- Having manufactured a dangerous drug;
- Selling Taxotere without properly testing it;
- Selling Taxotere without disclosing its damaging risks;
- Failing to determine whether Taxotere was safe;
- Failing to properly warn patients and health care providers about Taxotere’s damaging effects;
- Misleading the public in advertising and marketing Taxotere;
- Concealing information from the public; and,
- Downplaying the dangers associated with Taxotere.
The list above itemizes the several legal actions claimed in lawsuits filed against Sanofi-Aventis, the manufacturers of the popular intravenous chemotherapy drug Taxotere.
Taxotere (Generic name: Docetaxel) is an intravenous chemotherapy drug that is acknowledged as capable of improving life expectancy and overall life quality. It is manufactured and marketed by Sanofi-Aventis and was approved by the U.S. Food and Drug Administration in 1996 for breast cancer treatment. It has also been approved for the treatment of a variety of cancers including non-small cell lung cancer, prostate cancer, gastric cancer, and head and neck cancer.
The main difference Taxotere has with other chemotherapy drugs, including those in its own class (class of chemotherapy drugs called plant alkaloids), like Paclitaxel, which is said to be as effective as Taxotere, is its damaging effect: permanent alopecia or permanent hair loss (a significant number of women, though, complained of alopecia universalis or total hair loss on the scalp and body (this means loss of eyebrows and eyelashes, and hair growth under arms and around the genital area).
According to the law firm Williams Kherkher, Sanofi-Aventis knew about this side-effect as early as the 1990s through a study. In 2005, patients outside of the U.S. were warned about this side effect; however, patients in the U.S. were warned of this only in December of 2015, after the (FDA) mandated them to do so.
Permanent hair loss consistently appeared in various studies as one of the most stressful side effects of cancer treatment. It has profoundly impacted affected patients’ well-being and quality of life – a serious damaging condition Sanofi-Aventis will have to answer for.
Given the difficulty of applying for a visa in the United States, people will look for any channel that is available in order to successfully work and live in the country. One of the easiest and fastest ways they can become an American citizen is through an EB-5 visa.
In order to qualify for an EB-5 visa, you need to meet certain requirements which could include the following:
1. Investment Amount
An EB-5 visa applicant will usually be required to investment a minimum of $500,000 or $1 million. It can come in the form of cash, inventory, equipment, secured indebtedness, tangible property, or cash equivalents which is valued on the fair market value. $500,000 is invested if the business is located in a targeted employment area (TEA). To qualify as a TEA, the project must be done in a rural area or territory with high unemployment. Otherwise, the amount of investment will be $1 million.
2. Job Creation
For EB-5 , the required number of jobs that should be generated should be 10 full-time jobs for U.S. employees. The jobs should be created within two years after the investor has been granted their conditional permanent residency. In some cases, they must show that their investment resulted to job generation directly within the commercial entity that received the investment.
3. Business Entities
Applicants for an EB-5 visa must directly invest in a commercial enterprise or in a regional center. Older businesses can be qualifiesd as long as the investment can generate a 40-percent increase in the number of employees or net worth. Investing on a regional center-run project offers more benefits than investing in a new business since you do not have to set-up the project.
When applying for an EB-5 visa, you will need to file two petitions with the United States Citizenship and Immigration Services (USCIS). The I-526 petition should include the following:
- Proof that the source of funds comes from a legitimate source
- Evidence that the accumulated wealth is enough for an EB-5 investment
- Proof of fund transfer to the Regional Center’s escrow or project account
- Copies of passports for every family member on the petition
- Documents related to the education and employment background of the petitioner
- Birth and marriage certificates for all members of the family
- Additional information required on a case-by-case basis
Next, the applicant will file a separate I-829 petition which should include the following:
- Proof of investment amount
- Evidence that the funds were invested in the project and “at-risk” at the time the I-829 was filed
- The commercial entity created or is expected to generate at least 10 full-time jobs
- Once the I-829 petition is approved, the investor and their family members will get their green cards.
An EB-5 visa allows an investor to easily apply and get approved for a US green card.
As a result of its job of controlling the complete human body, the brain is, hence, regarded, as the human body’s most important part. Any force or blow, therefore that’ll influence the brain and harm it may affect how it functions which, consequently, may change the way the human body as a whole operates.
An explosion or a blast, an automobile wreck, or a diversion- related activity or injury, that could cause a strong blow to the head may make his/her brain bump against the skull’s internal walls. This can cause bruising of the brain, neural fibers getting ripped or hemorrhage which, consequently, can lead to an intracranial injury or traumatic brain injury (TBI).
According to the website of Habush Habush & Rottier S.C., you will find times when the symptoms and indications of TBI are perhaps not instantly clear after a collision. Gradually these symptoms may show themselves, yet, through neck pains, constant headaches, changes in sleep routine, slowed thinking, discussing, acting or studying, moodiness and vertigo. When symptoms, however, will contain continued vomiting, tingling or convulsion of the limbs and slurred speech, then it best that the individual is delivered to the hospital for treatment and the mandatory evaluations.
A brain injury could be a serious form of injury, consequences varying depending on the region or the specific part of the brain that has been affected. While some harms could be light, resulting merely to lost or short term headaches states, a serious head injury can lead to death, impairment, amnesia or, worse, coma.
According to the Centers for Disease Control and Prevention (CDC), a brain injury (TBI) may also be caused by: a smashed part of skull infiltrating the brain’s cells; the brain hitting a solid object (including pavement) throughout a bicycle accident; a gunshot wound in the head; and, falls, which is extremely common in children and seniors.
Cruise ship vacations are becoming exceedingly popular among tourists in the last recent years. More and more people prefer this particular method of travelling because it can provide plenty of enjoyable experiences. Vacationing on a cruise ship gives passengers access to luxurious accommodations while being transported across various locales. While enjoying the open sea, they also get to experience the different activities available to them on board. Plenty of cruise lines offer amenities such as restaurants, water parks, spas, and casinos to ensure that passengers have the best time while they travel to their destinations.
While cruise ships are definitely among the most attractive travel options available to tourists, there are still considerable concerns that passengers should be made aware of. As with any mode of transportation, there are certain risks involved in travelling by cruise ship. The website of the Vucci Law Group cruise ship lawyers delineates common accidents and injuries that passengers could face while on board a ship. Incidents such as slip and fall accidents, food poisoning, norovirus outbreaks, and accidents involving water slides, wave pools, and swimming pools are just some of the dangers that passengers should take note of. The threat of physical and sexual assault due to negligent security is another cause of concern, as well as fires caused by defective equipment and facilities.
Passengers who fall victim to these accidents can suffer from a variety of injuries. Some of these injuries can be severe and cause victims to deal with lifelong consequences. The worst on board accidents on a cruise ship can result in head trauma and spinal cord damage, leading to the possibility of temporary or permanent disability.
In this light, many legal experts assert that cruise lines should be vigilant in taking necessary precautions to ensure the safety of their passengers. It’s not enough that these lines provide state of the art facilities and luxurious accommodations, they should also be aware of their responsibility for the thousands of people on board their ship looking forward to an enjoyable time.
Popularly known as the City of Lakes, Madison, Wisconsin is a sight to behold. Situated in an isthmus flanked by two large glacial lakes, Madison is undoubtedly is full of interesting sights and views. One such attraction is Lake Mendota. Visitors can make the most of the Lake Mendota landscape by coming over to the Memorial Union Terrace and take a seat among the many brightly colored seats littered along the surrounding area.
The Memorial Union Terrace is by the University of Wisconsin. It is a place that was first constructed in 1928 to serve as a recreational area for the university’s students. Today, the Memorial Union Terrace is a place where students, residents, and tourists can unwind, socialize, and enjoy Lake Mendota. The terrace is particularly impressive during the spring and summer months when it becomes an area where people can enjoy the warm weather and relaxing breeze.
Of course, the view isn’t the only thing that is drawing crowds to the Memorial Union Terrace. Visitors looking to enjoy Madison’s social scene can take part in the live music events held in the terrace for 4 nights every week. There’s also a movie night every Monday, for those who prefer to lie back and enjoy a good story than dancing it out in the dance floor.
The Memorial Union Terrace is also home to several restaurants and cafes. There’s the favorite Babcock Ice Cream, as well as The Gazebo for some slow-roasted pork. There are several other places to enjoy good food in the area, but visitors should take note that some of these might be closed for the season. Be sure to check the Wisconsin Union website for more information.
There have been several instances when manufacturers for design or manufacturing defects have recalled millions of tires. The most recent one was announced on March 10, 2015 by Toyo Tires, which involved more than 190,000 tires sold in North and South America. The Japanese tire manufacturer state that these may have a manufacturing defect that affects the integrity of the belt edge.
Such announcements usually excite a blip or two in the news, but certainly not enough to capture the attention of many viewers that may be closely concerned i.e. they have the same kind of tires on their vehicles. That is, until a serious accident happens.
Tire recalls are problematic because of saturation. Even when distributors and dealers pull the products in question out of the market, tires that have already been sold may have gone to car owners that are not aware that they may have a potential problem on their hands. This is compounded by the fact that some distributors and dealers continue to sell these defective tires after a recall has been issued.
According to the National Transportation Safety Board, the failure to take old and defective tires off the road is an issue needs to be addressed as soon as possible. Every year, 6,000 people are injured and 200 die in defective tire accidents.
Defective tires are dangerous because they can explode at speed, causing the driver to lose control or the vehicle to roll over. The same applies for old tires, which weaken over time and should be replaced at least once every 6 years even if there is hardly any wear and tear. According to the website of Evans Moore, LLC, however, many tire blowouts are a result of design or manufacturing defects.
If you have been sustained serious injuries in a defective tire accident, you may have the right to seek compensation for what you have gone through. Consult with a defective tire lawyer in your state to find out your legal options.
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 on the website of lawyers Williams Kherkher, 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.