Lawsuits and Legal Update
Last Updated September 12, 2020
Over the past few decades, hip replacement surgery, or Total Hip Arthroplasty, to repair hip-joints, often damaged by osteoarthritis, rheumatoid arthritis, and traumatic arthritis, has become a commonplace procedure within hospitals and ambulatory surgical centers across the United States. Going forward, it is expected that the market for hip-joint replacement will dramatically expand. Due to a combination of the aging population trend and an explosion in robotically-assisted surgery, experts anticipate that the market for hip replacement devices will leap to $10.51 billion annually by 2026. Numbers like this are not lost on device manufacturers. Companies like DePuy (a Johnson & Johnson business unit), Stryker, Smith & Nephew, and Zimmer devote considerable resources and capitalization toward rapid development of newer hip-joint products in order to ensure that they capture a significant share of this highly profitable market.
With that in mind, the ability of these companies to rapidly develop and deploy new hip-joints rests squarely on navigating the U.S. Food and Drug Administration (FDA) pre-market approval process, and in particular its 510(k) Clearance process. If a new medical device product can be proven to be “substantially equivalent” to another previously-approved product line, then the 510(k) process allows that manufacturer to bypass the ordinary safety and effectiveness testing rigors involved with standard pre-market approval.
Starting in the early 2000s, several manufacturers aggressively marketed hip-joints through the 510(k) process featuring a “Metal-on-Metal” (MoM) coupling feature between the ball and socket of the joint. In MoM joints, the metal ball and metal cup slide against each other during walking or running. This friction between the ball and socket can cause the release of metal particles that will wear off of the device and embed in surrounding tissue as well as metal ions of cobalt and chromium entering the bloodstream. Over time, this leaching of metal from the joint into surrounding tissue causes “Adverse Local Tissue Reaction” (ALTR) and/or “Adverse Reaction to Metal Debris” (ARMD). The bottom line for patients implanted with MoM joints, however, is that they suffer damage and pain, device failure, loosening, and the need for revision surgery. Furthermore, patients implanted with MoM hip joints can also suffer from a condition known as “metallosis” – a potentially fatal complication arising from metallic erosion in the joint which induces pain around the joint, pseudotumors, and a noticeable rash.
By 2010, the issues with MoM were becoming apparent to both the manufacturers and the FDA alike. The first MoM joint recall involved the DePuy ASR followed by market withdrawals of the Biomet Magnum M2A and others. Lawsuits soon followed and between 2013 and the present, billions of dollars in verdicts and settlements were racked-up over these devices. Currently, there are six active multidistrict litigation (MDL) cases involving hip-joint devices and their manufacturers, taking place in federal courthouses across the country with nearly 11,800 claimants in various stages of progress – and a possible seventh on the way. Some of these cases have resulted in verdicts and settlements in the hundreds of millions or even billions of dollars.
Historic Hip Joint Lawsuits, Recalls, Verdicts, and Settlements:
DePuy ASR XL Acetabular System and ASR Hip Resurfacing Resurfacing Platform (MDL-2197)
DePuy manufactured the ASR Hip Implant Device line and is a business unit of the global device giant, Johnson & Johnson. The ASR XL Acetabular System was made up of three components:
- The metal femoral stem inserted inside of the femur.
- The metal femoral head (or ball) connected to the stem; and
- The metal acetabular cup (socket).
Similarly, the ASR Hip Resurfacing Platform involves a metal cap placed over the natural femoral head and replacing the acetabulum with a metal cup.
Beginning in 2008, the FDA started receiving approximately 400 complaints from patients in the United States who were implanted with the devices. These patients complained of pain, swelling, inflammation, and damage to the bone and tissue – as well as a lack of mobility. Many of these patients required expensive and painful revision surgeries.
In 2010, DePuy issued a voluntary recall of ASR Hip Implant Devices and the first lawsuits naming DePuy soon followed thereafter. The cases were consolidated into an MDL and between 2013 and 2017, DePuy paid nearly $4.8 billion to settle approximately 7,500 cases.
It has been over ten years since the original ASR recall. And although this MDL is technically still open, settlement protocols have a stipulated deadline for potential litigants requiring a revision surgery to have been performed no later than July 2017.
DePuy Pinnacle Hip Replacement System with TrueGlide Technology (MDL-2244)
The DePuy Pinnacle Acetabular Cup System was launched in 2001 and offered the option of either a polyethylene or metal insert for use with a titanium cup to replace the natural hip socket. This was followed by the launch of the Pinnacle system coupled with TrueGlide technology in 2007.
Although the Pinnacle system was not subject to recall, patients still reported many of the same issues as those suffering with the DePuy ASR devices. Issues with loose implants, inflammation, swelling and damage to surrounding tissue coupled with the spread of metal debris and contamination throughout the body were not infrequent. Many patients implanted with Pinnacle devices suffered loss of mobility and went through painful and expensive revision surgeries in an attempt to correct issues.
Lawsuits involving the Pinnacle Hip Replacement System were aggregated into an MDL in a federal courtroom in Texas. In 2016, the second bellwether case in the MDL yielded a verdict in favor of the claimants to the tune of $502 million (later reduced under Texas law limiting punitive damages). A third bellwether case resulted in a $1 billion verdict in favor of claimants (reduced to $543 million on appeal) and a fourth bellwether case wound up with a $247 million verdict in favor of claimants.
In June 2019, DePuy announced that it would settle up to 6,000 of the Pinnacle lawsuits for $1 billion. DePuy is settling each case individually and as a consequence, this MDL remains open with up to 9,155 cases still pending.
Stryker Rejuvenate and ABG II Hip Replacements (MDL-2441)
Howmedica Osteonics Corporation, under the market name, Stryker, designed, developed, and marketed the Rejuvenate and ABG II MoM hip replacement devices. In 2012, Stryker recalled the Rejuvenate system due to issues with fretting and corrosion at the modular-neck junction. Following the recall, patients came forward with lawsuits, and these were consolidated into an MDL in Minnesota.
Between 2014 and 2016, Stryker settled the bulk of these cases for an estimated $1.4 billion. Despite the settlement, the MDL remained open well into 2020 with over 360 cases still pending.
Stryker LFIT V40 Femoral Head (MDL-2768)
Starting in 2000, Stryker marketed its MoM Accolade hip replacement system to hospitals and surgeons which involves two crucial components: the TMZF Hip Stem and LFIT Anatomic V40 Femoral Head. It is called a “monoblock” or single-piece artificial hip replacement device that utilizes a proprietary titanium alloy consisting of titanium, molybdenum, zinc, and iron.
Following a 2016 investigative report in the Journal of Bone and Joint Surgery, which reported on issues involving corrosion in the V40 head as well as metallic debris and damage to the soft tissue, Stryker issued a recall of LFIT V40 heads. Lawsuits from implant patients suffering from metallosis and other issues associated with the LFIT V40 were then aggregated into an MDL in Massachusetts. In 2018, a confidential settlement was announced and individual cases are still being settled. Accordingly, this MDL remains open in 2020 with over 500 cases still pending.
Current Hip Joint Lawsuits
Smith & Nephew, Inc. Birmingham Hip Resurfacing System (MDL-2775)
In 2006, United Kingdom-based Smith & Nephew introduced the MoM Birmingham Resurfacing (BHR) system. A prosthesis, the BHR is comprised of two components:
- The Birmingham Resurfacing Femoral Head; and
- The Birmingham Resurfacing Acetabular Cup.
The FDA order allowing Smith & Nephew to market the BHR in the United States required the company to comply with several post-market survey and reporting practices relaying knowledge of adverse reactions, injuries or issues with the device, back to the FDA. Claimants in litigation pending before a Maryland federal court allege that Smith & Nephew in fact knew about a multitude of common MoM issues and adverse reports involving the BHR but either delayed reporting them to the FDA, underreported them or did not report them properly at all.
This MDL is still active and in its early stages. The first bellwether trials have been scheduled to commence in May 2021 and July 2021.
Zimmer M/L Taper Hip Prosthesis and Versys Femoral Head (MDL-2859)
Indiana-based Zimmer Biomet Holdings, Inc. developed and marketed the Zimmer M/L Taper hip implant with its proprietary Kinectiv Technology. This model of the M/L Taper with the Kinectiv technology utilized a modular MoM design that featured a cobalt-chromium coupling. In court documents, claimants allege that the Zimmer hip joint suffers from corrosion which introduces metal fragments into surrounding tissue as well as elevated levels of metals into the bloodstream causing pain, swelling, tissue necrosis, and other ailments.
This MDL is currently in its early stages and new cases are being added.
Bearing Scrutiny:
Stryker Tritanium Acetabular Shell
Stryker received clearance from the FDA to market its Tritanium Acetabular Cup in 2008 and later in 2011, received further clearance for a Tritanium Acetabular Shell with “Peri-Apatite” coatings on the bone-implant interface. Specifically, this coating added a “Particle Sintered Foam” (PFS) coating overlaid with Peri-Apatite.
In 2017, the journal Arthroplasty Today published an article on behalf of the American Association of Hip and Knee Surgeons which delved into the cases of five patients who underwent revision surgeries for loosening issues with Stryker’s tritanium acetabular cups resulting in groin and hip pain. A 2018 article in Orthopaedic Proceedings which evaluated 121 revision surgeries involving Stryker tritanium devices made similar findings of premature deterioration in the hip joint.
New legal complaints naming Stryker and alleging design defects in the Tritanium Acetabular Shell line were filed in state court in New Jersey in 2019 and are currently pending further action.
Sources Cited (30)
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Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.
