Defective Cold Therapy Unit Nerve Damage Lawsuits and Defective Cold Treatment Frost Bite Lawsuits

Defective Cold Therapy Unit Nerve Damage Lawsuits, Defective Cold Treatment Frost Bite Lawsuits, Defective Ice Therapy System Lawsuits, and Defective Cryotherapy Machine Nerve Damage Product Liability Lawsuits by Texas Defective Product Lawyer Jason S. Coomer

 

Defective products including Cold Therapy Units, Ice Systems, Cold Treatment Machines, and other Cryotherapy Devices can cause significant injuries including nerve damage, tissue damage, childbain, frostbite, immersion syndrome, hypoxia, and infarction necrosis.  The failure of many of these cryotherapy, ice, therapy and cold therapy devices is that they do not have proper temperature selection or time controls,  emergency shut off switches,  or warning alarms as well as do not provide adequate warnings of potential dangers or instructions for safe use.  These ice, cryotherapy, and cold therapy device defects can create dangerous situations for people including people recovering from surgery that are using the devices.  In selecting a Ice Therapy, Cryotherapy, or Cold Therapy Device, it is important to check with your doctor about the best cryotherapy system, unit, machine, or device, and be aware of the potential dangers of overuse or extended use including nerve damage, tissue damage, childbain, frostbite, immersion syndrome, hypoxia, and infarction necrosis. 

Cold Therapy Nerve Damage Lawsuits, Cryotherapy Recirculating Ice Cooler Frostbite Lawsuits, and Cryotherapy Hypoxia, Nerve Damage, or Immersion Syndrome Product Liability Lawsuits  

Cold therapy devices (aka cryotherapy devices) are commonly used to reduce swelling after surgery by cooling a swollen and inflamed area of the body.  These cryotherapy devices are typically filled with ice water and a pump circulates cold water to a pad that is fixed to the swollen and inflamed area.

The problem or defect with some of these cold therapy devices is that it is often difficult for patients and consumers to determine if a recirculating ice cooler is too cold or if the defective cryotherapy device has been used to long. Desensitization from surgery or the initial injury often can mask the patient's sensitivity to cold and create a situation where the recirculating ice cooler, ice machine, or defective cold therapy device is used too long or at too high of levels causing the patient to suffer serious injuries including including nerve damage, tissue damage, childbain, frostbite, immersion syndrome, hypoxia, and infarction necrosis.  Patients that have suffered injuries such as including nerve damage, tissue damage, childbain, frostbite, immersion syndrome, hypoxia, and/or infarction necrosis should immediately contact their health care provider.

Some of the problems associated with some defective cold therapy devices and defective cryotherapy devices are that the defective cold therapy device or cryotherapy device did not have proper automatic alarms or shut off information or  come with adequate cold therapy warnings or instructions including the following product defects and inadequate warnings.

• The defective cold therapy device did not come with a cryotherapy shut off alarm that warns users of potential dangers of prolonged use or dangerous temperature settings.
• The defective cold therapy device or cryotherapy device did not have an automatic off mechanism that prevents extreme temperature settings or cryotherapy over use.
• The defective cold therapy device or cryotherapy device did not come with instructions or warnings on selecting temperature settings or dangerous temperature settings.
• The defective cold therapy device or cryotherapy device did not come with instructions, warnings, or recommendation as to length of time for proper cold therapy treatment or use.
• The defective cold therapy device or cryotherapy device did not come with instructions or warnings concerning running too long or too cold.

As with any product, especially, products designed for post surgery patients, it is important for cold therapy or cryotherapy devices to have adequate safety features to protect post surgery patients and prevent serious injuries such as nerve damage, tissue damage, childbain, frostbite, immersion syndrome, hypoxia, and/or infarction necrosis. Further, it is also important that cryotherapy devices and cold therapy devices do not fail to warn cold therapy patients and cryotherapy patients of important health risks involved with long term use, unsupervised, unmonitored use, or extreme temperature use of ice cold therapy machines.

Extended use, extreme temperature use, unsupervised use, unmonitored use and prolonged use of these cold therapy and cryotherapy defective devices can cause serious injuries to both the skin and nerves resulting in skin damage, permanent nerve damage, chronic pain, nerve damage, tissue damage, childbain, frostbite, immersion syndrome, hypoxia, infarction necrosis, Complex Regional Pain Syndrome (CRPS), CRPS 1 (chronic nerve disorder in the arms or legs after a minor injury), CRPS 2 (caused by an injury to the nerve), Reflex Sympathetic Dystrophy (RSD), Reflex Sympathetic, Dystrophy Syndrome (RSDS), Complex Regional Pain Syndrome, Shoulder-Hand Syndrome, Causalgia, Sudeck’s Atrophy.

Cold Therapy Devices, Cryotherapy Devices, Ice Therapy Devices, Cold Therapy Systems, Cold Therapy Machines, Cold Therapy Units, Cryotherapy Machines, and Cryotherapy Units  

If your doctor has recommended the use of a ice, cryotherapy, or cold therapy system, device, machine, or unit for yourself or a loved one after surgery, it is important that everyone including the patient, doctor, and people helping the patient understand how to use the ice, cold therapy, or cryotherapy system, device, machine, or unit that has been selected as well as the potential dangers of over use, extreme temperature use, or prolonged use including skin damage, permanent nerve damage, chronic pain, nerve damage, tissue damage, childbain, frostbite, immersion syndrome, hypoxia, infarction necrosis, Complex Regional Pain Syndrome (CRPS), CRPS 1 (chronic nerve disorder in the arms or legs after a minor injury), CRPS 2 (caused by an injury to the nerve), Reflex Sympathetic Dystrophy (RSD), Reflex Sympathetic, Dystrophy Syndrome (RSDS), Complex Regional Pain Syndrome, Shoulder-Hand Syndrome, Causalgia, Sudeck’s Atrophy.

FDA Adverse Reaction Cold Therapy System 

FDA: Adverse Reaction Model Number 10B Event Date 11/02/2005 Event Type Injury Patient Outcome Required Intervention; Disability Event Description

"Ebice 10b cold therapy system was used following 2005 and 2006 podiatric surgical procedures performed for left foot problems and tarsal tunnel syndrome. The patient claims she has suffered cold thermal injury to the ankle, permanent nerve damage, chronic pain and rsd syndrome."

Manufacturer Narrative

"Although the unit was not returned for evaluation, the instructions for use was reviewed. Exerts taken from the ifu: read all instructions before using ebice. A licensed health care practitioner must determine the appropriate treatment setting and the length of treatment for each patient. Individual sensitivity to a cryotherapy application varies. It is important to periodically check the color and sensitivity of the skin at the treatment site. The patient should be instructed that if the skin appears discolored or feels numb, immediately discontinue the cold therapy treatment and notify your health care practitioner. Cooling for one hour at a water temperature of 30 - 48 deg f may induce redness and edema that last for 24 hours after exposure. Some individuals are allergic to cold, reacting with hives, joint pain and swelling. When cryotherapy is selected as a treatment modality, close monitoring of the patient's response to the cryotherapy treatment is critical. Water cycling adjustments or discontinuation of the treatment may be required if a patient demonstrates a localized hypothermia reaction. With a sudden sharp and persistent drop in temperature, vasoconstriction and increased viscosity of the blood in a local area may cause ischemic injury and degenerative changes in peripheral nerves. Localized reaction to cold may include childbain, frostbite or immersion syndrome. Prolonged tissues hypoxia and infarction necrosis of the affected tissue may develop. Vascular injury and edema become more evident as the temperature returns to normal." 

Product Liability Claims (Dangerous Drug Claims)

Dangerous and defective medical product lawsuits have become more common as the medical device and pharmaceutical industry has become more powerful.  With large medical device and drug companies seeking to sell more and more drugs and medical devices, some dangerous and defective medical devices and drugs have been pushed on the public.  It is important when using any medical device and taking any drug to make sure that you and your doctor understand potential benefits and dangers of the product as well as stay alert to any side effects or health issues that may arise from using the drug or medical device

For more information on defective medication lawsuits or defective medical device lawsuits, feel free to go to the following information pages on defective medical device and dangerous drug lawsuits including Implantable Neurostimulation System Lawsuits, Accutane Crohn's Disease and Inflamatory Bowel Diseases Lawsuits, Paroxetine, Seroxat, and Paxil Persistent Pulmonary Hypertension Lawsuits, Lyrica Suicide Lawsuit and Pregabalin Attempted Suicide Lawsuits, Reglan Tardive Dyskinesia Lawsuits, Anticonvulsant Drug, Antiepileptic Drug (AED), and Topamax Lawsuits,  SSRI Drug Lawsuits, Avandia Stroke and Heart Attack Lawsuits, Antidepressant Lawsuits, Ketek Lawsuits, and Gadolinium Contrast Dye and Nephrogenic System Fibrosis Lawsuits.   

Defective Cold Therapy Unit Nerve Damage Lawyers, Defective Cold Treatment Device Frost Bite Lawyers, Defective Ice Therapy System Lawyers, and Cryotherapy Machine Nerve Damage Product Liability Lawyers (Defective Ice Therapy, Cryotherapy, Cold Therapy Nerve Damage Product Lawsuits)

For more information on Defective Cold Therapy Unit, Defective Ice Therapy Device, and Defective Cryotherapy Product Liability Lawsuits, please go to the following web page Defective Cold Therapy Machine Nerve Damage Lawsuits, Defective Ice Therapy Unit Frostbite Lawsuits, and Defective Cryotherapy Device Complex Regional Pain Syndrome Product Liability Lawsuits.

United States and Mexico Bus Wrecks: Texas Serious Injury and Fatal Bus Accident Lawsuits

Texas Bus Company Accident Law Suits, Texas Charter Bus Lawsuits, Texas Bus Company Poor Maintenance Accident Lawsuits, and Texas Bus Driver Negligence Collision Lawsuits (Texas, Arkansas, Louisiana, Colorado, Oklahoma, and Mexico Fatal Bus Wrecks)

Catastrophic Injury and Fatal Bus Accident Lawsuits can be caused by a variety of reasons including negligent maintenance of buses, negligent bus drivers, over worked bus drivers, poor hiring of bus company drivers or employees, old bus fleets, or poor bus company policies and procedures.  In investigating or litigating a serious injury or fatal bus accident lawsuit, it is important to understand what caused the bus wreck and who the potential defendants are.  These issues not only help determine how to prevent future bus crashes, but also are determinative in where to file a potential bus collision lawsuit and what compensation may be available for those seriously injured in a bus collision or the family of a person killed in a deadly bus accident.

There are numerous Texas bus companies that provide bus and shuttle services that charter buses and provide bus travel through the states of Texas, Arkansas, Louisiana, Colorado,  Oklahoma, and  other parts of the United States as well as into Mexico.  Some of the bus companies that provide  bus transportation  and shuttle services in Texas and the surrounding states include: Arrow Trailways of Texas, Star Shuttle; Charter, River City Coaches, Lone Star Bus Lines Inc. Trailways, Greyhound Lines Inc., El Expresso Bus Company/A Coach USA Co., Eagle Tours Inc., Daisy Tours/Conventions San Antonio, Coach USA/Gray Line of San Antonio & Austin, Coach USA Inc., Coach USA Houston/Gray Line of Houston, Coach USA Dallas, Central West of Texas Inc., Central Texas Trails Inc., ACH Travel & Tours Inc.,Valley Transit, Greyhound Mexico (a Mexican subsidiary of Greyhound), and Autobuses Americanos.

Jurisdiction for Serious Injury and Deadly Bus Crashes in Texas, Arkansas, Louisiana, Colorado,  Oklahoma, and  other parts of the United States as well as Mexico may be in Texas Courts 

Potential deadly bus accident defendants that are Texas Bus Companies or run bus services through Texas can often be held liable in Texas courts for deadly bus crashes even if the deadly bus wreck occurred in Arkansas, Louisiana, Colorado,  Oklahoma, and other parts of the United States or in Mexico  This is important as victims of serious bus crashes and their bus collision attorneys often need to know where a potential catastrophic injury or fatal bus wreck lawsuit should or can be filed.

Texas Bus Company Crash Law Suits, Mexico Charter Bus Collision Lawsuits, Texas Shuttle Lawsuits, Texas Bus Company Poor Maintenance Accident Lawsuits, and Texas Bus Driver Negligence Collision Lawsuits

Most of the above bus and shuttle services provide safe travel for their passengers, but occasionally a negligent driver or negligent maintenance workers on the buses or shuttles will cause serious accidents or collisions that result in bus passengers or shuttle passengers suffering catastrophic injuries or deadly injuries. In these situations, it is important to thoroughly investigate the cause of the bus or shuttle accident to determine the cause of the shuttle or bus collision.  Not only is it important to determine the cause of the shuttle or bus accident for any potential bus accident or shuttle accident lawsuit, but also to make sure that similar fatal bus accidents, catastrophic injury bus accidents, fatal shuttle accidents, or catastrophic injury bus accidents do not happen again.

Because of the large sizes of buses and shuttles, it is extremely important that they be well maintained and operated safely.  Safe operation of buses not only is important to protect the shuttle and bus passengers, but also other drivers and vehicle passengers on roads and highways as well as pedestrians, bicyclists, runners, and people on a motorcycle or in a much smaller vehicle.  The damage that a large out of control bus can do to a person including a bus passenger, bus driver, shuttle passenger, cyclist, pedestrian, or passengers in other vehicles can cause serious injuries, catastrophic damages, and even death.

Because of the large potential damages and injuries that a shuttle or bus accident can cause, bus and shuttle charter companies are required to carry insurance to cover potential damages that they could cause in a bus or shuttle accident.  As such, it is important to have a Texas Shuttle or Bus Accident Lawyer that is able to understand different potential insurance coverages as well as how to deal with insurance adjusters and how to litigate a catastrophic injury or fatal bus accident law suit.

Texas Bus Pedestrian Collision Lawsuits, Texas Bus Motorcycle Wreck Lawsuits, Texas Bus Scooter Crash Lawsuits, and Texas Bus Bike Accident Lawsuits

A bus accident can be a devastating and life changing event, this is especially true if the bus hits a pedestrian, bicyclist, motorcycle, or a much smaller vehicle.  The damage that a large out of control bus can do to a person or other vehicle can cause serious injuries, catastrophic damages, and even death.

As many bus accidents involve private and governmental entities that own or control the bus, it is important to have a Texas Bus Accident Lawyer that is able to determine the correct way to investigate and litigate a serious injury or deadly bus crash lawsuit.  It is important to understand the notice periods, government bureaucrats, insurance adjusters, and risk departments, as well as the law, rules, and regulations regarding a bus wreck lawsuit and a bus accident claim.

   United States, Mexico, and Texas Catastrophic Injury and Fatal Shuttle and Bus Accident Lawyers for Texas Serious Injury and Deadly Bus Crash Lawsuits

As a Texas Shuttle and Bus Accident Lawyer, Jason Coomer, works on Texas Bus Accident Lawsuits involving serious injuries and fatal bus accidents all over the State of Texas and throughout the United States.  In working on Texas Bus Wreck Law Suits, Jason Coomer commonly works with other Texas Shuttle and Bus Accident Lawyers throughout Texas including Houston Fatal Bus Collision Lawyers, Dallas Fatal Bus  Wreck Lawyers, El Paso Bus Crash Lawyers, and San Antonio Bus Collision Lawyers. 

In working with other Fatal Shuttle and Deadly Bus Accident Lawyers, he is able to more efficiently investigate and litigate catastrophic injury and fatal shuttle and bus accident lawsuits.  

Texas Automobile Accident Lawyers & Deadly Car Wreck Lawsuits

Fatal and serious injury bus and automobile accident law suits need to be investigated and it is usually necessary to have an experienced Texas fatal automobile accident lawyer to file the law suit and litigate the fatal automobile accident claim.  The Texas automobile accident lawyer will have to investigate the claim, gather information, and prove liability, causation, and damages.  Automobile Accident Law Suits including Texas Bus Collision Lawsuits commonly have strict notice periods that need to be adhered to and will require a thorough accident investigation as well as an experienced negotiator to deal with the insurance company or risk manager that is handling the case.  These can be extremely difficult for a grieving family. 

Likewise people that are seriously injured in automobile accidents, typically need to be focusing on healing and their health.  The last thing they need to do is to be interrogated by an insurance adjuster regarding the automobile accident. Unfortunately, it is extremely common to have insurance adjusters contact people injured in an automobile accident to obtain evidence to dispute liability.  Many of these recorded statements are taken when the injured person is still hurt and on medication.  If you have been seriously injured in an automobile accident, it is often a good idea to speak to an automobile accident lawyer prior to agreeing to give a recorded statement.

Texas Bus Accident Lawsuits and Texas Bus and Shuttle Collision Lawyers

If you have been seriously injured by in a Bus Crash, it is important to seek medical help to determine how to treat the head trauma, back herniations, broken bones, or injuries you have suffered. It is then a good idea to contact the authorities and/or explore a possible law suit to make sure that the wrongful act or reckless bus driver can be removed from the road.  Texans do not need dangerous bus drivers or negligent bus drivers making our roads, streets, and highways more dangerous.  Large buses that weigh several tons are dangerous enough when driven safely and when they are well maintained.  Be careful out there and avoid being the victim of a bus accident or a serious bus collision.

For more information on a Texas Shuttle and Bus Accident Lawsuit or other vehicle collision lawsuit, please feel free to go to the following web page: Texas Shuttle and Bus Accident Lawsuit.

Traumatic Back Injury Lawsuits including Spinal Cord Injury Lawsuits as well as Crushed Disc, Bulged Disc, and Herniated Disc Lawsuits

Texas Traumatic Back Injury Lawsuits including Spinal Cord Injury Lawsuits as well as Crushed Disc, Bulged Disc, and Herniated Disc Lawsuits


Back and spinal injuries are some of the most difficult and life changing traumatic injuries that a person can suffer. Many types of traumatic accidents can cause a serious back injury that can cause significant pain as well as permanent physical impairment to a person. These back and spinal cord injuries can not only require significant and expensive medical treatment, but can also change a person's day to day life as well as end a person's career.

Treatment for Spinal Cord and Back Injuries include Cervical Decompression and Fusion Surgery, Lumbar Decompression and Fusion Surgery, Injections, Physical Therapy, and Spinal Implants 

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 will allow the injured person to focus on the healing process.

After a person has 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 that the injured person and their family knows their options 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.

Fortunately, medical science has come a long way in treating back injuries and spinal cord injuries. Good neurosurgeons and orthopedic surgeons can often perform back surgery that can help severe spinal cord and back injuries.

Some types of back and neck surgery include:

Artificial Disc Replacement - is a procedure that involves replacing a painful disc that is causing chronic back pain with an artificial disc that provides pain relief without compromising the spine's natural anatomical structure.

Cervical Spinal Fusion - uses a bone graft in the cervical or neck/upper back to stop the motion at a painful vertebral segment for the purpose of decreasing pain generated from the damaged part of the cervical back, upper back, or neck.

Cervical Decompression Surgery - Decompression surgery involves removing a small portion of the bone over the nerve root and/or disc material from under the nerve root to relieve pinching of the nerve and provide more room for the nerve to heal. Depending on the patient's condition including cervical impingement an Ananterior Cervical Decompression Surgery (Discectomy), a Posterior Cervical Decompression and Fusion Surgery (Microdiscectomy), or a combination of operating from the front and back of the patient may be used.

Cervical Decompression and Fusion Surgery - Decompression surgery involves removing a small portion of the bone over the nerve root and/or disc material from under the nerve root to relieve pinching of the nerve and provide more room for the nerve to heal. The decompression surgery will sometimes de-stabilize the spine and create the need for a fusion to add stability. In these cases spinal instrumentation (such as a small plate) can also be used to help add stability to the spinal construct. Depending on the patient's cervical impingement an Ananterior Cervical Decompression Surgery (Discectomy) or a Posterior Cervical Decompression (Microdiscectomy) and Fusion Surgery (Discectomy) or a combination of operating from the front and back of the patient may be used.

Lumbar Spinal Fusion - uses a bone graft in the lumbar or lower part of a person's back to stop the motion at a painful vertebral segment for the purpose of decreasing pain generated from the damaged part of the lumbar or lower back.

Lumbar Decompression Surgery (Laminectomy) - Decompression surgery involves removing a small portion of the bone over the nerve root and/or disc material from under the nerve root to relieve pinching of the nerve and provide more room for the nerve to heal.

Lumbar Decompression and Fusion Surgery - The decompression and fusion surgeries are often used together because decompression surgery involves removing a small portion of the bone over the nerve root and/or disc material from under the nerve root to relieve pinching of the nerve and provide more room for the nerve to heal. Thus, decompression surgery or a laminectomy will sometimes de-stabilize the spine and create the need for a fusion to add stability. In these cases spinal instrumentation (such as a small plate) can also be used to help add stability to the spinal construct.

In addition to the above back surgeries, there are numerous implants and spinal devices as well as injections that can help people recover from back and spinal cord injuries. These procedures and devices can reduce pain cause by back injuries as well as help reduce impairment. However, it is extremely important when considering back surgery or other spinal procedures to make sure that you have a competent doctor and medical staff that you trust. A failed back surgery or defective medical device can cause more impairment, pain, and health problems than none at all. It is important to understand the risks of any back surgery or medical treatment.


An Injured Person and their Family Should Focus on Healing after a Catastrophic Back Injury and Spinal Cord Injury, While Their Lawyer Litigates the Catastrophic Back Injury and Spinal Cord Injury Lawsuit with the Insurance Company and Large Corporation


The second step after suffering a serious back or spinal cord injury is to determine how to pay for the necessary medical treatment and if it is necessary to hire an attorney to thoroughly investigate 1) the accident that caused the injury, 2) all potentially responsible parties, and 3) what type of insurance coverage may apply.  This investigation may become complicated if a lawsuit is necessary. 

There are many types of traumatic back injury and spinal cord injury lawsuits including bike and cycling accident lawsuits, truck collision lawsuits, drunk driver lawsuits, bus accident lawsuits, pedestrian crosswalk accident lawsuits, helicopter crash lawsuits, medical malpractice lawsuits, premises liability lawsuits, motorcycle Accident lawsuits, catastrophic injury construction accident lawsuits, home accident lawsuits, defective product lawsuits, trucking accident lawsuits serious fall lawsuits, dangerous condition lawsuits, taxi cab accident lawsuits, trench collapse and excavator accident lawsuits, watercraft and jet ski accident lawsuits, road construction accident lawsuits (improper warning or barricade), and automobile accident lawsuits.  He also handles traumatic brain injury lawsuits and fatal accident lawsuits including accidental death lawsuits, fatal DWI lawsuit, workplace death & injury lawsuits, and wrongful death and survival actions.

It is important to hire an attorney that is interested in helping seriously injured individuals and their families recover compensation and assert their rights after an accident or crash. Whether a person is injured by a hazardous trap, falling object, helicopter crash, serious fall, dangerous defect, careless actions, or the negligence of another, individuals often need assistance from a Texas Catastrophic Back and Spinal Cord Injury Lawyer in dealing with and seeking money compensation from insurance companies and large corporations for the damages that they have suffered.

Texas Traumatic Back Injury Lawsuits including Spinal Cord Injury Lawsuits as well as Crushed Disc, Bulged Disc, and Herniated Disc Lawsuits

A serious back injury or spinal cord injury can cause extreme pain and paralysis requiring back surgery, physical therapy, home health care providers, and medical devices & equipment. Recovering from a back injury or spinal cord injury case take years and in many instances full impairment may never be obtained. In the more severe cases, the injured person may need help in their day to day life and may not be able to do many of things that they were able to do prior to the traumatic back injury or spinal cord injury.

For more information on Traumatic Back Injury and Spinal Cord Injury Lawsuits, please feel free to go to the following webpage on Traumatic Back Injury and Spinal Cord Injury Lawsuits.

 

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.

Failed Back Surgery and Implantable Neurostimulation System Lawsuits

Neurostimulator Medical Malpractice 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, Medical Negligence, & Defective Product 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 or medical negligence, and can take significant resources to investigate and litigate a lawsuit.  When investigating these potential failed back surgery lawsuits, it is important to know what implant had been used as well as to obtain medical records of the surgery.

Implantable Neurostimulation System Lawsuits, Defective Spinal 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.

In reviewing failed back surgery implant cases, the failed back surgery lawyers have to determine if the implantable neurostimulation system was properly implanted by the spinal surgeon that implanted the spinal device as well as if the spinal device has some type of defect such as loose leads.  For more information on this topic, feel free to go to the following web page, Failed Back Surgery and Defective Implantable Neurostimulation System Lawsuits. 

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.   

The "For Profit" System of Medicine Can Sometimes Cause Medical Negligence by Overworking Medical Professionals as well as Encouraging Clinics and Medical Providers to Maximize the Number of Surgeries and Procedures Performed Regardless of the Patient's Best Interest Resulting in Medical Malpractice Lawsuits

Unfortunately, medical mistakes happen when doctors and nurses get too busy, are understaffed, under the influence of drugs, are just not paying attention, or are encouraged to perform unnecessary procedures to make a profit.  As medical budgets go down and healing people becomes more of a "for profit" business, cost cutting measures are causing more medical mistakes and encouraging unnecessary procedures on those with good insurance.  Overworked surgeons, doctors, residents, and nurses are much more likely to make mistakes than well rested health care professionals.

Medical mistakes also happen more often when no one is watching.  It is extremely important when you are in the hospital to have someone that is with you and watching out for your well being.  This is especially true if you have an allergy to certain types of medicines.  Communication with your health care professionals is also important and can greatly limit medical mistakes.

Further complicated procedures such as spinal cord surgery require extremely competent surgeons that are on the top of their game to successfully complete.  A patient needs to be extremely careful when having spinal cord surgery to make sure that they have a good surgeon and everyone understands the risks of the procedure.  In some cases, even the best surgeons that do everything correctly will have bad results and the spinal cord surgery will fail.  However, at other times a defective product, a "for profit" surgeon or clinic, or a careless surgeon can cause a failed spinal cord surgery that will paralyze a patient for life.

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)

As the economic pressures of the medical system keep pushing medical providers to become "for profit" and prioritize making money over the health of individual patients; unnecessary procedures, overworked staff, using defective products, and making mistakes will become more common and hurt people.  It is extremely important to thoroughly investigate any clinic, hospital, surgeon or other health care provider prior to having spinal surgery, or any other complicated procedure.  Please feel free to go to the following web pages for more information on Failed Back Surgery and Defective Implantable Neurostimulation System Lawsuits, Texas Medical Malpractice Lawsuits, and Federal Medical Malpractice Lawsuits.

Fatal Helicopter Accident Lawsuits, Fatal Air Ambulance Lawsuits, and Fatal Aircraft Maintenance Lawsuits

Fatal Helicopter Accident Lawsuits, Fatal Air Ambulance Lawsuits, Fatal Blackhawk Crash Lawsuits, Fatal Aircraft Maintenance Lawsuits, Fatal Product Liability Lawsuits, and Fatal Military Aircraft Lawsuits by Texas Fatal Helicopter Accident Lawyer Jason S. Coomer 

Faulty maintenance or manufacturing of a helicopter including both civilian helicopters and military helicopters can lead to fatal and catastrophic injuries.  Every year many service personnel and civilians are killed in helicopter accidents caused by negligent maintenance, faulty manufacturing, and/or pilot error.  In some of these fatal helicopter accidents, it is possible to seek compensation from the responsible and negligent parties that caused the fatal helicopter accident through a helicopter crash lawsuit.

Fatal Military Aircraft Accidents and Fatal Civilian Helicopter Accidents Should be Investigated to Determine the Cause and Prevent Future Accidents

Military Aircraft and Civilian Helicopter accidents that result in someone's death or catastrophic injuries should be properly investigated to determine what happened to cause the helicopter crash and to make sure that other people are not killed or injured in similar fatal accidents.  In addition to the National Transportation Safety Board, military, and police investigations, it can also be helpful to have a Fatal Helicopter Accident Law Firm investigate a fatal helicopter accident. The information obtained through these investigations as well as the military and police investigations can be extremely important in determining the cause of a fatal helicopter crash and making sure that other similar air craft accidents do not occur.  By performing an independent investigation in addition to the military and/or police investigation, there is an opportunity to make sure that important facts are not missed and that there is no cover up of important information.  

Overseas Fatal Military Aircraft Accident Lawsuits, Iraq Fatal Military Transport Accident Lawsuits, Afghanistan Fatal Combat Military Attack Helicopter Accident Lawsuits, and other Foreign Military Aircraft Accident Lawsuits

Fatal Military Aircraft Accidents that occur overseas including transport helicopter crashes, transport military air craft accidents, observation helicopters crashes, attack helicopter accidents, can sometimes be brought into the United States Judicial System, if the responsible parties are subject to United States jurisdiction.  Defective maintenance and servicing on helicopters and other military aircraft by negligent government contractors can sometimes create jurisdiction in Texas or other parts of the United States. 

Medical Transport Helicopter Crash Lawsuits, Air Ambulance Helicopter Accident Lawsuits, News Helicopter Crash Lawsuits, Helicopter Tour Accident Lawsuits, and other Helicopter Accident Lawsuits

Helicopter crashes can be caused by a variety of negligent actions including pilot error, negligent maintenance, defective equipment, and worn parts.  Whether the helicopter crash is caused by defective parts, negligent maintenance, pilot error, or other reason, the National Transportation Safety Board will investigate every civil aviation accident including helicopter crashes in the United States. 

By working with the National Transportation Safety Board and other accident investigators, Fatal Helicopter Accident Lawyers can often determine what caused a fatal helicopter crash and seek compensation from those whose negligence caused the deadly air crash.   

Defective Helicopter Lawsuits, Defective Helicopter Engine Lawsuits, Defective Helicopter Part Lawsuits, and Helicopter Manufacturer Product Liability Lawsuits

There are several manufacturers of helicopters, helicopter engines, and helicopter parts including Boeing (Boeing Vertol and McDonnell Douglas), Bell Helicopter, and Sikorsky Aircraft.  These helicopter parts and helicopter manufacturers can cause a fatal or catastrophic injury helicopter crash if they produce a defective helicopter or helicopter part.

For more information on Fatal Helicopter Crash Lawsuits and Fatal Helicopter Crash Lawyers, feel free to go to the following web page on Fatal Aircraft Crash and Helicopter Accident Lawsuits.    

Gulf Coast Oil Spill Lawsuits, Toxic Spill Lawsuits, Mass Tort Lawsuits, and Oil Spill Causes Catastrophic Damage to People, Business, Environment, and Property

Gulf Coast Oil Spill Lawsuits, Toxic Spill Lawsuits, Mass Tort Lawsuits, Oil Spill Toxic Exposure Lawsuits, Oil Blow Out & Platform Death Lawsuits, and Business Loss Lawsuits 


The April 20, 2010 fatal blow out and oil spill at the Deepwater Horizon drilling rig in the Gulf of Mexico is one of the largest oil spills and environmental disasters in United States history.  The impact from the Gulf of Mexico Fatal Blow Out and Oil Spill is expected to poison many environments; kill many types of wildlife; hurt many businesses; contaminate land all along the Gulf coast; and will have a devastating impact on the Gulf of Mexico economy and ecology including Alabama, Texas, Florida, Mississippi, Mexico, and Louisiana.

Gulf Coast Fatal Blow Out and Oil Spill Responsibility, Liability, and Lawsuits

In the wake of the April 20, 2010 Fatal Blow Out Explosion that started the oil spill, top officials from BP (British Petroleum), Transocean, Ltd, and Halliburton, have already started to attempt to shift the blame for the fatal blow out and oil spill on anyone but their own companies.  Over the next several years, responsibility for and the extent of liability for the devastating fatal blow out and oil spill will be hotly contested in many Gulf of Mexico Fatal Blow Out and Oil Spill Lawsuits.  These Blow Out and Oil Spill Lawsuits will be fought in many jurisdictions and will include many different Plaintiffs that have suffered damages as a result of the Gulf of Mexico Fatal Blow Explosion and Oil Spill.

With the catastrophic damage caused by the Gulf Coast Fatal Blow Out and Oil Spill, there is a strong probability that capped liability and teams of defense lawyers may protect those responsible for the fatal oil rig blow out explosion and slow containment efforts  from having to compensate many of the businesses, property owners, industries, and people that have been significantly damaged by the fatal blow out and oil spill. 

It has been determined that British Petroleum, PLC. (BP) owned the site and managed the operation as a whole at the time of the fatal blow out explosion and through the attempts to contain the oil spill.  It is also agreed that Transocean, Ltd. was the owner and operator of the Deepwater Horizon drilling rig at the time of the fatal blow out explosion and that Halliburton provided well services to the well that blew out and exploded.


Fatal Blow Out Oil Rig Explosion Lawyers, Gulf Coast Oil Spill Lawyers, Gulf Coast Toxic Oil Spill and Failed Containment Lawyers, and Mass Tort Lawyers


Teams of Fatal Blow Out Oil Rig Explosion Lawyers and Gulf Coast Oil Spill Lawyers are now preparing for a huge litigation battle that could take more than a decade.  For more information on Mass Tort Litigation Lawsuits and Gulf Coast Fatal Oil Rig Blow Out Explosion and Oil Spill Lawsuits, feel free to go to the following web page on Mass Torts and Gulf Coast Oil Spill Lawsuits.

Hospital Whistleblowers and U.S. Department of Justice Recover Billions in Medicare Fraud

Hospital Administrator Whistleblowers Identify Medicare Fraud & Recover Money

Hospital Administrators including medical billing specialists, medical coding specialists, accountants, benefit specialists, facility coding supervisors, CEOs, vice presidents, and managers have been stepping up with doctors, nurses, and patients to blow the whistle on Medicare Fraud. These Hospital Administrators, Nursing Home Administrators, and Hospice Coordinators have been working with Medicare Fraud Qui Tam Lawyers and the United States Department of Justice to recover Billions of dollars in illegal kickbacks, medical double billing fraud, medical coding fraud, medical supplemental outlier payment fraud, and other forms of Medicare fraud. These hospital whistleblowers not only have been able to save United States Tax Payers Billions, but those that are the original source with special knowledge of the fraud and were first to file lawsuits on the fraud have been able to collect millions of dollars as a relator under the Federal False Claims Act.

Federal False Claims Act Amendments Encourage Medicare Fraud Recoveries

Recent Amendments to the Federal False Claims Act have not only increased protections for whistleblowers, but have also expanded the Federal False Claims Act to include subcontractors. By expanding the protections for whistleblowers and the potential liability for those committing Medicare fraud, the Federal Government is attempting to encourage more whistleblowers including hospital administrators to come forward and help fight Medicare fraud. The ultimate goal is to work with knowledgeable health care professionals to help reduce and recover more of the approximately $100 Billion in Medicare and Medicaid fraud that occurs each year.

In increasing the amount of potential Medicare fraud cases, the United States government had enacted an amendment to the Act that redefines "claim" to include claims submitted "to a contractor, grantee, or other recipient, if the money or property is to be spent or used on the Government's behalf or to advance a Government program or interest." This language makes explicit the ability of Government and whistleblowers to pursue subcontractors and grantees. This expansion will allow Hospital Administrators and other whistleblowers to potentially qualify as a relator and recover a portion of the recovered funds when turning in fraudulent health care providers and other businesses that contract with government programs.

Hospital Administrator Whistleblowers Have Specialized Knowledge

Because of the specialized knowledge that Hospital Network Administrators, Nursing Home Administrators, and other Health Care Professionals have regarding Medicare Coding, Outlier Payments, Medical Billing, Medicare Reimbursement, Medicaid Reimbursment, and Hospice Eligability, many are able to be the original source with special knowledge of fraud including Medicare Fraud, Tricare Fraud, VA Fraud, and Medicaid Fraud. This will allow many hospital administrators, nursing home administrators, and other health care professions that are the first to blow the whistle on Medicare Fraud, Medicaid Fraud, or other health care fraud to qualify as a relator and recover a portion of the recovered money.

For more information on Hospital Administrator Whistleblower Lawsuits, please feel free to go to the following web page, Hospital Administrator Whistleblower Medicare Fraud Lawsuits. This web page includes information on several recent lawsuits and settlements regarding Medicare and Health Care Fraud.

Antiepileptic Drug (AED) Topiramate andTopamax Suicide Lawsuits

Antiepileptic Drug (AEDs), Anticonvulsant Drugs, and Topamax FDA Warnings and Safety Alerts (Topiramate Suicide Lawsuits)

On May 5, 2009, the FDA mandated a new warning for Topamax and all anticonvulsant drugs. The antiepileptic drug (AED) class label changes mandated that Topamax and all anticonvulsant drugs update product labeling to include a warning about an increased risk of suicidal thoughts or actions. Further, these manufacturers were directed to develop a Medication Guide to help patients understand the risk of suicidal thoughts or actions caused by the antiepileptic drugs. These changes affected all approved AEDs including Topamax except those indicated only for short-term use.

The FDA approved advice to be given to healthcare professionals is that "epilepsy and other illnesses for which antiepileptic drugs are prescribed are associated with an increased risk of suicidal thoughts and behavior. If suicidal thoughts or behavior emerge during treatment with AEDs, the prescriber should consider whether these symptoms may be related to the illness being treated. All patients who currently are taking or starting on any antiepileptic drug for any indication should be monitored for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression."

Since the FDA issued safety alerts for the antiepileptic drugs on December 16, 2008 and January 31, 2008, the FDA has been working with the manufacturers of drugs in this class to better understand the suicidality risk. As described in the January 31, 2008, Information for Health Care Professionals Sheet on AEDS, eleven antiepileptic drugs were included in FDA’s original pooled analysis of placebo-controlled clinical studies in which these drugs were used to treat epilepsy as well as psychiatric disorders and other conditions. The increased risk of suicidal thoughts or behavior was generally consistent among the eleven drugs, with varying mechanisms of action and across a range of indications. This observation suggests that the risk applies to all antiepileptic drugs used for any indication.

Topamax Birth Defect Malformation Lawsuits and Cleft Lips or Palate Lawsuits (Topiramate Birth Defect Lawsuits)

The epilepsy and migraine drug Topamax has also been associated with an increased risk of birth defects for children of mothers that were taking the drug during pregnancy. Research studies have found that there are higher than expected rates of babies born with cleft lips, cleft palates, genital defects and other birth malformations when Topamax is used by women during pregnancy. Thus there is growing amounts of research that indicate that the use of the epilepsy and migraine drug, Topamax, either on its own or in combination with other epilepsy drugs, may increase the risk of birth defects when it is used during pregnancy.

Topamax and Topiramate FDA Approved Uses

Topamax (generic name: Topiramate) is an anticonvulsant drug also referred to as an antiepileptic drug (AED) that is produced by Ortho-McNeil Neurologics and Noramco, Inc., both divisions of Johnson & Johnson. Topamax was first approved by the Food and Drug Administration in 1996 to treat epilepsy. In 2010, Topamax is approved for use by itself or in combination with other meds to treat a variety of forms of epilepsy as well as to treat migraines.

Off-Label Uses of Topamax and Topiramate

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.

Topamax is also being marketed for several off-label uses. Some of the off-label uses of Topamax include for treatment of bipolar disorder, cluster headaches, eating disorders, obesity, fibromyalgia, depression, posttraumatic stress disorder (PTSD), alcoholism, sleep disorders, sleep-eating disorders, infantile spasms, autism, periventricular leukomalacia in preterm infants after an hypoxic-ischemic injury, essential tremor, bulimia nervosa, obsessive-compulsive disorder, smoking cessation, idiopathic intracranial hypertension, neuropathic pain, and cocaine dependence.

Topamax Suicide Lawsuits and Topiramate Suicide Lawyers

Topamax Topiramate Suicide Lawsuits are currently in the process of being filed in the United States. It is expected that several Topamax Suicide Lawsuits will be filed in 2010 and Multidistrict Litigation status will be sought by Topamax Lawyers. For more information on Topamax Lawyers and Lawsuits, please go to the following web page: Topamax Suicide Lawsuits Antiepileptic Drug Suicide Lawyer.

Drug Companies Aggressively Market Dangerous Drugs and Drugs for Off-Label Uses

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

The Pharmaceutical industry or "Big Pharma" has become extremely rich and powerful over the last decade as the industry has changed the way drugs are regulated and marketed in the United States and throughout the World. It is estimated that the drug industry will have drug sales of over $300 Billion in the United States in 2010 and over $750 Billion Worldwide. These revenues are over twice what they were 10 years ago.

The main reasons for this rapid growth are that the drug industry has been able to put their own people in top positions in the United States Food and Drug Administration to change regulations to relax the drug approval process, been able to help push through Medicare D (a major giveaway to the drug companies that increased government purchasing of drugs & limited competition), and been more aggressively marketing their drugs including off-label marketing regardless of dangers or effectiveness of the drug.

This article is intended to help explain the economic incentives that are encouraging the pharmaceutical industry to aggressively push drugs for approved and off label uses regardless of the effectiveness or potential dangerous side effects of the drugs as well as explain why additional safe guards are needed to help protect consumers from dangerous drugs and to curtail the drug industry's aggressive pursuit of profits regardless of the potential dangers or effectiveness of specific drugs.

Significant Investments in Research and Development Create Economic Incentives for Pharmaceutical Companies to Aggressively Market Drugs Regardless of Effectiveness or Potential Dangers

Because of the significant cost of researching and developing a drug, pharmaceutical companies have tremendous investments in making sure that a drug is profitable regardless of the effectiveness or potential dangers of a drug. Pharmaceutical professionals that have spent years and significant resources developing a new drug often cannot afford to risk their careers and company's profitability by having a drug's approval delayed, a drug taken off the market, or a drug sent back for further research. These precautions though often safer for consumers could allow another drug company or pharmaceutical professional to develop a similar drug and steal the potential market or cause potential profits to be delayed. Thus, the significant investment that a drug company has in a particular drug combined with fierce competition and the need for short term profitability create a strong economic incentive for a drug company to aggressively push patenting, approval, and marketing of a drug regardless of its effectiveness or potential dangerous side effects.

Further, once a drug is approved for a specific use there is also tremendous economic pressure to start marketing and pushing a drug for off label uses to increase the drug's profitability regardless of effectiveness or potential dangers. Even in cases where one drug company has been warned by the FDA not to market a drug for off label uses, other companies have purchased the drug and found it more profitable at least in the short term to market the drug and later pay any fines and/or lawsuits (Yasmin and Yaz example).

These economic incentives have led to increased emphasis on marketing and promotions rather than more research and development. In fact, studies have shown that the drug industry is now spending more on marketing and promotions than it is on research and development of new drugs. This startling fact is contrary to the drug industry's argument that most of their large revenues are needed for research and development of new drugs and suggests that new regulations are needed for drug marketing as many drug companies have found it more profitable to aggressively market drugs rather than to develop new drugs and/or make sure their product is safe and effective.

Economic Incentives Have Created More Aggressive Marketing Departments that Push Drugs Through Advertising and Doctors Regardless of Effectiveness or Dangerous Side Effects

Drug company spending on sales and marketing has increased significantly over the past decade. This increased focus on aggressive marketing has led to increased sales of drugs and profits for the pharmaceutical industry, but has also caused a large increase in off label use of drugs as well as the use of drugs that can cause significant health problems or death.

In pushing their drugs to consumers, some pharmaceutical marketing departments have turned many doctors and health care providers into drug pushers through incentive based marketing, kick back programs, and propaganda given to the doctors to encourage off label use of drugs and a push towards the use of more drugs and more expensive drugs regardless of necessity or effectiveness. The marketing departments have also in some instances taken control of the FDA to hide negative information about potential dangers of some drugs. These actions allowed the drug companies to sell more drugs even when they had information that the drugs were dangerous and could cause death or serious injuries.

Because of the large profits that have been made or can be made by the drug companies, many pharmaceutical executives have been willing to risk large fines for illegal and deceptive practices including off-label marketing, misleading advertisements, and hiding known dangers of drugs because they know that the profits will be larger than the potential fines. 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)

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 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 and 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.

These marketing schemes have been very successful in increasing pharmaceutical profits, but have led to False Claims Act Off-Label Marketing Lawsuits by the United States Department of Justice and False Claims Act Lawyers. These Off-Label Marketing False Claims Act Lawsuits have led to Billions of Dollars in Civil and Criminal fines against large drug companies. However, because of the extremely large profits that have been and can be made by off-label marketing, there is an economic incentive to continue the practice.

Recent Letter from the FDA Expresses Outrage at Wrongful and Criminal Actions of some Top FDA Officials During the Bush Administration that Changed Regulatory Procedures and Rubber Stamped Ineffective and Dangerous Drugs

Recent allegations have been made that the United States Food and Drug Administration (FDA) under the Bush administration in many instances ignored science and did not protect consumers from known dangers from pharmaceutical drugs. A letter dated April 2, 2009 from the Department of Health and Human Services FDA, confirms that top FDA Officials were suppressing science and information that could have hurt profits for the pharmaceutical companies. These FDA officials, FDA attorneys, and lawyers from the pharmaceutical companies, were working together in an effort to use false data and suppressed data to not only sell more dangerous drugs and medical devices to consumers, but also were attempting to block consumers that were severely injured or families that lost a loved one from defectively dangerous drugs from seeking any recourse through the justice system.

Fortunately, brave whistleblowers including FDA physicians and scientists, public advocacy groups, and the press were able to shine a light on some of the serious wrongdoing done by top FDA officials resulting in the letter. The letter expressed the outrage of many FDA professionals and other whistleblowers that are trying to root out FDA managers that failed to protect consumers from dangerous drugs.

It appears that the FDA is in the process of rooting out industry insiders that have valued their careers and/or helping drug companies make more money over the health and safety of American consumers. However, the fact that corrupt officials loyal to the drug industry were able to hijack the FDA is troubling. These outrageous actions have led to a call for new regulations and prohibitions against a revolving door policy between the FDA and the drug industry.

Product Liability Litigation, Dangerous Drug Lawsuits, and Seeking Compensation for & Protecting Consumers

Medications can be extremely beneficial, but when they are used incorrectly, marketed for the wrong purpose, or dangerous side effects are hidden; defective drugs can cause serious problems and catastrophic damages. In our modern society, the pharmaceutical companies have become extremely rich and powerful. Arguably this pooling of resources into the pharmaceutical companies allows these large corporations to spend billions of dollars on developing new drugs, but also on aggressive marketing and lobbying. Therefore, checks are need on how the drug industry uses their massive resources and power including limits on drug marketing, lobbying, and their influence on FDA regulations.

Further, it is important that consumers that have lost a loved one or have been seriously injured by a drug which is known to be unsafe have recourse in the United States justice system. Like the Pinto cases from the 1970s, large companies that determine that it is more profitable to aggressively market unsafe and dangerous drugs and pay any fine than it is to develop new and better drugs need to be made to answer for the damages that they cause. Allowing consumers to seek recourse from drug companies that have caused devastating health problems and death is an important check on the aggressive pharmaceutical marketing of drugs including off-label marketing that is currently occurring.

Defective drug lawsuits fall into product liability law. Product Liability Lawsuits that stem from defective medications can be extremely complicated and expensive to develop. Many of these defective medication lawsuits have aspects of medicine, science, evidence, and law to investigate, examine, and prove. To successful pursue defective and dangerous drug litigation, it is common to hire multiple experts to prove that a medication is defective and that it caused harm to a particular person or particular group of people. For this reason many defective medication lawsuits require severe catastrophic damages and/or multiple injured parties to be viable.

Even when a dangerous medication has caused catastrophic damages to many people and families, it can be quite a fight to prove that a medication is defective. Fighting through industry produced research and discovering hidden adverse research can be difficult. This is because the product's manufacturer has typically invested a significant amount of money in designing the product, manufacturing the product, and marketing the product. For some dangerous drugs billions of dollars have been invested in designing, manufacturing, marketing, and distributing the defective drug. As such, everyone in the production and distribution lines have a stake in disproving that the medication is defective or dangerous.

Defective Drug Litigation, Bad Drug Lawsuits, and other Drug Product Liability Lawsuits (Texas Defective Drug Lawyer)

These highly profitable, but aggressive, misleading, and sometimes illegal marketing practices have brought crack downs by the United States Department of Justice, the Food and Drug Administration, and Product Liability Defective Drug Lawyers. For more information on some types of defective drug litigation that are now pending please feel free to click on the following links: Chantix Suicide Lawsuits, Reglan Tardive Dyskinesia Lawsuits, Defective Birth Control (Yaz, Yasmine, & Ocella) Lawsuits, Avandia Lawsuits, Vioxx Lawsuits, Ketek Lawsuits, Gadolinium Contrast Dye Lawsuits, Trasylol Lawsuits, Zyprexa Lawsuits, Antidepressant (SSRI) drug Lawsuits, and other defective drug and medication Lawsuits.

Reglan GERD Tardive Dyskinesia Lawsuits (Tardive Dyskinesia Neuroleptic Medication Lawsuits)

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.

For more information on Reglan and Tardive Dyskinesia, please go to the following Reglan Tardive Dyskinesia GERD Lawsuit Webpage.

Chantix Suicide Lawsuits (Chantix Suicide Litigation)

Chantix is a stop smoking aid or smoking cessation medication that has been linked to mood and behavior changes in people that use the drug. These behavior changes include suicidal behavior and suicidal idealation. These changes are especially problematic when Chantix is used in combination with alcohol.

Health care professionals, patients, patients' families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of varenicline therapy.

• Patients should immediately report changes in mood and behavior to their doctor.

• Vivid, unusual, or strange dreams may occur while taking Chantix.

• Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.

FDA will continue to update health care professionals with new information from FDA's continuing review or if new information is received on Chantix and serious neuropsychiatric symptoms.

For more information on Chantix Suicide and Attempted Suicide Lawsuits, please go to the following Chantix Lawsuit Webpage.

Selective Serotonin Reuptake Inhibitor Antidepressants (SSRIs)
Birth Defect Lawsuits

Some medications that have been linked to birth defects include Selective Serotonin Reuptake Inhibitor Antidepressants (SSRIs). Women that have taken SSRIs after the 20th week of pregnancy have a 6-fold increased risk of developing persistent pulmonary hypertension, a life-threatening lung disorder. Infants with persistent pulmonary hypertension have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies and may become very sick or die. For more information on Selective Serotonin Reuptake Inhibitor Antidepressant Birth Defect Claims, please go to our SSRI Birth Defect Claim Information Page.

The SSRIs antidepressants that have been linked to persistent pulmonary hypertension (PPHN) include Paxil by GlaxoSmithKline, Zoloft marketed by Pfizer; Prozac sold by Eli Lilly; Celexa and Lexapro by Forest Laboratories, Effexor marketed by Wyeth, Luvox by Solvay, and the generic makers of these drugs include Barr Pharmaceuticals, Ranbaxy Labs and Genpharm.

Infants born with PPHN often require mechanical assistance to breath and even worse about 10% to 20% of the infants do not survive even when they receive treatment. The PPHN babies that do survive often experience developmental delays, brain abnormalities and hearing loss, experts say.

For more information on PPHN, PPH and SSRI Birth Defect Lawsuits, please go to the following SSRI Antidepressant PPHN Birth Defect Lawsuit Webpage.

Birth Control Medication Lawsuits (Yaz, Yasmin, and Ocella Birth Control Drug Lawsuits)

YAZ, Ocella, and Yasmin are oral contraceptives that produced over $1 Billion in sales in the United States and $1.8 Billion worldwide in 2008. These birth control pills are oral contraceptives that have been heavily marketed by Bayer HealthCare Pharmaceuticals, Inc., however, the FDA has found that past marketing campaigns were misleading as it minimized the potential health risks that have been associated with these oral contraceptives. These health risks include sudden death, cardiovascular problems, blood clots, heart attacks, stokes, and gallbladder disease

YAZ and Yasmin are combined oral contraceptive (COC) pills that contain ethinylestradiol (EE) and drospirenone (DRSP). These birth control medications are manufactured by Bayer HealthCare Pharmaceuticals, Inc., while Ocella is the generic equivalent of Yasmin that is manufactured by Barr Laboratories. Each of these birth control medications contain ethinyl estradiol and the new "fourth generation" progestin drospirenone (DRSP). Drospirenone is known for increasing the risk for hyperkalemia and these DRSP oral contraceptives have been associated with adverse health effects such as Death, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Strokes, Heart Attacks, Gallbladder Disease, and other health problems.

For more information on Yaz, Ocella, and Yasmin Lawsuits, please go to the following Yaz, Ocella, and Yasmin Lawsuit Webpage.

Neurontin FDA Actions and Warnings (Gabapentin and Antiepileptic Drug Suicide Lawsuits)

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.

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 Neurontin and Antiepileptic Drug Suicide Lawsuits, please go to the following Neurontin, Off Label Marketing, and Antiepileptic Drug Suicide Lawsuit Webpage.