Plaintiffs who have brought lawsuits over DePuy Orthopaedics’ ASR metal-on-metal hip implant may now also file claims over DePuy’s Pinnacle hip device, according to a recent judicial order. DePuy Orthopaedics is a subsidiary of Johnson & Johnson.
The plaintiffs impacted are those who are involved in seven lawsuits brought over DePuy’s ASR hip implant device. The plaintiffs were advised that they may also file claims over the DePuy Pinnacle acetabular cup device, according to a ruling issued by a California state judge, MassDevice.com reported.
The joint motion was just issued by Judge Richard Kramer of the California Superior Court in San Francisco. Now, plaintiffs seeking to include their DePuy Pinnacle claims to the DePuy ASR lawsuits may do so, according to MassDevice.com.
Johnson & Johnson is facing nearly 11,000 lawsuits that have been filed nationwide over the DePuy ASR metal-on-metal hip device, which was recalled in 2010 over reports of high and premature failure rates. The ASR is also the focus of mounting injury reports, which typically includes the need for patients to undergo complex surgery to remove and replace the defective device. Earlier this year, a California jury awarded a plaintiff $8.3 million in damages and found that DePuy’s ASR XL was defectively designed, MassDevice.com reported. Also, an internal company audit revealed that in under five years, one in three of DePuy ASRs could fail. That information was part of the testimony given this January in one of the lawsuits.
The device maker has since revealed that the ASR recall has cost the firm about $271 million during the first quarter of last year, alone. United States regulators also 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 issued a ruling this May that DePuy Orthopaedics must produce compliance reports on the Pinnacle.
In the U.S., metal-on-metal hip implants, as a class of devices, are the focus of safety concerns in the orthopedic community. The devices were approved under the U.S. Food and Drug Administration’s (FDA) fast-tracked 510(k) approval process, which enables device makers to bypass clinical testing of their products if a device is found to be substantially similar to an already-approved device. Studies reveal that metal-on-metal devices fail far more often than similar, but non-all-metal devices.
Metal-on-metal hip devices were designed to provide increased durability and longevity as the devices’ seemingly stronger components were believed to be able to provide increased benefits over traditional devices constructed with plastic or ceramic elements. Since, the devices have been at the center 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 ensuring consumers were kept in the dark about the risks associated with metal-on-metal hip implants. Many have criticized device makers for placing profits over patient safety. Meanwhile, the FDA has issued new guidelines to patients implanted with metal-on-metal hips, including that physicians conduct physical examinations, diagnostic imaging, and metal ion testing on symptomatic patients. The agency also proposed stronger regulations that would mandate manufacturers prove implant safety and efficacy prior to selling them.