A couple weeks ago, the Supreme Court (or SCOTUS, which to me sounds kinda dirty) came out with a ruling on Wyeth v. Levine. In short, Ms. Levine was given Wyeth’s anti-nausea drug Phenergan (promethazine) via arterial injection. As it happens, Phenergan carries an FDA-approved warning against arterial injection- it’s meant to be injected intravenously. Sadly, due to this error Ms. Levine’s forearm became gangrenous and had to be amputated. She sued Wyeth, and was awarded $6.5 million in damages by a Vermont state court. Wyeth appealed and it went all the way to SCOTUS (heh), which upheld the award.
So let me get this straight. Wyeth put a warning label on the drug, a label that was approved by the FDA, saying “Seriously, don’t put this in arteries, it’s bad. Real bad.” Someone injects it into an artery. And Wyeth is responsible for that? Really? Seriously? IANAL but this seems totally ridiculous. What about whoever screwed up the injection? This reminds me of the whole “firearm manufacturers are responsible for murders committed using their products” thing, except even worse.
Justice Stevens wrote the majority opinion, saying in part that, “State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.” Uh, well I would say that the warning label pretty clearly disclosed a known safety risk.
I briefly perused the court opinion[pdf] and a couple things became a little more clear. The real issue here is the adequacy of the warning, which states:
Due to the close proximity of arteries and veins in the areas most commonly used for intravenous injection, extreme care should be exercised to avoid perivascular extravasation or inadvertent intra-arterial injection. Reports compatible with inadvertent intra-arterial injection of Phenergan Injection, usually in conjunction with other drugs intended for intravenous use, suggest that pain, severe chemical irritation, severe spasm of distal vessels, and resultant gangrene requiring amputation are likely under such circumstances. Intravenous injection was intended in all the cases reported but perivascular extravasation or arterial placement of the needle is now suspect. There is no proven successful management of this condition after it occurs. . . . Aspiration of dark blood does not preclude intra-arterial needle placement, because blood is discolored upon contact with Phenergan Injection. Use of syringes with rigid plungers or of small bore needles might obscure typical arterial backflow if this is relied upon alone. When used intravenously, Phenergan Injection should be given in a concentration no greater than 25 mg per mL and at a rate not to exceed 25 mg per minute. When administering any irritant drug intravenously, it is usually preferable to inject it through the tubing of an intravenous infusion set that is known to be functioning satisfactorily. In the event that a patient complains of pain during intended intravenous injection of Phenergan Injection, the injection should be stopped immediately to provide for evaluation of possible arterial placement or perivascular extravasation.
So the question is whether or not that warning is adequate. Ms. Levine contended that it was not, because it didn’t specifically instruct clinicians to use an IV-drip instead of an IV-push (syringe), which has a higher risk of accidentally getting into an artery. That seems to be what happened- the arterial dosing was accidental. So here the case gets less clear-cut for me but i still think that it is an adequate warning, and the fault lies with the practitioners (against whom Ms. Levine had already settled lawsuits before going after Wyeth). I also (more or less) agree with Justice Alito, who wrote in the dissenting opinion that, “This case illustrates that tragic facts [i would say "sometimes"] make bad law. The Court holds that a state tort jury, rather than the Food and Drug Administration, is ultimately responsible for regulating warning labels for prescription drugs.” Now i tend to be more of a small federal government/more states’ rights kinda guy, but i think that in this case, maybe the state should not be usurping a federal agency. If one of the purposes of the FDA is to be the regulator of drug warning labels, and they approved the label in question, then perhaps they are at fault if the label is deemed inadequate. Wyeth seems to have fulfilled its legal obligation here.
It’s really not often that i find myself siding with a conservative judge and a big pharma company, sheesh. Either way, i guess it’s Pfizer’s problem now.
