The Food and Drug Administration recently announced a proposed set of rules that would make it much more difficult for medical equipment manufacturers to sell all-metal hip implants. Companies took advantage of not having to prove their products safe and effective, and were putting devices on the market that they knew caused injuries and were prone to early failure. Now, the F.D.A. seeks to rectify this, placing the onus on companies to show that their product is safe before they can begin or continue to sell an all-metal hip implant.
The South Florida defective hip implant lawyers at Friedman, Rodman & Frank are ready to use their product liability experience to aggressively seek the compensation you need to treat the injuries caused by an all-metal hip. They are very familiar with the problems caused by the metal-on-metal grinding that releases tiny metal shavings into the body, injuring nearby bone and tissue and elevating levels of cobalt and chromium in the blood to a point of toxicity.
Prior to its recall in 2010, the Johnson and Johnson’s Articular Surface Replacement (A.S.R.) device was a popular pick among doctors as they began using all-metal hip implants for its perceived durability benefits. A hip replacement for a metal-and-plastic implant usually lasts around 15 years. However, it has recently been shown that the manufacturers knew that an estimated 37% of patients using the A.S.R. will need to have it replaced within 5 years.
Hip replacements may be a common procedure, but they are far from easy to perform. Hip replacements, like any other serious medical procedure, can leave the patient exposed and prone to infections and blood clots. 29,210 Florida residents were hospitalized for hip replacements in 2011. Several hospitals had to readmit patients for complications related to the procedure. Complications can stem from the doctor choosing a faulty implant device. Any additional surgeries to replace previous hips are painful and increase a patient’s susceptibility to complications.
Johnson and Johnson’s DePuy Orthopaedics division withheld the results of their internal analysis that determined over 1/3 of the A.S.R.’s will need to be replace. They conducted this investigation while denying the results of a British implant registry that already determined the hip implants would fail at an early rate. Though the implant product had already been recalled during the internal analysis, there were still numerous patients who still had the A.S.R. implanted and were not notified of the potential risks.
This is analogous to the recently released documents regarding the drug Celebrex. The manufacturing company, Pfizer, only released the first six months of a study assessing the pain-killer’s effect on the stomach. Celebrex used the first half of the study in order to claim that their medication was safer than other over-the-counter drugs like ibuprofen, because it protected the stomach from complications often found when using a non-steroidal anti-inflammatory drug (NSAID). The full results showed Celebrex did not have an edge over any other pain reliever. Previously, Celebrex’s effectiveness was questioned because there hadn’t been any studies showing it to be more effective at treating arthritis than other over-the-counter medications.