1 Boring Old Man

We saw the morning testimony in the Janssen trial in Austin, then drove to San Antonio and flew to Atlanta, then drove home to our cabin in North Georgia. Quite a week! Quite a Day! It was hard to leave Austin [I think trials might be addicting].

First up Tuesday morning was Toni Jones who went to work for Janssen after college when he didn’t get drafted for the NFL, ultimately ending up as a District Sales Manager [Houston]. He was apparently approached by Janssen’s lawyers first and offered money to be a witness, claiming he owed loyalty to his former employers. He felt offended, and later responded to the plaintiff’s lawyers [who offered him nothing]. For a former football star, Toni was surprisingly softspoken, articulate, and straight-forward – lacking the defensiveness of the other Janssen sales people we heard earlier.

He freely described his Sales Reps promoting Risperal in children. One strategy was to start with Concerta [McNeil’s ADHD drug] then move to Risperdal – using Concerta to get in the door. He explained, "You can’t be a billion dollar product in a 1%  market [Schizophrenia]. The evidence [email chains, Call Notes] showed that the focus was on promoting Risperdal in kids, and went up and down the hierarchy in Janssen’s sales force – from the top dogs to the rep on the calls – in other words, it was corporate policy. Toni’s testimony included other things too. Texas Medicaid was a target ["big payer"]. The reps fought the allegations in the FDA Warning about Diabetes on "every sales call." They were trained on how to sell "off-label" eg, a training slide about promoting Risperdal in kids under 13 said "most diagnosed with behavior disorders or mood disorders", "No Indications!!!", "sell on symptoms not diagnosis". These were not rogue reps, they were trained to carry the message.

J&J’s Risperdal Sales May Have Broken Texas Agreement, Official Testifies
Bloomberg
By Jef Feeley, Margaret Cronin Fisk and David Voreacos
January 18, 2012

A Johnson & Johnson unit’s marketing of its Risperdal antipsychotic drug to doctors treating mentally ill children may have violated the drugmaker’s agreement with Texas, a state official testified.  A push by J&J’s Janssen unit to increase Risperdal prescriptions for children and adolescents before 2006 may have broken the drugmaker’s promises to “comply with all state and federal laws” in exchange for having the drug covered by the Texas Medicaid program, Billy Milwee, the state Medicaid director, told a jury today. The U.S. Food and Drug Administration didn’t approve Risperdal for any pediatric use until 2006. If the company pushed Risperdal for unapproved uses, “it would be operating outside state and federal law,” Milwee testified in the trial of the state’s lawsuit over Janssen’s marketing of the drug.

Texas contends New Brunswick, New Jersey-based J&J, the world’s largest health-care products company, defrauded the Medicaid program by promoting Risperdal for uses not approved by U.S. regulators, including for children with psychiatric disorders. The state joined a lawsuit filed by a whistle-blower, Allen Jones, a former Pennsylvania health-care fraud investigator. Lawyers for Texas Attorney General Greg Abbott are asking jurors in state court in Austin, Texas, to order J&J and Janssen to pay at least $579 million in damages over the companies’ Risperdal marketing practices.

Milwee said Janssen officials promised to honor all applicable laws in 1994 when it first applied to have Risperdal prescriptions in the state covered by Medicare. It reiterated the promise seven more times over the next 13 years, he added. Texas’s Medicaid agreement requires disclosure by drug companies if they violate state or federal laws, Milwee said. Janssen never made any such disclosure over the unapproved marketing of the drug to doctors who treat children suffering from mental illnesses, he added. The state’s Medicaid program “would not have engaged as great a cost as it did” if Janssen officials hadn’t misled doctors and regulators about Risperdal’s superiority to other antipsychotics and avoided marketing the drug for unapproved uses, Milwee added. The state contends it paid 45 times more for Risperdal than comparable drugs after accepting the company’s claims that it was superior to rival medications…

Jurors also heard testimony from Tone Jones, a former Janssen executive, who said company officials pushed salespeople to step up visits to child psychologists psychiatrists in hopes of pumping up Risperdal sales. The reason Janssen focused on children and adolescents as a source for more Risperdal prescriptions to broaden the market for the drug, said Jones, a former quarterback for Oklahoma State University who graduated in 1996. Federal regulators had only approved the drug for use in adult schizophrenics and that amounted to about 1 percent of the U.S. population, Jones said.  A drug “can’t be a billion-dollar product in a 1 percent market,” he testified in a videotaped deposition.

I hated to have to leave because the big experts for the Plaintiff were coming next, but I think I saw Janssen’s Achilles Heel in the morning testimony. Nobody listening to the deposed sales force people [Tiffany Moake, Shane Scott, Toni Jones] would doubt that Janssen was marketing Risperdal for use in children – "off-label." No one would doubt they were targeting Texas Medicaid kids. No one would read those signed VDAs and doubt that the ball was in Janssen’s court to report being in violation of State and Federal Law. And they didn’t do that.

I had an "Al Capone" feeling. They put Capone away based on Tax Evasion, not his crimes. That’s how our legal system works. And in this case, it was obviously Janssen’s corporate policy to market Risperdal to kids "off-label" – and that’s against the law of the land. They contracted to update their drug’s status in terms of the law to Texas Medicaid. They didn’t do that. Our laws are like that. Your not convicted for being "bad," you’re convicted for breaking the law, breaking a contract. Janssen clearly did that. That’s not an opinion, that’s a "fact" in the legal meaning of the term. They broke a law in order to defraud Texas Medicaid. No amount of clever cross examination or arguments that Risperdal really is superior, or that doctors prescribe off-label to kids all the time, etc. etc.

Dr. Steven Shon and the promotion of TMAP looked very very bad to me as does the jury-rigged science and ghost-writing, but those are complex issues that might be hard for the jury to understand. This piece was clear as a bell – Janssen illegally violated the law not to promote off-label having signed contracts that bound them to report such illegalities. On the plane ride back to Georgia, I was tired and sleepy. I didn’t know that sitting in a courtroom could be so mentally exhausting. I was sorry to be leaving the trial, the new friends we met there, and the twists and turns of a real world trial. But I felt like the Tuesday morning testimony I heard may well have been Janssen’s Waterloo. Check and Mate…