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.

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.

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 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 Yaz or Yasmin Lawsuit Can Help

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

What is the Problem?

Yaz and Yasmin belong to a new class of birth control pills that contain one controversial ingredient: drospirenone, a new synthetic chemical that mimics the female sex hormone progestin. Older types of birth control pills contain levonorgestrel, which is also a synthetic form of progestin. All birth control pills that contain progestin increase a woman’s risk of developing a blood clot. With levonorgestrel, the risk was approximately 6 per 10,000 women who took the pills. With drospirenone, the risk increased to approximately 10 per 10,000 women. Though, numerically, the risk is still very small, millions and millions of women use these medications every day to prevent pregnancy. A slightly increased risk translates to tens of thousands more women who suffered from blood clots. Many have died.

Blood clots often form in the large vessels in the legs or arms. Usually, they resolve on their own and cause no problems or symptoms. Sometimes, however, a blood clot breaks loose (called an “embolism”), traveling through the body. If it becomes trapped in an internal organ, it can cause death or permanent disability very quickly. Bloods clots trapped in the heart, brain, or lungs can cause heart attacks, strokes, and pulmonary embolisms.

FDA Reviews Safety of Yaz and Yasmin

Former FDA commissioner Dr. David A. Kessler is now working for Yaz lawyers who are suing Bayer. They accuse the drug-company of concealing safety information from the FDA during the approval process. The lawsuits against Bayer accuse the company of selectively presenting data regarding blood clots, leading Kessler and the FDA to approve the drug on incomplete safety data. Kessler maintains that if he had been aware of the safety data, he would have asked Bayer to conduct further safety research.

Bayer, the company responsible for Yaz and Yasmin, maintains that the medications are safe and effective.

However, some independent experts find it noteworthy that the studies funded by Bayer have shown no difference in risk for women taking Bayer’s drug, whereas all four of the independent studies have found an increased risk.

”Misleading” Advertising Campaign

When Yaz and Yasmin were launched a decade ago, they were popularly advertised as “miracle drugs” that could treat PMS, acne, and prevent pregnancy. Yaz sales skyrocketed to approximately $2 billion per year after it was released in 2006. The FDA, however, quickly sent Bayer warning letters stating that the claims were “misleadingly overstated.”

Partly due to the massive advertising campaign, millions of women believed that the new birth control pills were superior to the older pills, and they chose to switch to the new pills. Unfortunately, scientific data painted a different picture: Yaz and Yasmin were equally effective at preventing pregnancy as birth control pills already on the market, but they had a slightly higher risk of serious, life-threatening side effects.

Bayer denied that it had done anything wrong during its advertising campaign for Yaz and Yasmin. However, they agreed to pay $20 million to run a corrective advertising campaign with television advertisements. The Yaz ads clarified that the medication had only been approved by the FDA for treating mild acne and the symptoms of Premenstrual Dysphoric Disorder (PMDD), a severe mood disorder that accompanies some women’s menstrual cycles.

By the time the advertising campaign ran, however, millions of women had been taking Yaz and Yasmin.

FDA Meeting to Discuss Safety

In December 2011, an FDA panel met to discuss the Yaz and Yasmin safety information that had recently emerged. One panel voted 21-5 that the safety labeling information needed to be updated to include information about the increased risk of developing a blood clot. Another panel voted 15-11 that the benefits of Yaz and Yasmin remained a “beneficial” option for preventing pregnancy.

It was later discovered that several members of the panel that voted that Yaz and Yasmin were “beneficial” had ties to Bayer. Some of these members had conducted research for Bayer or its affiliated companies, or had directly received thousands of dollars in payments from the drug-company.

Officials at the FDA determined that there was no “conflict of interest” in allowing experts to vote on the panel who had been paid or employed by companies involved in the production of Yaz and Yasmin.

Do I have a Yaz Lawsuit?

The Schmidt Firm, LLP is currently accepting Yaz induced injury cases in all 50 states. If you or somebody you know has experienced a side effect after taking Yaz, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Yaz 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.

Researchers from the University of Bern in Switzerland looked at more than 31 clinical trials that involved 116,429 patients, all of whom had been taking painkillers. The researchers looked at seven commonly-used painkilling medications.

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are some of the most commonly-used medications for the treatment of pain, reduction of fever, and the treatment of mild to moderate pain. These medications include ibuprofen, naproxen, aspirin, and more.

• Ibuprofen, an NSAID painkilling medication, was shown to increase the risk of stroke by three times. It also significantly increased the risk of heart attacks and death.
• Rhumalgan (diclofenac), an arthritis medication, was shown to almost triple the risk of stroke and increased the risk of death caused by heart disease by a four-fold rate

The researchers looked at people who were taking a painkiller three or four times per day, at relatively high doses. People at high risk of heart attack, stroke, and death took doses of the medications up to 2,000 mg per day, every day, for several months or even years.

Most people are at minimal risk, because they only take the medications at high doses for short periods of time to treat acute pain. People with chronic pain, however, may he at higher risk of suffering problems.

The most common users of high-dose long-term painkillers were people who suffered from rheumatoid arthritis and osteoarthritis, which are inflammatory diseases that affect the delicate tissue between the joints in a person’s body. These conditions can be extremely painful, and many people take an NSAID to treat the inflammatory, painful symptoms of these diseases.

People who take a painkiller for arthritis or osteoarthritis tend to be in their later years. A stroke, heart attack, or other heart problem can be devastating and disabling for an older person.

How do I contact a Lawyer for a Drug Side Effect Lawsuit?

The Schmidt Firm, LLP is currently accepting medication induced injury cases in all 50 states. If you or somebody you know has experienced a side effect after taking a medication, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Drug Side Effect 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 Prozac PPHN Lawsuit Can Help

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

Prozac Overview

Prozac (fluoxetine) is a medication most often used in the treatment of depression, obsessive-compulsive disorder, some eating disorders, and panic attacks. There are also many off-label uses for the medication, including treatment of alcoholism, sleep disorders, Tourette’s syndrome, and more. It belongs to a class of medications called Selective Serotonin Reuptake Inhibitors (SSRIs) that make a person’s brain release extra serotonin, a chemical in the brain essential for balanced moods.

Prozac and PPHN

A recent study published in the British Medical Journal found that women who took antidepressants such as Prozac during the second half of pregnancy were about twice as likely to have a baby with Persistent Pulmonary Hypertension of the Newborn (PPHN).

The researchers analyzed data from 1.6 million births in five countries (Denmark, Finland, Iceland, Norway, and Sweden) between 1996 and 2007. The researchers found that 11,000 of the mothers took antidepressants late in pregnancy, and 17,000 took the medications early in pregnancy.

For the women taking antidepressants late in pregnancy, 33 babies were born with PPHN (0.2%), or about 3 per 1,000 live births. This is more than double the background risk of 1-2 babies who develop PPHN at birth.

In 2006, the FDA found that infants born to mothers who took SSRIs after the 20th week of pregnancy were six times more likely to have a baby with PPHN compared with mothers who did not take antidepressants during pregnancy. The background risk is estimated to be 1-2 infants with PPHN per 1,000 live births.

The FDA cautions that since the 2006 study was concluded, several new studies of the link between SSRI antidepressant use during pregnancy and PPHN have been inconclusive. The agency decided to update the safety labels of Prozac and other SSRI antidepressants to reflect the new data and the conflicting results.

What is PPHN?

Persistent Pulmonary Hypertension of the Newborn (PPHN) is a rare but serious complication of birth that is more likely to occur when pregnant mothers took Prozac or other SSRI antidepressants during pregnancy.

PPHN is a problem that occurs with a baby’s circulation system at birth, when it must transition from an oxygen-dependent state inside the mother to an oxygen-independent state outside the womb. Normally, while the baby is developing in the womb, the mother’s placenta supplies the baby with oxygenated blood. This blood actually bypasses the unborn baby’s lungs through a hole in the heart called the Patent Ductus Arteriosus (PDA), which closes shortly after birth. Just before a baby is born, the pressure in the baby’s lungs drops significantly, and blood floods the baby’s lungs. When it takes its first breath, the oxygen reaches a large amount of blood in the lungs, and the baby starts to supply its own oxygen. When a baby is born with PPHN, however, the pressure in the lungs remains persistently high. Consequently, very little blood flows into the lungs. When the baby takes its first breath, oxygen comes in contact with very little blood, and the baby is unable to supply its own oxygen. As a result, the infant becomes oxygen-deprived. PPHN is a life-threatening condition that can cause death. Between 5% and 10% of babies born with PPHN do not survive.

What are SSRI antidepressants?

The researchers found that Prozac was not the only SSRI antidepressant linked to PPHN. Several types of antidepressant medications, including Prozac, have been linked to an increased risk of having a baby with PPHN. These medications include:

• Paxil, Seroxat (paroxetine)
• Zoloft, Lustral (sertraline)
• Celexa (citalopram)
• Lexapro, Cipralex (escitalopram)
• Symbyax (fluxetine and olanzapine)
• Wellbutrin, Zyban (bupropion)
• Effexor (vanlafaxine)

If you have taken any SSRI antidepressant and you had a baby with PPHN, you may have a Prozac PPHN lawsuit and be entitled to compensation for injury to you and your child.

Do I have a Prozac PPHN Lawsuit?

The Schmidt Firm, LLP is currently accepting Prozac induced injury cases in all 50 states. If you or somebody you know has had a child with PPHN after taking Prozac, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Prozac PPHN 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 Tysabri Lawsuit Can Help

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

FDA Drug Safety Communication

The U.S. Food and Drug Administration has issued a new Drug Safety Communication to inform the public that they have identified a way to determine whether Tysabri patients are at higher risk of developing Progressive Multifocal Leukoencephalopathy (PML), a rare but serious type of brain infection.

What is PML? PML occurs in the part of the brain called the “myelin,” which covers and protects nerves in the white matter. The myelin is a layer of protein and fatty matter that helps nerve impulses travel quickly and efficiently in the brain. PML is caused by a virus that attacks the myelin, and can quickly cause severe damage to the central nervous system, disability, and death.

Researchers already suspected that a risk factor for PML was the John Cunningham (JC) virus, which is thought to be latent and harmless in 40-80% of the adult U.S. population. It can be reactivated when patients take certain medications, including Tysabri. It often causes problems for people with weakened immune systems. Once a patient develops PML, there is no way to cure the infection.

The link between Tysabri and PML was well-known. Tysabri weakens a person’s immune system, making them more susceptible to PML and other infections. Because of the risk of PML, Tysabri was pulled off the market in 2005, and then re-introduced in 2006 with new warnings. Meanwhile, the drug-company kept public records about the rate of PML, and funded research to screen patients who have a latent JC virus.

The drug-company recently gained FDA-approval for a diagnostic test that can identify people who have a latent JC virus and would be at a higher risk of developing PML if they took Tysabri. The test is called the Stratify JCV Antibody ELISA test.

The FDA also announced updates to the safety labeling for Tysabri that will include information that testing positive for the JC virus has been identified as a risk factor for developing PML.

Risk Factors for PML

The FDA identified three risk factors that increase a person’s risk of developing PML. Patients with all three risk factors have an estimated risk of 11/1,000 for developing PML.

• The presence of anti-JC virus antibodies, which can now be tested for using a blood test
• Longer Tysabri treatment, especially more than 2 years.
• Prior treatment with an immunosuppressant medication (for example: mitoxantrone, azathioprine, methotrexate, cyclophosphamide, or mycophenolate mofetil)

Tysabri Overview

Tysabri (natalizumab) is a medication used to treat people with multiple sclerosis or Crohn’s disease. It belongs to a class of medications called “immunomodulators,” which works by preventing certain immune cells from causing damage to a person’s nerves and spinal cord.

Multiple sclerosis (MS) is a disease in which nerves in the body degenerate over time. People with MS may experience weakness, numbness, gradual loss of muscle control, incontinence, and problems with speech and vision. Tysabri is used in patients who experience “flare-ups” of symptoms, and it is used to prevent these episodes. It is also used to slow the worsening of disability.

Crohn’s Disease is a condition in which the body’s immune system attacks the lining of a person’s intestinal tract. It causes pain, diarrhea, weight loss, and fever. It is caused by an over-reaction of a person’s immune system, in which the body can’t tell the difference between normal tissue and foreign substances. As a result, a person with Crohn’s disease suffers from chronic inflammation. Crohn’s disease may affect the small intestine, large intestine, rectum, or mouth.

Do I have a Tysabri Lawsuit?

The Schmidt Firm, LLP is currently accepting Tysabri induced injury cases in all 50 states. If you or somebody you know has experienced a brain infection, PML, or other serious side effect after taking Tysabri, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Tysabri 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.