Articles Posted in Smith & Nephew

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Orthopedic surgeon discussing revision surgery for recalled artificial hip
I get this question fairly often, and it’s a good one. It usually goes something like this: a person had a total hip replacement several years ago. A few years pass. Then out of the blue the individual receives a letter from the artificial hip manufacturer or from the implanting surgeon explaining that a recall has been issued for the artificial hip components implanted. (And these are the lucky patients; many people who receive an artificial hip that was later recalled never get notification from their doctor, the manufacturer, or anyone. They don’t discover they have a defective artificial hip until the pain, metallosis, or other injury develops.) If I were in this position, and I received a recalled artificial hip, I would want to know: Should I have the recalled hip removed? And should I have the hip removed immediately?

As with most things in life, the answer is not simple.

I have been a product liability lawyer for many years now, and in that time I have spoken with hundreds of people suffering from defective products. I have heard dozens of variations on a similar narrative. While this is neither medical nor legal advice, here are my suggestions:

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Smith & Nephew Birmingham hip replacement
Judge Catherine Blake, who is overseeing the Smith & Nephew Birmingham hip multi-district litigation in Baltimore, Maryland, recently issued an order setting out the bellwether trial schedule for the Birmingham Hip Resurfacing (BHR) cases.

Just to recap: there are two tracks of cases in the Smith & Nephew Birmingham hip litigation: BHR and THA. BHR refers to cases involving injured people who received Smith & Nephew Birmingham hip components as part of a resurfacing procedure. The BHR resurfacing system is a metal-on-metal (MoM) artificial hip, but in resurfacing procedures the  hip “ball” bone is resurfaced with a metal covering and a metal acetabular shell is implanted into the hip socket, thus creating a MoM articulation. Smith & Nephew used cobalt and chromium to construct both of these resurfacing components. As with all metal-on-metal artificial hips, the Smith & Nephew BHR has been shown to wear down and leach metals into the blood and tissue of the patient, a condition called metallosis.

The second track of cases involves total hip arthroplasties (THA) using Smith & Nephew Birmingham components. These total hip replacements are constructed with Smith & Nephew BHR components and non-BHR components, but instead of resurfacing the “ball-bone” with a metal covering the bone is removed and replaced with a metal ball component (a femoral head).

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If you’re reading this you probably know that over the past decade thousands and thousands of lawsuits have been filed by people injured by defective artificial hips. Several manufacturers have been involved, and while a few companies have resolved claims and moved on, thousands of other artificial hip lawsuits remain in courts across the country. Let’s take a look at active litigation involving artificial hips:

Smith & Nephew Birmingham Hip

Patient with Smith & Nephew BHR artificial hipThe Smith & Nephew “Birmingham” hip litigation is in full-swing. Plaintiffs in this litigation allege they were injured after receiving a Birmingham Hip Resurfacing (BHR) device, or a total hip arthroplasty (THA) utilizing Birmingham Hip components. In the resurfacing procedure, the  hip ball bone is shaped and resurfaced with a smooth metal covering and a metal shell is implanted into the hip socket, thus creating a metal-on-metal connection. Smith & Nephew uses cobalt and chromium to construct both of these resurfacing components. These metals have been shown to wear away and move into the blood and tissue of the patient, causing all kinds of symptoms and problems.

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Smith & Nephew Birmingham Hip Litigation
I have written about artificial hip litigation on this site more than any other area of product liability law, and for a very good reason: there is a lot to write about. Metal-on-metal hips have gravely injured tens of thousands of people, and new victims are undergoing revision surgeries each week to remove defective hips. One current active litigation involves Smith & Nephew “Birmingham” artificial hips. MDL 2775 is the multidistrict litigation court handling hundreds of lawsuits filed against medical device maker Smith & Nephew for these (allegedly) defective artificial hips. There are several artificial hip products involved in MDL 2775:

Birmingham Hip Resurfacing System (BHR). The multidistrict litigation court was first organized to handle these BHR lawsuits. The BHR system is a type of metal-on-metal artificial hip, but in resurfacing procedures the  hip “ball” bone is shaped and resurfaced with a smooth metal covering and a metal shell is implanted into the hip socket, thus creating a metal-on-metal connection or “articulation.” As with most metal-on-metal artificial hips, Smith & Nephew uses cobalt and chromium to construct both of these resurfacing components. These metals have been shown to wear away and leach into the blood and tissue of the patient, causing all kinds of symptoms and problems, including metallosis.

BHR Hip Components Used in Total Hip Arthroplasty (THA). These hip implants are constructed with Smith & Nephew BHR components and non-BHR components, but instead of resurfacing the “ball-bone” with a metal covering the bone is removed and a metal ball component is implanted. MDL 2775 added these Total Hip Arthroplasty (THA) cases to the litigation shortly after the MDL launched.

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I get calls from people who have been badly injured after surgery. If it’s straightforward surgery to repair a torn ACL, the question is whether the surgeon was negligent; if that turns out to be the case, the caller will have a claim for medical malpractice. But what if the surgeon is implanting a device: an artificial hip or knee or hernia mesh or pacemaker? And then after surgery the patient is worse off than before? If this is the result, the next question is this: was the person the victim of a defective product or medical malpractice? Or both?

So What’s the Difference?

Product liability or medical malpractice?Medical malpractice is the legal term for a doctor who has been negligent. This means that the doctor failed to perform the surgery with an expected degree of care and competence. In a phrase, the doctor simply screwed up the surgery. For a plaintiff to win a medical malpractice claim, he or she must show that the doctor failed to perform his duties with a normal “standard of care” typical of similarly situated doctors. This means that surgeons in small towns will be judged against similar doctors in similar towns, while doctors from major research hospitals in big cities will be judged against their similarly situated peers, and of course will be held to a higher standard. The bottom line is this: medical malpractice is the failure to provide competent medical care, causing the patient unexpected injury.

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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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A former client wrote a review of my work helping him through his metal-on-metal artificial hip case. I am very grateful for the review and would like to share it:

Former Client Writes Review of Attorney Clay HodgesI had one shot to even the score. I trusted Clay Hodges with my life. Mr. Hodges and his paralegal were spot-on with every aspect of my case. Throughout the process, beginning to end, I felt confident I had made the right choice. I needed a team that would press my rights swiftly and with results. I feel that Mr. Hodges’s experience, persistence and character led to these maximum results. Trustworthiness, operational expertise and great results . . . I couldn’t have asked for a better outcome.

R.N.