Let me state the obvious: companies sell you stuff with one purpose in mind, to make money. McDonald’s doesn’t sell you quarter pounders because the company believes what you need to live a better life is to eat more quarter pounders. The NRA doesn’t advocate gun ownership because it believes you need to own five Glock 9s (you don’t), but rather so the gun makers can sell more guns. Mercedes doesn’t make expensive cars because its board of directors hope to improve the world by selling you cars with heated leather seats. Every company sets out first to last to make money. And the more money the better.

So it goes with pharmaceutical companies. The general public may sleepwalk through the concept and lazily presume that the primary motivation for drug companies is to develop medications which cure diseases or which minimize the suffering from diseases. But in fact the motivation for pharmaceutical companies is to make money, and a lot of it. This is rather obvious and not a controversial point, and I’d like to believe that every “BigPharma” corporate board would agree with me. But it helps to keep this profit motive in mind when doing research on drugs you have been prescribed or which you are currently taking. And to be hyper-vigilant about assessing any new “wonder drugs” which hit the market.

“Off-Label” Drug Promotion

Recently, the pharmaceutical industry strenuously objected to new regulations implemented by the U.S. Food and Drug Administration (FDA) on off-label drug uses. Essentially, several advocacy groups supporting the pharmaceutical industry filed petitions opposing heightened restrictions on the marketing and sale of drugs for unapproved or “off-label” uses.

Let’s back up.

There are approved and unapproved uses for prescription drugs. For approved uses, the drug has been thoroughly tested and evaluated. The FDA has determined that the benefits and risks are acceptable and that this determination is backed by “strong scientific data.” Finally, for approved uses, the drugs have labels which set out clearly how to use the drug and for what specific purposes.

Then there are unapproved uses. Once the FDA approves any drug, your doctor is then allowed to prescribe the drug to treat another condition which is not listed as an approved use. Basically, once the FDA green-lights a drug, it relies on competent, unbiased physicians to make the best decisions for their patients in prescribing the drug, for whatever purpose.

Doctors may prescribe a drug for an unapproved use when the doctor believes the drug will help the patient in some way and there is no other drug available to help the patient. The FDA uses the example of a cancer drug approved for one type of cancer, but the oncologist prescribes it to treat a different form of cancer that does not have a similar medication available for treatment.

This sounds reasonably benign, even helpful, but drug companies can be aggressive in promoting off-label use. I have written about troubling off-label uses on this site. One off-label drug use nightmare occurred when doctors prescribed Risperdal for adolescent boys with certain behavior issues. Risperdal was originally approved solely to treat adult patients with schizophrenia. But Johnson & Johnson pressed for FDA permission to market the drug to treat other conditions, such as bipolar disorder and autism, and eventually to permit use in children. It was then expanded further to treat adults and children suffering from attention deficit disorder, anxiety and depression. As it turned out, Risperdal can promote the growth of female breast tissue (“gynecomastia”). Female breasts on adolescent boys is a terrible and traumatic disfigurement. And thousands of lawsuits have resulted from these injuries.

Thus, it is critically important that off-label drug use and off-label drug promotion are monitored carefully. You would think that the pharmaceutical industry would wholeheartedly agree, but . . .

BigPharma Objects to New FDA Off-Label Regulations

The FDA recently published its latest guidelines on regulating off-label drug use. The guidelines give the FDA new authority to police the selling of prescription drugs for unapproved uses. Specifically, the FDA focused on “intended use,” which is “the objective intent of the persons legally responsible for the labeling of drugs.” The goal is to make sure the companies promoting a drug are not pushing for it to be used in an unintended way. Intended use analysis is helpful to the FDA as it “helps the FDA gauge whether companies are intentionally marketing products for unapproved uses.” See FDA Website. The new rule was supposed to give more power to the FDA to hold manufacturers liable for promotion of off-label, unapproved uses of drugs.

The drug industry has objected, calling the new rule a “vague standard” with “no support in existing law.” At the end of the day, the drug companies simply do not want to be held liable for getting caught promoting drugs for off-label use. The industry’s position seems to be “get out of our way and let us make as much money as possible.”

They may get their wish. Recently, President Donald Trump has issued a “regulatory freeze” on all FDA rules and regulations. From what I’ve seen coming out of Washington lately, regulations on BigPharma are likely to get weakened, not strengthened, over the next four years. If you do not do your own research, you may be vulnerable to prescription drugs with unwelcome and harmful side effects.

What to Ask Your Doctor:

If your doctor prescribes a drug for an unapproved use, you should ask:

• What was the drug originally approved for?
• Why am I getting it for my condition?
• Are other drugs available that have been approved to treat my medical condition?
• Do studies support the use of this drug to treat my condition?
• Will this drug work better to treat my medical condition than using an approved treatment?
• What are the benefits and risks of treating my medical condition with this drug?

As always, be careful out there.

Of all the bad drug results you read about, you would think proving legal causation in a Risperdal case would be straightforward: a boy with autism or psychological issues is prescribed Risperdal; after a period of months or years on the drug, he begins to grow female breasts, a condition known as gynecomastia. Boys should not grow female breasts. It is extremely rare for an adolescent boy not taking Risperdal to grow female breasts. And studies have shown that Risperdal can cause gynecomastia. Ergo (sorry, I’ve been wanting to get that word in a post), if a boy is taking Risperdal, and fifteen months later grows female breasts, it should follow that the Risperdal caused the gynecomastia. And that the manufacturers of the drug should pay for the physical injury, the emotional trauma, and any other suffering.

But it doesn’t always work that way. Two recent court cases involving boys injured after taking Risperdal yielded two very different results, and the takeaway is the importance of medical experts who can testify to the connection of the injury (gynecomastia) to the cause (taking Risperdal).

more1. Risperdal Case Ends in Settlement

On January 6, 2017, just days before trial was to start, Johnson & Johnson settled a case involving Zachary Sabol, a boy from New York who grew breasts after taking the anti-psychotic drug Risperdal. The Sabol family alleged that Zachary began taking the drug before it had been approved for use with children. In addition, the drug label at the time Zachary began using the drug stated that gynecomastia was rare and occurred in approximately 1 out of 1,000 patients taking Risperdal. Later, the label was changed to indicate gynecomastia could occur 2.3% of the time. (Doing the math, that is 23 times as often as the original label indicated).

The terms of the settlement, of course, are confidential. So we don’t know how much J&J paid to settle this case. But J&J paid. In three previous Risperdal cases, juries awarded $4.75 million in total damages for plaintiffs. And in a case tried last summer, a jury awarded a stunning $70 million dollar award to a boy and his family. You can read about that case here.

Drug manufacturers are always aware of what past juries have done, and it’s reasonable to believe J&J took these past jury awards into its calculation of a settlement offer.

2. Risperdal Trial Ends in Sudden Dismissal

Now back to causation. As I said, causation should be straightforward in most Risperdal cases, because (1) Risperdal is known to cause female breast growth, (2) as an injury, female breast growth is quite easy to observe and establish (as opposed to, say, health problems from metallosis in an artificial hip case), and (3) adolescent boys should not be growing female breasts.

It appears from news reports that the plaintiff’s legal team was stunned by the judge’s ruling, and did not believe there were any deficiencies in the expert’s medical opinion or testimony. Tommy Moroni’s lawyers will appeal the ruling. I suspect Tommy Moroni may get a second chance at trying his case. I hope so.

At the end of the day, there are simply no guarantees in a civil case. Five judges can see valid testimony on legal causation and the sixth judge can reject the same testimony. Still, gynecomastia is a hideous and disfiguring injury, and no boy should have to go through such trauma. More than 2,000 Risperdal cases are still pending in the multidistrict litigation in Philadelphia. And more cases are being filed each day. I hope no boy in your family has grown female breasts after taking Risperdal, but if this has happened, give me a call, or call a lawyer you know and trust.

Communications between pharmaceutical companies and medical device manufacturers and physicians are highly regulated by the federal Food and Drug Administration (FDA), but the agency, as much as it may want to be, does not have the final say in all regulation. These companies have First Amendment commercial free speech rights (though they’re not as broad as the free speech rights individuals have) and there’s a tension between what the FDA wants companies to say, what these companies want to say, and what the courts say the companies can say.

The agency in late August published a notice of public hearing and request for comments concerning manufacturer communications regarding unapproved uses of approved or cleared medical products. The hearing will be held on November 9-10, 2016 in Silver Spring, Maryland, and in case you want to present information you must register by October 19. You could also send in written comments by January 9.

more Off-Label Drug Use

These are very hot button topics. Manufacturers can’t market their products for purposes that are not approved by the FDA (such as if a drug is approved to treat lung cancer only it can’t be marketed to treat malaria), but once approved by the FDA a physician can prescribe it for off label uses. There have been court rulings stating manufacturers can talk truthfully about unapproved uses of their products to physicians. It’s a fine line, and it can easily be abused.

To be approved for a particular use a drug manufacturer must go through a long and expensive process to show the FDA the drug is safe and effective. The danger to patients is that if they take a drug for an unapproved use it may not be safe or effective. It may be a waste of money, it may harm them directly, or the time wasted taking this ineffective drug may allow the disease or condition to worsen, possibly making treatment more difficult or impossible.

On the flip side patients may be suffering from a disease or condition that may be very difficult to treat or is untreatable. A drug approved for one purpose may show promise in clinical trials to battle this hard-to-treat or impossible-to-treat disease. Instead of potentially waiting years for formal approval, these patients may be able to benefit in the present instead of waiting to use it in the future (if they live that long).

FDA Public Hearing

The FDA poses a number of questions on which it would like input from a number of interested parties including manufacturers, health care providers, patient advocates, payors, academics and public interest groups. The topics generally cover:

• How off-label communications impact public health,
• How changes in the health care system result in data on new uses of approved products,
• How to preserve incentives for manufacturers to seek approval for new uses,
• Standards for truthful and non-misleading information provided by manufacturers,
• What the FDA should consider when it monitors and enforces the law on off-label communications by manufacturers, and
• Changes FDA should consider to regulations covering manufacturers’ communications about their products.

Can Congress Help?

Add Congress to the mix. In May the House Committee on Energy and Commerce sent a letter to Health and Human Services Secretary Sylvia Burwell:

• Showing concern that FDA hadn’t clarified its position on permissible manufacturer communications about uses of drugs and devices beyond their approved labeling; and
• Voicing displeasure that HHS apparently was stopping the FDA from issuing guidance or new regulations after a number of court victories for companies and individuals prosecuted for off-label communications about drug and medical devices.

First Amendment commercial speech protections have been interpreted by the courts to allow manufacturers’ truthful and non-misleading speech concerning their products even if that speech includes uses of their products that have not been approved by the FDA. Companies and groups impacted by the issue have encouraged FDA to issue new guidance or change its regulations so its oversight and enforcement actions reflect these court decisions. This announcement and these public hearings are a possible step in that direction.

But let’s back up.

What is Risperdal?

Risperdal is an anti-psychotic drug that was approved for limited use in 1993 to manage the symptoms of schizophrenia. According to multiple sources, in the years that followed Johnson & Johnson pressed the FDA for approval to treat other conditions, such as bipolar disorder and autism, and to permit use in children. Risperdal was soon prescribed for adults and children to treat attention deficit hyperactivity disorder, anxiety and depression. Treating these conditions using Risperdal is considered an “off label” use, which is the use of a drug in a manner unapproved by the FDA. Off-label use could involve using a drug to treat a condition which is not authorized by the FDA, or prescribing the drug to an unapproved age group. Shockingly, Risperdal has had horrific side effects in children. Among other symptoms, Risperdal can cause the growth of female breasts in male children, a condition known as gynecomastia. I have written about Risperdal often in this blog. You can check out those articles here.

The Case of Andrew Yount

Andrew Yount is a boy from Tennessee who was prescribed Risperdal in 2003 to treat attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder. At the time the FDA had not approved the drug for use in treating behavior disorders in children. Andrew was just five years old when he began taking the drug. A year after taking Risperdal, Andrew grew female breasts.

Andrew Yount is now in his late teens. He has had to deal with this embarrassing disfigurement for most of his life.

At trial, the lawyers for Andrew and the Yount family argued that Janssen Pharmaceuticals and its parent company Johnson & Johnson were aware of the risks of children growing female breasts but worked to downplay the risk involved. Despite the data showing a connection between use of Risperdal and the growth of female breasts in vulnerable boys, Janssen and Johnson & Johnson kept pushing the prescription to doctors and parents and children.

What the Jury Saw

The jury reviewed the evidence and concluded that Janssen and Johnson & Johnson failed to warn the Yount family about the risks of taking Risperdal. The jury also seems to have concluded that the defendant companies intentionally buried or falsified scientific evidence showing a link between Risperdal and gynecomastia. If this is true (and evidence supports the view), then it represents hideous behavior from the companies. The jury in the Yount case clearly saw this horrific corporate behavior and awarded Andrew Yount a huge monetary award. But just as likely, the jury got angry and awarded this money as a signal to Johnson & Johnson that this kind of corporate greed will be severely punished. The hope is that jury verdicts like this one will discourage Johnson & Johnson and all pharmaceutical companies to recommit to developing and testing and marketing safe and effective drugs.

Naturally, Janssen and J&J have stated they will appeal the verdict.

Other Risperdal Cases

I wrote about the Austin Pledger trial from last fall, which resulted in a $2.5 million verdict and which you can read about here. Other Risperdal trials have yielded jury awards ranging from $500,000.00 to $1.75 million. One jury trial ended in a defense verdict for Janssen and Johnson & Johnson, though I would not put much stock in that outcome, as plainly the plaintiffs are winning many more of these cases than they are losing. After this latest huge loss in the Yount case, Johnson & Johnson would be wise to consider settling many of the more than 1,500 cases still in the pipeline. Another Risperdal case goes to trial in Philadelphia later this month. I’ll let you know how it turns out.

The Takeaway

For much of my life I have mainly believed that pharmaceutical companies develop and market drugs with the overarching goal to improve and extend the lives of patients. But this is not always the case. Sometimes a company can become blinded by greed. Companies may then push an untested drug onto the market, or even sell a drug it knows to be unsafe. So be skeptical. Do some research. Ask your doctor many questions about the latest drug she wants to prescribe for you or your child. Get a second or a third opinion. You can never eliminate all risk, but you can at least learn how a product reached the market, whether it was adequately tested, and even whether lawsuits have been filed against the drug maker.

The case is titled A. Y. v. Janssen Pharmaceuticals, Pennsylvania Court of Common Pleas (No. 130402094)

Photographs for illustrative purposes only.

I have written on this site about the horrific side effects that some young men have suffered as a result of taking the antipsychotic drug Risperdal. Check out my recent post on the subject for further information.

Risperdal was developed by Janssen Pharmaceuticals (a company owned by Johnson & Johnson) to treat symptoms of schizophrenia and bipolar disorder. Unfortunately, Risperdal has caused terrible side effects, including gynecomastia, which is the growth of female breasts on boys and young men. As you can imagine, once this condition developed, and then developed again and again in many young men, it became clear that something was very wrong.

The lawsuits followed, over 5,000 so far, and more are being filed each week.

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Fortunately for these young men, after years of plodding litigation, these cases are finally getting to trial and to jury verdicts. The good news is that some plaintiffs have received more than a million dollars from juries for their injuries. The bad news is that in one case, a jury found no negligence by the manufacturer; in that case, as you will see below, that young man received no compensation for his injuries.

I’ve collected a list of recent cases and their jury verdicts involved. Other cases are moving to trial, and I will report on those outcomes when verdicts are reached in those cases, but this will give you a sense of what is going on with Risperdal cases in 2015:

Pledger et al. v. Janssen Pharmaceuticals and Johnson & Johnson et al., (Philadelphia County)

Jury Award: $2,500,000.00 for Austin Pledger. Defendants failed to warn.

Date of Jury Verdict: February 24, 2015

The Pledgers obtained their first prescription for Risperdal for Austin in June 2002. The good news with the drug is that it reduced the number of temper tantrums Austin suffered. Unfortunately, by 2005 it was obvious that Austin had gained a large amount of weight and, more horrifying, had grown large female breasts.

The Pledgers brought a lawsuit against Johnson & Johnson for their negligent failure to warn them about the potential side effects, especially the growth of breasts on boys. The trial took place in Philadelphia in February 2015. Unfortunately for the Pledgers, the judge in Pennsylvania held that plaintiffs could not pursue punitive damages against J&J and Janssen. This was a huge blow to the Pledgers and to all plaintiffs injured by Risperdal. Punitive damages are used to deter a defendant and others from engaging in conduct similar to that which formed the basis of the lawsuit—they are considered punishment damages. And they were not available to the Pledgers in their case.

After a contentious trial last several weeks, the jury found that J&J had failed to warn the Pledgers of the dangers of taking Risperdal, and that taking Risperdal has caused the growth of female breasts on Austin (and all his other injuries). The jury awarded the Pledger family $2,500,000.00 in damages. Members of the jury stated after the trial that they settled on $2.5 million by multiplying a fifty year life expectancy for Austin Pledger by $33,000.00 per year. Then they added a percentage to reflect what they imagined the attorneys would receive from the verdict.

Johnson & Johnson and Janssen have appealed the decision.

Cirba et al., v. Janssen Pharmaceuticals Inc., et al., (County of Philadelphia).

Jury Award: zero. Philadelphia jury found that Defendants failed to warn, but that Plaintiffs failed to connect Cirba’s gynecomastia to taking Risperdal.

Date of Jury Verdict: March 20, 2015

William “Billy” Cirba and his family sued Janssen Pharmaceuticals and Johnson & Johnson on the same theory as the Pledger case: that the defendant-companies had failed to warn the family about the risk of gynecomastia, the growth of female breasts on boys.

Strangely, the jury did find that Janssen and J&J failed to warn the families about the risks of side effects, but did not award any damages because the jury concluded that there was no established link between Risperdal drug and the growth of female breasts.

Janssen and J&J argued that Billy Cirba developed female breasts long after he stopped taking Risperdal, and that therefore the family could prove no link between the drug and the condition. The jury accepted this argument.

This is a strange result. The jury found that the companies failed to warn the Cirba family about the risks of the growth of female breasts, but somehow found that the Cirbas failed to prove that Billy Cirba’s breasts were caused—or likely caused—by taking Risperdal. Inherent in these findings is that the jury accepted that Risperdal causes the growth of female breasts. It seems implausible that the jury would then fail to see the link.

A Janssen spokesperson stated that the company was pleased the jury found that Risperdal was not the cause of Billy Cirba’s female breasts. However, that is not what the jury found; instead, the jury found that plaintiffs did not prove the link between the drug and the injuries. Think of this way: a finding of not guilty in a criminal case is not the same thing as a finding of innocence. The criminal defendant could well be guilty of the crime; the prosecutor simply failed to prove guilt. This is an important distinction.

Because of the jury’s findings, the Billy Cirba and his family received no compensation for Billy’s gynecomastia. At the end of the day, this jury verdict must be viewed as a substantial win for Janssen and J&J. I predict in future cases that Janssen and J&J will pound on this new defense: that even if the companies failed to warn consumers about potential side effects, the plaintiffs cannot establish a direct link between taking Risperdal and growing female breasts.

Murray et al. v. Janssen Pharamceuticals and Johnson & Johnson (Philadelphia Court)

Jury Award: $1,750,000.00. Jury found that Janssen and J&J failed to warn Plaintiffs about potential injuries from taking Risperdal.

Date of Jury Verdict: November 9, 2015

Nicholas Murray (now 21) took Risperdal as a teenager to treat his attention-deficit hyperactivity disorder (ADHD), which is considered an “off-label use.” He developed female breasts. There was evidence that Nicholas was teased at school and traumatized. The jury found that Janssen and J&J failed to warn Nicholas and his family about the potential side effects of gynecomastia and that the drug caused the growth of female breasts on Nicholas.

The jury awarded Nicholas $1,750,000.00 for physical disfigurement and mental distress. Punitive damages were not permitted in Murray case.

A fourth Risperdal trial began in October; no jury verdict has yet been reached in that case. Several other Risperdal cases are scheduled to be tried in 2016.

Punitive Damages Barred in 1,500 Cases

Punitive damages have been barred in 1,500 cases filed in Philadelphia. In May 2015, a judge ruled that punitive damages were not permitted because Janssen Pharmaceuticals is situated in New Jersey, thus triggering a protective statute that bars punitive damages against drug manufacturers in cases where the drug has been approved by the Food and Drug Administration. The question remains how this ruling will affect other plaintiffs who live in other states. Punitive damages are a critically important part of the nationwide Risperdal litigation, because even the threat of punitive damages will pressure Janssen and J&J to compensate other victims more generously.

Note: photograph is for illustrative purposes only.

In most product liability cases, injured persons bring claims based on one of three legal theories: (1) a defect in manufacturing the product, (2) a defect in the design of the product, or (3) failure to warn the consumer of the potential for injury. It was for this last legal claim, the “failure to warn,” which attorneys for Austin Pledger and his family brought a legal action against Johnson & Johnson and Janssen Pharmaceuticals.

Austin Pledger and Risperdal

Austin Pledger began taking Risperdal in 2002, when he was just seven years old. He suffered from severe autism, and the manifestations included fits of rage, tantrums, lashing out, banging his head against the floor, and hitting his special education classmates. As with many people with autism, Austin required a rigid daily routine, and when the routine was disrupted, he could grow angry and lash out. Nevertheless, from what I’ve read about his case, Austin has devoted parents who were and remain committed to making his life as happy and productive as possible.

Austin’s parents became more concerned with his outbursts in 2002. They scheduled an appointment with a pediatric neurologist. The doctor did not prescribe Risperdal at that meeting, but told them to consider medication to reduce the severity and duration of Austin’s violent behavior. The doctor also mentioned that Risperdal could cause some weight gain, but said nothing at all about the possibility of Austin growing female breasts (gynecomastia).

Risperdal Label Fails to Warn of Dangers

In 2002 Risperdal was not officially approved for use with children. Keep in mind that in 2000 21% of Risperdal sales was being sold “off-label” to children and adolescents. Johnson & Johnson was making it a focus of their sales efforts to increase Risperdal sales to children.

The Pledgers obtained their first prescription for Risperdal in June 2002. They tried to read the long, confusing drug label. The version of the label they would have received in the 2002 prescription did not mention side effects in children, and further stated that prolactin-related side effects would be rare. “Rare” was defined on the label as occurring in fewer than 1 in 1,000 patients. This was false.

The good news is that Risperdal reduced the number of tantrums Austin suffered. Unfortunately, by 2005 it was obvious that Austin had gained a large amount of weight and, more horrifying, had grown large female-type breasts (gynecomastia).

The Pledgers eventually brought a lawsuit against Johnson & Johnson for their negligent failure to warn them about the potential side effects, especially the growth of breasts on boys.

The Trial Against Johnson & Johnson

The trial took place in Philadelphia in February 2015. Thomas Kline, a respected plaintiff’s lawyer, represented Austin Pledger and his family. Diane Sullivan, a formidable corporate defense attorney from New York City, represented Johnson & Johnson and Janssen Pharmaceuticals.

No Punitive Damages

Unfortunately for the Pledgers, the judge in Pennsylvania held that plaintiffs could not pursue punitive damages against J&J and Janssen. This was a huge blow to the Pledgers and to all plaintiffs injured by Risperdal. Punitive damages are used to deter a defendant and others from engaging in conduct similar to that which formed the basis of the lawsuit—they are considered punishment damages. And the judge ruled they were not available to the Pledgers in their case.

The jury had to determine if J&J had known about the dangers of Risperdal but had failed to warn the Pledger family about those dangers, and if so, had the failure to warn caused Austin Pledger’s injuries. If the jury answered yes to both questions, it would then award “compensatory” damages to the Pledgers, which included pain and suffering damages.

After a contentious trial lasting several weeks, the jury found that J&J had failed to warn the Pledgers of the dangers of taking Risperdal, and that taking Risperdal had caused the growth of female breasts on Austin (and all his other injuries). The jury then awarded the Pledger family $2,500,000.00 in damages. In polling the jury afterward, members stated that they settled on $2.5 million by multiplying a fifty year life expectancy for Austin by $33,000.00 per year, which was an amount the jury determined would be necessary to take care of Austin each year. Then they added a percentage to reflect what they imagined the attorneys would receive in legal fees from the verdict.

(For more thoughts on the challenges of determining pain and suffering damages, see my post: Pain and Suffering Damages in a Personal Injury Case)

Johnson & Johnson immediately appealed the decision. This means J&J will ask an appeals court to determine if the trial was properly conducted and if there were any serious mistakes of law in the trial. What it really means is that J&J will spend more time litigating the case so they can delay payment of the jury award.

Was This Jury Verdict a Victory?

Is $2,500,000.00 a good result? How can anyone possibly say that? What amount of money would make it worthwhile for your son to grow huge female breasts? When I ask it that way, of course there is an easy answer: no amount of money would make such a disfigurement worthwhile. Ever. Sadly, once this permanent injury occurs, money damages are the only thing left for the courts to “compensate” an injured person.

If you know someone who has taken Risperdal and was disfigured or injured in some way, call me. Or call a lawyer you trust.

A major problem with a pharmaceutical industry that generates billions of dollars a year is that many corporations will do just about anything to get into that market and get a share of those drug profits. As a result, too often companies will rush a drug onto the market before it is fully tested, then market the drug aggressively, even for “off-label” uses, simply to increase profit margins. Even an established corporation like Johnson & Johnson is not immune. As reported by Stephen Brill, 91% of Johnson & Johnson profits derive from the sale of expensive medical devices like artificial hips and knees and pharmaceutical drug sales.

Risperdal is a prime example of a drug that generated billions of dollars in sales but also left thousands of people permanently disfigured or otherwise injured.

Risperdal

Risperdal (risperidone) is an antipsychotic drug that was developed by Janssen Pharmaceutica (a company owned by Johnson & Johnson) to treat schizophrenia and bipolar disorder. Essentially, it is used to reduce or diminish the most extreme symptoms and reactions in people with schizophrenia or bipolar disorder. A simple example would be that Risperdal could manage or reduce the manic episodes in a person with bipolar disorder. Originally, the Food and Drug Administration (FDA) approved the drug for use by adults only and specifically refused to permit Risperdal use in children. Over the years it became clear to Janssen and Johnson & Johnson that the target populations for the drug were too small; that is to say, there simply weren’t enough people suffering from schizophrenia or bipolar disorder to generate sufficient profit from Risperdal. Thus, Johnson & Johnson pressed the FDA for broader uses for the drug. J&J wanted to market and sale the drug for use in children suffering from autism and other disorders. Eventually, after several years of prodding, the FDA approved Risperdal for limited use in children for treatment of symptoms associated with autism.

Side Effects of Risperdal

Risperdal has many clinically-recognized side effects: these include somnolence (sleepiness), headaches, nausea, weight gain, diabetes, and other complications. Perhaps the most shocking of all: gynecomastia.

Gynecomastia

Gynecomastia is the growth or development of female breasts in men and boys. It is caused in males by an abnormal increase in female hormones or an imbalance in male and female hormones. Studies of Risperdal have shown that young people using the drug had elevated levels of prolactin, a hormone which allows women to produce breast milk. Elevated prolactin levels in young boys could cause them to grow female breasts. In a huge study conducted by Johnson & Johnson, it was determined that 5.5% of adolescent males developed gynecomastia. This was a horrible result. Johnson & Johnson, according to Brill, would spend years trying to run away and “adjust” those results (the label currently lists 2.3% as the predicted rate of acquiring gynecomastia after taking Risperdal). After all, such a high percentage would not be good for business.

RISPERDAL LABEL

At this point I must state that I do not intend to paint the entire pharmaceutical industry as a stock character villain. Pharmaceutical companies have created many life-saving and life-improving drugs for decades. And when these companies complete the appropriate amount of research and development and testing, and the drug “works” for its intended purpose, the company should be able to make a profit. Sadly, however, the story of Risperdal, which was played out in the marketing and sales departments of Johnson & Johnson as much or more than among the Janssen chemists and scientists, is a tragic cautionary tale of greed run amuck. Most tragic, the consequences of that greed occurred in our most vulnerable populations—children with debilitating disorders such as autism and severe manic depression.

In the next post we will look at a recent trial brought by parents of an autistic boy who developed grotesque female breasts after taking the drug Risperdal; the jury in that trial awarded a $2,500,000.00 verdict for the family and against Johnson & Johnson for its failure to adequately warn of the potential side effects of using Risperdal.