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Follow on Google News | Johnson & Johnson Chose Inventory Selloff Over Patient SafetyAfter FDA Denied Approval of the DePuy ASR Hip Resurfacing System, Johnson & Johnson Decided to Sell Off the Remaining Inventory Explains Ennis & Ennis, P.A.
By: Jami Angelini Haggerty The FDA confidentially notified Johnson and Johnson that it was turning down the company’s application to sell the device in the United States and requested additional safety data from DePuy if it wanted to pursue its US application for the all-metal hip resurfacing system. DePuy, a subsidiary of Johnson and Johnson, did not recall this defective device or a companion model that was already in use in the US, until August 2010, a full year after it received notice from the FDA. Instead, it chose to phase out the rejected device and sell the entire remaining inventory for use in patients abroad. It is estimated that over 30,000 patients in the US have received a DePuy ASR metal hip replacement, which suffers from a failure rate as high as 12% according to the National Joint Registry of England and Wales. [www.depuy.com/ As recently as March 13, 2012, a study published by the Lancet Medical Journal confirms that all-metal hip implants fail more often than other types of hip implant devices. This study analyzed data of more than 400,000 hip replacements, of which 31,171 were all metal ones implanted between 2003-2011. There is a 6.2 percent chance patients with all-metal hips will need a replacement within five years, which is three times greater than the revision rate seen with older patients. The authors of the study indicate, “Metal-on- Ennis & Ennis, P.A. recommends that anyone with a DePuy Hip Replacement or any other all-metal hip implant system, who is experiencing pain in the groin, hip or leg, swelling at or near the hip joint, or a limp/change in walking ability, first seek medical attention. Then file an adverse event report with the FDA at https://www.accessdata.fda.gov/ Ennis & Ennis is offering free, nationwide, confidential consultations to anyone who has an all-metal hip replacement system by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form. Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. that concentrates its practice in mass torts and represents individuals against pharmaceutical companies and medical device makers. Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients. Ennis & Ennis, P.A. is also investigating cases involving Accutane, Actos, Avandia, Fosamax, Paxil, Plavix, Pradaxa, Zoloft/Birth Defects, Prozac/Birth Defects, Zimmer Hip Recall, Wright Conserve Hip Implant, Wright Profemur Hip Implant, any all-metal hip implant, Depakote, Reglan, SJS/Dilantin, Yaz, Yasmin and Ocella Birth Control Pills. Remember the law limits the time in which you can file a claim, so don't wait to explore your legal rights. Call today toll free 1-800-856-6405 or visit www.ennislaw.com. End
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