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Risperdal (also sold under the brand name Invega or the generic names Risperidone and paliperidone) is an anti-psychotic drug manufactured by Johnson & Johnson and sold through its pharmaceutical unit Janssen, approved for use in adults.  Risperdal is a drug that was approved by the FDA for use in adults to treat psychosis.   However, as the market for anti-psychotic drugs became saturated, the manufacturer started getting creative with how else they could make money of this drug.   They believed Risperdal could be helpful in treating ADD and ADHD in adolescent children.  Unfortunately, the FDA had never approved the drug for this use and its safety and efficacy for such purposes had never been tested.
Using a prescription medication for a secondary use that has not been tested or approved by the FDA is called an “off label” use.   In other words, the prescribing doctor is giving it to a patient for an unapproved use that is not on the label.   The off label use of medications by doctors is not an uncommon practice.  However, the key is that they must use their independent sound medical judgment when deciding whether it is in the patient’s best interest to take this medicine for an off label use.  There are strict Federal and State regulations that prohibit drug manufacturers or sale people from marketing or trying to persuade doctors to use their drugs for off label uses.  A doctor can prescribe an off label use if he thinks it is reasonable but the drug sales team can under no circumstances push the drug for that purpose.
The problem with Risperdal was that J&J reps were actively marketing and attempting to persuade doctors to prescribe Risperdal to children for “off label” uses.   Doctors would be paid to give seminars to other doctors and invited to lavish  “educational” outings where between rounds of golf and dinners they would be taught about how Risperdal could be used for other purposes. The drug industry invested a great deal of money to convince physicians to prescribe their Risperdal for numerous unapproved uses in children.
The reason such off label uses are regulated is because we are not certain of all the potential harmful side effects when the drug is used in an unapproved population such as children or for an unauthorized use.   In the case of Risperdal it was discovered that its use in adolescent males could cause an increase in the hormone Prolactin which stimulates the growth of breast tissue and milk production.   In the St. Louis area and throughout Missouri and the rest of the nation, reports began to come in of pre-teen and teenage boys growing unwanted breast tissue and even lactating.  This medical condition is called gynecomastia and can have serious mental health consequences in a young boy just hitting puberty and struggling to find his sexual identity in addition to the obvious physical problems.
The first Risperdal gynecomastia lawsuit was filed by a young adult who developed breasts while taking Risperdal between the ages of 9 and 14. The young man required surgery to remove the breast tissue, and suffered from significant social and emotional distress. This and subsequent Risperdal lawsuits have asserted that Janssen and J&J failed to adequately warn consumers that boys could grow breasts while taking Risperdal.
Missouri Attorney General Chris Koster said it best  when he said, “Our health system does not work properly when drug manufacturers knowingly conceal the ineffectiveness or risks of drugs.  We will make them change their unlawful business practices when we discover they have cut corners or cheated the system.” After a four-year investigation, J&J agreed to change how it promotes and markets its antipsychotics and refrain from any false, misleading or deceptive promotion of the drugs.
The FDA has since warned consumers that the use of Risperdal stimulates the growth of breast tissue and milk production (which can require surgery to remove the unwanted breast tissue and cause serious psychological damage in young men just entering puberty).
Attorney Generals have filed lawsuits against J&J accusing the corporate giant of concealing the dangerous side effects of Risperdal and aggressively marketing it to children knowing it could cause permanent damage. In 2012 J&J reached a settlement with these states paying hundreds of millions of dollars in damages. More recently, in November of 2013 the Federal Government announced a 2.2 Billion dollar settlement with Johnson & Johnson to resolve criminal and civil allegations of wrongdoing involving its marketing of prescription drugs, including Risperdal, for “off label” uses. The majority of Risperdal gynecomastia cases are currently pending in a federal multidistrict litigation now underway in Pennsylvania’s Philadelphia Court of Common Pleas.  However, cases are happening everywhere. This past December (2014), a federal judge in Missouri remanded a Risperdone lawsuit (involving four plaintiffs with similar injuries) back to the state’s St. Louis Circuit Court, where it was originally filed.
If you have a boy or adolescent male in your family that was prescribed Risperdal, Risperidone, Invega or Paliperidone, and has suffered unwanted side effects we can help you.   What these drug manufacturers did in hiding known dangers in  order to increase their market share is corporate moral corruption and greed at its worst.  If you or a family member has suffered because of this let us help you get the compensation you deserve.  Call us or send us an email for a free consult with no obligation.