The plaintiff in a lawsuit brought against Johnson & Johnson over its DePuy Orthopaedics ASR metal-on-metal hip devices was questioned about surgery he had to undergo to remove the faulty hip implant. Loren Kransky’s lawsuit is the first of some 10,000 filed against the device maker over a now-recalled hip device.
Kransky testified that he dreaded having to undergo revision surgery to have the DePuy ASR removed, but he said he feared the device was poisoning him, he was unable to walk, and the pain was unbearable, said Bloomberg.com. As we’ve explained, revision surgery is a complex, painful, and dangerous procedure in which a faulty device is removed and a different device is implanted.
Retired prison guard Kransky, 65, of Montana told a Los Angeles jury that he was afraid the revision surgery would kill him, but underwent the procedure last February to remove the faulty ASR that was implanted in December 2007, said Bloomberg.com. “I didn’t want to have the hip done because I had 25 surgical procedures done prior to that,” Kransky told a state court jury, said Bloomberg.com. “I thought that surgery was going to kill me. I thought I was going to die.”
Johnson & Johnson recalled 93,000 ASR devices in a worldwide move in August 2010 after acknowledging that at least 12 percent of the hips failed. Since, noted Bloomberg.com, the failure rate has been reported as being higher. For instance, the ASR failure rate reached 40 percent, according to data from an Australian joint registry.
Not unsurprisingly, Johnson & Johnson denies Kransky’s claims that it defectively designed the ASR, failing to warn of its risks. An attorney for the device maker also said that Kransky’s claims of increased metal ions in his body are due to his other health issues such as diabetes, high blood pressure and cholesterol, strokes, and kidney cancer, said Bloomberg.com, and that Kransky is a vasculopath, meaning that his blood vessels are diseased.
“I came to believe that I was going to have to do it because I was told that something in my body was poisoning me,” Kransky said of the revision surgery, according to Bloomberg.com. “I was told it could be the hip. I thought, ‘I’m going to die either way.’ One way would be slow and one would be fast. I took the lesser of two evils.” Kransky described “a kind of stabbing type of pain. It was debilitating. I couldn’t do anything, couldn’t walk long distances,” adding that he was unable to appropriately rehabilitate following a stroke, could not use the bathroom appropriately, was unable to sleep, and needed a wheelchair, which he said was “humiliating.” Kransky explained, “I didn’t want anybody to see me in a wheelchair…. I was always independent and strong. Here I am in a wheelchair,” Bloomberg.com reported.
The trial has also revealed a troubling trend seen in the physicians who were paid consultants to DePuy. In one case, noted The New York Times previously, a doctor sent a note to a number of Johnson & Johnson executives stating that one of the firm’s artificial hips was so badly designed, its marketing should have been cut so that the firm could review why the device was injuring patients. The physician consultant wrote the note nearly two years before the DePuy Articular Surface Replacement (ASR) devices were recalled.
This was not the only “early waning” the device makers’ executives received from its paid consultants, noted The Times. Yet, despite numerous warnings DePuy Orthopaedics continued to tout the now-recalled device that is at the center of thousands of lawsuits and patient claims of serious injury. As bad, pointed out The Times, are the physician consultants who never went public with what they learned about the ASR to other surgeons and who kept implanting the faulty device. The startling memos have surfaced as part of the first trial brought against Johnson & Johnson over the ASR.
Metal-on-metal hip implant devices were created for greater durability and longevity and with the intention that the seemingly stronger components would be far superior over their more traditional counterparts that are constructed with plastic or ceramic components. In recent years, the metal devices have come under fire for failing at unexpectedly high rates and leaving patients with significant and, often, life long injuries. Some experts say that European and American regulators worked to ensure patients were unaware of the devices’ risks and many have criticized device makers for placing profits before patient safety.