Michael A. Smith v. Depuy Orthopaedics Inc

NOT PRECEDENTIAL
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
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No. 13-2148
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MICHAEL A. SMITH,
Appellant
v.
DEPUY ORTHOPAEDICS INC; DEPUY INC; DEPUY INTERNATIONAL LIMITED;
JOHNSON & JOHNSON; JOHNSON & JOHNSON INTERNATIONAL
______________
APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
(D.C. No. 2-11-cv-04139)
District Judge: Hon. Joel A. Pisano
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Submitted Under Third Circuit LAR 34.1(a)
January 7, 2014
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Before: SMITH, SHWARTZ, and SCIRICA, Circuit Judges.
(Filed: January 14, 2014)
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OPINION
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SHWARTZ, Circuit Judge.
Plaintiff Michael Smith appeals the denial of his cross-motion for a continuance
pursuant to Federal Rule of Civil Procedure 56(d) in his products liability action against

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DePuy Orthopaedics, Inc., DePuy, Inc., DePuy International Limited, Johnson &
Johnson, and Johnson & Johnson International (collectively, “Defendants”). Smith had
two knee surgeries, during which he received components of Defendants’ P.F.C. Sigma
Knee that were approved through the Food & Drug Administration’s (“FDA”) premarket
approval (“PMA”) process as supplements to Defendants’ LCS Total Knee System.
Defendants moved for summary judgment, arguing that Smith’s claims were preempted,
and Smith cross-moved for a continuance to conduct additional discovery. The District
Court denied Smith’s cross-motion when it granted Defendants’ motion for summary
judgment. For the reasons set forth herein, we will affirm.
I.
As we write principally for the benefit of the parties, we recite only the essential
facts and procedural history. Defendants manufacture the RP Knee, a medical device that
is a part of Defendants’ LCS Total Knee System. It is regulated through the Medical
Device Amendments (“MDA”) to the Federal Food, Drug, and Cosmetic Act (“FDCA”),
21 U.S.C. § 360c(a)(1)(C). In accordance with federal regulation, the RP Knee
underwent the PMA process, which “provide[s] reasonable assurance of its safety and
effectiveness,” 21 U.S.C. § 360c(a)(1)(C)(ii)(II); Riegel v. Medtronic, 552 U.S. 312, 317
(2008), and in 1985, the FDA approved its use in the LCS Total Knee System.
In 1996, Defendants introduced the P.F.C. Sigma Knee, which at the time was a
fixed-bearing system containing: (1) a femoral piece; (2) a patella; (3) a tibial tray; and
(4) a tibial insert. The FDA approved the P.F.C. Sigma Knee through a less-rigorous

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process called the 510(k) Pre-Market Notification process.1
In February 2000, Defendants submitted a PMA application to the FDA to
supplement2 the existing RP Knee with a new rotating platform, which was designed to
be used with the 510(k)-cleared femoral and patella components of the P.F.C. Sigma
Knee. The FDA approved this application in March 2000, memorialized as Supplement
69 to the LCS Total Knee System PMA.3
Soon after, in May 2000, Defendants submitted a PMA application to supplement
the RP Knee to include the 510(k)-cleared rotating platform tibial trays and bearings from
the P.F.C. Sigma Knee, thereby incorporating all components of the P.F.C. Sigma Knee
1 Under the 510(k) process, the FDA will approve a new device that is
“‘substantially equivalent’ to another device exempt from premarket approval.” Riegel,
552 U.S. at 317. This is in contrast to the PMA process, which makes a determination
regarding the safety and effectiveness of the new device. Id. at 318. Thus, the 510(k)
process focuses on equivalence, and the PMA process focuses on safety. See Lewkut v.
Stryker Corp., 724 F. Supp. 2d 648, 654 (S.D. Tex. 2010). If a component is approved
only through the 510(k) process and it is later incorporated into a premarket approved
device, it is subject to the federal regulations for the purpose of preemption. Id. at 657.
2 Any change to a PMA-approved device requires supplemental approval, which
“is evaluated largely by the same procedures, criteria, and extensive scrutiny as the
original PMA process.” Bass v. Stryker Corp., 669 F.3d 501, 508 (5th Cir. 2012)
(internal quotation marks omitted).
3 In its approval, the FDA acknowledged that certain components of the newly-
approved RP Knee were from the P.F.C. Sigma Knee and thus had been previously
cleared through the 501(k) process. Smith argued in the District Court that the
components were only approved through the 510(k) process, not the PMA process, but on
appeal, he has not challeneged the District Court’s holding that those components from
the P.F.C. Sigma Knee were incorporated into the RP Knee and thus received PMA
approval.

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into the RP Knee.4 The FDA approved that application in June 2000, memorialized as
Supplement 74 to the LCS Total Knee System PMA.
In February 2006, Defendants submitted yet another PMA application to
supplement the RP Knee, this time to notify the FDA that an inspection was being added
to the manufacturing process for certain tibial trays. The FDA approved this application
in February 2006, memorialized as Supplement 95 to the LCS Total Knee System.
On October 15, 2007, Smith underwent total right knee replacement surgery (the
“first surgery”), during which the RP Knee—including the P.F.C. Sigma tibial insert,
tibial tray, patella, and femoral component—was implanted. In mid-2008, Smith
allegedly experienced “chronic pain with swelling and locking of the joint.” App. 177.
Smith allegedly underwent a bone scan, which confirmed loosening of the femoral and
tibial components, and on July 20, 2009, Smith underwent a revision of his loose knee
implant (the “second surgery”), during which the tibial tray from the first surgery was
kept in place, but revision components from the P.F.C. Sigma Knee were added,
including a femoral component, tibial cemented stem, femoral adapter, femoral adapter
bolt, distal augmentations, posterior augmentation combo, and tibial insert. In 2010,
Smith allegedly developed a “snapping behind the patella-femoral joint.” App. 178.
Smith thereafter filed a complaint against Defendants, alleging violations of state
4Among other things, the application to the FDA explains that the modifications
included revised tibial tray stem lengths and locations to “allow the trays to be used with
both the LCS Complete and Rotating Platform bearings and the P.F.C. Sigma RP
bearings.” App. 113.

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law.5 The Magistrate Judge ordered that summary judgment motions on the issue of
preemption be filed by August 24, 2012 with a return date of September 17, 2012, and
stayed discovery pending the resolution of the motions, “except for the production of
manufacturing records requested by Plaintiff.” App. 211. Smith thereafter served a
request for documents related to both the regulatory approval and manufacture of the
components identified in the chart stickers from his surgeries. In response, Defendants
produced over 3,000 regulatory and manufacturing documents limited to the components
of the P.F.C. Sigma Rotating Platform Total Knee System.
On August 24, 2012, Defendants filed for summary judgment, asserting that all of
Smith’s claims were preempted. Smith requested two adjournments of the September 17,
2012 return date, which the Magistrate Judge granted, ultimately pushing the return date
to October 29, 2012. A day before his opposition to Defendants’ motion was due, Smith
asked Defendants for additional documents concerning the components used in the
second surgery. The next day, Smith filed his opposition to the summary judgment
motion and a cross-motion pursuant to Rule 56(d) for a continuance to allow for
additional discovery.
The District Court: (1) granted Defendants’ motion for summary judgment,
holding that Smith’s state law claims, which were related to the safety and effectiveness
5 These include claims under New Jersey’s Products Liability Act alleging a
manufacturing defect, design defect, and failure to warn, as well as negligence, breach of
express warranty, breach of implied warranty, negligent misrepresentation, fraudulent
concealment, fraud and deceit, and a claim under the Virginia Consumer Protection Act.

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of the device, were preempted under Riegel6 because the RP Knee and all of its
components were approved under the FDA’s PMA process; and (2) denied Smith’s cross-
motion for a continuance, holding that the affidavit that Smith filed in support of his
motion was deficient under Rule 56(d) because it failed to explain how further discovery
would preclude summary judgment. This appeal of the denial of the cross-motion
followed.
II.
The District Court had jurisdiction pursuant to 28 U.S.C. §1332. We exercise
jurisdiction pursuant to 28 U.S.C. § 1291. We review the denial of a motion for
additional discovery under Rule 56(d) for abuse of discretion. Murphy v. Millennium
Radio Grp. LLC, 650 F.3d 295, 309-10 (3d Cir. 2011). We therefore will not disturb the
District Court’s exercise of discretion unless it was “arbitrary, fanciful or clearly
unreasonable,” and “no reasonable person would adopt [its] view.” Stecyk v. Bell
Helicopter Textron, Inc., 295 F.3d 408, 412 (3d Cir. 2002) (internal quotation marks
omitted).
III.
A district court may grant summary judgment before discovery is completed as
long as the party opposing summary judgment has had “an adequate opportunity to obtain
6 In Riegel, the Supreme Court held that a state law is preempted if (1) “the
Federal Government has established requirements applicable to” the device; and (2)
plaintiff’s claims are based upon state “requirements . . . that are ‘different from, or in
addition to’ the federal ones, and that relate to safety and effectiveness.” 552 U.S. at 321-
22 (quoting 21 U.S.C. § 360k(a)).

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discovery.” Dowling v. City of Phila., 855 F.2d 136, 138-39 (3d Cir. 1988) (citing
Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986)). If a party opposing summary
judgment “believes that s/he needs additional time for discovery, Rule 56(d) specifies the
procedure to be followed.” Pa., Dep’t of Pub. Welfare v. Sebelius, 674 F.3d 139, 157 (3d
Cir. 2012) (quoting Dowling, 855 F.2d at 139, which addressed the predecessor to Rule
56(d), Rule 56(f)). Rule 56(d) provides:
If a nonmovant shows by affidavit or declaration that, for specified reasons,
it cannot present facts essential to justify its opposition, the court may:
(1) defer considering the motion or deny it;
(2) allow time to obtain affidavits or declarations or to take discovery; or
(3) issue any other appropriate order.
Fed. R. Civ. P. 56(d). The rule requires “a party seeking further discovery in response to
a summary judgment motion [to] submit an affidavit specifying, for example, what
particular information is sought; how, if uncovered, it would preclude summary
judgment; and why it has not previously been obtained.” Dowling, 855 F.2d at 139-40.
Except in rare cases, “failure to comply with [Rule 56(d)] is fatal to a claim of
insufficient discovery on appeal.” Bradley v. United States, 299 F.3d 197, 207 (3d Cir.
2002).
On appeal, Smith argues that the District Court abused its discretion by proceeding
with summary judgment before he received discovery on the components implanted
during his second surgery because he needs to confirm that they went through the PMA
process and received FDA approval. While the declaration submitted with Smith’s cross-
motion described what discovery he sought and why it had not previously been obtained,

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it failed to discuss how the discovery sought, if provided, would preclude summary
judgment.7 As a result, Smith failed to submit a compliant Rule 56(d) affidavit. Thus,
“as a procedural matter alone, [h]e has failed to comply with the rule,” Dowling, 855
F.2d at 140, and cannot rely on the purported lack of discovery as a basis to reverse the
District Court.
Moreover, because the components implanted during the second surgery all
related to the P.F.C. Sigma femoral piece, tibial tray, and tibial tray bearings,8 which
were approved by the FDA through the PMA process in Supplements 69, 74, and 95, and
which are components of the PMA-approved RP Knee, no discovery was necessary to
determine that these components were also subject to PMA preemption. See Gross, 858
F. Supp. 2d at 487 (holding that a device that received pre-market approval cannot be
7 In his brief and at oral argument, Smith told the District Court that he wished to
take additional discovery because the documents Defendants produced only showed
510(k) clearance for the components, which he claimed contradicted Defendants’
declaration that these components were included in the PM A process. As the District
Court explained, Smith misunderstood the facts: PMA Supplements 69, 74, and 95 to the
LCS Total Knee System incorporated the components of the P.F.C. Sigma Knee that had
previously been cleared through the 510(k) process, and thus these components are
subject to the same federal preemption. See Kemp v. Medtronic, Inc., 231 F.3d 216, 222
(6th Cir. 2000); Duggan v. Medtronic, Inc., 840 F. Supp. 2d 466, 471 (D. Mass. 2012).
Thus, Smith did not provide the District Court with a reason to delay consideration of
Defendants’ summary judgment motion.
8 While Smith argues that he cannot possibly know whether the components
inserted in his second surgery received PMA approval, the chart stickers from the second
surgery show that the pieces were related to the P.F.C. Sigma Knee, and the Supplements
themselves indicated that all components and bearings associated with the P.F.C. Sigma
Knee received PMA approval. Cf. Bass, 669 F.3d at 508 (looking to the language of the
FDA approval to confirm that component was included in PMA); Gross v. Stryker Corp.,
858 F. Supp. 2d 466, 485-86 (W.D. Pa. 2012) (same); Lewkut, 724 F. Supp. 2d at 654-56
(same).

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separated into its component parts to avoid application of express preemption); Duggan,
840 F. Supp. 2d at 471 (same); Lewkut, 724 F. Supp. 2d at 656 (same); Riley v. Cordis
Corp., 625 F. Supp. 2d 769, 780 (D. Minn. 2009) (same).
Furthermore, many PMA preemption motions are decided without any discovery.9
Here, the Magistrate Judge allowed discovery limited to the production of manufacturing
records, but regulatory documents were also produced. Smith’s request for additional
regulatory documents occurred just one day before his opposition brief was due and a
month and a half after he received Defendants’ production. Smith’s delay, together with
his failure to explain why the discovery was needed, provided the District Court with
sufficient grounds to deny the continuance motion. Accordingly, the District Court
“acted within the permissible bounds of its discretion when it ruled on the [Defendants’]
summary judgment motion on the record before it,” Dowling, 855 F.2d at 141, and
properly denied Smith a continuance.
IV.
For the foregoing reasons, we will affirm the District Court’s denial of Smith’s
cross-motion for a continuance.
9 See, e.g., Bass, 669 F.3d at 508 n.1; Gross, 858 F.Supp. 2d at 505; Lewkut , 724
F. Supp. 2d at 653 n.1, 655; Desai v. Sorin CRM USA, Inc., Civ. No. 12-2995, 2013 WL
163298, at *9 (D.N.J. Jan. 15, 2013); Hayes v. Howmedica Osteonics Corp., Civ. No. 08-
6104, 2009 WL 6841859, at *6-8 (D.N.J. Dec. 15, 2009); Delaney v. Stryker
Orthopaedics, Civ. No. 08-03210, 2009 WL 564243, at *4 (D.N.J. Mar. 5, 2009).

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