(I already printed a summary of this project Alpha testimony however, there are different perspectives offered each with a bit of different information.)
This week, a bioengineer for Johnson & Johnson’s DePuy Orthopaedics unit testified in Los Angeles state court in the first of 10,000 DePuy ASR lawsuits to go to trial. According to Bloomberg News, James Anderson worked on redesigning the ASR for three years before the project was ended; even though he found ways to potentially lower the amount of metallic debris released by the metal-on-metal hip implant, no changes were ever implemented.
“Again, we have evidence that Johnson & Johnson was aware of problems with the ASR hip implant prior to the recall in 2010,” said Daniel C. Burke, Senior Litigation Counsel at Parker Waichman LLP. “Despite knowing that this hip replacement has a high rate of wear, J&J did not actually make the necessary changes to try and improve the ASR.” Parker Waichman continues to offer free legal consultations to hip replacement patients implanted with the DePuy ASR, along with other all-metal hip replacements. The firm advises hip replacement patients to speak with their surgeons if they experience symptoms such as:
- Difficulty walking, or a change in your ability to walk
- Popping, creaking, or other sounds emanating from the area of the implant
- Metallosis, high levels of metal ions
- Early failure, revision surgery
According to Bloomberg News, this week jurors heard a videotaped testimony from Anderson stating that he was disappointed when the project to redesign the DePuy, known as “Project Alpha,” ended in 2008 without any changes to the all-metal hip implant. Anderson joined a team to study the “next generation ASR” in 2005. On April 7, 2008 he wrote to a superior, stating that “a small improvement to geometry could represent a large improvement for many patients.” In a separate document he wrote that by removing the groove on the ASR cup, wear on the cup “is approximately threefold less than the original design with the groove.”
Johnson & Johnson never implemented any changes to the ASR hip implant, which was recalled in 2010 due to a high failure rate. At the time of the recall, the company said that the implant failed in 12 percent of patients within five years. More recent data from an Australian national joint registry showed that the failure rate exceeded 40 percent.
This week, jurors also heard an expert witness testimony from a McGill University professor who stated that the ASR implant had a number of design defects causing it to fail more than other hip replacements. He said that cup shape, which is less than half a circle and has thin walls, attributed to the defective nature of the implant.
The U.S. Food and Drug Administration (FDA) has issued new guidelines for patients implanted with metal-on-metal hip implants such as the DePuy ASR. In a Safety Communication issued January 17th, the agency advised physical examinations, diagnostic imaging and metal ion testing as needed. The FDA is also looking to tighten regulations on all-metal hip replacements that would require manufacturers to prove the devices are safe and effective before selling them.