Several Maritimers are among those joining a class-action lawsuit against an artificial hip manufacturer.
DePuy Orthopaedics, a division of Johnson & Johnson, recalled its ASR series hip implants in August after receiving reports of a higher-than-normal number of patients requiring a second hip replacement or revision surgery.
The company said 2010 data show that five years after implantation, approximately 12 per cent, or one in eight patients who received an ASR device, needed to have revision surgery. ASR hip replacements only became available in Canada in 2006.
Zoey Nicoles, 37, had a hip replacement in late 2009, because of injuries he suffered in a car accident more than 15 years ago. He was shocked to discover there were problems with his new device.
"I received a letter from Horizon Health stating that the device that I have … there's been a voluntary recall on it and I should contact my doctor," said Nicoles.
"I was pretty shocked. I said you've gotta be joking me. I was just pretty much floored. I had put it off for so long, knowing that a person can only get so many hip replacements — they're supposed to be good for 20 to 25 years."
After doing some research, Nicoles discovered that an Ontario law firm, along with Wagners, a serious-injury law firm in Halifax, were filing a Canadian class action lawsuit against the company. There are similar claims in the United States and overseas.
Lawyer Ray Wagner said there are studies showing the hip products are defective and cause damage.
He mentioned "ongoing joint pain and damage to adjoining muscles, tendons and nerves that are attributable to tiny metallic particles that are being released from the device."
He estimates 1,500 to 4,000 of the ASR implants were used across Canada.
The class action has already been joined by Jo-Anne Scharf of Nova Scotia, who received her DePuy implant in April 2005. Scharf's statement of claim said she is "concerned about the possibility of an early revision surgery and her blood ion levels as a result of her DePuy hip implant."
Scharf's lawsuit also claims the defendants failed to disclose or warn Canadian patients of the significant risk of implant failure.
"The defendants were aware of many complaints made to the Food and Drug Administration in the United States and Health Canada regarding the failure of the DePuy implants," the statement of claim asserts.
"These complaints included component loosening, misalignment, dislocation and fracture, and the creation of abnormal or excessive metal debris in the hip socket. This metal debris could spread to surrounding tissue, causing severe inflammation and damage."
According to the National DePuy Orthopaedics Lawsuit Claim Center in the U.S., a number of orthopedic doctors believe the DePuy metal-on-metal implant had a design flaw that made it difficult to implant properly, specifically that the component has a narrow window for proper placement.
The ASR was approved for use by the U.S. Food and Drug Administration in 2005. However, it was cleared through a regulatory pathway that did not require it to undergo clinical trials.