In the ongoing trial against healthcare giant, Johnson & Johnson, over its DePuy Orthopaedics units’ ASR metal-on-metal hip device, jurors have been listening to testimony from a number of key executives and other staff. Most recently, jurors heard from a lead surgeon-designer.
Thomas Schmalzried testified via videotape in Los Angeles state court saying that, had he been aware of the more than 20 percent failure rate, he would never have sold the device, said Bloomberg Businessweek. The case is the first of some 10,000 brought over the failed DePuy, which was recalled in August 2010. That worldwide recall involved 93,000 ASRs; at that time, Johnson & Johnson admitted to a 12 percent failure rate within five years. Schmalzried’s deposition, taken April 11-13, 2012, was compressed down to 20 minutes for jury viewing.
As we’ve long explained, when medical devices fail, patients must undergo painful, complex, dangerous revision surgery to remove the failed device and be re-implanted with a different device.
When asked about an internal, 2011 DePuy study that revealed a 35.8 percent failure rate within 4.57 years, Schmalzried said of the 66 ASRs he implanted, 11 required revisions, said Businessweek. “If you knew it was going to fail and have to be revised 20 percent of the time within four years, would you as a designer have recommended this product to be put on the market?” Schmalzried was asked by one of Loren Kransky’s attorneys. Kransky, 65, is a retired prison guard from Montana who underwent revision surgery to remove a defective ASR.
“I would not have put the product on the market,” Schmalzried said, explaining that the revision rate was “higher than some products that were in the marketplace at the time,” noting that the ASR was introduced to the United States market in 2005, wrote Businessweek. Schmalzried also testified that he received net royalties of 2 percent on most devices sold and that he believed he received $2.5-$3 million, said Businessweek. Kransky’s attorney said he had calculated the royalties at $3.66 million; Schmalzried testified that he did not know the correct amount. In earlier testimony on which we wrote, another ASR surgeon designer, Thomas Vail, told jurors he received just less than $2 million in royalties, noted Businessweek.
Kransky’s lawsuit alleges 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 Businessweek. 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.
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.