Arkansas Transvaginal Mesh Attorney

Our Arkansas Product Liability Lawyers May be Able to Recover Compensation for Your Surgical-Mesh-Related Injuries

If you have been injured due to side effects associated with a transvaginal mesh (TVM) surgical device, you may have the basis of pursuing a lawsuit against the manufacturer of that device.

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It is imperative, before proceeding any further, that you fully realize the fact that even though a transvaginal mesh injury case might be a mass tort, individual attention must be paid to each piece of litigation. In order for the victim of a TVM injury to have the best chance possible of securing equitable restitution, each case must be handled on an individual basis by a skilled and seasoned Arkansas transvaginal mesh attorney. While all TVM injury victims have a shared cause of action, the variety and extent of the injuries attributed to the device are unique to each victim. In legal terms, the victim is known as the “plaintiff.”

Keeping You Informed: On January 5, 2012 The Food and Drug Administration ordered medical device manufacturers to further study safety complications with surgical mesh widely used in TVM surgeries. The announcement follows two previous warnings by the FDA on the dangers of surgical mesh devices. The agency said that manufacturers of medical mesh would be required to submit follow-up safety studies to the agency. The FDA is considering reclassifying the mesh as a "high-risk device."

What is a TVM Device?

A transvaginal mesh is a device used in surgery, and is implanted through the abdomen or vagina. It is, basically, a type of man-made net, and acts to support improperly functioning pelvic muscles that restrain certain parts of the patient’s anatomy. The U.S. Food and Drug Administration, or FDA first approved TVM devices for the treatment of pelvic organ prolapse, or POP, and stress urinary incontinence, or SUI. Patients suffering from POP have weakened muscles around the pelvis, allowing organs like the uterus or bladder dropping into the vagina. SUI, also known as “effort incontinence,” can result in an extremely negative impact on a sufferer’s life due to an involuntary leakage of urine. This condition is caused by a lack of strength in the muscles of the pelvic floor.

After surgery is performed on the affected area of the pelvis, the TVM is implanted to provide further support to the weakened tissue. The term “mesh” is derived from the synthetic material used in the procedure, and the device is usually found in the shape of a small ribbon. Approximately 200,000 women have had a procedure performed to treat SUI that involved the procedure, while about 75,000 women had surgery to treat POP that involved the use of the TVM device.

While several different manufacturers produce TVM devices, there are four that have the largest share of the market: Bard, Johnson & Johnson (Gynecare), American Medical Systems and Boston Scientific.


Complications of Transvaginal Mesh Use

Several problematic conditions have been linked to use of the TVM device during surgeries to treat prolapse. These complications range from minor ones to quite serious problems, and include:

  • The device eroding through the wall of the vagina, a condition known as exposure, extrusion or protrusion.
  • Pain and discomfort, including during sexual intercourse (also known as dyspareunia).
  • Infection and bleeding.
  • Painful urination.
  • Bowel, bladder and blood vessel perforation.
  • Shortening and tightening of the vagina.
  • Incontinence.

The risk or prolapse re-occurring is heightened due to the possibility of erosion. This means that the implant was not successful because the pelvic organs dropped again. According to an FDA study, more than 50 percent of women who had the device implanted needed another surgery to remove the TVM. Some needed even more than one additional surgery.


How to Pursue – and how not to Pursue – Restitution through TVM Legal Action

As there is in any sort of defective product injury litigation, there is a wrong way and a right way to pursue compensation from a TVM manufacturer. This is an especially difficult kind of case because it involves many different jurisdictions that have many different statutes of limitations, many concerns in regard to evidence associated with multi-district litigation (MDL) and other factors that arise due to the aforementioned mass torts. It is imperative that you hire a skilled Arkansas transvaginal mesh attorney who has extensive experience in product liability litigation to be able to handle this complex type of case.

Other problems arise for TVM victims in terms of the way their law firm handles their case. Many law firms will decide to lump victims into a single pile of cases, and then try and secure a settlement that would be divided equally among the plaintiffs if the attorney were successful. This may seem to be a huge benefit to someone who has only suffered a minor injury, but what about the victim of a severe TVM injury? How could this kind of settlement be of any advantage to that victim? The Arkansas transvaginal mesh attorneys with Grossman Law Offices feel this is not a fair way to provide service to a client. We resolve cases based on their individual merits, and help all of our clients on an individual basis. We will not arbitrarily lump together injury victims.


How Defective Product Litigation Works

A TVM device, just like any other product intended for use by the public, is supposed to, more or less, act as advertised, without causing any harmful, unintended side effects. You use most products with the expectation that they have been sufficiently tested and researched. In the same manner in which you would not expect a cell phone to explode in your hand, you should reasonably be able to expect that you will not be harmed by a TVM device.

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The physiology and chemistry of the human body are obviously quite complex. A TVM manufacturer cannot be expected to foresee each and every potential complication. But when hundreds, or thousands, of patients experience harm due to exceptionally dangerous complications, as has been alleged to be the case with TVM devices, injury victims can assume that the manufacturer of the device inadequately researched and tested the product. It is critically important that you know, however, that a plaintiff cannot win a defective product case – in the vast majority of instances – by counting on a technicality. Any plaintiff pursuing legal action against a manufacturer in a product defect injury case will have to present convincing evidence to the court in order to show that the manufacturer was guilty of committing negligence. In order to have a chance to win, the plaintiff must prove that the manufacturer either knew – or should have known before introducing it to the market – that the product could present a substantial risk of serious injury. We have seen several examples in past cases of manufacturers putting their profits ahead of the safety of its customers. If a plaintiff can prove this brazen behavior, the defendant will be found liable and forced to provide victims with compensation.


How Mass Torts and Class Action Lawsuits Differ

As we stated earlier, there is a great deal of complexity and intricacy associated with any sort of product liability case. In addition, there are several challenges associated with this kind of litigation as well. The biggest reason for these challenges is that several plaintiffs often take legal action simultaneously, and against the same defendant for the same negligent act. Think about a case where one driver hits 10 other cars. If that case winds up in court, the presiding judge will group all 10 cases into one. The court will always try and eliminate several identical lawsuits.

A defective product injury case works in a similar manner. When a defendant commits a single, wrongful act, and several people are injured due to that act, in many instances the victims will collectively work to take legal action against that defendant. They do this based on a shared and common cause of action. Legally, this is referred to as a “mass tort.” However, you should not confuse a mass tort with the term “class action suit,” which you have probably heard of before. In a class action, every plaintiff has basically the same claim and the same cause of action. However, while each plaintiff in a mass tort also shares a cause of action, each plaintiff also has an individual claim.

Basically, in a class action everyone receives an equal settlement amount, no matter how seriously they were injured. In a mass tort, on the other hand, each plaintiff wins restitution in accordance to the level of injury he or she suffered. You get what you get in a class action suit, while in a mass tort you get what you deserve.

There are a couple of other ways in which mass torts and class action suits differ. First, in a class action suit the court basically allows one lawyer to represent all of the plaintiffs. If a defective product injury victim, for instance, lives in Arkansas, and suffered his or her injury in Arkansas, then that person may be uncomfortable with being represented by a lawyer in New York. The second way is that, should the attorney prevail through either an out-of-court settlement or in trial, the amount of compensation the victim receives may not be proportionate to the damages the victim has incurred.

The following is an example of how difficult it can be for plaintiffs to obtain the compensation to which they are entitled in a class action lawsuit. In 2009, consumers filed a class action suit against Kellogg Company, claiming that the company had falsely advertised that two of its breakfast cereals, Rice Krispies and Cocoa Krispies, supported the immune system of a body. As many companies do when targeted by this sort of lawsuit, Kellogg settled the case for $2.5 million. But while the attorneys working the case won thousands and thousands of dollars, the plaintiffs “won” a $5 reimbursement for each box they had purchased – up to a maximum of three boxes. The attorneys had a windfall while the plaintiffs won basically nothing. There are some instances where a plaintiff can benefit from a class action lawsuit. A TVM lawsuit, however, is not one of those instances.


How a Mass Tort Works

A panel of judges that make up the United States Judicial Panel on Multidistrict Litigation undertake a review of all product liability cases where several persons are injured. The panel, during this review, determines whether or not the case warrants labeling as a mass tort. If the case does satisfy the requirements of a mass tort, then the panel will appoint a single judge to oversee the case’s discovery phase. This basically means that the panel will approve a group of attorneys to gather evidence needed to prove the negligence of the defendant, and to prove the defendant’s liability. Once that liability has been established in federal court, the presiding judge will send the individual cases to the lower courts to be resolved. However, these cases will be based on the evidence gathered through the discovery phase.

Each plaintiff will have the chance to file a suit against the defendant in the lower court and present evidence gathered in the discovery phase. There are laws unique to every state in terms of the kinds of damages that can be awarded in a product liability case. Each claim has its own statute of limitations and its own value. The statute of limitations applied depends on the state in which the victim sustained his or her injury. That is usually the state in which that victim resides.

In the lower courts, the defendants will try and set precedent by winning the first few cases, which are called the “bellwether cases.” If the defendant wins the bellwether cases, it will try and intimidate other victims into not pursuing legal action. The defendant will, basically, be telling future plaintiffs that since the defendant won the bellwether cases, it will win any future cases as well.


Why the Bellwether Cases are Significant

As stated earlier, the defendant and a few plaintiffs undertake a discovery phase that must occur before a TVM victim can take action against the manufacturer individually. This is how most mass tort claims work. A federal judge appointed by the U.S. Judicial Panel on Multidistrict Litigation will oversee the motion. Both the defendant and the plaintiffs will obtain evidence in regard to TVM claims, in order to, respectively, lessen their liability or strengthen their claim. The motion will be applied to all cases involving the dispute across the nation so that every TVM claim does not have to go through its own discovery phase, which would be a very inefficient way to conduct litigation.

A transvaginal mesh injury victim will be able to present her claim in her jurisdiction once both the judge, the defendant and the plaintiff are all satisfied with the discovery motion outcome. While the statute of limitations of the state in which the individual claim is filed will apply, the standard of evidence will be governed by the Federal Rules of Civil Procedure because the JPML notion is federal.

There is a windfall of a sort that happens, as you may expect, when this kind of claim is brought forth. This is particularly true in an area as large as Arkansas. Individual jurisdictions, in an effort to increase efficiency and prevent a backlog in the court system, will group a few plaintiffs into one claim, thus forming a perspective on TVM cases in the future. Unfortunately, this provides the defendant a great chance to devote a huge sum of money toward setting a precedent in regard to future individual claims. If the defense wins these cases, it will likely significantly reduce its settlement offers or even deny future claims. If the plaintiffs win, on the other hand, they defendant will probably offer settlements very quickly. They would rather do that in most cases than risk having to deal with even more litigation in the future.

However the bellwether cases turn out, a TVM injury victim will need to enlist the services of an experienced Arkansas transvaginal mesh attorney in order to be able to secure fair restitution. At the conclusion of the bellwether cases, any litigation that follows will more than likely proceed very quickly – this is especially true if the plaintiffs win. If this occurs, the defense, again, will more than likely make settlement offers in rapid fashion.


The Statute of Limitations

You may not have heard of the term “cause of action,” but it is critically important in determining how your TVM defective product case proceeds. If the defendant owes a duty of care to a plaintiff, and then violates that duty, that creates a cause of action. And if you have a cause of action, you have the opportunity to try and obtain compensation from the defendant in your litigation. However, a kind of “shelf life” is associated with every cause of action. This is the “statute of limitations” term that you have no doubt heard at one time or another. When your statute of limitations runs out, your cause of action expires. It does not matter how strong your case is, you will not have the chance to secure the equitable restitution to which you are entitled if you statute of limitations runs out.

As is the case in just about every form of defective product litigation, there are variables that affect the statute of limitations. The statute of limitations varies from state to state, and can even vary depending on what kind of cause of action that is involved. A plaintiff usually has two years to take action from the date that a duty of care was breached. However, when does the statute of limitations begin in the case of a defective product injury caused by a TVM? Was that date when the TVM was implanted during the surgical procedure? Was it when you first noticed that you have been harmed? Was it the day that your first linked your injury to the transvaginal mesh device?

The court, in all matters, makes an attempt to be as fair and reasonable as possible in regard to the statute of limitations in order to provide the plaintiff the full opportunity to seek equitable compensation. There have, of course, been a number of defective product injury lawsuits resolved in past years, and therefore there is a great deal of case law that has been established. A rule of thumb has been established through careful analysis of this case law, and according to this rule of thumb, the statute of limitations begins when the plaintiff should have known that the injury he or she suffered was incurred due to the defendant’s negligence. That date, in several previous cases, has been determined to be when a public statement was issued by the FDA warning of the potentially severe side effects associated with a product. The danger is made “common knowledge” when this statement is issued.

In regard to the TVM device, the date was October 20, 2008. Another, updated warning was issued by the FDA on July 13, 2011. There are some instances where a manufacturer can voluntarily make a statement warning of the potentially severe side effects of the use of a product. This is another way that common knowledge can be established.

The majority of product injury cases, however, normally take place only after a victim has used a product for several years. Typically, this use occurs many years before common knowledge has been established in regard to linking a product with hazardous side effects. By the strict definition of the statute of limitations, most causes of action in a defective product injury case have already expired because the statute of limitations has expired. Because of this technicality, you need a seasoned Arkansas transvaginal mesh attorney, who can argue that you should receive an extension of your statute of limitations. That attorney has to make a compelling argument that your statute of limitations began when the FDA issued its warning – not the day that your TVM was implanted by your doctor. The defense attorney will, of course, argue exactly the opposite – that the court should not grant your request for an extension of the statute of limitations. This issue will be hotly contested through the duration of the case. And when you factor in multi-district litigation, as will be covered in the next section, that can create even more challenges.


The Complexities Associated with Multi-District Litigation

The most obvious question associated with a statute of limitations is, “How does this apply to my case, and how much time after common knowledge has been established do I have to file a lawsuit?” The answer to that question depends on where you live. In Arkansas, for example, the statute of limitations is three years, while in Texas it is two. If several victims have been injured by a defective product, and these victims live in different states, which statute of limitations is observed?

Multi-district litigation provides the answer. As stated previously, all subsequent cases in a mass tort will be determined by the bellwether cases. The bellwether cases will determine the path all of these future cases take. And there is a great deal of work in store for the judge who is presiding in those cases. Not only will he or she have to oversee a trial that could last for months, that judge will also have to have a lot of foresight. The reason this foresight will be needed is that the judge’s decision will have a profound impact on the lives of the plaintiffs who pursue action in the future. These cases will occur in many different jurisdictions, however, they will observe the procedures and rules of the court where these cases are resolved. The statute of limitations where the plaintiff lives, however, will also apply. This creates a sort of hybrid between the two jurisdictions that is referred to as a “borrowed statute of limitations.”


How to Secure the Restitution to which You are Entitled

The judge presiding over the bellwether cases, as mentioned previously, will normally force a defendant to place money into a trust that will be used to compensate future defendants. This is yet another reason that you will need the help of an experienced attorney, because this fund adds another layer of complexity to a defective product injury case.

Plaintiffs, when they file a defective product lawsuit, have to deal with many nuances that can be overwhelming to a novice lawyer and seem like a completely foreign language to a non-attorney. There are meticulous rules and procedures that are unique to every court, and if these are not followed to the letter, a case can be immediately dismissed. Another complex factor is that when a defendant is defeated in a mass tort, it can be quickly drained of the money necessary to pay plaintiffs, and this can happen before all plaintiffs have been awarded compensation. Many times, and for just this reason, a mass tort case often becomes a race against time as plaintiffs work feverishly to make sure they are paid before the money disappears. You must also provide the court with an accurate calculation of the damages you have incurred due to the injury you have suffered, such as pain and suffering, medical expenses and lost wages. This is the process known in legal terms as “proving up” your damages. It is imperative that you have the help of a skilled and seasoned defective product/product liability attorney working on your behalf to protect your rights. The Arkansas transvaginal mesh attorneys with Grossman Law Offices have handled this sort of litigation for two decades, and as a result are extremely familiar with the process of acting decisively and aggressively in order for you to be able to secure the restitution you have coming before the defendant’s resources are depleted. We also know how to accurately calculate your damages so that you are not short-changed.


Who is Responsible for the Injury You have Suffered?

It is obvious, in just about every defective product injury case, that the manufacturer of the harmful device is the party that is most responsible for any injuries that are suffered. When any company introduces a product to the marketplace, the users of that product should reasonably be able to expect that the product will not cause them harm. Consumers should also have a reasonable level of knowledge in regard to that product, and know its potential hazards. When a surgical device in particular is brought to market, patients will usually expect a certain level of pain to be associated with its use. However, in regard to a TVM device, such severe complications as infections, erosion or dyspareunia go far beyond the scope of those reasonable expectations. This increased injury risk is the reason that manufacturers typically take the blame for any defective products they produce.

Some plaintiffs, however, not only feel that the manufacturer should be held responsible, but the doctor or surgeon should be held accountable as well. This does not make a lot of sense, however, from a legal perspective. To start with, there have been many patients who have had a TVM device implanted because they suffered from POP, and many of them have not suffered from the complications that were mentioned previously in this article. In addition, a TVM injury should not be considered to be the same thing as a prescription drug injury. In other words, the mesh is used to supplement a surgical procedure that is designed to strengthen a patient’s pelvic walls. For example, a drug such as Actos that results in an injury is a completely different matter. The reason is the doctor who prescribes such a drug does so with a certain level of knowledge concerning the medication’s potential side effects. However, it is an extremely rare occurrence when a doctor harms a patient intentionally; doctors, the vast majority of the time, use the information they have at their disposal in terms of prescribing medication, and they almost always act in good faith.

The FDA is another party that many TVM injury victims consider suing. But in nearly every single case, this is also not a recommended course of action. This is not an advisable way to try and obtain compensation because the federal government is exempt from tort claims due to the Federal Tort Claims Act of 1948. This act names several explicit situations where the federal government is protected from mass tort action. The federal government is exempt from several other kinds of claims as well, but as it pertains to a TVM injury, a plaintiff cannot sue the government for performance of for an inability to perform a “discretionary function or duty.” The goal of the FDA is to maintain the safety of the general public and to keep it aware of dangers. However, if it fails in this capacity it cannot be the target of any kind of lawsuit.


Determining Whether or not You have the Basis of a Transvaginal Mesh Injury Lawsuit

The answer to whether or not you have grounds for legal action in regard to a TVM injury is “maybe.” If a woman who has a TVM device implanted and suffers from relatively minor problems such as intermittent slight pain, more than likely she has not incurred damages that would be significant enough to justify the costs associated with filing fees and court costs. But if a woman has suffered one of the more serious complications that were previously mentioned, such as recurring prolapse, erosion of the medical device, or some other complication and requires surgery – not only to remove the mesh but to also repair the affected area – she could incur an immense amount of damages that would warrant the pursuit of legal action. A patient has to reason to expect to suffer severe complications from a surgical device, and will more than likely have incurred the damages necessary to make filing a lawsuit a worthwhile effort.


How Grossman Law Offices Can Help

After taking all of this information into consideration, hopefully you realize that if you are considering taking legal action and becoming part of a mass tort against the manufacturer of the TVM device that injured you, you will need a lawyer who is well versed in the intricacies and complexities involved in product liability litigation. You have to made aware that no two TVM injuries in Arkansas are the same, and thus these kinds of cases need to be treated on an individual basis.

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If you or someone you love has been injured by a TVM device, please call the Arkansas transvaginal mesh attorneys with Grossman Law Offices immediately at 1-855-589-5649 (toll free) for a confidential and free consultation. After we listen to all of the specific circumstances that surround your case, we will provide you with an honest assessment of your case’s strengths and weaknesses. We are standing by 24 hours a day, seven days a week and will gladly answer any questions you may have, whether they be on anything you’ve read in this article, defective product injury law in general, or your case in particular. Please call us so that we can put our two decades of experience to work for you, make sure your rights are protected, and help your obtain the compensation to which you are entitled.

The Arkansas transvaginal mesh attorneys with Grossman Law Offices have the experience and training necessary to handle the incredible complexities that are associated with these kinds of cases, and we are completely discrete in the way we handle TVM litigation. Please to not hesitate to call us at 1-855-589-5649 (toll free) if you or someone close to you have been injured by a TVM device so we can tell you how we may be able to be of assistance.



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