Depakote: A Medical Breakthrough Marred by its so Many Side-effects

For the millions of people in the US who suffer from epilepsy, bipolar disorder or migraine headache, it is the prescription drug Depakote which gives them great relief from their debilitating condition. Depakote, which was approved by the U.S. Food and Drug Administration (FDA) in 1983, is actually the brand name of Valproate (VPA), a type of medication used in treating epilepsy and bipolar disorder, and in preventing migraine headaches.

The FDA approval in 1983 was for treatment of epilepsy, specifically, to reduce or prevent severe epileptic seizures. In 1995, Depakote was approved by the FDA for yet another use: as treatment for manic episodes linked to bipolar disorder. Finally, in 1996, Depakote was approved to lessen the recurrence of severe, painful headaches which were caused by migraine.

Considered as a medical breakthrough, this mood stabilizer is able to increase the amount of gamma amminobutyric acid (GABA) in a patient’s brain. GABA is a neurotransmitter (chemical substance) that transports messages between brain cells; it also soothes overstimulated nerves, preventing brain signals which lead to seizures.

According to the Centers for Disease Control and Prevention (CDC), there are more than two million people in the U.S. suffering from epilepsy; about 125,000 more are added to their number every year. Those affected by migraine, on the other hand, are at least, 20 million.These numbers plus the effectiveness of Depakote eventually made this drug from Abbott Laboratories one of the most commonly prescribed drugs in the U.S.

Results from the use of Depakote, however, were not just good news as there were also reports of a large number of side-effects which, according to the website of Williams Kherkher, could either cause lasting health problems or death of patient. Due to these serious negative effects, the FDA was prompted to issue several advisories and warnings on the drug, as well as classify it as a class D drug.

Those who took Depakote reported of side-effects that included: tiredness, slow mental processes, nausea, tremors, weight gain, hair loss, suicidal thoughts or tendencies, pancreatitis and liver damage. In women, Depakote increased the risk of developing polycystic ovarian syndrome (PCOS), a condition which causes ovarian cysts and which affects their ability to get pregnant. If taken by a pregnant woman, however, then use of Depakote can result to severe birth defects, like: spina bifida and other neural tube defects besides spinal cord or brain damage; malformed limbs, brain or skull; deformed facial structures, also knows as facial dysmorphism; polydactyl, which is characterized by the growth of extra fingers or toes; facial malformation or cleft palate; autism and lower intelligence; and, different types of heart defects, such as atrial septal.

It is important that people who have been affected negatively by Depakote know that they have a right to pusue legal action against this drug’s manufacturer and probably even recover financial compensation for all the damages/harm they have been made to suffer.

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The EB-5 Visa: For Those Willing to Invest between $500,000 and $1 Million in the U.S.

Wealthy foreign nationals who are willing to invest between $500,000 and $1 million in the U.S., either by creating a new commercial enterprise or by investing in a Regional Center, wherein at least 10 full-time jobs for qualifying U.S. workers will be created or preserved, may be eligible for a conditional green card, one of the steps in obtaining a U.S. citizenship status.

Qualified foreign nationals would be issued an EB-5 immigrant visa, also called the employment fifth preference visa. The EB-5 visa program, which is managed by the U.S. Citizenship and Immigration Services (USCIS), was created by the U.S. Congress in 1990; its creation was aimed at fueling the U.S. economy through capital investment and job creation by foreign investors.

Between creating a new commercial enterprise and investing in a Regional Center, foreign investors may find it wiser to invest in the latter, which is a 3rd party (privately or publicly) managed investment vehicle. Besides being a job-creating business already, (thus saving the investor time and additional expenses in putting up their own business and recruitment concerns), investing in a Regional Center only usually costs $500,000.

Unlike other EB visas which require a job offer, professional experience, educational and/or post-graduate degree, and so forth, immigration attorneys from the AmLaw Group says that, under the Russian EB-5 visa, many things are no longer required, such as: direct family members already in the united states, residency, job offer, professional experience, educational requirement, and knowledge of the English language; for those investing in Regional Center projects, daily management/running of a business is also no longer necessitated.

If investing in a new commercial enterprise, an EB-5 investor must ensure that the commercial enterprise was established either after Nov. 29, 1990, or on/before Nov. 29, 1990, but on the condition that:

  • The purchased existing business would be reorganized or restructured in such a way that the change will result to a new commercial enterprise; and,
  • The purchased existing business would be expanded and result to a 40-percent increase either in the original number of employees or in its net worth.

By new commercial enterprise, the USCIS means “any for-profit activity formed for the ongoing conduct of lawful business including, but not limited to: a sole proprietorship, partnership (whether limited or general), holding company, joint venture, corporation, or business trust or other entity, which may be publicly or privately owned. . . This definition does not include noncommercial activity such as owning and operating a personal residence.”

Of the various Employment-Based or EB visa categories, establishing eligibility under EB-5 is one of the most challenging and the most expensive. Besides the $500,000 or $1 million capital investment required (which, by the way, should be made ahead of the green card application), an investor should also meet the job creation requirements within a specified time and make sure that the business receiving the investment meets all requirements in the EB-5 program. The amount of investment alone, with no certainty whether the venture will succeed or fail, makes everything a big risk. Thus, rather than making an investment without fully grasping the probable outcome of such a move, only to fail and waste a huge amount of money in the process, understanding first what this visa program is all about may be necessary.

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Even Parental Agreements or court Decision on Child Custody and Visitation Rights Can be Modified

“Mom knows best!” But does this include knowing fully what her child really needs after she and her husband decide to end their union through divorce?

One very important issue that divorcing couples need to settle is child custody. Whatever decision will be reached by the spouses or by a family court judge regarding who keeps custody of the child, the certain things is, this will affect the child for the rest of his or her life: the way he or she would think, behave, socialize, perform academically, and so forth. The Mayo Clinic emphasizes the need to ensure that it is important to share similar rules between homes, for consistency for the child.

Psychologists, counselors and other child custody experts know how vital it is for a child to have a strong relationship with, and be affected by his or her parents. This is why courts would rather decide on granting both spouses joint custody to allow them to enjoy equal time with their child/children, as well as share decision making duties in everything that will affect their child’s growth and development; joint custody, of course, becomes possible only if the court sees both spouses as “fit” parents, otherwise, custody would be given to just one parent or to whoever the court sees will be able to provide what the child really needs.

As explained in the website of the Law Offices of Baden V. Mansfield, any agreement or decision regarding child custody and visitation rights issues, whether amicably agreed upon by the spouses themselves (through the process of divorce mediation) or decided by a judge (if the divorce process is the traditional court litigation), is binding and will have to be complied with by both spouses. Many times, however things end up other than what the court expects. This is due to one or both parents becoming neglectful in his/her or their obligation, either in the performance of their parental function or in recognizing and respecting the other parent’s rights and person-hood. Most often, though, it is the custodial parent who fails to properly perform his or her function, doing everything possible to separate the child from the non-custodial parent. This failure is known legally as visitation or custody interference and it can be committed by the custodial parent through any one or a combination of any of the following:

  • Alienating the child from the non-custodial parent by creating situations that will render scheduled visitation rights impossible;
  • Severing the child’s affections for the non-custodial parent through negative comments, ill-talks and/or false accusations;
  • Turning the child against the non-custodial parent by consciously and systematically sullying his or her reputation or by spreading hurtful information against him or her. This attitude is more commonly known as Parental Alienation Syndrome (PAS).
  • Secretly moving to a distant location or another state in order to keep the children away from the non-custodial parent. This is actually a violation of a divorce decree stipulation which requires custodial parents to inform non-custodial parents regarding plans of moving to another residence, whether in the same city or in another state.

In the event of visitation or custody interference, the non-custodial parent may request the court for a modification in its original decision regarding custody. There are other reasons, of course, as mentioned by the Arenson Law Group, PC, why a request for modification may be made, like the custodial parent re-marrying, passing away, developing a health problem which can limit his or her capability in performing his or her duty in caring for the child, going on active duty, becoming unfit due to dependence to alcohol or illegal drug, getting involved in serious legal problems, or if the child reaches the age of 12 and personally requests for a change in living arrangements.

Seeking modification in custody and visitation agreements or decision is much more complicated and challenging than it seems.

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The Scary Results of Medical Negligence to Mothers and Their Newborns

Through modern medicine doctors are not only able to care more for expecting mothers; they are also able to make the process of birthing a much safer procedure. However, like other types of medical procedures, giving birth also has its trade-offs which present risks about which many mothers are never made aware of.

Ensuring that a baby born is healthy does not just happen in the delivery room. This includes the months when the baby is still inside the mother’s womb, the time when a doctor has to regularly and accurately monitor the baby’s health and condition, mainly by making sure that the mother herself is in good health and that, at the time of delivery, everything is performed in a way that will not cause any injury to the baby. Doctors, of course, observe medical standards of care in protecting the unborn and the mother; failure to do so can result to pregnancy complications and birth injuries.

Record of live births from the Centers for Disease Control and Prevention (CDC) show at least 3,900,000 births in the US every year. Mortality rate, on the other hand, is more than 23,000 annually. Besides the high mortality rate in infant death, another major concern of government agencies, such as the U.S. Department of Health & Human Services’ Agency for Healthcare Research and Quality (AHRQ), is the number of babies (and mothers) sustaining injuries during childbirth. In 2006, close to 157,700 mothers and newborns were reported to have sustained injuries during childbirth. Birth injury incidences are highest among 25 to 34 years old mothers who undergo tool-assisted deliveries. Of the many different kinds of birth injuries, Ravid & Assoc says that the most commonly reported are:

  • Brachial Plexus Injury (BPI). This injury, which can cause temporary or permanent disability, damages the bundle of nerves that runs from the upper spine to the hand.
  • Bone Fracture. This injury, which usually heals on its own, affects the collar bone or the clavicle. It results  from a difficult or complicated delivery.
  • Cephalohematoma. This involves the collection of blood underneath the skin, particularly, in the periosteum of the skull bone.
  • Caput Succedaneum. This injury is characterized by the swelling of the scalp. It is the result of using too much  pressure during delivery. This injury, though, is not life-threatening and usually heals on its own.
  • Cerebral Palsy. This injury causes damage to the brain, resulting to impaired muscle coordination. Babies who sustain this injury is affected by it for the rest of their lives as there is no known cure for this type of birth

The saddest thing about birth injuries, also called birth trauma, is the fact that these are nothing more than consequences of negligence. Had proper care been observed, these injuries would have been totally prevented. As a result, thousands of medical malpractice lawsuits have been filed in the past, while hundreds more are filed every year, all citing negligence as the cause birth injuries.

It is because of negligence why, according to the website of Habush Habush & Rottier SC ®, many medical professionals fail to provide the standard of care they owe their patients. Due to this failure, they can be held totally accountable whenever their errors result to injuries.

In its website, the law firm Schuler Halvorson Weisser Zoeller & Overbeck P.A., likewise mentions the unfortunate reality of medical professionals not always living up to the standards of their profession. Due to the important roles that they play, however, it is high time that they fully realize the devastating effects which even the smallest mistake can have on their patients and that though they may never have intended to cause any injury, full accountability still rests on their shoulders.

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Medicare and Healthcare Fraud: Putting Honest Medical Professional at Risk of being Wrongfully Accused

On Aug. 25, 2015, a “now former” owner and operator of multiple health care clinics in New York City was sentenced to 87 months in prison and three years of supervised release after pleading guilty to defrauding Medicare of more than $30 million. Oscar Huachillo, the man convicted of Medicare fraud and tax evasion, was also ordered to pay $31,177,987 in forfeiture and $3,454,244 in restitution.

The fraudulent scheme was committed through claimed provision of infusion treatments and injection to Medicare-eligible HIV/AIDS patients. In reality, however, the patients were all recruited and made to visit any of Huachillo’s Clinics many times a week for many months in order to receive expensive “treatments” which included administration of very expensive drugs that were reserved for anemia and cancer patients. Many times, however, no medications were actually provided or, if ever these were provided, these were given at highly diluted doses to people who really had no need for said medical treatment.

The $300 paid weekly by Huachillo and his companions to the HIV/AIDS patients in exchange for their coming to the Clinics and undergoing treatments was nothing compared to the tens of thousands of dollars that Huachillo received as reimbursement from Medicare. And, to make sure that they will never run out of people to treat, patients were offered about $50 more for every additional person they will be able to take and refer to the Clinics.

Medicare and Healthcare fraud, which financially burden the Medicare program, cheat honest taxpayers, put patients at risk, compromise the integrity of honest healthcare providers, and cost the US tens of billions of dollars every year. According to the Federal Bureau of Investigation (FBI), the prime agency tasked to expose and investigate health care fraud in private and federal insurance programs, this criminal activity, which continuously threatens the financial aspect of various government programs, is committed in many different ways, like:

  • Filing claims for treatments and tests (lab test) that were never performed;
  • Falsification of names when filing insurance claims;
  • Making claims for illnesses or injuries that do not exist;
  • Over-charging the government for treatments provided to patients; and,
  • Filing a claim for medical supplies that were not used;

To be able to identify and catch, especially those who aggressively commit fraud, the FBI works determinedly with the help of: various federal and state agencies; private investigative associations; and, different insurance groups. Due to the overzealousness of authorities and prosecutors, the federal government was able to recover $5.7 billion in 2014 (this was $1.9 billion higher than 2013). Besides this, many doctors, sources of medical supplies, executives and practice owners, now also get charged almost weekly. According to the U.S. Department of Health & Human Services, during the second quarter of 2015, about 243 individuals were charged for their alleged participation in Medicare fraud schemes. The arrests of the 243 individuals, which included doctors, nurses and other licensed medical professionals, were results of a nationwide sweep led by the Medicare Fraud Strike Force; some providers were also suspended by the Centers for Medicare & Medicaid Services (CMS) for their possible involvement in the fraud that amounted to $712 million in false billings.

Recovered money and people getting arrested are definitely good news for patients and taxpayers; however, for those who have been, and will be, wrongly charged, getting arrested is already a nightmare, how much more if they get convicted.

From the website of the law firm Kohler Hart Powell, SC, it is mentioned that the government, in an attempt to recover losses from fraud, often makes mistakes which result to the accusation of innocent medical professionals committing federal criminal offenses. Sadly, it is also irrelevant for many government authorities how this wrongful accusation will affect a person’s practice, family, career, and reputation.

Clearly, wrongfully accused healthcare professionals can lose more than just their profession and credibility. It is their very source of livelihood and, thus, their lives which are at stake in the event of a wrongful accusation.

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Defective Seat Belts Causing More Injuries and Deaths Than One Thinks

According to the National Highway Traffic Safety Administration (NHTSA), highway injuries and fatalities have declined for the last 10 years. One major reason for this decline is the rapid increase of seat belt use by motor vehicle drivers. Due to the protection it can provide, all U.S. states, with the exception of New Hampshire, now have mandatory seat belt use laws to make sure that motorists will buckle up or face the possibility of getting a citation.

Today, the best safety device that can protect car drivers and passengers from getting injured (or killed) during an accident is still a seat belt, a crash-safety device designed to protect car occupants from hitting with great force any of a car’s interior parts, like the dashboard, the door window or the windshield, as their car collides with another vehicle or a fixture on the road. A seat belt would also help keep a car occupant from smashing the windshield and getting thrown outside the car. State legislations on the use of seat belt was actually preceded by Title 49 of the United States Code, Chapter 301- Motor Vehicle Safety Standard, a federal law that took effect on January 1, 1968, and which required that all types of vehicles, with the exception of buses, be fitted with a seat belt in all seating positions designated by the law.

The most common stipulation of seat belt laws in all states is the use of a seat belt by the driver. With regard to passengers, the law considers the age and the specific seat where he or she is seated; thus, a person (depending on his or her age) at the backseat may not be required to buckle up. Only children seven years old and below should be restrained by a seat belt at all times.

In 2009, the Centers for Disease Control and Prevention (CDC) recorded 33,000 deaths and 2.2 million injuries due to road crashes; more than half the number of those killed were not restrained at the time of the crash. But while seat belts have saved thousands of lives, these devices have also been identified as the cause of injury or death rather than protection – due to poor design. Fatal car crash records, in fact, show that, of the more than 30,000 deaths every year, at least 10,000 are said to have died due to a faulty seat belt.

Defects in seat belts include a seat belt buckle loosening by itself, the belt tearing easily, the release buttons not working properly, and a vehicle being equipped only with a lap belt (which does not include an upper torso restraint).  These defects can cause serious harm, like spine fracture, head and facial injuries, abdominal injuries, lacerations, internal organ damage, dislocations, concussions, and whiplash; the severity of some injuries eventually result to death.

The dangers presented by defective seat belts are too serious to ignore. This is why even giant automobile manufacturers are either ordered (by the NHTSA) to recall or are forced to make voluntary recalls of certain vehicle models due to technical problems and design flaws in seat belts. Chrysler, for example, had more than 14 million of its vehicles recalled due to malfunctioning of defectively designed seat belts.

In its website, The Benton Law Firm strongly emphasizes the huge responsibility of automobile manufacturers and parts makers in accidents caused or exacerbated by their defective auto parts, accidents that can all too easily result in severe and long-term injuries such as those mentioned above. Following this thought, the firm Spiros Law, P.C. says that those who get involved in an accident and get injured or killed due to mechanical defect or malfunction in a seat belt may be eligible for financial compensation to help offset the costs associated with treatment and recovery.

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