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.

“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.

This is my pitch: People who had to undergo revision surgery because their DePuy ASR artificial hip failed should be compensated for their injuries, even if the revision surgery occurred beyond the ten-year anniversary date of the original implant surgery.

Let me admit the obvious: It’s a bit self-serving for me to argue this point. I am an attorney and I represent individuals injured by the failure of the DePuy ASR device. But I have read a lot about these cases, over many years, and the more I understand the science behind these metal-on-metal (MoM) hips (or the lack of science), I am more convinced that thousands of people have been unfairly injured, even if those injuries did not become obvious for several years. Even ten years.

The DePuy ASR Settlements

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

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

My Pitch:

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

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

Necessary Evils

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

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

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

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

What is Arthroplasty Cobalt Encephalopathy (ACE)?

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

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

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

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

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

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

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

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

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

The Takeaway

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

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

In 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.

By all accounts, each of the three bellwether trials in the DePuy Pinnacle artificial hip MDL has been contentious. In the fourth bellwether trial, which should wrap up this week, the litigants have been in a fierce battle again. The most recent skirmish has centered on allegations by plaintiffs suggesting that lawyers for DePuy Orthopaedics may have been trying to influence the testimony of a witness for the plaintiffs.

I want to share with you the affidavit submitted by Dr. David Shein, a surgeon who treated three of the six plaintiffs involved in the current trial. Dr. Shein was once expected to be called as a fact witness in the case by the plaintiffs.

Affidavit of David Shein, M.D.

1. On Friday, October 13, 2017, at approximately 11:00am while was scrubbing in for surgery at the Montefiore Hospital, I met with my DePuy sales representative Glen Swajger in connection with a procedure that required his involvement.
2. Mr. Swajger looked terrible and appeared stressed, so I asked him what was going on. He said the day before (October 12, 2017), he had been contacted by the DePuy lawyers and that discussion made him anxious. He said the lawyers were “on him like crazy.” They were putting “big time pressure” on him.
3. Mr. Swajger told me that as a result of the conversations with DePuy attorneys, he was worried there could be ramifications for me in my practice in connection with my upcoming Dallas testimony.
4. He indicated the lawyers were “peppering him.” He said the “business in Dallas was freaking [him] out.” He said he had a “terrible” day on Thursday as a result of this and my going to Dallas was driving him crazy. He said “I care about you.”
5. Mr. Swajger also told me on Friday that he knows as much about metal on metal as I do, and that he would still want metal on metal because the wear characteristics are better than metal on poly, and he would want me to do his surgery.

What Does All This Mean?

Frankly, this affidavit is astonishing. It suggests that lawyers for DePuy Orthopaedics may have reached out to a DePuy employee, medical device sales representative Glen Swajger, for the purpose of using Swajger to influence the testimony of Dr. Shein, who was scheduled to give testimony in the fourth DePuy Pinnacle bellwether trial.

In the affidavit Dr. Shein states under oath that the DePuy sales rep “looked terrible,” that the DePuy lawyers were putting “big time pressure on him,” and that Swajger stated “there could be ramifications” for Dr. Shein based on his testimony in the Depuy Pinnacle trial. Plainly, this would send up a huge red flag to any lawyer trying a case against DePuy. The implication is that the DePuy lawyers wanted to know what Dr. Shein was going to reveal at trial, and possibly wanted to alter what Dr. Shein intended to say. Granted, this affidavit represents hearsay statements attributed to a DePuy employee, and at this point it cannot be taken as anything more than an allegation. But it looks awful, and it suggests an attempt to intimidate a key witness.

The last paragraph may be the most alarming. In it Dr. Shein recounts that Swajger made unsolicited statements about the safety of metal-on-metal hip implants, and that if Swajger were to undergo hip replacement surgery he would want metal-on-metal “because the wear characteristics are better than metal on poly [polyethylene, or plastic] . . . .”

This is jaw-dropping.

If this statement were actually made by a DePuy employee to a surgeon who is preparing to testify in a case about the safety and effectiveness of the metal -on-metal Pinnacle hip, it is hard not to see it as anything other than an attempt to influence the witness’s testimony. Even the judge presiding over the DePuy Pinnacle MDL stated that the affidavit was “disturbing” and “disconcerting.”

If the allegations are proven to be true, a mistrial could be issued, and sanctions could be imposed on the defense team. Further, any lawyer found guilty of witness tampering could be prosecuted and/or disbarred. It is a very serious matter.

So What Did the Judge Do?

Judge Kinkeade ordered an investigation by the FBI and the U.S. Attorneys’ Office. This means that FBI agents and federal prosecutors will question Dr. Shein, Swajger, and the lawyers involved in connection with the affidavit. Following a hearing on the issue yesterday, 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 actions of their lawyers. It also appears the Swajger backed off his most alarming comments reflected in the affidavit.

The Takeaway?

The FBI investigation has not been completed. The affidavit, however, is troubling, and the call for an FBI investigation is the right one. At the very least this incident underscores how aggressive cases can become on the national stage. Billions of dollars may be at stake, not only for the six plaintiffs in this trial, but also for the thousands of plaintiffs that still have not resolved their cases in the MDL. With so much at stake, the takeaway so far is that both sides must remain vigilant at every turn to possible wrongdoing.

I will keep you posted on the outcome of the DePuy Pinnacle bellwether trial. Closing arguments in the case begin today, and the jury could reach a verdict by the end of the week.

This article was written based on my review of court documents, several news reports, and my previous writing on the subject.

In this post Suzanne recounts her slow recovery from artificial hip revision surgery. Suzanne received a metal-on-metal artificial hip, and four years later the hip was recalled. Suzanne was forced to undergo revision surgery a year later.

Part 3

Sitting on my night stand next to me here at home is a shiny steel sphere resting in rougher textured steel “cup.” When I hold it in my hand my fingers will not close around it and when I pick it up, the shiny steel ball is heavy and rolls back into the cup revealing a flat bottom with a hole in the middle of it. It was attached to an artificial titanium femur in my left leg just three days ago–prior to my revision surgery–and looks and feels so smooth and shiny it is hard to believe that it has wreaked such havoc on my unsuspecting body: staining the surrounding tissues an ugly gray, whipping up metal particles and spewing them into the orbit surrounding my recalled body parts and, worst of all, destroying any and all chances I may have had to develop a “J-Lo” like posterior due to irreparable damage to my gluteus medius and minimus muscles. Truthfully, I am more concerned with my ability to flow into a left legged lunge from a downward dog than to see my butt standing at attention, but that is too much to think about too soon and so instead I turn to my beautiful daughter who is giving me a bedside serenade on her guitar and think about how much I love my family and all my friends and the taste of lime popsicles.

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

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

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

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

Postscript

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

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

Part 2

I woke up before the sun feeling wide awake, but not ready to face the day, I forced myself to fall back asleep re-entering the world of dreams and mystery. My dreams have been fraught with intrigue, dysfunction, insanity and all kinds of craziness and no wonder! My life is a bit crazy these days. As crazy as my dreams can be, they are never too crazy for me to say. “Hey, wake up, this has gone too far!” I relish in the scenarios, the unconscious connections between everything that is happening in my life being played out in random dream dramas. It’s better than soaps.more

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

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

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

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

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

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

Behind every metal-on-metal (MoM) artificial hip that fails, there is a person and a story. Artificial hip manufacturers may see only a faceless crowd of victims. These defendant companies may attempt to resolve the claims in bulk and move on to market the next blockbuster medical device. But in that crowd of plaintiffs are thousands of individuals uniquely injured by a product that was implanted in their bodies. The product failure often requires revision surgery, and the injuries that result from the artificial hip failures change lives forever: accomplished tennis players no longer play tennis; couples no longer travel or walk together on a beach; others have to resign from jobs they love because they cannot sit a desk for any length of time. Each of these people has a unique story to tell.

In the next three posts, I will share one woman’s story. “Suzanne” [not her real name] received a metal-on-metal (MoM) artificial hip in 2006 after years of pain from arthritis. The hip was recalled in 2010, and Suzanne was forced to undergo revision surgery in 2011. This is her story:

Part 1

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

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

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

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

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

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

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

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

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

I will not forget my first jury trial. It was many years ago, not long after I graduated from law school, and let’s just say I was in over my head a bit. It was a simple car crash case. I represented a driver who was rear-ended and injured (but not seriously). I walked my client through his direct examination, and I thought it was going well. Then the insurance defense lawyer was given the opportunity to cross-examine my client. He asked simple questions about the severity of the injuries (“were you able to return to work a week later?”) and after eight or ten of these questions, I objected. The judge peered down at me over his reading glasses:

“Counselor?” “Yes your honor, I object.” “On what grounds?” “This line of questioning is prejudicial.” “Prejudicial?” “Yes, your honor. I move to strike the testimony as prejudicial.”

The judge sat back in his chair. “Mr. Hodges, wouldn’t every question on cross-examination be prejudicial to your case?” This query reminded me of the complete language of Rule of Evidence 403: The court may “exclude relevant evidence if its value is substantially outweighed by a danger of . . . unfair prejudice.” I had remembered most of the rule, but not the key word: unfair. All evidence presented in any court case is supposed to be prejudicial to the other side’s case. To exclude evidence under Rule 403, the testimony must be unfairly prejudicial.

But the judge was still waiting for my answer. The jury waited too. I tried my best: “Well, yes, your honor. But this testimony is unfairly prejudicial.” At least I had finally wedged in the key word. “I don’t think so, counselor, objection overruled.”

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The judge of course was correct. And in most trials, excluding evidence on the grounds of unfair prejudice is difficult. Each side is supposed to present evidence that is aggressively prejudicial to other side’s case. And the prejudicial evidence, even if unfair, can be excluded only if the unfairness substantially outweighs the value of the evidence.

Depuy Appeals to Fifth Circuit

Depuy Orthopaedics, manufacturer of the Depuy ASR hip and the Depuy Pinnacle hip, is arguing to a federal appellate court that it was prejudiced by the evidence presented in a 2016 Depuy Pinnacle trial. That trial ended in a whopping $502 million dollar verdict in favor of five plaintiffs. Depuy’s attorneys now argue to the Fifth Circuit Court of Appeals that Depuy is entitled to a new trial because the plaintiffs’ team had “a strategy” to “inflame the jury through highly prejudicial evidence and wholly inappropriate argument.” For Depuy to win this argument, Depuy must show that the totality of the evidence was not only unfairly prejudicial, but also that the unfairness substantially outweighed its “probative” value (probative is the ability to show or prove something).

Depuy Claims Plaintiffs’ Evidence was “Highly Inflammatory”

Depuy makes many legal arguments in its appeal to the Fifth Circuit. Primarily Depuy argues that the case should have never been allowed to be presented to a jury based on state and federal law, and because the statute of limitations had run for two of the five plaintiffs. I write about the statute of limitations here. I won’t address those arguments in this article (the brief is one hundred pages long), but I wanted to touch on a separate ground for appeal: that Depuy is entitled to a new trial based on “highly inflammatory, irrelevant, and prejudicial evidence” presented by the plaintiffs.

According to the appeal brief, Depuy alleges that plaintiffs’ attorneys referenced payments made by Depuy to “henchmen of Saddam Hussein.” This language is certainly colorful, but plaintiffs presented evidence at the trial indicating that affiliates of Defendants had made improper payments to the Iraqi government. Depuy argues that this evidence was unfairly prejudicial because the issue at trial concerned simply a defective hip product. But the trial judge allowed the improper payment evidence because Depuy made “character” an issue in the trial by referring to the company’s small town values. Plus, the case involved many other claims besides design and manufacturing defects, including a robust punitive damages claim.

Depuy also objects to the plaintiffs’ reading from a book titled Doubt Is Their Product: How Industry’s Assault on Science Threatens Your Health. The book, among other things, analyzed many of the product failures and toxic tort cases that have harmed thousands of people over the years.

Depuy objects as well to the plaintiffs’ attorney referencing a connection between the failure of metal-on-metal hip implants and the potential risk for cancer. Depuy argues that any reference to cancer violated Rule of Evidence 403.

Depuy continues in its appellate brief to object to testimony of “thousands” of other pending Depuy Pinnacle lawsuits. Depuy states that this evidence was inflammatory and unfairly prejudicial.

Depuy also alleges that plaintiffs made unfair reference to a letter written by a former employee accusing other Depuy employees of racism. Racism, Depuy argues, had nothing to do with the defective hips at issue. However, plaintiffs counter that the evidence is presented as character evidence.

Finally, Depuy argues that the attorney for the plaintiffs should not have been allowed to argue “unit of time” in arguing for a standard by which to award damages to the plaintiffs. This is a technique whereby the attorney suggests a method to calculate pain and suffering over time. For example, a lawyer may ask the jury to assign a value to the pain caused by a failed artificial hip over a week or even each day. Defense lawyers hate this concept; they protest that it leads to “excessive verdicts.” Plaintiffs’ lawyers counter that if a person suffers pain each day, then each day has a distinct value when determining pain and suffering damages.

Will Depuy Win Its Appeal?

I would say Depuy has an uphill slog to win this appeal. The brief is certainly well-written. After all, Depuy employs some of the strongest (and highest priced) defense law firms in the country. But at the end of the day, Depuy must show that the value of the evidence presented above was substantially outweighed by the danger of unfair prejudice. Plus, the trial judge gave explicit instructions to the jury about what evidence they could consider and how they could consider it. As the trial judge told me years ago, the evidence presented against my client is supposed to be prejudicial to my client’s case.

I will keep you posted on the outcome of Depuy’s appeal. And if you have a Depuy Pinnacle hip that is causing you problems, give me a call to discuss your legal options.

Note: The appeal brief in this case was one hundred pages long. I have had to distill much information into a brief article. I do not take a position on the evidence presented at trial or to the strength of Depuy’s appellate arguments. This post is for general informational purposes only.

I recently blogged about artificial hip failures. Fortunately, these hip failures are not common when you look at the total number of patients receiving hip implants every year. However, when there is a failure, it can be extremely unpleasant, to put it lightly.

And it’s not just one medical device manufacturer with implants that are causing problems. Stryker, DePuy, Zimmer, and Wright are just some of the companies who have had issues with their artificial hip implants. If you’re curious, you can read more about some of them in my other blog post.

One such company that’s been in the news lately is Smith & Nephew. Over the course of the past few years, Smith & Nephew has instituted a string of recalls and is now at the beginning of a potentially expensive legal fight, with even more lawsuits expected. So what exactly is going on with Smith & Nephew’s artificial hip implants?

Smith & Nephew Recalls

Smith & Nephew issued many recalls regarding its hip implant medical devices, with a select few being particularly noteworthy:

1. R3 Acetabular System: This hip implant consists of a femoral head and cup, with a metal liner between the two components. The R3 system is a metal-on-metal hip implant that has experienced many of the same problems that other metal-on-metal hip implants have faced, including metallosis, pain, infection and hip implant loosening. Many hip implants can suffer these problems, but the R3 System failed at a much higher rate, a whopping 6.3% versus 2.89% for other hip implants. In response to these problems, Smith & Nephew issued a voluntary recall in June of 2012. At the time of the recall, roughly 4,000 R3 Systems had been implanted in US patients.
2. Birmingham Hip Resurfacing (BHR) Femoral System: The BHR System is similar to the R3 System in that it has a metal femoral head and cup which creates a metal-on-metal hip implant. The BHR System was special in that it was designed to allow for the option of “resurfacing” of the hip joint. With resurfacing, the bone is resurfaced with metal, instead of being completely replaced. However, due to the metal-on-metal nature of the BHR System, patients began suffering from the same problems as R3 System patients. In June of 2015, Smith & Nephew withdrew the BHR System from the US market.
3. Tandem Bipolar Hip System: On August 29, 2016, Smith & Nephew recalled this medical device because “some bipolar shells were manufactured with an out of specification retainer groove.” This has resulted in hip implants literally falling apart after being implanted in the patient.
4. Modular SMF Hip Stem and Modular REDAPT Revision Femoral System: On November 15, 2016, Smith & Nephew issued two recalls for its SMF and REDAPT Hip Systems. The basis for the recalls is due to “a higher than anticipated complaint and adverse event trend.” Essentially, many of the problems with these two hip implant systems have involved the release of metal ions into the body, resulting in metallosis.

Smith & Nephew Litigation

Currently, there are several dozen active federal lawsuits concerning the R3 and BHR Systems. These thirty-one cases are spread out over twenty-two federal districts and in the beginning stages of litigation. Since the facts surrounding each case are similar, several plaintiffs have asked the court to consolidate all the cases into one multi-district litigation, or MDL.

The hope is to litigate these cases more efficiently, although Smith & Nephew has opposed this consolidation on the basis that the R3 and BHR Systems are two different products that rely on two different regulatory laws. A hearing is scheduled for March 30, 2017 to decide whether these lawsuits should obtain MDL status.

Currently, only the R3 and BHR Systems have a significant number of lawsuits pending. This shouldn’t be surprising since those devices were recalled or withdrawn from market a few years ago while the Tandem Bipolar, Modular SMF and Modular REDAPT systems were only recalled in the past few months. However, Smith & Nephew can expect to be in court concerning these recently recalled hip implant systems.

What Should I Do in the Meantime?

If you had any of the above products implanted, see your orthopedic surgeon and discuss the possibility that your implant may begin to fail, or may have already started to fail. Your doctor can perform tests to determine if your artificial hip is failing. And if you have legal questions, don’t hesitate to give me a call or send me a message.

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

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

What Is Metallosis?

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

The Latest Study on Metallosis

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

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

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

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

The Takeaway

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

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

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