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.
The Mass Tort Unit of Searcy Denney Scarola Barnhart & Shipley, led by veteran pharmaceutical and medical device lawyers Brenda Fulmer and C. Calvin Warriner, III, recently filed several more lawsuits against the manufacturers of Xarelto. The law firm has filed dozens of personal injury and wrongful death lawsuits against Bayer and Janssen Pharmaceuticals alleging that Xarelto is defective and has caused numerous serious and some fatal bleeding injuries to patients.
Searcy Denney Files Xarelto Lawsuits
One of the newly-filed lawsuits involves a Dade County, Florida resident who began taking Xarelto after being diagnosed with atrial fibrillation after failing aspirin therapy. The patient was placed on Xarelto in 2014. One of the allegations in the national Xarelto litigation effort is that prescribing doctors should have been warned by Xarelto’s manufacturers that this particular blood thinner should not be considered as first-line therapy in light of the reported increased incidence of bleeding injuries, the lack of an antidote to reverse the anti-clotting effects of Xarelto (which is available for Coumadin and Pradaxa), and the inability to determine which patients might be particularly susceptible to a bleeding episode while on Xarelto. This patient developed an acute upper GI bleed, the most common injury associated with Xarelto, after taking the drug for about a year. The patient developed significant hematuria (blood in urine), severe abdominal pain, and coffee-ground stool (a classic sign of bleeding in the gastrointestinal tract). The patient developed severe anemia which led to respiratory failure and significant abdominal bleeding which caused the bladder to rupture.
Searcy Denney’s pharmaceutical lawyers also filed a recent lawsuit on behalf of a Delray Beach, Florida patient who developed a GI bleed and bleeding in his brain after taking Xarelto for three years. This patient was prescribed Xarelto in 2012, shortly after this drug was approved by the FDA. At the time, there was a lot of hype over Xarelto and its ease of use over Coumadin, which requires regular blood monitoring of INR levels and dietary and medication restrictions. Patients were assured that Xarelto had the same safety profile as Coumadin, yet it would be easier to use and be less of a hassle, which was very compelling to young patients with busy lives. Unfortunately, since then, Xarelto has become one of the drugs with the highest number of adverse events reported to the FDA. In the pending Xarelto MDL litigation, the plaintiffs contend that Xarelto patients face a far greater risk of developing bleeding injuries than patients who ingest Coumadin and that representations in Xarelto’s warning label and marketing materials to the contrary were false.
The third recent lawsuit filing by our Mass Tort Unit involves a wrongful death claim on behalf of the surviving family members of a Pompano, Florida man who died in Broward County earlier this year due to an intracranial hemorrhage after ingesting Xarelto for a few months. Prior to starting Xarelto in 2016, the patient had taken Plavix and aspirin for several years for his atrial fibrillation. The primary use of Xarelto is in patients with this common heart arrhythmia who are at risk of developing blood clots and ischemic strokes from pooling of blood in the heart. Anticoagulant drugs (like Coumadin, warfarin, Xarelto, Pradaxa, and Eliquis) thin the blood and make patients less likely to develop blood clot-related injuries, including ischemic strokes where a clot blocks blood flow in the brain. Xarelto, however, has a propensity to cause hemorrhagic strokes, where there is bleeding in the brain (rather than a blockage).
Xarelto Lawsuits Consolidated into MDL
These individual lawsuits will become a part of MDL No. 2592, which are coordinated legal proceedings for Xarelto pending in New Orleans. Currently, there are more 18,000 individual lawsuits pending in these multi-district litigation proceedings. These cases include both personal injury and wrongful death claims, and most involve allegations that use of Xarelto led to the development of bleeding injuries in the GI tract or brain. Bleeding injuries have been reported after just a single dose of Xarelto. Judge Eldon Fallon is presiding over the national litigation and has extensive experience with supervising complex pharmaceutical cases. There are also nearly 1,500 cases pending in state court in Pennsylvania.
The third bellwether trial against Janssen Pharmaceuticals (a division of Johnson & Johnson) and Bayer Corporation began on August 7, 2017, at a federal courthouse in the Southern District of Mississippi in Jackson. This case involves Dora Mingo, a 69-year-old retired schoolteacher from Summit, Mississippi who developed deep vein thrombosis (a “DVT”) in January of 2015, after undergoing hip implant surgery earlier that month. She developed by the DVT while she was on the blood thinner Lovenox following her hip surgery, so a hospital doctor prescribed Xarelto 15 mg to be taken twice a day for 21 days and then a 20-mg dose to be taken daily after that. After taking Xarelto for only a few weeks, Ms. Mingo’s blood work showed significant abnormalities in her hemoglobin and hematocrit levels, and she was instructed to go to the ER immediately. At the hospital, she was diagnosed with severe anemia and testing showed that she had an acute upper GI bleed for which she received blood transfusions and underwent a procedure to clip a bleeding ulcer. She was hospitalized for two days for the Xarelto-induced bleed and associated anemia.
The Xarelto defendants sought to dismiss her lawsuit and prevent the jury trial from proceeding in July and contended that Ms. Mingo was unable to prove that Xarelto was defective under Mississippi’s product liability law which requires that the plaintiff prove that the product was unreasonably dangerous to consumer and that she was injured by the drug. Further, Bayer and Janssen contended that Ms. Mingo’s case should be dismissed as they do not believe that she can fulfill her burden to prove that the Xarelto that she ingested failed to function as expected and that there was a feasible alternative medication available that she could have taken and avoided the risk of developing the upper GI bleed and anemia. In the Xarelto MDL litigation, the plaintiffs contend that there are safer alternative blood thinners available, including Coumadin or warfarin (which have been prescribed for decades) as well as other modern blood thinners, including Eliquis (which has a different dosing regimen) and Pradaxa (which reportedly now has an antidote available). The plaintiffs have also argued that manufacturers should warn that patients be given a blood test (known as an anti-Factor Xa assay, which is being used in Europe to identify high-risk patients) prior to use of the newer blood thinners to confirm that the patient will tolerate the drug.
The biggest challenge in meeting the plaintiff’s burden of proof is that the FDA has not determined that Xarelto is unreasonably dangerous (and, in fact, has promoted the safety of the drug). The plaintiff also has a burden in proving that the risk of a GI bleed is higher with Xarelto than with the other blood thinners, as the studies on this issue are conflicting and all blood thinners can cause GI bleeding events. The FDA originally approved Xarelto (also known as rivaroxaban) in 2011 for blood clot and stroke prevention in patients with atrial fibrillation and those who have undergone orthopedic surgeries.
Request for Summary Judgment from Defendants Denied
On July 21, 2017, Judge Fallon denied the defendants’ request for a summary judgment dismissing the lawsuit under Mississippi’s product liability statute, finding that there were disputed fact issues that prevented the claims from being dismissed prior to trial. It is likely that these same issues will be raised during the course of the trial after evidence and testimony on the existence of a product defect is presented to the Mississippi federal court jury. Additional motions to dismiss the case on the basis of federal court preemption and claims that federal law prevented Xarelto’s manufacturers from enhancing the safety warnings for the blood thinner have also been denied by the MDL judge. Judge Fallon also considered and rejected motions from both parties to exclude their opponents’ expert opinions on the risks associated with other anti-coagulants, unapproved dosing and monitoring regimens, and whether Ms. Mingo’s injuries were caused by her short-term use of Xarelto.
Judge Fallon is expected to preside over a fourth Xarelto bellwether trial, the Henry case, in Texas federal court later this year. The first two MDL bellwether trials were tried before juries in New Orleans and both resulted in verdicts in favor of the drug’s manufacturers. Appeals are pending regarding these trial losses by the plaintiffs.
The law firm of Searcy Denney, with offices in West Palm Beach and Tallahassee, represents more than 50 clients in their mass tort product liability lawsuits against the manufacturers of Xarelto. The firm has a dedicated Mass Tort Unit that focuses solely on drug and medical device claims. The timeframe for filing of lawsuit over a defective drug can be short, so please do not delay in contacting a lawyer if you or a loved one have suffered a gastrointestinal bleed, bleeding in the brain, or other injury associated with the use of Xarelto.
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.