For a while now, Stryker has had issues with some of its hip replacement artificial implants. One troublesome type in particular has been the LFIT V40 series. Specifically, in some of these Stryker hips corrosion forms where the femoral head connects with the femoral stem. This would often lead to taper lock failure, or a compromised joint that would loosen and cause metallosis.

This issue helped lead to a recall in 2016 and an expanded recall in 2018. One of the reasons for the 2018 recall was a higher-than-expected number of reports of the femoral head disassociating (disconnecting) from the femoral stem.

What Is Artificial Hip Disassociation?

Also referred to as “dissociation,” disassociation describes situations where the femoral head (the round, ball-like part of the hip implant) actually breaks away from the stem of the hip implant. The image at right helps illustrate what these parts do and roughly where the dissociation would occur.

What Causes the Stryker LFIT V40 Dissociation Failures?

The main reason for dissociation in LFIT V40 artificial hips is corrosion where the femoral head joins the femoral stem. This usually starts slow and goes unnoticed by the patient for many months and even years. Over time, the corrosion gets worse and likely causes metallosis. Once enough time passes, the corrosion gets so bad that the head and stem joint break apart or disconnect leading to a catastrophic failure of the hip implant.

What Causes the Corrosion?

The corrosion could be caused by excessive friction between the metal components. Ideally, when the femoral head is attached to the femoral stem, it is a perfect joint, with no movement between the two parts. Unfortunately, the Stryker LFIT V40 components often wouldn’t be properly connected. This could lead to micromotion, or a very small amount of “wiggling” between the parts. Too much movement or grinding can cause the neck to grind down (sometimes referred to as “penciling”), where the neck grinds away to a sharpened point, like a pencil. Ultimately, this could result in corrosive wear and create a dissociation failure.

How Can I Tell if My Hip Replacement Has Disassociated?

If your artificial hip implant disassociates, you’ll most likely know something is very wrong with your hip. You will likely endure one or more of the following symptoms:

• Pain and/or inflammation (the pain is often significant).
• Joint instability.
• Metallosis.
• Reduced mobility (even inability to walk).
• One leg becoming longer or shorter.
• Broken bones in areas surrounding the joint.

What Do I Need to Do If My Stryker Hip Implant Disassociates?

You’ll almost certainly need hip revision surgery (most likely, immediately). Because the corrosion leading to dissociation will be severe, this surgery will likely be extensive, requiring not just the femoral head to be replaced, but also the femoral stem. The removal of the femoral stem is a big deal because it will probably be very well-established in your femoral bone. The femoral stem can be removed, but it won’t be a pleasant experience.

I’m Feeling Fine Right Now, So Now What?

The first thing you can do is talk to your doctor to confirm if you received the affected Stryker LFIT V40 hip components. If you did, you’ll need to discuss the medical benefits of removing the V40 femoral head. If you’re lucky, only the head will need to be replaced and the femoral stem can be left alone. While this still requires revision surgery, it’s a far less complex or involved procedure. As always, rely on the advice of a trusted orthopedic surgeon for these medical decisions.

To learn more about potential issues with your Stryker LFIT V40 hip implant and what legal options you may have available, you can contact my office or call me at (919) 830-5602

Not all artificial hips fail. Many total hip replacement surgeries are successful. Unfortunately, artificial hips, particularly “metal-on-metal” hips, have “failed” at a rate much higher than previous artificial hip systems, whose components typically consisted of a combination of metals, plastics, and ceramics. The metal-on-metal design placed a metal ball or head directly into a metal acetabular cup. By using a metal cup and a metal ball, these artificial hips forced metal to rub against metal with the full weight and pressure of the human body. As long as the metals held up, all would be well. But it turned out that this intense pressure and movement often caused the metals to grind and deteriorate, and too often releasing metal particles into the surrounding tissue and into the bloodstream. In other artificial hip failures, such as with the Stryker LFIT v40, femoral heads can malfunction 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. This can cause the neck on the femoral stem to grind down (sometimes referred to as “penciling”) and can even lead to a full disassociation (more on that below).

In still other artificial hip failures, the plastic liner (between the cup and ball) deteriorates and causes the total artificial hip system to fail. Polyethylene liners are very important in an artificial hip because over the years, it will serve as a buffer between the metal cup and also the metal femoral head or ball, so it can protect against excessive grinding of the hip components. But the studies have shown that Exactech hip plastic liners have been breaking down and showing signs of premature wear.

Please note that with any hip replacement surgery, there will be a period of rehabilitation. Even with great surgery results, the patient will suffer some soreness, stiffness, and a period to regain strength, mobility, and comfort. From the hundreds of people I have spoken with over the years who have undergone hip replacement surgery, even successful hip replacements do not turn you into a completely pain-free eighteen year old athlete.

For many patients, however, particularly those who received the metal-on-metal hip, there may come a point when they wonder if their artificial hip has failed. But given that all hip surgeries initially come with some discomfort and pain, how do they know if their hip has failed.

Let’s start with the basics:

What Is an Artificial Hip Failure?

Artificial hips fail in several ways:

1. Pain. This would be pain that lingers after the period of rehabilitation, or which arises months or years after the implant surgery. There is no marker for the precise amount of pain necessary to define a failure. If you are in pain, you need to assume that something is wrong and you need to schedule an examination.
2. Swelling. The area around your hip replacement should not swell after the period of surgery and rehab is past. Swelling is a sign of a problem.
3. Metallosis. This is the build up of metal levels in the blood and/or in body tissue. When a metal-on-metal artificial hip cup and ball grind together, tiny shavings can be released into the body, elevating metal levels. A simple blood test can identify metallosis.
4. Loosening components. This is when a component like the acetabular cup has become loose and shifted or moved. It can hurt (see #1).
5. Disassociation. In some cases, the femoral head and stem actually separate or break apart. In these cases, the hip and the leg are no longer connected. This can be caused by (for example) corrosion in the V40 femoral heads.
6. Inflammation of tissue. This is where the hip area becomes swollen, warm, red, and often painful, as a reaction to the hip failure and/or as a result of infection.
7. Pseudotumor. This is abnormal tissue growth that occurs as a reaction to metal particles being released near the site of the hip replacement. A pseudotumor is noncancerous. Pseudotumor does not always cause pain or other noticeable symptoms.
8. Sounds. Other the years, several clients have reported that their hip has begun to make ominous sounds, such as grinding, whistling, popping, or thumping. Your artificial hip should not make noises.

Understand that with most hip failures, several of these conditions may be present, not just one. You may have pain, and swelling, and loosening components. Sometimes you may have all the symptoms.

What Might Artificial Hip Failure Feel Like?

1. Pain. This is nearly always the first red flag. With artificial hip failure, there will likely be unusual pain and discomfort. As doctors like to say, “always listen to your body.” If something doesn’t feel quite right, it may not signal artificial hip failure. But it could.
2. Popping sounds. I’ve had people tell me that their failing artificial hip actually made noises. The popping sound typically comes from a component that is loose or becoming dislocated. It often occurs with pain.
3. Swelling or heat coming from the hip area. A sign of infection.
4. Uncertainty. The hip feels insecure, as if the person’s leg may “give out” while walking or standing. In other cases, the hip feels as if it is locking up on the person.
5. (Almost) nothing at all. Oddly, with some artificial hip component failures, you may not notice symptoms. This is when an artificial hip failure can be most frustrating; something is wrong, but you can’t detect anything serious. For years, one person I spoke with did not feel abnormal pain, but only some discomfort after walking for long periods on hard surfaces (like asphalt). The blood tests showed slightly elevated metal levels, but not outrageously high numbers. After several years, the pain grew incrementally, and the patient eventually chose revision surgery. The revision surgery revealed a very loose cup, dark metallic fluid, inflamed tissue around the hip, and other problems. Clearly the artificial hip components had failed, and revision surgery was necessary, even overdue. But the individual for years believed everything was “good enough.”
6. Other sensations. The human body can simply react in all kinds of ways. If the feeling is unpleasant, something may well be wrong.

Despite all this unpleasantness, there is no need to panic. Panic is not good for anyone. But I do believe you must take ownership of your medical care. If something “does not feel quite right,” schedule an appointment with your orthopedic surgeon. Ask questions. Ask for a blood test. Ask more questions. Keep a symptoms journal, which I wrote about here. Stay after it.

And call me if you have legal questions: (919) 830-5602.

No specific client information was used in writing this article. And of course, I am no doctor, and this is not medical advice.

Safe and Unsafe Activities and Sports Clay: What are some sports that you would discourage [after hip replacement surgery]? I know there is a huge range of results and people who are dealing with certain physical issues. But are there any sports you’ve seen as a physical therapist that you say “Do not do this after hip replacement surgery?”

Amy: Oh absolutely and just to clarify my youngest total hip replacement patient was eleven. This child had a very aggressive cancerous tumor that invaded her hip, and so she had what is called a Ewing sarcoma. And so, they ended up having to take the hip give her a new hip, and her big goal was she wanted to be able to drive a car. I mean that is really important. So, she was eleven when the process started and she did not drive a car. So, and I have treated, I actually had a ninety five year old who had, so the spectrum of age is even greater than thirty five to eighty two.

Clay: Sure.

Amy: But there are absolutely some things that are just absolute no’s. And most of them are things that make sense, like contact sports. So things like football, rugby, soccer. There was a great little study that came out, I think it was in 2011. Anyway, it basically looked at all of these different sports and it reviewed all of the literature and it was looking at what are the things that we know are absolute no-no’s.

Amy: And we know this because the literature shows us that these people had high rates of failure in their hips. Oh and by the way, this recommendation basically it was a systematic review and when they made these recommendations, they qualify them into three categories. So, the first category was not recommended after a total hip and so the contact sports hockey, football, soccer, rugby, any long distance running. And that just make sense.

Amy: A lot of people take a toll on their hips by doing a lot of running, and that does not mean that running causes hip arthritic changes that create a total hip that necessitated total hip replacements. Do not misunderstand that, but there is a wear and tear process that goes on with people that are running hundreds of miles a month. So, singles tennis, it gets down to just the numbers of steps that go through that new part; racquetball, squash, snowboarding, and that is because of the risk of dislocation for snowboarding.

Amy: High impact aerobics, fast pitch baseball and softball, because of sliding and contact. The kicking that is involved in many of the martial arts is not recommended. Water skiing and handball. So those are the things that under the category of not recommended. And I will tell people flat-out “Listen, you had a bad hip, you have gone through this process to get a good hip. Be nice to it, protect it.” I understand that you are putting yourself at great risk of early failure or other complications, like dislocation and things like that that necessitate revision. So that is in the not recommended category, and then they created this other category that they call “recommended with experience.” And this actually, again, makes sense. Cross-country skiing and downhill skiing, that is not the time to start learning to ski after you have had a new joint. Now, if you have been a lifelong skier and you have the experience, by all means do it. Make a choices. Mogul fields are probably not a great idea.

Clay: Right.

Amy: If you can cross country ski downhill ski safely. Doubles tennis again, not the time to take up tennis if you have never played in your whole life and you finally have a new hip. Now is not the time to take that up. But if you have been an avid tennis player, so I would absolutely and I have a lot of patients that have gone back and my brother included in that category who has gone back onto the tennis court with a joint replacement.

Amy: Ice skating not hockey. But ice skating is okay if you have experience doing that, things like rollerblading same thing kind of inline skating and Pilates. So those are things that we recommend that are qualified as recommended with experience. I will also add now, this study came out, this recommendation, systematic review was published in 2011. Surfing goes into that category. So if you are a surfer, absolutely if you have experience on a board, you are absolutely prepared to get back on that board after a hip replacement. Not the time to start introducing that into your sport life.

Clay: See it makes sense that if you have got experience you can keep yourself from potential injury.

Amy: Precisely, and then the list of things that are highly recommended because again, you know when you are in the rehab world what you realize that people go through the surgeries for they do it purposefully and it is usually to return to some type of function or activity, that they are arthritic or their painful joint would not let them take part in, so golfing, swimming, doubles tennis, stair-climbing, so like the elliptical walking, speed walking hiking, stationary biking, bowling, these are all things that are highly recommended. We want you to go back to these things because they are going to be healthy for you. They are going to sustain the strength in the mobility that you have recovered at that new joint. But they are also going to be safe for it. They are not going to put your new joint at risk.

Clay: I see. Well that gets to the point that staying active is absolutely essential. That you do not want to pick up downhill skiing necessarily, but you absolutely after hip surgery want to be active in something. And so, it is good to get going.

Amy: I am a physical therapist. I think we all should move. We should move, that is what our bodies are designed to do. They are not designed to sit and be sedentary. They are designed to move us through space.

What It Feels Like When Artificial Hips Fail Clay: Well, that is right. So, I have known you for quite a while and I know you have had patients that have had hip replacement surgeries fail. Can you tell me what symptoms you notice when a patient might come in and say “I had surgery a year and a half ago or two and a half years ago and something feels different. Something sounds different”? Talk about artificial hip failure.

Amy: Sure. Absolutely, well probably, so there are different reasons that hips can fail. But the number one thing that people complain of is pain that is out of context to what they should be experiencing at that point during the rehab process or during the recovery process. So obviously, you have had a joint replacement. We expect it to be swollen. We expect it to hurt. We expect it to be sluggish. It is not going to move well.

Amy: So, there is an expectation of some pain following the surgery but there is a point where that pain should be resolving. And it should be integrating and it usually lives as the tissue is healing. So the bony tissue is healing, where the new hip implant, the new appliance, has been mated with the bony surfaces, so that healing takes place and then the soft tissue around that joint is healing and you are becoming more mobile. So, that pain should frankly just gradually decrease until it is gone.

Amy: When someone’s hip has failed, that does not happen. The other thing that is really interesting, or I think that is telling, is that typically these patients have pain even when they are not moving, and a significant amount of pain. Now again, initially immediately after the surgery, it is normal to have night pain that makes it tough to be comfortable. But after a couple of weeks after a hip replacement, you should be able to sleep for periods of time. Many times people have so much pain that they cannot sleep. Like, it keeps them awake.

Amy: Nocturnal pain is always something that worries me because at the end of the day, we are kind of hardwired to get rest but pain prohibits that. To me, that is, I am always going to look very carefully at this patient because that should be something that initially pain management should be taken care of, so medications, icing, making sure that your activity levels are appropriate for that stage of your recovery.

Amy: If all of those things are in line, and this person is still telling me, “I slept an hour.” I do not like that. Immediately that is a red flag to me that I need to take a really close look at what is going on with this patient. So, pain is out of context to what the pain level should be at that point. Pain that is occurring without moving. So, it is not mechanically driven pain.

Amy: Any type of mechanical clicking, grinding, and these are things that people will sometimes report, you know, it clicks, it grinds, it snaps. Some people have reported they can actually feel it move. So those are things that tell me that something organically is not healthy in that hip, in that newly replaced hip.

Clay: Let me follow up on that. Is it your medical view that a successful hip replacement surgery should end with no pain at all after the rehab is over, and after the recovery is over that there should be little to no pain?

Amy: Absolutely, and when that does not happen, if let us say, and I have seen this before, I have had people show up a year after hip replacement and they say, “You know my hip still bothers me.” And upon assessment, there might be a really good reason. You are profoundly weak, you did not build the strength around this joint to give it stability. So your pain is actually not in the actual hip itself, it is in the pelvis because of the forces that are going through hip joint that and the musculature of the strength is not adequate to control those forces.

Amy: So, sometimes there is a reason that someone has got pain a year later. But in the absence of something like that going on, no, you should not have pain. That is the whole reason that you have this new hip put in. So if you are continuing to have pain, I tell my joint replacement patients that it takes a year to recover from these big surgeries. But that is a pretty reasonable expectation from any orthopedic surgery, be it a rotator cuff repair, an ACL reconstruction, certainly a knee or a hip replacement, or a shoulder replacement. It is not uncommon to have some discomforts and stiffness and irritability up to a year, but after that, no, it should not happen. It should not be painful. So there is a very big difference between, “like I am still aware of it” versus “this thing I can not put weight through it. It hurts so much. I can not walk. I can not sleep. I can not ascend or descend stairs. I can not lift my leg to put it into a car.” These are things that I have seen in failed hips.

Clay: Yes.

Amy: Or even just give way where you weight bear on the leg, on that failed hip, and they will fall. That is a result of a failure.

Part 3 next week.

My friend Amy Dougherty is a physical therapist in North Carolina and operates Outer Banks Physical Therapy. She is a graduate of the University of North Carolina at Chapel Hill (where I also attended college and law school). She is an outstanding physical therapist and is beloved by her patients on the Outer Banks. Amy answers many of your questions about hip replacement surgery, metal-on-metal artificial hips, and the problems that have arisen from these hip products.

Clay: I want to focus on hip replacement surgery and I know you work with patients who are dealing with that kind of surgery every week. So let me start by asking what are a few reasons a person might need a hip replacement surgery?

Amy: You know, the most common reason is arthritic changes in the hip. So basically arthritis, that is the most common reason. Other reasons can include things like trauma. Some people have congenital mal-alignments where, it is basically called dysplasia where through the process of their development in utero and then following their bony surfaces of the femur, that is the long thigh bone and the acetabulum which is in the pelvis. They do not form correctly, so they might have ill-formed femoral heads. They might have ill-formed or ill-shaped acetabulum. So, the ball and the socket are not really designed well to weight bear. So, a lot of folks that, especially in a young population, that have early onset hip replacements. It is more likely the result of some type of congenital dysplasia. It could be a trauma. So, but arthritic changes is the number one reason and I have total hip replacement patients in my clinic every day. Very popular surgery, yes.

Clay: Very common especially once you get into the middle age and even older.

Amy: Absolutely. It is very common.

Clay: Well, how soon would physical therapy start after a total hip replacement?

Amy: Typically, the PT shows up within 24 hours of your surgery when you are in the hospital. So, what you can expect is basically after you come out of recovery, the physician or the nurse will come and talk with you and tell you when you will start your first PT. Sometimes, it is within 12 hours. It really is all dependent on the amount of time that is projected to be your discharge. Time or day, and that is something that actually frankly is changing dramatically over the course of the last 18 to 24 months. So total hip replacement surgeries are moving from being a two-day event in the hospital, which is what we used to see very commonly, to most likely being a predominantly outpatient surgery within the next five years.

Clay: Outpatient surgery–is that right?

Amy: That is right, and there is some pretty reasonable science to support why transitioning to outpatient is a great idea and is basically because of infection rates and things like that. And so, they are looking, I mean they being the world of orthopedic surgeons and the world of joint replacement specialist. They are looking to transitioning. It is already happening in some places, not on the Outer Banks, but it is happening in some larger cities where they are doing small groups of folks who are good candidates, so they are essentially very healthy people who frankly do not need to be hospitalized. They can go to an Ambulatory Care Center and safely receive a total hip replacement and go home that same day.

Clay: Could it also be maybe that recovering at home is a happier place for people?

Amy: No question. All of us would rather be home than at the hospital, and so the biggest issues that come into play are first and foremost safety, so you have to be safe to go home. Once you are in the recovery room you have to be medically stable. Pain needs to be adequately manage and that is something within the Joint Replacement Community, that is really becoming more and more well-researched and well-managed is how to keep people comfortable while they are recovering from this very big surgery. That is a big event, so managing the pain, making sure that they are safe to ambulate because you can walk on that new hip pretty much as soon as their block wears off as soon as anesthesia allows.

Clay: So whenever you come home, whether it is the same day or a couple days later and the patient is able to get to your office, how soon– so walk us through what PT might look like in the first visit to your office and then in the weeks that follow.

Amy: Typically, I will sometimes see people that are coming straight from the O.R. Basically, they may spend a day and a night in the hospital they come home and they are usually starting with me within a day or two of being home. So sometimes I will see them immediately post-op, some surgeons want those patients to be seen at home anywhere from two to four weeks. Generally based on surgeon preference. Sometimes it has to do with family logistics in that patient might live alone. They can not drive those first couple of weeks. So there are some issues that play into the decision making on whether they start outpatient, which is my clinic, or whether there is seen at home for home-based physical therapy. But if you come to my clinic the first thing that is going to happen is you are going to undergo an assessment, and that is basically where after doing a bunch of intake paperwork, where we make sure that you are actually medically stable, we start talking about your function. We start talking about “Hey, how are you doing?” What is your pain like?” We use pain scales and I expect because it has become such a big movement in orthopedics to better manage people’s pain so that they move.

Because we know that one of the things that is most helpful after joint replacement surgery, be at a hip or knee, is the ability to move. If you have got so much pain, you can not move all of a sudden, your risk factors go up substantially in regards to blood clot or onset of pneumonia. So, we know that moving is important. We will talk about your pain. Make sure that your pain is being adequately managed and then we will start looking at that lower extremity. I will have you walk for me. I will look at edema, will look at bruising, depending on whether your surgical dressings are off or not. I will look at the surgery site. Make sure it all looks good clean and dry, occlusive bandages or it should be in place at that point and then, just basically initiate the onset of PT which is assessing, and then addressing strength loss this most in deficits. We spend a lot of time talking about precautions, because there are some precautions after hip replacements depending on the approach that the surgeon has taken. So, there are some options available in regards to whether you have what is called an anterior approach or posterolateral approach. And so, there are some precautions and we make sure that the patient is well versed in that, and understands why the precautions are important. And then, we start to exercise, we start to move.

Clay: I know it is different for different patients based on how fit they might be, how young they might be. But how long does that therapy last working with you? And then when do you say “Okay, you are free to go but take these exercises home with you and make sure you do them”?

Amy: We start immediately. We start the first day they are there. Nobody leaves my clinic without having things to work on at home.

Clay: And so how long do those exercises last with you versus when you say “Okay you are released from me and you can do these at home without me”?

Amy: Frankly, it depends, and what I have come to realize through a lot of years of clinical practice is the fitness level that someone takes into the operating room. Absolutely dramatically affects how long they are with me. So, if you are pretty active, pretty strong, pretty fit, you just have a bad hip, and you can be all those things by the way, and still have a bad hip. So if you are pretty mobile and you have maintained pretty decent strength pre-op, you are not going to spend much time with me. A couple weeks, maybe. If you are really debilitated and we see this very commonly in people who have really put off having the joint replacement, maybe waited a lot longer than they should have.

Sometimes, there is a concomitant problems going on at the knee, at the foot and ankle, on the contralateral side, will see some problems that affect their ability to ambulate. And at the end of the day, with a hip replacement, our goal is generally normalize gait. I mean, that is what we are looking for and everything that normalized gait entails and so that strength, mobility, balance, neuromuscular control of the extremity. So at the end of the day, that is really what we are looking for is normal gait.

That is what frankly people that are having their hips replaced, they will tell you “I can not walk. I can not ascend or descend the stairs.” I live at the beach, you know people’s inability to get onto the beach is a huge issue. So because you take gait, and now you put it on an unstable surface like sand and the demands are exceptionally greater to be able to walk the beach than are to walk on the sand. So that is something in that first visit that we talk about “What are your goals?” I will specifically ask the patient when I am interviewing them, when I am evaluating them “What are your goals?” [and] “What is it that you have this hip replacement for a reason?” [and] “It is an optional surgery. Your life did not depend on you getting a hip replacement. So, what are your goals?”, “What did you decide, you have decided to make this commitment of time, money, risk, you have done those things to do something. Is it to be able to get through the night without pain?” For some people, that is their ultimate goal. Most people, it is mobility. I want to be able to get onto the beach, you know, some people I work in a beach community. I have patients that their goal is: I need to get back on my surfboard.

Clay: Right.

Amy: If it is somebody who basically just wants to be able to grocery shop and, be able to get their groceries in and out of their car independently and walk with a normal gait, unless they are profoundly weak when we start, it is not going to be too long. So, I know that is a ridiculously vague answer.

Clay: No, everybody’s different.

Amy: But fundamentally, everybody’s different with what they bring into the operating room and everybody’s different with their expectations following. So, the way I rehab a 35 year old, and the expectations and the demands that 35 year old is going to place on that new hip is going to be profoundly different than my 82 year old.

In Part 2, Amy and I discuss recovering from hip replacement surgery, returning to activity and even sports after hip surgery, and the importance of getting active and staying active.

Hip replacements often use a variety of exotic metal alloys or ceramics to recreate the ball-in-socket mechanism of the human hip. A total hip replacement will typically consist of four parts:

• The socket (or acetabular component).
• The ball (or femoral head) that goes into the socket.
• A liner for the socket that is in direct contact with the ball.
• A stem for the ball (also known as a femoral stem) that connects the ball to the thigh bone (femur).

The liner is placed into the socket and the socket is placed into the pelvis. The ball attaches to the stem and the stem attaches to the femur. The result is a total artificial ball-in-socket hip replacement.

Sometimes, these hip replacements don’t work as expected. One such example comes from Zimmer US, Inc. and related companies (which we’ll collectively refer to as “Zimmer”). Many patients have reported problems with a particular set of Zimmer femoral head and stems.

What’s Wrong with Zimmer’s Artificial Hips?

At issue are two femoral stems: the M/L Taper Hip Prosthesis and the M/L Taper Hip Prosthesis with Kinectiv Technology. When either of these components is paired with the Zimmer VerSys Hip System Femoral Head, many artificial hip recipients have reported a variety of problems, such as:

• Metallosis (elevated metal levels in the body)
• Osteolysis (destruction of bone tissue)
• Pseudotumor formation

Often, any of these problems require revision surgery, which is surgery to replace the failed implant. It’s believed that many of these hips are failing due to corrosion, trunnionosis and the release of tiny bits of metal at the point where the femoral head connects with the femoral stem.

Have Patients with Failed Zimmer M/L Hip Replacements Taken Legal Action?

Yes. There have been hundreds of plaintiffs who have filed suit against Zimmer alleging defectively designed and manufactured hip components, Zimmer’s failure to warn patients and doctors about the risks of using the hip replacement and that Zimmer did not properly test the artificial hip components.

With so many lawsuits consisting of similar injuries and allegations, along with a single (or small number) of defendants, our court system has a special system in place to consolidate the cases for pre-trial matters. This consolidation is called multi-district litigation, or MDL.

The purpose of MDL is to handle much of the pre-trial matters, such as discovery, in a single court with a single judge. With a single judge handling these pre-trial matters, the cases can be processed more efficiently, as the judge’s decisions will apply to all cases at the same time.

The ultimate goal is to reach a comprehensive settlement that resolves all of the cases fairly. One way to do with is by having several bellwether trials. These sample cases are supposed to be representative of most of the cases in the MDL. Therefore, how they turn out can serve as a signal of what the plaintiffs and defendants can expect if their respective cases go to trial.

How these bellwether cases turn out will shape how settlement negotiations will go. As you can imagine, the better they go for the plaintiffs, the more negotiating leverage plaintiffs will have during settlement talks.

Right now, the Zimmer lawsuits involving the M/L Taper Hip Prosthesis, the M/L Taper Hip Prosthesis with Kinectiv Technology and the VerSys Hip System Femoral Head are in MDL in the US District Court for the Southern District of New York before Judge Paul A. Crotty.

Zimmer MDL’s Current Status

The Zimmer MDL is in the discovery phase, with the first bellwether trial scheduled for January 25, 2021. But if this date is pushed back, don’t be surprised. It was originally scheduled for September 14, 2020, then pushed back to October 19, 2020 and now has this date in early 2021.

All of this to say, there’s a lot of discovery and pre-trial motions to complete before a single trial takes place. As new developments arise in this case, I’ll post an update in this blog. Until then, there’s a long grind of pre-trial matters to get through.

Call me to discuss further: (919) 830-5602.

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.

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

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

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

So What is a Bellwether Trial?

A “bellwether” is a thing that shows others what is likely to happen in the future. It is an indicator of trends. In litigation, especially large-scale litigation like MDLs, a bellwether case can be a indicator of how strong or weak a type of case will look to juries. In multi-district litigation, there are simply too many cases to take to a jury verdict. It would take a lifetime to try all the cases in any MDL. For example, if one typical MDL trial lasts three weeks (they often last longer) and there are 1,000 cases in the MDL (the DePuy Pinnacle litigation alone had over 10,000 cases), it would take 57 years to try all those cases. Bellwether trials allow both sides to see (1) how strong is the evidence supporting liability for a defective product, and (2) what value a typical jury might assign to a particular type of injury caused by the product. If juries in bellwether trials consistently find no liability, it is a real signal that the cases may not be viable and certainly may not have much settlement value. On the other hand, if several bellwether trials yield large verdicts, it shows both sides, and especially the defendants, that the remaining cases pose serious financial risk to the manufacturer of the defective product. Bellwether trials provide a window into the challenges the clients face and give realistic expectations for settling cases.

Smith & Nephew Bellwether Trial Schedule

In Judge Blake’s recent order, the first bellwether trial for the BHR (resurfacing procedure) cases is scheduled for November 2, 2020. So a year from now. The second bellwether trial will begin January 11, 2021. The actual cases selected for these bellwether trials will be determined by June 15, 2020. The Order (Case Management Order No. 15) sets out all the key deadlines leading up to these bellwether trials, and I won’t list them all here, but one key date is October 2020, when Judge Blake will hold Daubert hearings to determine the admissibility of the scientific evidence and expert witness testimony. Judge Blake will decide then if the expert testimony is strong enough that it can be presented to a bellwether jury.

Finally, one “THA Track” bellwether trial is scheduled to begin March 1, 2021, but most of that scheduling has been deferred to a later order.

Can a Bellwether Trial Schedule Encourage Settlement?

Sure. Trial is always a motivator to resolve a case. Trials are extremely expensive and time-consuming for both sides. And if one side is aware that the facts don’t look so good for them, the imminent bellwether trial may inspire a renewed vigor to settle all the cases. Currently there is no indication that the Birmingham hip cases will reach a global settlement before the first bellwether trial, but it is certainly possible. I will keep you updated as always. Good luck.

Product Stickers: The Gold Standard

It all sort of starts with “product stickers.” These are the identifying stickers that are attached to the box containing the medical device, and they can be peeled off and affixed to a nurse’s hospital note or to another page in the hospital or surgeon’s record for the implant surgery. It goes something like this: the representative for the device maker shows up with the artificial hip components (or other medical device). The surgical nurse or the surgeon will double check that the components are the precise ones needed for the surgery, scan them into the system and note them in the record. The nurse will then peel off the product stickers and attach them to the hospital record and include them with all the other pages of documents explaining details of the surgery. The image at right is an approximation of what the stickers will look like: a bar code, the name of the manufacturer, the specific product name, the Lot and Reference numbers, and other identifying information.

Hospital Records: Typed Identification of Specific Components

For some reason, not all hospitals and surgery centers keep product stickers. Some simply throw them out with the boxes. It is not a good practice, but it happens. In those cases the person responsible for identifying the components usually types in the specific lot and reference numbers and other identifying information for each device component used in the surgery.

Operative Report

In any surgery the surgeon always writes up (usually dictates) an Operative Report where he or she describes what occurred during the surgery. In this report the doctor will explain the procedure and will reference the components used and implanted. In another section of this report, titled something like “Implants,” the doctor will list the specific components, with complete names and actual sizes.

Explants: Preserving and Keeping the Actual Device Removed From Your Body

The actual gun used in an armed robbery is better evidence than a description or a photo of the gun. The same holds for a product liability case involving a failed medical device. That’s why you should do all that you can to “preserve evidence” by making sure your surgeon understands you want to preserve and maintain any components removed from your body (“explants”). I wrote extensively about preserving explants here, and I invite you to read that article, but in a nutshell you need to send a letter to your physician asking her or him to preserve all evidence, especially explanted medical devices following the surgery. With written notice in advance, the doctor and the hospital usually understand the drill and will preserve the removed components, usually by sending the explanted components to the pathology department to hold the components for the patient or the patient’s attorney.

Surgeon’s Affidavit

As you can imagine, lawyers representing companies that sell defective medical devices will use every advantage to derail your case. If defense lawyers can cast doubt on what device is in your body, then you as the injured person cannot win your case. In some instances the product stickers were not maintained with the hospital records and the explanted components were not preserved. In that case, even with the typed identification of the products (see Hospital Records, above), you may need to obtain a signed and sworn affidavit from the surgeon testifying to the exact components implanted in your body. I have used this technique in the past and it has worked well.

Get Help From a Good Product Liability Lawyer

I’ve written about this subject on this site so often I’m not even going to link you to the other articles (they are easy to find). But I will say this: you need to work with an experienced product liability lawyer on any defective medical device case, and preferably before you undergo revision surgery (for several reasons, but mainly so the attorney can communicate with the surgeon and the hospital in advance about preserving all relevant evidence).

Identifying your medical device is very important. Being legitimately injured by a defective product is not enough. You have to show what product injured you. If you can’t, you don’t even know which medical device maker to sue. Put obviously: you cannot sue DePuy Orthopaedics for a defective Smith & Nephew artificial hip. So it is vital that you identify the exact components that injured you, in as many ways as possible. Good luck.

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

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

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

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

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

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

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

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

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

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

Smith & Nephew Mediation Scheduled for January 30, 2019

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

Trial Dates Scheduled

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

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

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

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

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

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

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

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

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

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

LFIT V40 Taper Lock Failure

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

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

Check back here for updates on the Stryker LFIT V40 femoral head settlement. And if you believe you have a failed artificial hip in your body, call me to discuss: (919) 830-5602.

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).

As we get older, our bodies weaken, bones become sore, and joints break down. Hip and knee problems are common conditions of aging. In fact, in the past decade millions of Americans have had hip replacement surgeries. Unfortunately, some defective artificial hips have caused patients more suffering than their original hip ailments. For one recent example, many patients who received the Birmingham Hip Resurfacing System by Smith & Nephew have had to undergo revision surgeries to cure new and unanticipated problems relating to the medical device. Many of these people have filed lawsuits.

Smith & Nephew’s Birmingham Hip Resurfacing System

Smith & Nephew designs and markets medical devices. One of the medical devices Smith & Nephew manufactures is a joint replacement system. An example of a joint replacement system is a hip implant. The Birmingham Hip Resurfacing (BHR) System is an artificial hip replacement made of metal components. BHRs have been used since 1997. The FDA approved BHRs for use in the United States in 2006; this approval was conditioned on Smith & Nephew reporting and analyzing adverse events, negative side effects, and complaints regarding the BHR. Just like any other medical device or medicine, the BHR must not provide false information (or false hope) to patients about what the device can accomplish.

The BHR is not the only hip replacement of its kind. There are similar metal-on-metal hip devices such as the M2A-Magnum Hip by Biomet, the Durom Cup by Zimmer, and the Accolade TMZF Femoral Hip Stem by Stryker.

However, there have been several recalls of these metal-on-metal hip replacements. While many manufacturers have voluntarily recalled their metal-on-metal devices, the FDA has had to mandate other recalls.

These recalls are due to medical complications and problems caused by the unexpected wear of the metal device over time. More specifically, as the metal artificial hip bends and moves, there is friction between the metal pieces which causes metal debris to collect in the joint and move to the bloodstream. Metal debris in the body causes pain, swelling, immune reactions, and other serious medical complications. Also, as the artificial hip moves and deteriorates, the implant may begin to loosen and require yet another hip surgery (“revision surgery”).

These medical complications have led to thousands of lawsuits against manufacturers of metal-on-metal artificial hips. Companies such as DePuy, Stryker, Zimmer, and Smith & Nephew are being sued by patients who have received these artificial hips and have experienced problems.

In fact, more than 200 suits from 42 states have been filed against Smith & Nephew regarding the BHR device. These claims have been joined together in multidistrict litigation in federal court in Maryland. A Memorandum and Order was issued last week on March 26, 2018. In the Order, the Court recognized some but not all legal claims under which Smith & Nephew may be liable for the harm and injuries experienced by these patients.

Federal Preemption and Product Liability

Patients had claimed that Smith & Nephew should be liable for their medical complications for its failure to warn patients of problems with the BHR under legal theories of strict products liability and strict liability. However, these claims, based on state laws, are preempted by federal law, which means that the state law claims are “inferior” to applicable federal laws and regulations. If a federal law applies and controls a specific legal claim, it “preempts” or takes precedence over a state law claim that may otherwise apply. Plaintiffs are typically not allowed to sue under both state and federal laws when federal law applies and controls the issue. Since federal law specifically empowers the FDA to regulate medical devices such as the BHR, the FDA laws and regulations govern some but not all of these claims. This means that Smith & Nephew may still be liable for violation of federal laws and regulations.

Further, the injured plaintiffs claim that there are manufacturing defects in the BHR. But since “the plaintiffs fail to allege how the BHR device deviated from FDA design specification and do not provide other specific factual support for the inference they ask the court to draw,” this claim was also dismissed.

Some Injury Claims Survive S&N’s Motion to Dismiss

Even though some claims were dismissed, the injured patients in this case survived S&N’s motion to dismiss on other claims, which means plaintiffs get to continue with their lawsuits against Smith & Nephew. These claims include allegations that Smith & Nephew:

• Failed to warn and report problems with the BHR to the FDA;
• Was negligent in failing to provide true information, report adverse events, and train medical professionals about the BHR;
• Breached their express warranty by making false claims about the BHR; and
• Negligently misrepresented the BHR “by marketing the device as safer than rival metal-on-metal devices.”

So what’s next? The discovery phase comes next, where patients will provide their stories and medical histories, and Smith & Nephew will be forced to turn over research, documentation, and information about the BHR and its complications. After discovery, “bellwether trials” will be scheduled. These bellwether trials will be vital in determining if a set of juries believes that the BHR was a flawed and defective product and whether S&N should pay for all these injuries.

If you have any kind of metal-on-metal hip replacement, including the BHR by Smith & Nephew, you should call a lawyer to discuss your legal options. Of course, you are welcome to call me (919.830.5602).

Smith & Nephew Artificial Hip Replacement

By way of background, the hip is a ball-and-socket joint, moving not just forward and back (like a knee joint) but also sideways. In a total hip replacement, part of the upper thigh bone and the ball portion of the hip joint are replaced with metal components. Part of the replacement includes a liner between the ball and the socket that allows the hip to rotate freely. Some patients have hip resurfacing surgery instead, where only the interface between the hip joint’s ball and its socket is replaced with a new surface.

The plaintiff in this case, Walter Shuker, received a total hip replacement using Smith & Nephew’s R3 Acetabular System. Although Smith & Nephew holds itself out as a “world leader in joint replacement systems,” the R3 hip replacement that Shuker received didn’t use a typical plastic liner.

Instead, the liner in Shuker’s replaced hip was an R3 metal liner designed for use in Smith & Nephew’s Birmingham Hip Resurfacing System. The R3 metal liner was neither designed nor approved for total hip replacement. In fact, its label states that it “must be replaced with an R3 poly[ethylene] liner” if used in a total hip replacement. Despite that label, Smith & Nephew marketed the R3 metal liner as an “option for its R3 Acetabular System” in its promotional materials.

Less than two years after having his hip replaced, Shuker developed hip pain that was severe enough to limit his activities. When his surgeon investigated, he found “metallic debris” indicating that the metal-on-metal joint in his hip was wearing away and had to be replaced. Shuker ended up needing multiple revision surgeries to correct the defective replaced hip.

Walter Shuker’s Case Against Smith & Nephew

Shuker brought three types of state law claims against Smith & Nephew: for its failure to warn patients about the dangers of the R3 metal liner, he claimed negligence, strict liability, and breach of implied warranty. Based on Smith & Nephew’s off-label promotion of the R3 metal liner, Shuker also claimed negligence, while his wife claimed loss of consortium. Finally, Shuker argued that Smith & Nephew engaged in fraud.

The trial court dismissed Shuker’s claims, finding that they were preempted by federal law.

Shuker appealed to the Third Circuit Court of Appeals, which recently issued its opinion. The appeals court agreed that the failure to warn claims should be dismissed due to federal preemption. However, it allowed Shuker’s off-label promotion claims to proceed.

So what does federal preemption actually mean, and how did it apply here?

Federal Preemption and Medical Device Lawsuits

The U.S. Constitution declares federal law to be the “supreme law of the land.” Therefore, when a state law conflicts with a federal law, the federal law controls and the state law is essentially voided. This concept is called preemption. Preemption may be express—where a federal law specifically says that it controls and that state laws can’t interfere—or it may be implied.

Medical devices are regulated under the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. That law expressly states that it preempts any state “safety or effectiveness” claims. Here, Shuker tried to claim that Smith & Nephew was negligent under state law even though it had passed the Food and Drug Administration’s safety regulations for medical devices. The Third Circuit held that Shuker’s state law negligence claim was preempted by federal law.

Why did Shuker attempt this argument? His lawyer argued that only the component that failed—the R3 metal liner—was regulated and governed by federal law. The system as a whole, the argument went, was not subject to the same strict federal regulation. It’s true that only the R3 metal liner was subject to a comprehensive testing and approval process. However, the appeals court held that a medical device is defined as any component within the device, not the entire system as a whole, preempting these claims.

Federal preemption is one of several powerful defenses available to negligent medical device manufacturers. Often people injured by the clear negligence of companies do not have a right to compensation because of the legal concept of preemption. (This is one reason it is critically important for federal agencies like the FDA to “get it right” when allowing products into the market.)

Fortunately for the Shukers, the appeals court also ruled that their off-label promotion claims—arguing that Smith & Nephew negligently marketed the R3 metal liner for an unsafe off-label use—were not expressly preempted by federal law. Those claims are still pending in the trial court.

What Does This Mean for Your Case?

As you’ve probably figured out, these cases can be complicated! Federal preemption often lurks to destroy what may seem to be a valid claim against a negligent manufacturer. If you’re having a problem with a medical device, you don’t have to try to fight the manufacturer alone. Give me a call today to discuss your specific injuries and your specific claims against the manufacturer (919.830.5602).

“Apples to Oranges”

In a stunning marketing document directed at surgeons titled “Apples to Oranges,” Smith & Nephew announced boldly that the Birmingham Hip Resurfacing system “is not your average ‘metal on metal.’ It’s BHR.” Depicted in the advertisement is an apple with the names of other artificial hip products: ASR, Durom, Cormet, Conserve. It is rather astonishing, suggesting that the BHR was better and safer than these other MoM hips. I guess the BHR is the orange.

[I must interject that most surgeons and hip device makers acknowledge by now that all metal-on-metal hip devices are not safe to implant in human beings.]

S&N did not stop there. In letter to physicians in 2010, S&N represented that:

• there is no evidence connecting hip replacement surgery to “any” malignant disease;
• there is no evidence that increased cobalt and chromium levels are associated with toxicity found in some MoM patients;
• there is no evidence that increased chromium and cobalt levels in the body cause adverse health effects.

Essentially, it appears that S&N represented that cobalt and chromium ions in the blood and tissue were not a health risk, or at least, that no evidence supported such a conclusion. Let me stop here and state that metallosis–caused by higher chromium and cobalt levels in the blood from MoM hips–is not safe. You can read more about these health risks here and here. In any event, the Master Complaint points out that S&N knew about the medical evidence showing that metal levels have harmful effects on the human body, but did not update its product materials or its communications to surgeons with this vital information.

“A Bald-Faced Lie”

In fact, S&N doubled-down on its representations of BHR’s superiority and safety. In an advertisement in the Journal of Bone and Joint Surgery, S&N announced:

• “The bottom line is that the poor results of a few [MoM hips] have painted a negative picture of all metal on metal devices. But the BHR hip is not your average metal on metal device; it’s BHR!” [I suppose the exclamation point settles the debate.]
• the BHR device had a 95% survivorship rate after ten years.
• A recent study . . . showed “no revisions of BHR hips due to metal wear.”

The Master Complaint calls the assertion that no BHR hips had required revision due to metal wear a “bald-faced lie.” MC Paragraph No. 79. Studies showed, instead, that patients with the S&N BHR were getting revision surgeries due to metal wear.

Surgeons Needed 1,000 Surgeries to Master the Hip Resurfacing Technique

Dr. Derek McMinn, the inventor of the S&N BHR device, stated that orthopedic surgeons needed to perform 1,000 resurfacing surgeries in order to get proficient with the surgical procedure. S&N did not disclose this information to surgeons. Further, as part of the premarket approval for the BHR, S&N was required to provide surgical training and to study the surgeons’ resurfacing techniques, but failed to complete this vital part of the PMA requirements.

Not surprisingly, a 2012 BHR study found that the revision rate was three times higher for BHR patients than it was for the specific English surgeons (including BHR inventor, McMinn) trained in the resurfacing technique. The study concluded that orthopedic surgeons who were not a part of the BHR design team were not able to reproduce the results of the BHR design team. Which is to say, if you were lucky enough to have the BHR implanted by one of the BHR designers in England, you may get a positive result with the BHR, but if your orthopedic surgeon down the street in your hometown performed the resurfacing procedure, there was a much greater likelihood the BHR would fail.

A second study in 2012 found even worse results for orthopedic surgeons not carefully (even exhaustively) trained in the BHR resurfacing technique. A third study in 2012 found similarly bad results for recipients of the BHR.

The Master Complaint then states the worst part of all this: Smith & Nephew did not provide these studies to the medical community or to the FDA. Instead, according to the Complaint, for years S&N cherry-picked the data to put the best spin on the results of the BHR.

Finally, after several years, several studies, and thousands of BHR failures, S&N finally recalled the BHR on September 10, 2015.

There is much more to process in the Master Complaint. I will continue to summarize my review in later posts. In the meantime, if you had the BHR implanted and it failed, requiring revision surgery, give me a call to discuss your possible legal case against Smith & Nephew.

Note: The information in this post was obtained from the Master Amended Consolidated Complaint in the S&N BHR MDL. The statements in the Master Complaint are allegations, which means they are not yet proven or established. Smith & Nephew has answered the Complaint and has denied many of the allegations.

But First, How Do We Get to a “Master Complaint”?

This is how product liability multidistrict litigation begins: a product (like an artificial hip) hits the market. The artificial hip is implanted in thousands of patients. A year passes, then a few more. Patients complain of aches, pains, inflammation, noises, maybe even neurological symptoms. Doctors notify the manufacturer and their patients of these bad outcomes. Post-market studies are done. Problems are discovered with the product (in the case of metal-on-metal artificial hips, those problems included metallosis, loosening, pseudotumors, and many other “bad outcomes”). Injured people file lawsuits in courts around the country. The Judicial Panel on Multidistrict Litigation (JPML) eventually realizes it needs to designate one court to handle pretrial issues with the hundreds of cases being filed, so a multidistrict litigation (MDL) site is chosen, and the lawsuits are transferred to that MDL court. From there, the plaintiffs consolidate their efforts, and eventually a Master Complaint is carefully drafted and filed.

Smith & Nephew Birmingham Hip MDL

So it was with the Smith & Nephew Birmingham Hip Resurfacing (“BHR”) Artificial Hip MDL. In April 2017, the JPML designated the federal court in Maryland as the site for the S&N BHR cases (MDL 2775). Once designated, plaintiffs organized themselves, began discovery, filed motions with the court, and eventually produced the Master Amended Consolidated Complaint. Filed with the court on August 11, 2017, it is a staggering document. The Master Complaint is 160 pages, and sets out allegations involving misrepresentations, misleading studies, cherry-picked data, aggressive marketing, corporate negligence, and hundreds of injured recipients of the S&N BHR device. In this post (and in later posts) I will set out the key allegations and claims in the S&N Master Complaint.

Misrepresentations Alleged in the Master Complaint

The S&N BHR was first sold in the United States in 2006. Although the BHR was approved by the FDA for sale following a “pre-market approval” (PMA) process, the plaintiffs allege that S&N failed to comply with many of the PMA conditions (more on that later). The Master Complaint alleges that S&N was also negligent in its manufacturing processes. And despite the fact that metal-on-metal artificial hips from other companies were failing and were recalled, and despite mounting evidence that the S&N BHR was also failing at an unacceptable rate, S&N did not recall the BHR until September 2015. This was more than five years after the DePuy ASR was recalled. In that five year period, many people received the BHR and were later harmed by the failure of the BHR.

In a hip resurfacing procedure, the femoral head is not replaced. Instead a smooth metal covering is fixed over the existing femoral head, and a metal acetabular cup secured in the patient’s acetabulum. From there, the cup and the metal femoral covering in a cup and ball system. When the patient walks, the acetabular cup and the femoral head metal cover “articulates” or moves together. In this motion, metal debris can be spun off and released into the person’s body. S&N represented early in the life-cycle of the BHR that its metal-on-metal construction was different from other metal-on-metal hips like the ASR and the Zimmer Durom. According to the Master Complaint, Smith & Nephew openly represented that the BHR components released less metal debris than other metal-on-metal hips, and also had higher success rates than other MoM hips. In one promotional marketing document, S&N stated that the amounts of chromium and cobalt released in the body from the BHR “are so small that they’re measured in a unit called a micron. For perspective, a human hair is about 100 microns in diameter.”

Further, in a 2012 press release, a senior VP from S&N stated that the BHR was “unlike any other [metal-on-metal] hip implant” and that the BHR had a “distinctive metallurgy heritage” (whatever that means). See Complaint, ¶ 41. S&N also allegedly stated that pseudotumors were “benign.” S&N pronounced the BHR safer than hips containing ceramic components (such as a femoral head).

Injured Plaintiffs: The Birmingham Hip Was Not Safe

The Master Complaint states that these representations by Smith & Nephew were false. Instead, plaintiffs allege that the BHR was not safe, that MoM hips as a class are unsafe, and that ceramic hips are safer than MoM hips. Beyond that, plaintiffs allege:

• the BHR failed at a much higher rate in women and in patients with smaller femoral head sizes;
• studies showing greater BHR safety were done by surgeons who designed and sold the BHR for S&N;
• one designer believed that surgeons needed 1,000 surgeries before they would be considered effective in the hip resurfacing technique, but did not widely convey this critical information to the medical community;
• metal ions in the blood are harmful, period;
• the BHR produced more metal ion levels than were normally found in the body;
• the S&N BHR studies lost track of many BHR patients;
• the real world failure rate was higher than early studies upon which S&N relied;
• the revision surgery for a resurfacing patient is more complex and difficult than a revision surgery for a patient with a total hip replacement.

In my next Smith & Nephew Birmingham Hip Resurfacing blog post, I will look further into the allegations made in the Master Complaint.

Note: The information in this post was obtained from the Master Amended Consolidated Complaint in the S&N BHR MDL. The statements in the Master Complaint are allegations, which means they are not yet proven or established. Smith & Nephew has answered the Complaint and has denied many of the allegations.

In the last three DePuy Pinnacle artificial hip bellwether trials, three juries awarded the following amounts of money: $502,000,000.00, $1,041,311,648.17, and $247,000,000.00. That’s a total of $1.79 billion dollars. The juries awarded plaintiffs compensatory damages (or actual damages) and punitive damages (to “punish” the defendant companies). Remember that these juries settled on these huge amounts of money based on their findings in three separate trials that DePuy and Johnson & Johnson were liable for design and manufacturing defects, that the defendants failed to warn plaintiffs about the risks of the defective artificial hip, and that defendants acted recklessly, intentionally, and even maliciously in marketing and selling the flawed DePuy Pinnacle hip. These last findings permitted the juries to award punitive damages.

In the bellwether trial in March 2016, a jury awarded more than $500,000,000.00 to five plaintiffs. On December 1, 2016 a jury awarded more than one billion dollars to six plaintiffs and four spouses. And finally, just two weeks ago, a jury awarded six plaintiffs (and four spouses) $247,000,000.00 in compensatory and punitive damages. Compared to the total awards, the amounts awarded to the spouses of the hip victims were modest, and appear to have totaled around $6,700,000.00.

Let’s do a little math:

Seventeen plaintiffs participating in the three bellwether trials were injured by the the DePuy Pinnacle artificial hip. Backing out out $7,000,000.00 for payments made to spouses, the total awarded specifically to the seventeen plaintiffs is $1.72 billion dollars. This averages $101,176,470.50 per plaintiff in the three bellwether trials.

I should write this a second time: for each plaintiff whose DePuy Pinnacle hip failed, the juries awarded over one hundred million dollars.

Now consider that more than 9,000 cases remain unresolved in the DePuy Pinnacle multidistrict litigation in Dallas, Texas. If each plaintiff remaining in the MDL were to win one hundred million dollars at trial, DePuy Orthopaedics and parent company Johnson & Johnson would owe more than nine hundred billion dollars.

I did a quick search, and it appears as if Johnson & Johnson is currently worth around 390 billion dollars. Obviously, nine hundred billion dollars would quickly bankrupt J&J.

Should every remaining plaintiff in the DePuy Pinnacle MDL expect to be awarded one hundred million dollars? Of course not. (And in fact, the seventeen plaintiffs who were involved in the three bellwether cases will not ultimately recover $100,000,000.00, because the judge has already reduced the punitive damages awards in two of those cases, which you can read about here and here.) My point is simply this: it is well beyond time for DePuy and J&J to come to the table and negotiate a generous settlement for the remaining plaintiffs and their spouses. These past three bellwether trials could not have gone much worse for the defendant companies, and the more bellwether trials that follow, the worse it may get for DePuy and J&J, which means the more money it will take to settle the remaining 9,000 cases.

If you have been injured by a DePuy Pinnacle artificial hip, give me a call to discuss your options (919.830.5602).

delivered a huge verdict to the victims of the DePuy Pinnacle artificial hip. In this fourth bellwether trial, the jury awarded $247,000,000.00 to six plaintiffs and their spouses. According to news reports, after a two-month, hard-fought trial, the jury found that DePuy Orthopaedics and parent company Johnson & Johnson were liable to plaintiffs for the Pinnacle’s design and manufacturing defects. But the jury went further, concluding that the actions of the companies were fraudulent and deceptive, and that they had acted recklessly and maliciously in manufacturing, selling, and promoting the flawed products.

These last terms have special meaning in law: findings of fraud, deception, recklessness, and malice indicate that the companies went beyond mere negligence, that the defendants misbehaved intentionally or with a reckless disregard to the fact that their actions would harm innocent people. Because of these special findings, the plaintiffs were entitled to receive “punitive damages” from DePuy and J&J, which are money damages intended to punish defendants for especially bad behavior.

The jury awarded $90 million dollars in punitive damages to be paid by J&J, and $78 million in punitive damages to be paid by DePuy. That’s $168 million in total punitive damages. It is a lot of money.

The jury also awarded “compensatory damages” for the six individual plaintiffs. These are damages meant to compensate individuals for actual injuries. The jury awarded $77 million for such actual injuries as pain and suffering, past and future medical expenses, and other damages. This money award will be divided among the six plaintiffs based on an agreement among the parties.

Finally, the jury awarded the four spouses in the bellwether case “loss of consortium” damages of $1.7 million. Loss of consortium is a claim that arises when a spouse or close family member of the person injured by the defendants suffers separate losses, such as a loss of companionship or intimacy.

The jury in this case found DePuy and J&J intentionally misrepresented the product to the surgeons who would go on to implant the defective devices in patients. The jury also found that the defendants fraudulently concealed important information from the plaintiffs and their surgeons. The jury found that DePuy and J&J failed to adequately warn the plaintiffs and their surgeons about the risks involved in using the artificial hip. Finally, the jury found for the plaintiffs with the claims of design defect, manufacturing defect, and several claims of negligence.

It was another big win for the victims of the DePuy Pinnacle artificial hip.

Fourth Bellwether Trial Was Contentious From the Start

Before the case even started, Defendants asked the Fifth Circuit Court of Appeals to stop the fourth bellwether trial on the grounds that the defendants did not waive their objections to holding the trial outside New York, which is where the plaintiffs lived. In multi-district litigation, the MDL is not permitted to try any case where venue is not otherwise proper unless the parties waive their objections to the improper venue. The DePuy Pinnacle MDL Judge Kinkeade ruled that Defendants had waived their objections to trying the case in the MDL court.

In reviewing the defendants’ writ of mandamus, two of three judges on the Fifth Circuit found that Defendants had not waived their objections. The Fifth Circuit encouraged but did not require that Judge Kinkeade postpone the fourth bellwether trial. Judge Kinkeade decided to move forward with the trial, but this will surely be one ground for appeal by DePuy and J&J.

At the trial Plaintiffs argued that DePuy and J&J rushed the medical device to market, failed to undertake adequate premarket studies, did not provide sufficient warnings about the dangers of the hip implants, and defectively manufactured these MoM artificial hips. Defendants countered that the Pinnacle hip is safe and that the failure rates are in line with industry standards.

Several weeks into trial a startling allegation emerged: that a lawyer for DePuy may have tried to influence the testimony of a surgeon who treated three of the plaintiffs. Dr. David Shein submitted an affidavit on October 14, 2017 stating that a DePuy sales rep was being pressured by DePuy lawyers regarding Dr. Shein’s upcoming trial testimony. Dr. Shein reported that the sales rep said the DePuy lawyers were “on him like crazy” and were putting “big time pressure” on him. According to Dr. Shein’s affdavit, the sales rep stated that “there could be ramifications” for Dr. Shein based on his testimony in the Depuy Pinnacle trial.

Judge Kinkeade ordered an investigation by the FBI and the U.S. Attorneys’ Office. Following a hearing on the issue, Judge Kinkeade denied plaintiffs’ request to introduce the allegation of witness tampering to the jury. The judge decided that there was insufficient evidence that tied DePuy and Johnson & Johnson to the alleged actions of their lawyers. It also appears the DePuy sales rep backed off some of his most alarming comments reflected in the affidavit.

You can read more about the alleged witness tampering here.

Three Pinnacle Hip Bellwether Trials Have Resulted in Huge Awards for Plaintiffs

On March 17, 2016, in the second bellwether trial, a Texas jury awarded five plaintiffs $502,000,000.00, which included $360 million in punitive damages, for the injuries the plaintiffs sustained after the DePuy Pinnacle failed. The jury concluded that the Pinnacle hip sold by DePuy was defective and that DePuy knew about the flaws but did not warn patients and their doctors of the risks.

On December 1, 2016, in the third bellwether trial, the jury awarded six plaintiffs $1,041,311,648.17, which included $28,311,648.17 in compensatory damages and $4,000,000.00 in loss of consortium damages to the spouses of four of the plaintiffs. Finally, the jury awarded $1,008,000,000.00 in punitive damages total for the plaintiffs, and $1,000,000.00 in punitive damages for the four spouses.

With the fourth bellwether trial now complete, three juries have now awarded $1.79 billion dollars in consecutive bellwether trials. Plainly, several juries have concluded that DePuy and J&J acted with reckless disregard to the safety of innocent people, who simply needed a functioning, non-defective artificial hip.

I believe it is past time for DePuy and J&J to come to the table and offer to settle the thousands of DePuy Pinnacle cases that remain in this litigation.

If you have a DePuy Pinnacle hip that may have failed and injured you, give me a call today.