Healthy Skepticism Library item: 19410

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
J&J Faces $360M Penalty Over Risperdal Marketing
Pharmalot 2011 Mar 23
http://www.pharmalot.com/2011/03/jj-faces-360m-penalty-over-risperdal-marketing/

Full text:

A South Carolina state court jury decided late yesterday that a Johnson & Johnson unit violated consumer protection laws by sending doctors a misleading letter in 2003 about the safety and effectiveness of the Risperdal antipsychotic. The jurors also found warning label info was deceptive. And so a judge will now decide whether $360 million in penalties will be paid, Bloomberg News writes.
South Carolina argued J&J’s Ortho-McNeil-Janssen Pharmaceuticals unit engaged in “unfair and deceptive acts” by claiming Risperdal was better than competing drugs in the letter, which was sent to some 700,000 doctors nationwide, including 7,200 in the state. The FDA issued J&J a warning letter about false and misleading claims that minimized risks, such as diabetes, and overstated benefits.
The state maintained J&J sent the letter in a bid to protect sales. Risperdal has been a huge seller for J&J. Sales peaked at $4.5 billion in 2007 but then began declining after the drug lost patent protection. Last year, Risperdal sales totaled $527 million, which is still more than the fine the drugmaker faces. J&J could be penalized $5,000 for each letter mailed to South Carolina doctors. “After the judge makes a determination as to damages, we will consider our options,” a J&J spokesman tells Bloomberg.
The case is the third of about 10 state lawsuits to be considered by jurors over Risperdal marketing. Last June, a lawsuit brought by Pennsylvania officials, who charged J&J hid the risk of diabetes and misled state regulators into paying millions more than they should have for the medicine, was dismissed (back story). A Louisiana jury ordered J&J in October to pay $257.7 million in damages for making misleading safety claims (see this), although $73 million in legal fees were later added. A West Virginia judge in a 2009 trial awarded $3.95 million, after finding J&J misled doctors about risks and benefits, although the state dropped its claim after J&J won an appeal, Bloomberg notes.