Johnson & Johnson Fined $1.2 Billion for Drug Labeling FailurePosted by Pratap Chatterjee on April 12th, 2012
Johnson & Johnson has been fined $1.2 billion over sales of Risperdal, an antipsychotic drug. Tim Fox, a circuit judge in Arkansas, ruled that the company has to pay $5,000 for each of the 240,000 prescriptions that were paid for by the state’s Medicaid program. (The program provides health care for low-income citizens, financed by the taxpayer)
Risperdal was introduced in 1994 by Janssen Pharmaceuticals Inc., a subsidiary of New Jersey-based Johnson & Johnson. It is prescribed for treatment of schizophrenia and short term episodes of bipolar disorder (manic depression) as well as irritability connected to autism in children.
In 2004 the U.S. Food and Drug Administration (FDA) forced the company to put labels on the drug to warn that Risperdal places elderly patients with dementia at an increased risk of strokes, seizures, major weight gain, possible diabetes and fatally high blood sugar, as well as potential death.
Fletch Trammell, a Houston lawyer acting on behalf of Arkansas, told jurors that the company had previously sent out a letter saying the drug did not increase the risk of developing diabetes. Tramell noted that some patients gained 60 to 100 pounds (27 to 45 kilos) in weight as a result of taking the medication, which in turn increased the risk of diabetes.
"The law is broken once they tell a lie," Trammell said. "You have to ring the bell. You have to tell the public.” He noted that patients in rural Arkansas were not able to get up to date information from specialists.
Jurors in the Arkansas trial were also told that the company avoided such labels because of the potential impact on its share price, which could have reached $200 million.
But Johnson & Johnson says that Arkansas has no grounds to sue them because it did not pull the drug at the time. “They didn’t run off and sound the alarm at the time this suit was filed,” James Simpson, a lawyer for the companies, told the jury. He says Arkansas should have told patients: “Whoa, whoa, whoa, this stuff is dangerous.”
Dozens of states have sued the company. Last year, Johnson & Johnson and Janssen was fined $327 million in South Carolina and in January, Texas settled a lawsuit against the company for $158 million.
The Arkansas fine is the biggest so far. “Johnson & Johnson and Janssen Pharmaceuticals lied to patients and doctors because they cared more about profits than people,” said Arkansas attorney general Dustin McDaniel.
The company has said it will appeal. "Janssen firmly believes it did not violate the Arkansas Medicaid Fraud False Claims Act or the Arkansas consumer fraud statute. ... It is our position that an individual state should not penalize a pharmaceutical company for using an FDA-approved package insert or decide for itself whether a company complies with FDA rules," the company said in a statement.
Johnson & Johnson is also facing lawsuits over its hip-replacement technology. DePuy, a division of Johnson & Johnson, recalled 93,000 XL Acetabular metal-on-metal hips in August 2010 after experiencing a 13 percent failure rate. Some 5,000 product liability lawsuits have since been filed against the company. An FDA advisory panel of experts is to examine this issue in late June.
William Weldon, the company’s outgoing CEO, was confident that the company's finances will recover from the string of lawsuits because of their target audience. “Populations in the developed world are ageing rapidly, and we consume more healthcare as we grow older,” Weldon said. “Our investments continue to be aligned with these market opportunities.”
At upcomming Q1 release of financial results to investors in J&J, aAnalysts likely will ask about liability in continued litigation over allegations J&J marketed former blockbuster schizophrenia drug Risperdal too aggressively, including for unapproved uses. On Wednesday, an Arkansas judge fined J&J more than $1.1 billion for downplaying and concealing Risperdal risks such as major weight gain and developing diabetes. That ruling, which will be appealed, could affect dozens of pending lawsuits over the drug, many by states seeking reimbursement for what their Medicaid programs spent on the drug.
WHY IT MATTERS: While J&J has gotten past a spate of generic competition that slashed sales of blockbuster drugs for infections and attention deficit disorder, it continues to lose hundreds of millions of dollars a year due to manufacturing quality problems. About 30 product recalls since September 2009 -- for faulty hip implants and contact lenses, a couple of prescription drugs and Tylenol and many other nonprescription medicines -- have kept products off the market for as long as two years. J&J is operating under increased government oversight and was forced to gut and rebuild a huge factory.
Sunday, April 15, 2012
The law suits keep on comming for J and J, the parent of Depuy.
Posted by Connie at 3:45 AM