In 2002, Levine received treatment for a migraine, including the drug
Phenergan. When arterial blood receives Phenergan it causes
irreversible gangrene so it is typically given by intramuscular
injection or by IV drip. In this case, a physician's assistant used a
third method known as an IV push but missed the vein, hitting an artery
instead. Levine's right hand and forearm turned gangrenous in a couple
of weeks and had to be amputated.
The FDA label advised that "inadvertent intra-arterial injection" can
result in gangrene requiring amputation, but did not prohibit the IV
push method of administration.
The drug company, Wyeth, appealed that ruling to the U.S. Supreme Court
arguing that it was exempt from injury claims in state courts because
the FDA had approved the product and its label.
At issue before the Supreme Court was whether FDA approval of a label
prevents lawsuits in state courts, which argued -- as Levine's did --
that labels did not contain adequate warnings. With support of the
administration of former President Bush, the Wyeth attorneys argued
that it had provided ample warnings on its labels and that it should
not be held liable because the FDA had approved its label.
The court disagreed, ruling that "it is a central premise of the Food,
Drug and Cosmetic Act and the FDA's regulations that the manufacturer
bears responsibility for the content of its label at all times," the
court majority wrote, upholding the 2006 Vermont Supreme Court case
which rejected Wyeth's argument.
It is patently immoral to suggest that an FDA approval and FDA approved
label could or should exempt any manufacturer, of any substance, from
the type of grievous bodily harm that occurred in this case. The trial
record includes reports of 20 similar amputations and no evidence that
Wyeth had thought to change its warning label to prohibit the IV push
method. That's irresponsible.
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