Democracy for Vancouver

Pacemaker dies, so you do, too? Bad luck, man. Knee replacements wear out before their time? Tough shit. Because according to 8 of our 9 illustrious SCOTUS justices (with their of the cadillac health care plan and the lifetime employment), even if a company knew its medical device was faulty, if the underfunded and bribe-financed FDA approved the hardware that killed you, left you disabled or subjected you to additional risky surgeries,

THAT’S TOO GODDAMN BAD:

Makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the Food and Drug Administration approved the device before it was marketed and it meets the agency’s specifications, the Supreme Court ruled on Wednesday.

According to Scalia, you see, if you were allowed to sue in state court because your hip replacement failed, leaving you without enough bone left to graft in another device so you’ll spend the rest of your life in a wheelchair, that would “disrupt the federal scheme” of regulation. The feds wanted the last word on medical devices, according to Nino, so the states can just go piss up a rope.

Scalia’s reasoning is more than a bit flawed, but it’s Grover Norquist’s dream. For years, corporations have been arguing that if the feds regulate something, the states can’t touch that issue, whether through regulatory agencies or in the courts. For the most part, the federal courts have laughed at this, saying sure, the states can hear the cases on the back end - they just can’t regulate the devices on the front end. (You wouldn’t want Mississippi having one standard for defibrillators and Massachusetts having another.) As Justice Ginsberg wrote in her dissent, it was not Congress’s intent to prevent suits in state courts, but to prevent states from imposing their own approval process on medical devices.

But evidently the time has come to change this long-standing rule - or rather the corporatist majority on the Supreme Court has finally been accomplished, so sit back and watch the dominoes fall.

“But what’s the harm?” you ask. Not many approved medical devices fail, right?

Well, I tried to check the FDA’s website to see just how many medical devices were recalled in 2007, but the website couldn’t handle my query:

But, I was able to narrow my search just to those devices that were recalled by the FDA in 2007 because “there is a reasonable chance that they could cause serious health problems or death.” Among these were:

• 5 different makes/models of medication pumps (”potential for inaccurate flow rate which may lead to a patient’s harm due to over-infusion”);

• 4 different makes/models of heart defibrillators (”devices may allow a self-test to clear a previously detected low battery condition… [T]he operator may be unaware of the low battery, and the device may be unable to deliver a defibrillation shock, which could result in failure to resuscitate a patient.”);

• 4 different makes/models of ventricular assist devices, also known as pacemakers (”The compressor motor can stop without warning. When the motor fails, there is a loss of VAD support for the patient. This results in inadequate blood flow to and from the heart.”);

• a software device for mixing IV solutions (”…allowed up to 50mL extra volume of an ingredient to be added to the IV solution that can be life-threatening, particularly in newborns.”);

• a duramater (brain membrane) substitute for use following brain surgery (”The environmental controls [in the manufacturing plant] can compromise the sterility of these products. The use of non-sterile products in patients can lead to life-threatening infections.”);

• a motorized wheelchair (”The wire may short circuit, resulting in a spark, smoke, or flame … material close to the wiring (such as bedding, clothing, etc.) may catch fire.”);

• a diabetic glucose meter (”The meters reported the wrong units of measure… [Users] may overestimate the glucose value by 18 times what they actually are and over treat themselves [resulting in hypoglycemia]“);

• a LASIK eye surgery laser (”caused corneal abnormalities [and] decreased visual sharpness (visual acuity). [M]ay not be correctable with lasers [or] glasses or contact lenses.”).

So, for all of these malfunctions and their cousins, no more state court; that’s fifty fewer venues for the manufacturers of deadly and damaging devices to worry about.

Why not just sue in federal court? Costs are much higher, and it’s harder to find an attorney to take the case because it’s so much easier for the defendant in a federal civil case to draw the case out for years and years. So a federal remedy ends up being no real remedy at all.

And, just in case this doesn’t screw the pooch enough, Big Pharma hopes to push this line of reasoning even farther, taking cases of federally approved drugs out of the hands of state courts, too:

The Food, Drug and Cosmetic Act of 1938, under which the F.D.A. regulates pharmaceuticals, does not contain a pre-emption clause. Nonetheless, the administration is arguing in the case the court has accepted for its next term, Wyeth v. Levine, No. 06-1249, that pre-emption is implicit in the structure of the statute.

It will be up to Congress to fix this mess. Should we give up now, or wait until January 2009?