Companies that manufacture medication or medical devices are required to report adverse events regarding their products to the FDA. When this system fails, it can come back to haunt both the company and the Food and Drug Administration itself. One only needs to look at the Medtronic bone graft issue to see this clearly.
It is a federal law that when an adverse health event related to a medication or a medical device is reported to the manufacturer, that must be reported to the FDA in turn within 30 days. Despite this, employees at Medtronic shut down a two-year study of 3,600 patients that had received the company’s Infuse bone graft without notifying the agency.
After this, thousands of patients would file complaints about the device. Investigations were opened by Congress, the Justice Department, and several states. These investigations demanded that information be handed over by Medtronic. Instead of answers, neither the company nor the FDA has released all of the results of the study.
The Infuse bone graft’s packaging details some of the potential side effects: bone overgrowth, spinal nerve inflammation, bowel problems, and male sterility to name a few. At the time that these side effects were released, Medtronic only had reported some 261 adverse reactions to Infuse. However, the second study turned over more than 1,000 adverse reactions and was handed over to the FDA nearly five years after it had been requested.
The FDA said nothing about the late reporting of the adverse events. In the three-sentence summary, the total number of adverse events was blacked out.
When Infuse was approved by the FDA in 2002, it was only for a specific type of surgery. Detractors had concerns about the approval of the bone graft device, stating that doctors and surgeons would begin to use it for other, unapproved types of surgery.
Initially, it was only approved for spinal fusion surgeries accessed through the abdomen. However, surgeons began using the bone graft for surgeries through the back and for other types of uses, including vertebral fusion and fusing more than one vertebrae or bone together.
In 2012, the Senate Finance Committee held an Infuse inquiry. The committee concluded that Medtronic had been heavily involved in shaping, editing, and writing the research of company-paid physicians. These physicians collected some $210 Million from 1996-2010. The committee also found that the research downplayed problems with Infuse and highlighted problems with competing products.
Today, Medtronic’s lawyers have their work cut out for them. They are sorting through more than 6,000 from Infuse patients. In addition, they are also fighting a racketeering lawsuit from Humana over Infuse claims. The company has also paid out more than $85 million to shareholders who claim that the Infuse controversies have hurt the company’s stock price.
Medtronic, however, continues to aggressively market the Infuse device. While in the recent past sales slumped, the most recent quarter in the United States shows double-digit growth in Infuse devices sold.
If you have suffered an adverse health event after having an Infuse bone graft performed, you may be entitled to compensation. Contact the law offices of John Foy & Associates. The “Strong Arm” attorneys will work to get you the compensation you deserve.