Big Pharma: Increasing Profits at the Expense of Patient Safety Through Off Label Marketing and Inadequate Warnings

The pinnacle of corporate greed was exposed in the lawsuit of Grimshaw v. Ford Motor Co., (1981) 119 CA3d 757, wherein evidence showed that Ford’s corporate executives made conscious decisions to avoid correcting dangerous conditions existing in the Pinto because it would be more cost effective to pay out on claims involving death or serious bodily injury. One would have thought that the results of this case would have stunned the corporate world and stifled this form of unethical business practice, but sadly, that does not appear to be the case…

Recently, the Huffington Post concluded a series regarding Johnson & Johnson’s blockbuster drug Risperdal and the billions of dollars the company made whilst failing to warn prospective patients, particularly young males, about the risk of developing breasts.  It is a series that I strongly recommend reading as it illustrates how Big Pharma can break laws, hurt people, get caught, but yet continue to make billions of dollars notwithstanding the payout of claims associated with whistleblower and personal injury lawsuits.  Moreover, the series reminds the reader that corporate corruption, most often, will advance unchecked without personal injury and whistleblower attorneys willing to take the inordinate amount of risk associated with these types of lawsuits.  This is true simply because our local, state and federal governments simply do not have the resources to investigate the vast majority of the suspected corporate wrongdoings.

The Huffington Post’s article begins by illustrating the business of health care – “As 100 stock analysts gathered in the ballroom of a luxury hotel to hear good news from top executives at Johnson & Johnson that it had 10 new drugs in the pipeline that might achieve more than a billion dollars in annual sales, far away a whistleblower sat in a sales meeting being drilled on promotional materials she was told should not be left behind for fear that federal regulators might see them.”  These types promotional materials are designed to unlawfully increase profits at the expense of the patient, while bilking the coffers of federally and state funded programs like Medicare and Medicaid.

You see in the United States a pharmaceutical company is not permitted to market a drug “off label;” otherwise known as marketing the use of a medication in a way that was not approved by the United States Food and Drug Administration (FDA).  The FDA’s decision to limit the marketing of a drug is based upon years of clinical trials and analyzing the data relative to the drug’s safety and efficacy.  Risperdal, an atypical antipsychotic, a “second generation” antipsychotic, is and was FDA approved for the treatment of schizophrenia and bi-polar disease.  Its designed to treat psychosis, a common feature of these illnesses.  Therefore, J & J is able to market Risperdal to doctors and patients for those disease processes.  However, J & J cannot market the drug to treat depression or anxiety, which involve much larger patient populations, even if the company has data to suggest that the medication can be useful to treat depression and anxiety.  This is so because the FDA believes that the data concerning the risks of the medication in these subpopulations outweigh the potential benefits.  Nonetheless, these limitations can be troubling to individuals charged with the duty of maximizing corporate profits because it limits the company’s ability to market the drug and make money.

It should be noted however, that doctors are permitted to prescribe medications off label, if they have a reasonable basis to do so.  For instance, if a doctor has a patient with a diagnosis of major depression disorder with psychotic features, then in that instance, a doctor may have a reasonable basis to treat his/her patient with an “off-label” medication such as Risperdal.  While the patient does not have the diagnosis of schizophrenia or bi-polar disease, the patient does suffer from psychosis, for which there are no FDA approved drugs on the market to treat.  Thus, a physician may be justified in prescribing off label.  In these circumstances, it is prudent for the physician to discuss the risks of that medication and the efficacy of the drug with the patient and the patient’s family.

Notwithstanding the aforesaid laws, in 2013, J & J’s pharmaceutical subsidiary, Janssen Pharmaceuticals, was ordered to pay the federal government (tax payer) more than $2 billion to settle charges that it illegally marketed Risperdal. In this “whistleblower” case, the J & J employee was being pressured by Janssen to market Risperdal off label to doctors and she was encouraged to market Risperdal to the elderly for issues such as dementia, which was not approved by the FDA, and to children with mental-health problems.  Ironically, while $2 billion dollars may seem like a lot of money, the article highlights that it pales in comparison to J&J’s company worth, which at the time, was estimated at $251 billion.

More recently, a Pennsylvania jury recently awarded $2.5 million dollars to Austin Pledger, a 21-year-old severely autistic male, who developed 46 DD breasts (“gynecomastia”) from taking the drug Risperdal.  The jury found that Johnson & Johnson had encouraged Austin’s doctor to prescribe it without warning of its risks. Whereas, the FDA had prohibited Johnson & Johnson salespeople from trying to promote Risperdal to doctors to treat children because of its feared side effects, including hormonal disorders.  But by the time Austin started growing breasts at the age of 12, Johnson & Johnson was reaping more than half of its Risperdal sales from prescriptions written for children to alleviate all kinds of behavior disorders.

As intimated above, there are times when these types of medications may be useful to treat a person’s psychosis; and, they may prove to improve the patient’s quality of life.  That being said, when a physician makes the decision to consider the use of off-label medications, the decision to commence and maintain the use of these potentially toxic medications should be made by a fully informed patient or legal guardian.  This is true because the patient and/or the family should know to be on guard for the early manifestations of the signs and symptoms of adverse effects such that they can decide whether the risks of the medications outweigh any potential benefit.  Unfortunately, patients and their families are not always advised of the risks of the medications, and opportunities to avoid tragic outcomes are lost.

Posted in In the Community | No Comments »