NeuroBlate System is a brain surgery probe that removes cancerous tumors using laser therapy, and it has device deficiency associated with harmful side effects.
From October to December 2017, Monteris provided three different advisories concerning unintended probe tip heating along with the NeuroBlate System. Even so, the FDA was concerned that the manufacturer's information had not adequately reduced the risk of accidental heating, and more people would still get injured during the procedure.
Before undergoing the NeuroBlate procedure, kindly read through this article to get a clear insight into the whole process. If you have suffered complications during a NeuroBlate procedure, contact a skilled attorney to help you join a mass tort. We invite you to contact us at Consumer Alert Now for help in joining a mass tort for any defective product.
What is the NeuroBlate Probe?
The NeuroBlate System by Monteris Medical put together an MRI imaging, a surgical laser, and software to ablate (remove), coagulate (solidify or thicken), or necrotize (destroy) cells in a minimally invasive brain operation.
The “NeuroBlate Laser Delivery Probe” is a tiny carbon dioxide catheter that is cooled and shaped to let minimally invasive entry into the brain.
The NeuroBlate System
Monteris Medical makes this surgical probe. It was introduced to the U.S market in 2009. The NeuroBlate laser is a cooled laser of carbon dioxide that is meant for minimally invasive surgery to eliminate tumorous or cancerous tissue from the brain.
Ablation takes place when you heat the laser to 60 degrees FH for around 30 seconds. The main aim is to kill the infected cells carefully without causing harm to the other brain tissues.
The design of the NeuroBlate is what contributes to the success of the procedure.
Despite its possibilities to save life and its innovation, the FDA has found possible risks associated with the NeuroBlate and its source, The Monteris Medical, and has announced recalls and warnings of the need to be extra careful.
Side Effects of NeuroBlate
Even though NeuroBlate is used to save lives, it also poses harm to human life. Some of the symptoms associated with it include:
- Swelling of the brain/Encephalitis
- Unable to generate or comprehend speech/Dysphasia
- Paralysis of half of the body/Hemiparesis
- Loss of vision on one or both eyes/Homonymous Hemianopia
- Burst blood vessel with surrounding tissue/ pseudoaneurysm
Note that these are the symptoms of a successful surgery.
In some instances, the probe can overheat and lead to the probe's tip breakage, causing carbon dioxide emissions into the brain. The excess heat has caused accidental damages to the tissues surrounding the brain. When combined with the emission of the flammable CO2, it causes more damage like burning sensitive brain tissue during the procedure. Other side effects that have been reported include permanent brain damage or bleeding.
According to the FDA report, the MRI monitors used to check the laser's status have been noted to give faulty temperature during operation.
In October 2017, Monteris Medical began a recall for various NeuroBlate Laser Delivery Probes after reports of accidental heating and damage to the probe during surgery.
After this, the FDA designated the "NeuroBlate recall a class 1 medical device recall," which shows that the probe is likely to cause severe injuries or even death.
The agency noted that Monteris Medical had given three different advisories from October to December concerning accidental probe heating. The FDA was worried that the Monteris had provided information that had not adequately reduced the risk of unintentional heating.
Several devices are affected by the NeuroBlate Probe recall with HAW and GEX product codes. These devices include:
- FullFire 3.3mm Diffusing Tip Laser Probe (DTP) (size 000-5)
- SideFire 3.3mm Directional Laser Probe (SFP) (SIZE 000-5)
- FullFire select 2.2mm Diffusing Tip Laser Probe(Size 000-5)
Fifty-two probes are affected by the recall, 49 were sold to the United States, and the rest were sold in Canada.
From April 2013 to July 2017, the recalled NeuroBlate probes were produced.
NeuroBlate Probe Brain Injuries
The brain injuries associated with NeuroBlateprobe include:
- Brain swelling
- Intracranial hemorrhage
- Permanent brain damage
- Accidental injury to other brain tissue
According to the FDA's letter on 22nd March 2018 to the health care providers, the problem that led to NeuroBlate probe recall seems to have been created by an interaction between thermocouple in probe and MRI.
NeuroBlate Probe Death
In its recall announcement, the FDA said that it had gotten various reports associated with excessive heating of the NeuroBlate probe together with a report of a victim who passed away after undergoing intracranial hemorrhage.
Use Alternatives - FDA To Healthcare Providers
The FDA has enlightened healthcare providers in all countries to be cautious of class 1 recall's gravity and requested them to use alternative options where applicable when treating patients. The device manufacturers have also been asked to follow the Medical Report's reporting Regulations and report any unpleasant event to the FDA to better understand the devices' risks.
What to Do if the Monteris Medical Neuroblate System has Injured You
Consider talking to a defective medical Device attorney if you have sustained injuries related to the use of the NeuroBlate System. Even though some injuries happen without the defective medical device, it is essential that you thoroughly discuss your situation with your attorney because the FDA has warned physicians and patients about the risk of death and injuries involved with the NeuroBlate System. An experienced attorney will look at your case and explain the legal options available for your situation.
For instance, if your injuries can be connected directly to the NeuroBlate system, you may have a potential lawsuit against the Monetarist and even against the surgeon who operated you with the NeuroBlate System. (For example, if the physician used the device after the class 1 recall was issued by the FDA and did not alert the patient about FDA recall). Your lawyer will examine your situation. Depending on various factors like where you reside and where you were injured, he/she may advise you to file a lawsuit against Monteris Medical. Some suits are settled out of court in some cases, and some legal claims can settle before filing the claim. These issues are involved. That is why it is advisable that you reach out to a qualified and experienced attorney.
About NeuroBlate Mass Tort Lawsuits
A mass tort is a lawsuit filed on behalf of a group of people (class) that have been wronged unlawfully or injured. The law firm represents the "class," and one member of the class known as "class representative" decides upon the case. These kinds of cases come in handy to reduce the similar flooding individual cases where multiple individuals have been affected.
For instance, multiple individuals negatively affected by Monteris Medical's NeuroBlate could join hands and file a legal lawsuit against this entity in a bid to get compensation. The lawsuit entails the following steps to hit off:
- Individuals in the class must be given prior notice to determine whether they want to sue solo or as a group.
- Filing a motion for the plaintiff to represent the class
- The plaintiff must show they represent the entire group regarding the negative effect of a company's product.
- The plaintiff must prove that a mass tort lawsuit is an ideal option to hold the defendant company accountable rather than a solo lawsuit arrangement.
- The compensation won by each individual should not be worth the cost and time of hiring an attorney if the class members decided to go file solo.
Requirements for Filing a NeuroBlate Mass Tort
The plaintiff’s legal representatives will always work to see that their clients’ claims meet the requirements for filing a mass tort. However, the judge is solely responsible for making the final decision on whether a case can proceed as a mass tort or not. While making the decision, the judge will mostly consider the following:
The Number of People Affected
The judge will assess the number of people purported to have been affected by a company's actions or products. If the number is just a handful of people, the judge might decide to file individual lawsuits rather than a mass tort. The more the plaintiffs, the more likely that a case will proceed as a mass tort.
Do the Claimants Share Common Law and Facts?
A lawsuit involves factual and legal issues that are common to all the claimants. Moreover, they all have to have suffered similar injuries. For instance, with Monteris Medical, the plaintiffs must all be victims of the entity's NeuroBlate probe shortcomings.
Are the Claimant’s Legal Claims Common for All Victims?
The lead plaintiff's presented claim should cover all typical potential class members' legal allegations and injuries. The lead plaintiff's bid should not be motivated by the fact that they incurred more losses or injuries from the defendant's actions. In such a case, the judge may advise them to file an individual lawsuit. The lead plaintiff's needs should not exceed those of other members. All members' claims and injuries should be similar to the court's perspective.
Is the Class Well-represented Legally?
The judge will also seek to establish whether the plaintiff's legal representation covers all potential class members' interests. The plaintiffs can join hands and seek legal representation as a unit. The attorney representing the entire class should be well experienced and braced to handle mass torts.
NeuroBlate Mass Tort Lawsuits
A mass tort is a lawsuit filed by many people injured on a large scale against one or more corporate entities. Good examples of these cases are mass toxic tort claims, product liability torts, among others. Monteris Medical's NeuroBlate is also a worthy example.
Like mass tort lawsuits, mass tort lawsuits help reduce the number of similar cases filed by individuals. Victims can seek the legal representation of a single or group of attorneys who conduct in-depth investigations for all the cases filed. After the inquiry, they can certify if the claimants can receive their deserved fair settlements.
Both the mass tort lawsuit and the mass tort lawsuits include a group of plaintiffs but differ significantly on how the cases are handled. In a mass tort, one lawsuit is filed on behalf of the entire group, while for the mass torts, each files their lawsuits. However, due to significant similarities, they are handled together for the convenience of the court.
It is imperative to know where your case stands between the two categories. It helps to help you identify what legal rights you have. Consequently, sound legal representation is in order.
Stages of a NeuroBlate Mass Tort Case
Like other legal proceedings, a mass tort case follows several stages. Moreover, the case can be won or lost at any stage of the case since an attorney may not be willing to file a suit until they have determined whether their clients have a valid claim. A typical mass tort cases will proceed in the following stages:
The first stage entails the attorney critically assessing a variety of records. These include the statements made by the plaintiffs and the allegations of injuries suffered. The lawyer will review several years of your medical records in a bid to establish whether you have a pre-existing condition. Moreover, it helps to establish a timeline when your injuries started.
This kind of review helps to identify consistencies among the clients. For instance, they have to establish whether Monteris Medical’s NeuroBlate is solely responsible for a group’s health misfortunes. For the case to be valid, the class’s story and records should rhyme accordingly.
Identification of Injury Consistencies
The attorney further has to identify whether the group's injuries are similar or consistent throughout the group. Each individual in the group should have identical injuries to validate the case. While the members' cases might be different, their structure should be similar since several instances in the group could determine the others' fate. If the outliers of individual cases don't rhyme, the group's compensation could be a far-fetched idea.
The attorney also has to categorize the cases accordingly. It could be on account of severity, the client's age, or duration of injuries. These categories come in handy during compensation allocation.
Filing the Lawsuit
After establishing that you have a valid claim case, the attorney will file a federal court lawsuit. No matter the plaintiffs' geographic differences, it is crucial to consolidate the cases by filing them together. Mass tort cases are usually filed in federal courts hence the need for an experienced legal entity.
Bellwether Case is Tried
Before attending to the entire group's cases, the court samples some cases. This is referred to as bellwether trials. In this case, the attorney may choose some of the most severe cases in the group. These could include individuals who have already succumbed to injuries, face imminent death, or those with the most severe damages.
Bellwether case could be likened to a test-drive for the judges or the juries. They play a significant role in the determination of other matters. If the court finds that the defendant has no case to answer in the bellwether cases, other cases will not proceed to trial. Consequently, an experienced lawyer comes in handy to push through to trial.
This is the final stage of the mass tort process. Most cases do settle no matter how long it takes. However, trials can be time-consuming and expensive, and even worse, the offending party could choose to appeal if the settlement goes against them. Consequently, most attorneys prefer and attempt to settle these kinds of cases out of the court.
Mass Tort Litigation Timelines
Mass torts can be a challenging endeavor for plaintiffs who can mobilize resources to fight a typical defendant. Unlike individual claim cases such as personal injury claims, which can be settled in an instance, a mass tort takes time. A mass tort may include many individuals with equally complex cases hence may lag through the court system.
It takes time to conduct investigations and evidence to prove the validity of each claimant’s case. Moreover, the parties have to engage with each other, share documents, motions, and determine bellwether trials. However, there is no set rule or guideline dictating how long a case may last. Some cases may take several years to settle, while others could take years. For instance, asbestos-related mass torts have been in the court system for more than 40 years and are still pending.
Advantages and Disadvantages of a NeuroBlate Mass Tort Case
If NeuroBlate mass tort cases are well organized and represented by the best attorney available, certain advantages should be expected. They include:
- The lawsuit provides a cost-effective means of acquiring justice for the claimants, unlike solo cases that may require individual legal representation. A mass tort ensures the claimants can share legal representation costs or any other expenses that may arise within their pursuit of justice.
- Easy to pressure the defendant and convince the court. With many valid claims, the defendant will be pressured to compensate them accordingly. Moreover, if their injuries and stories are consistent, the court will rule in their favor.
- Personalization of each case. Unlike a class-action lawsuit that handles all individual cases as a single unit, mass tort lawsuits focus on individual cases but work under a similar structure. Consequently, individuals are compensated according to the severity of their injuries or the different levels of their cases.
Mass tort lawsuits also come with the following challenges:
- Some courts might not be adequately equipped to handle many plaintiffs in one case; the court may be short of the needed resources and time to handle many-people cases. Consequently, the court may prefer to consolidate a worthy mass tort lawsuit into a mass tort that may not satisfy the plaintiff.
- Defendant entities may hang on to the claims of inability to defend themselves against any claims; a defendant entity such as Monteris Medical’s NeuroBlate could purport to dismiss the claims with the excuses of failure to protect against many claims.
- An inexperienced attorney may fail to adequately organize and conduct an in-depth investigation amongst a large group of claimants. A mass tort lawsuit may have large individuals with complicated yet valid individual claims.
Why are NeuroBlate Mass Torts Difficult to Resolve?
Mass tort lawsuits may be a pathway to deserved compensation, but they are a complicated endeavor that may be hard to resolve. They may be a headache to all the parties involved, from the plaintiff to the defendant. It could be attributed to the following:
- Factual and Complicated Issues — For a mass tort lawsuit to find grounds in court or even reach the court, the attorney must be convinced that its value is worth time and resource investment. Moreover, at the inception of the whole process, the expected value estimates might be uncertain with stakes and risks high. The process might even be ugly and messy as each party is looking to discredit the other.
- Establishment of Cause of Injuries Might be Difficult — The scientific evidence of the link between using a product and its harm is an expensive engagement and complicated. It is also hard to tell how the presiding parties will evaluate presented scientific evidence. Moreover, the claimants' legal representatives must prove that the defendants are legally responsible for their clients' injuries. On the other hand, the claimants must convince their attorney that their claims have outstanding monetary values.
- Mass Tort Lawsuits are a Risk to all Parties Involved — Asymmetric risks are expected for all parties involved at the beginning of the whole process. It moves the process in specific ways. For the claimant's legal representatives, the cost of losing the lawsuit is significantly determined by the firm's investment in the process. If the legal firm can win the case, the scores are high. For the defendant, the risks lie not only on the loss or compensation but also on the increased value of other claims that may arise should they lose. On the other hand, if they are willing to settle questionable claims to avoid unwarranted and ugly public trials, they may encourage the claimants' attorney to dip more in-depth in a bid to have a better negotiation card on the table.
Plaintiffs also risk ongoing court processes that may drain them psychologically and financially. Even worse, the court process could take many years to resolve yet yield unappealing results for the plaintiff. It can be quite depressing. However, we invite you to get in touch with us as soon as possible so that we can kick start the process of fighting for your justice.
Join a Mass Tort Lawyer Near Me
Suppose you or your loved one underwent surgery containing the systems Monteris Medical NeuroBlate and sustained brain injuries or soft tissue injuries. In that case, you may be eligible for compensation, and you could have a viable lawsuit. At Consumer Alert Now, we have experienced attorneys who are well-versed in defective product lawsuits, and we are ready to help you. Contact us at 800-511-0747 today.