Medical Device Daily Washington Editor

The U.S. Department of Justice reported Tuesday that it has arraigned four executives of the North American division of Synthes (Solothum, Switzerland), charging them each with one misdemeanor count of shipping adulterated and misbranded medical devices into commerce. The charges stem from the distribution of the Norian XR, approved as a bone void filler putty, that is said to have been the subject of a promotion for use in vertebral compression fractures. The indictment also charges Synthes North America (SNA; West Chester, Pennsylvania) with 44 misdemeanor counts for shipping the Norian XR, made by a subsidiary of SNA, Norian (also West Chester, Pennsylvania), which itself is charged with 52 felony counts, including seven counts of making false statements to an FDA investigator.

According to the June 16 DoJ statement, the indictment names Michael Huggins, the president of SNA, along with three others for conspiring with officials at Norian "to conduct unauthorized unauthorized clinical trials" for the unapproved indication despite the fact that pilot studies indicated "that the bone cement reacted chemically with human blood in a test tube to cause blood clots." Animal testing indicated that the clots broke loose and lodged in the lungs, inducing pulmonary embolisms.

Norian is said to have conducted two surgeon meetings and one surgeon forum to promote the device's off-label use between August 2003 and January 2004. The indictment alleges that the firms did not terminate the marketing practice "until after a third patient had died on the operating table," although DoJ does not specifically allege that any of the deaths were caused by the device. Later in 2004, FDA inspected the Norian plant where the product is made to check up on allegations of the unapproved trial, but "a number of Synthes employees," including the four executives named individually in the indictment, "made materially false and misleading statements" to the FDA investigator.

Norian faces fines of up to $26 million and five years probation, and Synthes could be fined as much as $8.8 million and could end up on probation for five years as well. The individual defendants could be sentenced to a year in jail and a year's probation, and may be fined $100,000 each.

According to a June 16 statement posted at the SNA web site, the company "has fully cooperated with the government's investigation, which began in 2006, and believes that its marketing practices in connection with Norian XR were proper." The company "intends to vigorously defend itself against the charges," the statement said.

The case serves as another flashpoint for the orthopedic industry, which has been tarred by allegations of improper promotion in connection with another bone void filler product made by Stryker Biotech (Hopkinton, Massachusetts: Medical Device Daily, April 21, 2009). These cases will not figure prominently in today's hearing in the House Energy and Commerce's health subcommittee on 510(k) clearances, but FDA commissioner Margaret Hamburg, MD, has indicated an interest in reining in approval and clearance activities at the Center for Devices and Radiological Health.

In an interview with the Wall Street Journal published yesterday, Hamburg said that "there obviously have been some problems" at CDRH, adding that she intends to take "a hard look" at the device approval processes. The bad news about Synthes cannot help but add fuel to the fire, and device makers are growing more concerned that device approval times will start inching back up and that investors will flee the industry for safer waters.

'Meaningful user' not yet defined

David Blumenthal, MD, director of the Office of the National Coordinator for Health Information Technology (ONCHIT) is in charge of overseeing a number of tasks in connection with HIT, but a Tuesday press conference showed that making strides in the proliferation of HIT will likely prove tougher than anticipated. Blumenthal said that despite the expenditure of a considerable amount of time and energy, the definition of "meaningful user" will not be ready to roll out just yet.

Blumenthal said this definition is "the critical criterion that adoption of HIT has to satisfy to get incentives" for physician practices and hospitals. The discussion of this definition undertaken by the HIT Policy Committee was "a lively discussion and it was decided ... that we would take the discussion back to work on a little longer," Blumenthal said, adding that the committee hopes to present the initial proposed definition in about a month.

Blumenthal said ONCHIT will be "receiving public comments over the next 10 days (until June 26) and a longer period of public input" as the draft fills out. As for physicians, he said, "I anticipate we will be hearing from them" on things such as "how fast they can adopt electronic records."

Blumenthal acknowledged that the HIT vendor industry may have a tough time dealing with an avalanche of demand should providers stampede toward electronic health records in response to incentives. "We're working on a series of programs that will enable us to provide support for" providers, he said, adding that "we'll do our best" to ensure that everyone who wants to get on board can do so. He also said that it is too early to determine whether, and even how, EHR systems would deal with unique device identifiers, and declined to offer a fixed date for publication of a final definition for "meaningful user."