Stryker Sued over Recalled LFIT V40 Femoral Head
As litigation mounts against Stryker over its LFIT V40 femoral head hip implant component, plaintiffs are asking for product liability lawsuits to be consolidated into a federal multidistrict litigation (MDL). Stryker recalled the metal-on-metal hip implant component last year due to reports of taper lock failure, which can cause adverse events leading to corrective surgery and other complications.
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 pursuing a case.
An MDL is a type of mass tort established by the U.S. Judicial Panel on Multidistrict Litigation (JPML), where lawsuits with common questions of fact are consolidated to one court before one judge. Transferring similar cases into an MDL makes complex litigation more efficient because it streamlines certain legal proceedings, such as the discovery phase, and makes the overall process faster. Unlike a class action lawsuit, an MDL contains individual lawsuits and plaintiffs are therefore treated separately in court.
According to court documents, Stryker plaintiffs have asked the JPML to consolidate LFIT V40 hip implant lawsuits to federal court in Massachusetts before Judge Joseph L. Tauro, Judge Patti B. Saris, Judge Richard Saylor or Judge Indira Talwani.
The LFIT V40 femoral head is a hip replacement component that can be used with different Stryker hip implant systems, such as the Accolade TMZF, Secur-Fit Max, Citation TMZF, and Hipstar. The head was recalled due to reports of taper lock failure, which can cause the implant to be unstable and lead to further complications. The taper lock refers to the portion of the implant connecting the femoral head to the neck.
Typically, a traditional total hip replacement consists of a femoral head or ball on top of the femoral stem, which is inserted into the thighbone (femur). These femoral components interact with an acetabular cup (replaces the hip socket) which contains a liner.
Stryker recalled the LFIT Anatomic V40 Femoral Head on Aug. 29, 2016. According to a recall notification posted on the U.S. Food and Drug Administration (FDA) website, the recall was issued because “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 FDA labeled the recall as Class 2. According to agency definitions, devices under Class 2 recall present a risk of temporary or medically reversible adverse health problems. Class 2 recalls can also describe situations where the risk of serious injury is remote.
Parker Waichman notes that other regulatory health agencies also warned of taper lock failure with the Stryker LFIT V40 femoral head. Health Canada issued a notification in August, stating “Stryker has received higher than expected complaints of taper lock failure for specific lots of certain sizes of LFIT Anatomic COCR V40TM Femoral Heads manufactured prior to 2011,”
The Therapeutic Goods Administration of the Australian Government Department of Health also warned of taper lock failure with the recalled hip implant heads. The regulator said 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
Plaintiffs in the litigation allege that the recalled hip implant component is defective and caused injuries. If a hip implant patient suffers serious complications, such as severe pain, tissue damage, bone damage metal poisoning (metallosis) or joint instability, it would lead to an early revision surgery to remove and replace the device.
Metal-on-Metal Hip Implant Lawsuits and Adverse Events
In metal-on-metal hip implants, the surfaces are made of metal. Experts have concluded that the metal surfaces can release metal particles when the components slide against one another during use. An FDA expert advisory panel discussed these “unique risks” in a 2012 meeting.
The agency states that, “In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running. Metal can also be released from other parts of the implant where two implant components connect. Metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint. This is sometimes referred to as an ‘adverse local tissue reaction (ALTR)’ or an ‘adverse reaction to metal debris (ARMD).’”
Stryker has had issues and litigation over metal-on-metal hip implants in the past. In 2012, the company recalled its Rejuvenate and ABG II modular-neck hip stems due to a risk of “fretting and corrosion”. Patients with the recalled hip devices may subsequently experience complications such as adverse local tissue reaction (ALTR), pain, or swelling near the hip joint.
Stryker was hit with a wave of litigation after the metal-on-metal hip replacement recall in 2012. Ultimately, the company offered $1.4 billion to settle Rejuvenate and ABG II hip implant recall lawsuits in November 2014. In recent news, Stryker has expanded the settlement to include plaintiffs who more recently underwent revision surgery. Specifically, the new settlement agreement resolves litigation on behalf of plaintiffs who underwent revision surgery prior to Dec. 19, 2016.
Metal-on-metal hip implants have become a subject of litigation because patients have been experiencing metal-related complications associated with a higher-than-expected rate of early failure. Plaintiffs, experts, and safety advocates note that metal hip implants were approved without rigorous clinical testing because they were approved through the FDA’s expedited 510(k) process. Even though this route was not intended for high-risk devices such as metal-on-metal hip implants, manufacturers were able to gain clearance through a loophole that temporarily allowed high-risk devices to be cleared without clinical data until the FDA made final determinations about device classification.
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 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).