Neurostimulation Product Liability Lawsuits and Implantable Neurostimulation Systems Lawsuits

Neurostimulation Product Liability Lawsuits, Implantable Neurostimulation Systems Lawsuits, and Failed Back Surgery Resulting in Permanent Disability and Paralysis Lawsuits 
by Texas Failed Back Surgery Product Liability Lawyer, Jason Coomer 

Failed back surgery including defective implantable neurostimulation  systems can cause catastrophic injuries and impairment.  These failed back surgery cases can be caused by defective spinal-devices and can take significant resources to investigate and file a lawsuit.  When investigating these potential failed back surgery lawsuits it is important to know what implant has been used as well as to obtain medical records of the surgery.

Implantable Neurostimulation System Lawsuits, Failed Back Implant Devices, and Failed Spinal Cord, Neck, & Back Surgery Lawsuits

Implantable Neurostimulation Systems have been used for a variety of types of chronic back pain situations including heriniated disks, postlaminectomy paid, Complex Reginal Pay Syndrome, unsuccessful disk surgery, Degenerative Disk Disease, and Failed Back Syndrome.  In fact, implantable neurostimulation systems and other spinal-devices are a huge business for the medical implant device industry including Medtronic, a leader in medical implantable devices.   Medtronic’s spinal-devices unit has about $3 billion in annual revenue from selling spinal devices including the Medtronic implantable neurostimulation system.  With this success, several other companies are developing similar implantable neurostimulation systems.  

The Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) as an aid in the management of chronic, intractable pain of the trunk and/or limbs—including unilateral or bilateral pain associated with several different conditions.   Unfortunately, there are several claims that the implantable neurostimulation system has some defects that can cause serious health problems.

Patients with Serious Back Injuries Including Severed Spinal Cords, Crushed Discs, Bulged Discs, and Herniated Discs when Seeking Pain Relief can sometimes Fall Victim to Defective Products, Negligent Health Care, and "For Profit" Medical Professionals Seeking to Increase Profits

The human spinal cord is basically a bundle of nerves which is surrounded by 33 bones or vertebrae.  Located between each vertebrae is a spinal disc which is a liquid filled disc shaped pouch.  These discs are stacked on top of one another and act as shock absorbers allowing the spine to flex, bend, and twist.  When functioning properly, the vertebrae and discs protect the spinal cord allow nerve impulses to travel from and to the brain to other parts of the body.  This allows us to experience sensations, move our bodies, and control many bodily functions.

Problems arise when the vertebrae, discs, or spinal cord are injured.  Broken vertebrae can damage and impinge on discs or the spinal cord causing extreme pain, numbness, and loss of control of bodily functions.  Back injuries can occur through traumatic events that result in paralysis.  Depending where and how severe the injury is will determine what type and how severe the paralysis is.   

The human body has remarkable healing potential.  Combining determination, proper medical attention, knowledge about an injury, and focus on the healing process can greatly help most injuries.  Hiring a lawyer to battle the insurance companies and responsible parties can allow the injured person to focus on the healing process.     

If you or a loved one have suffered a traumatic spinal cord injury or other serious back injury including a severed spinal cord, broken vertebrae, crushed discs, herniated discs, or a bulged discs; the most important thing you can do is to find a good medical doctor to assess the injury so you know what you are dealing with and how to best treat the injury.  From physical therapy and steroid injections to back surgeries (lumbar diskectomy, cervical fusion, and other lumbar or cervical procedures), there are many different ways to treat a back injury and it is important to know what will work best for you.   

Unfortunately, there are also medical clinics, medical implant sales people, and doctors that are more interested in profit and their bottom line than what is best for a patient.  Some of these medical professionals carelessly cause painful and difficult conditions to become much worse by paralyzing patients that are seeking relief from pain. 

Defective Implantable Neurostimulation System Lawyers, Medical Negligence Failed Back Surgery Lawyers, and Combination Failed Implantable Neurostimulation System Medical Negligence Spine Surgery Lawyers (Defective Implantable Neurostimulation System Medical Device and Medical Negligence Lawsuits)

Texas Failed Back Surgery Defective Implantable Neurostimulation System and Medical Negligence lawyer, Jason S. Coomer, helps individuals and families that have been injured or killed from defective products and surgeon negligence.  He commonly works with other Failed Back Surgery and Defective Implantable Neurostimulation System Attorneys throughout the United States and Texas on defective product lawsuits and medical negligence lawsuits.    

For more information on Texas Failed Back Surgery Defective Implantable Neurostimulation System and Medical Negligence lawyer, Jason S. Coomer, please go to the following web site, Failed Back Surgery & Implant Neurostimulator Lawsuit Lawyer.

Isotretinoin and Accutane Inflammatory Bowel Disease (Ulcerative Colitis and Crohn's Disease) Lawsuits

Accutane Crohn's Disease Lawsuits, Accutane Ulcerative Colitis Lawsuits, and Accutane Inflammatory Bowel Disease (IBD) Lawsuits by Texas Accutane Lawyer Jason S. Coomer

Isotretinoin which is sold under several tradename including Accutane is an acne medication that is a synthetic form of Vitamin A.  The drug has been commonly sold and marketed to alleviate severe acne symptoms by inhibiting oil gland and cell growth. Scientific evidence has linked the acne drug, Isoterinoin and Accutane, to severe side effects including increased risk of severe digestive problems, inflammatory bowel disease (IBD), Ulcerative Colitis, and Crohn's Disease.

Accutane and Isotretinoin Digestive Disorder Lawsuits including Inflammatory Bowel Disease (IBD), Crohn's Disease, and Ulcerative Colitis
The digestive system provides our bodies with nourishment as well as gets rid of toxins that can cause health problems.  The digestive system includes the stomach, large and small intestines, and rectum.  It converts the foods we eat into nutrients and absorbs these nutrients into the bloodstream to fuel our bodies. We seldom appreciate the workings of our digestive system unless something goes wrong, as in the case of inflammatory bowel disease (IBD).

Inflammatory bowel disease (IBD) is a group of inflammatory conditions of the colon and small intestine that can cause significant health problems and can be extremely unpleasant and can cause disability. The major types of Inflammatory Bowel Disease IBD are Crohn's Disease and Ulcerative Colitis

Crohn's Disease is a form of inflammatory bowel disease (IBD). It usually affects the intestines, but may occur anywhere from the mouth to the end of the rectum (anus).  Crohn's Disease symptoms depend on what part of the gastrointestinal tract is affected. Symptoms range from mild to severe, and can come and go with periods of flare-ups. The main symptoms of Crohn's disease are cramps and abdominal pain, fever, fatigue, loss of appetite, pain with passing stool (tenesmus), persistent & watery diarrhea, and unintentional weight loss.  Other symptoms may include constipation, eye inflammation, fistulas (usually around the rectal area, may cause draining of pus, mucus, or stools), joint pain, liver inflammation, mouth ulcers, rectal bleeding and bloody stools, skin rash, and swollen gums.


Ulcerative colitis is a type of inflammatory bowel disease (IBD) that affects the large intestine (colon) and rectum.  Symptoms of Ulcerative Colitis can include abdominal pain and cramping that usually disappears after a bowel movement; abdominal sounds (a gurgling or splashing sound heard over the intestine); diarrhea, from only a few episodes to very often throughout the day (blood and mucus may be present); fever;  tenesmus (rectal pain); weight loss; gastrointestinal bleeding; joint pain; and nausea and vomiting.


Isotretinoin Acne Medication and Related Health Problems including Inflammatory Bowl Disease IBD, Crohn's Disease, and Ulcerative Colitis

The leading pharmaceutical manufacturers of the acne drug, Isotretinoin, have received billions in revenue from the sale of the acne drug, Isotretinoin and Accutane.  Isotretinoin is sold under several trade names including Accutane, Amnesteem, Claravis, Decutan, Isotane, Izotek, Oratane, Isotrex, Isotrexin, Sotret, Ratane, and Raccutane.


Isotretinoin is a medication used for the treatment of severe acne. It was first developed to be used as a chemotherapy medication for the treatment of some forms of cancer.  It was later discovered that it was effective and treating severe acne.  Though Isotretinoin including Accutane was originally only meant for the treatment of severe acne, over time many dermatologists pushed by pharmaceutical marketing representatives began to prescribe the drug for mild cases. 

Isotretinoin including Accutane works by inhibiting the growth and reproduction of oil glands and cells. It depletes the body of molecules that hold water which help to keep skin, eyes, scalp, and joints well lubricated. Scientific research has determined that Isotretinoin including Accutane can cause several health problems including Crohn's Disease, irritable bowel disease, Ulcerative Colitis, depression, suicidal tendencies, birth defects, miscarriages, vision problems, ringing in the ear, psychosis, liver damage, heart attack, stroke, seizures, lowered white blood cell count, and inflammatory bowel disease.


Accutane FDA Action, Accutane Black Box Warning, and Accutane Lawsuits

The FDA has required a black box warning be put on all containers of Accutane, warning of all the known health risks associated with taking Isotretinoin including Accutane. A proper warning label notifying health care providers and users of a drug will typically protect a drug manufacturer from liability.  As such, it is thought that because Isotretinoin and Accutane had warnings about the drug potentially causing birth defects and warnings to patients and medical providers that women who are pregnant or about to get pregnant should not take the drug, it is thought that birth defect cases will probably not be viable against the makers of Accutane.

However, Plaintiffs that have suffered severe inflammatory bowel disease after taking Accutane and were taking the drug prior to the risk being added to the warning label may have viable claims.  This is because the drug manufacturer did not warn those outside the company of known serious risks of taking the drug.  Plaintiffs that have suffered inflammatory bowel disease (IBD) including Crohn’s Disease and Ulcerative Colitis and took Accutane prior to the warning label changes are expected to have viable cases because it is thought that some of the manufacturers of Isotretinoin hid known health risks of the drug from medical doctors and the public in order to increase their revenues and profits.

Additionally, there are potential off label marketing issues where patients were given Isotretinoin when they did not have severe acne.  These issue may impact the viability of potential cases if it is proven that the manufacturers provided false and misleading information to medical providers for the purpose of selling more of the drug.

Accutane Ulcerative Colitis Lawyers, Isotretinoin Crohn's Disease Lawyers, and Accutane Inflammatory Bowel Disease (IBD) Lawyers (Isotretinoin Ulcerative Colitis and Accutane Crohn's Disease Lawsuits)

For more information on Accutane Inflammatory Bowel Disease (IBD) Lawsuits and Accutane Inflammatory Bowel Disease (IBD) lawyers feel free to go to the following web page on Isotretinoin and Accutane Inflammatory Bowel Disease (IBD) Lawsuits.

Lyrica (Pregabalin) Off-label Use Suicide and Attempted Suicide Lawsuits

Lyrica Off-label Use Suicide and Attempted Suicide Lawsuits
(by Pregabalin Off-label Use Suicide Lawyer Jason Coomer)  

Lyrica (Pregabalin) is a derivative of the drug Neurontin.  Nuerontin has been aggressively marketed for many off-label uses and Lyrica has been also.  Some of the off-label uses of the drugs include pain relief, 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 recently issued a warning of an increased risk of suicidal thoughts and behaviors in patients taking pregabalin. 

Lyrica Approved Uses, FDA Actions, and FDA Warnings
(Pregabalin Suicide Lawsuits)

Lyrica (pregabalin) is a prescription medication approved for the treatment of the following conditions:

• Diabetic peripheral neuropathy -- Lyrica is approved to be used for the treatment of nerve pain associated with Diabetic Peripheral Neuropathy
• Epilepsy -- Lyrica is approved to be used with other medication for the treatment of seizures called partial seizures
• Fibromyalgia -- Lyrica is approved to be used in the treatment of fibromyalgia pain
• Postherpetic neuralgia -- Lyrica is approved to be used in the treatment of nerve pain that occurs after an outbreak of shingles.

The U.S. Food and Drug Administration (FDA) issued a warning of an increased risk of suicidal thoughts and behaviors in patients taking antiepileptic drugs (AED) including Lyrica (pregabalin). An independent analysis by the FDA showed that anticonvulsant drugs, including pregabalin, can increase suicidal thoughts in patients. The approved label for Lyrica 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 of Lyrica, Off-Label Criminal Penalties & Civil Fines Paid by Pfizer, 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.

Lyrica is one of four drugs which a subsidiary of Pfizer in 2009 pleaded guilty to misbranding "with the intent to defraud or mislead". Pfizer agreed to pay $2.3 billion in settlement, and entered a corporate integrity agreement. Pfizer illegally promoted the drugs and caused false claims to be submitted to government healthcare programs for uses that were not medically accepted.  For more information on Off-Label Marketing Fraud, go to the following web page on Off-Label Marketing Fraud. 

Lyrica is basically a next generation drug of gabapentin.  As the patents ran out on gabapentin (brand name Neurontin), Pfizer altered the medication slightly and created Lyrica (Pregabalin).  Both drug have 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 Lyrica and 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.  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.  (Pfizer Broke the Law by Promoting Drugs for Unapproved Uses)

Pfizer continues aggressively marketing Lyrica and is enjoying expanding sales of this product to about $3 Billion annually.  They continue to push for new approved uses through the FDA and were able to make Lyrica one of the first drugs approved for Fibromyalgia.  This drug is being pushed through television advertisements and doctors, despite dangerous side effects.  For more information on drug company aggressive marketing and pursuit of profits, go to the following web page: Economic Incentives for Drug Companies Lead to Aggressive Marketing of Defective & Ineffective Medications and Need for FDA Regulations, Checks on Drug Marketing, and Defective Drug Lawsuits. 

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

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.

The following antiepileptic drugs (AEDs) are required to add warnings about the risk of suicidality:

• Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR
• Clonazepam (marketed as Klonopin)
• Clorazepate (marketed as Tranxene)
• Divalproex sodium (marketed as Depakote, Depakote ER)
• Ethosuximide (marketed as Zarontin)
• Ethotoin (marketed as Peganone)
• Felbamate (marketed as Felbatol)
• Gabapentin (marketed as Neurontin)
• Lamotrigine (marketed as Lamictal)
• Lacosamide (marketed as Vimpat)
• Levetiracetam (marketed as Keppra)
• Mephenytoin (marketed as Mesantoin)
• Methosuximide (marketed as Celontin)
• Oxcarbazepine (marketed as Trileptal)
• Phenytoin (marketed as Dilantin)
• Pregabalin (marketed as Lyrica)
• Primidone (marketed as Mysoline)
• Rufinamide (marketed as Banzel)
• Tiagabine (marketed as Gabitril)
• Topiramate (marketed as Topamax)
• Trimethadione (marketed as Tridione)
• Valproic Acid (marketed as Depakene, Stavzor Extended Release Tablets)
• Zonisamide (marketed as Zonegran)

Neurontin and Lyrica Suicide Lawsuits (Gabapentin and Pregabalin Suicide Lawyers) 

In 2009, the first cases against Pfizer, the maker of Neurontin, began going to trial, and there are an estimated 1200 pending cases regarding the safety of Neurontin. Although a Pfizer spokesperson noted that "the reliable scientific evidence does not demonstrate a causal association between Neurontin treatment and suicidal behavior," the FDA analysis found an 80 percent rise in suicidal thoughts and behavior in data from 199 studies of gabapentin and other anticonvulsants.

In March 2010, a jury awarded $140 million in a Neurontin case.  Many more Neurontin cases are pending and are moving to trial.  Additionally, it is expected that Lyrica Suicide cases are going to filed in the near future and start going to trial in the future.

For more information on Neurontin (Gabapentin) and Lyrica (Pregabalin) Lawsuits, please go to the following web page on Lyrica (Pregabalin), Antiepileptic Drugs (AED), and Neurontin (Gabapentin) Suicide Lawsuits. 

Reglan and GERD Tardive Dyskinesia Lawyer (Drug Reactions)

Tardive Dyskinesia Lawsuits (Neuroleptic Drug Reactions)

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 is usually caused by the long-term and/or high-dose use of dopamine antagonists, usually antipsychotics and among them especially the typical antipsychotics. These neuroleptic drugs are generally prescribed for psychiatric disorders by psychiatrists.

If you or someone you love has been given high doses of neuroleptic drugs by a psychiatrist and  has exhibited Tardive Dyskinesia symptoms, mkae sure that you get this person to a proper medical doctor, then feel free to submit an inquiry or send an e-mail to Texas Tardive Dyskinesia lawyer Jason Coomer.  He may be able to help you recover your damages.

Reglan and GERD Tardive Dyskinesia Lawyer (Drug Reactions)

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.

Older typical antipsychotics appear to cause tardive dyskinesia more often than the newer atypical antipsychotics. Haldol® is an older typical antipsycotic and has been linked to tardive dyskinesia. Other dopamine antagonists that can cause tardive dyskinesia are drugs for gastrointestinal disorders ( metoclopramide ) and neurological disorders. In addition to the dopamine antagonists that cause tardive dyskinesia other drugs that are not intended to affect dopamine, such as SSRI antidepressants, may also cause tardive dyskinesia. Newer atypical antipsychotics such as olanzapine and risperidone appear to also cause tardive dyskinesia, but somewhat less frequently.

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.

Manufacturers are required to implement a risk evaluation and mitigation strategy, or REMS, to ensure patients are provided with a medication guide that discusses this risk.

The FDA wants patients and health care professionals to know about this risk so they can make informed decisions about treatment, said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk.

Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment. The development of this condition is directly related to the length of time a patient is taking metoclopramide and the number of doses taken. Those at greatest risk include the elderly, especially older women, and people who have been on the drug for a long time.

Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, or lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. These symptoms are rarely reversible and there is no known treatment. However, in some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.

Metoclopramide works by speeding up the movement of the stomach muscles, thus increasing the rate at which the stomach empties into the intestines. It is used as a short-term treatment of gastroesophageal reflux disease in patients who have not responded to other therapies, and to treat diabetic gastroparesis (slowed emptying of the stomach's contents into the intestines). It is recommended that treatment not exceed three months.

Metoclopramide is available in a variety of formulations including tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection. More than two million Americans use these products.

Recently published analyses suggest that metoclopramide is the most common cause of drug-induced movement disorders. Another analysis of study data by the FDA showed that about 20 percent of patients in that study who used metoclopramide took it for longer than three months. The FDA has also become aware of continued spontaneous reports of tardive dyskinesia in patients who used metoclopramide, the majority of whom had taken the drug for more than three months.

Reglan Tardive Dyskinesia Lawsuits (GER and GERD Malpractice)

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.

Tardive Dyskinesia Lawsuits (Drug Reaction Lawsuits)

Using neuroleptic or anti-psychotic medication is believed to be the leading cause of tardive dyskinesia. These drugs are typically prescribed to treat psychiatric disorders such as schizophrenia by psychiatrists. The class of drugs known as first generation antipsychotics, including Haldol, is believed to pose the greatest risk of tardive dyskinesia.  The newer atypical or second-generation antipsychotics, such as Risperdal or Geodon, appear to be safer but may still cause tardive dyskinesia. Additional medications that are prescribed to treat certain neurological and gastrointestinal disorders, such as Reglan, may also be linked to tardive dyskinesia.

There is no cure or customary treatment for tardive dyskinesia. Stopping the use of the medication or switching to another drug does not guarantee that the symptoms will improve or disappear.  It can also be dangerous to immediately stop the use of the drug and advice of a medical doctor should be sought when making this determination. Even after discontinuing use of the offending drug, the damage may have already been done and tardive dyskinesia symptoms may remain well after use of the drug has ended.

Texas Tardive Dyskinesia Lawyer (Drug Reactions)

If you or someone you love is suffering from tardive dyskinesia, Austin Texas Tardive Dyskinesia lawyer, Jason S. Coomer, helps individuals that have been injured from high doses or long term use of neuroleptic medications.  If you have a question about a anti-psychotic medication or other neurological or gastrointestinal medications that may have caused Tardive Dyskinesia, contact Austin Texas Tardive Dyskinesia Lawyer Jason Coomer.

He works with other Texas Psychiatrist Malpractice Lawyers including Houston psychiatrist malpractice lawyers, Dallas Psychiatrist Malpractice Lawyers, San Antonio Psychiatrist Malpractice Lawyers, and other Austin Psychiatrist Negligence Lawyers on a variety of psychiatrist malpractice claims.

Neurontin Off-label Use Suicide and Attempted Suicide Lawsuits

Neurontin Off-label Use Suicide and Attempted Suicide Lawsuits
(Gabapentin Off-label Use 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.

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

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.

The following antiepileptic drugs are required to add warnings about the risk of suicidality:

• Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR
  
• Clonazepam (marketed as Klonopin)
  
• Clorazepate (marketed as Tranxene)
  
• Divalproex sodium (marketed as Depakote, Depakote ER)
  
• Ethosuximide (marketed as Zarontin)
  
• Ethotoin (marketed as Peganone)
  
• Felbamate (marketed as Felbatol)
  
• Gabapentin (marketed as Neurontin)
  
• Lamotrigine (marketed as Lamictal)
  
• Lacosamide (marketed as Vimpat)
  
• Levetiracetam (marketed as Keppra)
  
• Mephenytoin (marketed as Mesantoin)
  
• Methosuximide (marketed as Celontin)
  
• Oxcarbazepine (marketed as Trileptal)
  
• Phenytoin (marketed as Dilantin)
  
• Pregabalin (marketed as Lyrica)
  
• Primidone (marketed as Mysoline)
  
• Rufinamide (marketed as Banzel)
  
• Tiagabine (marketed as Gabitril)
  
• Topiramate (marketed as Topamax)
  
• Trimethadione (marketed as Tridione)
  
• Valproic Acid (marketed as Depakene, Stavzor Extended Release Tablets)
  
• Zonisamide (marketed as Zonegran)
  

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.  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.  (Pfizer Broke the Law by Promoting Drugs for Unapproved Uses)

For more information on Off-Label Pharmacy Practices, please feel free to go to the following Website on Medicare Fraud and False Claims Act Qui Tam Claims.

Neurontin Suicide Lawsuits (Gabapentin Suicide Lawyers)

In July 2009, the first case against Pfizer, the maker of Neurontin, went to trial, and there are an estimated 1200 pending cases regarding the safety of Neurontin. Although a Pfizer spokesperson noted that "the reliable scientific evidence does not demonstrate a causal association between Neurontin treatment and suicidal behavior," the FDA analysis found an 80 percent rise in suicidal thoughts and behavior in data from 199 studies of gabapentin and other anticonvulsants.

If you or a loved one have been taking Neurontin have attempted suicide, it is important to seek to medical assistance.  For more information on a potential Neurontin lawsuit for the death of a loved one, please go to the following webpage on Neurontin Suicide Lawsuits or please feel free to e-mail Texas Neurontin Suicide Lawyer Jason Coomer with your name & contact information.