Metal-on-Metal: Should FDA Concerns Have Made DePuy Act Sooner Overseas?

In an interesting twist on events the New York Times has reported that “Johnson & Johnson continued to market an artifical hip (ASR, metal-on-metal… we all know the story by now) “overseas” after the FDA had rejected its sale in USA for safety reasons.”

The article, published on Feb 14th can be found here.

The article goes on to detail the chain of events surrounding the doomed product, from the first alerts through to ultimate global recall and all associated consequences. It suggests that somehow the company misled regulators, clinicians and patients in the markets in which it continued to sell the implants, claiming that somehow the evidence coming out of USA should have compelled the international community to act or at least spur the company into withdrawing it. But hold on a minute; the situation at the time was probably more like the rollercoaster of positives and negatives typical of many new technologies. If the company reasonably believed its product to be safe and the authorities had not seen fit to act, what was supposed to happen at that point?

20/20 Hindsight?

We’re all for medical device safety here, but let’s see if we can adopt a slightly more pragmatic tone and deal with the innuendo-laced commentary piece by piece.

Quotations are excerpts from the NY Times article:

“The DePuy orthopedic division of Johnson & Johnson, citing declining sales, began phasing out both models of the device — formally known as an articular surface replacement device, which DePuy marketed under the name ASR — in November 2009 and formally recalled them in August 2010 amid reports in databases of orthopaedic patients abroad (ie in Europe) showing they were failing prematurely at high rates.”

“But in a confidential letter, the FDA told Johnson & Johnson in August 2009 that company studies and clinical data submitted to gain approval in the United States to sell the model available overseas were inadequate to determine the implant’s safety and effectiveness, according to a summary of the letter reviewed by The New York Times.”

Well, that’s hardly a crime… more products than we can list suffer the same challenge because of the FDA’s known higher clinical requirement prior to approval. It certainly doesn’t imply any wrongdoing, otherwise many more companies and products are in the same position.

And again… 

“The agency also told the company it would need added clinical data to pursue the application, a process that would probably have taken a year or more. DePuy’s receipt of the notice came as regulators and surgeons abroad as well as doctors in this country were raising serious questions about growing failures of both models of the implant.”

Why didn’t DePuy disclose the letter in its financial reports?

“A principal researcher on the clinical studies submitted by the company to the FDA said he was not informed of the agency’s decision. Also, a review of publicly available information indicates that the company did not discuss the agency’s nonapproval letter in financial reports or in presentations to analysts while the device remained on the market.”

Well, there’s no doubt the researcher should have been told, but actually it’s not really his business if, as seems likely, there was a straightforward requirement for further clinical data… again, the norm. As far as not making a note in its financial reports, that “could” indicate that the company did not consider the problem to be sufficiently significant to adversely impact its financials. And of course this is a matter for the financial regulator rather than a matter of device regulation.

Surely the issue’s the regulators not J&J DePuy

“Regulatory standards in other countries, like those in Europe, for approving the sale of medical devices are typically lower than here (USA). A spokeswoman for a British regulatory agency, the Medicines and Healthcare Products Regulatory Agency, said that companies like Johnson & Johnson were not required to notify it when the FDA refused to approve a product that was used in patients there.”

Indeed, given the fact that our (EU) regulatory requirements are significantly different and that there is no cross-pond harmonisation, why would anyone expect that a lack of approval in one territory would mean a warning in another? It doesn’t work like that.

End of the line

“DePuy continued to insist then that it was safe, but in August 2010, after data in a British registry of orthopaedic patients showed high failure rates for the ASR, the company recalled both versions of the device.”

Again, this highlights the regulatory situation and doesn’t seem to indicate that DePuy was deliberately gaining revenue in one territory from a product it knew to be problematic. That would presumably have been self-defeating in the extreme and a ridiculous strategy if they genuinely knew they were storing up the kind of trouble that has impacted patients and cost the company so dear.

Source: New York Times, medlatest staff