Our firm represents many patients with defective Pinnacle hip implants. That’s why we felt it was important for our attorneys to be present at the first bellwether trial in Dallas, Texas. We believe the best way to represent our clients is to know first-hand about the strategy DePuy is taking in court. Below is a report from attorney Brian Franciskato, who works as co-counsel with Altom Maglio on metal on metal hip cases.
Live Testimony from Pinnacle Hip’s Designing Surgeon
Dr. Thomas Schmalzreid is an orthopedic surgeon who has worked as a consultant for DePuy Orthopedics as they developed their Pinnacle and ASR brands of metal on metal hip implants. Internal emails show that Dr. Schmalzreid repeatedly warned DePuy about potential problems with metal ions being released by the Pinnacle hip implant. Here’s a look at the chain of evidence presented in the Dallas trial showing that no testing was done to see how metal ions would affect patients:
- In February 2001, Dr. Schmalzreid discussed the need for blood serum and urine testing for metal ion levels, stating, “ions are still a major issue. More information is needed for assessment of any associated risk.” He then testified, “you gotta put the device in people in order to get this type of information”.
- In August of 2002, Dr. Schmalzreid submitted a research proposal for testing.
- In 2005, a study was published by Schmalzreid, discussing the relationship between patient activity level and ions in patients with M-O-M implants. Schmalzreid admitted this study does not tell us if there is a biological risk to patients from metal ions.
- In 2013, the FDA concluded in its summary investigation that M-O-M hip implants impose a risk to health causing adverse tissue reactions such as metallosis, hypersensitivity, pseudotumors, and ALVAL).
- Dr. Schmalzried agrees that metal wear particles and ions cause all four of the tissue reactions identified in the 2013 FDA investigation.
Testimony also uncovered false marketing materials claiming extremely high success rates based on misleading statistics:
- Pinnacle’s marketing materials claim that 99.9% of the 1 million Pinnacle hips being used are still implanted in patients after 5 years.
- Dr. Schmalzreid admits that the 99.9% figure doesn’t apply to the 1 million Pinnacle hips. According to Dr. Schmalzreid’s testimony, the 99.9% number only applies to the cup (as indicated in the footnote reference to the study).
- Dr. Schmalzried also admits that liner and/or ball revisions were not calculated in this marketing statistic.
DePuy would like witnesses to believe that the problem with the Pinnacle hip is because of doctor error, not a defect with the implant. However, Dr.Schmalzreid’s testimony shows the flaw with that defense:
- Johnson & Johnson says the angle of implantation can cause hip failures.
- Dr. Schmalzreid admits that 57% of all the revisions are happening to patients who have cup angles that were implanted well within the safe zone, meaning more than half of the failures cannot be blamed on the surgeon’s technique.
DePuy was unable to conduct its own examination of Dr. Schmalzreid’s testimony because Dr. Schmalzreid had to return to Los Angeles. It is anticipated he will return later in trial to complete his testimony.
Dr. Tony Nargol, an Orthopedic Surgeon from England, Testified via Videotaped Deposition:
Most of the testimony was about meetings in 2012 with DePuy, the National Joint Registry (NJR), the MHRA (British equivalent to the FDA) and the British Orthopedic Association. The discussions centered around Dr. Nargol’s failure rates and the fact that he was an “outlier” and had much higher rates than other surgeons.
It was pointed out that the NJR “national” failure rates for the Pinnacle were within internationally accepted guidelines. However, Depuy provided the NJR with failure statistics from all variants of the Pinnacle system without singling out those just for the metal-on-metal variant. Indeed, evidence provided during Mr. Nargol’s testimony showed that Depuy’s internal reporting indicated a 14.12% revision rate for the metal-on-metal Pinnacle hip at 5 years, which is well outside of the internationally accepted guidelines.
DePuy’s own internal reporting in the United States showed a 14.12% revision rate for the metal on metal Pinnacle hip at 5 years, which is well outside of the NICE guidelines.
Attorney Altom Maglio Attends Pinnacle Trial this Week
Altom Maglio will be in the Dallas federal courtroom this week as the first Pinnacle trial continues. Today Pam Plouhar, the Deputy Director of Clinical Trials/ Worldwide VP of Clinical Research, is scheduled to testify.