Life on The Bleeding Edge: How the FDA Won’t Help Keep You Safe

By S. Randall Hood | August 16, 2018

On July 20, 2018, Bayer announced that it would finally stop selling Essure, a form of birth control that was supposed to cause permanent female sterilization, at the end of 2018. On July 27, 2018, Netflix released a documentary titled The Bleeding Edge, a film about the $400 billion medical device industry – and which focused heavily on the women whose lives were ruined by Essure.

You might say that, since Bayer made its announcement a week before the film was released, that these two events are mere coincidence.

We don’t think so.

The Bleeding Edge is one of those documentaries that could change the way we, as medical consumers, choose to protect our health. It focuses on two separate issues: the dangerous medical devices that have led to tens of thousands of people across the country filing product liability lawsuits, and the Food & Drug Administration’s Premarket Notification 510(k) submission which allowed these devastating and deadly products to make it to market in the first place. If the movie teaches us anything, it is this: no one in the healthcare industry – not your doctors, not the FDA, not the medical device manufacturers – is looking out for you.

“We have more power in this room, than most governments around the world.”

Scott Whitaker, President and CEO of AdvaMed

AdvaMed is a medical device trade association – the largest in the world. By their own admittance, the group is dedicated to promoting policies which foster “rapid product approvals” both here and abroad. They spent $3.6 million in lobbying efforts in 2017. The association’s goal is not to protect consumers or patients: it’s to get as many products approved as they can, as quickly as they can, in order to increase the profits of the companies they represent.

This is the group with more power than governments. And much of that power resides in the loophole that is the 510(k) process.

A breakdown of the premarket approval (PMA) process vs. the 510(k) process

New medical devices, whether they’re new forms of tongue depressors or 3D-printed hands, must go through the FDA’s premarket approval, or PMA, process. For low-risk devices (Class I), this process may only last a few months. For risky devices (Class III), it could take years, and cost close to a hundred million dollars. Class II devices fall somewhere in-between in terms of risk to the consumer. It has been this way ever since 1976, when the FDA took over regulating medical devices.

There were many, MANY devices on the market before 1976, but those devices were grandfathered in, and could avoid PMA.

The device manufacturers, however, fought back against the PMA process. Many claimed that their new products were “substantially equivalent” to products that were already on the market. (Products already on the market are known as “predicate devices.”) To placate the manufacturers, the FDA created the 510(k) premarket submission, which allowed manufacturers to skip PMA if they could prove the equivalency to a predicate device:

“Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims. A legally marketed device is a device that was legally marketed prior to May 28, 1976 (preamendments device), or a device which has been reclassified from Class III to Class II or I…. The legally marketed device(s) to which equivalence is drawn is commonly known as the ‘predicate.’ Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate.”

Any legally marketed device may be used as a predicate. It does not matter if the predicate device is proven defective or dangerous. It does not matter if the predicate device was created pre-1976. It does not matter if the predicate device was pulled from the market at any time. Any legally marketed device may be used as a predicate.

How McGowan, Hood, Felder & Phillips, LLC can help you take the next step

Since our firm was founded, the defective medical device lawyers of McGowan, Hood, Felder & Phillips have stood on the side of what is right, and what is just. We understand the challenges of being your own advocate, and of navigating the civil justice system. We know that getting legislation passed that puts profits ahead of people can be a frustrating process.

But we also know that, with an experienced trial lawyer by your side, you don’t have to do it alone. We will help you gather your documentation, like medical records and witness accounts, and review your histories. We will handle the filing of your case, work with expert witnesses, and prepare you for your day in court. We make sure that you’re up-to-date on whatever is happening, and create different strategic approaches to ensure that you have the best possible chances at a successful resolution.

We have spent our careers fighting this type of injustice. Specifically, we have handled – and are currently handling – some of the most complex defective medical products claims there are, including the claims The Bleeding Edge talks about during the course of the film, including Essure birth control devices, DePuy hip replacements and transvaginal mesh claims.

We recommend that you watch The Bleeding Edge, especially if you or your loved one has ever had problems with a medical device that led you to sustain additional harm. When you are ready to fight for the justice you deserve, McGowan, Hood, Felder & Phillips, LLC will proudly stand by your side. To schedule a free initial consultation at one of our office locations near you, please call 803-327-7800, or fill out our contact form. You don’t have to be alone; let us help.

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