AGREE OR DISAGREE? DEBATE:

With regard to the testimony from Mr. Rooning, I believe his testimony undermined the government's case. This case involved a medical device marketed for the treatment of varicose veins. The government alleges that the device was marketed incorrectly, and although the testimony did not clearly indicate the FDA approval of the device for perforator veins, the government came across as a bully to Mr. Rooning, attempting to intimidate him into allocution. I believe that Mr. Rooning and the company did their due diligence on compliance protocols and billing practices. The government would have you believe that the company was completely derelict in its duty and utilized a device in a harmful way. That is simply not the case.

The second testimony I chose for discussion purposes was that of Catherine (Cate) Haven. This testimony to me bolstered the government's claims because of the legal allegations brought forth from the separated employee. While the employee may have come forth from a place of retaliation, the alleged wrong doing by the organization is fairly blatant here, particularly when Ms. Haven stated that if these statements had been made prior to the employee's leaving, she would have been duty bound to perform more investigation.

All of the testimony together provides an intriguing picture for the court to decipher. The internal emails and documents provided by the company as a whole clearly indicate that the company knew the device was not FDA approved for that indication and proceeded to market it to physicians for use anyway. However, as reiterated in the testimony of Ms. Haven's if the physician had discovered the use for the device, we wouldn't be having this discussion. I think the FDA uses the off label use guidelines in some cases to bolster their recovery numbers.