Johnson & Johnson, the blue-chip pharmaceutical and medical goods company, is recalling products through a subsidiary, DePuy Orthopedics, Inc., after finding a high rate of failure for their ASR™ XL Acetabular System and ASR™ Hip Resurfacing System. This line of medical devices replaces parts of the hip, specifically a bone called the acetabulum, in common hip implant surgeries. Reports indicate the devices have a failure rate of 1 in 12 over five years, more than double the common industry standard. Estimates also show more than 90,000 of these implants have gone out to patients worldwide. According to Associated Press reports, the U.S. Food and Drug Administration (FDA) received complaints about the hip implant for two years before the company decided to pursue a recall. In a related case, the FDA is also warning DePuy about the sale of some devices for “unapproved uses.”
Medical Issues Surrounding the ASR Hip System Recall
Recalling medical products implanted in a patient’s body is quite different from almost any other kind of medical recall. Doctors have to do extensive work in some cases just to diagnose problems. Another problem is the range of issues that can threaten patients with these devices. In addition to the risk of failure because of loose fitting, the ASR™ Hip System also creates debris in the form of metal particles as the artificial joint wears over time. Some patients may be sensitive to these metal particles. Other damages include a dislocation or separation between the bone and the implant. Fluid also collects around the joint leading to pain and other symptoms over time. Treatment is required or permanent damage can occur to the bone and soft tissue.
It is advisable for Florida citizens with the ASR™ Hip System to contact their treatment providers to address the medical issues created by this defective product. DePuy Orthopaedics has released instructions to medical professionals for the necessary follow-up testing and care, which includes diagnostic tests of x-rays, blood work and magnetic resonance imaging (MRI) to determine if surgical revision is necessary.
Orlando Product Liability Lawyer
The ASR™ Hip System recall is provoking a closer look at the regulation and sale of medical devices, and what product liability results when surgically implanted devices appear defective. The resolution of this major recall promises to be complicated. DePuy has agreed to pay “reasonable costs” related to replacement of the hip implants. However, the physical and emotional impact upon patients goes far beyond the cost of the medical care. Hip implants require major surgery. There is a great deal of pain and extensive rehabilitation. Recipients of hip implants are generally at an advanced age, which poses an even greater personal health risk.
If you or a close family member is a recipient of the ASR™ XL Acetabular System and ASR™ Hip Resurfacing System, feel free to contact the Orlando product liability lawyer at the Law Offices of James O. Cunningham, P.A. Mr. Cunningham and his professional legal team are well versed in Florida product liability, and are willing to answer any questions you might have about your legal options. You can reach Mr. Cunningham at 877-FL-INJURY or through his online contact form.