What is Abilify?
Abilify is the brand name of the drug aripiprazole. Created by the Japanese company Otsuka Pharmaceutical, it is marketed in North America by Otsuka America and their partner company Bristol Myers-Squibb, an enormous biopharmaceutical manufacturer/marketer. In 2015 alone Abilify pulled in six billion dollars' worth of revenue for these companies.
The medication's primary function is to treat schizophrenia and/or bipolar disorder in patients. It has additional "off-label" applications in the treatment of depression and autism.
Sounds Helpful. What's the Problem?
Abilify was approved for use in 2002 by the FDA, and has generally enjoyed great success in the medical market. However, as it does with most prescription medications, Abilify use comes with significant risk of side effects.
It is a manufacturer's obligation to disclose all known possible risks of using their created product. This is especially important for items to be internalized, like food or medication.
A short list of known potential side effects was published on the Abilify website:
Sounds like a party, right? But nothing here, from cardiac problems to seizures to pregnancy risks, is all that surprising for anyone who has been prescribed a long-term medication. Many drug formulas involve similar potential side effects. When you introduce an outside agent to your body, there's a likelihood it will cause reactions, at least during the period where you're getting accustomed to it. It's an unfortunate but understood risk of altering one's internal chemistry.
The real problem comes into play when side effects come up that are not in the published literature.
Abilify is marketed as an atypical antipsychotic. It is a partial dopamine agonist, meaning that it triggers dopamine receptors in the brain without the presence of the actual chemical. Dopamine is a major neurotransmitter, responsible for feelings of pleasure and reward. It is released during activities the body associates with enjoyment. Like most of the body's neurochemistry, it's vital in the right quantities, and its natural production is often hindered in people suffering mental disorders. In excessive amounts, though, it is thought to play a part in the development of addictive and compulsive behaviors.
Unstated Side Effects of Abilify Use: Impulse Control
Studies are being conducted and published that suggest prescribed aripiprazole can cause a mental short-out in its users. This rewiring of the brain creates an exaggerated positive feedback response from activities known to create dopamine release.
In simpler terms, Abilify can create ideal psychological circumstances for crippling addiction. This lack of impulse control can manifest as hypersexuality, binge eating, or compulsive spending/gambling. These damages, while not necessarily physical in nature, can absolutely ruin lives.
Take another look at the warnings I posted above. That's the official list of side effects, pulled directly from the Abilify website. The closest they come to saying "you might devote all your time and money to an obsession out of your control" is to warn that "Abilify may affect your judgment or thinking."
That's a very lukewarm warning, wouldn't you say? It tiptoes around the issue, making vague allusion to the possibility of mental side effects without noting anything in particular. That's a violation of Otsuka and BMS's obligation to the public to disclose a full list of specific adverse effects their products could cause.
Think of it like this: If you went to the zoo and they used the same "Danger--Keep Out" sign for every creature, do you think you'd feel adequately informed of the dangers a particular animal could pose? Is a cockatiel as hazardous to a zoo patron as, say, a komodo dragon?
Not even close. Wandering fecklessly into a cockatiel enclosure is probably dangerous, sure. You can get bloodied up by bird talons, maybe pecked, and you'll leave in worse shape than you arrived. Cross a komodo when it's in a foul mood, though, and you'll get bled out and torn to bits. They are venomous and highly lethal, and the younger ones have been known to run around biting everything they see to find out if it's food.
That "Danger--Keep Out" sign is good general advice, but doesn't offer specific insight into what a person should look out for or might experience. That's the same idea presented in these warning labels--"affected judgment" is vague admission of danger without adequately explaining what you might experience.
Pharmaceutical companies have an obligation to the public to release drugs that at a minimum do more good than harm, and they are also obligated to alert consumers of the specific risks inherent to their products. In the name of their bottom lines, these companies push new drugs through FDA approval before they are fully tested or ready for the market, leading to widespread problems for patients who faithfully use the medications prescribed by their doctors. They try to compensate for the unforeseen by using inadequate warnings, but "DANGER: POSSIBLE BAD THINGS" doesn't fulfill their legal obligations.
Vague warnings are an attempt by pharmaceutical companies to have their cake and eat it too. Incomplete warnings are an attempt to claim that they have fulfilled their duty to the patient, while at the same time not scaring the patient so much that they won't want to take the drug. It's human nature to dwell on the negative side effects of any situation. That is why, while the possibility of a plane crash is remote, the consequences of a crash are so dire that millions of people have a fear of flying, despite knowing that nothing bad is even remotely likely to happen.
If enough adverse events are reported, the FDA can take the burden of testing a product upon itself. After rigorous testing of Abilify, the agency released warnings about the risk of compulsive behavior in early May of 2016, but the damage was already done.
Manufacturers Are on the Hook
I don't want to have to say this, but it's important: Big companies don't create warnings because they care about protecting their customers. They're businesses trying to cover their rears. You know those tiny pamphlets that come in prescription boxes--the ones that fold out to be ten feet across? Ever notice how they often include statements typed up in a large, bold font and surrounded by thick black borders to maximize your chance of seeing them?
Those are called "black box warnings," and they include expansive information about what the drug does, how to take it, and what problems could arise. By including those admonitions on the box or fold-out sheet, the company is creating an effective legal defense for at least attempting to warn the user of specific side effects. In black box situations, companies also create a "safe usage" guide that's meant to be handed out by prescribing physicians or the pharmacists filling the prescriptions.
It's the consumer's choice to read all that info, and most won't, but by creating the materials the company is armoring itself against the event where those side effects occur. If people try to sue them, it can be argued as a defense that the patient acted with informed consent, which is defined as "permission granted in the knowledge of the possible consequences."
A germane example of this concept is an unrelated black box warning that was already issued for Abilify itself. After the drug had been on the market for some time and the FDA had accrued information about its effects, they required Otsuka/BMS to include a warning about the increased risk of young adult depression and suicide. That wasn't covered in the first run of materials, so a black box warning was issued on subsequent Abilify packaging to alert the public of the danger.
Someone has grounds to sue a company if the use of their product can be shown to be the proximate, or direct, cause of his or her injuries. If Bob takes Drug X for heartburn and has a stroke, and medical examiners confirm that Bob's stroke was caused by Drug X, there could be grounds for a case under strict liability--especially if the makers of Drug X made no effort to tell Bob he could have a stroke from using it. This absence of information can be construed as negligence on the part of the company selling the dangerous drug.
Failure to warn is one of the causes of action for suing a manufacturer. If enough users begin to suffer the same adverse side effects, and those effects were not mentioned in any of the manufacturer's promotions or accompanying literature, then it posits two options:
- The manufacturer released the drug without testing it fully, not realizing it was possible for it to create said reaction.
- The manufacturer knew about the issue, but chose for whatever reason not to warn consumers.
Obviously, neither of these is acceptable. Purchases are understood by the law as unwritten contracts, and judicial ruling has extended the chain of connections all the way from the product's maker to its end-user. Customers injured by purchased goods may have legal recourse against their creators.
Users of products perceived to be "inherently" or "imminently" dangerous have been in a position to hold their manufacturers liable since the early 20th century, thanks to the case of MacPherson v Buick Motor Company. The Hon. Judge Benjamin Cardozo spoke lasting words in a ruling that dissolved many previous restrictions on liability claims:
"If the nature of a thing is such that it is reasonably certain to place life and limb in peril when negligently made, it is then a thing of danger. Its nature gives warning of the consequence to be expected. If to the element of danger there is added knowledge that the thing will be used by persons other than the purchaser, and used without new tests, then, irrespective of contract, the manufacturer of this thing of danger is under a duty to make it carefully. That is as far as we need to go for the decision of this case . . . . If he is negligent, where danger is to be foreseen, a liability will follow."
This, coupled with some high-profile interpretations of the ground it laid over the next century, helped create the precedent needed for injured consumers to seek compensation from the groups that make faulty products.
Many Abilify users have reported that they never exhibited compulsive behaviors before their prescriptions, but say they now struggle with:
- significant debt
- loss of savings
- unemployment
- irreversible damage to personal relationships
- severe emotional damage
- damage to public reputation
The compulsive symptoms allegedly subside for many people if they discontinue use of the drug, but that's not in itself an attractive option to someone who is fighting schizophrenia. Many patients have sought alternative medications from their doctors after learning of Abilify's negative impact.
Dozens of patients have stepped forward around the country claiming to have Abilify claims along these lines. Their attorneys are seeking to consolidate the claims into a multi-district litigation (MDL).
Why Abilify and Manufacturer Accountability Matter
I want to be clear: it's not guaranteed that something like this will happen. I'm not a doctor, and for every case of someone developing compulsive behavior, there's probably hundreds where nothing went wrong. I'm only trying to note that it's becoming more evident through these studies that such a thing can happen. I've spoken to Abilify users who maxed out their credit cards and leveraged the equity of their cars and homes against their mounting casino debts. They never knew that their medicine, ostensibly meant to help them, could put them in such a tough spot.
While financial restitution is certainly a goal in these lawsuits to help damaged parties recover their quality of life, the overarching objective is to teach American manufacturers and marketers that accountability up-front helps them avoid expensive liability suits in the end.
Let's hope they learn.