2018 Concerta Lawsuit News: According to the latest U.S. Food and Drug Administration’s (FDA) Adverse Events Report, over 6,700 cases have been reported since Concerta was first approved in 2000. If you or a loved one have suffered severe side effects from taking Concerta, talk to an attorney about your legal rights.

Concerta is a prescription medication for treating attention-deficit/hyperactivity disorder (ADHD). The drug’s active ingredient, methylphenidate, has been linked to cardiovascular and psychiatric problems, including suicidal thoughts. These severe side effects have led many patients and their families to file Concerta lawsuits.

Why People are Filing Concerta Lawsuits

6.1 million
children age 2 – 17 have ever been diagnosed with ADHDCDC

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 billion dollar opportunity, with many ADHD drugs now available on the market, like Adderall, Ritalin, Strattera and Concerta.

Janssen Pharmaceuticals, a branch of Johnson & Johnson, first introduced Concerta to the market in 2000 after the drug was FDA approved. 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 HCI, 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 ADHD medication available, expected to last 10 – 12 hours, which was ideal for children in school as they wouldn’t need to take the medication again during the day. Because of this long, steady release, Concerta quickly became popularly prescribed. Initially, Janssen Pharmaceuticals described side effects common to other CNS stimulants and ADHD medications.

Common Side Effects of Concerta

  • Decreased appetite
  • Nausea and vomiting
  • Dry mouth
  • Headache
  • Muscle twitching
  • Sleep problems or insomnia
  • Nervous feeling or anxiety
  • Upper abdominal pain
  • Increased sweating
  • Irritability

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.

Concerta 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 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 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 high risk of suicidal behavior, not finding a significantly increased association of Concerta users and suicide risk. However, since its release in 2000, the FDA has received 251 reports of suicidal ideation, with another 179 reports of suicide attempt. These instances may also be even more frequent than it appears, as not all families necessarily reported to the FDA on these side effects.

Studies 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 EffectNumber of Instances (2000 – 2018)
Anxiety246
Depression240
Abnormal behavior225
Agitation173
Hallucination162
Psychotic disorder137
Emotional disorder73

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

Unfortunately, suicidal thoughts and other psychiatric conditions aren’t the only severe side effects children and adults have experienced from the ADHD medication. Many patients have experienced serious cardiovascular events as a result of taking the medication, including heart attacks, stroke, and even sudden death in adults. Children and adolescents have also seen various heart health concerns like irregular heartbeat (tachycardia), heart muscle disease (cardiomyopathy), coronary artery disease and other heart abnormalities.

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)
  • Seizures
  • 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 6,785 adverse reports against the medication, with 5,106 of them considered to be serious. So far, there have also been 133 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 of 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 because of these health risks. In 2015, Health Canada had additional warnings added on drug labels for a number of ADHD medications, including Concerta, Adderall and Ritalin, for the increased risk of suicidal tendencies. The FDA has yet to issue a suicide warning for consumers in America.

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. It’s important to talk with a lawyer about your options and if a lawsuit is right for you.

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.