One-in-ten Americans have at least a medical device implanted in their bodies.
That equates to 32 million people.
Given the magnitude of that number – one would assume that medical devices are reviewed and approved as safe by the FDA before they are sold to the public – right?
Most devices – including those that come with a high degree of risk have undergone no clinical testing.
For a new drug to be approved by the FDA, two randomized, controlled clinical trials must be submitted to the agency before consideration is given that drug. And while that process is often imperfect (some would say corrupted by the drug companies), it does provide some evidence of efficacy and safety.
There is simply no evidentiary standard for medical devices.
Do medical devices even fall under FDA regulatory control?
That happened in 1976 – and at the same time, the FDA grandfathered in all devices already on the market with a provision that “allows manufacturers to sell most new devices without requiring any clinical testing as long as the manufacturer says its product is ‘substantially equivalent’ to an existing device.”
Additionally, device makers can avoid FDA scrutiny by claiming that any new device is a near replica of a prior device.
What does this mean in practical terms?
Let’s look at cardiac implants as an example…
A study published in JAMA in 2009 found that only 5 percent of high-risk implanted cardiac devices even partly met the standard for drug testing.
Does the FDA require testing in some cases?
Yes, but sadly in cases where the FDA requires a safety and efficacy trial, the agency has been known to ignore danger signs contained in that research.
This much we know… lax regulations and oversight are a danger to the public. To make matters worse, President Trump is appointing people to key regulatory roles that are known for favoring further deregulation in the name of speeding products to market.
Why would the FDA put device company profits ahead of public safety?
Could it have something to do with Ronald Reagan changing the role of FDA Commissioner from civil servant to political appointee in the late 1980s?
That change has allowed a number of sitting Presidents to appoint commissioners friendly to the drug and device makers – improving the chances that those same companies will then donate generously to upcoming political campaigns.
Is the process flawed – and possibly corrupt? Absolutely.
What can consumers do about it?
The best chance for reform will come when voters demand a higher level of accountability from our political and corporate leaders.
If you or a loved one has been harmed by a medical device or drug, call a qualified Connecticut product liability lawyer. A knowledgeable product liability attorney can help to ensure that your rights are protected.
RisCassi & Davis has handled hundreds of product liability cases over our more than 60 years serving the people of Connecticut.
What’s more, our Connecticut product liability lawyers have received local and national recognition for our handling of these cases.
We have a great team of legal experts dedicated to protecting consumers in Connecticut. Please contact us if we can help you.
The consultation is free, and there is no obligation of any kind.