Clay: Over the past ten years you have seen a lot of metal-on-metal hip implants. Several years ago an attempt was made to put a metal-on-metal artificial hip together, and that was supposed to last forever, or last a whole lot longer, and it turned out that it was problematic. And I know you have had many patients who have had that [implant]. What did you see out of the metal-on-metal hip implants when they were failing?

Amy: Again, the first cardinal sign that I saw was chronic pain, an inability to weight bear normally through that joint. So even after normal hip replacement, the patient should be able to weight bear through it. It should not feel like they collapse on that hip, and so a limp that never resolves or an inability to get away from an assistive device. So, I had a patient in her 50s that could not get off a walker. She was 50. She was playing tennis five days a week before she had her hip replaced. Yes, with the metal-on-metal she suffered metallosis and she had an overt failure of that joint replacement. She was a candidate for this new [metal-on-metal implant], now widely known to be a bad device, because she was so young, active, fit, and healthy. It was supposed to last for longer. It was supposed to allow her to have more function larger range of motion, less risk of dislocation and all of those things. So as we know, that did not really work out so well.

Clay: Yes.

Amy: So the folks that had the metal-on-metal problems, metallosis was the biggest problem that ended up causing really frankly catastrophic changes in these people’s lives because the metals in the two appliances, they ground on each other and it leaks metal, particularly cobalt. That was a big metal that became known to become systemic and to basically create toxicity in the tissue surrounding the joint.

The metal would basically eat or erode away musculature bone, osteolysis was one of the biggest problems where it caused bone to basically just break down and be eroded away. I was actually in the operating room and saw some revision of a hip that experienced metallosis. And in the revision the musculature that was away from the hip, so when you go in to do a hip replacement, obviously, it is an open field and so you can see all of the connective tissue all the layers of musculature of the capsule of the joint this particular patient.

The capsule of the joint was this dingy gray looking color. You knew inherently. You did not have to know anything about science or medicine to know that it is probably not supposed to look like that. And what is astounding was how far away that metal leached into the musculature and so because it is toxic, because it is corrosive, that tissue had to be ripped [out]. It had to be excised. So some people lost part of their musculature and some of it was very important musculature around the hip in regards to stability and mobility restoration in the hip.

So, because the metallosis affected the bone, revision surgeries then became a bit tricky because, so when these folks went in for their first hip replacement, they had this beautiful landscape. They had a bad hip. They had a bad articular surface, but the landscape around it, and by that I mean the bony components that are going to hold that new joint, they were healthy. Otherwise, they would not have been a candidate for a hip replacement. Okay, so they had a healthy landscape to put those two new pieces in the socket. The acetabulum and the femoral head. So, once the metal started breaking down some of the bone, now all of a sudden you have got a landscape. It is not all that great in regards to the how to receive this new joint. So these folks had significantly limited post-op. They had to protect those joints dramatically for long periods of time so that could allow this bone that had really taken a hit to grow into the new prosthesis, which is how you heal a hip replacement. So, it made the post-operative course significantly different than a primary hip replacement where you walk immediately after surgery. I mean, I have seen patients ten days post-op, that are already on a cane and have a pretty decent gait. So–

Clay: Well, that is kind of horrifying, a revision is one thing but a revision when the whole landscape of the hip and the thigh and the leg and all that area is severely compromised. It makes the revision surgery less likely to be successful. So, that gets me to this question. I know you have seen it quite a bit. Tell me what the rehab might look like and I know it is different for all people. But what might the rehab look like for a person who has to get multiple surgeries on the same hip? I know it is compromising. How would it be compromised?

Amy: So that same patient when they had the first hip put in, when as soon as they started physical therapy within 24 hours of their surgery. They would be putting weight if they are usually what is called “weight bear,” as tolerated. So basically, we want you putting weight through that new joint. So as much weight as you feel like you can safely place through that leg using a walker, because everybody starts out on a walker, their weight bear is tolerated.

So, that is in the primary hip replacement that is uncomplicated. In just a plain revision, they can be non-weight-bearing for four to six weeks. So just right out of the gait. They are not putting any weight at all through it for four to six weeks. In the cases where these folks had really substantial metallosis, sometimes that non-weight-bearing was extended 8 to 12 weeks. And now you are talking about being completely non-weight bearing which, by the way, is very difficult to do.

Clay: Yes.

Amy: It is really hard if you think about how difficult that is for your upper body and for your contralateral side, for that other leg to be completely off that leg for anywhere from six to twelve weeks. And the reasoning is because that landscape they wanted, the surgeons wanted, every opportunity for that bone to accept that new part for it to heal because bone is live. So it grows into the prosthesis, into the implanted part of the prosthesis.

So they want that bone grow in because over the course of time, that is where the fixation actually lives. That prosthesis becomes incorporated into the bone itself. It great becomes part of that bone. So that is one of the biggest things that occurs postoperatively in those revisions. And so, then you have to think about everything that happens with that revision. So let us say your non-weight-bearing for six weeks, well, if you took your very healthy hip and you got off of your leg for six weeks, you would be astounded at how much strength you lose.

Clay: All right.

Amy: It is astounding through the entire extremity. And so there is profound strength loss.

Clay: So what is your medical opinion about the likelihood that a follow-up surgery or revision surgery will be successful? I mean does the chance for success just drop through the floor once there has been a failure of an artificial hip? Such that you say to yourself “My goodness. This person is going to really struggle,” or is it case by case? And in a lot of cases revision surgery can be fine for a patient.

Amy: I think that any joint replacement hips included the first one that you get because of that pristine landscape is the best chance you have to have a great outcome. Every time that that surgeon has to go back in, the opportunity for a great success go down.

Clay: Right.

Amy: And that is just the way it is. But the problem is that, like for the folks that had these metal-on-metal joints, they did not have an option. I mean, they were in such profound pain. The debility they had to get that hip taken out. And they just basically had to deal with whatever that metal did to the surrounding tissue and they had to try to protect the healing tissue the best they could and understand that their outcomes were going to be less than perfect.

Clay: Right.

Amy: Not what they had planned. Not what my fifty year old patient who had every plan of going back to the tennis court because that is why she had a hip replacement, because we know that she can go back to doubles tennis.

Clay: Right. Did not happen.

Amy: No, matter of fact, she was just happy frankly at the end of the day after a exhausting very very physically and emotionally challenging rehab process. She is happy to be able to walk and to not feel like she has a nail being driven through her hip every time she way bears.

Clay: I see.

Amy: So her measure of success changed dramatically after her revision.

Clay: I bet. Well, let me try to end on a slightly more upbeat note. Have you seen better outcomes in the last few years since we have learned what we have learned about metal-on-metal hips? And have there been fewer revision surgeries among your patient population?

Amy: There absolutely have been. As matter of fact, it probably in the last four years, I have had quite a few patients that have not even needed to do anything with me postoperatively. They were strong enough, healthy enough, and had prepared themselves for their surgery enough that they did not even need to do PT. Basically, they just had to protect their hip for a little bit, gradually get their weight back on it. And so, there is no question that the hip surgery that is going on right now, the total hip replacement surgeries, and I am seeing are phenomenally successful. If we look at the whole spectrum of success, I think the last that American Academy of Orthopedic Surgeons was a 95% success rate. I mean that is pretty high success rate for a very dramatically large spectrum of people [aged] 11 to the 90s. So, you know, it inherently has great outcomes. It is just when the outcomes are not great, it is bad.

Clay: Yes. I have seen it in my work as well. This is what I wanted to talk to you about today. This has been fantastic.

Amy: Well, I hope I answered your questions adequately, and I am happy to talk with you.

Clay: Well, thank you so much and who knows, if I have another subject to discuss, maybe we can do this again one day.

Amy: I would love to do that, Clay.

Clay: Well, thank you Amy. I really appreciate your time.

Amy: My pleasure. Have a great night.

Clay: You too.

Note: You can also listen to this conversation with Amy Dougherty in my podcast. If you want to talk about a possible defective artificial hip case, call me: (919) 830-5602.

What We Have Here is a Failure to Communicate

Often, the problem starts with the lawyer’s failure to communicate. People will tell me that they never hear from their attorney, and then suddenly, after many months or even years have passed, the lawyer will call and quickly explain the terms of a settlement offer then hurry off the phone. This is a mistake. The lawyer should take as long as necessary to fully explain why the settlement number is what it is. In fact, it is important for the lawyer to keep the client updated on developments throughout the litigation. For example, if another plaintiff in the larger litigation loses an important bellwether case, the lawyer should call and report the loss and what it may mean for the litigation and how it might impact settlement (obviously, it’s not good for all plaintiffs if a bellwether case is lost). If the client understands generally how the multi-district litigation is progressing, the client will be more prepared when a settlement offer finally arrives.

Suffering is Very Real and Very Personal

I have represented many people who have truly suffered when a medical device like an artificial hip has failed. The suffering is real. Some people endure tremendous pain and can’t get a good night’s sleep. Others must give up tennis; some can no longer garden or walk; still others have to quit their jobs. Let’s face it: money—even a lot of money—will not compensate the person for these hardships. It is difficult to walk with pain for years, then hear that the manufacturer who sold the defective product is offering X to settle all claims the person has now and in the future. For most people, X (no matter what it is) is never enough.

Settlement Offers Always Reflect the Strength of the Plaintiff’s Case

This is an obvious point but it must be emphasized: some cases are better than others. In the metal-on-metal (MoM) artificial hip litigation (several manufacturers were involved) it became clear that it was a big mistake to rush these MoM artificial hips to the market under the 510(k) pathway (which I have written about often). It would have been much safer if the companies slowed down, performed pre-market testing and analysis of the metal hip, and then made a prudent and careful decision about whether to move forward. Several companies didn’t choose that path, many thousands of people were injured as a result, and plaintiffs won a lot of bellwether trials. Eventually, the manufacturers of these metal-on-metal hip products paid billions of dollars to settle thousands of valid claims.

By contrast, in the Xarelto litigation, plaintiffs lost six bellwether cases. This does not mean the product is safe or even non-defective, but it does mean that the plaintiffs’ litigation teams struggled to marshal the facts sufficient to convince juries of the defects and defendants’ failure to warn of the risks. (A few plaintiffs in other Xarelto trials won their cases.) These bellwether trial losses undoubtedly affected the size and scope of the larger settlement that followed.

Every Product Case is Different

The individual confined to a wheelchair has a different claim and different damages from the person who had revision surgery but is now walking and pain-free. If one person is rendered disabled at a young age, he or she should have a strong lost earnings claim. If the second individual was injured after his retirement, he would not be in position to recover lost earnings. In defective product cases, some people have extraordinary injuries and others have more modest injuries. Both cases are important, but the settlement outcomes will be different.

Above all, before you sign anything, talk to your lawyer, ask all the questions you have, read the settlement documents carefully, and make an informed decision.

Note: This article was written in general terms and does not represent any details from any current or former client or any caller to this law office.

Most of us pay our bills on time. If we break a neighbor’s rake, we promptly purchase a replacement. If our child dumps fruit punch on a friend’s carpet, we pay to have it cleaned. In fact, we don’t really think about these unwritten rules often; it’s just the right thing to do, so most of us do it instinctually: if we cause damage, we pay for the damage. But too often companies refuse to pay fair settlements to resolve product failure cases, even in the face of a mountain of evidence that (1) the product clearly failed and (2) the failure physically injured the person. For example, let’s say a sixty-eight year old retired schoolteacher learns her metal-on-metal artificial hip implant has failed; her doctor tells her that, in addition to the pain she feels in her hip and leg, she now suffers from dangerously high cobalt and chromium levels (a condition called “metallosis”). Thousands of other injured people have similar claims, but the manufacturer of the failed hip product simply won’t pay. Why not?

Well, I can’t know all the reasons, but let’s look at a few theories:

Companies Don’t Like to Pay Settlements

Companies do not like to pay claims, period. Companies are in the business of making money, not paying out money. Corporations are under enormous pressure to maximize value for their stakeholders, primarily those people who buy their stock. Paying out two billion dollars in settlements for a failed artificial hip is never good for the bottom line.

Companies Can Get Away with Not Paying

The playbook is no secret: when a company first receives complaints about a failing product, it almost always denies that the product is defective. When scholarly, peer-reviewed studies establish that the product is defective, the company invariably commissions its own studies on the product, and often those studies conclude that the product is safe or that the dangers have not been proven. When litigation begins, the company defends itself vigorously, because it is always the case that the company has much more money than any injured plaintiff and can use its superior financial position to grind down injured plaintiffs, even thousands of them.

Settlement Delays Are Profitable

Let’s say a defective product injures 12,000 people, and the company negotiated three billion dollars in a global settlement for the injured plaintiffs. And let’s say the company could pay today or, through artful delays, two years from now. Eight percent interest on three billion dollars for two years is four hundred and eighty million dollars ($480,000,000). That’s real money. If a corporation can delay settlement discussions for two or four or six years before finally paying out claims, the company comes out ahead.

Another positive result of delays is this: some injured people just give up. Some plaintiffs may walk away, or accept a reduced offer, or lose interest, or may even grow old and die. There is no question that justice delayed is justice denied for injured people. Corporations understand this.

One Example: Johnson & Johnson

Recently, Johnson & Johnson has taken a harder line against paying settlements. One Johnson & Johnson defense attorney said that J&J is inundated with lawsuits and that if the company paid every claim it could get a reputation as an “easy mark.” In 2018 alone, J&J spent two billion dollars on settlements and attorneys’ fees. According to reports, J&J is defending 100,000 lawsuits involving hip implants, surgical mesh, baby powder, prescription drugs, and other product cases. One school of thought holds that the massive number of pending lawsuits is actually a deterrent to settlement for J&J.

Medical device and drug companies like J&J can get burned with aggressive no-settlement policies. DePuy Orthopaedics, owned by J&J, lost several huge verdicts in the DePuy Pinnacle hip litigation. And last year a jury awarded damages of $4.7 billion to a group of women who used J&J’s baby powder and were later diagnosed with cancer. There is no question that J&J could have settled with these 22 women years ago for a fraction of that jury verdict. (Of course, J&J has appealed.)

Then there is the loss of goodwill in this scorched-earth litigation strategy. According to a report in Law360, in 2016 J&J was considered the sixth most reputable company in the United States. By 2018 it had dropped out of the top 100. Goodwill matters.

Finally, one important reason for companies like Johnson & Johnson to pay valid claims is this: it is the right thing to do. When corporations offer safe products that improve people’s lives, they should make a lot of money selling the products. But when one of their products turns out to be flawed and harmful, companies should want to do the right thing and pay all the valid claims, promptly.

Note: References to individuals in this article are fictional and hypothetical and do not represent any current or former clients, or any other person. Information about Johnson & Johnson was distilled from online news sources, including Law360, which own their content.

Smith & Nephew Birmingham Hip

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

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

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

Stryker LFIT v40

Unlike other artificial hips currently in litigation, the Stryker LFIT V40 Hip is not a metal-on-metal artificial hip. The LFIT V40 system includes a metal acetabular cup, a polyethylene (or plastic) liner, a cobalt-chromium femoral head, and a titanium femoral stem. The failure of the Stryker LFIT V40 involves the junction of the neck of the femoral stem and the femoral head or ball. The neck connects and attaches to the femoral head (the ball), thus connecting the leg bone to the hip bone. This connection was intended to be permanently secured through a taper lock system, holding the stem securely to the ball. In many cases, however, once implanted the V40 femoral head began to corrode. The corrosion occurred at the site of the connection to the neck. Over time the corrosion can cause the taper lock to become compromised and loosen. Eventually, the neck would corrode as well, and once the neck began to corrode the breakdown of the artificial hip would advance more quickly. According to one study, the loosening would cause fretting and micro-motion at the taper lock site, and this movement or friction would cause metals to be released into body. Thus, the Stryker metal-on-polyethylene (MoP) artificial hip resulted in patients suffering from metallosis, just like other patients who received metal-on-metal artificial hips.

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

DePuy Pinnacle and ASR

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

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

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

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

What is Arthroplasty Cobalt Encephalopathy (ACE)?

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

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

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

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

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

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

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

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

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

The Takeaway

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

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