X-rays of Margaret Wente’s right hip replacement.Louie Palu/The Globe and Mail
Eight years ago, I sat in a surgeon's office as he showed me X-rays of my deteriorating hips. He told me they were finished. I was only in my 50s, but I wasn't surprised. By the time I saw him, I could scarcely walk. I had skied and hiked and led a reasonably active life, but now I was a cripple. Sometimes I had to use the railings to drag myself hand over hand up the stairs.
Artificial hip replacements are among the great blessings of modern medicine. They have restored mobility to millions of people. Hip surgery is generally low-risk and highly successful. For aging boomers, that's the good news. For me, the bad news was that I would have to spend a long time disabled and in pain before having the surgery. The backlog in Ontario was much bigger than now. I would have to wait about a year for my first hip and another year for the second. After that, I'd have to be careful. No tennis, no yoga, no skiing.
The other problem was that the new joints wouldn't last forever; I would need replacements when they wore out. I hobbled back to my car and cried. Then I did what modern patients do: I consulted Dr. Google.
Soon I found some more good news. A top orthopedic surgeon in Montreal was doing a newer procedure called hip resurfacing, specifically targeted at younger, active people. Resurfacing, which is an alternative to total hip replacement, had been popular in Europe for years. The advantage was that, after surgery, you could do everything again. There was also another innovation on the market – all-metal implants that promised to last much longer than the standard metal-and-plastic devices that had been in use for years. My crumbling arthritic joints would be replaced by a shiny ball and socket made of cobalt and chromium – a miracle of medical engineering.
The waiting list in Montreal was short. Within months, I had two new metal hips made by DePuy Orthopaedics Inc., which started out making splints for Indiana farmers in 1895. I even wrote about them in The Globe and Mail. Readers across the country asked for my advice. Many of them wound up getting the same type of implant.
I also heard from orthopedic surgeons. One or two were surprisingly vitriolic. They didn't trust the new devices. They warned me that bad things would happen to my hips. That was when I learned that medical opinion, to put it mildly, was sharply divided.
Today, the miracle has turned into a nightmare.
With the aging of baby boomers, joint replacement is big business – about 40,000 Canadians will receive one this year alone. But metal-on-metal hip devices, including the kind I have, have failed in thousands of patients, with several models taken off the market and leading companies facing massive litigation.
Many of the half-million people to receive metal implants worry about the future, warned by lawyers that they may feel fine, but tiny fragments may leach into their bodies and poison them.
I have always been skeptical of medical scare stories. I know that litigation lawyers are paid to make the worst of things, and the pharmaceutical industry is a ripe target. The high cost of medical litigation drives up the cost of medicine for us all, and may even slow the pace of innovation. In many cases, the biggest winners are lawyers, not patients.
Yet, my faith in medicine and Big Pharma – DePuy is a division of Johnson & Johnson, the biggest pharmaceutical company in the world – has been well and truly shaken. Sometimes the latest shiny product is not so great. Things can go wrong, even if you are an educated consumer.
Gloria McSherry was an educated consumer – the active wife of a successful business executive and once a keen runner. Now a resident of Dunedin, Ont., about an hour's drive north of Toronto, she was in her early 50s when she was diagnosed with arthritis in her hip.
In 2007, she was given a Zimmer Durom Cup. "The surgeon praised it highly," she says. It was supposed to make her more mobile than other implants, and to last longer.
It was a catastrophe. After receiving the new hip, she says, "I just could not get well. I got these incredible episodes of pain where I felt as if it would exit my body." A year after her surgery, walking was still difficult and painful. The implant scraped and jammed. Even though her X-rays looked fine, she wasn't functioning. Her surgeon had no answers and neither did anybody else. The wear and tear on her personal and family life was profound.
More than 21/2 years after her initial surgery, she and her husband consulted a U.S. hip surgeon. He told them the implant had proved problematic, and the only solution was to have it taken out. She had it removed by a second Toronto surgeon, who found that the bone had never adhered to the cup, as it was supposed to. He replaced it with another device, and she immediately felt better.
Problems with the Durom Cup were well known in the United States, but nobody in Canada seemed on top of things. (There is a registry to track joint replacements but participation is voluntary.) In 2011, the product was withdrawn from the Canadian market after about 5,000 had been sold here. Today, Ms. McSherry is one of the plaintiffs in a Canadian class-action suit alleging that Zimmer (founded by a disgruntled DePuy employee, it, too, is based in Warsaw, Ind.) was negligent in its development and manufacture. Klein Lyons, the law firm that represents her, has received certification for the action, and says it has been contacted by about 70 Canadians eager to participate.
Patients here also have joined suits against DePuy and Stryker, another manufacturer with implant woes, but the real action is in the United States, where product-liability lawsuits are a true bonanza. Tort lawyers troll aggressively for clients, and settlements can run into the billions. Johnson & Johnson is the richest target of all – it had sales of $65-billion, and profits of $9.7-billion in 2011 – and currently faces more than 10,000 lawsuits. The legal documents run to 50 million pages.
DePuy alone had revenues of $5.8-billion, and has sold 93,000 of its metal-on-metal implants worldwide (about 1,400 in Canada). The first trial over those implants began in California late in January, and is being watched closely as a sign of things to come.
Plaintiff lawyers have put company executives through the wringer. Their strategy is to persuade the jury that greedy business people recklessly sacrificed safety for profits. They say DePuy knew that its design was flawed but kept selling the product anyway. The company argues that it behaved responsibly and acted promptly when adverse information came to light. By 2010, the data were so clearly bad that it issued a recall.
Thanks to aging boomers, the market for medical devices is lucrative, and huge. Not only will 40,000 Canadians receive an artificial joint this year, about 2.5 per cent of us all will get one at some point, and suppliers compete aggressively. Conflicts of interest – such as fat "consulting" fees to doctors – are common in the United States. In 2007, several leading device makers, including Johnson & Johnson, were fined $311-million to settle claims that they had paid hundreds of millions to surgeons to use their products exclusively.
When the new metal-on-metal models were introduced, they quickly gained a big share of the market. The U.S. Food and Drug Administration allowed DePuy to sell one version of its device – for total hip replacement – without testing it on humans, because it was similar to products already available. The FDA wanted more data on the version for hip resurfacing (the one I was given), but both models were approved in Canada and other countries.
DePuy Canada representative Jennifer Goode says the company conducted "more than 60 tests on the devices, including lab tests, wear tests, torque testing and many others," including use in "hip simulators that ran five million cycles of motion, representing 21/2 years of use by a patient."
She contends that DePuy "exceeded the international standard," and "will defend itself against the allegations raised in the litigation."
The implants did work fine in the lab. But the real world turned out to be another matter. For reasons still not clearly understood, different surgeons and even different countries had wildly varying results. The magic number for hip "revisions" (surgeries that have to be redone) is 1 per cent per year. Anything higher is deemed unacceptable.
Failure rates in Britain and Australia reached 35 to 40 per cent after five years, while in the United States, the figure is 12 to 13 per cent (according to the company) or nearly 40 per cent (according to some media reports).
The overall rate in Canada is unclear, but most of the DePuy implants were performed by my own surgeon, Dr. John Antoniou, who says his record meets the benchmark standard of 1 per cent per year. But some of his patients have joined the lawsuits, and he declines to comment further on the situation.
Why the discrepancies in results? Los Angeles surgeon Thomas Schmalzried, the lead designer for the implant, says one reason is surgical skill. Because of its size and design, the device had to be installed with great precision. Surgeons who did only a few procedures a year had bad outcomes – but then so did a few who did lots, and Dr. Schmalzried testified last week that he wouldn't have put the device out had he known it would fail so often.
Patient selection was another factor. The device I got worked extremely well in younger men with good bones, but not so well in women, and terribly in the old. And then there's the plaintiff lawyers' argument: It was just badly engineered.
But the biggest potential problem may be metallosis: Tiny particles of metal can rub off, causing pain and swelling around the joint. Depending on whom you ask, it is either a rare complication or a major life-threatening hazard.
"Even if you don't feel any discomfort, you may be experiencing cobalt and chromium poisoning," says Regina lawyer Evatt Merchant of Merchant Law Group, a leading class-action firm (founded by his father, Tony) that he says has been contacted by about 500 unhappy patients.
"And that is a dangerous medical health problem because it gets into the bloodstream. It's carcinogenic – that's the fear."
The trouble is that metallosis is a murky subject. Everyone with metal hips is supposed to have blood tests. But no one can agree what metal levels are problematic. Some people are so frightened that they insist on having their implants removed even though they feel fine and there is no evidence so far that particles from hip implants cause cancer.
I can almost see why they worry, given the truth, half-truth and scare stories on the Web: I have learned that I could develop aseptic lymphocyte-dominated vasculitis, silent soft-tissue pathology, and "pseudo tumours" (I have no idea what these conditions are, but I'm sure they're deeply unpleasant). I have even read of surgeons opening up patients to find that the tissue around their implants has been destroyed.
As for me, I'm fine. Although my hips aren't perfect, they are very good. I can't hike the way I used to, and hard city pavement quickly wears me out. But I can bike and ride a horse and bend and stretch as well as ever. I have my life back.
The people at DePuy are being very nice. They will pick up all my hip-related medical bills, including blood tests for metal levels, travel costs to Montreal for follow-ups, and costs connected to revision surgery, if I ever need it. They are hoping very much that I don't sue them.
Gloria McSherry is not so lucky. "My life will never be the same," she says. "I never dreamed that I could ever have anything like that happen to me."
She doesn't need the money, but says that "we decided to sue because we couldn't believe the injustice of it all. They are supposed to be in business to improve lives."
If I had gone through what she has, I would sue too. And yet I'm not sure the hip debacle is the incredible disaster the litigation industry says it is. All medical devices and procedures can fail. And despite the terrible publicity, some surgeons still use metal-on-metal implants. In the right hands, they say, the technology works well for certain patients.
In the world of high-tech medicine and high-stakes litigation, we patients are largely on our own. No matter how diligent regulators are, they will never protect us all. It's up to us to figure out whom to trust. Dr. Google doesn't have all the answers.
As the trial in California grinds on, insiders say that J&J is negotiating to settle the 10,750 U.S. cases for around $2-billion, a sum that will barely dent its profits.
As for me, I've decided to stop worrying. What else can I do? It seems foolish to be consumed by fear of hypothetical harm. With luck, my hips will be buried with the rest of me, far in the future.
But I have learned a lot. I am much more skeptical of the wondrous new offerings from Big Pharma. I'm sorry I wrote that piece in the paper, and I worry about the people I encouraged. I hope they're all okay. From now on, I will offer only two pieces of advice to people whose hips are shot. Pick a good surgeon. And caveat emptor.