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Courthouse News Service
Wednesday, April 08, 2015
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.
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Bennet v. Forest Laboratories — (UNITED STATES DISTRICT COURT MIDDLE DISTRICT OF FLORIDA FORT MYERS DIVISION)
9 Apr, 2015
This matter comes before the Court on Forest Laboratories’ Motion to Exclude the Testimony of George S. Glass, M.D. (Doc. #75) filed on January 5, 2015. Plaintiff Brett A. Bennett filed a response in opposition on January 29, 2015 (Doc. #88) and filed supplemental authority on February 20, 2015. (Doc. #103). This matter is ripe for review.
Bennett retained Dr. George S. Glass as a case specific causation expert witness. At trial, Glass is expected to opine that Terri Renè’s consumption of Lexapro, a drug manufactured by Forest Laboratories, was a significant contributing factor to her suicide. (Doc. #88-5, at 10) (“It is my opinion to a reasonable degree of medical certainty that Lexapro was a significant contributing factor to Terri Renè Bennett’s violent death by suicide.”). Glass’s conclusion as it relates to Terri Renè’s consumption of Lexapro is as follows:
This matter proceeded in the Multi-District Litigation (“MDL”). General discovery and causation experts were vetted in the MDL process. This matter was remanded from the MDL and now the undersigned is facilitating the case specific facts and legal issues.
To summarize, in my medical opinion, based on reasonable medical probability, the clinical evidence and factual record points to the fact that Ms. Terri Rene Bennett suffered emotional blunting, emotional disinhibition, and emotional disinhibition which would have looked to be a worsening depression during the 16 days she was on Lexapro, particularly after she took the larger 10mg daily dose. In my opinion the medication was a significant contributing factor to her violent death by suicide, and while she had been depressed and had some anxiety before she began the medication, she became increasingly depressed, withdrawn, lethargic, unable to focus, anergic, and unable to function as she had before she was put on the medication. I believe that Ms. Bennett was one of the small subgroup of unusual responders to SSRI’s, and manifested aspects of two of the three different pathways which can cause suicidal thinking and or behavior that Drs. Healy and Glenmullen have described. First she developed akathesias when she was put on Paxil, and then she became emotionally blunted, with emotional dysregulation when she was on Lexapro. It was that reaction to the medication, as well as the lack of sensitivity to her behavior, or fear of the consequences of her acts that were the reasons that she committed suicide.
These are my opinions based on the information I have been provided at this time. I reserve the right to modify my opinion should I be provided with additional information.