Surgeons use all sorts of tools to help their patients. Figuring out which is the best is not always easy. This can make an offer to try a new medical device tempting, but physicians are wise to take care before accepting such offers. Failure to follow the rules can lead to allegations of criminal wrongdoing.
How can the use of surgical devices lead to allegations of criminal wrongdoing?
Johnson & Johnson provides a recent example. The healthcare industry mega-giant found itself at the center of allegations of a serious healthcare law violation earlier this year. The federal government built a healthcare fraud case against the corporation, claiming it illegally provided a surgeon with medical devices. The prosecution argued the company attempted to illegally incentivize the physician into further use of the products.
The government states that there were multiple violations from 2013 through 2018. The violations allegedly involved a subsidiary of Johnson & Johnson providing spinal implants and instruments for spine surgery to aid in procedures. Neither the surgeon nor the hospitals paid for the devices. The government argues this violated the Anti-Kickback Statute (AKS).
A violation of the AKS can come with serious penalties. Individual physicians can face criminal penalties and administrative sanctions. This can range from time in prison to hefty financial penalties to exclusion from the ability to bill federal providers like Medicare.
How do those who face these types of allegations resolve their case?
In this case, Johnson & Johnson chose to settle the allegations instead of moving forward with a trial. They agreed to a $9.75 million settlement, with a portion going to the federal government, another to the state government, and approximately $1 million to a whistleblower who originally filed the case.
Negotiations are one option. In other cases, it may make sense to move forward with litigation. The best route depends on the details of the situation.
Attorney John Rivas is responsible for this communication
