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The family of a teenager who committed suicide in 2002 after taking
the antidepressant drug Paxil is not barred from suing the
manufacturer, because the U.S. Food and Drug Administration had not
yet taken any position on whether there was a link between the use of
such drugs by pediatric patients and an increased risk of suicidality,
a federal judge has ruled.
In his 55-page opinion in Knipe v. SmithKline Beecham, Senior U.S.
District Judge Ronald L. Buckwalter of the Eastern District of
Pennsylvania concluded that a jury must decide whether the drug
manufacturer "indeed possessed information, not available to the FDA,
upon which it could have unilaterally added a warning to its
labeling."
Buckwalter rejected arguments by SmithKline's defense team that the
suit was pre-empted by FDA regulations which, at the time, did not
call for suicide warnings for pediatric patients on drugs known as
SSRIs, or selective serotonin reuptake inhibitors.
"As the FDA never had the opportunity, prior to Jake Garrison's
suicide, to consider the propriety of the warning proposed by
plaintiffs in this case, the 'balance of risks and benefits set by the
FDA when it approves a drug label,' remains unaffected," Buckwalter
wrote.
"Mere speculation as to whether the FDA would or would not have
approved such a warning is insufficient to create a direct conflict
upon which the court can find pre-emption," Buckwalter wrote.
Significantly, Buckwalter rejected SmithKline's argument that the
decision earlier this year from the 3rd U.S. Circuit Court of Appeals
in Colacicco v. Apotex -- an alleged Paxil-related adult suicide case
-- directly controlled the outcome of the suit brought by Marion
Knipe, the administratrix of the estate of Jake Garrison.
In Colacicco, the 3rd Circuit voted 2-1 in April in holding that the
makers of Paxil and Zoloft cannot be sued for failing to warn of a
risk of suicide because the FDA had explicitly refused to order such
warnings.
Writing for the majority, U.S. Circuit Judge Dolores K. Sloviter said
the FDA has "actively monitored" the possible risk of suicide from
taking SSRIs for two decades, and concluded that the suicide warnings
demanded by plaintiffs "are without scientific basis and would
therefore be false and misleading."
But Sloviter also emphasized the ruling was a narrow one, saying: "Our
holding is limited to circumstances in which the FDA has publicly
rejected the need for a warning that plaintiffs argue state law
requires."
In dissent, U.S. Circuit Judge Thomas L. Ambro said he would have
allowed both cases to go forward because "the FDA has for over three
quarters of a century viewed state tort law as complementary to its
warning regulations. Only for the last two years has it claimed
otherwise."
Now Buckwalter has ruled that Colacicco cannot apply to a suit over an
alleged Paxil-related suicide by a teenager.
"This case is clearly exempted from the Colacicco holding," Buckwalter
wrote. "The 3rd Circuit focused solely on whether a claim for failure
to issue a warning regarding adult suicidality was pre-empted. At no
point did the court mention any studies that were done with respect to
pediatric use of Paxil."
Instead, Buckwalter found, Paxil "has never been approved for
pediatric use and, therefore, the FDA never reviewed any safety and
efficacy data regarding pediatric use prior to approval of the drug."
Buckwalter also found that the 3rd Circuit "did not cite to any pre-
September 2002 FDA document, public announcement or health advisory
regarding the FDA's position on pediatric suicidality associated with
Paxil."
And while the Colacicco decision noted that the FDA had "publicly
dismissed any link between SSRIs and adult suicidality," Buckwalter
said the court also recognized that the FDA had "expressly warned of a
risk of increased suicidality in pediatric users of antidepressants."
As a result, Buckwalter said, "quite unlike the concerns regarding
adult suicidality, the FDA had not 'clearly and publicly stated its
position' dismissing any risk of pediatric suicidality" prior to the
Paxil prescriptions given to Jake Garrison.
"As the 3rd Circuit left open the question of whether such evidence
existed with respect to pediatric use of Paxil, we decline to deem
Colacicco controlling of the outcome of this litigation," Buckwalter
wrote. The ruling is a victory for attorneys Bijan Esfandiari, George
W. Murgatroyd III, Kate E. Gillespie and Frances M. Phares of Baum
Hedlund Aristei & Goldman in Los Angeles.
In an interview, Esfandiari called the decision a "huge victory" that
shows the ruling in Colacicco was a narrow one.
SmithKline's lead lawyer, Andrew T. Bayman of King & Spalding in
Atlanta, said he believed Buckwalter erred because the Colacicco
decision "ought to be controlling here."
Bayman said the courts that have barred such suits as pre-empted
premised their rulings on the notion that "the FDA is in the best
position" to decide which warnings should be included on drug labels,
and that the FDA has consistently held that "unsubstantiated" warnings
must be avoided because patients will be unnecessarily discouraged
from taking drugs they need.
SmithKline, he said, disputes the allegation that it had any evidence
of a risk of suicide among teenagers and young adults that it withheld
from the FDA.
But Buckwalter accepted the plaintiffs' allegations as true and found
that a jury must decide whether SmithKline failed to add warnings as
soon as it was aware of the increased risk of suicide among in
pediatric patients taking Paxil.
"Drug manufacturers have [the] best information about the safety of
their own products and, thus, under the regulations, they have the
ability to alter a drug label prior to FDA evaluation and approval,"
Buckwalter wrote.
In such a situation, Buckwalter said, a state-law based failure to
warn claim "will not usurp or undermine the FDA's responsibilities to
ensure an accurate label, but rather will close the void in the
authority of the FDA, which can neither independently regulate off
label use nor require additional clinical trials."
Such litigation, Buckwalter said, "will not result in exaggerated
risks associated with drugs" because the standard for adding a warning
under the FDA's rules requires only "reasonable evidence of
association of a serious risk with the drug" while the state failure
to warn claims under New Jersey law require "the more stringent proof
of causation between the drug and the injury."
As a result, Buckwalter concluded that "only a drug manufacturer who,
in fact, possessed such reasonable evidence, yet failed to add a
warning, would be potentially liable."
Federal Judge Allow Suit Against SmithKline Beecham Over Paxil Suicide 
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