DePuy Hip Replacement Failure Data Concerned FDA in 2009
Recent news stories about the Depuy hip recall have focused not on the events leading up to the recall itself but on actions the company took one year earlier in 2009. According to the New York Times, DePuy sold the ASR XL Acetabular System overseas even though it failed to gain approval to do so in the United States. The FDA sent DePuy a letter of non-approval, which has recently been disclosed. It contains some surprising statements about DePuy hip replacement failure data that should interest DePuy ASR hip recall lawyers representing recipients who believe the company’s products injured them.
ASR Device Produced ‘Somewhat Poorer Results’
The non-approval letter (PDF) for the ASR XL Acetabular System, sent on August 13, 2009, included the steps DePuy would have to take to successfully obtain approval if it reapplied. Two points in particular stand out, the first having to do with the ASR’s hip replacement failure data and the second with the ASR’s alleged tendency to cause metal poisoning.
Regarding the failure rates, the FDA questioned the data DePuy used to show that the ASR was safe. The agency went so far as to suggest that DePuy engaged in “study selection bias,” implying the company excluded hip replacement failure data that made the ASR look unsafe. The FDA requested DePuy include all data from foreign sources, no matter how damaging it would be to Depuy’s case.
Later in the letter, the FDA noted the device’s correlation with DePuy hip replacement metal poisoning. The FDA stated, “You have provided several abstracts with selected blood metal ion analyses from patients implanted with the ASR™ Hip System. The high concentration of metal ions observed in some of these patients is concerning.” So serious was the issue that the FDA requested DePuy to include “patient-level data, including clinical and radiographic outcomes and adverse events/revisions/reoperations for these patients” if it chose to reapply.
DePuy did not revise its application for premarket approval, and instead it gave up. However, rather than probe the data suggesting high failure rates and a potential to cause metal poisoning, DePuy stopped manufacturing the ASR. In November 2009, it announced it planned to sell the existing units and begin encouraging orthopedists to use newer Depuy products. By May 2010, most of the remaining ASRs had been sold. DePuy did not consider recalling the device until the summer of 2010, long after many people had received the devices.
RLG Represents People Injured by All-Metal Hip Replacements
The DePuy ASR recall has been an immense disaster, and if DePuy had decided to resubmit its application to the FDA, recipients might have been better informed of the risks. They did not, and now they are left with few options. In this context, it’s important to know that the amount of compensation from a DePuy lawsuit might be greater than what the company is willing to offer via its recall compensation program. A plaintiff can claim full medical expenses, lost income, damages for pain and suffering, and punitive damages in a lawsuit. The Rottenstein Law Group is offering free, confidential legal consultations to ASR recipients. To speak with a lawyer, all you need to do is click on this link or call 1-877-312-3274.