Federal Officials Scrutinizing Company Payments to Doctors


By BARRY MEIER
Published: September 22, 2006
Ela Medical, a small producer of implantable heart devices, said this week that it had received a subpoena from federal health care fraud officials seeking information about possible inducements paid by the company to doctors using its products.

In response to an inquiry last week from a reporter, Ela Medical stated that it had received an administrative subpoena from the inspector general of the Department of Health and Human Services. The company is a division of the Sorin Group, which is based in Milan.
According to Ela Medical, the subpoena sought any documents related to “arrangements, clinical studies, provision of monitoring equipment and services and other agreements by which the company may have provided benefits to persons in a position to recommend purchase of devices.”

Federal law prohibits certain types of payments to doctors that are meant to influence their choice of a particular product. Ela Medical, which has previously said that it complied with all relevant laws, said in its statement that it was cooperating with the investigation.

Last year, the Justice Department started to investigate the country’s biggest makers of heart devices — Medtronic, St. Jude and Guidant — to determine if they provided doctors with excessive payments to enroll patients in postmarketing studies of their devices as a way of increasing sales. All three companies have said they did nothing wrong.

Such studies can have questionable scientific value, experts say.

In March, a federal official said that the government had begun an inquiry into Ela Medical that was focusing on, among other things, financial relationships between the company and doctors in the Miami area, including physicians who were enrolling patients in postmarketing trials.

At that time, however, officials of Ela Medical said they were unaware of any government inquiries into its practices. Earlier this week, a spokeswoman for the Sorin Group said it had received a subpoena last week.

Ela Medical had only a small piece of the market in this country for heart devices like defibrillators, according to analysts’ estimates. Together, it and Biotronik, based in Berlin, have about a 5 percent market share.