State turns focus onto J&J sales efforts – News – Bartlesville Examiner-Enterprise

NORMAN (TNS) — For six hours in a downtown Norman courtroom, a corporate representative for Johnson & Johnson and an attorney for the state of Oklahoma debated the company’s sales practices.

Brad Beckworth questioned Johnson & Johnson corporate representative Kimberly Deem-Eshleman for the second consecutive day, focusing on dozens of call notes written by Oklahoma sales representatives, primarily from between 2002 and 2005.

In a 2001 summary of a meeting between Janssen and more than a dozen industry opinion leaders, Janssen was warned about using the reportedly low abuse potential of its fentanyl patch Duragesic in sales calls. Some of the industry leaders also warned that using data from several studies or information from the Drug Abuse Warning Network (DAWN) was problematic, because the studies were flawed or incomplete.

Selected call notes presented by Beckworth repeatedly mentioned these studies and data, as well as sales reps discussing Duragesic’s relatively low abuse potential during visits with doctors. Beckworth noted that while Janssen was warned in 2001 about using such information, sales reps continued to do so. He also noted repeated use of the words “drive,” “influence” and “close” in relation to sales reps’ conversations with doctors and their staffs.

Sales reps also often mentioned vouchers or coupons in the presented call notes. These vouchers could be given by doctors to patients so they could receive a free, limited-time prescription to Janssen medications. Call notes also referenced “switching” doctors and patients from competitors’ products like OxyContin to Janssen products.

“The activities of Company sales representatives were appropriate, proper, and lawful, and they received extensive compliance training,” John Sparks, Oklahoma counsel for Janssen and J&J, said. “Any switching of patients from hydrocodone or oxycodone to Janssen’s medications stood to decrease overall abuse because the Company’s products had lower rates of diversion and abuse.”

In 2004, the FDA warned Janssen that the file card for Duragesic “makes false or misleading claims about the abuse potential and other risks of the drug, including unsubstantiated effectiveness claims for Duragesic.”

Deem-Eshleman said the data used by sales reps was, at the time, considered good data.

“All of those studies were valid studies. They were studies that were considered good science. They were reviewed in peer review journals,” she testified. “The FDA indicated they just did not want us to use them in promotional activity. And that letter came in 2004, and we didn’t agree that they were bad studies or bad science and we talked to the FDA about that. But ultimately, we did pull that sales aid…”

• Fundamental disagreement: Attorneys for Johnson & Johnson/Janssen filed a renewed motion Friday to exclude Deem-Eshleman’s testimony on documents and topics she had no knowledge of. While Deem-Eshleman was designated as J&J’s corporate representative, J&J attorneys assert she was never designated to represent J&J subsidiaries or related companies Janssen, Noramco or Tasmanian Alkaloids. Cleveland County District Judge Thad Balkman, who is presiding over the case, said the state will have an opportunity to read and respond to the motion, and then he will rule on it.

Beckworth quizzed Deem-Eshleman about company documents she consistently testified she had no knowledge of, read portions of the documents and then asked her to read other portions. J&J asserts in the motion that doing so is a waste of the court’s time and out of her scope as a lay witness.

Beckworth argued Friday that J&J sent Deem-Eshleman as the face of its company and J&J should have sent someone who had knowledge of its subsidiaries.