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.
Carbon monoxide (CO) poisoning causes more than 20,000 emergency room visits and 400 deaths each year in the U.S., according to the Centers for Disease Control and Prevention. It is a colorless, odorless, tasteless gas, making it difficult to detect and therefore difficult to prove as the culprit in countless CO poisoning cases. Many injuries and deaths can be avoided if proper precautions are taken, such as installing CO detectors and designing products to minimize the risk of CO exposure. Despite CO’s deadly effects, it seems the government has done little to recognize the issue as a serious one, while the automobile and manufacturing industries have barely acted to fix the problem at all.
Sources and Effects of CO Poisoning
The matter of CO poisoning warrants greater attention and awareness, especially after being responsible for so many deaths, like the deaths of Rodney Eric Todd and his seven children. They were all killed from accidental CO poisoning. The carbon monoxide was leaking from a gas generator inside the house that ran out of fuel but was still turned on. While this sounds like an improbable way for eight people to die, CO is known as the silent killer. Perhaps if there were clearer warnings about the dangers of keeping gas generators inside, Todd’s family would still be alive.
Carbon monoxide is a byproduct of many different products such as fuel-burning cars, household appliances, and business operations making CO poisoning possible from many different sources. The estimated annual societal cost of this poisoning is about 1.3 billion dollars based on the medical expenses and lost wages of those affected. Since the compound is commonplace, greater awareness of its effects would decrease the social burden and inadvertent deaths.
Oftentimes it can be difficult to recognize CO poisoning for its flu-like symptoms. Doctors are susceptible to misdiagnosing and improperly treating patients. Symptoms can include headache, dizziness, chest pain, vomiting, and confusion, and even loss of consciousness. One of the most commonly reported conditions is brain damage, caused by the deprivation of oxygen to the tissue and brain as CO binds to hemoglobin in the blood and spreads through the body. There is no cure for CO-related brain injuries, however there are several ways to treat patients. Treatments include cognitive and vocational rehabilitation and hyperbaric oxygen therapy, which is breathing pure oxygen in a chamber with higher-than-normal air pressure. The latter is typically used for severe cases of CO poisoning; it replaces the CO in your bloodstream faster than simply breathing fresh air. The severity of the symptoms depends on the duration of exposure, level of CO, and height and weight of the individual.
CO Poisoning Cases Are Complicated
Hyperbaric oxygen chambers like this one are sometimes used to treat victims of severe carbon monoxide poisoning.
The wide range of CO sources and the many variables that can affect CO poisoning provides a challenge to the plaintiffs in these cases because they need to prove the source of the CO, establish the cause of harmful exposure, and demonstrate the medical connection between the exposure and injuries. To gather this evidence, many types of expert analyses may be necessary, such as physicians, engineers, medical experts, and a variety of others. A different set of experts are needed to substantiate the effects CO has on the body, including cardiologists, neurologists, toxicologists, and others. Proving damages from CO poisoning is expensive for plaintiffs and results in some difficult obstacles. Another pitfall of these cases are negligence claims based on failure to install a CO detector alarm in the first place. These alarms are an easy way to prevent injury from CO. Unfortunately, CO alarms are only mandated in private domiciles by twenty-seven states via state statute and only five states require them in school buildings. More state laws requiring installation of CO alarms would help to reduce the number of CO poisoning cases.
The type of defendant also changes the way CO poisoning cases are handled. Defendants can range from property owners to hotels and restaurants to appliance repair providers. In the case of property owners, it is vital that they complete preventative maintenance and inspections to determine possible hazards before they occur. If they do not do this, it can constitute a breach of applicable duty of care. There are also various codes that apply in different situations, such as International Fire Codes, International Building Codes, and International Mechanical Codes, as well as standards such as the American National Standards. All of these codes add different layers to defending CO poisoning cases.
Determining the amount of CO in the air that is permissible can also be a contentious issue that often impedes litigation. Governmental agencies and associations have differing opinions. For example, the Occupational Safety Health Administration sets the exposure limit for the workplace at fifty parts per million as a time-weighted-average over an eight-hour period. The recommended exposure limit from the National Institute for Occupational Safety and Health is thirty-five parts per million as a time-weighted average over an eight-hour period. In living spaces, the permissible exposure limit is nine parts per million with the desired level to be zero according to the American Society of Heating, Refrigerating, and Air Conditioning Engineers. These varying numbers suggests that the amount of CO in the air can vary on a case-by-case basis, although the ideal rate is zero parts per million.
Proliferation of Keyless Ignitions in Automobile Industry Presents New Challenges
There are separate challenges presented by keyless ignition cases, which are an excellent example of the automobile industry’s lack of recognition on the issue of CO poisoning. While push-to-start features and smart keys are a technological advantage, they can lead to cars being unintentionally left on after the driver leaves the vehicle. The longer the car is left on, the more harmful exhaust full of CO is released, which can then travel from the garage into the house and harm unsuspecting families, especially if the car is left on overnight. These cars are designed to start when the key fob is nearby, however the fob can be taken away and the car will remain on. While this is a safety problem, automakers have failed to publicize this problem and will continue to promote these cars because the National Highway Traffic Safety Administration is not acting.
All of the above-mentioned complications of CO poisoning result in costly and complex litigation. Each case entails a unique set of requirements and must be approached with individual manner. More accidental deaths will continue to happen, and they will require more persistent advocates to get the attention and care their cases require unless awareness of CO poisoning is more widely spread.
One trillion dollars. That’s how much the country spent on the opioid epidemic between 2001 and 2017, according to a report released by the nonprofit institute Altarum, a consulting group focused on improving public health.
The cost of the crisis trickles both up and down and impacts corporations, governments and insurance companies, as well as families, local businesses and neighborhoods.
“The greatest cost comes from lost earnings and productivity from overdose deaths – estimated at $800,000 per person based on an average age of 41 among overdose victims,” the report states. “This figure is largely made up of lost wages of workers and productivity losses of employers, but it also weighs on government in the form of lost tax revenue. It has increased in recent years as the epidemic has transitioned away from older people to younger ones and from prescription opioids to illicit drugs.”
Opioid Epidemic Results in High Costs to Society
More than 42,000 deaths were caused by opioid overdoses in 2016, according to the U.S. surgeon general’s office. In 2010, the death toll was 21,000. The startling spike spurred the office to take action, with Dr. Jerome Adams issuing an advisory: “Be prepared. Get naloxone. Save a life.” Naloxone is an easily administered nasal spray that quickly reverses the deadly symptoms of an overdose.
“Health care costs related to the opioid crisis reached $215.7 billion from 2001 to 2017,” the report states. “This stemmed largely from emergency room visits to treat and stabilize patients after an overdose, any associated ambulance and Naloxone use required, and related indirect health care costs associated with the increased risk of other diseases or complications.”
And the costs have nowhere to go but up.
“An additional $500 billion is estimated through 2020 if current conditions persist,” the report states.
Governing magazine, a nonpartisan news outfit, reports that Middletown, Ohio, spent $1 million-plus on ambulance dispatches for overdoses between October 2016 and October 2017. It also reports that Pennsylvania will spend $5 million this year on naloxone alone. In Nebraska, the epidemic costs $465 per resident. In West Virginia, it costs $4,793 per resident. The state has one of the highest rates of opioid overdoses in the country.
“The costs build up slowly over time, so you almost don’t even notice it,” Nashville lawyer Mark Chalos told the magazine in an article titled “How Much Is the Opioid Crisis Costing Governments?” “But when our people really started to dig into the budgets, they realized the costs are more significant.”
Geographic Factors in Opioid Epidemic
The American Enterprise Institute, a public-policy think tank, conducted a study on “The Geographic Variation in the Cost of the Opioid Crisis” and found the costs of the opioid epidemic are disproportionate at state and local levels, as exemplified by the Nebraska / West Virginia comparison.
“The types of costs attributable to opioid abuse – health care costs, criminal justice costs, and lost productivity, for example – are fairly well understood, as is the economic impact of the crisis at the national level,” the study states. “However, the economic burden of the opioid epidemic is unevenly distributed across the country, with many communities especially hard hit. As federal, state, and local policymakers and stakeholders seek to curb the epidemic, it is vitally important that they know how these costs are distributed.”
VSL – Value of a Statistical Life – A New Way to Measure Cost of Opioid Epidemic
Enter the White House’s Council of Economic Advisers, or CEA. The federal agency compiled a paper in November 2017 that used a metric called the Value of a Statistical Life, or VSL, to gain insight into the costs of the opioid epidemic. The VSL essentially puts a price tag on one’s willingness to lower his or her death risk. It is helpful for shaping policies and programs that reduce fatalities.
“CEA finds that previous estimates of the economic cost of the opioid crisis greatly understate it by undervaluing the most important component of the loss – fatalities resulting from overdoses,” states the executive summary of the paper, titled “The Underestimated Cost of the Opioid Crisis.” “CEA estimates that in 2015, the economic cost of the opioid crisis was $504.0 billion, or 2.8 percent of GDP that year. This is over six times larger than the most recently estimated economic cost of the epidemic.”
The paper states that though this is the first of its kind to be published, it will not be the last.
“A better understanding of the economic causes contributing to the crisis is crucial for evaluating the success of various interventions to combat it,” it concludes. “CEA will conduct further economic analysis of actual and proposed demand- and supply-side interventions; consider the impact of public programs such as Medicare and Medicaid; and explore the important role of medical innovation in combatting the crisis.”
The next hearing session of the United States Judicial Panel on Multidistrict Litigation is scheduled for November 30, 2017 in St. Louis, Missouri. Eight matters are set for oral argument to consider motions to transfer each to one centralized district for coordinated pretrial proceedings. The matters include trending issues such as Equifax’s massive 2017 data breach and the national opioid litigation against Big Pharma manufacturers and distributors. Ten matters will be considered for centralization without the parties making oral arguments.
What is the United States Judicial Panel on Multidistrict Litigation?
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. 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. 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. If the Judicial Panel determines a case should be centralized, they will also determine at the hearing which Judge will handle the centralized proceedings.
The Judicial Panel on Multidistrict Litigation consists of seven sitting federal judges appointed to serve on the panel by the Chief Justice of the United States Supreme Court. Appointment is reflective of a judge being held in high esteem on the bench. The current Chair of the panel is Judge Sarah S. Vance from the Eastern District of Louisiana.
Currently, there are Multidistrict Litigation matters pending in disaster cases involving the September 11 terrorist attacks, the Deepwater Horizon oil spill; intellectual property; employment cases; securities litigation; and several others. Multidistrict Litigation is most frequent in cases involving products liability, antitrust, or marketing and sales practices. To date in 2017, Multidistrict Litigation has been formed in 9 products liability matters; 4 marketing and sales practice matters; and 2 antitrust matters.
Matters Set for Oral Argument
The following matters are scheduled for oral argument during the hearing session:
- MDL No. 2777 – In re: Michael Stapleton Associates, Ltd., Fair Labor Standards Act (FLSA) and Wage Hour Litigation
- MDL No. 2800 – In re: Equifax, Inc., Customer Data Security Breach Litigation
- MDL No. 2801 – In re: Capacitors Antitrust Litigation (No. III)
- MDL No. 2802 – In re: Epipen (Epinephrine Injection, USP) Employee Retirement Income Security Act (ERISA) Litigation
- MDL No. 2804 – In re: National Prescription Opiate Litigation
- MDL No. 2806 – In re: McGregor-Mayweather Boxing Match Pay-Per-View Litigation
- MDL No. 2807 – In re: Sonic Corp. Customer Data Security Breach Litigation
- MDL No. 2808 – In re: Anthony Spencer Green, Sr. Litigation
Notable Motions to Transfer
MDL No. 2800 – In re: Equifax, Inc., Customer Data Security Breach Litigation. This matter involves over 300 cases filed against the consumer credit agency, alleging violations of state and federal laws for the company’s purported failure to use adequate safeguards to protect consumers. The alleged failures resulted in unauthorized individuals gaining access to Equifax, Inc.’s data network storing the private information of 143 million consumers. The Plaintiffs suing Equifax, Inc. moved for consolidation when only 22 cases were pending and noted numbers were likely to rise quickly given the amount of victims; by the morning of the hearing, over 300 cases had been filed. Equifax, Inc. acknowledged the data breach in September 2017; records accessed included names, Social Security numbers, birth dates and, in some cases, driver’s license numbers.
MDL No. 2804 – In re: National Prescription Opiate Litigation. Counsel representing several Plaintiffs filed for consolidation of the actions of state, county, and municipal governments and other agencies against opiate manufacturers Purdue Pharma, Teva/Cephalon, Janssen, Endo, Actavis, and Mallinckrodt and distributors McKesson Corporation, AmerisourceBergen Corporation, and Cardinal Health, Inc. The lawsuits allege negligence as well as violations of public nuisance laws, state consumer protection statutes, and the Federal Racketeer Influenced and Corrupt Practices Act, 18 U.S.C. §§1961, et seq. Plaintiffs allege opioid manufacturers and distributors misrepresented the risk of addiction associated with opioid use to regulators, doctors, and patients and failed to report suspiciously large orders of their drugs, actions which allegedly contributed to the current nationwide opioid epidemic.
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.