QUESTIONS:

BRIEF a summary of your reaction and lessons learned from the jury deliberation. Answer these questions:

• Were you able to come to an agreement? Why or why not?
• What evidence did others focus on that you had not previously considered? Do you think you should have focused on it more or did the others give it too much weight? Why/why not?
• Did anything surprise you in the jury deliberations?
• What additional evidence would you need to see to change your mind as to whether VSI was guilty?
• What changes would you make to your closing argument to try to convince any jurors who disagreed with you?
• Do you think the jury deliberation process is an effective tool for determining whether someone violated the law? How could it be improved?

OVERVIEW:

https://www.justice.gov/opa/pr/vascular-solutions-inc-pay-520000-resolve-false-claims-allegations-relating-medical-device

VSI is a publicly traded medical device company Employs hundred of people, including marketing and other personnel at headquarters, along with a sales force that travels the country Company sells many devices to treat vein-related disorders

Laser device that treats people with varicose veins in the leg Varicose veins is a disease of the vein in the leg Leg veins carry blood that needs oxygen back to the heart and lungs Veins closer to the skin are in the superficial system Veins deep in the leg are part of the deep system Two systems are connected by perforator veins

When valves in the legs stop working they are called varicose veins The blood can flow backwards and pool in the leg Untreated veins can cause serious pain and become infected

Case focuses on how company promoted the Vari-Lase device Device includes a console and kit Console creates laser energy Kit has tools to access veins and burn them shut VSI sells the product to doctors who use the device to treat varicose veins

Vari-Lase product line has over 80 different versions, including different consoles and kits Longer fibers treat longer veins, and shorter fibers treat shorter veins VSI developed a "Short Kit" that was only 10cm in length. It was designed to treat short segments of veins. The Short Kit could be used to treat perforator veins

Recall 510(k) submission process from prior lectures FDA considers whether a device is substantially equivalent to one that's already on the market Once you have a legally marketed device, company can change the device's intended use as long as it's not a "major" change.

Vari-Lase product was first cleared in 2003. Added third part to indications statement that focused on superficial veins VSI filed new 510(k) in 2005 to seek change to indication statement

In 2007, VSI again wanted to add to the indications for use statement. Filed a 510(k) proposing to add three specific types of veins: Short Saphenous vein, tributary veins, and perforator veins FDA raised concerns and asked that VSI additional research because treatment of perforator veins might be different VSI never did additional research FDA sent letter to VSI that indicated it could not market the device

VSI launched the Short Kit around the same time Company did not use the Indication for Use that referred to perforator veins Company created a new Indication for Use that referred to "Short Vein Segments"

VSI instructed sales force not to promote the Short Kit for use on perforator veins Sales force instructed to promote the device for use on short vein segments Company promoted the device until government began investigating VSI's promotion of Short Kit for use on perforator veins.

Summary Response:

The evidence presented by the prosecution does not prove that Vascular Solutions, Inc. (VSI) knowingly promoted the Vari-Lase device for an off-label use. There is no direct evidence that VSI intended to promote the device for perforator veins, and the testimony of Fred Rooning and Dan McGaff is unreliable. Additionally, the evidence does not prove that VSI violated the Fraudulent Claims Act, Anti-Kickback Statutes, and Parks Doctrine.

• We have given evidence that shows that Vascular Solutions, Inc. (VSI) did not knowingly and willfully advocate the use of its Vari-Lase device for the treatment of perforator veins. Ladies and gentlemen of the jury, we thank you for your attention to this matter. VSI developed the Short Kit to treat short segments of veins, including perforator veins. This kit was designed to treat short segments of veins. On the other hand, VSI told its sales team not to market the Short Kit as an option for use on perforator veins.
• The evidence that was given by the prosecution was circumstantial, and it did not prove that VSI pushed the Vari-Lase device for an off-label usage intentionally. There is no information that can be directly interpreted to suggest that VSI planned to market the device for use in perforator veins. There is no indication in the emails and account communication papers provided by the government that VSI had any intention of promoting the Vari-Lase device for perforator veins.
• The testimony provided by Fred Rooning and Dan McGaff cannot be relied upon and does not indicate that VSI intentionally advertised the gadget for an unapproved use. The testimony provided by Mr. Rooning implicates himself and his own wrongdoings, while the testimony provided by Mr. McGaff does not present any direct evidence of VSI's intention to promote the device for an off-label usage.
• In addition, the evidence that was presented by the prosecution does not demonstrate that VSI violated the Fraudulent Claims Act, the Anti-Kickback Statutes (AKS) for Dr. Black, or the Parks Doctrine for the executives of VSI who had direct knowledge of promoting off-labeling products that were not affirmed by the United States Food and Drug Administration (FDA). The government contends that VSI deliberately marketed the use of the Vari-Lase Short Kit for perforator veins, which was not an approved use by the FDA, and that the business devised a new indication for use statement that referred to "Short Vein Segments" in order to avoid being discovered. Additionally, the government claims that VSI knew promoted the use of the Vari-Lase Long Kit for spider veins, which was also not an allowed use by the FDA.