Updates

March 25, 2013
USA Today (source)
Recall of hip replacement system was the right decision at the right time
By Pam Plouhar, worldwide vice president for clinical research at DePuy

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.

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.

Statement Regarding ASR Hip System Verdict in Los Angeles, CA

March 8, 2013

In the first ASR™ Hip System case to go to trial in the United States, a jury in the California Superior Court, Los Angeles County, returned a mixed verdict after a five week trial. The jury found that the ASR XL was defectively designed. The jury rejected the plaintiff’s claim that DePuy Orthopaedics, Inc. failed to adequately warn of the risks associated with ASR XL.

“We believe ASR XL was properly designed, and that DePuy’s actions concerning the product were appropriate and responsible,” said Lorie Gawreluk, a spokeswoman for DePuy. “We plan to appeal the jury’s decision on design defect pending the outcome of post-trial motions. We believe we have a number of valid grounds for appeal, notably that the court didn’t let the company tell the jury about the Food and Drug Administration’s review and clearance of the device.”

The jury rejected plaintiff’s claim for punitive damages and awarded $8,338,000 in compensatory damages.

For additional information on the ASR Hip System, please visit: www.ASRHipInfo.com

ASR Hip System Recall Information

In 2010, the company received new information from the National Joint Registry of England and Wales reporting that some ASR patients were undergoing a second hip replacement surgery sooner than expected. After receiving this information, the company acted quickly by voluntarily recalling the product in every country where it was sold. Before August 2010, the totality of the data available to the company showed ASR was performing consistent with the class of monoblock metal-on-metal hip implants.

93,000 ASR implants were sold worldwide.

Supporting Patients

Within days of the recall, the company set up a Help Line for patients that is now available in dozens of countries and has served tens of thousands of callers. The company created a worldwide reimbursement program for ASR patients that, so far, has resulted in thousands of payments to patients for testing and treatment and other out-of-pocket expenses. DePuy also set up a process to provide information to surgeons and to work with surgeons so that they could get information to their patients.

“DePuy is committed to improving patients’ lives, and the company regrets that the ASR Hip System did not perform as expected for some patients. Since the recall, DePuy has worked to provide patients and surgeons with the information and support they need,” added Gawreluk. “Joint replacement surgery is one of the greatest medical advances of our time, and we remain dedicated to serving patients who need this important treatment.”

Litigation Information

DePuy believes the ASR Hip System was properly designed, physicians were properly informed of the product’s risks, and the company’s actions concerning the product were appropriate.

As of December 30, 2012, in the U.S. there were approximately 10,750 plaintiffs with direct claims in pending lawsuits with respect to the ASR™ XL Acetabular System.

Cases filed in federal courts in the United States have been organized as a multi-district litigation in the United States District Court for the Northern District of Ohio. The first case as part of the multi-district litigation is scheduled for May 2013.

Media Contact Information

Lorie Gawreluk
732-524-1413
lgawrel1@its.jnj.com

Mindy Tinsley
574-372-7136
mtinsley@its.jnj.com

Letter to the Editor from DePuy Published in the New York Times (source)
To the Editor:

Re “What a Company Knew About Its Metal Hips” (editorial, Feb. 11):

All of us at DePuy are united by the goal of improving patients’ lives, so we understand that the Articular Surface Replacement Hip System recall has been of concern for patients, their family members and surgeons. I disagree with how your editorial described company actions regarding ASR testing, data analysis and communications.

ASR was tested for years before receiving regulatory clearance around the world. Once on the market, we carefully considered all the data and investigated product complaints individually, while also looking for broader performance trends. We continued to share appropriate and validated data with regulators and surgeons.

When we received new registry data reporting that ASR patients were undergoing a second hip replacement surgery sooner than expected, we recalled the product and immediately supported patients with a reimbursement program for their medical costs.

Joint replacement surgery is one of the greatest medical advances of our time. We remain dedicated to serving patients who need this important treatment option.

ANDREW EKDAHL
President, DePuy Orthopaedics
Warsaw, Ind., Feb. 25, 2013