JEFFREY D. CONNELL; JANET CONNELL, Plаintiffs-Appellants, v. LIMA CORPORATE; LIMA USA, INC., an Indiana corporation, Defendants-Appellees, DJO GLOBAL, INC., a Delaware corporation; ENCORE MEDICAL LP, a Delaware corporation, Defendants-Intervenors.
No. 19-35797
UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT
Filed February 17, 2021
D.C. No. 1:16-cv-00456-CWD. 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.
Before: Johnnie B. Rawlinson, Mary H. Murguia, and Ryan D. Nelson, Circuit Judges. Opinion by Judge R. Nelson
FOR PUBLICATION
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“),
COUNSEL
Eric S. Rossman (argued) and Erica S. Phillips, Rossman Law Grouр 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.
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“),
I
A
Encore Medical L.P., doing business as DJO Surgical (“DJO“), manufactures and
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 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 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
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.
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 dеfinitive 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.
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
The Connells timely requested reconsideration under
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
The district court also denied the Connells’ motion to implead Lima under
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.”
The denial of a
III
We begin by interpreting the language of the BAAA. Whether a company like Lima is immune from liability as a “biomaterials supplier” undеr 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).
“[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.
Congress included a statement of findings in the BAAA that clarified its purpose in immunizing biomaterials suppliers.
medical devices,
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.”
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.”
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,
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.
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“); sеe 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.
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 сannot 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.
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
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
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.
The text of the BAAA differentiates a component part from the final implant. See, e.g.,
In light of the statutory context and purpose, we read the words “intended ... to be placed” in
Whether the manufacturer DJO intended the Hip Stem to be implanted as it was received from Lima is therefore determinative. DJO is indisрutably the statutory “manufacturer” of the Hip Stem under
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 purposes here—medical device, and manufacturer‘s intent for implant.
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
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
heading of a section are tools available for the rеsolution of a doubt about the meaning of a statute.” (internal quotation marks and citations omitted)). Thus, we read
Moreover, the Connells’ interpretation of
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.”
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’ preemptive intent.” Puerto Rico, 136 S. Ct. at 1946 (cleaned up). Immunity under BAAA preemption hinges on the statutory definition of “biomaterials supplier.”
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.”
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,
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.
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.”
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,
* * *
Altogether, Lima meets the elements of the definition of a biomaterials supplier under
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 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
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 . . .
(A) the negligence or intentionally tortious conduct of the dismissed supplier was an actual and proximate cause of the harm to the сlaimant; and
(B) the claimant is unlikely to be able to recover the full amount of its damages from the remaining defendants.
Prior to the district court‘s order, no court had interpreted
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 agаinst a manufacturer,”
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
Thus, there is “an action by the claimant against a manufacturer” under the BAAA if the manufacturer was 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
But the crux of the motion to implead here turns on the language, context, and purpose of
The plain text of
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 “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
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 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 “strоng affirmative evidence” supports our interpretation of
And the text of
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 “vоid,” Young, 135 S. Ct. at 1352. Filing a motion after final judgment necessarily means there are no remaining defendants—the action has already been
Sections
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
Moreover,
The BAAA also generally requires a claimant to name the manufacturer as a party.
To the еxtent 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 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
Claimants must first show a biomaterials supplier is liable under one of the bases of liability in
Reading
V
We hold Lima is a biomaterials supplier of the Hip Stem under the BAAA and thus
AFFIRMED.
Notes
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 likеly 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 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.“).
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.