Sep 4, 2014
Boehringer Ingelheim, not willing to give up its leadership in anticoagulants, has managed to get approval from the Food and Drug Administration (FDA) to include deep vein thrombosis (DVT) and pulmonary embolism in the list of indications for its drug Pradaxa (dabigatran etexilate mesylate). The contender for the throne of Pradaxa is Xarelto (rivaroxaban), the hot newcomer in the field distributed in the US Johnson & Johnson (J&J) in partnership with manufacturer Bayer AG. J&J posted a 3.5% increase in its first quarter earnings for 2014 compared to the same period the previous year, and Xarelto sales contributed significantly to this revenue.
However, J&J and Bayer have had no such luck so far with expanding the use of Xarelto to manage acute coronary syndrome (ACS), embolic stroke, and peripheral artery disease. They have been turned down by the FDA three times for clinical trial design problems, the latest in March 2014, but the two companies are not giving up. They are currently in the throes of three new studies that will hopefully get the nod from the regulatory body. Xarelto is currently approved for ACS in 40 countries outside the US.
The biggest hurdle for Pradaxa in regaining its client base is the ongoing litigation that brings into question the safety of using the drug. It was approved in 2010 and the first lawsuit was filed in March 2012 at the height of its popularity and is currently in multidistrict litigation (MDL). However, Xarelto may be going down the same road. It was approved in July 2011, and the first lawsuit was filed in February 2014. According to the website of law firm Williams Kherkher, more cases are being filed for dangerous side effects. There has been speculation that an MDL may also be in the offing in the near future.
If you are currently on Xarelto and have sustained serious harm from its side effects, don’t be afraid to draw your own gun. Consult with a reputable Xarelto lawyer in your area and find out how you can get compensation for your injuries and losses.
Aug 2, 2014
Enhancing one’s eyes, lips and cheeks with the use of make-up may be easy to some, but may be hard for others. Well, regardless of the level of ease, one thing is sure – it takes time. And to do it every day, plus a couple more times daily, can be a tiring routine.
It was during the early part of the 20th century when the application of what is now called “permanent makeup” began; but it was in the 1930s when the technique became a hallmark in fashion that salons offered it to women as a form of complexion treatment, using vegetable dyes as pigments.
Today, this same treatment is called dermapigmentation, cosmetic tattooing, permanent makeup, permanent cosmetics or micropigmentation (which is its most common name). Micropigmentation adds permanent color to the skin through the use of organic pigments that are embedded beneath the epidermis. This is done by using a hand-held device with a very thin needle that can puncture the skin hundreds of times a minute, making the treatment basically much like a tattooing procedure. The purpose of the treatment, however, can either be as corrective procedure or cosmetic enhancement.
As a corrective procedure, micropigmentation is done to solve uneven skin pigmentation, scarring to the skin, and so forth. As cosmetic enhancement, it helps to define the eyes, and make the lips and eyebrows look fuller; it also gives an eye shadow and a look of blush effects.
Over time, other uses for micropigmentation were introduced, including removal of beauty spots, camouflage of scarred skin, nipple reconstruction (which involves enlarging or decreasing the size of the area around the nipples), and hairline tattooing.
Though being punctured by a thin needle hundreds of times a minute definitely sounds painful, it is not the same in a micropigmentation procedure. In fact, a treatment that usually lasts for 40 minutes, aside from the possibility of some mild discomfort, is essentially painless. Clients, though, have the option of being injected with an anesthetic to do away with any discomfort during the treatment.
A well-trained and experienced plastic surgeon, who should be the person performing the procedure, recommends micropigmentation to those who:
- Value good looks the whole day every day, but with minimal effort
- Want to correct uneven facial features;
- Do not have enough time every day for make-up application;
- Have oily and sensitive skin, or have allergies to make up;
- Are too active and/or sports minded (like swimmers) and would always want to look great;
- Have shaky hands and/or poor eyesight and, so, find applying make-up quite a difficult task; and,
- Have thin or missing eyebrows because of alopecia, constant tweezing, or chemotherapy treatments
On its website, the Bergman Folkers Plastic Surgery clinic believes that good make-up makes a person look good, and feel good and confident, and it is this confidence that propels a person to do well. Micropigmentation may not only be directed at making people look great, but in making them feel good to excel in whatever they do.
Jul 28, 2014
The story that began in 2012 when vials of pain and swelling relief medication were found to be contaminated with fungal meningitis continues to unfold. Failed mediation has signaled a resumption of civil litigation.
New England Compounding Center (NECC) was first named in civil lawsuit alleging liability for the production and distribution of contaminated methylprednisolone acetate. Sixty-four people died and 751 people were infected before the contaminated batches of medication were pulled out. NECC has since declared bankruptcy, but not before agreeing to a $100 million settlement to benefit the victims and the company’s creditors.
Now the curtain has gone up against Liberty Industries Inc., the contractor which designed and maintained the clean rooms at NECC. According to www.unionlawfirm.com, Liberty had taken on the duty to provide facilities that would ensure the safety and cleanliness of the medications that went through these clean rooms, and failed miserably. In the case of NECC, other preparations that may have also been contaminated due in part to Liberty’s negligence include betamethasone, triamcinolone, and cardioplegia solution.
While this does not let NECC off the hook, the focus is now on the clean room company. NECC is based in Massachusetts but shipped the contaminated products to at least 23 states, including California where one personal injury case was filed by Dawn Younani, who received three shots from contaminated batches of methylprednisolone acetate following a surgical procedure. Other Californians may soon have use for Irvine personal injury lawyers to represent them in civil litigation against Liberty and to make a claim against NECC.
While the fungal meningitis outbreak scare is winding down, the statute of limitations has not yet run out for those who have only been recently made aware that their conditions may have been due to inoculation via contaminated drugs caused by the negligence of NECC and Liberty. Symptoms of fungal meningitis include:
- Altered mental state
- Sensitivity to light (photophobia)
- Neck pain or stiffness
If you suspect that you may have contracted fungal meningitis from contaminated drugs from NECC, have yourself tested immediately. If the tests come back positive, contact a personal injury lawyer in your area to assess your case.
Jul 25, 2014
Fiduciary duty may seem like a dry legal concept that has very little to do with everyday life, but in fact it acts on most people on a daily basis. Fiduciary duty is defined as the responsibility of one party who is placed in a position of trust to act on behalf of another party’s best interests. Examples of instances when fiduciary duty is relevant include transactions between a doctor and a patient, a bank and a depositor, and a priest and a confessor. In each of these relationships, one party has complete confidence that the other party will not profit from their association to his or her detriment.
Of course, fiduciary duty is not a phrase that is commonly used. What would be more familiar to a lay person would be doctor-patient confidentiality and sanctity of the confessional. When it comes to estate planning and probate, however, a fiduciary plays a crucial role. The fiduciary is expected to carry out the wishes and directions of the principal as stated in a last will and testament, trusts, or other legal document even if it conflicts with the fiduciary’s beliefs, opinions, or benefit. Examples of fiduciaries in estate planning would be executors, banking institutions, asset managers, and probate lawyers.
For example, if a millionaire in Los Angeles leaves a will dividing the estate equally between his wife and his daughter, his executor would need to determine which goes what to who while the Los Angeles probate lawyer would ensure that the estate goes through probate court as speedily as possible. It would be a break of fiduciary duty for the executor to under-appraise an asset and then acquire it from the estate. In the case of the probate lawyer, it would be a breach to delay the probate process to motivate one or more heirs to “grease the wheels” to make the process go faster.
Fiduciary duty is considered one which is brought to the highest legal standard, and it is easy to breach it unknowingly or unintentionally. If you suspect a breach of fiduciary duty in estate planning or probate in yourself or others, consult with a lawyer experienced in such matters.
Jul 23, 2014
This last six months or so has been a rollercoaster ride for pharmaceutical giant Johnson & Johnson (J&J) when it comes to its Jekyll and Hyde product Topamax. J&J recently received approval for the use of Topamax (topiramate) for 12 to 17-year-olds to prevent the onset of migraines. This was a few months after the company suffered its second major setback in court for failure to warn litigation for the same product where the plaintiff was awarded $11 million in damages.
Topamax is an anti-epileptic medication that was first introduced in 1996 and was found to be highly efficacious, contributing to its popularity. However, the product was routinely prescribed for off-label uses such as weight loss and for treating bipolar disorder, which would have been fine…except for the side effects. By 2011, it was apparent that Topamax caused birth defects in women who took the medication while they were pregnant.
Topamax lawyers for the plaintiffs alleged that J&J’s subsidiary Janssen Pharmaceuticals has known about the risk to patients and their unborn children but failed to warn them or their physicians about it. That, coupled with aggressive marketing strategies that encouraged off-label use of Topamax, was a recipe for disaster for which J&J is now financially liable.
With this new approved use of Topamax, which is now clearly labeled to indicate risks to pregnant women and for off-label uses, it is presumed that J&J will more than recoup their present and future losses in the legal arena, although the company intends to appeal the 2 verdicts that have been handed down against them. There are currently more than 130 cases still pending against J&J for Topamax.
If your child was born with birth defects because of Topamax, you may have an actionable case. Consult with an experienced Topamax lawyer in your area to find out if you can sue for compensation.
Jul 22, 2014
Preparations for a day meant to be in celebration were cut short when a trailer full of fireworks exploded, killing one person and seriously injuring three others. Investigations are ongoing, and a reckoning will have to be made soon.
Kiwanis Club members who were setting up the famous fireworks display slated as the culminating activity for the upcoming Fourth of July celebrations in the small town of Comanche near Fort Worth were interrupted by a loud explosion coming from the direction of the local high school. One volunteer was near enough to the trailer to have been killed on the spot. The planned activities for the next day were canceled as a result.
The fireworks display had been a tradition in the town (population 4,500) for 24 years, drawing visitors from Fort Worth, Dallas, and Austin, and nothing untoward had happened before. It is unclear what triggered the explosion. State fire marshals and agents from the Bureau of Alcohol, Tobacco, Firearms and Explosives are investigating.
There are many possible explanations for the explosion, such as manufacturing defects or improper handling that caused the fireworks to go off unprovoked. It may be that someone had unintentionally or deliberately set it off by throwing a lighted match or live cigarette in the vicinity of the trailer. It is likely that the explosion was a result of some type of negligence, if not malice.
If and when the triggering agent is identified, families of the deceased and injured club members may seek to get compensation from the responsible parties. It will not be an easy task as explosion accidents often leave very little behind. In this case, Fort Worth personal injury lawyers should be engaged as they would have the resources to acquire the evidence to support a claim that is not available to most lay people.
Jul 21, 2014
Child custody is hands-down the most emotionally-charged issue in a contentious divorce, and that is true in Texas as anywhere else in the US. Most state laws would encourage parents to share custody (or conservatorship in Texas) of their children based on the premise that it would be in their best interest to have significant contact with both parents. The Woodlands child custody lawyers can explain each parent’s rights when it comes to child custody so that an equitable agreement can be forged. However, when the parents can agree on nothing, they are unlikely to come up with a parenting agreement to present to the court. The courts will then have to decide for them.
Winning a child custody case requires extensive preparation, and it goes beyond financial or emotional capacity. In most cases, very young children are awarded custody to the mother even now because there are roles that a mother typically assumes, although this is no longer automatic. A father who wants to take over these roles will have to prove that he has the requisite qualities to do so, and that can be tricky, especially if the father has not taken on such roles i.e. homemaker prior to the divorce.
There is also the question of time. Most spouses work to make ends meet, which means that both parents may be out of the house most of the time. Sole physical conservatorship may be awarded to the parent who has a more flexible or regular schedule, while the other parent may be required to pay child support. This does not mean that one parent is more capable than the other, though.
Geography may also play a role in the court’s decision to award conservatorship. A parent who plans to relocate to another city or state may be at a disadvantage when it comes to winning conservatorship, as children may suffer from having their whole lives disrupted because of a divorce. Being in familiar surroundings among people they know may be beneficial for them to provide stability at a time when everything they know is changing.
If you are considering divorce but worried about your children, you should consult with an experienced divorce lawyer in your area to find out what you could be facing. If child custody is apt to become a problem, your lawyer will be able to advise you about how best to proceed.
Jul 19, 2014
Alcohol-related motor vehicle accidents most frequently happen in the three days surrounding New Year’s Day, perhaps understandably, but not justifiably. It is never a good idea to drink and drive, which is a crime in all states in the US, and yet Denver car accident lawyers frequently handle cases where the driver was impaired from alcohol consumption.
The most common injuries sustained in motor vehicle accidents range from minor scratches to life-changing damage to the spine or the brain, and often it is a lopsided occurrence. A face-off between a passenger car and an 18-wheeler truck, for example, can be catastrophic for the car passenger whilst leaving the truck driver unscathed. This is the reason why truck drivers are held to a higher standard of care than regular drivers, and still Tennessee truck accident lawyers routinely handle claims of serious injury or wrongful death against negligent truck drivers and/or truck companies.
It seems that no matter how vigorous the campaign to improve road safety, drivers just don’t understand the responsibility they take on when they get behind the wheel of a motor vehicle. Because of the size, speed, and weight of even a small passenger car, it is equivalent to having a loaded gun when handled by an irresponsible person. If a reckless driver is lucky, the only damage sustained is to property, but unfortunately, this is not the case as Nashville personal injury lawyers know only too well.
With the current power of social media, perhaps actually witnessing the consequences of motor vehicle accidents through video would have a greater impact on drivers than current awareness campaigns. Most people react to news of accidents with a shrug of their shoulders, but it is much more difficult to shrug off the image of a toddler flying out of a vehicle hit by a speeding, impaired truck driver.
Jul 18, 2014
British Petroleum Plc (BP) was principally responsible for the Deepwater Horizon oil rig that spilled millions of tons of crude oil into the Gulf of Mexico, triggering the largest and costliest oil spill in the history of the oil and petroleum industry. BP and associate companies were found negligent and faced thousands of individual and business claims potentially worth billions, enough to bring the oil giant to its knees. To stave off litigation costs, BP drafted and submitted a proposed settlement program, which was approved by the federal court in 2012. Lafayette lawyer Patrick Juneau was tasked to administer the program. Almost from the start, BP complained about how the claims were being processed, although the settlement agreement merely required business owners in the affected areas to submit financial records to determine if they suffered a loss within the prescribed time period.
BP has taken over the claims administration under close supervision of the courts under new rules that experts criticize as unfairly prejudicial to cash-based businesses such those in the agricultural industry. Out of the 292,800 claims filed so far, 60,525 have been denied and would have to go through the BP claim appeals process, which is strictly timed and difficult to undertake without the help of an experienced BP claim appeal lawyer. Critics of the delaying tactics of BP believe that Juneau was mistaken in trying to placate the oil giant by imposing stricter requirements in making a claim than warranted by the original agreement.