Investigative Report Calls J&J “America’s Most Admired Lawbreaker”

In what is being referred to as a “docu-serial,” the Huffington Post has launched a 15-chapter, in-depth examination of the illegal sales practices of Johnson & Johnson, focusing on the pharmaceutical company’s promotion of the antipsychotic Risperdal to the elderly and children, despite reports of severe problems among those users. 

The series, titled “America’s Most Admired Lawbreaker”, is being released one chapter per day, and includes a blistering analysis, complete with court records and company memos, of how the Johnson & Johnson exposed children and the elderly to potential Risperdal side effects, such as breast growth among boys and an increased risk of death for dementia patients, in order to reach projected sales numbers.

In a letter from the editors of the Huffington Post, they warn that the series is emotional and may change how consumers across the U.S. feel about the pharmaceutical industry and the drugs they consume.

“At some point over the course of this massive, magisterial 15-chapter story, you will get angry, and you will stay angry,” the letter previewing the series warns. “It may happen when you learn that Johnson & Johnson handed out promotional Legos to pediatricians so that they’d be more likely to prescribe a drug called Risperdal to children with behavioral problems, although the FDA had repeatedly told the company not to market it to children. It may happen when you read that a team of scientists and company executives decided to massage the numbers on a study showing that Risperdal puts little boys at risk of developing large breasts…”

Risperdal (risperidone) is a popular antipsychotic medication, which is widely used among children for treatment of schizophrenia, bipoloar disorder and irritability associated with autism. However, side effects of the medication have been linked to an increase in the amount of the hormone prolactin in the blood, which is a protein hormone that induces and maintains lactation in women after they give birth.

For boys and young men using Risperdal, prior research has suggested that this may result in the development of enlarged breasts as part of a medical condition known as gynecomastia.

Johnson & Johnson currently faces more than 1,300 Risperdal lawsuits over failure to adequately warn about the risk of breast growth for boys, alleging that the drug maker withheld known information about the risk of male breast growth from consumers and the medical community.

According to evidence presented in the litigation, Johnson & Johnson has reportedly known about the link between Risperdal and gynecomastia since at least 2001, yet chose not to update warnings provided to parents about the male breast growth risks for years.

Cases Uncovered Corporate Wrongdoing

In addition to verdicts and Risperdal settlements for victims, the cases have led to the release of documents detailing just how far Johnson & Johnson went to flaunt the law.

While under a prohibition by the FDA from promoting Risperdal for use by children, Johnson & Johnson’s own documents detail how the company went ahead and did just that, a procedure known as “off-label” marketing. Call report notes, linked to in the story, include sales representatives gloating over getting doctors to prescribe the drug to children.

“Sold him on efficacy and safety in children,” one rep is quoted as saying. “Remind[ed] her that Risperdal is very effective and safe because she sees lots of children and adolescents,” another is quoted as saying in the company’s own call notes.

Off-label marketing is illegal. While doctors can prescribe approved drugs for any reason they see fit, drug companies cannot promote or market them for uses that have not been established as safe and effective.

Without the off-label marketing rules, which were put in place by the John F. Kennedy administration, drug companies could tell you cough syrup cured cancer, and you would have little means to find out otherwise. A number of pharmaceutical companies are pushing for the law to be overturned, claiming it violates their First Amendment rights.

Eventually, Johnson & Johnson’s activities were exposed by a former sales representative, Judy Doetteri, who wore a recording device to marketing presentations that the federal government said established Johnson & Johnson was conspiring to market Risperdal for uses that were not approved by the FDA.

Doetteri and several other employees filed whistleblower lawsuits that not only revealed the company’s illegal promotions to children, but also uncovered a kickback scheme with the nation’s number one provider of drugs to nursing homes, where Risperdal was used as a chemical restraint to control and sedate dementia patients, although the FDA warns that antipsychotics do not help elderly patients with dementia and increases their risk of dying.

The Department of Justice (DOJ) began investigating Johnson & Johnson’s marketing of Risperdal in 2004, looking into an alleged kickback scheme between the drug maker and Omnicare, the nation’s largest provider of drugs to nursing homes.

In 2009, Omnicare reached a settlement with DOJ over kickback charges. DOJ investigators indicated that Johnson & Johnson paid Omnicare millions to push off-label use of Risperdal to nursing home doctors and hid the kickbacks as data fees, education fees and payments to attend Omnicare meetings.

In January 2010, the DOJ filed a civil False Claims Act complaint againstJohnson & Johnson, which also accused the drug maker of illegally promoting Risperdal for use among children prior to obtaining FDA approval for such use.

The investigation resulted in a $2.2 billion agreement to settle the government’s Risperdal marketing claims in November 2013, including $485 million in criminal fines and forfeitures, as well as $1.72 billion in settlements split between the states and federal government.

In the Huffington Post story, analysts note that the company’s legal costs are a cost of doing business, and the company’s more than $20 billion in revenue barely twitched at the federal and legal payouts. No one went to jail, and the head of Risperdal marketing at the time, Alex Gorsky, is now the current Johnson & Johnson chairman and chief executive.

However, most of the lawsuits against the company remain unresolved, and could end up costing the company significantly more.

In February 2015, the first Risperdal bellwether trial to go before a jury resulted in a $2.5 million jury award for Austin Pledger, a young man with autism who now has 46DD breasts and is a major subject of the Huffington Post investigation.

A second case the following month ending with a defense verdict. However, while that second jury found that the plaintiff failed to establish that his abnormal breast growth was caused by the medication, the same jury determined that Johnson & Johnson failed to adequately warn the boys and their parents about the gynecomastia risks.

A third bellwether case was settled out of court in May.