Over the course of the next three months, eight top DePuy Orthopaedics executives will be required to testify in the DePuy ASR multidistrict litigation under the Honorable David A. Katz. The company leaders, which include the former and current company presidents, will be required to produce ASR-related documents, notes, outlines, presentation materials, testimonies and oral proposals prepared or given to them.
After this year’s discovery of a smoking gun email between top executives, DePuy has been questioned as to exactly how much – and for how long – they knew about failure rates.
The DePuy ASR XL system was passed through the FDA through the 510(k) clearance program, which does not require rigorous clinical trials before it is approved for the U.S. market. However, the ASR Resurfacing System did not qualify for 510(k) clearance, thus requiring the FDA’s review of clinical trials. After their review, the FDA rejected DePuy’s application, requesting additional trials due to safety concerns. In August of 2009, internal emails uncovered executives’ doubts that additional testing would improve safety data.
According to a drugwatch argicle, the multidistrict litigation is now made up of over 6,000 federal cases. DePuy will also face over 2,000 more lawsuits are filed in state courts.
To see the company executives that will be expected to testify, see the drugwatch article by clicking here.