Another marketing executive at Johnson & Johnson’s DePuy Orthopaedics unit was called to testify in the first of 10,000 lawsuits to be brought to trial over the failed DePuy ASR metal-on-metal hip device. Some 93,000 ASRs were globally recalled in August 2010 following mounting failure reports, criticism, and lawsuits.
Jurors were told that, three years before the recall, marketing staff at DePuy expressed concern over the repercussions related to metal ions shedding from the devices into patients’ bloodstreams, said Bloomberg.com. Randall Kilburn, a DePuy marketing executive was asked about a July 2007 meeting that convened in Chicago in which the marketing team discussed some of the firm’s hip devices.
The sales team was shown a PowerPoint presentation entitled “What Scares Us the Most in the Year Ahead?” Nine items were listed; the first was “Metal Ion Backlash,” Bloomberg.com pointed out. Johnson & Johnson implemented the recall when the ASR’s failure rate reached 12 percent; however, jurors heard testimony concerning an internal 2011 DePuy ASR study that revealed a 35.8 percent failure rate within 4.57 years. Failures necessitated revision—replacement—surgeries.
When Kilburn was asked if he considered the metal ion backlash a threat, he responded, “Yes, it’s one of many threats,” wrote Bloomberg.com. Kilburn was called to testify in a lawsuit filed by Loren Kransky, 65, who alleges that DePuy’s ASR hip was defectively designed and that, although surgeons reported the ASR’s failure for years prior to the recall, DePuy never appropriately warned of its risks. Johnson & Johnson denies that the ASR was defectively designed and that it contributed to Kransky’s health issues, and says it appropriately warned of the device’s risks.
Patients suing Johnson & Johnson allege that the DePuy ASR left them in pain or unable to walk due to joint dislocations, infections, and fractures and that they suffered from elevated chromium and cobalt ion levels because of the way in which the device’s components wear on one another in normal use, said Bloomberg Businessweek previously. The ASR is comprised of a metal ball that is placed atop the femur and which rotates in a cup implanted in the hip. 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. Johnson & Johnson denies these claims, said Bloomberg.com.
Kilburn was asked, “Weren’t you aware that surgeons complained that the ASR shed excessive debris?” Kilburn responded, “When it was malpositioned, yes,” wrote Bloomberg.com. “That would be a red flag, wouldn’t it?” Kilburn was asked. He answered, “Yes, when it was malpositioned.”
Then, jurors were shown a 2008 sales meeting video in New Orleans in which Kilburn announced that the ASR hip division increased its 2007 sales by $62 million over 2006, at one point exclaiming, “Game on!”
Kilburn was asked, “This was after you had received many pieces of information raising red flags?” Kilburn agreed. “You were still out there—game on—selling as much as you could,” Kilburn was asked. He agreed, said Bloomberg.com.
Kransky’s lawyers say his cobalt level was 47-53 parts per billion prior to his February 2012 revision surgery to replace the DePuy ASR he had been implanted with in December 2007, said Businessweek. Johnson & Johnson’s attorney stated in the trial’s opening statements that Kransky’s elevated metal ion levels were due to his poor health and that Kransky is a vaculopath, which means Kransky’s blood vessels are diseased and that his chronic kidney disease “impacted his ability to excrete cobalt chromium metal ions,” wrote Businessweek.
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.