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Stephen Csengeri, Esq. SBN 97505
Csengeri Law Offices
21250 Hawthorne Boulevard, Suite 500
Torrance, CA 90503
(310) 373-9330
(310) 373-9040 (Fax)
Csengeri@Shangri-Law.com
Attorney for Plaintiff,
SUSAN BRAUN
ELECTRONICALI
FILED
Superior Court of
County of San
08/10/201
Clerk of the Cour
BY-WILLIAM TRUPEK
Deputy Clerk
SUPERIOR COURT FOR THE STATE OF CALIFORNIA
COUNTY OF SAN FRANCISCO
CIVIC CENTER COURTHOUSE
SUSAN BRAUN
Plaintiff,
vs.
ZIMMER, INC.; ZIMMER FEGAN &
MALONEY, INC.; JAMES PALMER; DOE
CORPORATIONS 1 TO 25 INCLUSIVE;
AND DOE DEFENDANTS 26 TO 100
INCLUSIVE.
Defendants.
FIRST AMENDED COMPLAINT FOR
DAMAGES
CASE NUMBER: CGC-14-541588
COMPLAINT FILED; September 10, 2014
COMPLAINT FOR DAMAGES
Plaintiff SUSAN BRAUN sues the defendants ZIMMER, INC.; ZIMMER FEGAN
& MALONEY, INC.; JAMES PALMER; DOE CORPORATIONS 1 TO 25 INCLUSIVE;
AND DOE DEFENDANTS 26 TO 100 INCLUSIVE and alleges:PARTIES
1. Plaintiff SUSAN BRAUN is a citizen and resident of the State of
California.
2. Defendant Zimmer, Inc. is a corporation incorporated in the State of
Delaware with its principal place of business in the State of Indiana, which at all times
designed, developed, tested, assembled, manufactured, compounded, fabricated,
analyzed, packaged, labeled, prepared, recommended, merchandised, advertised,
promoted, distributed, marketed, supplied, and/or sold, and thus placed into the stream
of commerce the defective products under the name "Zimmer Trilogy ® Acetabular
System, Zimmer Epoch ® Fullcoat Hip Prosthesis, and Zimmer Versys ® Hip System"
(herein after "Zimmer Hip System’), directly or indirectly, to members of the general
public in the State of California, including the plaintiff SUSAN BRAUN, and instructed
physicians regarding the advantages of and their method of implanting their product.
3. Defendant ZIMMER FEGAN & MALONEY, INC. is a domestic
corporation in the State of California with its principal place of business in the City of
San Francisco, County of San Francisco, and State of California who distributed and
placed into the stream of commerce the Zimmer Hip System in the State of California
through their independent contractor sales representative, defendant JAMES PALMER,
and instructed physicians regarding the advantages of and their method of implanting
their product.
4, Defendant JAMES PALMER is a resident of the state of California who
was an independent contractor who acted as a sales representative of defendant
ZIMMER FEGAN & MALONBRY, INC. to distribute and place into the stream of
commerce the Zimmer Hip System in the state of California and instructed physicians
regarding the advantages of and their method of implanting their product.
5. Doe Corporations, parent corporations and subsidiary corporations of
Zimmer, Inc., and ZIMMER FEGAN & MALONEY, INC., or any of them, and
FIRST AMENDED COMPLAINT - 2corporations related to said defendants, the true names and capacities of Doe
Corporations 1 through 25 (hereinafter, jointly and severally, Doe Corporations), and
each of them, are unknown to plaintiff SUSAN BRAUN, who therefore sues these
defendants by such fictitious names and will ask leave of court to amend her complaint
when the same have been disclosed or ascertained.
6. Doe Defendants 26 through 100, which at all times designed, developed,
tested, assembled, manufactured, packaged, labeled, prepared, distributed, marketed,
supplied, and/or sold the defective product the Zimmer I lip System, directly or
indirectly, to members of the general public in the State of California, including the
plaintiff SUSAN BRAUN, and instructed physicians regarding the advantages of and
their method of implanting their product and plaintiff SUSAN BRAUN therefore sues
these defendants by such fictitious names and will ask leave of court to amend her
complaint when the same have been disclosed or ascertained.
7) Atall times relevant to their Complaint, defendant Zimmer, Inc. regularly
engaged in business in the State of California.
8. Upon information and belief, at all relevant times, defendant Zimmer, Inc.
was present and transacted, solicited and conducted business in the County of San
Francisco, State of California through its employees, agents, and/or sales
representatives,
9, Atall times material hereto, the defendant Zimmer, Inc. through
defendants ZIMMER FEGAN & MALONEY, INC. and independent contractor sales
representative JAMES PALMER placed the Zimmer Hip System into the stream of
commerce that was implanted in the plaintiff SUSAN BRAUN in the County of San
Francisco, State of California.
10. Defendant Zimmer, Inc. is conclusively presumed to have been doing
business in the State of California and is subject to California's long arm jurisdiction.11, Atall relevant times, defendant Zimmer, Inc. expected or should have
expected that its acts and omissions would have consequences within the State of
California including the County of San Francisco.
12. Defendant ZIMMER FEGAN & MALONEY, INC., a California
Corporation, sold and distributed the Zimmer Hip System in the City of Fremont,
County of San Francisco, and State of California.
13. Defendant JAMES PALMER, a California resident, acted as an
independent contractor sales representative for defendants Zimmer, Inc. and ZIMMER
FEGAN & MALONEY, INC. who sold and distributed the Zimmer Hip System in the
City of Fremont, County of San Francisco, and State of California.
14, Plaintiff SUSAN BRAUN'S damages in their matter accrued in the County
of San Francisco, State of California.
15. The defendant Zimmer, Inc. designed, developed, tested, assembled,
manufactured, compounded, tested, fabricated, analyzed, packaged, labeled, prepared,
recommended, merchandised, advertised, promoted, distributed, marketed, supplied,
and/or sold, and thus placed into the stream of commerce the defective product under
the name Zimmer Hip System, directly or indirectly, to members of the general public
including the plaintiff SUSAN BRAUN, for the purpose of replacing the bones and
joints of hips in people that required total hip replacements and instructed physicians
regarding the advantages of and their method of implanting their product.
16. The defendant ZIMMER FEGAN & MALONEY, INC. distributed,
marketed, supplied, and placed the defective product under name Zimmer Hip System
into the stream of commerce by making sales of such defective product in the County of
San Francisco, State of California through the independent contractor sales
representative defendant JAMES PALMER and instructed physicians regarding the
advantages of and their method of implanting their product.
FIRST AMENDED COMPLAINT ~ 4ne
17, The independent contractor defendant JAMES PALMER distributed,
marketed, and supplied the defective product Zimmer Hip System into the stream of
commerce by making sales of such defective product for defendants Zimmer, Inc, and
ZIMMER FEGAN & MALONEY, INC. when the product was sold to the plaintiff
SUSAN BRAUN in the County of San Francisco and State of California and instructed
physicians regarding the advantages of and their method of implanting their product.
18. The defendant ZIMMER FEGAN & MALONEY, INC. is, and at all times
herein mentioned was, engaged in the business of distributing, supplying, and selling
medical products and specifically the Zimmer Hip System which was to be used for the
purpose of total hip replacements and instructed physicians regarding the advantages
of and their method of implanting their product.
19, The defendant JAMES PALMER is, and at all times herein mentioned was,
engaged in the business of distributing, supplying, and selling medical products as an
independent contractor for the defendants Zimmer, Inc. and ZIMMER FEGAN &
MALONEY, INC. and specifically the Zimmer Hip System which was to be used for the
purpose of total hip replacements and instructed physicians regarding the advantages
of and their method of implanting their product.
20. In June of 2006, defendant Zimmer, Inc. began selling the Zimmer Hip
System in the United States to be used for hip replacement surgeries,
21, At that time defendants Zimmer, Inc. and ZIMMER FEGAN &
MALONEY, INC, began an intensive campaign to promote the use of the Zimmer Hip
System by orthopedic surgeons, including plaintiff SUSAN BRAUN’S orthopedic
surgeon.
22. Defendants Zimmer, Inc. and ZIMMER FEGAN & MALONEY, INC.
subsequently instructed and trained plaintiff SUSAN BRAUN’S orthopedic surgeon in
the use of and implantation of the Zimmer Hip System.
23. Sometime prior to December 8, 2010, defendant Zimmer, Inc.
ED COMPLAINT - 5manufactured the Zimmer Trilogy Acetabular System Shell with Cluster holes,
Reference No. 6200-50-22, Lot No, 60623752, Zimmer Trilogy Acetabular System Liner,
Reference No. 6305-50-32, Lot No. 61580949, Zimmer Bone screw, Reference No. 6250-
66-30, Lot No. 61526231, Zimmer Epoch Fullcoat Hip Prosthesis Femoral Stem,
Reference No, 00-4088-012-06, Lot No, 61498370, Zimmer Versys Hip system Femoral
Head 12/14 Taper, Reference No. 8018-32-03, Lot No, 51542839, in addition to other
Zimmer components, which were subsequently implanted into the bod y of plaintiff
SUSAN BRAUN.
24, The Zimmer Hip System and its component parts were distributed and
sold to the plaintiff SUSAN BRAUN in the City of Fremont by defendant Zimmer, Inc.
through their California distributor defendant ZIMMER FEGAN & MALONEY, INC.
and independent contractor sales representative defendant JAMES PALMER,
25, Using the training and instructions provided by defendants Zimmer Inc.,
ZIMMER FEGAN & MALONEY, INC. and independent contractor sales representative
JAMES PALMER, on December 8, 2010, the Zimmer Hip System was implanted into the
body of the plaintiff SUSAN BRAUN at the Washington Hospital Healthcare System
located in City of Fremont, County of San Francisco, and State of California by John T.
Dearborn, M.D.
26. Atall times during the surgery on December 8, 2010, the defendant
ZIMMER FEGAN & MALONEY, INC, independent contractor sales representative
defendant JAMES PALMER was present to instruct, provide, distribute, and organize
for surgery using the Zimmer Hip System and its component parts.
27, Following the surgery, plaintiff SUSAN BRAUN'S wounds healed withou
infection, x-rays showed the hip replacement to be properly positioned and affixed, and
the hip replacement suffered no unexpected impacts.
FIRST AMENDED ColN
28. Despite these ideal conditions for a hip replacement, following the
surgery, plaintiff SUSAN BRAUN eventually experienced pain and extreme weakness
in her hip and other areas.
29, During their time, defendants Zimmer Inc., ZIMMER FEGAN &
MALONEY, INC. and independent contractor sales representative JAMES PALMER
were aware of a high rate of unexplained failures of the Zimmer Hip System, but did
not provide their information to plaintiff SUSAN BRAUN’S orthopedic surgeon.
30. As a result of defendants Zimmer Inc., ZIMMER FEGAN & MALONEY,
INC. and independent contractor sales representative defendant JAMES PALMER
failing to provide their crucial information to plaintiff SUSAN BRAUN’S orthopedic
surgeon, plaintiff SUSAN BRAUN’S orthopedic surgeon had little reason to suspect that!
the source of plaintiff SUSAN BRAUN’S ongoing pain and weakness was the result of
the failure of the Zimmer Hip System.
31, After the plaintiff SUSAN BRAUN had her hip replacement surgery on
December 8, 2010, the plaintiff SUSAN BRAUN had pain and weakness in her hip and
other areas after the implant surgery.
32, Numerous X-Rays were taken of the plaintiff SUSAN BRAUN'S hip since
December 8, 2010 that showed proper placement of the acetabular component, but the
plaintiff SUSAN BRAUN experienced pain and limitations in the hip after that surgery.
33. On September 13, 2012, the plaintiff, SUSAN BRAUN, underwent a
revision surgery by Michael J. Bellino, M.D. to remove the Zimmer Hip System and
replace it with another components. The procedures were radical excision pseudotumor
left hip and pelvis, decompression femoral nerve, decompression lateral femoral
cutaneous nerve, revision left total hip of femoral head. The post surgical diagnosis was
a loose acetabular component that was removed with a tap, large dense mass below
femoral nerve and iliac vessels, mass encompassed entire psoas as well as a portion of
the iliac, and corrosion around the femoral head and taper
> COMPLAINT - 7to
34, At the time of the revision surgery on September 13, 2012, the plaintiff
SUSAN BRAUN showed no signs of infection and the acetabular component in the
plaintiff SUSAN BRAUN'S left hip was inspected.
35. At the time of the revision surgery on September 13, 2012, milky fluid and
pseudotumor with corrosion was detected that was extremely unusual for a porous-
coated implant that had been in the plaintiff SUSAN BRAUN'S hip for almost two
years
36. The corrosion of the femoral head and taper with pseudotumor is
unusual. In performing the revision surgery, the revising orthopedic surgeon found
that the Zimmer Hip System had catastrophically failed.
37. Since the revision surgery of September 12, 2012 the plaintiff SUSAN
BRAUN has suffered numerous dislocations.
38, Asa direct and proximate result of defendants Zimmer, Inc. and ZIMMER
FEGAN & MALONEY, INC. and JAMES PALMER placing the defective product,
Zimmer Hip System, into the stream of commerce, plaintiff SUSAN BRAUN has
suffered and continues to suffer both injuries and damages within the County of San
Francisco in the State of California, including but not limited to: past, present and future
medical, hospital, monitoring, rehabilitative and pharmaceutical expenses and loss of
earnings and earning capacity.
39, Plaintiff believes that defendant Zimmer, Inc. obtained approval from the
United States Food and Drug Administration (FDA) to market the hip prosthesis of the
Durom acetabular component under 510(k) procedure and not under a pre-market
approval (PMA) procedure.
FIRST CAUSE OF ACTION
(Product Liability - Defective Design)
40. Plaintiff incorporates all of the preceding paragraphs of this Complaint as
if fully set forth herein and further alleges as follows:
AMENDED22
41, Atall times material to this action, ZIMMER was responsible for
designing, developing, manufacturing, testing, packaging, promoting, marketing,
distributing, labeling, and/or selling the Zimmer Hip System.
42. The Zimmer Hip System is defective and unreasonably dangerous to
consumers.
43. The Zimmer Hip System is defective in its design or formulation in that it
is not reasonably fit, suitable, or safe for its intended purpose and/or its foreseeable
risks exceed the benefits associated with its design and formulation,
44, Atall times material to this action, the Zimmer Hip System was expected
to reach, and did reach, consumers in California and throughout the United States,
including the Plaintiff herein, without substantial change in the condition in which it
was sold.
45. Atall times material to this action, the Zimmer Hip System was designed,
developed, manufactured, tested, packaged, promoted, marketed, distributed, labeled,
and/or sold by ZIMMER in a defective and unreasonably dangerous condition at the
time it was placed in the stream of commerce in ways which include, but are not limited
to, one or more of the following particulars:
a. When placed in the stream of commerce, the Zimmer Hip System
contained unreasonably dangerous design defects and was not
reasonably safe as intended to be used, subjecting Plaintiff to risks
that exceeded the benefits of the subject product, including but not
limited to the risks of severe and constant pain and suffering,
swelling, lack of mobility, damage to surrounding tissue and bone
caused by inflammation, metallosis, pseudotumours, bone erosion
and/or the need for additional surgery to repair, remove and/or
replace the Zimmer Hip System, as well as other severe and
personal injuries which are permanent and lasting in nature;
IMPLAINT - 9b. When placed in the stream of commerce, the Zimmer Hip System
was defective in design and formulation, making the use of
Zimmer Hip System more dangerous than an ordinary consumer
would expect, and more dangerous than other risks associated with
other hip replacement systems on the market;
5
The subject product's design defects existed before it left the contro
of ZIMMER;
d. The Zimmer Hip System was insufficiently tested;
e. The Zimmer Hip System caused harmful side effects that
outweighed any potential utility;
f. The Zimmer Hip System was not accompanied by adequate
instructions and/or warnings to fully apprise consumers and their
physicians, including Plaintiff and Plaintiff's physician, of the full
nature and extent of the risks and side effects associated with its
14 use, thereby rendering ZIMMER liable to Plaintiff;
15 g. The Zimmer Hip System sold by ZIMMER was expected to reach,
ie
and did reach physicians and consumers, including Plaintiff and
1? Plaintiff's physician;
18 h The Zimmer Hip System that was implanted into Plaintiff had not
19 been materially altered or modified prior to the implantation of the
device; and
i, Plaintiff was a foreseeable user of the device and the device was
implanted into his for its intended purpose.
46. In addition, at the time the subject product left the control of ZIMMER,
there were practical and feasible alternative designs that would have prevented and/or
significantly reduced the risk of Plaintiff's injuries without impairing the reasonably
anticipated or intended function of the product. These safer alternative designs were
FIRST AMEa
economically and technologically feasible, and would have prevented or significantly
reduced the risk of Plaintiff's injuries without substantially impairing the product's
ulility.
47, Asa direct and proximate result of the failure of the defective Zimmer Hip
System, Plaintiff suffered the injuries and damages as described herein.
SECOND CAUSE OF ACTION
(Product Liability - Manufacturing Defect)
Against All Defendants
48, Plaintiff incorporates all of the preceding paragraphs of this Complaint as
if fully set forth herein and further alleges as follows:
49, Atall times material to this action, ZIMMER was engaged in the business
of designing, developing, manufacturing, testing, packaging, promoting, marketing,
distributing, labeling, and/or selling the Zimmer Hip System.
50, Atall times material to this action, the Zimmer Hip System was expected
to reach, and did reach, consumers in the State of California and throughout the United
States, including Plaintiff herein without substantial change in the condition in which it
was sold.
51. Atall times material to this action, the Zimmer Hip System was designed,
developed, manufactured, tested, packaged, promoted, marketed, distributed, labeled,
and/or sold by ZIMMER in a defective and unreasonably dangerous condition at the
time it was placed in the stream of commerce in ways which include, but are not limited
to, one or more of the following particulars:
a. When placed in the stream of commerce, the Zimmer Hip System
contained manufacturing defects that rendered the product
unreasonably dangerous;
b. The Zimmer Hip System’s manufacturing defects occurred while
the product was in the possession and control of ZIMMER;
) AMENDED COMPLAINT - 1123
c The subject product was not made in accordance with ZIMMER’s
specifications or performance standards; and
d. The Zimmer Hip System’s manufacturing defects existed before it
left the control of ZIMMER.
52, Atall times material hereto, Zimmer Hip System that was designed,
manufactured, promoted, distributed, marketed, and sold by ZIMMER was expected to
reach, and did reach, physicians and consumers, including Plaintiff and Plaintiff's
physician, without substantial change in the condition in which it was sold.
53. Asa direct and proximate result of the failure of the defective Zimmer Hip
System, Plaintiff suffered injuries and damages, as described herein.
THIRD CAUSE OF ACTION
(Product Liability ~ Failure to Warn)
54, Plaintiff incorporates all of the preceding paragraphs of this Complaint as
if fully set forth herein and further alleges as follows:
55. The Zimmer Hip System was defective and unreasonably dangerous
when it left the poss
ion of ZIMMER in that it contained warnings insufficient to alert
physicians and consumers, including Plaintiff and Plaintiff's physician, of the
dangerous risks and reactions associated with the subject product, including but not
limited to its propensity to cause severe and constant pain and suffering, swelling, lack
of mobility, damage to surrounding tissue and bone caused by inflammation,
metallosis, pseudotumours, bone erosion and/or the need for additional surgery to
repair, remove and/or replace the Zimmer Hip System, as well as other severe and
personal injuries which are permanent and lasting in nature
56. Plaintiff was implanted with and used the Zimmer Hip System for its
intended purpose.
57. Plaintiff could not have discovered any defect in the Zimmer Hip System
through the exercise of reasonable care.
ED COMPLAINT 12wm
18
58. ZIMMER, as manufacturer and/or distributor of the subject product, is
held to the level of knowledge of an expert in the field.
59, The warnings that ZIMMER gave were not accurate, complete, clear
and/or were ambiguous.
60. The warnings that ZIMMER gave failed to properly warn physicians of
the increased risks of severe and constant pain and suffering, swelling, lack of mobility,
damage to surrounding tissue and bone caused by inflammation, metallosis,
pseudotumours, bone erosion and/or the need for additional surgery to repair, remove
and/or replace the Zimmer Hip System, as well as other severe and personal injuries
which are permanent and lasting in nature.
61, Plaintiff, individually and through her treating physicians, reasonably
relied upon the skill, superior knowledge and judgment of ZIMMER.
52, ZIMMER had a continuing duty to warn the Plaintiff of the dangers
associated with the Zimmer Hip System.
63, Had Plaintiff received adequate warnings regarding the risks of the
Zimmer Hip System, she would not have used it,
64. Asa direct and proximate result of the failure of the defective Zimmer Hip,
System, Plaintiff suffered the injuries and damages as described herein,
FOURTH CAUSE OF ACTION
(Negligence)
65. Plaintiff incorporates all of the preceding paragraphs of this Complaint as
if fully set forth herein and further alleges as follows:
66. Atal times herein mentioned, ZIMMER had a duty to exercise reasonable
care in the design, manufacture, testing, inspection, labeling, promotion, marketing, and
sale of the Zimmer Hip System to ensure that it would be safely used in a manner and
for a purpose for which it was made.
FIRST AMENoD
67, ZIMMER maliciously, recklessly, and/or negligently failed to exercise
ordinary care in the design, manufacture, testing, inspection, labeling, promotion,
marketing, and sale of the Zimmer Hip System.
68. ZIMMER maliciously, recklessly, and/or negligently made
misrepresentations about the safety and effectiveness of the Zimmer Hip System to
Plaintiff and Plaintiff's orthopedic surgeon. In reliance on these misrepresentations,
Plaintiff's orthopedic surgeon decided to use the Zimmer Hip Implant in Plaintiff's
surgery. But for the misrepresentations made by ZIMMER, Plaintiff's orthopedic
surgeon would not have used the Zimmer Hip System in Plaintiff’s surgery.
69. ZIMMER maliciously, recklessly and/or negligently failed in its duty to
exercise reasonable care in the provisions of an adequate warning to Plaintiff and
Plaintiff's physicians as to the risks of the Zimmer Hip System.
70. ZIMMER maliciously, recklessly and/or negligently failed to exercise
reasonable care in the post-marketing warnings as to the risks of the Zimmer Hip
System when it knew or should have known of said risks.
71, Asa result of ZIMMER’s wrongful conduct, Plaintiff suffered injuries and
damages as alleged herein.
"TH CAUSE OF ACTION
RES IPSA LOQUITUR
72, Plaintiff repeats, re-alleges, and incorporates herein by reference each and
every allegation contained in paragraphs 1 through 50 as set forth in full herein.
73, The character of the failure of the Zimmer Hip System and its Zimmer
component parts was such that it would not ordinarily occur without negligence.
74. The Zimmer Hip System and its Zimmer component parts were under the
custody and control of the defendants.
75, The defendant Zimmer, Inc. was in control of the Zimmer Hip System and
its Zimmer component parts at issue in the lawsuit at the time the negligence occurred,
IDED COMPLAINT = 14so that the reasonable probabilities point to the defendant Zimmer, Inc. and support a
reasonable inference that the defendant Zimmer, Inc. was the negligent party.
76. Defendant Zimmer, Inc. had superior knowledge or means of information
to determine the cause of the incident that is the basis of this lawsuit.
77. By reason of the above and foregoing circumstances, among others, the
jury is permitted to infer the defendant Zimmer Inc.'s negligence.
PRAYER FOR RELIEF
78. | WHEREFORE, Plaintiff demands judgment for the following:
I. Judgment in favor of Plaintiff and against ZIMMER, for damages in
such amounts as may be proven at trial:
2. Compensation for past and future economic and non-economic losses,
including but not limited to medical expenses, loss of earnings,
disfigurement, pain and suffering, mental anguish, and emotional
distress, in such amounts as may be proven at trial;
3, Punitive and/or exemplary damages in such amounts as may be
proven at trial;
4. Restitution and disgorgement of all revenue that ZIMMER has
obtained through the manufacture, marketing, sale and administration
of the Zimmer Hip System;
5. Attorneys’ fees and costs;
6. Pre- and post-judgment interest; and
N
Any and all further relief, both legal and equitable, that the Court may
deem just and proper.
JURY DEMAND
PLAINTIFF HEREIN DEMANDS A TRIAL BY JURY.
DED COMPLAINT 15Dated: August 5, 2015
AMENDED
CSENGERI LAW OF EICES
J
Stéphen sengeri, Esq. SBN 97505
Attorney for Plaintiff
SUSAN BRAUN
COMPLAINT - 16
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Stephen Csengeri, Esq. SBN 97505 Csengeri Law Offices 21250 Hawthorne Boulevard, Suite 500 Torrance, CA 90503 (310) 373-9330 (310) 373-9040 (Fax) Csengeri@Shangri-Law.com Attorney for Plaintiff, SUSAN BRAUN ELECTRONICALI FILED Superior Court of County of San 08/10/201 Clerk of the Cour BY-WILLIAM TRUPEK Deputy Clerk SUPERIOR COURT FOR THE STATE OF CALIFORNIA COUNTY OF SAN FRANCISCO CIVIC CENTER COURTHOUSE SUSAN BRAUN Plaintiff, vs. ZIMMER, INC.; ZIMMER FEGAN & MALONEY, INC.; JAMES PALMER; DOE CORPORATIONS 1 TO 25 INCLUSIVE; AND DOE DEFENDANTS 26 TO 100 INCLUSIVE. Defendants. FIRST AMENDED COMPLAINT FOR DAMAGES CASE NUMBER: CGC-14-541588 COMPLAINT FILED; September 10, 2014 COMPLAINT FOR DAMAGES Plaintiff SUSAN BRAUN sues the defendants ZIMMER, INC.; ZIMMER FEGAN & MALONEY, INC.; JAMES PALMER; DOE CORPORATIONS 1 TO 25 INCLUSIVE; AND DOE DEFENDANTS 26 TO 100 INCLUSIVE and alleges:PARTIES 1. Plaintiff SUSAN BRAUN is a citizen and resident of the State of California. 2. Defendant Zimmer, Inc. is a corporation incorporated in the State of Delaware with its principal place of business in the State of Indiana, which at all times designed, developed, tested, assembled, manufactured, compounded, fabricated, analyzed, packaged, labeled, prepared, recommended, merchandised, advertised, promoted, distributed, marketed, supplied, and/or sold, and thus placed into the stream of commerce the defective products under the name "Zimmer Trilogy ® Acetabular System, Zimmer Epoch ® Fullcoat Hip Prosthesis, and Zimmer Versys ® Hip System" (herein after "Zimmer Hip System’), directly or indirectly, to members of the general public in the State of California, including the plaintiff SUSAN BRAUN, and instructed physicians regarding the advantages of and their method of implanting their product. 3. Defendant ZIMMER FEGAN & MALONEY, INC. is a domestic corporation in the State of California with its principal place of business in the City of San Francisco, County of San Francisco, and State of California who distributed and placed into the stream of commerce the Zimmer Hip System in the State of California through their independent contractor sales representative, defendant JAMES PALMER, and instructed physicians regarding the advantages of and their method of implanting their product. 4, Defendant JAMES PALMER is a resident of the state of California who was an independent contractor who acted as a sales representative of defendant ZIMMER FEGAN & MALONBRY, INC. to distribute and place into the stream of commerce the Zimmer Hip System in the state of California and instructed physicians regarding the advantages of and their method of implanting their product. 5. Doe Corporations, parent corporations and subsidiary corporations of Zimmer, Inc., and ZIMMER FEGAN & MALONEY, INC., or any of them, and FIRST AMENDED COMPLAINT - 2corporations related to said defendants, the true names and capacities of Doe Corporations 1 through 25 (hereinafter, jointly and severally, Doe Corporations), and each of them, are unknown to plaintiff SUSAN BRAUN, who therefore sues these defendants by such fictitious names and will ask leave of court to amend her complaint when the same have been disclosed or ascertained. 6. Doe Defendants 26 through 100, which at all times designed, developed, tested, assembled, manufactured, packaged, labeled, prepared, distributed, marketed, supplied, and/or sold the defective product the Zimmer I lip System, directly or indirectly, to members of the general public in the State of California, including the plaintiff SUSAN BRAUN, and instructed physicians regarding the advantages of and their method of implanting their product and plaintiff SUSAN BRAUN therefore sues these defendants by such fictitious names and will ask leave of court to amend her complaint when the same have been disclosed or ascertained. 7) Atall times relevant to their Complaint, defendant Zimmer, Inc. regularly engaged in business in the State of California. 8. Upon information and belief, at all relevant times, defendant Zimmer, Inc. was present and transacted, solicited and conducted business in the County of San Francisco, State of California through its employees, agents, and/or sales representatives, 9, Atall times material hereto, the defendant Zimmer, Inc. through defendants ZIMMER FEGAN & MALONEY, INC. and independent contractor sales representative JAMES PALMER placed the Zimmer Hip System into the stream of commerce that was implanted in the plaintiff SUSAN BRAUN in the County of San Francisco, State of California. 10. Defendant Zimmer, Inc. is conclusively presumed to have been doing business in the State of California and is subject to California's long arm jurisdiction.11, Atall relevant times, defendant Zimmer, Inc. expected or should have expected that its acts and omissions would have consequences within the State of California including the County of San Francisco. 12. Defendant ZIMMER FEGAN & MALONEY, INC., a California Corporation, sold and distributed the Zimmer Hip System in the City of Fremont, County of San Francisco, and State of California. 13. Defendant JAMES PALMER, a California resident, acted as an independent contractor sales representative for defendants Zimmer, Inc. and ZIMMER FEGAN & MALONEY, INC. who sold and distributed the Zimmer Hip System in the City of Fremont, County of San Francisco, and State of California. 14, Plaintiff SUSAN BRAUN'S damages in their matter accrued in the County of San Francisco, State of California. 15. The defendant Zimmer, Inc. designed, developed, tested, assembled, manufactured, compounded, tested, fabricated, analyzed, packaged, labeled, prepared, recommended, merchandised, advertised, promoted, distributed, marketed, supplied, and/or sold, and thus placed into the stream of commerce the defective product under the name Zimmer Hip System, directly or indirectly, to members of the general public including the plaintiff SUSAN BRAUN, for the purpose of replacing the bones and joints of hips in people that required total hip replacements and instructed physicians regarding the advantages of and their method of implanting their product. 16. The defendant ZIMMER FEGAN & MALONEY, INC. distributed, marketed, supplied, and placed the defective product under name Zimmer Hip System into the stream of commerce by making sales of such defective product in the County of San Francisco, State of California through the independent contractor sales representative defendant JAMES PALMER and instructed physicians regarding the advantages of and their method of implanting their product. FIRST AMENDED COMPLAINT ~ 4ne 17, The independent contractor defendant JAMES PALMER distributed, marketed, and supplied the defective product Zimmer Hip System into the stream of commerce by making sales of such defective product for defendants Zimmer, Inc, and ZIMMER FEGAN & MALONEY, INC. when the product was sold to the plaintiff SUSAN BRAUN in the County of San Francisco and State of California and instructed physicians regarding the advantages of and their method of implanting their product. 18. The defendant ZIMMER FEGAN & MALONEY, INC. is, and at all times herein mentioned was, engaged in the business of distributing, supplying, and selling medical products and specifically the Zimmer Hip System which was to be used for the purpose of total hip replacements and instructed physicians regarding the advantages of and their method of implanting their product. 19, The defendant JAMES PALMER is, and at all times herein mentioned was, engaged in the business of distributing, supplying, and selling medical products as an independent contractor for the defendants Zimmer, Inc. and ZIMMER FEGAN & MALONEY, INC. and specifically the Zimmer Hip System which was to be used for the purpose of total hip replacements and instructed physicians regarding the advantages of and their method of implanting their product. 20. In June of 2006, defendant Zimmer, Inc. began selling the Zimmer Hip System in the United States to be used for hip replacement surgeries, 21, At that time defendants Zimmer, Inc. and ZIMMER FEGAN & MALONEY, INC, began an intensive campaign to promote the use of the Zimmer Hip System by orthopedic surgeons, including plaintiff SUSAN BRAUN’S orthopedic surgeon. 22. Defendants Zimmer, Inc. and ZIMMER FEGAN & MALONEY, INC. subsequently instructed and trained plaintiff SUSAN BRAUN’S orthopedic surgeon in the use of and implantation of the Zimmer Hip System. 23. Sometime prior to December 8, 2010, defendant Zimmer, Inc. ED COMPLAINT - 5manufactured the Zimmer Trilogy Acetabular System Shell with Cluster holes, Reference No. 6200-50-22, Lot No, 60623752, Zimmer Trilogy Acetabular System Liner, Reference No. 6305-50-32, Lot No. 61580949, Zimmer Bone screw, Reference No. 6250- 66-30, Lot No. 61526231, Zimmer Epoch Fullcoat Hip Prosthesis Femoral Stem, Reference No, 00-4088-012-06, Lot No, 61498370, Zimmer Versys Hip system Femoral Head 12/14 Taper, Reference No. 8018-32-03, Lot No, 51542839, in addition to other Zimmer components, which were subsequently implanted into the bod y of plaintiff SUSAN BRAUN. 24, The Zimmer Hip System and its component parts were distributed and sold to the plaintiff SUSAN BRAUN in the City of Fremont by defendant Zimmer, Inc. through their California distributor defendant ZIMMER FEGAN & MALONEY, INC. and independent contractor sales representative defendant JAMES PALMER, 25, Using the training and instructions provided by defendants Zimmer Inc., ZIMMER FEGAN & MALONEY, INC. and independent contractor sales representative JAMES PALMER, on December 8, 2010, the Zimmer Hip System was implanted into the body of the plaintiff SUSAN BRAUN at the Washington Hospital Healthcare System located in City of Fremont, County of San Francisco, and State of California by John T. Dearborn, M.D. 26. Atall times during the surgery on December 8, 2010, the defendant ZIMMER FEGAN & MALONEY, INC, independent contractor sales representative defendant JAMES PALMER was present to instruct, provide, distribute, and organize for surgery using the Zimmer Hip System and its component parts. 27, Following the surgery, plaintiff SUSAN BRAUN'S wounds healed withou infection, x-rays showed the hip replacement to be properly positioned and affixed, and the hip replacement suffered no unexpected impacts. FIRST AMENDED ColN 28. Despite these ideal conditions for a hip replacement, following the surgery, plaintiff SUSAN BRAUN eventually experienced pain and extreme weakness in her hip and other areas. 29, During their time, defendants Zimmer Inc., ZIMMER FEGAN & MALONEY, INC. and independent contractor sales representative JAMES PALMER were aware of a high rate of unexplained failures of the Zimmer Hip System, but did not provide their information to plaintiff SUSAN BRAUN’S orthopedic surgeon. 30. As a result of defendants Zimmer Inc., ZIMMER FEGAN & MALONEY, INC. and independent contractor sales representative defendant JAMES PALMER failing to provide their crucial information to plaintiff SUSAN BRAUN’S orthopedic surgeon, plaintiff SUSAN BRAUN’S orthopedic surgeon had little reason to suspect that! the source of plaintiff SUSAN BRAUN’S ongoing pain and weakness was the result of the failure of the Zimmer Hip System. 31, After the plaintiff SUSAN BRAUN had her hip replacement surgery on December 8, 2010, the plaintiff SUSAN BRAUN had pain and weakness in her hip and other areas after the implant surgery. 32, Numerous X-Rays were taken of the plaintiff SUSAN BRAUN'S hip since December 8, 2010 that showed proper placement of the acetabular component, but the plaintiff SUSAN BRAUN experienced pain and limitations in the hip after that surgery. 33. On September 13, 2012, the plaintiff, SUSAN BRAUN, underwent a revision surgery by Michael J. Bellino, M.D. to remove the Zimmer Hip System and replace it with another components. The procedures were radical excision pseudotumor left hip and pelvis, decompression femoral nerve, decompression lateral femoral cutaneous nerve, revision left total hip of femoral head. The post surgical diagnosis was a loose acetabular component that was removed with a tap, large dense mass below femoral nerve and iliac vessels, mass encompassed entire psoas as well as a portion of the iliac, and corrosion around the femoral head and taper > COMPLAINT - 7to 34, At the time of the revision surgery on September 13, 2012, the plaintiff SUSAN BRAUN showed no signs of infection and the acetabular component in the plaintiff SUSAN BRAUN'S left hip was inspected. 35. At the time of the revision surgery on September 13, 2012, milky fluid and pseudotumor with corrosion was detected that was extremely unusual for a porous- coated implant that had been in the plaintiff SUSAN BRAUN'S hip for almost two years 36. The corrosion of the femoral head and taper with pseudotumor is unusual. In performing the revision surgery, the revising orthopedic surgeon found that the Zimmer Hip System had catastrophically failed. 37. Since the revision surgery of September 12, 2012 the plaintiff SUSAN BRAUN has suffered numerous dislocations. 38, Asa direct and proximate result of defendants Zimmer, Inc. and ZIMMER FEGAN & MALONEY, INC. and JAMES PALMER placing the defective product, Zimmer Hip System, into the stream of commerce, plaintiff SUSAN BRAUN has suffered and continues to suffer both injuries and damages within the County of San Francisco in the State of California, including but not limited to: past, present and future medical, hospital, monitoring, rehabilitative and pharmaceutical expenses and loss of earnings and earning capacity. 39, Plaintiff believes that defendant Zimmer, Inc. obtained approval from the United States Food and Drug Administration (FDA) to market the hip prosthesis of the Durom acetabular component under 510(k) procedure and not under a pre-market approval (PMA) procedure. FIRST CAUSE OF ACTION (Product Liability - Defective Design) 40. Plaintiff incorporates all of the preceding paragraphs of this Complaint as if fully set forth herein and further alleges as follows: AMENDED22 41, Atall times material to this action, ZIMMER was responsible for designing, developing, manufacturing, testing, packaging, promoting, marketing, distributing, labeling, and/or selling the Zimmer Hip System. 42. The Zimmer Hip System is defective and unreasonably dangerous to consumers. 43. The Zimmer Hip System is defective in its design or formulation in that it is not reasonably fit, suitable, or safe for its intended purpose and/or its foreseeable risks exceed the benefits associated with its design and formulation, 44, Atall times material to this action, the Zimmer Hip System was expected to reach, and did reach, consumers in California and throughout the United States, including the Plaintiff herein, without substantial change in the condition in which it was sold. 45. Atall times material to this action, the Zimmer Hip System was designed, developed, manufactured, tested, packaged, promoted, marketed, distributed, labeled, and/or sold by ZIMMER in a defective and unreasonably dangerous condition at the time it was placed in the stream of commerce in ways which include, but are not limited to, one or more of the following particulars: a. When placed in the stream of commerce, the Zimmer Hip System contained unreasonably dangerous design defects and was not reasonably safe as intended to be used, subjecting Plaintiff to risks that exceeded the benefits of the subject product, including but not limited to the risks of severe and constant pain and suffering, swelling, lack of mobility, damage to surrounding tissue and bone caused by inflammation, metallosis, pseudotumours, bone erosion and/or the need for additional surgery to repair, remove and/or replace the Zimmer Hip System, as well as other severe and personal injuries which are permanent and lasting in nature; IMPLAINT - 9b. When placed in the stream of commerce, the Zimmer Hip System was defective in design and formulation, making the use of Zimmer Hip System more dangerous than an ordinary consumer would expect, and more dangerous than other risks associated with other hip replacement systems on the market; 5 The subject product's design defects existed before it left the contro of ZIMMER; d. The Zimmer Hip System was insufficiently tested; e. The Zimmer Hip System caused harmful side effects that outweighed any potential utility; f. The Zimmer Hip System was not accompanied by adequate instructions and/or warnings to fully apprise consumers and their physicians, including Plaintiff and Plaintiff's physician, of the full nature and extent of the risks and side effects associated with its 14 use, thereby rendering ZIMMER liable to Plaintiff; 15 g. The Zimmer Hip System sold by ZIMMER was expected to reach, ie and did reach physicians and consumers, including Plaintiff and 1? Plaintiff's physician; 18 h The Zimmer Hip System that was implanted into Plaintiff had not 19 been materially altered or modified prior to the implantation of the device; and i, Plaintiff was a foreseeable user of the device and the device was implanted into his for its intended purpose. 46. In addition, at the time the subject product left the control of ZIMMER, there were practical and feasible alternative designs that would have prevented and/or significantly reduced the risk of Plaintiff's injuries without impairing the reasonably anticipated or intended function of the product. These safer alternative designs were FIRST AMEa economically and technologically feasible, and would have prevented or significantly reduced the risk of Plaintiff's injuries without substantially impairing the product's ulility. 47, Asa direct and proximate result of the failure of the defective Zimmer Hip System, Plaintiff suffered the injuries and damages as described herein. SECOND CAUSE OF ACTION (Product Liability - Manufacturing Defect) Against All Defendants 48, Plaintiff incorporates all of the preceding paragraphs of this Complaint as if fully set forth herein and further alleges as follows: 49, Atall times material to this action, ZIMMER was engaged in the business of designing, developing, manufacturing, testing, packaging, promoting, marketing, distributing, labeling, and/or selling the Zimmer Hip System. 50, Atall times material to this action, the Zimmer Hip System was expected to reach, and did reach, consumers in the State of California and throughout the United States, including Plaintiff herein without substantial change in the condition in which it was sold. 51. Atall times material to this action, the Zimmer Hip System was designed, developed, manufactured, tested, packaged, promoted, marketed, distributed, labeled, and/or sold by ZIMMER in a defective and unreasonably dangerous condition at the time it was placed in the stream of commerce in ways which include, but are not limited to, one or more of the following particulars: a. When placed in the stream of commerce, the Zimmer Hip System contained manufacturing defects that rendered the product unreasonably dangerous; b. The Zimmer Hip System’s manufacturing defects occurred while the product was in the possession and control of ZIMMER; ) AMENDED COMPLAINT - 1123 c The subject product was not made in accordance with ZIMMER’s specifications or performance standards; and d. The Zimmer Hip System’s manufacturing defects existed before it left the control of ZIMMER. 52, Atall times material hereto, Zimmer Hip System that was designed, manufactured, promoted, distributed, marketed, and sold by ZIMMER was expected to reach, and did reach, physicians and consumers, including Plaintiff and Plaintiff's physician, without substantial change in the condition in which it was sold. 53. Asa direct and proximate result of the failure of the defective Zimmer Hip System, Plaintiff suffered injuries and damages, as described herein. THIRD CAUSE OF ACTION (Product Liability ~ Failure to Warn) 54, Plaintiff incorporates all of the preceding paragraphs of this Complaint as if fully set forth herein and further alleges as follows: 55. The Zimmer Hip System was defective and unreasonably dangerous when it left the poss ion of ZIMMER in that it contained warnings insufficient to alert physicians and consumers, including Plaintiff and Plaintiff's physician, of the dangerous risks and reactions associated with the subject product, including but not limited to its propensity to cause severe and constant pain and suffering, swelling, lack of mobility, damage to surrounding tissue and bone caused by inflammation, metallosis, pseudotumours, bone erosion and/or the need for additional surgery to repair, remove and/or replace the Zimmer Hip System, as well as other severe and personal injuries which are permanent and lasting in nature 56. Plaintiff was implanted with and used the Zimmer Hip System for its intended purpose. 57. Plaintiff could not have discovered any defect in the Zimmer Hip System through the exercise of reasonable care. ED COMPLAINT 12wm 18 58. ZIMMER, as manufacturer and/or distributor of the subject product, is held to the level of knowledge of an expert in the field. 59, The warnings that ZIMMER gave were not accurate, complete, clear and/or were ambiguous. 60. The warnings that ZIMMER gave failed to properly warn physicians of the increased risks of severe and constant pain and suffering, swelling, lack of mobility, damage to surrounding tissue and bone caused by inflammation, metallosis, pseudotumours, bone erosion and/or the need for additional surgery to repair, remove and/or replace the Zimmer Hip System, as well as other severe and personal injuries which are permanent and lasting in nature. 61, Plaintiff, individually and through her treating physicians, reasonably relied upon the skill, superior knowledge and judgment of ZIMMER. 52, ZIMMER had a continuing duty to warn the Plaintiff of the dangers associated with the Zimmer Hip System. 63, Had Plaintiff received adequate warnings regarding the risks of the Zimmer Hip System, she would not have used it, 64. Asa direct and proximate result of the failure of the defective Zimmer Hip, System, Plaintiff suffered the injuries and damages as described herein, FOURTH CAUSE OF ACTION (Negligence) 65. Plaintiff incorporates all of the preceding paragraphs of this Complaint as if fully set forth herein and further alleges as follows: 66. Atal times herein mentioned, ZIMMER had a duty to exercise reasonable care in the design, manufacture, testing, inspection, labeling, promotion, marketing, and sale of the Zimmer Hip System to ensure that it would be safely used in a manner and for a purpose for which it was made. FIRST AMENoD 67, ZIMMER maliciously, recklessly, and/or negligently failed to exercise ordinary care in the design, manufacture, testing, inspection, labeling, promotion, marketing, and sale of the Zimmer Hip System. 68. ZIMMER maliciously, recklessly, and/or negligently made misrepresentations about the safety and effectiveness of the Zimmer Hip System to Plaintiff and Plaintiff's orthopedic surgeon. In reliance on these misrepresentations, Plaintiff's orthopedic surgeon decided to use the Zimmer Hip Implant in Plaintiff's surgery. But for the misrepresentations made by ZIMMER, Plaintiff's orthopedic surgeon would not have used the Zimmer Hip System in Plaintiff’s surgery. 69. ZIMMER maliciously, recklessly and/or negligently failed in its duty to exercise reasonable care in the provisions of an adequate warning to Plaintiff and Plaintiff's physicians as to the risks of the Zimmer Hip System. 70. ZIMMER maliciously, recklessly and/or negligently failed to exercise reasonable care in the post-marketing warnings as to the risks of the Zimmer Hip System when it knew or should have known of said risks. 71, Asa result of ZIMMER’s wrongful conduct, Plaintiff suffered injuries and damages as alleged herein. "TH CAUSE OF ACTION RES IPSA LOQUITUR 72, Plaintiff repeats, re-alleges, and incorporates herein by reference each and every allegation contained in paragraphs 1 through 50 as set forth in full herein. 73, The character of the failure of the Zimmer Hip System and its Zimmer component parts was such that it would not ordinarily occur without negligence. 74. The Zimmer Hip System and its Zimmer component parts were under the custody and control of the defendants. 75, The defendant Zimmer, Inc. was in control of the Zimmer Hip System and its Zimmer component parts at issue in the lawsuit at the time the negligence occurred, IDED COMPLAINT = 14so that the reasonable probabilities point to the defendant Zimmer, Inc. and support a reasonable inference that the defendant Zimmer, Inc. was the negligent party. 76. Defendant Zimmer, Inc. had superior knowledge or means of information to determine the cause of the incident that is the basis of this lawsuit. 77. By reason of the above and foregoing circumstances, among others, the jury is permitted to infer the defendant Zimmer Inc.'s negligence. PRAYER FOR RELIEF 78. | WHEREFORE, Plaintiff demands judgment for the following: I. Judgment in favor of Plaintiff and against ZIMMER, for damages in such amounts as may be proven at trial: 2. Compensation for past and future economic and non-economic losses, including but not limited to medical expenses, loss of earnings, disfigurement, pain and suffering, mental anguish, and emotional distress, in such amounts as may be proven at trial; 3, Punitive and/or exemplary damages in such amounts as may be proven at trial; 4. Restitution and disgorgement of all revenue that ZIMMER has obtained through the manufacture, marketing, sale and administration of the Zimmer Hip System; 5. Attorneys’ fees and costs; 6. Pre- and post-judgment interest; and N Any and all further relief, both legal and equitable, that the Court may deem just and proper. JURY DEMAND PLAINTIFF HEREIN DEMANDS A TRIAL BY JURY. DED COMPLAINT 15Dated: August 5, 2015 AMENDED CSENGERI LAW OF EICES J Stéphen sengeri, Esq. SBN 97505 Attorney for Plaintiff SUSAN BRAUN COMPLAINT - 16