Patients sue maker of recalled hip replacement device

Patients sue maker of recalled hip replacement device

CHAMPAIGN – If there was anything worse for Kim Horbas than having to go through hip replacement surgery once, it was having to go through it twice.

"If you ask anyone, once is enough," she says.

Horbas, 55, of Champaign, is one of 13 patients in Illinois and Indiana who have joined in a lawsuit filed in Champaign County against the maker of a faulty hip replacement device being recalled by its manufacturer, DePuy Orthopaedics.

DePuy last month announced a voluntary recall of its ASR XL Acetabular System, a hip resurfacing and replacement device consisting of a metal ball and metal socket launched in 2004 and available worldwide. The company is also recalling another ASR hip system available since 2003 and approved for use only outside the U.S.

Over a five-year period, the company said, about 12 percent of the patients who got the hip introduced earlier and about 13 percent of the patients who got the later product have required a second hip replacement procedure called a revision surgery.

Horbas underwent her first hip replacement surgery in February 2008 to correct the painful effects of arthritis, and then underwent a two-month recovery process, she said.

"It's pretty debilitating. You can't move, you're on a walker for four to six weeks, then you move on to a cane," she recalls.

After the surgery and rehab, she was mobile and pain-free, but come summer she began hearing a clicking sound as she walked, Horbas said.

"It got louder and louder, so you could hear me coming from a pretty far distance," she said.

Horbas went back to her doctor at Carle, and he decided to take a look inside, Horbas said.

What he found was metal staining in the tissues, "so the hip had been deteriorating inside, and the metal had gotten into the tissues," she added.

About 10 months after her first surgery and recovery, Horbas underwent surgery again to have the DePuy hip device removed and a different one implanted, "then it was the same process all over again," she said.

Horbas said her doctor, Carle orthopedic surgeon Robert Bane, was as concerned about what happened as she was.

"I think he did all he could," she said. "I still trust my doctor. It was a faulty device."

Carle spokeswoman Jennifer Hendricks said about 300 Carle patients have received the DePuy hip, and about 10 percent of them have required a second surgery.

Bane said the DePuy hip system was widely used in the area at Carle and other medical facilities. He first began using it in 2006, because its metal-on-metal construction was intended to make it more durable and last longer than the traditional device used in hip replacement surgery. But he stopped using it once the first problem developed with a patient in late 2008, he said.

In an Aug. 26 statement, DePuy Orthopaedics said it intends to cover costs of monitoring and treatment services for patients, including their second surgeries associated with the recall.

"We regret that this recall will be concerning for patients, their family members and surgeons," said David Floyd, DePuy's president. "We are committed to assisting patients and health care providers by providing information through multiple channels and paying for the cost of doctor visits, tests and procedures associated with the recall."

The 26-count lawsuit filed by the Urbana law firm of Phebus & Koester (one of many lawsuits being filed in connection with the DePuy product) also names DePuy's parent company, Johnson & Johnson, and a Johnson & Johnson British subsidiary, DePuy International Limited.

At the time of Horbas' first surgery, the defendants "knew that very high revision rates were being reported in patients with the ASR prosthesis and knew that patients were experiencing metal particles or ions entering into surrounding tissues, causing deterioration of the tissue and entering into the blood stream through which they were distributed throughout various parts of the body," the lawsuit sates.

Yet, it goes on to state, the defendants continued to manufacture and distribute the part and failed to warn doctors.

Urbana Attorney Joseph Phebus said people who had the recalled device implanted are being urged to go back to their doctors and undergo blood tests, even if they don't have any symptoms.

Carle has also sent letters to its patients who have the DePuy hip system, urging annual lab tests and X-rays, Bane said.

If left undetected for a long time, the tiny metal particles or metal ions from the hip device can become toxic to surrounding tissue. But once the metal-on-metal parts are removed and the revision surgery is done, these particles are eliminated through the kidneys, he said.

"These are very unfortunate events when they happen,' Bane said. "DePuy still makes very good orthopedic products. Unfortunately this one just didn't pan out."

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coleinglaw wrote on October 14, 2010 at 12:10 pm

I found this link to be a good resource on some of the background behind the Depuy hip replacement recall, http://www.franklingrayandwhite.com/news/hip-replacement-implant-defect-...

I for one would like to hear more of response from Depuy's parent company, Johnson & Johnson. Its their problem too.