Sullo & Sullo LLP: May 2011

New Data from Britain about DePuy ASR Acetabular Hip Replacement Devices

Is Johnson and Johnson Telling the Truth About the Failure Rate?

Johnson and Johnson claimed the failure rate was 13% when it recalled the DePuy product in 2010, according to its press release. Johnson and Johnson started using the device in the United States in 2005 and based its failure rate on five years of research. However, England has a hip registry dating back well before 2005.

This week a report by The British Orthopedic Association revealed the DePuy ASR XL hip replacement unit fails as often as 49% of the time. This is an astounding four times what Johnson and Johnson reported stated when it recalled the device last year.

Dr. David Beverland, an Irish orthopedic surgeon who does massive numbers of hip and knee replacements reported that he started implanting the ASR devices in his patients in September 2004 and stopped in May 2007. He declined to say why he stopped the implants, but reported that 32% of his ASR XL patients have been or will need a second hip replacement (revision) and 44% are symptomatic. Only about 22% of his ASR XL patients seem to have achieved a good result and three of his patients died after receiving the implant. This is a serious problem for the defense since Beverland has been a major consultant and product champion for DePuy.

Here are the real facts:

- August 2010 - Johnson and Johnson recalled the ASR XL Acetabular System and DePuy ASR Hip Resurfacing System used in hip replacement surgery due to the number of patients who required a revision.

- April 2011 - Johnson and Johnson agreed to pay $70 million in civil and criminal fines for bribing European doctors to induce them to prescribe their drugs or implant medical devices in patients unaware of their doctors' financial incentives, according to The New York Times.

- May 2011 - The British Orthopedic Association and British Hip Society released data that the DePuy ASR XL hip replacement unit fails as often as 49% of the time - four times more than reported by Johnson and Johnson in 2010.

Based on the evidence there are thousands of patients that appear to be healthy now, yet likely will have complications in the next 3-5 years as a result of the ASR XL device.

What Does the U.S. Food and Drug Administration’s Letter to Hip Makers Mean?

The U.S. FDA ordered 21 manufacturers to collect information from patients.

The U.S. FDA ordered 21 manufacturers to collect information from patients in a recent letter to hip manufacturers. Click here for report. The three-page letter demands blood tests and other studies within thirty days. Here is a summary of the information and questions the FDA is requiring from manufacturers:

The harmful events observed in patients with Metal-on-Metal (MoM) total hip replacement (THR) systems.
The levels of serum and chromium in patients prior to THR.
The patient population's average levels of chromium and serum in the blood for a minimum of eight years after the implant (patient population is the demographics and other particulars of a particular population).
Do the average levels of chromium and serum in the blood increase during the first eight years (or the length of time on the market)?
Reasons for revision (alteration of a medical device) and patient population's average levels of chromium and serum in the blood at the time of the revision.
The number of patients with pain and biological and psychological symptoms associated with the THR.
The quantity of harmful reaction of body tissues in patients who did not have a revision.
How differences in revisions vary over time after the initial implant?
What demographics have higher metal ion concentrations in their blood?
What demographics have higher risks of needing revisions?
What causes the THRs to fail?