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.

Smith & Nephew R3 Liners. This hip implant consists of a metal liner placed between the femoral head and cup, which creates a metal-on-metal articulation. The R3 has experienced many of the same problems that other metal-on-metal hip implants have caused, including metallosis, pain, and loosening. Smith & Nephew issued a voluntary recall in June of 2012. At the time of the recall, approximately 4,000 R3 liners had been implanted in patients in the United States.

Judge Catherine Blake–who oversees the MDL–has divided the cases into two tracks: the “BHR Track” and the “THA/R3 Track.” For a person injured by the failure of one of these hip implant systems, you will need to verify the exact components implanted and file the proper case under the BHR Track or the THA/R3 Track. (Of course, your attorney is supposed to do all of this work, and you need an attorney for these kinds of cases, as I discuss here.)

Some Smith & Nephew Cases Dismissed Because They Were Filed Too Late

On November 19, 2018, Judge Blake considered motions to dismiss from Smith & Nephew lawyers, who argued that dozens of cases in the MDL were time-barred. I wrote about statutes of limitations in a prior post, and I’ve referenced it often on this site, but in a nutshell it is one major defense for a company sued by a person injured by a defective product.

Judge Blake denied most of the motions to dismiss in her Order. So that’s the good news. She observed that many of the cases hailed from states with “discovery rules.” The discovery rule clarifies when the clock starts ticking to file a product liability case. It typically means that the clock cannot start ticking against the injured person until the person discovers (or reasonably should have discovered) that he or she was injured by a defective product. As I’ve discussed, determining that moment of “discovery” can be difficult for medical devices.

With regard to Smith & Nephew’s motions to dismiss, Judge Blake dismissed a few cases that were clearly outside the time-limits for bringing a case in that plaintiff’s home state, but kept most of the cases where discovery rules applied or where there was some ambiguity about the passage of time.

As you can imagine, defense attorneys press these statutes of limitation defenses aggressively, so be careful. The takeaway: do not “sleep on your rights.” If you think you have been harmed by a defective product, contact an attorney immediately.

Smith & Nephew Mediation Scheduled for January 30, 2019

Smith & Nephew has not yet made any serious effort to settle these cases, although the company initially expressed some willingness to discuss settlement of the THA/R3 track cases. Judge Blake ordered mediation to be held on January 30, 2019. Smith & Nephew is asking all THA/R3 Track plaintiffs to produce relevant medical records so that the company can properly evaluate each of the THA/R3 cases. If mediation does not lead to a global settlement of these cases, discovery will continue, including depositions to be taken in the coming months.

Trial Dates Scheduled

The BHR Track cases have trial dates set for March 2020. If THA/R3 mediation is not successful at the end of this month, the plaintiffs’ team will ask Judge Blake for a trial date to be scheduled shortly after the trial for the BHR Track cases.

If you were implanted with a Smith & Nephew artificial hip (of any kind) and are suffering problems, give me a call to discuss further: (919) 830-5602.

Note: All information in this post was distilled from publicly available information and news sources.

Dr. Tower’s Backstory

Steven 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.

Dr. Tower’s Chrome Cobalt Hip Study

The metal-poisoning ordeal stayed with Dr. Tower, so he decided to study the symptoms of his orthopedic patients. In March 2015 he started a screening program to measure cobalt levels in the blood of patients who received an artificial hip with any chrome-cobalt component. Astonishingly, Dr. Tower discovered that over half of his patients with a chrome-cobalt hip part had measurable cobalt in their urine. A quarter of those patients had a metal-on-metal (“MoM”) artificial hip, but most had the metal-on-plastic hips, which are thought to be safer. Steven Tower didn’t buy it.

Ominously, Dr. Tower discovered that 81% of his patients with cobalt presence in the urine suffered from “Arthroplastic Cobalt Encephalopathy” or “ACE,” which is a collection of troubling mental symptoms he believes are caused by elevated metal levels in the blood and tissue. You can read more about Steven Tower’s discovery that high metal levels in the blood can cause serious neurological problems here.

Among other things, Dr. Tower’s study concluded:

• One million Americans could be at extreme risk for ACE from metal-on-metal artificial hips. The good news is that MoM hips are no longer actively marketed and sold; the bad news is that many individuals still have MoM hips in their bodies.
• Five to ten million individuals could be at some risk for ACE from metal-on-plastic hips. Few surgeons and fewer manufacturers are studying the health effects of metal-on-plastic hips.
• One million people could be at risk for ACE from shoulder replacements. Shoulder replacement surgeries use chrome-cobalt implants.

Dr. Tower’s Recommendations for Hip Replacement Surgery

If you read nothing else, read this: Steven Tower does not recommend any patient consent to hip replacement surgery involving components containing “any chrome-cobalt hip part.” This means that patients should never receive a MoM artificial hip, where the femoral head articulates with a metal acetabular cup or a metal liner. But Dr. Tower goes further than rejecting the M0M hip. He also believes that a hip replacement with any chrome-cobalt component should be avoided. Dr. Tower’s study on his patients indicates that many hip replacements using any chrome-cobalt part can increase metal levels in the blood and cause significant negative symptoms. This means that even if your orthopedic surgeon suggests a metal-on-plastic hip system, and the metal component is made from chrome-cobalt (and most of them are), you should avoid it.

Instead, Dr. Tower recommends a cemented stainless steel stem with a stainless steel head or a ceramic head along with a polyethylene (plastic) socket. For revision surgeries Dr. Tower recommends a Titanium stem with a ceramic head “articulating” with a polyethylene socket. In his work as an orthopedic surgeon, Dr. Tower does not implant artificial hips with any chrome cobalt components because “proven safe alternatives exist.”

Please note: I am not a doctor and this is not medical advice. This article represents my understanding of Steven Tower’s artificial hip study and recommendations. Dr. Tower has not affirmed the accuracy of this article, and if any mistake is made it is mine alone. As always, if you have medical questions about your hip, talk to your doctor. If you have legal questions, call me (919.830.5602).

Dr. Steven Tower, an orthopedic surgeon in Alaska, recently gave a fascinating (and alarming) talk about the many neurological problems he has observed in hip patients with elevated cobalt levels in the body. For years the focus following hip replacement surgeries has been on the physical condition of the hip itself. Dr. Tower has concluded that this approach is wrong, or at least incomplete, and he has seen that often the first signs of trouble with hip replacement patients are neurological symptoms. He has even given it a name: Arthroplasty Cobalt Encephalopathy, or ACE.

What is Arthroplasty Cobalt Encephalopathy (ACE)?

ACE is meant to identify a brain disease or associated neurological symptoms caused by elevated levels of cobalt from a metal artificial hip. Cobalt poisoning is a common problem in patients with artificial hips. The neurological symptoms that occur with cobalt metal poisoning include:

• tremors
• memory problems
• fatigue
• weakness or imbalance
• mood alterations
• sleep issues
• pain
• weight loss
• executive dysfunction
• blindness
• other symptoms

Dr. Tower did a post-surgical study of his patients with artificial hips containing at least one component made from chromium/cobalt. He discovered that 57 were cobalt positive, meaning the cobalt urine test revealed 1 part per billion (ppb) or higher. Of the 57 patients with a cobalt positive test, 28 had symptoms consistent with Arthroplasty Cobalt Encephalopathy.

One issue Dr. Tower discovered was that ACE could occur with lower readings of cobalt in the body. It has generally been accepted that cobalt readings below 4 ppb was not cause for concern, and some surgeons would not order further testing until the cobalt readings exceeded 7 ppb or even 10 ppb. Dr. Tower found that patients could have serious neurological issues caused by cobalt with readings of 1 ppb.

Among the patients who were diagnosed with ACE, the median length of time for onset of neurological symptoms was around seven years. ACE symptoms usually occurred one year before hip symptoms (pain, weakness, clicking, loosening, etc.) occurred.

Are Neurological Problems From Metallosis Limited to Metal-on-Metal Artificial Hips?

Unfortunately, no. As recently as five years ago, the medical community mostly believed that metallosis derived from metal-on-metal artificial hips. This would include products such as the DePuy ASR hip and the Zimmer Durom hip (and several other metal-on-metal hip products, about which I have written often on this website). But Dr. Tower has observed neurological problems in several patients with metal-on-plastic hips, or hips utilizing a ceramic ball with a metal cup. In fact, if any part of an artificial hip contains chrome or cobalt materials, the patient is at risk for higher metal levels in the blood and neurological symptoms as a result. He notes that the onset of symptoms with metal on plastic or ceramic occurs more slowly, but the symptoms themselves can be just as severe.

This finding, if true, could be a game changer. The medical community has (slowly) accepted that MoM hips were a health problem and have moved away from their use. But now a thoughtful surgeon is saying, “Hold up. We are finding cobalt poisoning in too many patients with metal-on-plastic and metal-on-ceramic hips. The risk to the patient occurs with any artificial hip containing a cobalt component.” Conventional wisdom has been that eliminating the metal on metal contact should eliminate the risk of metallosis, but Dr. Tower at least does not accept this thinking.

In his discussion Dr. Tower noted that after nine of his patients had revision surgeries, seven patients no longer showed signs of being cobalt-positive, and five of those seven improved neurologically. That’s a promising sign.

The Takeaway

Does this settle the questions regarding artificial hip implants and metallosis? Of course not. But we need to start looking much more closely at the things we put into our bodies, whether it’s a Twinkie, a sleeping pill, or a metal artificial hip. Also, it is well past time for medical device companies to slow down and return to more extensive testing of new medical products. Too often the pursuit of a blockbuster medical device or new prescription drug clouds a corporate board’s better judgment. And clouded judgment hurts people.

Remember I am not a doctor and this is not medical advice. I am a product liability lawyer with many clients who were injured by artificial hips containing cobalt and chromium.

Over the years I have worked with many people who had hip replacement surgery. Many of these clients discovered high metal levels in their bodies from metal-on-metal (MoM) hip components. Often the person would let me know that she had her metal levels checked and that the blood work came back with abnormally high readings of cobalt, chromium, or other metals. Still, the treating physician would occasionally dismiss the blood work results. At least one doctor told a patient, “no one knows the effects of higher metal levels on the body. We haven’t studied the impact of metallosis sufficiently. It is nothing to be worried about at this point.”

Sadly, this isn’t true. And it’s not the best medical advice. There have been several studies over the years that looked at metallosis in the body derived from metal-on-metal hip components. The first incident of metallosis from MoM hip implants was reported in 1971. Since then, doctors have been reporting the higher incidence of metallosis in patients who received MoM artificial hip implants. Several scholarly studies have been conducted, including a recent one whose results were published this month examining the impact of metallosis on the cells of patients.

What Is Metallosis?

Metallosis is a serious medical condition involving the deposit and build-up of metal debris in the soft tissues of the body. Metallosis has been shown to occur when metal components in medical implants rub or scrape against each other. Imagine the metal cup and the metal ball in an artificial hip grinding against each other day after day, for months and years. Very tiny metal shavings can be scraped away and released into the human body. Over time, these tiny shavings can build up alarming metal levels in the blood. It is common in hip replacements but also occurs in other joint replacements.

The Latest Study on Metallosis

In the August 2016 edition of Biomaterials, an international research team looked at the physical impact of metallosis on the body. They studied metal-on-metal hip components made of cobalt and chromium and/or molybdenum alloys (CoCrMo). The study confirmed that use of these hip components can lead to the “release of wear products such as metallic particles and dissociated metal species, raising concerns regarding their safety” for orthopedic surgeons and patients. The study showed that release of these metal particles in the body are capable of producing problems on a cellular level, and can cause “aseptic osteolysis” and other health problems. Osteolysis is the destruction or disappearance of bone tissue.

The study also examined the impact of metallosis on “mesenchymal stromal cells.” These are multi-functional cells that can develop into several different cell types which produce bone, cartilage, muscle or fat. According to the study, metallosis interferes with this cell development and can cause serious problems and “impair osteogenic differentiation of MSCs.” That’s a mouthful, but it’s not good.

Importantly, the study concluded by saying that the continued use of cobalt, chromium, and molybdenum alloys for joint replacement implants “needs critical reconsideration.”

Dr. James Pritchett is an orthopedic surgeon who writes a lot about the onset of metallosis following hip implants. He states that symptoms of metallosis include pain, instability, and increasing noise from the hip. In addition, metallosis may cause some or all of these symptoms: pseudo-tumors, nerve and thyroid problems, brain impairment, heart problems, depression and anxiety, visual impairment, rashes, infection, and implant loosening.

The Takeaway

The takeaway is that more and more studies are showing that high metal levels in the blood are a bad thing. The recent study in Biomaterials journal points to harmful changes that metal levels can cause to the cells of human tissue, and that use of metal-on-metal components for artificial hips and other joints must be “reconsidered.” I hear that to mean: “discontinued immediately.” In any event, do not accept your physician’s offhand comment that your higher metal levels (even if only slightly higher than normal) are of no concern. Get a second opinion. Metallosis is not a healthy condition. Good luck.

Note: This post does not reference any individual person or client. The information is general and is derived from many circumstances over several years.

For further information, check out the Biomaterials website. Biomaterials is an international journal covering the science and clinical application of biomaterials. But be warned: these are people with high levels of very specific knowledge. Pack a medical dictionary.