Whistleblower attorney Erika Kelton responds to claims about Jazz Pharmaceuticals’ off-label case

NEW YORK CITY, Jan. 10, 2012 -- The Wall Street Journal published on Jan. 4, 2012, an edited version of the following letter to the editor written by Phillips & Cohen partner Erika A. Kelton, who represented the whistleblower in a qui tam case against Orphan Medical (later acquired by Jazz Pharmaceuticals). The government joined the whistleblower lawsuit. Jazz Pharmaceuticals paid $20 million to settle the qui tam case and a related criminal fine.

Dear Editor:

Harvey Silverglate's op-ed Dec. 26 ("A Doctor's Posthumous Vindication") distorts both a federal appeals court ruling and the grounds for Dr. Peter Gleason's conviction. The court ruled that pharma sales representatives can't be convicted for making truthful statements about a drug's effectiveness in treating particular medical conditions even if the Food & Drug Administration hasn't approved that use. There was nothing truthful about Gleason's statement that "table salt is more dangerous" than Xyrem or other sales pitches (which Silverglate calls "lectures") he made to convince fellow doctors to prescribe Xyrem. For those sales pitches, Gleason was paid tens of thousands of dollars by Xyrem's manufacturer, Orphan Medical - a point Silverglate omitted.

The government was right to prosecute Gleason because he violated the law and people's health and lives were at stake. Xyrem can have serious side effects and when improperly used can induce comas and cause death, which is why it has a "black-box" warning. Orphan also was prosecuted for promoting Xyrem for dangerous, unapproved uses and pleaded guilty. Jazz Pharmaceuticals, which acquired Orphan, paid $20 million to settle civil and criminal charges. In no way did the appeals court ruling vindicate Gleason or Orphan.

Erika A. Kelton
Phillips & Cohen LLP