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Johnson & Johnson Pays the Piper for Lying about Risperdal

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When people get sick, they rely upon their physicians and the medications they prescribe to help them regain their health. It is a significant responsibility as the combination of medical care and medication are the cornerstones of healing. Treatment can effective only if both the medical care and medications prescribed are properly applied for their intended purpose and that any side effects of medication are fully identified and carefully considered prior to the administration of treatment.

This was not the case when Johnson & Johnson marketed their antipsychotic medication Risperdal for use in the elderly and boys. Specifically, they deliberately manipulated the data regarding the development of breast tissue when administered to male patients. The reason for this is very simple; greed.

The patent on Johnson & Johnson's previous antipsychotic medication was expiring, and in 1994 when the company released Risperdal to replace it, the FDA applied their litmus test for new drugs and came to the conclusion that Risperdal was no more significant than its predecessor in relieving the debilitating impacts of schizophrenia and similar mental illnesses.

Furthermore, the company acknowledged that the patient pool for antipsychotic medications was limited and would not provide them the blockbuster drug they were seeking to release. Thus, the company refocused the intended application of the drug to include a broader spectrum of health conditions to include seniors suffering from dementia to young children coping with autism.

Redirecting the intended purpose of a medication for off-label usage is not illegal, however, the company did this while at the same time masking the side effects the use of the drug would have in its newly identified target market. Specifically, they hid data that showed an alarming incidence of gynecomastia among users of Risperdal. The psychological and physiological impact of this condition are considerable. In fact, it is estimated that men who develop gynecomastia face a five-fold increase in the risk of developing breast cancer.

Johnson & Johnson's own internal research showed that the development of gynecomastia and an increased prevalence of seizures in elderly patients were potential side-effects of Risperdal. However, the company chose to aggressively market the drug for use within pre-pubescent boys and the elderly. The results were devastating. While statistics are still being compiled, it is estimated that the improper application of Risperdal has impacted tens of thousands of patients, including those whom have contacted their own Johnson City personal injury lawyer to pursue their own cases against the company.

By relabeling Risperdal, Johnson & Johnson achieved over $30 billion in sales since 1994. They achieved these astronomical figures by lobbying physicians to prescribe Rispderdal in place of generics, and for states such as Texas to do the same within their Medicaid programs. In the case of Texas, the state paid nearly $3,000 per patient as opposed to the $250 they would have paid for generics. In the case of Omnicare, one of the nations largest nursing home providers, they gave the company a kickback for every patient they prescribed the drug for.

At this point, the FDA took notice. Noting the increased mortality rates of seniors taking the drug, they warned the company of their concerns. The company ignored these and continued to make enormous profits by selling Risperdal to seniors in nursing facilities.

Finally, the FDA conducted a more thorough investigation during the course of which they uncovered Johnson & Johnson's own internal communications and records showing the company's deliberate decision to ignore data on Rispderdal's dangers, and to misguide and misdirect physicians and nursing care providers tasked with prescribing and administering it.

As a result, the Department of Justice chose to pursue the company for their illegal promotion of Risperdal. This past week, Johnson & Johnson agreed to settle the government's claims for up to $2.2 billion. This fine will be split between the federal government and the state's which were affected. This settlement does not include remedy for lawsuits that individual states have filed, nor does it include protection from the numerous class action lawsuits that are being filed across the country.

It is estimated that when the dust finally settles, Johnson & Johnson could be facing settlements exceeding $6 billion. This is still less than 20% of the $30 billion dollars in profit they made from the sale of the drug. What is more concerning is that it is clear to every Johnson City personal injury lawyer that the company factored this into their strategy when they made the decision to relabel and retarget the drug.

In the case of Johnson & Johnson, it's a case where safety regulations were not properly enforced which allowed the company to exploit the law knowing that the payoff would more than adequately cover the fines and settlements of the ripoff. However, no settlement will ever be able to cover the psychological damage and physical trauma suffered by patients improperly prescribed Risperdal.

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