DePuy Metal-on-Metal Hip Recall
DePuy ASR metal-on-metal acerbetal cup recalled for premature failure and defective design. 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. The DePuy Hip Recall and Lawsuit were caused by the poor design of the ASR metal-on-metal hip replacement.
DePuy ASR Hip Design
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.
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).
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.
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. Because DePuy chose to circumvent the premarket approval process, the DePuy Hip Recall and Lawsuit are not preempted by the FDA.
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 made of 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. The DePuy lawsuit was filed as a result of injuries from these defects including metalosis, revision surgery, and untold pain and suffering.
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.
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.
Defendants knew that the ASR hip was defective for years prior to the DePuy 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.
DePuy ASR Defect History
During the DePuy Hip Recall and Lawsuit, lots of information surfaced that DePuy knew its hip was defective. 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.
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.
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.
DePuy Hip Recall
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.
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.
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.
DePuy Hip Failures
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 wears out quickly and flakes 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.
Defendants failed to disclose material facts regarding the design defects and failures of the ASR devices. Defendants knew that Plaintiff Sarah Singleton and those similarly situated would not know about these design defects and failures.
DePuy Hip Lawsuit - MDL in Ohio
All of the cases filed across the nation involving the DuPuy ASR metal-on-metal hip have been consolidated in Ohio in a single MDL. "MDL" stands for multi-district litigation and allows a single court to consolidate all related actions into a single court for uniform pre-trial. Once all of the discovery (exchange of documents and depositions of key witnesses) and the MDL is complete each Plaintiff is afforded the opportunity to litigate his or her case where it was originally filed, assuming that jurisdiction and venue are proper in the originating court.
The MDL has proceeded more-or-less smoothly since it began a couple of years ago. Please check our blog periodically for updates on how the MDL is proceeding and for recent developments. If you or a loved one has suffered pain, memory loss and/or a revision surgery following the implantation of a DePuy ASR hip, contact the Merman Law Firm for immediate representation.