In the face of mounting lawsuits, problematic hip devices have led to a huge, and growing, debacle that includes reports of serious adverse reactions, global recalls, and regulatory and medical reviews. In fact, some experts say that European and American regulators ensured patients were not made aware of these devices’ risk. Now, court documents reveal that executives at Johnson & Johnson were aware that its artificial hip device had significant issues years before its recall.
It seems that the Articular Surface Replacement (ASR) was known to have issues in 2005, five years prior to its eventual recall in 2010, said The New York Times. Not only were the issues known, they were concealed, court documents indicated, from physicians and patients. Making matters worse, Johnson & Johnson’s DePuy Orthopaedics unit had received physician complaints about its ASR device as it was being marketed in the United States in 2005.
In fact, the ASR failed an internal test in 2007 when internal engineers compared the device’s performance to that of another of its device’s, according to the documentation the Times noted. The Times also pointed out that surgeons who worked as consultants with the device maker stopped using the device and DePuy executives discussed how to correct the defect, citing the records. Despite all of this, DePuy executives continued to sell the ASR and a correction was never made.
As we’ve long written, research has linked metal-on-metal hip implant devices to an increasing array of adverse events that include tissue necrosis, pain at the implant site that sometimes spreads to the groin and back, inflammation, swelling, metal poisoning, high failure rates, osteolysis (bone loss), and fluid collection/solid masses around the hip joint. The issue appears to be with the metal used in the construction of the implants, which was touted to last for at least two decades. More and more, reports and research indicate that some patients have required painful revision surgeries just two or three years after original implantation.
Earlier this month, the U.S. Food & Drug Administration (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 experience pain; swelling; a change in their ability to walk; or who hear noises emanating from the hip, such as popping, squeaking, and grinding, should speak with their physicians. These symptomatic patients should be considered for metal ion testing, the agency said. The FDA also recommended that metal-on-metal hip implant patients undergo regular physical examinations, routine radiographs, and diagnostic imaging for ongoing assessment of the patient reaction to metal-on-metal devices.
From a legal standpoint, these changes are an important step in attempting to hold manufacturers responsible for dangers associated with their products.
Meanwhile, the damaging documents were introduced late last week in Los Angeles Superior Court during opening arguments. This is the first ASR-related lawsuit to go to trial, noted the Times, adding that Johnson & Johnson faces more than 10,000 lawsuits in the U.S. over the device. Some 93,000 patients worldwide received an ASR; one-third of them in the U.S.
Although an attorney for DePuy argued that the firm acted ethically, the plaintiff’s attorney provided data that suggested the device maker’s concern appeared to be profits over patients, noted the Times.