Risperdal Overcharge Trial Against J&J Begins

Posted by msch on Mar 10, 2011 10:24:00 AM

Donald Coggins and Steven Pugh in Risperdal Opening StatementsSouth Carolina v. Janssen Pharmaceutica (Spartanburg, South Carolina).

South Carolina's Attorney General sued Janssen Pharmaceutica and its parent pharmaceutical company, Johnson & Johnson, to recover damages and civil penalties for alleged fraud and overcharges in the marketing and sale of the psychiatric medication Risperdal (risperidone).

For the plaintiff, Don Coggins, of Harrison, White, Smith, & Coggins, told the jury, "When these drugs are prescribed correctly -- when doctors have full and fair information, and they can weigh the risks and benefits of these drugs against the side effects -- these drugs are good drugs. The people who are severely mentally ill need these drugs, and there's no problem with that. But ladies and gentlemen, with respect to the side effects that these drugs have, the evidence is going to show that Johson & Johnson, that Janssen Pharmaceutica, was not honest, and did not give full and fair information."

Mr. Coggins reviewed for the jury statements that allegedly mischaracterized the risks associated with Risperdal, and a warning letter from the FDA stating that a Risperdal "Dear Healthcare Provider" letter was "false or misleading" under federal law.

According to Mr. Coggins, Johnson & Johnson also claimed that Risperdal had fewer side effects than competing drugs, even though they had evidence at the time showing that Risperdal's side effects were as serious. Mr. Coggins also reviewed emails from when Johnson & Johnson "got caught" by the FDA, which suggested that Janssen was willful and intentional about what they did.

Mr. Coggins urged the jury to disregard any objections from Johnson & Johnson that no physicians were in fact deceived by any misstatements, because the plaintiff's burden in an enforcement case was only to show bad-behavior, not reliance.

For the defense, Steve Pugh, of Richardson Plowden, pointed out to the jury that South Carolina's complaint essentially revolved around an FDA-approved package insert or label, and a November 10, 2003 letter, which allegedly failed to properly disclose certain risks -- risks of weight gain, diabetes, hyperprolactinemia. However, said Mr. Pugh, "those side effects have been in the Risperdal FDA-approved package insert from Day One."

"Those side effects, those issues, those known risks...the state says they are in the wrong place! Ladies and gentlement...those side effects are in the label," said Mr. Pugh, "where the FDA says they're going to be. That's the FDA's decision. They tell us what our label is."

Because the label was meant for doctors, said Mr. Pugh, the lack of  evidence that any doctor was misled by the allegedly false communication, suggested that the what Janssen communicated was not in fact misleading.

The jury in the trial will be asked to rule only on liability, not damages; damages would be awarded by the Court in a subsequent proceeding. However, a subsequent damage award by the Court could potentially exceed $1B.

Timeline of Risperdal Approvals

CVN is webcasting the South Carolina v. Johnson & Johnson Risperdal trial live.


Topics: Pharmaceutical, Trade Regulation, SC v. Janssen Pharmaceutica