Hip implant didn’t have clinical safety trials, now, Cobalt Poisoning

It’s one thing to get a recall on a part in your car. It’s quite another when the faulty device is in your body. That’s what 59-year-old Clayton Blosser of Newport News faced when he opened a letter last year that said the artificial hip he’d had implanted in 2006 was being recalled by the […]

It’s one thing to get a recall on a part in your car. It’s quite another when the faulty device is in your body.

That’s what 59-year-old Clayton Blosser of Newport News faced when he opened a letter last year that said the artificial hip he’d had implanted in 2006 was being recalled by the manufacturer.

“I thought, ‘You can recall my car, my GPS, my TV, but you can’t call my hip back, come on,’ ” he said. “I had to read it three times before I realized they were serious.”

Priscilla LeMoine of Suffolk received a similar letter in September announcing a recall of the artificial joint she received in 2007. The 69-year-old woman had been complaining that the device in her left hip had been slipping and popping and grinding for several years, causing pain that was close to driving her to a wheelchair.

Blosser had his artificial hip replaced with another model last month.

LeMoine had hers switched out in January, but that’s not the end of her travails: She has an identical model in her right hip.

LeMoine and Blosser are among the hundreds of DePuy ASR hip replacement patients across the country and dozens in Hampton Roads who have filed suit against the maker of the device, DePuy Orthopaedics, and its parent company, Johnson & Johnson.

Central to the case against DePuy is the fact that the manufacturer gained Food and Drug Administration approval for the hip using a process that bypassed clinical safety trials.

The courtroom saga is a small corner of a larger issue: The market for joint replacement is booming, and not just because people are living longer. Baby boomers put a premium on staying active as long as they can, jogging and biking long past previous generations. Another portion of the population carries too many pounds, which is hard on joints.

Hospital discharges for total hip replacement increased by one-third from 1996 to 2006, and are expected to grow an estimated 175 percent by 2030. That’s created a steady stream of new devices boasting better, quicker and longer-lasting qualities. The recalled DePuy hip device, though, begs a question:

Are medical devices adequately tested before bodies are cracked open to put them in place?

Williard Moody Jr., a lawyer who practices in Portsmouth, doesn’t think so.

He’s filed 15 cases against DePuy in federal district court and says he’s received hundreds of phone calls from people across the country. The cases have been transferred and consolidated in what’s called a “multiple district litigation” in a federal court in Ohio, where more than 500 cases have beenfiled against the manufacturer.

DePuy estimates that 93,000 people worldwide had the company’s implants between 2003 and 2010, and that the rate of revision after five years has been 12 to 13 percent. A British orthopedic organization released results in March of a study that showed an even higher revision rate, ranging from 21 percent after four years to 49 percent after six years.

That’s a lot of hips.

What aggravates LeMoine, who hired Moody to represent her, is how long it took for her to find out.

She had her right hip replaced in March 2007. She recovered fairly quickly from the surgery and followed that replacement with one in her left hip in July of that year.

“I was told it would last my lifetime,” she said.

The right one continued to feel fine, but the left gave her problems from the start. She could feel the ball move out of place in the cup device and hear it pop, grind and snap dozens of times a day.

One day she counted how many times she felt it pop out of place: 150.

It also hurt: “I was afraid to walk anywhere.”

She tried to make the best of it for a while, but the pain kept getting worse, leading her to curtail her work as a real estate agent.

“I knew something wasn’t right. Your body is telling you something is wrong, but they were telling me nothing was wrong. You begin to think you’re crazy.”

When she received the recall letter, it all made sense.

She had a bone scan and blood tests. The blood work showed she had elevated levels of chromium and cobalt, which doctors have said could be from the metal of the cup and socket rubbing together. That can lead to tissue death at the site of the implant, which leads to pain. The scan showed cysts in the area where the prosthesis was.

LeMoine decided to first have the left one removed since that was the most painful. She had it replaced with a plastic-and-ceramic device on Jan. 19.

She still doesn’t know what to do about her right hip, since she didn’t have as many problems with it. She continues to have her blood checked. She said if her blood levels continue to show high levels of cobalt and chromium, she’ll probably have the other one replaced too.

“I’m angry at DePuy for the time it took for them to recall it,” she said. “The worst part is not knowing what that metal content will do.”

A critical piece of the case lies in the way the FDA approved the DePuy device. Usually, pre-market approval requires clinical studies and investigations for safety and effectiveness. Under something called the 510(k) provision, however, devices that are “substantially” like ones already on the market do not need the same rigorous testing.

That’s how DePuy gained approval for the ASR in 2005. Most devices on the market at the time used a metal or ceramic material for the ball of the hip, and plastic for the cup.

The ASR used metal for both the cup and the ball, with the idea that the combination would last longer.

A disadvantage arose when the metal rubbing against metal produced debris that leached into the bloodstream and settled in the surrounding tissue, causing pain and tissue damage, according to the cases filed. The cup also was more difficult to align than typical models, according to the lawsuits.

Some countries have registries of joint replacements. The Australian Joint Registry issued seven reports to DePuy concerning the ASR starting in 2007, and the ASR was withdrawn from the Australian market in December 2009.

A registry of joint replacements in England and Wales also began raising red flags, and in August 2010, DePuy voluntarily recalled the device.

The FDA announced in February that it is re-evaluating metal-on-metal devices. Its website notes that there is “insufficient data” to track the long-term effects of metal in the bloodstream, and that some people might have a greater sensitivity to metal than others. The site noted there have been some reports of problems in the nervous system, heart and thyroid gland that might be linked to high metal content in the blood.

Mindy Tinsley, spokeswoman for DePuy, said in an email that the company is committed to addressing “reasonable and customary costs” of testing and treatment problems related to the recall, including revision surgery.

That offer didn’t stop the flood of lawsuits, most citing the length of time it took DePuy to recall the device and the process used to approve it.

Diana Zuckerman, president of the Washington-based National Research Center for Women & Families, is well acquainted with the 510(k) process.

The patient safety advocate has long argued against using the process to approve implanted medical devices. She and two colleagues did a study that was published in the Archives of Internal Medicine in February that examined recalled medical devices in Class I categories, those that can cause death or serious health problems if defective.

The study found that of 113 devices recalled from 2005 to 2009, 80 percent went through the 510(k) process.

“We got interested in this for the reason we knew there were a lot of implanted devices that were not required to be studied in clinical trials, and that seemed crazy,” Zuckerman said. “How do you explain that?”

The study didn’t include hip joint replacements, because problems with them don’t have the life-threatening potential of, for example, a faulty heart implant device.

But Zuckerman was interested in hip devices, too, and found that 158 of them had been recalled during the same period. Even if they aren’t life-threatening, poorly designed devices can cause a lot of suffering.

Zuckerman, 60, could speak from experience: She needed a hip replaced last year.

She was disappointed at how little she was able to find out, both as a regular consumer and as a researcher, when she tried to see which devices had the best records.

The United States does not have a registry of joint devices to track problems and alert the public, though an orthopedic association began a trial of one last December.

As with so many things in medicine, it often comes down to money. The more research, the more costly, and manufacturers have argued that more regulation would reduce and slow access to the latest medical technology.

Zuckerman knew enough from her research to stay away from the metal-on-metal hips. She also heard the ceramic ones squeak.

So she went with a metal-on-plastic device.

The manufacturer?


Is she happy with it?

“I was told within a few months, I’d be back to where I had been before,” Zuckerman said. “And it’s just not true.”

Dr. Boyd Haynes, an orthopedic surgeon in Newport News, encourages patients to do their homework before getting a joint replaced.

While some doctors say patients get bogus information or data that doesn’t apply to them, Haynes said, patients can help doctors find the right device for them by doing research on credible websites.

Because people are getting joint replacements earlier and living longer, there’s interest in devices that last. Haynes, who practices at the Orthopaedic and Spine Center in Newport News, said the metal-on-metal idea appealed to him at first for that very reason.

He said the devices seemed to work well for some people, but not everyone. About 8 to 10 percent of the patients he implanted with the device have returned for revisions – higher than the normal revision rate, which he said is less than 5 percent, but lower than what the registry studies were showing.

Terrie Edwards, administrator at Sentara Leigh Hospital in Norfolk, said the revision rate of the DePuy ASR there has been about 2 percent.

Other reasons for revision besides a defective device include poor after-care by the patient, problems with how the device was implanted, and simple wear and tear.

Haynes said it’s important to remember that the vast majority of joint replacements are successful, and the recall is no reason to avoid hip replacement or to shy away from innovation in general.

A technique he’s incorporated into his practice is the “Jiffy” hip, which replaces the joint through incisions made in the front of the hip rather than the side. That requires less cutting of muscle, and has a quicker recovery, he said.

Haynes did Blosser’s revision surgery in March at Bon Secours Mary Immaculate Hospital in Newport News using that method. Blosser said the difference between his first and second surgery “was like night and day. I knew immediately when I came back from recovery that I was good.”

LeMoine said her revision required one day in the same hospital instead of three. She’s still wondering what to do about her right hip, since she has a DePuy ASR implant there.

Blosser, who also is suing DePuy but is represented by a Florida attorney, said that when it comes to hip replacements, patients are at the mercy of their doctors, and doctors are at the mercy of manufacturers.

That leaves him with a question as his lawsuit wends its way through the court system:

“Are they making oodles of money by not testing stuff?”


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