Just last week we discussed the especially bad week suffered by Johnson & Johnson. Unfortunately, for the medical device company, the bad news appears to keep on coming. The U.S. Food and Drug Administration announced a major Class I recall of yet another Johnson & Johnson orthopedic device. The recall is for a device known as an LPS Diaphyseal Sleeve. The device is used during reconstructive knee surgeries.
The FDA said the knee sleeve has been recalled due to a risk of fracturing. The regulatory agency says that it has received 10 reports so far of incidents involving the malfunctioning device. The affected devices were made by J&J’s DePuy division between 2008 and 2012.
The risks associated with a possible fracture in the device are great. According to the FDA, should the device fracture then it could result in a loss of function or even the total loss of a limb due to infection, possibly even death. The seriousness of the harm is why the recall was given a Class I designation. Class I recalls are reserved for those dangerous or defective products that are capable of causing the most serious health problems or death.
The news comes at a bad time for Johnson & Johnson and its orthopedic unit, DePuy. Currently, the company is in the midst of a critical lawsuit that could determine how many billions the company may have to fork over due to the failure of the DePuy all-metal ASR hip implant. The lawsuit, brought by Loren Kransky, is the first of nearly 10,000 such suits to go to trial.
Kransky testified this week, claiming that he was terrified before undergoing much needed revision surgery after receiving the metal-on-metal hip implant. He explained to the jury that he only underwent the extremely painful revision surgery because his doctors told him that he was being slowly poisoned by the metal shavings released by the hip implant and that if he didn’t remove the ASR device, he’d die from complications.
Kransky also explained the problems he experienced as a result of the hip implant. Before revision he says he suffered from horrible stabbing pains that prevented him from leaving the house. He also experienced swelling and had trouble walking and complained that the hip frequently made popping and other loud creaking noises when he moved.
Experts believe that these cases, which concern the recall of 93,000 DePuy ASR implants, could end up costing Johnson & Johnson well over a billion dollars. For the 500,000 Americans and more than 1,000,000 people around the world with metal hip implants, the verdict in the Kransky case will be closely watched. If you or someone you know have been injured by a defective product and you would like to discuss your case with an attorney, please contact the Georgia product liability litigation attorneys at Pope McGlamry P.C. today to schedule a free consultation.
Source: “FDA recalls J&J’s orthopedic device because of fracture potential,” published at Reuters.com.
See Our Related Blog Posts: