June 23, 2011
WASHINGTON — The Supreme
Thursday handed drug companies two significant victories, one limiting
suits from people injured by generic drugs and the other striking down a law
that banned some commercial uses of prescription data.
In the first case, Pliva v.
No. 09-993, the court split 5 to 4 along ideological lines in ruling that
the makers of generic drugs — which account for 75 percent of
nationwide — may not be sued under state law for failing to warn
customers about the risks associated with their products.
Two years ago, in Wyeth v.
the court decided the same question in the context of brand-name drugs but
came to the opposite conclusion. That decision was based in large part on
the fact that such drug companies can sometimes change the labels on their
products without permission from the Food and Drug Administration.
Justice Clarence Thomas, writing for the majority on Thursday, acknowledged
that in the eyes of injured consumers, the new distinction between generic
and brand-name drugs “makes little sense.” But he said it followed from the
way the two kinds of companies are treated under federal law.
The manufacturers of generic drugs, he said, must use the same warning
labels as the corresponding brand-name drugs, and they may not unilaterally
alter those labels. That means, Justice Thomas wrote, that makers of generic
drugs are caught in an impossible bind: they can comply with a state law
requiring them to change their labels or the federal law prohibiting
changes, but not both.
Given that impossibility, federal law pre-empts state law under the
Constitution’s supremacy clause, he wrote.
In dissent, Justice Sonia Sotomayor said the majority opinion invented “new
principles of pre-emption law out of the air” and will lead to “absurd
“As the majority itself admits,” Justice Sotomayor wrote, “a drug consumer’s
right to compensation for inadequate warnings now turns on the happenstance
of whether her pharmacist filled her prescription with a brand-name drug or
The decision considered three consolidated cases brought by women who took
generic metoclopramide, which is sold under the brand name Reglan. They took
the drug for stomach ailments and developed a serious neurological disorder.
Appeals courts ruled against the drug makers, saying that the federal
regulatory regime did not block claims under state law.
The Supreme Court reversed those decisions on Thursday, rejecting what
Justice Thomas called the “fair argument,” that the defendants should have
at least tried to persuade the federal drug agency to let them use a safer
But the process of asking the agency to change a label, he wrote, can be as
complicated as a children’s board game.
“If they had done so,” Justice Thomas wrote of a possible request for a
label change, “and if the F.D.A. decided there was sufficient supporting
information, and if the F.D.A. undertook negotiations with the brand-name
manufacturer, and if adequate label changes were decided on and implemented,
then the manufacturers would have started a Mouse Trap game that eventually
led to a better label on generic metoclopramide.”
Chief Justice John G. Roberts Jr. and Justices Antonin Scalia, Anthony M.
Kennedy and Samuel A. Alito Jr. voted with the majority.
In her dissent, Justice Sotomayor wrote that she agreed that the makers of
generic drugs could not unilaterally change their labels. But she said that
did not allow them to remain idle after learning of safety issues.
“Had the manufacturers invoked the available mechanism for initiating label
changes,” she wrote, “they may well have been able to change their labels in
sufficient time to warn” the women injured by their drugs.
The majority opinion, Justice Sotomayor said, may reduce the demand for
generic drugs and put doctors in an ethical bind.
Justice Ruth Bader Ginsburg, Stephen G. Breyer and Elena Kagan joined the
In a second decision on Thursday, Sorrell v. IMS
No. 10-779, a six-justice majority of the court struck down a Vermont law
that banned some but not all uses of prescription information collected by
The law sought to restrict a form of marketing called “detailing,” in which
representatives of drug companies pitch information about new drugs to
doctors known to be prescribing certain kinds of medicine. The companies
obtain prescription records to help them identify the most suitable doctors
from data mining companies, which buy the records from pharmacies. The
records are meant to be stripped of information that identifies individual
The law banned the use of prescription data for detailing but allowed other
uses of it, including by law enforcement, insurance companies and
journalists. Drug companies remained free to market their drugs in a more
indiscriminate fashion, without knowing the prescribing habits of individual
The law was challenged by data mining and drug companies, who argued that
the law’s point seemed to be to protect doctors from hearing about more
expensive drugs while the state pushed cheaper generic drugs. The state, as
its lawyer Bridget C. Asay put it at the
April, said the law sought to address “an intrusive and invasive
Justice Anthony M. Kennedy, writing for the majority, said the case
presented fundamental First Amendment issues because it restricted the use
of truthful information in private hands based on the identity of the
speaker and the content of its speech. He supported his decision with
citations to classic First Amendment decisions outside the realm of
commercial speech, including ones on prior restrain and incitement.
“If pharmaceutical marketing affects treatment decisions,” he wrote, “it
does so because doctors find it persuasive. Absent circumstances far from
those presented here, the fear that speech might persuade provides no lawful
basis for quieting it.”
Chief Justice Roberts and Justices Scalia, Thomas, Alito and Sotomayor
joined the majority opinion.
Justice Breyer, joined by Justices Ginsburg and Kagan, dissented. Justice
Breyer said the majority had looked at the case through the wrong First
It is a mistake, he said, “to apply a strict First Amendment standard
virtually as a matter of course when a court reviews ordinary economic
regulatory programs.” Under ordinary standards applicable to commercial
speech, Justice Breyer continued, the Vermont law should have been upheld.
“At best,” he wrote, “the court opens a Pandora’s box of First Amendment
challenges to many ordinary regulatory practices that may only incidentally
affect a commercial message.”
The majority opinion is an echo, he continued, of Lochner v. New
a 1905 decision that struck down a New York work-hours law and has become
shorthand for improper interference with matters properly left to
“At worst,” Justice Breyer wrote of the majority opinion, “it reawakens
Lochner’s pre-New Deal threat of substituting judicial for democratic
decision-making where ordinary economic regulation is at issue.”