Articles Posted in Artificial Hip

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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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Artificial Hip Joint Showing femoral head and femoral neck and stem

Stryker Orthopaedics has announced that it reached a national settlement in the multidistrict litigation focused on the Stryker LFIT V40 femoral head. The LFIT V40 femoral head is one component of Stryker’s artificial hip system. This settlement announcement is a bit surprising, as the MDL was created for the LFIT V40 femoral head in April 2017. As medical device multidistrict litigation goes, this is a very quick path from formation of the MDL to settlement. One reason for the speed is that this MDL is smaller than other artificial hip MDLs based on the number of injured plaintiffs. The LFIT V40 settlement involves approximately 125 cases in the federal court MDL and an additional 140 cases in New Jersey state court.

In any event, for those people hurt by the LFIT V40 femoral head, this is good news. The terms of the settlement have not been released. I will certainly update this website when the settlement agreement is made available. As for now, all discovery and trial preparation have been stayed (or stopped). The first bellwether trial, scheduled for September 2019, will be removed from the trial calendar. The focus now will be on processing individual settlements for plaintiffs.

Remember that each plaintiff in this or any other medical device litigation is not required to accept the settlement. Although it is often reasonable for the plaintiff to accept the terms of settlement, no plaintiff will be compelled to accept any settlement. As with any litigation, it is important for individual plaintiffs and their attorneys to slow down, review all the terms of settlement, and make a careful decision on whether to participate in the settlement.

I have written about the LFIT V40 femoral head product failure several times in the past. Problems with the hip component began several years ago. On August 29, 2016, Stryker announced a recall for the LFIT V40 head. The recall focused solely on the femoral head, which is the “ball” part of the hip replacement. This femoral head fits inside the “cup” and is also attached to the “stem” (which is connected to the femur, or thigh bone).

The recall involved LFIT V40 heads manufactured before 2011 with the following catalog numbers and sizes:

Catalog Number Femoral Head Diameter Offset
6260-9-236 36mm +5
6260-9-240 40mm +4
6260-9-244 44mm +4
6260-9-340 40mm +8
6260-9-440 40mm +12
6260-9-344 44mm +8
6260-9-444 44mm +12

LFIT V40 Femoral Head Is a Metal-on-Polyethylene (MoP) Artificial Hip

Unlike many other artificial hip product failures, the Stryker LFIT V40 not part of a metal-on-metal artificial hip system. The LFIT V40 system is built utilizing a metal acetabular cup, a polyethylene (plastic) liner, the LFIT V40 cobalt-chromium femoral head, and a titanium femoral stem. Unfortunately, soon after being sold and implanted, the Stryker LFIT V40 began to fail, at a high rate. Patients who received the Stryker LFIT V40 suffered similar symptoms as those who received metal-on-metal hips, including metallosis.

LFIT V40 Taper Lock Failure

LFIT V40 Femoral Head

The failure of the Stryker LFIT V40 involved the junction of the neck of the femoral stem and the femoral head or ball. This connection was intended to be permanently secured through a taper lock system, holding the stem securely to the ball. However, in many cases the LFIT V40 femoral head began to corrode, which means to disintegrate and lose metal. The corrosion occurred at the site of the connection to the neck (the taper lock). This corrosion in the head would progress slowly, but over time the corrosion would cause the taper lock to loosen. Eventually, the neck would corrode as well, and once the neck began to corrode the breakdown of the artificial hip would advance more quickly. One study found that the loosening would cause fretting and micro-motion at the taper lock site, and this friction would cause metals to be released into body. Thus, the Stryker metal-on-polyethylene (MoP) artificial hip resulted in patients suffering from metallosis, just like so many other patients who received metal-on-metal (MoM) artificial hips.

Keep in mind that the corrosion in the LFIT V40 can be slow. This means you may not know the Stryker hip is failing and releasing cobalt and chromium into the body for years. By then, the neck may have begun to corrode, and when that happens the femoral stem may need to be removed and replaced, which can be a very difficult surgery. The femoral stem is implanted down the center of the femur bone, and when it sets it is usually there permanently. Removing the femoral stem is difficult and painful.

Check back here for updates on the Stryker LFIT V40 femoral head settlement. And if you believe you have a failed artificial hip in your body, call me to discuss: 919.546.8788.

 

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If you have any interest in artificial hips, you need to follow the work of Dr. Steven Tower. An orthopedic surgeon in Anchorage Alaska, Dr. Tower has built a one-man research laboratory studying the horrifying health effects of chrome and cobalt hip components. While hip manufacturers have been slow to produce meaningful studies on the ill-effects of metallosis on the human body, Dr. Tower decided to study his own patients. What he discovered could save lives.

Dr. Tower’s Backstory

Orthopedic Surgeon Steven TowerSteven Tower’s story is remarkable. He is featured in the Netflix medical device documentary The Bleeding Edge. Dr. Tower is an avid cyclist and needed a hip replacement several years ago. He chose the DePuy ASR metal-on-metal artificial hip because it was marketed to “exceptionally active individuals.” Several months after his hip replacement surgery, however, Dr. Tower noticed a tremor in his hand. His ears started ringing, his thinking became confused and he began repeating himself when he spoke. One night while attending a medical conference Dr. Tower had a mental breakdown and trashed his hotel room. He wrote all over the walls with sharpies and pens, and wrote on the hotel mirrors with soap. When he returned home he measured the metal levels in his blood, and the test results revealed 100 times the normal amount of cobalt that should be in his body. Dr. Tower soon arranged to have his metal hip components removed in a revision surgery. Within a month his thinking cleared and his other symptoms mostly disappeared. He was relieved, but also intrigued.

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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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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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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.