Webb v. Ethicon Endo-Surgery, Inc.

Filing 383

ORDER Affirming District Court Decision 372 ORDER RE: APPEAL/OBJECTION OF MAGISTRATE JUDGE DECISION to District Judge(Written Opinion) Signed by Chief Judge John R. Tunheim on September 22, 2015. (DML)

UNITED STATES DISTRICT COURT
DISTRICT OF MINNESOTA
SUSAN WEBB,

Civil No. 13-1947 (JRT/JJK)
Plaintiff,
MEMORANDUM OPINION
AND ORDER AFFIRMING
ORDER OF MAGISTRATE JUDGE

v.
ETHICON ENDO-SURGERY, INC.,
Defendant.

William L. Tilton and Grace Davies, TILTON & DUNN, P.L.L.P., 101
Fifth Street East, Suite 2220, St. Paul, MN 55101, for plaintiff.
David R. Noteware and Timothy E. Hudson, THOMPSON & KNIGHT
LLP, One Arts Plaza, 1722 Routh Street, Suite 1500, Dallas, TX 75201;
and Sheryl A. Bjork, BOWMAN & BROOKE LLP, 150 South Fifth Street,
Suite 3000, Minneapolis, MN 55402, for defendant.

This is a products liability, negligent manufacturing, failure to warn, and breach
of warranty action brought by Plaintiff Susan Webb (“Webb”) against Defendant Ethicon
Endo-Surgery, Inc. (“Ethicon”). On June 26, 2015, Webb moved to compel production
of all Product Inquiry Verification Reports (“PIVRs” or “incident reports”) – customer
complaint reports – for the TX stapler line, as well as any emails related to those PIVRs.
On July 10, 2015, United States Magistrate Judge Jeffrey J. Keyes issued an oral order
granting in part Webb’s motion to compel. Magistrate Judge Keyes ordered Ethicon to
produce additional PIVRs from only the following categories: firing issues; found during
analysis; malformed staples; miscellaneous; not specified; would not fire; and nonspecific noise. The Magistrate Judge denied Webb’s motion to the extent it sought

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PIVRs beyond those categories and also denied the motion to compel production of
emails relating to the PIVRs.
This matter is now before the Court on Webb’s appeal of the Magistrate Judge’s
order. Because the Court finds that the Magistrate Judge’s order was neither clearly
erroneous nor contrary to law, the Court will overrule Webb’s objection.
BACKGROUND1
I.

DOCUMENT REQUEST NO. 40
On June 6, 2014, Webb served Ethicon with Document Request Number 40

(“Document Request No. 40”). (Decl. of Grace Davies (“Davies Decl.”), Ex. A at 7-9,
June 26, 2015, Docket No. 356.) Document Request No. 40 has multiple subparts and
states, in its entirety, as follows:
Document Request No. 40:

a. All Premarket Notification Applications which mention any Ethicon
Proximate Linear Staplers, pursuant to section 510(k) of the U.S. Food,
Drug and Cosmetic Act and 21 C.F.R. §807.81, and all supplements or
revisions to any related Premarket Notification;
b. All Device History Record documents relating to Ethicon Proximate
Linear Staplers, as defined by 21 C.F.R. §803.3(i) and required by 21
C.F.R. §820.184(a) through (f);
c. All documents relating to the Quality System Record for Ethicon
Proximate Linear Staplers as required by 21 C.F.R. §820.186;
d. Any and all documents related to any Complaint File as defined by
21 C.F.R. §820.3(b) and required by 21 C.F.R. §820.198(a) through (g),
relating to:
1

A full factual background of the underlying events in this case can be found in the
Court’s previous Order. See Webb v. Ethicon Endo-Surgery, Inc., No. 13-1947, 2014 WL
7213202, at *1-*4 (D. Minn. Dec. 17, 2014).
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i. Ethicon Proximate Linear Staplers;
ii. All other stapler devices, including any software and components
thereof, that has been at any time identified as “Substantially
Equivalent” to Ethicon Proximate Linear Staplers (including the TX
series) in any Premarket Notification for this or any other stapler
product, pursuant to section 510(k) of the U.S. Food, Drug, &
Cosmetic Act;
e. All Quality Audit documents, as defined by 21 C.F.R. §820.3(t) and
as required by 21 C.F.R. §820.22, relating to Ethicon Proximate Linear
Staplers and other stapler products made in whole or part in Juarez,
Mexico;
f. All Nonconformity documents relating to the Subject Ethicon
Proximate Linear Staplers, as defined by 21 C.F.R. §820.3(q), including the
procedures required by 21 C.F.R. §820.90;
g. Any and all documents related to all corrective and preventative
actions (CAPA) as required by 21 C.F.R. §820.100, relating to the Ethicon
Proximate Linear Staplers and to any other stapler product which relies on a
Vision-type system for seeking to identify the presence of staples during
production; and any component thereof, including, but not limited to
Quality Improvement Requests, Continuous Improvement Requests, QIR
logs, and non-conformance procedures and training; this includes minutes
of any meetings of any committee of defendant related to CAPA matters
related to defendant’s facilities in Juarez, Mexico;
h. Any and all documents related to changes or modifications to the
manufacture and production of Ethicon Proximate Linear Staplers and any
component parts thereof, including, but not limited to, changes or
deviations to specifications and guidelines, and all risk assessments,
internal risk assessment memos, Top Level Design Control Procedures
including risk analysis and human factors consideration, internal summary
memos, correspondence, validation processes, testing, and approvals
generated therefrom;
i. Any Ethicon Policy and/or Procedure for handling reports of nonworking products, including but not limited to any products approved by
the FDA;
j. Copies of all legal complaints and claim letters received by Ethicon
(including Johnson and affiliated entities) wherein any allegation is made

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that an injury occurred due to an Ethicon surgical stapler or that a stapler
was made with staples missing.
(Id. at 7-8.)
On August 8, 2014, Magistrate Judge Jeanne J. Graham granted in part Webb’s
motion to compel production of the documents covered by Document Request No. 40,
along with several other document requests. (Order (“August 8 Order”), Aug. 8, 2014,
Docket No. 144.) Ethicon requested permission to file a motion for clarification and
reconsideration of the August 8 Order, and on August 18, 2014, Magistrate Judge
Graham denied that request.

(Order (“August 18 Order”), Aug. 18, 2014, Docket

No. 150.) Both parties objected to Magistrate Judge Graham’s orders, and on January 26,
2015, this Court overruled both objections and affirmed the Magistrate Judge’s rulings.
(Mem. Op. & Order Affirming Orders of Magistrate Judge, Jan. 26, 2015, Docket
No. 264.) In this Court’s January 26 Order, the Court explained that the Magistrate
Judge’s orders struck a careful balance between allowing discovery into all of Ethicon’s
surgical staplers and too narrowly restricting discovery, which would risk Ethicon
withholding potentially relevant information about similar flaws in staplers with related
designs. (Id. at 10-11, 13 & n.2.)

II.

JULY 10, 2015 HEARING
On December 5, 2014, Webb filed a Second Motion to Compel PIVRs. (Pl.’s

Second Mot. to Compel, Dec. 5, 2014, Docket No. 228.) PIVRs are customer complaints
for Ethicon products. Each PIVR is classified as belonging to a particular Voice of
Customer (“VOC”) category. Ethicon has 94 VOC categories in total.

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Following a hearing on December 19, 2014, Magistrate Judge Keyes ordered
Ethicon to produce all PIVRs relating to the following VOC coding categories: Missing
Staples, Incomplete Staple Line, Would Not Staple, Firing Empty, Hemostasis
Controllable, Hemostasis Intervention, Leak Controllable, Leak Intervention, Packaging
Device Issue, and Patient User Related Issue. (Oral Order on Pl.’s Second Mot. to
Compel, Dec. 19, 2014, Docket No. 249.) Magistrate Judge Keyes denied Webb’s
motion to compel disclosure of PIVRs from 19 additional VOC categories. (Id.) Ethicon
subsequently produced approximately 20,000 documents, including 800 PIVRs, roughly
670 of which are unique (not duplicates).
Nevertheless, Webb insisted that Ethicon was refusing to produce a multitude of
PIVRs and related emails, and on June 26, 2015, Webb filed an additional motion to
compel. (Pl.’s Mot. to Compel Disc. & for Sanctions, June 26, 2015, Docket No. 351.)
On July 10, 2015, Magistrate Judge Keyes held a motion hearing on Webb’s motion to
compel. At the hearing, the parties disagreed about the number of outstanding PIVRs;
Webb suggested that approximately 1,000 PIVRs have not been produced, and Ethicon
posited that for all 94 VOC categories, the number was closer to 2,200. With respect to
emails related to the PIVRs, Ethicon estimated that it would cost in the neighborhood of
$2,000,000 to identify and produce the emails, while Webb maintained that the cost
would be lower because they have agreed to limit the number of custodians from whom
they seek emails.
Based on the parties’ arguments, Magistrate Judge Keyes concluded that the
production of PIVRs relating to seven additional categories is appropriate.

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The

Magistrate Judge denied Webb’s request for emails relating to PIVRs, finding Webb’s
request “overly broad and the cost of production outweighs benefits to be derived from
the e-mail discovery.” (Mins. for July 10, 2015 Proceedings Held Before Magistrate
Judge Jeffrey J. Keyes, July 10, 2015, Docket No. 368.) Webb appealed the ruling on the
PIVR-related emails, and this matter is now before the Court on Webb’s objection. (Pl.’s
Objection to the Order Dated July 10, 2015 (“Objection”), July 24, 2015, Docket
No. 372.)
DISCUSSION
I.

STANDARD OF REVIEW
A magistrate judge has broad discretion over matters of discovery. Shukh v.

Seagate Tech., LLC, 295 F.R.D. 228, 238 (D. Minn. 2013). A district court’s review of a
magistrate judge’s order on a nondispositive matter is “extremely deferential.” Roble v.
Celestica Corp., 627 F. Supp. 2d 1008, 1014 (D. Minn. 2007); see also United States v.
Raddatz, 447 U.S. 667, 673 (1980). The Court will reverse such an order only if it is
clearly erroneous or contrary to law. See 28 U.S.C. § 636(b)(1)(A); Fed. R. Civ. P. 72(a);
D. Minn. LR 72.2(a)(3). For an order to be clearly erroneous, the district court must have
a “definite and firm conviction that a mistake has been made.” Lisdahl v. Mayo Found.,
633 F.3d 712, 717 (8th Cir. 2011) (quoting Anderson v. Bessemer City, 470 U.S. 564, 573
(1985)).

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II.

MOTION TO COMPEL
Webb seeks the production of all remaining PIVRs for all 94 VOC categories, as

well as any related emails. Under Federal Rule of Civil Procedure 26, “[p]arties may
obtain discovery regarding any nonprivileged matter that is relevant to any party’s claim
or defense . . . . Relevant information need not be admissible at the trial if the discovery
appears reasonably calculated to lead to the discovery of admissible evidence.” Fed. R.
Civ. P. 26(b)(1). Under the wording of Rule 26(b)(1), discoverable evidence is limited to
relevant information. The scope of discoverable evidence is further limited by Rule
26(b)(2)(C)(iii), under which “the court must limit the frequency or extent of discovery
otherwise allowed by these rules or by local rule if it determines that . . . the burden or
expense of the proposed discovery outweighs its likely benefit . . . .” Fed. R. Civ. P.
26(b)(2)(C)(iii) (emphasis added).
Webb argues that this Court’s January 26 Order and Magistrate Judge Graham’s
August 2014 orders allowed discovery of all TX line PIVRs and related emails. Webb is
correct that those orders required the production of all relevant documents in connection
with Document Request No. 40, but the orders are, of course, to be read and followed in
conjunction with the Federal Rules of Civil Procedure. Although Webb has amended her
complaint to include claims for failure to warn and breach of warranty, the information
she seeks must be not only relevant to her claims but also not unduly burdensome to
produce.
The Court concludes that the Magistrate Judge’s ruling with respect to the emails
was neither clearly erroneous nor contrary to law. Webb argues that Ethicon’s PIVR-

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related “emails will either show a rigorous process by defendant to truly understand what
is causing the hundreds of stapler failures or they will reflect defendant’s shallow efforts
characterized by the repeated use of boilerplate language in the PIVRs.” (Objection at
11-12.)

Irrespective of whether such emails would be relevant, if the burden of

producing them outweighs the value of the emails’ production, the Federal Rules of Civil
Procedure permit the court to restrict the scope of discovery.

Fed. R. Civ. P.

26(b)(2)(C)(iii).
The burden of production in this case is significant.

Ethicon estimated that

production of the additional PIVRs and PIVR-related emails would cost $2,000,000 and
involve sifting through emails from hundreds of custodians. Although Webb maintains
that the cost would be much lower and the number of custodians fewer, when asked
directly by the Magistrate Judge at the hearing for an alternative estimated cost and
scope, Webb’s counsel was unable to provide different figures, responding, “It’s hard for
me to know how many are there.” Webb’s objection goes into great detail about the
agreement reached between the parties to narrow the scope of discovery, but it offers no
alternative cost estimate.
The Magistrate Judge was aware that the parties had agreed to narrow the scope
when he concluded that Webb’s request was still too costly and overbroad. Even if Webb
is correct that the $2,000,000 estimate is overstated, substantial room remains within
which the Magistrate Judge could credibly determine that the cost was too great to
warrant compelling production. Without a time and cost projection against which to
compare the Magistrate Judge’s conclusion, the Court finds that the Magistrate Judge’s

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determination was not clearly erroneous.2 Therefore, the Court will overrule Webb’s
objection and affirm the order of the Magistrate Judge.

ORDER
Based on the foregoing, and all the files, records, and proceedings herein, IT IS
HEREBY ORDERED that Webb’s objection [Docket No. 372] is OVERRULED and
the Order of the Magistrate Judge on Plaintiff’s [351] Motion to Compel Discovery dated
July 10, 2015 [Docket No. 368] is AFFIRMED.
DATED: September 22, 2015
at Minneapolis, Minnesota.

____s/
____
JOHN R. TUNHEIM
Chief Judge
United States District Court

2

The Court reminds the parties that objections to a Magistrate Judge’s order or report and
recommendation are not merely a chance to rehash the same arguments rejected by the
Magistrate Judge. Objections to a Magistrate Judge’s findings and recommendations are an
integral part of the federal system when warranted, but “Congress created this process to
promote judicial economy and there is no net efficiency when the losing party uses the objection
process as a second bite at the apple.” Ayotte v. Am. Economy Ins. Co., No. 09-57, 2010 WL
10862749, at *1 (D. Mont. Dec. 10, 2010). Where objections cite no case law and merely repeat
the same arguments presented to the Magistrate Judge, hoping for a different result, the Court
must retread ground already covered by the Magistrate Judge. “This duplication of time and
effort wastes judicial resources, rather than saving them, and runs contrary to the purposes of the
Magistrates Act.” Howard v. Sec’y of Health & Human Servs., 932 F.2d 505, 509 (6th Cir.
1991). If the parties are not simply disappointed with the result but have a good faith belief that
the Magistrate Judge has committed clear error or reach a result that is contrary to law, the Court
certainly welcomes objection to that decision. But particularly on discovery matters, where
Magistrate Judges have considerable discretion, the Court expects objecting parties to present
specific arguments and support for the position that the Magistrate Judge erred as a matter of
law, rather than reciting facts that were before the Magistrate Judge and asking for the opposite
outcome.
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