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

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

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

So What is a Bellwether Trial?

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

Smith & Nephew Bellwether Trial Schedule

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

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

Can a Bellwether Trial Schedule Encourage Settlement?

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

Dr. Tower’s Backstory

Steven Tower’s story is remarkable. He is featured in the Netflix medical device documentary The Bleeding Edge. Dr. Tower is an avid cyclist and needed a hip replacement several years ago. He chose the DePuy ASR metal-on-metal artificial hip because it was marketed to “exceptionally active individuals.” Several months after his hip replacement surgery, however, Dr. Tower noticed a tremor in his hand. His ears started ringing, his thinking became confused and he began repeating himself when he spoke. One night while attending a medical conference Dr. Tower had a mental breakdown and trashed his hotel room. He wrote all over the walls with sharpies and pens, and wrote on the hotel mirrors with soap. When he returned home he measured the metal levels in his blood, and the test results revealed 100 times the normal amount of cobalt that should be in his body. Dr. Tower soon arranged to have his metal hip components removed in a revision surgery. Within a month his thinking cleared and his other symptoms mostly disappeared. He was relieved, but also intrigued.

Dr. Tower’s Chrome Cobalt Hip Study

The metal-poisoning ordeal stayed with Dr. Tower, so he decided to study the symptoms of his orthopedic patients. In March 2015 he started a screening program to measure cobalt levels in the blood of patients who received an artificial hip with any chrome-cobalt component. Astonishingly, Dr. Tower discovered that over half of his patients with a chrome-cobalt hip part had measurable cobalt in their urine. A quarter of those patients had a metal-on-metal (“MoM”) artificial hip, but most had the metal-on-plastic hips, which are thought to be safer. Steven Tower didn’t buy it.

Ominously, Dr. Tower discovered that 81% of his patients with cobalt presence in the urine suffered from “Arthroplastic Cobalt Encephalopathy” or “ACE,” which is a collection of troubling mental symptoms he believes are caused by elevated metal levels in the blood and tissue. You can read more about Steven Tower’s discovery that high metal levels in the blood can cause serious neurological problems here.

Among other things, Dr. Tower’s study concluded:

• One million Americans could be at extreme risk for ACE from metal-on-metal artificial hips. The good news is that MoM hips are no longer actively marketed and sold; the bad news is that many individuals still have MoM hips in their bodies.
• Five to ten million individuals could be at some risk for ACE from metal-on-plastic hips. Few surgeons and fewer manufacturers are studying the health effects of metal-on-plastic hips.
• One million people could be at risk for ACE from shoulder replacements. Shoulder replacement surgeries use chrome-cobalt implants.

Dr. Tower’s Recommendations for Hip Replacement Surgery

If you read nothing else, read this: Steven Tower does not recommend any patient consent to hip replacement surgery involving components containing “any chrome-cobalt hip part.” This means that patients should never receive a MoM artificial hip, where the femoral head articulates with a metal acetabular cup or a metal liner. But Dr. Tower goes further than rejecting the M0M hip. He also believes that a hip replacement with any chrome-cobalt component should be avoided. Dr. Tower’s study on his patients indicates that many hip replacements using any chrome-cobalt part can increase metal levels in the blood and cause significant negative symptoms. This means that even if your orthopedic surgeon suggests a metal-on-plastic hip system, and the metal component is made from chrome-cobalt (and most of them are), you should avoid it.

Instead, Dr. Tower recommends a cemented stainless steel stem with a stainless steel head or a ceramic head along with a polyethylene (plastic) socket. For revision surgeries Dr. Tower recommends a Titanium stem with a ceramic head “articulating” with a polyethylene socket. In his work as an orthopedic surgeon, Dr. Tower does not implant artificial hips with any chrome cobalt components because “proven safe alternatives exist.”

Please note: I am not a doctor and this is not medical advice. This article represents my understanding of Steven Tower’s artificial hip study and recommendations. Dr. Tower has not affirmed the accuracy of this article, and if any mistake is made it is mine alone. As always, if you have medical questions about your hip, talk to your doctor. If you have legal questions, call me (919.830.5602).

The Bleeding Edge

is a remarkable film investigating the public health crisis caused by our current medical device industry. It examines the two main causes permitting the manufacture and sale of defective medical devices: corporate greed and inadequate FDA oversight. It is a tragic story, particularly when the film takes a close look at many of the actual victims of these harmful medical devices. It’s one thing to hear that the Essure birth control device has injured thousands of women; it’s quite another when you see a woman on screen explain how she has given up on her hope to find love because she can no longer have intercourse due to permanent internal injuries. It is deeply sad to hear these stories. And it may have you writing your member of congress. Which you should.

I urge you to check out the film. Here are a few key takeaways:

Medical Device Regulation and the FDA

The 1976 Medical Device Amendments Act (“MDA”) was a positive step forward for regulating medical devices and for protecting human health. However, over the years certain loopholes in the MDA have allowed medical device companies to run amuck. The worst of these loopholes is the 510(k) process, which I have written about extensively on this site. Under 510(k), a medical device company may avoid clinical testing and the “Pre-Market Approval” process if the company can show that the new device is “substantially equivalent” to a similar device already approved and on the market. This may sound benign–after all the products are equivalent–but it has allowed many inadequately tested and dangerous devices to hit the market. One of the best examples of this 510(k) failure is the metal-on-metal (MoM) artificial hip. Because the MoM hip was “substantially equivalent” to previous artificial hip systems, the FDA permitted several device companies to manufacture and sell MoM artificial hips. Turns out, in many cases the MoM construction allowed metals to grind and be released into the blood and tissue of patients, causing all kinds of problems, from severe leg pain to neurological symptoms. Check out this site for many articles on the MoM artificial hip.

According to The Bleeding Edge, in some cases a new medical device is approved under 510(k) because of its substantial equivalence to an existing product that has been recalled because of health concerns. The FDA has explained that, under 510(k), it does not look at the safety of the underlying medical device; rather, it simply examines whether the new product is “substantially equivalent” to the predicate product. If this sounds loony, then you are paying attention. As a former FDA commissioner noted in the documentary, “we built a system that doesn’t work.”

Dr. Stephen Tower and Metal-on-Metal Artificial Hips

If you have had a metal-on-metal artificial hip implanted, you should know the name Stephen Tower. Dr. Tower is an orthopedic surgeon who figures prominently in The Bleeding Edge. And he deserves the screen time. I first wrote about Dr. Tower in 2017 after I discovered a lecture he had given on the potential for neurological problems associated with increased cobalt levels caused by metal-on-metal artificial hips. Dr. Tower is in a unique position as a hip surgeon but also as a victim of a MoM hip replacement, the DePuy ASR MoM hip. After his hip replacement surgery, he suffered memory loss, ringing in his ears, tremors, and mood swings. He even trashed a hotel room. Dr. Tower discovered that the metal levels in his blood were causing these neurological symptoms. After revision surgery, his metal levels dropped and his symptoms disappeared.

The documentary looks at several of these harmful medical devices, from artificial hips to hernia mesh to the Essure birth control device. More importantly, it takes a long look at several of the victims of these devices. The human suffering is intense and hard to watch, but it is vitally important to see it.

What Should You Do If Facing a Medical Device Implant Surgery?

At the end of the film the producers list a few smart moves you should make if your doctor has advised you to have a medical device implanted:

1. Do your research on the device. Distrust the “newest innovation.” As Dr. Tower said, innovation is not always a good thing.
2. Get a second opinion. Trust me, this is a good idea. And you may be surprised how different is the opinion of the surgeon a mile up the street from your treating surgeon.
3. Ask your surgeon how many times he or she had done the surgery. In some surgeries, like the Smith & Nephew hip resurfacing technique, the surgeon is expected to practice the procedure hundreds of times before he or she performs the surgery on patients. Often doctors begin these procedures after just a few practice sessions. Which is scary.
4. Take a friend or family member with you to the hospital. Have them pay attention and advocate for you.
5. Find out whether your doctor was ever paid directly by a medical device company at openpaymentdata.cms.gov.

Disclaimer (However Mild)

The Bleeding Edge presents the medical device industry in a sharply critical light. The documentary “takes a position,” and the position is that for-profit corporations who develop and manufacture medical devices often push these devices into the market without adequate testing and guided too often by a profit motive. I happen to agree with this position. However, it’s no surprise that medical device companies have been pushing back on the film’s allegations. Bayer, for example, maker of Essure, “fact checks” The Bleeding Edge on its website. I encourage you to check it out it if you would like to read the company’s response to the documentary.

If you want to discuss The Bleeding Edge, or if you have a medical device that has caused you problems, give me call: (919) 830-5602.