Yesterday, jurors watched previously taped video from a deposition taken of the president of DePuy Orthopaedics concerning its failed ASR metal-on-metal hip device.
Throughout the previously taped deposition, Andrew Ekdahl maintained that 93,000 DePuy ASR hip devices were recalled not for safety reasons, but because the devices, “did not meet the clinical needs for the product,” later stating “It was taken off the market because it did not meet the clinical needs for the product in the marketplace,” according to Bloomberg.com.
This is the first of 10,000 other cases filed against DePuy, a unit of Johnson & Johnson, and was filed on behalf of Loren Kransky, 65, of Montana. Allegations include that the ASR design is defective and that the device maker neglected to warn consumers and physicians of the device’s risks, said Bloomberg.com. Johnson & Johnson continues to deny that it designed a defective device or that the device contributed to Kransky’s health issues, said Bloomberg.com.
Although DePuy stopped selling the defective ASR in 2009, it took until August 2010 for the worldwide recall to be implemented. At the time of the recall, Johnson & Johnson said that 12 percent of the devices failed, according to analyst estimates in the United Kingdom.
Jurors also heard segments of the deposition involving DePuy ASR revision rates. Ekdahl was unable to provide information on why he believes the U.S. revision rate would not reach the 40 percent revision rate seen in Australia. Of the 93,000 devices recalled, 32,000 represent implants made in the U.S. According to Ekdahl, “somewhere in the neighborhood of 15 to 20 percent” of DePuy ASR hips implanted in the U.S. failed, Bloomberg.com reported.
When the devices fail, revision surgery is required. This surgery is a painful, long, and complex process in which the defective device is removed and a different device is implanted. This process is not always accomplished in one surgery and patients are sometimes left with no device in place between surgeries, leaving them bed-ridden for some time.
Ekdahl was also questioned about how DePuy handled safety complaints filed by patients concerning the DePuy ASR. Thousands of patients have filed lawsuits after they suffered pain, joint dislocation, infections, fractures, and issues associated with metallosis. The device’s metal components rub against one another during normal wear, shedding dangerous chromium and cobalt ions into patients’ bloodstreams. This can lead to an array of issues such as pseudotumors, tissue necrosis, and metal poisoning. Patients have also reported implant site pain that can spread to the groin and back, inflammation, swelling, osteolysis (bone loss), and fluid collection and solid mass development around the hip joint.
The plaintiff’s attorney told jurors that surgeon William Griffin emailed Ekdahl and others on December 18, 2008, writing that he had “concerns about the design and have started to see failures consistent with my concerns.” Griffin also indicated that the DePuy ASR did not stimulate sufficient bony ingrowth, its cup was too small, and its design created sharp edges, said Bloomberg.com. “DePuy should at least de-emphasize the ASR cup while the clinical results are studied,” Griffin wrote. “I do not use the ASR. The ASR is not the only bad design out there but it certainly is not as good as some of the others,” Griffin’s email continued, said Bloomberg.com.
When asked if Griffin’s email was submitted to DePuy’s clinical team. Ekdahl responded, “I believe this was reported to our clinical team…. I just don’t recall who did it. We should have done it. I’m assuming that we did it. I don’t recall.”
Ekdahl was also questioned about 2008 discussions at DePuy regarding redesign of the ASR cup. An email from Graham Isaac, a DePuy engineer, to Ekdahl on April 30, 2008 stated that the ASR is “susceptible to extreme metal ion levels,” pointing out that a competitor device did not face these issues. “We need to discuss that at the earliest possible opportunity as I believe it means that we need to start any ASR upgrade sooner than our previous plans had suggested,” Isaac wrote. When asked about this, Ekdahl said that he spoke to members of the marketing team, said Bloomberg.com.
The metal-on-metal devices were created for greater durability and longevity over traditional implants constructed with plastic or ceramic components, but are failing at high and unexpected rates. Some experts say that European and American regulators worked to ensure patients were unaware of the devices’ risks.