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Biomet Hip Replacement Lawsuit

Metal on Metal Hip Replacement Update

The Saunders & Walker Analysis of the Official FDA Action of May 6, 2011 Ordering Investigation of Metal on Metal Hip Replacements is Provided Below.

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ABOUT FDA’S RECENT 522 ORDERS On May 6, 2011 FDA issued 145 orders for postmarket surveillance (PS) studies regarding metal-on-metal hip systems.

  • What is postmarket surveillance?

Postmarket surveillance means the active, systematic, scientifically valid collection, analysis and interpretation of data or other information about a marketed device to identify potential safety or effectiveness issues.

  • What devices can be cited in a 522 order?

Section 522 of the Food Drug and Cosmetic Act empowers FDA to order post-market studies for Class II and III products that are life-sustaining or life-supporting; are implanted in the body for more than a year; have significant use in pediatric populations; or whose failure would likely lead to serious health consequences.

  • What prompts the FDA to issue a 522 order?

Put simply, postmarket surveillance addresses an important unanswered question about a marketed medical device. Historically FDA has not enforced active PS requirements, but the agency has signaled this practice will change. In this case, FDA seeks to better understand metal-on-metal hip systems and their safety profiles, including information related to adverse events that may be associated with increased levels of cobalt and chromium in the bloodstream resulting from device wear.

  • Why metal-on-metal hip systems?

Though Class III devices, metal-on-metal total hip systems gained entry to the marketplace via the less rigorous 510k process . With less clinical data requirements, problems are more likely to emerge after such “grandfathered” devices have been cleared to market. Case reports in the medical literature have suggested the potential for systemic effects of elevated metal ion levels, including cardiomyopathy, thyroid dysfunction, and neurological changes. Also, metal-on-metal hip systems meet the criteria for PS under section 522 because they are class III devices intended to be implanted in the body for more than one year; and, FDA adds, that the failure of these hip systems “would be reasonably likely to cause pain, dislocation, or device loosening, leading to revision (any secondary surgical procedure), which would meet the definition of ‘serious adverse health consequences.’”

  • Does FDA define the postmarket surveillance plan?

Although ordered by FDA, PS plans are developed by industry, but are subject to FDA approval. However, FDA has listed the questions that manufacturers must address in their PS plans:

  1. What are the adverse events observed in patients with Metal-on-Metal (MoM) total hip replacement (THR) systems seen within patients included in your study? What are the rates of expected (included in labeling) and unexpected adverse events with MoM THR? Do these rates vary across time since initial implant?
  2. What are the baseline serum and whole blood levels of chromium, and serum or whole blood levels of cobalt in patients prior to THR? What are the patient population’s average levels of chromium in serum and whole blood and cobalt in serum or whole blood for each year for a minimum of eight years (or length of time on market) post-implant? Do these average levels increase over a minimum of the first eight years (or length of time on market) post-implant?
  • What are the reasons for revision? What are the patient population’s average levels of chromium in serum and whole blood and cobalt in serum or whole blood at the time of revision? Is there a statistically significant difference in these levels among patients who have revisions compared with those who do not? Is there a difference in these levels at the time of initial THR compared with the levels at the time of revision?
  • Among patients who do not have a revision, what is the incidence of pain or functional symptoms? Is there a difference in chromium or cobalt levels among patients who have pain, functional symptoms or adverse events compared with those who do not exhibit these symptoms?
  • Among patients who do not have a revision, what is the incidence of adverse local tissue reaction as measured by patient physical examination and imaging? Is there a difference in chromium or cobalt levels among patients who have an adverse local tissue reaction compared with those who do not? What proportion of patients with an adverse local tissue reaction have a revision within one year?
  • How do differences in revisions, pain or functional symptoms, and adverse local tissue reactions vary across the time since initial implant?

3. What demographics or patient selection criteria are associated with higher metal ion concentrations? What demographics or patient selection criteria are associated with higher risk of revision?

4. What are the modes and causes of failure based on analysis of all of your reasonably available explanted retrieved devices?

What happens after the manufacturer receives the 522 order?

  • The device manufacturer has 30 days to submit the PS plan, and the FDA has 60 days to review the plan. An FDA order for a Section 522 study carries substantial force. Unlike with PMA post-approval studies, failure to complete a 522 study constitutes device misbranding, and can result in civil money penalties, product seizure or prosecution.
  • Who received 522 orders regarding metal-on-metal hip systems? FDA sent 145 orders to several companies. Many devices date back to the early ’80s and are no longer marketed. Some of the companies no longer market hip prosthesis, while others have been acquired or dissolved.

The entities include: Advanced Bioresearch Association, a regulatory affairs firm consulting with medical device and pharmaceutical companies American Ortomed Corporation, now dissolved Biomet Inc., makers of the M2a-Magnum™ System Large Metal Articulation (Total MOM Hip) and ReCap (Resurfacing Femoral Head , not MOM system), and others no longer marketed C.R. Bard Inc., no current MOM system DePuy Orthopaedics, Inc., a Johnson & Johnson company, makers of ASR (Total Hip, Resurfacing, Recalled); Pinnacle Metal-on-Metal (Total Hip with Ultamet Insert), and others no longer marketed. Downs Surgical Ltd., no current MOM system Encore Medical, now DJO Surgical, makers of metal-on-metal liners for use with FMP acetabular system, and others no longer marketed Endomedics, Inc., no current MOM system Implantology Corporation, no current MOM system Joint Medical Products Corporation, acquired by Johnson & Johnson April 1, 1995 Link America, Inc., no current MOM system Med-Tek Corporation, no current MOM system Orthopaedic Device Corporation, no current MOM system Orthopaedic Manufacturing Company, no current MOM system Osteotechnology, Inc., no current MOM system Pfizer, Inc., no current MOM system Stryker Orthopaedics for Howmedica Osteonics Corp., markets the Cormet Resurfacing System in the US; MITCH PER Mini Hip (resurfacing, not marketed in US) and others no longer marketed Synergy Orthopaedics Intl., Inc., no current MOM system Techmedica, Inc., no current MOM system Turnkey Intergration USA, Inc., no current MOM system Waldemar Link GMBH & Co. KG, no current MOM system Wright Medical Technology, Inc., DYNASTY® Acetabular Cup System with A-CLASS® Metal-on-Metal; Conserve (Partial Resurfacing); Conserve Plus (Total Resurfacing) and others no longer marketed

Zimmer Spine, Inc., (Zimmer), Durom/Metasul (Total Hip, Recalled) and others no longer marketed

What are the revision rates for currently marketed metal-on-metal systems?

The Australian Orthopaedic Association Joint Replacement Registry reports revision rates for the following metal-on-metal systems with femoral head sizes greater than 32 mm: DePuy ASR: 7.8 at five years (total hip, recalled in US) DePuy Pinnacle with Ultamet metal insert (total hip): 3.5 (with Articul/Eze head) and 3.8 (with S-Rom head) at five years Smith & Nephew Birmingham Hip with BHR and R3, resurfacing: 4.9 at five years (with BHR head) at five years and 2.4 (with R3 head) at one year ESKA Bionik (resurfacing, not sold in US): 8.0 at three years Corin Medical Cormet, resurfacing: 7.1 at five years IO International Orthopaedics ICON (total hip and resurfacing, not sold in US): 6.5 at three years Biomet M2a with M2a liner (total hip) or Recap (resurfacing): 4.0 (with M2a liner) at three years and 2.2 (with Recap) at three years Zimmer Durom (total hip, recalled in US): 4.6 at five years Stryker Mitch TRH (resurfacing, not marketed in US): 1.5 at one year

Data were not reported for the following systems: Metal/Metal CoCr acetabular liners and femoral heads, and FMP™ acetabular system with metal-on-metal liners, by DJO Surgical, formerly Encore Orthopedics ADEPT (resurfacing) by Finsburgy Orthopaedics Ltd., UK CONSERVE (partial resurfacing) and CONSERVE PLUS (total resurfacing) by Wright Medical Technology

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IN THE UNITED STATES DISTRICT COURT

MIDDLE DISTRICT OF FLORIDA

TAMPA DIVISION

DARRYL RICHARDS and JANET
RICHARDS, his wife,Plaintiffs,
vs.BIOMET ORTHOPEDICS, LLC and BIOMET, INC.,

Defendants.
____________________________________/

Civil Action No. __________JURY TRIAL DEMANDED

C O M P L A I N T

Plaintiffs, DARRYL RICHARDS and JANET RICHARDS, by their undersigned attorney, sue the Defendants, DIOMET ORTHOPEDICS, LLC and BIOMET, INC. and allege:

  1. NATURE OF THE ACTION

  1. This action arises from injuries sustained by the Plaintiff, DARRYL RICHARDS, as the result of being implanted with a defective metal-on-metal Biomet M2a Magnum Metal-on-Metal Hip System into his left hip, which was designed, manufactured, marketed and sold by the Defendants or their predecessors.
  2. Although the metal-on-metal M2a Magnum Hip System (hereinafter referred to as the “Hip System” or “Device”) has not been recalled, there have been numerous adverse event reports regarding failure or complications and resulting injury associated with the Device.
  1. JURISDICTION AND VENUE

  1. This Court has jurisdiction over this action pursuant to 28 U.S.C. §1332 because the amount in controversy exceeds the sum of $75,000.00 exclusive of interest and costs and because Plaintiffs are citizens of the State of Florida and Defendants are citizens of the State of Indiana, creating complete diversity.
  2. Pursuant to 28 U.S.C. 1391, venue is proper in the Middle District of Florida in that a substantial portion of the events tiving rise to this action occurred in Pinellas County, Florida, which is located within this District.
  1. THE PARTIES

  1. At all times material to this cause, Plaintiffs, DARRYL RICHARDS and JANET RICHARDS were and are residents of Pinellas County, Florida.
  2. At all relevant times, Defendant, BIOMET ORTHOPEDICS, LLC was a limited liability Indiana corporation with its primary place of business at 56 East Bell Drive, Warsaw, Indiana 36582 and was a subsidiary of Biomet, Inc.  Biomet Orthopedics, LLC is registered to do business in the State of Florida and has substantial contacts with the State of Florida.
  3. At all relevant times, Biomet Orthopedics LLC designed, manufactured, marketed, promoted, sold and introduced into interstate commerce, either directly or indirectly, the M2a Magnum Hip System that is the subject of this lawsuit.
  4. At all relevant times, BIOMET, INC. was an Indiana corporation with its principal place of business at 56 East Bell Drive, Warsaw, Indiana 36582.  Biomet, Inc. is registered to do business in the State of Florida and has substantial contacts with the State of Florida.
  5. At all relevant times, Defendant, Biomet, Inc. designed, manufactured, tested, labeled, marketed, promoted, sold and introduced into interstate commerce, either directly or indirectly, the M2a Magnum Hip System that is the subject of this lawsuit.
  6. At all relevant times, Biomet Orthopedics, LLC and Biomet, Inc. (hereinafter referred to collectively as “Biomet”) were representatives, agents, employees, joint venturers, or alter egos of one another and, for purposes of this lawsuit, acted within the scope of one another’s authority.  Specifically, each Defendant was but an instrumentality or conduit of the other in the prosecution of a single venture, namely the design, manufacture, promotion and sale of the M2a Magnum Hip System. Therefore, it would be inequitable for either Defendant to escape liability for any obligation of the other.
  1. GENERAL ALLEGATIONS

  1. Nature and purpose of the Device
  1. The Biomet M2a Magnum Hip System was developed for uncemented use in a total hip joint replacement.  In a healthy hip, 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 into 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.
  2. The metal-on-metal M2a Magnum System includes a femoral head (or ball) that is fitted into a metal acetabular cup.  This device is known as a “metal-on-metal” system due to the fact that both articulating surfaces, i.e. the acetabular (socket) liner and femoral head (ball) – are comprised of cobalt-chromium metal.
  1. Although Defendants’ Hip System was a Class III Device, it was cleared for marketing as a Class II Device without premarket approval.
  1. In 1976, the Medical Devices Amendment was passed, pursuant to which the FDA classified medical devices into three categories.  A Class I category device poses almost no safety issues.  A Class II category device poses moderate safety issues.  A Class III device operates to sustain human life, is of substantial importance in preventing impairment of human health, or poses potentially unreasonable risks of harm to patients.
  2. Generally, Class III devices must undergo the PreMarket Approval (PMA) process to be marketed in the United States.  Premarket Approval is a rigorous process that requires a manufacturer to submit what is typically a multivolume application that includes, among other things, extensive clinical data to support the  device’s safety and effectiveness; a full statement of the device’s components, ingredients, and properties, and of the principles of operation; a full description of the methods used in, and the facilities and controls used for, the design, 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.  When undergoing Premarket Approval, a Class III device may not use an existing device as a predicate, but rather the safety and effectiveness of the device must be independently shown.
  3. 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.
  4. The use of metal-on-metal hip joint replacement devices predates the Medical Device Amendments (MDA) of 1976.  Metal-on-metal devices were formally classified into Class III on September 4, 1987.  However, because these Class III devices predate the MDA, and because the FDA has neither called for a PMA nor down-classified these devices, metal-on-metal hip systems bypassed the rigorous scrutiny of the PreMarket Approval Process.  Instead, they were and are “grandfathered in” and cleared for market through demonstrating substantial equivalence to other “predicate” metal-on-metal systems already on the market.  This is the PreMarket Notification or 510(k) process by which a Class II, a less risky device, is cleared for market.
  5. The metal-on-metal M2a Magnum Device which is the subject of this lawsuit is a Class III medical device; however, it received clearance from the FDA through the 510(k) process generally reserved for Class II devices, which only requires a showing of substantial equivalence to a device already on the market.  In obtaining clearance for marketing of the M2a Magnum Device, Biomet bypassed the PreMarket Approval (PMA) process altogether.
  6. Biomet applied for market clearance of its first metal-on-metal acetabular system on February 18, 2000 (Premarket Notification K993438), based upon substantial equivalence to four devices.   Three of the four devices were components manufactured by Biomet and were used in metal/polymer systems, not metal-on-metal systems.  The fourth predicate device, which was by Sulzer Orthopedics, was also not an exclusively metal-on-metal system, in that is included a plastic liner with a metal inlay.  Although the Sulzer metal head interfaced with the metal inlay,  Sulzer incorporated plastic in the shell liner, designed to dampen the load against the acetabulum.
  7. Subsequent premarket notifications cleared additions and modifications to this device, including different shell/liner locking mechanisms, metal alloys, and sizes.
  8. The premarket notification for the M2a Acetabular System, submitted March 30, 2001 (K011110), introduced a one-piece cobalt chrome (CoCr) acetabular component with no liner.  Substantial equivalence was based on earlier M2a systems, the DePuy Pinnacle Metal-on-Metal Acetabular System, and a first generation metal-on-metal device, the McKee Farrar, a grandfathered Pre-Amendment Device known for early failures due to acetabular loosening.
  9. On July 28, 2004, Biomet applied for market clearance of the M2a Magnum System (K042037), the Device at issue in this Complaint, based, in part, upon substantial equivalence to the M2a Acetabular System cleared via K011110, as well as two Wright Medical Technology one-piece CoCrMo acetabular shells.  That 510K states that mechanical testing was performed to establish substantial equivalence to the predicate device, but no clinical testing was used.  However, based upon substantial equivalence to predicate devices, clearance by the FDA for the M2a Magnum System was received on October 1, 2004.
  1. Defendants knew or should have known that its metal-on-mental Hip System would lead to metallosis and other complications, but failed to subject the Device to clinical testing prior to releasing it on the market.
  1. While many hip replacements use an acetabular liner that fits inside the acetabular cup, Biomet’s M2z Magnum Hip System does not.  Instead, the System fits a metal femoral head directly into a one-piece metal acetabular cup, forcing metal-on-metal articulation with the full weight and pressure of the human body.   This causes prosthesis-derived metal wear debris to be generated by mechanical wear, surface corrosion or a combination of both, in both particle and soluble forms.  Corrosion products predominantly consist of metal oxides and hydroxides within the synovial fluid and peri-prosthetic tissues.   Inside the hip joint, the metal reaction often causes fluids to accumulate and soft tissues and bone to die.  If the metal fragments travel through the bloodstream, the patient can suffer systemic symptoms, such as extreme fatigue, headaches, and other chronic ailments.
  2. In 1996, Jonathan Black, Ph.D., an industry consultant and Clemson professor emeritus of bioengineering who specialized in production and biological sequelae of wear debris, warned in a medical journal article that metal-on-metal designs posed significant risks because little was known about the biological havoc that metallic debris might cause.  Dr. Black also argued that, given the high success rate of existing designs, it would be statistically impossible to run enough studies to prove the new implants’ supposed superiority.
  3. In the November 1, 2001 issue of The Journal of Bone and Joint Surgery, Issue 83, S68-72,  Dr. Seth Greenwald and Dr. Jonathan Garino, echoed Dr. Black’s fear regarding the longer-term concern about metal particle and ion generation, citing increased chromium concentrations at the time of long-term follow-up of McKee-Farrar implant patients.
  4. In 2003, the British Journal of Bone and Joint Surgery reported the work of Clarke, Lee, Arora and Villar who found that large diameter metal on metal bearing result in a greater systemic exposure of cobalt and chromium ions.
  5. In its July 2005 issue, The Journal of Bone and Joint Surgery published the results of a study that retrospectively analyzed 165 patients (169 hips) who had undergone primary cementless total hip replacement with a contemporary metal-on-metal total hip design between 2000 and 2002.  The findings of the study raised the fear that early osteolysis in patients with this second-generation metal-on-metal hip replacement is associated with abnormalities consistent with delayed-type hypersensitivity to metal.
  6. Had Defendants heeded Dr. Black’s warning and the warnings published thereafter, and closely monitored the performance of second generation metal-on-metal systems and the post-market experience of the metal-on-metal M2a Magnum Hip System, they would have discovered that the Device results in a high percentage of patients developing metallosis, biologic toxicity and an early and high failure rate due to the release of metal particles in the patients’ surrounding tissue when the cobalt-chromium metal femoral head rotates with the cobalt-chromium metal acetabular liner.
  7. The formation of metallosis, pseudotumors, and infection and inflammation causes severe pain and discomfort, death of surrounding tissue and bone loss, and lack of mobility.  It further makes revision surgery exponentially more difficult to perform.
  8. At all relevant times, Defendants were aware that the metal-on-metal M2a Magnum System posed an unreasonably high risk of developing metallosis, biologic toxicity, and total hip failure, and Defendants were aware that the Device resulted in unsafe release of toxic metal ions into the tissues and bloodstream of the hip implant recipients.
  9. Long before Plaintiff was implanted with his M2a Magnum System, the Biomet Defendants were on actual notice of metallosis issues that required revision surgery with both the M2a System and the M2a Magnum System as reflected by Adverse Event Reports (AER’s) submitted to the FDA.  Those AER’s included, but were not limited to, metallosis of adjacent tissue noted during explant surgery in 2004; multiple effusions noted in January, 2005; metallosis noted during revision surgery in January, 2006; metal debris found during revision surgery in December, 2007; and increased metal ion levels discovered during revision surgery in February, 2008.
  10. Despite public knowledge to the contrary, Defendants have misrepresented, and continue to misrepresent the metal-on-metal M2a System not only as a high-quality, safe and effective hip replacement product, but as highly superior to other metal-on-metal hips on the market.
  11. For example, Biomet published marketing brochures touting the safety and durability of the M2a Magnum Hip System, claiming that it was superior to other more safe hip implants on the market, stating:

• “The M2a-MagnumTM Large Metal Articulation System offers optimal joint mechanic restoration and ultra low-wear rates in vivo.

• Many studies conducted over the last several decades have shown no definitive correlation of negative health issues to ion levels exhibited from metal-on-metal implants.”

  1. These brochures were given to doctors around the world, including Plaintiffs orthopedic surgeon, to encourage them to use the M2a Magnum Hip System.
  2. Further, Biomet represented as recently as December, 2011 in the Journal of Arthoplasty:

“Well designed metal-on-metal (MoM) hips are good options for many patients.  However, design features in certain MoM components have led to increased failure rates.  Biomet’s 2a-Magnum System delivers a clinically proven, unique design that has shown a statistically significant lower revision rate than other MoM implants.

M2a-Magnum System

  • Lowest cobalt ion levels in a peer-reviewed, head-to-head study of four MoM implant designs;

  • Over 98% median reported survivorship at three years;

  • In over 10,000 cases, revision rate is less than 2.5%;

  • Similar revision rate to metal-on-poly in the Australian and New Zealand NJR (2.6% and 2.9%)

  • Statistically significant lower revision rate than other MoM constructs in the New Zealand NJR (3.9%)”

  1. Defendants continue to sell the M2a Magnum Hip System to doctors who implant them in countless numbers of patients with an unreasonably high percentage of those patients being forced to endure serious injury from metallosis, pseudotumors, and biologic toxicity, revision surgery and other complications.
  1. Federal Requirements
  1. Pursuant to federal law, a device is deemed to be adulterated if, among other things, it fails to meet established performance standards, or if the methods, facilities or controls used for its manufacture, packaging, storage or installation are not in conformity with federal requirements.  See 21 U.S.C. 351.
  2. Pursuant to federal law, a device is deemed to be misbranded if, among other things, its labeling is false or misleading in any particular manner, or if it is dangerous to health when used in the manner prescribed, recommended or suggested in the labeling thereof.  See 21 U.S.C. 352.
  3. Pursuant to federal regulation, manufacturers must comply with specific quality system requirements promulgated by the FDA.  These regulations require manufacturers to meet design control requirements, including but not limited to, conducting design validation to ensure that devices conform to defined user needs and intended uses.  Manufacturers must also meet quality standards in manufacture and production.  Manufacturers must establish and maintain procedures for implementing corrective actions and preventative actions, and investigate the cause of nonconforming products and take corrective action to prevent recurrence.  Manufacturers are also required to review and evaluate all complaints and determine whether an investigation is necessary and are required to use statistical techniques where necessary to evaluate product performance.  See 21 CFR 820.
  4. The regulations requiring conformance to good manufacturing practices are set forth in 21 CFR 820 et seq.  as explained in the Federal Register, because the Current Good Manufacturing Practice (CGMP) regulations must apply to a variety of medical devices, the regulations do not prescribe the details for how a manufacturer must produce a device.  Rather, the quality system regulations provide a framework of basic requirements for each manufacturer to use in establishing a quality system appropriate to the devices designed and manufactured, and the manufacturing processes employed.  Manufacturers must adopt current and effective methods and procedures for each device they design and manufacture to comply with, and implement, the basic requirements set forth in the quality system regulations.
  5. Pursuant to 21 CFR 820.1(c), the failure to comply with any of these provisions in Part 820 renders a device adulterated under section 501(h) of the Federal Food, Drug & Cosmetic Act (“the Act”)(21 U.S.C. 351).
  6. Defendants’ metal-on-metal M2a Magnum System is adulterated pursuant to 21 U.S.C. 351 because, among other things, it failed to meet established performance standards, in that it caused severe injuries to recipients of the Device, including metallosis, pseudo-tumors, osteomyelitis, loosening of the components, and other conditions, which often required premature, painful revision surgery.
  7. In addition, Defendants’ metal-on-metal M2a Magnum System is misbranded because, among other things, it causes severe injuries to the recipients of the Device when used in the manner prescribed, recommended or suggested in the labeling thereof.  See 21 U.S.C. 352.
  1. Plaintiff’s M2a Magnum Implant and Injuries
  1. On or about April 17, 2008, Plaintiff, DARRYL RICHARDS, underwent a left total hip replacement at Bayfront Medical Center in St. Petersburg, Florida by Charles A. Finn, MD.  At that time, Plaintiff was implanted with a Biomet metal-on-metal M2a Magnum Cup, Reference number US157858,  Lot number 195520; a Biomet M2A modular head, Reference number 157452, Lot number 999380; a Biomet Mallory femoral head, Reference number 11-104113, Lot number 537690; and a Biomet M2A Magnum Taper Adapter, Reference number 139264, Lot number 946420.
  2. Following surgery, Plaintiff’s wounds healed without infection, and x-rays showed the hip replacement to be properly positioned and the hip replacement suffered no impacts.
  3. Despite these optimal conditions for a hip replacement, M. Richards began to experience pain and discomfort in the site of his left prosthetic hip.
  4. On November 3, 2011, Plaintiff was evaluated for left hip pain and an NM Bone Scan showed aseptic loosening of the acetabular cup.  At that time, Plaintiff was advised to have revision surgery.
  5. On or about November 30, 2011, Plaintiff  underwent  painful revision surgery at St. Anthony’s Hospital in St. Petersburg, Florida by John B. Pope, MD to remove the failed M2a Magnum Hip System from his body, due to persistent left groin pain, muscle breakdown around the hip and aseptic loosening of the acetabular cup.  During that procedure, the surgeon noted that “There was metal staining evident throughout the acetabular tissue.”   The pathology report of the explanted tissue was positive for reactive fibroadipose tissue.  At that time, Plaintiff was implanted Zimmer Continuum trabecular shell with a polyethylene liner and a Biomet ceramic femoral head.
  6. Revision surgeries are generally more complex than the original hip replacement surgery, often because there is a reduced amount of bone in which to place the new hip implants.  Revision surgeries also usually take longer than the original hip replacement surgery and present a higher risk of complications.  Studies have shown that hip replacement patients who have undergone a revision surgery are almost four times more likely to suffer from a hip dislocation than those who have not. (Phillips CB, et al. Incidence rates of dislocation, pulmonary embolism, and deep infection during the first six months after elective total hip replacement. American Journal of Bone and Joint Surgery 2003; 85:20-26.)
  7. On or about November 30, 21011, only hours after Plaintiff’s revision surgery, Plaintiff suffered dislocation of the left hip, which required Plaintiff to undergo an additional surgery for closed reduction of the dislocated hip.
  8. As a direct and proximate result of the defects in the M2a Magnum Hip System and Biomet’s wrongful conduct, Plaintiff was implanted with an M2a Magnum Hip System which failed, causing him to sustain severe injury, suffer economic damages (including medical, hospital, therapy, pharmaceutical and other expenses), physical and emotional pain and suffering, and loss of ability to enjoy life, and will continue to suffer those losses in the future.
  9. Plaintiff, in the exercise of due diligence, could not have reasonably discovered the cause of his injuries, including but not limited to, the defective design and/or manufacturing of the Biomet Device implanted inside of him until he underwent revision surgery on November 30, 2011.

  10. Subsequent to that surgery, Plaintiff’s left hip improved, but he continues to suffer fatigue and inflammation of the wound site, which he fears is secondary to metallosis.
  11. Plaintiff will require continuing metal ion testing and monitoring as a direct result of having been implanted with a defective metal-on-metal M2a Magnum implant.
  12. All of the injuries suffered by the Plaintiff were caused by the defective design, warnings, construction and unreasonably dangerous character of the M2a Magnum System that was implanted into Plaintiff.  Had Defendants not concealed the known defect, the early failure rate, the known complications and unreasonable risks of metallosis and failure associated with the use of the metal-on-metal M2a Magnum Hip System, Plaintiff would not have consented to the metal-on-metal M2a Magnum Hip System being used in his total hip arthroplasty.
  13. Plaintiff was unaware of any causal link between the injuries he suffered and any wrongdoing on the part of the Defendants due to the defective nature of the M2a Magnum Hip due in part to the failure of Defendants to properly warn Plaintiff or his physicians, or issue any recall, or take other proactive action regarding the M2a Magnum Hip’s defective and faulty nature from prior to the time he was implanted with the hip to the present.

COUNT I

(Strict Liability – Defective Design)

  1. Plaintiffs incorporate and reallege the General Allegations in paragraphs 1 through 55 in Count I of this Complaint.
  2. At all times material hereto, the Biomet Defendants engaged in the business of designing, developing, manufacturing, testing, packaging, labeling, distributing, marketing, selling, and/or distributing, the Biomet metal-on-metal M2a Magnum System/
  3. The M2a Magnum System was intended for use in hip replacement procedures for consumers, and Plaintiff, DARRYL RICHARDS, was a consumer and relied upon the manufacturing safety of the device.
  4. At all relevant times, Defendants expected the M2a Magnum System to reach, and it did reach, consumers in the State of Florida, including Plaintiff, without substantial change in the condition in which it was sold.
  5. The M2a Magnum System was defectively designed, manufactured, and/or tested so as to be unreasonably dangerous to consumers and to Plaintiff at the time it was placed into the stream of commerce, in that:

a)  When placed in the stream of commerce, the device contained unreasonably dangerous design and manufacturing defects and was not reasonably safe as intended to be used, subjecting the Plaintiff to an unreasonably high risk of failure of the total hip replacement and the necessity of further invasive surgery;





b)  When placed in the stream of commerce, the device created unreasonably high risk of failure which exceeded the benefits of the device;





c)  When placed in the stream of commerce, the device was more dangerous than an ordinary consumer would expect and more dangerous than other similar prosthetic hip components that were already on the market;





d)  When placed in the stream of commerce, the device failed to comply with federal requirements.


  1. The M2a Magnum System that was implanted into the Plaintiff had not been materially altered or modified prior to the implantation of the device.

  2. Plaintiff was a foreseeable user of the device and the device was implanted into him for its intended purpose, a total hip replacement.
  3. Had the M2a Magnum System not been defective, Plaintiff would not have sustained the injuries alleged herein.
  4. As the direct and proximate result of the defective design of the M2a Magnum System, the Plaintiff, DARRYL RICHARDS, was implanted with a M2a Magnum System on April 17, 2008 and suffered painful failure of that hip replacement, which necessitated additional revision hip surgery, from which he suffered further complications.
  5. As a further proximate result of the defective design of the M2a Magnum System, Plaintiff suffered debilitating physical pain and mental suffering; was required to undergo an additional hip surgery; incurred substantial hospital, medical, nursing, rehabilitative, pharmaceutical and other expenses therefrom; suffered emotional distress, anxiety, depression and disability; and lost quality of life, and all of these injuries are permanent and continuing.

WHEREFORE, Plaintiff, DARRYL RICHARDS, demands judgment against Defendants, BIOMET ORTHOPAEDICS, LLC and BIOMET, INC., for damages, as well as all costs of this action and a trial by jury of all issues to be tried.



COUNT II



(Strict Liability – Manufacturing Defect)


  1. Plaintiffs reallege and incorporate the General Allegations contained in Paragraphs 1 through 55 in Count II of this Complaint.

  2. At all relevant times, the Biomet Defendants manufactured, designed, distributed, and/or sold the Biomet M2a Magnum Hip System that was implanted into the Plaintiff, DARRYL RICHARDS.
  3. The M2a Magnum System was intended for use in hip replacement procedures for consumers, and Plaintiff was a consumer who relied upon the manufacturing safety of the device.
  4. At all relevant times, Defendants expected the M2a Magnum System to reach, and it did reach, consumers in the State of Florida, including Plaintiff, without substantial change in the condition in which it was sold.
  5. The M2a Magnum System that was manufactured, designed, marketed, distributed, sold and/or placed in the stream of commerce by the Defendants was defective in its manufacture and construction in that, when it left the hands of the Defendants, it deviated from product specifications and/or applicable federal requirements for these medical devices, posing a serious risk of injury to the consumer into whom it was implanted.
  6. Plaintiff was a foreseeable user of the device and the device was implanted into him for its intended purpose, i.e. a total hip replacement.
  7. Had the M2a Magnum System not been defectively manufactured, Plaintiff would not have sustained the injuries alleged herein.
  8. As the direct and proximate result of the defects in the M2a Magnum System, Plaintiff, DARRYL RICHARDS, was implanted with a M2a Magnum System on April 17, 2008 and suffered painful failure and loosening of that hip replacement, which necessitated additional revision hip surgery from which he suffered further complications.
  9. As a further proximate result of the defective manufacturing of the M2a Magnum System, Plaintiff suffered debilitating physical pain and mental suffering, was required to undergo additional hip surgeries, incurred substantial hospital, medical, nursing and rehabilitative expenses therefrom; suffered emotional distress, anxiety, depression and disability; and loss of quality of life, and all of these injuries are permanent and continuing.

WHEREFORE, Plaintiff, DARRYL RICHARDS, demands judgment against Defendants, BIOMET ORTHOPAEDICS, LLC and BIOMET, INC., for damages, as well as all costs of this action and a trial by jury of all issues to be tried.



COUNT III



(Strict Liability – Failure to Warn)


  1. Plaintiffs reallege and incorporate the General Allegations contained in Paragraphs 1 through 55 in Count III of this Complaint.

  2. At all relevant times, the Biomet Defendants manufactured, designed, tested, distributed and/or sold the Biomet M2a Magnum Hip System that was implanted into the Plaintiff, DARRYL RICHARDS.
  3. The M2a Magnum System that was implanted into the Plaintiff was defective and unreasonably dangerous when they left the possession of the Defendants in that:

a)  The device contained insufficient warnings to alert consumers and their prescribing physicians that the System posed an unreasonably high risk of failure once implanted;





b)  Defendants’ promotional materials, labeling and instructional materials that accompanied the System were inadequate and misleading to consumers and their prescribing physicians;





c)  Even after Defendants received notice from reputable medical sources prior to the sale of the device to the Plaintiff, that the devices presented an inordinately high risk of failure and harm to the consumer, Defendants knowingly and deliberately failed to warn the public, including Plaintiff and his prescribing physician, of the serious risk of injury and failure occasioned by the defects in the device;





d)  The System did not conform to the representations made by Defendants concerning the devices;





e)  Defendants’ representations concerning the System did not conform



to applicable federal requirements;


  1. The Defendants, as manufacturers of the M2a Magnum System, are held to the level of knowledge of experts in the field of that type of prosthetic device, and had a duty to warn their consumers and prescribing physicians of the dangers associated with the device and failed to do so.

  2. At the time Plaintiff’s physician prescribed and implanted the device, the physician did not have substantially the same knowledge as the Defendants about the unreasonably high risks of failure of the M2a Magnum System because Defendants failed to provide adequate warnings of those risks to him.
  3. As the direct and proximate result of Defendants’ failure to warn of the defective condition of the M2a Magnum System, the Plaintiff, DARRYL RICHARDS, was implanted with a M2a Magnum System on April 17, 2008 and suffered painful failure of that hip replacement, which necessitated additional revision hip surgery and further complications.
  4. As a further proximate result of Defendants’ failure to warn of the defective condition of the M2a Magnum System, Plaintiff suffered debilitating physical pain and mental suffering, was required to undergo additional hip surgeries, incurred substantial hospital, medical, nursing and rehabilitative expenses therefrom; suffered emotional distress, anxiety, depression and disability; and loss of quality of life, and all of these injuries are permanent and continuing.

WHEREFORE, Plaintiff, DARRYL RICHARDS, demands judgment against Defendants, BIOMET ORTHOPAEDICS, LLC and BIOMET, INC., for damages, as well as all costs of this action and a trial by jury of all issues to be tried.



COUNT IV



(Negligence)


  1. Plaintiffs incorporate and reallege Paragraphs 1 through 55 into Count IV of this Complaint.

  2. At all times material hereto, the Biomet Defendants,  directly or indirectly,  created, manufactured, assembled, designed, tested, packaged, labeled, marketed, promoted, advertised, sold and/or distributed the Biomet M2a Magnum Hip System, that was implanted into the Plaintiff, DARRYL RICHARDS.
  3. At all relevant times, Defendants owed a duty to the public and to the Plaintiff to exercise reasonable care in the design, manufacture, testing, processing, advertising, marketing, testing, labeling, assembling, packaging, distribution, promotion and sale of the M2a Magnum System.
  4. Defendants negligently breached that duty to the Plaintiff in that:

a)  Defendants designed, manufactured and sold the device that they knew or should have known created an unreasonably high risk of failure when implanted into patients, including the Plaintiff;





b)  Defendants failed and/or refused to include adequate warnings with the device that would alert Plaintiff and his prescribing physician to the potential risks and serious side effects of the device;





c)  Defendants failed and/or refused to adequately and properly test the device before placing the device on the market;





d)  Defendants failed to conduct sufficient testing on the device both before and after the device was placed on the market which, if properly performed, would have shown that the device caused serious side effects, including, but not limited to, severe pain and disability, metallosis, synovitis, loosening, and failure of the total hip replacement;





e)  Defendants failed to adequately warn the Plaintiff or his prescribing physician that the device caused or was associated with an unreasonably high risk of failure and pain, debilitating side effects;





f)  Defendants failed to warn, or adequately warn the Plaintiff or his prescribing physician that the device created a higher risk of failure than other similar devices currently on the market;





g)  Defendants failed to provide adequate post marketing warnings or instructions to the Plaintiff and/or his prescribing physician of the significant risk of injury and failure of the total hip replacement associated with the device;





h)  Defendants placed an unsafe and defective hip prosthetic device into the stream of commerce;





i)  Defendants failed to conform to the applicable federal laws and regulations in designing, manufacturing, marketing, selling and distributing the device;





j)  Defendants underplayed the significant risk of failure of the device to the public, including the Plaintiff and/or his prescribing physician in order to make a profit from sale of the device.



 


  1. Defendants knew or should have known that M2a Magnum System caused unreasonably dangerous risks and serious side effects of which the Plaintiff and his prescribing physician would not be aware, but nevertheless advertised, marketed, sold and distributed the device knowing that there were safer comparable products for hip replacements.

  2. As a direct and proximate result of Defendants’ negligent acts and omissions, Plaintiff, DARRYL RICHARDS, was implanted with a M2a Magnum System on April 17, 2008 and suffered chronic pain, metallosis, and painful failure of that hip replacement, which necessitated additional revision hip surgeries.
  3. As a further proximate result of Defendants’ negligent acts and omissions, Plaintiff suffered debilitating physical pain and mental suffering, was required to undergo additional hip surgeries, incurred substantial hospital, medical, nursing and rehabilitative expenses therefrom; suffered emotional distress, anxiety, depression and disability; and loss of quality of life, and all of these injuries are permanent and continuing.

WHEREFORE, Plaintiff, DARRYL RICHARDS, demands judgment against Defendants, BIOMET ORTHOPAEDICS, LLC and BIOMET, INC., for damages, as well as all costs of this action and a trial by jury of all issues to be tried.



COUNT V



(Negligent Misrepresentation)


  1. Plaintiffs incorporate and reallege Paragraphs 1 through 55 into Count V of this Complaint.

  2. At all relevant times, Defendants knew or should have known that their M2a Magnum Hip System that was implanted into Plaintiff, DARRYL RICHARDS, was defective, and failed to comply with federal requirements for safe design and manufacture and/or was in other ways out of specification.  Yet Defendants negligently misrepresented to the Plaintiff and/or his physicians that the device was safe and met all applicable design and manufacturing requirements.
  3. The Plaintiff and/or his physicians reasonably relied upon Defendants’ misrepresentations and omissions concerning the safety of the device to Plaintiff’s detriment.
  4. As the direct result of Defendants’ negligent misrepresentations and omissions and/or failure to disclose its violations of federal requirements applicable to its M2a Magnum System, Plaintiff was implanted with a M2a Magnum System and suffered serious physical and emotional injury, harm, damages and economic loss and will continue to suffer such harm, damages and economic loss in the future.

WHEREFORE, Plaintiff, DARRYL RICHARDS, demands judgment against Defendants, BIOMET ORTHOPAEDICS, LLC and BIOMET, INC., for damages, as well as all costs of this action and a trial by jury of all issues to be tried.



COUNT VI



(Fraudulent Misrepresentation)


  1. Plaintiffs incorporate and reallege Paragraphs 1 through 55 into Count VI of this Complaint.

  2. On or about April 17, 2008, Plaintiff, DARRYL RICHARDS, was implanted with Biomet M2a Magnum Hip System in his left hip, that was designed, manufactured, packaged, labeled, marketed, distributed and/or sold by the Biomet Defendants.
  3. At the time Plaintiff purchased and was implanted with the M2a Magnum System,  Defendants had actual knowledge that the device was defective in that it created an unreasonably high risk of metallosis and injury to the tissues surrounding the implant and created an unreasonably high risk of failure of the implant when implanted and used as directed.
  4. Despite Defendants’ actual knowledge of the unreasonably high risk of metallosis, loosening and failure of the device and/or severe injury to the recipient of the device, and despite complaints and adverse event reports that Defendant received concerning defects in the M2a Magnum System, Defendants acted with gross negligence and willful and wanton disregard of the safety of the general public and of the Plaintiff  by knowingly and intentionally continuing to market, promote and sell the device with no warning concerning the known high risk of failure and injury, so as to maximize their sales and profits at the expense of the health and safety of the public and of the Plaintiff.
  5. Defendants’ culpable fraudulent misrepresentations to the public and to Plaintiff include, but are not limited to:

a)  Failing or refusing to conduct adequate pre-market and post-market testing of the device;

b)  Failing or refusing to conduct adequate testing of the device even after having received numerous adverse event reports and complaints that the M2a Magnum Systems had a high risk of failure and a high risk of causing severe side effects when implanted and used as directed;

c)  Failing or refusing to warn consumers and their prescribing physicians, including the Plaintiff, that the device had a high risk of failure and of causing serious injury;

d)  Intentionally omitting any mention on the advertisements and labeling that the use of the device had been associated with an unreasonably high risk of component loosening, component malalignment, infection, metallosis, bone fracture, dislocation and pain, despite the fact that Defendants were made aware of adverse event reports and complaints long before the Plaintiff was implanted with the device;

e)  Intentionally failing and refusing to change the label of the device to reflect the high risk of failure of the devices and injury to its recipient;

f)  Engaging in a promotional campaign for the M2a Magnum Systems that minimized the high risk of serious injuries and the need for revision surgery caused by the device, and embarking on a campaign that discounted reports of failure of the device and injury to the recipients of the device;

g)  Falsely and fraudulently representing to the medical community and to the Plaintiff  and the public in general that the devices had been tested and were found to be safe and/or effective as a hip replacement system.

  1. All of the above misrepresentations and concealments of the Defendants were intentional acts specifically directed to keep safety concerns about the M2a Magnum System from decrease in the sales of the Devices, and were undertaken with the intent that Plaintiff and other consumers would rely upon them.
  2. Defendants’ misrepresentations and concealments were undertaken with the intent of defrauding and deceiving Plaintiff and other consumers, to induce and encourage the sale of the M2a Magnum Systems.
  3. If the representations and warnings concerning the M2a Magnum Systems had been accurate and truthful, such representations and warnings would have dissuaded the Plaintiff and her prescribing physicians from purchasing or using the device and Plaintiff would not have used the M2a Magnum System had he known it would cause him to suffer subsequent pain,  disability and metallosis, and require a total hip revision surgery just three years later.
  4. Plaintiff relied upon and was induced by Defendants’ misrepresentations, omissions and/or active concealment of the dangers of injury and further surgery in selecting the M2a Magnum System to his detriment.
  5. The aforementioned actions of Defendants constituted knowing and intentional misconduct and/or conduct undertaken with reckless, willful and wanton disregard for the safety of the public and of the Plaintiff, and such conduct was at all times ratified by the Defendants.
  6. As the direct and proximate result of Defendants’ fraudulent misrepresentations and omissions, Plaintiff, DARRYL RICHARDS, was implanted with a M2a Magnum System on April 17, 2008 and suffered painful failure of that hip replacement, which necessitated additional revision hip surgeries.
  7. As the further proximate result of Defendants’ fraudulent misrepresentations,  Plaintiff suffered debilitating physical pain and mental suffering, was required to undergo additional hip surgeries, incurred substantial hospital, medical, nursing, rehabilitative, pharmaceutical and other expenses therefrom; suffered emotional distress, anxiety, depression and disability; and loss of quality of life, and all of these injuries are permanent and continuing.

WHEREFORE, Plaintiff, DARRYL RICHARDS, demands judgment against Defendants,  BIOMET ORTHOPAEDICS, LLC and BIOMET, INC., for compensatory and punitive damages, as well as all costs of this action and a trial by jury of all issues to be tried.


COUNT VII

Consortium Claim of JANET RICHARDS

104.  Plaintiffs reallege and incorporate paragraphs 1 through 55 into Count VII of this Complaint.

79.  At all relevant times, Plaintiff, JANET RICHARDS, was the wife of DARRYL RICHARDS, and, as a result of the injuries sustained by her husband as hereinabove alleged, Mrs. Richards has lost the services, support, companionship, affection and consortium of her husband, and will continue to lose said services, companionship, affection and consortium in the future.

80.  In addition, as the wife of DARRYL RICHARDS, JANET RICHARDS has in the past and will in the future become obligated to pay medical expenses on behalf of her husband.

WHEREFORE, Plaintiff, JANET RICHARDS, demands judgment for damages, costs and interest against the Defendant, BIOMET ORTHOPEDICS, LLC and BIOMET, INC., a trial by jury and such other relief to which the Plaintiff may be justly entitled.

Dated this ___ day of May, 2012.

_____________________________

Joseph H. Saunders, Esquire

SAUNDERS & WALKER, P.A.

P. O. Box 1637

Pinellas Park, FL 33780-1637

(727) 579-4500, FAX (727) 577-9797

FBN 341746

joe@saunders-lawyers.flywheelsites.com

Attorney for Plaintiff

 

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