ABILIFY


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Abilify (aripiprazole) is a widely sold anti-psychotic medication used to treat various mental conditions. However, in recent years, concerns of serious side effects that include compulsive behavior issues have spurred class action lawsuits, filed against the drug manufacturers for failing to warn consumers and doctors of the potential risks.

Plaintiffs claim that Abilify causes eating and gambling addictions and other forms of compulsive behavior. Studies suggest these dangerous urges are not rare, and as many as 10 percent of patients experience issues with severe impulse control.

In 2016, the FDA added an additional warning to Abilify (aripiprazole) drug labels which include an entire list of potential compulsive behaviors linked to the drug. Aripiprazole is sold under the brand names Abilify, Abilify Maintena, Aristada, and also sold as generics.

Joe Lyon is a highly-rated Cincinnati product liability attorney and Ohio personal injury lawyer representing plaintiffs nationwide in a wide variety of product liability claims against pharmaceutical companies


Abilify Compulsive Behaviors


The Food and Drug Administration (FDA) has recently warned of cases in which patients taking the antipsychotic medication Abilify (aripiprazole) have experienced uncontrollable urges to gamble, which has deeply affected the lives of thousands of individuals and families.

Although pathological gambling was already listed as a reported side effect in the current aripiprazole drug labels, the FDA noted, “This description does not entirely reflect the nature of the impulse-control risk.”

As a result, the FDA is adding a new mandate to include the entire list of potential compulsive behaviors. These warnings will be added to the drug labels and the patient Medication Guides for all aripiprazole products.

Abilify is an anti-psychotic drug typically used to treat the following mental disorders:

  • Schizophrenia
  • Bipolar disorder
  • Tourette’s Syndrome
  • Autism
  • Depression

Abilify Warnings


The drug is designed to improve behavioral tendencies in patients, however, the U.S. Food and Drug Administration (FDA) warns that anyone taking the medication may be affected by a compulsion to gamble, drink alcohol, eat or spend money excessively, or experience an increased impulse to engage in sex.

In most reported cases, patients with no prior compulsive behavior history had uncontrollable urges soon after starting Abilify (aripiprazole) treatment. Experts have noted that within days to weeks of reducing doses or discontinuing aripiprazole, these urges or compulsions resolved. Some cases reported the return of compulsive behaviors when aripiprazole treatment was reinitiated.


Abilify Side Effects


The purpose of taking Abilify is to prevent or decrease visual and auditory hallucinations, mood swings, depression, and suicidal thoughts in those suffering from psychiatric conditions.

However, the drug is associated with so many side effects, that it has been argued that the drug does more harm than good. Some common side effects include the following:

  • Compulsive Behavior
  • Weight gain
  • Blurred vision
  • Eye Spasms
  • Nausea and vomiting
  • Persistent headache
  • Fatigue
  • Dizziness
  • Anxiety
  • Insomnia
  • Cardiac interruption
  • Trouble breathing or swallowing
  • Convulsions
  • Unusually high or low blood pressure
  • Loss of bladder control
  • Muscle spasms
  • Severe muscle stiffness
  • Hives or skin rash
  • High blood sugar
  • Suicidal tendencies

Who is at Risk?


The FDA said in it last warning that anyone taking the medication, including children, can be affected by a compulsion to gamble, drink alcohol, eat or spend money excessively, as well as experience an increased impulse to engage in sex.

In the majority of reported cases, patients with no prior history of the compulsive behaviors listed above had uncontrollable urges soon after starting aripiprazole treatment.

In studies, within days to weeks of reducing the dose or discontinuing aripiprazole, these urges or compulsions are resolved completely. Some cases reported the return of compulsive behaviors when patients restarted aripiprazole.


Abilify Impulse Control


Studies suggest these dangerous urges are not rare at all. In fact, as many as 10 percent of patients may experience issues with impulse control.
Thomas Moore, of the Institute of Safe Medication Practices (ISMP), said “It’s an astronomical rate, in terms of adverse event risk.”

Moore also notes that many events go unreported because many people are embarrassed to tell doctors about these kinds of pathological behaviors.
When considering the number of patients taking this particular drug, thousands who could be at risk. In 2015, approximately 7.7 million prescriptions for oral aripiprazole were dispensed. Around 1.6 million patients in the US received an outpatient prescription for aripiprazole.


Abilify Treatment


Aripiprazole is used to treat certain mental disorders. Aripiprazole has been used to treat a number of conditions, including the following:

•    Parkinson’s disease
•    Restless leg syndrome
•    Hyperprolactinemia
•    Schizophrenia
•    Bipolar disorder
•    Tourette’s disorder
•    Autism
•    Depression (in combination with antidepressants)


Abilify Gambling & Compulsive Behavior


The FDA Adverse Event Reporting System database and other literature available through mid-January 2016 identified 184 case reports indicating an association between aripiprazole and impulse-control problems.

This is not only a recent finding. Impulse-control disorders, and pathological behaviors such as compulsive gambling, shopping, eating, and hypersexuality, have long been reported in association with the use of dopamine agonist drugs. Such cases of impulse control have been reported to the FDA for the last 15 years, since the drug was approved in the US in November 2002.

From foreign and domestic reports, there are over 710 impulse-control disorder events reported in recipients of dopamine receptor agonist drugs. The recent decision by the FDA further bolsters these prior concerns.

Abilify Lawsuits


Antipsychotic medications are used as a treatment for bipolar disorder and schizophrenia to control psychotic symptoms that may occur during acute mania or severe depression. Some anti-psychotics have demonstrated long-term value in preventing future episodes of mania or depression, though the class of drugs has significant side effects that may do more harm than good.

Bristol-Myers Squibb, the developer of Abilify, has been the target of lawsuits related to Abilify in the past. The pharmaceutical giant reportedly paid hundreds of millions to settle charges for illegally marketing Abilify to nursing homes, despite knowledge that the drug can cause death in patients with dementia. Abilify was never approved by the U.S. Food and Drug Administration for dementia treatment.

Lawyers argue that the makers and distributors of Abilify have failed to warn consumers of the potential serious side effects of the drug. Drug companies have an obligation to inform consumers about harmful side effects of drugs they market and sell. Compulsive behavior warnings on Aripiprazole products did not exist, however, until many patients had already suffered from the harmful side effects.

Plaintiffs who reported related Abilify compulsive behaviors say they have never experienced similar urges or compulsions prior to taking the drug, and also report that immediately after they stopped taking Abilify, the compulsive urges diminished or ceased altogether.


What is a Depressive Disorder?


A depressive disorder is an illness that involves the body and mind, greatly interfering with daily life, normal functioning, and causes significant emotional and psychological pain. Depressive disorders like bi-polar disorder and schizophrenia are different from a passing blue mood. Without treatment, symptoms can last years.

Depressive disorders come in different forms, and there are variations in specific symptoms as well as their severity and persistence of manic episodes.

  • Schizophrenia—schizophrenia is a serious mental disorder which affects how a person thinks, feels and acts. Someone with schizophrenia may have difficulty distinguishing between realities, may be unresponsive or withdrawn, and may have difficulty expressing normal emotions.
  • Psychotic depression—occurs when a severe depressive illness is accompanied by some form of psychosis.
  • Bipolar disorder—also called manic-depressive illness, bipolar cases are characterized by cycling mood changes: extreme highs and lows.

Symptoms of Depressive Disorders


Individuals diagnosed with depressive disorders like schizophrenia and bipolar disorder may exhibit unique signs and symptoms which a doctor is charged with treating. Medications may help to treat some specific symptoms or to treat the disorder as a whole.

Treatment with drugs should be accompanied with counseling and monitoring to see how the patient is responding. Some people experience a few symptoms, and others may exhibit several. Some common symptoms of depressive disorders may include:

  • Persistent sadness or anxiety
  • Feelings of hopelessness
  • Feelings of guilt, worthlessness, or helplessness
  • Loss of interest or pleasure in activities that were once enjoyed
  • Decreased energy and fatigue
  • Difficulty concentrating or making decisions
  • Insomnia
  • Loss of appetite/weight loss, or overeating/weight gain
  • Thoughts of death or suicide
  • Restlessness, irritability

Some antipsychotics stabilize patients, and may be used alone as long-term treatment for people who don’t respond to other available medications. For patients with depressive disorders, anti-psychotic drugs may help regulate normal thinking, mood, and perception, and have been known to quickly improve manic episodes.

Anti-psychotics usually act quickly and help patients avoid impulsive behaviors associated with mania. The benefits may come with significant risks, however.

A medical expert has argued in a leading medical journal that despite many cases of successful treatment, psychiatric drugs like Risperdal, Zyprexa and Abilify may do more harm than good.

Some studies have suggested that this class of drugs may have unintentional effects on patients, especially adolescents and geriatric patients. The FDA’s review of published and unpublished controlled clinical trials has prompted several “Black Box” warnings for some anti psychotic drugs.

Drug makers have been accused in many lawsuits of failing to properly test drugs before putting them to market, and downplaying the risks of their drugs.

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A Voice for Those who have suffered 

Why are these cases important?

By taking the initiative and filing drug injury lawsuits, plaintiffs can receive proper compensation and hold a corporation accountable for their negligent actions. Consumer safety depends largely on making sure companies operate within the law and within ethical boundaries.

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Questions about Pharmaceutical Litigation

What is Pharmaceutical Litigation?

When drug makers and large corporations are negligent and produce dangerous products that lead to serious illness and injury, legal action can be necessary. In the current corporate environment, filing lawsuits is one of the only ways to keep drug companies from selling untested and dubious pharmaceuticals in the name of profit. Pharmaceutical litigation – through a lawsuit against a drug manufacturer- helps bring awareness to these companies as to the necessary changes that need to occur in order to keep people safe a healthy while taking a  certain drug. 

By taking the initiative and filing drug injury lawsuits, plaintiffs can receive proper compensation and hold a corporation accountable for their negligent actions. Consumer safety depends largely on making sure companies operate within the law and within ethical boundaries.

How does the drug label come into play?

In past litigation, it has been discovered that drug companies often delay adding serious side effects to a drug’s label due to concerns about the impact on the sales and marketing. If a drug carries more serious side effects, physicians and patients look for alternative treatments with less risk and the same or similar benefit.  As a result, there is a financial incentive not to strengthen the warning label.

However, the label is the source of information that physicians and patients rely upon when making these important health decisions.  There is no excuse for a company not to update its label when the science is sufficient to show an association with the medication.

How does this related to the FDA?

Most experts would agree that the FDA is not designed nor does it have the resources to monitor every product through the post approval process once it has been granted clearance. Very simply, the volume of medical devices that are presented for review is too demanding, so, while the FDA is a good initial step in the process, the responsibility of providing safe and effective pharmaceutical companies remains on the companies that profit from the sales.

While the pharmaceutical companies have yielded more influence over the review process, ultimately, the law is very clear that it is the company’s responsibility to run the appropriate tests, track the data, and to identify the side effects and then warn consumers and physicians adequately and in a timely manner. Government approval is not a shield for liability. The Failure to timely and sufficiently warn of side effects operates as the primary cause of action for pharmaceutical claims.

Most importantly, the FDA and the government do not provide for compensation when someone is injured by a pharmaceutical product.  The civil justice system provides the means for an individual harmed by a pharmaceutical product to obtain justice and recover for the losses suffered.

Without the civil justice system, companies would not be required to pay for the harm they cause, and the public tax system, in terms of Medicare and Medicaid, would have to absorb that loss. In other words, without pharmaceutical lawsuits, the tax payers would pay for corporate malfeasance and neglect.

What are some examples of Pharmaceutical Settlements?

The current opioid crisis is a good example of how over-prescribing medications can lead to a huge public health crisis. Pain medications have been a great tool for physicians in treating a wide variety of conditions, however, the abuse of prescribing and using pain medication has turned into one of biggest areas of pharmaceutical litigation today.

It is not only opioids that have been prescribed in huge numbers. Other drugs that have only been tested in short trials are released to the market each year and injure patients. A few examples of drug injury:

Testosterone: Low T clinics are under investigation after many patients receiving testosterone therapy have reported strokes and heart attacks. Experts say doctors may be pushing the therapy when not every aging man requires testosterone therapy.

AntibioticsAntibiotic injuries are being reported at record rates as the drugs are prescribed more than ever before. Drug resistance and drug injury rates are on the rise, concerning the medical community and consumer protection attorneys.

Diabetes Drug Injury: Severe side effects are being reported by diabetes patients taking Invokana and other diabetes medications. Amputations and gangrene cases have opened the eyes of many taking the drugs, and lawsuits have been filed on their behalf.

Drug Contamination: Valsartan and Losartan contamination cases have raised the risk of patient cancer. Drug companies have failed to control the production process and put consumers at unnecessary risk.

Opioid Painkiller Lawsuits: Purdue Pharma, Johnson & Johnson and other large drug companies are deep in pharmaceutical settlement talks many years after the beginning of the opioid addiction crisis. Thousands of Americans die each year in opioid-related overdose deaths, many of which begin with doctors over-prescribing pain medications.

Depo Provera: Confidential settlement from Pfizer to resolve all of the claims currently pending in the New Jersey State coordinated litigation. Joseph Lyon represented 13 females who suffered osteoporosis due to the failure of Pfizer to properly warn them and their physicians.

Seroquel: AstraZeneca resolved claims for $198 Million regarding claims that the company failed to warn about risks of diabetes and excessive weight gain. The Lyon Firm participated in this settlement and represented numerous claimants. In addition to the individual claims, Federal prosecutors and authorities from several U.S. states investigated whether AstraZeneca promoted Seroquel off-label, or for uses not approved by the U.S. Food and Drug Administration. The company announced a settlement of $520 million with the U.S. Justice Department over the matter.

Trasylol: Bayer resolved certain claims for $60 Million for patients who suffered heart failure and death as a result of the drug Trasylol.  Trasylol was a drug used to prevent excessive bleeding during heart surgery. The science unequivocally showed Trasylol can cause kidney damage, heart failure and strokes, and greatly increase patients’ risk of post-surgery death when compared to rival treatments.

In 2006, a study by Dr. Dennis Mangano was published in the New England Journal of Medicine concluding that the drug more than doubled the risk of renal failure.  After fourteen years on the market, Bayer suspended sales in November 2007. The Lyon Firm participated in this settlement.

Vioxx: Merck settled the outstanding Vioxx claims for $4.85 billion. The Lyon Firm participated in this settlement.  In 2004, after a study showed Vioxx doubled the risk of heart attacks and strokes, Merck pulled Vioxx from the market. The case was then litigated with 16 trial ultimately going to the jury for a decision. Merck prevailed in 11 of the 16 trials.

Despite the settlement, Merck has not admitted that that Vioxx caused injuries. Each claim under the settlement was analyzed under an protocol that weighed such factors as a user’s age, their length of use, and their health risks such as obesity or hypertension. The individual extraordinary payout for a heart attack case was capped at $600,000.

How are the cases handled?

Pharmaceutical litigation is a complex area of law that combines dense regulation, developing science, and multi-jurisdictional questions of law. Most cases involving claims of drug injury and pharmaceuticals become centralized in the federal multidistrict litigation process. Pharmaceutical litigation involving injury claims are not in most cases not class action lawsuits, but they are very similar.

Due to the volume of cases and number of similar issues, most pharmaceutical cases are handled through Multidistrict Litigation (MDL). The multidistrict litigation procedure is guided by the Judicial Panel for Multidistrict Litigation, where the case is centralized before one federal Judge for the purposes of pre-trial discovery.

The MDL process is appropriate where there are one or more common questions of fact in multiple cases pending in different federal district courts.  While there often are parallel state consolidated proceedings, the federal MDL process is generally supported by both Plaintiff and Defendants in these cases.

The MDL process allows for efficiency where there are millions of pages of documents, many expert witnesses across multiple disciplines from epidemiology, pharmacology, toxicology and the specific discipline for the relevant mechanism of injury.

Although 28 USC 1407 does not specify a specific number of cases required before the formation of an MDL is appropriate, the Judicial Panel for Multidistrict Litigation reviews the Motions and conducts a hearing to determine whether consolidation is ripe given the number and location of the pending cases.

What is an MDL?

Most people understand what a class action lawsuit is, and fewer are aware of what an MDL refers to. It is important for a claimant to know, however, that an MDL is not a class action, as the term is often misapplied in this context, and the original court (home or transferee jurisdiction) retains the authority to present the case at trial.

In most MDL settings, the case is resolved by way of settlement or a summary judgment motion on the questions of science (i.e., Daubert Motion). If either settlement or dismissal on Motion occurs, the case is not remanded to the originating court. If the case is not resolved at the MDL, then the case may be remanded to original jurisdiction for additional discovery on the case specifics and ultimately trial.

Why Hire the Lyon Firm?

Our Firm will help you find the answers.  The Firm has the experience, resources and dedication to take on difficult and emotional cases and help our clients obtain the justice for the wrong they have suffered. 

 Experience:  Joe Lyon is an experienced Cincinnati Pharmaceutical Lawyer. The Lyon Firm has 17 years of experience and success representing individuals and plaintiffs in all fifty states, and in a variety of complex civil litigation matters. Pharmaceutical lawsuits can be complex and require industry experts to determine the root cause of an accident or injury. Mr. Lyon has worked with experts nationwide to assist individuals understand why an injury occurred and what can be done to improve their lives in the future. Some cases may go to a jury trial, though many others can be settled out of court.

Resources/Dedication: Mr. Lyon has worked with experts in the fields of accident reconstruction, biomechanics, epidemiology, metallurgy, pharmacology, toxicology, human factors, workplace safety, life care planning, economics, and virtually every medical discipline in successfully representing Plaintiffs across numerous areas of law. The Lyon Firm is dedicated to building the strongest cases possible for clients and their critical interests.

Results:  Mr. Lyon has obtained numerous seven and six figure results in personal injury,  automotive product liability, medical Negligence, construction accidents, and auto dealership negligence cases.  The cases have involved successfully litigating against some of  the largest companies in the world 

Our Victories

The Lyon Firm aggressively, professionally, and passionately advocates for injured individuals and families against companies due to a drug to obtain just compensation under the law. 

IN RE: VIOXX

Nationwide Consolidation in U.S. District Court, E. Dist. of LA. 

This pharmaceutical case involved claims that the blockbuster painkiller was causing heart attacks and strokes in consumers. The FDA ultimately recalled the medication. Merck settled the outstanding Vioxx claims for $4.85 billion following multiple trials in both state and federal courts. Joe Lyon was co-counsel in a number of individual claims that were successfully resolved in the federal MDL. The funds received for Lyon Firm clients helped several elderly clients with additional medical and home health care.

IN RE: TRASYLOL

Nationwide Consolidation in Civil Complex Litigation Center Philadelphia, PA. 

A pharmaceutical case involving claims that a popular surgical medication was causing kidney failure and death. The FDA recalled the medication in question, but not before thousands of patients died due to related complications. Bayer resolved certain claims for $60 Million for patients who suffered kidney failure and death as a result of using the drug Trasylol. Joseph Lyon represented a widow from Kentucky whose husband died due to kidney failure following the administration of Trasylol. The recovered funds assisted the surviving family members in resuming farming operations.

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