Metropolitan News-Enterprise


Wednesday, February 12, 2020


Page 1


Ninth Circuit:

Warning on Label Precludes Action Over Daughter’s Suicide

Panel Rejects Parents’ Effort to Plead Negligence Claim Based on Alleged Failure of Drug Manufacturer To Adequately Apprise Doctors, Pharmacists, Members of the Public of Dangers of Antidepressdant


By a MetNews Staff Writer


The Ninth U.S. Circuit Court of Appeals yesterday affirmed the dismissal with prejudice of an action by the parents of a 15-year-old girl who committed suicide after taking the antidepressant Lexapro, holding that where the packaging contains a warning as to that risk, liability cannot be predicated on a claim that the manufacturer spread false assurance of the drug’s safety to the medical community and pharmacists.

The memorandum opinion declares that “the defendants did warn of the particular risk at issue, and the district court correctly held that plaintiffs have not stated a claim for negligence.”

Yesterday’s opinion also affirms the dismissal of other causes of action by District Court Judge Michael W. Fitzgerald of the Central District of California. Those causes of action were for violation of California’s Unfair Competition Law and for wrongful death.

The action was initially filed in Riverside Superior Court but was removed to federal court based on diversity of citizenship. Several drug-makers were initially named as defendants, but the action was later narrowed to the manufacturer of Lexapro, Allergan.

False Impression

Plaintiffs Stephanie Patton and Kendrick Knighten blamed the suicide of their daughter, Kennadi, on Allergan. They sought to plead around the warning on the label with allegations that Allergan and others created a false impression as to the drug’s propensities.

Fitzgerald said the plaintiffs “seemingly acknowledge the suicide warnings” on packaging of Lexapro and its generic equivalent.” He recited that their “core allegation” in the pleading was that “prior to Kennadi’s suicide, the Defendants had the knowledge, the means and the duty to provide the medical community…and the consuming public…with a stronger warning” as to the link between use of the drug and teenage suicide.

The second amended complaint suggests that could have been accomplished “through reasonable means, including but not limited to labeling, continuing education, symposiums, posters, sales calls to doctors, advertisements and promotional materials, etc.”

Scheme to Deceive

The pleading included an averment, in support of the negligence theories, that Allergan and others “spent hundreds of millions of dollars running a successful scheme to deceive the medical profession and the general public about Lexapro” and “presented Lexapro as the go-to drug for children, adolescents and adults suffering from nearly any type of depression without establishing the severity of the risks of suicide among those children.”

It also said that the defendants “never informed the FDA. physicians or the general public” of “serious, known risks” in ingesting Lexapro “and continue to falsely represent (to this day) that Lexapro is safe for use by children and adolescents.”

What Fitzgerald found determinative was the content of the label, which says:

“WARNING: Suicidility and Antidepressant Drugs See full prescribing information for complete boxed warning. Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders. Lexapro is not approved for use in pediatric patients less than 12 years of age.”

Warning Is Adequate

The judge said in his order dismissing the negligence claim:

“This warning, standing on its own (i.e., without accounting for the other suicide warnings elsewhere on the Lexapro package insert), ‘directly warns in plain and explicit terms of the specific risk that caused injury’ to Kennadi and Plaintiffs, and is thus adequate.”

In affirming, a three-judge Ninth Circuit panel pointed to the California Supreme Court’s 1996 opinion in Carlin v. Superior Court in which it was held that a cause of action lies against the manufacturer of a drug where it “did not warn of a particular risk for reasons that fell below the acceptable standard of care.”

The panel—comprised of Circuit Judge Kenneth Kiyul Lee, Senior Circuit Judge Richard R. Clifton, and District Court Judge Frederic Block of the Eastern District of New York, sitting by designation—said:

“Here, as mandated by federal law, the drug’s packaging contained clear warning labels about a heightened risk of suicidality for adolescents.”

That, the panel found, eliminated the claims based on negligence.

The claim under California’s Unfair Competition Law was predicated on fraud, and the panel found that Fitzgerald correctly found that the pleading failed state a claim with requisite specificity.

No mention is made of the wrongful death claim. Fitzgerald dismissed that claim on the basis of no wrongful act having been set forth.

The case is Patton v. Forest Laboratories, Inc., 18-56336.


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