John Bower v. Wright Medical Technology Inc. et al
Filing
98
MINUTES OF Motion Hearing held before Judge Christina A. Snyder: RE:JUDGES ORDER GRANTING IN PART AND DENYING IN PART PLAINTIFFS MOTION TO COMPEL FURTHER RESPONSES AND PRODUCTION OF DOCUMENTS 90 .P laintiffs motion for review of Magistrate Judge Karen Stevensons order dated September 12, 2018 is DENIED. Court Reporter: Lisa Gonzalez. .(lc) Modified on 12/4/2018. (lc).
UNITED STATES DISTRICT COURT
CENTRAL DISTRICT OF CALIFORNIA
Case No.
Title
CIVIL MINUTES – GENERAL
‘O’
2:17-cv-03178-CAS (KSx)
Date December 3, 2018
2:17-cv-03196-CAS (KSx)
JOHN BOWER V. WRIGHT MEDICAL TECHNOLOGY INC. ET AL.
CATHERINE PRATER V. WRIGHT MEDICAL TECHNOLOGY, INC.
ET AL.
Present: The Honorable
CHRISTINA A. SNYDER
Catherine Jeang
Lisa Gonzalez
N/A
Deputy Clerk
Court Reporter / Recorder
Tape No.
Attorneys Present for Plaintiffs:
Attorneys Present for Defendants:
Cherisse Cleoffe
Melanie Palmer
Ryan O’Neil
Proceedings:
I.
PLAINTIFFS’ MOTION FOR REVIEW OF MAGISTRATE
JUDGE’S ORDER GRANTING IN PART AND DENYING IN
PART PLAINTIFFS’ MOTION TO COMPEL FURTHER
RESPONSES AND PRODUCTION OF DOCUMENTS (Filed
September 26, 2018, Dkt. 90)
INTRODUCTION
On April 27, 2017, plaintiffs John Bower (“Bower”) and Catherine Prater
(“Prater”) filed separate but substantially similar complaints against defendants Wright
Medical Technology, Inc. (“Wright”) and MicroPort Orthopedics, Inc. (“MicroPort”).
See Case No. 2:17-cv-03178-CAS, Dkt. 1 (“Bower Compl.”); Case No. 2:17-cv-03196,
Dkt. 1. (“Prater Compl.”).1 Both plaintiffs assert seven claims against defendants: (1)
strict products liability—manufacturing defect, (2) strict products liability—failure to
warn, (3) negligence, (4) negligence—failure to recall/retrofit, (5) fraudulent
misrepresentation, (6) fraudulent concealment, and (7) negligent misrepresentation. Id.
In brief, plaintiffs allege that they received the same artificial hip devices manufactured
by defendants and that the devices subsequently fractured causing them serious injury.
1
For sake of clarity and convenience, the following references are to the record in
the Bower action unless otherwise specified.
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UNITED STATES DISTRICT COURT
CENTRAL DISTRICT OF CALIFORNIA
Case No.
Title
CIVIL MINUTES – GENERAL
‘O’
2:17-cv-03178-CAS (KSx)
Date December 3, 2018
2:17-cv-03196-CAS (KSx)
JOHN BOWER V. WRIGHT MEDICAL TECHNOLOGY INC. ET AL.
CATHERINE PRATER V. WRIGHT MEDICAL TECHNOLOGY, INC.
ET AL.
See id. On January 3, 2018, the Court consolidated the Bower and Prater actions for all
pre-trial purposes. Dkt. 48.
On September 22, 2018, Magistrate Judge Karen L. Stevenson (“the Magistrate
Judge”) granted in part and denied in part plaintiffs’ motion to compel further discovery
responses and production of documents. Dkt. 80 (“Order”). On September 26, 2018,
plaintiffs filed the instant motion for review of the Order. Dkt. 90 (“Mot.”). Defendants
filed an opposition on November 12, 2018. Dkt. 94 (“Opp’n”). Plaintiffs filed a reply on
November 19, 2018. Dkt. 95 (“Reply”). The Court held a hearing on December 3, 2018.
Having carefully considered the parties’ arguments, the Court finds and concludes as
follows.
II.
BACKGROUND
Plaintiffs allege the following facts. Both plaintiffs had hip replacement surgeries
performed by Dr. Jason Snibbe (“Dr. Snibbe”) at Cedars-Sinai Medical Center in Los
Angeles, California. Bower Compl. ¶ 8; Prater Compl. ¶ 8. Prater underwent a right total
hip arthroplasty on January 17, 2012. Prater Compl. ¶ 3. Bower underwent a left total
hip arthroplasty on October 1, 2013. Bower Compl. ¶ 3. In both cases, Dr. Snibbe
surgically implanted defendants’ PROFEMUR® Total Hip System, specifically the “VV”
Long neck, model PHAC-1254, made from cobalt chrome alloy. Bower Compl. ¶¶ 3, 66;
Prater Compl. ¶¶ 3, 66. While Bower and Prater were performing normal and expected
activities of daily living on December 4, 2016 and January 9, 2017 respectively, the
modular neck of both devices suddenly and catastrophically failed. Plaintiffs were
subsequently hospitalized and the devices were surgically removed. Bower Compl. ¶¶
69–72; Prater Compl. ¶¶ 69–72.
Wright began manufacturing and selling the PROFEMUR® Total Hip System after
December 13, 2000, when Wright received permission to distribute the device from the
United States Food and Drug Administration (“FDA”). Bower Compl. ¶¶ 17, 20. The
device the FDA approved contains a modular neck that was designed and had previously
been distributed in Europe by Cremascoli Ortho (“Cremascoli”), which Wright acquired
in December 1999. Id. ¶¶ 16, 18. The FDA never considered and approved the safety of
the PROFEMUR® Total Hip System, but instead concluded it was substantially
equivalent to an already legally marketed device manufactured by Cremascoli. Id. ¶ 19.
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UNITED STATES DISTRICT COURT
CENTRAL DISTRICT OF CALIFORNIA
Case No.
Title
CIVIL MINUTES – GENERAL
‘O’
2:17-cv-03178-CAS (KSx)
Date December 3, 2018
2:17-cv-03196-CAS (KSx)
JOHN BOWER V. WRIGHT MEDICAL TECHNOLOGY INC. ET AL.
CATHERINE PRATER V. WRIGHT MEDICAL TECHNOLOGY, INC.
ET AL.
On August 25, 2009, the FDA permitted Wright to distribute and market a PROFEMUR®
device made from cobalt chrome alloy instead of the titanium-aluminum-vanadiam alloy
used since 2000 without assessing the safety of the device but rather finding that the
devices are substantially similar. Id. ¶¶ 21–22.
Plaintiffs allege that Wright made “representations, statements, claims, and
guarantees about its PROFEMUR® modular necks” in “various marketing and
promotional material published and distributed by Wright from approximately” 2002 to
2005. Id. ¶ 24. Specifically, Wright represented that the devices “have been successfully
implanted in over 50,000 patients” and that “[n]one of the necks has experienced a
clinical failure since their inception.” Id. Wright represented that “[e]xtensive laboratory
tests have proven that the coupling between the modular neck and femoral implant
guarantees” “[s]tructural reliability,” the “[a]bsence of significant micromovement,” and
the “[a]bsence of fretting corrosion.” Id. Despite these representations, plaintiffs allege
that defendants had in fact received notice of fractures of the modular necks that had been
implanted in patients in Europe prior to 2001. Id. ¶ 28. However, defendants allegedly
failed to disclose this history of fractures in European patients to the FDA until April 19,
2005. Id. ¶ 33.
Plaintiffs further allege that defendants did not inform surgeons known to have
implanted the device of any fractures until December 1, 2008, when they issued a safety
alert to medical professionals. Id. ¶ 40. This safety alert provided that defendants had
“received reports of 43 modular neck failures as of November 21, 2008” and that “initial
investigations have revealed several commonalities in these failures: heavyweight males,
long modular necks and patient activities such as heavy lifting and impact sports.” Id.
Despite their investigations into these fractures, defendants allegedly did not issue
warnings that the device should not be used in heavier patients or in patients who engage
in heavy lifting or impact sports prior to August 2010. Id. ¶¶ 43–49. On August 25,
2009, Wright began distributing modular necks made from cobalt chrome alloy. Id. ¶ 50.
Despite the change in materials, the devices remain “susceptible to micromotion and
fretting corrosion at the neck-stem junction” and continue to fracture “from cyclic
loading and metal fatigue.” Id. ¶¶ 52–53. However, Wright did not inform patients that
the device has a “higher than anticipated” rate of failure. Id. ¶ 54.
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UNITED STATES DISTRICT COURT
CENTRAL DISTRICT OF CALIFORNIA
Case No.
Title
CIVIL MINUTES – GENERAL
‘O’
2:17-cv-03178-CAS (KSx)
Date December 3, 2018
2:17-cv-03196-CAS (KSx)
JOHN BOWER V. WRIGHT MEDICAL TECHNOLOGY INC. ET AL.
CATHERINE PRATER V. WRIGHT MEDICAL TECHNOLOGY, INC.
ET AL.
In 2014, MicroPort acquired the division of Wright responsible for designing and
selling the device. Id. ¶ 59. On August 11, 2015, MicroPort announced a voluntary
recall of the device implanted in Bower and Prater in the interest of “patient safety.” Id.
¶¶ 60, 62. On September 28, 2015, the FDA issued a Class 1 recall of the device. Id. ¶
64.
III.
LEGAL STANDARD
Pursuant to Federal Rule of Civil Procedure 72(a), a party may file objections to a
magistrate judge’s non-dispositive order within fourteen days. The party shall file a
motion for review by the assigned district judge “designating the specific portions of the
ruling objected to and stating the grounds for the objection.” Local Rule 72–2.1. Under
this rule, the district judge will not modify or set aside a magistrate judge’s ruling unless
the objecting party shows that the ruling was “clearly erroneous or contrary to law.” 28
U.S.C. § 626(b)(1)(A). “The ‘clearly erroneous’ standard applies to the magistrate
judge’s factual determinations and discretionary decisions, including orders imposing
discovery sanctions.” Computer Econ., Inc. v. Gartner Grp., Inc., 50 F. Supp. 2d 980,
983 (S.D. Cal. 1999). “A finding is ‘clearly erroneous’ when although there is evidence
to support it, the reviewing [body] on the entire evidence is left with the definite and firm
conviction that a mistake has been committed.” Concrete Pipe & Prods. Of California,
Inc. v. Constr. Laborers Pension Tr. for S. California, 508 U.S. 602, 623 (1993). The
“contrary to law” standard allows “independent, plenary review of purely legal
determinations” by the magistrate judge. Jadwin v. Cty. of Kern, No. CV-F-07-026
OWW/TAG, 2008 WL 4217742, at *1 (E.D. Cal. Sept. 11, 2008). An order is “contrary
to law when it fails to apply or misapplies relevant statutes, case law, or rules of
procedure.” Id.
When reviewing a magistrate judge’s decision concerning relevance, the standard
of review is not the explicit statutory standard under § 626, but rather the “clearly implicit
standard of abuse of discretion.” Zakaria v. Gerber Prod. Co., No. CV 15-00200-JAK,
2016 WL 6871277, at *5 (C.D. Cal. July 1, 2016) (quoting Geophysical Sys. Corp. v.
Raytheon Co., 117 F.R.D. 646, 647 (C.D. Cal. 1987)). “A magistrate abuses this
discretion ‘only when his decision is based on an erroneous conclusion of law or where
the record contains no evidence on which he rationally could have based that decision.’”
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UNITED STATES DISTRICT COURT
CENTRAL DISTRICT OF CALIFORNIA
Case No.
Title
CIVIL MINUTES – GENERAL
‘O’
2:17-cv-03178-CAS (KSx)
Date December 3, 2018
2:17-cv-03196-CAS (KSx)
JOHN BOWER V. WRIGHT MEDICAL TECHNOLOGY INC. ET AL.
CATHERINE PRATER V. WRIGHT MEDICAL TECHNOLOGY, INC.
ET AL.
Id. (quoting Premium Serv. Corp. v. Sperry & Hutchinson Co., 511 F.2d 225, 229 (9th
Cir. 1975)).
IV.
DISCUSSION
A.
Plaintiffs’ Discovery Requests
Plaintiffs moved to compel discovery related to the following five disputed issues:
Issue #1: Documents related to fractures in the entire PROFEMUR® product line,
including individual complaint files concerning all other [cobalt chrome] neck
fractures, including other [cobalt chrome] long neck fractures, not just the
PHAC-1254 component implanted in Plaintiffs;
Issue # 2: Documents concerning PROFEMUR® TITANIUM LONG NECK implant
device (Product No. PHAO-1254);
Issue # 3: Documents evidencing failures in PROFEMUR® [cobalt chrome] devices,
including evidence of corrosion present in any PROFEMUR® neck
component, including long, short, and titanium models, including evidence
related to adverse tissue reactions;
Issue # 4: Documents relating to the failure rate of the PROFEMUR® neck line of
products, including titanium and [cobalt chrome] necks, without limitation by
time or specific model; and
Issue # 5: Communications with the FDA regarding the PROFEMUR® line, including
individual complaint files relating to titanium neck fracture incidents.
Order at 4 (citations omitted). The instant motion concerns the Magistrate Judge’s ruling
regarding the relevance and proportionality of discovery pertaining to fracture incidents
occurring in the PHAO-1254 model—the titanium predecessor of the long neck device
made from cobalt chrome alloy that is the subject of the instant actions. Mot. at 1.
Plaintiffs contend that this discovery is relevant because the titanium and cobalt chrome
long necks are substantially similar components that fractured in the same manner and in
the same location, thus fractures in the titanium long neck bear on defendants’ continuing
duty to warn with respect to the substantially similar cobalt chrome long necks implanted
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UNITED STATES DISTRICT COURT
CENTRAL DISTRICT OF CALIFORNIA
Case No.
Title
CIVIL MINUTES – GENERAL
‘O’
2:17-cv-03178-CAS (KSx)
Date December 3, 2018
2:17-cv-03196-CAS (KSx)
JOHN BOWER V. WRIGHT MEDICAL TECHNOLOGY INC. ET AL.
CATHERINE PRATER V. WRIGHT MEDICAL TECHNOLOGY, INC.
ET AL.
in plaintiffs, as well as defendants’ alleged misrepresentations regarding the safety and
efficacy of the cobalt chrome device. Mot. at 7–8. To support this theory, plaintiffs rely
heavily on Dr. Snibbe’s contention that he would not have implanted the cobalt chrome
devices, or would have performed prophylactic revision surgeries to replace the cobalt
chrome devices, if he had known that the titanium long necks were continuing to fracture
at a high rate even after 2009. Id. at 8–9. Plaintiffs also contend that they require this
discovery because they anticipate that defendants will try to introduce evidence showing
that the overall fracture rate of the titanium long neck was within expected parameters
through 2018. Id. at 9.
Defendants challenge the relevance of the titanium device because various experts,
including plaintiffs’ expert, have opined that the damage observed in the cobalt chrome
devices is inconsistent with the damage observed in the titanium devices. Order at 7.
Defendants also argue that complaints involving the titanium long neck are not relevant
to plaintiffs’ claims because “every modular neck failure, whether fracture-related or not,
has distinguishing features that are vastly different than Plaintiffs’ fracture failures with
respect to causation, symptomology, and patient experiences, among other factors—
particularly where those fractures involve a different modular neck component [ ] than
the one which Plaintiffs received and is at issue in these cases [ ].” Opp’n at 7. And
despite plaintiffs’ assertions to the contrary, defendants state that they do not intend to
introduce evidence of the fracture rate of the titanium long neck at trial because,
according to defendants, such evidence is not relevant. Id. at 12.
B.
The Magistrate Judge’s Order
After reviewing the parties’ joint stipulation, holding a hearing that lasted over
three hours, and holding an additional telephonic hearing, the Magistrate Judge granted
plaintiffs’ motion in part, but denied it in part, by limiting the scope of production related
to the titanium device to the period of 1999 to 2009. Order at 8, 12, 13; Dkt. 85, August
22, 2018 Hearing Transcript (“Hearing”); Dkt. 87, September 7, 2018 Telephonic
Conference Transcript (“Telephonic Conf.”). In the Order, the Magistrate Judge applied
the correct standards for relevance and proportionality under Federal Rule of Civil
Procedure 26, and explained that information related to fractures of the titanium necks is
relevant to plaintiffs’ claims because the similarity (or dissimilarity) of the fracture
patterns for the two products goes to the merits of plaintiffs’ claims. Order at 7–8. The
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UNITED STATES DISTRICT COURT
CENTRAL DISTRICT OF CALIFORNIA
Case No.
Title
CIVIL MINUTES – GENERAL
‘O’
2:17-cv-03178-CAS (KSx)
Date December 3, 2018
2:17-cv-03196-CAS (KSx)
JOHN BOWER V. WRIGHT MEDICAL TECHNOLOGY INC. ET AL.
CATHERINE PRATER V. WRIGHT MEDICAL TECHNOLOGY, INC.
ET AL.
Court also found that production of this information would not be burdensome because
the defendants had previously produced the design and regulatory files for the entire
titanium neck product line and documents related to the fractures in the titanium long
neck from 1999 to 2009 in Sarafian v. Wright Medical Technology, Inc., Case No. CV
15-09397-CAS (KSx), and Biorn v. Wright Medical Technology, Inc., Case No. CV 1507102-CAS (KSx)—two separate but similar cases involving the same cobalt chrome
device (collectively, the “Biorn/Sarafian Actions”).
However, with respect to information relating to fractures in the titanium long
necks that occurred after 2009—which the plaintiffs claimed was relevant to the issue of
defendants’ continuing duty to warn and representations regarding the safety of the cobalt
chrome device—the Magistrate Judge found that this additional discovery was not
relevant or proportional to the needs of these cases because it concerns a product that is
not at issue in this case and incidents that “occurred years after the Cobalt Chrome
Device replaced the Titanium Device.” Order at 12–13. The Magistrate Judge similarly
found that this information was not relevant or proportional with respect to plaintiffs’
argument that they required this information because defendants might introduce the
fracture rate of titanium long necks at trial. Id. at 12.
C.
Analysis
In the instant motion, plaintiffs argue that the “record provides no rational basis for
permitting discovery concerning pre-2009 fractures but denying discovery of post-2009
fractures of the same component.” Reply at 2. But it is apparent from the face of the
Order that the Magistrate Judge did not abuse her discretion when she found that
plaintiffs’ discovery requests concerning post-2009 fractures in the titanium long neck
are neither relevant nor proportional to the needs of these cases. The rationale of the
Magistrate Judge’s finding is further bolstered by the transcripts of the hearing and
telephonic conference, which demonstrate that the Magistrate Judge carefully considered
and rejected plaintiffs’ arguments with respect to the relevance of the post-2009
discovery that they sought. In direct response to plaintiffs’ argument regarding notice,
the Magistrate Judge explained:
There had already been incidences of the titanium fracture well before [the
cobalt chrome devices were implanted], which was one of the reasons why
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UNITED STATES DISTRICT COURT
CENTRAL DISTRICT OF CALIFORNIA
Case No.
Title
CIVIL MINUTES – GENERAL
‘O’
2:17-cv-03178-CAS (KSx)
Date December 3, 2018
2:17-cv-03196-CAS (KSx)
JOHN BOWER V. WRIGHT MEDICAL TECHNOLOGY INC. ET AL.
CATHERINE PRATER V. WRIGHT MEDICAL TECHNOLOGY, INC.
ET AL.
the manufacturer shifted to the cobalt chrome [ ] so, the notice has been
established here, well-established for the predecessor product. . . . I’m not
seeing what the more notice adds once they’ve already shifted to a new
product and the implanted product is the one that is squarely at issue here.
Telephonic Conf. at 8:20–24. With respect to plaintiffs’ argument that Dr. Snibbe would
have acted differently had he known that the titanium neck was continuing to fracture, the
Magistrate Judge explained that she was “not following the inferential leap” that Dr.
Snibbe would have acted differently based on fracture rates of a product that was not
implanted in plaintiffs. Id. 9:19–10:3.
As to plaintiffs’ argument regarding the defendants’ potential introduction at trial
of the fracture rate of the titanium long neck up until 2018, the Magistrate Judge
explained that “[i]t seems highly tangential to the substantive issues in the case[,]” id.
62:1–11, and suggested that plaintiffs’ concerns could be addressed with a motion in
limine, id. 47:10–14.
The Magistrate Judge carefully considered plaintiffs’ discovery requests and
arguments and ultimately decided that discovery related to the fractures in the titanium
long neck—after it was taken off the market and replaced by the cobalt chrome long neck
in 2009—was not relevant to defendants’ duty to warn. The Magistrate Judge did not
abuse her discretion when she rejected plaintiffs’ theory that such discovery was relevant
because ongoing fractures in the titanium long neck would have influenced Dr. Snibbe’s
decision to use the cobalt chrome device, or to later perform a prophylactic revision
surgery.
And although plaintiffs speculate that defendants may attempt to introduce the
fracture rate for the titanium long neck through 2018, despite the defendants’ contention
that they do not plan to do so, the Magistrate Judge did not abuse her discretion by
declining to find that plaintiffs’ requested discovery was relevant or proportional.
Relevance cannot be established solely on plaintiffs’ speculation that defendants may
introduce certain evidence at trial, especially when defendants repeatedly deny an
intention to do so. Plaintiffs’ concerns on this point can be addressed through a motion in
limine.
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Page 8 of 9
UNITED STATES DISTRICT COURT
CENTRAL DISTRICT OF CALIFORNIA
Case No.
Title
CIVIL MINUTES – GENERAL
‘O’
2:17-cv-03178-CAS (KSx)
Date December 3, 2018
2:17-cv-03196-CAS (KSx)
JOHN BOWER V. WRIGHT MEDICAL TECHNOLOGY INC. ET AL.
CATHERINE PRATER V. WRIGHT MEDICAL TECHNOLOGY, INC.
ET AL.
The Order also presents no misunderstanding of proportionality. Faced with a
record consisting of extremely broad discovery requests, spanning decades and
concerning multiple products that were not implanted in plaintiffs, the Magistrate Judge
carefully determined that plaintiffs’ requests were not proportional and that the
Biorn/Sarafian production would be sufficiently comprehensive with respect to any
relevant information concerning the titanium long neck. Telephonic Conf. at 14:3–8.
At hearing, the plaintiffs argued that the Magistrate Judge’s findings on relevance
would prevent plaintiffs from pursuing any discovery regarding post-2009 titanium long
neck fractures. But plaintiffs’ concerns are misplaced because the Magistrate Judge’s
findings are based on the voluminous, overbroad discovery requests that were before her.
Nothing in the Order precludes plaintiffs from pursuing narrowly tailored discovery
requests regarding the titanium long neck.
V.
CONCLUSION
For the foregoing reasons, plaintiffs’ motion for review of Magistrate Judge Karen
Stevenson’s order dated September 12, 2018 is DENIED.
IT IS SO ORDERED.
Initials of Preparer
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14
CMJ
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