Monday, March 25, 2013

On hip replacement, DePuy acted properly: Opposing view

USA today

When DePuy, a Johnson & Johnson company, decided to recall the Articular Surface Replacement (ASR) Hip System in August 2010, it was the right decision at the right time.

OUR VIEW: Where's the corporate responsibility?

Only at that point did new data from a United Kingdom national joint registry report that 13% of patients were undergoing a second hip replacement surgery, called revision surgery, sooner than expected. We immediately recalled the product in every country where it was sold.

We regret that the ASR hip product did not meet the needs and expectations of some patients and, as a result, our own expectations. Our first priority is patients, and we immediately set up a help line and a program to reimburse patients for medical and out-of-pocket costs related to the recall.
So far, this program has assisted thousands of patients. To our knowledge, this was the first program of its nature and scale ever instituted by a medical device company.

More than 10 years ago, DePuy scientists, working with expert surgeons, set out to design an improved metal hip implant as an option for the increasing number of younger, active patients who needed hip replacement surgery. That is our mission at DePuy: to develop products that meet the needs of patients.

Following years of design and testing, the ASR Hip System was cleared for sale through the regulatory processes of various countries around the world. After the system was on the market, DePuy continued to study the device and closely watched how it was performing.

The company looked at data from a variety of sources around the world and sponsored studies in which doctors monitored patients and reported data about ASR. The company openly and rigorously evaluated the data on the device and shared information with surgeons and regulators.

We firmly believe that DePuy acted properly and responsibly with the information it had and that the full history of ASR shows DePuy is a company working to improve patients' lives through innovation, taking action when necessary and standing by patients today.

We remain dedicated to serving patients who need joint replacement surgery.

Pam Plouhar is the worldwide vice president for clinical research at DePuy.

In response to:

Hip replacement throws Johnson & Johnson: Our view

USA Today 3/24/13

Subsidiary DePuy failed to alert the public of mounting failures of some implants, leaving a trail of pain.

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.

OPPOSING VIEW: DePuy acted properly

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% 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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