Medical devices – artificial hips, etc. – are poorly regulated, and patients who receive them can suffer devastating consequences. A recent New York Times article sheds some light on this shocking industry: Lenzer, J. “Can Your Hip Replacement Kill You?” New York Times, January 13, 2018. The article includes a horrifying anecdote about a physician who received a metal-on-metal artificial hip called the ASR XL, made by Johnson & Johnson. Five years later, the patient had the artificial hip removed, because he was in excruciating pain. Here’s what his surgeon found:
When the surgeon sliced into his hip, what he saw looked like a crankcase full of dirty oil. Tissue surrounding the hip was black. Cobalt leaking from the ASR hip had caused a condition called metallosis, destroying not only local muscle, tendons and ligaments, but harming [the patient’s] heart and brain as well.
This, sadly, is not an isolated occurrence. Despite warnings that the artificial hips ere harming patients, Johnson & Johnson continued to sell the ASR XL model for years, and later sold another similar model, the Pinnacle, until 2013.
9000 patients have now sued Johnson & Johnson for the injuries and losses caused by the hip implants and for failing to warn doctors and patients about its dangers. Recently, a group of six plaintiffs won a verdict of $247 million dollars against Johnson & Johnson for injuries caused by the Pinnacle model.
The numbers are enormous. As the author notes, “about 32 million Americans — or about one in 10 — have at least one medical device implanted, from artificial joints to cardiac stents, surgical mesh, pacemakers, defibrillators, nerve stimulators, replacement lenses in eyes, heart valves and birth control devices.”
It is certainly true that many of these devices have helped many, many patients. But – there are also significant problems. As the article notes:
Medical interventions are now the third-leading cause of death in the United States, and devices play an increasing role in that statistic.
Many people assume that the Food and Drug Administration requires rigorous testing of medical devices before they are approved, the same as the lengthy approval process it requires for new drugs. In fact, most high-risk devices on the market, including implants, have undergone no clinical testing at all.
It’s not just artificial hips, either. “In October 2007, Medtronic, a leading medical device manufacturer, recalled the lead wires in its Sprint Fidelis defibrillator after they were found to fracture and misfire, harming or even killing patients. . . . After the recall, many patients rushed to have the devices removed, but removal posed its own dangers, causing major complications in 15 percent of patients.”
The number of medical devices, which have been recalled, has risen over the least several years, from 8 in 2003, to 117 in 2016. And these are not minor recalls either – these are recalls of Class 1 devices, which the F.D.A. defines as indicating “a reasonable probability” that a device will “cause serious adverse health consequences or death.”
You might think that better governmental oversight and regulation would help ensure the safety of new medical implants and devices.
Yet the Trump administration’s picks to lead the Department of Health and Human Services and the F.D.A. are advocates of deregulation, which they insist will speed the march of “lifesaving” devices to market. This presumes that such speed and innovation is actually lifesaving or life-enhancing. The number of device-related deaths shows how dangerous that presumption is.
The tort system, which lets injured patients sue the manufacturers of dangerous and defective medical devices is – so far, at least – one remedy. Still, prevention is better, and stronger oversight and testing of medical devices might prevent injury to tens of thousands of Americans.