DePuy Pinnacle Hip System
In 2009, it became evident that DePuy and Johnson and Johnson’s Pinnacle hip device was failing at a higher than expected rate. This device make up includes a metal cup, metal head, and metal liner. While some doctors used a poly (plastic) liner, many used the metal liner. A high number of recipients of the DePuy Pinnacle Hip System experience unexplained hip pain, difficulty standing or walking, loss of mobility, loosening of the joint, and dislocation. Failure of the device is often due to metallosis and its side effects. Though it was never recalled, there is a great amount of evidence showing that the DePuy Pinnacle Acetabular Cup System has similar defects to the recalled DePuy ASR system.
How does the Pinnacle work?
The DePuy Pinnacle Hip System is different from the ASR System in that it is a modular system instead of a monoblock design. In addition, the ASR cup is one solid piece of metal whereas the DePuy Pinnacle cup has an outer shell with options for a metal, ceramic, or polyethylene liner.
The Ultamet, which is the metal inner liner for the DePuy Pinnacle shell, is of special concern. The metal shell makes the DePuy Pinnacle even more similar to the ASR because it is a metal-on-metal device. Metal-on-metal devices initially promised greater stability and longevity than traditional implants. However, metal-on-metal implants have been found to be flawed and potentially dangerous.
What injuries do recipients experience?
When the metal components loosen, metallic ions are released at a higher level into the patient’s bloodstream which can cause metallosis, osteolysis, pseudo tumors, and necrosis. As in the ASR cases, high rates of metallic ions have been found in recipients of the DePuy Pinnacle metal-on-metal device.
How was the Pinnacle approved?
The DePuy Pinnacle System was approved by the FDA with only 510(k) clearance. This type of approval allows for devices to skip standard testing procedures because they are similar to an already-tested device. The system underwent small design changes, in order to “increase mobility,” but was never thoroughly tested by the FDA.
Pinnacle Hip Systems: A Timeline
2011: A multidistrict litigation was consolidated in the Northern District of Texas for the Pinnacle hip litigation.
2013: DePuy pulled the Pinnacle System’s Ultamet metal liner component from the market, but refused to issue a recall.
2014: The first Pinnacle bellwether case was tried with a defense verdict due to very specific details of that Plaintiff’s case.
2015: In December 2015, the second Pinnacle trial began. It involved five Texas plaintiffs. The jury awarded $500 million in total to the five plaintiffs – including $360 million in punitive damages. The judge overseeing the trial later reduced the verdict to $151 million in compliance with Texas state law. Depuy and Johnson and Johnson have appealed the verdict. Appeal is currently pending decision.
2016: The third Pinnacle bellwether trial began in early October of 2016. The jury returned a $1.04 billion verdict in favor of the plaintiffs sending a clear message of disapproval to J&J for their actions.