Report on Depuy ASR Hip Recall & the Impact on Patient Lives

The re-posted news article below with how patients are dealing with the DePuy ASR Hip Recall.  It’s amazing to hear the emotional stories of what these patients have had to go through once they discover their DePuy hip implant is the cause of their pain.

Click here for a direct link to the news article: The Enemy Within:  When high-tech hip replacements hurt more than help

The Enemy Within: When high-tech hip replacements hurt more than help

By BARBARA PETERS SMITH
Published: Tuesday, December 21, 2010 at 1:00 a.m.

After years of enduring chronic pain as she worked outdoors at her family’s campground, Kathy Margenau was finally declared a candidate for hip replacement surgery. At 57, her doctor said, she could benefit from new medical advances that would give her more years of mobility. But instead of being delivered by the latest technology, Margenau said, she became one of its victims.

In June the North Fort Myers retiree — with the help of a Sarasota attorney — became the first plaintiff in the United States to sue the maker of her second hip implant, the DePuy ASR XL Acetabular System. And on Aug. 25, the manufacturer announced an unprecedented worldwide recall. In its recall letter, DePuy cited “new, unpublished 2010 data” from the National Joint Registry of England and Wales — a database of surgical outcomes — showing a 13 percent failure rate of its state-of-the-art, metal-on-metal device. Orthopedic surgeons say an acceptable maximum failure rate for a hip implant is closer to 3 percent.

Even now, it is not entirely clear why this particular implant comes loose from the pelvis — and inflicts excruciating pain — in some patients and not others. It could be a design flaw, or the body’s reaction to metal debris, or a combination of both. Because the United States maintains no joint replacement registry, and the Food and Drug Administration relies on manufacturers’ data to approve medical devices, there is no direct government oversight of joint replacement surgery. Since the recall, litigation against DePuy has swelled. The company said some 93,000 of the devices have been sold worldwide, but gave no sales figures for the United States.

For Margenau, now 62 — who had lived with a congenital hip deformity and was no stranger to pain — this new device became an enemy within, attacking her with every step she took. “It just plain stops you dead in your tracks,” she said, trying to describe the sensation of a hip replacement failure. “… The pain just travels down your whole leg.”

When bone damage or arthritis makes a patient unable to walk, a total hip replacement can feel like a miracle. More than 193,000 such surgeries are performed each year in the United States, according to the American Academy of Orthopaedic Surgeons. The procedure has progressed dramatically from its crude beginnings in 1960, with new surgical techniques and technology that offer better mobility for longer periods of time.  But the race to improve durability may be driving patients and their doctors to rely on a trial-and-error process, full of unknowns — especially with metal-on-metal implants, developed to last longer and provide more range of motion for younger, active patients.

DePuy, a unit of Johnson & Johnson, makes several hip implants, and only the ASR has been recalled. Its withdrawal follows that of another metal-on-metal hip cup, the Durom made by Zimmer Holdings, taken off the market in July 2008 after 13,000 implantations. “Both Zimmer and DePuy have excellent reputations,” said Altom Maglio, the Sarasota attorney who filed that first lawsuit for Margenau. “This is very much the exception to the rule. It’s not an indictment of the whole joint replacement concept or industry. The ASR, unfortunately, looks like it is going to be a tremendous failure.”

Johnson & Johnson answered the Herald-Tribune’s request for comment by asking for a list of questions, to which it offered no response. The company’s letter to physicians told them to contact clients who have the implant, saying “DePuy intends to cover reasonable and customary costs of monitoring and treatment for services, including revisions” associated with the recall. But it remains unclear how this reimbursement will work.

Maglio, the Sarasota attorney, came to specialize in medical product liability law after working on a medical malpractice defense and becoming fascinated with its technological aspects. One quandary in this case, he said, is the vagueness of DePuy’s offer to reimburse costs. “How exactly do you recall a product that’s been implanted in somebody’s body?” asked Maglio, 38. “I don’t even understand it.”In addition to Margenau, Maglio now has about 70 ASR clients. He was also the first attorney to file a lawsuit over the Zimmer Durom cup, which he said has “potentially a 30 percent failure rate.” He expects the DePuy ASR failure rate to climb as news of the recall spreads.

“The recall does potentially pose a problem for people who have these things fail down the road,” he said, “because I foresee a possibility of a defense being raised that everyone is on notice at this point that there’s a defect with this product.” Maglio is only handling clients who have had their hip devices removed and replaced, because surgeons’ findings are crucial in building a case. But he worries that patients whose implants have not yet failed may come up against a statute of limitations deadline. In Florida that would be four years from the August recall letter, but other states have a one-year limit.  “There are exceptions” to these statutes, he said. “It’s not black and white; it’s definitely gray. But it still poses problems. It causes uncertainty. And uncertainty is always not helpful to someone with a potential case.”

Hip replacement surgery is a violent assault on the body. Once the old joint is removed, the concave part of the pelvis that held it in place — called an acetabulum, after the Latin word for a “little vinegar cup” — is sanded down, and then the implant is forcibly jammed in, so that it can fuse to the pelvis. The operation is considered a last resort, after exercise, medication and physical therapy.  “I don’t replace hips so somebody can play tennis. I say, you can’t play tennis? Take up Ping-Pong,” said Dr. Edward J. Stolarski, a surgeon at Kennedy-White Orthopaedic Center in Sarasota. By his count, he has performed roughly 1,000 “revisions” — surgeries to replace failed joint replacements. “We take a thing that looks like a cheese grater, and it makes the bone bleed,” Stolarski explained. “You want bleeding bone. Then we take a cup that’s a millimeter bigger, and pound it in. Your body heals to that cup, the same as if you had a broken bone. And if it doesn’t, it’s considered a failure, and it will move; it will be loose.

Joshua Hodge, 29, is a client of Maglio’s who owns an architectural design firm in Tallahassee. He underwent hip replacement in September 2009, a year after a car accident shattered his acetabulum. His age made him a logical candidate for a metal-on-metal device. His doctor chose the DePuy ASR, less than a year before the recall. “It’s not like a recall of a car, where you can just take it back,” Hodge said. “Hip surgery is amazingly painful. I thought I was tough until I went through this.” After his hip replacement a year ago, Hodge said, “I noticed in November a huge area on my hip beginning to swell. … By February I couldn’t walk at all.” His doctor was stumped, Hodge said, and “it crossed his mind that I just wanted more pain medicine.”

Maglio said he has heard similar stories from other clients, whose doctors could find nothing amiss from the usual tests. “I have a client in Orlando whose surgeon told her she should go see a psychiatrist,” he said.
Fortunately for Margenau, her doctor believed her. Her first hip replacement in 2006 had been grueling but successful. The only difference with the second, in March 2008, was that this time her doctor had chosen to use the ASR. In December 2008, he told her the only way to find out what was wrong with the device was to take it out. “I do remember breaking down and crying in his office,” said the normally stoic Margenau, “and he’s looking around for his box of Kleenex to give me, and I said, ‘I don’t think I can do this for the third time.’ My biggest fear was that he was not going to find anything.”

Bill Margenau, her husband, remembered this as the low point. “There was such an anxiety about getting this done,” he said. “She came out and said, ‘I don’t even want to do this.’ Kathy Margenau said it might have been harder for him: “This poor man has been through a lot the last few years. When we went to the hospital this last time, he had sunglasses on, because he said, ‘I think I’m going to cry.'”

There is no such thing as an easy revision, said Stolarski, the Sarasota surgeon. “If I have to cut into your body, chisel out the whole cup — or even if your old cup falls out — re-ream it and put a new cup in, your risks for complications are even higher than they were at your first surgery,” he said. “There are different levels of technical difficulty, but from the patient’s perspective, none of this is simple.”

After her revision, Margenau said, her doctor told her it was the first socket failure he had seen in 11 years of surgeries. And when she went in for a checkup in March 2010, she said, he told her something else: “He looked at me and said, ‘There was a big article in The New York Times, and it has to do with that hip socket that I put into you.'” That was when DePuy acknowledged an Australian implant database showing a “higher-than-expected” failure rate, according to the Times.

The United States has had no such registry. But the American Academy of Orthopaedic Surgeons created a pilot registry program last year in Illinois. And since the August recall, DePuy and seven other device makers have signed on to the academy’s effort to create a registry that would cover 90 percent of U.S. hospitals.

While pointing out a need for safeguards against mining such data for litigation purposes, Stolarski said, “I think we need a registry, bottom line, so that things like this don’t happen. It’s kind of embarrassing that the most medically advanced country in the world has to look at other countries’ registries to make clinical decisions here.” Stolarski, who keeps a box of failed implants that he calls his “Island of Misfit Toys,” said there are two separate issues with the DePuy ASR and Zimmer Durom. One is the cups’ tendency to come loose.

“I think that they’re getting a bite on the rim and it’s appearing to the surgeon when he puts it in that it’s well fixed,” he said. “But there’s enough micromotion that the body doesn’t grow onto it. I just took a Durom out last week or the week before, and it looked like it just came out of the package.

“The other concern is potential inflammation from the metals — chromium and cobalt — that can enter the bloodstream as debris from the grinding joint. In a small number of patients, this could lead to infection and tissue death.  “It’s kind of a chicken and egg problem,” said Maglio. “Did the metal debris form because of the cup becoming loose, or did the metal debris cause the cup to become loose?”

Stolarski said he still recommends metal-on-metal for some young and active patients, but he is hopeful about a new option that uses a polyurethane liner inside the metal,and allows for a more flexible swivel action. He is waiting for this new device to establish a track record, he said.

“What we don’t want to do is put new technology ahead of common sense,” he said. “The FDA does a great job, but there’s no way they can anticipate everything. … Who would have thought there would be this much trouble with metal-on-metal in general? Nobody.”