OCTOBER 31, 2011 – She is a former gymnast turned spokesmodel for DePuy who has joined in a lawsuit against the device maker, Johnson & Johnson, after receiving a hip implant that’s left her in crippling pain.
Endorsed J & J Medical Device
Penny Brown was a poster woman who encouraged others to have the artificial hip implant. Now she tells The Daily Mail she feels guilty she may have encouraged others to have the implant. After suffering from arthritis, she had a DePuy implant (articular surface replacements or ASR) in 2004. By 2009 Brown says she felt constant pain and heard and felt a “clunking” sensation. Brown, 51, could not sit or stand and said she was a shadow of her former self.
“I could not believe that I, who had so promoted and believed in the product, was falling victim to the design defect,” she says to the newspaper.
She was told the hip had worn down and would have to be removed. She had it taken out last month. Brown, 51, told The Daily Mail (here) “My life has been devastated and not only feel let down personally but also feel guilty that I might have encouraged others to have the ASR implanted,” she said.
In its place she had a resurfacing procedure.
The DePuy ASR hip system was implanted in about 93,000 patients before being pulled from the market in 2010 because about 12-13% needed a second procedure within five years. The ASR XL Acetabular and ASR Hip Resurfacing systems were removed but that didn’t stop the lawsuits. Brown is represented by UK “solicitors” who are coordinating a seriously injured group of about 300 patients and suing for damages.
The J&J DePuy Pinnacle artificial hip was approved for marketing by the FDA under the 510(k) approval process, which does not require scientific clinical trials as long as the device is a “substantial equivalent” to another artificial hip on the market.
In the U.S., multi-district litigation (MDL) has been gathered in the U.S. District Court for Northern Ohio, while another consolidated action has been filed in Texas. Ortho Streams reports 350 cases were filed in Ohio in August alone.
The Street (here) reports J&J could be facing about $1 billion in liability for the 1,000 or so cases which allege J&J knew about the problems but continued to make the defective metal-on-metal hips to be implanted in the unsuspecting.
In an unusual move, the company has hired an outside firm, Broadspire Services Inc. to handle the recall of DePuy ASR hip implants and presumably to manage who should and who should not receive a replacement device.