Today, jurors heard from the president of beleaguered device maker, DePuy Orthopaedics, via previously taped deposition in a trial over its ASR metal-on-metal hip device. This is the first of 10,000 other cases filed against DePuy, a unit of health care giant, Johnson & Johnson.
Andrew Ekdahl told jurors that DePuy recalled 93,000 of its metal-on-metal hip implant devices, not over safety reasons, but because the devices, “did not meet the clinical needs for the product,” according to Bloomberg.com.
At the time of the recall in August 2010, Johnson & Johnson said 12 percent of the devices failed according to analyst estimates in the U.K. Patients allege 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. This case was filed on behalf of Loren Kransky, 65, of Montana.
Kransky attorney continued to question Ekdahl—who took over as president at DePuy last January—about if DePuy recalled the hips over safety concerns. In the videotaped deposition taken last December, Ekdahl said, “It was taken off the market because it did not meet the clinical needs for the product in the marketplace,” Bloomberg.com reported.
Johnson & Johnson continues to deny that it designed a defective device or that the device contributed to Kransky’s health issues, said Bloomberg.com.
Kransky’s attorney asked Ekdahl in a number of ways if DePuy considered ASR hips to be unsafe or harmful to patients. Ekdahl continually cited clinical needs as the reason for the recall, said Bloomberg.com.
Kransky’s attorney advised the jury that DePuy’s own review in September 2011 revealed that 37 percent of DePuy’s ASR hip devices failed in under five years and that the Australian national joint registry revealed last year that 44 percent of the devices failed after seven years, wrote Bloomberg.com. When these devices fail, revision surgery is required, which involves a painful, long, and complex process in which the defective device is removed and a different device is implanted. Often, this is not always accomplished in one surgery, leaving the patient bed-ridden for some time.
Ekdahl admitted that the ASR did not have an acceptable revision rate. When asked what the acceptable revision rate would be, he said, “I don’t think we put a revision rate on paper and said this is a revision rate that was acceptable,” reported Bloomberg com. When asked how many revision surgeries DePuy forecasted for U.S. patients, Ekdahl said, “We’re not forecasting a revision rate.” Ekdahl’s deposition will likely be aired in many other pending lawsuits.
Kransky’s attorneys seek to show jurors how DePuy long knew its device suffered from a serious design defect that was kept from surgeons, and allege that the ASR led to hip instability and that the device’s chromium and cobalt construction have allegedly caused toxic metal ions to seep into the bloodstream, leading to dangerous adverse effects. Kransky’s case alleges failure to warn, defective design, and negligent recall. DePuy denies these allegations and accuses Kransky’s attorney of weaving “snippets of e-mails, smidgens of depositions and sound bites of memos” to falsely present the device maker, said Bloomberg.com earlier this week.
As we recently wrote, in response to mounting adverse event reports, litigation, regulatory and medical probes, and global recalls, the U.S. Food & Drug Administration (FDA) announced that metal-on-metal devices can lead to pain, soft tissue damage, and metal shedding in the area where the device’s components meet—typically at the ball and cup junction. Metal shedding can occur when the device’s socket is in normal use, such as during walking or running.
Although these devices were created for greater durability and longevity over traditional implants constructed with plastic or ceramic components, the metal devices 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.
Research has linked metal-on-metal hip devices to adverse events that include tissue necrosis, implant site pain that can spread to the groin and back, inflammation, swelling, metal poisoning, high failure rates, osteolysis (bone loss), and fluid collection/solid mass development around the hip joint.