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Smith & Nephew Statute of Limitations Battles Begin This Week

Smith & Nephew’s BHR (Birmingham Hip Resurfacing) Statute of Limitations is a hotly debated issue for this week’s Federal Court hearing in Baltimore. There are over 500 filed cases in that Court, and many more yet to be filed, making this an extremely significant hearing. It will be the first time the MDL Judge considers this particular defense in regards to this defendant, but it will certainly not be the last. They will undoubtedly echo this strategy when the non-BHR cases head to trial in a couple years – in the same Court.

What is a Statute of Limitations? It is a major legal hurdle. Every state in America provides that there is a limited amount of time to bring your lawsuit once you have a right to file it. But there are some extenuating circumstances, and that is what will be debated this week. Basically, it is a moving target, and attorneys for both sides, under the Judge’s purview, will hash out the various arguments.

This week’s hearing involves Smith & Nephew asking the Court to throw out a few dozen BHR cases because they were filed questionably late. Smith & Nephew’s Motion, the Plaintiffs’ Response, and the company’s Reply are all in the “Hip Implant Legal Page” section of my website. They are easy to find because that page is in chronological order, and the filings all occurred recently.

It is very common to see this particular defense whenever there are a large number of plaintiffs, and this MDL is no exception. The basic argument is that the plaintiffs in each case knew they had a possible products liability lawsuit but that some waited too long to file. Smith & Nephew has analyzed the individual facts of each case and has identified the length of time available to file suit within each state’s Statute of Limitations. The company is asking the Court to throw out those barred by the Statute. This is serious business, because a case is OVER if it was filed too late.

Again, this argument requires a certain level of interpretation and is affected by various dynamics. For example, some medical device companies argue that the Statute of Limitations begins to run when the Plaintiff first had reason to believe there was a possible problem with the product. This could occur long before revision surgery, perhaps when the client first experienced an implant dislocation or an abnormally high metal level in his or her blood or simply due to recurrent ongoing pain. Smith & Nephew has focused on a later but more certain date – the date when the Plaintiff had surgery to revise the original implant. The company is arguing that every claim “accrues” or starts when the Plaintiff has revision surgery, and then is arguing for dismissal if the case wasn’t filed within the number of years allowed by that state’s Statute of Limitations.

This week, we will begin to learn how the MDL Judge will analyze these legal issues in the BHR cases, but it will likely be a forecast for non-BHR because Smith & Nephew will definitely raise these same defenses across the board. My prediction is that the Judge will throw out some BHR cases relatively quickly on the basis of being filed inarguably too late – too far outside the allowable time in a particular state. I predict “close calls” will go in favor of the Plaintiffs – for now. That said, one Federal Court recently threw out a hip implant case against Zimmer, Inc. that was filed just one day late – which is a little severe. It is a “bright line” legal issue, and while some Smith & Nephew cases will not make the cut, I predict most will.

The bottom line is this: Those who have had Smith & Nephew implants and are experiencing chronic issues, especially if they have already had revision surgery, must file inside the limited period of time for their state. If the deadline to file passes or is coming up soon, it will be difficult to convince an attorney to take your case or a judge to sympathize with the delay. Even if you are uncertain you have a viable case, find an attorney now. If you are reading this, chances are you believe your hip – or a loved one’s hip – has failed. The Statute of Limitations clock is ticking. Time is not on your side. There is literally no benefit to waiting, and acting quickly (i.e., now) could preserve your place in line!

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SMITH & NEPHEW HIP IMPLANT MID-YEAR UPDATE – PART 2

NATIONWIDE LITIGATION BEGINS AMID A RAPIDLY INCREASING NUMBER OF CASES

My last Blog promised an overview of the Smith & Nephew metal hip litigation at the halfway mark of 2018. Today I will highlight some of the key litigation events that have already happened nationwide this year, and I’ll also predict what is likely to occur in this rapidly expanding litigation for the rest of 2018.

There are two types of court systems in America, and there are cases filed against Smith & Nephew, regarding bad metal hip devices, in both. You have probably heard the expression, “Don’t make a Federal Case out of it!” Most people with lawsuits currently pending against Smith & Nephew are doing exactly that: filing their cases in Federal Court, apparently disregarding potentially beneficial state court alternatives. In my opinion, they are missing an opportunity. Let me explain.

FEDERAL COURT LITIGATION UPDATE.

If you have a metal on metal hip implant case filed against Smith & Nephew, then your case most likely is in Federal Court in Baltimore, Maryland. As of yesterday’s official update, there are currently 308 BHR (resurfacing) cases and 88 THA (total hip arthroplasty) cases in the “MDL” (the official grouping of federal cases).

New cases are filed weekly, and the MDL Judge continues to establish a framework for resolving the growing docket by holding monthly hearings, the next of which is tomorrow. The Agenda for tomorrow’s hearing in Baltimore contains just four entries: (1) “In Chambers Meeting”, (2) “Status of MDL filings”, (3) “Status of BHR discovery”, and (4) “Coordination and management of THA cases (including R3 cases).” Those are the same general topics that will probably be discussed in one form or another at all the remaining hearings in the MDL Court this year.

* The BHR Cases. The MDL Proceedings in Baltimore began with BHR cases in early 2017, and it looks like the Court is going to push them to trial first. The Court and parties are fully engaged in defining how the BHR cases will be litigated.

The BHR cases involve a relatively new “resurfacing” procedure that supposedly involves less bone loss than a traditional THA surgery.  It was FDA approved for marketing to “young people who might need a revision procedure later in life.” The vast majority of BHR Plaintiffs with cases are suing because they ended up needing a revision procedure later in life. A March 26, 2018 Memorandum Opinion from the MDL Judge limited the scope of valid claims involving this procedure and product, so current discussions seek to define how Plaintiffs will be allowed to develop their cases within this limited framework.

There is a tentative trial date of March 2020 for one or more of the BHR cases. No one, including the Judge, knows exactly how the first BHR case(s) will go to trial, but March 2020 in Baltimore appears to be a firm trial date – at least for now. Absent a settlement, that is apparently the soonest any BHR trial Plaintiff will see the inside of a Federal Courtroom.

* The “THA” Cases. Probably one of the biggest developments of 2018 for the Smith & Nephew cases in Federal Court was the inclusion of two additional types of Smith & Nephew hip cases. Both are THA cases, meaning there is an artificial femoral component that replaces the entire tip of the natural femoral bone as well as an acetabular component similar to the one used in resurfacing. Including these in the MDL came as a surprise to people familiar with these cases, because the Panel of Judges overseeing them had earlier ruled against their inclusion. The first THA cases were included in March 2018, and there has been a steady stream of new additions since then. The Federal Court THA cases are all in the MDL in Baltimore, and that’s probably where they’ll stay for years, absent a settlement.

* Smith & Nephew’s Defenses. The most recent Smith & Nephew Court filing was a weekly update that merely listed the number of THA and BHR cases pending in the MDL Court as of Monday of this week. There were three separate law firms and six separate lawyers representing Smith & Nephew on that one uncontested document. These firms comprise a team of very experienced product liability lawyers who are going to assert every reasonable defense imaginable against both the BHR and the THA cases. They will continue to assert defenses even when they lose them the first time around. For example, Smith & Nephew sought complete dismissal of all the BHR cases and lost, but I predict they will re-urge the same basic defenses at later stages of the BHR cases. The same approach will be taken with the Federal Court THA cases. There will be constant battles about dismissal of BHR and THA cases on numerous legal and factual grounds. And while Smith and Nephew will surely trim the plaintiffs’ claims in both sets of cases, I’m confident the MDL Plaintiffs will ultimately see their BHR and THA claims survive these attacks.

STATE COURT LITIGATION UPDATE.

People filing new cases against Smith & Nephew are not limited to Federal Court. There is also the State Court Option, which is what I have always strongly preferred. A few cases were filed in various state courts this year, and more are expected soon. For various reasons, there are far more cases in Federal Court than in State courts, but a brief overview of the State court cases is necessary here for the sake of completeness.

The Smith & Nephew cases in State courts are primarily centered in two places – Tennessee and Texas. The Tennessee cases are in Shelby County, the U.S. home base for Smith & Nephew. In addition, I personally filed two cases in Texas courts this month. They are not drawing as much attention as their Federal counterparts, but I think they serve an important purpose in the grand scheme of things. Because of these state-filed cases, numerous depositions have already been taken and many thousands of internal company documents have been collected, perused, and carefully dissected.

There may be a relatively small number of State court cases in comparison to the Federal Court cases, but their momentum shows no sign of slowing. While MDLs are notoriously sluggish due to the volume and scope, state court cases are frequently free of the burden of all that additional baggage, and that is often where the most valuable discovery takes place. So far, there have been more depositions taken in State court cases than in the MDL. There are exciting times ahead in State court litigation! Mark my words.

While there have been many cases filed and large jury verdicts won against its competitors, Smith & Nephew has managed to avoid trials involving metal on metal hips implants thus far, and its MDL is still relatively new. I predict that the company’s lucky streak is coming to an end. Plaintiffs’ lawyers have them on the run in Federal and state courts. As with any new movement, it takes time and patience to organize. But now the Plaintiffs’ attorneys all have a common goal: to hold Smith & Nephew accountable for their inferior products and to provide justice for our clients who were unfortunate enough to trust a dangerous product. 2018 has been a good year for people with cases against Smith & Nephew, and the next year or so will probably be even better as we learn the inside story about how this company sold inferior metal hip products in America. I will be there asking questions of company witnesses and reading company documents, and I’ll continue to share some of that information here.

If you have any questions or comments about this or any of my blogs, contact me through the online forms at KipPetroff.com. Use the Contact Form for general questions, and use the Hip Implant Questionnaire if you have specific questions about your individual hip implant situation.

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SMITH & NEPHEW HIP IMPLANT LAW SUITS: A MID-YEAR UPDATE

The year 2018 has been the most active year yet in litigation involving Smith & Nephew metal hip implant cases, and we’re only halfway! There have been a number of fascinating developments, and with the increased volume of cases, there is also an increase in misinformation. Many people, including lawyers, are still confused about which types of cases are the best ones and why. I can help clear up the confusion.

In my Blogs this summer, I will share my Smith & Nephew experiences and keep readers up to date with a convenient one-stop resource for everyone, including victims of the bad devices and fellow lawyers. Public and private comments are welcome, and I will try to answer every question.

Why should a hip implant victim listen to me? Because I know the time, consideration, and emotion involved in each step of the process, from having the surgery to recovery and physical therapy to the uncertainty that accompanies each discomfort afterward. I’m a former athlete with three implants myself – both knees and a full, ten piece lower back.

And I’m a Plaintiff’s lawyer (meaning a victims’ advocate) representing those with Smith & Nephew metal hip complaints – and I’m one of the few lawyers actively working to develop individual cases against this company. There are only a handful of lawyers who are actively litigating these cases on an individual basis, and currently, my experiences – in both state and federal court – are the most diverse and among the most successful. I understand this company’s methods and can make reasonable predictions about what is likely to happen next. A Federal Court of Appeals ruled in my favor last year in a Smith & Nephew case, and I successfully procured almost a dozen depositions of Smith & Nephew witnesses in three other cases. And in April, I argued a Motion in the “MDL Court” in Baltimore. I covered a lot of Smith & Nephew ground in the last couple years. I am 100% committed to the litigation and to seeing this company do what is right for its consumers.

SMITH & NEPHEW HIP CASES.

The first thing you need to know about any medical device case is the exact brand of your implant. The laws that apply to your case will be vastly different depending on the brand and the construction. For example, a plaintiff with a device that received full FDA premarket approval or clearance will have a tougher time in court than one whose product was never FDA approved at all.

Smith & Nephew has hundreds of cases filed against them involving their FDA approved hip resurfacing device, and there are dozens of cases involving two types of metal devices that did not have approval. It is easy to tell the difference, if you know what you are looking for, and it is crucial to understand this before you start investigating the possibility of a lawsuit. The product brand and its regulatory history are the most determinative factors in predicting success.

If you don’t know your product, I can help. Stop right here and contact me using my online contact form, as the remainder of my blogs are written under the assumption that readers or their clients have a Smith & Nephew metal hip implant.

My goal is to provide you with as much useful information as possible to help you understand your case and eventually resolve your complaint. Start by reading Chicago Bet the Company Seminar,  a paper I wrote for a speech I gave to a group of lawyers in Chicago in May. Take a look around my website for other information about Smith & Nephew, including historical company documents of interest and a comprehensive time line that will put your potential case in context.

And please stay tuned for my next few blogs, keeping clients and attorneys apprised of Smith & Nephew developments so far this year. I will provide updates as they occur, and will make predictions about this massive corporation’s next self-serving moves.

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Chicago “Bet the Company” MDL Seminar + What’s So Special About Smith & Nephew Metal Hip Implant Cases?

There is a new type of metal on metal hip implant case recently sent to the Smith & Nephew MDL that is among the strongest products liability cases being litigated today. It is a metal on metal hip implant construct involving Smith & Nephew metal parts that were never approved for use together. A similar Smith & Nephew part is likely to be included in this MDL any minute now, thereby making the Smith & Nephew MDL a relatively new MDL as hip implant MDLs go. These new cases highlight some of the factors that can make or break any products liability personal injury case. It is useful to consider this information even if you are not currently defending or prosecuting any Smith & Nephew hip implant cases.

The Smith & Nephew cases described here involve products that couldn’t gain FDA marketing clearance despite multiple attempts and submissions to the FDA over a four-year period. A meeting was held with FDA officials and the company hired outside experts on FDA matters, but the company still failed to convince the FDA. The company sold the devices anyway.

 

To view this article in PDF format and to view all attachments, please view the PDF version here.

 

  • HOW TO SPOT A GOOD PRODUCTS LIABILITY CASE.

All products liability cases involve the age old, three-part question about the company’s
knowledge and product-related conduct:

  1. What did the company know?
  2. When did they know it?
  3. What did they do about it?

Seems like every discussion about products liability cases eventually turns to these three questions. I have used this exact trilogy of questions when it helps me at trial, and Zimmer, Inc. used it successfully against me in a hip implant trial last year. Whether you represent Plaintiffs or Defendants, the answers provide a good, common sense framework for assessing the facts and your likely success with any particular products liability case. The Judge, jury, and your opponent have likely already begun framing their own conclusions.

With the above three questions in mind, consider what Smith & Nephew executives at the highest levels of the company knew about their metal on metal hip implants and what they did about it when they learned it.

 

  • BACKGROUND OF SMITH & NEPHEW HIP IMPLANTS.

In the past several years, there have been many thousands of product liability lawsuits filed in U.S. courts claiming medical problems from allegedly defective metal on metal hip implants. The following brief history will demonstrate what most of us already know – metal on metal hip implant cases can make for a good trial story. Several MDLs have been established for metal on metal hip implant cases against Zimmer, DePuy, Stryker, Wright Medical, and Biomet. The organization of these MDLs occurred while the FDA was acquiring knowledge and voicing increased concern about the emerging medical problems associated with this class of implantable metal medical device. The FDA began a process in 2011 that resulted in a Final Order on February 18, 2016 that essentially banned metal on metal hip implants from the total hip replacement market in this country. Thousands of cases have settled as part of the MDL process and some have been resolved in other ways, but more than ten thousand metal on metal hip implant cases are still on file in Federal and state courts today. Many thousands of people have  suffered significant injuries because of metallosis and other serious health problems directly linked to this dubious class of metal medical device. Revision surgeries involving metal on metal hip implants continue to occur at an alarming rate.

A newcomer to the hip implant MDLs is Smith & Nephew, Inc. The Smith & Nephew MDL wasn’t even created until March of last year, and the cases discussed below were only added to MDL 2775 beginning in January of this year. Lawyers with experience in the other hip implant MDLs may find the significant differences between their cases and the Smith & Nephew cases intriguing. A quick review of the products involved in MDL 2775 will make it easier to recognize what makes the Smith & Nephew total hip arthroplasty cases different from the others.

MDL No. 2775 is formally known as the “Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, MDL 17-MD-2775.” It is pending in front of Senior Judge Catherine C. Blake in the U.S. District Court in Baltimore, Maryland. A detailed discussion of the background of the Smith & Nephew MDL can be found in Judge Blake’s March 26, 2018 written opinion concerning Smith & Nephew’s Motion to Dismiss. See Memorandum, In re: Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, CCB-17-2775, Document 608 (D. Md. Mar. 26, 2018). This MDL Memorandum Order is recommended reading for anyone with Smith & Nephew metal hip cases in the MDL or in state court.

MDL 2775 now involves two types of Smith & Nephew hip implant cases with another one soon to be included. The two new ones involve a combination of metal parts that the FDA never approved or cleared at all [The term, “approved” means the device reached the market through the premarket approval process in the Medical Device Amendments of 1976, 21 U.S.C. sec. 360c et seq and “cleared” means the FDA determined under 21 U.S.C. sec. 510(k) that the device was substantially equivalent to devices already on the market in 1976. See generally, Medtronic v. Lohr, 116 S. Ct. 2240 (1996); Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008)]. This alone makes MDL 2775 unusual, because other hip implant MDLs have primarily involved a company’s integrated product system that received FDA approval or clearance. The two devices already involved in MDL 2775 are as follows:

  • Birmingham Hip Resurfacing Device: Commonly referred to by its abbreviation “BHR,” this device is what is shown in the left hip in the illustration below. It is not considered a “traditional” total hip arthroplasty because it only resurfaces, or shaves down, the femoral head instead of replacing the entire femoral head and neck. It was FDA-approved under PMA number P040033 on May 9, 2006.
  • Modular Femoral (Hemi) Head and Modular Sleeve: These two metal parts mated together and were sold and marketed in Europe and Australia as the main components of the Birmingham Hip Modular Head System. The head and sleeve were never cleared or approved for total hip arthroplasties, but this device was used almost exclusively in the U.S. off-label for that surgery.

A third product, the Smith & Nephew R3 Acetabular System metal liner, is likely to be included in the MDL soon. The metal liner was approved on November 13, 2008 as PMA supplement S006 to the BHR. The metal liner was never approved in the U.S. for use in traditional total hip arthroplasties, but the vast majority of them were used for that surgery. The analysis below does not change whether the liner is or is not included in the MDL, because the “modular femoral (hemi) head” is the same with or without the liner.

The illustration below from a Smith & Nephew Power Point depicts the difference between the two surgeries. The one on the left is the BHR and the one on the right is the THA.

 

smith-and-nephew-hip-implant-illustration

 

The most notable difference is the large spike-like stem in the THA on the right.

For the first year of its existence, MDL 2775 was a single product affair, involving only the BHR hip resurfacing cases. The MDL Panel not only consolidated all the Birmingham Hip Resurfacing (BHR) cases into one MDL in early 2017, but the Panel also expressly declined to include S&N’s Total Hip Arthroplasty (“THA”) cases. This MDL remained a single product case until January 2018 when the MDL Panel began sending THA cases to Baltimore. It now involves the resurfacing and THA cases involving the BHR cup, and it will probably include the R3 Metal Liner cases before long. There are 318 cases currently in this MDL, according to the “Notice of Filing Updated Listings of Pending BHR Track and THA Track Cases” filed on May 21, 2018, with 264 described as “BHR” cases and 54 listed as “THA” cases. New cases are currently being filed in or transferred to this MDL almost every day.

 

  • REGULATORY SHENANIGANS.

The regulatory history of the Smith & Nephew metal hip devices is unique in metal-onmetal hip litigation for at least two reasons. Unlike other hip implant MDLs, there is no FDA cleared total hip replacement or resurfacing system involved. There is no name for the configuration of THA implants involved in this MDL because the company was unable to obtain clearance for a metal on metal total hip implant system. The parties and the MDL Court just call them “THA cases”, referring to the generic name for the surgery as opposed to an actual legally marketed product. The case is also unusual because the FDA expressly rejected the femoral part of the THA metal parts involved in this MDL. The company obviously knew this when it happened, but what they did about it is probably what got them into MDL 2775.

The FDA refused to allow Smith & Nephew to market their THA device three separate times from 2005 to 2010. Many of us have handled cases involving implantable devices that were FDA approved or FDA cleared, and some might have even handled cases involving hybrid devices that were part approved and part cleared. Issues of the prescribing doctor’s off label use of the drug or device frequently permeate many of our pharmaceutical cases. But the Smith & Nephew metal on metal total hip arthroplasty cases always involve a rare four-part combination in each surgery of the following: (1) parts approved by the FDA’s premarket approval process, (2) parts cleared by the FDA’s premarket 510(k) notification process, (3) surgeon use of the parts in unapproved ways, and (4) parts that the FDA specifically refused to allow for sale in this country – three separate times. Sparks are going to fly whenever a case involves all these conflicting elements, and the Smith & Nephew total hip replacement cases will be no exception. The next section of this paper will briefly explain how all these facts have resulted in a remarkably troublesome case for Smith & Nephew. The Smith & Nephew THA cases will undoubtedly present unique factual and legal questions as they work their way through our court systems.Numerous FDA “No Sell”

1. Numerous FDA “No Sell” Letters.

It goes without saying that you cannot properly analyze a products liability case without first determining how the offending product got on the road, in the air, in your home, or on hospital shelves. This is usually easy to determine, especially if the product was expressly approved by the governing body. Of course, in a regulated society the product is usually on the market legally. In my experience, it is very rare to find a products liability case where the product itself was not even allowed on the market. But that’s what we seem to have in the Smith & Nephew THA cases.

Starting as early as 2005, Smith & Nephew began efforts to gain FDA clearance for a traditional THA system in the U.S. Its first 510(k) application for this involved a product called the “Birmingham Hip Modular Head System.” This application was filed on October 4, 2005. The FDA assigned it file number K052808. It was intended to be marketed both for primary (e.g. first) traditional hip arthroplasty procedures and as a revision option for failed BHRs. The FDA confirmed receipt of the premarket notification and included this written warning: “YOU MAY NOT PLACE THIS DEVICE INTO COMMERCIAL DISTRIBUTION UNTIL YOU RECEIVE A LETTER FROM FDA ALLOWING YOU TO DO SO.” Letter from FDA to Smith & Nephew, at 1 (Oct. 4, 2005), emphasis in original. I call this a “No Sell” letter. All manufacturers understand that they cannot sell a product involved in FDA premarket notification activities unless and until the FDA issues a written determination allowing it [Attached to this paper are a few of the No Sell letters for the very Smith & Nephew products involved in the “THA Track” of MDL 2775. These are just samples and there are more, but this will give you the idea. See the PDF version of this document for all attachments.]

Two months later, the FDA concluded that it was unable to determine that the Birmingham Hip Modular Head System was substantially equivalent to the predicate devices in the 510(k) application. The FDA explained that there was a lack of clinical data supporting the device, noting that it disagreed with Smith & Nephew’s attempt to rely on BHR clinical data for its THA submission. The FDA further explained that “the clinical data for a resurfacing hip prosthesis can not be used to predict the safety and effectiveness of a total hip prosthesis.” K052808. Letter from FDA to Smith & Nephew, at 1 (Dec. 12, 2005). The FDA basically rejected all the clinical data the company offered. The FDA even suggested that the application might be better suited as a supplement to the BHR. The FDA issued another No Sell letter. Smith & Nephew withdrew K052808 on March 1, 2006, and the FDA issued yet another No Sell letter.

Smith & Nephew had hit a THA dead-end with the FDA after failing to gain FDA clearance for the Birmingham Hip Modular Head System. It decided to approach the problem one component part at a time. On May 1, 2006, Smith & Nephew filed a 510(k) application for a “monoblock” femoral head. It was assigned 510(k) number K061243, and the FDA cleared the device on July 17, 2006, but only for use in hemi-arthroplasties. An application for the “Modular Femoral (Hemi) Head” was filed a month later, on August 17, 2006. (K062408) The FDA granted that application on September 12, 2006. These two applications for 510(k) premarket clearances were granted only for “hemiarthroplasty” procedures, where the metal femoral head articulates only against natural bone. Again, the metal femoral head used in the Smith & Nephew THA cases in MDL 2775 was never approved or cleared for THA procedures. A hemiarthroplasty can never be a metal on metal hip device, and none of the cases in the MDL should ever involve this procedure. This is important because every Smith & Nephew metal on metal THA case involves a femoral component that was only cleared for a hemiarthroplasty.

The illustration below 3 depicts the difference between a hemiarthroplasty and a total hip arthroplasty.

hip-replacement-illustration

Source: India Health Help, http://Russian.indiahealthhelp.com/procedure/hip-arthroplasty/ (last visited May 22, 2018).

The most notable difference in the above illustrations is that the hemiarthroplasty does not have any artificial acetabular component.

Around this same time, on July 28, 2006, Smith & Nephew filed a second 510(k) application for the Birmingham Hip Modular Head System (K062189). Soon thereafter, the FDA issued a ten page No Sell letter and advised Smith & Nephew that it still couldn’t determine whether the device was substantially equivalent to the predicate devices. The FDA’s concerns with the clinical data for this application were similar to its concerns with the first application; the long list of deficiencies included criticisms about the investigative site’s location and investigator, and noted that the study had no “clear patient inclusion/exclusion criteria.” Letter from FDA to Smith & Nephew re: FDA’s K062189, at 1 (Oct. 25, 2006). The FDA also found that there was a significant amount of missing data, id. at 2, and the FDA recommended that an application for this device for a THA should “be submitted as a PMA supplement” to the BHR. Id. at 9. Rather than curing the deficiencies in the No Sell letter, Smith & Nephew withdrew its 510(k) application on March 21, 2007, and the FDA issued yet another No Sell letter.

Smith & Nephew was not so quick to file its third 510(k) application for a THA system, waiting until after it launched its R3 Acetabular System and secured PMA approval for the R3 Metal Liner for use as part of the BHR. However, Smith & Nephew filed another 510(k) application for the Birmingham Hip Modular Head System on October 1, 2009 (K093095). Unsurprisingly, the FDA issued another lengthy No Sell letter and again told Smith & Nephew that it was unable to determine substantial equivalence. Like clockwork, Smith & Nephew withdrew its 510(k) application a few months later, on February 24, 2010. The FDA issued yet another No Sell letter.

There were about a dozen No Sell letters issued for Smith & Nephew’s THA metal on metal hip products eventually. Smith & Nephew stopped trying to obtain clearance for these components for use in total hip arthroplasties after their third failure. All of the No Sell letters involve the same femoral head that is in all the Smith & Nephew metal on metal THA cases. After years of trying and after collecting a dozen or so No Sell letters, Smith & Nephew abandoned its efforts to obtain FDA clearance or approval to sell the combination of metal parts used in its THA cases.

2. Sell Despite No Sell Letters.

It is important to emphasize that use of these devices for unapproved THA surgeries was not rare or isolated. The most frequent use for the modular femoral head was off-label as part of metal-on-metal total hip arthroplasties, usually articulating against either the R3 Metal Liner or an unlined BHR acetabular cup. That is how they are almost always used if they are used in a metal-on-metal THA. The company knew their THA product was not approved and had been expressly rejected three times by early 2010, but the company still distributed the parts for these uses. Unable to lawfully promote the parts for THA surgeries, they employed a business model similar to a politician engaging strictly in negative politics. Among other tactics, they employed a sales campaign known as “Take the Gloves Off,” which allowed the sales reps to vigorously criticize the competition, but strictly prohibited them from saying anything positive about their own products.

It should not be surprising that Smith & Nephew’s commission-based sales reps complained when they had to meet quotas but didn’t have a full line of products they could sell their customers. Internal company documents show sales reps nationwide complaining and asking when they would finally be allowed to sell a metal-on-metal THA product. Some hospitals wouldn’t even discuss THA implants with the Smith & Nephew sales reps due to lack of FDA cleared hip devices. The pressure on sales reps to quietly promote the hemiarthroplasty head for unapproved THA surgeries was enormous. I know of at least two surgeons who have testified that the Smith & Nephew sales reps did exactly that.

An integral part of Smith & Nephew’s sales campaign also involved keeping the foregoing regulatory history from the doctors and sales reps. Smith & Nephew usually did not inform surgeons and sales reps of this dubious regulatory history. You will probably never meet a surgeon or sales rep who admits they knew these regulatory facts at the time a Smith & Nephew THA surgery occurred. Smith & Nephew, Inc. executives in Memphis, Tennessee and at the home office in the United Kingdom knew these facts. The doctors and sales reps did not know them. Of course, the patients did not know either.

3. FDA Reclassification of Metal Hip Implants.

An implanting surgeon in one of my Smith & Nephew cases testified that the metal on metal hip situation in America was a “human experiment.” It was a failed experiment by all accounts, but Smith & Nephew wasn’t even allowed to participate in this failed “experiment.” According to the FDA’s website [U.S. Food & Drug Administration, Metal-on-Metal Hip Implant Systems, (Dec. 28, 2017).], “as of Nov. 30, 2012, the FDA had cleared 190 submissions for metal-on-metal hip replacement systems.” The FDA could probably be criticized for allowing so many metal on metal hip systems to easily slip through its regulatory system, but no one can say they let Smith & Nephew slip by. The FDA did what they could to stop Smith & Nephew, but it wasn’t enough, and that’s why there’s a new “THA Track” for the Smith & Nephew MDL.

 

CONCLUSION

The metal liner that will probably soon be involved in the Smith & Nephew MDL was recalled from the U.S. market for safety reasons in 2012 and the modular femoral head already in the MDL was withdrawn for safety reasons in 2015. The FDA issued more than a dozen No Sell letters in response to Smith & Nephew’s repeated efforts over four + years to secure clearance to market a metal-on-metal THA hip product in this country. They probably thought they had stopped Smith & Nephew with all their No Sell letters over the years, but the existence of 50 + THA cases already on file in MDL 2775 suggests otherwise.

All of the documents referenced in this paper are available on this website at https://www.kippetroff.com/smith-and-nephew-hip-implant-legal-information/. You can also email me using the convenient online contact form here, or call me at (972) 294-7530 with any questions.

 

To view this article in PDF format and to view all attachments, please view the PDF version here.

 

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Smith & Nephew Hip Implant Litigation Website Launched Today

Today is the day I launch my new website. It is dedicated to highlighting the metal on metal hip implant products and related conduct of Smith & Nephew, a multibillion-dollar medical device company from the United Kingdom. I looked around for websites that discussed Smith & Nephew, and I couldn’t find any resources that were helpful. That’s one reason I’m dedicating my new website to this company’s metal hip implants and the ongoing litigation against them nationwide.

 

    • Why Smith & Nephew? I have spent most of the last three years working on personal injury cases involving Smith & Nephew hip implants, and that has given me the chance to get to know this company. What I’ve learned is shocking. This website will focus on some of the ways that Smith & Nephew has manipulated our regulatory and legal system in this country over the years. The new pages today provide only a rough outline of what is to come. I will add to this reference library regularly. My goal is to provide an online library of regulatory and legal information about this company and their metal-on-metal hip implants that have harmed and continue to harm many people nationwide on a regular basis.
    • What’s in the website? My new website has many features that will make it easy to understand why I’m so interested in tracking this company. I will preview some of my favorite features here.
    • Timeline. One of my favorite new features is a Smith & Nephew timeline that begins with the FDA’s first classification meeting over metal-on-metal hip implants in 2001 and ends with the FDA issuing its final order regulating metal-on-metal hips in 2016. In between is a detailed account of what Smith & Nephew did to get its metal-on-metal hip portfolio cleared in the U.S. and when it began pulling these disastrous devices from the market. It is color coded based on the topics covered. For example, purple is regulatory and orange is for tracking this company’s criminal activities involving their hip implants.  Make sure to expand the timeline to see it better. There is more information there than you may realize.
    • Court Documents and Filings. I will gather and comment on some of my favorite court documents in this section of the “Smith & Nephew Legal Page.” There are so many to choose from! I will add to this page regularly.
    • Criminal Proceedings. Smith & Nephew got in trouble for the way they sold their hip implants in the U.S. and internationally. They paid more than one hundred million dollars in fines and had to agree to several years of direct regulatory oversight to avoid more serious criminal punishment. Read about it in the “Criminal Proceedings” section of the “Smith & Nephew Legal Page.”
    • Regulatory Shenanigans. Smith & Nephew is a company that had difficulty convincing the FDA to clear their metal hip implant systems for sale in this country. The documents in the “Regulatory Violations” section of the “Smith & Nephew Legal Page” will focus on some of the company’s unsuccessful attempts to obtain clearance for their metal on metal hip implant systems. The company followed the same pattern of (1) filing an application for clearance, followed by (2) failure, then (3) asking for more time, and then (4) withdrawing the application rather than complying with FDA requirements. The company tried to obtain clearance in this manner for their metal on metal hip system three times over five-plus years but met failure each time. But that didn’t stop Smith & Nephew from selling their hip implants anyway. I will explain how they did that in future pages on this website.
  • Comments? Questions? I hope this new website is useful and informative. I welcome feedback, good or bad, about these pages. Use my online contact form to provide feedback, questions, or ideas for future Smith & Nephew topics to discuss here.
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SMITH & NEPHEW LOSES ANOTHER FEDERAL COURT APPEAL INVOLVING METAL HIP IMPLANTS

Yesterday was a good day for people fighting Smith & Nephew over defective metal on metal hip implants. On March 1, 2018, the U. S. Circuit Court of Appeals in Philadelphia ruled in favor of the consumers in Walter and Vivian Shuker v. Smith & Nephew. Sickened by the implants he received in 2009, Mr. Shuker’s case landed in the Federal appeals court process, where I watched it for the past two + years. The good guys won yesterday, and it spells trouble for Smith & Nephew, an overseas company with a reputation for selling harmful, unapproved hip implants.

  • Unapproved Hip Parts.

Mr. Shuker’s metal on metal implant case was unusual for many reasons. For one, the Food and Drug Administration (FDA) officially weighed in on the legal arguments and actually filed a brief in Federal court. Secondly, it involved a combination of metal parts that received FDA clearances through two entirely different regulatory classification systems. The specific combination of Smith & Nephew parts in this case involved an “R3 Shell and Liner”, a femoral head, and a stem that connected the metal head to the thighbone. The metal liner was FDA approved as a “Class III device”, meaning it supposedly underwent a rigorous pre-market approval process. The other parts, however, all were cleared as Class II devices, involving a much more lenient process.

In the end, the Third Circuit ruled that the Shukers should have a chance to prove that Smith & Nephew is legally responsible for injuries caused by the unapproved device combo.  But it hasn’t been smooth sailing. Far from it! While Smith & Nephew must face the Shukers’ claims for negligently promoting this combination of parts for use together, the Court threw out claims for strict products liability, breach of warranty, and general negligence.  But after more than four years of waiting, this victory should be encouraging for all people with failing Smith & Nephew hip implants!

  • Trouble for Smith & Nephew.

The Shuker case is similar to another case against Smith & Nephew, Joe Mink v. Smith & Nephew, Inc. In 2017, I presented oral argument in the Mink case in the U. S. Circuit Court of Appeals in Miami. Mink and Shuker are unique in that, to date, they are the only two Federal Appeals Court metal on metal hip implant cases in the country decided against Smith & Nephew. It is doubtful they will remain alone! Smith & Nephew’s unapproved metal on metal hip implants used for hip replacements are failing at an alarming rate.  New cases are being filed against this company weekly and nationwide. There is an active and growing mass of Smith & Nephew cases in Baltimore Federal Court in MDL # 2775.

Smith & Nephew, Inc. is a Tennessee company whose parent company, Smith & Nephew, plc, is an international, multi-billion-dollar enterprise based in the United Kingdom. Smith & Nephew’s disdain for the FDA is apparent, leaving in its profitable wake failure after failure after failure. For three years, I’ve devoted myself practically full-time to seeking justice for those injured by this British company’s arrogance. For various reasons that I’ll explain in future blogs, Smith & Nephew has managed to largely avoid the costly nationwide litigation that ensnared its competitors in the metal hip implant industry. Yesterday’s win in Philadelphia is especially encouraging, signaling a new era of accountability.

  • No more FDA Shenanigans.

In 2016, the FDA finally changed regulatory requirements in this country for manufacturers of metal hip systems used for total hip replacements. (See “METAL HIP IMPLANT MAKERS STOP SELLING PRODUCTS RATHER THAN PROVE THEY ARE SAFE”, posted on March 8, 2016). The FDA had previously allowed metal hip implants to be sold in this country via a regulatory “fast track” loophole, but growing concern about their safety and effectiveness resulted in the FDA basically closing that loophole for good in May 2016. The FDA gave the companies more than three years advance notice and then issued an Order requiring them to quit selling the devices or prove they were safe by May of 2016. I predicted in early 2016 that none of the hip implant makers would try to prove their products were safe and effective, and I was right. The companies all chose to quietly discontinue selling their metal hip replacement systems as soon as the FDA required them to prove they were safe and effective.

Smith & Nephew, however, was able to avoid FDA scrutiny of their metal hips because the company never obtained approval to sell a metal on metal hip replacement system in the first place. The companies that legally sold FDA-cleared implants had to undergo the expense and embarrassment of publicly withdrawing their bad products. But in an ironic and twisted turn of events, Smith & Nephew was exempt from complying with the FDA’s orders because it had never obtained approval to sell metal on metal hip replacements in the first place. The one company that never obtained approval was also the only company that did not have to comply with the May 2016 deadline.

And so, while yesterday was a banner day, signaling a new era of accountability, it is still just the beginning. Other hip implant manufacturers have been paying significant settlement money for hip implant injuries for years, but Smith & Nephew has managed to benefit from its unique position of non-approval and non-regulation … until recently. I predict Smith & Nephew, a British mega-company that routinely engages in regulatory shenanigans in this country, will pay a hefty price for their smugness. And when it happens, I’ll be there to tell you I predicted it all.

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HOW TO SPOT THE RIGHT LAWYER FOR YOUR PERSONAL INJURY CASE

HOW TO SPOT THE RIGHT LAWYER FOR YOUR PERSONAL INJURY CASE.

My friend was looking for a lawyer for a business dispute and was at a loss. She didn’t know who to hire or how to even get started looking, so she began by asking me. I pointed her in the right direction, but her quest made me realize that most people – those who don’t practice law – lack the resources to find good legal counsel.

So how does a non-lawyer determine who is a qualified candidate for their particular case? Of course, you can’t get all the information for your decision in this Blog, but I’ll try to help with some general questions and considerations that apply to most cases.

General Considerations. Does your case involve a fairly typical fact pattern, like an automobile intersection collision? Or does it involve some unusual legal issue? Is yours the type of case where you want a local lawyer or is there some strategic benefit to having a lawyer nearer where the lawsuit might be filed? Are you looking for a specialist? Do you want to pay by the hour or are you more comfortable with a contingent fee?

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METAL ON METAL HIP IMPLANT PATIENTS NEED TO KNOW THIS!

I don’t like drug and medical device companies that cheat or make bad products, and it looks to me like the manufacturers of metal on metal hip implants are some of the biggest cheaters and have made some of the worst medical products ever. A Dallas, Texas jury apparently agreed with me, and last week unanimously found that a subsidiary of Johnson & Johnson, the baby powder people, sold defectively designed metal on metal hip implants that significantly harmed five people. The jury awarded more than $400 million in punitive and compensatory damages against Johnson & Johnson and its subsidiary after a ten-week trial. I watched almost every day of that trial, and I came away with a good understanding of how bad these particular medical products are and how much harm they can cause. I also know that far too many people are unaware of the silent harm that these products can cause. This is because the manufacturers, the government, and far too many doctors don’t publicize when bad products, like metal on metal hip implants, are unleashed on the public.

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METAL HIP IMPLANT MAKERS STOP SELLING PRODUCTS RATHER THAN PROVE THEY ARE SAFE

One of my previous blogs mentioned that medical device makers could learn something from frozen food manufacturers who seem more concerned about customer safety than about company brand and damage control. I suggested that two ice cream makers caught up in a Listeria crisis last year exhibited more compassion and common sense than most medical device makers when it came time to pull bad products from store shelves.

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Medical Device Makers should follow Frozen Treat Makers’ Recall Strategy

Two makers of ice cream and frozen yogurt products issued voluntary recalls of ALL their frozen treats this week amid fears of potential listeria contamination. This has provided a glimpse into the way two different frozen food companies have contemporaneously handled similar product safety crises, and it also offers a chance to highlight how irresponsibly and unprofessionally some medical device companies handle their own product safety disasters. There will undoubtedly be some who will criticize the frozen treat companies for being too slow or not responsive enough to their respective crises, but even those critics would have to agree that medical device companies could learn from following the frozen treat companies’ recall strategies.

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