`
`UNITED STATES DISTRICT COURT
`MIDDLE DISTRICT OF FLORIDA
`JACKSONVILLE DIVISION
`
`
`
`ROBERT C. HOVEY,
`
`
`Plaintiff,
`
`
`
`
`
`
`
`CASE NO.: 3:22-cv-970
`
`
`
`v.
`
`TRACPATCH HEALTH INC.
`F/K/A CONSENSUS ORTHOPEDICS INC.
`F/K/A HAYES MEDICAL,
`a California corporation.
`
`
`
`
`
`
`
`
`
`
`Defendant.
`
`
`
`
`
`
`
`
`
`COMPLAINT FOR DAMAGES AND DEMAND FOR JURY TRIAL
`
`COMES NOW, Plaintiff, ROBERT C. HOVEY (hereinafter “Plaintiff”), by
`
`and through his undersigned attorneys and files this Complaint against
`
`Defendant, TRACPATCH HEALTH INC. F/K/A CONSENSUS
`
`ORTHOPEDICS INC. F/K/A HAYES MEDICAL (hereinafter “TRACPATCH
`
`HEALTH” or “Defendant”); and alleges as follows:
`
`TABLE OF CONTENTS
`
`INTRODUCTION .................................................................................... 2
`I.
`II. PARTIES, JURISDICTION, AND VENUE ........................................ 4
`III. HIP REPLACEMENT SURGERY ........................................................ 5
`IV. DEFENDANT USED A LOOPHOLE TO MARKET THE
`CONSENSUS HIP SYSTEM ................................................................. 7
`THE DESIGN OF THE CONSENSUS HIP SYSTEM ....................... 9
`
`V.
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`
`
`1
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`
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`Case 3:22-cv-00970 Document 1 Filed 09/07/22 Page 2 of 22 PageID 2
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`VI. PLAINTIFF WAS IMPLANTED WITH THE CONSENSUS HIP
`SYSTEM .................................................................................................. 10
`VII. THE CONSENSUS HIP SYSTEM WITHERED AWAY AND FELL
`APART INSIDE PLAINTIFF’S HIP .................................................. 11
`VIII. PLAINTIFF’S HIP DISLOCATES ..................................................... 14
`IX. DAMAGES .............................................................................................. 14
`X. CAUSES OF ACTION .......................................................................... 15
`XI. PRAYER FOR RELIEF ....................................................................... 22
`
`
`I.
`
`Introduction
`
`
`
`1.
`
`This lawsuit involves causes of action related to a defective hip
`
`replacement system that was designed, researched, developed, tested,
`
`assembled, manufactured, packaged, labeled, prepared, promoted, marketed,
`
`distributed, sold, serviced, and supported by Defendant.
`
`2.
`
`The system at issue in this case is the “Consensus Hip System”
`
`(often referred to as “the Device” in this Complaint).
`
`3.
`
`Defendant marketed the Consensus Hip System as having
`
`advantages over other hip devices and hip replacement systems.
`
`4.
`
`Despite Defendant’s claims of advantages, the Consensus Hip
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`System was defective and unreasonably dangerous because
`
`it
`
`is
`
`unreasonably prone to cause fretting and/or corrosion.
`
`5.
`
`When this problem occurs, it can lead to the release of toxic heavy
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`metal ions and/or wear debris.
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`
`
`2
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`Case 3:22-cv-00970 Document 1 Filed 09/07/22 Page 3 of 22 PageID 3
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`6.
`
`The fretting/corrosion problem with the Consensus Hip System
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`is so severe that components of the Device can wither away until they break
`
`apart inside a patient’s body. This type of fracture is called a “dissociation”
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`(and may also be referred to as “disassociation”).
`
`7.
`
`Defendant is and was aware that the Consensus Hip System
`
`resulted in unreasonably high rates of negative clinical outcomes, including:
`
`a. Dissociation;
`b. Fretting;
`c. Corrosion;
`d. Trunnionosis;
`e. Tissue death; and
`f. Bone death.
`
`Defendant is and was aware that these negative clinical
`
`8.
`
`outcomes:
`
`a. manifest in severe pain and limitations on mobility;
`b. are progressive in nature such that the impact worsens with
`time and exposure;
`c. represent an unreasonable risk of harm to patients;
`d. results in a higher than expected rate of failure necessitating
`additional surgeries to replace failed implants; and
`e. lead to injuries which can persist even beyond the removal of
`the failed implant.
`
`Plaintiff, ROBERT C. HOVEY, was implanted with the
`
`9.
`
`Consensus Hip System and has suffered substantial injuries and damages as
`
`a result.
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`
`
`3
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`Case 3:22-cv-00970 Document 1 Filed 09/07/22 Page 4 of 22 PageID 4
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`10.
`
`As a direct and proximate result of the defects and unreasonable
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`dangers of the Consensus Hip System, Plaintiff suffered extensive injuries,
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`including but not limited to: bodily injury; severe physical pain and suffering;
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`surgeries; rehabilitation; distress; physical impairment; disfigurement;
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`mental anguish; inconvenience; loss of capacity for enjoyment of life; and loss
`
`of mobility.
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`
`
`II. Parties, Jurisdiction, and Venue
`
`11.
`
`At all times relevant to this complaint, Plaintiff, ROBERT C.
`
`HOVEY, was and is a citizen and resident of Jacksonville, Florida.
`
`12.
`
`At all times relevant to this complaint, Defendant, TRACPATCH
`
`HEALTH, is a California Corporation organized and existing under the laws
`
`of state of California with its principal place of business located at 2020 L.
`
`Street, Suite 220, Sacramento, California 95811, and conducts business
`
`throughout the United States, including the State of Florida.
`
`13. Defendant is a California based corporation that was founded in
`
`1992 by Mr. Daniel Hayes, and the company was originally known as Hayes
`
`Medical. In 2008, Defendant changed its name to Consensus Orthopedics
`
`Inc.; and in 2021, Defendant changed its name a third time to its current
`
`name, TRACPATCH HEALTH, INC.
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`
`
`4
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`Case 3:22-cv-00970 Document 1 Filed 09/07/22 Page 5 of 22 PageID 5
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`14.
`
`At all times relevant to this complaint, Defendant designed,
`
`developed, tested, assembled, manufactured, packaged, labeled, prepared,
`
`distributed, marketed, supplied, and sold the Consensus Hip System, either
`
`directly or indirectly, to members of the public throughout the United States,
`
`including in the State of Florida.
`
`15.
`
`This court has subject matter jurisdiction over this action
`
`pursuant to 28 U.S.C. §1332(a) in that there is complete diversity of
`
`citizenship between the parties and the amount in controversy exceeds the
`
`sum of seventy-five thousand dollars ($75,000), exclusive of interests and
`
`costs.
`
`16.
`
`Venue is proper in this district pursuant to 28 U.S.C. 1391, in
`
`that a substantial part of the events giving rise to the claim occurred in this
`
`district, Plaintiff’s injury occurred in this district, and majority of witnesses
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`reside in this district.
`
`
`
`III. Hip Replacement Surgery
`
`17.
`
`A patient’s natural hip joint connects the thigh (femur) bone of
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`his or her leg to the pelvis. The hip joint is characterized as a ball and socket
`
`joint. The socket is the cup shaped portion of the acetabulum into which the
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`femoral head (ball) at the top of the femur bone inserts and articulates. Both
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`
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`5
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`Case 3:22-cv-00970 Document 1 Filed 09/07/22 Page 6 of 22 PageID 6
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`the femoral head and acetabular socket are covered with cartilage forming a
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`natural surface upon which the parts may move freely.
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`18.
`
`In some patients, cartilage can be damaged due to either trauma,
`
`disease, or aging (arthritis). When this occurs, a hip replacement may be
`
`indicated. A total hip replacement utilizes parts manufactured from metal
`
`alloys, plastic, or ceramic to replace a patient’s damaged native anatomy.
`
`19.
`
`A total hip replacement typically consists of four separate
`
`components: (1) a femoral stem, (2) a femoral head, (3) an acetabular liner,
`
`and (4) an acetabular shell. The procedure requires removing the arthritic
`
`femoral head and replacing the patient’s natural anatomy with a femoral
`
`stem upon which a femoral head is impacted. The acetabulum is then
`
`reamed to accommodate the acetabular shell into which, once fixed, the
`
`liner is then placed. Once all the parts are inserted, the ball articulates within
`
`the acetabular liner much like the patient’s natural hip.
`
`20.
`
`The Consensus Hip System was intended to replace Plaintiff’s
`
`damaged or diseased natural anatomy.
`
`21.
`
`The Consensus Hip System is indicated for patients, like
`
`Plaintiff, requiring total hip arthroplasty.
`
`
`
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`
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`6
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`Case 3:22-cv-00970 Document 1 Filed 09/07/22 Page 7 of 22 PageID 7
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`IV. Defendant Used a Loophole to Market the Consensus Hip
`System
`
`22. Defendant received “clearance” from the Food and Drug
`
`
`
`Administration (hereinafter referred to as the “FDA”) to market the
`
`Consensus Hip System in the United States pursuant to Section 510(k) of the
`
`Food, Drug and Cosmetic Act. 1
`
`23.
`
`A medical device cleared under Section 510(k) does not have
`
`to go through any clinical study to gain clearance by the FDA, meaning it
`
`does not have to be tested in a single human being before placed on the
`
`market.
`
`24.
`
`The 510(k) pathway to market is a “grandfather” clause which
`
`allows devices to avoid clinical study and any testing for safety or efficacy.
`
`Instead, it allows devices to be fast-tracked to market within 90 days based
`
`solely on a showing of “substantial equivalence” to any number of multiple
`
`products previously cleared through the same 510(k) pathway, including
`
`products which may have since been abandoned due to safety concerns.
`
`
`1 See, https://www.consensusortho.com/wp-content/uploads/2015/10/K922560_Clearance-
`and-Summary.pdf containing Defendant’s Premarket 510(k) Notification (last accessed
`Aug. 25, 2022).
`
`
`
`7
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`Case 3:22-cv-00970 Document 1 Filed 09/07/22 Page 8 of 22 PageID 8
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`25.
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`This is compared with the “Premarket Approval” pathway which
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`requires stringent laboratory and clinical testing for safety or efficacy prior
`
`to a product being marketed.
`
`26.
`
`"Because of this loophole, companies that market these devices
`
`are often legally able to obtain clearance without demonstrating safety and
`
`effectiveness through clinical studies, but by claiming substantial
`
`equivalence to earlier “predicate devices” - or pieces of those devices - which
`
`may also have been found substantially equivalent to even earlier devices,
`
`and so on, all the way back to preamendment devices. Because many
`
`predicates have never been assessed for safety and effectiveness, an FDA
`
`finding of substantial equivalence does not mean that a new device is safe
`
`and effective; it means only that the device is deemed no less safe and no less
`
`effective than a predicate.” 2
`
`27. Defendant knew or should have known that the 510(k) pathway
`
`did not adequately assess the safety or efficacy of the Consensus Hip System.
`
`Despite this, Defendant used the 510(k) “grandfather clause” loophole to fast
`
`track the Consensus Hip System to market without adequate testing.
`
`
`2 Ardaugh, BM, et al. The 510(k) Ancestry of a Metal-on-Metal Hip Implant. N Engl. J.
`Med. 2013; 97-100.
`
`
`
`
`
`
`8
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`Case 3:22-cv-00970 Document 1 Filed 09/07/22 Page 9 of 22 PageID 9
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`28. Had Defendant conducted reasonable pre-market testing for
`
`safety and efficacy on the Consensus Hip System, Defendant would have
`
`known of the Device's unreasonable propensity to harm patients, consistent
`
`with the harm Plaintiff experienced.
`
`
`
`V.
`
`The Design of the Consensus Hip System
`
`29.
`
`The Consensus Hip System is a hip prosthesis that Defendant
`
`asserts is compatible with previously cleared cobalt-chrome/cobalt chromium
`
`(CoCr) heads, zirconia heads, unipolar heads, bipolar heads, ultra-high-
`
`molecular-weight-polyethylene (UHMWPE) inserts and acetabular cups. It is
`
`designed for total or partial hip arthroplasty and is intended to be used with
`
`compatible components for impaired joints.
`
`30.
`
`The flawed design of the Consensus Hip System caused Plaintiff’s
`
`hip to experience fretting and corrosion of the trunnion. This is the area of
`
`the implant in which the femoral head and femoral stem connect. This
`
`process led to heavy metal poisoning. Ultimately, the fretting and corrosion
`
`process wore completely through, shearing off at the top of the trunnion. This
`
`“dissociation” left Plaintiff with no skeletal connection between his torso and
`
`his leg.
`
`31.
`
`The Consensus Hip System’s femoral head is available in metal
`
`as a Cobalt Chrome alloy, or in ceramic as a Biolox delta or Zirconia variant.
`
`
`
`9
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`Case 3:22-cv-00970 Document 1 Filed 09/07/22 Page 10 of 22 PageID 10
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`32.
`
`The Device’s acetabular component consists of a metal shell made
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`of a titanium alloy and an insert made of polyethylene plastic.
`
`33.
`
`The Device’s femoral stem is made from a metal cobalt chrome
`
`alloy or titanium alloy.
`
`34. Defendant knew or should have known that the poor design and
`
`material choices of the Defendant’s Consensus Hip System would lead to
`
`micro-motion, fretting, corrosion and ultimately the total failure of the
`
`implant.
`
`35.
`
`This process can result in so much material wearing off of the
`
`area where the head and stem connect that the femoral head can actually
`
`fall off the femoral stem, a phenomenon described in medical literature as
`
`catastrophic dissociation. This is exactly what occurred in Plaintiff’s case.
`
`
`
`VI. Plaintiff was Implanted with the Consensus Hip System
`
`36. On or about November 9, 2010, Plaintiff underwent a right total
`
`hip arthroplasty at Baptist Medical Center in Jacksonville, Florida, by
`
`Steven J. Lancaster, M.D.
`
`37. During this surgery, Dr. Lancaster implanted Plaintiff with the
`
`Consensus Hip System, consisting of the following components:
`
`a. Hayes Medical, Inc. Acetabular Shell, Flared Rim with Holes, PC
`Ti; Size 58mm; Ref 1708-0-0058; Lot 271182A
`
`10
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`
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`
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`Case 3:22-cv-00970 Document 1 Filed 09/07/22 Page 11 of 22 PageID 11
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`b. Consensus Hip System Acetabular Insert, 10° Hood, X-Link PE;
`Size 36mm x 58mm; Ref 1008-0-3658; Lot 750196 2014-10
`
`c. Consensus Hip System Femoral Stem, Collarless, Ti, PC; Size 14;
`Lot 473630 2014-12; Ref 1610-3-0014
`
`d. Consensus Hip System Femoral Head, 36mm (+5mm); Ref 0007-
`1-3603; Lot 740320
`
`38.
`
`Plaintiff recovered from the surgery and utilized the implant in
`
`
`
`
`
`
`
`a reasonably foreseeable manner.
`
`39.
`
`Post Plaintiff’s surgery, he did not experience any symptoms with
`
`the implant which would lead to any concern about any failure of the Device.
`
`40. Over the ensuing years since the implant and unbeknownst to
`
`Plaintiff, however, fretting and corrosion began to take place, causing the
`
`Device’s trunnion to weaken and to release toxic metal ions and particles into
`
`Plaintiff’s body.
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`41.
`
`At the time Defendant sold the Consensus Hip to Plaintiff,
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`Defendant knew or should have known the defects in the Device resulted in
`
`an unreasonable risk that it would cause severe and unusual fretting,
`
`corrosion, and toxic metal release, leading to a catastrophic failure.
`
`VII. The Consensus Hip System Withered Away and Fell Apart
`Inside Plaintiff’s Hip
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`11
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`Case 3:22-cv-00970 Document 1 Filed 09/07/22 Page 12 of 22 PageID 12
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`42. On or about November 30, 2021, Plaintiff was at Admira
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`Dentistry in Jacksonville, Florida, sitting in a chair waiting to be seen by his
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`dentist.
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`43. While seated, suddenly and without warning, Plaintiff began
`
`experiencing excruciating pain in the right hip.
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`44.
`
`Plaintiff was unable to move his right leg and he was unable to
`
`get up from the chair.
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`45.
`
`Jacksonville Fire and Rescue was immediately called to the
`
`scene, and they transported Plaintiff to Baptist Medical Center in
`
`Jacksonville, Florida.
`
`46. While at Baptist Medical Center, medical personnel examined
`
`Plaintiff and discovered a dissociated right femoral head from the femoral
`
`stem.
`
`47.
`
`This means that Plaintiff’s Consensus Hip System had fallen
`
`apart in his body, severing any skeletal connection between his hip and his
`
`leg.
`
`48.
`
`This was the first notice to Plaintiff that the Consensus Hip
`
`System had failed.
`
`49.
`
`Plaintiff was forced to wait days in the above-described condition
`
`before medical providers could perform revision surgery.
`
`
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`12
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`Case 3:22-cv-00970 Document 1 Filed 09/07/22 Page 13 of 22 PageID 13
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`50.
`
`As a result of the catastrophic failure, the Consensus Hip System
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`had to be completely removed from Plaintiff’s body.
`
`51. On or about December 1, 2021, Plaintiff underwent revision
`
`surgery of the right hip at Baptist Medical Center, in Jacksonville, Florida,
`
`by Brett P. Frykberg, M.D.
`
`52. During the revision surgery, Dr. Frykberg made note of,
`
`“significant metal staining and metallosis throughout the entirety of the
`
`hip…we removed all necrotic tissue using rongeurs. The hip was already
`
`disassociated with the cobalt-chrome femoral head and the acetabular
`
`component. The femoral stem had sheared off the top portion of the trunnion,
`
`likely over time, and had a large notch on the neck of the femoral stem. As
`
`we expected, the femoral stem would have had to have been removed to fix
`
`this problem.”
`
`53.
`
`After Plaintiff’s complex revision surgery, he began the recovery
`
`process.
`
`54.
`
`Plaintiff was prescribed medication for pain relief, he was
`
`instructed to place ice over his right hip to help with pain and inflammation,
`
`and he was instructed to attend physical therapy.
`
`55.
`
`Plaintiff followed the instructions given by his medical providers
`
`and began the long road to recovery.
`
`
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`13
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`Case 3:22-cv-00970 Document 1 Filed 09/07/22 Page 14 of 22 PageID 14
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`
`
`VIII. Plaintiff’s Hip Dislocates
`
`56.
`
`The damage and trauma caused by the defects in Defendant’s
`
`implant, and the surgery necessitated by the dissociation, left Plaintiff’s hip
`
`in a weakened condition and prone to horrific and excruciatingly painful
`
`dislocations.
`
`57. On March 7, 2022, Plaintiff was getting up from a chair when his
`
`right hip suddenly dislocated.
`
`58.
`
`EMS were called to the scene, and Plaintiff was taken to the
`
`nearest hospital for care.
`
`59.
`
`At the hospital, medical personnel took x-rays, and they
`
`discovered that Plaintiff’s right hip had dislocated.
`
`60. Medical personnel performed a closed reduction and put
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`Plaintiff’s femoral head back into the socket.
`
`
`
`IX. Damages
`
`61. Defendant’s conduct and defective product, as described above,
`
`was the direct and proximate cause of Plaintiff’s injuries.
`
`62.
`
`Plaintiff was forced to endure incredible pain and lack of mobility
`
`due to the traumatic nature of the catastrophic dissociation and dislocation,
`
`as well as the invasive and damaging nature of the surgeries required to treat
`
`the failed Device in Plaintiff’s right hip.
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`
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`14
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`Case 3:22-cv-00970 Document 1 Filed 09/07/22 Page 15 of 22 PageID 15
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`63.
`
`As a direct and proximate result of the defective Device, Plaintiff
`
`was required to undergo surgical removal of the Device, a post-revision
`
`dislocation, and now has a hip replacement with decreased longevity.
`
`64.
`
`As a direct and proximate result of the defective Device, Plaintiff
`
`suffered injuries including but not limited to significant pain, tissue
`
`destruction, bone destruction, metal wear, toxic heavy metal poisoning, and
`
`decreased mobility.
`
`65.
`
`As a direct and proximate result of the defective Device, Plaintiff
`
`expects to continue suffering such injuries in the future.
`
`66.
`
`As a direct and proximate result of the defective Device, Plaintiff
`
`incurred medical expenses and expects to incur additional medical expenses
`
`in the future.
`
`67.
`
`As a direct and proximate result of the defective Device, Plaintiff
`
`experienced emotional trauma, distress, and is likely to experience emotional
`
`trauma and distress in the future.
`
`X. Causes of Action
`
`COUNT ONE -- Strict Liability Failure to Warn
`
`68.
`
`Plaintiff re-alleges and incorporates by reference all paragraphs
`
`
`
`in Section IX above as if fully stated herein.
`
`
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`15
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`Case 3:22-cv-00970 Document 1 Filed 09/07/22 Page 16 of 22 PageID 16
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`69.
`
`At all times relevant to this action, while Defendant engaged in
`
`the business of designing, developing, promoting, manufacturing, selling,
`
`marketing, and placing into the stream of commerce the Consensus Hip
`
`System, the Device contained defects that made it unreasonably dangerous
`
`beyond the expectations of the ordinary consumer, such as Plaintiff, and the
`
`Device was unfit for its intended use.
`
`70.
`
`The Consensus Hip System reached Plaintiff without substantial
`
`change in the condition in which it was designed, developed, promoted,
`
`manufactured, and sold.
`
`71.
`
`At the time and on the occasions in question, the Consensus Hip
`
`System was being properly used for the purpose for which it was intended,
`
`and such device was in fact defective, unsafe, and unreasonably dangerous.
`
`72.
`
`The foreseeable risk of harm from the defects in the Consensus
`
`Hip System could have been reduced or avoided by providing adequate
`
`instructions or warnings.
`
`73.
`
`At all times relevant to the action, the dangerous propensities of
`
`the Consensus Hip System were known to Defendant or were reasonably and
`
`scientifically available to them through appropriate research and testing by
`
`known methods, at the time they distributed, supplied, or sold their
`
`respective product, and not known to the ordinary consumers.
`
`
`
`16
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`Case 3:22-cv-00970 Document 1 Filed 09/07/22 Page 17 of 22 PageID 17
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`74.
`
`The Consensus Hip System was defective and unreasonably
`
`dangerous in that labeling was insufficient to warn users of the hazardous
`
`conditions posed by said items, including but not limited to its propensity to
`
`cause permanent tissue and muscle death associated to release of heavy
`
`metal ions.
`
`75.
`
`The Consensus Hip System was defective due to inadequate, or
`
`the absence of, warnings or instructions, including warning stickers,
`
`placards, or proper documentation to alert users regarding the hazards posed
`
`by the Consensus Hip System.
`
`76.
`
` Defendant has a duty to warn, including a continuing post-sale
`
`duty to warn, regarding the unreasonable risk of harm associated with the
`
`Consensus Hip System, particularly due to the progressive nature of the risk
`
`of the toxic heavy metal poisoning.
`
`77. Defendant failed to exercise reasonable care to inform Plaintiff,
`
`Plaintiff’s doctors, and the medical community about the dangers regarding
`
`the Consensus Hip System.
`
`78.
`
`As a direct and proximate result of the lack of reasonable and
`
`adequate instructions or warnings regarding the defects in the Consensus
`
`Hip System, Plaintiff suffered the injuries described in Section IX above.
`
`
`
`
`17
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`Case 3:22-cv-00970 Document 1 Filed 09/07/22 Page 18 of 22 PageID 18
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`COUNT TWO -- Strict Liability Design and Manufacturing Defect
`
`Plaintiff re-alleges and incorporates by reference all paragraphs
`
`79.
`
`in Section IX above as if fully stated herein.
`
`80.
`
`At the time Defendant designed, manufactured, promoted,
`
`marketed, sold, supplied, distributed and/or serviced the Consensus Hip
`
`System, the Device contained defects that made the product unreasonably
`
`dangerous beyond the expectations of the ordinary consumer, and were unfit
`
`for their intended use.
`
`81. Under a Risk-Utility Analysis, the likelihood that the product
`
`would cause Plaintiff’s harm or similar harms, and the seriousness of those
`
`harms, outweighed the Defendant’s burden to design a product that would
`
`have prevented those harms and the adverse effect that an alternative design
`
`that was practical and feasible would have on the usefulness of the product.
`
`82. Under a Consumer Expectation Analysis, the product was more
`
`dangerous than the ordinary consumer would reasonably expect, considering
`
`relevant factors, such as the product’s intrinsic nature, relative cost, severity
`
`of potential harm (including death), and the cost and feasibility of minimizing
`
`such risk.
`
`83.
`
`The Consensus Hip System reached Plaintiff without substantial
`
`change in the condition in which it was sold.
`
`
`
`18
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`Case 3:22-cv-00970 Document 1 Filed 09/07/22 Page 19 of 22 PageID 19
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`84.
`
`At the time and on the occasion in question, the Consensus Hip
`
`System was being properly used for the purpose for which it was intended,
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`and such product was in fact defective, unsafe, and unreasonably dangerous.
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`85.
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`As a direct and proximate result of the defects in the Consensus
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`Hip System, Plaintiff suffered the injuries described in Section IX as
`
`described above.
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`
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`COUNT THREE – Negligence
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`86.
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`Plaintiff re-alleges and incorporates by reference all paragraphs
`
`in Section IX above as if fully stated herein.
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`87. Defendant designed,
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`tested, manufactured, distributed,
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`advertised, sold, marketed, and serviced the Consensus Hip System for
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`implantation into consumers such as Plaintiff.
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`88. Defendant was negligent and careless in the design, testing,
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`manufacture, distribution, advertising, sale, marketing, and service of the
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`Consensus Hip System.
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`89. Defendant had a duty to perform adequate evaluation on the
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`safety and efficacy of the Consensus Hip System. This included by reasonably
`
`gathering information regarding complaints and revisions and conducting
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`adequate analysis on the information gathered.
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`
`
`19
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`Case 3:22-cv-00970 Document 1 Filed 09/07/22 Page 20 of 22 PageID 20
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`90. Defendant further had a duty to share the results of its
`
`evaluation so that Plaintiff, Plaintiff’s orthopedic surgeons, and the
`
`orthopedic community could be adequately apprised of the risks of the Device.
`
`91. Defendant failed to adequately evaluate the safety and efficacy
`
`of the Consensus Hip System.
`
`92. Defendant failed to adequately share the results of its
`
`evaluations of the Consensus Hip System with Plaintiff, Plaintiff’s orthopedic
`
`surgeons, or the orthopedic community.
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`93. Defendant’s failure to discharge their duties were a direct and
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`proximate cause of Plaintiff’s injuries described in Section IX as described
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`above.
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`
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`COUNT FOUR – Breach of Warranty
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`94. Defendant expressly and
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`impliedly warranted that the
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`Consensus Hip System reasonably fit for its intended purpose as a hip
`
`replacement.
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`95.
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`The warranties regarding the Consensus Hip System included,
`
`without limitation:
`
` a.
`
` b.
`
`That the Device restores the original anatomic position of
`the femoral shaft to the acetabulum;
`That the Device restores hip function;
`
`
`
`20
`
`
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`Case 3:22-cv-00970 Document 1 Filed 09/07/22 Page 21 of 22 PageID 21
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` c.
`
` d.
`
` e.
`
` f.
`
`That the Device is designed to transmit load to the femur
`during daily activities including, but not limited to walking,
`stair climbing, and chair ascent;
`That the Device is designed to minimize stress shielding at
`the bone implant interface when compared with CoCr;
`That the Device is intended to reduce wear of the natural
`acetabular cartilage;
`That the Device was clinically proven.
`
`96. Defendant issued these warranties to develop and promote the
`
`
`
`sale of its product through its distribution chain.
`
`97.
`
`As a Florida resident, Plaintiff was a reasonably foreseeable user
`
`of the product, and was a beneficiary of all warranties made by Defendant.
`
`98. Defendant’s warranties regarding product related to material
`
`facts regarding the safety and efficacy of the consensus Hip System.
`
`99. Defendant’s warranties were part of the basis of the bargain for
`
`Plaintiff’s purchase of the product.
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`100. Defendant’s warranties were untrue. The Consensus Hip System
`
`did not conform to the representations that were made.
`
`101. As a direct and proximate result of the breach of Defendant’s
`
`warranties, Plaintiff suffered the injuries described in Section IX as described
`
`above.
`
`
`
`21
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`Case 3:22-cv-00970 Document 1 Filed 09/07/22 Page 22 of 22 PageID 22
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`
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`XI. Prayer for Relief
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`WHEREFORE, the Plaintiff respectfully requests judgment against
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`Defendant, TRACPATCH HEALTH, and requests that the Court:
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`(a) Award damages in an amount to be proven at a jury trial;
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`(b) Award reasonable attorney’s fees and costs;
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`(c) Award such other relief as the Court deems just and proper under
`
`the circumstances of this case.
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`DEMAND FOR JURY TRIAL
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`Plaintiff hereby demands a trial by jury on all claims in this lawsuit.
`
`
`DATED: September 7, 2022
`
`Respectfully submitted,
`
`
`
`_______________________________
`Ilyas Sayeg, Esq., FL Bar No: 99140
`Tamara J. Williams, Esq., FL Bar No: 127625
`mctlaw
`1605 Main Street, Suite 710
`Sarasota, FL 34236
`Phone: 888-952-5242
`Fax: 941-952-5042
`Email: isayeg@mctlaw.com
`Email: twilliams@mctlaw.com
`Secondary email: abrooks@mctlaw.com
`Secondary email: lwilliams@mctlaw.com
`Attorneys for Plaintiff
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`22
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