Ever since the Supreme Court ruled, in Riegel vs. Medtronic, that FDA approval of a medical device preempts most state suits for damages from it, a nightmare has hidden behind the industry gloating.
What if the FDA approval process is corrupted?
That nightmare may have come true, the FDA now admits. Within months of the Medtronic decision New Jersey Democrats put pressure on the agency to approve a new knee implant from ReGen Biologics, called Menaflex. And the agency buckled.
The Menaflex (shown) replaces the soft tissue within the knee joint and is called a "collagen scaffold," in that natural tissue is supposed to grow around it. ReGen tried three times to get approval for the device and then called its Congresscritters -- four Democrats.
One of those Democrats, Frank Pallone, has already introduced the Medical Device Safety Act, which would specifically overturn the Medtronic decision. (Wags might call it the "stop me before I lobby again" act.) The New England Journal of Medicine likes it. (So does the plaintiff's bar.) The industry does not.
Medical devices are a $192 billion market, and FDA approval is often the gateway to worldwide opportunity. This is a big piece of America's export pie. How much care must be taken before setting our new wares before that market?
The Administration seems to think a bit more, according to the FDA Law blog. Kurt Karst writes that the Administration is slowly backing away from the preemption doctrine that started all this. The Administration has even entered a case concerning the preemption of suits against anti-depressants, on the plaintiffs' side.
This sounds like inside baseball, but given how loudly Republicans involved in health reform are calling for "tort reform" -- removing grounds to sue for malpractice and limiting awards -- it deserves to be asked.
How much care should be taken with drugs and devices that go into your body? When is that care enough to keep you out of court, if you think you were harmed?
A personal story on that, before you start your weekend.
A few decades ago my dad needed his aorta replaced. (Dad passed away in 1999.) The doctor assured him the new one would last 10,000 years. (It did last out his life.)
"But what if it goes out then?" my dad said he asked.
"In that case the replacement part will be free," said the doctor. "Just the labor is extra." Dad got more than the part's value out of recounting the story, and I can still hear his chuckle as I write this.
But is that enough?