Much at stake as J&J hip implant case nears trial

  • Article by: BARRY MEIER
  • New York Times
  • January 22, 2013 - 8:40 PM

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

Johnson & Johnson never released those projections for the device, the Articular Surface Replacement, or ASR, which the company recalled in mid-2010. But even as the medical products giant was performing that analysis, it was publicly disputing similar findings from a British implant registry about the device's early failure rate.

The company's analysis also suggests the implant is likely to fail prematurely over the next few years in thousands more patients in addition to those who have already undergone procedures to replace it.

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

The trial, expected to begin Friday in Los Angeles Superior Court, might also provide a guide to both the financial and reputational consequences of the ASR episode for Johnson & Johnson. Last year, the company took a $3 billion special charge, much of it related to medical and legal costs associated with the ASR. DePuy has offered to pay patient costs for replacement.

The ASR belonged to a once-popular class of hip implants in which a device's cup and ball were made of metal. While the ASR was the most failure-prone of those implants, surgeons have largely abandoned using such devices in traditional hip replacement because components can grind together, releasing metallic debris.

Judge J. Stephen Czuleger, presiding over the Los Angeles case, unsealed a number of motions last Friday that contained portions of a pre-trial deposition of a DePuy official as well as related company records. Those disclosures, such as the company's estimate of the ASR's failure rate, represent a tiny fraction of the information that will become public if the trial proceeds. Over the past two years, plaintiffs' lawyers have reviewed tens of thousands of internal DePuy documents and deposed dozens of company executives.

Executives of DePuy have long insisted their handling of the ASR 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 ASR 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 ASR lawsuits have been consolidated in a federal court in Ohio. Another 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 has cancer and might not live much longer, lawyers in the case said. DePuy has settled a few ASR cases before trial.

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

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