Concerta lawsuits may claim the attention deficit disorder (ADD) drug caused severe side effects like suicidal thoughts, anxiety, depression, and psychotic disorders. A handful of lawsuits have been filed nationwide against manufacturer Janssen Pharmaceuticals (a division of Johnson & Johnson), but none have settled or reached verdicts favoring plaintiffs.
Why are People Filing Concerta Lawsuits
Attention-deficit/hyperactivity disorder, or ADHD, is one of the most common diagnoses in the United States, with the most recent data from the Centers for Disease Control estimating that approximately 9.4% of children between the ages of 2 and 17 have ever been diagnosed. Drug manufacturers saw this diagnosis as a substantial opportunity and developed a number of drugs to treat it. Adderall, Ritalin, Strattera and Concerta have all become household names as a result.
Janssen Pharmaceuticals, a branch of Johnson & Johnson, first introduced Concerta to the market in 2000 after the drug was approved by the U.S. Food and Drug Administration (FDA). Concerta is an extended release ADHD medication intended for children 6 and older and adults up to the age of 65. The drug's active ingredient is methylphenidate HCl, the same active ingredient as Ritalin, and is considered a central nervous system (CNS) stimulant.
Concerta is meant to help increase attention and decrease restlessness in overactive children and adults. It was the first extended-release drug to treat ADHD. Because of its extended efficacy window, Concerta quickly became a popular drug to prescribe for children in school. It prevented the need to take medication multiple times throughout the school day. Initially, Janssen Pharmaceuticals warned Concerta patients about potential side effects common to other CNS stimulants and ADHD medications.
Common Side Effects of Concerta
- Decreased appetite
- Nausea and vomiting
- Dry mouth
- Muscle twitching
- Sleep problems or insomnia
- Nervous feeling or anxiety
- Upper abdominal pain
- Increased sweating
However, as the prescription became more widely prescribed, consumers filed numerous adverse event reports to the FDA because of various severe side effects, with over 200 filed just one year after the drug came to market.
Risk of Suicidal Thoughts and Psychiatric Adverse Events
Various studies have focused on how Concerta and similar drugs may lead to depression, suicidal thoughts and increased risk of suicidal attempts. One case report focused on two children, ages 7 and 8, who were prescribed 10 mg and 5 mg of Concerta daily.
The children's parents noted that both children began to express suicidal ideation in conversation, with no history of mental or behavioral issues in the family. The 7-year-old additionally began to withdraw from social interactions, slapped himself and even appeared to crudely attempt suicide. After immediately stopping use of Concerta, both children appeared normal and didn't experience further symptoms. Other related studies have noted similar events.
Some researchers have contested the risk of suicidal behavior, not finding a significantly increased association between Concerta use and suicide risk. However, since its release in 2000, the FDA has received 251 reports of suicidal ideation, with another 179 reports of suicide attempts. It's important to keep reports like these in context though. Some drugs may treat patients whose illnesses alone put them at higher risk of mental health problems like suicidal thought. If they experience such symptoms, it may be the illness itself causing the symptom and not the drug intended to treat the illness.
Studies have also pointed to other psychiatric events that could occur in children and adults without a prior history of such conditions. Consumers could experience hallucinations, delusional thinking and mania as a result of taking a normal dose of Concerta.
A long list of additional psychiatric and physical adverse events have been reported to the FDA.
FDA Reported Psychiatric Adverse Events
|Side Effect||Number of Instances (2000 - 2018)|
Concerta's label currently has a warning for psychiatric adverse events, like hallucinations and manic symptoms, but has no warnings about the potential for suicidal thoughts and behavior.
Other Concerta Side Effects
Suicidal thoughts and other psychiatric conditions aren't the only severe side effects children and adults have experienced from the ADHD medication. Some patients have experienced serious cardiovascular events after taking the medication, including heart attacks, stroke, and even sudden death in adults. Children and adolescents have also seen various heart problems like irregular heartbeat (tachycardia), heart muscle disease (cardiomyopathy), coronary artery disease and other heart abnormalities, all of which are mentioned on the drug's label.
A wide variety of other side effects have been noted in adverse event reports and clinical studies observing the effects of methylphenidate.
Other Severe Concerta Side Effects
- Tics (uncontrolled, repetitive motor movement)
- Priapism (painful, long-lasting erections)
- Blurring of vision
- Gastrointestinal obstruction
- Long-term suppression of growth in children
FDA Adverse Events Report and Black Box Warning
In addition to the adverse events reported above, consumers have recorded hundreds of other side effects and dangers of taking Concerta. Since its release, there have been 7,040 adverse reports against the medication, with 5,211 of them considered to be serious. So far, there have also been 138 death cases reported to the FDA.
Despite these dangers, there has never been a Concerta recall. The FDA has only released safety warnings in relation to some of the adverse events. Concerta also now needs to include a black box warning on its label as of 2011. Black box warnings are the strictest warnings for prescription drugs to protect against the most severe risk or risks the drug may cause. Concerta's black box warning is about the risk of dependency.
Concerta is classified as a Schedule II controlled substance, meaning it has a high potential for abuse which can lead to dependence. As such, the black box warning tells consumers that the drug should be given to previous alcoholics or others with a history of drug dependence with caution. The warning explains abuse of Concerta can lead to psychological dependence on the drug, abnormal behavior and psychotic episodes. Concerta can also have severe withdrawal symptoms, like depression, so careful supervision is required for those coming off of a dependency on the medication.
Canadian legislators have taken even further action than their American counterparts because of these health risks. In 2015, Health Canada added additional warnings to drug labels for a number of ADHD medications, including Concerta, Adderall and Ritalin, for the increased risk of suicidal thoughts. The FDA has yet to issue a suicide warning for consumers in America.
As of March 2019, there are no Concerta class action lawsuits, nor have any individual suits been consolidated via multidistrict litigation (MDL). This may be attributable to the conflicting scientific studies linking or failing to link the drug to adverse events, including psychiatric side effects, as well as the presence of clear warnings on the label. Every drug carries the risk of certain side effects. When patients are clearly informed of side effect risks, lawsuits against the drug manufacturers rarely meet with success.
How Do I Qualify for a Concerta Lawsuit?
If you or a loved one has been prescribed Concerta and suffered side effects like suicidal ideation, you may be eligible to file a claim against Janssen Pharmaceuticals.
A Concerta lawsuit can potentially provide compensation in relation to:
- Medical bills: In some instances, the negative side effects of Concerta may require further medical treatment or even hospitalization, which can result in expensive bills.
- Lost wages: For adults taking Concerta, severe side effects could result in the inability to work for some time or permanently.
- Pain and suffering: A verdict may award damages for the pain and suffering of Concerta's adverse events, like suicidal thoughts and other mental conditions patients may suffer as a result of the prescription.
- Funeral costs: In some cases, the severe side effects of Concerta have resulted in death. If your loved one passed away because of the drug, a jury may offer damages to help cover funeral expenses.
- Punitive damages: Johnson & Johnson and Janssen Pharmaceuticals made over $791 million in Concerta sales in 2017 alone. Punitive damages would punish the manufacturers for not properly testing the drug and false marketing, and hopefully, deter similar conduct in the future.
Currently, there are only individual lawsuits filed against the drug manufacturer. There have been no Concerta class action lawsuits to date. According to the most recent reports, there has yet to be a motion to transfer the pending civil cases under one federal multidistrict litigation (MDL). This may happen in the future, as experts expect the number of Concerta lawsuits to continue to grow.