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Maker Aware of 40% Failure in Hip Implant

An internal analysis conducted by Johnson & Johnson
in 2011 not long after it recalled a troubled hip implant estimated
that the all-metal device would fail within five years in nearly 40
percent of patients who received it, newly disclosed court records show.

Johnson & Johnson never released those projections for the device,
the Articular Surface Replacement, or A.S.R., which the company recalled
in mid-2010. But at the same time that the medical products giant was
performing that analysis, it was publicly playing down similar findings
from a British implant registry about the device’s early failure rate. 
     

The company’s analysis also suggests that the implant is likely to fail
prematurely over the next few years in thousands more patients in
addition to those who have already had painful and costly procedures to
replace it.       

The internal Johnson & Johnson analysis is among hundreds of
internal company documents expected to become public as the first of
over 10,000 lawsuits by patients who got an A.S.R. prepares to go to
trial this week. The episode represents one of the biggest medical
device failures in recent decades and the forthcoming trial is expected
to shed light on what officials of Johnson & Johnson’s DePuy
Orthopaedics division knew about the device’s problem before its recall
and the actions they took or did not take.       

The trial, which is expected to begin Friday in California Superior
Court in Los Angeles, may also provide a guide to the consequences of
the A.S.R. episode to Johnson & Johnson, both for the company’s
finances and its reputation. Last year, the company took a $3 billion special charge,
much of it related to medical and legal costs associated with the
device. DePuy has offered to pay patient costs for replacement
procedures.       

The A.S.R. belonged to a once-popular class of hip implants in which a
device’s cup and ball component were both made of metal. While the
A.S.R. was the most failure-prone of those implants, surgeons have
largely abandoned using such devices in standard hip replacement because
their components can grind together, releasing metallic debris that
damages a patient’s tissue and bone.       

On Friday, Judge J. Stephen Czuleger, who is presiding over the Los
Angeles case, unsealed a number of motions that contained portions of
pretrial depositions of DePuy officials as well as related company
records. Those disclosures, like the company’s estimate of the A.S.R.’s
failure rate, represent only a tiny fraction of the information that
will become public if the trial proceeds. Over the last two years,
plaintiffs’ lawyers working on A.S.R.-related lawsuits have reviewed
tens of thousands of internal DePuy documents and taken depositions from
dozens of company executives.       

Executives of DePuy have long insisted that their handling of the A.S.R.
was forthright and appropriate. In mid-2010, when DePuy recalled the
implant, officials said they were doing so because data that year from
the National Joint Registry of England and Wales showed for the first
time that it was failing prematurely at a higher rate than competing
implants. In 2011, the British implant registry updated its projected
failure rates for A.S.R. patients who had had it the longest, saying it
was failing in one-third of them. It was that estimate that was
challenged by DePuy.       

About 7,000 of the A.S.R. lawsuits have been consolidated in a federal
court in Ohio. An additional 2,000 cases have been consolidated in a
California state court. The California case chosen to go to trial this
week was selected because the plaintiff, a man named Loren Kransky, has cancer
and may not live much longer, lawyers involved in the case said. DePuy
has already settled a few A.S.R. cases before trial and it may choose to
do so in Mr. Kransky’s case as well.       

About 93,000 patients worldwide received an A.S.R., about one-third of them in the United States.       

There are two versions of the A.S.R., one used in standard hip implants
and the other used in an alternative replacement procedure known as
resurfacing. Only the standard implant was sold in the United States.
Both versions of the A.S.R., however, used the same metal hip cup as
part of their design.       

Asked for comment about the company’s internal analysis, a spokeswoman
for DePuy, Mindy Tinsley, said in a statement that it “was based on a
small, limited set of data that could not be used to generalize” the
overall failure rate for the A.S.R.       

In 2011, when DePuy challenged the British joint registry’s findings,
the company made similar comments. Other medical organizations, however,
have also projected very high failure rates for the A.S.R.       

Hip implants, which are generally made from metal and plastic, often
last for 15 years before they wear out and need to be replaced. Such
devices can fail prematurely for a variety of reasons, but the early
replacement rate is typically 1 percent after a year, or 5 percent at
five years.       

In pretrial testimony, Paul Voorhorst, DePuy’s director of biostatistics
and data management, said that the company performed several reviews of
A.S.R. failures in patients in fall 2011, a year after it recalled the
model.       

Based on the number of patients who had already undergone device replacement at the time, DePuy estimated that about 37 percent of patients who got an A.S.R. might need to have it replaced within five years of receiving it.       

Last year, The New York Times reported that DePuy executives decided in 2009 to phase out the A.S.R.
and sell off its inventories weeks after the Food and Drug
Administration asked the company in a letter for additional safety data
about the implant.       

The F.D.A. also told the company at that time that it was rejecting its
efforts to sell the resurfacing version of the device in the United
States because of concerns about “high concentration of metal ions” in
the blood of patients who received it.       

In other pretrial testimony released Friday, a DePuy engineer stated
that company officials were aware in 2008 of reports by an English
surgeon that the resurfacing version of the A.S.R. was releasing high
levels of metallic ions, particularly in women. As a result of the
reports, company officials felt they had to move quickly to redesign the
implant.

 

Source: http://www.nytimes.com/2013/01/23/business/jj-study-suggested-hip-device-could-fail-in-thousands-more.html?_r=0

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