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Medical Devices 101

The term “medical device” covers a huge range of products used in the medical treatment of humans and animals.  A medical device can be as simple as a tongue depressor or as complex as a transcatheter aortic valve.  Medical appliances, materials, software and other devices are employed alone or together with other devices to diagnose, prevent, cure, monitor, treat or alleviate injuries, physical handicaps and disease. They are also used to modify physiological processes such as contraception.

In the United States, the Food and Drug Administration (FDA) has governmental oversight over medical devices.  The FDA delineates three classifications based on the level of control required to assure both effectiveness and patient safety:

Class I: General Controls

Class I medical devices are not critical to patient health and have the least regulatory control.  Most are not subject to 501k pre-market notification or manufacturing regulation.  Bandages, exam gloves and tongue compressors are examples of Class I devices.

Class II: General Controls with Special Controls

Devices in this category are designed to perform as indicated with no harm to the patient or user. Examples include air purifiers, surgical drapes and cardiac monitors. Class II devices are subject to special controls.

Class III: General Controls, Special Controls with Premarket Approval

A Class III device is one for which insufficient information exists to assure safety and effectiveness solely through the general or special controls. These devices require premarket approval to ensure the device's safety and effectiveness. They often support human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury. Pacemakers, cardiovascular stents and breast implants are Class III medical devices.

When medical devices go bad

There are more than 1,700 types of medical devices in use today on hundreds of thousands of people and most of them work exactly as intended. However,when a medical device with a faulty design or flawed manufacturing process is marketed, sold, used or surgically implanted it can fail to operate as intended, fail completely and in the worst cases, further harm or cause the death of a patient. The Associated Press recently reported that over 80,000 deaths were caused by medical devices since 2008. Further, just six of these 4,000 devices caused a quarter of the 1.7 million device injuries reported in this same time period.

How defective medical devices get to market

Most devices are not adequately tested.  In fact, the FDA does not require clinical trials on 98% of medical devices. Only Class III medical devices must undergo Premarket approval (PMA) before they are permitted to be sold and used.

Class I and Class II devices are required to submit a 510(k). This is where the loophole lies. From the FDA website:

Click to expand the infographic

“There is no 510(k) form; however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission. Before marketing a device, each submitter must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S. This order "clears" the device for commercial distribution.”

This means that a device manufacturer need only show that their device is substantially equivalent to another device that was legally marketed prior to May 28, 1976--even if that device was recalled by the FDA.  To compound the problem, devices that were already on the market when regulation began in 1979 were grandfathered; they may be used as a predicate even though they never had to demonstrate safety or efficacy.

Another loophole exists. The current FDA rules do not require device manufacturers such as DePuy, Zimmer, Smith & Nephew and Stryker to notify the FDA when they bundle together components from approved and unapproved devices. This loophole has allowed defective devices such as DePuy’s ASR Hip Replacement to be implanted in approximately 93,000 patients beginning in 2003.

Due to the sheer volume of medical devices, the FDA does not have the resources to test all of them. The FDA does have a database of patient complaints, but only 3-4% of complaints are entered into the database, making it unlikely that serious problems will be spotted, particularly early in a device’s lifecycle.

And, as always, cash is king. The medical device industry is extremely powerful and has a hugely influential lobbying presence in D.C. The market size in the U.S. alone was $156 billion in 2017 and $521 billion worldwide. According to   device manufacturers and associations spent more than $36 million in campaign contributions and employed over 411 lobbyists since the start of the Trump Administration.

How to Protect Yourself

Be proactive. Ask your doctor if implant surgery is your only option and make sure you understand the ramifications and risks involved regarding both scenarios.  For example, many women who underwent transvaginal mesh implantation to alleviate symptoms caused by pelvic organ prolapse most likely did not need surgery. If your doctor feels strongly that surgery is necessary, explore all available surgical techniques and devices before making a decision.

Do your homework. Don’t assume that your doctor knows if a specific medical device is harmful.  Many doctors assume that if a device is on the market, it was thoroughly tested on patients.  Also, he or she may also assume that a newer model is more effective and safer than an older device. First, get the brand name and exact model of the device. Go to FDA’s Medical Device Safety page to see if it has been recalled or banned.  Then go online and do further research on the specific device and surgical technique.  If you see a large number of law firms seeking clients injured by the device that is a huge warning bell.

If you:

You may have the right to seek compensation from the manufacturer. If this is the case, seek help from an experienced defective medical device lawyer with a track record of outstanding results.

Need Revision Surgery? What Are Your Rights?
You underwent knee or hip replacement surgery to improve the quality of your life. Like so many patients before you, the implanted medical device loosened or failed prematurely, became infected or sickened you with metallosis.  You now are in more pain and have less mobility than before your replacement surgery. Your doctor tells you the only option is costly and painful revision surgery. What should you do? Where do you go from here? What are your rights?

Many people decide to pursue legal action against the manufacturer or distributor of their hip or knee replacement system or other medical device such as an IVC filter or hernia mesh.  If the device or implant is faulty in its design, manufacture or marketing a patient may be able to obtain compensation for their pain, suffering, lost wages and other damages.

What are your rights?
First and foremost, the medical device implanted in your body is your property! It is your right to keep the device after it is removed during revision surgery. Be sure to inform your surgeon and the hospital or surgery center in advance of your surgery to save and pack it for you to take home.  Why should you do this? If you decide to file a claim or lawsuit against the manufacturer, the faulty medical implant can be a vital piece of physical evidence to support your claim.

What you should do immediately if your doctor recommends revision surgery
Call a qualified, proven and reputable product liability lawyer that specializes in injuries caused by bad medical devices.  Your attorney will sit with you and thoroughly discuss the facts of your case--from pre-surgery to the present. It is very important to meet with an injury lawyer before you undergo revision surgery to help ensure you receive the maximum compensation and best possible outcome.  Your lawyer will dive into and document  the extent of your injuries and damages prior to as well as after your revision surgery.  All of this evidence will be used not only in your legal action against the medical device company, but also to negotiate on your behalf with insurance companies and other healthcare organizations such as Medicare.

What it will cost to file a lawsuit for a defective medical device? Nothing. Legal action in defective medical device matters are handled on a contingency basis. This means that your lawyer will pay for all legal expenses related to your matter. When your case is settled, your attorney’s fees and legal expenses are deducted from the settlement amount or trial award. A reputable lawyer will spell this out for you in plain English prior to accepting your case. He or she will also provide this in writing in your retainer agreement.

How much money can you get from a defective medical device lawsuit?
The amount of money awarded to a patient will depend on factors such as the extent of their illness and injuries, lost income and pain and suffering. For example, on April 25, 2019, a Philadelphia court awarded $120 million to a plaintiff injured by pelvic mesh manufactured by Ethicon, a Johnson & Johnson subsidiary. In another Johnson & Johnson matter, $125,000 was awarded to each patient that sustained injuries from their Defective Pinnacle Hip replacement devices.

If you decide to pursue a claim, be sure to work with the best possible product liability attorney. Keefe Law Firm has a national defective medical device practice with a reputation for obtaining the maximum compensation for our clients injured by bad medical devices. We have obtained settlements and won lawsuits amounting to hundreds of millions of dollars for consumers across the country against Johnson & Johnson/DePuy, Smith & Nephew, Zimmer Biomet, Stryker, Wright and other major medical device manufacturers and distributors.

A National Personal Injury and Medical Device Law Firm.

Wilentz has recovered hundreds of millions of dollars for people who have been injured, disabled or have died due to a faulty or defective medical device implant. Our mission is to achieve excellence in providing experienced and competent representation while never losing sight of the fact that our clients are human beings that have suffered from the negligence of medical device manufacturers. Our deep and broad expertise in defective products cases is why we consistently achieve maximum compensation for our clients.

As a result of the firm’s hard work for victims of faulty medical implants, our attorneys were appointed co-lead counsel in the DePuy ASR hip implant litigation for the State of New Jersey and as a member of the Science Committee of the New Jersey Stryker Rejuvenate and ABG II Multi-County Litigation.

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Medical Device Watch is sponsored by Wilentz, Goldman & Spitzer, P.A. The medical device approval process in the U.S. allows for the sale of some devices that have not been tested in clinical trials on humans. Our goal is to help people protect themselves from the physical, emotional and financial harm that can be caused by medical devices that are defective.


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