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What They Knew

The FDA approved Abilify in 2002. In May 2015, the FDA published a safety announcement stating that Abilify is linked to several “compulsive or uncontrollable urges” including compulsive gambling. On May 4, 2016, the FDA required that Abilify have a new warning label listing the potential for these hazardous behaviors.

When They Knew It

In the early stages of testing Abilify, doctors recognized that hypersexuality, a form of compulsive behavior, was an adverse effect of patients who took this medication. However, the warning label never alerted patients to this potential problem. Additionally disconcerting is that in October 2012, the European Medicines Agency (EMA) – which is like our FDA – added a warning label to Abilify to reflect the potential for pathological gambling. Even Canada added this warning to Abilify labels before the United States in November 2015.

Countless patients around the world have been reporting that after taking Abilify, they had an uncontrollable urge to gamble.

  • In March 2010, a 64-year-old women who was taking 15 mg of Abilify reported that she couldn’t stop gambling or over-eating.
  • In December 2010, a study was published that found a link between how mutant HTR2B (a receptor that Abilify effects) increases impulsive behaviors.
  • In January 2016, Nicholas T. Meyer filed a lawsuit against Bristol-Myers Squibb which caused him, “harmful compulsive behaviors including compulsive gambling [and resulted] in substantial, financial, mental, and physical damages.”

What Can You Do

If you took Abilify and had a gambling problem after taking this medication, you may be able to receive compensation. You and your family may have experienced stress and suffering as a result of this destructive compulsive behavior and have accumulated bills or were forced to take time off of work because of it. There was a minimum of 3 ½ years where Bristol-Myers Squibb knew that their drug could cause uncontrollable urges, and yet they never warned doctors or patients of these horrible adverse effects. Contact us today to see if you qualify to make a claim.

Abilify Warnings In The News

BREAKING (5/30/18): Abilify and Gambling: The Truth Behind the Prescription

For patients with schizophrenia or bipolar disorder, just performing daily activities to live a normal life seems like a dream. Many times, medication seems like the best option to help individuals with mental disorders which has made Abilify one of the most popular drugs on the market. However, the FDA has published a safety communication that states that Abilify is linked to uncontrollable behaviors including compulsive gambling. Here’s what you should know before you or a loved one starts taking prescription Abilify.

Read Full Article

 

BREAKING (5/1/18): First Abilify Case Set for Trial Settled Out of Court!

 

Recently, the first Abilify case against Otsuka Pharmaceuticals & Bristol-Myers Squibb set for trial settled out of court. Learn more about what this means–get info on Abilify, the link between Abilify usage & compulsive gambling & the implications of these early, bellwether Abilify cases.

Read Full Article

5/3/16: FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada)

The U.S. Food and Drug Administration (FDA) is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced. These impulse-control problems are rare, but they may result in harm to the patient and others if not recognized.

Read Full Article

2/17/17: Revealed: the Prescription Drug for Depression That 'Drives Users to Binge on Sex, Gambling, Shopping and Food'

It’s one of the most profitable drugs in America that is supposed to treat depression.But hundreds of users claim it has driven them to binge on gambling, sex, food and shopping. Abilify, the antipsychotic drug, has been accused in hundreds of lawsuits for causing compulsive behavior, especially gambling. And now patients are demanding answers from the makers and the Food and Drug Administration (FDA), accusing them of hiding the ‘life-ruining’ side effects.

A woman, who spoke to FOX31 on the condition of anonymity, was prescribed Abilify for depression in 2008. She said things took a downward spiral soon afterwards. ‘Eventually, I was asked to leave my parents’ house because I couldn’t stop gambling,’ she said. The mother-of-two ended up losing custody of her kids and possession of her house to her gambling habit. Living in Las Vegas at the time, the woman said she never was tempted to gamble until she started taking the drug.

Read Full Article

2/17/17: Revealed: the Prescription Drug for Depression That 'Drives Users to Binge on Sex, Gambling, Shopping and Food'

It’s one of the most profitable drugs in America that is supposed to treat depression.But hundreds of users claim it has driven them to binge on gambling, sex, food and shopping. Abilify, the antipsychotic drug, has been accused in hundreds of lawsuits for causing compulsive behavior, especially gambling. And now patients are demanding answers from the makers and the Food and Drug Administration (FDA), accusing them of hiding the ‘life-ruining’ side effects.

A woman, who spoke to FOX31 on the condition of anonymity, was prescribed Abilify for depression in 2008. She said things took a downward spiral soon afterwards. ‘Eventually, I was asked to leave my parents’ house because I couldn’t stop gambling,’ she said. The mother-of-two ended up losing custody of her kids and possession of her house to her gambling habit. Living in Las Vegas at the time, the woman said she never was tempted to gamble until she started taking the drug.

Read Full Article

5/4/16: FDA Issues New Abilify® Warning

The Food and Drug Administration (FDA) has issued a new warning that links the use of Aripiprazole (Abilify, Abilify Maintena, Aristada) with compulsive or uncontrollable urges such as binge eating, excessive shopping, gambling, and an increase in sex drive. Abilify® users reported that these behaviors stopped when the medicine was discontinued or the dose was reduced. Cory Watson Attorneys is representing hundreds of Abilify® victims nationwide.

Read Full Article

Filed Abilify Complaints & Damages

1/25/16: Meyer V. Bristol-Myers Squibb Company

Defendants’ drug Abilify harmed Plaintiff, having caused harmful compulsive behaviors including compulsive gambling, resulting in substantial financial, mental, and physical damages. Defendants knew or should have known that Abilify, when taken as prescribed and intended, causes and contributes to an increased risk of serious and dangerous side effects including, without limitation, uncontrollable compulsive behaviors such as compulsive gambling.

Read Full Case

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Abilify Tied To Compulsive Gambling

Countless people have reported overwhelming compulsions to gamble after taking Abilify.

If you had no prior obsessive behavior and began gambling soon after taking Abilify, you could be eligible to receive compensation for your losses. Call 1-877-466-2000 now to find out.

GET YOUR FREE Abilify CASE REVIEW TODAY

Abilify settlements are now being negotiated, but there is a limited window to pursue help. If you think you, a friend, or a family member may qualify, get your free case review today… before it’s too late!

  • * Submit now to learn if you may be eligible for a cash settlement or call (800) 511-3838 now.

Our in-house legal counsel, Matthew J. Daher, earned his Bachelor of Arts degree from the University of Utah and his law degree from the University of Missouri – Columbia School of Law. Matt has devoted his entire practice to civil litigation, and has spent his career representing the rights of individuals who have been injured by pharmaceuticals, medical devices, medical malpractice, defective products, and motor vehicle accidents. As in-house counsel for Periscope Group, Matt leads our internal legal team and liaises with our external partners.

Trademark Info: Abilify® is a registered trademark of Bristol-Myers Squibb and Otsuka America Pharmaceutical and is used here for informational and product identification purposes only.

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LATEST ARTICLES

As the Race for Presidential Candidates Heats Up, Roundup Becomes Hot Topic

There are many controversial issues that political candidates build their platforms on, and public health and the environment are certainly hot topics. Congresswoman Tulsi Gabbard (D-Hawaii) is the first federal legislator and presidential candidate to call for a ban on Roundup weedkiller and we’re thrilled that she’s bringing this important topic to the forefront of political debate.

As the Race for Presidential Candidates Heats Up, Roundup Becomes Hot Topic

Financial Contributions and Political Support

It’s no secret that mega corporations give financial contributions to political candidates and officials, not to mention lobbyists. In fact, Monsanto’s website even admits:

“Monsanto is committed to participating constructively and transparently in the political process, as such participation is essential to the Company’s long-term success. Our approach on corporate political contributions is driven by the significant impact that public policy decisions can have on our business and on the interests of our stakeholders.”

Fortunately, these political contributions are open to the public to view, so here are some numbers to think about:

Paid to the House of Representatives in 2013

Total paid by Monsanto to Democrats: $72,000
Total paid by Monsanto to Republicans: $190,500

Paid to Senate in 2013

Total paid by Monsanto to Democrats: $37,500
Total  paid by Monsanto to Republicans: $85,000

Contributions to Federal Candidates, 2018 cycle

Total Contributions from this PAC to federal candidates: $315,000 (33% to Democrats, 67% to Republicans)

House: Total to Democrats: $92,500; Total to Republicans: $193,500
Senate: Total to Democrats: $23,500; Total to Republicans: $41,500

When you consider the bills and political decisions that involve adding a warning label to the products, banning glyphosate, use on city property, and more, Monsanto’s contributions are having an impact on government regulations and thereby public health and safety.  

This is precisely why it’s so refreshing to hear that Congresswoman Tulsi Gabbard is standing up against Bayer (who acquired Monsanto in 2018) by stating on Twitter, “I’ve said it before, I’ll keep saying it: Ban roundup! It’s long past time we stopped relying on corrupt corporations with a profit incentive to fund science telling us their chemicals are ‘safe.’ Victims shouldn’t have to go to trial to get the truth.”

Between the two recent California trials that found in favor of the plaintiffs who were diagnosed with cancer due to use of Roundup, new studies that found that Roundup causes a 40% increased risk of cancer, and LA County’s recent ban of Roundup on county property, hopefully more politicians will listen to researchers and their constituents and ban Roundup.

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Sources
“Presidential Candidate Says ‘Ban Roundup!’” Organic Consumers Association. Accessed April 4, 2019. https://www.organicconsumers.org/blog/presidential-candidate-says-ban-roundup#close
“Extensive List of Politicians Paid Off By Monsanto”. Natural Society. Accessed April 4, 2019. http://naturalsociety.com/list-politicians-paid-off-by-monsanto/
“Political Disclosures”. Monsanto. Accessed April 4, 2019. https://monsanto.com/company/governance/political-disclosures/
“Monsanto Co.” Open Secrets. Accessed April 5, 2019. https://www.opensecrets.org/pacs/pacgot.php?cmte=C00042069

Why Post-Market Medical Device Follow-up is Necessary But Ignored or Hidden

As someone who’s had medical issues ranging from chronic pain to infertility, I’m no stranger to being poked, prodded, given a plethora of prescriptions, and feeling more like an alien abduction than a patient being presented solutions to feel better. Sound familiar?

Why Post-Market Medical Device Follow-up is Necessary But Ignored or Hidden

And why do we subjugate ourselves to being guinea pigs to test which therapies, pills, and mechanical parts will torment our bodies? It’s simple. We’re desperate for help and we trust the men and women in scrubs and suits to honestly want to help us. The FDA’s fast tracked 510(k) process,  doctors receiving “gifts” from pharmaceutical companies for prescribing their products, and sky high drug prices are just a few examples of the many parts of the system that are broken at the expense of patient health. Here’s another important flaw with the FDA and Big Pharma: their lack of post-market medical device follow-up.

But why should you take the time to learn about this? Consider these statistics:

  • In 2018, medtech (medical technology) stocks climbed 26%.
  • About 1.4 million hip and knee replacement surgeries were performed in 2017 alone and the number continues to increase each year.
  • The U.S. medical device market was $147.7 billion in 2016 and is projected to grow to $173 billion in 2019.

If you don’t already have a medical device, chances are high that you’ll either have one or you know someone who has one. Plus, this is big money for pharmaceutical companies so a variety of products are probably going to be advertised or recommended to you. Don’t you want to make sure that something this important is proven to help and not harm you?

The FDA’s 510(k) Approval and Post-Market Follow-up Process

The FDA established the 510(k) process to promote medical innovation and approve needed products to market quickly. However, this once “noble” function has now turned into a manipulation of Big Pharma to speed devices to market to for profit and to bypass expensive testing. The 510(k) process allows the FDA to fast-track paperwork through the system as pharmaceutical companies base their devices on previously approved ones… all without human clinical trials.

There are many problems to this practice. First of all, the products that they’re comparing the new one to may have been ineffective or harmful and taken off the market (such as the case involving Protegen transvaginal mesh). Secondly, this is how 70 percent of medical devices are being approved; again, WITHOUT human clinical trials. Is it any wonder why there are so many health complications and recalls concerning medical devices?!? Finally, the FDA is understaffed and underfunded which makes approving, monitoring, and following up on drugs and medical devices a nightmare.

Post market follow-up is critical to patient safety, as the FDA explains that the requirements, “include such things as tracking systems, reporting of device malfunctions, serious injuries or deaths, and registering the establishments where devices are produced or distributed. Postmarket requirements also include postmarket surveillance studies required under section 522 of the act as well as post-approval studies required at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application.”

Let’s take a closer look at a recent example that hit the news in March 2019. Mentor Worldwide MemoryShape breast implants were approved in 2013. It came to the FDA’s attention that the company failed to enrol the required number of subjects in the post market study, had poor follow-up rates with patients (only 61 percent), and significant data wasn’t consistent.

These studies are particularly important because in 2016 it was determined that breast implants can cause breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, which is a type of non-Hodgkin’s lymphoma (cancer of the immune system). Post-market surveillance could not only ensure the safety of those in the study, but it can provide valuable information to prevent future patients from suffering from this disease.

Post-market surveillance is a critical part of the FDA’s job and public health depends on it. To quickly approve high risk medical devices and neglect monitoring how they work is not only negligent, but it deliberately disregards the health of the millions of patients that the FDA and pharmaceutical companies claim to be helping. It’s time to put patient health first.

 

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Sources
“FDA warns J&J unit and Sientra over breast implant compliance”. Medical Device Network. Accessed March 25, 2019. https://www.medicaldevice-network.com/news/fda-warns-jj-sientra-breast-implants/
“Robots, DNA And Implantable Devices — Why 2019 Isn’t Your Dad’s Medtech”. Investor’s Business Daily. Accessed March 25, 2019. https://www.investors.com/news/technology/medical-equipment-medtech-2019-preview/
“Defenders: How medical devices are approved by the FDA and why some say it no longer works” KVUE. Accessed March 25, 2019. https://www.kvue.com/article/news/defenders-how-medical-devices-are-approved-by-the-fda-and-why-some-say-it-no-longer-works/269-2a9bfbe6-dd7d-4b2b-a0c1-6bebe24998cb
“Postmarket Requirements (Devices)”. FDA. Accessed April 2, 2019. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/default.htm
“Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)”. FDA. Accessed April 2, 2019. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm

Why Are There So Many Drug and Medical Device Recalls?

As an advocacy group that strives to keep the FDA and big pharmaceutical companies accountable, we’ve seen our share of hundreds of thousands of people angry, disillusioned, and scared because their medicine or medical device has been recalled. They trusted that their doctor or surgeon chose the best decision for their condition. They put their faith in the company that produced their drug or implant to monitor their materials for safety. The believed that the FDA would only approve products that were properly tested and proven safe. Now many of these patients are living in a new normal where they’re worried about whether their pills are safe or they’re in excruciating pain from an implant that can’t be removed. How can this happen? Why does it seem that drugs and medical devices are being recalled more than ever before?

Why Are There So Many Drug and Medical Device Recalls?

Reasons for Recalls

Drug and medical device recalls can either be required by the FDA based on reports they’ve been receiving or it can be voluntary on behalf of the company when their product(s) are potentially unsafe. Here are the main reasons for recalling a medical product:

  • Health Risks – If a medicine or implant is found to harm patients and causes a high potential for injury, then it could be recalled. For example, phenylpropanolamine (PPA), a drug that was used in decongestants and weight loss medicines, was recalled because it was found to increase the risk of hemorrhagic stroke (bleeding in the brain).
  • Poor labeling or packaging – If the dosing instructions are confusing, if the dosing device is faulty, or perhaps the packaging proves not to be childproof, then it could be recalled.
  • Mislabeled – Let’s say that you purchased a generic medication that was labeled gluten free but it in fact did contain gluten, then the company would have to rectify this error.
  • Compromised Manufacturing – This has been in the news a lot lately. Recently (January 2019) it was found that the popular blood pressure medication Valsartan was contaminated with N-nitrosodimethylamine, or NDMA, a possibly cancer-causing substance and an additional contaminant called nitrosodiethylamine, or NDEA.  

2018 – The Year of the Recall

Let’s look at some of the stats for 2018 from R&D Magazine to see how they were broken down into the above categories:

Pharmaceuticals (percentage of total drug recalls)

  • Failure to meet product specifications: 25%
  • Deviations from current Good Manufacturing Practice (cGMP): 23.9%
  • Sterility: 12%
  • Mislabeling: 10.9%
  • Foreign Materials: 7.6%

Medical Devices (number of recalls per cause)

  • Software issue: 79
  • Mislabeling issue: 43
  • Quality issue: 36
  • Sterility issue: 27

A Few of the Top Drug and Medical Device Recalls of 2018:

Other Important Facts to Know

  • Five companies reported ten or more recalls in the quarter. This is the highest number since Q3 2016 and the second highest since Q3 2013.
  • You can check the FDA’s website to see if your medication or implant has been recalled by clicking here.

Why Are There So Many Drug and Medical Device Recalls?

There are many reasons why the number of recalls are increasing. First of all, we’ve talked a lot about how the FDA and pharmaceutical companies fast-track medical devices to market without testing using the 510(k) process. Another problem is that many products and drugs are produced overseas (learn more here).  A third broken part in the system is that Big Pharma funds not only the FDA, but politicians who monitor this appendage of the government. An additional glitch is that the FDA is overworked and underfunded; they can’t keep up with all the applications, adverse effect reports, and follow-up documents causing many issues to fall into the cracks.

Clearly the FDA is broken at the cost of innocent patients and their health. It’s time we voice our concerns, educate ourselves about our health, and hold the FDA and Big Pharma accountable for harming millions of people.

 

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Sources
“Drug Recalls Increased, Medical Device Recalls Decreased in Q3”. R&D Magazine. Accessed April 2, 2019. https://www.rdmag.com/news/2018/11/drug-recalls-increased-medical-device-recalls-decreased-q3
“What Is a Drug Recall?”. WebMD. Accessed April 2, 2019. https://www.webmd.com/a-to-z-guides/what-is-a-drug-recall#1

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

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