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Hip implant defects should have been admitted

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When seven people died in 1982 after taking Tylenol spiked with cyanide, drugmaker Johnson & Johnson pulled millions of bottles off store shelves within days, fearing the unknown killer might have sabotaged more pills. Soon, the company introduced tamper-resistant packaging that became an industry standard. Its speed and candor during the Tylenol tragedy became the textbook case for handling corporate crises.

Now, it seems, J & J has thrown out that textbook.

In the late 2000s, as evidence mounted that two of its hip implants were failing at high rates, a J & J subsidiary left the devices on the market for several years. It finally recalled them in 2010 — but not before surgeons had put them in 93,000 patients, more than a third in the U.S.

This month, a Los Angeles jury found the design of the ASR XL implant defective and awarded $8.3 million to a retired Montana prison guard — one of 10,000 patients who have sued J & J and its DePuy unit.

Hip replacements have become big business, as Baby Boomers age and seek implants with more stability and longer lives. In 2001, DePuy set out to produce a new metal device with those qualities.

But all-metal hip devices shed metallic debris, which can inflame and damage tissue and bone. The ASR implants, according to J & J’s own statistics, will fail in about 37 per cent of patients in fewer than five years, forcing a second painful operation to remove and replace the device. Artificial hips are supposed to last 15 years.

J & J isn’t the first pharmaceutical company to keep bad news under wraps. But its shift away from more responsible practices is a notable violation of its own policies, which state that the company’s "first responsibility" is "to the doctors, nurses and patients... who use our products and services."

Letters and e-mails introduced at the Los Angeles trial raise serious questions about how J & J lived up to that credo. In 2006, a DePuy executive wrote that an influential surgeon in the Netherlands was seeing significant failure rates with one of the ASR products. In 2007, an Australian surgeon wrote to DePuy that one ASR device was "a flawed prosthesis and should be withdrawn from the market." In 2008, one of DePuy’s own highly paid consulting surgeons warned of problems, adding, "I do not use the ASR."

How did DePuy respond?

The company says it studied the device and monitored its performance. But in December 2008, it also ran a full-page ad in an orthopedic journal touting the device’s "99.2% survivorship" — a far cry from statistics released this year showing that more than a third will have to be removed and replaced within five years. Finally, in August 2010 — four years after the first hint of trouble — DePuy issued its recall.

Blame for this mess goes beyond DePuy. Congress approved the loophole that allowed swift government clearance for such products without clinical trials. And surgeons warned DePuy about problems but didn’t blow the whistle publicly.

Ultimately, though, makers of medical devices have the best data on whether their products work. Had J & J followed the precedent it set in the Tylenol case, the company would have saved patients a lot of pain and, judging from the lawsuit awards likely to come, saved itself a lot of money.

 

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