Update on Surgeons' Subpoenas (DOJ Investigations)
BY SUSAN BERSON, NOVEMBER 9, 2005
[Editor's note: We welcome attorney Susan Berson of Mintz, Levin as a guest blogger. See her profile here.]
Earlier this year, the government announced investigations of several device manufacturers charging that the manufacturers were offering inappropriate incentives to referring physicians to use their devices. If the past provides a clue to the future, it was only a matter of time before surgeons were subpoenaed to provide information to the government on the arrangements that the manufacturers had entered into with the provider community.
In previous government investigations, including one of the first in the area of illegal remuneration (Hanlester Network) and also one of the most recent and largest (TAP Pharmaceuticals), the government interviewed hundreds of physicians to gather information about the arrangements under scrutiny. In fact, not only were the physicians interviewed, but in many cases charges were brought against them in connection with the claims of illegal marketing activities undertaken by the targeted companies.
While there is not a great deal of information yet available, we understand that surgeons are being subpoenaed in connection with the ongoing device manufacturer investigations. We understand that some surgeons are being contacted just as witnesses, while others may be subjects or potentially targets. If we take a lesson from the TAP investigation, the contacts being made, may, in addition to serving the purpose of determining if some of the surgeons should in fact be under investigation, be for purposes of simple information gathering or for pressuring the manufacturers to make full disclosure and/or settle.
From the information gathering perspective, the government may be trying to distinguish between bona-fide agreements for services and those that have only one purpose - to reward referrals. In contrast to some of the investigations in the pharmaceutical industry, the investigations in the implantables industry involve consulting agreements that may be critical to the development of advanced technology. The government itself has recognized that in the device area, there is a bona-fide need for consulting arrangements that ensure the development of technology. Thus, while information gathering as to the purposes behind an agreement between a supplier and a referral source is always critical to an investigation, it may be even more so under these circumstances where more "gray" may exist as to the bona-fides of the relationships. That being said, if the government believes that there are surgeons who requested and/or participated in arrangements that serve no real purpose other than to reward the surgeon for the use of the company's product, those surgeons could easily find themselves next to the company as a target of the investigation.
