United States District Court, D. Idaho
JEFFREY D. CONNELL and JANET CONNELL, husband and wife, Plaintiffs,
LIMA CORPORATE; LIMA USA, INC., an Indiana corporation; and JOHN DOE CORPORATIONS I through V, Defendants.
MEMORANDUM DECISION AND ORDER
W. DALE, U.S. MAGISTRATE JUDGE
motions are pending before the Court: Lima
Defendants' 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
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
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
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.)
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.
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.
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 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
2009 Supply Agreement
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.”
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 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.
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.
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.” Id. The
agreement required Lima to “assist” DJO in
obtaining the certifications by providing declarations of
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.
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.
DJO's 510(k) Application to the FDA
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
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 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 ...