The lawsuit filed against Johnson & Johnson—the first of some 10,000—continues to reveal a growing back story concerning the now-recalled DePuy ASR metal-on-metal hip implant device. DePuy Orthopaedics, a unit of Johnson & Johnson, recalled 93,000 of the faulty devices in August 2010 following mounting adverse event reports and litigation.
In the most recent testimony, the president of DePuy advised a California surgeon, months before the 2010 recall, that sales of the ASR would be ceased. The doctor, Craig Swenson, testified that he was not told the devices were increasingly failing and that DePuy then-President, David Floyd, had lunch with him in La Jolla, California, in March 2010. Swenson previously testified he had implanted 200 of the ASR XL hips in question prior to this visit. “He informed me that they were going to discontinue sales of the ASR,” Swenson said. “He didn’t give me a reason why,” Swenson said, according to a Bloomberg News report.
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.
Swenson had previously testified on January 29, resuming that testimony late last week. He told jurors that he “pretty much stopped’ using the ASR as patients were reporting pain and high levels of metal ions from wear on the device’s cobalt and chromium components, according to Bloomberg News. Lawsuits brought by patients include allegations of the ASR leaving them in pain or immobilized due to joint dislocations, infections, and bone fractures, Bloomberg News reported.
According to Swenson, Floyd, president of DePuy from 2007 to March 2011, discussed Swenson’s experiences with the device but never said that DePuy received a number of complaints from other surgeons or that DePuy had ever considered a re-design of the ASR, wrote Bloomberg News. ‘‘He said they were going to stop supporting it,” Swenson said. “There was no part of the conversation that there was any significant problem or that patients needed any special care.”
Swenson testified in January that Floyd visited eight San Diego surgeons who were key ASR users. Swenson said he implanted more than 5,000 hip devices over 30 years; 200 were ASRs and, of those, 38 percent failed, wrote Bloomberg News. That failure rate, testified Swenson, was a much higher rate that seen in any other device he used. Swenson was testifying in support of the plaintiff in this case, Loren Kransky, 65, a retired Montana prison guard. Kransky was implanted with the ASR in December 2007; the device was removed in February 2012. Johnson & Johnson continues to deny it designed a defective device or that the ASR contributed to Kransky’s health problems, said Bloomberg News.
In opening remarks, Johnson & Johnson’s attorney said that the metal “staining” caused by Kransky’s hip “did not damage Mr. Kransky’s tissue or create the need for the revision” surgery. When Swenson was asked about those remarks by Kransky’s attorney, he answered, “You’ve got to be kidding…. The metal staining damaged his tissue. Those tissues are damaged. We take those tissues out because they are non-functional,” according to Bloomberg News.
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.
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.