Tuesday, January 22, 2013

Metal on metal hips - worse than expected

J.&J. Study Suggested Hip Device Could Fail in Thousands More

An internal analysis conducted by Johnson & Johnson in 2011 after it recalled a troubled hip implant projected that the all-metal device could fail within five years in nearly 40 percent of patients who received it, newly disclosed court records show.

The analysis, which the company has never released, suggests that thousands of additional patients may have to undergo painful procedures over the next few years to replace the implant, known as the Articular Surface Replacement, or A.S.R. It also indicates that the episode’s cost to Johnson & Johnson will continue to grow.

The analysis was part of a small set of records unsealed Friday by a judge in California Superior Court in Los Angeles as part of pretrial proceedings in a lawsuit brought by a patient against the DePuy Orthopaedics unit of Johnson & Johnson.

Over 10,000 lawsuits have been filed against DePuy by patients who got an A.S.R. If the California case, which involves a man named Loren Kransky, goes forward this week as scheduled, it will be first of those cases to go to trial.

The records released Friday by Judge J. Stephen Czuleger represent a tiny fraction of the tens of thousands of internal DePuy documents that the plaintiff’s lawyers say they have reviewed in connection with the California lawsuit. As a result, it is difficult to assess the strength of the case against the implant maker based on them.

Asked for comment, a spokeswoman for DePuy, Mindy Tinsley, said in a statement that the company’s internal analysis “was based on a small, limited set of data that could not be used to generalize” the overall replacement rate for the implant. She added that any documents or partial testimony released before the trial “may not be able to be fully understood without proper context.”

For years, executives of DePuy insisted that the A.S.R. was performing on par with other types of artificial hips, and said that they moved to recall the device in mid-2010 when new data from an orthopedic registry in England showed it was failing more frequently.

Documents in the Los Angeles case and other lawsuits nationwide against DePuy are expected to reveal what actions company officials took — or did not take — before the implant’s recall and when they became aware of its problems.


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