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NBC News medical contributor Dr. Vin Gupta tells TODAY that the current surge in U.S. Coronavirus cases is "not just about increased testing … this is not going away." He says that Johnson & Johnson putting its vaccine trial on hold after a patient came down with an unexplained illness is actually reassuring: "This says that the process is working … but we need to learn more."Oct. 13, 2020
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Johnson And Johnson Heads To Jury Trial Over Hip Implants
Jury selection was set to begin today in the first of about 6,000 claims against Johnson & Johnson's DePuy subsidiary over its Pinnacle artificial hip.
Plaintiff Kathy Herlihy-Paoli alleges in her complaint that she suffered metallosis--a result of cobalt poisoning--due to large amounts of metal debris left in her body by the cobalt and chromium artificial hips. The Montana woman had cobalt levels 85 times higher than normal, the suit alleges. She claims to have had the hips removed due to infections.
Paoli further alleges the Pinnacle implants are "inherently dangerous products" and that J&J (New Brunswick, NJ) and DePuy (Warsaw, IN) failed to warn anyone about them. Johnson & Johnson denied the allegations.
The Pinnacle artificial hip is not covered under the company's earlier $2.5 billion settlement of about 8,000 claims over DePuy's ASR artificial hips. DePuy recalled the ASR metal-on-metal hips in 2010.
J&J stated publicly that the five-year failure rate of the ASR hips was only 12%, but internal documents showed the failure to be much higher at 37%, according to Bloomberg News. The failure rate in Australia was 44% within seven years.
The 6,000 current cases have been consolidated before U.S. District Judge Ed Kinkeade in Dallas for pretrial information exchanges, Bloomberg said. Kinkeade will preside over Herlihy-Paoli's trial.
A DePuy spokesperson said in an emailed statement to Bloomberg that the company acted "appropriately and responsibly in the development, testing and marketing of" the artificial hips.
First introduced to the market in 1997, metal-on-metal hip implants were hailed for their durability and were designed to last a lifetime. Manufacturers targeted early metal-on-metal implants to active, young patients who needed a device that could hold up for decades. While all artificial hip implants can wear down over time, metal-on-metal hip implants carry a variety of unique risks, according to a 2013 report on medical materials by Qmed.Com.
Failure rates for metal-on-metal hip implants are significantly higher than other devices, according to a 2012 British Medical Journal report by Deborah Cohen. While failure rates can vary by brand, the seven-year average failure rate for metal-on-metal hip implants is 13.6%. This compares with an average seven-year failure rate of 3.3% to 4.9% for hip implants manufactured from other materials.
In many cases, metal-on-metal hip implants undergoing wear and tear will release chromium and cobalt ions. These ions can seep into local tissue near the site of an implant, potentially destroying bone and muscle. If these ions manage to enter a patient's circulatory system, they can injure the kidneys, liver, spleen and lymph nodes before elimination from the body through urine.
While cobalt is an essential element for proper health in most animals in small doses, in high doses, cobalt can lead to severe injury or death. Cobalt toxicity can lead to skin rashes, peripheral neuropathy, hypothyroidism, cognitive impairment, cardiomyopathy, hearing loss, and vision loss.
Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.Nancy Crotti is a contributor to Qmed and MPMN.
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