Today, the Supreme Court issued a ruling that the Wyeth pharmaceutical company is liable for injuries sustained to a patient when a drug was improperly administered despite a warning explicitly called out on the label.  It wasn’t even a close vote (6-3) nor was it a new drug.  Here are the details per the NY Times.  The patient, Diana Levine, went to a clinic in 2000 with migraine pain for a shot of Demerol.  As part of this treatment, the clinic also prescribed Phenergan for nausea.  The Wyeth drug Phenergan has been in use since it was approved in 1955, but if misused, it has a horrendous side effect.  Contact with arterial blood can, according to the warning on the label, cause “gangrene requiring amputation”!  That is what happened in this case.  The clinic improperly administered the drug, accidently injecting it into an artery instead of the target vein and the patient eventually lost her arm.  So how is Wyeth liable?  If you have a drug on the market for half a century with 200 million successful uses and a warning on the label that details out the risk, what more must you do?  The Vermont jury that heard the case said that the label could have been more explicit or banned injection completely.  So I feel for Ms. Levine (who also settled a case for $700,000 against the clinic), but what is the responsibility of Wyeth here?  This is not a drug that you buy over the counter at Rite Aid.  You would only expect it to be used in a hospital or clinic setting and it would be administered (as it was in this case) by medical professionals.  Administering the drug by intermuscular injection or IV is supposed to be very safe.  The warning is spectacularly specific.

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 unintentional intra-arterial injection. Reports compatible with unintentional 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 unintentional intra-arterial injection or perivascular extravasation after it occurs.

“There is no proven successful management of unintentional intra-arterial injection.”  Once you make this mistake it is over, there is no treatment, there is no going back.  Isn’t that clear enough?  I’m not sure what the Supreme Court is trying for here.  Their opinion said that the FDA label is a floor on what information must be provided, and that Vermont can demand more.  Still, Wyeth’s label seems pretty specific to me while leaving some leeway for medical professionals to use their judgement.

There are many, many good lawsuits out there.  Unfortunately, ones like this one distort the entire debate.  It’s hard to look at someone who lost her arm through no fault of her own pitted against a large multinational corporation and not throw her some money, but this lawsuit will be used against the tort legal system for years to come to argue for throwing out the baby with the bathwater.  Another possible result is that drugs with significant side effects may be dropped from the pharmacopia of clinics and drug manufacturers, limiting our access to drugs that might be the best choice in a particular situation.  Perhaps the Supreme Court was just upholding the right of a Vermont jury to rule as they see fit when they wrote “Wyeth could have unilaterally added a stronger warning about IV-push administration”, but would that have made a difference?  Would the jury have found otherwise if Wyeth had painted the warning in neon paint?  I find myself in the minorty with Justices Alito, Roberts and Scalia, and that’s an unusual place.  Can someone tell me what the others were thinking?