Plaintiffs involved in a number of lawsuits brought over the DePuy Orthopaedics’ ASR metal-on-metal hip implant device may now also file claims over the device maker’s Pinnacle device. DePuy Orthopaedics is a unit of Johnson & Johnson.
The plaintiffs are involved in seven lawsuits filed over the DePuy ASR and were just advised that they are also permitted to file claims over the Pinnacle acetabular cup device, also manufactured by DePuy, according to a California state judge’s ruling, MassDevice.com reported.
Judge Richard Kramer of the California Superior Court in San Francisco permitted a joint motion that was filed by the plaintiffs who seek to include their DePuy Pinnacle claims to the DePuy ASR lawsuits, court documents indicate, according to MassDevice.com.
Johnson & Johnson faces more than 10,000 lawsuits nationwide over the DePuy ASR, which was recalled in 2010 over reports of high failure rates; premature device failure; and injury reports, including the need for revision surgery to remove and replace the faulty device. This March, a California jury awarded one plaintiff $8.3 million in damages and found that the DePuy ASR XL metal-on-metal implant was defectively designed, according to MassDevice.com. An internal company audit revealed that one in three of the devices could fail in under five years. That information was part of testimony revealed this January in one of the lawsuits.
The device maker has since revealed that the DePuy ASR recall cost it $271 million during 1st quarter 2012. Regulators in the U.S. have initiated a probe into possible marketing violations tied to the DePuy ASR, according to MassDevice.com. Meanwhile more than 900 DePuy Pinnacle cases have been included in a multidistrict litigation (MDL) in Texas. The judge overseeing that litigation ruled this May that DePuy Orthopaedics must produce compliance reports on its Pinnacle device.
In the U.S., all-metal devices, as a class, are the focus of safety concerns in the orthopedic community. The devices were approved using the U.S. Food and Drug Administration’s (FDA) fast-tracked 510(k) approval process in which clinical testing is bypassed. Studies are now revealing that the metal-on-metal devices fail more often than their non-all-metal counterparts.
The all-metal hip devices were created for increased durability and longevity and with the intention that the seemingly stronger components would offer greater benefits when compared to the more traditional devices constructed with plastic or ceramic elements. In recent years, the metal devices have been highly criticized for failing at unexpectedly high rates and leaving patients with significant, often life-long injuries.
Some experts accuse European and American regulators of working to ensure patients were not made aware of the devices’ risks; many have criticized device makers for placing profits before patient safety. Meanwhile, the U.S. Food and Drug Administration (FDA) just issued new guidelines to patients implanted with metal-on-metal hip replacement devices including that physicians conduct physical examinations, diagnostic imaging, and metal ion testing, as needed. The agency also proposed stricter regulations requiring manufacturers prove the implants are safe and effective before selling them.