How Do Dangerous Medical Devices Reach the Market?
When a medical device requires clearance from the FDA, there are two ways for the medical devices to get on the market:
- To gain premarket approval, the medical device manufacturer must demonstrate through clinical trials that the device can be safely used for intended purposes.
- Premarket notification, on the other hand, allows for clearance of device that is shown to be "substantially equivalent" in safety and effectiveness to another device that has already been cleared for the market by the FDA. This is commonly called the 510(k) process.
Problems arise when medical device manufacturers withhold certain negative results in clinical trials that would undermine their claims that their device is safe and effective, or when the manufacturer misrepresents the actual intended use for their product in a bid to get it to market quickly through the 510(k) process. This is often referred to as "off-label" usage.
Off-label usage may also include the marketing of the product for a use it was not intended for which, in effect, causes serious medical harm to its recipients. Sometimes pharmaceutical manufacturers include side effects on their labels, but downplay the severity of them.
There are many ways in which drug manufacturers can manipulate the system to get their product on the market, and the motivation is almost always money at the expense of safety. This type of corporate misconduct cannot be tolerated. Negligent or reckless medical device manufacturers must be held accountable when they put profits above patient safety. Fortunately, state and federal law provides relief for those who have been harmed by products that should never have been allowed to go on the medical device market.