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Kip Petroff to speak at MDL Mass Torts Seminar

The Mass Tort Litigation Landscape—A Critical Analysis MDL Conference + Don’t Shoot from the Hip: Navigating Medical Device Mass Torts in Multidistrict Litigation

The Law Office of Kip Petroff announced today that Kip Petroff will be speaking at an upcoming “MDL Mass Torts” seminar in Napa, California. The seminar, entitled, “MDL Conference: The Mass Tort Litigation Landscape—A Critical Analysis” is held the day before the MDL Court hearing in Napa this week. Kip Petroff was quoted saying, “As I predicted in May when I spoke at the Chicago MDL [multidistrict litigation] conference, Smith & Nephew metal-on-metal total hip arthroplasties involving the R3 Metal Liner or Modular Femoral Head have been added to the Birmingham Hip Resurfacing (“BHR”) MDL. This makes the BHR MDL a unique litigation because of the many challenges it presents to plaintiff’s lawyers. I touch on these issues this week at the HarrisMartin’s MDL Conference in Napa, California.

I am hopeful that the considerations I raise in this paper and in my presentation are going to be helpful in ensuring that the many victims of the Smith & Nephew metal-on-metal experiment can get justice. My paper for this seminar is on my website at  https://www.kippetroff.com/defective-products/the-mass-tort-litigation-landscape-a-critical-analysis-mdl-conference

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


Don’t Shoot from the Hip: Navigating Medical Device Mass Torts in Multidistrict Litigation

By Kip Petroff and Caio Formenti1

This paper and my brief presentation at the HarrisMartin MDL Conference seminar on September 26, 2018 will discuss an unusual type of products liability personal injury mass tort because, unlike most of the cases discussed here, new hip implant cases and new hip implant MDLs just keep on coming. The physical materials and surgical procedures used in hip arthroplasties are constantly changing, and new shapes, styles, instruments, pegs, sheaths, finishes, adapters, guides, and accessories are still appearing on hospital shelves at a dizzying pace. But one thing remains unchanged: the “mass tort landscape” has included hip implant cases in one form or another for several years, and there’s no end in sight.

This paper will provide a broad historical overview of recent hip litigation in courts throughout the country. I’ll discuss what many of you already know, such as where the hip implant MDLs are and what products are involved. I’ll also provide some practical suggestions based on having personally (1) tried a Zimmer hip case to a jury last year, (2) argued a federal court appeal involving Smith & Nephew hips, (3) watched an entire ten-week Team Lanier hip implant trial against J & J, (4) read hundreds of thousands of “confidential” hip implant documents, and (5) taken almost twenty Zimmer and Smith & Nephew hip implant depositions—so far. For those who are future-oriented but don’t have a crystal ball, I’ll even tell you how to predict where the next hip implant mass torts might be in the future.


I. FDA MoM Regulation

It is not surprising that there is, and will continue to be, hip implant litigation in this country. The hip replacement procedure has been successfully performed on millions of Americans since the earliest procedures were performed using metal-on-metal Charnley Hips in the early 1970s—before metal debris concerns led to a transition to metal-on-plastic in the mid-1970s.2 The procedure is considered one of the most successful and life-changing procedures in America today, and its usage nationwide will continue to increase as we all live longer due to other medical advances. But the ceaseless competitive desire of medical device companies to rush to market with “the latest and greatest” products and procedures for this ever-growing population ensures that mistakes will be made, and hip implant litigation will undoubtedly continue. This paper focuses on so-called “metal-on-metal” cases, because that’s where the cases are today. But the discussion below and the “three-legged stool” analogy applies to almost any implantable medical device products liability case.

Metal-on-metal total hip arthroplasties have been around since before the Medical Device Amendments of 1976 to the Food Drug and Cosmetics Act. They were classified as “Class III” medical devices in 1987.3 Unless there is a substantially equivalent predicate device (making clearance through 510(k) possible), a Class III device must be cleared through the slower, more expensive Premarket Approval (“PMA”) process. Interest in the metal-on-metal total hip replacement procedure waned and then resurged in the late twentieth century, leading to a device classification panel meeting in mid-2001.4 That’s when the FDA Orthopaedic and Rehabilitation Devices Panel held a public meeting on the possible reclassification of metal-on-metal hip devices to Class II. At this meeting, the Orthopaedic Surgical Manufacturers Association (the representative for the medical device manufacturers) asserted that “sufficient information now exists to support the conclusion that the risks from metal-on-metal hips are no greater than those for metal-polyethylene hip prostheses.”5 However, the panel members had many concerns 6 and ultimately voted 5-2 to keep metal-on-metal devices in Class III, which meant that any new metal-on-metal devices must first clear the 510(k) clearance (if a substantially equivalent, cleared predicate device already exists) or PMA process.

Undeterred by this regulatory setback, manufacturers continued promoting this new technology and metal-on-metal hip implant use skyrocketed in the 2000s (without any company actually proving they were safe), at one point comprising almost a third of the total hip market:

Kip-Petroff-Hip-Implant-Article-Napa-Seminar-09.26.18-fig3.3.b

Figure 3.3 (b) 7

Pushed on by manufacturer promotions and manufacturer-sponsored papers praising the potential longevity of these devices, surgeons and device manufacturers developed extremely close relationships. In the absence of concrete ethical guidelines on surgeon-company relationships, four of the major manufacturers were the subject of criminal complaints in federal court in New Jersey, and they all entered into Deferred Prosecution Agreements with U.S. prosecutors in September 2007 for bribing surgeons.8

As use increased, so did reported failures. These reports prompted the FDA to take an active interest in evaluating the safety and efficacy of metal-on-metal hip implants. In early 2009, the FDA released a 515(i) “Call for Safety and Effectiveness Information,” which five manufacturers responded to.9 A year later, the FDA met with “professional societies to better understand current clinical practices”10 and by early 2011 had created a website with patient and physician recommendations.11 Section 522 postmarket surveillance orders—requiring manufacturers of metal-on-metal devices to provide information to the FDA about adverse events and metal ion levels in the metal-on-metal hips they invariably collected data on—were issued in May 2011.12

In mid-2012, the Orthopaedic and Rehabilitation Devices Panel held a two-day meeting to review metal-on-metal hips.13 By this time, hundreds of 510(k) premarket notifications for metal-on-metal total hip systems had been filed, and 188 of them had been cleared by the FDA (although many of these 510(k)s were for the same “systems”).14 The Orthopaedic and Rehabilitation Devices Panel’s goals included reviewing data on metal-on-metal hip systems, describing “potential and real safety risks,” and generating recommendations on how to “best communicate and mitigate risks.”15 The Panel ultimately noted that there were still “questions about the interpretation of imaging and ion testing results, questions about the performance of [metal-on-metal] devices relative to therapeutic alternatives, and . . . the need for some prospective longitudinal, randomized controlled studies to fill in some of these gaps.”16 By this time, the medical community had given up on metal-on-metal hip implants, and almost no one in America was still using them for total hip replacements. The metal-on-metal technology that received great fanfare in the mid-2000s was abandoned before the FDA finally got around to issuing new regulations less than a decade later.

This regulatory scrutiny over a then-abandoned technology culminated in a proposed FDA rule in 201317 requiring PMAs for all metal-on-metal hips and calling a meeting of a device classification panel for that same purpose. This rule was finalized and adopted in 2016 and required “a PMA . . . to be filed on or before May 18, 2016, for any of these preamendment class III devices that were in commercial distribution before May 28, 1976, or that has been found by FDA to be substantially equivalent to such a device.”18 This meant that every metal-on-metal system in America would need medical proof of safety and effectiveness after May 18, 2016. More importantly, should a device’s PMA application be denied, the device is immediately considered “adulterated.”19 Adulterated devices cannot be placed into the stream of commerce, and doing so exposes both the distributor and seller to serious financial and criminal sanctions both at the state and federal level. These regulatory proceedings were the beginning of the end for metal-on-metal total hip replacements in America.

 

II. Hip Implant Litigation Today

Manufacturers stopped selling the devices and surgeons stopped prescribing them, but hundreds of thousands of people were implanted with this dubious combination of metal parts before the authorities could catch up with them. Given both metal-on-metal’s high failure rate and the fact that over a million Americans received such an implant, metal-on-metal revisions are likely still being performed daily.20 A firestorm of litigation began long before the FDA finally placed stringent regulations on metal-on-metal hip implants. This paper will briefly discuss that litigation. My main emphasis will be on Smith & Nephew metal-on-metal hip implant litigation because I can’t cover everything and because the Smith & Nephew MDL is one of the most active and rapidly-growing hip implant MDLs in America today. It is also one of the more problematic of the MDLs for the reasons discussed below.

There are three “tracks” in the Smith & Nephew MDL: (1) the Birmingham Hip Resurfacing, a single device system entirely approved through PMA-approval; (2) the R3 track, which is a “traditional” total hip that includes the R3 Metal Liner (which was, confusingly, approved as a supplement to the Birmingham Hip Resurfacing PMA only for use in total hip resurfacings and not in “traditional” total hip arthroplasties), and; (3) the Modular Femoral Head hips, which involve the 510(k)-cleared Modular Femoral Head (cleared for use in hemiarthroplasties, where the femoral head articulates against the natural hip socket) and either an R3 Acetabular Shell or BHR Acetabular Shell (Tracks 2 and 3 will be collectively referred to as “S&N THAs”). Smith & Nephew THAs are metal-on-metal and unquestionably “off-label,” unapproved uses.

Because of this, S&N THA litigation is one of the most interesting and risky litigations because you usually cannot have a Smith & Nephew total hip case in the MDL unless your case involves these two critical factors:

  1.  Your client’s surgeon used at least two metal parts that were very obviously not approved or intended for use together.
  2. Your client’s surgeon was not sued for using at least two metal parts that were very obviously not approved or intended for use together.

A plaintiff with a S&N THA case is always a plaintiff whose surgeon ignored explicit statements from the manufacturer about how and where to use the parts that were implanted. There are, of course, exceptions to these requirements, but they are very rare.

It looks like all the 100+ total hip replacement cases currently in the Smith & Nephew MDL meet the above two criteria. Some of the cases in the Smith & Nephew MDL even involve situations where the above two factors are met and the implanting surgeon was told in writing before the surgery that the metal parts used were not FDA-approved for use together. Some lawyers would agree that filing a case in an MDL under such circumstances is just too risky. The strategy of not suing a surgeon who carelessly disregarded obvious lack of FDA approval for a medical device is, in my opinion, too risky. Products liability cases are expensive and time-consuming to prove under the best of circumstances, but the risk of not suing negligent doctors and uncaring, dishonest sales representatives is simply too high for me.

 

III. Proving Your Case

It is not surprising that litigation has surrounded metal-on-metal total hip prosthetics in recent years. Whether it’s Wright Medical, Biomet, DePuy, Smith & Nephew, or Stryker, the plaintiff’s bar has eagerly tried to hold these manufacturers accountable. Many of these lawsuits have been consolidated into federal multi-district litigations. As of August 15, 2018, the following hip implant MDLs are still pending: Wright Medical Technology, Inc. Conserve Hip Implant (MDL-2329, 203 still-pending cases out of 641 total cases filed); Biomet M2a Magnum Hip Implant (MDL-2391, 402 out of 2,824); Stryker LFIT V40 Femoral Head (MDL-2768, 365 out of 373); Smith & Nephew Birmingham Hip Resurfacing (MDL-2528, 418 out of 437); Stryker Rejuvenated and ABG II Hip Implant (MDL-2441, 1,248 out of 3,498); Zimmer Durom Hip Cup (MDL-2158, 131 out of 732); DePuy Orthopaedics, Inc. ASR Hip Implant (MDL-2197, 1,715 out of 10,153), and; DePuy Orthopaedics, Inc. Pinnacle Hip Implant (MDL-2244, 9,644 out of 9,836). 21

An individual lawyer’s ability to fight for his or her client with products involved in the older MDLs is limited because discovery about the company’s conduct is already completed in most of them. However, there are still opportunities to undertake discovery in cases outside the MDLs. Just last year, I tried a Zimmer case that was not in an MDL and the appeal I argued against Smith & Nephew in the Eleventh Circuit involved a case that had been dismissed before the Smith & Nephew MDL even existed. For the reasons discussed below, lawyers involved in these cases should consider alternatives to the MDLs when possible.

The remainder of this paper will discuss some considerations that might help you decide whether to accept a hip implant case and where to file it if you end up getting that far. I will use the Smith & Nephew MDL as an example of the ways in which I am developing cases outside the MDL and why I am doing that in the Smith & Nephew cases. The analysis I am using for the Smith & Nephew hip implant cases applies to, and is useful in, any case involving injuries from implantable medical devices.

 

IV. The Non-MDL Option

I believe that too many cases are filed in MDLs without seriously considering alternative venues and litigation options. Filing in an MDL that involves devices that were granted FDA clearance for marketing and used that way is one thing, but do you really want to file your case in an MDL if the product was used in an off-label or unapproved way? What about the sales representative who mislead the surgeon and what about the surgeon who used the product in ways that were inconsistent with the manufacturer’s written instructions for use and package inserts? You may eventually have to prove your allegations against the manufacturer you sued in an MDL, and failing to include the sales representatives and surgeons who disregarded instructions for use can be very troubling when it comes time for proof of defect.

Many lawyers sign up a client with a metal-on-metal claim and immediately join the MDL. Many lawyers won’t even take a “one-off” case if there is no MDL involving that device. However, other lawyers will take a case if the product was recalled for safety reasons—even in the absence of an MDL. I tried such a case in federal court against Zimmer last year, but it involved an FDA-cleared device and there were no issues about the surgeon’s unapproved, off-label use. On the other hand, I took depositions and obtained documents in several Smith & Nephew cases in state and federal court for almost two years before the MDL was formed. I have seen documents that clearly show what the surgeons were told about Smith & Nephew products, and this information makes me very hesitant to file Smith & Nephew cases without including the surgeon and sales representative as defendants. A brief description of the Smith & Nephew BHR MDL22 will explain why I believe in this approach.

The Smith & Nephew MDL, first established in April 2017, is one of the newest, quickest-moving, and smallest hip implant MDLs. Since then, Judge Catherine C. Blake has already denied (in part) the defendant’s motion to dismiss in the hip resurfacing cases, and the parties are now proceeding towards discovery. In contrast, the larger DePuy Pinnacle MDL, filed in mid-2011, is still ongoing.23 Part of why avoiding these MDLs is useful is because it allows you to explore who knew what, and when, on your own terms. More likely than not, if a device subject to an MDL was widely-used, it will follow similar timelines to these two litigations. When that happens, everything slows down: trial settings are later, discovery takes longer, and your motions might not even be “your” motions anymore.

Kip-Petroff-Hip-Implant-Article-Napa-Seminar-09.26.18--tableThe BHR MDL is unique because it illustrates the biggest challenge of MDLs: they forcibly create and exacerbate the “empty chair” problem. When litigating medical device products liability cases, the empty chair is a three-legged stool. One leg is the manufacturer, the second the sales representative, and the third is the doctor. If any one leg of the stool is absent, the empty chair becomes unstable. If two are gone, it will almost certainly topple.

The BHR MDL is a fascinating case study in the empty chair problem because, to be a total hip plaintiff in that MDL, the doctor had to have played a much larger role in the underlying claim than for most other devices. In fact, one cannot even have a total hip replacement case in the Smith & Nephew MDL case unless the surgeon used the components in ways that are drastically inconsistent with the written instructions both on and in the boxes containing them.

By definition, surgeons and local sales representatives are not part of the MDL, but their role in choosing and implanting these dangerous, U.K-sold but U.S.-uncleared devices makes them the perfect scapegoat. Holding the manufacturer liable is a challenge when the manufacturer can prove that the doctor and sales representative had to both look at, and then ignore, instructions like the ones on the packaging below.

Kip-Petroff-Hip-Implant-Article-Napa-Seminar-09.26.18--sn-packaging

These instructions on the boxes themselves make it clear that the modular heads were for “HEMI-ARTHROPLASTY ONLY” and that the metal liner was intended for resurfacing only. The package inserts inside the boxes say essentially the same thing. Your plaintiff never would have received a total hip replacement using these metal parts if the surgeon had simply followed these basic instructions. It is impossible to have a metal-on-metal hip case if the surgery performed is a hemiarthroplasty. These instructions are not in the fine print hidden somewhere inside the boxes. They are in ALL CAPITAL LETTERS on the first line of the box, and they make the surgeon and sales rep an easy scapegoat for the manufacturer when the surgeon is an “empty chair” because the company can disclaim their ability to prevent this: “We can’t tell surgeons what to read or how to do their jobs!”

However, by bringing the surgeon in to the case, you both fill the empty chair and create a new avenue through which you can solidify the other two legs of the stool: the manufacturer and the sales representative. Plaintiffs in other MDLs have avoided dismissal because of what sales representatives told the patient’s doctor, but that will usually not work in Smith & Nephew cases because the sales representatives are “independent” and have a contract with Smith & Nephew that makes off-label promotion explicitly improper.

For example, in the DePuy Pinnacle Hip litigation, the bellwether plaintiffs defeated a motion for summary judgment on failure to warn, misrepresentation, and omission claims, in part because of what the doctors were told (or not told): one doctor “obtained information from—and relied on—the scientific and medical information the sales representative provided to him”; doctors were paid to “market and present DePuy products through what appeared to be neutral, even peer-reviewed sources”; the doctor might have read the literature that accompanied the products.24 There was specific testimony in the DePuy case that at least one of the surgeons “would have wanted to know that [the device]’s predecessor was taken off the market in Europe,” and that “[had he] been informed of such problems he would not have used the [device] or would have at least discussed these warnings with his patient.”25

These statements are from an MDL that did not involve surgeons, but the products were FDA-cleared and widely promoted. Not so with the S&N THAs. In fact, the FDA specifically rejected multiple Smith & Nephew 510(k) submissions seeking to promote these parts for total hip replacements.26 The only written statements that accompanied the parts used in S&N THA cases noted that the products were not intended for use in such procedures.

Without the surgeon in an off-label use case, only two legs remain. Although coexistent, the manufacturer and the sales representative cannot be combined, and the sales representative is often overlooked (and excluded) in litigation like this. With the BHR MDL, the sales representatives were typically “independent contractors” with shell companies and lengthy sales representative agreements. On paper, they were beyond the control of the manufacturer. In reality, they regularly conferred with their superiors and company executives, strategizing what products they plan to talk up to which surgeons. The surgeons and sales representatives are integral to proving liability in the context of the BHR MDL, and leaving them out of the case is an unnecessary gamble, in my opinion.

Without a doubt, the most important leg of our three-legged stool analogy is still usually the manufacturer themselves.27 Their significance doesn’t need explanation, but an understated benefit they bring is that they can help show you exactly what third parties knew about their devices. What the FDA knew about a device, gleaned from the publicly-available 510(k) or PMA records, can go a long way towards constructing both a timeline and liability list for a device. Although “Fraud on the FDA” is not actionable under federal law, the regulatory history of a device is a powerful tool in highlighting differences in how the manufacturer portrayed the intended uses, indications for use, and safety of the device to the FDA and to doctors, patients, and the public. The bad news? There is extensive evidence that Smith & Nephew explicitly informed many surgeons in writing and informed all their sales representatives that none of the Smith & Nephew metal parts were approved or intended for use in a metal-on-metal hip construct. That evidence is too strong for me to take a case without doing everything I can to include the surgeons and sales representatives who totally ignored the clear evidence that confronted them before they used these parts together in surgery.

The source of most of your discovery will be the doctor and the manufacturer, who is totally content to let these cases slowly develop in an MDL without surgeons or sales representatives. However, if you can stay in state court, you have access to much, much more discovery. Although the DePuy Pinnacle plaintiffs eventually acquired their surgeon information through depositions, the motion for summary judgment was ruled on in early 2016—nearly five years after the litigation had commenced. Again, the Pinnacle was FDA-cleared, so the empty chair is not nearly as obvious in those cases. But if the doctor is included in the initial state-court lawsuit, then this information could come much sooner. I have obtained hundreds of thousands of pages of Smith & Nephew documents in my state court cases, whereas the year-old MDL is just now beginning formal discovery. State court or non-MDL federal court litigation in these cases involves a lot more work in a shorter period of time, often without the support of other good attorneys like you’d have in an MDL, but you get to the good information a lot quicker.

 

V. Foreign Registries and the “Human Laboratory”

Mass torts aren’t going away anytime soon, and one reason for that is the “human laboratory.” This term was used by a surgeon I deposed in one of my metal-on-metal cases to describe how we learn about the safety of many implantable devices. Regrettably, laboratory, mechanical, and animal testing are not enough to give us a long-term insight into how safe or unsafe medical devices are. Often, the only way to truly discover the safety of a device is to track it in humans. What this means is that, as new medical technology is developed, we’ll only find out that the “latest and greatest” medical device is actually the next mass tort after people have gotten seriously injured—just like we saw with metal-on-metal hips.

To better identify problematic implants earlier, a handful of nations have developed “joint registries”28 which track, in excruciating detail, the survival rates of different joint replacements. Registries can be a valuable tool in taking on both the surgeon, who might have trusted a sales representative a little too much, and the device manufacturer, who might deny that its device was bad at all. You need to learn about these registries because they will always be used against you if they don’t help prove your case.

If you know what you’re looking at and how to use them, the annual reports that registries publish are great sources of information for both seeing what is showing high rates of early failure and looking at older annual reports to see what the surgeon or manufacturer knew or should have known when your client received an implant.

Newer reports are not as useful for showing what a doctor did—or did not—know when the device was used. For that, you need the data that was available when the device was implanted. We know that metal-on-metal hip implantations peaked in 2009. If we pull up a publicly-available foreign registry—for example, the 2009 Australian Orthopaedic Association National Joint Replacement Registry (“AOANJRR”) Annual Report—and look for the component combination that the total hip plaintiffs from the BHR MDL received, we find these two tables:

Kip-Petroff-Hip-Implant-Article-Napa-Seminar-09.26.18--table-HT31-32

Table HT31 and HT32 29

There’s a good chance that the S&N THA plaintiffs received either an R3 Acetabular Shell with an R3 Metal Liner or a Modular Femoral Head paired with a BHR cup, and a strong likelihood that they received it sometime in or around 2009. Looking at this data, the first two entries might be what we’re looking for. Place yourself in a reasonable surgeon’s shoes: with what they had, would it be reasonable to use these devices? The revision rate in year one for the Synergy-BHR is alarmingly high, and the R3 doesn’t have enough data to develop a revision rate. The revision rate for both is very high because the sample sizes are so small: the possible revision rate for the Synergy-BHR could be anywhere from .36% to 1.39% per year, and the Synergy-R3 ranges from 0.66% to 4.75% per year! What that means is that these devices could just as easily be one of the best hip implants or one of the worst.

Just like most of its metal-on-metal competitors, we now know that these devices fall squarely into the latter group. Any surgeon who bothered to look at these publicly available registries would know that this early data was not reassuring at all. That same surgeon would have to know that their use together is off-label. Is a surgeon being careful enough if he or she still used that combination of parts in or around 2009? Let’s see.

The American Academy of Orthopaedic Surgeons Guide to the Ethical Practice of Orthopaedic Surgery defines off-label use as “any use that is not included in the cleared ‘indications for use.’”30 Although ethical, off-label use requires that the surgeon “be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain awareness of the product’s use and effects.”31 Surgeons should also

be aware of company sales and marketing tactics that may undermine the free and credible exchange of scientific information on new products . . . including inappropriate product comparisons between FDA approved and cleared products, misleading claims regarding product safety, efficacy, . . . and the omission of adverse clinical data.32

Imagine confronting a surgeon with this standard and the registry data above. Should a surgeon be comfortable implanting a device that could pose such a great risk in patient, when safer alternatives were readily available? Would the patient consent if all this was explained to him or her? The answer is almost certainly “no.” As their insurer and attorney look over their shoulder, the probable response (and the truth) is: “the manufacturer/sales representative told me different!” And suddenly, two of the three legs get much sturdier.

The above analysis is a quick example of the value of these published registries, but the wealth of information in each year means that a resourceful and creative attorney can enhance their advocacy through the careful use of these documents.

 

VI. Mirror, Mirror, On the Wall: What’s the Worst Device of Them All?

Nobody I know has a crystal ball that can identify the next mass tort. However, registries can help you identify some devices that are problematic and might warrant some closer investigation. How would that work?

This first table is taken directly from the U.K. National Joint Registry Annual Report:

Kip-Petroff-Hip-Implant-Article-Napa-Seminar-09.26.18-NJR

NJR 2017 at 71 33

If we were going to try and pick out the “next metal-on-metal,” most of the total hip revision rates in this chart would not raise any red flags. None of these entries—save for the one metal-on-metal device, discussed below—are alarming and most of the devices have at least 7 years of data with revision rates that are well within the NICE standards (typically, a cumulative one percent per each year). These charts show that there aren’t really any other hip implants that are failing at rates as high as metal-on-metal, so as of now, this data alone probably does not allow for prediction of a viable mass-tort here. You might need to follow the FDA recall announcements to find another way to identify the next types of cases.

Notably, one entry is still being litigated today. The MoM—Metal on Metal—data for the Corail/Pinnacle implant shows revision rates that far exceed NICE standards five years on, ballooning to almost fourteen percent by year ten. That means that, for this data set, fourteen percent of these hips have been revised within a decade of implantation. Not exactly “safe or effective,” a pattern that has held true for most if not all metal-on-metal hip implants:

Metal-on-metal stemmed and resurfacing implants continue to fail at higher than expected rates and their use is now extremely rare. The best performing brands of resurfacing have failure rates greater than 8% at ten years. It is striking to note the high rates of revision for adverse soft tissue reaction to particulate debris in patients who have received metal-on-metal bearings. Analysis of stemmed metal-on-metal bearings by head size shows that 28mm heads have the best survivorship, but this is still poor compared to alternatives.34

That device likely showed similar issues in earlier annual reports, and someone reviewing the data might have been able to pick up on that. This can be illustrated by looking at a different section of the report:

Kip-Petroff-Hip-Implant-Article-Napa-Seminar-09.26.18-table330

Table 3.30 35 © National Joint Registry 2017

These are the results for some knee replacements. Knees probably have a higher NICE benchmark than hips, given how high the revision rates are for all of them; regardless, you can immediately pick out some implants that are still far and away worse. In particular, the Preservation, the Journey PFJ Oxinium, and (if the projection holds) the patellofemoral Sigma HP merit a closer look. The legend, which explains that the Preservation has been “discontinued/withdrawn/not implanted in last three years,”36 confirms this. This is a quick example, but it shows you how to put certain devices on your radar. It doesn’t guarantee that these products are going to be the “next big thing,” but they might help you narrow the field next time you are surveying the mass tort landscape.

 

VII. Conclusion

An MDL might be great at helping stop the already-overwhelmed court system from becoming even more weighed down by mass torts. However, its usefulness comes at a cost, especially for plaintiff’s lawyers and their clients. Between the “empty chair” problem and the longer amount of time it usually takes for justice to be served in an MDL, any advantage is useful. Seminars like this might allow us to share ideas about these cases and learn that some people are independently litigating the very cases that are in the MDLs. Hopefully, by pointing out how to avoid the “empty chair” and using joint implant registries to your advantage, I have provided some new arrows for your quiver. Good luck!

 

Kip A. Petroff
Dallas, Texas
(972) 294-7530
kpetroff@petroffassociates.com
www.KipPetroff.com

 

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

Footnotes:

  1. Kip Petroff of Law Office of Kip Petroff in Dallas, TX is a plaintiff’s lawyer who has focused his litigation on Smith & Nephew metal-on-metal hip implants. Caio Formenti is a recent law graduate of SMU Dedman School of Law in Dallas, TX awaiting results from the 2018 July Texas Bar Examination.
  2. Witness Seminar held by the Wellcome Trust Centre for the History of Medicine at UCL London (ed. L.A. Reynolds and E.M. Tansey), Early Development of Total Hip Replacement, at xxvii (2006).
  3. Glenn Steigman (speaking on behalf of the FDA Orthopaedic Devices Branch), FDA, Orthopaedic and Rehabilitation Devices Panel transcript. August 8, 2001. Available at http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3780t1.rtf (accessible via Wayback Machine).
  4. Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint Systems, 81 Fed. Reg. 8,146-49, 8,147 (Feb. 18, 2016).
  5. Tom Craig (speaking on behalf of the Orthopaedic Surgical Manufacturers Association), FDA, Orthopaedic and Rehabilitation Devices Panel transcript.
  6. See e.g., id. for Stephen Li, Ph.D. lead panel member comments (“So the question for the design parameters is how were these actually arrived at, although it appears they just picked a range describing previous results,” “I have projected four histories just to demonstrate that although hip simulation is important and a necessary test to pass, it does not guarantee clinical success.”).
  7. National Joint Registry for England, Wales, Northern Ireland and the Isle of Man, 14th Annual Report at 45 (2017) (“NJR 2017”).
  8. These criminal proceedings were widely publicized, but a press release from Christopher J. Christie, U.S. Attorney, can be found at http://www.usdoj.gov/press/index.html. The September 27, 2007 press release is also on my website’s Legal Page under “Criminal Proceedings.” See https://www.KipPetroff.com.
  9. FDA, Orthopaedic and Rehabilitation Devices Panel Transcript, at 26. June 27-28, 2012.
  10. Id. at 27.
  11. Id.
  12. Id.
  13. See generally id.
  14. Id. at 21.
  15. Id. at 28.
  16. FDA, 24-Hour Summary: Orthopaedic and Rehabilitation Devices Panel, Day 2, at 2. June 28, 2012.
  17. 81 Fed. Reg. at 8,147.
  18. Id. at 8,148.
  19. Id.
  20. Deborah Cohen, “Hip Implants: How Safe is Metal on Metal?” 344 BMJ 18, 18 (2012).
  21. Judicial Panel on Multidistrict Litigation, “Pending MDLs by District as of August 15, 2018” (2018). Accessible at http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-August-15-2018.pdf.
  22. In re: Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, 1:17-cv-00943-CCB (MDL No. 2775) (D. Md. 2017).
  23. See In re: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, 3:11-md-02244-K (N.D. Tex. 2011).
  24. In re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation, No. 3:11-MD-2244-K, 2016 WL 6268090, at *5 (N.D. Tex. Jan. 5, 2016).
  25. Id.
  26. Chicago “Bet the Company” MDL Seminar, “What’s So Special About Smith & Nephew Metal Hip Implant Cases?” May 23, 2018. Available on my website at https://www.kippetroff.com/pdf/smith-and-nephew/reg/chicago-mdl-paper.pdf.
  27. I’ve also talked about some creative ways to investigate a device and its manufacturer before even filing suit, using things like pre-suit depositions. See Kip Petroff and Caio Formenti, “Preempting Preemption: Device Cases After Shuker—Part 1,” LAW360 (Apr. 12, 2018).
  28. Including the UK, Australia, and New Zealand. An American joint registry is in its infancy but will be an invaluable tool as its database grows.
  29. Australian Orthopaedic Association National Joint Replacement Registry, Annual Report 2009 at 76, 77 (2009).
  30. American Academy of Orthopaedic Surgeons, Guide to the Ethical Practice of Orthopaedic Surgery, “Position Statement: Off-Label Use of Medical Products,” at 125 (2013).
  31. Id.
  32. Id. at 127.
  33. NJR 2017 at 71.
  34. Id. at 83.
  35. Id. at 137.
  36. Id.
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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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