The Food and Drug Administration (FDA) is responsible for assessing and approving new drugs that are being proposed to be marketed in the US as well as for deciding if the conditions for which an existing drug is already approved for can be expanded. This is a long, complicated process, requiring extensive preparations including properly designed clinical trials, and even then there is no guarantee that the FDA will give its blessing.
A good example for this is the oral anticoagulant drug Xarelto (rivaroxaban), which was first approved by the FDA in July 2011 for distribution the US, initially for the treatment of atrial fibrillation (irregular heartbeat). Currently, Janssen Pharmaceutical can market Xarelto as a treatment for six conditions, namely:
- Atrial fibrillation
- Deep vein thrombosis (DVT)
- Pulmonary embolism (PE)
- Recurrent DVT or PE post acute venous thromboembolism treatment
- Post-surgical prophylaxis following knee replacement procedures
- Post-surgical prophylaxis following hip replacement procedures
This puts Xarelto on the top of other anticoagulants in terms of broadness in its indication profile, and J&J together with the drug’s manufacturer Bayer are making significant efforts to broaden it even more by including acute coronary syndrome (ACS), peripheral artery disease, and embolic stroke. So far, though, the FDA has withheld approval for these latest applications.
Different anticoagulants target specific factors in the coagulation cascade, and may have varying degrees of risk of side effects. Xarelto is a direct factor Xa (10-a) inhibitor, a class of drugs known as “xabans.” According to an article in http://www.williamskherkher.com/practice-areas/defective-pharmaceuticals/xarelto/, serious side effects can happen with Xarelto which include uncontrollable bleeding in the brain and liver failure. Even worse, there is no known way to reverse its effects, which can lead to potentially fatal complications.
If you have been prescribed with Xarelto and suffered serious injuries because of it, you need to get legal representation to help you get compensation. Make an initial consultation with a Xarelto lawyer as soon as possible to find out how to get started.
Most categories for the basis of personal injury require proof of negligence. Manufacturing defects, however, fall under strict liability. This means that even if there is no negligence on the part of the manufacturer, it can still be held liable for any injuries or deaths that result from manufacturing defects.
Manufacturing defects are defined as an unintentional departure from the design of the product which renders the product dangerous to consumers or users. Under the strict liability rule, manufacturing defects renders the manufacturer liable even if “all possible care was exercised in the preparation and marketing of the product” (American Law Institute, Restatement (Third) of Torts: Products Liability).
Victims of manufacturing defects can sue for compensation for their injuries. Some manufacturing defects have more serious consequences for the user than others, such as car parts. A defective brake, for example, or faulty ignition assembly can malfunction at any time and case a catastrophic accident for the driver, passengers, and other people or vehicles that may be in the immediate vicinity. This can render the car part manufacturer liable for all the injuries or deaths resulting from an accident caused by the defective part.
However, it is not always easy to prove that a part was defective, or that it was this defect that caused an accident. In a car accident, for example, the damage to the car may be so extensive that determining whether a part was defective or not may be impossible. The defense may also propose that it was human error rather than a defective part that was responsible for the incident.
Because the legal ramifications of a manufacturing defects claim can be difficult for a layman to follow, consultation with a products liability lawyer should be the first order of business. It is important to establish as early as possible whether manufacturing defects was the cause of an accident, and a lawyer experienced in these matters will know what steps to take to accomplish this.
People with disabilities, who are blind, or are over 65 years old, can benefit from having Supplemental Security Income (SSI). This is a program that is funded by the United States Treasury general fund, although it is given and dispersed by the Social Security Administration. It is a cash allowance for those who are in need of clothing, shelter, and food.
Eligibility for the SSI benefit depends on the evidence that the person will submit, such as their birth certificate (or legal documents proving they are 65 years old or older), that they are a legal resident of any 50 states of America, their income and resources have certain limits, and that they have applied to avail of the benefit. There are certain circumstances where a person can be made ineligible for SSI benefits: having unfulfilled arrest warrants or have violated their parole conditions, they have failed to apply for all other benefits that they may be qualified for, and many other restrictions. These restrictions are present in order to properly monitor who are given because SSI is considered a welfare benefit.
There are questions that are asked for people who are applying for SSI benefits. These questions can be accessed online on the SSA website and they are often about the present living conditions and situations, the amount of money that you currently have as well as the value of all the properties that you posses. After answering these questions, your results will be immediately shown on screen to see if you are eligible or not.
If you have been approved of your application for SSI benefits you will be receiving cash payments every month, although amounts may differ depending on each circumstance. It should be noted that these cash allowance are not taxable. With proper information and help from a lawyer about how to get the SSI benefit, you can avail of it and worry less about making ends meet.
A recurring theme in many da Vinci robot lawsuits naming Intuitive Surgical Inc. as a defendant is that of inadequate training of surgeons in the use of the company’s robotic surgical system. Surgical injuries can occur with robot-assisted surgery in a number of ways, most commonly when blood vessels are nicked or organ linings are punctured by accident. It is also possible for a patient to be harmed when the electric current jumps from the instruments to the patient, causing burns that can lead to serious health issues or even death.
The surgeon’s training comes into play in this last instance with the simple act of cleaning an instrument that came with the da Vinci system in the midst of a procedure. Properly trained surgeons would know not to scrape instruments together to clean them as this causes the protective coating to be scraped off as well. This increases the risk of “arcing,” which is when an electrical current appears to jump from one surface to another.
Plaintiffs in the cases against Intuitive claim that the company knew of this particular risk, yet failed to inform surgeons about it. Moreover, in order to increase the number of surgeons who are credentialed for its use and thus increase demand for the product, da Vinci system salespeople aggressively push hospitals relax credential requirements for surgeons being trained to use it. Since robot-assisted surgery is physically easier on the surgeon and comes at a premium, the tendency is for surgeons who have credentials to recommend the da Vinci system to their patients needing gynecologic, cardiothoracic, urologic and general surgery.
In most cases where burning occurred, surgeons are seldom listed as a defendant in personal injury claims because they are not considered to be at fault. The manufacturer is responsible for providing users of the new technology with the skills and knowledge to use the tool safely and effectively.
Over-the-counter medication that is readily available in most household first-aid cabinets now includes warnings about components that could lead to overdoses.
Tylenol, produced by McNEIL-PPC, Inc., now comes in bottles where the caps include warnings that the medication contains acetaminophen, a pain reliever that has long been misused, possibly resulting in overdose and liver problems.
Many people think that over-the-counter (OTC) drugs are harmless and may be ingested with impunity. The truth is, it is easier to abuse and misuse OTC medications because it is so readily available. Pharmaceutical companies are not always so concerned with consumer awareness, which is why the potential for product liability lawsuits is present. Not so with the makers of Tylenol.
In general, acetaminophen is safe as long as the dose does not exceed 3,000 milligrams a day. This is about six tablets of Tylenol, which is a lot even on the most stressful of days. However, an overdose can occur accidentally when the medication is taken with another drug which already contains acetaminophen such as Sudafed or other prescription medication, or when it is mixed with alcohol. In roughly 50% of overdose cases, the excessive amounts were taken deliberately. The most recent additional warnings in the cap is to ensure that no liability can be attached to the drug manufacturer in case of an overdose.
Divorce is always a time of stress and worry, but usually grandparents merely play a supporting role, perhaps provide testimonials to support their respective child’s claims when necessary. But when grandparents believe that their grandchildren suffer under the custody of unfit parents, they take on a more active role.
Grandparents’ rights refer to custody of a grandchild in lieu of one of the biological parents. Typically, grandparents can ask and receive visitation rights in Texas if any of the conditions apply:
- Parents are divorced
- Custodial parent is abusive or neglectful
- Custodial parent is dead, in prison or found incompetent
- The parent-child relationship has been legally terminated by a court
- The grandchild has been in the custody of the grandparent for a minimum of 6 months
It is not at all easy to prove that a parent is unfit or that it is in the best interest of the child to be in the custody of his or her grandparents. This is especially true, according to the legal website Holmes, Diggs & Eames, PLLC, when the custodial parent is resistant. It has to be proven in court that the child’s physical and emotional health is being impaired significantly by being under the continued supervision of the custodial parent.
In Texas, grandparents may sue for custody of a grandchild only if at least one biological or step- parent is alive and has parental rights to the child. Grandparents’ rights are superseded by the rights of an adoptive parent if he or she is a person other than a step-parent, and grandparents may not sue for access or custody to the child.
Once grandparents’ rights have been established, grandparents take on the role of conservators. Financial support may be claimed from both parents for medical and living expenses as this is their legal responsibility.
If you believe that your grandchild is being abused, neglected, or otherwise not being reared in a reasonably healthy environment, then you can assert your rights as a grandparent. Contact a grandparents’ rights attorney to get the wheels started on your petition before more damage to the child is done.
A physically traumatic event can result in brain damage, such as in a vehicular accident. But to say that there is brain damage can mean a lot of things. The damage may be mild and temporary and may resolve without any treatment. Alternatively, according to the Perth Amboy-based law firm Levinson Axelrod, P.A., brain damage can be extremely severe, resulting in permanent and total disability or death. The type of brain damage will depend on the amount and location of the force, and what portions of the brain was affected. Below are some of the more common types of brain damage.
When the brain is subjected to a sudden and violent force, cranial nerves and blood vessels may be affected, causing disorientation, dizziness, and/or loss of coordination, consciousness, and memory. It is not easy to diagnose, which is why patients who sustained a blow to the head or involved in a vehicular accident are required to keep conscious for 24 hours after to report on symptoms. There is no treatment for a concussion, and may take a few months to a few years to heal. Occasionally, a blood clot can form which can lead to death. Concussions are the most common types of brain damage.
When the brain bleeds from direct impact to the head, this is called a contusion. Small ones may be left alone to resolve by itself, but large ones may have to be removed surgically. There are several types of contusions, including:
- Coup-Contrecoup Injury – the force is hard enough that the brain is “bounced off” the wall of the skull, creating contusions at both the original point of impact and at the opposite side
- Diffuse Axonal Injury – when rotational forces, such as in a car accident occur, the violent movement causes the axons from all over the brain to shear away, causing interruptions in the firing of information from the brain to the body and vice versa. The effects can be temporary or permanent, depending on the amount of force and the site of shearing.
There are other types of brain damage. The aforementioned are simply the most common that occurs in car accidents. If you or someone close to you sustained any form of brain damage as a result of the negligent actions of a third party, you may have a case for a personal injury claim.
Rape and sexual assault are considered by most people as the basis for criminal prosecution, but few consider the personal injury aspects of this particular type of crime. Sexual offenses against women and children often have far-reaching and life-long consequences, and it is not always enough that the perpetrator is put in prison. The physical, psychological and emotional damage to survivors of sexual assault are arguably much more serious than other types of civil torts, usually referred to as personal injuries.
This option for civil remedies to sexual assault has been around since the early 1900s, but it is only recently that victims have become aware that they can get financial compensation for what they had gone through. This could be due to the increasing popularity of personal injury lawsuits since the 1970s. Whatever the reason, this accommodation is probably most appropriate for victims of sexual assault than any other personal injury. Under civil tort law, survivors of sexual assault may be able to redress their grievances in employment, immigration, education, public benefits, housing and family law. As a civil tort action, however, the focus is on seeking financial compensation for injuries suffered from sexual assault.
The parties that may be considered liable in civil court may also be much broader than that available in the criminal justice arena. Prior to 1960, it was the perpetrator which was the sole focus of the lawsuit. However, the circle of responsibility has become much wider in recent years, as the law accommodates the concept that other parties which may have foreseen or should have foreseen the potential for sexual assault may also be held liable. According to the website of Habush Habush & Rottier S.C. in Wausau, the gathering of evidence to prove negligence of other parties is essential for bringing about a successful civil tort action. An example would be a school which fails to check on the background of their staff, one of whom is a registered sex offender. If one or more of the children under their care are sexually assaulted by this person, the school may be held liable for what is considered a breach of their duty of care to their students.
If you are a victim of sexual assault, you can get the compensation you need to pay for therapy, medication, special equipment, medical bills, and other costs associated with the attack on your person. Consult with an experienced personal injury lawyer in your area and get your civil tort action going.