DePuy Orthopaedics (Johnson & Johnson)
DePuy ASR Hip Implant Recall
Estimated impact: $2.5B in settlements; 93,000 patients affected worldwide
J&J recalled the DePuy ASR metal-on-metal hip implant after failure rates reached 13% within 5 years. Internal documents showed J&J knew about elevated metal ion levels and high revision rates but delayed recall, settling 8,000+ lawsuits for $2.5B.
Decision context
Whether to recall the ASR hip system when internal data showed failure rates significantly above the industry average, or wait for more definitive evidence.
Biases present in the decision
Toxic combinations
- Status Quo Lock
- Echo Chamber
Reference class base rates
Across all 146 curated case studies in our library:
Lessons learned
- Loss aversion around a profitable product line delayed a recall that internal data warranted years earlier
- Selective perception in interpreting post-market surveillance data allowed J&J to dismiss adverse signals
- Metal-on-metal hip implants were adopted industry-wide based on theoretical advantages without adequate long-term human data
Source: FDA Class II Recall of DePuy ASR Hip System (2010); BMJ Investigation by Deborah Cohen (2011) (FDA Action)
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