The California jury sent a clear message today that Johnson & Johnson and DePuy put profit over safety by awarding Loren Kransky, the plaintiff in the California case of Kransky v. DePuy Orthopedics, $ 8.3 million for damages caused by Mr. Kransky’s implantation and revision of the recalled DePuy ASR XL hip implant. Even though Dr. Trotsky, Mr. Kransky’s surgeon, felt that Mr. Kransky might not live through the revision surgery, Dr. Trotsky felt that removal and replacement of the DePuy ASR XL implant was absolutely necessary due to Mr. Kransky’s highly elevated levels of cobalt and chromium ions in his bloodstream, which were being shed from his recalled hip implant. Johnson & Johnson and DePuy aggressively marketed and allowed over 33,000 of these recalled hip implants to be distributed and implanted in patients across the United States, despite their knowledge that high levels of cobalt and chromium ions posed a serious threat for unaware patients.
In August 2010, when DePuy announced its recall of the DePuy ASR XL hip implant, the attorneys of Levin, Papantonio questioned DePuy’s motives behind what they deemed to be a voluntary recall based on newly received data (a 12 to 13 percent revision) from the England & Wales registry. The Australian Registry had shown signs of high revision rates for the DePuy ASR since 2007; so why didn’t DePuy act on this data and recall the device sooner? Numerous surgeons across the United States and key surgeons in the international community had condemned the DePuy ASR; so why didn’t DePuy listen to these well-respected surgeons and pull the product off the market? Why did DePuy withdraw the DePuy ASR from the Australian market in 2009, but continue to allow this device to be implanted in the United States? Why did DePuy brag in notable Orthopaedic publications that the DePuy ASR had a 99.2% success rate, when the Australian Registry and the England & Wales registry clearly showed this figure to be false?
When corporations are not regulated properly, all too often corporate GREED takes precedence over patient safety and the recalled DePuy ASR XL fiasco is a perfect example. The FDA’s deplorable 510(k) clearance process allowed DePuy to aggressively market an inadequately tested device and caused 33,000 patients across the United States to become guinea pigs for the recalled DePuy hip implant. The documents and testimony that became public during the first DePuy ASR XL trial in California have been reported in various newspapers across the nation and all over the internet. In addition to the $ 8.3 million award for for Mr. Kransky’s damages, over 10,000 other lawsuits filed on behalf of patients that have been injured by the DePuy ASR XL have not yet been determined.
Daniel Nigh is an attorney with Levin, Papantonio law firm.
