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FDA challenges marketing of DMAA products for lack of safety evidence

Paris — Wed, 16 May 2012 14:44:45 +0000

The U.S. Food and Drug Administration has issued warning letters to at least ten manufacturers and distributors of dietary supplements containing dimethylamylamine, more popularly known as DMAA, for marketing products for which evidence of the safety of the product had not been submitted to the FDA. Also referred to as dimethylamylamine, methylhexanamine, or geranium extract, the ingredient is in dietary supplements and is often touted as a “natural” stimulant. Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that and that makes the products adulterated. Specifically, the warning letters cite the companies for marketing products for which a notification had not been submitted for the use of DMAA as a New Dietary Ingredient (NDI). Under current law, dietary supplement manufacturers or distributors who use certain dietary ingredients not marketed in a dietary supplement prior to October 15, 1994, are responsible for notifying the FDA of evidence to support their conclusion that their dietary supplements containing NDIs are safe. Manufacturers or distributors must submit notification at least 75 days before marketing their products. The companies warned were marketing products for which this requirement had not been met. The FDA warning letters also advised the companies that the agency is not aware of evidence or history of use to indicate that DMAA is safe. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers, marketers and distributors of dietary supplements are responsible for ensuring that they are marketing a safe product. The FDA letters noted that DMAA is known to narrow the blood vessels and arteries, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath and tightening in the chest to heart attack. The agency has received 42 adverse event reports on products containing DMAA. While the complaints do not establish that DMAA was the cause of the incidents, some of the reports have included cardiac disorders, nervous system disorders, psychiatric disorders, and death. The agency additionally warned the companies that synthetically-produced DMAA is not a “dietary ingredient” and, therefore, is not eligible to be used as an active ingredient in a dietary supplement. The companies have a limited amount of time to respond to the FDA with the specific steps they will take to address the issues in the warning letters.

Some of the companies who were issued warnings include:

Exclusive Supplements – Product: Biorhythm SSIN Juice

Fahrenheit Nutrition – Product: Lean Flex

Gaspari Nutrition – Product: Spirodex

iSatori Global Technologies – Product: PWR

Muscle Warfare – Product: Napalm

Muscle Meds Performance Technologies – Product: Code Red

Nutrex Research – Products: HemoRage Black and Lipo- 6

SEI Pharmaceuticals – Products: MethylHex

SNI LLC – Product: Nitric Blast

USP Labs, LLC – Products: Oxy Elite Pro and Jack 3D

The attorneys at Balkan & Patterson, LLP are experienced in class action litigation and will act to protect consumers against corporate wrongdoers. If you believe you have potential for a class action involving DMAA or a similar product, please contact us immediately and we will review your case at no charge.

The law firm of Balkan & Patterson, LLP was founded in 2006 and is headquartered in Boca Raton, Florida, at 601 S. Federal Highway, Suite 302, with offices in Broward County. Mr. Balkan and Mr. Patterson can be contacted at (561) 750-9191. Additional information about Balkan & Patterson, LLP may be obtained from the firm’s website at www.balkanpatterson.com.

Balkan & Patterson Files Suit Against School Board of Lee County for Abuse of Special Needs Student

chrissy — Wed, 01 Feb 2012 01:43:12 +0000

The personal injury and abuse law firm of Balkan & Patterson filed a lawsuit this week against the School Board of Lee County on behalf of a family whose child was abused by his kindergarten teacher at Gulf Elementary School.

The child, whose name and age are withheld to maintain privacy, is a low functioning, non-verbal special needs students with very limited abilities to communicate with his parents or the outside world. While a student in the classroom of Catherine Hile, his teacher, she subjected him to physical violence and abuse. Hile’s actions were seen by a number of teachers’ aids, who reported the abuse to the school’s administration.

“The school had a responsibility to our clients and their child, which was to provide him with a safe, healthy environment in which to learn,” said attorney Adam Balkan. “However, this child, who is virtually helpless against the abuses he suffered, received nothing but inadequate care and was subjected to physical violence over an extended period of time.”

Despite the fact that the school board was aware of Hile’s actions, she remained in her classroom where she continued to abuse our client. It was not until the end of the school year that she was removed from her position. She had a prior history of violence toward students in other schools, and the School Board of Lee County failed to properly evaluate their teachers, provide sufficient training and an appropriate level of supervision.

“In addition to failing to take action to put an end to the mistreatment of our minor client, the school board has a duty to fully investigate the backgrounds of their employees to ensure they are qualified to work with special needs students. This did not happen with Ms. Hile,” Mr. Balkan said.

The attorneys of Balkan & Patterson have filed suit in the United State District Court, Middle District of Florida, Fort Myers Division. Mr. Balkan is a board certified civil trial lawyer and a partner in the law firm of Balkan & Patterson, LLP. The firm was founded in 2006 and is headquartered in Boca Raton, Florida, at 601 S. Federal Highway, Suite 302. Mr. Balkan can be contacted at (561) 750-9191. Additional information about Balkan & Patterson, LLP may be obtained from the firm’s website at www.balkanpatterson.com.

FDA Classifies Voluntary Physician Advisory Letter on Riata and Riata ST Silicone Defibrillation Leads as Class I Recall

Paris — Fri, 16 Dec 2011 15:35:57 +0000

St. Jude Medical, Inc., a global medical device company, recently announced that the U.S. Food and Drug Administration (FDA) has sent its voluntary medical device advisory letter to physicians instituting a Class I Recall regarding the performance of Riata and Riata ST Silicone Defibrillation Leads. The classification of this recall is part of the process that follows any medical device advisory issued by a device manufacturer to physicians. An estimated 79,000 Riata and Riata ST family of silicone leads remain active in patients in the U.S. The company stopped distributing the Riata and Riata ST family of silicone leads in December, 2010. The FDA has classified this recall as a Class I recall because of the potential risk of serious injury or patient death if affected devices malfunction. The clinical implications of externalized conductors in a defibrillation lead without electrical anomalies are not fully known or understood at this time. Externalized conductors can present as only a visual observation on x-ray or fluoroscopy without any associated clinical or device-related observations. If the electrical intergrity of a lead were to be compromised, failure to deliver appropriate therapy, or the delivery of inappropriate therapy, could potentially occur, and could lead to a serious adverse event or death. Reports to St. Jude Medical associated with extraction of a Riata lead with externalized conductors include two patient deaths and one serious injury (effusion requiring thoracotomy). In addition, one patient death and one serious injury in patients with externalized conductors were reported, but were determined not to be due to the presence of externalized conductors. The attorneys at Balkan & Patterson, LLP are experienced in class action litigation and will act to protect consumers against corporate wrongdoers. If you believe you have potential for a class action in relation to the performance of Riata and Riata ST Silicone Defibrillation Leads, please contact us immediately and we will review your case at no charge.

Toy Safety: Smart Shopping Can Protect Your Children from Dangerous, Unsafe Products

chrissy — Thu, 01 Dec 2011 03:03:28 +0000

The holidays bring a new collection of toys into South Florida’s homes each season, and it is vital for parents to ensure that these toys are safe for our children. In the last year, more than 250,000 children went to the emergency room on account of toy-related injuries, and, as always, the best medicine is prevention.

While shopping for children’s toys, there are several steps parents can take to avoid these injuries that include lead poisoning, strangulation and choking. Buying toys that are age-appropriate is the first step to avoiding problems.

Age 3 & Under

Children under 3 tend to put everything in their mouths. Avoid buying toys intended for older children that may have small parts that pose a choking danger.
Never let children of any age play with uninflated or broken balloons because they could choke on the material.
Avoid marbles, balls, and games with balls, that have a diameter of 1.75 inches or less, as they are a choking hazard to young children.
Children at this age pull, prod and twist toys. Look for toys that are well-made with tightly secured eyes, noses and other parts.
Avoid toys that have sharp edges and points.

Ages 3 through 5

Avoid toys that are constructed with thin, brittle plastic that might easily break into small pieces or leave jagged edges.
Look for household art materials, including crayons and paint sets, marked with the designation “ASTM D-4236.” This means the product has been reviewed by a toxicologist and, if necessary, labeled with cautionary information.
Teach older children to keep their toys away from their younger brothers and sisters.

Ages 6 through 12

For all children, adults should check toys periodically for breakage and potential hazards. Damaged or dangerous toys should be repaired or thrown away.
If buying a toy gun, be sure the barrel, or the entire gun, is brightly colored so that it’s not mistaken for a real gun.
If you buy a bicycle for any age child, buy a helmet too, and make sure the child wears it.

Additional information on toy safety can be found online through the CPSC website.
The law firm of Balkan & Patterson is experienced in dealing with dangerous products and subsequent injuries. As part of the litigation team of a class action lawsuit against Mattel, the attorneys of Balkan & Patterson recognize the lack of oversight in children’s toys and are ardent advocates for increased safety regulations and standards.

For additional information, please contact us at www.balkanpatterson.com or call (561) 750-9191.

Citigroup to Pay $300M to Settle Mortgage Case

Paris — Wed, 30 Nov 2011 19:37:40 +0000

Citigroup has agreed to pay nearly $300 million to settle a civil fraud complaint alleging that the banking giant promoted an investment tied to the housing market, yet failed to tell investors it was betting those securities would fail. The Securities and Exhchange Commission (SEC) claims that Citigroup packed the $1 billion investment with assets that buckled during the mortgage meltdown. Citi traders then bet against the security, or shorted it, eventually making money at the expense of its clients, the complaint says. One trader wrote in an email obtained as part of the SEC investigation that the Citi investments were possibly “the best short EVER!” Robert Kuzami, director of the SEC’s enforcement division, said that “Investors were not informed that Citigroup had decided to bet against them and had helped choose the assets that would determine who won or lost.” The settlement is the latest in a number of regulatory actions against banks for their role during the housing market collapse and ensuing financial crisis. The SEC has been investigating how Wall Street firms packaged risky mortgages into instruments such as collateralized debt obligations and other investments, which imploded when housing markets tumbled. Compared with Goldman Sachs, which agreed to pay $550 million to settle a mortgage-related securities case, the SEC said that Citi was more integrally involved in the alleged wrongdoing. Citi employees designed the security, marketed it to investors and made $160 million betting against it. In a statement, Citi acknowledged that it made money from the securities but claimed that it had lost money on other collateralized debt obligations, debts that nearly helped bring Citi down as the crisis reached its heights in 2008. The attorneys at Balkan & Patterson, LLP are experienced in class action litigation and will act to protect consumers against corporate wrongdoers. If you believe you have potential for a class action, please contact us immediately and we will review your case at no charge.

Consumers Fight Against ATM Fees

Paris — Mon, 21 Nov 2011 15:59:30 +0000

Consumers are sending the message that they are fed-up with ATM Fees. Three anti-trust class action lawsuits have been filed recently which allege that companies such as Visa, MasterCard, Bank of America, J.P. Morgan Chase and Wells Fargo are unfairly “fixing” prices against both consumers and independent ATM providers. In the most recent suit filed in New Jersey, a class action is proposed against the top providers of automated teller machine (ATM) services for orchestrating, implementing and facilitating a conspiracy to fix the prices for ATM access fees. All three lawsuits have been filed in the District of Columbia and generally claim that the largest ATM providers and other financial institutions are unfairly restricting market movement by preventing ATMs from charging different fees to consumers based on their type of debit card. In addition, over 50,000 people have joined an online group saying they will leave banks for what they say are unfavorable practices, such as Bank of America’s planned $5 debit card fee. The attorneys at Balkan & Patterson, LLP are experienced in class action litigation and will act to protect consumers against corporate wrongdoers. If you believe you have potential for a class action, please contact us immediately and we will review your case at no charge.

General Mills Faces Deceptive Advertising Lawsuit for Fruit Snacks

Paris — Fri, 18 Nov 2011 15:18:32 +0000

The Center for Science in the Public Interest (CSPI) has filed a class action lawsuit in California charing General Mills with misleading consumers about the nutrition and health qualities of its fruit snacks. The lawsuit alleges that General Mills is giving consumers the false impression that their fruit snacks are somehow more wholesome, and charging more for these products. It is alleged to be an elaborate hoax on parents who are trying to do right by their kids. General Mills is accused of basically dressing up a very cheap candy as if it were a fruit and charging a premium for it. In its complaint, CSPI asserts that the labeling on the packages for General Mills products (including Fruit Roll Ups, Fruit by the Foot, and Fruit Gushers) imply that the food is a lot healthier than it really is. Fruit snacks are labeled as “fruit flavored snack,” “naturally flavored, a “good source of Vitamin C,” a low number of calories, ”low fat” and “gluten free,” when, in fact, these fruit snacks contain trans fat, added sugars, artifical food dyes and lack significant amounts of real, natural fruit. The lawsuit cites several California laws governing misleading and deceptive advertising and fraudulent business practices. The attorneys at Balkan & Patterson, LLP are experienced in class action litigation and will act to protect consumers against corporate wrongdoers. If you believe you have potential for a class action, please contact us immediately and we will review your case at no charge.

Democratic Lawmakers Seek Antitrust Probe of Bank of America’s Debit Card Fees

Paris — Wed, 16 Nov 2011 16:03:12 +0000

Democratic lawmakers have asked the Justice Department to investigate whether Bank of America and other major banks improperly worked together to charge customers new monthly fees for using their debit cards. Rep. Peter Welch, D-Vt., and four other Democrats said recently that they asked Attorney General Eric Holder to see if big banks violated antitrust laws before announcing the fees. Welch said the lawmakers have no evidence of collusion. However, the timing of the fees and the statements made by some of the banks raise questions of coordination and merits further investigation. Bank of America announced that it would charge its customers $5 per month if they use their debit cards for purchases. Customers who use their cards only at ATMs will not have to pay the fee. Chase and Wells Fargo are also testing $3 monthly debit-card fees in select markets. The fees have sparked public outrage and helped fuel anti-Wall Street protests. Many have criticized the banks for charging to use debit cards after those same banks received hundreds of billions of dollars in taxpayer-funded bailouts. Bank of America, Chase and Wells Fargo were among the recepients of rescue funds. Bank of America will begin charging the fee early next year. Chase and Wells Fargo haven’t said when they will make a final decision on whether to roll-out the debit card fee more broadly. The attorneys at Balkan & Patterson, LLP are experienced in class action litigation and will act to protect consumers against corporate wrongdoers. If you believe you have potential for a class action, please contact us immediately and we will review your case at no charge.

Quaker Oats Must Face Deceptive Advertising Class Action Lawsuit

Paris — Tue, 15 Nov 2011 17:46:45 +0000

A federal judge has ruled that Quaker Oats Company must face a class action lawsuit filed in Illinois that claims that Quaker lured consumers into paying top-dollar prices for its “wholesome heart-healthy” oatmeal and granola products, when in reality the products contain unhealthy trans fats. According to the Quaker Oats class action lawsuit, Quaker has engaged in a marketing campain to mislead consumers about the nutritional and health qualities of its products since 2006. Specifically, Quaker states on its packages that its products contain “O grams trans fat,” are “wholesome” and “heart healthy,” and constitute nutritious “smart choices made easy.” These descriptions are misleading, says the Quaker class action lawsuit, because in reality the products contain highly unhealthy, unwholesome artifical trans fat and the lawsuit cites studies finding that dietary trans fats contribute to heart disease, diabetes and cancer. Quaker tried to dismiss the class action lawsuit on the grounds that its products contained “insignificant levels of trans fats,” rendering the Plaintiff’s claims for injury as hypothetical and not a real injury. The court disagreed, ruling that ”regardless of whether the Plaintiff was physicially harmed by the products he consumed, the complaint alleges that he would not have purchased them absent the allegedly misleading statements that the products did not contain trans fats. The attorneys at Balkan & Patterson, LLP are experienced in class action litigation and will act to protect consumers against corporate wrongdoers. If you believe you have potential for a class action, please contact us immediately and we will review your case at no charge.

Lawsuit Claims Bayer HealthCare and Merial Limited Make False Claims For Flea and Tick Products

Paris — Tue, 08 Nov 2011 19:40:50 +0000

A class action lawsuit in Ohio has been filed on behalf of dog and cat owners alleging, among other things, that Bayer HealthCare, LLC, and Merial Limited regularly make false and deceptive claims in advertisements for their flea and tick pet products. Bayer is the manufacturer of the family products made for dogs and cats under the trade names Advantage and Advantage II. Merial is the manufacturer of the family of products made for dogs and cats under the trade names Frontline and Frontline Plus. These products are sold as treatments for dogs and cats suffering with fleas, ticks, adult flea eggs, larvae, mosquito, heartworm, ear mites, and sarcoptic mange. While each one of the individual products targets only a limited subset of the pet aliments, all of the products target fleas and their larvae. The lawsuit alleges that Bayer and Merial collectively sell approximately $2 billion of these products annually under the allegedly false and/or misleading assertions claiming that the products: are self-dispersing and cover the entire surface area of the dog or cat’s body when applied in a single limited spot; are effective for one month and require monthly application to continue to be effective; do not enter the blood stream of the pet and instead move across the pet’s skin to cover the pet; and are waterproof and remain effective following shampoo treatments, swimming, or after exposure to rain or sunlight. The suit seeks to prevent Bayer and Merial from continuing to allegedly misrepresent these products and seeks to recover damages on behalf of all those who purchased the products. The attorneys at Balkan & Patterson, LLP are experienced in class action litigation and will act to protect consumers against corporate wrongdoers. If you believe you have potential for a class action, please contact us immediately and we will review your case at no charge.