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

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

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

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

Let’s start with the basics:

What Is an Artificial Hip Failure?

Artificial hips fail in several ways:

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

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

What Might Artificial Hip Failure Feel Like?

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

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

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

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

COVID-19 has altered everyone’s schedule. Schools, colleges, and restaurants have closed. Even courts have shut down for non-urgent hearings and trials. In June, Judge Catherine Blake, overseeing the Smith & Nephew Birmingham hip litigation, issued an amended Case Management Order to extend discovery deadlines and bellwether trial dates for the multidistrict litigation.

Remember the Smith & Nephew Birmingham hip MDL is moving forward on two tracks: one set of cases involve the BHR components that were used in hip resurfacing procedures, and a second set of cases (“THA Track”) involve those individuals who received Birmingham hip components as part of a total hip arthroplasty (THA). Let’s breakdown the recent schedule changes for each track:

BHR (Resurfacing) Track:

Amended Case Management Order No. 16 has rescheduled the first BHR bellwether trial for May 25, 2021 and the second bellwether for July 26, 2021. This means the new CMO has pushed these trials out six months. It’s disappointing that we won’t get our first Smith & Nephew jury verdict by the end of this year, but totally understandable in these unprecedented times.

Discovery is the sharing of documents, materials, information, and evidence between the plaintiffs and the defendant prior to trial. The close of “general liability fact discovery” for BHR Track cases is now July 15, 2020, and case-specific fact discovery will be completed by October 20, 2020.

Expert discovery deadlines for both sides, which includes expert disclosures, expert reports, and depositions, now stretch from July 15, 2020 to October 30, 2020.

For the cases chosen to be considered for bellwether trials, case specific discovery will now run from November 30, 2020 through February 5, 2021.

Motions often follow discovery. These motions may involve one side’s challenge of the validity of expert testimony, or the admissibility of certain evidence, or the science behind certain claims. In the Smith & Nephew litigation, these motions will now be filed beginning November 30, 2020, and hearings on these motions will continue through June 4, 2021.

THA (Total Hip Arthroplasty) Track:

Discovery for the THA Track cases chosen as possible bellwether cases will end on December 1, 2020. From there, plaintiffs and defendant will select two cases to be considered for bellwether trials. Any additional discovery for these four cases will continue until March 12, 2021. Judge Blake has stated that she will issue a separate scheduling order for the THA Trial cases down the road.

Finally, the coronavirus is even changing the way the law is practiced. Many depositions are now being handled through secure video conferencing (remote depositions). While in-person depositions remain the gold standard, remote/video depositions are now being pressed into service to encourage social distancing. Judge Blake issued CMO No. 17 to set forth guidelines for handling remote depositions. These things can be a bit clunky, such as when you are handing over several exhibits for the deponent (the person being asked questions under oath). CMO No. 17 attempts to provide guidance on these issues for the Smith & Nephew Birmingham litigation, including authorizing the use of a deposition “concierge” to help with technical issues and even to hand over exhibits.

In general I think video depositions are great. Setting aside the health advantages in a pandemic, video depositions cut down on travel and litigation expense. I believe the legal profession should always do whatever it can to reduce the costs of litigation, as these costs inevitably reduce net awards for plaintiffs. So that’s a small bit of good news. I suspect when this pandemic is behind us, many of the changes created by the need for social distancing will remain because it simply works better.

The Takeaway:

Multidistrict litigation involves hundreds and often thousands of individual plaintiffs, from all across the country, who have been injured in similar ways by a defective product. Even without a pandemic it takes years to corral this information, to try bellwether cases and to negotiate fair settlements. The COVID-19 pandemic has caused delays in the Smith & Nephew Birmingham hip litigation and will likely cause further delays. You should always be patient when you have a case in any MDL; now you must be especially patient.

As always, you can call me to discuss your potential case: (919) 830-5602. Good luck!

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.

Smith & Nephew Birmingham Hip

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

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

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

Stryker LFIT v40

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

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

DePuy Pinnacle and ASR

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

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

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

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

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

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

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

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

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

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

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

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

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

Smith & Nephew Mediation Scheduled for January 30, 2019

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

Trial Dates Scheduled

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

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

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

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

Smith & Nephew’s Birmingham Hip Resurfacing System

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

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

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

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

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

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

Federal Preemption and Product Liability

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

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

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

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

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

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

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

“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.