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Off-Label Marketing Issues Explored at CLE Program

hli-cle-4-25-2008-web

From left to right: Hamline law student Mark Gardner, Michelle Kern, General Counsel at Cima Labs; Hamline law student Amy Fowler; Marc Raspanti, partner at Pietragallo Gordon Alfano Bosick & Raspanti; Michael Loucks, First Assistant U.S. Attorney, U.S. Attorney's Office, District of Massachusetts; Mary Prentnieks, senior attorney with Medica; and Mark DuVal, partner at DuVal & Associates.

Business pressures in the pharmaceutical and medical device industries have led some companies to take quality "shortcuts" and sometimes break the law, reported Massachusetts First Assistant U.S. Attorney Michael Louks at a recent breakfast CLE sponsored by Hamline's Health Law Institute and the Minnesota State Bar Association.

"The vast majority of companies do the right thing, but sometimes they fail to comply with FDA regulations due to negligence or tremendous pressures to get products out on time," he said.

Nearly 100 people attended the program, "Off-Label Marketing of Prescription Drugs and Medical Devices," many of whom were professionals from the medical device industry in Minnesota. It was held at Hamline University School of Law and moderated by Hamline Health Law Institute Director Lucinda Jesson. A copy of Marc Raspanti's presentation is available here. A copy of Michael Louks' is available by following this link.

Marc Raspanti, a partner at Pietragallo Gordon Alfano Bosick& Raspanti in Philadelphia, was the second speaker. He said "There are a lot of opportunities to do things wrong" and cited examples of companies that participate in kickbacks to physicians or misrepresenting results during clinical results. Raspanti also said the trend of large companies acquiring smaller ones has made it difficult for "the mother ship company" to effectively police their own internal practices.

The number of cases brought against medical device and pharmaceutical companies has "more than doubled in the past fours over the previous four years," said Louks.