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.

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.