Clark, Love & Hutson, GP

Absent FDA oversight, what options remain?

Here are a few numbers to ponder; 401(k), 501c(3), 1099. And let's not forget Social Security Numbers, driver's license numbers, and credit card and personal identification numbers. As much as we would like to think that our individuality has not been reduced to digits, there seems to be a lot of evidence to the contrary. Here's another number worth knowing. It's 510(k).

Eroding safety

The number refers to the program new medical devices must go through to gain government approval to be marketed in the U.S. However, under the aegis of getting useful products to market quicker, Congress passed laws allowing the Food and Drug Administration to grant approvals without much review. If a manufacturer can convince regulators a new device is similar to one already on the market, the device can gain approval without review, even if the previous device was flawed.

Critics call it "the weakest and most nonsensical program in the FDA." As evidence of its flaws, they point to the fact that medical device recalls have spiked in recent years. Indeed, the first quarter of this year alone saw more device recalls than any other quarter going back to 2005.

Risks to the unsuspecting

Despite that, the FDA is taking evenĀ more steps to reduce oversight on more devices. At the same time, opposition to the regulatory relaxation is increasing, as indicated by the volume of critical articles and even a new Netflix documentary.

In some regard, even the law that established the 510(k) process is misleading. The fact it exists might lead consumers to think that 510(k) approvals are tantamount to an official seal of approval that indicate products are safe and effective. But the law clearly states that clearance is not official approval at all. It's even illegal to represent it as such.

The bottom line in the view of many health care advocates is that consumers face increased risks to life and limb because of the easing of regulations, and most probably do not know it. That is something they say they are working to change. But in the absence of action, it seems fair to ask what options do consumers have in the event they fall victim to defective products?

The best answer is found in consultation with an attorney experienced in defective device litigation.

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