether Lima, as a biomaterials supplier, may
nevertheless be considered the manufacturer of the implant. See 21 U.S.C. § 1604(a)(1).
Under the BAAA, this exclusion applies only in the three situations. First, if Lima
registered or was required to register with the Secretary of Health and Human Services
and included or was required to include the implant on a list of devices filed with the
Secretary. Id. at § 1604(b)(2)(A)(i-ii). Second, if Lima was subject to a declaration issued
by the Secretary that stated Lima was required to so register and list the implant but failed

MEMORANDUM DECISION AND ORDER - 16

to do so. Id. at § 1604(b)(2)(B)(i-ii). Third, if Lima was related by common ownership or
control to an entity meeting the requirements set forth in Section 1604(A) or (B).
Plaintiffs do not assert that any of these situations apply to exclude Lima from the
BAAA’s preemption protections for biomaterials suppliers. (See Plaintiffs’ Memorandum
in Opposition, Dkt. 112 at 10-11.) Lima, however, states it was neither required to
register with the Secretary, nor was it ever the subject of an independent finding by the
Secretary that it was required to register. See 21 U.S.C. § 1604(3). Lima asserts that it
was not required to register with the Secretary because the components were not ready to
be used as they were not “packaged or labeled for commercial distribution” when shipped
to DJO (citing 21 C.F.R. 807.65(a) and 807.20(a)(6)).
After careful review of the record, the Court finds no facts that dispute or
introduce any doubt as to Lima’s representations regarding the inapplicability of this
exemption. Therefore, the Court finds the BAAA applies to preempt Plaintiffs’ product
liability claims and will grant Lima’s motion summary judgment.
CONCLUSION
For the reasons outlined herein, the Court will grant Lima’s motion for summary
judgment based on its finding that, as a matter of law, Lima Corporate, S.p.a. was in this
case a biomaterials supplier of component parts under the BAAA. As such, the five
remaining motions must be denied as moot.

MEMORANDUM DECISION AND ORDER - 17

ORDER
NOW THEREFORE IT IS HEREBY ORDERED:
1)

Defendants’ Motion for Summary Judgment (Dkt. 104) is GRANTED.

2)

Defendants’ Motion to Exclude Sharlin “Rebuttal” (Dkt. 97) is DENIED as
MOOT.

3)

Defendants’ Motion to Exclude Burns Explant Evidence (Dkt. 106) is
DENIED as MOOT.

4)

Plaintiffs’ Motion for Partial Summary Judgment (Dkt. 98) is DENIED as
MOOT.

5)

Plaintiffs’ Motion to Amend (Dkt. 99) is DENIED as MOOT.

6)

Plaintiffs’ Motion to Exclude Expert Testimony of Dr. Timothy Wright
(Dkt. 73) is DENIED as MOOT.
January 30, 2019

MEMORANDUM DECISION AND ORDER - 18