Plaintiffs Ask for LFIT Metal Hip Implant Lawsuits to be Transferred into MDL
Stryker Corporation is facing a new influx of lawsuits alleging injuries from its LFIT Anatomic CoCr V40 Femoral Head commonly used with the Stryker Accolade Hip replacement system, as well as other models. The metal-on-metal hip implant component was recalled in August 2016. Plaintiffs suing over the LFIT are now seeking a multidistrict litigation (MDL).
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.
According to court records, a plaintiff suing over the Stryker LFIT V40 Anatomic Femoral head has asked the U.S. Judicial Panel on Multidistrict Litigation (JPML) to establish an MDL for LFIT lawsuits. An MDL is a type of mass tort where similar federally filed lawsuits are transferred to one court in order to consolidate the litigation and streamline certain pretrial proceedings, including the discovery phase.
The LFIT V40 femoral head is used in several different hip replacement systems, including the Stryker Accolade TMZF, Stryker Accolade 2, the Citation stem, and the Meridian stem. The taper lock is a component of the implant joining the femoral head to the femoral neck. The recall was issued due to the risk of taper lock failure, which can lead to pain, inflammation, loss of mobility, tissue death and other adverse events.
Canadian health regulators recalled the LFIT V40 femoral heads in August 2016, 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,”
Regulators in Australia also issued a warning. The Therapeutic Goods Administration of the Australian Government Department of Health released a “hazard alert” in September 2016 stating “that some LFIT Anatomic CoCr V40 femoral heads manufactured before 2011 have a higher than expected incidence of taper lock failures. The taper lock is the part of the implant that connects the femoral head to the femoral neck.”
Regulators in Australia warned that 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
Taper lock failure can cause dissociation of the femoral head from the hip stem, fractured hip stem trunnion, increased metallic debris, insufficient range of movement, insufficient soft tissue tension, noise from the implant, loss of implant, bone fixation strength, increased wear debris and implant construct with a shortened neck length.
Stryker Metal-on-Metal Hip Implant Recall and Lawsuits
Parker Waichman notes that Stryker has faced other lawsuits over metal-on-metal hip implants. The company recalled its Rejuvenate and ABG II modular-neck hip stems in 2012. The metal-on-metal hip devices were recalled because patients are at risk for “fretting and corrosion” at the modular-neck junction. This can cause injuries such as adverse local tissue reaction (ALTR), pain and swelling at or around the hip joint.
Stryker faced a flood of lawsuits following the recall. Plaintiffs in the litigation allege that the metal hip device caused complications and that Stryker failed to warn of the risks.
In November 2014, Stryker agreed to pay $1.4 billion to settle lawsuits over the ABG II and Rejuvenate. Recently, the company expanded the settlement to include more plaintiffs. The settlement agreement includes plaintiffs who underwent revision surgery to replace their failed hip implant before Dec. 19, 2016. When metal-on-metal hip implants fail and cause complications, a revision surgery is performed. Metal-on-metal hip implant lawsuits have sparked lawsuits because patients have been experiencing a higher rate of early failure.
Metal-on-metal Hip Implant Background
Metal-on-metal hip implants can cause adverse events if the metal surfaces of the device rub against one another, shedding metal debris into the body. Symptoms of metal hip implant failure can include pain, inflammation, tissue damage, bone damage, metallosis (metal poisoning) and the need for early revision surgery.
Thousands of lawsuits have been filed over metal-on-metal hip implants against several different device makers. DePuy Orthopaedics sparked concerns in 2010 when it issued a worldwide recall for its ASR metal-on-metal hip implants. The company faced numerous lawsuits, which ultimately led to a $2.5 billion settlement. DePuy is now in the midst of litigation over the DePuy Pinnacle metal-on-metal hip implant.
In 2012, the U.S. Food and Drug Administration (FDA) convened the Orthopaedic and Rehabilitation Devices Advisory Panel to discuss the safety of metal-on-metal hip implants. The panel issued a safety communication stating that metal-on-metal hip devices present “unique risks.”
The agency said, “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).’”
Plaintiffs, experts and safety advocates point out that metal-on-metal hip implants were approved through 510(k), a fast-track route that allows devices onto the market without substantial clinical testing. Manufacturers seeking approval through 510(k) only need to show that their product is similar enough, or “substantially equivalent” to a previously approved product known as a predicate. High-risk devices such as metal-on-metal hip implants were not intended for 510(k). However, these products were cleared through 510(k) due to a loophole that temporarily allowed high-risk devices to be cleared without clinical data until the FDA made final determinations about device classification. The route has since been criticized, with some arguing that it is inappropriate for certain medical devices.
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).