The FDA has – through budget cuts and restructuring of its funding, political pressures from Big Pharma lobbyists, and a revolving door which shuffles drug and medical device company employees in and out of FDA employment – now become little more than a pawn for medical device and drug makers. Medical device companies making billions of dollars on dubious devices – like overused IVC filters, over-prescribed heart stents, and dangerous metal-on-metal hip implants – use the FDA primarily as a cover. They use the agency to imply that it has verified the safety and efficacy of their medical devices, and to help them sidestep liability lawsuits.
Full FDA approval can and does help medical device makers sidestep many liability lawsuits; however, FDA approval does not verify the safety and efficacy of medical devices.
The Danger Within Us: America’s Untested, Unregulated Medical Device Industry
This is not Conspiracy Theory 101. This is the fact of the matter, and it is well documented in at least a dozen extensively-researched books. One of the latest, The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It, by Jeanne Lenzer, makes the case all over again. Ms. Lenzer shows just how broken our medical regulatory system is. The book should be required reading for the U.S. Supreme Court, which has ruled in some landmark cases that FDA approval grants medical device makers a free pass to harm people at will with poorly tested or even arguably worthless medical devices.
Despite the woeful state the FDA has been left in after billions of Big Pharma lobbying dollars have worked to undercut and weaken it, the U.S. Supreme Court has ludicrously ruled that FDA approval of a medical device gives its maker license to avoid legal responsibility for injuring people.
Riegel v. Medtronic: Justice Denied by Preemption
In Riegel v. Medtronic and other miscarriages of justice, the highest court has ruled that medical device makers get a free pass when they make a device that injures or kills someone, if that device was approved by the FDA. The ruse is called “preemption.” It adds an additional injury to people whose lives were taken entirely or perhaps only badly damaged by some dubious medical device. The preemption argument, in a nutshell, claims states can’t comply with both federal and state laws; therefore, federal laws “preempt” state’s rights. Preemption is a Sophist argument easily refuted on both legal and ethical grounds by anyone (such as Justice Ginsburg) who believes in civil liberty, corporate responsibility, and the U.S. Constitution. But all is not lost, yet.
Medical devices which have not gone through the FDA’s full PMA approval process are still fair game for liability lawsuits. That is at least the case for now, though several bills written by medical device and drug company lobbyists are currently being pushed by Big Pharma’s lackeys in congress. The obvious goal for the Western medical “industry” is to remove all vestiges of remaining protections for people injured by dangerous drugs and medical devices. Unfettered profits with zero accountability has always been the goal of every corporation, of course, but in the case of the healthcare “industry,” that goal strikes one as especially unmoored from any basic semblance of human decency.
The FDA 510(k) Clearance Process
But even in today’s wild west of a healthcare system broken both legally and morally, medical device makers can sometimes still be made to face some legal liability. Medical device makers can still sometimes be held accountable if, rather than gaining full FDA approval for the device in question, it was allowed on the market via the FDA’s 510(k) clearance process. The 510(k) clearance process has so lowered the bar to the open market that even the corporate-friendly judges of the high court have been forced to see that it does not even imply that the FDA has researched the product sufficiently to ensure its safety or effectiveness.
IVC Filter Lawsuits
Because IVC filters were allowed on the market via the FDA’s 510(k) clearance process, IVC filter makers like Cook Medical , C.R. Bard, Cordis, and Rex Medical can still be held accountable when their filters fail to perform as advertised.