Plaintiffs in DePuy ASR Cases May Include Pinnacle ClaimsJul 30, 2013
Individuals who have brought some specific lawsuits over DePuy Orthopaedics’ ASR metal-on-metal hip implant device are now able to also file claims over the device maker’s Pinnacle implant. DePuy Orthopaedics is a subsidiary of Johnson & Johnson.
The plaintiffs are involved in seven lawsuits that have been filed over the DePuy ASR device. They were just advised that they may also file claims over the Pinnacle acetabular cup device, which is also made by device manufacturer, DePuy. This is according to a ruling issued by a California state judge, MassDevice.com reported.
In a joint motion issued by Judge Richard Kramer of the California Superior Court in San Francisco, plaintiffs seeking to include their DePuy Pinnacle claims to the DePuy ASR lawsuits will now be able to do so, according to MassDevice.com.
Nationwide, Johnson & Johnson faces nearly 11,000 lawsuits over the DePuy ASR, a metal-on-metal hip device recalled in 2010 over reports of high and premature failure rates and injury reports, including the need for revision surgery to remove and replace the faulty device. Earlier this year, a California jury awarded a plaintiff $8.3 million in damages and also found that the DePuy ASR XL metal-on-metal implant was defectively designed, MassDevice.com reported. An internal company audit revealed that in less than five years, one in three of these devices could fail. The information was included in testimony given this January in one of the lawsuits.
The device maker has since revealed that the ASR recall cost about $271 million during the first quarter of 2012 alone. U.S. regulators have also initiated an investigation into potential marketing violations associated with the DePuy ASR, according to MassDevice.com. To date, more than 900 DePuy Pinnacle cases have been included in a multidistrict litigation (MDL) in Texas; the judge overseeing that litigation ruled in May that DePuy Orthopaedics is required to produce compliance reports on the Pinnacle.
In the United States, metal-on-metal hip implants, as a class of medical devices, are the focus of safety concerns in the orthopedic community. The all-metal devices were approved under the U.S. Food and Drug Administration’s (FDA) fast-tracked 510(k) approval route. This process enables device makers to bypass clinical testing of their products if a device is substantially similar to a previously approved device. Studies now reveal that metal-on-metal devices fail more often than similar but not-all-metal devices.
The all-metal hip devices were created for increased durability and longevity and holding the belief that the devices’ seemingly stronger components would provide increased benefits over more traditional devices constructed with plastic or ceramic elements. Metal-on-metal devices have been the focus of growing criticism for failing at unexpectedly high rates and leaving patients with serious, sometimes life-long injuries.
Some experts have accused European and American regulators of working to make sure that patients were kept unaware of the all-metal devices’ risks. In fact, many have criticized device makers for putting profits over patient safety and the FDA recently issued new guidelines to patients implanted with metal-on-metal hips. Among these guidelines is that physicians conduct physical examinations, diagnostic imaging, and metal ion testing, as needed, on symptomatic patients. The agency also proposed stronger regulations requiring that manufacturers prove the implants’ safety and efficacy prior to selling them.