In yesterday’s Wyeth v. Levine, the Supreme Court decided that approval of a drug label by the FDA did not prevent a Vermont jury from finding that the warnings cautioning strongly about the risks of a particular mode of administration were still inadequate, and that the drug maker must pay when an error by a physician’s assistant caused a tragedy.
The drug involved was Phenergan, an anti-nausea medication. It can be injected intra-muscularly or intravenously. If the latter, it can be added to an on-going IV drip – the best method -- or it can be injected directly into a vein, for quicker action. The last mode, called “IV push,” is not favored because if an error is made and the drug is injected into an artery, severe damage will result, including gangrene.
This hazard is well-known, and has been discussed for over 30 years. Nonetheless, the IV push method remains on the books because physicians need the option of rapid action. The label warns of the danger six times, in capital letters and in red print.
Levine had a migraine, and was given Phenergan via IV push, for good reason.
For her part, respondent does not dispute the FDA’s conclusion that IV push has certain benefits. At trial, her medical practitioners testified that they used IV push in order to help her “in a swift and timely way” when she showed up at the hospital for the second time in one day complaining of “intractable” migraines, “terrible pain,” inability to “bear light or sound,” sleeplessness, hours-long spasms of “retching” and “vomiting,” and when “every possible” alternative treatment had “failed.” (Dissent, Slip. Op. at 16)
The injection went wrong. Gangrene resulted and Levine's arm was amputated. She sued everyone in sight, and, after settling malpractice claims against the physician and his assistant, got a $7 million verdict against Wyeth for inadequate labeling.
The Supreme Court held for plaintiff, 6-3, arguing that FDA requirements are a floor and not a ceiling, that the drug company could have asked for more stringent warnings and that it retains responsibility even after the FDA approves label language.
The problem is that to get to this result the majority had to misrepresent the facts, to put the matter charitably. Wyeth said the plaintiff was contending that the warning should have outlawed IV push completely, an argument that some might think supported by the comment of the state supreme court that this was indeed plaintiff’s argument, coupled with numerous quotations from the lawyer. This made it an effort to regulate the basic usages of the drug, a topic that is clearly given to the FDA, and clearly outside of the state's authority.
Not so, said the Supreme Court majority. The Vermont
This is nonsense. As the dissent noted, the label already contained six prominent warnings, including a specific warning against administering the drug at the site use by the PA, and this warning had been added at the specific direction of the FDA. How could one possibly say that a seventh warning would have helped, when the PA was obviously unfamiliar with the label in any event?
For the Court to assume that there is some abstract standard that would have been sufficient, without making any effort to specify it, is logic-chopping formalism run amok.
The immediate result is that the Phenergan will have to be relabeled to prevent IV push, So future patients all over the nation will be deprived of the benefits of a useful method of drug administration because a PA in Vermont forgot to read a label.
The broader ramifications will be to throw drug liability law into further disarray, and enrich the trial lawyers.