Why Are People Filing Abilify Lawsuits?

$535
Million in compensation paid by Bristol-Myers Squibb for Abilify settlements

Dozens of lawsuits have been filed against Otsuka Pharmaceuticals, the makers of Abilify, and Bristol-Myers Squibb, which markets the drug. These lawsuits claim that the drugmaker knew or should have known about the dangerous side effects of the antipsychotic, and failed to warn prescribers and patients of these risks.

Abilify is used to treat several disorders, including schizophrenia and bipolar disorder in adults, and Tourette syndrome in younger people. Despire growing concerns over stroke risks in elderly patients and compulsive behaviors in adults, Bristol-Myers Squibb continues to market Abilify as a safe and effective treatment for psychological disorders.

Previously, European and Canadian health officials increased regulation of Abilify, requiring changes to the drug’s labelling and marketing materials. These changes ensured that doctors and patients were informed of the possible risks of using the antipsychotic drug. In the U.S., however, Abilify does not carry these warnings, which some patients argue proves that the company is willfully deceiving consumers.

FDA Warning about Abilify

In May 2016, the FDA issued a boxed warning about Abilify’s risks for compulsive behavior. This warning was based on approximately 200 reported cases of compulsive gambling, eating, shopping, or sexual behaviors by patients taking Abilify. A black box warning is the most severe warning that the FDA can issue about a medication. It also required Bristol-Myers Squibb to add additional information to Abilify’s medication guides, to more explicitly address the compulsion risks.

Abilify has also been used for off-label uses for years. Many doctors will prescribe Abilify to elderly patients with dementia-induced psychosis, or children with autism, to help with aggression and mood swings. While it’s not illegal for a doctor to prescribe a medication for an off-label use, it is illegal for the manufacturer to market the drug for off-label uses. None of the off-label uses for Abilify have been studied for efficacy or safety, and the drug is not approved by the FDA for these uses.

Common Abilify Lawsuit Claims

The severe and unpredictable side effects of Abilify have led to a number of legal claims from individuals. One of the biggest claims is that the drug causes impulse control problems, leading to addictive activities like gambling and binge eating. Other claims focus on detrimental health effects of the drug, including a higher risk for stroke and type 2 diabetes.

Compulsive Behavior

The most common claim in Abilify lawsuits is that the drug led to compulsive behavior – that is, uncontrollable actions or addictive patterns. Patients have reported gambling obsessions that lead to significant financial losses, unusual hypersexuality, which in some cases became sex addiction, or similar compulsions to eat or shop. Of these, the most often reported side effect was a compulsion to gamble.

Dozens of case reports support the link between Abilify use and compulsive behavior, especially gambling. Additionally, Abilify acts as a dopamine agonist, which means it stimulates a part of the brain responsible for rewarding feelings. Such feelings include those experienced after winning a bet, engaging in sexual activity, or eating a delicious meal. Researchers believe that the link between Abilify and changes to dopamine pathways is cause of strong compulsions in patients.

Although the science is inconclusive, this link did drive European and Canadian health officials to order Bristol-Myers Squibb to change the labels on Abilify to reflect the risk for compulsive behavior and gambling addiction. In 2016, the FDA followed suit, requiring a black box warning on Abilify labels.

Stroke

Like several other antipsychotic medications, Abilify has been linked to an increased risk of stroke, which can be deadly. Despite these discoveries, Abilify is often prescribed as a treatment for dementia-induced psychosis in elderly patients, even though the drug is not approved to treat this mental disorder. In 2016, the FDA issued a warning about the increased risk of death in elderly patients who take Abiilfy.

Many legal claims have alleged that Bristol-Myers Squibb illegally marketed the drug to treat psychotic behavior in elderly patients who have dementia, knowing it was not indicated for that use and without disclosing the increased risk of death.

Hyperglycemia and Type 2 Diabetes

As with other medications for mental disorders, Abilify can cause patients to gain as much as a pound per week while taking the drug. Additionally, Abilify can sometimes cause an increase in blood sugar, known as hyperglycemia.

Both hyperglycemia and rapid weight gain are risk factors for type 2 diabetes. Some patients who took Abilify and later developed type 2 diabetes have filed lawsuits claiming that Bristol-Myers Squibb did not adequately warn them of this risk.

Abilify Settlements

In addition to the dozens of individual lawsuits filed against Bristol-Myers Squibb for Abilify, 22 cases have been pulled together in a multidistrict litigation (MDL), designated MDL 2734, in re: Abilify Products Liability Litigation.

This litigation is currently in the discovery phase of litigation. The first bellwether trials are expected to begin in late 2018, depending on the various motions that occur and assuming the cases are not settled.

2016 Settlement: $19.5 million

In 2016, Bristol-Myers Squibb and a coalition of 42 states agreed to settle claims that the company had illegally promoted Abilify for off-label uses, including use by children and elderly patients with dementia. The claim also raised questions about whether Bristol-Myers Squibb mislead patients about the risk of weight gain when taking Abilify.

Though Bristol-Myers Squibb maintains that they haven’t marketed Abilify since 2013, and denies any wrongdoing, they did agree to a few terms in the settlement. They were prohibited from promoting Abilify for off-label use, making false claims about the drug, and obscuring information about side effects. They also are prohibited from paying health care providers to attend promotional events for Abilify, among other restrictions.

2007 Settlement: $515 million

In September 2007, Bristol-Myers Squibb paid more than $515 million to settle a federal investigation into its marketing techniques for Abilify. The U.S. government claimed that between 2000 and 2003 pharmaceutical company made illegal payments to physicians for prescribing Abilify and provided similar illegal benefits to pharmacies that filled the prescriptions.

Furthermore, the government accused Bristol-Myers Squibb of marketing their drug for off-label uses and to unapproved age groups. The allegations also claimed that the drugmaker had purposefully and irresponsibly inflated the price of the drug.

The settlement let Bristol-Myers Squibb escape a full trial, but it also came with strings attached. Part of the agreement required the corporation to report accurate drug prices to the Office of Inspector General of the Department of Health and Human Services.