DePuy Orthopaedics, a unit of Johnson & Johnson, is facing billions of dollars in costs over a hip artificial recall after several patients reported they were suffering from its defective hip implants, legal experts say. There are some lawsuits being filed amid allegations of metallosis.
The Johnson & Johnson unit recalled its metal ASR hip system in 2010 after finding it had failed at a higher-than-expected rate. Aside from the danger it poses from metallosis, which may cause systemic damage to the central nervous system, thyroid and heart, it may also let patients experience pain, swelling over joint dislocation.
Metallosis is described as the result of the body reaction to a metal implant such as the ASR hip replacement. The immune system sees this device as foreign and it mounts a defensive action against the device and tries to rid itself of it, causing inflammation and scarring around the implant .
Therefore, every time there is a metal-on-metal articulation, small particles of the metal are shaved off and released into the blood stream, It also produces tiny specks called metal ions which human tissue doesn’t much care for. Such metal ions set up a foreign-body reaction in which the body's immune system (special white blood cells called macrophages), attacks the area in an attempt to rid the body of the foreign substance. In the process, bone and soft tissue may be destroyed as the body tries to respond to the metal ions. The ultimate result may be failure of the implant from loosening of the device where the bone has been destroyed causing more damage with the patient’s health.
Fracture, infection, or loosening of the implant usually requires a second surgery in which the hip implant is replaced with a different type of device, resulting to more painful experience for the patient. According to several surgeons, revision is considered as the most difficult and painful surgical operation.
Because of the negative impact caused by their defective hip implants reaching up to 93,000 worldwide, the company is currently facing about 8,000 in state and federal court in the United States alone.
In a highly unusual move, DePuy has hired a third party -- Broadspire Services Inc, which manages workers compensation and other medical claims on behalf of insurance companies and employers -- to administer patient claims for out-of-pocket medical costs associated with the recall.
The move has prompted debate among industry and legal experts. Some see it as an efficient way to outsource a process that is unrelated to making artificial hips. Others see it as a way for the company to limit payments while gaining control of medical records and other material that could be used against patients in court.
In general, companies and their lawyers handle recalls directly. They answer patient queries and pay claims for reimbursement. Typically, companies accept a treating physician's recommendation when it comes to determining if a device should be removed or replaced.
In DePuy's case, it is Broadspire's physicians, not the patient's own doctor, who, in effect, makes the final decision on whether a patient's hip should be replaced. While Broadspire physicians cannot directly override a patient's doctor in terms of treatment, they make the decision on whether to pay. That can effectively rule out surgery for patients who cannot pay. For more information on related cases, check DePuy Hip Recall News Center at depuyrecallnewscenter.com