Texas Lawyers Blog

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The Texas Lawyers Blog provides useful information on the law and Texas lawyers. For more information on this Blog or a legal topic, please feel free to submit an inquiry or send an e-mail message to blog@texaslawyers.com

Monday, December 28, 2009

Texas Probate Law, Inheritance, and Out of State Relatives

Texas Will Probate Lawyer and Texas Estate Lawyer for Out of State Relatives

Many families have spread out throughout the United States and around the World. For many families, gone is the time where several generations live with in a few miles of each other in the same town, city, or county. This disbursement of families throughout the United States and the World can make if difficult when a family member in Texas passes away.

For the family member that lives out of state and has never been through the Texas probate process, Texas Probate Law and Texas Probate Courts can be overwhelming. At a time when they want to grieve the loss of their loved one, they are forced to deal with difficult issues including:

1) Who should be in control of their loved ones' estate?
2) What needs to be done to have an administrator or executor appointed?
3) What is probate & non-probate property?
4) What should be done to protect estate property?
5) How does someone probate a Will?
6) How should estate property be transferred to beneficiaries? Can it be sold?

It is often helpful to speak with and hire a Texas probate lawyer to help take care of many of the probate issues. A Texas probate lawyer can help "out of town" relatives through the probate process and taking care of the ir loved ones' estate. This is extremely helpful when relatives and loved ones want to focus on the grieving process instead of learning Texas Probate Law and navigating Texas Probate Courts.

Locating Unclaimed Texas Wealth, Estate Assets, and Non-Probate Assets (Real Estate, Oil Interests, Bank Accounts, & Stock)

In addition to what is inherited, there is a significant amount of unclaimed wealth including bank accounts, houses, oil interests, safety deposit boxes, stocks, and other wealth that is forgotten about. In our modern society families don't always live close and some wealth is lost or forgotten. Death or incapacity is not always anticipated and many people will unfortunately loose track of stocks, bank accounts, oil interests, and other wealth. It is a good idea to keep a safety deposit box with an inventory of all your assets and have people that you trust that can get access to your safety deposit box should something happen to you.

It is also becoming more common for family members not living close to a recently deceased relative to not know how to handle a probate matter or have enough money to clear title to property. In these instances it is good to locate a local attorney that can assist in appraising an estate including real estate and houses to determine if it would be beneficial to probate an estate or to determine the most efficient method to clear title to property.

Locating Unclaimed Texas Wealth, Estate Assets, and Non-Probate Assets (Real Estate, Oil Interests, Bank Accounts, & Stock)

In addition to what is inherited, there is a significant amount of unclaimed wealth including bank accounts, houses, oil interests, safety deposit boxes, stocks, and other wealth that is forgotten about. In our modern society families don't always live close and some wealth is lost or forgotten. Death or incapacity is not always anticipated and many people will unfortunately loose track of stocks, bank accounts, oil interests, and other wealth. It is a good idea to keep a safety deposit box with an inventory of all your assets and have people that you trust that can get access to your safety deposit box should something happen to you.

It is also becoming more common for family members not living close to a recently deceased relative to not know how to handle a probate matter or have enough money to clear title to property. In these instances it is good to locate a local attorney that can assist in appraising an estate including real estate and houses to determine if it would be beneficial to probate an estate or to determine the most efficient method to clear title to property.

Austin Texas Inheritance Lawyer, Jason Coomer helps families evaluate the estates of their lost loved ones to determine if a full probate is necessary and if so if the probate is economically feasible.

Austin Texas Estate, Probate, and Inheritance Lawyer

Austin Texas Probate Lawyer Jason Coomer handles Texas Probate matters including probating Wills, helping Executors, drafting Wills, contesting Wills, filing Suits to Determine Rightful Heirs of property and estates, filing Small Estate Affidavits, filing Affidavits of Heirship, filing Applications for Guardianships, fighting Involuntary Guardianships, filing Guardianship Reports, filing breach of fiduciary duty claims, estate planning, and clearing title to property & assets.

Texas Will Contest Lawyer, Texas Will Probate Lawyer, and Texas Estate Lawyer Handles Probate and Estate Matters for Out of State Beneficiaries and Heirs as well as Grieving Loved Ones
(Texas Will Contest, Estate, and Probate Lawyer Jason Coomer)

Texas Will Contest, Will Probate, and Estate Lawyer Jason Coomer represents heirs, family members, and beneficiaries including those from out of state that need to have a Will probated, a Will contested, or an Estate taken through probate. He probates Wills and contests Wills in the Austin Area including Travis County, Williamson County, Bexar County, and Hays County as well as works with other Texas probate lawyers across Texas including Dallas, Houston, San Antonio, Fort Worth, Dallas County, Harris County, Fort Bend County, and Tarrant County.

For more information on this Austin Texas Estate Lawyer for an Austin Texas Will Probate or Travis County Estate Matter, feel free to go to the following web page, Austin Texas Will Probate and Estate Lawyer.

Monday, December 14, 2009

Off-Label Drug Marketing and Off-Label Pharmaceutical Marketing Medicare Fraud Lawsuits

Off-Label Drug Marketing and Off-Label Pharmaceutical Marketing Medicare Fraud Lawsuits

Off-label marketing is the practice of pharmaceutical marketing professionals creating financial incentives and pressuring doctors to prescribe pharmaceuticals for an unapproved uses. In the United States, the Food and Drug Administration Center for Drug Evaluation and Research (CDER) reviews a company's New Drug Application (NDA) for data from clinical trials to see if the results support the drug for a specific use or indication. If satisfied that the drug is safe and effective, the drug's manufacturer and the FDA agree on specific language describing dosage, route of administration, and other information to be included on the drug's label. More detail is included in the drug's package insert.

The Federal Food Drug and Cosmetic Act (”FDCA”), provides a specific regulation process for the approval of new drugs and new drug formulations intended to be marketed for use in interstate commerce. Under the FDCA, a new drug product cannot be marketed unless the FDA approves the product and determines that it is safe and effective for its intended use. When the FDA approves a drug, it approves the drug only for the particular use for which it was tested, but after the drug is approved for a particular use, the FDCA does not regulate how the drug may be prescribed by doctors. Thus, a drug that has been tested and approved by the FDA for one use only can also be prescribed by a physician for another use, known as off-label. Though physicians may prescribe drugs for off-label usage, the FDA prohibits drug manufacturers from marketing or promoting a drug for a use that the FDA has not approved.

In the past ten years some pharmaceutical marketing departments have found it extremely profitable to market their drug for non-FDA approved uses. The FDA's inability to regulate physicians allowed the drug company marketing departments and drug representatives to set up elaborate schemes to encourage physicians to prescribe drugs for off-label uses including misleading doctors as to the efficacy of a drug for a particular treatment and forms of kickbacks including vacations, conferences, initial free samples, hiring physician's families.

Penalties for Off-Label Drug Marketing and Whistleblower Rewards for Stopping Off-Label Pharmaceutical Marketing

Pfizer has paid a total of $2.75 billion in off-label penalties since 2004 which is a little more than 1 percent of the company’s revenue of $245 billion from 2004 to 2008.

JUSTICE DEPARTMENT ANNOUNCES LARGEST HEALTH CARE FRAUD SETTLEMENT IN ITS HISTORY

Pfizer To Pay $2.3 Billion For Fraudulent Marketing

WASHINGTON – American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (hereinafter together “Pfizer”) have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products, the Justice Department announced today.

Pharmacia & Upjohn Company has agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead. Bextra is an anti-inflammatory drug that Pfizer pulled from the market in 2005. Under the provisions of the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to FDA. Once approved, the drug may not be marketed or promoted for so-called “off-label” uses – i.e., any use not specified in an application and approved by FDA. Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns. The company will pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the United States for any matter. Pharmacia & Upjohn will also forfeit $105 million, for a total criminal resolution of $1.3 billion.

In addition, Pfizer has agreed to pay $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs – Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug – and caused false claims to be submitted to government health care programs for uses that were not medically accepted indications and therefore not covered by those programs. The civil settlement also resolves allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe these, as well as other, drugs. The federal share of the civil settlement is $668,514,830 and the state Medicaid share of the civil settlement is $331,485,170. This is the largest civil fraud settlement in history against a pharmaceutical company.

Pharmaceutical Marketing Executives, Drug Representatives, Lawyers, Hospital Administrators, Health Care Professionals, Accountants, Benefit Coordinators, Drug Representatives, Marketing Professionals, Physicians as Health Care Fraud and Qui Tam Whistleblowers Are Stepping Forward to File Health Care Billing Fraud Law Suits (Off-Label Pharmaceutical Whistleblower Qui Tam Law Suits)

Through Whistleblower Lawsuits, Qui Tam Lawsuits, and other Health Care Fraud Lawsuits, hundreds of billions of dollars have been recovered from individuals and organizations that have committed health care fraud and stolen large amounts of money from the government. It is extremely important that Whistleblowers continue to expose fraud schemes, off-label marketing schemes, illegal kickbacks, fraudulent billing practices and unnecessary treatments that cost hundreds of billions of dollars. For more information on this topic including Off-Label Drug Medicare Fraud Lawyers, go to the following web page Off-Label Pharmaceutical Medicare Fraud Whistleblower Lawsuits.


Sunday, December 13, 2009

Reglan Tardive Dyskinesia Lawsuits and GERD Treatment Lawsuits

Reglan Tardive Dyskinesia Neurological Disorder Lawsuits
(GERD and GER Drug Reaction Lawyer)

Tardive dyskinesia is a neurological disorder that exhibits itself through repetitive, involuntary, & purposeless movements like grimacing; tongue protrusion; lip smacking, puckering & pursing; and rapid eye blinking. Victims of tardive dyskinesia also can exhibit rapid & involuntary movements of the arms and legs. The neurological disorder can be caused by Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injections.

Reglan Tardive Dyskinesia Lawsuits (GER and GERD Malpractice Lawsuits)

Gastroesophageal reflux disease (GERD) is a more serious form of gastroesophageal reflux (GER), which is common. GER occurs when the lower esophageal sphincter (LES) opens spontaneously, for varying periods of time, or does not close properly and stomach contents rise up into the esophagus. GER is also called acid reflux or acid regurgitation, because digestive juices—called acids—rise up with the food.

When acid reflux occurs, food or fluid can be tasted in the back of the mouth. When refluxed stomach acid touches the lining of the esophagus it may cause a burning sensation in the chest or throat called heartburn or acid indigestion. Occasional GER is common and does not necessarily mean one has GERD. Persistent reflux that occurs more than twice a week is considered GERD, and it can eventually lead to more serious health problems. People of all ages can have GERD.

An estimated two-thirds of all infants suffer from GER, though the pathological condition called GERD (gastroesophageal reflux disease) affects approximately only one in 300 babies.

Reglan is a neuroleptic medication used to treat gastrointestinal problems that have had many cases of Tardive Dyskinesia reported in response to it. Reglan is supposed to increase the stomach and small intestine contractions to help the passage of food. As every medication, Reglan has side effects associated to it and some of them are very serious. In February 1996, the FDA warned that Reglan causes an increased risk of Parkinsonism.

Reglan is a dopamine antagonist that increases lower esophageal sphincter pressure and improves gastrointestinal emptying. The FDA approved Reglan, which is manufactured by Baxter Healthcare Corporation, for short-term treatment (between 4 and 12 weeks) of these conditions only after conservative methods of treatment have failed. However, it is common that patients are prescribed Reglan for longer than 12 weeks, which is against FDA recommendations.

This is problematic because prolonged use of Reglan can cause Tardive Dyskinesia, a serious and often irreversible movement disorder. Infants who are given Reglan appear to be at an even greater risk for this serious drug side effect.

The symptoms a person can experience from Tardive Dyskinesia can vary from mild barely noticeable facial ticks and involuntary movements to severe problems. Severe cases of Tardive Dyskinesia can have a significant impact on a person's life disabling them from normal functioning. Severe facial ticks and involuntary body movements can be extremely embarrassing cause a person to withdraw from social interactions.

FDA Requires Boxed Warning for Reglan and other Metoclopramide Containing Drugs (Tardive Dyskinesia GER and GERD Lawsuits)

On February 26, 2009, the U.S. Food and Drug Administration announced that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken.

Reglan Tardive Dyskinesia Neurological Disorder Lawsuits
(GERD and GER Drug Reaction Reglan Lawyer)

For more information on how the use of metoclopramide and Reglan have been linked to tardive dyskinesia and other causes of Tardive Dyskinesia, please go to the following website, Reglan Tardive Dyskinesia Lawsuits, Gastroenterologist malpractice Lawsuits, and GERD/GER Drug Reaction Neurological Disorder Lawsuits.


Saturday, December 12, 2009

Neurontin Suicide Lawsuits, Gabapentin Off-Label Use Lawsuits and Neurontin Attempted Suicide Lawsuits

Neurontin Suicide Lawsuits (Off-label Gabapentin Suicide Lawyer)

Gabapentin (brand name Neurontin) is a GABA analogue. It was originally developed for the treatment of epilepsy, but has been aggressively marketed for many off-label uses including to relieve pain, migraine headaches, neuropathic pain, nystagmus, Complex Regional Pain Syndrome, mood-stabilizing treatment for bipolar disorder, menopausal hot flashes, and idiopathic subjective tinnitus. The FDA has issued a warning of an increased risk of suicidal thoughts and behaviors in patients taking gabapentin.

Neurontin FDA Actions and Warnings (Gabapentin Suicide Lawsuits)

The U.S. Food and Drug Administration (FDA) has issued a warning of an increased risk of suicidal thoughts and behaviors in patients taking gabapentin. An independent analysis by the FDA showed that anticonvulsant drugs, including gabapentin, can increase suicidal thoughts in patients. The approved label for Neurontin now includes a warning about an increased risk of suicidal thoughts or actions and a guide to help patients understand this risk.

Off-Label Marketing Claims and Off-Label Marketing Lawsuits

The Federal Food Drug and Cosmetic Act (”FDCA”), provides a systematic scheme for the approval of new drugs and new drug formulations intended to be marketed for use in interstate commerce. Under the FDCA, a new drug product cannot be marketed unless the FDA approves the product and determines that it is safe and effective for its intended use. When the FDA approves a drug, it approves the drug only for the particular use for which it was tested, but after the drug is approved for a particular use, the FDCA does not regulate how the drug may be prescribed. Thus, a drug that has been tested and approved for one use only can also be prescribed by a physician for another use, known as “off-label.”

Though physicians may prescribe drugs for off-label usage, the FDA prohibits drug manufacturers from marketing or promoting a drug for a use that the FDA has not approved. A manufacturer illegally “misbrands” a drug if the drug’s labeling includes information about its unapproved uses. A drug is deemed misbranded unless its labeling bears adequate directions for use. The courts have agreed with the FDA that the FDCA requires information not only on how a product is to be used (e.g. dosage and administration), but also on all the intended uses of the product. Oral statements and materials presented at industry-support scientific and educational activities may provide evidence of a product’s intended use. If these statements or materials promote a use that is inconsistent with the product’s approved labeling, the product is misbranded under the FDCA for failure to bear labeling with adequate directions for all intended uses.

Gabapentin (brand name Neurontin) has been aggressively marketed for many off-label uses including to relieve pain, migraine headaches, neuropathic pain, nystagmus, Complex Regional Pain Syndrome, mood-stabilizing treatment for bipolar disorder, menopausal hot flashes, and idiopathic subjective tinnitus. This off-label marketing for Neurontin is a serious problem in that the FDA has issued a warning of an increased risk of suicidal thoughts and behaviors in patients taking Neurotin.

It is estimated that over 90 percent of Pfizer's revenue from Neurontin which is in the billions of dollars is from off-label use.

FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications

In December 2008, the U.S. Food and Drug Administration announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.

The FDA is also requiring the manufacturers to submit for each of these products a Risk Evaluation and Mitigation Strategy, including a Medication Guide for patients. Medication Guides are manufacturer-developed handouts that are given to patients, their families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information about the risks of suicidal thoughts and behaviors associated with the class of antiepileptic medications.

"Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. " Patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their health care professional."

The FDA today also disseminated information to the public about the risks associated with antiepileptic medications by issuing a public health advisory and an information alert to health care professionals. Health care professionals should notify patients, their families, and caregivers of the potential for an increase in the risk of suicidal thoughts or behaviors so that patients may be closely observed.

The FDA's actions are based on the agency's review of 199 clinical trials of 11 antiepileptic drugs which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent). This difference was about one additional case of suicidal thoughts or behaviors for every 500 patients treated with antiepileptic drugs instead of placebo.

Four of the patients who were randomized to receive one of the antiepileptic drugs committed suicide, whereas none of the patients in the placebo group did. Results were insufficient for any conclusion to be drawn about the drugs' effects on completed suicides. The biological reasons for the increase in the risk for suicidal thoughts and behavior observed in patients being treated with antiepileptic drugs are unknown.

The FDA alerted health care professionals in January 2008 that clinical trials of drugs to treat epilepsy showed increased risk of suicidal thoughts and actions. In July 2008, the FDA held a public meeting to discuss the data with a committee of independent advisors. At that meeting the committee agreed with the FDA's findings that there is an increased risk of suicidality with the analyzed antiepileptic drugs, and that appropriate warnings should extend to the whole class of medications. The panel also considered whether the drugs should be labeled with a boxed warning, the FDA's strongest warning. The advisers recommended against a boxed warning and instead recommended that a warning of a different type be added to the labeling and that a Medication Guide be developed.

Acting under the authorities of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA is requiring manufacturers of antiepileptic drugs to submit to the agency new labeling within 30 days, or provide a reason why they do not believe such labeling changes are necessary. In cases of non-compliance, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.

Neurontin Suicide Lawsuits, Gabapentin Attempted Suicide Lawsuits, and Neurontin Off-label Use Suicide Lawsuits

For more information on this topic, please go to the following web page on Neurontin Off-label Use Suicide and Attempted Suicide Lawsuits.