The Huffington Post has been publishing Steven Brill’s writing about Johnson & Johnson’s Risperdal product and the litigation involved. If you haven’t read it you should. It’s very well written and informative. See it at: http://highline.huffingtonpost.com/miracleindustry/americas-most-admired-lawbreaker/chapter-1.html 

The product resulted in major litigation. For example, the nation’s largest nursing home pharmacy, Omnicare Inc. of Covington, Kentucky paid  a $98 million penalty for accepting  kickbacks from Johnson & Johnson in exchange for agreeing to recommend that physicians prescribe Risperdal to nursing home patients.

And in November 2013, Attorney General Eric Holder announced the Justice Department’s $2.2 billion settlement with Johnson & Johnson for  wrongful promotion of the drug for children.

Brill’s report describes the case of Austin Pledger, an autistic child who took the drug and suffered the side effect of developing large breasts. His trial was in Philadelphia. Plaintiff  was represented by my friend, the outstanding plaintiff’s lawyer, Tom Kline. The company was defended by Diane Sullivan a partner at Weil, Gotshal & Manges, a 1,100-lawyer Wall Street firm.

Brill says the jury was made up of six men and six women, of whom 11 were African American and one was white. They included a security guard, a clerk at Macy’s and a nurse’s aide. Their job was to answer two questions: 1) Had Johnson & Johnson known and failed to warn Austin Pledger’s doctor that Risperdal was dangerous when taken by children like him? 2) Had that failure to warn caused Austin’s injuries?

The discovery documents were voluminous. Johnson & Johnson turned over some 3.5 million documents containing 21.7 million individual pages. The discovery information revealed considerable improper and even illegal activity by Johnson & Johnson regarding the product.  For example, as plaintiff’s lawyers, we know that medical articles regarding drug products are subject to suspicion about ghostwriting and faulty research when funded by drug companies. This case demonstrates this fact. Johnson & Johnson had signed a contract with a company called Excerpta Medica. Its specialty was medical marketing. Its sub-specialty was producing ghostwritten, data-filled studies on the efficacy and safety of a client’s drugs, finding the right academic scholars to be listed as the authors and then placing the articles in prestigious academic journals.

What was also interesting was the comments by the foreperson about the trial. I’m quoting some examples in this post and here is one impression. The former head of the FDA testified for plaintiff and was a powerful witness.  Brill reports:

“Kessler’s testimony about the manipulation of the numbers was not lost on the jury. “Kline showed it to us pretty clearly with the FDA guy,” a woman who became the jury’s forewoman told me later. “He just repeated it over and over and there was a chart of some kind that he used. .. You could see what they had done.  I thought he was by far the best witness.”

Note her comments about showing his point “clearly” and using a chart to explain while he “repeated it over and over.” He was a good expert witness because it was clear and simple plus explained instead of rushing past the point.

During trial Sullivan had raised an unexpected legal objection to the Plaintiff’s medical doctor who had examined the child and was going to testify about his condition. That forced  Kline to find and produce a last minute substitute, a plastic surgeon, with experience in this area of medicine. When Sullivan attacked him in argument for lack of credentials and the failure of plaintiff to find a specialist in this particular area to testify. Kline immediately objected given the fact the defendant had kept the experienced witness from testifying just before being called.  Brill reports:

“This time, the judge lost his cool: “The conduct by the defense on that entire episode was very, very disturbing.” He sustained the objection and advised he would instruct the jury on this issue given Sullivan’s improper argument. As a result, he instructed the jury:  “it was suggested to you again by Ms. Sullivan that the plaintiff could not produce an endocrinologist and suggested that they could not because they could not. You are instructed to disregard that line of argument in its entirety as it is not accurate and its disingenuous based on matters of law that occurred outside of your presence.”

Kline used photos of the child, before and after, to show the deformity. This impressed the jury foreperson and reminds us of the importance of compelling demonstrative evidence.

“The pictures, I think, made an impression on all of us,” recalls the forewoman of the jury. “I still remember them.”

As a reminder that cross examination doesn’t have to be “cross” and that we should adjust our demeanor for the witness involved, Brill talks about the mother’s cross examination. Sullivan read parts of the child’s school reports to try to show the drug had helped the child.  She would raise her voice when she read the reports as if she had caught the mother misrepresenting the situation. The foreperson’s reaction was not favorable:

“I thought the mother was quite brave to subject herself to all of this,” recalls the jury forewoman. “I felt bad for her.”

The first rule of communication, for lawyers and witnesses, is to listen carefully. The second rule is what you say must be clear, understandable and brief.  Johnson and Johnson’s key expert violated that rule when he tried to explain why tables weren’t really in conflict. The foreperson’s impression was not favorable.

“I never got the Johnson & Johnson scientist’s explanation of the numerator-denominator percentage thing,” she recalls. “I didn’t know what he meant.”

There was an issue of whether Johnson and Johnson had withheld information from the FDA and the significance of testing shown in tables about the studies done. Note that during cross examination Kline used the tried and true whiteboard, Brill reports:

“He wrote Caers’ answers on a whiteboard for the whole courtroom to see. He then got Caers to concede that all but one of the gynecomastia cases had turned up among the children in the smaller subset of long-term studies. That meant that a truly relevant sample—children taking the drug long-term.”

What happened on re-cross was powerful. Brill says Kline shot up from his chair and asked:

Kline: Sir, table 21 was not given to the FDA?

Caers: That’s correct.

Kline: Wow!

Sullivan: Your honor, I object to the interpretation.

Brill reports about this exchange:

“According to an experienced lawyer who was in the courtroom but was not allied with either side, “That moment seemed like a big surprise to the jury—that after all he had said about all the studies Janssen had turned over to the FDA, that he had never turned that one over. … There was a pregnant pause after that.

The jury forewoman agrees. “I thought that was really important, when he said he had thrown out that study. … What this was really about, was that you can’t keep testing over and over again and then use the results you like and throw out the rest.”

Here is what Brill reports about the foreperson’s impression of the lawyers. There is a lesson here:

“We thought that Kline did a really good job communicating with us,” says the jury forewoman. “Sullivan tried to, but she was too harsh at times. She badgered people, and kept going around and around when she questioned someone and got an answer she didn’t like.”

The jurors spent one day reviewing the evidence. The next day they voted 11-1 the company had failed to warn and that was the cause of the child’s injuries.  The dissenting juror argued that it was the doctor’s fault in prescribing the drug. What Brill reports about the deliberations is also revealing. Keep in mind since punitive damages were not involved plaintiff is not permitted to suggest a figure for the jury to award as a verdict. They were not given a non economic recommended verdict for that reason:

“That afternoon, they debated how much Johnson & Johnson should pay Austin’s family. Some wanted to award as much as $5 million; others favored a far lower sum, even below a half million dollars. Soon, they focused on what they thought would be Austin’s 50-year life expectancy and began to calculate what he should be paid per year. Dividing a hypothetical total into 50 parts seemed to make everyone more comfortable with a relatively high award. By Wednesday morning, some of the jurors urged the others to consider that the lawyers, as the forewoman puts it, “were likely to get about a third of the money, and we needed to take that into consideration. … We spent a lot of time trying to calculate that.”

Just before lunchtime, they arrived at a figure: $2.5 million, which worked out to about $33,000 a year after the expected 33 percent in lawyers’ fees. The jurors sent word that they had reached a decision.”

I recommend Steve Brill’s excellent writing and research about his drug. It is as informative and well written about pharmaceutical litigation as anything I’ve read.

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