Class Action Blog : Consumer Fraud, Consumer Protection, Securities and Antitrust Lawyer & Attorney : Meiselman, Denlea, Packman, Carton & Eberz

U.S. health regulators are considering tougher standards for home glucose monitors.  Home glucose monitors are used by diabetics, as well as people with hypoglycemia to keep tabs on the level of glucose in the blood.  According to a report in The New York Times, the use of home glucose meters is on the rise, even in hospitals.  Current international standards for the devices allow them to be inaccurate by as much as 20 percent, the Times said.  This can lead to serious health problems, including seizure and coma.

A government study comparing tests from five different popular home glucose monitors found results varied by as much as 32 percent. What’s more, the accuracy of the devices can be affected if people are taking drugs like Tylenol, the Times said.

In a May letter to the FDA, the American Association of Clinical Endocrinologists wrote that home glucose monitor technology is not up to par.  One concern is that hospitals are switching to home meters in an effort to cut cost, and a former president of the group told The New York Times that no one knows how many hospital deaths may be related to the accuracy of home glucose meters, but said such deaths probably are not rare.

“Because of the highly variable quality of the meters and the glucose testing strips in widespread use, the safety of our patients who depend upon those meters is threatened,” the Associations’ letter said.  In response, the FDA acknowledged that it receives reports of several deaths and thousands of device-related failures associated with home glucose monitors every year.  The agency said it had contacted the International Standards Organization, which sets the parameters for home glucose monitors, asking that the accuracy standards for the devices be revised.

If you suffered a serious injury because of a defective home glucose monitor, or know someone who has died as a result of a defective glucose monitor, please contact us to discuss your legal options.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The Food and Drug Administration (“FDA”) has issued warning letters to 8 companies who are illegally marketing over-the-counter ("OTC") products that contain topical ibuprofen.  The FDA warning letter states:  “Orally administered ibuprofen has been approved as a safe and effective treatment for pain and inflammation. There are no approved applications for topical ibuprofen products. Although the FDA has proposed to add orally administered ibuprofen to the applicable OTC monograph, it has never proposed that topical ibuprofen be added to any OTC monograph.”

Topical ibuprofen is often promoted as a “safer” alternative that can be used in place of oral ibuprofen because of certain side effects, such as stomach ulcers and cardiovascular effects that are associated with prolonged use of oral ibuprofen.  However, FDA officials warn that "these safety claims for topical ibuprofen have not been reviewed by the FDA, nor has the agency evaluated what side effects might be associated with such products."

"These companies have an obligation to the public to demonstrate to the FDA that their products are safe and effective, and they have failed to do so," said Deborah M. Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research.  Companies that received warning letters may not continue to market their products without FDA approval, and have been identified by the FDA as:

Progressive Emu, Inc. (Emuprofen)

BioCentric Laboratories, Inc. (BioEntopic 15% Ibuprofen Créme)

Core Products International, Inc. (Ibunex topical ibuprofen)

Geromatrix Health Products (LoPain AF 15% Ibuprofen Créme)

MEKT LLC (IB-Relief)

Ridge Medical Products (Profen HP)

Meditrend, Inc. d/b/a Progena Professional Formulations (IbuPRO-10 Plus)

Wonder Laboratories (IBU-Relief 12)

If you have purchased topical ibuprofen, or have been injured as a result of using topical ibuprofen, please contact us to discuss your legal options.

• Email This
• Print
• Comments (2)
• Trackbacks
• Share Link

The Food and Drug Administration (“FDA”) has issued a warning letter to Bodee, LLC, a company based in Century City, California, regarding the marketing and sale of its dietary supplement Zencore Plus (“Zencore”).  The FDA alleges that laboratory analysis of the product concluded that five lots of Zencore contain benzamidenafil, which is in the same class of pharmaceutical ingredients that include phosphodiesterase type 5 inhibitors.  Pharmaceutical ingredients that include type 5 inhibitors include sildenafil (Viagra), tadalafil (Cialis) and vardenafil (Levitra), which are all FDA approved drugs for the treatment of erectile dysfunction (“ED”).

The FDA states in its warning letter that Zencore -- marketed as a dietary supplement -- is misbranded because it is in fact a drug under the FDA Act.  For example, as the FDA letter points out, statements on Zencore’s labeling and on its website claim, among other things, that Zencore, “contains a combination of powerful natural herbs that supports long lasting, hard and firm erections . . .” and “stimulates the production of nitric oxide, leading to the production of cyclic GMP (cGMP).  It is the cGMP which ultimately affects smooth muscle relaxation, allowing the penile arteries to expand and fill with blood.”  In fact, as the FDA alleges, it is the undisclosed ED ingredients in Zencore that may aid men suffering from ED, not any herbal supplements contained in the product.  And because Zencore labeling does not declare that it contains benzamidenafil (an ED drug) and falsely asserts that it does not have the potential to cause side effects, the FDA alleges that Zencore’s labeling is “false and misleading” under the FDA Act.

Moreover, the FDA warning letter further alleges that because Zencore is misbranded in that it’s labeling lacks adequate warnings for users of the product, there is a potential for adverse events associated with its use.  For example, patients who take nitrates and consume Zencore may be at risk of life-threatening hypotension.

If you have purchased Zencore Plus, or have been injured as a result of using Zencore Plus, please contact us to discuss your legal options

• Email This
• Print
• Comments (2)
• Trackbacks
• Share Link

On July 1, 2009, the Food and Drug Administration (“FDA”) issued an alert that requires manufacturers of several popular prescription smoking cessation drugs to add additional warnings to their products highlighting the risk of serious neuropsychiatric symptoms in persons using the drugs.  The FDA also issued a Public Health Advisory to the public that these drugs have been associated with reports of changes in behavior such as hostility, agitation, depression and suicidal thoughts and actions, and that people who have had any of these serious symptoms should stop taking the medication and call their health care professional right away.

The drugs varenicline (which is marketed under the name Chantix) and bupropion (which is marketed under the name Zyban and is also marketed generically) are prescription drugs that have been prescribed to millions of people who wish to stop smoking.  According to the FDA, some people who have taken these drugs have experienced serious and dangerous psychiatric side-effects, which include agitation, depression, hallucinations, mania, nightmares and psychosis.  The most serious side-effect has been people having suicidal thoughts, and attempting to or actually committing suicide.   Some people have reported having automobile and other accidents while taking the drugs, and other people have reported violent episodes associated with the drugs.

The reports of the psychiatric side-effects have mostly been in the “postmarket” period, meaning that the FDA has learned about the side-effects after the drugs were approved for use in the United States.  The “postmarket” experiences with Chantix and Zyban led the FDA to issue new requirements that these drugs have “Boxed Warnings” to alert consumers about the serious psychiatric side-effects that have been documented, and also led the FDA to warn the public about the side-effects.

Stopping smoking is a positive thing, but consumers should be cautious about the medications that they use to help quit smoking. If you or someone you know has experienced serious psychiatric side-effects that you believe are associated with Chantix or Zyban, please contact us to discuss your legal options.

• Email This
• Print
• Comments (5)
• Trackbacks
• Share Link

Detox Foot Pads and similar products are seen everywhere.  They are depicted in television and Internet advertisements.  They are in drug stores of all varieties.  They are also on the bottom of lots of feet.  Successful marketing, however, does not mean they actually do anything beneficial for you.  Detox Foot Pads claim they remove “toxins” from your body.  The ingredients in the pad placed on the bottom of the foot allegedly remove heavy metals, metabolic wastes and other health-threatening substances by drawing them through the pores of the skin on the sole of your foot where they are absorbed by the pad for disposal the next morning.  Their effectiveness is proven by how the white pad attached to the foot turns dark overnight.

The Official Foot Detox Home of The Official Detox Foot Pad claims its pads (as opposed to the cheap imitations found elsewhere) can treat “sleep disturbances, muscle tension, headaches, gastrointestinal disturbances, fatigue, nervousness, anxiety, changes in eating habits including overeating, loss of enthusiasm or energy and mood changes” for only $17.99 for a box of 14 pads.  The Detox Foot Pad contains tourmaline, “a mineral found in Brazil,” that emits “far infrared rays” that generate “negative ions.”  These negative ions stimulate acupressure points to promote wellness.  The website even contains an acupressure diagram of the foot showing where to apply the pad to treat various organs of the body.

The Detox Foot Pad also contains “a vinegar essence from Bamboo trees,” a healing substance known to Chinese villagers for “thousands of years.”  Combined with other substances, it forms a “powerful synergistic detoxification product.”  To certify the integrity of this product, the website even has an Anti-Fraud Policy and proclaims that they “Actively Pursue and Prosecute Fraud Offenders.”  The website also contains a disclaimer that advises that the Food and Drug Administration ("FDA") had not certified the effectiveness of the product and that you should consult with your physician.

The Detox Foot Pad and similar products are not supported by scientific evidence.  The vinegar in the pad will clean your skin during prolonged contact and turn the pad brown.  Beyond that there is very little to suggest the products work.  In fact, according to the Mayo Clinic, “no scientific studies have been published that demonstrate that these products actually remove toxins from the body.”  Moreover, tourmaline is mined primarily as a gemstone.  While some tourmaline has colors vivid enough to appear to glow (perhaps the source of the claim to emit far infrared rays), other stones are irradiated to improve their color.  There is no scientific evidence to indicate that tourmaline, a crystal silicate mineral, once ground up in a form that can be combined with the other substances in the Detox Foot Pad would emit anything, let alone far infrared rays.  Notably, the product’s website does not indicate how much tourmaline is in each pad.

If you have purchased Detox Foot Pads or any similar product, please contact us to discuss your legal options.

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

On May 7, 2009, the Food and Drug Administration ("FDA") issued an advisory notifying healthcare professionals that it will require two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products’ labels after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products. The FDA has received numerous reports of secondary exposure to testosterone in children ranging in age from nine months to five years. Adverse events reported in children inappropriate enlargement of the genitalia, premature development of pubic hair, advanced bone age, increased libido and aggressive behavior. The gels are approved for use in men who either no longer produce testosterone or produce it in very low amounts. Both products are applied once daily, to the shoulders or upper arms.

If you or your child has been harmed by a topical testosterone gel product, please contact us to discuss your legal options.

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

The Food and Drug Administration (“FDA”) in conjunction with the Federal Trade Commission ("FTC") has issued a warning to consumers to avoid Internet sites and other promotions for products that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus, more commonly known as the Swine Flu.  Many of these deceptive products are being sold over the Internet, and the websites selling these products are hoping to take advantage of the public’s concerns about the Swine Flu pandemic sweeping the country and the world.  As such, in their desire to protect themselves and their families, consumers may be easily tricked into purchasing fraudulent products which claim to cure Swine Flu.

These deceptive products come in all varieties and could include dietary supplements or other food products, or products purporting to be drugs, devices or vaccines.   According to the FDA and FTC, such fraudulent products will not prevent the transmission of the virus or offer effective treatments against infections caused by the H1N1 influenza virus.  “Consumers who purchase products to treat the novel 2009 H1N1 virus that are not approved, cleared or authorized by the FDA for the treatment or prevention of influenza risk their health and the health of their families,” said Michael Chappell, acting FDA Associate Commissioner for Regulatory Affairs.

Consumers can visit the FDA and Centers for Disease Control and Prevention web sites for more information about the 2009 H1N1 influenza virus, and to determine which products the FDA has approved, cleared or authorized for use to diagnose, treat, prevent, mitigate or cure infections caused by H1N1 influenza virus.   Currently, there are only two antiviral drugs approved by the FDA for treatment and prophylaxis of the 2009 H1N1 influenza virus: Tamiflu (oseltamivir phosphate) and Relenza (zanamivir).

 If you have a purchased any products which claim fraudulently to diagnose, treat, prevent, mitigate or cure infections caused by H1N1 influenza virus, please contact us to discuss your legal options.

• Email This
• Print
• Comments
• Trackbacks
• Share Link