ASR Implants with a 40+% Failure Rate?

By Rheingold Giuffra Ruffo & Plotkin LLP

The Loren Krantz trial in Los Angeles started last week and previously shocking confidential information is reaching the light. In opening statements, plaintiff’s counsel discussed DePuy’s internal post-recall study which estimated a 40% failure rate. This was a 2011 internal evaluation at 5 years after implantation, obviously significantly higher than their only public projection, which was 13%.

This is a shocking failure rate, as the industry standard is 1% failure per year, translating to 1% on the first year, up to 5% in five years. The Australian Implant Registry data for 2012 showed a 44% rate at 7 years. Now we see essentially an identical failure rate two years earlier!

When asked why this information was not made public, a DePuy employee said there wasn’t enough data to extrapolate to a larger population. Certainly this contention will be attacked at trial. As this trial and others play out, we will need to monitor how high the failure rate becomes. DePuy’s defense trial playbook will be that there’s a lawyer-driven hysteria which leads patients to revisions which would not otherwise happen. This is a very weak argument which is insulting to patients, as well as highly skilled orthopedic surgeons who are the ones ultimately decide what is in the medical best interests of a patient.

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