Articles Tagged with Smith & Nephew

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Smith & Nephew Birmingham Hip Resurfacing System
As we get older, our bodies weaken, bones become sore, and joints break down. Hip and knee problems are common conditions of aging. In fact, in the past decade millions of Americans have had hip replacement surgeries. Unfortunately, some defective artificial hips have caused patients more suffering than their original hip ailments. For one recent example, many patients who received the Birmingham Hip Resurfacing System by Smith & Nephew have had to undergo revision surgeries to cure new and unanticipated problems relating to the medical device. Many of these people have filed lawsuits.

Smith & Nephew’s Birmingham Hip Resurfacing System

Smith & Nephew designs and markets medical devices. One of the medical devices Smith & Nephew manufactures is a joint replacement system. An example of a joint replacement system is a hip implant. The Birmingham Hip Resurfacing (BHR) System is an artificial hip replacement made of metal components. BHRs have been used since 1997. The FDA approved BHRs for use in the United States in 2006; this approval was conditioned on Smith & Nephew reporting and analyzing adverse events, negative side effects, and complaints regarding the BHR. Just like any other medical device or medicine, the BHR must not provide false information (or false hope) to patients about what the device can accomplish.

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Have you ever had a problem with a medical device? If you want to bring state law claims against the manufacturer or a doctor, there’s an important legal concept you should know about: federal preemption. In a recent case, the court dismissed several of the plaintiff’s claims against Smith & Nephew, finding that the claims were preempted by federal law. Let’s look at what happened in that case to illustrate how preemption works. Note that while this case involves a hip replacement, the same legal principle could apply to any medical device regulated under U.S. law.

Smith & Nephew Artificial Hip Replacement

Artificial hip replacement and hip resurfacing
By way of background, the hip is a ball-and-socket joint, moving not just forward and back (like a knee joint) but also sideways. In a total hip replacement, part of the upper thigh bone and the ball portion of the hip joint are replaced with metal components. Part of the replacement includes a liner between the ball and the socket that allows the hip to rotate freely. Some patients have hip resurfacing surgery instead, where only the interface between the hip joint’s ball and its socket is replaced with a new surface.

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As we saw in the previous post, the “Birmingham plaintiffs” submitted a 160-page Master Complaint in August 2017, alleging many Smith & Nephew misrepresentations that led to the introduction of an unreasonably dangerous product into the marketplace. In this post we continue our deep dive into the Smith & Nephew Birmingham Hip Master Complaint. (Part 2 in a series.)

“Apples to Oranges”

Smith & Nephew Birmingham Hip Like Other MoM Hips
In a stunning marketing document directed at surgeons titled “Apples to Oranges,” Smith & Nephew announced boldly that the Birmingham Hip Resurfacing system “is not your average ‘metal on metal.’ It’s BHR.” Depicted in the advertisement is an apple with the names of other artificial hip products: ASR, Durom, Cormet, Conserve. It is rather astonishing, suggesting that the BHR was better and safer than these other MoM hips. I guess the BHR is the orange.

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This is the story about the Smith & Nephew Birmingham Hip Resurfacing Device, the patients harmed by the metal-on-metal artificial hip, the lawsuits that followed, and the massive Master Complaint filed last August against Smith & Nephew.

But First, How Do We Get to a “Master Complaint”?

Smith & Nephew lawsuits moved to MDL
This is how product liability multidistrict litigation begins: a product (like an artificial hip) hits the market. The artificial hip is implanted in thousands of patients. A year passes, then a few more. Patients complain of aches, pains, inflammation, noises, maybe even neurological symptoms. Doctors notify the manufacturer and their patients of these bad outcomes. Post-market studies are done. Problems are discovered with the product (in the case of metal-on-metal artificial hips, those problems included metallosis, loosening, pseudotumors, and many other “bad outcomes”). Injured people file lawsuits in courts around the country. The Judicial Panel on Multidistrict Litigation (JPML) eventually realizes it needs to designate one court to handle pretrial issues with the hundreds of cases being filed, so a multidistrict litigation (MDL) site is chosen, and the lawsuits are transferred to that MDL court. From there, the plaintiffs consolidate their efforts, and eventually a Master Complaint is carefully drafted and filed.

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Woman Recovering From Artificial Hip Revision Surgery Tells Her Story
In this post Suzanne recounts her slow recovery from artificial hip revision surgery. Suzanne received a metal-on-metal artificial hip, and four years later the hip was recalled. Suzanne was forced to undergo revision surgery a year later.

Part 3

Sitting on my night stand next to me here at home is a shiny steel sphere resting in rougher textured steel “cup.” When I hold it in my hand my fingers will not close around it and when I pick it up, the shiny steel ball is heavy and rolls back into the cup revealing a flat bottom with a hole in the middle of it. It was attached to an artificial titanium femur in my left leg just three days ago–prior to my revision surgery–and looks and feels so smooth and shiny it is hard to believe that it has wreaked such havoc on my unsuspecting body: staining the surrounding tissues an ugly gray, whipping up metal particles and spewing them into the orbit surrounding my recalled body parts and, worst of all, destroying any and all chances I may have had to develop a “J-Lo” like posterior due to irreparable damage to my gluteus medius and minimus muscles. Truthfully, I am more concerned with my ability to flow into a left legged lunge from a downward dog than to see my butt standing at attention, but that is too much to think about too soon and so instead I turn to my beautiful daughter who is giving me a bedside serenade on her guitar and think about how much I love my family and all my friends and the taste of lime popsicles.

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In this post, “Suzanne” describes the days leading up to revision surgery. Suzanne received a metal-on-metal artificial hip in 2006. The hip was recalled in 2010, and Suzanne was forced to undergo revision surgery in 2011.

Part 2

Woman Waits for Depuy ASR Revision Surgery

I woke up before the sun feeling wide awake, but not ready to face the day, I forced myself to fall back asleep re-entering the world of dreams and mystery. My dreams have been fraught with intrigue, dysfunction, insanity and all kinds of craziness and no wonder! My life is a bit crazy these days. As crazy as my dreams can be, they are never too crazy for me to say. “Hey, wake up, this has gone too far!” I relish in the scenarios, the unconscious connections between everything that is happening in my life being played out in random dream dramas. It’s better than soaps. Continue reading →

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Woman waiting for Depuy ASR revision surgery
Behind every metal-on-metal (MoM) artificial hip that fails, there is a person and a story. Artificial hip manufacturers may see only a faceless crowd of victims. These defendant companies may attempt to resolve the claims in bulk and move on to market the next blockbuster medical device. But in that crowd of plaintiffs are thousands of individuals uniquely injured by a product that was implanted in their bodies. The product failure often requires revision surgery, and the injuries that result from the artificial hip failures change lives forever: accomplished tennis players no longer play tennis; couples no longer travel or walk together on a beach; others have to resign from jobs they love because they cannot sit a desk for any length of time. Each of these people has a unique story to tell.

In the next three posts, I will share one woman’s story. “Suzanne” [not her real name] received a metal-on-metal (MoM) artificial hip in 2006 after years of pain from arthritis. The hip was recalled in 2010, and Suzanne was forced to undergo revision surgery in 2011. This is her story:

Part 1

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Metal-on-metal artificial hip
I recently blogged about artificial hip failures. Fortunately, these hip failures are not common when you look at the total number of patients receiving hip implants every year. However, when there is a failure, it can be extremely unpleasant, to put it lightly.

And it’s not just one medical device manufacturer with implants that are causing problems. Stryker, DePuy, Zimmer, and Wright are just some of the companies who have had issues with their artificial hip implants. If you’re curious, you can read more about some of them in my other blog post.

One such company that’s been in the news lately is Smith & Nephew. Over the course of the past few years, Smith & Nephew has instituted a string of recalls and is now at the beginning of a potentially expensive legal fight, with even more lawsuits expected.  So what exactly is going on with Smith & Nephew’s artificial hip implants?