Napolitano v. Synthes, Inc
ORDER granting 91 plaintiff's Motion to Compel; granting 92 plaintiff's Motion to Compel; denying 93 plaintiff's Motion to Compel; denying 94 plaintiff's Motion to Compel. See ruling attached. Signed by Judge Holly B. Fitzsimmons on 4/29/13. (Esposito, A.)
UNITED STATES DISTRICT COURT
DISTRICT OF CONNECTICUT
CIV. NO. 3:09CV828 (TLM)
RULING ON PENDING DISCOVERY MOTIONS
This is a product liability case involving a medical
implant device called a locking reconstruction plate (“LRP”),
designed for use on the human jaw. [Compl. Doc. #1].
alleges that defendant negligently and recklessly manufactured
and sold the plate; failed to provide adequate
warnings/instructions; and breached an implied warranty of
merchantability and express warranties. [Doc. #1].
As a result
of a fractured plate, plaintiff alleges she suffered an
exacerbation of her pre-existing mandibular condition, suffered
and continues to suffer emotional distress, pain and suffering,
and has incurred medical and hospital expenses for the
replacement of this defective plate and the consequential
medical care arising therefrom. [Doc. #1].
Defendant represents that the LRP was designed in Europe by
Mathys, Ltd. and Synthes was licensed to sell the LRP in the
United States. One of the clinical indications for the LRP is
represents that Synthes USA Sales, LLC, is the proper
defendant and will accept liability if Synthes, Inc. is
determined to be liable. [Doc. #9; #54 at 1]. The Court will
refer to defendant as Synthes.
reconstruction of the jaw (mandible).
sold by Synthes on August 4, 2003.
The plate at issue was
Plaintiff, who suffered from
osteoradionecrosis of her mandible, underwent surgery in 2003 to
resect (remove) approximately 5 centimeters of the right side of
The oral surgeon who performed her surgery, David
Shafer, DDS, used a Synthes catalog no. 449.633 LRP and screws
to hold the resected parts of the mandible in anatomic
alignment. The subject plate was implanted in Ms. Napolitano on
May 1, 2006, and fractured approximately six weeks later.
Joint Agenda Prepared for April 10, 2013 Conference
A status conference was held on April 10, 2013. Plaintiff
provided an eight page agenda of outstanding discovery issues
which were discussed on the record.
plaintiff’s Motions to Compel.
Also pending are
[Doc. ##91, 92, 93, 94].
b. – RE: Request for Production #28 dated June 22, 2011.
Defendant will provide copies of the surgeon surveys
relating to the Matrix plates to the Court for in camera
review by April 19, 2013.
- RE: Request for Production #40 dated June 22, 2011.
Defendant will supplement its response and state under oath
that, after a diligent search, the materials do not exist.
c. -RE: Interrogatory 1 and Request for Production No. 1,
dated December 8, 2011.
Defendant will supplement its
response and state under oath that, after a diligent
search, no other 2005 lawsuit exists.
-RE: Request for Production No. 3, dated December 8, 2011.
Defendant will supplement its response and state under oath
that, after a diligent search, all of the responsive
documents have been produced.
-RE: Request for Production No. 4, dated December 8, 2011.
In light of the ruling on plaintiff’s Motion to Compel
[Doc. #91], defendant will provide a supplemental response.
d. – RE: Requests for Production Nos. 6, 10, 13, dated
February 22, 2012,
Defendant will supplement its responses
to these requests. Defendant will state under oath if no
additional materials exist after a diligent search.
It is HEREBY ORDERED that, regarding Request for Production
No. 6, dated February 22, 2012, defendant will provide
litigation materials in the Casey case, subject to a
protective order. Counsel will confer re whether additional
measures must be taken to protect the Casey discovery
materials and provide a draft protective order for entry by
- RE: Request for Production No. 15, dated February 22,
In light of the ruling on plaintiff’s Motion to
Compel [Doc. #91], defendant will provide a supplemental
response verifying that plaintiff has all the complaint
files, explain why these are the only reports that are
available, and identify the person on whom defendant is
relying for this response.
-RE: Requests for Production Nos. 3 and 8. Defendant will
provide a supplemental response.
e). RE: Agenda Items 1-38, Defendant agrees to provide
supplemental responses to all of these requests as part of
the master supplementation.
Defendant agrees to provide responses to plaintiff’s
Requests to Admit dated December 31, 2012, by May 10, 2013.
g). This issue will be deferred by agreement.
a) This issue has been addressed.
b) Plaintiff will renew this request after an opportunity to
review defendant’s supplemental document production.
c) Plaintiff will renew this request at another time.
Sections 3 through 6
Plaintiff will serve Requests for Production by April 19,
2013. Defendant’s response is due by May 6, 2013.
Plaintiff’s Motion to Compel Information Regarding
Similar Incidents [Doc. #91]
Plaintiff moves to compel production of information
concerning failures of the non-locking version of the series 449
plates as set forth in Requests for Production Nos. 14 and 15,
dated February 22, 2012.
Request for Production No. 14: Produce all complaint files for
all complaints involving fracture or failure of the 449 series
non-locking mandibular reconstruction plates. This is intended
to include domestic (within the US) and foreign complaints. If
complaint files were not maintained for these foreign
complaints, then produce all documentation maintained regarding
any such complaints.
Request for Production No. 15: Produce copies of all complaint
trend data maintained for both the 449 series locking and non-
locking mandibular reconstruction plates from 1996 to the
present. This request is intended to include the number of
plates sold as well as the number of complaints received
regarding fracture or failure of these plates.
Plaintiff contends that “[e]vidence of other similar
incidents (“OSI”) is frequently admitted in product liability
litigation for a number of different purposes including notice,
foreseeability, and the appropriateness of punitive damages.”
[Doc. #91 at 10].
Plaintiff argues that the locking and non-
locking 449 series plates are very similar. [Doc. #91 at 11
(emphasis in original].
“The many shared characteristics of the
locking and non-locking versions of the 449 series plates
include: same dimensions, same shape, same material; same
indications for use; same product insert/instructions for use.”
[Doc. #91 at 11]. Plaintiff states that the “only difference
between the 2 plates is that the locking version has threaded
holes for a locking screw while the non-locking version has
holes that receive non-locking screws.” [Doc. #91 at 11-12].
Moreover, plaintiff notes that “Synthes developed the nonlocking version of the series 449 plates first.” [Doc. #91 at
“This is why the information concerning failures of the
non-locking 449 plates are so important here on the issues of
notice, foreseeability, and the appropriateness of punitive
Defendant’s RFP responses raise boilerplate relevancy
objections in addition to stating that the requests are overly
broad and unduly burdensome. In response to plaintiff’s motion
to compel, defendant argues that this discovery “relates to a
model of product that is fundamentally different than the
product at issue.” [Doc. #89 at 6].
In Fine v. Facet Aerospace Products Co., the Court held
that the party seeking the requested discovery must make a
“threshold showing of relevance” before the opposing party is
obligated to provide discovery on “a variety of designs not
directly at issue in the litigation.” 133 F.R.D. 439, 443
“[W]here there has been no suggestion that
other models share pertinent characteristics with the products
at issue, discovery relating to those models will be
Id. at 442.
Defendant argues that plaintiff cannot make the threshold
relevancy showing that the different Synthes models, “share
those characteristics pertinent to the legal issues raised in
this litigation.” Fine, 133 F.R.D. at 441.
that the locking reconstruction plate (“LRP”) at issue in this
case is a Synthes catalog no 449.633 locking reconstruction
plate with angle. The Synthes LRP had 29 holes, six vertical
holes before the angle, and 23 horizontal holes after the angle.
The plate is 2.5 mm thick, and each hole is threaded to enable
screws to be locked into the plate.2
29(6 x 23)
18(5 x 13)
Here, defendant argues that
the non-locking plate is both thicker than the LRP and
non-locking plate could not have been used in plaintiff’s case
because it was shorter than the LRP, and did not have locking
technology.” [Doc. #89 at 7].
In addition, the non-locking
plate was not the device cited by Synthes as the predicate
device in its 510(k) application to the FDA clearance for the
LRP. [Doc. #105 at 77].
In order for the requested discovery to be
relevant, then, it must be demonstrated that the
designs are truly alternatives and that they are
potentially safer. Of course, the party seeking
discovery need not prove its case on the merits
in order to obtain disclosure. It must however,
make some threshold showing of relevance before
the opposing party is obligated to open to
discovery a variety of designs not directly at
issue in the litigation.
Fine, 133 F.R.D. at 443.
The Court finds that plaintiff has
made a threshold relevancy showing under Rule 26.
Fed. R. Civ.
P. 26 (b)(1) (“Relevant information need not be admissible at
the trial if the discovery appears reasonably calculated to lead
to the discovery of admissible evidence.”); see Culligan v.
Yamaha Motor Corp., 110 F.R.D. 122, 126 (S.D.N.Y. 1986 (finding
“discovery of similar, if not identical, models is routinely
permitted in product liability cases.”);
Fine, 133 F.R.D. at
442 (“there is support for the proposition that a plaintiff who
raises a design defect claim is entitled to broader discovery
that, for example, if the claim were solely one of negligent
This information will be subject to a
has alleged that the Plate was defectively designed,
was defectively manufactured, and caused an unreasonably
protective order. The Court defers the question of admissibility
at trial until after the parties’ experts have been disclosed
and motions in limine are filed.
Plaintiff seeks information regarding the non-locking plate
going back to 1996. If the parties are unable to agree, counsel
will contact the Court to schedule a telephone status conference
to discuss a reasonable time frame for the discovery and a
schedule for production. In advance of the conference,
defendant’s counsel will confer with his client regarding a
timeline for production as this information will assist the
Court in setting a reasonable schedule for production of these
Accordingly, plaintiff’s Motion to Compel is GRANTED. [Doc.
Plaintiff’s Motion to Compel FDA Warning Letters and
Form 483s [Doc. #92]
Plaintiff moves to compel production of Forms 483 or
Warning Letters received from the FDA from June 26, 1996 to
present, as set forth in plaintiff’s Supplemental Request for
Production No. 11, dated February 22, 2012.
Request for Production No. 11: Produce copies of any Form 483s
or Warning Letters received from the FDA from June 26, 1996 to
present that would encompass the manufacturing process and/or
design process and/or complaint handling process for any 449
series LRP as referenced in part on page 194, line 5 [through]
page 197, line 6 of Jodi Temple’s transcript of 1/19/12.
dangerous condition, i.e. in that the Plate was not sufficiently
thick at the angle of the human jaw where the mechanical force
of chewing is great, and in that the IFU [instructions for use]
did not warn against using the plate for bridging large gaps
without bone graft.” [Doc. #91, n.5].
RESPONSE: Objection. The information requested is neither
relevant to the claim or defense of any party nor reasonably
calculated to lead to discovery of admissible evidence. Rule
26(b)(1). Without waiving this objection, Synthes has not
received any FDA Form 483s or warning letters relating to the
family of 2.4 mm locking reconstruction plate at issue, catalog
The Court finds the information sought in this RFP to be
discoverable under a Rule 26 analysis.
Fed. R. Civ. P. 26
(b)(1) (“Relevant information need not be admissible at the
trial if the discovery appears reasonably calculated to lead to
the discovery of admissible evidence.”). Defendant will produce
copies of any Forms 483 or Warning Letters received from the FDA
from June 26, 1996 to present that would relate to the
manufacturing process and/or design process and/or complaint
handling process for any 449 series LRP. If no Forms 483 and
Warning Letters exist, defendant will state that under oath and
in writing within fourteen (14) days.
Motion to Compel is GRANTED. [Doc. #92].
Plaintiff’s Motion to Compel Depositions of Huggins and
Bohner [Doc. #93]
Plaintiff renews her request to depose Michael Huggins,
former President of Synthes North America, and Richard Bohner,
former President of Synthes U.S. Operations.
On July 30, 2012,
the Court denied her request without prejudice to renewal.
Plaintiff renewed her request at the November status conference
and by motion. [Doc. #93].
On renewal, plaintiff has not provided any evidence that
Huggins or Bohner had personal knowledge of facts relevant to
None of the employees listed by plaintiff reported
to Huggins or Bohner or could say they were briefed on the
issues in this case. Thus, plaintiff has not provided new
information regarding Huggins’ or Bohner’s personal knowledge
regarding this issues raised in this litigation. Plaintiff’s
argument that Huggins and Bohner “should have information” or
that “it does not make sense that the deponents would not have
knowledge of issues pertinent to this case . . . .” is not a
sufficient basis for ordering their depositions. [Doc. #93 at 1,
Plaintiff’s request to reconsider the Court’s July 30, 2012,
ruling is GRANTED. Upon reconsideration and review of
plaintiff’s renewed motion and supplemented record, the Court
affirms its prior ruling. Accordingly, plaintiff’s Motion to
Compel is DENIED. [Doc. #93].
Plaintiff’s Motion to Compel Sales Training Materials
Plaintiff’s Request for Production No. 21, dated April 19,
2012, seeks “all sales training/marketing documents, videos and
slides referred to in [the document] bate stamped #01746-747 if
not already produced.”
Plaintiff’s Request for Production No. 22, dated June 11,
2012, seeks “a copy of the documents concerning the training or
education of the Synthes sales force as to the biomechanics of
why plates fail.”
On July 30, 2012, the Court ruled that plaintiff had “not
shown how the sales documentation would be helpful in proving
the claims in her case, nor has she provided any citation to Dr.
Schafer or Ms. Healy’s depositions to counter defendant’s
representations.” [Doc. #68 at 10].
Plaintiff renewed her
request during the November status conference and by motion.
In her renewed motion, plaintiff has not provided
evidence that Ms. Healy used or relied on training materials in
her interactions with Dr. Shafer; rather, plaintiff argues that
she is “entitled to discover everything Synthes said about its
product, and especially what it told its own sales personnel.”
[Doc. #94 at 3]. Plaintiff contends that training materials are
admissions, “likely to show what Synthes knew and when it knew
it, and may also be evidence of recklessness.” Id.
has reviewed the transcript excerpts of Ms. Healy and Dr.
Schafer’s depositions. The evidence does not show that Ms. Healy
relied on training materials in her interactions with Dr.
Shafer. [Doc. #94 at 3 (plaintiff admits that this fact is
“besides the point.”]. Moreover, there is no evidence to show
there were communications between Ms. Healy and Dr. Shafer
regarding the biomechanics of plate failure before the plate at
issue was sold.
Plaintiff’s request to reconsider the Court’s July 30,
2012, ruling is GRANTED. Upon reconsideration and review of
plaintiff’s renewed motion and supplemental record, the Court
affirms it prior ruling denying Requests for production No. 21
dated April 19, 2012, and No. 22 dated June 11, 2012.
Accordingly, plaintiff’s Motion to Compel is DENIED. [Doc. #94].
Accordingly, plaintiff’s Motion to Compel [doc. #91] is
GRANTED as set forth in this opinion.
Plaintiff’s Motion to Compel [doc. #92] is GRANTED as set
forth in this opinion.
Plaintiff’s Motion to Compel [doc. #93] is DENIED as set
forth in this opinion.
Plaintiff’s Motion to Compel [doc. #94] is DENIED as set
forth in this opinion.
This is not a recommended ruling.
This is a discovery
ruling and order which is reviewable pursuant to the "clearly
erroneous" statutory standard of review.
28 U.S.C. '636
(b)(1)(A); Fed. R. Civ. P. 6(a), 6(e) and 72(a); and Rule 2 of
the Local Rules for United States Magistrate Judges.
it is an order of the Court unless reversed or modified by the
district judge upon motion timely made.
SO ORDERED at Bridgeport this 29th day of April 2013.
HOLLY B. FITZSIMMONS
UNITED STATES MAGISTRATE JUDGE
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