Abilify Injury Attorneys in Boston
As our Boston Abilify injury lawyers have represented numerous dangerous drug cases and can explain, there have been many recent lawsuits filed by plaintiffs who have suffered or otherwise been injured after taking Abilify. Specifically, these drugs have been shown to cause some patients to experience uncontrolled urges, and to engage in high risk behavior such as gambling, sex, binge eating, and shopping. These lawsuits have been filed on the basis of Bristol Myers Squibb failing to adequately test the drug for safety, failing to warn doctors and patients of dangers they knew or should have known about, and failing to disclose known dangers to the FDA.
Bristol Myers Squibb is the manufacturer of a powerful drug known as Abilify. Abilify was developed as an atypical antipsychotic drug and submitted to the U.S. Food and Drug Administration (FDA) for approval.
FDA has approved Abilify for the following uses:
- The treatment of bipolar I disorder with manic or mixed episodes in adult patients and juvenile patients who are between the ages of 13 and 17.
- Use as an add-on treatment for adults who suffer from major depressive disorder (MDD) when traditional antidepressants do not work sufficiently on their own.
- The treatment of schizophrenic adults and children who are between the ages of 13 and 17.
- The control of autism-related irritability in patients who are between the ages of 6 and 17.
In addition to these uses, Abilify is also being used to treat those who suffer from facial tics, when traditional antianxiety drugs do not prove sufficient. While other uses are not approved by the FDA, the drug has been used for various other "off-label" uses. This is where a doctor can use a drug for a purpose other than what the FDA has approved directly, so long as he or she is treating based upon symptoms alone and is acting with the accepted knowledge of the medical community. This does not give a doctor the right to experiment on patients without approval and informed consent, but there are some valid off-label uses for Abilify.Abilify Risks and Safety Test
While there are often many risks to taking a powerful antipsychotic drug, it is essential a drug company has taken all steps required and expected to make sure their drug is not only a drug which works, but also a drug which is safe. There are many safety tests that must be done and these results must be submitted to the FDA for review prior to approval and after approval. These tests are accomplished through pre-market studies and post-market studies with market being the point at which a drug is approved for being sold on the market --permitting doctors to prescribe the drug to patients.FDA Warns of Dangers of Abilify
In the wake of these recent discoveries by patients and the general public about the potential dangers of Abilify, the FDA has issued a Drug Safety Communication warning patients and doctors about the dangers of impulse-control problems associated with Abilify, which is known by its generic name of aripiprazole, and other brand names, including Maintena and Aristada.
Prior to this warning, there were indications on the drug monograph that pathological gambling was a possible side effect, but the FDA has concluded this existing warning did not accurately reflect what it deems risk-impulse control issues associated with Abilify. The FDA has now added labels to include warnings of compulsive gambling, sexual behavior, binge eating and compulsive shopping.
While there is evidence the impulsive behavior will subside or stop once the drug is discontinued, there is no question serious damage may be done prior to these uncontrollable impulses stopping. In the case of a gambling addiction, it is possible a plaintiff could have lost his or her savings and incurred significant debt. These damages could affect the plaintiff's entire family. It is certainly true in a typical defective drugs case we are normally dealing with some type of medical injury. However, if this damage was a foreseeable harm in taking the drug, it is certainly within the scope of damages a plaintiff could demand.
There are essentially two main claims that can be brought in a products liability action, including those involving a defective drug. The first is a claim of defective manufacture. This means the company manufactured the drug in a defective manner and knew or should have known of these dangers as a result of the performance of adequate safety testing.
In addition to a claim of defective manufacture, there is also the possibility of filing a claim of failure to warn of a known danger. This is accomplished through the completion of multiple phases of laboratory experiments and human clinical trials. While clinical trials are heavily regulated by the FDA, they are not performed by the FDA itself. The drug company will contract with research universities and private clinical trial organizations. The drug company will set the study parameters and may even provide the necessary testing equipment. In many labs, there will be individual pieces of equipment for each study being performed, so we can see just how much control the drug company has over its studies.Injury Lawsuit Filed Against Makers of Abilify
In some cases, there will be a danger discovered, which is reported to the FDA, and this may result in the drug going back to an earlier stage in development, and in some cases, the drug company will scrap work entirely. This is no easy decision, as we have seen some companies losing a substantial portion of their value on the stock market following such an announcement of problems in clinical trials. This can cost a drug company hundreds of millions of dollars so there is no question as to why they might be motivated to hide negative results of these studies if they have an opportunity to do so. This is not to say every drug company acts dishonestly, but we have seen many examples in the past with other drugs, and this is what has been alleged in the injury lawsuit cases already filed against the makers of Abilify.
At the Law Offices of Jeffrey S. Glassman, LLC, we have represented injured victims throughout Boston and the entire state of Massachusetts for more than 19 years. Contact us today at using our online form to learn how we can put our legal experience to work for you.