Recently released Court documents in the first lawsuit to come to Trial in the US which is being heard in California this week has revealed that executives at Johnson & Johnson were aware that its artificial hip device had significant problems years before its recall. The first law suit to come to trial is being taken by Loran Kransky whose Lawyers allege that the ASR given to him led to his hip instability. His case alleges failure to warn, defective design and negligent recall. DePuy had denied the allegations and accuses Kransky’s Lawyers of “weaving” snippits of e-mails, smidgeons of depositions and sound-bites of memos to falsely present the device maker.
The Court Papers have revealed that the Articular Surface Replacement (ASR) was known to have issues in 2005, 5 years prior to its eventual recall in 2010. Not only were the issues known, they were concealed from Doctors and patients it is claimed. Johnson & Johnson’s DePuy Orthopaedics unit had received Doctors complaints about its ASR device in the US in 2005.
According to the Court documentation the ASR device failed an internal test in 2007 when internal engineers compared the devices performance to that of another of its devices. Surgeons who worked as Consultants with the device makers then stopped using the device and DePuy executives discussed how to correct the defect according to the records. Despite all of this DePuy executives continued to sell the ASR and the correction was never made.
Earlier this month the US Health Watchdog (FDA) issued new guidelines for patients with metal-on-metal hip implants. The guidelines warned that the devices can cause bone and tissue damage due to the release of metal ions and also advised that patients who experienced pain, swelling, a change in their ability to walk or who hear noises emanating from the hip such as popping or squeaking should speak with their Doctors. These symptomatic patients should also be considered for metal ion testing, the agency said. The Authority recommended that metal-on-metal hip implants patients should undergo regular examinations, routine x-rays and MRI’s for on-going assessment of their reaction to the metal-on-metal devices.
Johnson & Johnson faces more than 10,000 lawsuits in the US alone over the device. Over 93,000 patients worldwide received an ASR, one third of them in the USA. Over 3,500 patients in Ireland received the same device and hundreds of claims have now been lodged in the High Court against the Company.