Singulair lawsuits claim the drug caused users, many of whom were children, to develop serious mental health side effects. Singulair lawsuits allege Merck failed to adequately warn of these risks. A large group of cases have been consolidated into multicounty litigation (MCL) 637 in New Jersey.
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Latest Singulair Lawsuit Updates
As of December 2024, the U.S. Judicial Panel on Multidistrict Litigation has not consolidated any Singulair lawsuits into one federal court. However, a group of cases is in multicounty litigation, MCL 637, in New Jersey.
According to our research, there were 247 lawsuits when the cases were first consolidated in New Jersey in March 2022. There is no current publicly available case list from the New Jersey MCL. It’s difficult to know exactly how many cases there are now. By researching court documents and talking to lawyers, we’ve detailed the most recent updates below. Check back often for our updates.
Singulair Lawsuits Timeline
November 2024
A new study has further linked Singulair to serious mental health issues. Reuters reported that FDA researchers have determined that the drug attaches to brain receptors that are critical to psychiatric functioning. The research has not yet been released publicly.
August 2024
A California judge has opted to award summary judgment in the first two Singulair cases that were prepared for trial. Judge Marilyn Huff based her decision in part on the determination that the existing warning labels for the drug were not inadequate, as plaintiffs had argued.
June 2024
Defendants selected Kelly Takasch to replace Khiayn Brown in the initial bellwether pool of cases. There haven’t been any orders detailing the exact schedule of bellwether trials yet. There are 24 cases in the initial pool of bellwether cases for discovery. We are hopeful to hear about trial dates soon and which cases will move forward.
May 2024
Defendants selected Margie Giancontieri’s case to replace Karen Ginter’s case as an initial bellwether pool case for discovery. According to our research, defendants may choose replacement cases from the entire case pool to replace claims without merit or claims that may have been dismissed prior to going to trial for any number of reasons.
April 2024
Defendants selected Katherine Boeck’s case to replace Meagan Michelle Dyrdek’s case as an initial bellwether pool case for discovery. They also selected Karyn Brotzman to replace Tracy Rivera-Jimenez. From what we know from discussing bellwethers with our legal partners, bellwether trials are often called test trials because these cases are used to gauge how a jury will react to each side’s arguments and theories about the case. In this instance, both sides will be putting forth their theories before a jury about the link between Singulair and psychiatric side effects as well as what, if anything, the defendant knew about these side effects. The cases chosen should be representatives of the entire group of cases.
March 2024
Judge Porto issued Case Management Order #12, which outlined the bellwether test trial discovery protocols, according to our review of court records. Protocols included procedures for requesting medical records and for scheduling the depositions of plaintiffs and parents/guardians of a minor plaintiff. Other instructions included rules for medical provider depositions and how to resolve disputes between plaintiffs and defendants. This is a step that means we are that much closer to potential bellwether trials. In our experience, discovery may be a lengthy process.
February 2024
New York’s attorney general asked the FDA to add a stronger warning to Singulair.
December 2023
There had been no global settlements and no bellwether trials in the Singulair litigation.
April 2023
U.S. District Court Judge Timothy S. Hillman denied Merck’s motion to dismiss a Singulair lawsuit for lack of personal jurisdiction. He argued Merck manufactured, marketed and sold the drug in the state and allowed the case to continue.
February 2023
Judge John C. Porto in the New Jersey MCL ruled Plaintiffs Facts Sheets for 30 cases in the first group of lawsuits were due Feb. 7, 2023.
December 2022
The judge decided on the Plaintiff Fact Sheet and authorization for use in the New Jersey MCL.
September 2022
Merck won a Wisconsin lawsuit that claimed Singulair caused a child’s suicidal and homicidal thoughts. The judge ruled federal drug labeling law preempted the lack of warning claims.
January 2022
Singulair cases were first consolidated into multicounty litigation in New Jersey.
Lawyers continue to accept Singulair lawsuits across the country. In July 2021, the Plaintiffs’ lawyers requested the cases be consolidated in multicounty litigation in New Jersey. The court agreed and cases are now combined in MCL 637 in the Superior Court of New Jersey Law Division: Atlantic County.
Why Are Singulair Lawsuits Being Filed?
Plaintiffs, including the parents of children who suffered psychiatric disorders after taking Singulair, are filing lawsuits that accuse Merck of designing a defective drug, negligence and failure to warn about the risk of mental problems.
“When the drug launched in 1998, its label said the drug’s distribution in the brain was ‘minimal,’ with no mention of psychiatric side effects.”
Montelukast, Singulair’s active ingredient, has gone through extensive testing prior to being approved in 1998 through today, and these studies linked using the drug to neuropsychiatric events, according to court documents we researched.
We also analyzed the FDA’s adverse event reporting system, and reports of Singulair psychiatric adverse event reports have only increased in recent years, especially in 2021, 2022 and 2023. It’s important to note that the FDA cannot prove these adverse events were caused by Singulair because they are voluntary reports.
“Singulair users and parents of children who have taken Singulair need to be aware of the potential mental health side effects that may result following continued use. If you or your child have suffered medical issues after using Singulair, then you should reach out to a lawyer to determine if you qualify for a lawsuit. ”
Singulair is prescribed for severe allergies and asthma in adults and children. Out of 7,944 psychiatric adverse events reported as the FDA’s latest available information released on March 31, 2024, the age group of two months to 17 years had 2,872 reports.
In March 2020, the U.S. Food and Drug Administration added a Singulair boxed warning, its strongest label warning, for serious mental health side effects. Prior to this label change, there were insufficient warnings, according to lawsuits.
Do I Qualify for a Singulair Lawsuit?
According to our legal partners, you or a loved one may qualify for a Singulair lawsuit if brand name Singulair use led to a diagnosis for one or more of the mental health conditions listed below.
Qualifying injuries in Singulair lawsuits:
Aggressive behavior
Agitation
Anxiety
Attention problems
Confusion or disorientation
Depression
Hallucinations
Hostility
Insomnia
Memory problems
Nightmares or vivid dreams
Obsessive-compulsive symptoms
Stuttering
Suicidal thoughts
Suicide
Tremors and tics
Uncontrolled muscle movements
In addition to having a mental health diagnosis, our partners shared the additional qualifications below.
You may qualify if you:
Took Singulair and received a mental health side effects diagnosis.
Were 25 years or younger when the side effects started.
Could not perform at work or school or participate in social activities because of psychiatric symptoms.
In general, the time limit to file a claim for injuries caused by a drug is about three years, but this varies by state and may be less in your jurisdiction. This time limit can change depending on when you took the drug or when you discovered the drug’s side effects. Make sure you contact an attorney right away if you believe you qualify to file a claim.
Filing on Behalf of a Family Member
It’s important to know that parents or caregivers can file on behalf of their children, and family members can file a suit for loved ones who died as a result of Singulair’s side effects.
When parents file on behalf of their child, they claim damages they incurred as guardians of the child, such as paying for medical bills. They also file for injuries their child suffered. Wrongful death claims are filed on behalf of deceased family members.
Experienced law firms like our legal partners can walk parents and family members through the process of starting a claim.
SINGULAIR LAWSUIT EXAMPLE:
We examined the case of a mother who filed a lawsuit on behalf of her minor child in the Eastern District of Wisconsin in September 2020.
Singulair Usage:
The plaintiff’s minor child took Singulair from December 2010 to August 2012 to treat asthma and hay fever.
Injuries Alleged:
The drug caused the plaintiff’s child to be admitted to an inpatient psychiatric center, according to the lawsuit. Her child was admitted for homicidal and suicidal thoughts. Doctors diagnosed the child with major depressive disorder, anxiety disorder, obsessive-compulsive disorder, sexual thoughts, poor coping and other mental problems.
Relief Sought:
Compensatory damages, all attorney’s fees and costs as well as punitive damages to punish the defendant and deter the defendant from future wrongful practices.
Preparing To File a Singulair Lawsuit
Once you’ve confirmed you took the brand name Singulair and have received a diagnosis, it’s time to start the lawsuit process. Our legal partners can help walk you through the process, and a case evaluation is free.
Step 1: Finding an Experienced Law Firm
The first thing you need to do is find a law firm that has experience handling complex pharmaceutical litigation claims.
While we recommend our legal partners because they all have proven track records and have extensive experience litigating complex cases against big drug companies like Merck, it’s an important decision. Make sure you ask about the firm’s track record and experience. Remember, you can interview more than one firm.
Step 2: Preparing Necessary Documentation
Once you’ve decided on the law firm you want to hire, sign up for a free consultation.
Before you talk to your attorney, make sure you have proof you took the brand name Singulair, such as a receipt. Also, gather medical records showing your diagnosis.
If you have difficulty getting these records, your attorney may be able to help.
Step 3: File the Claim
Once your attorney has determined you qualify to file a claim, he or she will start the process by writing up the complaint and filing the claim in the appropriate court.
Drugwatch partners with trusted law firms to help you take legal action. After submitting the form, one of Drugwatch's partners will contact you for a free case review.
Singulair Boxed Warning Leads to Lawsuits
Plaintiffs began filing lawsuits shortly after the FDA added a boxed warning for serious neuropsychiatric events to Singulair’s drug label in March 2020.
A boxed warning is the FDA’s most severe warning. These warnings contain important side effect information surrounded by a thick black border and bold lettering to warn of permanent, serious or fatal side effects. The Singulair boxed warning links the drug to suicide, depression, aggression, agitation, suicidal thoughts and sleep disturbances.
Singulair Black Box Warning Timeline
March 4, 2020
The FDA announced it was adding a boxed warning for serious mental health side effects because many health care professionals, patients and caregivers were not aware of the risk.
Aug. 28, 2009
The FDA announced an update to Singulair’s “Precautions” section of the prescribing information to reflect neuropsychiatric events including, “postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor.”
March 3, 2008
The FDA announced it was investigating “a possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide.”
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“Singulair users and parents of children who have taken Singulair need to be aware of the potential mental health side effects that may result following continued use. If you or your child have suffered medical issues after using Singulair, then you should reach out to a lawyer to determine if you qualify for a lawsuit. ”
