A July 12 Reuters article projects Johnson & Johnson’s Depuy Pinnacle Hip Replacement device may incur more costly lawsuits for J&J on the horizon. Presently, according to Reuters, the Pinnacle metal-on-metal hip device has approximately 1,600 lawsuits pending in U.S. courts. Following on the heels of the J&J ASR hip recall in August 2010, these complaints may eat further into the company’s profit margin, but the problem is self-inflicted.
The DePuy Pinnacle Hip Replacement device approved by the FDA for use in 2000 originally was designed for a variety of material combinations, including ceramic-on-polyethylene, metal-on-polyethylene, ceramic-on-ceramic, metal-on-metal, and ceramic-on-metal. The metal-on-metal design of the DePuy Pinnacle Hip Replacement device is known to produce friction between the cup and the ball-shaped replacement portion of the thigh bone. The friction causes erosion of the metal device and metal particles can leech into the body tissues. The FDA has received a bevy of adverse reaction reports and patients having to obtain revision surgery to remove the device sooner than expected has become commonplace.
While the metal-on-metal hip joints were originally thought to be more durable and last longer than other combinations, a 2010 American Academy of Orthopaedic Surgeons survey indicates fewer surgeons (16%) have been using the metal-on-metal hip replacement following an FDA warning of adverse reactions with the use of the Pinnacle Hip Replacement device. Common problems associated with the Pinnacle hip replacement have been pain, swelling, limited mobility and dislocation, as well as cobalt and chromium ions seeping into the bloodstream, causing "metallosis," which can lead to more serious problems, such as nerve damage, bone staining, even renal failure.
As metal-on-metal hip revision surgeries rise, surgeons use fewer of the metal-on-metal hip replacement devices, and sooner-than-expected failures and lawsuits increase, J&J’s recent $21.3 billion acquisition of Synthes, a premier global manufacturer of orthopedic devices, may become an even more valuable asset.
Regardless, doctors with knowledge of this issue predict that more than 10 percent of the Pinnacle metal-on-metal hips will have failed within the next 2-3 years. That is not an acceptable failure rate for any product, much less one that is implanted in people. If 10 of all airplanes built totally failed within 5 years, or 10 years, or even 15 years of manufacture, that would cause a public outcry and serious investigations. Any qualified engineer will say that a 10 percent failure rate, or even a 1-5 percent failure rate, is too high and indicates a serious, systemic problem.
Dr. Mary O'Connor, an orthopedic surgeon at the Mayo Clinic has indicated that she believes that we are just now seeing "the tip of the iceberg with metal-on-metal failures". Approximately 500,000 patients have received metal-on-metal hips in the United States, with 150,000 receiving the Pinnacle and about 37,000 receiving the ASR (recalled in August 2010). The Pinnacle metal-on-metal implants appear to be trending toward failure rates approaching the ASR's, but the overall Pinnacle failure rate is watered down because it includes metal-on-ceramic and metal-on-polyethylene versions, which have lower failure rates than the metal-on-metal models.
A recent FDA panel concluded that there was little reason for surgeons to use metal-on-metal hip implants given the risks. In fact, there are some surgeons who are so upset with DePuy over the failed ASR hips that they filed a class action against Johnson & Johnson and DePuy over the misrepresentations made concerning the recalled ASR. The case was filed in the United States District Court for the Eastern District of Virginia, but was transferred to the pending ASR multi-district litigation (MDL) in Ohio.