Apparently Amiodarone is a drug developed in Belgium in the 1960s to treat angina, but that has a ton of really bad side effects, "including pulmonary fibrosis, blindness, thyroid cancer, and death." Presumably for that reason, it wasn't approved for use in the United States.
Notwithstanding that fact, in the 1970s, doctors in the U.S. started importing the drug from other countries as a "drug of last resort" for patients suffering from "life-threatening ventricular fibrillation" -- the "v-fib" from all those emergency medical shows on television. Again, the drug wasn't approved in the U.S., but so be it; potential side effects don't mean much when you're heart is literally about to stop beating in the next minute or so.
Eventually, however, the foreign manufacturers of the drug threatened to cut off the supply of the thing to U.S. patients unless the FDA approved the drug. Which is a pretty nifty trick, eh? The FDA relents and approves the drug as a last-ditch treatment for ventricular fibrillation.
But then, once it's in the U.S., doctors start prescribing the drug for other things as well: "off-label" use. The biggest off-label use seems to be for treatment of "atrial fibrillation, a more common—and less serious—condition than ventricular fibrillation. The manufacturer of the drug -- Wyeth -- had previously gotten into tons of trouble with the FDA for false advertising for pushing doctors to use amiodarone in situations far beyond the whole "last resort" purpose for which it was approved.
Fast forward to the present day, in which a large number of patients injured by the drug sue the drug manufacturer for the side affects they suffered while taking the drug for a-fib, an off-label use.
The Court of Appeal affirms the dismissal of this lawsuit at the pleading stage. Sure, doctors definitely prescribe the thing for a-fib, likely when they shouldn't. And, sure, the manufacturer has clearly overly aggressively falsely advertised the drug in the past.
But the Court of Appeal holds that there's no possible linkage between the two. That there's no proof at the pleading stage that anything that the manufacturer did caused the particular doctors at issue to prescribe the drug to their patients.
Which somewhat leads to the question: Well, then, how exactly did the drug become so popular for this particularly dangerous off-label use? Is it really so radically implausible to think that the manufacturer's pushing of the drug had something to do with this popularity?
I mean, yeah, a lot of the really bad stuff that the manufacturer did -- or at least the stuff that they were caught doing by the press -- occurred a decade ago, so there's definitely a remoteness issue. But I don't tend to think that off-label use of little-known drugs suddenly becomes popular completely randomly. And when a manufacturer has a history of falsely pumping up a particular drug, it doesn't seem totally crazy to me to think that the manufacturer might have something to do with the current off-label craze for that particular (dangerous) drug.
But the Court of Appeal hold that that's not good enough. Even at the pleading stage. There's not enough here to even permit discovery.
An interesting story about how the whole drug approval and off-label processes work. As well as how manufacturers can avoid liability for even the dangerous use of their products.
