What You Can Do & How an Advil Lawsuit Can Help

The Schmidt Firm, LLP is currently accepting Advil induced birth defect injury cases in all 50 states. If you or somebody you know has had a baby with a birth defect caused by this medication, you should contact our lawyers immediately for a free Advil lawsuit consultation. Please use the form below to contact our Advil Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Advil Overview

Advil is a medication used for the treatment of mild to moderate pain, reduction of fever, and several chronic arthritic conditions. The active ingredient in Advil is ibuprofen, a type of anti-inflammatory drug that has been available in the U.S. since 1974. Advil is manufactured by Pfizer and has been available since 1984.

Advil and other NSAIDs work by inhibiting an enzyme that produces prostaglandins. Prostaglandins are necessary for pain, fever, and inflammation. By blocking these enzymes, Advil and other NSAIDs reduce pain and fever. As a class of medications, NSAIDs are some of the most popularly used medications in the world. You probably have at least one NSAID floating around in your medicine cabinet — aspirin, naproxen, and ibuprofen are some of the most common NSAIDs. These medications have a long history of use, so many people may believe that they are always safe to use. Unfortunately, recent research suggests that NSAIDs and Advil during pregnancy may increase the risk of having a baby with a birth defect.

Advil and Pregnancy

What birth defects have been linked to Advil?

• Clubfoot: This occurs when the baby is born with one or both feet turned inward and downward at a sharp angle. Though it looks like this condition is caused by the way a baby develops in the womb, it is actually caused by abnormal development of the calf muscles, tendons, and ligaments in a baby’s foot. About half of cases involve both the baby’s feet, called “bilateral clubfoot.” Modern treatment has greatly improved, and children rarely undergo extensive surgery. In the Ponseti method, the baby’s foot is gradually stretched and casted into position. Usually, by the time the child is learning how to walk, the birth defect has been corrected.
• Amniotic Band Syndrome (ABS): Children born to mothers who took an NSAID were three times more likely to suffer from ABS. This condition is thought to arise when there are ruptures to the amniotic sac, which is the sac that surrounds a developing baby in the womb. Fibrous bands of the sac float around in the amniotic fluid, and a developing baby can become entangled. The severity of ABS depends on what part of the baby is entangled and how tightly the bands are constricting the child. In severe cases, the child may suffer amputations caused by constricted bands.
• Spina Bifida: This birth defect was 60% more likely to occur in children born to mothers who took an NSAID during pregnancy. Though most babies with spina bifida actually have no disability, in severe cases, children are born with paralysis and incontinence and they must use a wheelchair. Severe spina bifida occurs when the neural tube that normally protects the spinal cord fails to close during the first few weeks of fetal development. Damage to the exposed spinal cord cannot be cured.
• Anophthalmia and Microphthalmia: These exceptionally rare birth defects are three times more likely to occur to children whose mothers took an NSAID during pregnancy. They may occur in just one eye or both eyes. Anophthalmia is the condition of being born with no eye tissue, leaving the child irreparably blind. Microphthalmia occurs when the child’s eyes are significantly smaller than usual.
• Cleft Lip and Palate: These orofacial clefts were 30-80% more likely in children whose mothers took an NSAID during pregnancy. Babies born with clefts often have problems eating, sucking, and swallowing. In severe cases, babies must undergo multiple-stage surgeries to improve their facial appearance and improve their ability to eat normally.

Scientific Study of NSAIDs, Advil and Pregnancy

In December 2011, the Journal of Obstetrics and Gynecology published the results of a study that found a link between painkillers and birth defects. The researchers analyzed data on more than 20,000 women and looked for links between painkillers and 29 different birth defects. The good news is, most birth defects were not linked at all. Unfortunately, a few birth defects were linked to the maternal use of painkillers, and these birth defects were severe, debilitating, and sometimes deadly.

The conclusions of the study were based on information from 15,000 women whose babies had birth defects. The mothers all participated in the National Birth Defects Prevention study. The researchers analyzed this data, and compared it to data from 5,500 women whose babies had no birth defects. The researchers found that the maternal use of painkillers early in pregnancy increased the risk of having a baby with clubfoot, anophtalmia, microphthalmia, spina bifida, cleft lip, cleft palate, and amniotic band syndrome.

The researchers concluded that women who are pregnant should talk to their doctor about safe painkillers to take during pregnancy.

Do I have an Advil Lawsuit?

The Schmidt Firm, LLP is currently accepting Advil induced birth defect injury cases in all 50 states. If you or somebody you know has had a child with a birth defect after taking Advil, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Advil Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.

What You Can Do & How an Arthrotec Lawsuit Can Help

The Schmidt Firm, LLP is currently accepting Arthrotec birth defect injury cases in all 50 states. If you or somebody you know had had a child with a birth defect after taking this medication, you should contact our lawyers immediately for a free Arthrotec lawsuit consultation. Please use the form below to contact our Arthrotec Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Arthrotec Overview

Arthrotec is an arthritis medication that is actually a combination of two drugs: diclofenac and misoprostol. Diclofenac is an NSAID anti-inflammatory medication, and misoprostol helps protect a user’s gastrointestinal tract. Arthrotec is commonly prescribed to treat the symptoms of rheumatoid arthritis and osteoarthritis, two inflammatory conditions that cause chronic pain, tenderness, stiffness, and swelling of the delicate lining between the joints.

Diclofenac belongs to a class of medications known as “Non-Steroidal Anti-Inflammatory Drugs” or NSAIDs for short. This class of medications includes aspirin, naproxen, and ibuprofen, making them the most commonly used medications in the world. Millions of people use these medications to treat mild to moderate pain, inflammation, reduce fever, and more. Unfortunately, the chronic use of these medications has been linked to stomach ulcers and other gastrointestinal problems. Because arthritis is a chronic condition, many people who were taking an NSAID as a treatment were suffering from gastrointestinal problems. As a solution, the makers of Arthrotec combined diclofenac with another drug, misoprostol.

Diclofenac inhibits enzymes in the body that are involved in pain and inflammation. These enzymes also help protect the lining of the stomach and promote clotting. Misoprostol is a synthetic enzyme that stimulates the stomach to produce mucus, which protects the lining of the stomach and the gastrointestinal tract.

Arthrotec and Pregnancy

Unfortunately, new research has emerged that has found a link between the maternal use of NSAIDs (such as Arthrotec) and an increased risk of several severe, debilitating birth defects. Researchers now recommend that women who are pregnant avoid taking all NSAID painkillers while they are pregnant, and talk to their doctor about alternative painkillers that are less risky to an unborn baby.

The following birth defects were linked to the maternal use of NSAIDs:

• Clubfoot: This is a birth defect that can affect one foot or both feet. Clubfoot is diagnosed in a physical examination when the baby is born. The foot is turned inward or downward at the ankle, resembling a club. One treatment option involves gradually stretching and casting the foot. A typical regimen of stretching, casting, and wearing a brace will last three years. Ideally, the child will have a normal foot by the time he or she is learning how to walk.
• Amniotic Band Syndrome (ABS): The severity of ABS varies greatly. ABS may cause no problems, or it can cause amputations, deformities, miscarriage, and death. On its own, ABS is not a birth defect, but rather a complication that occurs during fetal development. It is thought to occur due to a partial rupture in the amniotic sac that causes bands of the sac to separate. Fibrous bands float in the amniotic fluid and can entangle a developing baby.
• Cleft Lip and/or Cleft Palate: These birth defects are 30-80% more likely to occur in babies born to mothers who took an NSAID, such as Arthrotec, during pregnancy. They can cause serious problems eating, sucking, and swallowing, and can lead to severe nutritional deficits if they are not managed properly. Fortunately, advancements in modern surgery have greatly improved the outcome for children born with cleft lip or cleft palate.
• Anophthalmia / Microphthalmia: When a baby is born with no eyes, this condition is called anophthalmia. When a baby is born with abnormally small eyes that are almost always blind or nearly blind, this is called microphthalmia. The two terms are sometimes used interchangeably. There is no cure for either of these conditions. Advancements in modern surgery can improve the facial appearance of a baby born with one of these conditions, and may include fitting the child with a prosthetic eye. The risk of anophthalmia and microphthalmia increases by a three-fold rate when mothers take NSAIDs during pregnancy.
• Spina Bifida: The risk of spina bifida was 60% higher in babies born to women who took an NSAID, such as Arthrotec, during pregnancy. Many children who are born with spina bifida have some level or paralysis and will need to use a wheelchair or other assistive device. In the most severe cases of spina bifida, the child is born with severe paralysis of the legs and may also be incontinent. Spina bifida is caused by the abnormal development of the neural tube, which normally protects and covers the spinal cord. If there is an opening in the neural tube, the spinal cord can become permanently damaged.

Scientific Studies of Arthrotec and Birth Defects

The researchers who found the link between common NSAIDs and the aforementioned birth defects announced the results of their study in December 2011 in the American Journal of Obstetrics and Gynecology. They were pleased to report that the maternal use of medications does not increase the risk of most birth defects. However, a few rare birth defects were more likely when a woman took an NSAID during pregnancy. The risk was greatest when she took the medications early in pregnancy.

The researchers analyzed the following data: information on 15,000 women who participated in the National Birth Defects Prevention study, compared with information on 5,500 women whose babies had no birth defects.

The researchers looked for links between the maternal use of painkillers and 29 different birth defects. Of these 29 birth defects, 7 birth defects were associated. However, because these birth defects were exceptionally rare, even a three-fold increase in the rate of these birth defects translates to relatively few cases. Even so, the researchers concluded that women who are pregnant should avoid using NSAIDs, including Arthrotec, during pregnancy until more conclusive research is conducted.

Do I have an Arthrotec Lawsuit?

The Schmidt Firm, LLP is currently accepting Arthrotec birth defect cases in all 50 states. If you or somebody you know has had a baby with a birth defect after taking this medication, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Arthrotec Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.

What You Can Do & How a Motrin Lawsuit Can Help

The Schmidt Firm, LLP is currently accepting Motrin induced injury cases in all 50 states. If you or somebody you know has had a child with a birth defect caused by this medication, you should contact our lawyers immediately for a free Motrin lawsuit consultation. Please use the form below to contact our Motrin Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Motrin Overview

Motrin is the prescription-strength brand-name version of one of the most popular painkilling medications in the world: ibuprofen. It is regularly used by millions of people worldwide for the treatment of mild or moderate pain, inflammation, and to reduce fever. It belongs to a class of drugs called “Non-Steroidal Anti-Inflammatory Drugs” or NSAIDs for short. You probably have at least one NSAID in your medicine cabinet: aspirin, naproxen, and ibuprofen all belong to this popular group of painkillers.

Motrin is prescription-strength ibuprofen, and doctors usually prescribe this medication to treat pain, swelling, and stiffness caused by osteoarthritis and rheumatoid arthritis. These painful conditions are caused when there are problems with the delicate lining between a person’s joints. Motrin can help reduce a the body’s inflammation response to alleviate pain and suffering.

Unfortunately, recent research has found a link between Motrin and other NSAIDs and several severe, life-threatening birth defects. The researchers are now warning women not to take Motrin or other NSAIDs during pregnancy.

Motrin and Pregnancy

New research has found that there is a slightly increased risk of having a baby with a birth defect when pregnant women took an NSAID, such as Motrin, during pregnancy. The risk is greatest when these women took an NSAID during the first trimester of pregnancy, though there may be risks to an unborn baby if the medication is taken at any time during pregnancy.

The following birth defects have been linked to Motrin and other NSAIDs:

• Amniotic Band Syndrome (ABS): ABS is not actually a birth defect, but it can cause a baby to be born without fingers or limbs. ABS is actually a complication that occurs during fetal development. Normally, during fetal development, a baby is surrounded by the amniotic sac. When ABS occurs, parts of this sac detach and form bands, which can then entangle a developing baby. If ABS is not corrected early, a baby can become strangled by the bands, leading to the amputation of fingers or limbs. ABS is 60% more likely to occur in babies born to mothers who took an NSAID during pregnancy.
• Clubfoot: This condition is named after the shape of a baby’s foot when it is born. The foot is turned inward at a sharp angle at the baby’s ankle, resembling a club. The condition is readily treatable — surgery may be an option, though many parents choose a less-invasive, gradual stretching of the baby’s foot. New techniques have been developed using bands and casts to gradually correct the child’s foot position. If the condition is not treated, the child will often have serious impediments when he or she begins learning how to walk.
• Anophthalmia and Microphthalmia: These are birth defects affecting the eye. Both cause blindness and are incurable. Normally, these birth defects are exceptionally rare. But when mothers took an NSAID during pregnancy, the risk of these birth defects increased by a three-fold rate. Anophthalmia is a serious condition in which the baby is born without eyes. Microphthalmia is also a serious condition, and occurs when the baby is born with abnormally small eyes.

• Cleft Lip and Cleft Palate: Oral / facial clefts are some of the most common birth defects that occur in the United States. When the baby is developing in the womb, these birth defects occur when the flesh in the upper lip or the roof of the mouth fails to fuse together. A baby with cleft lip may have just a small notch, or a wide gap that extends into the nose. Similarly, a baby with cleft palate may have a cleft that involves only the hard palate, or both the hard palate and the soft palate. For both cleft lip and cleft palate, the infant often has serious problems eating, swallowing, and forming suction on its mother’s breast. For this reason, babies with clefts are at risk of nutritional deficiencies. Cleft lip and cleft palate were 30-80% more likely to occur when the mother took an NSAID during pregnancy.
• Spina Bifida: This is a severe, life-threatening, and often debilitating birth defect that occurs when the baby is developing in the womb. Normally, in the first few weeks of fetal development, the neural tube closes and protects the spinal cord. In a baby with spina bifida, the neural tube fails to close and the spinal cord is exposed to amniotic fluid in the womb. This causes severe, permanent damage to the spinal cord. Babies with spina bifida often have some level of paralysis. Spina bifida was 60% more likely to occur in babies born to mothers who took an NSAID.

What is the problem with Motrin?

In December 2011, researchers announced the results of a study of more than 20,000 women. The researchers found a link between the maternal use of NSAIDs, such as Motrin, and several several severe birth defects. The researchers looked at data from 15,000 women who had a baby with a birth defect, and compared the data to 5,500 women whose babies had no defects. The researchers then looked for links between the maternal use of medications and more than 29 different birth defects. Though the vast majority of birth defects were not correlated with the maternal use of medications, a few were. This analysis led the researchers to conclude that women should avoid all NSAIDs during pregnancy, and talk to their doctor about what painkillers would be safe to use instead.

Do I have a Motrin Lawsuit?

The Schmidt Firm, LLP is currently accepting Motrin induced injury cases in all 50 states. If you or somebody you know has had a baby with a birth defect after taking Motrin, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Motrin Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.

What You Can Do & How a Cataflam Lawsuit Can Help

The Schmidt Firm, LLP is currently accepting Cataflam induced injury cases in all 50 states. If you or somebody you know has had a baby with a birth defect caused by this medication, you should contact our lawyers immediately for a free Cataflam lawsuit consultation. Please use the form below to contact our Cataflam Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Cataflam Overview

Cataflam is primarily a medication used to treat pain, tenderness, swelling, and stiffness caused by osteoarthritis and rheumatoid arthritis. It is the brand name of the medication “diclofenac.” Cataflam is one brand-name version of diclofenac. Other brand-name versions of diclofenac include: Cambia, Voltaren, Voltarol, and Zipsor. The arthritis medication Arthrotec also contains a combination of diclofenac and another medication.

Cataflam and diclofenac belong to a class of medications known as NSAIDs, which is short for “Non-Steroidal Anti-Inflammatory Drugs.” You probably have at least one NSAID in your medicine cabinet — this class of drugs are some of the most popular, widely-used medications in existence. Other NSAIDs include aspirin, naproxen, and ibuprofen. Most people use these medications for the treatment of mild to moderate pain. These medications are also useful to treat chronic inflammatory diseases, which is why many people with arthritis take an NSAID.

Unfortunately, new research has found a link between Cataflam and other NSAIDs and some serious, life-threatening birth defects.

Cataflam and Pregnancy

Doctors now recommend that pregnant women avoid taking Cataflam while pregnant, because this medication may slightly increase your risk of having a baby with a birth defect. It has also been linked to serious complications during labor and delivery. The following birth defects have been linked to Cataflam:

• Amniotic band syndrome: This rare but serious complication was 60% more likely to occur when the mother took an NSAID during pregnancy. It is not actually a birth defect, but rather a complication that occurs while the baby is developing in the womb. Parts of the amniotic sac separate, forming bands, which then become tangled around a developing baby. In severe cases, the bands can strangle the baby, and cause the amputation of parts of the infant’s body.
• Clubfoot: This birth defect occurs when a baby’s foot does not form properly. When the baby is born, its foot (or both feet) turn sharply inward at the ankle. This syndrome is called “clubfoot” because the baby’s foot resembles a club. Treatment may involve surgery to correct the tendons and ligaments. If the syndrome is not too severe, the foot may be gradually stretched into the correct position. If the condition is not corrected, it can lead to complications when the baby is beginning to learn how to walk.
• Anophthalmia / Microphthalmia: These are two eye defects that cause a baby to be born blind, and they are not correctible. In anophthalmia, the baby is born without any eyes. In microphthalmia, the baby is born with eyes that are too small to see. These two rare conditions were three times more likely to occur when the mother took an NSAID, such as Cataflam, during pregnancy.
• Cleft Lip / Cleft Palate: These two birth defects are some of the most common birth defects that occur in babies, and they vary widely in severity and treatment. A cleft lip occurs when the flesh of the upper lip does not fuse during fetal development, causing a separation. Sometimes it is just a small notch; other times it is a wide separation that extends into the nose. Cleft palate is a condition in which the roof of the baby’s mouth (involving the hard and/or soft palate) is separated. Cleft palate often causes problems with eating, sucking, and swallowing. Cleft lip and cleft palate were 30-80% more likely to occur when the baby’s mother took an NSAID during pregnancy.
• Spina Bifida: This is a serious, potentially life-threatening birth defect that is often associated with paralysis and other serious complications. Spina bifida was 60% more likely to occur to babies whose mothers took Cataflam or another NSAID during pregnancy. This birth defect occurs during fetal development, when the neural tube fails to close, and there is an abnormal opening at the base of the baby’s skull. The neural tube normally covers and protects the spinal cord. A baby with spina bifida often suffers irreparable damage to the spinal cord, which can cause severe paralysis.

What is the problem with Cataflam?

In December 2011, researchers announced the results of a study of the link between NSAIDs and birth defects. Though the majority of the birth defects the researchers studied were not linked to NSAIDs, a few severe birth defects were associated. The researchers looked at information from 15,000 women who had a baby with a birth defect, and they compared with information to 5,500 women who had a baby without a birth defect. The researchers found that the maternal use of NSAIDs, particularly during the first trimester, was linked to a few severe birth defects. They warned that this does not prove the painkillers are to blame, but it should should serve as a warning to pregnant women. They recommended that women consult their physician before taking any painkillers while pregnant, and they should probably avoid all NSAIDs until more studies are conducted.

Do I have a Cataflam Lawsuit?

The Schmidt Firm, LLP is currently accepting Cataflam induced injury cases in all 50 states. If you or somebody you know has had a child with a birth defect after taking Cataflam, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Cataflam Lawsuit Group or call toll free 24 hours a day at (866) 920-0753.

Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.

What You Can Do & How a Wingspan Brain Stent Lawsuit Can Help

The Schmidt Firm, LLP is currently accepting Wingspan Brain Stent induced injury cases in all 50 states. If you or somebody you know has been injured by this medical device, you should contact our lawyers immediately for a free Wingspan Brain Stent lawsuit consultation. Please use the form below to contact our Wingspan Brain Stent Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Wingspan Brain Stent Overview

The Wingspan Brain Stent System with Gateway PTA Catheter is a medical device used to open brain blood vessels in patients who have recently had a stroke caused by a narrowing of the brain blood vessels. According to the National Institute of Neurological Disorders and Stroke, every year at least 55,000 strokes are cased by blockages in the small blood vessels in the brain.

Medical stents already exist for people at risk of blockages in the heart. It was hoped that a similar, smaller device would work for people at risk of blockages in the brain. The Wingspan Brain Stent system is a wire mesh tube that is designed to be used in the small, delicate blood vessels in the brain. It is much smaller than stents that are used in the heart.

The U.S. Food and Drug Administration initially approved the device in 2005. It is approved for use in patients who have had at least one stroke and are at risk of having another stroke.

What is the problem with Wingspan Brain Stent System?

The device was approved on the basis of a humanitarian exception, which did not require stringent safety data or solid evidence that the device could prevent strokes. The manufacturer conducted a 45-person trial that lacked a control group to compare whether the brain stents were safer or more effective than other methods.

After the medical device was approved, surgeons used it on thousands of people who were at high risk of suffering a stroke.

In April 2011 — more than six years after the brain stent system started being used on people — the first controlled study was performed on 450 patients. The patients were randomly divided into two groups: one group received brain stents, and the other group received aggressive treatment with drugs and lifestyle changes. The study was funded by the National Institute of Neurological Disorders and Stroke.

The study was aborted prematurely after researchers found that patients treated with the brain stent had a 2.5-fold increased risk of suffering a stroke or dying within 30 days of surgery. They found that almost 15% of the brain stent patients suffered strokes in the first 30 days, compared with 6% of the people on medical therapy.

Humanitarian Device Exemption

A Humanitarian Use Device (HUD) is a device that is intended to be used to treat, prevent, or diagnose a disease that affects fewer than 4,000 people in the United States every year.

A device approved under the Humanitarian exception is not required to contain the results of a scientifically valid clinical investigation demonstrating that the device is effective for its intended purpose. However, the application must sufficiently show that the device does not pose an unreasonable risk to patients, and the benefits of its use outweigh its risks.

FDA Under Scrutiny for Approving Dangerous Medical Devices

In November 2011, an expert panel at the Institute of Medicine recommended that the FDA overhaul its medical device review process after it failed to establish the safety of less-risky medical devices. The FDA has come under intense scrutiny regarding several medical devices that were later found to be more dangerous than expected (including brain stents, Lap Band, defective hip implants, and transvaginal mesh).

House Democrats have recently called for Congressional hearing regarding Johnson & Johnson’s transvaginal mesh, Allergan’s Lap Band.

Do I have a Wingspan Brain Stent Lawsuit?

The Schmidt Firm, LLP is currently accepting Wingspan Brain Stent induced injury cases in all 50 states. If you or somebody you know has been injured by the Wingspan Brain Stent, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Wingspan Stent System Lawsuit Group or call toll free 24 hours a day at (866) 920-0753.

Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.

The doctors originally voiced their concerns in 2007 over 12 radiological devices whose effectiveness was not proven and could pose health risks to millions of people.

• Three devices risked missing signs of breast cancer
• One device risked missing signs of osteoporosis, leading to unnecessary treatments
• One ultrasound machine could malfunction and harm an unborn baby
• Several devices for colon cancer screening could accidentally use a much higher dose of radiation, giving cancer to otherwise health patients
• One device that searched for signs of breast cancer. Although doctors, scientists, and their middle-managers recommended against approval, a senior manager approved the device in 2008.

The six doctors and scientists have filed a lawsuit against the FDA in U.S. District Court, based on information they collected under the Freedom of Information Act.

The doctors and scientists worked together in an office and were responsible for reviewing medical devices used for cancer screening and more. Their lawsuit against the FDA accuses the administration of monitoring their personal emails for two years. In January 2009, the FDA intercepted emails between Congressional staffers and the men, including draft versions of a whistle-blower lawsuit.

They were using government computers for personal communications. When they logged on to the government computers, they were met with a prominent warning alert box that clearly said “you have no reasonable expectation of privacy regarding any communications,” and “for any lawful government purpose, the government may monitor, intercept, and search and seize any communication or data.”

The doctors and scientists who filed the lawsuit contend that their actions were lawful. Indeed, they have a legal right to voice their concerns to Congress or journalists.

The Department of Health and Human Services’ inspector general, which oversees the FDA operations, found no evidence of criminal misconduct and is not pursuing an investigation against the doctors and scientists.

The lawsuit brings to light just how far this federal agency is willing to go to monitor and surveil its employees. The agency took snapshots of the employees’ computer screens, showing documents and emails, and stored the information.

The news of this lawsuit comes at a time when the FDA is under intense Congressional scrutiny regarding the safety of medical devices. In January 2012, House Democrats began calling for a Congressional Hearing on Johnson & Johnson’s transvaginal mesh and Allergan’s Lap Band. The FDA is under scrutiny regarding several medical products:

• Transvaginal mesh: The companies selling the medical products did not conduct pre-market or post-market safety studies, a lawful exception under the FDA’s 501(k) program. After the products were sold, many people experienced serious complications. The FDA is considering re-classifying the devices.
• DePuy Hip implants: Sold as “custom” devices to avoid safety testing. After people received the implants, they were found to have a high rate of failure.
• Lap-Band: Studies found that 1/3 of patients experience a serious complication, and 40% fail to lose weight with the device.
• Brain Stents: Used to open blocked arteries during cardiac surgery. Patients with the device were found to have twice the rate of strokes and death compared to patients without the stents.

The U.S. Congress has until October 2012 to decide whether they will authorize funding to the FDA review of medical products.

“The committee should hold hearings to examine whether FDA device regulation has been ineffective in protecting the public from dangerous medical devices like the Lap-Band and intravaginal mesh,” Democrats said in a letter to the Republicans. “We need to understand the safety of devices on the market, the tactics device manufacturers and others use to market these devices, and the extent to which these tactics may increase risks.”

How do I contact a Lawyer for a Defective Medical Device Lawsuit?

The Schmidt Firm, LLP is currently accepting medical device induced injury cases in all 50 states. If you or somebody you know has been injured or experienced a side effect caused by a medical device, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.

The FTC accuses the men of running fake news sites. When prospective customers were lured onto the sites, they appeared to be objective journalism. Some articles appeared to be written by reporters who were skeptical of the Acai weight-loss claims, but once they tried the product, they experienced miraculous weight-loss without altering their diet or lifestyle.

All six websites have since been taken off the internet.

The companies behind the marketing scheme also spent millions of dollars to buy ad space on reputable sites. When people clicked on the ads, they were taken to the company’s fake “news sites,” where interested customers could then click on commercial sites to buy the Acai weight-loss products. The supplements cost between $70-100 for a supply of diet pills.

Most of the FTC judgment against the men involved in the scheme will be suspended when the agency receives personal financial assets. Because the men violated federal law, they will be required to pay around $500,000 to the FTC. The men who agreed to settle are: Ricardo Jose Labra in Michigan; Zachary S. Graham in Minnesota; Tanner Garrett Vaughn in Washington State; Thou Lee in Minnesota; Carles Dunlevy in Pennsylvania; and Michael Volozin in New York.

The settlement will also require that if the men operate any more “news sites” in the future, they must make it clear when their commercial messages are advertisements so consumers are not misled into believing that they are reading objective journalism on the internet. The men will also be banned from making misleading claims regarding health products and the benefits of dietary supplements.

The action against the individuals involved in the “news sites” follows FTC action against Central Coast Nutraceuticals, which sold Acai berry weight-loss supplements. The company offered “free trials,” but it was nearly impossible not to pay full price once a consumer provided billing information. The Better Business Bureau was flooded with complaints from consumers who had been victims of the scam. An $80 million judgment against Central Coast was suspended when the CEO was forced to pay $1.5 million in person assets to a fund where consumers could then get a refund.

What is Acai?

Acai berries are a dark purple fruit found on a 60-foot species of palm from Central and South America. Some believe that the fruit may have beneficial health properties. However, there is no scientific evidence that the products can help a person lose weight. In fact, there is no scientific evidence linking the acai berry to any health claims, though the products are marketed to treat everything from diabetes to sexual dysfunction.

The Acai products were marketed as “Oprah’s favorite diet secret!” In 2004, there were only four Acai berry products. In 2008, the number had skyrocketed to 53. Profits from acai products exceeded $106 million in 2008. Though the berry does contain antioxidents (molecules that can slow damage caused by the oxidation of other substances in the body) there is no scientific evidence linking the products to weight loss, wrinkle reduction, detoxification, and more. Many of the advertisements claimed Oprah Winfrey and Rachel Ray advocated acai products, but the women did not endorse the advertisements.

There have only been a few small studies of the Acai berry in humans. One study involved 12 fasting volunteers who consumed one serving of Acai juice or pulp. The patients showed a short-term increase in the antioxidant capacity of the volunteers’ blood. The study only looked at the immediate effect of consuming Acai.

The 12-person sample size in the study was small, and it would be hard to make a valid long-term health claim (like weight loss or improved health) based on this short-term outcome.

How do I contact a Lawyer for an Acai Berry Consumer Fraud Lawsuit?

The Schmidt Firm, LLP is currently accepting Acai Berry consumer fraud cases in all 50 states. If you or somebody you know has been the victim of consumer fraud regarding Acai berry products, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Consumer Fraud Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.

A spokesman for the Department of Insurance would not confirm or deny that the Department was investigating surgical centers affiliated with 1-800-GET-THIN. The massive insurance company Aetna Inc. said that it was cooperating with authorities, telling the Times “Since this is an ongoing investigation, there is no additional information that I can share.”

A lawsuit was recently filed against 1-800-GET-THIN and its affiliates by more than a dozen people, including 11 patients who say they were billed exorbitantly more than was necessary. A typical Lap Band surgery should cost between $12,000 and $20,000. One woman in the lawsuit says she was charged more than $179,000 for her procedure, which she says also included “medically unnecessary” procedures. Some patients say they underwent surgery for gallbladder removal, X-rays, and “sleep studies.”

The insurer Aetna Inc. said that it was cooperating with the California Department of Insurance law enforcement branch, as it “investigates alleged fraud against our members by the 1-800-GET-THIN … surgery centers.” The law enforcement branch of the Department has the power to make arrests and pursue criminal charges.

The Los Angeles County Coroner is also investigating the death of Paula Rojeski, an Orange County woman who died during Lap Band surgery at a center affiliated with 1-800-GET-THIN. The lawsuit against the company alleges that employees were instructed to cover up important evidence in the case to prevent law enforcement from investigating circumstances that contributed to Ms. Rojeski’s death.

The U.S. Food and Drug Administration (FDA) has also recently sent warning letters to eight surgical centers affiliated with 1-800-GET-THIN, saying that the advertising campaign is “misleading” and minimizes the risks of Lap Band surgery. In response to the FDA, the president of 1-800-GET-THIN, Robert Silverman, appeared before the L.A. County Supervisors to assure them that he would comply with the FDA’s instructions. Since that meeting, the company has placed a warning on its website that Lap Band surgery can cause death. Silverman told the supervisors “We are currently reviewing the television advertisements, the radio advertisements, and the billboards, as well as how we can develop even more substantial disclosures to comply with the FDA.”

The Lap Band is a silicone ring that is surgically implanted around a obese person’s upper stomach, intended to discourage eating and promote weight-loss. The device creates a small “pouch” in the upper stomach, and a person can only eat small amounts of food at a time, or they risk stretching the stomach. Many are concerned about the safety and efficacy of these products, after 10-year research found that one out of three patients experience a major complication, 40% of patients fail to lose weight, and results worsen over time.

How do I contact a Lawyer for a Lap Band Lawsuit?

The Schmidt Firm, LLP is currently accepting Lap Band side effect cases in all 50 states. If you or somebody you know has suffered a side effect or complication after Lap Band surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Lap Band Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.

By law (the Dietary Supplement Health and Education Act of 1994 (DSHEA)) dietary supplements that contain established ingredients can be sold in the U.S. without submitting and pre-market safety information to the FDA or proving that are effective.

Any ingredient that was not sold before 1994 is considered a new ingredient. After 1994, manufacturers of new ingredients in dietary supplements must submit data to the FDA supporting a “reasonable expectation of safety.”

Unfortunately, the FDA has had a very hard time enforcing this requirement:

• Since DSHEA passed in 1994, the number of dietary supplements has increased from 4,000 to 55,000. Yet although there are more than 50,000 new products, the FDA has received only 170 notifications of “new ingredients” since 1994 — potentially, thousands of dietary supplements are being sold in the U.S. without undergoing even preliminary safety testing of “new ingredients”

In the 18 years since DSHEA passed, it is unlikely that there have actually been just 170 new ingredients.

In response to this situation, in July 2011, the FDA has proposed new guidelines that would clarify what constitutes a “new ingredient” and what safety information manufacturers would be required to submit.

The proposed changes would clarify the level of evidence that a manufacturer of dietary supplements would need to submit to the FDA so the agency could determine whether the supplement is safe. Safety would be evaluated based on three factors:

• Documented history of use (if the ingredient has a long history of use in foods, supplements, or herbal medicine)
• Formulation and proposed daily dose (if the proposed dose exceeds historical ingestion rates, the FDA would require safety testing)
• Recommended duration of use

Dr. Pieter Cohen argues that the FDA’s proposed guidelines are inadequate.

The easiest way a manufacturer could avoid expensive clinical studies is to claim that the product has a “documented history of use.”

Sometimes, dietary supplement manufacturers claim that their products are safe because the ingredients have a “history of use,” but the actual product formulates the ingredient in a new way. For example, sometimes manufacturers make a synthetic replica of a botanical compound and then claim that their product is “herbal.” For example, DMAA, a synthetic chemical that was labeled as “geranium extract,” sold as a dietary supplement, and linked to heart attacks and several deaths.

Instead of conducting clinical trials, manufacturers can use historical data to claim a supplement is safe. Cohen argues that simply because an ingredient has been used in the past does not necessarily guarantee its long-term safety, and scientific studies should be required instead. Under the guidelines, not even a single-dose tolerability study would be required to introduce a new ingredient.

Furthermore, even if the manufacturers conduct safety studies, the FDA guidelines do not require a manufacturer to submit all safety data. The manufacturer could cherry-pick study information that favors its product.

Even so, dietary supplement industry advocates say that the FDA’s proposed guidelines go too far in their regulation. They say that requiring scientific evidence of safety undermines DSHEA, which grants dietary supplements exceptional status. The safety requirement of a dietary supplement is far lower than for food additives. The industry advocates say the new regulations violate this law by elevating the status to the level of food additives. Cohen argues that the industry’s argument is invalid, because the FDA has an established legal authority over new ingredients that is higher than its authority over established ingredients.

More than 100 million people in the U.S. spend $28 billion on “dietary supplements” — products that include vitamins, minerals, herbal ingredients, and other products. They assume that they are both safe and effective. In reality, according to Cohen, they cannot be assured that products are safe because the FDA’s regulations are too weak.

Do I have a Dietary Supplement Lawsuit?

The Schmidt Firm, LLP is currently accepting Dietary Supplement induced injury cases in all 50 states. If you or somebody you know has experienced a side effect after taking a Dietary Supplement, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Dietary Supplement Lawsuit Group or call toll free 24 hours a day at (866) 920-0753.

Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.

The whistle-blower suit brings some serious accusations against 1-800-GET-THIN, LLC and the people involved in its conduct, particularly Julian and Michael Omidi, two ex-doctors reputedly behind the operation. The lawsuit is brought by Dyanne Deuel, a former manager at surgery centers affiliated with 1-800-GET-THIN, and Karla Osorio, a surgical technician.

The whistle-blower lawsuit accuses the Omidi brothers and 1-800-GET-THIN of the following actions:

• Employing commission-based illegal immigrants to staff the 1-800-GET-THIN call center, who then refer patients to one of the Omidi’s surgical centers
• Submitting fraudulent billings to patients’ health insurance
• Unsanitary and substandard surgical facilities
• Staff were instructed by the Omidis to perform medically unnecessary surgical procedures in order to increase the billing to patients’ health insurance
• They do not properly sterilize medical equipment
• They do not stock medications or equipment to handle a life-threatening medical emergency
• Staff are required to perform procedures that they are not qualified to perform
• When patients have died, they have covered up the evidence to prevent investigations by public health authorities and law enforcement, including falsifying medical records, removing malfunctioning medical equipment, and concealing information from inspectors

Some of these allegations have evidence in public records. Inspectors from the Department of Public Health documented unsanitary conditions at the centers, following an unannounced visit to a Beverly Hills facility in May 2009. Although the agency filled 22 pages with health and safety violations, they did not shut down the facility. Furthermore, they never again conducted an unannounced inspection of the facility, or any other facilities under the Omidis’ control or management.

The whistleblower suit also says that staff at the facilities regularly perform medical duties beyond their training or licensing. In 2007, the Medical Board of California accused Michael Omidi of allowing unlicensed employees to perform liposuction and suture patients. However, the Board did not revoke his medical license — instead, they placed him on a 3-year probation.

At least five patients have died in surgical centers affiliated with the 1-800-GET-THIN campaign since 2009. If you or someone you know has been injured because of weight-loss surgery, you may be entitled to compensation for your injuries if you file a Lap Band lawsuit or a 1-800-GET-THIN lawsuit.

How do I contact a Lawyer for a 1-800-GET-THIN Lawsuit?

The Schmidt Firm, LLP is currently accepting 1-800-GET-THIN injury cases in all 50 states. If you or somebody you know has been injured by Lap Band surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Lap Band Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.