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Complaint and Allegations against DePuy and Johnson & Johnson

in Defective Product Recall Blog

The Merman Law Firm is active in the DePuy ASR hip recall litigation.  Below are excerpts from one Complaint filed in the Southern District of Texas, which has been consolidated in Ohio:

FACTUAL ALLEGATIONS

  1. The ASR devices were developed by DePuy Orthopaedics, Inc. and/or Johnson & Johnson, Inc. in order to reconstruct human hip joints due to conditions such as osteoarthritis, rheumatoid arthritis, avascular necrosis (AVN), or fracture.  The hip joint connects the femur bone of a patient’s leg to the patient’s pelvis.  The hip joint is a ball that fits in the 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 ASR XL Acetabular System is made up of three components: the metal femoral stem is inserted inside the femur, the metal femoral head (or ball) connects to the stem and then fits inside the metal acetabular cup (socket).  The ASR Hip Resurfacing Platform has two components: a metal cap is placed over the natural femoral head and the metal acetabular cup is placed in the acetabulum.  Once implanted, these devices are intended and marketed to last for an average of 15 or more years.
  3. The ASR devices were not subject to the rigorous premarket approval (PMA) testing and approval pursuant to 21 U.S.C. § 360(e).  Instead, DePuy Orthopaedics, Inc. and/or Johnson & Johnson, Inc. obtained approval from the FDA to market the ASR XL Acetabulum System in the United States through the 510(k) premarket notification process pursuant to 21 U.S.C. § 360(k) asserting that it was substantially equivalent to other hip replacement systems already available on the market.  The ASR Hip Resurfacing Platform was not approved for use in the United States by the Food and Drug Administration (FDA).
  4. Defendants marketed the ASR devices as having many advantages over other hip replacement or hip resurfacing systems.  Defendants described the ASR devices as a “high performance hip replacement” and advertised them with pictures of a woman running on a sandy beach, and a man taking an aggressive golf swing.  Defendants advertised the ASR devices as superior devices because the bone in the hip socket was preserved, the hip replacement was subject to reduced wear, the hip replacement matched the hip’s natural anatomy, the surgery only required a small incision, and the efficacy of the device was based on a strong clinical history.
  5. Defendants further advertised the ASR devices as superior to other devices representing that they had a strong clinical history, were less prone to dislocation and wear and more closely simulated the body’s anatomy.
  6. Contrary to Defendants’ marketing campaigns and representations, many patients experienced premature failure due to component loosening, component misalignment, dislocation and fracture, due to the unsafe design of the ASR devices.  In addition, reports were received that the implant’s “ball” and “socket” that make up the hip-joint, which were both metal, generate metal debris from wear which can spread throughout the surrounding bone and tissue and cause severe inflammation and damage.  These problems have necessitated premature removal of the device in many patients.
  7. Most hip replacement systems use a polyethylene plastic acetabular cup, but Defendants chose instead to use a metal acetabular cup.  This forces metal to rub on metal with the full weight and pressure of the human body pushing down on it.  Unlubricated, metal-on-metal moving parts are widely known to be prone to excessive wear, friction and flaking.
  8. At the time the ASR devices were designed, tested, manufactured, marketed and introduced into the stream of commerce, safer, more effective alternative designs of hip revision and replacement systems existed and were available to patients.
  9. Defendants knew that the ASR hip was defective for years prior to the recall.  In the United States, hundreds of complaints were made to the Defendants and the FDA concerning the high failure rates, popping and pain associated with the ASR hips.  By 2007, over one hundred doctors and patients had complained to DePuy that the hip had to be replaced soon after implantation. Even earlier, Defendants knew of these problems through registries in the UK and Australia, yet continued to market the ASR hip in the United States.
  10. In 2008, the Australian Orthopaedic Association – National Joint Replacement Registry released their 2008 annual report, which was updated in September, 2008.  This report analyzed the hip replacement information in the registry for the years 2003 to 2007.  The report specifically stated that the ASR devices had a higher than anticipated rate of revision (required replacement surgery) as compared to all other devices.  More specifically, the ASR devices were found to have a risk of revision more than twice that of other hip replacement systems.
  11. Defendants continued the sale of the ASR devices despite this knowledge and failed to warn the public of these findings.  Instead, throughout 2007, 2008 and 2009, they continued to market the ASR devices as safe and effective.  Information from Johnson & Johnson, Inc. indicates that approximately 93,000 of the ASR devices were used worldwide.  In the last quarter of 2009, Defendants indicated that they had decided to stop sales of the devices supposedly due to decreased demand.
  12. In March, 2010, Defendants sent a warning letter to healthcare providers regarding the ASR devices.  In this letter, Defendants warned doctors that recent data from the United Kingdom indicated higher than expected failure rates at three years of the ASR devices when used in hip replacements for patients with smaller femoral heads.
  13. On July 17, 2010, the FDA announced a Class II nationwide recall of the DePuy ASR hip system.  The FDA scheduled the recall as “Class II” because exposure to the product could cause severe health problems, including death, and may cause medically irreversible consequences.
  14. On August 24, 2010, Defendants issued a voluntary recall of the ASR devices after stating that new data was released confirming the already known dangers of the devices and corroborating the many complaints received by the FDA from physicians and patients.
  15. Unpublished data from the National Joint Registry (NJR) of England and Wales showed the five year revision rate for the ASR Hip Resurfacing System was approximately 12 percent.  The NJR data showed that the ASR XL Acetabular System five year revision rate was approximately 13 percent, or more than 1 in 8 patients.
  16. Medical information indicates that a principal reason for the high failure rate of the ASR devices is the design of the acetabular metal cup which is shallower than other safer, more effective acetabular cups on the market.  The cups also included a beveled edge, which further reduced the surface area of the acetabular cup in contact with the femoral head.  Moreover, the design utilized a metal-on-metal, unlubricated joint that wear out quickly and flake metal shavings into the patient.  These defective, dangerous design components have led to edge loading in many patients, often generating dangerous cobalt and chromium metal debris.  This defective design is a producing cause of problems such as loosening of the device, poor alignment of the device, and fracture of the device from the bone, all of which can cause severe infection and inflammation.  Additional complications may include increased metal ion levels in the blood, bone staining, necrosis, swelling, nerve damage, pain, tissue damage and/or muscle damage.
  17. Defendants failed to disclose material facts regarding the design defects and failures of the ASR devices.  Defendants knew that Plaintiff  and those similarly situated would not know about these design defects and failures.
  18. On or about February 6, 2007, Plaintiff  underwent total left hip arthroplasty at in Tomball, Harris County, Texas.  Her surgeon performed the surgery using the DePuy – Johnson/Johnson 10 standard Corail femoral stem with a 50 ASR acetabular cup, a 45 ASR femoral head and +2 ASR neck sleeve.
  19. Since the surgical implantation of the ASR XL Acetabular System in her left hip, Plaintiff has suffered symptoms including but not limited to severe pain, problems sitting and standing, elevated levels of metal ions in her blood, and possible loosening.  Due to these complications, Plaintiff now faces the grim potential for a painful and expensive revision surgery in the future.
  20. Had Plaintiff known that the defects in the ASR XL Acetabular System would cause severe pain, problems sitting and standing, elevated levels of metal ions in her blood, possible loosening, and the potential for a revision surgery in the future, Plaintiff would not have elected to have had the ASR XL Acetabular System implanted in her hip.
  21. As a result of the implantation of ASR XL Acetabular System, Plaintiff has suffered permanent injuries and damages, including, but not limited to past and future medical expenses, past and future physical pain and mental anguish, past and future physical impairment, past and future disfigurement, and past and future loss of earning capacity.  Plaintiff faces the potential for a revision surgery to remove the ASR XL Acetabular System in the future, which will present an enormous risk to her because it is technically more difficult than the original implant surgery, there is an increased risk of complications and death, and the recovery is more prolonged than the original hip replacement surgery.  The first surgery was a very difficult ordeal and she is terrified of having to undergo another total hip replacement on her left hip.  She will continue to suffer damages in the future.

 

FIRST CAUSE OF ACTION

Negligence

  1. Plaintiff incorporates by reference and re-alleges each and every allegation set forth in the preceding paragraphs of this Complaint as though set out in full here.
  2. Defendants had a duty to exercise reasonable care in the design, manufacture, testing, marketing and distribution into the stream of commerce of the ASR devices, including a duty to ensure that the ASR devices did not pose a significantly increased risk of adverse events.
  3. Defendants failed to perform adequate testing and evaluations of the ASR devices prior to providing them to patients.
  4. Defendants have received repeated reports by healthcare providers of complications and failures with the ASR devices in the United States and other countries, including dislocation, misalignment, metal debris in the patient’s body and loosening of component parts.  Defendants had a duty to perform further testing and investigate the cause of these complaints, and warn physicians and patients of these possible complications.
  5. Defendants failed to exercise reasonable care in the design, manufacture, testing, marketing and distribution into the stream of commerce of the ASR devices.  Defendants knew or should have known that the ASR devices could fail prematurely in patients therefore giving rise to Plaintiff’s injuries and damages, including, but not limited to past and future medical expenses, past and future physical pain and mental anguish, past and future physical impairment, past and future disfigurement, past and future loss of earning capacity, and loss of household services, and therefore were not safe for use by Plaintiff Sarah Singleton.
  6. Despite the fact that Defendants knew or should have known that the ASR devices could fail prematurely in patients, therefore giving rise to pain and suffering, disability and the need for a possible revision surgery to replace the device, Defendants continued to market the ASR devices as safe and effective hip replacement systems.
  7. As a direct and proximate result of Defendants’ negligence, Plaintiff has suffered permanent injuries and damages, including, but not limited to past and future medical expenses, past and future physical pain and mental anguish, past and future physical impairment, past and future disfigurement, past and future loss of earning capacity and loss of household services.
  8. In taking the actions and omissions that caused these damages, Defendants exhibited malicious conduct and/or conscious disregard for the rights and safety of others.  Plaintiff seeks recovery for punitive damages.

SECOND CAUSE OF ACTION

Strict Product Liability TPLA – Design Defect

  1. Plaintiff incorporates by reference and re-alleges each and every allegation set forth in the preceding paragraphs of this Complaint as though set out in full here.
  2. Defendants designed, manufactured, tested, marketed and distributed into the stream of commerce the ASR devices.
  3. At the time of the design, manufacture and sale of the ASR devices, a safer alternative design was available that would have prevented or significantly reduced the risk involved with the ASR devices without substantially impairing its utility and was economically and technologically feasible at the time they left the control of Defendants by the application of existing or reasonably achievable scientific knowledge.
  4. The ASR device that was surgically implanted in Plaintiff was defective in its design when it left the hands of Defendants in that the design was unreasonably dangerous, as stated above, thereby posing a serious risk that the device could fail prematurely in patients, giving rise to Plaintiff’s injuries and damages, including, but not limited to past and future medical expenses, past and future physical pain and mental anguish, past and future physical impairment, past and future disfigurement, past and future loss of earning capacity and loss of household services.
  5. Defendants’ introduction of the defective and unreasonably dangerous ASR devices into the stream of commerce was a producing cause of the damages and injuries suffered by Plaintiff, including, but not limited to past and future medical expenses, past and future physical pain and mental anguish, past and future physical impairment, past and future disfigurement, past and future loss of earning capacity, and loss of household services.
  6. Defendants are therefore liable to Plaintiff for their violations of the Texas Product Liability Act (“TPLA”), including but not limited to selling a defective product that left their control in substantially the same condition as it was in when implanted in Sarah Singleton.  Defendants’ breaches of the TPLA were the producing and proximate cause of Plaintiff’s damages.
  7. In taking the actions and omissions that caused these damages, Defendants exhibited malicious conduct and/or conscious disregard for the rights and safety of others.  Plaintiff seeks recovery for punitive damages.

THIRD CAUSE OF ACTION

Strict Product Liability TPLA – Failure to Warn

  1. Plaintiff incorporates by reference and re-alleges each and every allegation set forth in the preceding paragraphs of this Complaint as though set out in full here.
  2. Defendants designed, manufactured, tested, marketed and distributed into the stream of commerce the ASR devices.
  3. The ASR devices placed into the stream of commerce by Defendants were defective due to the failure to warn of the harms known or which should be known to Defendants.  Defendants knew or should have known that the ASR devices could fail prematurely in patients therefore giving rise to Plaintiff’s injuries and damages, including, but not limited to past and future medical expenses, past and future physical pain and mental anguish, past and future physical impairment, past and future disfigurement, past and future loss of earning capacity, and loss of household services, but failed to give consumers adequate warnings of such risks.
  4. The ASR devices placed into the stream of commerce by Defendants were surgically implanted in a manner reasonably anticipated by Defendants.
  5. Defendants had notice of complications and failures of the ASR devices as reported by healthcare providers in the United States and other countries in which the ASR devices were marketed and sold.  These reports began several years prior to the recall as indicated above.  Defendants had received hundreds of complaints and notices of revision surgeries prior to the implantation in Plaintiff.  Defendants did not take actions to notify healthcare providers, patients or the FDA of any complications and/or failures until March, 2010.
  6. Defendants’ introduction of the defective and unreasonably dangerous ASR devices into the stream of commerce was a producing cause of the damages and injuries suffered by Plaintiff, including, but not limited to past and future medical expenses, past and future physical pain and mental anguish, past and future physical impairment, past and future disfigurement, past and future loss of earning capacity, and loss of household services.
  7. Defendants are therefore liable to Plaintiff for their violations of the Texas Product Liability Act (“TPLA”), including but not limited to failure to warn of a defective product that left their control in substantially the same condition as it was in when implanted in Sarah Singleton.  Defendants’ breaches of the TPLA were the producing and proximate cause of Plaintiff’s damages.
  8. In taking the actions and omissions that caused these damages, Defendants exhibited malicious conduct and/or conscious disregard for the rights and safety of others. Plaintiff seeks recovery for punitive damages.

FOURTH CAUSE OF ACTION

Strict Products Liability TPLA – Manufacturing Defect

  1. Plaintiff incorporates by reference and re-alleges each and every allegation set forth in the preceding paragraphs of this Complaint as though set out in full here.
  2. Defendants designed, manufactured, tested, marketed and distributed into the stream of commerce the ASR devices.
  3. The ASR device that was surgically implanted in Plaintiff was defective  and unreasonably dangerous in its manufacture when it left the hands of Defendants in that it deviated from product specifications, posing a serious risk that it could fail prematurely in patients therefore giving rise to Plaintiff’s injuries and damages, including, but not limited to past and future medical expenses, past and future physical pain and mental anguish, past and future physical impairment, past and future disfigurement, past and future loss of earning capacity and loss of household services.
  4. Defendants’ introduction of the defective and unreasonably dangerous ASR devices into the stream of commerce was a producing cause of the damages and injuries suffered by Plaintiff, including, but not limited to past and future medical expenses, past and future physical pain and mental anguish, past and future physical impairment, past and future disfigurement, past and future loss of earning capacity, and loss of household services.
  5. Defendants are therefore liable to Plaintiff for their violations of the Texas Product Liability Act (“TPLA”), including but not limited to selling a product that was defective because it differed in material ways from the specifications to which it was intended to be manufactured and that left their control in substantially the same condition as it was in when implanted in Sarah Singleton.  Defendants’ breaches of the TPLA were the producing and proximate cause of Plaintiff’s damages.
  6. In taking the actions and omissions that caused these damages, Defendants exhibited malicious conduct and/or conscious disregard for the rights and safety of others.  Plaintiff seeks recovery for punitive damages.

FIFTH CAUSE OF ACTION

Breach of Express Warranty

  1. Plaintiff incorporates by reference and re-alleges each and every allegation set forth in the preceding paragraphs of this Complaint as though set out in full here.
  2. Defendants designed, manufactured, tested, marketed and distributed into the stream of commerce the ASR devices.
  3. Defendants expressly warranted that the ASR devices were safe and effective hip replacement systems and superior to other artificial hip systems, as stated above.
  4. The ASR devices placed into the stream of commerce by Defendants did not conform to these express representations thereby giving rise to Plaintiff’s injuries and damages, including, but not limited to past and future medical expenses, past and future physical pain and mental anguish, past and future physical impairment, past and future disfigurement, past and future loss of earning capacity, and loss of household services.
  5. Defendants’ breach of express warranties regarding the safety and effectiveness of the ASR devices was a producing cause of Plaintiff’s permanent injuries and damages, including, but not limited to past and future medical expenses, past and future physical pain and mental anguish, past and future physical impairment, past and future disfigurement, past and future loss of earning capacity, and loss of household services.
  6. Defendants knowingly and/or intentionally committed these actions and omissions that caused these damages.  Plaintiff seeks recovery for punitive damages.

SIXTH CAUSE OF ACTION

Breach of Implied Warranty of Merchantability

  1. Plaintiff incorporates by reference and re-alleges each and every allegation set forth in the preceding paragraphs of this Complaint as though set out in full.
  2. Defendants designed, manufactured, tested, marketed and distributed into the stream of commerce the ASR devices.
  3. At the time Defendants designed, manufactured, tested, marketed and distributed into the stream of commerce the ASR devices, Defendants knew the use for which the ASR devices were intended, and impliedly warranted the ASR devices to be of merchantable quality and safe for their intended use.
  4. Plaintiff and her healthcare providers reasonably relied upon the skill and judgment of Defendants as to whether the ASR devices were of merchantable quality and safe for their intended use.
  5. Contrary to Defendants’ implied warranties, the ASR devices were not of merchantable quality or safe for their intended use, because the ASR devices were unreasonably dangerous as described above.
  6. Defendants’ breach of implied warranties regarding the safety and effectiveness of the ASR devices was a producing cause of Plaintiff’s permanent injuries and damages, including, but not limited to past and future medical expenses, past and future physical pain and mental anguish, past and future physical impairment, past and future disfigurement, past and future loss of earning capacity, and loss of household services.
  7. Defendants knowingly and/or intentionally committed these actions and omissions that caused these damages.  Plaintiff seeks recovery for punitive damages.

SEVENTH CAUSE OF ACTION

Breach of Implied Warranty of Fitness for a Particular Purpose

  1. Plaintiff incorporates by reference and re-alleges each and every allegation set forth in the preceding paragraphs of this Complaint as though set out in full here.
  2. Defendants designed, manufactured, tested, marketed and distributed into the stream of commerce the ASR devices.
  3. At the time Defendants designed, manufactured, tested, marketed and distributed into the stream of commerce the ASR devices, Defendants knew the particular purpose for which the ASR devices were intended, and impliedly warranted the ASR devices to be fit for their particular purpose.
  4. Plaintiff and her healthcare providers reasonably relied upon the skill and judgment of Defendants as to whether the ASR devices were fit for their particular purpose.
  5. Contrary to Defendants’ implied warranties, the ASR devices were not fit for their particular purpose, because the ASR devices were unreasonably dangerous as described above.
  6. Defendants’ breach of implied warranties regarding the ASR devices fitness for their particular purpose was a producing cause of Plaintiff’s permanent injuries and damages, including, but not limited to past and future medical expenses, past and future physical pain and mental anguish, past and future physical impairment, past and future disfigurement, past and future loss of earning capacity, and loss of household services.
  7. Defendants knowingly and/or intentionally committed these actions and omissions that caused these damages.  Plaintiff seeks recovery for punitive damages.

EIGHTH CAUSE OF ACTION

Fraud

  1. Plaintiff incorporates by reference and re-alleges each and every allegation set forth in the preceding paragraphs of this Complaint as though set out in full here.
  2. For several years, Defendants had actual knowledge that the ASR devices could fail prematurely thereby giving rise to unnecessary pain and suffering, disability, and the need for a possible revision surgery to replace the device.
  3. The fact that the ASR devices could fail prematurely thereby giving rise to unnecessary pain and suffering, disability, and the need for a possible revision surgery to replace the device was and is a material fact.
  4. Defendants intentionally and/or recklessly made false representations of material fact to Plaintiff, including but not limited to claims that the ASR devices were safe and effective hip replacement systems.  For example, Defendants claimed that the devices were based on a strong clinical history, and that the devices would allow patients to return to a more active lifestyle – when, in fact, these claims were false and Defendants knew they were false when they made them.
  5. Defendants had a duty to disclose these facts to Plaintiff and her healthcare providers.
  6. In reliance on Defendants’ misrepresentations of material fact, Plaintiff obtained the ASR device.  Had Plaintiff known that the ASR device could fail prematurely thereby giving rise to Plaintiff’s injuries and damages, including, but not limited to past and future medical expenses, past and future physical pain and mental anguish, past and future physical impairment, past and future disfigurement, past and future loss of earning capacity, and loss of household services, she would not have elected to obtain the ASR devices.
  7. As a result of Defendants’ intentional and/or reckless misrepresentations, including but not limited to claims that the ASR devices were safe for use, Plaintiff has suffered permanent injuries and damages, including, but not limited to past and future medical expenses, past and future physical pain and mental anguish, past and future physical impairment, past and future disfigurement, past and future loss of earning capacity, and loss of household services.
  8. In taking the actions and omissions that caused these damages, Defendants exhibited malicious conduct and/or conscious disregard for the rights and safety of others.  Plaintiff seeks recovery for punitive damages.

NINTH CAUSE OF ACTION

Negligent Misrepresentation

  1. Plaintiff incorporates by reference and re-alleges each and every allegation set forth in the preceding paragraphs of this Complaint as though set out in full here.
  2. For several years, Defendants have had actual knowledge that the ASR devices could fail prematurely thereby giving rise to injuries and damages, including, but not limited to past and future medical expenses, past and future physical pain and mental anguish, past and future physical impairment, past and future disfigurement, past and future loss of earning capacity and loss of household services.
  3. The fact that the ASR devices could fail prematurely thereby giving rise to unnecessary pain and suffering, disability, and the need for a possible revision surgery to replace the device was, and is, a material fact.
  4. Defendants recklessly and/or negligently made false representations of material fact to Plaintiff, including but not limited to claims that the ASR devices were safe and effective hip replacement systems.  For example, Defendants claimed that the devices were based on a strong clinical history and that the devices would allow patients to return to a more active lifestyle – when, in fact, these claims were false and Defendants knew they were false when they made them.
  5. Defendants failed to disclose material facts regarding the design defects and failures of the ASR devices.  Defendants knew that Plaintiff and those similarly situated would not know about these design defects and failures.
  6. These representations were made with the intent to induce Plaintiff to obtain an ASR device.
  7. In reliance on Defendants’ misrepresentations of material fact, Plaintiff obtained an ASR device.  Had she known that the ASR devices could fail prematurely thereby giving rise to Plaintiff’s injuries and damages including but not limited to past and future medical expenses, past and future physical pain and mental anguish, past and future physical impairment, past and future disfigurement, past and future loss of earning capacity and loss of household services, she would not have elected to obtain the ASR device.
  8. As a result of Defendants’ reckless and/or negligent misrepresentations, including but not limited to claims that the ASR devices were safe for use, Plaintiff has suffered permanent injuries and damages, including, but not limited to past and future medical expenses, past and future physical pain and mental anguish, past and future physical impairment, past and future disfigurement, past and future loss of earning capacity, and loss of household services.

TENTH CAUSE OF ACTION

Violation of the Texas Deceptive Trade Practices Act

  1. Plaintiff incorporates by reference and re-alleges each and every allegation set forth in the preceding paragraphs of this Complaint as though set out in full.
  2. Plaintiff  is a consumer as defined in the Texas Deceptive Trade Practices Act (DTPA), Tex. Bus. & Comm. Code § 17.41, et seq.
  3. The wrongful conduct of Defendants, as described herein, constitutes one or more violations of the Texas DTPA, including but not limited to the following:
    1. False, misleading, unfair and/or deceptive acts or practices including, but not limited to, representing that the ASR device had characteristics and/or benefits that it did not have; representing the ASR device was of a particular standard or quality that it was not; and/or failing to disclose known information about the ASR devices in order to induce consumers, such as Plaintiff, into a transaction that the consumers would not have entered into had the information been disclosed;
    2. Breach of an express and/or implied warranty; and
    3. Unconscionable acts or practices involving the design, manufacture, testing, marketing, promotion, distribution, and sale of the ASR devices, defective and unreasonably dangerous products which put unknowing consumers at risk of serious bodily injury.
  4. Plaintiff and Plaintiff’s healthcare providers relied on Defendants’ false, misleading and/or deceptive acts and practices to Plaintiff’s detriment.
  5. Defendants’ acts and/or omissions in violation of the Texas DTPA were a producing cause of Plaintiff’s injuries, including but not limited to economic damages and mental anguish.

Defendants’ wrongful conduct was committed knowingly and/or intentionally making Defendants liable for treble damages under the Texas DTPA.  Plaintiff is entitled to and will seek three times the mental anguish and economic damages sustained, plus reasonable and necessary attorneys’ fees, and costs of court, in accordance with section 17.50 of the Texas Business and Commerce Code.

For further information about the DePuy hip recall, please visit our DePuy recall page