A class action lawsuit has just been certified by an Ontario, Canada judge against DePuy Orthopaedics over its recalled ASR metal-on-metal hip implant device. DePuy Orthopaedics is a unit of Johnson & Johnson. The ASR is the focus of large-scale litigations in the United States.
The class action, which was filed in Ontario’s Superior Court of Justice, seeks damages for all patients implanted with DePuy’s ASR hips and is meant to cover medical monitoring and emotional distress. The complaint, according to MassDevice.com, might include about 4,000 Canadian patients.
DePuy has been at the center of litigation worldwide; some bellwether trials are scheduled to begin in the United States next week in the multidistrict litigation (MDL) consolidated in the U.S. District Court for Northern Ohio, MassDevice.com reported. The first lawsuit involving the DePuy ASR settled in August 2012 before it went to trial. A jury awarded another plaintiff $8.3 million, finding that the ASR was defectively designed, according to MassDevice.com. The judge denied DePuy’s request for a new trial and most recently, an Illinois state jury found for the device maker in another case.
Meanwhile, attorneys representing thousands of alleged victims of DePuy Orthopaedics’ ASR metal-on-metal hip implant are calling for federal regulators to initiate a probe of the defective device. Attorneys told the U.S. Food and Drug Administration (FDA) that the Johnson & Johnson subsidiary violated federal law by keeping experts’ concerns about the device under wraps, according to Law360. One attorney group said that DePuy broke with federal reporting requirements from 2006 to 2010 by neglecting to advise the FDA about evidence that its ASR XL implants were not safe; this after two bellwether personal injury cases publically presented testimony concerning the device, Law 360 noted. Prior to that, the evidence was sealed under protective court orders.
The device maker recalled 93,000 ASR devices in a global recall in 2010; to date, more than 11,000 lawsuits have been brought against the device maker. Law 360 pointed out that Johnson & Johnson stated that 37 percent of the implants will fail earlier than expected; however, other estimates indicate that the premature failure rate exceeds 60 percent.
The attorney letter indicates, in part, that most of the injuries could have been avoided had DePuy complied with agency reporting requirements and heeded expert warnings about the devices’ dangers, according to Law 360. The letter also alleges that, in 2011, DePuy’s internal premature failure projections exceeded 30 percent in under five years but that DePuy never advised surgeons who were treating ASR patients and may not have advised the agency. For the most part, lawsuits allege that the DePuy ASR fails early and sheds toxic metals into patients’ tissues and bloodstreams, causing pain and resulting in more painful, invasive revision surgeries, according to Law 360.
Recently, Johnson & Johnson entered into talks about potentially paying more than $3 billion to settle the litigation. Five people familiar with the matter told Bloomberg.com that the drug maker is looking to pay more than $300,000 per each case, which would be more than $3 billion if most of the more than 11,000 plaintiffs accept the terms. The $3 billion is more than 50 percent greater than the amount discussed previously.
Metal-on-metal hip implants, as a class, have become the subject of safety concerns. These devices received clearance using the fast-tracked 510(k) route, which bypassed clinical testing. Now, studies reveal that metal hip replacements tend to fail more often than other implants, although the 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 constructed with plastic or ceramic elements. 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.