• Public trust in a vaccine is crucial to beating the COVID-19 pandemic
• Is Johnson & Johnson - with a $500m federal grant - a company the public still trusts?
• J&J CEO Alex Gorsky’s role in a jury’s outrage and $8 billion punitive verdict

Massive jury verdicts against Johnson & Johnson have become so commonplace that a recent $8 billion punitive damage award against the company dropped from public view after a single news cycle.

Big punitive damages often are interpreted as a jury “sending a message” about outrageous conduct. The $8 billion “message” might have been appropriately aimed at J&J President Alex Gorsky.

Evidence in court shows Gorsky’s fingerprints all over a marketing scheme for a drug called Risperdal. The company succeeded in getting thousands of pre-pubescent boys to take Risperdal despite a nasty side effect that caused them to grow large female breasts.

During relevant time periods, Gorsky served as vice-president of sales and marketing, and later as president, of J&J’s Janssen division which was responsible for Risperdal. More recently, as CEO and chairman, Gorsky remained in the loop on evolving Risperdal matters.

Evidence emerging from thousands of lawsuits tell a story of J&J hiding data and manipulating scientific studies on the safety and effectiveness of Risperdal. The endgame was to turn a drug with limited profit potential into a financial blockbuster.

The scheme figured into one of the largest healthcare fraud settlements in U.S. history in 2013 when J&J paid $2.2 billion to end a U.S. Justice Department criminal investigation into illegal marketing of Risperdal and kickbacks paid to doctors who prescribed it.

Gorsky was promoted to chairman and CEO of Johnson & Johnson in 2012, a year before the company settled the criminal fraud allegations over Risperdal.

Today, with additional consumer lawsuits proliferating over the company’s involvement in the opioid crisis, cancer claims about its iconic baby powder, damages from its discontinued vaginal mesh and other drugs and products, the question becomes whether Johnson & Johnson is a company the public can/will/should trust when it comes to the coronavirus vaccine.

Read on Fortune: How Johnson & Johnson Is Dealing With Its Trust Issues

Gorsky and Risperdal timeline from court records

1988

Gorsky joined Janssen as a sales representative in 1988.

1993

Five years later, in 1993, Risperdal was approved by the FDA as an anti-psychotic treatment only for adult schizophrenics. Although Janssen tried twice to get FDA approval for use of Risperdal in children, the agency refused in 1997 and 2000 because of the lack evidence of the drug’s safety and effectiveness for kids.

1994

Janssen knew two things at least as far back as 1994 when Risperdal first came on the market:

1) that there weren’t enough adult schizophrenics to make Risperdal very profitable unless they could sell the drug to a wider audience, particularly to children; and

2) that Risperdal increased the hormone prolactin more than other drugs in its class, according to testimony in a 2015 deposition of Ivo Caers, a longtime Janssen employee in Belgium who helped lead development and global marketing of Risperdal.

When prolactin levels are elevated in children, young girls can lactate and boys can grow female breasts, according to Caers. The breast growth is permanent.

1998

Gorsky testified in a deposition that he was promoted in 1998 to vice president of sales and marketing at Janssen where he had responsibility for Risperdal.

1999

Despite the FDA’s refusal to approve Risperdal for children, Janssen in 1999 deployed an aggressive marketing campaign to encourage pediatricians to prescribe the drug to children for a wide variety of behavioral issues, according to the DOJ.

Read on Justice.gov: Johnson & Johnson To Pay More Than $2.2 Billion To Resolve Fraud And Misbranding Allegations

Risperdal sales in the U.S. increased from $500 million to $800 million.

2001

Gorsky was involved in meetings and marketing plans to promote use of Risperdal for children, including a plan to spend $7.4 million to gain market share. The plans acknowledged the prolactin problem.

Gorsky in 2001 sent an email to other Janssen managers concerning “competitive activity” around Risperdal. In the email, he showed awareness of the prolactin problem for children, writing:

“While we cannot respond to each and every competitive jab…we should expect that we will be challenged on a number of competitive fronts due to our market position…therefore we need to be proactive in expanding on our competitive strengths (efficacy long and short term, agitation, weight gain, etc.) and defeating our weak spots (prolactin, QTc, EPS)”

2002

By 2002, Johnson & Johnson knew from its own studies that gynecomastia – or female breast growth in boys – occurred frequently in boys taking Risperdal. A data set known as Table 21 in a company study showed a “significant correlation” between prolactin levels in the boys taking Rispersal and instances of gynecomastia.

Word about Risperdal’s prolactin problem was leaking out to competitors and the medical community.

Looking for a way to assuage concerns about Risperdal, the company’s marketing team found three outside doctors lead by Robert Findling, later a professor of child and adolescent psychiatry at the Johns Hopkins University, who would sign off as authors on a paper for a medical journal about Risperdal that Janssen would ghost-write for them.

After much machination internally, the company arranged for the submission and publication of the final manuscript in the Journal of Clinical Psychiatry in November 2003. Table 21 and its finding about the prolactin problem were excluded.

2013

Word that J&J managed to keep the Table 21 data out of the scientific article and hidden from the medical community leaked out in 2013 as lawyers began investigations on behalf of thousands of disfigured Risperdal boys who were suing J&J for damages.

Denis Daneman of the University of Toronto, one of the doctor/co-authors of the 2003 Risperdal article in the Journal of Clinical Psychiatry, began asking that his name be removed from the article and demanding an apology from the company for keeping him in the dark about Table 21. Gorsky was aware of the controversy and that news reporters were looking into the story, according to testimony.

2015

In 2015, Table 21 became public knowledge in the first case to go to trial of thousands pending in Philadelphia alleging the company failed to adequately warn doctors and the public about the risk of gynecomastia.

The trial involved Austin Pledger of Alabama, who was prescribed Risperdal in 2002 at age seven and whose breasts grew to size 46DD.

After a day and a half of deliberations, the jury awarded Pledger $2.5 million.
Following the Pledger verdict, Janssen hired biostatistician Warren Bilker and told him to re-analyze the data to refute Table 21, according to Bilker’s description of his assignment in a company email.

2016

In February 2016, based on Bilker’s work to refute Table 21, Findling and Daneman, published a 16-page letter to the editor of the same journal, standing by their original article.

Five months later, in July 2016, another Philadelphia jury in another Risperdal trial heard that Janssen hired Bilker to refute the previously hidden information contained in Table 21 and shore up the journal article.

The jury awarded plaintiff Andrew Yount of Tennessee a record $70 million in actual damages.

2019

In October 2019, Nicholas Murray, a 26-year-old from Maryland, became the first plaintiff allowed by the courts to seek punitive damages against J&J for downplaying the risks of Risperdal to young boys.

The jury’s $8 billion punitive damage award has since been reduced by a judge to $6.8 million. But the message remains loud and clear. In a statement after the jury made the award, Murray’s lawyers, Jason Itkin and Thomas Kline issued a statement that said in part, “This is an important moment, not only for this litigation, but for J&J, which is a company that has lost its way.”

 

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