In April of 2017, multi-district litigation (known as “MDL 2775”) was established in federal court in Baltimore, Maryland before United States District Court Judge Catherine C. Blake against Smith & Nephew, which is based in England and sells its products, which are not limited to hip implants, in 90 countries across the world. The headquarters for Smith & Nephew in the United States are located in Memphis, Tennessee.
An MDL is a “Multi-District Litigation” and these are used to more efficiently speed up the legal process when cases involving many people, such as class actions and mass torts, are filed in the US. Their purpose is to instead of having thousands of cases filed in dozens of jurisdictions is to consolidate these to one court and under one judge.
From 28 to over 600 lawsuits
The Smith and & Nephew MDL began with 28 individual defective hip lawsuits transferred from 19 district courts from across the country. Since then, the coordinated litigation has grown to include more than 600 individual lawsuits. Most of the pending lawsuits relate to cases where patients were implanted with Birmingham resurfacing hip implants (which include a femoral head and acetabular cup but not a femoral stem) and underwent revision surgery due to metallosis, elevated cobalt and chromium ions in the bloodstream and joint fluid, pseudotumor formation, and premature failure of the devices.
There are also a number of individual lawsuits pending and coordinated in the MDL that relate to Smith & Nephew R3 and Birmingham total hip implant devices (which include a femoral stem in addition to the cobalt-chrome femoral head and acetabular cup), which the MDL was expanded to include in 2018. These total hip implant lawsuits also allege that the Smith & Nephew metal-on-metal hip implant products are defective due to an excessive failure rate, the need for revision surgery, and injuries to patients due to heavy metal toxicity and poisoning.
As of May of 2019, more than 1 million pages of documents have been produced from the manufacturer in MDL 2775 with additional discovery continuing through the end of 2019. Most of the discovery so far has focused on the Smith & Nephew Birmingham Resurfacing hip implant. Discovery relating to Smith & Nephew total hip arthroplasty devices, including the Birmingham THA and R3 products, is continuing on a parallel track and expected to be expedited soon, especially in light of the failed mediations and settlement discussions for these particular lawsuits. Dozens of depositions of witnesses in the United States and overseas will also be completed in the coming months in preparation for the first jury trials in the MDL proceedings, which are anticipated to begin in March of 2020. We anticipate that case-specific discovery will be initiated in the latter part of 2019 once Judge Blakes decides which individual patient lawsuits will be included in the pool of cases for these initial MDL bellwether trials in 2020. Judge Blake has encouraged the parties to continue to engage in settlement talks, especially with regard to the THA lawsuits. Smith & Nephew has not been as motivated to discuss settlement on the hundreds of lawsuits involving resurfacing devices, as it contends that those cases are subject to dismissal due to federal medical device preemption laws.
Legal Claims Against Smith & Nephew
The lawsuits that have been filed on behalf of injured patients allege various claims against Smith & Nephew for the metal-on-metal total hip and resurfacing implant products, including that:
- The devices are defectively designed and generate dangerous metal debris through contact on the articulating surface which causes harm to patients;
- The warnings that accompanied the products and information that was provided to implanting surgeons and patients were inadequate;
- The products were not properly approved or cleared by the FDA for implantation in patients;
- The products have an excessively high failure rate after implantation in patients due to metallosis;
- The marketing and promotion of the implant system to surgeons was deceptive and misleading;
- Smith & Nephew failed to properly monitor patients, the published medical information, international device registries, and other sources to identify and address potential safety risks;
- The hip implants products were not properly tested and studied prior to implantation in patients;
- The manufacturer violated various federal and state consumer protection requirements relating to design and manufacture of the devices; and
- Various other allegations relating to defects and negligence in the design, manufacture, marketing, promotion, and safety surveillance and monitoring of the Smith & Nephew hip implant products.
Smith & Nephew has been selling Birmingham resurfacing total hip arthroplasty hip implant products in the United States since 2006. This resurfacing hip implant, often referred to as a “BHR implant” includes a femoral head and a matching acetabular cup, both of which are made from a cobalt-chromium alloy. The R3 Acetabular Hip System incorporates the Birmingham components but has interchangeable liners made of polyethylene, ceramic, or metal. The R3 implant with a metal liner is the product that is included in the MDL litigation, and has been marketed in the United States since 2009.
Dispute Over FDA Approval and Federal Medical Device Preemption Immunity
One of the critical issues in the pending lawsuits across the county is the manner in which the BHR implant components were approved or cleared by the FDA for sale. Smith & Nephew contends that it is immune from liability for any alleged defects in the design of its BHR products on the basis that the Food & Drug Administration approved the product through a Premarket Approval application, commonly known as the “PMA” process (which is a more rigorous review process by the FDA than is often used for other hip implant products). The Defendant also contends that this immunity extends to the Birmingham and R3 total hip implant products as well.
This legal doctrine, approved by the United States Supreme Court, is medical device preemption and is highly controversial and unknown to most patients that assume that a company that produces a medical product that causes an injury should be able to be sued in court by the patient. The Plaintiffs claim in this litigation that the BHR acetabular cup was approved by the PMA process, but that the modular femoral head and femoral stem components used to construct the Smith & Nephew total hip arthroplasty system were not approved by the FDA, such that the Defendant should not be immune from liability for the alleged defects in the design of the product.
10+ Years of Hip Implant Safety Issues
Over the last 10 years, there have been numerous recalls and safety alerts regarding metal-on-metal and modular hip implants. The first recalled devices included the Zimmer Durom Cup and DePuy ASR metal-on-metal hip implant products. These products were noted to have an excessive premature failure rate due to excessive metallic debris emanating from the articulating surface of the implant, where the cobalt-chromium metal femoral head was coming into contact with the cobalt-chromium metal acetabular cup (the part of the implant that replaces the hip socket). This process is known as metallosis and leads to bone and soft tissue damage in the hip joint which undermines support and proper functioning of the hip implant. Ultimately, patients with failed metal-on-metal or modular hip implants require revision surgery and are faced with a number of potential complications including the need for revision surgeries, dislocations, infections, pseudotumor formation, elevated cobalt and chromium metal ions, fluid accumulations around the hip, persistent hip pain, loss of abductor muscles, and inability for the hip to function properly.
Since the first recalls by Zimmer and DePuy in 2008-2010, other metal-on-metal and modular hip arthroplasty devices have been recalled by Biomet, Smith & Nephew, Wright Medical, and Stryker.
The modular hip implant recalls have focused on similar injuries of metallosis leading to premature failure of the devices and the need for revision surgery and medical treatment for various complications, including significant damage to hip muscles, post-operative infections, dislocations, and femur fractures due to the trauma of the revision surgery to remove the well-incorporated femoral stem from the patient’s leg bone. In addition to the device recalls, some of these manufacturers and other, smaller companies decided to stop selling metal-on-metal and modular hip implants due to decreased demand for the products and/or an inability to meet the FDA’s request for enhanced data and studies to substantiate the long-term safety of the implanted devices. There have also been various recalls of these hip implant products in Australia, the United Kingdom, and other parts of the world due to the same concerns.
A worldwide recall of Smith & Nephew’s R3 metal liner was initiated in 2012 after post-surgery surveillance, as documented in international joint registries, noted a 6.3% revision rate within four years of implantation, which was substantially higher than expected based upon published medial data. Post-marketing reports also indicated that female patients, male patients older than 65, and patients that required a femoral head larger than 48 millimeters were at a greater risk of requiring a revision surgery than expected.
The Mass Tort Team at Searcy Denney has nearly two decades of experience in litigating more than 1,000 product liability lawsuits against modular and metal-on-metal hip implant manufacturers. In addition, partners Cal Warriner and Brenda Fulmer have been appointed by state and federal court judges to leadership positions for coordinated litigation involving these defective devices.
3M Combat Arms Earplugs May Have Caused Hearing Loss
The Judicial Panel on Multidistrict Litigation (JPML) issued a Transfer Order on April 3, 2019 centralizing lawsuits against 3M relating to allegations of issues regarding the design, testing, sale, and marketing of the dual-ended Combat Arms Earplugs, Version 2. The newly created Multidistrict Litigation (MDL) will be overseen in the Northern District of Florida by Judge M. Casey Rodgers, a federal judge with prior experience handling a large-scale MDL.
In July 2018, 3M announced a $9.1 million payment to resolve allegations that it knowingly sold its dual-ended Combat Arms Earplugs, Version 2 to the United States military without disclosing defects that hampered the effectiveness of the hearing protection device. On the heels of this announcement, individual service members suffering from problems including hearing loss and tinnitus began filing lawsuits alleging their hearing injuries resulted from use of the earplugs.
JPML Coordination of 3M Combat Arms Earplugs Hearing Loss Lawsuits
In early 2019, Plaintiffs requested coordinated pretrial proceedings, otherwise known as the formation of an MDL, over the eight lawsuits filed at the time on the basis that the lawsuits all made similar allegations of wrongdoing against 3M. Less than four months later and on the date the JPML entered the Transfer Order, the Court noted it was aware of 635 related lawsuits (in addition to the original eight) filed in 33 different courts. The JPML granted the Transfer Order after finding the lawsuits “involve common factual questions arising out of allegations that defendants’ Combat Arms earplugs were defective, causing plaintiffs to develop hearing loss and/or tinnitus…[c]entralization will eliminate duplicative discovery; prevent inconsistent rulings on Daubert issues and other pretrial matters; and conserve the resources of the parties, their counsel, and the judiciary.”
Barring objections, all of the related lawsuits – and future lawsuits filed by Combat Arms Earplugs, Version 2 users – will be transferred to the Northern District of Florida. The JPML reviewed suggestions to transfer the cases to other locations including the District of Minnesota – the location of 3M’s corporate headquarters, the Western District of Missouri, the District of Columbia, the Middle District of Georgia, and the Southern District of Florida, among others. It ultimately chose the Northern District of Florida as “a forum with the necessary judicial resources and expertise to manage this litigation efficiently and in a manner convenient for the parties and witnesses.” It is important to note that any lawsuits that are not resolved through settlement, bellwether trial, or motion practice during pretrial proceedings will be transferred back for plaintiffs to have individual trials at the conclusion of the MDL.
JPML Appoints the Honorable M. Casey Rodgers to Preside Over 3M Combat Arms Hearing Loss Cases
The JPML transferred this new MDL to Judge M. Casey Rodgers. The panel noted that Judge Rodgers is “an able jurist with experience in presiding over a large products liability MDL.” Judge Rodgers was previously appointed to oversee MDL No. 2734, In Re: Abilify (Aripiprazole) Products Liability Litigation in October 2016. The Abilify MDL held over 2,000 lawsuits at its height. This MDL arose from lawsuits alleging the drug, an atypical anti-psychotic medication prescribed to treat a variety of mental disorders, can cause impulse control problems in users. A confidential settlement was announced in February 26, 2019, beginning the process of winding down MDL No. 2734.
Judge Rodgers became a United States Magistrate Judge in May 2002. On November 21, 2003, President George W. Bush appointed her to a position as United States District Judge for the Northern District of Florida. She served as Chief United States District Judge for the Northern District from June 2011 to June 2018.
On March 28, 2019, the United States Judicial Panel on Multidistrict Litigation will hear arguments from attorneys representing individual service members across the country and attorneys from 3M Company regarding whether claims against 3M for hearing loss injuries stemming from use of the earplugs during active duty should be consolidated for pretrial proceedings. In these lawsuits, service members claim the company defectively designed its earplugs such that they did not provide sufficient levels of hearing protection. Additionally, the lawsuits claim 3M misrepresented the effectiveness of its hearing protection devices to the military during the proposal process when seeking to procure a government contract to be the exclusive earplug provider to the military and thereafter. As a result, service members who used the earplugs allege incurring noise-induced tinnitus and hearing loss.
Background of 3M Combat Arms™ Earplug Litigation
Military service members in training, standard military operations, and especially those in combat, are often exposed to high intensity noise of various types. Between 2003 and 2015, Aero Technologies and 3M Company (who acquired Aero Technologies in 2008) sold millions of the Combat Arms™ earplugs to the military for use by service members in active combat and otherwise. The earplugs are non-liner, or selective attenuation earplugs; this means there are two sides to give soldiers two options for hearing reduction in one product. When worn on the olive-colored side, or the “closed” position, the earplugs were intended to block noise like a traditional earplug. When worn on the yellow side, the “open” position, the earplugs were intended to block or significantly reduce loud noises while allowing the user to hear lower level noises, like communications from commanding officers.
In May 2016, Moldex-Metric, Inc. filed a qui tam lawsuit against 3M Company alleging violations of the False Claims Act for representations it made to the United States about the hearing protection afforded by the Combat Arms™ earplugs. The qui tam action followed lawsuits both 3M and Moldex-Metric, Inc. had previously filed against each other; news reports indicate 3M sued Moldex-Metric, Inc. for earplug patent infringement and Moldex-Metric, Inc. countersued for fraud and failure of 3M’s earplugs to pass safety tests, in violation of its contracts with the military.
A qui tam lawsuit is a lawsuit brought by a private citizen – here, a competitor earplug manufacturer – that alleges false statements in the performance of contract with the government or in violation of government regulation. In other words, the lawsuits allege fraud on the government. Here, Moldex-Metric, Inc. alleged Aero Technologies designed the Combat Arms™ earplugs in a manner that was too short for correct insertion, resulting in loosening without recognition by the person wearing them – and that Aero Technologies knew about the product defect as early as 2000. The lawsuit maintained Aero Technologies/3M did not disclose this defect to the United States. Notably, according to the U.S. Department of Veterans Affairs (VA), tinnitus and hearing loss are the two most common health conditions among military veterans. The qui tam lawsuit cited sources quantifying VA service member hearing loss treatment at over $1 billion per year.
In a qui tam lawsuit, the government has the option to join the private citizen as a plaintiff in the lawsuit or to opt out and have the private citizen pursue the fraud claims on his or her own. In July 2018, the United States joined as a party and publicly announced a settlement with 3M. As part of the settlement, 3M paid $9.1 million to the United States “to resolve allegations that it knowingly sold the dual-ended Combat Arms Earplugs, Version 2 (CAEv2) to the United States military without disclosing defects that hampered the effectiveness of the hearing protection device.” The settlement resolved claims the U.S. government had against 3M; it did not resolve any claims of individual service members for injuries suffered as a result of 3M’s alleged false statements.
Following the announcement of the settlements and primarily starting in January 2019, individual service members who used the Combat Arms™ earplugs as instructed and suffered noise-induced hearing loss during their time in service began filing individual lawsuits against 3M. As of February 14, 2019, service members have filed over 150 lawsuits in various state and federal courts.
The United States Judicial Panel on Multidistrict Litigation and the Case for Consolidation of 3M Combat Arms™ Earplug Lawsuits
Multidistrict litigation is a mechanism for increasing efficiency in the federal court system. Created through an Act of Congress in 1968, 28 U.S.C. 1407, the law allows for the transfer of civil actions involving common questions of fact to one federal district court for coordinated or consolidated pretrial proceedings. The efficiency in transferring cases to on federal court, or “centralization,” is accomplished through avoidance of discovery duplication, prevention of inconsistent pretrial rulings, and conserving resources of the parties, their attorneys, and the judiciary.
Attorneys representing one of the service member plaintiffs filed a motion seeking transfer of claims by U.S. military personnel and other wearers of the Combat Arms™ earplugs who suffered hearing-related injuries for coordinated proceedings on January 25, 2009. To transfer a case, the Judicial Panel on Multidistrict Litigation must determine that the transfer will (1) be for the convenience of parties and witnesses; and (2) promote the just and efficient conduct of the related lawsuits. If the Judicial Panel determines a case should be centralized, they will also determine at the hearing which judge will handle the centralized proceedings. General opinion is in favor of consolidation, given the similarity of all of the claims asserted and the number of claims filed – as well as the scores of lawsuits expected to be filed in the future. The real question may be which judge is appointed to oversee centralization – suggestions have included judges in the District of Minnesota (where 3M headquarters is located), the Eastern District of Louisiana, and the Western District of Missouri.
Searcy, Denney, Scarola, Barnhart & Shipley, P.A. is currently investigating and handling cases of service members who suffered hearing loss and tinnitus injuries arising from use of the 3M Combat Arms™ earplugs. If you have any questions about these cases, please give us a call.
Almost half a million pacemakers implanted in patients with heart disease have been recalled because of a scary and shocking scenario: The life-saving devices could be tampered with remotely by computer hackers – pacemaker hacking is becoming a possibility.
The U.S. Food and Drug Administration released a safety alert in August of 2017 about potential pacemaker hacking, stating the potential for personal harm. The safety alert, titled “Implantable Cardiac Pacemakers by Abbott (formerly St. Jude Medical): Safety Communication – Firmware Update to Address Cybersecurity Vulnerabilities,” immediately grabbed headlines.
Pacemaker Hacking Fears Stoked by FDA
“White hat hackers have previously pointed out the risks with connected medical devices,” according to an article in Fortune titled “465,000 Pacemakers Recalled on Hacking Fears.” “In its announcement, the FDA noted that this vulnerability could allow third parties to rapidly drain the pacemaker’s battery or adjust the operation of the device.”
Josh Corman, director of the Atlantic Council’s Cyber Statecraft Initiative, which focuses on the public impact of cybersecurity vulnerabilities, said the threats involving such medical devices are real.
“Corman says people should not have a crisis of confidence that imperils future medical breakthroughs, despite the reality that nothing is unhackable,” CNN Money reports in an article titled “Over half a million hackable pacemakers can now be fixed.” “Instead, he says, it’s important to determine what connectivity is actually needed, and balance it with acceptable risks.”
The fix actually is easy and takes no more than three minutes, although it will require everyone affected to make an appointment with his or her doctor. The corrective action is a firmware update.
“The FDA and Abbott do NOT recommend prophylactic removal and replacement of affected devices,” the FDA states in the safety alert. “Print or digitally store the programmed device settings and the diagnostic data in case of loss during the update.
After the update, confirm that the device maintains its functionality, is not in backup mode, and that the programmed parameters have not changed.”
The FDA stated that no injuries have been reported yet but made clear the danger of that happening in the future.
“Many medical devices – including St. Jude Medical’s implantable cardiac pacemakers – contain configurable embedded computer systems that can be vulnerable to cybersecurity intrusions and exploits,” the safety alert states. “As medical devices become increasingly interconnected via the Internet, hospital networks, other medical devices, and smartphones, there is an increased risk of exploitation of cybersecurity vulnerabilities, some of which could affect how a medical device operates.”
Pacemaker Hacking Scenarios Explained
The scary and shocking scenario might play out like this: A computer hacker gains access to an implanted pacemaker and changes its programmed data, resulting in improper pacing – making the heart beat too fast or too slow – depleting the battery in the process. While the FDA’s safety alert is limited to pacemakers, there is no reason bad actors are unable to gain access to other devices connected to the Internet. The firmware of these devices forms the basis of their operating systems.
Included in the recall list are the Accent DR RF, Accent MRI, Accent SR RF, Allure Quadra RF, Allure RF, Anthem RF, Assurity, Assurity MRI and Quadra Allure MP RF.
“All industries need to be constantly vigilant against unauthorized access,” Robert Ford, Abbott’s executive vice president of medical devices, said in a press release titled “Abbott Issues New Updates for Implanted Cardiac Devices.” “This isn’t a static process, which is why we’re working with others in the healthcare sector to ensure we’re proactively addressing common topics to further advance the security of devices and systems.”
The topic of hacking and health care is not a new one. In 2013, former Vice President Dick Cheney revealed on CBS’ 60 Minutes he disabled a feature on his defibrillator that enabled it to be connected to Wi-Fi out of fear of being assassinated by terrorists. Also in 2013, the FDA and the Industrial Control Systems Cyber Emergency Response Team, which works to reduce the risks surrounding 16 critical-infrastructure sectors in the United States, came out with dual studies not only on pacemakers and defibrillators but on drug-infusion pumps, patient monitors and ventilators, as well – all containing passwords. A blog later published the findings.
“Pacemaker programmers do not authenticate to pacemaker devices,” the blog, titled “Understanding Pacemaker Systems Cybersecurity,” states. “Any pacemaker programmer can reprogram any pacemaker from the same manufacturer. This shows one of the areas where patient care influenced cybersecurity posture.”
Patients and physicians are urged to contact Abbott’s customer hotline for technical support. The number is 800‐722‐3774 and patients can call with questions regarding the firmware update. They additionally are urged to report any adverse events via the FDA’s MedWatch Online Voluntary Reporting Form.
Please note: At this time, the dangerous drug attorneys at Searcy Denney are not accepting cases for injuries from the Medtronic Infuse Bone Graft. If you or a loved one has suffered injuries by another dangerous drug or medical device, we are always available to answer your legal questions for free.
Medtronic, one of the world’s largest medical-device makers, already has been the focus of high-profile litigation that resulted in an $8.45 million settlement. The Dublin, Ireland, company whose operational headquarters are in Fridley, Minnesota, is now the focus of more high-profile litigation involving thousands of Medtronic Infuse cases that could result in $300 million in payouts.
All of the cases surround the Infuse Bone Graft product. Infuse Bone Graft, when used correctly, is surgically implanted in an area of the body where bone growth is lacking. It consists of a naturally occurring protein carried via a sponge, which releases the protein in stages so it can be absorbed properly.
“Using Infuse Bone Graft eliminates the need for a second surgery to harvest, or remove surgically, bone from your body (“autogenous” bone) for placement at the surgery site,” the Medtronic Web site states. “Autogenous bone harvest has the risk of pain, complications, longer surgical time, and more anesthesia.”
Problems with Medtronic Infuse Bone Graft Explained
Problem is, Infuse Bone Graft has not been used correctly, according to the plethora of plaintiffs who have suffered debilitating and permanent injuries as a result. In some cases, patients said they were unaware they were going to receive the product.
Medtronic’s Headquarters in Fridley, Minnesota. By Group29 – Own photo, CC BY-SA 3.0, Wikipedia.
“Many of the injured patients allege in their lawsuits that they found out about the use of Infuse only after their surgery ended with complications,” reports the StarTribune in an article titled “Medtronic says it’s close to resolving Infuse lawsuits.” “Some say Medtronic sales reps were present in the operating rooms during their surgeries.”
That allegation was the root of the problem in the first case, where two men being treated at the University of California Los Angeles said their doctors were getting kickbacks from Medtronic.
“Patients Ralph Weiss and Jerome Lew alleged that hundreds of thousands of dollars in Medtronic consulting, grants and royalty payments to UCLA surgeon Jeffrey Wang created conflicts of interest that led to risky treatments about which they were not informed,” the StarTribune reports in another article titled “Patients who received Medtronic’s Infuse product to get $8.45 million in settlements.” “They said they were not told that they were receiving Infuse or that it was being inserted into mechanical devices with which it had never been tested for safety.”
In addition to the sponge, there is another carrier for Infuse Bone Graft – the LT-Cage Device. Small, hollow and thimble-like, it is used for spinal fusion.
“Today there is a clinically studied, proven alternative to taking bone graft from the patient,” according to Medtronic. “A potential advantage to having spinal-fusion surgery using the Infuse Bone Graft and LT-Cage Device is that it removes the need to collect bone from your hip.”
Weiss and Lew both experienced extra spinal bone growth that led to nerve damage. Weiss had lumbar surgery, while Lew’s condition prompted Wang to insert the LT-Cage Device into Lew’s neck even though the U.S. Food & Drug Administration warned that could cause nerve damage.
“The following is a list of potential adverse events which may occur with oral maxillofacial surgery using the INFUSE® Bone Graft:” reads a document on the FDA’s Web site. “Some of these adverse events may have been previously reported in the adverse events table below or have been reported to the manufacturer.”
Off-Label Use of Medtronic Infuse Bone Graft Exacerbates Problems
“Ectopic and/or exuberant bone formation” is listed as a risk in addition to nerve damage. Other potential adverse events include allergic reaction, death, fetal-development complications, itching, scar formation, tissue damage and antibodies to certain types of collagen.
Such off-label use of a medical device is acceptable, according to the FDA. In response to the question of whether the FDA requires and Institutional Review Board to approve off-label use, the agency states, “No, when a physician uses a legally marketed device outside its labeling to treat a patient and no research is being done, IRB review is not required. Note: Although not required by FDA, an IRB may still decide on its own initiative to review such use.”
The $8.45 million settlement was split between Weiss and Lew. Their doctor, Jeffrey Wang, is believed to have received $300,000 in consulting fees, grants and royalties from Medtronic beginning in 2000, and at one point appeared as an endorser on the company’s Web site.
“Substantially all” of the thousands of other cases that stem from the product’s misuse have reached agreements, says Mark Reilly, managing editor of the Minneapolis / St. Paul Business Journal, in an article titled “Medtronic could soon settle thousands of Infuse lawsuits.”
Reilly notes that Medtronic will pay $22 million to 950 plaintiffs, already paid $85 million to settle a shareholder lawsuit and paid another $40 million to the U.S. Department of Justice.
“In all the settlements, Medtronic denied wrongdoing,” Reilly says.
The FDA announced a recall of Zimmer Biomet’s SpF PLUS Mini and SpF XL IIb implantable spinal fusion stimulators. This is due to the high levels of potentially harmful chemicals that are potentially harmful to tissues and organs (cytotoxicity). The recall of the implantable device affects certain serial numbers that were manufactured between Oct. 11, 2016 and Jan. 18, 2017 and distributed between March 28, 2017 and April 6, 2017. This discovery was made during a routine monitoring procedure. The cytotoxicity can cause chronic infections, long-term hospitalization due to revision surgeries, paralysis, and death. On April 20th, Zimmer Biomet released an urgent Medical Device Removal notification to all of its customers to seek medical treatment to quarantine the devices.
Though not the same device, this is what a spinal fusion stimulator can look like.
Spinal Fusion Stimulator Failed Cytotoxicity Tests
“A cytotoxicity test is a part of the biological evaluation of medical devices to ensure compatibility with the device and the human body,” said the FDA. “A positive cytotoxicity test (failed result) can indicate that a device contains potential harmful chemicals at amounts or levels that could be dangerous to the patient.” The FDA has labelled this as a Class 1 recall which is the most serious classification of recall. This severity of classification is only reserved for products that could be linked to serious complications or death.
These devices are used during spinal fusion surgery. They increase the possibility of permanently connecting two or more bones of the spine together. They are implanted in patients backs and provide constant electrical stimulation to the surgical site. This assists in fusing the vertebrae bones.
Zimmer Biomet will apparently schedule a time for removal of the quarantined devices from medical facilities by one of their sales representatives. Surgeons who extract these devices should conduct normal clinical monitoring for 3-6 months postoperatively for implanted patients. Hopefully the spinal fusion simulators were recalled in time to avoid adverse health effects in patients. However, with 100,000 of these devices already implanted in patients, that may not be the case.