An internal analysis conducted by Johnson & Johnson (NYSE:JNJ) concluded that 37% of subsidiary DePuy Orthopaedics’ metal-on-metal ASR hip implants would fail within 5 years, according to documents uncovered during a patient injury lawsuit.
The report was passed around internally in 2011, in the midst of the high-profile recall which has spurred about 10,000 lawsuits and which may cost J&J upwards of $1 billion in liability charges, by some analysts’ estimates.
DePuy biostatistician Paul Voorhorst testified on the figures during pre-trial hearings, affirming that an internal study of about 550 implanted hips concluded that 37% would require revision or replacement in less than 4.6 years.
J&J spokeswoman Lorie Gawreluk told Bloomberg that the figures came from a "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."
Read more of MassDevice.com’s coverage of metal-on-metal hip implants.
The documents, which were unsealed by a California Superior Court, further suggest that J&J got wind of the potential failures in the ASR hips in 2008, 1 year before beginning to phase out the product line and 2 years before the company announced a recall in August 2010.
The lawsuit, filed by patient Loren Kransky who claims his ASR hip failed less than 5 years after he received it, is the 1st to go to trail against J&J. The healthcare giant in August 2012 paid as much as $600,000 to 3 patients in the 1st settled lawsuits against the company’s metal hip implants, according to reports.
Jurors are expected to begin hearing the Kransky case later this week, Bloomberg reported.