Smith & Nephew Birmingham Hip

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

In Smith & Nephew’s Birmingham Total Hip Arthroplasty (THA) the artificial hip is constructed with Smith & Nephew BHR components and non-BHR components, but instead of resurfacing the ball-bone with a metal covering as in the resurfacing procedure, the bone is removed and a metal ball component is implanted.

Cases involving failed Smith & Nephew’s resurfacing hips and THA hips are now consolidated in multidistrict litigation No. 2775 in Baltimore, Maryland. Litigation is currently active and the first bellwether trial for a BHR case is scheduled for spring of 2020. In January 2019, mediation was held to attempt settlement for most of the S&N THA cases, but that mediation was not successful (at least, at that time). I suspect the litigation to continue for another eighteen months at least.

Stryker LFIT v40

Unlike other artificial hips currently in litigation, 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 failure of the Stryker LFIT V40 involves the junction of the neck of the femoral stem and the femoral head or ball. 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. In many cases, however, once implanted the V40 femoral head began to corrode. The corrosion occurred at the site of the connection to the neck. Over time the corrosion can 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, the loosening would cause fretting and micro-motion 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 other patients who received metal-on-metal artificial hips.

In November 2018 Stryker Orthopaedics reached a settlement in the multidistrict litigation involving the LFIT V40 hip. The settlement involves approximately 125 cases in the federal court MDL and an additional 140 cases in New Jersey state court. Although this agreement settles many lawsuits previously filed in the MDL, there remain many lawsuits that were later filed and have not been resolved, so this litigation is not over. I believe Stryker will work to extend the settlement agreement to the remaining claims, or the litigation will need to ramp up again very shortly.

DePuy Pinnacle and ASR

The DePuy Pinnacle litigation has been slow-going. DePuy Orthopaedics stood by the Pinnacle device in a way it did not with the ASR. For one thing, it did not officially recall the Pinnacle hip, as DePuy did with the ASR. The Pinnacle MDL was formed in March 2011, just six months after the ASR MDL was established. However, while DePuy recalled the ASR device and entered the first ASR settlement agreement in 2013 (see below) it stood defiantly against allegations of defect involving the Pinnacle. Years passed, and thousands and thousands of individuals filed suit against DePuy and Johnson & Johnson for injuries caused by the Pinnacle. One Pinnacle bellwether trial after another came and went, and still the plaintiff and defense teams could not reach a larger settlement. As of today no global settlement has been reached, and the litigation is far from over.

The DePuy ASR hip litigation has been powering along for a decade. On August 24, 2010 DePuy Orthopaedics announced a worldwide recall of the ASR artificial hip system. In November 2013 the first Settlement Agreement was reached in the ASR multidistrict litigation. To qualify for this “first” settlement the injured plaintiff must have had revision surgery to remove the ASR hip by August 31, 2013. The second agreement included plaintiffs whose revision surgery occurred on or before January 31, 2015. The third settlement agreement offered settlements to those injured people who had revision surgery on or before February 15, 2017. And then everything . . . stopped. Many court watchers believed a “fourth” settlement would be reached to resolve the hundreds of cases involving plaintiffs whose ASR revision surgeries occurred after February 15, 2017, but so far, nothing. Currently over 1,600 people have cases filed and pending in the ASR MDL. I expect either a new settlement extension to be announced or an order from the judge remanding these remaining cases to their home courts for further litigation and trial.

Note: All information in this article is distilled from publicly-available information, including media reports, and my previous posts.

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).

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.

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.

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.

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.

I get calls from people all over the country worried that they may have missed a deadline for participation in the Depuy ASR Artificial Hip Settlement. I understand the alarm. It would be dreadful to have the ASR metal-on-metal hip implanted, suffer mysterious pains and then elevated metal levels in the blood, discover the artificial hip components failed, go through a painful revision surgery, and then find that the settlement deadlines have all passed. The reality is this: at the moment, all the deadlines have passed. But many viable ASR claims against Depuy and Johnson & Johnson are still out there, and they should be fairly compensated like all the injured people that have come before.

Third Settlement (Second Extension)

In the most recent extension of the ASR Master Settlement Agreement, the deadline to enroll in the settlement was July 19, 2017. This second extension of the Master Settlement applied to individuals who had the ASR hip removed in revision surgery between between January 31, 2015 and February 15, 2017. The reason for this specific set of dates is that the settlement committees for plaintiffs and defendants wanted to include victims who had revision surgery somewhat late in the game. Recall that the Depuy ASR hip was first sold in 2005, twelve years ago. It was sold aggressively for five years, until it was finally recalled on August 24, 2010. Thousands of people were implanted with the ASR hip in that five-year period. Most of them were forced to undergo revision surgery before August 31, 2013, the deadline for participation in the first settlement. But hundreds of people did not undergo revision surgery until after August 31, 2013. Therefore, a first and then a second extension of the original agreement was established.

At this point the settlement(s) applied to all individuals who received revision surgery from 2005 through February 15, 2017. That covers a lot of people. But not everyone. I have clients who have undergone revision surgery after February 15, 2017. I have others who have revision surgery scheduled for later this year. They have been injured in many of the same ways as those people who had revision surgery in 2007, and 2010, and 2015. And they absolutely deserve fair and complete compensation for their injuries.

Why Further Settlement Extensions Are Necessary

Let’s look at the calendar for a moment. The recall for the Depuy ASR was August 24, 2010. This means that many people received the ASR hip in 2009 and 2010, and possibly even beyond August 2010 (as one can’t assume that the implantation stopped on a dime precisely on the recall date). With MoM hips, the outward signs of failure may not be obvious for years. A person with rising metal levels in the body may not have noticeable symptoms. They may learn of their elevated levels of cobalt and chromium (the metals associated with ASR MoM hip failures) in a routine blood test as part of a physical. A person who received the ASR hip in July 2010 is just seven years removed from surgery. Many people who had revision surgery seven or eight or nine years after the implant surgery have already received compensation under the settlement. The person who received an ASR hip in 2009 or 2010 should not be punished simply because they received the ASR hip late in the period when the hip was marketed, sold, and implanted.

The Takeaway

My point is this: I am quite certain further extensions of the Master Settlement will happen. The Depuy ASR litigation has been massive, and thousands of people have been compensated already. It would be extremely unfair and unjust to deny recovery for those remaining people who were injured “late in the game.” I suspect a third extension may be announced in 2018.

When Will It End?

Plainly, the litigation and the extensions won’t continue forever. One arbitrary cut-off I have seen is ten years. That is to say, so far, Depuy has not shown willingness to compensate individuals who received revision surgery more than ten years after the original implant surgery. The logic behind this cut-off is that typical artificial hips historically last twelve to fifteen years, so revision surgery of more than ten years is within normal ranges in the life-cycle of an artificial hip. I don’t buy it. If the Depuy ASR hip fails, even ten and a half years after implantation, the patient should be compensated.

It may be that future extensions may stretch to include ASR failures beyond ten years. But I am not at all certain of this. The reality is this: if you have a failed ASR hip and your surgeon advises you to have it removed, don’t delay. Go ahead and schedule revision surgery. It is important mainly for your health but also, potentially, for your case against Depuy.

One date to keep in mind is August 24, 2020, which is the ten-year anniversary of the date Depuy recalled the ASR hip. I don’t see it as an absolute hard deadline to bring a viable claim against Depuy, but it will mark a key milestone in the multidistrict litigation.

Until then, more people with viable cases against Depuy for the failure of the ASR hip will come forward. If you are one of them, and would like more information, give me a call (919.830.5602).

1995

In 1995, Dr. Graham Isaac released a short paper discussing the problems with metal-on-metal (MoM) artificial hips. Dr. Isaac explained how metal wear debris created from MoM hip joints was a serious problem because of poor design and manufacturing of the metal components. Dr. Isaac also stated that even with higher quality manufacturing and engineering techniques, the performance of MoM hip implants were as “unpredictable as ever, working well for a period of time before suffering catastrophic breakdown . . . accompanied by a release of a large volume of debris.” This paper and Depuy’s other internal documents suggest that Depuy Orthopaedics most likely knew of the MoM risk factors in 1995, twenty-two years ago, and ten years before the company began selling the Depuy ASR artificial hip. In fact, one doctor noted that Depuy needed “to be cautious of the legal/litigation issues and lawyers, etc…perception of metal debris and metal-ion release.” I wrote more about what Depuy may have known about the serious risks of the ASR hip here.

August 2005

In August 2005, the FDA approved the Depuy ASR artificial hip for sale by means of the 510(k) process. The FDA did not require the Depuy ASR hip to undergo clinical trials. This turned out to be a big mistake. In 2005, Depuy submitted a section 510(k) premarket notification of intent to market the Depuy ASR Hip. By representing to the FDA that the Depuy ASR hip’s design was “substantially equivalent” to other hip products on the market, Depuy was able to avoid the important safety review required for premarket approval under FDA regulation, including vital clinical trials.

August 24, 2010

After hundreds of reports of failures of the Depuy ASR MoM artificial hip in patients, Depuy Orthopaedics issued a worldwide recall of the Depuy ASR on August 24, 2010.

September 3, 2010

The Judicial Panel on Multidistrict Litigation (JPML) approved a multidistrict litigation site for injury claims involving the Depuy ASR. The MDL is situated in the Northern District of Ohio with Judge David Katz. After Judge Katz’s death, Judge Jeffrey Helmick was appointed to preside over the Depuy ASR MDL. (1:10-md-2197)

November 19, 2013

The first Depuy ASR hip Settlement Agreement was reached on November 19, 2013. The first settlement agreement required that a plaintiff had revision surgery on or before August 31, 2013. In the Agreement Depuy agreed to pay $2.5 billion dollars to settle thousands of claims.

March 2, 2015

The second settlement agreement was reached on March 2, 2015, which allowed participation in the settlement if a plaintiff received a revision surgery after August 31, 2013 but no later than January 31, 2015. The material terms in the second settlement agreement were the same as those in the first settlement.

March 3, 2017

On this date an extension of the second settlement agreement was reached. Let’s call it the “Third Settlement.” The Third Settlement covered people who were implanted with the Depuy ASR hip and underwent revision surgery between January 31, 2015 and February 15, 2017.

February 16, 2017

If you had revision surgery on this date or afterward, you (technically) do not qualify for participation in the Third Settlement. However, if you had revision surgery on February 16, 2017 or later, you should still be able to recover from Depuy, either in a Fourth Settlement or outside the MDL altogether. After all, you were injured by a failed medical device and were forced to undergo revision surgery (which should not have been necessary). Give me a call to discuss your revision surgery occurring after February 15, 2017.

July 19, 2017

This is the deadline to file a claim for participation in the Third Settlement. If you had revision surgery between January 31, 2015 and February 15, 2017, you have just a few weeks longer to enroll in the Third Settlement. Do not delay!

October 27, 2017

This is the deadline to file claims in the “Part B” portion of the Third Settlement. I wrote about Part B “Extraordinary Injury Fund” here and here and here, but briefly, Part B recognized “extraordinary injury” that followed Depuy ASR 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 lost earnings.

August 24, 2020

This will be the ten-year anniversary of the date Depuy recalled the Depuy ASR artificial hip. After this date, I imagine it will be difficult to bring injury claims against Depuy Orthopaedics for the failure of the Depuy ASR, though some claims should still be viable depending on the timeline.

Please check this site for all kinds of information on the Depuy ASR hip, the Depuy Pinnacle hip, the Stryker and Smith & Nephew hips, and other MoM artificial hips that have harmed thousands and thousands of people all over the world. As always, good luck.

Depuy MoM Hip Implants: An Overview

Hip implants have been around for a long time. They can be made of various materials. Some older models use a polyethylene cup and a metal ball to create the artificial hip joint. While this combination works well, it’s not perfect. Engineers have looked for other materials to find a hip joint that can last longer with fewer adverse effects.

One attempted solution was to have both the cup and ball made out of metal, hence a metal-on-metal hip joint. However, the performance of these hip implants was even worse than joints that used polyethylene and metal. Problems with MoM hip implants included significant pain, bone loss, hip implant failure and metallosis.

As a result of these problems, thousands of lawsuits have sprung up, not just against Depuy, with its ASR and Pinnacle MoM implants, but other MoM hip implant manufacturers such as Biomet and Stryker. Many of the Depuy lawsuits have been consolidated into multi-district litigation, or MDL. A few initial bellwether trials involving the Depuy Pinnacle have resulted in massive verdicts against Depuy, which I wrote about here.

Basically, things have not been looking good for Depuy. And they just got worse.

more The Incriminating Documents

The Daily Telegraph recently published a story, based on internal documents recently made available, that show Depuy actually knew it had serious problems with its MoM hip implants for years. The company deliberately took steps to ignore the problems. The released documents include:

• A paper written by Graham Isaac, Ph.D., discussing problems with MoM hip implants.
• A letter from Dr. John F. Irving, MD, to Depuy’s head of US marketing (Paul Berman).
• Depuy corporate meeting minutes where Depuy executive met to discuss various topics, including MoM hip implants.
• Internal Depuy e-mail exchange discussing MoM hip implant problems.
• A July 2008 paper on the topic of MoM hip implant problems.

These papers are especially incriminating because they show what Depuy knew (or should have known) and when they knew it.

What Did Depuy Know?

In Dr. Graham Isaac’s paper, he explains how metal wear debris created from MoM hip joints were a serious problem due to poor design and manufacturing of the metal components. However, Dr. Isaac goes on to state that even with higher quality manufacturing and engineering techniques, the performance of MoM hip implants were still “as unpredictable as ever, working well for a period of time before suffering catastrophic breakdown…accompanied by a release of a large volume of debris.”

Dr. Isaac went on to conclude that metal-on-polyethylene hip implants performed significantly better than MoM implants. He also mentioned that using ceramics can produce hip implants that perform better than MoM hip implants.

In Dr. John Irving’s letter to Paul Berman, he spoke of his data collection which shows that Depuy’s MoM hip implants were dramatically underperforming other types of hip implants. When looking at metal-on-polyethylene hips from the last 10 years, Dr. Irving had a 1.2% failure rate, or eight revisions out of 660 hip implants.

Contrast this with Depuy’s MoM hip implants, where out of 262 implants, 31 required revision surgery. This was an 11.8% failure rate, almost 10 times that of the conventional metal-on-polyethylene hip implants.

As if that wasn’t bad enough for Depuy, Dr. Irving complained about Depuy’s “lack of attention and head-in-the-sand response to this problem.” Dr. Irving went on to state that “these products are harming patients,” that he “did not feel Depuy [was] doing enough to understand the extent of the Pinnacle MoM hip disease” and it would be “unethical to continue to market the product.”

And in 2010, when Depuy finally starting taking action with its MoM hip implants, there was an e-mail exchange among Depuy executives and experts acknowledging a “link to a failure pattern of the ASR XI to the Pinnacle with 36 mm heads when used with metal liners” and that “the problem may be widespread” with “evidence of metal on metal and ceramic on metal failings.”

There was also the recognition that when a hip implant failed, it was “sometimes catastrophic.” One of the e-mails ended with the belief that Depuy should “investigate and manage this growing problem.”

When Did Depuy Know?

So these internal documents go to what Depuy knew, but how long did Depuy know this? Corporate minutes show Depuy most likely knew of the MoM risks in 1995, over twenty years ago. One of the meeting’s attendees, Dr. Paul Peters, noted that Depuy needed “to be cautious of the legal/litigation issues and lawyers, etc…perception of metal debris and metal-ion release.”

Additional notes from the corporate minutes indicated that Depuy observed the following problems with MoM hip implants:

• Large volume of metal particles being released from the hip implants
• Metal ions being released into the body
• Poor wear results
• Metal scratches in the components taking the form of peaks and valleys (as opposed to just valleys, which would result in the hip implant lasting longer).

What Does All this Mean?

These documents appear to be from discovery in recent litigation concerning the Depuy Pinnacle hip implants, and they may have been used in Depuy Pinnacle bellwether trials. However, it’s somewhat unusual that these have been made public (by sources other than this website). The level of incriminating evidence contained in these documents is also quite unusual. If Depuy had all this information at its disposal more than twenty years ago, the injuries to patients who received the Depuy ASR and Depuy Pinnacle artificial hips in the years since then are particularly horrifying and egregious. I hope such bad publicity will further motivate Depuy to resolve its pending Depuy Pinnacle lawsuits as soon as possible.

*Note: The documents referenced and linked in this post are widely available from other news sources and were released prior to the publication of this article. The Daily Telegraph originally published “End Game” and other documents. I can not and do not verify the authenticity of these documents, nor can I confirm the truth of the statements made in the documents.

We are getting more clarity on the recent extension of the Settlement Agreement in the Depuy ASR artificial hip litigation. As I wrote about in a previous post, the ASR Settlement has now been extended to cover people implanted with the Depuy ASR hip who received a revision surgery between January 31, 2015 and February 15, 2017. This is an important development because up to this point the Settlement did not include any injured people who had undergone revision surgery after January 31, 2015. And this represented a lot of people.

Last week the Depuy ASR MDL executive committees sent correspondence with more clarification of the extension agreement. To make things easy, I am going to refer to this Depuy ASR extension agreement as the “Third Settlement” (because it follows two prior Settlement Agreements which had clearly defined terms and clearly defined deadlines).

Third Settlement Enrollment Deadlines

The deadline to enroll in the Third Settlement is now June 19, 2017. If you are representing yourself in the settlement, please mark this number on your calendar. If you have an attorney he or she should be ready with all documents and forms to enroll you by that time. Seriously, this is an important deadline, so don’t overlook it. Also, this deadline is a change from the first announcement of the Third Settlement; originally, the deadline was May 5, 2017. That has now been extended, so that’s a bit of good news.

The deadline to file claims in the “Part B” portion of the Third Settlement is October 27, 2017. I wrote about Part B “Extraordinary Injury Fund” here and here and here, but briefly, Part B recognized “extraordinary injury” that followed ASR hip failure, and provided additional compensation to people suffering from particularly bad results, such as heart attack, stroke, foot drop, pulmonary embolism, deep vein thrombosis, dislocation, or infection, and lost earnings.

“Future injuries,” which is defined under the Part B section of the master settlement agreement, will be those injuries that arise after September 1, 2017. If you do not have an attorney helping you, I urge you to read the settlement agreement carefully (even two or three times) so you do not miss any opportunities for Part B EIF compensation.

What If My Depuy ASR Revision Surgery Occurred Nine Years After Implant Surgery?

For the first time, the Third Settlement addresses the issue of a revision surgery that occurs more than nine years after the original Implant Surgery. Up to this point, the Depuy ASR settlement agreements did not recognize injury or provide compensation for revision surgeries beyond the nine-year anniversary. I wrote about the nine-year cut-off here. The Third Settlement appears to recognize this “blind spot” and provides an opportunity for patients who had revision surgeries between nine and ten years to receive compensation.

The Third Settlement will pay $50,000.00 for these nine-to-ten years claims, but the agreement also calls for additional compensation from the Part B EIF Fund of $50,000.00. So it appears that injured people who received revision surgeries between nine and ten years after implantation will receive a total of $100,000.00 in a Part A base award. These people will also be able to participate in Part B funding if they can show extraordinary injury.

For patients with revision surgery between eight and nine years, the Part A base award will be $125,000.00, with $25,000.00 provided by the EIF Fund.

This is a positive development, because it recognizes that with the passage of years, many victims are still going through revision surgeries, even beyond the eight or nine year anniversaries of the original surgeries. These people have been injured by the failure of the Depuy ASR hip system and should be compensated. The Third Settlement finally recognizes this group of injured people.

Remember that the Depuy ASR hip was recalled on August 24, 2010, almost seven years ago. So, for example, if you had the original implant surgery on March 21, 2008 but did not feel severe pain for six or seven years and did not undergo revision surgery until April 1, 2017, until now you would have no recognized claims under the settlement agreements. Now you do.

If you are attempting to handle this settlement by yourself (that is, without an attorney) you will need to keep up with all developments from the U.S. ASR Hip Settlement website operated by Brown Greer. Keep in mind that for pro se litigants (those people representing themselves) there is a 29% reduction in the overall settlement payment. If you would like help navigating your case, or the Depuy settlement, or if you just have general questions, you can call me at (919) 830-5602. Either way, good luck.

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.

First, let me make the case for smoking:

You enjoy it. It tastes good (I guess). It makes you alert (I hear); but also, oddly, it can calm you as well (from what I’ve read). You also look cool doing it (I confess; this last part is often true). And it’s legal. But perhaps the strongest argument I hear from smokers is this: no one is going to tell me I can’t smoke. This is a free country after all.

That’s about it, really. That’s all I’ve got. And I’m not here to nag you. By all means, smoke if you must. But let me present a different perspective: setting aside the many health problems smoking causes, it can also destroy or damage your product liability or personal injury case.

Smoking Can Make Proving Causation More Difficult

In many cases, the fact that you are a smoker may make it more difficult for you to prove your case. I recently investigated a potential case against a medical professional for injury to a patient. I had a medical expert review the case and give me his opinion. He said, “it looks like it could be an injury caused by negligence, but the patient was a heavy smoker, so she likely failed to heal properly after the injury because of all the smoking.” Translation: this person may have been injured through the negligence of the medical professional, but it would be very difficult to separate the actual injury from the failure to heal, and the heavy smoking probably contributed to the client’s failure to heal. So there it was. I may be able to prove that the medical professional injured my client, but even an average defense lawyer could make the case that it was the smoking that caused much of the the pain and suffering and slow recovery after the injury.

And that’s the thing: smoking injures people. It also prevents healing. Putting all that together, smoking can make it difficult or impossible to prove injury in a product liability or personal injury case.

Even if you prove your case, and you can show injury caused by the negligence and not caused by the smoking, you can lose thousands of dollars in settlement or through a jury verdict simply by being a smoker. In many product liability master settlement agreements, the fact that you smoked can reduce your total settlement award.

The Loss of Money Is Quantifiable

By quantifiable I mean you can actually calculate (often to the penny) the money you will lose just by being a smoker. In the Depuy ASR hip settlement agreement, the Part A base award for qualifying plaintiffs was reduced by 5% if the individual used tobacco products at the time of the revision surgery. The base award in the ASR settlement scheme was $250,000.00, which means the smoker lost $12,500.00 right out of the gate, simply by being a smoker.

But that’s not all: the ASR settlement also provided an opportunity for extra payments classified as “extraordinary injury.” If the plaintiff could show some extra injury, such as a second revision surgery (“re-revision”), or a condition such as foot drop or pulmonary embolism, that person qualified for additional compensation. Nevertheless, out of the gate these amounts were reduced if the plaintiff was a smoker:

“There will be an up to 10% reduction of the QUSC’s [plaintiff’s] applicable PART B Award if the QUSC (or Product User) was a current smoker of cigarettes or other tobacco products at the time of ASR Revision Surgery or Covered Post-ASR Re-Revision Surgery as reflected in the contemporaneous medical records (with the exact percentage to be determined by the SOC).”

For example, a re-revision surgery typically qualified for $150,000.00 in extra compensation under the Part B portion of the settlement agreement. But if the injured person were a smoker, she would lose 10% of that amount, or $15,000.00. Just like that, the Depuy ASR plaintiff in this example lost $27,500.00 simply because she was a smoker, and that’s presuming she did not qualify for other compensation under the settlement, which would have resulted in further reductions of the total settlement amount.

Other settlements reached in other product liability multidistrict litigation also include reductions in pay-outs if the plaintiff smoked. The thinking in all these reductions is simple: smoking causes all kinds of health problems, so it is logical to presume that the injuries relating to the failed product or prescription drug was at least made worse by smoking. It may not seem fair; it may not even be true, but it happens often.

The Takeaway

From what I hear, it is very difficult to quit smoking. And there are many better reasons to quit smoking than to preserve or strengthen your product liability or personal injury case. I just want you to be aware that smoking can make it more difficult to prove an injury case, and it can reduce your settlement offer in cases ranging from defective artificial hips to harmful medications to medical malpractice. If you can quit now, for all kinds of great reasons, quit.

That is exactly what happened in one of the first important Depuy ASR Hip trials in California.

The Jury Trial

On March 8, 2013, a jury in Los Angeles Superior Court awarded $8,338,236.12 for a man injured by the failure of the Depuy ASR Hip. Loren Kransky alleged that the Depuy ASR hip components were negligently designed, that the components had a design defect, and that Depuy failed to warn him and his doctors about the potential risks involved in implanting the device.

After a five-week trial in 2013, the jury in the California case awarded Mr. Kransky $338,236.12 in “economic damages” and $8,000,000.00 in “pain and suffering” damages. Jurors in the case found that the device was defective at the time of sale, and that it injured the plaintiff. The jury found in favor of Mr. Kransky and awarded damages for medical costs and for emotional suffering and distress.

The jury did not award punitive damages to Mr. Kransky. The jury did not find that Depuy acted with fraud or malice, which prevented an award of punitive damages. Which was good for Depuy, as Mr. Kransky’s legal team aggressively argued for punitive damages in amounts that could have exceeded $100,000,000.00.

more The Appeal

After the jury verdict, Depuy filed a flurry of post-trial motions, which the trial court rejected. Depuy then filed appeal. Depuy argued several issues on appeal, but I want to focus on the most important defense argument: that the trial court made a fatal error when it prevented Depuy from entering evidence at trial that the U.S. Food and Drug Administration approved the Depuy ASR device for sale and marketing. Let me explain.

Before the start of the 2013 trial, Mr. Kransky filed a motion in limine asking the court to exclude evidence that the Depuy ASR device was approved by the FDA. Kransky argued that because the Depuy ASR hip hit the market under the abbreviated and less rigorous 510(k) process (which I’ve written about often), that mentioning FDA “approval” would confuse the jury and unfairly prejudice the Plaintiff’s case. The judge agreed, noting that the 510(k) was a limited review process which was not as rigorous as the comprehensive Premarket Approval process, and that it could confuse the relevant issues and consume too much time for a limited purpose.

On appeal Depuy hammered away at this decision by the trial judge, arguing that it was prejudicial to Depuy not to be allowed to present evidence that the FDA approved the device. On July 21, 2016, the California Second District Court of Appeal upheld the decision of the trial judge on this issue, writing that evidence of the FDA’s 510(k) device approval “was not relevant to, or had little probative value in, a Montana products liability design defect claim.” California Appeal Decision, July 21, 2016.

Although the appellate court in California was required to interpret Montana law for this appeal (because Kransky was a Montana citizen and first filed suit in Montana), I believe the decision is very important for all future cases because it shines a light on the rather easy road a medical device can travel to the marketplace under the limited 510(k) review process.

The Takeaway: Rejection of 510(k) as Valid “FDA Approval”

The Opinion should be read as a rejection of the defense “don’t blame me judge; the FDA approved our medical device.” The appeal’s court shut down that argument, clearly recognizing that Depuy chose to seek approval of the Depuy ASR hip through the much easier 510(k) process, which is inherently less credible than a full blown Premarket Approval (PMA) process. Because of the decision by Depuy to opt for the 510(k) process, the FDA had much less evidence to guide its ultimate decision to approve a device for sale. If Depuy wanted the full value and protection of “FDA approval,” Depuy should have put the ASR Hip through rigorous testing and clinical trials, which are required under PMA.

Depuy can’t have it both ways. It can’t choose a limited review process to get its ASR product quickly to the market, then when the device fails, defend itself by saying it received approval from the FDA. In California, the trial court and now the appellate court rejected that sleight of hand argument by Depuy.

Further Takeaway: Justice Delayed

But note the key dates in this case: Mr. Kransky received the Depuy ASR hip implant in 2007. He then suffered pain and high metal levels in his blood. By 2012 the device had to be removed. In 2013 Kransky won an $8.3 million jury verdict from Depuy. Now here we are, more than three years after the trial, and the appellate court has finally rendered a decision on Depuy’s appeal. Depuy can certainly attempt to appeal further, but the hope is that this decision ends the case and Depuy pays Mr. Kransky his money. After all, it’s been nine years since the defectively designed Depuy ASR hip was surgically implanted in his body. The man has suffered enough.

Finally, the hope is that with this appellate decision upholding a large jury award, Depuy will work more generously to resolve the remaining lawsuits over the Depuy ASR hip. We will see.

The case is Kransky (Ellis) v. DePuy Orthopaedics (Los Angeles Superior Court)

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.

I have been getting a few calls recently from people who still have the Depuy ASR hip implanted in one or both hips. They are asking the right questions: Are the metal levels in my blood too high? How will metallosis affect my long-term health? Will the component slip on me now and cause all kinds of new pain? Should I schedule surgery and have the Depuy ASR components removed? Plainly, these are questions for a doctor, not a lawyer. I can’t answer any questions specific to your health. Eventually, however, these callers ask an intriguing question: I have the Depuy ASR hip implanted in my body and I have not yet scheduled revision surgery: Do I have a valid claim against Depuy and Johnson & Johnson? It’s a good question.

People with Depuy ASR hip components implanted in their bodies who did not undergo revision surgery did not “qualify” for the two settlements that have been reached in the Depuy ASR multidistrict litigation (DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation, MDL 2197). But this does not mean they are not injured or that they do not have a valid claim. All it means is that they did not qualify to participate in the settlement based on the timelines in the settlement agreements. Let’s take a step back.

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Two settlement agreements were reached in the Depuy ASR 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.

Depuy ASR Hips Still Implanted After January 31, 2015

Plainly this creates a group of people who could not participate in the settlement: those who had not undergone revision by January 31, 2015. This includes a substantial number of people (some of whom I represent). Let’s take a quick look at the calendar: Depuy issued a recall of the ASR hip on August 24, 2010. This means that people were receiving Depuy ASR implants in 2010, and quite likely after August 24, 2010 (as it often takes time before a recall is fully communicated to the broader medical community). Let’s say you had hip replacement surgery on in May 15, 2010, and for a few years the implant felt OK. But then you started to feel some pain, and then six months ago had blood work done. Your doctor told you that you had elevated levels of chromium and cobalt in your system. Your doctor then said this is likely the result of your metal-on-metal Depuy ASR hip implant. At this point you are beyond the January 31, 2015 deadline to undergo revision surgery, so you cannot participate in the 2015 Settlement. But you still have a valid claim.

Valid ASR Claims After January 31, 2015

First, the Depuy ASR hip components failed at an unacceptably high rate. Thousands of revision surgeries have taken place because the metal-on-metal Depuy ASR hips failed. Second, in your specific case you are suffering injury; namely, pain and elevated metal levels in the blood (and you do not yet know if other complications are developing). Third, even if your revision surgery occurred after January 31, 2015, you were still injured by a defective product. In the eyes of the law, your claim should be as valid as the person who received revision surgery on July 15, 2013 or January 15, 2015. Fourth, even if you do not undergo revision surgery, you may possibly have a valid claim against Depuy and Johnson & Johnson. If you can show injury—high metal levels, a loose acetabular cup causing pain, or other complications, you have compensable claims. Most people suffering these injuries will schedule revision surgery (and should) but the absence of revision surgery does not mean you have no compensable injury.

My Hunch

I would presume that Depuy and the plaintiffs’ executive committee will eventually agree to a third settlement agreement to cover those people who had revision surgeries after January 31, 2015. But even if this third agreement does not happen, each person who was injured by the Depuy ASR hip has a valid claim and should bring such a claim against Depuy and Johnson & Johnson (preferably with the help of a knowledgeable attorney).

Beware the Statute of Limitation

But with any valid personal injury claim, you must always be aware of the relevant statute of limitation (SOL) in your state. I have written about these statutes here. The SOL limits the amount of time a person is permitted to bring a lawsuit after an injury, including a physical injury from a medical device like the Depuy ASR hip. Often the period of time begins to run when the injury is discovered. So in the hypothetical above, the injured person should argue that she was unaware of her injury until the blood work was done and her elevated metal levels were discovered. Still, ferocious battles often occur in court over whether the SOL has run on any claim. Don’t “sleep on your rights.”

The Takeaway: If you still have the Depuy ASR hip (or the Depuy Pinnacle hip) implanted, don’t presume you no longer have a claim against Depuy and Johnson & Johnson, but be vigilant and bring your claim as soon as you are aware you were injured by the Depuy artificial hip.

Note: The information in this post regarding the Depuy ASR settlement agreements is publically available. No information in this post should be considered legal advice. Feel free to call me for more information: (919) 830-5602.