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If a device used off-label causes harm, is the maker responsible?


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One of the intriguing things about the law is that it often plays catch up. Rules and regulations sometimes are passed to mitigate possible harm from dangerous devices. But then people come up with new ways to put them to use.

For example, readers of this blog are likely aware that Texas doctors regularly prescribe medications for off-label uses. In their own experience they have found the drug works well for something other than what it was approved. It’s not recommended, but it’s not illegal.

The same happens sometimes with medical devices. A tool gets developed for one thing and doctors find it’s suited for something else, so they begin using it for something it wasn’t specifically approved. It’s not illegal, but that doesn’t mean its safety can be guaranteed.

In such situations it might be worth asking whether the manufacturer designed the tool for the off-label use from the outset but used a loophole in the regulatory process to get it approved quickly. If that happens and proper warnings about potential dangers aren’t provided, it might warrant a product liability claim.

Whether this is an issue related to a device called the Lariat is not clear. What is clear is that a study by a team at the University of Pennsylvania has found that there may be a link between the off-label use of the device and some adverse events that followed.

A review of data of some 300 cases found that 23 patients who had the off-label procedure required urgent cardiac surgery later and five died. Doctors had used the Lariat to cinch off a small sac-like heart appendage suspected of being a source of potentially deadly or stroke-causing clots.

The Lariat won approval from the FDA in 2006 as a general suturing device. It didn’t get tested because the manufacturer said it was largely similar to other devices already on the market. But the Penn study’s senior author says the device’s design and the fact that the manufacturer has now filed for a patent as a tool to close the heart sac leaves him thinking it was always meant for that procedure.

The device company says it agrees that more research is needed and it’s now working to set up clinical trials.

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