MORRISTOWN, N.J., June 23, 2011 /PRNewswire/ — Actavis applauds
the U.S. Supreme Court’s decision in the Mensing and
Demahy cases as an important step forward for consumer
safety and the continued availability of affordable generic
medicines.
By a 5-4 majority, the court rejected arguments that
generic-drug manufacturers should be subject to state lawsuits
alleging “failure to warn” over the contents of their products’
labels. Justice Clarence Thomas authored the majority opinion,
which concluded that federal law requiring the labels on generic
products to be identical to that of their brand counterparts, and
prohibiting generic manufacturers from making changes to them,
preempted such cases.
Actavis Inc. CEO Doug Boothe called the decision “an important
and necessary step by the Supreme Court to clarify the proper
interpretation of the regulations governing pharmaceutical
labeling.”
“A consistent drug-labeling standard, overseen by the federal
Food and Drug Administration, as contemplated by the federal
regulations is absolutely essential to protecting the safety and
wellbeing of the of American consumers who rely upon generic
medications for their health and quality of life,” he said. “This
ruling furthers meaningful consumer protection while also
safeguarding against lawsuits that threaten the availability of
safe and affordable pharmaceutical products by misconstruing the
labeling responsibilities of generic manufacturers.”
The ruling covered three separate cases that were consolidated
for argument before the court in March: Actavis v. Mensing,
Pliva v. Mensing and Actavis v. Demahy. The key question
centered on whether consumers may sue generic drug manufacturers in
state court over the contents of product labels that the companies
do not control.
Boothe believes a necessary next step is for Congress to take
guidance from the decision and address ambiguities in existing laws
to confirm t
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