Galfand Berger Products Liability Attorneys in Philadelphia: DePuy Failed to Warn of Risks Associated with ASR Hip Implant
April 30, 2013
The products liability lawyers at Galfand Berger in Philadelphia have been following developments related to the DePuy hip replacement system implanted in thousands of people between the years 2005 and 2010. Johnson & Johnson, parent corporation of DePuy, is currently facing nearly 11,000 lawsuits regarding the recalled DePuy ASR and DePuy ASR XL hip replacement systems. This represents one of the biggest medical device failures in decades. A recent case concluded in Los Angeles with the plaintiff being awarded $8.3 million for injuries connected to use of the defective medical device. In that case, the plaintiff alleged that Johnson & Johnson knew about the dangers and risks associated with their product long before they initiated a recall, but deliberately concealed them and failed to warn patients.
Johnson & Johnson Knew the Hip Implants Were Defective
The DePuy Articular Surface Replacement (ASR) hip implant, manufactured by DePuy Orthopaedics, a division of Johnson & Johnson, gained approval for use through the Food and Drug Administration’s 510(K) clearance plan, a fast tracked program that did not require the medical device to undergo human testing. It was sold around the world for several years even after the FDA raised some health and safety concerns about the success of the medical device in other countries. It has now been discovered that the company may have known as early as 2008 that the medical device had a serious design flaw based on earlier testing as well as reports from physicians that the implants were failing within just a few years. Typically, an implant should last for about 15 years.
In 2009, DePuy decided it would start to phase out the ASR hip implant, claiming low sales. In early 2010, DePuy began warning doctors that the hip implant device had a higher failure rate for specific patient populations including individuals with weak bones and those of a small stature, namely women. Physicians were encouraged to use other DePuy hip replacement products. Finally in August 2010, a global recall was issued. By this time, approximately 93,000 patients worldwide had received the ASR hip implant with about one-third of them in the United States.
Johnson & Johnson conducted an internal analysis of the hip implant after the major recall was announced in 2010. Based on this review, the company projected that nearly 40 percent of the patients who received the medical device would have it fail within 5 years after implantation. Johnson & Johnson never released this information or predictions to the public. Moreover, at the same time that they were conducting their research, they minimized similar findings made by the National Joint Registry of England and Wales, a British implant registry. Their research showed that 12 to 13 percent of patients who already had the hip implant needed to have a revision surgery with 5 years of receiving it. This is equivalent to 1 out of every 8 patients.
Serious Health Complications Linked to the DePuy ASR Hip Replacement System
The DePuy ASR hip implant is a cup and ball metal on metal device that is made of cobalt and chromium. When these defective medical devices have failed at a premature rate, patients have experienced pain, swelling, joint tenderness and difficulties walking. In addition, there have been patients that have suffered from the affects of metal poisoning. Elevated levels of cobalt and chromium have been documented. Small metal shavings or debris are released into the bodies of patients after the metal on metal components grind against each other. This can cause damage to the bones and tissues surrounding the hip implant as well as the potential to cause central nervous system injuries. Numerous patients have suffered debilitating injuries with many requiring painful revision surgeries to replace their defective implants.
Galfand Berger in Philadelphia: Products Liability Lawyers Committed to Helping Victims Injured by DePuy Hip Replacement System
If you or someone you love has a DePuy hip replacement implant, we encourage you to first contact your physician immediately to seek medical advice about the potential failure of the medical device. Then, contact the Philadelphia products liability attorneys at Galfand Berger so that we may assist you in determining if you have a valid claim against Johnson & Johnson for injuries resulting from the implanted hip replacement system or an implant that has previously been removed. You may be entitled to recover compensation for your medical bills, pain and suffering, and lost income. Our product liability attorneys maintain offices in Philadelphia, Reading and Bethlehem, Pennsylvania. Call us today at 1-800-222-USWA (8792) to schedule a free consultation with one of our personal injury attorneys or submit a free online inquiry.