Last week we did that usual, well-balanced thing we do of leaping to the defence of the “wronged” party, or at very least offering the “other side of the story”. DePuy were being accused by the New York Times among others of continuing to supply their ultimately-to-be-doomed ASR all-metal prostheses outside USA long after FDA had expressed its concerns.
DePuy’s defence was that, far from being worried about the product, it stopped its PMA for sales and marketing (ie demand) reasons, rather than underperformance of the product. Yet now the New York Times has reported the existence of internal emails within DePuy, expressing concern about the number of revisions being performed on ASR patients. Indeed it cites an email, written by DePuy executive Pam Plouhar, outlining the FDA’s decision not to grant pre-market approval to the ASR implant and noting the higher number of corrective surgeries required by patients who received the device compared to a control group.
The email states “the FDA took issue with several aspects of the pooled clinical data,” especially concerned that “there have been a significant number of revisions within the ASR group (both in the IDE and in the OUS study) as opposed to very few in the control group.”
“The team’s concern is that given the revision rate in the ASR group that we will still not be able to demonstrate non-inferiority with additional downside risk,” Plouhar added. “This comes at a time when ASR data from national registries (Australia and UK) is being closely scrutinized because of higher revision rates.”
So the question; Did DePuy knowingly continue to market a product internationally (for about a year) after it was made aware of a worrying failure rate?
Let’s do the balanced thing again and suggest that this is not black and white. It could be that the company was absolutely sincere in its belief that technique issues rather than fundamental product failings led to the higher revision rate, but surely if that was the case it should be showing us internal emails now containing conjecture about the subject or at least some reassuring commentary from internal regulatory staff.
It’s a really difficult one to call, not helped by EU regulatory controls being comparatively weak when put alongside FDA’s. The New York Times seems determined to unearth the truth.
Source: New York Times, Massdevice