Articles Posted in Risperdal

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Drug Companies MoneyLet 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

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Causation is usually simple: this happened because of that. The wheel fell off my bicycle, causing me to fall and break my arm. Legal causation is not so simple, and it can be very difficult to prove in a civil case. Legal causation or “proximate cause” involves an event (or thing) which is sufficiently related to an injury such that the cause of the event or thing is held legally liable for injuries sustained. It may not sound all that complicated, but millions of attorney hours are spent each year fighting over proximate cause. In fact, it’s one of the main reasons we have courthouses.

Young man Risperdal gynecomastia

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).

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FDA Open Meeting on Off-Label Drug Use

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.

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On July 1, 2016 a jury in Philadelphia sent a very loud and angry message to Johnson & Johnson. After a lengthy trial, the jury awarded a young boy who grew breasts after taking the drug Risperdal a staggering $70,000,000.00. This verdict is far and away the largest money judgment awarded (yet) to a victim of the drug Risperdal. As one of the attorneys representing the disfigured child stated, “this verdict is a game-changer.” I think he is right.

But let’s back up.

What is Risperdal?

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Boy taking Risperdal

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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This is the story of the lawsuit involving Austin Pledger, an autistic boy who grew large female breasts as a result of taking Johnson & Johnson’s antipsychotic drug Risperdal.

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

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Unless you do not own a television, you have likely seen the endless parade of commercials for drugs in this country. Apparently there is a medication that can fix any problem you have–hair loss, high cholesterol, even of course the dreaded erectile dysfunction. Drugs make corporations billions of dollars each year. If they didn’t you wouldn’t have to explain to your eight-year old why that couple on TV is lounging in two claw foot bath tubs on a mountaintop.

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.

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Risperdal: The Tragic Consequences of Aggressive Drug Marketing
I need to pause for a moment in discussing artificial hip litigation and draw your attention to a shocking series of articles on the Johnson & Johnson drug, Risperdal.  Steven Brill has written a compelling series titled America’s Most Admired LawbreakerBrill makes the argument that Johnson & Johnson pushed the prescription drug Risperdal onto the elderly and children, for all manner of unapproved uses, with devastating results.  The series began yesterday on Huffington Post and can be found here.

Risperdal is an anti-psychotic drug that was first approved for use in 1993 to manage the symptoms of schizophrenia.  In the years that followed, Johnson & Johnson pressed for FDA approval to treat other conditions, such as bipolar disorder and autism, and to permit use in children.  More recently, Risperdal has been prescribed for adults and children to treat attention deficit hyperactivity disorder, anxiety and depression.  Treating these conditions using Risperdal is considered “off label” use, which is the use of a drug in a manner unapproved by the FDA.  Off-label use could be using the drug to treat a condition which is not authorized by the FDA, or prescribing the drug to an unapproved age group.

Tragically, Risperdal has had horrific side effects in some cases, particularly in children.  Among other symptoms, Risperdal can cause the growth of breasts in male children, a condition known as gynecomastia.