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.
Wyeth’s defense was that FDA labeling requirements should
pre-empt any state law inadequate warning requirements.
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 jury found only
that the warning was inadequate. It did not specify any particular way in which
it could have been made adequate, so therefore it was not mandating that the IV
push method be ruled out.
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.
