Smith and Nephew SMF and Redapt MDL Update

In April of 2017, multi-district litigation (known as “MDL 2775”) was established in federal court in Baltimore, Maryland before United States District Court Judge Catherine C. Blake against Smith & Nephew, which is based in England and sells its products, which are not limited to hip implants, in 90 countries across the world. The headquarters for Smith & Nephew in the United States are located in Memphis, Tennessee.

An MDL is a “Multi-District Litigation” and these are used to more efficiently speed up the legal process when cases involving many people, such as class actions and mass torts, are filed in the US. Their purpose is to instead of having thousands of cases filed in dozens of jurisdictions is to consolidate these to one court and under one judge.

From 28 to over 600 lawsuits

The Smith and & Nephew MDL began with 28 individual defective hip lawsuits transferred from 19 district courts from across the country. Since then, the coordinated litigation has grown to include more than 600 individual lawsuits. Most of the pending lawsuits relate to cases where patients were implanted with Birmingham resurfacing hip implants (which include a femoral head and acetabular cup but not a femoral stem) and underwent revision surgery due to metallosis, elevated cobalt and chromium ions in the bloodstream and joint fluid, pseudotumor formation, and premature failure of the devices.

There are also a number of individual lawsuits pending and coordinated in the MDL that relate to Smith & Nephew R3 and Birmingham total hip implant devices (which include a femoral stem in addition to the cobalt-chrome femoral head and acetabular cup), which the MDL was expanded to include in 2018. These total hip implant lawsuits also allege that the Smith & Nephew metal-on-metal hip implant products are defective due to an excessive failure rate, the need for revision surgery, and injuries to patients due to heavy metal toxicity and poisoning.

As of May of 2019, more than 1 million pages of documents have been produced from the manufacturer in MDL 2775 with additional discovery continuing through the end of 2019. Most of the discovery so far has focused on the Smith & Nephew Birmingham Resurfacing hip implant. Discovery relating to Smith & Nephew total hip arthroplasty devices, including the Birmingham THA and R3 products, is continuing on a parallel track and expected to be expedited soon, especially in light of the failed mediations and settlement discussions for these particular lawsuits. Dozens of depositions of witnesses in the United States and overseas will also be completed in the coming months in preparation for the first jury trials in the MDL proceedings, which are anticipated to begin in March of 2020. We anticipate that case-specific discovery will be initiated in the latter part of 2019 once Judge Blakes decides which individual patient lawsuits will be included in the pool of cases for these initial MDL bellwether trials in 2020. Judge Blake has encouraged the parties to continue to engage in settlement talks, especially with regard to the THA lawsuits. Smith & Nephew has not been as motivated to discuss settlement on the hundreds of lawsuits involving resurfacing devices, as it contends that those cases are subject to dismissal due to federal medical device preemption laws.

Legal Claims Against Smith & Nephew

The lawsuits that have been filed on behalf of injured patients allege various claims against Smith & Nephew for the metal-on-metal total hip and resurfacing implant products, including that:

• The devices are defectively designed and generate dangerous metal debris through contact on the articulating surface which causes harm to patients;
• The warnings that accompanied the products and information that was provided to implanting surgeons and patients were inadequate;
• The products were not properly approved or cleared by the FDA for implantation in patients;
• The products have an excessively high failure rate after implantation in patients due to metallosis;
• The marketing and promotion of the implant system to surgeons was deceptive and misleading;
• Smith & Nephew failed to properly monitor patients, the published medical information, international device registries, and other sources to identify and address potential safety risks;
• The hip implants products were not properly tested and studied prior to implantation in patients;
• The manufacturer violated various federal and state consumer protection requirements relating to design and manufacture of the devices; and
• Various other allegations relating to defects and negligence in the design, manufacture, marketing, promotion, and safety surveillance and monitoring of the Smith & Nephew hip implant products.

Smith & Nephew has been selling Birmingham resurfacing total hip arthroplasty hip implant products in the United States since 2006. This resurfacing hip implant, often referred to as a “BHR implant” includes a femoral head and a matching acetabular cup, both of which are made from a cobalt-chromium alloy. The R3 Acetabular Hip System incorporates the Birmingham components but has interchangeable liners made of polyethylene, ceramic, or metal. The R3 implant with a metal liner is the product that is included in the MDL litigation, and has been marketed in the United States since 2009.

Dispute Over FDA Approval and Federal Medical Device Preemption Immunity

One of the critical issues in the pending lawsuits across the county is the manner in which the BHR implant components were approved or cleared by the FDA for sale. Smith & Nephew contends that it is immune from liability for any alleged defects in the design of its BHR products on the basis that the Food & Drug Administration approved the product through a Premarket Approval application, commonly known as the “PMA” process (which is a more rigorous review process by the FDA than is often used for other hip implant products). The Defendant also contends that this immunity extends to the Birmingham and R3 total hip implant products as well.

This legal doctrine, approved by the United States Supreme Court, is medical device preemption and is highly controversial and unknown to most patients that assume that a company that produces a medical product that causes an injury should be able to be sued in court by the patient. The Plaintiffs claim in this litigation that the BHR acetabular cup was approved by the PMA process, but that the modular femoral head and femoral stem components used to construct the Smith & Nephew total hip arthroplasty system were not approved by the FDA, such that the Defendant should not be immune from liability for the alleged defects in the design of the product.

10+ Years of Hip Implant Safety Issues

Over the last 10 years, there have been numerous recalls and safety alerts regarding metal-on-metal and modular hip implants. The first recalled devices included the Zimmer Durom Cup and DePuy ASR metal-on-metal hip implant products. These products were noted to have an excessive premature failure rate due to excessive metallic debris emanating from the articulating surface of the implant, where the cobalt-chromium metal femoral head was coming into contact with the cobalt-chromium metal acetabular cup (the part of the implant that replaces the hip socket). This process is known as metallosis and leads to bone and soft tissue damage in the hip joint which undermines support and proper functioning of the hip implant. Ultimately, patients with failed metal-on-metal or modular hip implants require revision surgery and are faced with a number of potential complications including the need for revision surgeries, dislocations, infections, pseudotumor formation, elevated cobalt and chromium metal ions, fluid accumulations around the hip, persistent hip pain, loss of abductor muscles, and inability for the hip to function properly.

Since the first recalls by Zimmer and DePuy in 2008-2010, other metal-on-metal and modular hip arthroplasty devices have been recalled by Biomet, Smith & Nephew, Wright Medical, and Stryker.

The modular hip implant recalls have focused on similar injuries of metallosis leading to premature failure of the devices and the need for revision surgery and medical treatment for various complications, including significant damage to hip muscles, post-operative infections, dislocations, and femur fractures due to the trauma of the revision surgery to remove the well-incorporated femoral stem from the patient’s leg bone. In addition to the device recalls, some of these manufacturers and other, smaller companies decided to stop selling metal-on-metal and modular hip implants due to decreased demand for the products and/or an inability to meet the FDA’s request for enhanced data and studies to substantiate the long-term safety of the implanted devices. There have also been various recalls of these hip implant products in Australia, the United Kingdom, and other parts of the world due to the same concerns.

A worldwide recall of Smith & Nephew’s R3 metal liner was initiated in 2012 after post-surgery surveillance, as documented in international joint registries, noted a 6.3% revision rate within four years of implantation, which was substantially higher than expected based upon published medial data. Post-marketing reports also indicated that female patients, male patients older than 65, and patients that required a femoral head larger than 48 millimeters were at a greater risk of requiring a revision surgery than expected.

The Mass Tort Team at Searcy Denney has nearly two decades of experience in litigating more than 1,000 product liability lawsuits against modular and metal-on-metal hip implant manufacturers. In addition, partners Cal Warriner and Brenda Fulmer have been appointed by state and federal court judges to leadership positions for coordinated litigation involving these defective devices.

Sources:
https://www.mdd.uscourts.gov/re-smith-nephew-birmingham-hip-resurfacing-bhr-hip-implant-products-liability-litigation-mdl-no2775

https://www.smithnephew.com/global/assets/pdf/products/surgical/bhr_urgent_field_safety_notice.pdf

https://www.tga.gov.au/alert/metal-liner-components-r3-acetabular-system-used-hip-replacements