Winnipeg Free Press - ONLINE EDITION

Hip implant defects should have been admitted

  • Print

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 In 2007, an Australian surgeon wrote to DePuy that one ASR device was "a flawed prosthesis and should be withdrawn from the market."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.


Fact Check

Fact Check

Have you found an error, or know of something we’ve missed in one of our stories?
Please use the form below and let us know.

* Required
  • Please post the headline of the story or the title of the video with the error.

  • Please post exactly what was wrong with the story.

  • Please indicate your source for the correct information.

  • Yes


  • This will only be used to contact you if we have a question about your submission, it will not be used to identify you or be published.

  • Cancel

Having problems with the form?

Contact Us Directly
  • Print

You can comment on most stories on You can also agree or disagree with other comments. All you need to do is be a Winnipeg Free Press print or e-edition subscriber to join the conversation and give your feedback.

You can comment on most stories on You can also agree or disagree with other comments. All you need to do is be a Winnipeg Free Press print or e-edition subscriber to join the conversation and give your feedback.

Have Your Say

New to commenting? Check out our Frequently Asked Questions.

Have Your Say

Comments are open to Winnipeg Free Press print or e-edition subscribers only. why?

Have Your Say

Comments are open to Winnipeg Free Press Subscribers only. why?

The Winnipeg Free Press does not necessarily endorse any of the views posted. By submitting your comment, you agree to our Terms and Conditions. These terms were revised effective April 16, 2010.


Make text: Larger | Smaller


Jets this week - Game 2 with Tim and Gary

View more like this

Photo Store Gallery

  • MIKE APORIUS/WINNIPEG FREE PRESS STANDUP - pretty sunflower in field off HWY 206 near Bird's Hill Park Thursday August 09/2007
  • STDUP ‚Äì Beautiful West End  begins it's summer of bloom with boulevard s, front yards  and even back lane gardens ,  coming alive with flowers , daisies and poppies  dress up a backyard lane on Camden St near Wolseley Ave  KEN GIGLIOTTI  / WINNIPEG FREE PRESS  /  June 26 2012

View More Gallery Photos


Do you agree with the sale of the Canadian Wheat Board to foreign companies?

View Results

View Related Story

Ads by Google