Healthy Skepticism Library item: 19356

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Publication type: news

Feeley J, Henderson G
J&J Misled South Carolina Officials About Drug, Jury Told
Bloomberg News 2011 Mar 8
http://www.bloomberg.com/news/2011-03-08/j-j-misled-south-carolina-officials-about-risperdal-jury-told.html

Full text:

Johnson & Johnson duped South Carolina officials into buying the antipsychotic drug Risperdal for Medicaid patients by making false claims about its safety and effectiveness, a lawyer for the state told jurors.

Officials of J&J, based in New Brunswick, New Jersey, made misleading claims about Risperdal’s health risks in a letter sent to South Carolina regulators and doctors to protect sales of a medicine that generated $33 billion in revenue for the drugmaker during a 13-year period, the lawyer, Donald Coggins Jr., said today in state court in Spartanburg, South Carolina.

“This case is about corporate responsibility and not going out to lie to defenseless people in pursuit of the almighty dollar,” Coggins said in opening statements of the trial of the state’s lawsuit against Johnson & Johnson.

The state’s case centers on drug safety claims that J&J and its Ortho-McNeil-Janssen Pharmaceuticals unit made in November 2003 correspondence to 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.

A J&J attorney, Steven J. Pugh, urged jurors in his opening statement to reject allegations by state Attorney General Alan Wilson that the drugmaker duped doctors and state regulators into approving the drug for Medicaid patients.

Third Jury Trial

“The state is not going to bring in a single South Carolina doctor to say they were deceived,” Pugh told the jury today.

Risperdal’s global sales peaked at $4.5 billion in 2007 and declined after the company lost patent protection. It 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, according to a January earnings report.

Risperdal Consta, the long-acting version of the antipsychotic drug, generated $1.5 billion in sales last year for Johnson & Johnson (JNJ), officials said this month.

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.

$257.7 Million Verdict

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.

Johnson & Johnson’s Risperdal marketing didn’t violate South Carolina’s unfair-trade practices law, company officials said in an e-mailed statement.

The drugmaker “is prepared to vigorously defend itself against” the state’s claims, Greg Panico, a company spokesman, said in the statement.

Coggins told jurors that FDA regulators sent J&J a warning about its Risperdal marketing practices in 1999, well before the company sent its letter on Nov. 10, 2003. J&J wrote to tell doctors the FDA wanted all makers of so-called antipsychotics, including J&J, Pfizer Inc. (PFE) and Eli Lilly & Co. (LLY), to warn about the risk of diabetes on product labels.

Warning Letter

An FDA warning letter sent in April 2004 said J&J’s missive from the previous November failed to disclose new data on diabetes in the warning label, Coggins said.

The FDA letter said the drugmaker minimized “the risk of hyperglycemia-related adverse events” that can lead to coma or death, failed to recommend glucose control monitoring for patients, and misleadingly claimed Risperdal was “safer than other atypical antipsychotics.”

The case is State of South Carolina v. Janssen Pharmaceuticals, 2007-CP-4201438, Circuit Court for Spartanburg County, South Carolina (Spartanburg).