Lawyers suing the makers of
Accutane over allegations the acne drug increases the
risk of suicide cannot share the company's internal
memos and other documents with the public or federal
regulators, a judge ruled.
The attorneys had sought
to make public as many as 1 million documents produced
by Hoffman-La Roche Inc., saying the disclosure was
needed as Accutane's safety comes under increased scrutiny
by the U.S. Food and Drug Administration.
U.S. District Judge James
Moody rejected the request, saying attorneys could ask
the court to open up records if they discover a matter
of public safety as they prepare their cases. But in
a victory for the plaintiffs, he said the drug maker
cannot redact documents before handing them over to
the attorneys.
Moody, based in Tampa,
is presiding over the management of dozens of lawsuits
filed nationwide over Accutane, used by about 5 million
Americans.
The drug, which has been
dispensed in the United States since 1982, has been
blamed for increased rates of suicide and gastrointestinal
diseases in some users and birth defects in babies born
to mothers who took Accutane.
Hoffman-La Roche contends
the drug is safe, although it recommends that users
be screened for depression. The company notes that teenagers
and young adults, the groups most likely to use the
drug, have higher suicide rates than the general population.
The documents at issue
include internal company discussions about the safety
of the drug and how to handle allegations of an increased
suicide risk.
Hoffman-La Roche attorney
Ed Moss said the company fought the release of the documents
mostly out of concern for protecting Accutane's "recipe,"
and that federal officials already have internal documents
relating to the drug's safety.
"We are not trying to
hide documents from the public," Moss said. "We have
given everything in the world to the FDA."
FDA scientist David Graham
testified before Congress last year that Accutane was
one of five dangerous drugs that should be restricted
or removed from the market. In November, federal regulators
toughened rules on Accutane, requiring doctors and pharmacists
who dispense the drug to register patients on a central
database.
Among the Accutane cases
is a $70 million lawsuit brought by the mother and
grandmother of Charles Bishop, the 15-year-old who stole
a small airplane and crashed into a Tampa high rise
in January 2002. His family blames his use of the drug
for bringing on the dramatic suicide, but the company
contends that he was a troubled young man and it is
not to blame.
Hoffman-La Roche Inc.,
based in Nutley, N.J., is the United States prescription
drug unit of the Swiss drug maker Roche Group.