Trade Regulation

Defense Verdict in Lemon Law Trial

May 11th, 2011  |  Published in Trade Regulation

Brian Cline and Julian Senior in Guillermo v KiaGuillermo v. Kia Motors (Los Angeles, California)

Fabian Guillermo claimed that his brand new 2006 Kia Sorrento began malfunctioning immediately after he purchased the car from the dealership, and he requested that the company replace the car. When Kia refused, Mr. Guillermo sue Kia under California’s Lemon Law.   

Julian Senior (O’Hagan Spencer LLP), representing Kia Motors America, Inc., suggested that the Mr. Guillermo’s claim was merely a cover for buyers’ remorse. According to Mr. Senior, nothing was wrong with the car, and that Mr. Guillermo was unable to find a specific fault that met the Lemon Law’s stric procedural requirements. “This is a case of buyers’ remorse. This is a case where the witness testified specifically on the stand that within 11 days of him…buying this car, he was back at the dealership complaining about a problem,” Senior said.  

Brian Cline (Bickel Law Firm), representing the plaintiff, countered that if it were a mere cover for buyer’s remorse, it would be strange to request that Kia repurchase the vehicle and sell him a new one, rather than refund Guillermo’s money. Further, Mr. Cline argued something was in fact wrong with the car, as evidenced by multiple service invoices and receipts for replaced parts and work done, by both the dealership and a local mechanic, all of which failed to eliminate stalling, electrical problems, and a problem with the drive shaft. “The facts of this case as you’ve heard them…require that Mr. Guillermo’s vehicle be repurchased,” Cline said. “They gave him the runaround. They said go to the dealer, the dealer said go to Kia, Kia said go back to the dealer. He asked for a repurchase … they didn’t even check the car.”  

The jury decided in favor of the defense, finding that there was no particular and substantial defect in the vehicle that substantially impaired its use, value, or safety.

Watch CVN’s webcast of the Guillermo v. Kia Lemon Law trial.

South Carolina Prevails in Risperdal Overcharge Trial

March 23rd, 2011  |  Published in Pharmaceutical, SC v. Janssen Pharmaceutica, Trade Regulation

John Simmons Steven Pugh John White LawyersSouth Carolina v. Janssen Pharmaceutica (Spartanburg, South Carolina).

South Carolina prevailed today on its Risperdal overcharge claim when a jury found that Johnson & Johnson’s Janssen Pharmaceutica misled consumers in its marketing for the antipsychotic Risperdal (risperidone). Louisiana last October prevailed on a similar claim and was awarded $257M; however, Johnson & Johnson won a Risperdal challenge in Pennsylvania. Texas’ Risperdal overcharge claim will be tried in June 2011.

With hundreds of millions in civil penalties potentially at stake, South Carolina sent attorney John Simmons of the Simmons Law Firm to make the closing argument.  Mr. Simmons told the jury, “As far back as 1994 the FDA told these guys you can’t make comparative claims [against first-generation atypical antipsychotics] outside of the label…They knew…You can’t bury studies. You can’t hide information…Yet you’ve got their own executives saying [in emails shown to the jury], ‘That’s what happened here.‘…The label is only as fair and truthful as the company and the people writing it.

We’re talking about a powerful drug going into the bodies of children in South Carolina, not even four years of age,” Mr. Simmons told the jury. “Is it important for drug companies to tell the truth? Absolutely…If this had happened twenty years ago, a lot of this we wouldn’t have had a record of. Because these are people communicating [by] talking; there’s nothing there. You now are able to see with your own eyes what actually happened, and what was said, largely because of the preservation of the electronic mail here. Digital footprints.

For the defense, Richardson & Plowden’s Steven Pugh characterized the state’s case as a “smoke screen,” and pointed out that millions of people had been helped by Risperdal. According to Mr. Pugh, Risperdal had been prescribed millions of times, “not because of some spin, not because of some way to make a bunch of money, not because of hidden data — they were prescribed Risperdal because, as the FDA has told us six times, it’s safe and effective. It works! Doctors saw that. They exercise their clinical judgment and decide what drug they are going to prescribe for their patient…The State doesn’t claim that Risperdol isn’t good medicince, and the State doesn’t claim that Risperdol has harmed anyone in South Carolina.”

“I submit to you ladies and gentlemen that unproven allegations of potential harm to the elderly and children has nothing to do with this case…The case is about two things: A letter, November 10, 2003, and the FDA-approved insert for Risperdal. The State has failed to prove that either is a violation of the South Carolina Unfair Trade Practices Act.”

In his closing rebuttal on behalf of the State, John B. White, Jr., of Harrison, White, Smith & Coggins told the jury, “We started out this case with ‘Thou shalt not lie.’ Maybe we should have said, ‘Don’t sell your soul for the almighty dollar…Corporate ethics is an issue that’s current. It’s affected our nation and South Carolina for the last 3-4 years. That’s what we’re talking about in this case. It’s not science — it’s corporate ethics…It’s about what Janssen knew, and didn’t tell.”

The jury found that Janssen Pharmaceutica made willful misstatements on both the Dear Doctor Letter and the label/package insert.

The amount of civil penalties to be imposed will be determined by the Court.

CVN webcast the South Carolina Risperdal overcharge trial live.

Risperdal Overcharge Trial Against J&J Begins

March 10th, 2011  |  Published in Pharmaceutical, SC v. Janssen Pharmaceutica, Trade Regulation

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.