KANSAS CITY — A federal judge in the United States District Court for the Western District of Missouri has denied a motion to dismiss a lawsuit filed by a U.S. naval commander, allowing his claims against Oracle Health Government Services, Cerner Corporation and Cerner Innovation to move forward.
The order, issued Jan. 26 by U.S. District Judge Greg Kays, rejects the defendants’ arguments that Andrew Whaley failed to state a claim and that a prior lawsuit bars his case.
Whaley alleges he suffered severe neuropsychiatric injuries after taking the allergy medication montelukast, the generic form of Singulair, in November 2019.
According to the complaint, he was prescribed the drug by Navy medical personnel at Naval Air Station Lemoore in California. He received a drug monograph when he filled the prescription at the base pharmacy.
The monograph, which he and his wife read before he began taking the medication, warned users to call a doctor for “unusual changes of mood or behavior” but did not list specific neuropsychiatric side effects that had appeared in earlier versions.
Whaley took one dose per day from Nov. 6 to Nov. 8, 2019.
Beginning after the first dose and intensifying over the next several days, he allegedly experienced restlessness, insomnia, anxiety, unexplained energy bursts and inability to focus.
On Nov. 9, 2019, he was admitted to a local hospital emergency room with confusion, hallucinations, disorientation, catatonia, self-harm and detachment and was later transferred to a Veterans Affairs hospital in Fresno, Calif.
He was placed on non-flying limited-duty status in January 2020 and reassigned to an administrative position.
The complaint states he was hospitalized multiple times for psychiatric care between February and October 2020 and participated in in-patient and out-patient treatment.
In August 2021, his psychiatrist indicated he suffered from “substance-induced bipolar disorder” and noted that the provisional cause of the neuropsychiatric episode could be Singulair, which the psychiatrist stated is known to trigger psychotic disorders.
Whaley alleges he had no prior mental health issues.
The lawsuit claims the defendants were negligent and engaged in negligent misrepresentation by failing to include accurate warnings about possible neuropsychiatric side effects in the montelukast monograph they authored and distributed through the Department of Defense’s MHS Genesis electronic medical records system.
Earlier monograph versions issued between 2008 and 2012 referenced side effects consistent with FDA-approved labeling, including anxiety, depression, hallucinations, suicidal thoughts and actions, tremors and sleep disturbances
The defendants argued the complaint lacked substantive allegations against Oracle Health Government Services and Cerner Corporation, that Cerner Innovation owed no legal duty to Whaley under the learned intermediary doctrine, that no affirmative false statement supported a negligent misrepresentation claim and that the lawsuit was barred by res judicata because Whaley previously sued the drug’s manufacturer, Merck and 100 Doe defendants in California.
Kays rejected each argument at the pleading stage.
He found Whaley alleged sufficient facts tying all corporate defendants to the production, marketing and distribution of the drug monographs through the Multum database and MHS Genesis system.
The judge also determined that Whaley adequately alleged “misleading half-truths” by asserting that the defendants removed known neuropsychiatric side effects from the monograph while including other warnings, which could constitute an affirmative misrepresentation under state law.
The order denies the motion to dismiss in full, allowing Whaley’s negligence and negligent misrepresentation claims to proceed.
U.S. District Court for the Western District of Missouri, Western Division case number: 4:25-cv-00488
