Plaintiffs who were injured by Smith & Nephew’s Birmingham Hip Resurfacing (“BHR”) system and R3 metal-on-metal liner (“R3”) have filed a motion with the Judicial Panel on Multidistrict Litigation to create new MDL No. 2775 in the US District Court for the District of Maryland.
There are now 31 cases involving the BHR and R3 devices pending in 22 US district courts, with 32 different law firms involved. Most cases were filed in the last 12 months.
The BHR and the R3 are components in “metal-on-metal” hip implant systems made by Smith & Nephew, Inc. Similar metal-on-metal hip systems have been the subject of widespread mass tort litigation in recent years.
Toxic levels of metal
The BHR and R3 devices have caused toxic levels of cobalt and chromium in the bodies of patients implanted with the devices, and caused other symptoms including pain, adverse local tissue reaction, pseudotumor, bone and tissue necrosis, metallosis, and other symptoms leading to revision surgery. The lawsuits charge failure to warn patients and doctors, suppressing important information, defective design, and illegal marketing practices.
The JPMDL previously granted motions to transfer cases involving six other metal-on-metal hips:
- MDL 2158, In re: Zimmer Durom Hip Cup Products Liability Litigation
- MDL 2197, In Re: DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation
- MDL 2144, In Re: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation
- MDL 2329, In re: Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation
- MDL 2391, In re: Biomet M2a Magnum Hip Implant Products Liability Litigation
- MDL 2441, In re: Stryker Rejuvenate and ABG II Hip Implant Products Liability Litigation.
The BHR consists of a femoral head component and a hemispherical acetabular cup made in a range of 12 sizes. The cup fits into the patient’s hip socket, or acetabulum, and then rubs against the femoral head during articulation (movement) of the patient’s hip joint. Both components are made of cobalt and chromium metal alloys.
The BHR may be used as part of a hip resurfacing, or it may be combined with a femoral stem in a total hip arthroplasty. The U.S. Food and Drug Administration approved the BHR for sale in the U.S. on May 9, 2006, through the Premarket Approval (“PMA”) process for Class III medical devices.
High failure rates
The R3 system consists of a femoral head and cup, with a metal acetabular liner separating the two components. These two devices share a similar mechanism of failure, and the FDA initially approved the R3 to be used as part of the BHR system. Smith & Nephew recalled the R3 in June 2012 due to high failure rates. 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.
The problems associated with the BHR and the R3 liner are similar to the injuries caused by other metal-on-metal hip devices, which have been well documented starting with the August 2010 recall of the DePuy ASR device. Data compiled by the National Joint Registry of England and Wales show the BHR has a seven-year revision rate of 11.76 percent, well above the normal acceptable failure rate for a device of this type. Similar data compiled by the National Joint Replacement Registry of Australia in 2015 show the BHR has a ten-year revision rate of 14.5 percent for women. Other studies place the failure rate for women as high as 26 percent.
Smith & Nephew continued selling its metal-on-metal hips for years even after most of its competitors recalled or withdrew similar devices from the U.S. market in 2010 and 2011.
Warnings about BHR system
Smith & Nephew issued an urgent field safety notice in 2015 updating the instructions for use of its Birmingham Hip Resurfacing System. The notice reveals that certain groups of patients are more likely to require revision surgery after receiving a Birmingham Hip Resurfacing System implant. These groups include women, men aged 65 or older, and patients who require an implant head equal to or smaller than 48mm.
This was followed in May 2016 with a new hazard alert issued by the Australian government, also applying to women, men aged 65 or older, and patients who require an implant head equal to or smaller than 48mm.
“Consolidation of other metal-on-metal hip cases has proven to be an efficient and cost-effective tool to resolve products liability litigation where a single manufacturer is connected to hundreds or even thousands of similar claims,” the motion states.
“For example, there are currently 1,452 actions pending in MDL 2197 for the DePuy ASR device, compared to 9,929 total actions historically. Likewise, there are 455 actions pending in MDL 2391 involving Biomet metal hips, compared to 2,642 total actions historically. Finally, there are 1,794 actions pending in MDL 2441 involving Stryker metal hips, compared to 3,356 historically.”
The plaintiff’s nominated Judge Catherine C. Blake, who is familiar with key issues related to Smith & Nephew’s metal-on-metal hip devices. Notably, she evaluated and ruled upon PMA preemption issues in Williams in August 2015 and she recently accepted a second BHR case. Judge Blake has been an Article III judge for more than two decades, and she has presided over at least two other MDLs. She recently presided over MDL 2294, a patent infringement case filed in 2011 that appears to have been resolved as of June 2016.