Ralph Waldo Emerson is credited with the brilliant observation
that "consistency is the hobgoblin of little minds." Certainly
no one would accuse U.S. Solicitor General Donald Verrilli or
his immediate predecessor, acting solicitor general Neal Katyal,
of having little minds. Perhaps that's why the Justice
Department, in a pair of amicus briefs at the U.S. Supreme
Court, filed two years apart and signed by different SGs, seems
to espouse inconsistent views of the same issue: whether
state-law product liability claims against generic drugmakers
are barred because generics are required by federal law to carry
warning labels approved by the Food and Drug Administration.
Two years ago, when the Supreme Court was considering that
question, the Justice Department filed an amicus brief on behalf
of two women supposedly injured when they took generic heartburn
medication. Not all state failure-to-warn claims are pre-empted
by federal law, the solicitor general's brief argued, because
generic and brand-name drugmakers both have a duty to alert the
FDA to problems with their products. If they don't -- and if the
FDA is not made aware of information that would cause it to
revise warning labels -- then generics should be held
responsible alongside their brand-name counterparts.
The Justice Department (and consumers) lost that fight. In
June 2011, the Supreme Court held in Pliva v. Mensing that
federal law pre-empts state failure-to-warn suits against
generic drugmakers because FDA regulations prohibit generics
from making changes to their FDA-approved labeling. The court
acknowledged the ruling's somewhat perverse effect -- consumers
can sue brand-name makers under its 2009 ruling in Wyeth v. Levine yet cannot bring claims against generic makers of the
same product -- but said it's up to Congress and the FDA to
change the law if they don't like that outcome.
Eleven months later, the 1st Circuit Court of Appeals
created an exception to Mensing. In a case brought by a New
Hampshire woman who suffered grave side effects of a generic
painkiller known as sulindac, the appeals court ruled that
state-law design-defect claims against generics are not
pre-empted by federal labeling requirements. That's because, in
the 1st Circuit's reasoning, a generic drugmaker could comply
with both state and federal law by opting not to make an
unreasonably dangerous product.
The generic defendant in that case, which was on the hook
for a $21 million jury verdict, asked the Supreme Court to take
up the case and clarify whether design-defect claims, like
failure-to-warn claims, are pre-empted. Without any input from
the Justice Department, the Supreme Court granted cert in Mutual
Pharmaceutical v. Bartlett in November.
Typically, both sides in Supreme Court cases make pitches to
the solicitor general, seeking the Justice Department's amicus
support. It's a good bet that the Supreme Court veterans who are
counsel of record in this case -- Jay Lefkowitz of Kirkland &
Ellis for Mutual Pharmaceutical and David Frederick of Kellogg,
Huber, Hansen, Todd, Evans & Figel for Karen Bartlett -- made
such presentations to the government. (Lefkowitz was out of the
office and didn't respond to my message; Frederick declined to
comment.) And lo and behold, when the amicus brief hit the
docket this week, the Justice Department sided with Mutual.
The government's new brief seems designed to underline the
authority of the FDA, in contrast to the Mensing brief's
emphasis on the reporting duties of drugmakers. "Tort judgments
second-guessing FDA's expert drug safety determination would
undermine the federal regime to the extent that they forbade or
significantly restricted the marketing of an FDA-approved drug,"
the brief said, rejecting the 1st Circuit's finding that courts
can hold generic drugmakers liable for failing to take unsafe,
but FDA-approved products off of the market. Mensing is
controlling law, according to the Justice Department, and under
Mensing, design-defect claims against generics are pre-empted.
I emailed the Justice Department to ask specifically whether
the Bartlett brief is meant as a repudiation of the solicitor
general's position in Mensing but didn't hear back.
Interestingly, a footnote in the amicus brief suggests that
all of the Supreme Court Sturm und Drang over product liability
for generics may be unnecessary. "This office has been informed
that FDA is considering a regulatory change that would allow
generic manufacturers, like brand-name manufacturers, to change
their labeling in appropriate circumstances," the brief said.
"If such a regulatory change is adopted, it could eliminate
pre-emption of failure-to-warn claims against generic-drug
manufacturers."
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