FDA Investigation Sought in DePuy ASR Debacle

de-puy-investigationAttorneys 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 the device maker stated that 37 percent of the implants will fail earlier than expected; however, other estimates indicate that the premature failure rate is more than 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 were approved 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.

The hip implants 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.

Research has linked metal-on-metal hip implant devices, such as the DePuy ASR, to a number of adverse events such as 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.

On January 17, the U.S. Food and Drug Administration (FDA) issued a Safety Alert acknowledging these risks and issuing new guidelines for all-metal hip patients. The agency advised that people implanted with all-metal devices undergo physical exams, diagnostics imaging, and metal-ion testing, when necessary. In that same alert, the FDA also proposed new, stricter guidelines mandating manufacturers prove their devices are safe and effective through clinical testing, a method known as “premarket approval.”

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