Johnson & Johnson lost another case involving its outrageously deceptive marketing of the antipsychotic, Risperdal. This time, a South Carolina jury saw a "smoking gun" letter sent in 2003 to hundreds of thousands of doctors which deliberately deceived them about the risk of diabetes.
The FDA had ordered manufacturers of antipsychotics to issue warning letters to doctors apprising them about the increased risk of diabetes and deaths linked to Risperdal and the other drugs in its class.
Instead of complying with FDA’s requirement to warn about the serious risk, J & J/ Janssen, followed the example of Eli Lilly, which promoted its antipsychotic Zyprexa in violation of FDA’s requirement to issue warning letters to US doctors about the diabetes risk and reported deaths.
J & J sent a promotional letter that deliberately deceived doctors by claiming that "Risperdal is not associated with an increased risk of diabetes."
Jim Edwards (BNet blog, below) suggests that the jury was convinced of the company’s guilt by the internal company emails in which senior company officials acknowledged their own deceptive actions were "ugly" and not "competent."
"The warning letter is ugly … it’s really a black mark for J&J … [and] no competent person would have let [the ‘dear doctor letter’] go out”
These documents can be downloaded at Courtroom View Network :
Earlier, A Louisiana jury ordered the drugmaker in October to pay $257.7 million in damages to that state for making misleading claims about Risperdal’s safety. A judge later added $73 million in legal fees to the award.
Vera Hassner Sharav
Internal J&J Emails Detail “Ugly” Chapter in Mismarketing of Antipsychotics
By Jim Edwards | March 25, 2011
One of the reasons Johnson & Johnson (JNJ) lost a recent trial verdict over its misleading marketing of Risperdal was because jurors saw the company’s internal emails in which senior staff described their own actions as “ugly” and not “competent.”
Although the emails don’t reveal anything we don’t already know about Risperdal — J&J marketed the atypical antipsychotic for years by playing down the risk of weight gain and diabetes associated with the drug — the communications do give us a rare glimpse into the backbiting that happens inside drug companies when they fall afoul of the FDA. Pharmaceutical companies almost never discuss this kind of thing in public. (The documents can be downloaded at CourtroomView Network.)
In 2003, the FDA became increasingly concerned that use of drugs such as Risperdal and Eli Lilly (LLY)’s Zyprexa led to weight gain, diabetes and, in some patients, an early death. So it wrote to all antipsychotic drug companies to require them to send a “dear health care provider” letter to all U.S. doctors advising them of this risk (click to enlarge):
But J&J began trying to figure out whether the “dear doctor letter” could actually be used to promote Risperdal, which executives believed was not as risky as similar drugs. SVP/R&D Scott Reines (pictured) had seen a previous “dear doctor letter” from Eli Lilly that had used the same sleight of hand, and he asked a colleague, “how much commercial liability would we incur if we sent a similar letter about Risperdal”?:
When J&J’s letter went out, instead of heightening doctors’ awareness of the risk of diabetes it said the opposite: “Risperdal is not associated with an increased risk of diabetes”:
The FDA — unsurprisingly — hit the roof, and sent J&J a warning letter, blasting the company for being “false and misleading.”
Inside J&J, Reines was furious: “The whole management team almost got canned,” he wrote to chief medical officer Joanne Waldstreicher. “The warning letter is ugly … it’s really a black mark for J&J … [and] no competent person would have let [the ‘dear doctor letter’] go out”:
J&J faces up to $36 million in fines as a result.
J&J Risperdal Letter Violated Consumer Law, Jury Finds
By – Mar 24, 2011
(Corrects amount of potential penalties in second paragraph of story published March 22.)
A Johnson & Johnson (JNJ) unit violated consumer-protection laws by sending South Carolina doctors a misleading letter about the safety and effectiveness of the antipsychotic drug Risperdal, a jury concluded.
Jurors in state court in Spartanburg, South Carolina, deliberated more than six hours before finding today that J&J’s Ortho-McNeil-Janssen Pharmaceuticals unit engaged in “unfair and deceptive acts” by sending a 2003 letter touting Risperdal as better and safer than competing drugs to more than 7,000 doctors across the state. A judge will decide later whether the drugmaker should pay $36 million in penalties over the mailings.
“The verdict they handed down is just and speaks the truth,” John White, a Spartanburg-based lawyer representing the state, said in an interview. Jurors also found that J&J warning label information on Risperdal was deceptive.
The state’s case centered on drug-safety claims that New Brunswick, New Jersey-based J&J and Janssen made in November 2003 correspondence to about 700,000 doctors across the U.S., including 7,200 in South Carolina.
The U.S. Food and Drug Administration responded with a warning letter saying J&J made false and misleading claims that minimized the potentially fatal risks of diabetes and overstated the drug’s superiority to competitors’ products.
“We are disappointed,” Greg Panico, a J&J spokesman, said in a statement. “Janssen acted responsibly and believes it did not violate” South Carolina law, he said.
South Carolina officials argued in the case that J&J sent the letter to protect billions of dollars in sales of the antipsychotic drug.
Risperdal’s global sales peaked at $4.5 billion in 2007 and declined after the company lost patent protection. Risperdal generated $3.4 billion in sales in 2008, or 5.4 percent of J&J’s total sales, according to company filings. Sales of the drug fell to $527 million last year, J&J said in a January earnings report.
Risperdal Consta, the long-acting version of the antipsychotic drug, generated $1.5 billion in sales last year for J&J.
The case is the third of about 10 state lawsuits to be considered by jurors over J&J’s Risperdal marketing campaigns. In June, J&J won dismissal of Pennsylvania’s suit alleging the company hid the drug’s diabetes risk and tricked regulators into paying millions more than they should have for the medicine.
A Louisiana jury ordered the drugmaker in October to pay $257.7 million in damages to that state for making misleading claims about Risperdal’s safety. A judge later added $73 million in legal fees to the award.
A West Virginia judge in a 2009 non-jury trial awarded $3.95 million, finding the company misled doctors about the risks and benefits of Risperdal. The state dropped its Risperdal claim after J&J won an appeal, company officials said in February.
Under South Carolina’s unfair trade practices law, Janssen can be fined as much as $5,000 for each Risperdal letter sent to South Carolina doctors. Judge Roger Couch will decide the financial-penalty issue after an April 18th hearing.
“After the judge makes a determination as to damages, we will consider our options,” Panico said in his statement.
The case is State of South Carolina v. Janssen Pharmaceuticals, 2007-CP-4201438, Circuit Court for Spartanburg County, South Carolina (Spartanburg).
To contact the reporters on this story: Jef Feeley in Wilmington, Delaware, at firstname.lastname@example.org; Gary Henderson in Spartanburg, South Carolina at email@example.com.
To contact the editor responsible for this story: David E. Rovella at firstname.lastname@example.org.