Lexapro Maker Must Face Claims Tied to Suicide — (Courthouse News Service)

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Courthouse News Service

by Julia Filip

FORT MYERS, Fla. (CN) – Federal law does not pre-empt claims stemming from a Florida woman’s suicide after she took the antidepressant Lexapro, a federal judge ruled.
Brett Bennett sued Forest Laboratories in February 2006 for product liability and failure to warn, claiming that his wife’s suicide was related to her taking the prescription antidepressant Lexapro.

Bennett’s wife killed herself shortly after starting to take Lexapro, which is manufactured and distributed by Forest Laboratories, according to the lawsuit.  December 2003.

In the following months, the FDA asked manufacturers of antidepressants like Lexapro to include additional warnings related to worsening depression and suicide risk when marketing their drugs. In October 2004, the FDA required sponsors of certain antidepressants to include a “black box warning” regarding the increased risk of suicide.
Doctors have warned that antidepressants may have a role in worsening depression and the emergence of suicide tendencies in certain patients during the early phases of treatment. Clinical studies showed that children, teenagers and young adults who took antidepressants such as Lexapro were more likely to become suicidal, according to the National Institutes of Health.
Bennett claimed that Forest Laboratories not only made and sold a defective product, but also failed to warn consumers that the drug was potentially harmful and to test the association between Lexapro and suicide.

Forest Laboratories argued that Bennett’s state-law claims were preempted by federal law because they conflicted with provisions of the Food, Drug and Cosmetic Act and with FDA regulations.

The company claimed that it could not have changed its warning labels or medication guides before 2004, as Bennett suggested, without FDA approval. What’s more, there was no scientific support to add a black box warning at the time, according to Forest Laboratories.
U.S. District Judge Sheri Polster Chappell disagreed, noting that Forest Laboratories was free to participate in a process that lets drug manufacturers change labels when necessary without FDA pre-approval.

Moreover, drug makers have a duty to propose stronger warning labels to the FDA when needed, according to the 10-page order.
Forest Laboratories failed to prove that it approached the FDA about stronger warning language for Lexapro, or that the FDA would have rejected the proposed warning before revising warning requirements in 2004, Chappell concluded.

Although the company’s proposed label for Lexapro, which excluded the black box warning, was approved in part in late 2004, the FDA later adopted a standardized warning for antidepressants, which required a black box warning and additional information about suicide risk, according to the ruling.