When Off-Label Use Becomes a Problem

When Off-Label Use Becomes a Problem

Australian food and drug regulators are investigating Medtronic and the selling of a controversial product, Infuse Bone Graft, without a safety component necessary for compliance. The Minnesota-based medical device giant denies the product was pulled due to compliance issues. In the meantime, a whistleblowing former employee told regulators the company has been selling the product without the safety feature—a titanium LT-cage device. While the company maintains doctors have the choice to use the product in an off label manner, the risks of doing so appear significant. A government investigation in Australia ensues. 

Wrongdoing in Australia?

Recently, Jim Spencer and Joe Carlson with the Minneapolis StarTribune report on an interview with Craig Moy, a consultant with a group representing private health insurance funds in Australia (Private Healthcare Australia or PHA), who commented, “There has never been an LT-Cage funded by one of our [private] health insurance funds in the 14-plus years Infuse was sold in Australia. Australian payers have paid up at least $350 million for Infuse since 2006 estimates PHA. Apparently little of these funds went to the actual indicated use which is the fusion of two bottom spinal vertebrae. Medtronic has denied any wrongdoing.”

Medtronic Position

A large, regulated company such as Medtronic must follow strict compliance and quality guidelines via quality management systems, which applies to commercial activity as well. Medtronic maintains strict policies, procedures and myriad systems to control for breaches in quality and compliance.  

A spokesperson, Ben Petok, commented that, “Medtronic policies and training expressly provide that the company and its employees promote our products only for those consistent with the labeling approved by the appropriate regulatory authority.” This author has interfaced with Medtronic before and can attest the company manages and maintains a vast compliance operation cutting across all departments and divisions.

Off-Label Use

Medtronic maintains it is perfectly acceptable for physicians to opt to use the safe feature, again known as LT-cage. The medical device company maintains that the physician must have the flexibility to determine depending on the specific situation in surgery whether this specific feature is used or not. The feature involves a cage, which inhibits bone growth in the spinal canal, a threat to nerves (e.g. heterotopic ossification).

Spencer and Carlson report that perhaps the crux of the matter is that Medtronic supports the use by doctors of Infuse off-label. However, intense litigation has ensued in association with such off-label use, including, according to the StarTribune:

·         Several government investigations

·         7,000 patient lawsuits

·         Half-billion dollars in legal settlements

·         The company admits to no wrongdoing

As it turns out, studies reveal most of the use is off label, hence the number one revenue generation channel.

Value for Whom?

According to the StarTribune report, this product remains on the market despite all this controversy. Australian (and American) doctors have the right to use drugs and devices in ways they think can help their patients (e.g. off label). A spokesperson for the Australia Therapeutic Goods Administration (TGA) said, “It is important that both patients and clinicians who use medical devices off-label are aware of the potential harms, understand that there is no regulatory oversight on these occasions, and have undertaken their own risk assessment.”

Investigation Down Under

The Australian government commenced its investigation into Medtronic and its “safety and supply arrangements” after the whistleblower came forward.