12-18-15 - Niedernhofer Vs DePuy J&J - Wrongful Death PDF

Case 3:15-cv-03905-K Document 1 Filed 12/08/15 Page 1 of 32 PageID 1
UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF TEXAS
DALLAS DIVISION
HEIDI NIEDERNHOFER, individually and as MDL 2244

Trustee for the heirs and next of kin of
KATHLEEN NIEDERNHOFER;
PLAINTIFF, Civil Case No.: ____________
v. Honorable Ed Kinkeade
DEPUY ORTHOPEDICS, INC.; DEPUY COMPLAINT AND DEMAND

PRODUCTS, INC.; DEPUY SYNTHES, FOR JURY TRIAL
INC.; JOHNSON & JOHNSON; JOHNSON
& JOHNSON SERVICES, INC.; and
JOHNSON & JOHNSON INTERNATIONAL;
DEFENDANTS.
COMPLAINT
Plaintiff, Heidi Niedernhofer, individually and as Trustee for the heirs and
next of kin of Kathleen Niedernhofer, by and through her undersigned counsel, for her
Complaint against DePuy Orthopaedics, Inc., DePuy Products, Inc., DePuy Synthes, Inc.,
Johnson & Johnson, Johnson & Johnson Services, Inc., and Johnson & Johnson
International (hereinafter collectively referred to as Defendants), alleges on personal
knowledge as to herself and on information and belief as to all other matters as follows:
PARTIES, JURISDICTION AND VENUE
1. Kathleen Niedernhofer was a resident of St. Paul, Ramsey County,
Minnesota. On or about April 16, 2008 and February 8, 2009, Kathleen Niedernhofer
underwent a right and left total hip arthroplasty procedure and was implanted with DePuy
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Pinnacle MoM Devices. Kathleen Niedernhofer died on May 14, 2014 in Rochester,
Olmsted County, Minnesota as a result of injuries caused by her Pinnacle MoM Devices.
2. Heidi Niedernhofer is a resident of St. Paul, Ramsey County, Minnesota
and has been appointed as Trustee for the Heirs and Next of Kin of Kathleen
Niedernhofer pursuant to Minn. Stat. 573.02.
3. Defendant DePuy Orthopaedics, Inc. is a corporation organized and
existing under the laws of the State of Indiana with its principal place of business located
at 700 Orthopaedics Drive, Warsaw, IN 46581. At all times relevant to this action,
defendant DePuy Orthopaedics, Inc. has conducted business in the State of Minnesota.
4. Defendant DePuy Products, Inc. is a corporation organized and existing
under the laws of the State of Indiana with its principal place of business located at 700
Orthopaedics Drive, Warsaw, IN 46581. At all times relevant to this action, defendant
DePuy Products, Inc. has conducted business in the State of Minnesota.
5. Defendant DePuy Synthes, Inc. is a corporation organized and existing
under the laws of the State of Delaware, with its principal place of business located at 700
Orthopaedics Drive, Warsaw, IN 46581. At all times relevant to this action, defendant
DePuy Synthes, Inc. has conducted business in the State of Minnesota.
6. Defendant Johnson & Johnson is a corporation organized and existing
under the laws of the State of New Jersey, with its principal place of business located at
One Johnson & Johnson, New Brunswick, NJ 08933. Defendant Johnson & Johnson is the
parent company of Defendants DePuy Synthes, Inc., Johnson & Johnson Services, Inc.,
and Johnson & Johnson International. At all times relevant to this action, Defendant
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Johnson & Johnson. has conducted business in the State of Minnesota.
7. Defendant Johnson & Johnson Services, Inc. is a corporation organized and
existing under the laws of the State of New Jersey, with its principal place of business
located at One Johnson & Johnson, New Brunswick, NJ 08933. Defendant Johnson &
Johnson Services, Inc. is a subsidiary of Defendant Johnson & Johnson. At all times
relevant to this action, Defendant Johnson & Johnson Services, Inc. has conducted
business in the State of Minnesota.
8. Defendant Johnson & Johnson International is a corporation organized and
existing under the laws of the State of New Jersey, with its principal place of business
located at One Johnson & Johnson, New Brunswick, NJ 08933. Defendant Johnson &
Johnson International is a subsidiary of Defendant Johnson & Johnson. At all times
relevant to this action, Defendant Johnson & Johnson International has conducted business
in the State of Minnesota.
9. With respect to the allegations in this Complaint and the conduct leading to
Kathleen Niedernhofers injuries, the Defendants acted in concert with one another,
pursuant to a common design, provided substantial assistance and/or encouragement to
the tortious conduct of the others, and participated in their tortious conduct.
10. At all times relevant hereto, Defendants were engaged in the business of
designing, developing, manufacturing, testing, packaging, advertising, promoting,
marketing, distributing, labeling, and/or selling the subject product.
11. At all relevant times, Defendants expected, or should have expected, that
its acts would have consequences within the United States, and in Plaintiffs judicial
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district, in particular.
12. At all times relevant herein, Defendants were the agents of each other,
and in doing the things alleged herein, each Defendant was acting within the course and
scope of its agency, and was subject to, and under the supervision of, its co-defendants.
13. The Court has diversity jurisdiction of the parties pursuant to 28 U.S.C.
1332(a). At least one defendant is a citizen of a different state as the Plaintiff and the
amount in controversy exceeds $75,000.00, exclusive of interest and costs.
14. Venue is proper in this Court under Case Management Order #1, dated
June 29, 2011, permitting direct filing into this Court and for consideration for transfer
into MDL No. 3:11 MD 244 K. But for Case Management Order No. 1, the venue for this
action lies in the United States District Court, District of Minnesota under 13 U.S.C
1391(b).
ALLEGATIONS COMMON TO ALL CLAIMS
15. In this action, Plaintiff seeks compensation for injuries resulting from
implantation in Kathleen Niedernhofer of the defective Pinnacle hip implant device with
a metal-on-metal liner (Pinnacle MoM Device).
16. Defendants designed, manufactured, marketed, and sold the Pinnacle
MoM Device. The Pinnacle MoM Device was designed, developed, marketed, and
sold for human hip joints damaged or diseased due to, inter alia, fracture, osteoarthritis,
rheumatoid arthritis, and avascular necrosis. The Pinnacle MoM Device was
designed and sold to provide pain relief and consistent and smooth range of motion.
Defendants marketed the Pinnacle MoM Device as having significant advantages over
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other hip devices and hip replacement systems. Defendants marketed and described
the Pinnacle MoM Device as "[u]niquely designed to meet the demands of active
patients like you - and help reduce pain" and advertised it with pictures of a young
woman trying on sneakers in an athletic shoe store. Defendants advertised the Pinnacle
MoM Devices as superior devices featuring TrueGlide technology, allowing the body to
create a thin film of lubrication between surfaces, which enables "a more fluid range of
natural motion." Defendants also advertised and sold the Pinnacle MoM Device as
the best surgical option that "[r]ecreates the natural ball-and- socket joint of your hip,
increasing stability and range of motion."
17. Defendants sold approximately 150,000 Pinnacle MoM Devices, each with
the Johnson & Johnson logo on the package. In marketing and advertising the
Pinnacle MoM Devices, Defendants made use of the Johnson & Johnson name and
the familiarity of doctors and the public at large with Johnson & Johnson and its
products. DePuy refers to itself as a Johnson & Johnson Company on letterhead
and logos. When problems became apparent with DePuys ASR hip implant, another
metal-on-metal design, DePuy relied on its status as a Johnson & Johnson Company in
an attempt to restore confidence among surgeons, and to encourage them to use the
Pinnacle MoM Device in place of the ASR hip after it was recalled. All of these
actions were taken with the knowledge, approval and encouragement of Johnson &
Johnson. Johnson & Johnson directly participated in promotional and marketing efforts to
promote the use of metal-on-metal hips in general, and the Pinnacle MoM Device in
particular. Johnson & Johnson personnel approved specific marketing and promotional
messages, approved Defendants marketing of devices, including the Pinnacle MoM

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Device, and directly participated in damage control in the wake of the ASR recall,
including efforts to convince surgeons that the Pinnacle MoM Device was still safe for
use. In addition, Johnson & Johnson specifically undertook to perform certain services
for Defendants that it knew or should have known were necessary for the protection of
patients implanted with Defendants Pinnacle MoM Devices, Johnson & Johnson failed
to exercise reasonable care in performing those services, patients such as Kathleen
Niedernhofer relied on Johnson & Johnsons performance and reputation, and
Johnson & Johnsons performance of those services increased the risk of harm to
patients, including Kathleen Niedernhofer.
18. Defendants have stated in promotional materials that 99.9% of Pinnacle
hip components are still in use today. Plaintiff has learned, however, that over 1,300
adverse reports have been submitted to the U.S. Food and Drug Administration (FDA)
regarding failures or complications of Pinnacle MoM Devices.
19. Despite their marketing of the Pinnacle MoM Device as a safe and
superior device, Defendants were at all relevant times aware that Pinnacle MoM Devices
may result in metallosis, biologic toxicity, and unreasonably high, early failure rates.
Moreover, the Pinnacle MoM Device may result in unsafe release of toxic metal wear
debris and metal ions into hip implant recipients' tissue and bloodstream. At all
relevant times, Defendants were aware that metal particles from Pinnacle MoM Devices
result in metallosis, tissue death, bone erosion, and the development of pseudotumors.
Defendants further were aware that particulate debris from the Pinnacle MoM Devices
can cause severe inflammation, severe pain, tissue and bone loss, and other related
diseases. Finally, Defendants were also aware Pinnacle MoM Device recipients often
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have elevated cobalt and chromium levels greatly exceeding acceptable safety
standards.
20. Kathleen Niedernhofer was implanted with the Pinnacle MoM Device
and suffered substantial injuries and damage, including death.
The Pinnacle MoM Device
21. The Pinnacle hip implant system was developed by Defendants for the
purpose of reconstructing diseased human hip joints from conditions such as
osteoarthritis, rheumatoid arthritis, avascular necrosis (AVN), fracture, and other
degenerative conditions. The hip joint connects the thigh (femur) bone of a patient's
leg to the patient's pelvis. The hip joint is like a ball that fits in a socket. The socket
portion of the hip is called the acetabulum. The femoral head at the top of the femur
bone rotates within the curved surface of the acetabulum.
22. The Pinnacle implant system is made up of four components: the metal
femoral stem, which is inserted inside the femur bone; the metal femoral head (or ball),
which connects to the top of the stem; the metal acetabular cup or shell (socket), which
attaches to the pelvis; and the liner, which sits inside the acetabular cup. The
acetabular cup is made of titanium. The liner may be polyethylene (plastic),
ceramic, or cobalt-chromium metal. The metal femoral head articulates within the
liner. The Pinnacle MoM Device the Pinnacle implant system when used with a
metal liner -- is a metal-on-metal device because both articulating surfaces -- the
femoral head (ball) and acetabular liner (socket) -- are comprised of cobalt-chromium
metal.
Defendants Did Not Seek Premarket Approval from the FDA, and Thus the FDA
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Made No Finding That the Pinnacle MoM Device is Safe or Effective
23. The Pinnacle MoM Device is a Class III medical device. Class III
devices are those that operate to sustain human life, are of substantial importance in
preventing impairment of human health, or pose potentially unreasonable risks to
patients.
24. The Medical Device Amendments to the Food, Drug, and Cosmetics Act
of 1938 ("MDA"), in theory, require Class III medical devices, including the Pinnacle
MoM Device, to undergo premarket approval by the FDA, a process which obligates
the manufacturer to design and implement a clinical investigation and to submit the
results of that investigation to the FDA.
25. Premarket approval is a rigorous process that requires a manufacturer
to submit what is typically a multivolume application that includes, among other
things, full reports of all studies and investigations of the device's safety and
effectiveness that have been published or should reasonably be known to the applicant;
a full statement of the device's components, ingredients, and properties and of the
principle or principles of operation; a full description of the methods used in, and the
facilities and controls used for, the manufacture, processing, and when relevant,
packing and installation of, such device; samples or device components required by the
FDA; and a specimen of the proposed labeling. The Pinnacle Device was developed for
the purpose of reconstructing diseased human hip joints from conditions such as
osteoarthritis, rheumatoid arthritis, avascular necrosis (AVN), fracture, and other
degenerative conditions. This hip joint connects the thigh (femur) bone of a patients leg
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to the patients pelvis. The hip joint is like a ball that fits in a socket. The socket portion of
the hip is called the acetabulum. The femoral head at the top of the femur bone rotates
within the curved surface of the acetabulum.
26. The FDA may grant premarket approval only if it finds that there is
reasonable assurance that the medical device is safe and effective and must weigh
any probable benefit to health from the use of the device against any probable risk
of injury or illness from such use.
27. A medical device on the market prior to the effective date of the
MDA -- a so-called grandfathered device -- is not required to undergo
premarket approval. In addition, a medical device marketed after the MDA's effective
date may bypass the rigorous premarket approval process if the device is substantially
equivalent to a grandfathered pre-MDA device (i.e., a device approved prior to May
28, 1976). This exception to premarket approval is known as the 510(k) process and
simply requires the manufacturer to notify the FDA under 510(k) of the MDA of its
intent to market a device at least 90 days prior to the device's introduction on the market,
and to explain the device's substantial equivalence to a pre-MDA predicate device. The
FDA may then clear the new device for marketing and sale in the United States.
28. Rather than being approved for use by the FDA pursuant to the
rigorous premarket approval process, the Pinnacle metal-on-metal total hip replacement
system was cleared by the FDA on the basis of Defendants' claim that, under 510(k)
of the MDA, it was substantially equivalent to another older metal-on-metal hip
implant device that was sold and implanted prior to the enactment of the MDA in 1976.
29. Accordingly, under the 510(k) process, Defendants were able to market
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the Pinnacle MoM Device with virtually no clinical or non-clinical trials or FDA review
of the implant for safety and effectiveness.
Defendants Did not Adequately Test the Pinnacle MoM Device and They Should
Have Discovered That It Leads to Metallosis and Other Complications Before
Releasing It into the Market
30. Defendants failed adequately to test the Pinnacle MoM Device before
releasing it into the market. Had Defendants properly tested the Pinnacle MoM Device,
they would have discovered the dangers of the device before bringing it to market.
31. Defendants knew or should have known that the Pinnacle MoM
Device results in an unreasonably high percentage of patients developing metallosis,
biologic toxicity, and an early and high failure rate due to the release of metal particles
in the patient's surrounding tissue when the cobalt-chromium metal femoral head
articulates against the cobalt-chromium metal acetabular liner and implant components
corrode inside the body.
32. In other words, implantation of the Pinnacle MoM Device results in the
nearly immediate systemic release of high levels of toxic cobalt-chromium metal wear
particles and metal ions into every hip implant patient's tissue and bloodstream. This
is because cobalt-chromium metal particles are released by friction from the metal
femoral head articulating within the metal liner, in addition to particles and ions being
released by corrosion reactions. The particles and ions then accumulate in the patient's
tissue surrounding the implant giving rise to metallosis, pseudotumors or other conditions.
33. The formation of metallosis, pseudotumors, infection and inflammation
causes severe pain and discomfort, death of surrounding tissue, bone loss and lack of
mobility.
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34. FDA has received more than 1,300 adverse reports regarding problems
associated with or attributed to the Pinnacle MoM Device.
35. Many recipients of the Pinnacle MoM Device are suffering from
elevated levels of chromium and cobalt. Plaintiff further alleges on information and
belief that Defendants are aware that certain recipients of the Pinnacle MoM Device
have significantly elevated levels or chromium and cobalt in amounts many times
higher than acceptable or recommended safety levels.
36. A number of governmental regulatory agencies have recognized and
cautioned against the problems that are caused by metal-on-metal implants such as the
ASR and Pinnacle MoM Device. For instance, the United Kingdoms Medicines and
Healthcare products Regulatory Agency ("MHRA") investigated Defendants' metal-on-
metal total hip replacement system after receiving widespread reports of soft tissue
reactions and tumor growth in thousands of patients who had received these implants.
MHRA has required physicians to establish a system to closely monitor patients known
to have metal-on-metal hips by monitoring the cobalt and chromium ion levels in their
blood and to evaluate them for related soft tissue reactions.
37. Similarly, the Alaska Department of Health recently issued a bulletin
warning of the toxicity of Defendants' metal-on-metal total hip replacement systems.
The State of Alaska, like the MHRA, identified the need for close medical monitoring,
surveillance and treatment of all patients who had received these and similar metal-on-
metal implants.
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Defendants Failed Adequately to Disclose and/or Warn About the Dangers of the
Pinnacle MoM Device.
38. Defendants failed to warn Kathleen Niedernhofer and/or her doctor, the
medical community, and the public at large about the dangers of the Pinnacle MoM
Device.
39. In particular, Defendants failed to warn that metal-on-metal implants,
such as the Pinnacle MoM Device, could experience unusual, premature, or
increased friction and/or wear and tear, and that such wear and tear could damage
surrounding tissues and/or cause premature failure of the implant. Furthermore, toxic
metal wear debris and metal ions could enter the bloodstream and cause life threatening
injuries.
40. Defendants also failed to warn that metal-on-metal implants, such as the
Pinnacle MoM Device, generated unusually high amounts of metal wear debris and
metal ions over time due to the premature and/or increased friction and/or wear and tear
of the device. This debris and ions can spread throughout the surrounding bone and
tissue and cause serious complications and damage, including possible development
of conditions commonly referred to in the medical community as ARMD (adverse
reaction to metal debris), ALTR (adverse local tissue reaction), ALVAL (aseptic
lymphocyte-dominated vasculitis- associated lesion), metallosis, and pseudotumors.
Furthermore, toxic metal wear debris and metal ions can enter the bloodstream and cause
life threatening injuries.
41. Defendants knew or should have known of these risks and dangers, but
failed to disclose them, and, in particular, failed to warn the medical community,
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including Kathleen Niedernhofers doctor, of these risks and dangers.
42. In concealing, and failing to disclose, the risks and dangers of the
Pinnacle MoM Device, Defendants conduct was fraudulent, malicious, oppressive,
willful, and/or so grossly negligent as to indicate a wanton disregard of the rights of others.
43. Kathleen Niedernhofer, and/or her doctor, was not aware of the risks and
dangers of the Pinnacle MoM Device at the time the device was implanted in Kathleen
Niedernhofer.
Defendants Misrepresented the Benefits of the Pinnacle MoM Device
44. Defendants advertised the Pinnacle MoM Device as a superior device
featuring TrueGlide technology, allowing the body to create a thin film of lubrication
between surfaces, which enables a more fluid range of natural motion.
45. This representation was false and/or misleading, and Defendants knew
that it was false and/or misleading because Defendants knew that fluid film
lubrication occurs rarely and is not present during the majority of movements
of the Pinnacle MoM Device.
46. Defendants have stated in promotional materials that 99.9% of Pinnacle
hip components are still in use today.
47. This representation was false and/or misleading, and Defendants knew
that it was false and/or misleading. Defendants knew that the actual survival rate
of the device was lower and knew that the data they cited in support of the 99.9%
statistic did not in fact support that representation.
48. Defendants marketed the Pinnacle MoM Device as especially suitable
for younger and/or more active patients because of the claimed survivability rate of the
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device.
49. In 2013, the FDA announced it would no longer allow Defendants to
market metal-on-metal hip implants, including the Pinnacle MoM Device, under the
grandfather/510(k) method, and would instead require a Pre-market Application for any
such devices. In response, Defendants announced they were discontinuing sales of the
Pinnacle MoM Devices in August of 2013.
50. In misrepresenting the benefits of the Pinnacle MoM Device,
Defendants conduct was fraudulent, malicious, oppressive, willful, and/or so grossly
negligent as to indicate a wanton disregard of the rights of others.
Kathleen Niedernhofer Was Implanted with a Pinnacle MoM Device and as a Result
Has Suffered Injuries, Including Death
51. On or about April 16, 2008, Kathleen Niedernhofer underwent a right
total hip arthroplasty procedure. A Pinnacle MoM Device was implanted in place of her
right hip. On or about February 18, 2009, Kathleen Niedernhofer underwent a left total
hip arthroplasty procedure. A Pinnacle MoM Device was implanted in place of her left
hip. After her surgery, Kathleen Niedernhofer began experiencing pain and
difficulty with her implant. Over time, the known and common problem of corrosion
and friction wear is believed to have caused amounts of toxic cobalt-chromium metal
debris to be released throughout Kathleen Niedernhofers body, including but not limited
to, the tissue surrounding the implant and into her bloodstream. Kathleen Niedernhofer
was eventually diagnosed with cobalt induced cardiomyopathy.
52. Kathleen Niedernhofer had to undergo a revision surgery on May 5, 2014
to remove the Pinnacle MoM Devices and replace them with ceramic on polyethylene
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implants.
53. Kathleen Niedernhofer died on May 14, 2014 as a result of multiple
complications of cobalt cardiotoxicity caused by her Pinnacle MoM Devices.
54. Plaintiff only recently became aware of the causal link between Kathleen
Niedernhofers injuries that she suffered, including her death, and any wrongdoing on
the part of Defendants due to the faulty and defective nature of the Pinnacle MoM
Device and to the failure of Defendants to properly warn Kathleen Niedernhofer and/or
her physicians about the Pinnacle MoM Device's defective and faulty nature. Plaintiff
was unable to make an earlier discovery of the causal link despite reasonable diligence
because of Defendants failure to properly warn Kathleen Niedernhofers physicians
about the Pinnacle MoM Device's defective and faulty nature, and their failure to issue
any recall or take any other proactive action to date with respect to the injuries being
caused to patients that have been implanted with a Pinnacle Device.
55. All of the injuries and complications suffered by Kathleen Niedernhofer
were caused by the defective design, warnings, construction and unreasonably
dangerous character of the Pinnacle MoM Device that was implanted in Kathleen
Niedernhofer, and by the negligence and other wrongful conduct of Defendants. Had
Defendants not concealed the known defects, the early failure rate, the known
complications and the unreasonable risks associated with the use of the Pinnacle MoM
Device, Kathleen Niedernhofer would not have consented to the Pinnacle MoM
Device being used in her total hip arthroplasty surgeries.
56. Plaintiff was unaware of any causal link between the injuries Kathleen
Niedernhofer suffered and any wrongdoing on the part of Defendants due to the faulty
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and defective nature of the Pinnacle MoM Device and due in part to the failures of
Defendants to properly warn Kathleen Niedernhofer, and/or his physicians about the
Pinnacle MoM Device's defective and faulty nature.
57. Kathleen Niedernhofer was harmed as a result of the Defendants
wrongful acts and omissions and Plaintiff files this suite to recover damages, as described
below.
CLAIMS FOR RELIEF
Count 1 - Negligence
58. Plaintiff incorporate by reference all preceding paragraphs as if fully set
forth herein and further allege as follows:
59. Defendants designed, manufactured, marketed, detailed, and advertised,
both to physicians and consumers, the Pinnacle MoM Device.
60. As a result, Defendants had a duty to perform each of these functions
reasonably and with reasonable and due care for the safety and well-being of patients in
whom the devices would be implanted, including Kathleen Niedernhofer. Defendants
failed to reasonably execute these duties.
61. Defendants failed to use reasonable and due care for the safety and well-
being of those in whom the Pinnacle MoM Device would be implanted, including
Kathleen Niedernhofer, and are therefore negligent in the following respects:
a. Negligently designing the Pinnacle MoM Device in a manner which was
dangerous to those individuals who had the device surgically implanted;
b. Designing, manufacturing, producing, creating, and/or promoting the

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Pinnacle MoM Device without adequately, sufficiently, or thoroughly
testing it;
c. Not conducting sufficient testing programs to determine whether or not the
aforesaid Pinnacle MoM Device was safe for use;
d. Defendants herein knew or should have known that the Pinnacle MoM
Device was unsafe and unfit for use by reason of the dangers to its users;
e. Selling the Pinnacle MoM Device without making proper and sufficient
tests to determine the dangers to its users;
f. Negligently failing to adequately and correctly warn Kathleen
Niedernhofer or her attending physician, surgeon, hospitals and/or
healthcare providers of the dangers of the Pinnacle MoM Device;
g. Negligently failing to recall their dangerous and defective Pinnacle MoM
Device at the earliest date that it became known that the device was, in
fact, dangerous and defective;
h. Failing to provide adequate instructions regarding safety precautions to be
observed by surgeons who would reasonably and foreseeably come into
contact with, and more particularly, implant the Pinnacle MoM Device into
their patients.
i. Negligently advertising and recommending the use of the Pinnacle MoM
Device despite the fact that Defendants knew or should have known of its
dangerous propensities;
j. Negligently representing that the Pinnacle MoM Device offered was safe
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for use for its intended purpose, when, in fact, it was unsafe;
k. Negligently representing that the Pinnacle MoM Device offered low wear
and high stability, when, in fact, the opposite was true;
l. Negligently manufacturing the Pinnacle MoM Device in a manner which
was dangerous to those individuals who had it implanted;
m. Negligently producing the Pinnacle MoM Device in a manner which was
dangerous to those individuals who had it implanted;
n. Negligently assembling the Pinnacle MoM Device in a manner which was
dangerous to those individuals who had it implanted;
o. Defendants under-reported, underestimated and downplayed the serious
danger of the Pinnacle MoM Device;
p. Defendants failed to accompany the Pinnacle MoM Device with proper
warnings and instructions for use; and,
q. Defendants failed to conduct adequate testing, including pre-clinical and
clinical testing and post-marketing surveillance to determine the safety of
the Pinnacle MoM Device.
62. Defendants, as manufactures, suppliers and sellers of these medical devices
had superior knowledge and owed a duty of care to their customers and to the patients
themselves, including Kathleen Niedernhofer, in whom the Pinnacle MoM Devices were
implanted.
63. Defendants breached their duty of care. The above conduct demonstrates
Defendants failure to exercise reasonable and appropriate care.
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64. It was foreseeable that this wrongful conduct and omissions would lead to
premature device failure as well as severe, permanent, debilitating injuries to patients,
including causing Kathleen Niedernhofers death.
65. As a direct and proximate result of Defendants negligence, Kathleen
Niedernhofer experienced severe harmful injuries and damages, including, but not limited
to, complete loss of mobility, loss of range of motion, the need for revision surgery to
replace the devices, as well as complications of cobalt cardiotoxicity that led to her death.
Count II Negligence Per Se
66. Plaintiff alleges and incorporates by reference the allegations set forth
above as if set forth herein and further alleges as follows:
67. Defendants had an obligation to not violate the law in the manufacture,
design, testing, assembly, inspection, labeling, packaging, supplying, marketing, selling,
advertising, preparing for use, and warning of the risks and dangers of the Pinnacle MoM
Device.
68. Defendants failed to comply with federal requirements. Specifically, it is
believed that with respect to the Pinnacle MoM Device, Defendants failed to timely report
adverse events; failed to timely conduct failure investigations and analyses; failed to
timely report any and all information concerning product failures and corrections; failed
to timely and fully inform the FDA of unanticipated adverse effects, increased in the
incidence of adverse effects, or Pinnacle MoM Device failures necessitating a labeling,
manufacturing or device modification; failed to conduct necessary design validation; and
sold a misbranded and adulterated product.
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69. As a direct and proximate result of Defendants negligence per se,
Kathleen Niedernhofer experienced severe harmful effects, including, but not limited to,
complete loss of mobility, loss of range of motion, the need for revision surgery to replace
the devices, as well as complications of cobalt cardiotoxicity that led to her death.
Count III Strict Products Liability Defective Design
70. Plaintiff alleges and incorporate by reference the allegations set forth
above as if set forth herein and further allege as follows:
71. This is an action for strict liability based upon design defect against
Defendants.
72. Defendants Pinnacle MoM Device is designed in such a way that when
used as intended, the Pinnacle MoM Device causes serious, permanent, and devastating
damage to patients in who the Pinnacle MoM Device are implanted. The damage and
mechanism of injury have been previously described herein. Defendants acted
unreasonably in its design of the Pinnacle MoM Device in that Defendants failed to adopt
a safer design for the Pinnacle MoM Devices that was practical, feasible, and otherwise a
reasonable alternative design or formulation that would have prevented or substantially
reduced the risk of harm without substantially impairing the usefulness, practicality, or
desirability of the product.
73. The Pinnacle MoM Device does not perform as safely as an ordinary
consumer would expect when used as intended or in a manner reasonably foreseeable to
Defendants.
74. The risks of using the Pinnacle MoM Device outweigh the benefits of
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using the Pinnacle MoM Device.
75. There were numerous safer alternative designs to the Pinnacle MoM
Device which in reasonable probability would have prevented or significantly reduced the
risk of the personal injuries suffered by Kathleen Niedernhofer wherein without
substantially impairing the products utility and such safer alternative designs were
economically and technologically feasible at the time the Pinnacle MoM Device left the
control of Defendants by the application of existing or reasonably achievable scientific
knowledge.
76. As a direct and proximate result of Defendants defectively designed
Pinnacle MoM Device, Kathleen Niedernhofer experienced severe harmful effects,
including, but not limited to, complete loss of mobility, loss of range of motion, the need
for revision surgery to replace the devices, as well as complications of cobalt
cardiotoxicity that led to her death.
Count IV Strict Products Liability Manufacturing Defect
78. This is an action for strict liability based on a manufacturing defect.
79. The Pinnacle MoM Device was designed for implantation into the human
body and to last for fifteen or more years. The Pinnacle MoM Device was also designed
to be compatible with human tissue and bone.
80. The Pinnacle MoM Devices implanted in Kathleen Niedernhofer herein
failed and were removed within a short period of time after the original dates of
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implantation.
81. The Pinnacle MoM Devices implanted in Kathleen Niedernhofer were not
compatible with human tissue and bone. Through a process of wear, fretting and
corrosion, the Pinnacle MoM Devices released heavy metals into Kathleen Niedernhofers
body causing severe and permanent destruction of bone, tissue, and organs that ultimately
led to Kathleen Niedernhofers death. Defendants failed to manufacture the Pinnacle
MoM Device in a manner that prevented wear, fretting and corrosion, and, in fact,
manufactured the product such that it caused wear, fretting and corrosion.
82. Upon information and belief, the Pinnacle MoM Devices implanted in
Kathleen Niedernhofers body contained manufacturing defects.
83. As a direct and proximate result of the Pinnacle MoM Devices
manufacturing defects, Kathleen Niedernhofer experienced severe harmful effects,
including, but not limited to, complete loss of mobility, loss of range of motion, the need
for revision surgery to replace the devices, as well as complications of cobalt
Count V Strict Products Liability Failure to Warn
85. The Pinnacle MoM Devices implanted into Kathleen Niedernhofers body
contained no warnings or, in the alternative, inadequate warnings as to the risks that the
product could cause significant heavy metal toxicity by wear, corrosion, or other means.
86. The warnings that accompanied the Pinnacle MoM Device failed to
22
provide the level of information that an ordinary consumer, including Kathleen
Niedernhofer, would expect when using the implants in a manner reasonably foreseeable
to the Defendants.
87. Moreover, the Pinnacle MoM Device left the Defendants control without
an adequate warning or instruction, and created an unreasonably dangerous condition in
that Defendants, as the seller and manufacturer, knew or in the exercise of ordinary care
should have known that the Pinnacle MoM Device posed a substantial risk of harm.
Alternatively, after the Pinnacle MoM Device left Defendants control, Defendants
became aware of, or in the exercise of ordinary care should have known, that the Pinnacle
MoM Device posed a substantial risk of harm to patients, including Kathleen
Niedernhofer, yet Defendants failed to take reasonable steps to give adequate warning or
instruction or to take other reasonable action under the circumstance.
88. As a direct and proximate result of Defendants failure to warn, Kathleen
Niedernhofer was implanted with Pinnacle MoM Devices and experienced severe harmful
effects, including, but not limited to, complete loss of mobility, loss of range of motion,
the need for revision surgery to replace the devices, as well as complications of cobalt
Count VI Breach of Express Warranty
90. Defendants designed, manufactured, tested, marketed and distributed into
the stream of commerce the Pinnacle MoM Device.
23
91. Defendants expressly warranted that the Pinnacle MoM Device was safe
and effective hip replacement systems.
92. The Pinnacle MoM Device placed into the stream of commerce by
Defendants did not conform to these express representations because they failed early
thereby giving rise to unnecessary physical injury, pain and suffering, debilitation, and the
need for a revision surgery to replace the device with the attendant risks of complications
and death from such further surgery.
93. As a direct and proximate result of Defendants foregoing acts and/or
omissions, Kathleen Niedernhofer was implanted with Pinnacle MoM Devices and
experienced severe harmful effects, including, but not limited to, complete loss of
mobility, loss of range of motion, the need for revision surgery to replace the devices, as
well as complications of cobalt cardiotoxicity that led to her death.
Count VII Breach of Implied Warranties
94. Plaintiffs alleges and incorporates by reference the allegations set forth
95. At all relevant and material times, Defendants manufacture, distributed,
advertised, promoted, and sold the Pinnacle MoM Device.
96. At all relevant times, Defendants intended that the Pinnacle MoM Device
be used in the manner that Kathleen Niedernhofer used the Pinnacle MoM Device, and
Defendants impliedly warranted the Pinnacle MoM Device to be of merchantable quality;
safe and fit for such use, and warranted that the Pinnacle MoM Device was adequately
tested.
24
97. Defendants were aware that consumers, including Kathleen Niedernhofer,
would use the Pinnacle MoM Device as hip implants, which is to say that Kathleen
Niedernhofer was a foreseeable user.
98. Kathleen Niedernhofer was at all relevant time in privity with Defendants.
99. The Pinnacle MoM Device was expected to reach and did in fact reach
consumers, including Kathleen Niedernhofer, without substantial changes in the condition
in which the Pinnacle MoM Device was manufactured and sold by Defendants.
100. Defendants breached various implied warranties with respect to the
Pinnacle MoM Device in the following manner:
a. Defendants represented through their labeling, advertising, marketing
materials, detail persons, seminar presentations, publications, notice
letters, and regulatory submissions that the Pinnacle MoM Device was
safe and fraudulently withheld and concealed information about the
substantial risks of serious injury and/or death associated with using the
Pinnacle MoM Device;
b. Defendants represented that the Pinnacle MoM Device was safe, and/or
safer than other alternative hip implants and fraudulently concealed
information which demonstrated that the Pinnacle MoM Device was not
safer than alternatives available on the market; and
c. Defendants represented that the Pinnacle MoM Device was more
efficacious than other alternative devices and fraudulently concealed
information, regarding the true efficacy of the Pinnacle MoM Device.
25
101. In reliance upon Defendants implied warranties, Kathleen Niedernhofer
used the Pinnacle MoM Device as prescribed and in the foreseeable manner normally
intended, recommended, promoted, and marketed by Defendants.
102. Defendants breached their implied warranties to Kathleen Niedernhofer in
that the Pinnacle MoM Devices were not of merchantable quality, safe and fit for their
intended use, or adequately tested, in violation of Minn. Stat. Ann. 336.2-314 et seq.
omissions, Kathleen Niedernhofer was implanted with Pinnacle MoM Devices and
experienced severe harmful effects, including, but not limited to, complete loss of
mobility, loss of range of motion, need for revision surgery to replace the devices, as well
as complications of cobalt cardiotoxicity that led to her death.
Count VIII Fraudulent Concealment
105. Defendants had a duty to inform Kathleen Niedernhofer of all material
facts about the Pinnacle MoM Device based upon their assumption of that responsibility
be representing to consumers that the Pinnacle MoM Device was a safe and effective hip
replacement systems.
106. Upon information and belief, since 2007/2008, Defendants have had actual
knowledge that the Pinnacle MoM Device could fail early thereby giving rise to
unnecessary pain and suffering, debilitation, and the need for a revision surgery to replace
the device with the attendant risks of complications and death from such further surgery.
26
107. The fact that the Pinnacle MoM Device could fail early thereby giving rise
to unnecessary pain and suffering, debilitation, and the need for a revision surgery to
replace the device with the attendant risks of complications and death from such further
surgery was, and is, a material fact.
108. Defendants failed to disclose this material fact to consumers, including
Kathleen Niedernhofer. Instead, Defendants took affirmative steps to prevent physicians
and consumers from learning of this material fact, while aggressively marketing the
Pinnacle MoM Device as safe and effective hip replacement systems. This concealment
was done with the intent to induce Kathleen Niedernhofer to purchase the Pinnacle MoM
Device so that their physicians could surgically implant the device into Plaintiff.
109. In reliance on Defendants fraudulent concealment of a material fact,
Kathleen Niedernhofer purchased the Pinnacle MoM Devices so that the attending
physicians could surgically implant the device into Kathleen Niedernhofer. Had Kathleen
Niedernhofer known that the Pinnacle MoM Device could fail early thereby giving rise to
unnecessary physical injury, pain and suffering, debilitation, the need for a revision
surgery to replace the device with the attendant risks of complications and death from
such further surgery, and other cobalt related injuries, Kathleen Niedernhofer would not
have purchased or used the Pinnacle Devices.
110. As a result of Defendants unlawful and fraudulent concealment of the
effects of the Pinnacle Devices, the running statute of limitations has been suspended with
respect to claims that the Plaintiff has brought or could bring.
27
omissions, Kathleen Niedernhofer experienced was implanted with Pinnacle MoM
Devices and suffered severe harmful effects, including, but not limited to, complete loss
of mobility, loss of range of motion, revision surgery, the need for revision surgery to
replace the devices, as well as complications of cobalt cardiotoxicity that led to her death.
Count IX Negligent Misrepresentation
113. Defendants made misrepresentations of material facts in the course of their
business, including, but not limited to:
a. That Kathleen Niedernhofers Pinnacle MoM Device was fit for its
intended use;
b. That Kathleen Niedernhofers Pinnacle MoM Device was safe and
effective in the treatment of her medical condition; and
c. That Kathleen Niedernhofers Pinnacle MoM Device would
function as intended when necessary.
114. Defendants omitted to reveal material facts, including, but not limited to:
a. That Kathleen Niedernhofers Pinnacle MoM Device was
defective, such that it would fail to function as intended;
b. That Kathleen Niedernhofers Pinnacle MoM Device presented a
risk of injury and harm in their ordinary and intended use; and
c. That Kathleen Niedernhofers Pinnacle MoM Device was
unreasonably dangerous.
28
115. These representations and/or omissions were false and misleading at the
time they were made.
116. False information about the characteristics and safety of the Pinnacle MoM
Device was supplied by Defendants for the guidance of others.
117. Defendants did not exercise reasonable care or competence in obtaining or
communicating this information, but rather negligently and carelessly made the foregoing
misrepresentations without a basis.
118. Defendants were awarded that they did not possess information on which
to accurately base the foregoing representations and concealed form Kathleen
Niedernhofer that there was no reasonable basis for making said representations herein.
119. When Defendants made the foregoing representations, they knew or should
have known them to be false.
120. When Defendants made the foregoing representations, they intended to
induce Kathleen Niedernhofer and/or her doctor to select the Pinnacle MoM Device for
use in Kathleen Niedernhofers arthroplasty surgery.
121. In reliance upon the foregoing misrepresentations by the Defendants,
Kathleen Niedernhofer was induced to and did subject herself to the use of the Pinnacle
MoM Device. If Kathleen Niedernhofer had known of the true facts, she would not have
taken such action and risk. Kathleen Niedernhofers reliance on Defendants
misrepresentation and omissions was reasonable because said representations were made
by individuals and entities in a position to know the true facts.
122. As a result of the foregoing negligent misrepresentations made by
29
Defendants, Kathleen Niedernhofer and her heirs were injured and damaged, and will
continue to suffer injury, expense and economic loss as previously described.
omissions, Kathleen Niedernhofer suffered injuries which caused her wrongful death.
Count Xx Violation of Minnesota Deceptive Acts and Practices, Unfair Trade

Practices, Consumer Protection, Merchandising Practices and False
Advertising Acts.
125. By reason of the conduct alleged herein, and by inducing consumers and
their physicians to use the Pinnacle MoM Device\ through the use of deception, fraud,
false advertising, false pretenses, misrepresentations, unfair and/or deceptive trade
practices and the concealment and suppression of material facts, including but not
limited to fraudulent statements, concealments and misrepresentations identified herein
and above, Defendants violated the provisions of Minn. Stat. 325F.67, 325F.69,
325D.13, and 325D.44.
126. As a direct and proximate result of Defendants statutory violations,
Kathleen Niedernhofer was implanted with Pinnacle MoM Devices which would not
have occurred had Defendants not used deception, fraud, false advertising, false
pretenses, misrepresentation, unfair and/or deceptive practices and the concealment and
suppression of material facts to induce Kathleen Niedernhofer and her physician to use
the Pinnacle MoM Device.
127. By reason of such violations and pursuant to Minn. Stat. 8.31, subd. 3a,
30
and 325D.44, 325F.67, and 325F.68-70, Plaintiff is entitled to recover all of the
monies paid for the product; to be compensated for the cost of the medical care arising
out of the use of the product; and to recover any and all consequential damages
recoverable under the law including, but not limited to, medical expenses and pain,
suffering, disability and emotional distress. Plaintiff is entitled to see compensatory
damages, attorneys fees, injunctive and equitable relief, and other remedies as
determined by the Court pursuant to Minn. Stat. 8,31, subd. 3a, and 325D.44,
325F.67, and 325F.68-70.
Count XI Wrongful Death
128. Plaintiffs alleges and incorporates by reference the allegations set forth
129. Plaintiff alleges, on information and belief, that the sudden, premature, and
untimely death of Kathleen Niedernhofer was the result of the defective Pinnacle MoM
Devices pursuant to Minn. Stat. 573.02.
130. As alleged throughout this Complaint, and as reincorporated herein,
Plaintiff alleges that Kathleen Niedernhofer would not have received the Pinnacle MoM
Devices but for the intentional and negligent tortious conduct of Defendants; similarly, as
alleged throughout this Complaint and as incorporated herein, Plaintiff alleges the
Defendants are strictly liable for the Kathleen Niedernhofers death and all injuries and
damages flowing from Kathleen Niedernhofers death, for the reasons alleged in this
Complaint.
131. Plaintiff seeks to recover damages for all legally compensable injuries and
31
damages relating to Kathleen Niedernhofers wrongful death.
PRAYER FOR RELIEF
WHEREFORE, Plaintiff seeks judgment in her favor as follows:
1. Compensatory damages in excess of the jurisdictional amount, including,
but not limited to non-economic damages in excess of $75,000.00;
2. Medical expense and other economic damages in an amount to be
determined at trial of this action;
3. Attorneys fees, expenses, and costs of this action; and
4. Such further relief as this Court deems necessary, just, and proper.
JURY DEMAND
Plaintiff hereby requests a trial by jury, pursuant to Rule 38 of the Federal Rules of
Civil Procedure, on all claims and issues so triable.
Dated: December 8, 2015 MESHBESHER & SPENCE, LTD.
By_/s/ Jason P. Johnston__________

Genevieve M. Zimmerman (MN #330292)
Jason P. Johnston (MN #391206)
1616 Park Avenue
Minneapolis, MN 55404
Telephone: (612) 339-9121
Facsimile: (612) 339-9188
gzimmerman@meshbesher.com
jjohnston@meshbesher.com
ATTORNEYS FOR PLAINTIFF
32
JS 44 (Rev. 12/12)
Case 3:15-cv-03905-K Document 1-1 Filed 12/08/15 Page 1 of 1 PageID 33
CIVIL COVER SHEET
The JS 44 civil cover sheet and the information contained herein neither replace nor supplement the filing and service of pleadings or other papers as required by law, except as
provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is required for the use of the Clerk of Court for the
purpose of initiating the civil docket sheet. (SEE INSTRUCTIONS ON NEXT PAGE OF THIS FORM.)
I. (a) PLAINTIFFS DEFENDANTS

HEIDI NIEDERNHOFER, individually and as Trustee for the heirs and DePuy Orthopaedics, Inc., DePuy Products, Inc., Depuy Synthes, Inc.,
next of kin of KATHLEEN NIEDERNHOFER Johnson & Johnson, Johnson & Johnson Services, Inc., and Johnson
& Johnson International
(b) County of Residence of First Listed Plaintiff Ramsey County of Residence of First Listed Defendant Kosciusko
(EXCEPT IN U.S. PLAINTIFF CASES) (IN U.S. PLAINTIFF CASES ONLY)
NOTE: IN LAND CONDEMNATION CASES, USE THE LOCATION OF
THE TRACT OF LAND INVOLVED.
(c) Attorneys (Firm Name, Address, and Telephone Number) Attorneys (If Known)
Genevieve M. Zimmerman, Esq. Jason P. Johnston, Esq.
Meshbesher & Spence, Ltd.
1616 Park Avenue Minneapolis, MN (612) 339-9121
II. BASIS OF JURISDICTION (Place an X in One Box Only) III. CITIZENSHIP OF PRINCIPAL PARTIES (Place an X in One Box for Plaintiff
(For Diversity Cases Only) and One Box for Defendant)
1 U.S. Government 3 Federal Question PTF DEF PTF DEF
Plaintiff (U.S. Government Not a Party) Citizen of This State 1 1 Incorporated or Principal Place 4 4
of Business In This State
2 U.S. Government 4 Diversity Citizen of Another State 2 2 Incorporated and Principal Place 5 5
Defendant (Indicate Citizenship of Parties in Item III) of Business In Another State
Citizen or Subject of a 3 3 Foreign Nation 6 6

Foreign Country
IV. NATURE OF SUIT (Place an X in One Box Only)
CONTRACT TORTS FORFEITURE/PENALTY BANKRUPTCY OTHER STATUTES
110 Insurance PERSONAL INJURY PERSONAL INJURY 625 Drug Related Seizure 422 Appeal 28 USC 158 375 False Claims Act
120 Marine 310 Airplane 365 Personal Injury - of Property 21 USC 881 423 Withdrawal 400 State Reapportionment
130 Miller Act 315 Airplane Product Product Liability 690 Other 28 USC 157 410 Antitrust
140 Negotiable Instrument Liability 367 Health Care/ 430 Banks and Banking
150 Recovery of Overpayment 320 Assault, Libel & Pharmaceutical PROPERTY RIGHTS 450 Commerce
& Enforcement of Judgment Slander Personal Injury 820 Copyrights 460 Deportation
151 Medicare Act 330 Federal Employers Product Liability 830 Patent 470 Racketeer Influenced and
152 Recovery of Defaulted Liability 368 Asbestos Personal 840 Trademark Corrupt Organizations
Student Loans 340 Marine Injury Product 480 Consumer Credit
(Excludes Veterans) 345 Marine Product Liability LABOR SOCIAL SECURITY 490 Cable/Sat TV
153 Recovery of Overpayment Liability PERSONAL PROPERTY 710 Fair Labor Standards 861 HIA (1395ff) 850 Securities/Commodities/
of Veterans Benefits 350 Motor Vehicle 370 Other Fraud Act 862 Black Lung (923) Exchange
160 Stockholders Suits 355 Motor Vehicle 371 Truth in Lending 720 Labor/Management 863 DIWC/DIWW (405(g)) 890 Other Statutory Actions
190 Other Contract Product Liability 380 Other Personal Relations 864 SSID Title XVI 891 Agricultural Acts
195 Contract Product Liability 360 Other Personal Property Damage 740 Railway Labor Act 865 RSI (405(g)) 893 Environmental Matters
196 Franchise Injury 385 Property Damage 751 Family and Medical 895 Freedom of Information
362 Personal Injury - Product Liability Leave Act Act
Medical Malpractice 790 Other Labor Litigation 896 Arbitration
REAL PROPERTY CIVIL RIGHTS PRISONER PETITIONS 791 Employee Retirement FEDERAL TAX SUITS 899 Administrative Procedure
210 Land Condemnation 440 Other Civil Rights Habeas Corpus: Income Security Act 870 Taxes (U.S. Plaintiff Act/Review or Appeal of
220 Foreclosure 441 Voting 463 Alien Detainee or Defendant) Agency Decision
230 Rent Lease & Ejectment 442 Employment 510 Motions to Vacate 871 IRSThird Party 950 Constitutionality of
240 Torts to Land 443 Housing/ Sentence 26 USC 7609 State Statutes
245 Tort Product Liability Accommodations 530 General
290 All Other Real Property 445 Amer. w/Disabilities - 535 Death Penalty IMMIGRATION
Employment Other: 462 Naturalization Application
446 Amer. w/Disabilities - 540 Mandamus & Other 465 Other Immigration
Other 550 Civil Rights Actions
448 Education 555 Prison Condition
560 Civil Detainee -
Conditions of
Confinement
V. ORIGIN (Place an X in One Box Only)
1 Original 2 Removed from 3 Remanded from 4 Reinstated or 5 Transferred from 6 Multidistrict
Proceeding State Court Appellate Court Reopened Another District Litigation
(specify)
Cite the U.S. Civil Statute under which you are filing (Do not cite jurisdictional statutes unless diversity):
28 U.S.C. 1332
VI. CAUSE OF ACTION Brief description of cause:
Health Care/Pharmaceutical Personal Injury Product Liability
VII. REQUESTED IN CHECK IF THIS IS A CLASS ACTION DEMAND $ CHECK YES only if demanded in complaint:
COMPLAINT: UNDER RULE 23, F.R.Cv.P. 75,000.00 JURY DEMAND: Yes No
VIII. RELATED CASE(S)
(See instructions):
IF ANY JUDGE Honorable Ed Kinkeade DOCKET NUMBER 11-md-2244
DATE SIGNATURE OF ATTORNEY OF RECORD
12/08/2015 /s/ Jason P. Johnston
FOR OFFICE USE ONLY
RECEIPT # AMOUNT APPLYING IFP JUDGE MAG. JUDGE
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12-18-15 - Niedernhofer Vs DePuy J&J - Wrongful Death PDF

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12-18-15 - Niedernhofer Vs DePuy J&J - Wrongful Death PDF

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Case 3:15-cv-03905-K Document 1 Filed 12/08/15 Page 1 of 32 PageID 1

UNITED STATES DISTRICT COURT

HEIDI NIEDERNHOFER, individually and as MDL 2244

PLAINTIFF, Civil Case No.: ____________

DEPUY ORTHOPEDICS, INC.; DEPUY COMPLAINT AND DEMAND

International (hereinafter collectively referred to as Defendants), alleges on personal

PARTIES, JURISDICTION AND VENUE

1. Kathleen Niedernhofer was a resident of St. Paul, Ramsey County,

2. Heidi Niedernhofer is a resident of St. Paul, Ramsey County, Minnesota

Niedernhofer pursuant to Minn. Stat. 573.02.

3. Defendant DePuy Orthopaedics, Inc. is a corporation organized and

4. Defendant DePuy Products, Inc. is a corporation organized and existing

DePuy Products, Inc. has conducted business in the State of Minnesota.

5. Defendant DePuy Synthes, Inc. is a corporation organized and existing

DePuy Synthes, Inc. has conducted business in the State of Minnesota.

6. Defendant Johnson & Johnson is a corporation organized and existing

Johnson & Johnson. has conducted business in the State of Minnesota.

7. Defendant Johnson & Johnson Services, Inc. is a corporation organized and

business in the State of Minnesota.

8. Defendant Johnson & Johnson International is a corporation organized and

Johnson International is a subsidiary of Defendant Johnson & Johnson. At all times

in the State of Minnesota.

pursuant to a common design, provided substantial assistance and/or encouragement to

designing, developing, manufacturing, testing, packaging, advertising, promoting,

marketing, distributing, labeling, and/or selling the subject product.

amount in controversy exceeds $75,000.00, exclusive of interest and costs.

ALLEGATIONS COMMON TO ALL CLAIMS

a metal-on-metal liner (Pinnacle MoM Device).

16. Defendants designed, manufactured, marketed, and sold the Pinnacle

increasing stability and range of motion."

products. DePuy refers to itself as a Johnson & Johnson Company on letterhead

messages, approved Defendants marketing of devices, including the Pinnacle MoM

to exercise reasonable care in performing those services, patients such as Kathleen

Niedernhofer relied on Johnson & Johnsons performance and reputation, and

patients, including Kathleen Niedernhofer.

18. Defendants have stated in promotional materials that 99.9% of Pinnacle

regarding failures or complications of Pinnacle MoM Devices.

and suffered substantial injuries and damage, including death.

The Pinnacle MoM Device

purpose of reconstructing diseased human hip joints from conditions such as

osteoarthritis, rheumatoid arthritis, avascular necrosis (AVN), fracture, and other

bone rotates within the curved surface of the acetabulum.

acetabular cup is made of titanium. The liner may be polyethylene (plastic),

metal liner -- is a metal-on-metal device because both articulating surfaces -- the

Made No Finding That the Pinnacle MoM Device is Safe or Effective

preventing impairment of human health, or pose potentially unreasonable risks to

results of that investigation to the FDA.

25. Premarket approval is a rigorous process that requires a manufacturer

to submit what is typically a multivolume application that includes, among other

osteoarthritis, rheumatoid arthritis, avascular necrosis (AVN), fracture, and other

within the curved surface of the acetabulum.

of injury or illness from such use.

MDA -- a so-called grandfathered device -- is not required to undergo

equivalent to a grandfathered pre-MDA device (i.e., a device approved prior to May

of the MDA, it was substantially equivalent to another older metal-on-metal hip

of the implant for safety and effectiveness.

Device results in an unreasonably high percentage of patients developing metallosis,

corrode inside the body.

33. The formation of metallosis, pseudotumors, infection and inflammation

associated with or attributed to the Pinnacle MoM Device.

higher than acceptable or recommended safety levels.

36. A number of governmental regulatory agencies have recognized and

Healthcare products Regulatory Agency ("MHRA") investigated Defendants' metal-on-