Articles Tagged with medical devices

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Let me see if I have this straight: There is a huge medical device manufacturer that earns over $75 billion dollars each year. This corporation decides to market and sell a new medical device. The corporation refuses to do extensive testing on the device because that would take too long and cost too much money. In fact, preliminary studies showed problems with the device, and the company believes extensive clinical testing may reveal more problems, further slowing its path to the market (and to big profits). Instead, the company seeks fast-track approval of the device. The company argues that because the device looks similar to a device already on the market, it should be allowed to sell the new device without extensive testing. This process is known as the 510(k) pathway, and I’ve written about it a ton on this site, including last week. In the application the company reassures the FDA: “and don’t worry, we will keep an eye on the device and the patients who receive the device and if problems arise down the road we will let you know.”

So the FDA gives the multi-billion dollar corporation 510(k) approval to sell the device. In the first year the company sells one billion dollars’ worth of the device. In the second year it sells $1.5 billion in new devices, but it also begins to receive an alarming number of “adverse event” reports. This means patients are reporting problems and injuries after receiving the device. The company undertakes an internal study but does not report its findings to the FDA. In the third year it sells even more devices, but by now hundreds of adverse reports are rolling in. The injuries finally get the attention of the FDA, and the company reluctantly hands over its data on the many serious injuries caused by the new device.

Plaintiffs' Lawyers Are Consumer Protection Heroes
In the fourth year a woman with the implanted device is forced to undergo “revision surgery” to remove the device, and her recovery is lengthy and painful. She calls me and tells me her story. It is awful. She was once a competitive tennis player, but now she walks with a cane. She hasn’t played tennis in two years. She had to take time away from her job. Even with decent health insurance she has thousands of dollars in out-of-pocket medical bills related to the failure of the device.

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FDA Considering Changes to 510(k) Process
At some point in your life, a medical device will likely become a necessary part of your medical care. You may need external items such as hearing aids, blood glucose meters, insulin pumps, or feeding tubes. You may also need the help of  surgically implanted medical devices like artificial hips, heart pacemakers, breast implants, spine screws, rods, artificial discs, intrauterine devices, metal screws, pins, plates and rods, artificial knees, or coronary stents. No matter what type of medical device you need, you deserve safe devices of only the best quality that are responsive to technological updates. As a patient, you should have the right to make a fully informed decision about whether you want to use a newer or older version of a particular medical device. The FDA is now considering making changes to its (infamous) 510(k) medical device approval process.

FDA Pressures Medical Device Manufacturers to Utilize Newer Technologies 

You only have to look at the evolution of cell phone technology to appreciate the abundance of technological changes that have occurred over the past decade. So, why should you be provided with the medical device equivalents of flip phones? That’s one of the key focuses of the proposed new changes to the 510(k) Approval Program the U.S. Food and Drug Administration (FDA) which would be incorporated in 2019. The 510(k) Approval Program, put in place originally in 1976, has provided an approval “short-cut” for medical devices which are based on medical devices currently on the market. I have written about the 510(k) process often on this site. The medical device currently on  the market, upon which the new product is based, is known as a “predicate device.” Historically, there have been no restrictions concerning the age of the predicate device. This is about to change.

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Surgeon implanting artificial hipIt’s nice to see that I may be out in front of a national publication like The New York Times. For two and a half years I have been writing on the dangers of metal-on-metal artificial hips and the deeply-flawed 510(k) medical device approval process. On Saturday Jeanne Lenzer published a very informative piece in the Times on the potential dangers of hip replacement surgery: Can Your Hip Replacement Kill You? Ms. Lenzer examines the way too many medical devices reach the marketplace without proper clinical testing. It is a subject I have written about often. Most people don’t realize how easy the FDA has made it for companies to release new medical products, but it is important to be aware of this weak regulatory system before you allow any surgeon to implant a device in your body. Federal courts across the country are littered with multidistrict litigation involving dozens of failed medical devices. In my view the 510(k) process is the reason for much of this litigation and misery. With proper testing and analysis, many of these serious injuries from dangerous products could be avoided.

One chilling statistic in the NYT article: medical interventions–including artificial hip and other medical implant surgeries–are the third leading cause of death in the United States.

By the way, Jeanne Lenzer recently published a book that you should read: The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It. I just bought a copy, have already begun reading it, and will discuss in a later post.

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supermoon-724384_1920-287x300If you’ve kept up with politics even a little bit, you know how much gridlock exists in Congress. It’s amazing that anything can get done in Washington. However, a new law called the 21st Century Cures Act just passed with tremendous bipartisan support; this law must be really good, right?

21st Century Cures Act: The Good

The 21st Century Cures Act has the potential to save lives. For instance, it will provide funding for cancer research, fight painkiller drug abuse, advance Alzheimer’s research and improve mental health treatments.

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Exercise and Medical Device Failures

I was reading an article about the latest study touting the benefits of exercise. It was stunning. The study involved analyzing the brains of two groups of mice: one group in a cage with an exercise wheel; the other in a cage without the wheel. Researchers watched the mice for four weeks. Predictably, the mice with the exercise wheel exercised; the mice without the wheel did not. After a month the scientists measured brain activity in both groups.

Turns out, running and other forms of exercise produce a protein in the brain called “brain-derived neurotropic factor” or BDNF (I feel smarter just writing that name). This stuff is very good for your brain. BDNF promotes the growth and vigor of neurons. BDNF has also been shown to strengthen the synapses that connect neurons, which allows the brain to function better. Low levels of BDNF has caused cognitive decline in people and animals. Exercise increases levels of BDNF in the brain.

Exercise Promotes BDNF and Ketones

In the study scientists discovered that in the brains of mice who exercised regularly, a molecule which blocked the growth of BDNF was less effective. As a result, much more BDNF was produced in the mice who exercised. Sadly but predictably, less BDNF was produced in the sedentary mice. Researchers also found that the exercising mice produced ketones which make their way to the brain and fight off the bad molecules and further promote the growth of BDNF. The guy who directed the study, NYU professor Moses Chao, said: “It’s incredible just how pervasive and complex the effects of exercise are on the brain.”

You can check out the new study here. It’s the latest in a long line of studies which prove time and again that exercise is vital to your health. Seriously, people have to exercise. Not exercising causes all kinds of physical and mental problems.

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Corporate Responsibility For Medical Devices and Drugs

I don’t drink the Kool-Aid. I distrust simple answers, group-think, zealotry. I can’t stand when people make sweeping generalizations about the absolute evil of one side and the unconditional good of the other side. I don’t usually spend much time with plaintiffs’ attorneys who think every corporate decision is an act of violence and malfeasance. I am convinced there are two sides to every story (even if, often, one side of the story is weaker).

Medical Devices and Drugs Have Saved Many Lives

So it is with my law practice. I do not believe major companies are evil, that they are out to hurt people, that all the conspiracy theories are true. I am convinced the life-cycle of a medical device or drug begins with a beautiful idea: to develop a product that will save lives, that will make people more active, that will help people and not hurt them. In fact, virtually all medical devices or drugs are first developed by one or a few smart people attempting a solution to a pressing health problem.

And these medical devices and drugs have saved lives. And as a society we have to create an environment where doctors and scientists and corporations have the freedom and the opportunity to build new medical devices and new drugs to solve vexing health problems.

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