Australia, Cobalt chrome, Cobalt poisoning, DePuy, DePuy ASR Hip, depuy hip recall, DePuy Hip Recall Litigation, DePuy Lawsuit, DePuy Orthopaedics, FDA, Hip Replacement, Johnson, Johnson & Johnson, Journal of Occupational and Environmental Medicine, Kransky, Loren Kransky, metal-on-metal hips, metallosis, Paustenbach
The metal debris Johnson & Johnson (J&J)’s DePuy ASR hip implant shed into a man’s bloodstream and tissue is harmless, a toxicologist claimed in the first of 10,000 lawsuits that allege J&J defectively designed the device. Dennis J. Paustenbach – a researcher paid by J&J – told jurors on J&J’s behalf that the cobalt and chromium from the implant did not cause or worsen plaintiff Loren Kransky’s health problems, and that his chromium levels were “basically of no health risk.”
J&J’s lawyers claim Kransky already has diseased blood vessels in his body, and that the elevated metal levels in Kransky’s body can be traced to diabetes, high blood pressure and cholesterol, stroke and kidney cancer instead of hip replacement failure, a Bloomberg article reported.
J&J recalled the ASR hip in August 2010 after 12 percent of the devices had failed. That number has since climbed to 40 percent in Australia.
Paustenbach was part of a team of researchers who claim they were unable to find previously published medical literature on the effects of cobalt on the body. The research conducted by the firm ChemRisk Inc. – which been retained in the past by companies accused of being responsible for chromium pollution – has cost J&J’s DePuy unit at least $5 million over the past 18 months. Paustenbach also claimed they found no evidence of an increased cancer risk associated with the device, and that cobalt is “not an issue to be concerned about at concentrations observed in patients with implants.”
Paustenbach cited several different studies to support his claims, including 1950s research of anemia patients given cobalt doses. “In the blood, we found that there were virtually no adverse effects in the people who had levels up to 300 parts per billion,” while Kransky’s highest cobalt reading was 57 parts per billion. He also cited an unpublished study of ten people who received cobalt doses for 30 days with no adverse effects (although the men’s blood levels reached 32 parts per billion and the women reached 91 parts per billion).
Kransky’s attorney read a list of dozens of corporations by which Paustenbach was paid to conduct research; his work has been used on numerous occasions to undermine carcinogen exposure concerns involving materials such as asbestos. When asked if he was referred to as the “go-to guy for industry,” Paustenbach reacted angrily and then acknowledged he had been described that way.
Paustenbach was also questioned extensively about ChemRisk’s Journal of Occupational and Environmental Medicine article that reversed a study that found a significant association between chromium in drinking water and high rates of cancer in certain regions of China. The journal retracted the article in 2006 for failing to disclose that it was written by his company.
- Metal Debris in Patients’ Bloodstream is “Harmless,” J&J Toxicologists Say (earlsview.com)
- Bullshit-R-Us …. J&J’s Toxicologist Says Metal From Recalled Hip Harmless – Bloomberg (earlsview.com)
- J&J’s Toxicologist Says Metal From Recalled Hip Harmless – Bloomberg (bloomberg.com)
- DePuy ASR Lawsuit Update: Toxicologist Testifies That Plaintiff Kransky Has High Levels of Metal in His Blood – Yahoo! Finance (earlsview.com)
- DePuy ASR Hip Recipient Feared for His Life before Revision Surgery (earlsview.com)
- J&J Failed to Weigh Hip Metal Debris Risk, Witness Says – Bloomberg (earlsview.com)
- J&J metal hip failed because of toxic debris -expert at trial | Reuters (earlsview.com)
- J&J metal hip failed because of toxic debris – expert at trial | Reuters (earlsview.com)
- Metal hip patients ‘need annual checks’ – Health News – Filey and Hunmanby Mercury (earlsview.com)
- J&J Failed to Warn of Metal Hip Implant Flaws, Lawyers Argue (earlsview.com)