DePuy Hip Replacement Side Effects
DePuy Orthopaedics is a subsidiary of Johnson & Johnson, the largest healthcare products company in the world with estimated annual revenue of $72 billion. With an individual yearly revenue of over $9 billion, DePuy specializes in joint replacement and orthopedic surgical devices with over 200 individual products. Over its near 100 year history, DePuy has created hundreds of products that have found success but three of the hip replacement devices have shown a higher than usual rate of failure. Because of these devices, the Pinnacle Hip Replacement System, ASR XL Acetabular System, and ASR Hip Resurfacing System, DePuy and its parent company, Johnson & Johnson are facing thousands of lawsuits due to severe and permanent medical injury.
Two of the faulty DePuy products have been recalled (DePuy Articular Surface Replacement (ASR) Hip Resurfacing System and the ASR XL Acetabular System for total hip replacement) but the Pinnacle hip replacement system remains on the market.
Like many other hip implant devices, some of the DePuy products have been constructed with metal-on-metal (MoM) construction. Manufactures of MoM devices, designed the implants to be longer lasting and to increase mobility for active and younger replacement. Unfortunately, the MoM design has instead caused unexpectedly high failure rates specifically because of metal-on-metal grating that releases small amounts of metal into surrounding tissue.
Patients who received these MoM devices may require replacement surgery or reconstructive surgery to repair tissue damage and joint failure caused by the devices.
Faulty DePuy Hip Implant Design
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.
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.