An internal analysis by Johnson & Johnson shows that the company has been aware of high metal hip implant failure rates since 2011. According to a report by Bloomberg, the J&J analysis concluded that approximately 37 percent of DePuy Orthopaedics’ ASR metal-on-metal hip implants would require replacement at five years. DePuy Orthopaedics is a subsidiary of J&J. The internal documents showing this high failure rate were revealed during the discovery process of a patient lawsuit.
In 2011, the company circulated the analysis internally. During this time, a high-profile recall of its metal-on-metal ASR hip implants was underway. The recall led to approximately 10,000 lawsuits against the company. According to some analysts, the final costs from the faulty hip implants could cost the company up to $1 billion in liability damages.
Paul Voorhorst is a biostatistician at DePuy. During pretrial hearings for an injury lawsuit, he corroborated the accuracy of the internal analysis. The internal study showed that out of 550 implant hips, approximately 37 percent would require replacement or revision after 4.6 years or less.
J&J attempted to downplay concerns over the internal analysis. In prepared remarks, Loie Gawreluk, a spokeswoman for the company, stated that the 37 percent figure originated from "a small, limited set of data that could not be used to generalize the revision rate for ASR, unlike published data from national joint registries that include large numbers of patients and detailed revision information."
- Laser Ablation - Supplier Resource
- Learning from Hospital Acquired Infections (HAIs): Understanding Current Reprocessing Regulations, Product Validation and Clinical Human Factors - Webcast
- Best Practices for Medical Device Manufacturers to Ensure Quality - Supplier Resource
- Custom Products List - Supplier Resource
- Manufacturing - Supplier Resource
- Risky Business: Why Excluding Suppliers from Your Quality Processes Could Cost You - Supplier Resource