The United States Judicial Panel on Multidistrict Litigation (JPML) has centralized lawsuits in federal district courts in connection with HowmedicaOsteonics Corp.’s Stryker-branded LFIT Anatomic CoCR V40 femoral heads and Smith & Nephew’s Birmingham Hip Resurfacing (BHR) system.
In re: Stryker LFIT V40 Femoral Head Products Liability Litigation
The JPML created MDL No. 2768 (In re: Stryker LFIT V40 Femoral Head Products Liability Litigation) to transfer 33 pending federal lawsuits from 17 district courts, along with all future claims, asserting injury caused by HowmedicaOsteonics Corp.’s Stryker-branded LFIT Anatomic CoCR V40 femoral heads, a prosthetic hip replacement device. In an order issued April 5, the JPML ordered the transfer of all cases currently filed outside the United States District Court for the District of Massachusetts to the court so that they can be coordinated before U.S. District Judge Indira Talwani, who the panel noted has not yet had an opportunity to preside over an MDL.
As set forth in our February 13, 2017 blog post, Stryker’s LFIT V40 Anatomic CoCr Femoral Heads are made of a cobalt and chromium alloy and were designed to offer surgeons the intra-operative flexibility to better match patient anatomy and restore natural movement to enhance hip stability, minimize dislocation and maximize range of motion. The heads are used in combination with several of modular hip implants, including Accolade TMZF, Accolade 2 Stems, Meridian Stems, and Citation Stems. More than 100,000 LFIT V40 components may have been implanted in patients
Stryker issued an urgent voluntary medical device recall on August 29, 2016 related to the Stryker LFIT Anatomic CoCr V40 Femoral Heads manufactured prior to 2011. Potential hazards listed in the recall notice included excessive metal debris, disassociation of the head from the stem/failure, trunnion fracture, and corrosion at the femoral head and stem junction.
Filed lawsuits allege that the titanium material of the hip stem did not maintain structural integrity when used with the chromium and cobalt V40 femoral heads, thereby causing disassociation of the head from the hip stem, hip stem fractures, high levels of metallic debris in the bloodstream (metallosis), poor range of motion, loss of implant and/or bone fixation strength, debris from excessive wear, low tissue tension and noise. Accordingly, patients suffered injuries including loss of mobility, pain, inflammation, adverse local tissue reaction, dislocation, joint instability, broken bones, leg length discrepancy, which necessitated painful revision surgeries.
In consolidating the lawsuits, the JPML considered that the lawsuits have common issues about the development, manufacture, testing, regulatory history, promotion, and labeling of the LFIT V40 cobalt-chromium femoral head. “We note, though, that the transferee judge might find it useful, for example, to establish different tracks for the different femoral stems that can be mated with the LFIT device,” the JPML said.
In re: Smith & Nephew Hip Implant Products Liability Litigation
The JPML created MDL No. 2775 to centralize Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation. United States District Judge Catherine C. Blake in the District of Maryland will hear 28 actions pending in 19 districts, plus 11 related actions pending in 11 other district courts. Judge Blake already presided over two Smith & Nephew hip lawsuits, with the JPML stating she “is an experienced MDL judge with the willingness and ability to manage this litigation efficiently. She is well situated to structure this litigation so as to minimize delay and avoid unnecessary duplication of discovery and motion practice.”
As set forth in our February 2, 2017 blog post, the BHR was approved by the U.S. Food and Drug Administration (FDA) on May 9, 2006 through its expedited Premarket Approval process for Class III medical devices as one of the first metal-on-metal hip replacement systems on the market, designed relieve pain and improve hip joint function. The BHR system consisted of two parts: (1) a ball-shaped cap called the femoral resurfacing component, and (2) a cup-shaped socket called the acetabular component. The acetabular component was designed to replace the damaged surface of the hip socket, while the femoral resurfacing component was inserted into the top of the thigh bone. This system was created to work modularly, wherein surgeons would have multiple options for individual fit in each patient.
Smith & Nephew has faced litigation involving its hip implants since 2010. The lawsuits share factual questions concerning the design, manufacture, marketing or performance of Smith & Nephew’s BHR system, and allege that (i) they have suffered pain, adverse local tissue reaction, pseudotumors, bone and tissue necrosis, metallosis, or other symptoms, often necessitating revision surgery, (ii) the FDA approval of the BHR required Smith & Nephew to meet several post-marketing surveillance and reporting requirements that were designed to ensure that in real-world use, the hip replacement system was safe and effective, and (iii) the manufacturer has failed to do so, claiming that Smith & Nephew knew for years about reports of complications with Birmingham hip resurfacing, including revision surgeries and failures, yet failed to adequately inform the doctors or patients. The company later withdrew the BHR device from the U.S. market in June 2015 due to similar high failure rates, particularly in women and in patients with smaller hip joints.