We’ve been following the developments in a lawsuit filed by Loren Kransky against Johnson & Johnson over the DePuy Orthopaedic ASR metal-on-metal hip device, which was recalled in 2010. DePuy Orthopaedics is a unit of Johnson & Johnson and this case is the first of some 10,000 filed against the device makers.
The most recent testimony was of a DePuy bioengineer who said he spent three years analyzing a metal-on-metal redesign that was recalled in 2010 over the hip device’s failure rate, said Bloomberg News. James Anderson was testifying by videotape in state court in Los Angeles.
Anderson, said Bloomberg News, discussed disappointment he had over so-called “Project Alpha” work that ended in 2008 because there was no change made to DePuy’s ASR hips. Some 93,000 ASR hips were involved in the global recall.
“Were you frustrated when you heard that the project was being ended?” Kransky’s attorney asked, said Bloomberg News. Anderson testified that, “Yes, I was frustrated.”
When Anderson was asked what he said to his superiors after he “came up with some good suggestions and useful solutions,” he testified that “I think I would have said that I was disappointed that the last six months of my work had come to nothing,” Bloomberg News reported. According to Anderson’s testimony, he began working at DePuy in 2005 when he was 25, after graduating from the University of Strathclyde in Glasgow, Scotland; there, he said, he was part of a team studying the “next generation ASR.”
According to Anderson, the ASR was constructed of cobalt and chromium; a metal ball placed atop the femur rotates in a cup that is placed in the hip, said Bloomberg News. Anderson said he studied the ASR cup design, which is smaller than a half-circle and is made with a groove meant to better enable a surgeon to place the device in the patient’s hip. The plaintiff’s team says the design is faulty and causes metal ions to enter patients’ bloodstreams, causing an array of adverse reactions.
In an email Anderson wrote to his superiors dated April 7, 2008, he said that “a small improvement to geometry could represent a large improvement for many patients.” In another document, Anderson wrote that if the groove is removed from the device, cup wear “is approximately threefold less than the original design with the groove.” On that same day, Anderson also wrote, according to Bloomberg News, “I have a huge volume of information on ASR bearings now but have absolutely no direction.”
We recently wrote that a DePuy engineer Graham Isaac testified that the recall was based on safety concerns. Isaac’s testimony conflicts with prior testimony given by DePuy president, Andrew Ekdahl just days prior. Ekdahl insisted that the recall was issued because the device “did not meet the clinical needs for the product.”
At the time of the ASR’s worldwide recall, Johnson & Johnson stated that the metal-on-metal hip implants failed in 12 percent of patients within five years. An internal DePuy analysis in 2011 showed that the devices failed at a rate of 37 percent in 4.5 years. Last year, Australian national joint registry data suggested that the failure rate was 44 percent in seven years.
Kransky’s lawsuit, like thousands of other similar cases pending in the litigation, alleges that the DePuy ASR generated a toxic amount of chromium and cobalt ions. This buildup of metal debris allegedly caused complications such as blackened tissue and early revision surgery. Isaac also acknowledged during his earlier testimony that DePuy did not disclose information about the release of metal ions in ASR patients.
Meanwhile, in an unprecedented move, the U.S. Food and Drug Administration (FDA) recently advised that metal ion testing be conducted for all-metal hip replacement patients experiencing symptoms such as pain, swelling, or difficulty walking. In issuing these new guidelines, the agency also recommended diagnostic imaging and regular physical examinations.