A month ago, I wrote about how the Office of the Comptroller of the Currency had inexplicably and inexcusably written several banking regulations to protect banks that fraudulently re-ordered bank withdrawals to create additional overdraft fees. Last week presented another example of obvious “regulatory capture” with the FDA’s astonishingly belated action on metal hip implants.
On January 17, the Food and Drug Administration issued a “Safety Communication” for metal-on-metal hips, noting “Metal-on-metal hip implants have unique risks in addition to the general risks of all hip implants” and recommending orthopedic surgeons “select a metal-on-metal hip implant for your patient only after determining that the benefit-risk profile of using a metal-on-metal hip implant outweighs that of using an alternative hip system.”
The FDA’s warning would have been prompt if it had been issued four years ago, by which point there was already substantial data showing the DePuy hip implants were failing at four to five times the expected rate; in 2009, Johnson & Johnson had already started to phase out the DePuy ASR, (falsely) claiming “slowing sales.” The FDA’s warning would have at least been timely if it had been issued in March 2010, when the NYTimes ran an article on the DePuy hip implants being withdrawn from the market, or perhaps April 2010, when the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a medical device alert that included specific follow-up recommendations for patients with metal-on-metal hip replacements.
By August 2010 — two and a half years ago — DePuy finally recalled all 93,000 of the ASR and ASR XLs it had implanted in patients; had the FDA warning sent out their warning then, it would have been charitably described as “belated.” (Indeed, within six months after that, so many lawsuits had been filed by the hundreds of patients who had already had revision surgeries — and thousands more who were told to get one — that multi-district litigation had been created, and we trial lawyers already knew just how awful these devices were.)
But January 2013? I would say that’s like closing the barn door several years after the cow got out, but the barn door isn’t actually closed, because the FDA hasn’t actually prohibited the sales of metal-on-metal hip implants. All the Safety Communication did was warn doctors about something they should have known years ago: metal-on-metal hips are a bad idea, and shouldn’t be used unless there’s a good reason why. The recent “Safety Communication” admits as much, and admits — without saying it — that metal-on-metal hips should be pulled from the market entirely.
Consider the FDA’s own “General Recommendations for Orthopaedic Surgeons,” which struggle to dream up even a hypothetical patient who would do better with them. The “Recommendations” say “Members of the FDA’s Orthopedic and Rehabilitation Devices Advisory Panel identified young males with larger femoral heads as the best candidates for MoM hip resurfacing systems,” but then the “Recommendations” also warn about an increased risk of adverse local tissue reactions in patients with “high levels of physical activity,” or “who are severely overweight,” or have one of a dozen other common ailments. Together, that means the FDA believes the only patient for whom the metal-on-metal implants weren’t obviously worse are young men (already a tiny minority of hip implant patients) who are neither highly active nor severely overweight. In other words, virtually no one.
So what took the FDA so long? And why haven’t they prohibited the devices entirely?
The problem originates from the dismal laws written around the FDA, particularly the the 510(k) clearance loophole. (The same loophole that gave us the appalling vaginal mesh medical disaster.) Under that loophole, if a medical device manufacturer can convince the FDA that some medical device is “substantially equivalent” to another approved device on the market, then it’s approved, even without any actual testing to see if it’s safe or even useful. It’s a bad idea, which is why the Institute of Medicine — which investigated 510(k) clearance at the request of the FDA — recommended the 510(k) process be abolished.
Once you have such a dismal system in place, where a medical device can be approved merely because the manufacturer says its like something else — something else that might also not be worth it — then there’s no end to the types of useless and dangerous medical devices that can be approved. I would give the FDA credit for proposing new regulations to remove metal-on-metal hips from the 510(k) process (and thus force them into the more rigorous Class III “premarket approval” process, which requires safety testing), but for two problems. First, as noted above, the FDA already has trouble identifying patients who should have this implants. Second, the primary effect will be to render these manufacturers immune from patient lawsuits, because of the various legal protections granted to “premarket approved” implants — protections that these same medical companies’ Wall Street funders periodically lobby Congress to extend to all medical devices, even the dangerous 510(k) devices.
The resilience of the metal-on-metal hips, and of the 510(k) process in general, are more sad reminders of how our government can be bent to put profits over safety, and reminders that, in many cases, civil liability is the only incentive these companies have to make their products safe.