Articles Posted in 510(k) Process

My Challenge to Medical Device and Drug Companies: Put Me Out of Business!

Published on: April 11, 2016 | By Clay Hodges

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.

Transvaginal Mesh: What Is It and Why So Many Lawsuits?

Published on: November 27, 2015 | By Clay Hodges

You have probably seen news reports (or at least the flood of TV commercials from law firms) about the suffering caused by the failure of transvaginal mesh (TVM) products. This is a unique medical device failure “story” because of the large number of women who have been affected. It is estimated that transvaginal mesh is implanted in more than 200,000 women each year in the United States. And by early 2015 well over 70,000 lawsuits have been filed against transvaginal mesh manufacturers because of injuries caused by TVM. More lawsuits are being filed each week.

But let’s back up.

Surgical mesh is a medical product that “is used to provide additional support when repairing weakened or damaged tissue.” FDA News Release April 29, 2014. It is a plastic lattice-type mesh that is surgically implanted around weakened, loose, sagging, or otherwise compromised human tissue (such as a vaginal wall). While surgical mesh can be used to treat different kinds of problems, such as hernia, the mesh that has caused much of the current suffering and most of the lawsuits involves transvaginal mesh.

Zimmer Persona Artificial Knee Recall: Lawsuits Mounting

Published on: November 11, 2015 | By Clay Hodges

“The Most Anatomically Accurate Knee Implant”

In 2012, medical device manufacturer Zimmer, Inc. introduced the Persona artificial knee to the public with lofty language. Zimmer announced that the company was “redefining knee arthroplasty and ushering in a new era of personalization with the introduction of the Persona Knee.” Zimmer stated on its website that by “working with more than 50 of the world’s most respected orthopaedic surgeons, and utilizing analytics from both genders and 1,500 different bone types from 26 different ethnicities, Zimmer was able to create the most anatomically accurate knee implant.”

The reported advantage of the Persona knee system, according to Zimmer, was that it would give surgeons several component options for each patient and each surgery, thus assuring a tailored fit for the patient. Again, from Zimmer: “the result is an implant system that addresses the unique needs of the patient and accommodates surgeon-specific preferences — all while empowering surgeons to minimize “trade-offs” and better optimize results.” Sounds great, doesn’t it?

Zimmer sold the Persona knee from November 2012 through March 2015. A lot of them. But bad things began to happen. People began reporting pain and other symptoms, including loosening of the knee components inside the leg.

The Depuy ASR Artificial Hip Metal-on-Metal Design

Published on: July 24, 2015 | By Clay Hodges

In the previous post we looked at artificial hips and what should happen before a new medical device product like the Depuy ASR Hip gets to the marketplace. Now, let’s look a little deeper into the Depuy ASR hip system, its metal-on-metal cup and ball design, and how it failed:

What is “ASR” anyway?

“ASR” stands for “Articular Surface Replacement.” ASR is a surgical procedure that is an alternative to a total hip replacement procedure. In an ASR procedure, only the articular surface of the hip (the cup and the ball) is replaced. On the other hand, a total hip replacement includes not only the cup and the ball, but also a large piece of metal (known as a femoral stem) that is implanted deep into the patient’s femur and on which the ball is attached.

How Did the Problems Begin with the Depuy ASR Artificial Hip? (A Little History)

Published on: July 21, 2015 | By Clay Hodges

First, a little history is in order to see how a medical device like a Depuy ASR artificial hip gets to the market (and ultimately, into your body).

What is a total hip replacement?

A “total hip replacement” replaces the body’s hip joint with an artificial one, and these artificial hips are usually made out of metal or plastics. A total hip replacement typically consists of four separate parts: (1) a stem, (2) a head, (3) a liner, and (4) a cup (called an “acetabular cup” or shell). After the surgeon hollows out the patient’s femur bone, the stem is implanted. The head is a metal ball that is fixed on top of the stem. The femoral head forms the hip joint when it is placed inside the liner and the cup (the “acetabular shell”).

★★★★★

I was involved in a case for the faulty hip replacements. Clay Hodges represented me. I can't say enough about how much he has helped me. Clay was able to win multiple settlements on my behalf with most of them being the maximum amount able to be awarded. Matt J.

Clay, thank you sir for making a disheartening experience at least palatable, you and your staff were honest, caring and understanding through the entire process of my wife’s hip replacements, while monetary settlements never make the pain and suffering end, it sometimes is the only way people can fight back to right a wrong. J. V.

We are absolutely pleased with how Clay Hodges handled my husband’s hip replacement claim. He always kept us informed of the progress. And, his work resulted in a settlement which we are extremely pleased. Thank you, Clay! Carol L. & Norm L.