How Supreme Court nominee Neil Gorsuch could help medical device companies — 5 notes

Spinal Tech

Supreme Court nominee Neil Gorsuch's pre-emption interpretation will likely aid medical device companies if he is confirmed later this month, according to the Star Tribune.

Here are five things to know:

 

1. In 2015, Mr. Gorsuch denied a woman the right to sue Dublin-based Medtronic for injuries she claimed were caused by the company's Infuse bone graft's off-label promotion.

 

2. Mr. Gorsuch's ruling applies the restriction to situations where devices were used in non-FDA-approved ways.

 

3. His opinion in rooted in the notion that state law can't impose new requirements on FDA-approved medical devices, as he said, "A state's judgment that a device is unsafe for a particular off-label use could require design changes that adversely affect the device's safety for on-label uses."

 

4. Should Mr. Gorsuch be confirmed, he is expected to bring similar beliefs to Supreme Court cases.

 

5. Physicians aren't legally obligated to warn patients if a device is used in an off-label manner. Technically, once the FDA approves a device for a single use, physicians and patients may use it however they wish.

 

More device articles:
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Amend Surgical earns FDA clearance for NanoFUSE BA: 4 things to know

$33.2B medical device outsourcing market to grow at a CAGR of 11.5% — 5 details

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