DePuy Orthopaedics is a subsidiary of the pharmaceutical and medical products giant, Johnson & Johnson, the largest pharmaceutical company in the world. DePuy has been in business for more than a century and was the first orthopedics company in the US. DePuy has created hundreds of successful orthopedic products, however three of their hip replacement systems that have shown an unusually high failure rate. The Pinnacle Hip Replacement System, ASR XL Acetabular System, and ASR Hip Resurfacing System are facing legal issues from implant patients.
Both the DePuy Pinnacle and ASR hip implant systems were created to increase mobility and last longer than other hip implant systems. These types of hip replacement products are designed for a younger demographic of patients who wish to maintain an active lifestyle and will need an implant that will last for a longer period of time. Despite the intentions in the design, both systems have a high failure rate and have been linked to serious complications.
Some of the DePuy implants were designed as metal-on-metal (MoM) construction. MoM was supposed to decrease failure rates due to its robust construction. It was intended to reduce the chance that a hip implant would “wear out” and require replacement. MoM construction was also intended to reduce the chance that small fragments of material would be shed into surrounding tissue like other previous devices that used plastic liners in construction.
MoM devices have unfortunately shown that though they have eliminated plastic particles, the metal against metal movement has resulted in shearing off of metal fragments. Small, sometimes microscopic metal fragments can cause a condition known as metallosis when deposited into surrounding tissues. Metallosis is essentially metal poisoning of local tissues.
Like several other MoM hip implant systems, the DePuy Pinnacle and ASR implants have shown an alarming failure rate that has contributed to thousands of injury reports and has required numerous replacement surgeries which are painful, costly and often much more invasive than the original surgery.
Design of DePuy Hip Replacement Products
The DePuy Pinnacle Acetabular Cup Liner is a metal liner designed for use with the Pinnacle Acetabular Shells and the matching femoral head which are constructed with a proprietary alloy containing cobalt, chromium, and molybdenum. This design was based on a near-identical DePuy product that had already been approved, the Ultima MoM Acetabular cup – also a device with both a metal liner and shell.
The acetabular cup is a portion of the hip implant which is set in the acetabulum portion of the hip bone which acts as the “socket” of the hip’s ball and socket joint system. The liner sits over the top of the femoral head which is the “ball” portion of the hip joint.
Despite DePuy’s intention that the implants would last longer, estimates show that more than 10 percent of the Pinnacle products will fail, resulting in tissue death and other joint injuries. The Ultima system that the Pinnacle design was based on has shown an even greater requirement for replacement.
In addition, the alloy used in the MoM construction may cause increased damage as it contains cobalt, chromium, and molybdenum, all of which are toxic to the human system. Side effects from systemic (body-wide) absorption could go even further than local toxicity and result in nerve and heart damage.
Despite these known problems with the Pinnacle system, the implants were never officially recalled through the Food and Drug Administration but were instead simply discontinued in 2013. Discontinuation allows the manufacturer to avoid an admission of defects.
The DePuy ASR XL Acetabular total hip replacement and the ASR hip resurfacing system were used in over 93 thousand hip replacement procedures. Both products were part of a large-diameter design class which reportedly increased stability and mobility in patients who received the implants. They were also created from a single sheet of metal which was molded rather than cast – again to increase their durability.
The ASR XL system was used in the US for total hip replacements, while the ASR resurfacing system was only used outside of the US. Within five years of implant, up to 40 percent of patients may have required a revision surgery. DePuy recalled both systems in August of 2010 due to the high rate of failure.
Some of the problems caused by the ASR systems have been identical to issues caused by the Pinnacle and prior Ultima Systems manufactured by DePuy.
History of the DePuy Hip Implant Devices
The DePuy ASR products were in use in the international community as early as 2003. The ASR XL Acetabular System was approved by the FDA for use in the US in 2005 using the FDA’s 510(k) program which allowed the company to avoid lengthy and costly clinical trials required for most medical devices.
DePuy attempted to have the ASR resurfacing device approved but it did not qualify for the 510(k) program and the application was recalled due to issues with the clinical trials which showed femur fractures. Despite known clinical failure, ASR resurfacing devices continued to be sold outside of the US.
Although it was not approved in the US, physicians could use the device obtained elsewhere as an “off-label” use. Unfortunately off-label procedures are treatments are not well-tracked here in the US, so it is not known how many of the ASR resurfacing products may have been used and the lack of tracking made it difficult for physicians to be aware of problems with the resurfacing system which had begun to fail.
The lack of knowledge and transfer of information from foreign markets also delayed any knowledge the physicians may have had regarding the ASR products as a whole. Complicating this lack of knowledge, hospitals and physicians are not required to report adverse events as the reporting system is voluntary. Despite that, there were more than 300 complaints reported to the FDA between 2008 and 2010 regarding the ASR.
Many surgeons also choose devices based on marketing information that was given them by the company. In most cases, marketing claims have been substantiated by clinical trials. As the ASR devices and Pinnacle devices were not required to have clinical data, physicians were left to rely on company reports regarding robustness of the devices and an expectation for reduced numbers of adverse events.
In addition, DePuy was among four device makers who settled with US government officials in 2007 regarding an investigation into payments that were made by the companies to physicians who agreed to use their devices. DePuy paid $84.7 to avoid prosecution.
Questions about the ASR devices came to the forefront in 2007 when a British orthopedist, Dr. Antoni Nargol approached DePuy after seeing multiple patients return with complications. DePuy claimed that surgical technique was the issue and not the devices; however his presentation at the Seventeenth Annual Fall Meeting of the American Association of Hip and Knee Surgeons resulted in a number of physicians coming forward to say that they had seen similar problems.
According to the British Medical Journal, despite DePuy claims that the device was not at fault, the Australian joint registry had warned DePuy 17 times between 2007 and 2009 and reported that the ASR had a revision rate that was twice the normal level.
Many physicians also identified increased chromium and cobalt levels in their patients which was suspected to be caused by the shallowness of the cup leading to excessive wear. This was reported at the British Orthopaedic Association Conference but nothing changed. Despite the fact that DePuy representatives were present at the conference, the company claimed they were unaware of any issues.
In 2009, DePuy voluntarily pulled the ASR resurfacing from the Australian market but made no changes in the total hip replacement system and phased the resurfacing device out in 2010. No changes were made in the total hip replacement system though international tracking showed that both ASR systems had a higher than normal failure rate and DePuy focused most of the attention on the resurfacing products alone.
In August of 2010 DePuy announced a worldwide recall of both products due to their identification of “new” data from England and Wales which showed a double revision rate – almost identical to that already seen in Australia.
DePuy has continued to maintain they were unaware of issues until the 2010 data, despite the warnings and information they had been receiving since 2007. The devices were implanted in thousands of patients after reports began to surface.
The DePuy Pinnacle hip replacement devices, unlike the ASR devices were never recalled. The Pinnacle was approved by the FDA in 2002. It followed a near-identical device, the Ultima device which has also shown a high rate of revision surgery. The Pinnacle device’s metal failure has been shown to prematurely erode, releasing metal particles that may cause both short-term and long-term adverse events. Estimates show that as many as 10 percent of patients who received the Pinnacle device have faced or will face revision surgery. The Pinnacle device was not recalled by DePuy who would have been required to give a reason for a recall but was discontinued in mid-2013.
Serious Adverse Events and Complications the DePuy Hip Implant Products
Since the introduction of the MoM hip implant products, there have been hundreds of recalls and discontinuations. In addition, thousands of lawsuits have been filed against the manufacturers including DePuy Orthopedics for the ASR and Pinnacle hip systems.
The majority of the problems associated with MoM devices are because of the tendency for the metal to be shed into body tissues. This results in poisoning of the local tissue known as metallosis. The DePuy devices are also suspected of causing brain and heart damage due to the proprietary composition of the alloy which contains chromium, cobalt, and molybdenum – known to be toxic to the human body, particularly nerve and muscle tissue.
Metallosis injury can sometimes be remedied with a revision surgery, however that type of surgery often requires reconstruction of bone tissue and is much more invasive and requires a longer rehabilitation time than the original surgery. Systemic or body-wide toxicity caused by the absorption of chromium, cobalt and molybdenum metal ions is likely permanent and is life-threatening in many cases.
DePuy hip implants, including both the ASR and Pinnacle systems can cause serious adverse events such as:
- Metallosis – local toxicity caused by particles of metal that have been shed from the implants and are deposited into body tissues.
- Osteolysis and necrosis – dissolution of the bone tissue and death of bone and surrounding tissues due to metallosis poisoning. This is due to direct poisoning but also due to an inability of the body to supply oxygen and other nutrients to the area. Death and dissolution of bone tissue may result in the requirement for bone reconstruction during revision surgery as bone tissue does not easily grow back.
- Periprosthetic fractures – fractures in the surrounding bone, usually the femur neck. This was the primary reason why the ASR Resurfacing implant was not introduced to the US as clinical studies showed a high incidence of Periprosthetic fractures.
- Pseudotumors – large collections of solid or semi-solid mass around the implant which cause inflammation, pain and restricted movement
- Extreme Pain and Inflammation – Pain is likely the common symptom of adverse reactions to the ASR and Pinnacle hip replacement products. This is due to the metal fragments that may be shed by the metal-on-metal design which causes inflammation and pain.
- Hip Revision Surgery – Revision surgery is the most common ultimate result from all adverse events associated with hip replacements. It is usually required due to severe pain and malfunction of the joint as tissue is damaged and no longer able to function appropriately. It will require removal of the malfunctioning device, reconstruction as needed and the implant of a new device. Recovery is often much longer than the original surgery.
- Systemic metal poisoning – caused by chromium, cobalt, and molybdenum which has been shown to be higher than normal in laboratory results of some patients who have received the DePuy devices. This has resulted in claims of brain damage, cancer and cardiac damage.
DePuy Hip Side Effects
The severe side effects caused by the DePuy hip devices are primarily a result of a faulty design. The devices were manufactured to offer customization for each patient and the ball-and-socket components of the devices were available in combinations of ceramic, polyethylene, and metal. A high number of patients found that the metal-on-metal option could result in severe DePuy side effects.
Most modern hip implant devices were approved under the Food and Drug Administration’s 510(k) device exemption. The 510(k) Premarket Notification Process allows for medical devices to forgo stringent and costly clinical testing by claiming that devices are enough like other approved medical devices that testing is not needed. Because of this 510(k) approval, DePuy hip implants had not been tested in humans prior to marketing for public use.
DePuy Side Effects
DePuy hip implants may cause a number of side effects that are not medically serious but may impact the patient’s quality of life and ability to perform normal activities including:
- Pain and inflammation in area surrounding implant
- Hip instability or hip dislocation causing difficulty with walking or standing
- Muscle atrophy due to immobility
DePuy Serious Adverse Events
All hip implants may cause severe side effects but the DePuy devices have resulted in a higher than normal failure rate due to the metal-on-metal construction.
DePuy hip implants may cause severe side effects such as:
- Metallosis – metal fragment and ion release causing toxicity
- Necrosis – bone and other tissue death from metallosis toxicity
- Osteolysis –bone dissolution due to metallosis poisoning
- Systemic metallosis – whole-body inflammation from metal ions
- Pseudotumors – formation of tumor like deposits surrounding affected joints
- Bone fractures – weakening and breakage of bones surrounding hip implant
- Revision Surgery or Reconstructive Surgery– to replace implant or reconstruct bones surrounding injured joint (femur and pelvis)
Metallosis is a type of metal poisoning caused by the release of metal fragments and metal ions into tissue surrounding the implant site. This metallic debris, caused by components of the metal-on-metal devices grating against one another may also be released into the bloodstream. Patients who get metallosis from DePuy hip implants may experience localized reactions of pain and swelling but may also experience necrosis and osteolysis.
Patients who have had metal ions enter the bloodstream may experience systemic effects of metal poisoning such as fatigue, headache, body aches, rashes, and other flu-like or inflammation-like symptoms.
DePuy Implant Failure
Some patients have experienced complete device failure which is caused by loosening of the implant. This may limit the patient’s range of motion or may cause dislocation and misalignment of the joint and device resulting in pain and immobility. Some experts have observed that the design of the ASR cup component may be excessively shallow and contribute to device failure.
DePuy Bone Fracture
DePuy severe side effects have also included bone fractures. Metallosis may cause breakdown of the bone tissue in surrounding the implant site, resulting in weakened femur and pelvic bones which may fracture and require reconstruction.
DePuy Revision Surgery or Reconstructive Surgery
In many severe side effect cases caused by DePuy Pinnacle Hip Replacement System, ASR XL Acetabular System, or ASR Hip Resurfacing System implants, patients must undergo revision surgery. Some patients may also require reconstructive surgery.
Revision and reconstructive surgeries are often much more invasive and painful than the original joint replacement surgery. Patients are required to undergo longer rehabilitation periods and are exposed to additional surgical and recovery risks including: infection, inflammation, pain, and immobility. Some patients have to undergo multiple surgeries to repair damage caused by DePuy implants.
The FDA 510(k) approval process
The FDA identifies hip replacement devices as “Class III” medical devices indicating that they pose a greater risk of harm to the patient than lower classed devices. Normally, Class III devices are required to go through the Premarket Approval (PMA) process which requires significant clinical testing in human patients proving that the device is safe and effective for its intended use.
For devices that are substantially similar to currently approved devices may be exempt under the FDA 510(k) approval process which allows the company to avoid clinical testing. The Pinnacle Hip Replacement device was exempted based on a prior DePuy product, the Ultima. Once the Pinnacle device was on the market, DePuy was able to claim exemption for the ASR total replacement hip device based on the Pinnacle. The ASR resurfacing system was never approved in the US because it did not qualify for the 510(k) exemption and clinical testing demonstrated failures, consequently the application was withdrawn though the device was in use in other parts of the world.
The 510(k) process requires that the company conduct post-market surveillance of the product based on reported adverse events. This reporting is generally only based on events that are voluntarily reported but such reporting is not required. DePuy was made aware of issues surrounding both systems based on information released in 2007 and reports of failure in the earlier device, Ultima. Despite this knowledge, the company did not recall the ASR device until 2010 and discontinued the Pinnacle device in 2013, having never issued a recall.
DePuy ASR and Pinnacle Hip Replacement Lawsuits
DePuy faces both state and federal lawsuits that number in the thousands for both its ASR and Pinnacle hip replacement systems.
The first ASR lawsuit, filed in California resulted in an $8.3 million judgment in 2013. Documents presented at the trial indicate that as many as 40 percent of ASR hip patients may require revision surgery. More than 8,600 lawsuits filed against DePuy regarding the ASR devices have been consolidated into multidistrict litigation (MDL) in the US District Court for the Northern District of Ohio which is overseen by Judge David Katz. Thousands of cases are pending in state courts, including over 2,000 cases in the State of California alone. Johnson and Johnson will reportedly pay $2.5 billion to settle 7,500 ASR cases.
DePuy and Johnson & Johnson also face over 5,400 cases regarding the Pinnacle hip implant system which have been consolidated into an MDL in the US District Court for the Northern District of Texas, overseen by Judge James Kinkeade. The first trial regarding the Pinnacle system is set for September of 2014.
Attorneys for the plaintiffs (patients) claim the DePuy marketed a defective medical product, failed to provide adequate warnings and information regarding the potential for adverse events and that the company used improper and illegal practices in its marketing of devices.
In addition to the lawsuits that have been filed, thousands more are expected. Learn more about DePuy Lawsuits here.
DePuy Litigation and Lawsuits
DePuy, along with several other hip device manufacturers were forced to address charges by the U.S. Department of Justice regarding payments that had been made to orthopedic surgeons for use of the DePuy devices. Five companies, including DePuy were found to have paid over $198 million to 939 surgeons in 2007 and over $228 million to 526 surgeons in 2008. DePuy voluntarily disclosed continuing payment information in 2009 and 2010.
Over 90,000 patients worldwide received a DePuy ASR implant and nearly 40 percent of those devices may be expected to fail. The first lawsuit regarding DePuy ASR implants was settled in 2013 for more than $8.3 million. Johnson & Johnson, the parent company of DePuy has already agreed to settle more than 8,000 federal lawsuits in Ohio for $2.5 billion. Additional lawsuits are consolidated in New Jersey, Indiana and California and in other state and local courts. The manufacturer and may be expected to pay at least another $1.5 billion for ASR implant lawsuits.
DePuy also faces almost 6,000 federal lawsuits regarding the Pinnacle devices. These lawsuits have been consolidated into mdl in the U.S. District Court for the Northern District of Texas and additional lawsuits exist in other areas such as Florida. The first federal trial regarding the Pinnacle device was begun in September of 2014. The outcome of that trial will determine DePuy’s decision to consider a settlement but additional lawsuits are expected.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.