Speak Up

This is one in a series of posts written by David Harlow, Chief Compliance and Privacy Officer, adapted from our internal “Compliance Corner.”

Last summer, a medical device company settled a False Claims Act case by agreeing to pay nearly $40 million. In this case, the medical claims were considered "false claims" because the device sold to Medicare beneficiaries and billed to Medicare was defective.

The Acting U.S Attorney who announced the settlement said:

Health care companies have an obligation to be candid and clear in their disclosures to the FDA. The government expects companies to be proactive in investigating issues affecting patient safety. The U.S. Attorney's Office … will hold accountable any company that fails to meet these obligations.

The company in question made blood coagulation monitors for patients taking anticoagulation drugs and allegedly sold monitors when it knew that the algorithm in the monitors had a material defect (not disclosed to the FDA), making the measurements unreliable. There were over a dozen deaths and hundreds of injuries allegedly associated with the defect, and the company allegedly concealed the defect and billed Medicare for the monitors, and didn't take appropriate corrective action until the FDA required a nationwide recall.?

This case demonstrates the importance of quality control, of internal communication, communication with regulators, and integrity. As I recently shared with my colleagues (at Insulet, a medical device company), if we do our best with respect to each of these four key building blocks, we will dramatically limit the chances of going down this sort of path.

The issue, in this case, was described as a "system limitation." It may be human nature to minimize the importance of such a limitation, thinking that there may be workarounds available to compensate for such a problem.

My company also designs, manufactures and sells medical devices. There are really two lessons here for us, and for any enterprise that aspires to operate as a high-functioning team:

• One can be summed up by the old carpenter's saying: Measure twice, cut once.
• The other makes me think of … well … the Grateful Dead (or their source, Elmore James) and Benjamin Franklin. Do you know who said (sang) which? "When things go wrong, wrong with you, it hurts me too." and "We must, indeed, hang together or, most assuredly, we shall all hang separately."

The first lesson, in other words, is that we all need to be careful, we all need to double-check our own work, and we need to check others' work when that is our job or when we see something that seems out of whack.?

The second lesson is that we are all, at a fundamental level, accountable for each other and accountable to each other. We help each other by being the best we can be and ensuring that our work is the best it can be.

That is how we support each other and all our constituencies, both within our immediate community and beyond.

David Harlow

Chief Compliance and Privacy Officer ?