Articles Posted in 510(k) Process

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I get these calls fairly often. The caller will explain that her lawyer just called out of the blue with an offer to settle an artificial hip or prescription drug case. The person believes the offer is too low. Well, is it? That’s a complex question, and it may be, but there are distinct reasons why the person believes the offer is too low. Let’s take a look at what may be happening:

What We Have Here is a Failure to Communicate

Lawyer explaining settlement terms to client
Often, the problem starts with the lawyer’s failure to communicate. People will tell me that they never hear from their attorney, and then suddenly, after many months or even years have passed, the lawyer will call and quickly explain the terms of a settlement offer then hurry off the phone. This is a mistake. The lawyer should take as long as necessary to fully explain why the settlement number is what it is. In fact, it is important for the lawyer to keep the client updated on developments throughout the litigation. For example, if another plaintiff in the larger litigation loses an important bellwether case, the lawyer should call and report the loss and what it may mean for the litigation and how it might impact settlement (obviously, it’s not good for all plaintiffs if a bellwether case is lost). If the client understands generally how the multi-district litigation is progressing, the client will be more prepared when a settlement offer finally arrives.

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Harmful Medical Devices on HBO's Last Week Tonight with John Oliver

I’ve been writing about dangerous medical devices on this site for four years. Over that time I’ve reached thousands and thousands of people injured by these harmful implanted medical products. John Oliver, host of Last Week Tonight, picked up the subject this week, and I am grateful to him and to HBO because he reached more people in twenty minutes than I have in four years. I want more people to get the word out about the serious problems with medical devices rushed to market and “cleared” through the 510(k) loophole because it’s a public health crisis. Too many companies are pushing too many untested medical devices to market, and the FDA is not doing enough to protect the public from these devices. John Oliver talks about all of this on the latest episode of his show. It’s funny (and profane), but he lays out accurately the way massive profits have driven companies to push harmful medical devices on to an unsuspecting public. You can check it out at the link below:

Warning: This is HBO. Oliver speaks freely: the language is salty and the subject matter adult. Companies and people other than me own the content linked above. The show is the property of HBO and whoever owns HBO. Neither HBO nor John Oliver has any affiliation with my website.

 

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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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For more than three years I have been writing about the dangers of certain implanted medical devices. These devices include artificial hips, hernia mesh, IUDs, IVC filters, and others. And some have caused massive human suffering: neurological problems, sexual dysfunction, immobility, infertility, headaches, pain, even death. If you are reading this sentence then you discovered my site because of your interest in medical devices and the problems they can cause. And if you are interested in this subject, you must see the new Netflix documentary The Bleeding Edge.

The Bleeding EdgeThe Bleeding Edge is a remarkable film investigating the public health crisis caused by our current medical device industry. It examines the two main causes permitting the manufacture and sale of defective medical devices: corporate greed and inadequate FDA oversight. It is a tragic story, particularly when the film takes a close look at many of the actual victims of these harmful medical devices. It’s one thing to hear that the Essure birth control device has injured thousands of women; it’s quite another when you see a woman on screen explain how she has given up on her hope to find love because she can no longer have intercourse due to permanent internal injuries. It is deeply sad to hear these stories. And it may have you writing your member of congress. Which you should.

I urge you to check out the film. Here are a few key takeaways:

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Plaintiff Sherri Booker Wins Jury Verdict Against C.R. Bard
Victims of C.R. Bard’s IVC filters got some great news two weeks ago. An Arizona jury in the first bellwether trial awarded a woman $3.6 million for injuries she suffered after Bard’s “G2” IVC filter broke into pieces in her inferior vena cava vein, requiring open heart surgery to remove the broken pieces.

The plaintiff, Sherri Booker, was implanted with Bard G2 IVC filter to prevent blood clots from reaching the heart and lungs. The problem was, the G2 moved inside her inferior vena cava (it is not supposed to move), then it broke apart. In 2014, she had to undergo open heart surgery. The surgeon was not able to retrieve all the broken pieces.

The Jury’s Verdict

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Advocating for compensation for DePuy ASR plaintiffs
This is my pitch: People who had to undergo revision surgery because their DePuy ASR artificial hip failed should be compensated for their injuries, even if the revision surgery occurred beyond the ten-year anniversary date of the original implant surgery.

Let me admit the obvious: It’s a bit self-serving for me to argue this point. I am an attorney and I represent individuals injured by the failure of the DePuy ASR device. But I have read a lot about these cases, over many years, and the more I understand the science behind these metal-on-metal (MoM) hips (or the lack of science), I am more convinced that thousands of people have been unfairly injured, even if those injuries did not become obvious for several years. Even ten years.

The DePuy ASR Settlements

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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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Last week I wrote a timeline on the key events surrounding the failure of the Depuy ASR artificial hip. Today I want to take a similar look at the Depuy Pinnacle artificial hip. The Pinnacle was supposed to be the ASR’s more active and athletic brother. But it didn’t turn out that way.

1995: Study on Metal-on-Metal Hips Released

Study on Metal on Metal Artificial Hips
For all metal-on-metal artificial hips, we have to start with the central question: what did the manufacturer know, and when did the manufacturer know it? In 1995, Dr. Graham Isaac released a short paper discussing the problems with metal-on-metal (MoM) artificial hips. Dr. Isaac explained that the performance of MoM hip implants was “unpredictable,” that the hips may work well for some time “before suffering catastrophic breakdown . . . accompanied by a release of a large volume of debris.” This paper and Depuy’s other internal documents suggest that Depuy Orthopaedics should have known about the metal-on-metal risk factors in 1995. In fact, one doctor noted that Depuy needed “to be cautious of the legal/litigation issues and lawyers, etc…perception of metal debris and metal-ion release.” That’s not good.

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Physiomesh Hernia Mesh
Hernia mesh is causing problems. People who have been implanted with hernia mesh have suffered adhesions (scar tissue that sticks together), inflammation, pain, allergic reactions, internal bleeding, infections, and many other injuries.

One of the hernia mesh products sold for years, Ethicon’s Physiomesh, has caused many of these health problems in patients. In revision or removal surgeries, the Physiomesh has been discovered to have shrunk, folded, or curled. Surgeons have found scar tissue surrounding the mesh. This scar tissue can cause severe pain and discomfort. In many cases, by the time the mesh is removed, the damage has been done and long-term problems remain.

What Is Hernia Mesh?