Stryker continues to face growing metal-on-metal hip implant litigation as lawsuits mount over the company’s LFIT V40 Femoral Head. The hip replacement component was recalled in 2016 due to reports of taper lock failure, which may lead to various adverse events and, ultimately, the need for early revision surgery to remove and replace the device. The Stryker LFIT™ CoCr V40™ Femoral Head may be used with various Stryker hip replacement products, including the Accolade TMZF, Accolade 2 Femoral Stems, Meridian Demoral Stems, and Citation Femoral Stems.
The Parker Waichman LLP personal injury law firm notes that metal-on-metal hip implants have come under scrutiny following recalls and thousands of lawsuits. The firm represents numerous clients in metal-on-metal hip implant lawsuits and continues to offer free legal consultations to individuals who have questions about filing a Stryker LFIT CoCr V40 Femoral Head lawsuit.
Litigation over the hip replacement heads is underway. Plaintiffs suing over the Stryker LFIT V40 femoral head have asked the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidate lawsuits into a federal multidistrict litigation (MDL). The JPML establishes MDLs, a type of mass tort, when there are a growing number of lawsuits with the same basic allegations. The purpose of an MDL is to resolve the litigation faster and in a more efficient manner by centralizing the cases in one court before one judge.
Court records indicate that plaintiffs are requesting a Stryker LFIT V40 Femoral Head MDL in Massachusetts before Judge Joseph L. Tauro, Judge Patti B. Saris, Judge Richard Saylor, or Judge Indira Talwani.
Stryker has also been sued over its metal-on-metal ABG II and Rejuvenate hip implant products, which were recalled in 2012 due to a risk of “fretting and corrosion.” The company recently expanded its $1.4 billion settlement for these lawsuits to include plaintiffs who have undergone revision surgery before December 19, 2016.
MDL Transfer Order and Litigation Caption Approved for Change
Plaintiffs have presented a Transfer Order before the United States Judicial Panel on Multidistrict Litigation, In Re: Stryker Orthopaedics LFIT v40 Femoral Head Products Liability Litigation MDL No. 2768 in an action in the District of Massachusetts (O’Hare) to centralize pretrial proceedings in the District of Massachusetts or, alternatively, the District of Minnesota.
The cases involve alleged defects in Stryker-branded LFIT Anatomic CoCR V40 femoral heads, which is a prosthetic hip replacement device. The plaintiffs’ motion includes six actions pending in three districts. Since plaintiffs filed this motion, the parties have notified the Panel of 27 additional potentially related actions. Defendant Howmedica Osteonics Corp. (HOC) opposes centralization, suggesting selection of the District of New Jersey or, alternatively, the Southern District of New York as the transferee district. HOC also prefers litigation be retitled “In re: HOC LFIT V40 Taper Lock Litigation.”
The Panel indicated that, after considering the argument of counsel, it found that “the actions in this litigation involve common questions of fact, and that centralization in the District of Massachusetts will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation.” The Panel was advised of two actions that do not involve the LFIT V40 device and these will not be placed on a conditional transfer order.
The actions involve common factual questions concerning alleged defects in HOC’s Stryker-branded LFIT Anatomic CoCr V40 femoral heads. On August 29, 2016, Stryker issued a voluntary recall of certain lots of the device that were manufactured prior to March 2011, due to harm secondary to failure of the femoral head to fully lock onto the stem at the stem-head taper junction, known as “taper lock failure.” Plaintiffs’ allegations are specifically concerned about the performance of the LFIT V40 cobalt-chromium device and the alleged propensity of the device to cause corrosion at the taper junction when paired with femoral stems manufactured from different alloys, including HOC’s proprietary TMZF, which is an alloy of titanium, molybdenum, zirconium and iron; corrosion allegedly leads to failure of the implant or other serious health consequences that require revision surgery to remove and replace the implants.
Centralization avoids duplicative discovery on complex issues, including design, testing, manufacturing, and marketing of the LFIT V40 cobalt-chromium femoral head device and related motion practice. Centralization is also consistent with the Panel’s past decisions in other similar hip implant dockets.
For its part, HOC opposes centralization on the grounds that there are only a few actions, that informal cooperation is workable, and that centralization will prove inefficient given the wide variety of combinations—stem type, different lengths, and offsets—that may be used with its femoral head product.
The Panel indicated that it is not persuaded by HOC’s arguments, noting that there are significant cases pending, including 33 cases in 17 different districts, with no less than eight groups of what appear to be competing plaintiffs’ counsel involved. The Panel also indicated that, “Without a doubt, there will be some individualized factual issues in each action, but these issues do not at this early stage of litigation negate the efficiencies to be gained by centralization.”
The Panel also noted that, the variety of different combinations of sizes and types of stems that may be used with the modular LFIT V40 device “is not an insurmountable barrier to centralization,” pointing out that this type of argument may be “applied to many prior hip implant MDL dockets involving allegedly problematic metal-on-metal articulation.” The Panel also indicated that it has previously stated that “[a]lmost all personal injury litigation involves questions of causation that are plaintiff-specific. Those differences are not an impediment to centralization where common questions of fact predominate.”
As well as the specific causes of the failure of each plaintiff’s device, the cases now involve a number of common issues concerning how the LFIT V40 cobalt-chromium femoral head was developed, manufactured, tested, promoted, and labeled, as well as its regulatory history. The Panel noted that the transferee judge may find it useful to establish different tracks for the various femoral stems that may be mated with the LFIT device, for example.
Also, the defendant requested that the MDL title of In re: Stryker Orthopaedics LFIT V40 Femoral Head Products Liability Litigation be changed to In re: HOC LFIT V40 Taper Lock Litigation. The Panel indicated that it will eliminate the word “Orthopaedics” from the title, as Stryker Orthopaedics is a predecessor of HOC, but declines to change “Stryker” to “HOC,” as the defendant marketed the device to physicians under the Stryker brand name. The Panel also declined to change the title to add the words “taper lock” to the litigation caption or to limit the scope of the MDL to recalled devices only. Few plaintiffs specifically state “taper lock” as an issue, instead they discuss issues with problems experienced, including those listed as potential hazards in the recall notice, including excessive metal debris, disassociation of the head from the stem/failure, trunnion fracture, and other related descriptions such as corrosion at the femoral head and stem junction. Because the plaintiffs allege that all LFIT V40 devices are substantially similar, regardless of recall status, and that they have experienced similar problems, the claims regarding non-recalled devices should be included in the MDL, according to the Panel.
The Panel also indicated that it is persuaded that the District of Massachusetts is the appropriate transferee district for this litigation. Five LFIT V40 cases in the District of Massachusetts are pending before Judge Indira Talwani, who has not yet had an opportunity to preside over an MDL docket; however, Boston offers an accessible transferee forum for this litigation, which involves a product that was distributed nationwide and the District of Massachusetts is relatively close to HOC’s Mahwah, New Jersey headquarters, where relevant documents and witnesses may be found. Also, the caption of the litigation shall be changed to “In re: Stryker LFIT V40 Femoral Head Products Liability Litigation.”
What are the Safety Concerns with the Stryker LFIT V40 Head?
Parker Waichman notes that regulators, both within and outside of the U.S., have issued recall notifications for the Stryker LFIT V40 head. In a total hip replacement, there is usually a femoral component that replaces the thighbone (femur). The femoral component is made up of several different parts: A stem inserted into the bone itself, and a ball (head) sitting on top. The ball and stem are joined at the femoral neck; this is also known as a taper lock system. The femoral ball connects to the acetabular component, a cup that essentially replaces the hip socket, to replicate the natural motion of the hip joint.
The Stryker LFIT V40 femoral head raises safety concerns because patients have been experiencing failure at the taper lock portion, causing the hip to be unstable and leading to other complications.
An August 29, 2016 recall notification on the U.S. Food and Drug Administration (FDA) website indicates that “Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads,”
The device was also recalled in Canada at around the same time. Similarly, the Therapeutic Goods Administration of the Australian Government Department of Health issued a “hazard alert” warning of taper lock failure with the devices.
Symptoms of taper lock failure may include:
- loss of mobility
- adverse local tissue reaction
- joint instability
- broken bones around the components
- leg length discrepancy
- need for revision surgery
Stryker Faces Mounting Litigation over LFIT V40 Metal Hip
The LFIT V40 Femoral Head is part of a metal-on-metal hip replacement system. These devices have become controversial over the past several years, following recalls and thousands of lawsuits. Metal-on-metal hip implants can release metal particles into the patient’s body when the surfaces of the implant grind against one another while the patient is walking or running. Adverse events associated with metal-on-metal hip implants include metal poisoning (metallosis), bone damage, tissue damage, pain, inflammation, pseudotumors, difficulty walking, and other injuries.
Complications from metal-on-metal hip implants may force patients to undergo a revision surgery to remove or replace the implant. Lawsuits are often filed on behalf of metal-on-metal hip implant patients who underwent an early revision surgery due to device complications.
Legal Help for Stryker Metal-on-Metal Hip Implant Recipients
Parker Waichman has years of experience representing clients in numerous metal-on-metal hip implant lawsuits. If you or someone you know was implanted with a Stryker metal-on-metal hip implant such as the Stryker ABG II, Rejuvenate, or the LFIT, you may have valuable legal rights. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).