Risperdal and Invega: Potential Side Effects and Personal Injury Lawsuits

What are Risperdal and Invega?

Risperdal is the trade name attached to the medication risperidone, a powerful "atypical antipsychotic" medication designed primarily to treat schizophrenia, bipolar disorder, and irritability caused by autism. Invega, a metabolite of Risperdal, is in the same family of medications. It is the brand name for paliperidone.

Both drugs are manufactured by Janssen Pharmaceutical, a subsidiary of the parent corporation Johnson & Johnson. You may recognize that second name from...well, just about anywhere (it's a $65 billion-dollar-a-year corporation with roughly 250 sub-companies, and a broad catalog of health and wellness products. Coincidentally, it has made the news recently for another of its products' side effects). Risperdal was approved by the FDA in 1993, and Invega in 2006. Both drugs have done brisk business since their introduction to the market; Risperdal alone has done over $30 billion in total sales worldwide.

In 2003, Janssen's patent for Risperdal expired and a number of manufacturers began to create generic risperidone derivatives for the market. An estimated 51 companies now market risperidone products.

The graphic to the right is a rough timeline of Risperdal's history. Invega has its share of blemishes, but Risperdal's make for better reading.

The drug has its limitations, however. In terms of autism, it is only recommended for severe and enduring problems with violence, aggression, and/or self-injury. It is not suggested for autism cases involving only mild aggression, or for explosive behavior absent any long-term pattern.

Doctors additionally were known to prescribe the medication for other uses including anger management, elderly dementia, ADHD in children, depression, and anxiety. These "off-label prescriptions" are not approved by the FDA. Despite the drugs not being sanctioned for use in these areas, as well as not being adequately tested by the company before their release, Johnson & Johnson encountered very little friction from its decision to market the drug to patients for these unapproved uses.

Is It Just Risperdal and Invega That Are Affected?

To be accurate, risperidone is the medication causing the difficulties. Risperdal is the name Janssen patented and used when marketing the product. Same goes for paloperidone and its trade-name Invega.

I wouldn't bother to split that hair except there's a legal distinction made between name-brand medications and their generic equivalents. While Janssen Pharmaceutical and Johnson & Johnson can be held liable for the damages caused by Risperdal and Invega, a 2011 decision by the United States Supreme Court protects most makers of generic risperidone/paloperidone from litigation.

We're really talking about the effects of all risperidone and paloperidone, but because name-brand Risperdal and Invega are the products against which plaintiffs currently have recourse, those are the terms I'll use going forward.

What Specifically Is the Issue with Risperdal?

While patients have several complaints about the drug, the current multi-district litigation (MDL) directed at Johnson & Johnson focuses mainly on one very uncomfortable side effect of Risperdal and/or Invega use.

Gynecomastia is the clinical term for enlarged male breasts. It is a symptom of endocrine malfunction, usually traced to an imbalance in a patient's estrogen/androgen (female/male hormone) levels. It is generally expressed as an overproduction of estrogen, an underproduction of androgen, or a combination of both. Risperdal is thought to increase prolactin production, which in turn leads to breast development, in both adipose (fat) and glandular tissue.

The degree of enlargement differs from case to case. While gynecomastia can affect a single breast, it most often occurs in both, and each can be affected differently. In some cases of gynecomastia, males also produce breast milk due to an excess production of prolactin, the hormone responsible for lactation in mammals.

Even without these medications, some pubescent boys do develop short-term gynecomastia during their early teen years while their bodies are trying to find the right hormonal balance. Studies have shown that this naturally-occurring breast growth vanishes within eighteen months. The breast tissue that develops during Risperdal and Invega's artificially-induced gynecomastia doesn't just vanish on its own, and most often requires mastectomy or liposuction to remove the tissue. This can be very costly, and most insurance regards it as a cosmetic procedure, meaning that they will refuse to cover the surgery.

When Googling "gynecomastia," look what the search engine helpfully includes:

Google is casually tossing out the phrase "man boobs" as acceptable nomenclature for this condition. This is a product prescribed to teenagers who are already in unimaginable distress. Imagine being an unusually troubled teen and looking up the term the doctor told you to find more information, or see if there's any hope of reversing it. Seeing that from your search results is bound to cut pretty deeply.

If It's Hurting So Many People, Why Is the Lawsuit So Specific?

Why are only young males getting representation for this lawsuit if these drugs can do so much harm? That question can be answered one of a few ways:

For other representative groups, there are other reasons that breast tissue might grow.

While Risperdal or Invega may have been contributing factors, other biological or external factors can be argued as confounders by Johnson & Johnson. They can use these to "muddy the waters" about where liability for the breast growth truly lies. Some examples:

• Around middle age, men's bodies naturally begin to reduce testosterone production. Unless they get supplemental "Low-T" treatments, men's androgen production naturally declines as they get older. This in turn can cause unbalanced hormones, producing similar breast growth.
• Certain genetic disorders, such as Klinefelter syndrome or certain cancers of the endocrine or metabolic system, can cause the hormone imbalances responsible for gynecomastia.
• If a patient is prescribed any other medications in addition to the Risperdal or Invega, those drugs can be argued partially or fully responsible for the breast growth. Adverse drug interactions can cause many negative health effects.
• In the regrettable cases of excessive female breast growth, one confounder is the idea that because women already produce significant quantities of female hormones, it is more difficult to quantify overproduction than it is in males.

If Johnson & Johnson can convince a jury that these or other confounders are present, they can mitigate or even eliminate their liability.

The drugs' labeling contains warnings about many other possible side effects.

One of the key elements of a claim against a major manufacturer like Johnson & Johnson is proving negligence, which is defined legally as "a failure to exercise the care that a reasonably prudent person would exercise in like circumstances." In drug claims this usually requires proving they failed to warn consumers about the side effect in question, causing injury by way of leaving out important information.

If Johnson & Johnson fails to warn the public that something hazardous can occur from normal use of one of their many goods, they can potentially be sued for that failure since it causes harm to their customers. This is a violation of their implicit agreement with end-users.

Risperdal and Invega, as it happens, have a fairly long list of potential damages beyond breast growth and lactation. That list includes:

• Dizziness
• Dry Mouth
• Sexual Dysfunction
• Increased Appetite & Weight Gain
• Fever
• Uncontrollable Movements or Tics
• Seizures
• Problems with Breathing or Swallowing
• Increased risk of death among elderly patients suffering from dementia

The drug's long-term injectable form, Risperdal Consta, warns of further effects:

• High Blood Sugar & Diabetes
• Painful, Long-Lasting Erections
• Extrapyramidal Symptoms (EPS), including tardive dyskinesia and dystonia
• Neuroleptic Malignant Syndrome (NMS)

That's only a partial list, but it is derived from the company's own literature.

Because Risperdal's box and accompanying literature warn of these possible damages, they have fulfilled their obligation through the Federal Food, Drug, and Cosmetic Act (FDCA) to alert the consuming public. Taking the medication after these warnings and information are publicly available constitutes informed consent per the letter of the law, which defines it as:

"Permission granted in the knowledge of the possible consequences, typically that which is given by a patient with knowledge of the possible risks and benefits."

For many sufferers, the statute of limitations has already passed for pursuing a claim.

In essence, statute of limitations is the amount of time a plaintiff has to seek damages for injuries caused by a defendant's action (or failure to act). This time interval varies from state to state; in our home state of Texas, for example, the standard SOL for an injury claim is 2 years after the date of the injury.

This rule does come with certain exceptions that allow a plaintiff more time:

• Age of Majority - If the injured party has not yet reached the age at which they are legally recognized as an adult in the forum state, the SOL will not begin to run until they turn that age. In Texas and many other states, the age of majority is 18 years old.
  As an example, say a Texan boy takes Invega at the age of 13 and develops breast tissue. He would have until 2 years after he becomes an adult, so the age of 20, to file for damages.
• Discovery Rule - With Discovery, a plaintiff may be able to argue that they were unaware that the drug was the cause of the gynecomastia until later, when they encountered a news piece, website, or other information about the side effect.
  Discovery is interpreted quite strictly along the lines of due diligence, which is here interpreted as a patient's active attempts to discover the source of their damages through available information sources.
  In the case of drug-manufacturer negligence, discovery is often measured from the time at which the company or the FDA released warning information to the general public, issued a recall, or changed the label to include information about the new possible hazard. The clock starts at that time, and the burden of due diligence then falls on the injured party or his family to examine that information within a reasonable period of its release.
  Earlier cases tried with discovery in mind have not met with a great deal of success; a Philadelphia judge set precedent by suggesting that the warnings for Risperdal were adequately updated as of October 2006, when Janssen added a statistic about pediatric gynecomastia to its label.

These are the most-cited reasons why the suit is more or less restricted at this time to young males. While it cannot be denied that the medication can cause other serious effects, many people are effectively barred from pursuing damages because of these defenses.

How Many People Are Affected by This Issue?

Its rocky history aside, Risperdal has dominated the treatment of schizophrenia and bipolar disorder for approximately two decades. After its approval by the FDA, Invega joined Risperdal in being a "go-to" for these treatments.

If we do a little estimating, we can look at the national effect of Risperdal and Invega:

Based upon the reported revenues and the current price of $328 per prescription, at least 91 million Risperdal prescriptions have been filled since the drug came on the market. That figure represents only Risperdal, not the many generic variants.

The generic forms of both these drugs have been available for some time as well; while many of the patients prescribed these substitute drugs have undoubtedly suffered side effects as well, their legal recourse is sadly much more limited at this time.

Can Attorneys Sue the Company for Risperdal Injuries?

We've touched on this a little, but the short answer is yes.

Johnson & Johnson has been exceedingly stubborn with respect to these issues, which is slightly puzzling. They can certainly afford the fight (company revenue exceeds $70 billion annually), but the history of this drug is littered with evidence of corporate malfeasance, making their position a shaky one.

• Within a few short years of Risperdal's commercial release, Johnson & Johnson was unsatisfied with its narrow FDA-approved category of treating adult schizophrenia. Aiming for a larger market share, it began to push the drug for a variety of issues, from elderly dementia to childhood autism. The FDA backlash against this campaign seemed largely toothless, so the company more or less shrugged it off.
• Internal documents have come to light suggesting that Johnson & Johnson paid doctors consulting fees in exchange for their promises of regular Risperdal prescriptions. They also allegedly engaged in collusion with Omnicare, a corporation responsible for pharmaceutical services in nursing homes. Omnicare filled prescriptions for seniors with Risperdal, and in return it was guaranteed a share of the profits Johnson & Johnson made from the drug sales. That's the very definition of "kickbacks."
• Around the same time, the company started directing their marketing at pediatricians. By the year 2000, more than one-fifth of Risperdal was going to children and adolescents. In 2003, the company even ran a "back to school" Risperdal campaign. It allegedly considered including lollipops and small toys in sample packages as enticement.
  During this period, Johnson & Johnson actually conducted studies which found that Risperdal use led 5.5 percent of boys to develop gynecomastia. Executives allegedly chose to suppress these results, fearing their impact on sales.
• To further stretch profits, the company also lobbied for the state of Texas to adopt Risperdal as a default prescription in place of other generic antipsychotic medications on the market. This meant that the state paid $3,000 a year for every Medicaid claim involving Risperdal, rather than around $250 a year as they would have with other drugs.
• By 2004, Johnson & Johnson's efforts had reaped over $3 billion a year in profits. By the end of 2015 it had earned around $20 billion domestically and another $10 billion globally--much of that gained through the dubious promotion and distribution of their drug to the wrong target groups.
• In August of 2012, the company settled a lawsuit brought against it by 36 states claiming it had engaged in deceptive marketing practices, which in turn led to a number of false Medicaid claims as patients were incorrectly prescribed the medication (Companies are not allowed to promote drugs for unapproved uses). Johnson & Johnson settled the case for $181 million.
• In late 2013, the company settled a similar suit with the United States Department of Justice regarding its encouragement of pediatric Risperdal use before such treatment was approved. In the same vein, it promoted the drug for treatment of the elderly, when it was not approved for this purpose. DOJ investigations had also begun to reveal evidence of Johnson & Johnson covering up information about gynecomastia risks. Johnson & Johnson paid around $2.2 billion to close out the criminal and civil probes.

Currently, hundreds of Risperdal claims from all over the country are filed in the Philadelphia courts, where the MDL was centralized. Johnson and Johnson has settled approximately 85 of them. Several multi-million dollar judgments have been awarded, though by far the most potent result was a $70 million dollar settlement. Thousands more people are coming forward to report adverse effects; of these, hundreds will likely be added to the lawsuit. It's believed that a few more of these legal blows will prompt Johnson & Johnson to start settling out of court on a more wholesale level.

What Does All This Mean?

Ultimately, the Risperdal controversy is a product liability issue. Product liability is rooted in the idea that manufacturers have a duty not to harm consumers and are in the best position to mitigate the risks of their products. There is a reasonable expectation of quality control and safety precautions taken before a consumer product is released to market, and in the event that the possibility of harm can't be entirely removed, the company at least owes consumers a warning about that potential harm. Those warnings help people make informed decisions about whether they want to make use of the possibly-dangerous product.

I'm not saying that drug manufacturers don't test their products. Exhaustive lab work and clinical trials go into each and every new drug's release, as mandated by the FDA. With that said, though, there's a marked history of company decisions—not just Johnson & Johnson, but also other big conglomerates like them—to ignore or suppress findings that might affect profits or release dates.

Take that Department of Justice investigation from 2013, for example. Part of the DOJ's findings involved Johnson & Johnson's internal cover-up of gynecomastia hazards. That means they knew, but determined that company profits would have been negatively affected, and hoped the problem would just go away on its own. Choosing not to act on the knowledge of their product's serious side effect is a compelling argument that they were negligent, but anyone hoping to hold them accountable for it would still have to prove it.

In order to prove negligence, the plaintiff must be able to prove all four elements of a "failure to warn" allegation:

1. Duty - The defendant owes a duty to the claimant not to bring him to harm.
   In the early days of liability claims, Johnson & Johnson would have had to sell people pills directly in order to be liable. This was based on a legal doctrine known as privity of contract, which holds that an implied contract exists between a buyer and seller, but only the buyer and seller. Since Johnson & Johnson doesn't sell directly to consumers, they wouldn't have been liable in that legal climate.
   Fortunately, privity of contract is a dead letter as far as products liability is concerned. Johnson & Johnson makes a product and ships it to stores, where people fill their prescriptions with Risperdal. If they develop breast tissue, they can claim that Johnson & Johnson failed to warn them of that possible side effect. That's a violation of the implicit agreement between the maker and the consumer of a product, aka the maker's duty.
2. Breach - The defendant failed to observe or adequately perform their duty to the claimant.
   Breach can be defined a couple of ways; let's call them secrecy and ignorance.
   If a company knows their product is bad news but decides not to tell anyone and hope it never comes up, that would be secrecy. Knowingly exposing customers to the risk of serious loss is a breach of the company's duty.
   On the other hand, if they didn't even know that risk was possible, and it's decided that a reasonable person should have known what could happen, that would be ignorance. Failure to do enough homework on their own product is not an excuse for putting its end-users at risk.
   Given that the Department of Justice seems to have unearthed evidence of hushed research about gynecomastia, I think we're dealing more with secrecy than ignorance.
3. Causation - The defendant's breach of duty was the proximate cause of the plaintiff's injuries.
   We test causation using the "but for" statement, which looks to tie the cause to the effect: But for Johnson & Johnson's failure to warn patients about gynecomastia, Bobby would not have taken the drug and developed breast tissue.
   This seems to hold up: Keeping the information to themselves instead of warning consumers means that many boys and men were given the medication without foreknowledge that the drug could cause them to grow breasts. Had they or their parents been properly advised of this risk, they may have chosen to try other methods. Taking that choice away from them in order to sell more pills could certainly be argued as a causal factor in a gynecomastia claim.
4. Damages - Plaintiff must have demonstrable damages from the harm caused by the breach of duty.
   Given the visible damage done to patients' bodies and the less-visible but still potent psychological harm of growing unwanted breast tissue, it would be hard for defense to debate the presence of damages. I have a feeling they'd dispute the severity of the damage, but there is always back-and-forth of that nature as a company defends itself.

The Lingering Impact of Risperdal and Invega

I quoted a lot of numbers during this article, particularly jury award/settlement figures. I would be remiss if I didn't point out that a) those numbers aren't necessarily indicators of what an average settlement might look like, because every case is weighed on its individual merits, and b) The money's not the point. Yes, it will help cover the costs of getting Bobby's breasts surgically removed because there is essentially no other way, but more important than the settlement is the message it sends.

Johnson & Johnson is one of about a dozen companies that sits at the top of the mountain. Having been there for quite some time, it may have forgotten that it didn't start there. That's when it began taking advantage of the customer base that helped lift it up, and disregarded some of the basic tenets of its business: It is not okay to push drugs to market without knowing what they can do. It is not okay to hide what a drug can do from consumers to fluff up your quarterly sales. It is not okay to exploit the health care system in collusion with doctors and hospitals to have them prescribe your drug for things it's not even meant to treat.

Sometimes companies like this need reminding that they can't run roughshod over their customer base. They know they need you, or they wouldn't hide things that might keep them from getting your money. To make them remember it, and to make them remember to be ethical in their business practices, they have to be sent a message: We're onto you. And we're not taking it.