There are already hundreds of Medtronic bone graft lawsuits waiting in the courts, and the company will likely face serious legal repercussions for its unethical business practices. Civil action against pharmaceutical companies is nothing new. Drug and medical device manufacturers are regularly taken to task over their lack of safety research and often reckless promotion of their products. In this instance, though, the company’s negligence is so severe that it has attracted attention from the FDA, the Department of Justice (DOJ) and even the U.S. Senate. As a result, the company will likely face major punitive damages in addition to standard negligence claims.
Known as the INFUSE, this bone graft implant was approved for use in 2002 by the FDA. At the time, it was only approved for use in a small number of spinal surgeries. By 2007, it had also been approved for use in tibia and dental surgeries. The implant uses a synthesized protein known as rhBMP-2 to promote tissue growth around the spine and other implant areas. When it was first made available to the public, it was hailed as a major step forward in spine treatment.
However, the company wasn’t satisfied with its strong position in the market, and aggressively pushed off-label uses for its product – applications that the treatment was not tested for. This typically meant using the implant in cervical spine surgeries instead of the lumbar spine surgeries that the treatment was approved for. This aggressive promotion boosted the company’s sales in 2011 to nearly $900 million, and 85 percent of these implant sales were for off-label use. In 2006, the company paid a $40 million settlement to the DOJ for its unethical promotion of the implant, so it was apparently undeterred by the government’s attention.
The company also paid about $200 million to study authors to present the implant as completely safe to healthcare providers. In October 2012, the Senate Finance Committee reviewed the company’s interactions with study authors and determined that it was a major safety risk to consumers.
Perhaps some of this could be forgiven if the implants were indeed safe, but they are not. Hundreds of people are now claiming that the implant made their chronic pain worse or has resulted in nerve damage. Some people who received off-label treatment in the cervical region have suffered from deadly inflammation around the neck, restricting respiration and putting people at sudden risk of asphyxiation. The FDA has released several safety alerts in response, telling healthcare providers and patients to seek out alternative approved treatments when possible.
With its extreme recklessness, the company has even drawn civil action from its shareholders, which is rare. Company officials find themselves attacked from all sides, and with so many Medtronic bone graft lawsuits awaiting them in the near future, the company’s negligent business practices will be soundly punished.