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.

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.

1995

In 1995, Dr. Graham Isaac released a short paper discussing the problems with metal-on-metal (MoM) artificial hips. Dr. Isaac explained how metal wear debris created from MoM hip joints was a serious problem because of poor design and manufacturing of the metal components. Dr. Isaac also stated that even with higher quality manufacturing and engineering techniques, the performance of MoM hip implants were as “unpredictable as ever, working well for a period of time before suffering catastrophic breakdown . . . accompanied by a release of a large volume of debris.” This paper and Depuy’s other internal documents suggest that Depuy Orthopaedics most likely knew of the MoM risk factors in 1995, twenty-two years ago, and ten years before the company began selling the Depuy ASR artificial hip. In fact, one doctor noted that Depuy needed “to be cautious of the legal/litigation issues and lawyers, etc…perception of metal debris and metal-ion release.” I wrote more about what Depuy may have known about the serious risks of the ASR hip here.

August 2005

In August 2005, the FDA approved the Depuy ASR artificial hip for sale by means of the 510(k) process. The FDA did not require the Depuy ASR hip to undergo clinical trials. This turned out to be a big mistake. In 2005, Depuy submitted a section 510(k) premarket notification of intent to market the Depuy ASR Hip. By representing to the FDA that the Depuy ASR hip’s design was “substantially equivalent” to other hip products on the market, Depuy was able to avoid the important safety review required for premarket approval under FDA regulation, including vital clinical trials.

August 24, 2010

After hundreds of reports of failures of the Depuy ASR MoM artificial hip in patients, Depuy Orthopaedics issued a worldwide recall of the Depuy ASR on August 24, 2010.

September 3, 2010

The Judicial Panel on Multidistrict Litigation (JPML) approved a multidistrict litigation site for injury claims involving the Depuy ASR. The MDL is situated in the Northern District of Ohio with Judge David Katz. After Judge Katz’s death, Judge Jeffrey Helmick was appointed to preside over the Depuy ASR MDL. (1:10-md-2197)

November 19, 2013

The first Depuy ASR hip Settlement Agreement was reached on November 19, 2013. The first settlement agreement required that a plaintiff had revision surgery on or before August 31, 2013. In the Agreement Depuy agreed to pay $2.5 billion dollars to settle thousands of claims.

March 2, 2015

The second settlement agreement was reached on March 2, 2015, which allowed participation in the settlement if a plaintiff received a revision surgery after August 31, 2013 but no later than January 31, 2015. The material terms in the second settlement agreement were the same as those in the first settlement.

March 3, 2017

On this date an extension of the second settlement agreement was reached. Let’s call it the “Third Settlement.” The Third Settlement covered people who were implanted with the Depuy ASR hip and underwent revision surgery between January 31, 2015 and February 15, 2017.

February 16, 2017

If you had revision surgery on this date or afterward, you (technically) do not qualify for participation in the Third Settlement. However, if you had revision surgery on February 16, 2017 or later, you should still be able to recover from Depuy, either in a Fourth Settlement or outside the MDL altogether. After all, you were injured by a failed medical device and were forced to undergo revision surgery (which should not have been necessary). Give me a call to discuss your revision surgery occurring after February 15, 2017.

July 19, 2017

This is the deadline to file a claim for participation in the Third Settlement. If you had revision surgery between January 31, 2015 and February 15, 2017, you have just a few weeks longer to enroll in the Third Settlement. Do not delay!

October 27, 2017

This is the deadline to file claims in the “Part B” portion of the Third Settlement. I wrote about Part B “Extraordinary Injury Fund” here and here and here, but briefly, Part B recognized “extraordinary injury” that followed Depuy ASR hip failure and provided extra compensation to people suffering from particularly bad results, such as heart attack, stroke, foot drop, pulmonary embolism, deep vein thrombosis, dislocation, or infection, and lost earnings.

August 24, 2020

This will be the ten-year anniversary of the date Depuy recalled the Depuy ASR artificial hip. After this date, I imagine it will be difficult to bring injury claims against Depuy Orthopaedics for the failure of the Depuy ASR, though some claims should still be viable depending on the timeline.

Please check this site for all kinds of information on the Depuy ASR hip, the Depuy Pinnacle hip, the Stryker and Smith & Nephew hips, and other MoM artificial hips that have harmed thousands and thousands of people all over the world. As always, good luck.

Depuy MoM Hip Implants: An Overview

Hip implants have been around for a long time. They can be made of various materials. Some older models use a polyethylene cup and a metal ball to create the artificial hip joint. While this combination works well, it’s not perfect. Engineers have looked for other materials to find a hip joint that can last longer with fewer adverse effects.

One attempted solution was to have both the cup and ball made out of metal, hence a metal-on-metal hip joint. However, the performance of these hip implants was even worse than joints that used polyethylene and metal. Problems with MoM hip implants included significant pain, bone loss, hip implant failure and metallosis.

As a result of these problems, thousands of lawsuits have sprung up, not just against Depuy, with its ASR and Pinnacle MoM implants, but other MoM hip implant manufacturers such as Biomet and Stryker. Many of the Depuy lawsuits have been consolidated into multi-district litigation, or MDL. A few initial bellwether trials involving the Depuy Pinnacle have resulted in massive verdicts against Depuy, which I wrote about here.

Basically, things have not been looking good for Depuy. And they just got worse.

more The Incriminating Documents

The Daily Telegraph recently published a story, based on internal documents recently made available, that show Depuy actually knew it had serious problems with its MoM hip implants for years. The company deliberately took steps to ignore the problems. The released documents include:

• A paper written by Graham Isaac, Ph.D., discussing problems with MoM hip implants.
• A letter from Dr. John F. Irving, MD, to Depuy’s head of US marketing (Paul Berman).
• Depuy corporate meeting minutes where Depuy executive met to discuss various topics, including MoM hip implants.
• Internal Depuy e-mail exchange discussing MoM hip implant problems.
• A July 2008 paper on the topic of MoM hip implant problems.

These papers are especially incriminating because they show what Depuy knew (or should have known) and when they knew it.

What Did Depuy Know?

In Dr. Graham Isaac’s paper, he explains how metal wear debris created from MoM hip joints were a serious problem due to poor design and manufacturing of the metal components. However, Dr. Isaac goes on to state that even with higher quality manufacturing and engineering techniques, the performance of MoM hip implants were still “as unpredictable as ever, working well for a period of time before suffering catastrophic breakdown…accompanied by a release of a large volume of debris.”

Dr. Isaac went on to conclude that metal-on-polyethylene hip implants performed significantly better than MoM implants. He also mentioned that using ceramics can produce hip implants that perform better than MoM hip implants.

In Dr. John Irving’s letter to Paul Berman, he spoke of his data collection which shows that Depuy’s MoM hip implants were dramatically underperforming other types of hip implants. When looking at metal-on-polyethylene hips from the last 10 years, Dr. Irving had a 1.2% failure rate, or eight revisions out of 660 hip implants.

Contrast this with Depuy’s MoM hip implants, where out of 262 implants, 31 required revision surgery. This was an 11.8% failure rate, almost 10 times that of the conventional metal-on-polyethylene hip implants.

As if that wasn’t bad enough for Depuy, Dr. Irving complained about Depuy’s “lack of attention and head-in-the-sand response to this problem.” Dr. Irving went on to state that “these products are harming patients,” that he “did not feel Depuy [was] doing enough to understand the extent of the Pinnacle MoM hip disease” and it would be “unethical to continue to market the product.”

And in 2010, when Depuy finally starting taking action with its MoM hip implants, there was an e-mail exchange among Depuy executives and experts acknowledging a “link to a failure pattern of the ASR XI to the Pinnacle with 36 mm heads when used with metal liners” and that “the problem may be widespread” with “evidence of metal on metal and ceramic on metal failings.”

There was also the recognition that when a hip implant failed, it was “sometimes catastrophic.” One of the e-mails ended with the belief that Depuy should “investigate and manage this growing problem.”

When Did Depuy Know?

So these internal documents go to what Depuy knew, but how long did Depuy know this? Corporate minutes show Depuy most likely knew of the MoM risks in 1995, over twenty years ago. One of the meeting’s attendees, Dr. Paul Peters, noted that Depuy needed “to be cautious of the legal/litigation issues and lawyers, etc…perception of metal debris and metal-ion release.”

Additional notes from the corporate minutes indicated that Depuy observed the following problems with MoM hip implants:

• Large volume of metal particles being released from the hip implants
• Metal ions being released into the body
• Poor wear results
• Metal scratches in the components taking the form of peaks and valleys (as opposed to just valleys, which would result in the hip implant lasting longer).

What Does All this Mean?

These documents appear to be from discovery in recent litigation concerning the Depuy Pinnacle hip implants, and they may have been used in Depuy Pinnacle bellwether trials. However, it’s somewhat unusual that these have been made public (by sources other than this website). The level of incriminating evidence contained in these documents is also quite unusual. If Depuy had all this information at its disposal more than twenty years ago, the injuries to patients who received the Depuy ASR and Depuy Pinnacle artificial hips in the years since then are particularly horrifying and egregious. I hope such bad publicity will further motivate Depuy to resolve its pending Depuy Pinnacle lawsuits as soon as possible.

*Note: The documents referenced and linked in this post are widely available from other news sources and were released prior to the publication of this article. The Daily Telegraph originally published “End Game” and other documents. I can not and do not verify the authenticity of these documents, nor can I confirm the truth of the statements made in the documents.

We are getting more clarity on the recent extension of the Settlement Agreement in the Depuy ASR artificial hip litigation. As I wrote about in a previous post, the ASR Settlement has now been extended to cover people implanted with the Depuy ASR hip who received a revision surgery between January 31, 2015 and February 15, 2017. This is an important development because up to this point the Settlement did not include any injured people who had undergone revision surgery after January 31, 2015. And this represented a lot of people.

Last week the Depuy ASR MDL executive committees sent correspondence with more clarification of the extension agreement. To make things easy, I am going to refer to this Depuy ASR extension agreement as the “Third Settlement” (because it follows two prior Settlement Agreements which had clearly defined terms and clearly defined deadlines).

Third Settlement Enrollment Deadlines

The deadline to enroll in the Third Settlement is now June 19, 2017. If you are representing yourself in the settlement, please mark this number on your calendar. If you have an attorney he or she should be ready with all documents and forms to enroll you by that time. Seriously, this is an important deadline, so don’t overlook it. Also, this deadline is a change from the first announcement of the Third Settlement; originally, the deadline was May 5, 2017. That has now been extended, so that’s a bit of good news.

The deadline to file claims in the “Part B” portion of the Third Settlement is October 27, 2017. I wrote about Part B “Extraordinary Injury Fund” here and here and here, but briefly, Part B recognized “extraordinary injury” that followed ASR hip failure, and provided additional compensation to people suffering from particularly bad results, such as heart attack, stroke, foot drop, pulmonary embolism, deep vein thrombosis, dislocation, or infection, and lost earnings.

“Future injuries,” which is defined under the Part B section of the master settlement agreement, will be those injuries that arise after September 1, 2017. If you do not have an attorney helping you, I urge you to read the settlement agreement carefully (even two or three times) so you do not miss any opportunities for Part B EIF compensation.

What If My Depuy ASR Revision Surgery Occurred Nine Years After Implant Surgery?

For the first time, the Third Settlement addresses the issue of a revision surgery that occurs more than nine years after the original Implant Surgery. Up to this point, the Depuy ASR settlement agreements did not recognize injury or provide compensation for revision surgeries beyond the nine-year anniversary. I wrote about the nine-year cut-off here. The Third Settlement appears to recognize this “blind spot” and provides an opportunity for patients who had revision surgeries between nine and ten years to receive compensation.

The Third Settlement will pay $50,000.00 for these nine-to-ten years claims, but the agreement also calls for additional compensation from the Part B EIF Fund of $50,000.00. So it appears that injured people who received revision surgeries between nine and ten years after implantation will receive a total of $100,000.00 in a Part A base award. These people will also be able to participate in Part B funding if they can show extraordinary injury.

For patients with revision surgery between eight and nine years, the Part A base award will be $125,000.00, with $25,000.00 provided by the EIF Fund.

This is a positive development, because it recognizes that with the passage of years, many victims are still going through revision surgeries, even beyond the eight or nine year anniversaries of the original surgeries. These people have been injured by the failure of the Depuy ASR hip system and should be compensated. The Third Settlement finally recognizes this group of injured people.

Remember that the Depuy ASR hip was recalled on August 24, 2010, almost seven years ago. So, for example, if you had the original implant surgery on March 21, 2008 but did not feel severe pain for six or seven years and did not undergo revision surgery until April 1, 2017, until now you would have no recognized claims under the settlement agreements. Now you do.

If you are attempting to handle this settlement by yourself (that is, without an attorney) you will need to keep up with all developments from the U.S. ASR Hip Settlement website operated by Brown Greer. Keep in mind that for pro se litigants (those people representing themselves) there is a 29% reduction in the overall settlement payment. If you would like help navigating your case, or the Depuy settlement, or if you just have general questions, you can call me at (919) 830-5602. Either way, good luck.