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:

Don’t panic. Panic never helps, whether you are confronting a decision on revision hip surgery or trying to escape from a bear. (I know, this is easy for me to say.) You do not need to rush out and schedule emergency surgery as soon as get the recall letter. But you should start taking deliberate steps to find answers to your questions and to protect your health, which means first:

Take stock of your physical condition. How do you feel? How does the hip function? Do you feel any pain? Any other symptoms? Can you still exercise, or have you slowly given up many of the physical activities you used to enjoy? What has your doctor said to you in your recent office visits related to the condition of the hip replacement?

Schedule an appointment with your orthopedic surgeon. You need to meet with your orthopedic surgeon and ask him all the questions you have about the recall and the implanted artificial hip: why was it recalled? what is the defect? how has the defect harmed people? what symptoms can the defect cause? And of course: should I get the revision surgery?

Get metals levels checked. As part of this visit with your surgeon, you will want to have him or her order lab work to check your cobalt and chromium levels. Even artificial hips that are not metal-on-metal (MoM) can leach metals into the blood and tissue. It is important to get blood work done to see if you have elevated metal levels.

Do your research. Read as much as you can about the recalled artificial hip, starting with the FDA website but also working your way to reputable news sources. Find out what is defective about the artificial hip and what problems it is causing when the hip fails.

Self-assess. What is your level of anxiety? Are you the kind of person who will suffer with the idea of a recalled product in your body, even in the absence of serious symptoms? Or do you trust your surgeon to give you good advice on revision surgery? If your hip feels good and you have no anxiety, you may be able to hold off on revision surgery. As part of this step, it would also be helpful to discuss revision surgery with your spouse, your family, and even with trusted friends.

Get revision surgery if you need revision surgery. Once you go through the steps above, you and your surgeon should have a long discussion about the pros and cons of revision surgery. No surgery is low-risk, so you need to make this decision deliberately and carefully. If you have pain, and if you have elevated metal levels, your surgeon will most likely advise revision surgery. On the other hand, if your hip is functioning well, and you have no discernible metal levels, and you otherwise feel fine, you and your surgeon may decide to take a wait-and-see approach. In this case, however, you need to maintain vigilance: schedule periodic metal blood tests, arrange frequent follow-ups with your surgeon, and keep a symptoms journal if they arise.

If necessary, seek out a second opinion. It is vital that you trust your surgeon. If you feel you are not getting your surgeon’s full attention or consideration, find another orthopedic surgeon. Ask around for trusted surgeons in your area. Go through the process with the new surgeon. Occasionally some surgeons have reasons for dismissing the importance of recalled medical devices like artificial hips, so they may downplay the importance of removing the recalled artificial hip. (I’ve known at least one surgeon who said high metal levels were not a health risk.) Above all, you should always rely on doctors you trust to make decisions on surgery.

This is not legal or medical advice.

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

I have written extensively about the ASR Settlements. The first and second agreements offered compensation for individuals who had revision surgery up to nine years after the original implant surgery. The third settlement agreement (or second extension agreement if that makes more sense), for the first time, extended the offer of compensation to those individuals who underwent revision surgery after the nine year anniversary up to the ten year anniversary. So that was progress.

The deadline for the third settlement deadline has passed. It applied to people who had revision surgery prior to February 15, 2017 (essentially a year ago). Still, there are many people out there who had revision surgery after February 15, 2017. Other people are having problems but haven’t scheduled revision surgery. Some of these people had the ASR implanted eight years ago, but others may have had it implanted ten years ago, and even longer.

My Pitch:

Most of these people implanted with the ASR have no idea the product in their bodies fails at a much greater rate than other artificial hip systems. Many of these people are not aware that they have been injured. For example, many people do not immediately feel the effects of metallosis (the build up of metals in the blood and tissue). Others have neurological symptoms related to elevated metal levels but assume it is part of aging or caused by something else. A few victims know their DePuy ASR hip has failed but so dread further surgery that they put revision off and simply live with the unpleasant symptoms. These people are injured by the DePuy ASR device, much like people who had revision surgery five or six or eight years after implant surgery.

Beyond that, important information regarding the high failure rate of the ASR took years to be discovered. In hindsight it appears the makers of the ASR were in no hurry to release studies, information, and documentation detailing the high failure rates. I wrote about some of that extensive evidence here. The point is, if a person doesn’t know what has caused her injuries, how can she pursue a claim?

Necessary Evils

Settlements are necessary evils in litigation. With hundreds or thousands of injured plaintiffs in huge product cases, there is simply no other way to resolve so many lawsuits. And let’s face it: in many cases, both sides go away unhappy. The medical device makers don’t want to pay billions of dollars to settle cases, and the injured plaintiffs think the terms of settlement are not generous enough to compensate them for their specific injuries. And with any settlement, there will be deadlines that are completely arbitrary. These deadlines inevitably create bizarre and unfair results. For example, I suspect there are at least a handful of people who got revision surgery to remove the DePuy ASR hip on February 16, 2017. Those people did not qualify for the latest settlement agreement. By one day. And there will be plenty of people who received revision surgery at ten years and one day, or ten years and one month. It is simply bewildering that those people should not be permitted to participate in some kind of meaningful settlement.

I believe these people have viable claims. And DePuy Orthopaedics should recognize and pay these claims.

The bottom line is this: time is running out. If you have the DePuy ASR hip implanted, and you have had or need revision surgery, talk to a lawyer immediately about reviewing your possible claims. My firm number is (919) 830-5602. Good luck.

The Attune Artificial Knee

The DePuy Synthes Attune artificial knee is marketed as an “innovative, comprehensive, integrated knee system” that provides stability, strength, and a greater range of motion post-surgery. This novel design was created to be a better approach to traditional knee replacements. But many people have experienced complete failure of their Attune knees shockingly soon after surgery.

To understand what goes wrong, let’s first consider how an artificial knee is supposed to work. The replacement joint has to sit right where the knee originally was, connecting the femur, or thigh bone, with the tibia, or shin bone. The new knee must be firmly attached to both bones or it won’t work. Imagine a single hinge holding a door onto a wall and allowing it to swing. If the hinge comes detached from either the wall or the door, the door will pull away from the wall and fall down as it swings.

Last year, a group of orthopedic surgeons reported in The Journal of Knee Surgery that this is exactly what happens with a disconcertingly large proportion of Attune artificial knees. While the replacement joint remains solidly cemented to the femur, the lower bond to the shin has a tendency to fail. The cement that should hold the knee to the tibia binds to the bone but not to the Attune device itself. Therefore, the detached joint floats, and just like the failed hinge that allows the door to fall, the replacement knee can’t hold any weight.

People with defective Attune knees experience significant knee pain, especially when they try to bear weight on the knee when standing or walking, as well as a restricted range of motion. The study revealed that these problems sometimes occurred within just a few months of the original knee replacement.

The only way to correct a failed Attune knee is to undergo a second or “revision” surgery. That second surgery—where the useless cement must be removed from the tibia and the solid femur connection must be broken—is more involved and more painful than the initial knee replacement procedure. To make matters worse, the surgeons’ report indicated that the separated knee generally doesn’t show up on X-rays; it can only be detected during the revision surgery. In other words, a doctor may not realize that the replaced knee has failed.

The Attune knee’s defects are further evident in the U.S. Food and Drug Administration’s Medical Device Adverse Events (MAUDE) database. Even though MAUDE is a self-reporting system, such that only the manufacturer, DePuy Synthes, can report its knees’ failures, there are dozens of recent reports. The Attune knee has been redesigned and may now be less prone to separation from the shin bone, but the original design has not been recalled, and the recipients of that faulty device have been left to fend for themselves.

Fortunately, DePuy Synthes is now being forced to answer for these defects in court.

The Attune Lawsuit(s)

Last September, a law firm filed the first lawsuit involving a defective Attune knee in Tuscaloosa County, Alabama. The case alleges that its client’s artificial knee failed prematurely, resulting in substantial pain, delayed recovery, and significant medical expenses. Expect to see more lawsuits in the future involving Attune knees. These cases are likely to involve not only damages for pain and suffering but also for the costs of the second replacement knee surgery and the accompanying physical therapy.

Have you had a knee replacement that ultimately failed or that caused more problems than it solved? We can advise you whether you may have a case against the manufacturer or another involved party. Please contact us to talk with a lawyer about your situation.

In litigation, there are several harsh and punishing deadlines. The worst one is the statute of limitations (“SOL”). The SOL is a statute in state or federal law that limits the time you are allowed to file a lawsuit. In North Carolina, for example, the SOL for bringing a personal injury claim against a person or company for negligence is three years. This means if a guy runs a red light and “T-bones” your car, causing you to break your leg, you have three years from the date of the car crash to file a lawsuit. This may seem like a reasonable amount of time; as the injured person you certainly have an obligation to pursue valid claims in a timely manner, but it can also lead to unintended and unfair results.

The SOL is just one unforgiving deadline that a person faces in the bumpy wagon ride of civil litigation. There are also discovery deadlines, deadlines to respond to motions, scheduling order deadlines, and others. One deadline may involve a settlement deadline. A settlement deadline is a date negotiated by both sides in a large-scale litigation requiring plaintiffs to take certain actions by a specific date or lose the right to participate in the settlement. In “mass tort” product liability cases, courts want to resolve hundreds or even thousands of cases as efficiently as possible. And settlement deadlines are a valuable tool in getting large numbers of plaintiffs to take quick action. Let’s look at one example:

The DePuy ASR Hip Settlement Deadlines

The parties in the DePuy ASR artificial hip litigation have negotiated three settlements so far, all with different deadlines. I wrote about those deadlines here. In a nutshell, each of the three settlements allowed plaintiffs to participate in settlement if conditions were met by a certain deadline. The most important date was the date the plaintiff had revision surgery to remove the (bad) artificial hip. In all three settlement agreements, an amount of money was offered based on the length of time the person had the hip implanted. If the plaintiff had the hip implanted for less than five years, that plaintiff was entitled to the full amount of the settlement (with some exceptions). After the five-year anniversary, the amounts paid for the injury went down. After the ten-year anniversary, the injured person was not entitled to compensation under the agreements. Why? That’s a good question. I don’t know exactly. But based on the most recent settlement, a person who had revision surgery nine years and eleven months after the original implant surgery was eligible for settlement but a person who had revision surgery thirty-five days later was not eligible. This is simply an unfair result, and it occurs any time there is some (arbitrary) settlement deadline imposed. The product-maker defendants will say: “Wait a minute. We have to draw the line somewhere, and in any case most non-defective artificial hips have a normal product life-span of around fifteen years. So we shouldn’t have to pay beyond ten years.”

I don’t accept this logic. If the product failed, there should be compensation, even if the revision surgery occurred beyond ten years.

So What if You Are Approaching the Anniversary of Your Implant Surgery?

I’ve gotten several calls from people who are nearing the ten-year anniversary from the original implant surgery. Some have pain; some have elevated cobalt and chromium metal levels; others have different symptoms. A few of them ask me: “Should I go ahead and get revision surgery to beat the settlement deadline?” It’s a good question.

My answer: get revision surgery if you need revision surgery. Medical decisions are always separate from legal considerations. Whether to get revision surgery is solely a decision to be made in careful discussion with your surgeon and your family.

That said, if you need revision or repair surgery, and if you make the decision to have revision surgery, and if you have some control over the scheduling of the surgery, and if a surgery anniversary is approaching, you may want to get revision surgery prior to the anniversary date of the original implant surgery. For example, if you had the DePuy ASR hip implanted on March 1, 2010, and you now need revision surgery, and your surgeon is available for revision surgery on February 20, 2018 and March 5, 2018, choose the earlier date. (This suggestion goes for any brand of failed artificial hip or other medical device.) If both dates work for you and your doctor, don’t potentially lose money simply by putting off the revision surgery by just a few weeks or months.

This is not legal or medical advice.

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.

I made it to the couch today! Yesterday I encircled and scrutinized the curvaceous crimson sectional several times, a bit unsteady, all the while trying to reconcile my personal vision of my recuperation–me all cozy on the couch in front of the fire reading and sipping ginger ale on ice, while the family bustles around me baking and cooking in the kitchen, busying themselves with holiday projects–with the realization that the couch was too low for me to sit on, not a comfortable chair was anywhere in sight and navigating the narrow passageways on my crutches between the couch and the Christmas tree, the coffee table and the couch, over computer chords and the like, even without medication, would be dangerous! I was facing the possibility of spending my recuperation holiday in my bedroom alone where the temperature seemed to grow colder as the fire in the living room grew warmer.

This morning I knew as soon as I moved from the bed to my crutches that my body had healed just a little bit more through the night. I felt lighter and moved more fluidly, as fluid as one can on meds and in skin-tight support stockings. I know that my nursing care–my husband John–has a lot to do with my comfort and progress. He has been my nurse, keeping track of my medication and administering it too, including daily shots in my stomach, my physical therapist, making sure I go through all of my exercises and moving my leg for me when I can’t, a parent, stroking my hair and cooing kinds words when I need them and a husband, the kind of person who looks at me with love as he kindly makes sure I am safe and have everything I need for my first shower in five days. Bliss. So now I am on the sofa, tucked in a corner of this giant, plush red nest that our family of four plus Weenie, our cat, fits on quite comfortably. The room is warmed by the fireplace and I’m getting ready to doze some more, wondering what tomorrows healing will bring.

Emerging from this drug induced haze, malaise, apathetic daze, it’s hard to want to do anything. Today I had a severe reaction to what I can only guess was caused by pain medication, Oxycodone to be exact. I’m not a medicine consumer. I had two natural childbirths and one of them in my own home and although I’ll take a sleep aid once or twice a year, ibuprofen is my drug of choice. So I was surprised to find myself covered in welts, looking like an avatar with the corners of my eyes and the bridge of my nose appearing as one facial feature, and itching uncontrollably, after scaling down my oxycodone intake to only two small pills at bedtime. Now it is after two in the morning and sleep eludes me. I am twelve days into my recovery after having a faulty artificial hip removed from my body in a revision surgery and replaced with a hopefully better model, and I’m angry.

Ironically the hip and site of the operation itself is not bothering me as much as a strange patch located just above my left knee on my quadriceps muscle. It is a site for searing pain that appears as fire, daggers and heat when I move my leg a certain way. Nerve pain. It causes blood-curdling, uncontrollable screams when it happens. I let one out at the medical center today after the nurse and my husband tried to get me off a ridiculously high examining table I had no business being on. I somehow managed to get on it without screaming. After several attempts at inserting an IV unsuccessfully, which required another nurse to give it a try, then lying for what seemed like an eternity on this sketchy, antiquated piece of medical hardware that was obviously not functioning, the contents of the IV dripping agonizingly slow, me completely uncomfortable, when it was time to be released, I couldn’t get off the table. All efforts to assist me were unsuccessful. I let out a good one. The nurse had no idea what to do and ended up leaving the room to let my husband and me deal with it. Soon we were walking, me hobbling along on crutches, out the door with the entire staff just looking at us as we exited their torture chamber. I guess blood curdling screams are not uncommon there. It did not really seem to faze anyone and to be honest, once the pain subsided, I kind of liked the feeling of this unbridled, wild and scary sound coming out of me.

Postscript

This entire journey from my first hip replacement surgery until today has been almost ten years. I was only 42 when I received my first hip replacement. The trauma and the drama around the recall, physical damage and physical and financial aftermath consumed the entirety of my forties. What should have been some of my best and vibrant years. Today I am 51. The damages I sustained from the second surgery have left me with a partially paralyzed left leg. I have to pick it up with my hands to put my shoes and socks on. I live with chronic nerve pain and hip joint pain that I manage with ibuprofen. With that said, I can walk and I can bike. I also recently became a certified yoga instructor, and although many of the postures are unavailable to me, I have a strong practice that I share with other people who have physical limitations and who are searching for a way to move their bodies as best they can.

Disclaimer: This narrative is not intended to represent any specific person or specific product. Names and details have been changed.

Part 2

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.more

I had planned to travel today to settle in and enjoy some time before checking in to the hospital before my surgery on Thursday, but after sleeping until 11:00 am and working on things on the home front, we decided to head out tomorrow and instead spent the afternoon working out, John running on the treadmill and me swimming a mile in the pool of our local YMCA. Swimming for me is an old friend. My father introduced me to the water at a very young age–it was in fact in a pool. Being landlocked in rural Wisconsin, my father, an avid swimmer himself, took his children–at that time five girls–to any public pool in the winter months that he could find. Summer in Wisconsin, of course, afforded days of fresh water swimming in a multitude of lakes and that is where we could be found, coolers full of drinks and sandwiches camped out for the day. I was a competitive swimmer in high school, but not very dedicated. I think I was voted the least likely to succeed in the sport or something along those lines, but the swimming, the style of it, the finesse of breathing and reaching out for the stroke, always stayed with me. To this day I have great form and probably good potential as a distance swimmer. Today, I was happy knocking out a mile, but I am also integrating swimming as something important to my future physical well being and it feels good to conquer!

The rest of the evening was spent finding the best oysters in town, and why not? I am facing at least five days of no eating and no drinking so John and I set out to eat as many steamed local crab slough oysters as we could, all washed down with healthy amounts of beer and wine. All I can say is I hope those post surgery days of not eating balances out my present over-indulgences! It’s hard to resist eastern North Carolina oysters in season.

Yesterday I noticed small raised bumps on my ankles and I am thinking it must be fleas, so I spent my last minutes at home before checking in to surgery cleaning blankets, vacuuming carpets and this morning before leaving for the hospital, kidnapping my unsuspecting cat, zipping her quickly into a small cat carrier and dropping her off at the vet. Two things happened. The vet called–no fleas–and the bumps on my body are slowly but surely taking over. I have hives. It is amazing the utter lack of control one can have over ones body when it comes to stress. I am a person who usually can maintain a semblance of calm and fortitude even during the worst of times, but for some reason this time, my body has its own plan. It started having anxiety attacks a few weeks ago, commanding my attention just enough to procure a prescription for Xanax, my very first, and after becoming completely catatonic after taking just one, it is my last.

I wanted so bad to blame this current outbreak on fleas, spiders or even bed bugs. The thought of having a rogue body acting on its own accord frightens me. Anxiety ruled my day today. My husband encouraged me to breathe through my stress and to try to avoid taking any drugs. I complied, wanting to have a last night of fun, connection and clarity. So we roamed around town eating and drinking in some amazing local establishments, eating local food, talking to local folk, counting down the hours to when we had to surrender to the “system.”

The time is now. It is after midnight and I can no longer eat, drink or even swallow water when I brush my teeth. Tomorrow at 10:00 am I will have revision surgery, where a recalled hip device will be removed from my body and in its place, hopefully, a safe, functional replacement will be implanted. As for now, John is dozing beside me, I am itching like crazy and almost ready to have this all behind me no matter what it entails. The support and love I feel from all of my friends and family is palpable and I am grateful. And ready.

Disclaimer: This narrative is not intended to represent any specific person or specific product. Names and details have been changed.

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

I have been home in North Carolina from my two month sabbatical in Costa Rica for almost four months now. The memories of my time there, the simple routines, new friendships and the feeling that I would return home and make significant changes in my life after “re-entry” have faded into the urgency of daily demands from work, family, relationships and most urgently: my body. Any time I am away from home I look forward to the pile of mail waiting for me when I return, most of it is junk, I know, but I still get excited by post that is addressed to me personally. Now after two months away from home my stack of mail was significant and I settled into the comfort of my screened in porch in anticipation of what I had missed.

After separating the junk from the catalogs, the catalogs from the bills, the personal emerged and that is where I started. What was waiting for me on that September afternoon among the pile of letters that were a combination of known and unknown, was a curious letter from Duke Diagnostic Clinic. I read it twice to make sure that what I was reading was true and then with an unsettling feeling growing in the pit of my stomach, I looked for my husband John [not his real name]. “John, you are never going to believe what I am reading here in this letter from Duke University. It seems that the artificial hip I received four years ago has been recalled.”

The letter went on to say that only a small percentage of recipients would have complications, but I didn’t need to read any further to know that these were going to be my complications–my life–starting now. Since then I have been traveling the two hundred plus miles back and forth to Durham, the home of Duke University and the Duke medical complex to find that every test that I have taken indicates my device has not only failed, but has been poisoning my blood, damaging surrounding tissue, and quite possibly–we will not know for certain until the surgeons are inside–infecting me.

In the past I spoke of bold action and, with trust, falling into the arms of the universe. Now, faced with major surgery in four days and all of the unanswered questions surrounding this endeavor, I feel like I am falling, but I’m not sure where.

Today was my last day at work before embarking on a two month medical leave to have my left hip re-replaced due to a device “recall.” I left work feeling almost completely satisfied that I could face the impending circumstances with almost no work-related stress or unfinished business. I just have to let it go. I’m finding that I am letting go of a lot of things these days. I will no longer be able to run after my bionic-titanium parts are replaced with more fragile parts. Ceramic, plastic and metal will probably not invoke words from my surgeon like the words after my first hip replacement: “Do whatever you want as long as it does not cause you pain.” Not that pain has ever stopped me before. No pain, no gain, right?

I will miss running though, and I’ll have to face other limitations head-on as they come. Since I am returning home from the hospital mere days before Christmas, I am letting that go too. My family, my husband, and our two children have been trying to create a family holiday experience as far from the consumer, commercial version as we can, spending our time making gifts, cooking food, playing games and music–and if we are not on a traveling adventure–staying home and just having fun. Two years ago our kids, they are twenty six and twenty one now, squirreled away and wrapped random objects from our home so when we woke on Christmas morning, John and I really thought Santa had come. The gifts were spilling out from under the tree, until I looked closer at the bicycle with the big red ribbon tied around it, noticing the rust and dirty tires–who’s bike was that?

In the days leading up to this week I have amassed a stack of books to read while recovering. I have selected various tomes for friends and family as gifts this season and that is all I am doing. Cooking, traveling, creating, taking care of family and friends, I’m letting it go. The first time I had total hip replacement surgery was four years and four months ago. John and I are amazed that we have almost no recollection of what happened the first time I had surgery. We are trying to put the pieces together in order to prepare ourselves this time around, but we have hardly any memory of the experience. This time I have the full support and care of a loving man–my husband of almost twenty seven years. And it’s funny because this second surgery, this “do-over” is like another chance to make all my stories right, to let go of those stories and parts that “no longer serve me,” as one of my wise friends noted.

And so here it is, another chance to let go, another chance to continue creating my story.

Disclaimer: This narrative is not intended to represent any specific person or specific product. Names and details have been changed.

The vast majority of artificial hip failures over the past decade involved metal-on-metal (MoM) hip components. These medical devices were meant to revolutionize the artificial hip market. Specifically, the all-metal hip components were intended to last a long time, and much longer than older generation artificial hips using materials like ceramics and plastics, which had a tendency to wear down and “fail” after twelve or fifteen years. Beyond that, the metal-on-metal artificial hips were touted to withstand the rigors of active, athletic patients. It sounded like a terrific advancement in the development of artificial hips. The problem is, the metal-on-metal design did not work, in many cases because the metal acetabular cup and the metal femoral head would grind together day after day, month after month, releasing harmful metal debris (metallosis) into the patient’s body. Far too many people were forced to get revision surgeries a few years after the implant surgery to remove the metal hips.

It turned out to be a disaster for thousands of patients and for several large medical device manufacturers. Depuy and Zimmer, to name just two companies, faced thousands of lawsuits from people injured by the metal-on-metal artificial hips. Many of those cases are resolved or resolving, but many more await settlement or jury trials.

The LFIT V40 Is a Metal-on-Polyethylene Artificial Hip

The Stryker LFIT V40 Hip is not a metal-on-metal artificial hip. The LFIT V40 system includes a metal acetabular cup, a polyethylene (or plastic) liner, a cobalt-chromium femoral head, and a titanium femoral stem. The exploded-view diagram at top right gives you an idea of how the Stryker LFIT V40 hip is assembled. Stryker avoided the problematic construction of direct metal-on-metal components.

So far so good, right? Well, unfortunately, no. Soon after being released into the market, the Stryker LFIT V40 began to fail, at an unusually high rate. And patients who received the Stryker LFIT V40 were suffering from similar symptoms as those who received metal-on-metal hips. Even, oddly, diagnoses of metallosis. It was an unexpected result. So what happened?

Something called a taper lock failure. Let’s take a closer look:

The LFIT V40 Taper Lock Failure

The failure of the Stryker LFIT V40 concerns the junction of the neck of the femoral stem and the femoral head or ball. In the illustration above, the neck is that small metal rod that extends out from the femoral stem. The neck connects and attaches to the femoral head (the ball), thus connecting the leg bone to the hip bone. This connection was intended to be permanently secured through a taper lock system, holding the stem securely to the ball.

But as it turned out, in many cases once in the body the V40 femoral head began to corrode, which means to slowly 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 become compromised and 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. According to one study from 2016, the loosening would cause fretting and micromotion at the taper lock site, and this movement or 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 artificial hips.

The corrosion in the LFIT V40 can be slow. This means that the average patient may not know the Stryker hip is failing and releasing cobalt and chromium into the body. It can take years for the loosening to cause problems that are recognizable to the patient. At that point, the neck may have begun to corrode, and when that happens the femoral stem may need to be removed and replaced. This 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 invasive and problematic and painful.

So How Can You Salvage the Femoral Stem?

You must remove the failing V40 femoral head as soon as possible. This means artificial hip revision surgery. If you remove the head at the beginning of the period of corrosion, and the femoral neck is not corroding, you should be able to revise your artificial hip without the difficult work of removing the femoral stem. But either way, you will have to undergo revision surgery, which is no fun at all. My thought would be: check with your surgeon and confirm the exact components you have in your body. If the doctor reports that you have the Stryker LFIT V40, you need to have a lengthy discussion about removing the v40 femoral head, even if you are not currently having symptoms.

I wrote more about the Stryker LFIT V40 artificial hip here. If you would like to read more on the study identifying failures of the Stryker LFIT V40 taper lock, google Trunnion Corrosion Causing Filure in Metal-on-Polyethylene Total Hip Arthroplasty with Monolithic Femoral Components in Reconstructive Review (April 2016).

Note: I am not a doctor, and this is not medical advice. The diagram at the top is for illustrative purposes only and is not intended to depict the specific Stryker LFIT V40 artificial hip.

If you have been the victim of a failed medical device like a metal-on-metal artificial hip, you may not ever think about preserving evidence. But it is essential to your product liability case. In this post I want to give you some tips about preserving medical device components that have been removed (“explanted”) from your body in a revision surgery. This information is important for all those undergoing revision surgery, but especially those of you who hope to pursue a product liability case without a lawyer.

Here is a quick illustration: You undergo hip replacement surgery in October 2009. In August 2010, you receive a letter from the manufacturer of the artificial hip stating that a recall has been issued on the medical device implanted in your body. Since the device is implanted in your body, you can’t easily turn it back in for a refund. So you monitor the situation. Ten months later, you begin to feel discomfort, and then outright pain. After a few more months you and your orthopedic surgeon decide to have the device removed in a revision surgery. In this operation, the surgeon will remove the defective parts of the artificial hip and replace them with new, non-defective parts. Those removed parts will sit on a surgical tray, and after the surgery they will end up . . . somewhere. They could be thrown out; they could be placed in a Ziploc bag and abandoned in a storage room; they could be handed over to the medical device manufacturer’s representative, who is often in the room during your surgery.

But they need to go to you.

Quite simply, before the revision surgery, the patient should take steps to ensure that he or she will be given the explanted medical device components. This usually involves careful conversations with the surgeon and the surgeon’s nurse or other staff. Unfortunately, most patients have no idea that need to take this step.

more If You Have a Lawyer

To start with, I highly recommend that you hire a product liability lawyer to handle your medical device drug case, because there are simply too many steps in the process. You can read my thoughts on that subject here. If you hire a lawyer, he or she will be responsible for gathering all available evidence. If you have hired your attorney before you undergo revision surgery, your lawyer will need to send a Preservation of Explanted Components Letter to your surgeon and the hospital or surgery center prior to the scheduled surgery. This letter must be delivered along with an authorization for the release of medical information signed by you. (Without the release, the attorney will have no power to obtain your protected medical information, or to get possession of the explanted components.)

The Preservation Letter will spell out what you as the patient expect with respect to the identification and preservation of the components after surgery. It should include language similar to this:

• Please be advised that we represent Patient “X” in a potential product liability claim against Manufacturer “Y” related to the “Z” artificial hip components. Enclosed is an Authorization for Release of Medical Information signed by Ms. X.
• It is our understanding that Patient X is currently scheduled for hip revision surgery to be performed by Dr. “A” on [date] at “B” Hospital in “C” City. Because of Ms. X’s potential claim against Manufacturer Y, any hardware components that are explanted must be preserved for possible use as evidence and delivered to my office.
• This letter is to serve as notification that Ms. X wants to retain possession of any and all components removed during this surgery and that these components are not to be destroyed, disposed of, or returned to Manufacturer Y or its representative.
• Please take care to identify the explanted components, indicating the patient’s name and date removed. A compliant biological substance shipping kit will be provided to the hospital by our office.
• Additionally, if during the surgery any intra-operative photographs and/or video are taken, we ask that those also be preserved as well.

Following this letter and shortly before the scheduled revision surgery, your attorney may follow up with the surgeon and/or hospital to confirm that the surgical team is aware of and understands the component preservation request.

But Stay Involved in the Process

I advise my clients to stay actively involved in the process when trying to preserve explanted components. Doctors and hospitals can be flaky about these requests. Some nurses or hospital staff may not understand what you are hoping to accomplish, and medical malpractice alarms often sound in their heads. In other cases, medical care providers simply forget about the preservation letter and may hand off the components to the manufacturer’s sales rep, or may even simply toss the components in the trash. But you have a right to obtain these removed components (with or without a lawyer) so you need to (nicely but firmly) remind the surgeon and the surgical nurse that you desire to take possession of the components after the revision surgery.

If You Do Not Have a Lawyer

If you choose to represent yourself in the product liability lawsuit, you will need to make sure that you seek to preserve the explanted components on your own. This means that you should write a letter detailing most of the points listed above, and you should persistently remind your surgical team that you want the explanted components. Make sure the components are delivered to you with identification stickers establishing that the components were removed from your body in a revision surgery on a specific date. When you get them home, place the components in a safe and secure and remembered location.

Please note: I use artificial hip components as one example in this post, but preserving explanted device components is important in any medical device case, including those involving defective hips, knees, shoulders, surgical mesh, or IVC filters. Often, the surgeon cannot remove and preserve the entire defective device (as with mesh or IVC filters); in those cases, take as much as the surgeon could remove.

Why Is It Important to Preserve Explanted Components?

Here’s the thing: you may settle your case without ever needing to hand over the explanted components. But I have seen cases where the hospital did not preserve the product stickers from the original implant surgery. In that case there is no absolute evidence for what exact medical components were implanted in the patient. After all, the person injured by a failed medical device must establish which recalled or failed medical device was implanted. In those cases, you will need your surgeon to submit an affidavit testifying to the specific medical device components implanted in your body, and/or you will need the actual components when they are removed in the revision surgery. So even if you do not ever need to “hand over” the explanted components as part of your lawsuit or your settlement, it is always the best practice to make sure you or your lawyer obtain the components after the revision surgery.

Note: this is not legal advice.

Some late-breaking news: The Depuy ASR Settlement Agreement has been extended to cover injured people who received a revision surgery after January 31, 2015. The extension was announced yesterday. Here’s how it works: if you received a Depuy ASR artificial hip, and then had revision surgery to remove the component between January 31, 2015 and February 15, 2017, you now may qualify to participate in the Settlement Agreement negotiated between plaintiffs and the defendants.

Let’s back up.

Before Yesterday, Where Were We?

Two settlement agreements have been reached in the Depuy ASR multi-district litigation (MDL). To qualify for the “2013 Settlement” you must have undergone revision surgery on or before August 31, 2013. To qualify for the “2015 Settlement” you must have undergone revision surgery between August 31, 2013 and January 31, 2015. The key terms in both settlement agreements were essentially the same, and the amounts you were entitled to recover were also the same.

These settlement agreements had deadlines which created a large group of people who could not participate in the settlement, specifically those who had not undergone revision by January 31, 2015 (including some of my clients).

The Depuy ASR hip was recalled on August 24, 2010, over six years ago. That meant that people were still receiving the Depuy ASR implants in 2010 and likely after August 24, 2010 (as it takes time before a recall is fully communicated to the medical community). Let’s say you had hip replacement surgery on in May 15, 2010, but you did not feel severe pain for a few years, then finally decided to undergo revision surgery on February 15, 2015. At that point you were beyond the January 31, 2015 deadline in the second Settlement Agreement and could not participate in settlement.

Even though your claims for injuries were just as valid as any other injured person who came before and who qualified to participate in the settlement based on (arbitrary) settlement deadlines, you could not settle your case. First, remember that the Depuy ASR hip components failed at an unreasonably high rate for patients. Second, even though your revision surgery occurred after January 31, 2015, it is still revision surgery, a painful procedure which became necessary only because the Depuy ASR hip failed. So there was always a group of people who were injured but not eligible to participate in the settlement. Fortunately, that temporary injustice was rectified yesterday.

I predicted last year the Depuy ASR MDL would eventually extend the deadlines for participation in the settlement. I am glad they finally made the announcement yesterday.

Recap: ASR Revision Surgery Between January 31, 2015 and February 15, 2017

Again, to be eligible you must have first received a Depuy ASR artificial hip and then had revision surgery to remove the ASR components between January 31, 2015 and February 15, 2017. Before this decision those people who received revision surgeries after January 31, 2015 were essentially left in limbo.

Deadlines Extended for Late Filers

In addition, the Plaintiffs’ Executive Committee for the Depuy ASR litigation announced that those cases that had been eligible to participate in the first two rounds of settlement were still eligible to participate in the settlement program. I understand this to mean that if you received a revision surgery prior to January 31, 2015, but somehow failed to bring a claim by the deadlines (maybe you were not aware of the settlement or the deadlines) you can now request to participate fully in the settlement (if you meet all criteria for settlement). This is a nice development, as the language of the first two settlements indicated that if you did not bring a claim by a certain date, you would not be eligible to participate. My takeaway is that all sides are now working hard to include every available person who may have been harmed by the failed Depuy ASR components.

Part B “Extraordinary Injury Fund” Also Extended

The Part B section of the Settlement Agreements, which I wrote about here, will also be made available for individuals who received revision surgeries after January 31, 2015. As I’ve written about on this site, the Part B awards were built around “extraordinary injury” following the artificial hip failure, and provided extra compensation to people suffering from particularly bad results, such as heart attack, stroke, foot drop, pulmonary embolism, deep vein thrombosis, dislocation, or infection, and monetary losses like lost earnings.

If you had the Depuy ASR artificial hip implanted, and underwent revision surgery on or after February 1, 2015, you may now be eligible to participate in the Depuy ASR settlement program. Good luck, and call me if I can answer any other questions.

Unfortunately, not all artificial hips have performed as intended, resulting in serious complications for many patients. I have written often about failed artificial hips on this site. One such example has occurred with the Stryker Orthopaedics’ (Stryker) LFIT V40 femoral head. On August 29, 2016, Stryker issued a voluntary recall for this particular hip replacement product. If you or someone you know may have received this hip replacement product, there are certain things you need to know.

What’s Being Recalled?

This isn’t the first time Stryker has had a problem with its hip replacement products. Back in 2012, Stryker recalled its Rejuvenate and ABG II modular-neck hip stems. However, the current recall concerns the LFIT Anatomic CoCr V40 Femoral Head (V40 femoral head).

The recall focuses not on the entire hip replacement prosthesis, but rather just the femoral head; the femoral head is the “ball” part of the hip replacement. This femoral head fits inside the “cup” (which is located in the pelvis) and is also attached to the “stem” (which is connected to the femur, or thigh bone). Neither the cup nor the stem are currently a part of this recall.

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Not every V40 femoral head is being recalled. The recall includes those manufactured before 2011 that have the following catalog numbers and sizes:

Many patients who received the V40 femoral head also received additional Stryker hip replacement components, such as the Accolade TMZF, Accolade 2, Meridian and Citation stems.

What’s Wrong With the V40 Femoral Head?

Stryker has observed that a higher than expected number of its V40 femoral heads are malfunctioning due to a failure in the taper lock. The taper lock is the part of the hip prosthesis that connects the femoral head to the stem. When the taper lock fails, various symptoms can result, such as:

– Loss of movement – Joint instability – Legs of differing lengths – Severe pain – Annoyance – Inflammation – Joint dislocation

These symptoms can be caused by any of the following:

– Metallosis – Fractured hip stem trunnion – Disassociation of femoral head from hip stem – Excessive wear debris – Insufficient soft tissue tension – Loss of implant: bone fixation strength

These are just some of the possible symptoms and hazards associated with a failing V40 femoral head. Two of the more serious issues are metallosis and disassociation of the femoral head from the stem.

Metallosis occurs when metal particles build up in human tissue. This can cause inflammation, metal poisoning and necrosis. The metal particles are created when bits of the hip replacement wear away due to the grinding and rubbing that occurs within the hip replacement over time.

Disassociation of the femoral head from the stem is another way of saying that the femoral head and stem break apart. This can be caused by corrosion in the V40 femoral heads.

How Can These Issues Be Fixed?

The exact cause of taper lock failures in the V40 femoral heads has not yet been provided by Stryker. But regardless of how the V40 femoral head is defective, if you are suffering any of the above symptoms, there’s a good chance you may have a V40 femoral head hip replacement component that needs to be fixed or “revised.”

In order to fix the problem, many patients will need revision surgery. Revision surgery is basically another hip replacement surgery to remove the problematic hip prosthesis component and replace it with a different one. As you can imagine, a revision surgery is the last thing a hip replacement recipient wants to go through.

So What Now?

If you are the recipient of a Stryker LFIT V40 femoral head subject to this recall (or believe you may be), you should see your orthopedic surgeon as soon as possible, regardless of whether you’ve experienced problems with your hip replacement.

If you have suffered some of the symptoms described in this blog, you may want to consider having your situation reviewed by a competent product liability attorney. You may call me at (919) 830-5602 or send me a message. Either way, good luck.

Many people still have the Depuy ASR hip components implanted in their bodies. I get calls from them. Some have elevated metal levels in their blood; others are telling me about pain in the hip area, popping sounds, and other problems. They are preparing to schedule revision surgery, and they want to know if they may qualify for compensation based on the settlements that have been reached with Depuy, Inc. and Johnson & Johnson, the parent company.

These are good questions. I want to make sure you are aware of a nine-year window for undergoing revision surgery.

Two Settlement Agreements So Far

As I have explained in this blog, there have been two Depuy ASR settlement agreements, mostly identical in material terms. The major difference is that the first settlement agreement covered those who had undergone revision surgery prior to August 31, 2013. The second settlement covered those people who had revision surgery between August 31, 2013 and January 31, 2015.

more No Settlement Agreement (Yet) for Recent Revision Surgeries

There has been no “third” settlement agreement. This means that there is currently no procedure in place to settle claims with individuals who received revision surgery after January 31, 2015. I suspect that a third settlement agreement (looking much like the first two) will eventually be established and announced. But as of today there is no agreement by which a person revised after January 31, 2015 can pursue settlement compensation with Depuy and J&J.

Length of Time Between Implant and Revision

The 2013 Settlement Agreement did not explicitly set out a cut-off date for settlement eligibility based on the length of time between implant surgery and revision surgery. In that agreement, to be an “Eligible United States Claimant,” you had to be a U.S. Patient, had implantation of the Depuy ASR, and underwent revision surgery.

The 2015 Settlement Agreement added a fourth condition: The time between implantation and revision surgery must be less than nine years. Which is to say, if nine years or more have passed between implantation surgery and revision surgery, you would not be eligible to participate in the settlements.

Nine-Year Cut Off

So that seems to be a bright line drawn in the sand: If you lived with the Depuy ASR hip in your body for nine years or longer, Depuy and J&J do not seem willing to recognize a compensable injury. (Note: This does not mean you cannot attempt to seek compensation outside the settlement scheme if you had revision beyond the nine-year cut-off. In fact you should. But it does signal that Depuy is not willing to recognize damages in cases where the individual lived with the Depuy ASR hip for nine years or longer.)

Example: if the Depuy ASR hip was implanted in your body on May 12, 2008, you would arguably have until May 11, 2017 to undergo revision surgery to be considered “eligible” for participation in any settlement.

Remember that the official recall of the Depuy ASR artificial hip was August 24, 2010. For the sake of simplicity, let’s presume that no Depuy ASR hips were implanted after the recall date (and this can’t be true, but go with it). In that case, the outermost limit for eligible claims under the settlement agreement would be August 23, 2019. Keep these timelines in mind.

Always Beware the Statute of Limitation

Even though you may still be able to schedule revision surgery less than nine years from implantation, the statute of limitation could still end your case. I wrote about statutes of limitation here. I will say to be very cautious about delaying legal action if you believe you have a claim. A case involving revision surgery more than eight years after implantation may well have a statute of limitation issue lurking. And if it does, it could stop an otherwise valid claim in its tracks.