SHUKER et al v. SMITH & NEPHEW, PLC et al

Filing 99

MEMORANDUM. SIGNED BY HONORABLE JUAN R. SANCHEZ ON 8/13/2015. 8/13/2015 ENTERED AND COPIES E-MAILED.(amas)

IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA
WALTER SHUKER, et al.
v.
SMITH & NEPHEW PLC, et al.

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CIVIL ACTION
No. 13-6158

MEMORANDUM
Juan R. Sánchez, J.

August 13, 2015

Plaintiffs Walter and Vivian Shuker ask this Court to certify for interlocutory appeal its
March 31, 2015, Orders dismissing the Shukers’ products liability-related claims against
Defendants Smith & Nephew, Inc. (S&N) and Smith & Nephew plc (PLC). Plaintiffs also seek
leave to take discovery regarding S&N’s alleged off-label promotion of artificial hip components
used in Walter Shuker’s hip replacement surgery so they may attempt to replead a nonpreempted
state-law claim based on such off-label promotion, consistent with the Court’s dismissal order.
For the reasons set forth below, both requests will be denied.
BACKGROUND
Plaintiffs filed their original Complaint in this action in state court in September 2013,
seeking damages for injuries Walter Shuker sustained after undergoing hip replacement surgery
with components manufactured by one or both Defendants and for Vivian Shuker’s loss of
consortium. The claims in the original Complaint—for negligence/negligence per se, strict
products liability, breach of express warranty, breach of implied warranties, fraud, and loss of
consortium—were based on the understanding that all of the artificial hip components used
during Mr. Shuker’s surgery—a femoral head, a femoral stem, an acetabular shell, and a metal
liner for the shell—entered the market pursuant to what is known as the § 510(k) process, as
opposed to the substantially more rigorous premarket approval (PMA) process. As explained in

the Court’s March 31, 2015, Memorandum, the process by which a manufacturer receives
authorization to market a medical device has significant implications with respect to the
manufacturer’s potential tort liability. In general, under the Medical Device Amendments of
1976 (MDA), state tort claims relating to the safety or effectiveness of a medical device that
received premarket approval are expressly preempted, insofar as state tort law imposes on the
manufacturer requirements that differ from or add to the federal requirements applicable to the
device. Such claims are not preempted, however, as to devices cleared via the § 510(k) process.
S&N removed this case to federal court based on diversity jurisdiction in October 2013
and, after answering the Complaint, filed a motion for judgment on the pleadings. In its motion,
S&N noted Plaintiffs “misapprehend[ed] the regulatory status of the . . . components used in
[Walter Shuker’s] surgery,” S&N’s Mem. in Supp. of Mot. for J. on the Pleadings 1, and argued
their claims were expressly preempted because some of the components—including the metal
liner—had received premarket approval.1 Following a Rule 16 conference, held before Plaintiffs
responded to the motion for judgment on the pleadings, the Court granted Plaintiffs’ oral request
for leave to amend their Complaint and denied S&N’s motion without prejudice. At the same
time, the Court entered a scheduling order setting a March 6, 2014, discovery deadline, which
was later extended to May 5, 2014.
In December 2013, Plaintiffs filed their First Amended Complaint, again alleging that all
of the components used during Mr. Shuker’s surgery were part of Defendants’ R3 Acetabular
System, a § 510(k)-cleared device. Nevertheless, the First Amended Complaint included a new
claim for negligence based on Defendants’ alleged violation of certain FDA regulations in the
event that such a “parallel” claim was necessary to avoid preemption. See First Am. Compl.

1

S&N also argued the claims were inadequately pleaded.
2

¶ 84.2 S&N promptly moved to dismiss the new Complaint, arguing most of Plaintiffs’ claims
were preempted because the R3 metal liner used in Mr. Shuker’s surgery received premarket
approval as part of a separate medical device, the Birmingham Hip Resurfacing (BHR) System,
and Plaintiffs’ nonpreempted parallel claim failed to comply with applicable pleading standards.
After an oral argument, the Court denied the motion to dismiss in March 2014, finding the FDA
documents S&N had attached to the motion fell short of establishing that the metal liner used in
Mr. Shuker’s surgery had, in fact, received premarket approval. Recognizing that the resolution
of the preemption issue was potentially dispositive of most (if not all) of Plaintiffs’ claims and it
was therefore in the parties’ interest for the Court to decide the issue at an early stage of the
litigation, the Court exercised its discretion under Federal Rule of Civil Procedure 26(d) to
amend the scheduling order so as to permit S&N an opportunity to revisit its preemption defense
on a motion for summary judgment following a brief period of discovery. The Court deferred
ruling on whether Plaintiff had adequately pleaded a parallel claim until the preemption issue
was rebriefed.
The parties thereafter conducted discovery on preemption. As part of this discovery,
Plaintiffs sought to depose Mr. Shuker’s surgeon to determine whether S&N promoted the metal
liner used in Mr. Shuker’s surgery for off-label use with the R3 Acetabular System. S&N sought
to preclude the deposition, and the Court granted the request, finding that whether S&N had
engaged in off-label promotion was not relevant to whether Plaintiffs’ claims were preempted
because the First Amended Complaint—which was premised on the theory that the metal liner

2

The MDA preempts state tort claims only when the duties state tort law imposes on a device
manufacturer differ from or add to the federal requirements applicable to the device in question.
The MDA does not preempt state tort claims that are premised on violations of the federal
requirements as “the state duties in such a case ‘parallel,’ rather than add to, federal
requirements.” Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008).
3

was part of the § 510(k)-cleared R3 Acetabular System—did not include any claims based on
off-label promotion.
Following completion of the preemption discovery, S&N filed a motion for summary
judgment on the issue of preemption and sought dismissal of Plaintiffs’ parallel claims as
inadequately pleaded. Plaintiffs opposed the motion and also filed a motion for leave to amend
their First Amended Complaint so as to (1) clarify the regulatory status of the components used
in Mr. Shuker’s surgery based on the results of the preemption discovery, 3 (2) add claims based
on Defendants’ alleged off-label promotion of the metal liner, and (3) clarify their parallel
claims. In addition, PLC, S&N’s English parent company (through a series of intermediaries),
filed a motion to dismiss this action for lack of personal jurisdiction.
On March 31, 2015, this Court granted Plaintiffs’ motion for leave to amend and, treating
Plaintiffs’ Second Amended Complaint as the operative complaint, granted S&N’s motion for
summary judgment/dismissal, concluding that most of Plaintiffs’ claims were preempted and that
any nonpreempted claims based on Defendants’ alleged violations of federal law lacked the
facial plausibility necessary to survive a motion to dismiss. The Court granted Plaintiffs leave to
amend their parallel claims based on off-label promotion, a theory Plaintiffs had not previously
pursued. In a separate Order, the Court granted PLC’s motion to dismiss, finding Plaintiffs had
failed to establish a prima facie case that PLC was subject to personal jurisdiction in
Pennsylvania and denying Plaintiffs’ request for jurisdictional discovery.

3

Discovery confirmed both that the metal liner used in Mr. Shuker’s surgery received premarket
approval as part of the BHR System and that the FDA had never approved the metal liner for use
with the other components of the R3 Acetabular System in a hip replacement.
4

DISCUSSION
A.

Motion for Discovery
Plaintiffs now seek formal discovery on the issue of off-label promotion before filing a

further amended complaint. Plaintiffs argue such discovery is necessary because they lack
personal knowledge as to how S&N marketed the R3 metal liner to physicians such as Mr.
Shuker’s surgeon, the public information available to them on this issue is limited, and the
surgeon has retained his own counsel and is not cooperating with Plaintiffs.
Although Plaintiffs invoke Federal Rule of Civil Procedure 26(b)(1)4 in their motion for
discovery, given the current procedural posture of this case, they are, in essence, seeking precomplaint discovery in order to investigate whether S&N engaged in off-label promotion and
whether such off-label promotion played a role in Mr. Shuker’s surgeon’s decision to use the R3
metal liner in Mr. Shuker’s hip replacement surgery, despite the lack of FDA approval for such
use. The Federal Rules of Civil Procedure do not authorize such pre-complaint discovery, except
as needed to perpetuate testimony that might otherwise be lost. See Fed. R. Civ. P. 27(a)(3)
(authorizing depositions to perpetuate testimony as necessary to “prevent a failure or delay of
justice”); see also Ash v. Cort, 512 F.2d 909, 912 (3d Cir. 1975) (holding “Rule 27 is not a
substitute for discovery” but “is available in special circumstances to preserve testimony which
could otherwise be lost”); Mixing & Mass Transfer Techs., LLC v. Lightnin, Inc., No. 05-1519,
2006 WL 140414, at *3 & n.3 (M.D. Pa. Jan. 18, 2006) (directing plaintiff to file an amended
complaint with a more definite statement of its fraud claim and dismissing references in
plaintiff’s briefs to pre-complaint discovery as “no such pre-complaint discovery is available
under the Federal Rules of Civil Procedure”); In re Chester Cnty. Elec., Inc., 208 F.R.D. 545,
4

Rule 26(b)(1) authorizes a court, “[f]or good cause,” to “order discovery of any matter relevant
to the subject matter involved in the action.”
5

547 (E.D. Pa. 2002) (noting the Third Circuit “has decisively rejected the attempt to use Rule
27(a) as a mechanism to draft a complaint or conduct pre-trial discovery”).5 Plaintiffs have made
no showing that, absent pre-complaint discovery, testimony or tangible evidence is likely to be
lost in this case.
Plaintiffs also argue discovery is necessary in light of the level of detail the Court expects
from their pleadings, which they contend may be unrealistic without discovery. Plaintiffs note
that other courts have recognized the difficulty of pleading a parallel claim with respect to a
PMA-approved device, given that information regarding the applicable federal requirements,
such as the terms of the FDA’s premarket approval, are confidential. See Pls.’ Mem. in Supp. of
Mot. for Discovery 7-8 (citing Swisher v. Stryker Corp., No. 14-28, 2014 WL 1153716 (W.D.
Okla. Mar. 14, 2014), and Killen v. Stryker Spine, No. 11-1508, 2012 WL 4482371 (W.D. Pa.
Aug. 21, 2012), report and recommendation adopted as modified by 2012 WL 4498865 (W.D.
Pa. Sept. 28, 2012)). Neither case cited by Plaintiffs supports their request for discovery as both
address how federal pleading standards should be applied when information about the federal
requirements with respect to a medical device is unavailable to the plaintiff, not the availability
of pre-complaint discovery in such cases.

Insofar as Plaintiffs disagree with this Court’s

application of the pleading standards to the parallel claims in their Second Amended Complaint,
they may obtain immediate appellate review by electing to stand on that complaint.
5

Plaintiffs cite Reints v. Sheppard, 90 F.R.D. 346 (M.D. Pa. 1981), in support of the proposition
that pre-complaint discovery is proper “when the ‘critical information lies within the exclusive
possession of the defendants.’” Pls.’ Mem. in Supp. of Mot. for Discovery 6 (quoting Reints, 90
F.R.D. at 347). In Reints, however, the court specifically acknowledged that discovery of
information needed to frame an amended complaint “is not the type of discovery envisioned in
Rule 27(a).” 90 F.R.D. at 347. And while the court indicated it “would be willing to grant” a
request for such discovery “in a situation where plaintiff truly did not have knowledge of
sufficient facts to plead his case,” the court had no occasion to actually decide the issue, as the
plaintiff was “not in that predicament.” Id. at 347-48.
6

Because Plaintiffs have not shown pre-complaint discovery is warranted, their motion for
leave to take such discovery will be denied.
B.

Motion to Certify
Plaintiffs also ask this Court to certify for interlocutory appeal pursuant to 28 U.S.C.

§ 1292(b) its Order dismissing most of their claims as preempted by the MDA as well as its
Order dismissing PLC for lack of personal jurisdiction.

A district court may make such

certification when (1) the order at issue “involves a controlling question of law”; (2) the
controlling question of law is one “as to which there is substantial ground for difference of
opinion”; and (3) “an immediate appeal from the order may materially advance the termination
of the litigation.” 28 U.S.C. § 1292(b). The party seeking certification must show all three
factors are met. Duffy v. Lawyers Title Ins. Co., No. 11-4503, 2012 WL 2527027, at *2 n.6 (E.D.
Pa. July 2, 2012). The certification procedure is to be “sparingly applied.” Milbert v. Bison
Labs., Inc., 260 F.2d 431, 433 (3d Cir. 1958). As the Third Circuit has recognized, § 1292(b) “is
to be used only in exceptional cases where an intermediate appeal may avoid protracted and
expensive litigation and is not intended to open the floodgates to a vast number of appeals from
interlocutory orders in ordinary litigation.” Id.
The Court agrees with Plaintiffs that the Court’s preemption ruling presents controlling
questions of law, including whether the MDA preempts state tort claims concerning the safety or
effectiveness of a non-FDA-approved medical device created by a physician’s use of a
component of a PMA-approved device off-label with components from a § 510(k)-cleared
device.

See Katz v. Carte Blanche Corp., 496 F.2d 747, 755 (3d Cir. 1974) (holding a

controlling question of law encompasses “every order which, if erroneous, would be reversible
error on final appeal” as well as questions “serious to the conduct of the litigation, either

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practically or legally”). In concluding Plaintiffs’ claims are preempted, this Court recognized
that there is scant case law addressing the MDA’s preemption provision in these unusual
circumstances. Given the lack of authority on point and the different conclusions reached by
those few district courts that have addressed the same or similar issues,6 the Court also agrees the
preemption question in this case is one as to which there is substantial ground for difference of
opinion. See In re Chocolate Confectionary Antitrust Litig., 607 F. Supp. 2d 701, 706 (M.D. Pa.
2009) (holding “[t]he existence of conflicting judicial opinions provides support for certification
of an appeal, as does a lack of binding precedent”).
Plaintiffs have not shown, however, that allowing an immediate appeal would materially
advance the termination of this litigation. This third requirement for certification is met if an
appeal “could eliminate the need for a trial, simplify a case by foreclosing complex issues, or
enable the parties to complete discovery more quickly or at less expense.” Id. at 707. In this
case, an immediate appeal, if successful, would expand the claims Plaintiffs may pursue, thereby
expanding the scope of discovery and trial. See L.R. v. Manheim Twp. Sch. Dist., 540 F. Supp.
2d 603, 613 (E.D. Pa. 2008) (denying certification when a successful interlocutory appeal
“would result in neither the termination nor the narrowing of th[e] litigation”). Plaintiffs argue
this third requirement for certification is satisfied because a successful appeal would render
litigation of any surviving parallel claims unnecessary. See Pls.’ Mot. for Certification ¶ 6. But
this argument is entirely hypothetical at this juncture as Plaintiffs have yet to plead a plausible
6

As discussed in the Court’s March 31, 2015, Memorandum, the two district courts that have
considered the preemption issue with respect to the device at issue in this case have concluded
that claims relating to the R3 metal liner or to the liner’s interface with other components are
preempted. See Simon v. Smith & Nephew, Inc., 18 F. Supp. 3d 423, 428-29 (S.D.N.Y 2014);
Bertini v. Smith & Nephew, Inc., 8 F. Supp. 3d 246, 254-58 (E.D.N.Y. 2014). A district court
presiding over multidistrict litigation regarding a different medical device in West Virginia has
disagreed with this analysis. See, e.g., Huskey v. Ethicon, Inc., 29 F. Supp. 3d 736, 749-52 (S.D.
W. Va. 2014).
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state tort claim based on off-label promotion. If Plaintiffs are unable to state a plausible parallel
claim, this case will soon be ripe for a final appeal of all issues. Further, it remains to be seen
whether Plaintiffs would voluntarily relinquish any such claims in the event of a successful
appeal. Because Plaintiffs have not shown an immediate appeal would materially advance the
termination of this action, certification of the Court’s preemption ruling is not warranted.
Plaintiffs address this Court’s Order dismissing PLC for lack of personal jurisdiction only
briefly. They suggest certification of that Order is warranted because another federal district
court held a different plaintiff had made a prima facie showing that personal jurisdiction could be
exercised over PLC in New York based on allegations that PLC placed the hip replacement
system at issue in the stream of commerce in New York and recruited the plaintiff’s New York
surgeon to attend a training session in England so that the surgeon could market the hip
replacement system to his New York patients. See Gale v. Smith & Nephew PLC, No. 12-3614,
2015 WL 328127, at *3-4 (S.D.N.Y. Jan. 20, 2015). Plaintiffs acknowledge that, unlike the
plaintiff in Gale, they have not alleged that PLC specifically targeted Mr. Shuker’s surgeon in
the forum state, an allegation crucial to the court’s decision in Gale. See id. at *3 (noting “PLC’s
expectation that the System would be shipped, purchased, and used in New York, alone, may be
insufficient to show PLC transacted business in New York,” but, “combined with [Defendants’]
recruitment of [the plaintiff’s surgeon], [wa]s sufficient to show PLC purposefully availed itself
of New York’s market”). They argue, however, that this Court committed reversible error by not
permitting jurisdictional discovery.7

7

Plaintiffs’ suggestion that the Court ignored their request for jurisdictional discovery and the
proposed discovery they sought to take is incorrect. Contrary to Plaintiffs’ assertion, the Court
denied their request for jurisdictional discovery, finding Plaintiffs had failed to “present[] factual
allegations that suggest with reasonable particularity the possible existence of the requisite
9

Because the denial of a request for jurisdictional discovery may constitute reversible
error, this Court assumes the denial of such discovery in this case is controlling question of law.8
See Katz, 496 F.2d at 755. But see In re Carco Elecs., 536 F.3d 211, 214 n.6 (3d Cir. 2008)
(observing that discovery orders “will not ordinarily present a controlling question of law”).
Nevertheless, Plaintiffs have made no showing that there is a substantial ground for difference of
opinion as to whether such discovery was warranted in this case and offer no explanation as to
how an immediate appeal from this Order would materially advance the ultimate termination of
this litigation. Certification is therefore not warranted as to the Court’s jurisdictional ruling.
For the reasons set forth above, Plaintiffs’ motions for leave of court to take discovery
and to certify orders for interlocutory appeal will be denied. An appropriate order follows.

BY THE COURT:

/s/ Juan R. Sánchez
Juan R. Sánchez, J.

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contacts between [PLC] and the forum state.” Order 5, Mar. 31, 2015, ECF No. 90 (quoting
Toys “R” Us, Inc. v. Step Two, S.A., 318 F.3d 446, 456 (3d Cir. 2003)).
8

Plaintiffs do not argue this Court erred in holding they had failed to establish a prima facie case
of personal jurisdiction on the existing record, but instead maintain the Court erred in not
permitting jurisdictional discovery.
10