A lawyer for a boy who allegedly grew breasts from taking Risperdal told a Philadelphia jury Monday that Johnson & Johnson illegally marketed the antipsychotic drug to kids as part of a national policy to increase the sales of the drug to patients beyond the 1 percent of the population who has schizophrenia.
While the plaintiffs painted a picture of a national scheme by Johnson & Johnson subsidiary Janssen Pharmaceuticals to market based on dollars instead of science, Janssens attorneys continually emphasized in their opening statements that this case was about one boy and the decision by his doctor to give him what many view as a miracle drug.
Opening statements in A.B. v. Janssen Pharmaceuticals were held before Philadelphia Court of Common Pleas Judge Mark I. Bernstein. The case makes for the first of the 86 cases in the courts Risperdal mass torts program to open to a jury.
There were eight bellwether cases selected by the parties, with four chosen by the plaintiffs counsel and four by a team of defense lawyers representing Janssen. The first of the bellwether cases was scheduled for trial earlier this month but settled before opening arguments. That case, Banks v. Janssen Pharmaceuticals, had been selected by the plaintiffs and settled for an undisclosed amount. The 12-member jury and three alternates in A.B. are hearing a case selected by the defense in which Texas law has been found to apply. Four other cases are scheduled for trial in the coming months.
Robert Hilliard of Hilliard Muñoz Gonzales in Corpus Christi, Texas, presented opening statements to the jury Monday. His firm is working with Brian McCormick and Stephen Sheller of Philadelphia-based Sheller P.C. on behalf of the plaintiffs, a 17-year-old boy with Aspergers syndrome, and his mother.
Theres just not enough schizophrenics in the United States for them to make enough money, Hilliard told the jury.
He said that fact not only caused Janssen to market the drug to treat kids with schizophrenia, which he said was not FDA-approved at the time, but to treat kids with other problems, such as bipolar disorder or behavioral problems.
Hilliard said the evidence would show that at about the same time A.B. was prescribed Risperdal in 2000 for conduct disorders, Janssen wrote in an internal marketing report that Risperdal increased the hormone prolactin, which typically causes breast enlargement and milk secretion during pregnancy. This in turn can cause gynecomastia in men, which is the production of mammary glands, Hilliard said the marketing report detailed.
When a drug increases prolactin in a boy, prolactin doesnt know its in a boy, Hilliard said.
He said his client was on the drug during several different periods of time between 2000 and 2007, when his mother noticed he grew breasts. Hilliard said his client has texture sensitivity as part of his Aspergers and his breast and nipple sensitivity against his clothing is now excruciating.
Hilliard told the jury there were three main issues he would prove at trial. The first was that Janssens drug reps were taught to tell doctors the threat of gynecomastia was a problem caused by all second-generation antipsychotic drugs even though, Hilliard said, Risperdal was the only one to have such an effect.
The second issue was that Janssen noted on its Risperdal label that the possibility of gynecomastia was rare, even though its own tests showed that it occurred more than frequent[ly], Hilliard said.
The third and biggest issue Hilliard said he intended to prove at trial was that in 2006, when Janssen again asked the FDA to approve the marketing of Risperdal for the treatment of children, it provided allegedly false data that suggested gynecomastia was not a side effect. The FDA granted approval based on that data, he said.
But when Laura H. Smith of Friday Eldredge & Clark in Arkansas gave her opening remarks on behalf of Janssen and Johnson & Johnson, Smith said the results of every one of the 18 studies Janssen conducted were turned over to the FDA and were included on the drugs label after the FDA approved the use of Risperdal for children.
Smith noted several times throughout her opening statements that the FDA approved the drugs use.
There is nothing ever shown to a physician that the FDA didnt bless in advance, Smith said.
She also repeatedly drew the jurys attention to the fact that the case was not about what the world knew or thought of Risperdal, but about what A.B.s doctor knew of the drug and whether he would have prescribed A.B.s medication differently had he known. Smith added that A.B.s doctor will testify that no Janssen representative ever marketed Risperdal to him for off-label uses. Smith is working on the case along with Janssens counsel from Drinker Biddle & Reath.
Smith said that while Hilliard only noted A.B. had Aspergers, A.B. actually has severe mental disabilities and a number of symptoms that were treated over the years by Risperdal and other antipsychotics. Smith said A.B.s doctor noted Risperdal was uniquely helpful to A.B. Smith told the jurors that they would not hear anyone testify that Risperdal did not help A.B.
Smith then told the jury it wasnt clear whether A.B. even had gynecomastia. It was not until 2009, two years after A.B. stopped taking Risperdal, that his mother first learned there were lawyers in Philadelphia willing to take cases of boys who developed breasts and took the drug, Smith said.
According to Smith, A.B.s mother testified at her deposition that she had not been concerned with breast growth in her son prior to 2009 and had known small breast growth during puberty was normal. Smith said the mother had such little concern that she never took A.B. to a doctor to check the breast growth until lawyers told her to in 2009.
That was the one and only time the mother took A.B. to a doctor for the breast growth and an ultrasound suggested follow-up clinical correlation was needed to show the breast buds seen in the ultrasound were in fact gynecomastia, Smith said. Apparently that follow-up has never been done, Smith said. Smith also noted that the mother didnt first note the growth of breast buds in 2007, but rather when asked at her deposition when she thought it started, guessed it was around that time, noting it was when her son was going through puberty.
Smith told the jurors they would hear from pediatric endocrinologist experts who would testify that breast growth occurs in pubescent boys 4 percent to 69 percent of the time when no medication is at issue.
While breast growth can also occur secondary to medication use and Risperdal is one of the medications that can cause it, Smith noted that the other medications A.B. had been prescribed can also cause the problem.
The trial is set to go for three weeks. Under Texas law, punitive damages are not available unless a child is involved. A plaintiffs motion to allow the jury to decide punitive damages was granted. A motion by the defense to block testimony from J&J CEO Alex Gorsky was also granted.
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