Possible MDL Ahead for Smith & Nephew BHR, R3 Hip Implant LitigationMar 17, 2017
Smith & Nephew Face BHR, R3 Metal-on-Metal Hip Implant Lawsuits
Smith and Nephew is facing product liability lawsuits alleging injuries from its Birmingham Hip Resurfacing (BHR) system and R3 liner metal-on-metal hip implant products. According to court records, plaintiffs in the litigation are asking for cases to be consolidated into a federal multidistrict litigation (MDL).
The product liability lawyers at Parker Waichman LLP have decades of experience representing clients in lawsuits over allegedly defective or dangerous products. The firm continues to offer free legal consultations to individuals with questions about filing a Smith & Nephew hip implant lawsuit.
Plaintiffs have requested that Smith and Nephew BHR and R3 metal-on-metal hip implant lawsuits be consolidated in the U.S. District Court for the District of Maryland. A motion has been filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML), court records show. The JPML creates MDLs in order to make complex litigation more efficient. Similar lawsuits are centralized to one court before one judge. Consolidating cases in this manner streamlines the legal process because certain proceedings, such as the discovery phase and expert witness testimony, only need to be conducted once. Plaintiff complaints are also replaced with a Master Complaint that applies to all plaintiffs and a Short Form Complaint for individual allegations.
Smith and Nephew currently faces 31 BHR and R3 lawsuits in 22 U.S. District Courts. The devices fall into the category of metal-on-metal hip implants, meaning the contacting surfaces are made of metal. Thousands of lawsuits have been filed over metal-on-metal hip implants, particularly following high-profile recalls and reports of high failure rates. The R3 Acetabular System was recalled in 2012 and the BHR was withdrawn from the market in 2015.
Smith and Nephew has also recalled other hip implant products. Three Class 2 recalls were issued for its Modular Redapt Hip System, the Modular SMF Hip System, and Modular Necks "due to a higher than anticipated complaint and adverse event trend." The recall affects a total of 32,000 products. The FDA labels a recall as Class 2 when exposure to the recalled device presents a reasonable risk of medically reversible or temporary injuries, or where the risk of serious injury is remote.
Injuries associated with the Modular systems includes include pain, swelling, limited mobility, and an enlarged bursa. Doctors may want to test patients for increased levels of cobalt or chromium ions, Smith and Nephew said. The presence of metal ion levels over 7 parts per billion "may indicate the potential for soft tissue reaction,"
"The need for any additional follow-up should be determined on an individual case-by-case basis following an assessment of patients' clinical circumstances," Smith and Nephew stated. "Revision surgery should only be considered after a comprehensive examination of all the clinical findings, including blood work, imaging and especially if an adverse soft-tissue reaction is confirmed,"
Additionally, in August 2016, Smith and Nephew recalled its Tandem Bipolar Hip System because it can detach after surgery. The company said "some Bipolar shells were manufactured with an out-of-specification retainer groove,"
Metal-on-Metal Hip Implant Lawsuit Background
Plaintiffs in the litigation allege that the BHR and R3 hip implants are defective due to their metal-on-metal design. Smith and Nephew allegedly knew about the risks but failed to warn patients or their physicians.
When metal-on-metal hip implants were first introduced, they were marketed as being more durable and better suited for younger, more active patients. However, in recent years, experts have found that the implants can shed metal debris into a patient's bloodstream and local tissue. This can lead to adverse events such as metallosis (metal poisoning), bone damage, soft tissue reaction, pain, inflammation, pseudotumors, and the need for early revision surgery.
In 2012, the FDA convened an expert panel who concluded that metal-on-metal hip implants pose "unique risks." The agency states, "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),"
Several other device makers have been sued over metal-on-metal hip implants. Litigation primarily started with DePuy Orthopaedics, who initiated a worldwide recall for its ASR hip implants in 2010. The JPML has established MDLs against several metal-on-metal hip implant makers, including Zimmer, Wright Medical Technology, Biomet and Stryker.
Filing a Hip Replacement Lawsuit
Parker Waichman has years of experience representing clients in medical device injury lawsuits. If you or someone you know is interested in filing a hip replacement lawsuit, contact one of our experienced product liability lawyers today. 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).