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 In 2011, the product was withdrawn from the Canadian market after about 5,000 had been sold here.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.