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| 27 August 2013 | By Alexander Gaffney, RAC,
Can an approved medical device be set up in such a way that it breaks federal law? That's the question behind a new Citizen Petition filed on 26 August 2013 with the US Food and Drug Administration (FDA), which argues that exclusive servicing agreements for prosthetic devices break the Americans With Disabilities Act (ADA) by discriminating against amputees who are held hostage to high fees and a lack of competitive pricing.
The petition, authored on behalf of a private individual, targets C-Leg products manufactured by Otto Bock. The C-Leg prosthetic is a microprocessor-controlled device used by tens of thousands of above-the-knee amputees, according to Otto Bock.
The problem, the Petition goes on to explain, is that the device is susceptible to battery failures over time, requiring servicing to either repair or replace the power source of the prosthetic. "The C-Leg presents an extremely dangerous condition when the Li-on battery reaches its end of serviceable life," it explains. "The C-Leg will change unexpectedly into a free swinging mode and the wearer looses [sic] all hydraulic support."
"One could fall and injure themselves," the petition adds.
But unlike many petitions that call attention to potential safety issues, this is not a petition principally concerned with safety. Rather, the petition goes on to explain the difficulties of obtaining service for the device as a result of its prescription status. Because the device is a prescription-only, Otto Bock "must handle all service and support themselves-of course for extra costs," the petition states. And due to proprietary programming-based controls, users are physically unable to self-service the device.
The result, the petition goes on to say, is an "extortive fee"-so high, in fact, that it and "the entire external prosthetics industry in general" are guilty of maintaining a "discriminatory sales and distribution model in violation of the ADA."
"Otto Bock, as well as the entire external prosthetics industry in general, have used the word 'prescription' to self-add a restriction to refuse to sell to the amputee wearer directly who may want to build their own prosthetic or has a need to do simple service or parts replacement on their own prosthetic," the petition continues. However, under Section 12182 of the ADA, companies are barred from discriminating against persons in their ability to fairly obtain services.
In other words, this restriction-unnecessary, the petition argues-leaves amputees in an extorted position with no other options to remedy their care.
The petition goes on to say that FDA should remove the prescription-only status of the devices and make them available over-the-counter (OTC), thereby allowing patients to purchase parts or do other work on the device (i.e. change out old batteries). Under the status quo, the costs for doing simple parts maintenance can be prohibitively expensive for patients despite the low cost of parts and skill needed to install them, the petition adds-a significant barrier to those without insurance in particular.
Prescription status, it continues, is only necessary when a device's misuse would have a potentially harmful effect or requires medical supervision. External prosthetics fail to meet this standard, especially as certified maintenance professionals-not medical professionals-conduct the maintenance on the devices, it argues.
The petition also extensively references the court case Olmstead v. L.C, a landmark rights case dealing primarily with the unnecessary segregation of disabled persons. In this case, the petition argues that as there is no conceivable reason that a layperson couldn't change a battery, this meets the standard of creating an institutional barrier to a proper and integrated system of care.
FDA now has several months before it is required to respond to the petition, after which time it may either agree in full or part, deny the petition, or ask for more time to consider its issues.
Reginald Burgess (Garrett Skelly, ESQ) - Citizen Petition
Tags: Citizen Petition, medical device