Class Action Blog : Class Action Lawyer & Attorney : Meiselman, Denlea, Packman, Carton & Eberz : Consumer fraud, Personal Injury

More so than ever, pharmaceutical companies are getting caught offering incentives to their sales representatives to advocate to medical providers to prescribe their medications for off-label use. That is, for use in treating various diseases which have not been approved by the Food & Drug Administration (“FDA”). As a result, a number of pharmaceutical representatives have reaped huge rewards from successful Qui-Tam actions which are lawsuits filed under the False Claims Act.

Many recent examples abound, such as a whistleblower action filed by a former Pfizer sales representative against Pfizer alleging that the company promoted the sale of four drugs -- Bextra, Geodon, Zyvox, and Lyrica -- for unapproved uses, which in turn caused Medicaid and Medicare to pay false claims for reimbursement submitted to them by medical providers across the country. In 2009, after a six-year legal battle, Pfizer settled the case for $2.3 billion dollars. The former sales representative was awarded $51 million dollars as a result.

One of the very first such Qui-Tam lawsuits was filed 14 years ago by another former Pfizer employee, David Franklin. The whistleblower suit alleged that the Pfizer was illegally promoting the prescription drug Neurontin for off-label uses.  Indeed, during one training trip for its sales representatives, the company videotaped its lawyers instructing Pfizer employees that off-label promotion was illegal. The whistleblower suit alleged that Pfizer then proceeded to turn off the videotape, joked about making sure it was off, and trained their representatives on how to break the law and promote off-label uses. As a result, Pfizer sales representatives were promoting Neurontin to medical providers for treatment of seizures, bipolar disorders, migraines and other ailments.

Even though the government decided not to intervene and prosecute the case, Mr. Franklin continued with his Qui-Tam lawsuit on his own. Pfizer finally settled the action this year for $430 million and Mr. Franklin was awarded about $26 million for his whistleblower role.

Another famous Qui-Tam lawsuit was filed by 6 employees of Eli Lilly & Company alleging that Zyprexa was marketed off-label for untested and unapproved uses.  Eli Lilly allegedly created a sales team of 180 "specialty" sales representatives to promote Zyprexa for a number of off-label, unapproved FDA uses to sedate and control elderly nursing home residents exhibiting symptoms of agitation, anxiety, insomnia, depression and dementia. But the medication had been approved by the FDA to treat only bipolar and schizophrenic patients. In 2009, the US Attorney's Office for the Eastern District of Pennsylvania announced that Lilly will pay $1.4 billion for its illegal off-label marketing of the antipsychotic drug. The six whistleblowers who brought the whistleblower suit will share approximately 18 percent of the recovery.

 

If you are a current or former employee of a pharmaceutical company and believe that your employer is engaged in unlawful practices, including promoting its medications for off-label uses thereby engaging in Medicaid and/or Medicare fraud, you may be entitled to a multi-million dollar award. You can help your fellow hardworking taxpayers -- and earn millions of dollars in the process -- by blowing the whistle on unlawful pharmaceutical practices.

If you know or suspect that a pharmaceutical company is engaged in unlawful sales practices, including Medicaid and/or Medicare fraud and/or promoting its medications for off-label treatments, please contact us to discuss your legal options.

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The Food and Drug Administration (“FDA”) has warned three large manufacturers to stop marketing ear candles and has posted a consumer warning on its web site.  The warning page states that during the past decade, the FDA has received reports of burns, punctured eardrums, and blockage of the ear canal that required outpatient surgery.

An ear candle is a hollow cone about 10 inches long made from a fabric tube soaked in beeswax, paraffin, or a mixture of the two.  In ear candling, also called ear coning or thermal auricular therapy, a patient lies on his or her side while a candle is placed in the outer ear and lit.  Marketers claim that warmth created by the device produces suction that draws wax and other impurities out of the ear canal.  However, tests by Health Canada found that ear candles produce no measurable effect in the ear and have no therapeutic value.

“Some ear candles are offered as products that purify the blood, strengthen the brain, or even 'cure' cancer," says Eric Mann, M.D., Ph.D., clinical deputy director of the FDA's Division of Ophthalmic, Neurological, and Ear, Nose, and Throat Devices. But the FDA warns that ear candles can cause serious injuries, even when used in accordance to manufacturers' directions.  "Also," says Mann, "FDA believes that there is no valid scientific evidence for any medical benefit from their use."

The FDA says that ear candling -- the procedure is also called "ear coning" and "thermal auricular therapy" -- exposes the recipient to risks such as:

• starting a fire;
• burns to the face, ear canal, eardrum, and middle ear;
• injury to the ear from dripping wax;
• ears plugged by candle wax;
• bleeding;
• puncture of the eardrum; and
• delay in seeking needed medical care for underlying conditions such as sinus and ear infections, hearing loss, cancer, and temporomandibular joint (TMJ) disorders. (TMJ disorders often cause headache and painful sensations in the area of the ear, jaw, and face).

Over the past decade, FDA has received reports of burns, punctured eardrums, and blockage of the ear canal which required outpatient surgery from the use of ear candles.  And in a survey published in 1996, the medical journal Laryngoscope reported 13 cases of burns of the ear, seven cases of ear canal blockage due to wax, and one case of a punctured eardrum.

If you or someone you know purchased and used ear candles and have been injured as a result, please contact us to discuss your legal options.

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A few months ago, we published blog posts on the dangers of Yaz birth control pills.  We also pointed out that Public Citizen, a consumer rights group based in Washington, D.C., had petitioned the Food and Drug Administration (“FDA”) to remove the medication from sale.  According to another recent petition the consumer group sent the FDA, Public Citizen has requested that Savella, manufactured and sold by Cypress Bioscience, Inc. and Forest Laboratories, Inc. and used to treat fibromyalgia, be removed from the market immediately because its dangers outweigh its benefits.

Public Citizen alleges that Savella has highly questionable clinical efficacy and has been found, in randomized controlled trials, to cause a large number of potentially serious adverse reactions including hypertension, increased heart rate, and increased suicidal ideation.

In its petition, Public Citizen notes the European Medicine Agency, as of July 23, 2009, turned down the application for Savella for the treatment of fibromyalgia, citing both the lack of efficacy and data on long-term effects.  After the drug's sponsors challenged that decision, the European Medicine Agency reconfirmed its original decision.  Public Citizen’s petition states that the “FDA should never have approved Savella for fibromyalgia, and should now immediately undo its error by removing it from the market before large numbers of people in this country suffer serious harm from this marginally effective drug.”

If you were injured as a result of taking Savella, please contact us to discuss your legal options.

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Johnson & Johnson's subsidiary McNeil Consumer Healthcare (“McNeil”) recalled six million bottles of Tylenol Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-Open Cap in early December, which follows a November recall of five lots of the drug.  But the Food and Drug Administration ("FDA") waited an additional ten days -- until December 28^th -- before it issued its more widely seen and publicly accessible medical alert for the contaminated pills.  Thus, many consumers may not have been aware that they had purchased and ingested contaminated Tylenol caplets.

The all-out recall encompasses arthritis pain reliever produced over the past three years, stemming from contamination likely caused by the breakdown of a chemical treatment used on wooden pallets.  The chemical contaminant 2,4,6-tribromoanisole is believed to have seeped into empty medication bottles.  The contamination resulted in a musty odor and consumers who have taken the contaminated pills have allegedly suffered from cases of nausea, vomiting and diarrhea.  According to the FDA, consumers who purchased Tylenol Arthritis Pain Caplets from the lots included in this recall should stop using the product.

If you purchased Tylenol Arthritis Pain Caplets and have suffered nausea, vomiting, diarrhea and/or any other injuries, please contact us to discuss your legal options.

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A lawsuit has been filed against pharmaceutical company Salix Pharmaceuticals Inc. (“Salix”) alleging that its OsmoPrep medication, used to cleanse the intestines in preparation for a colonoscopy, causes kidney damage.  The lawsuit filed on behalf of four individuals alleges that the plaintiffs sustained a variety of serious kidney injuries, including acute phosphate nephropathy, and that some of the injuries resulted in the need for dialysis.

In December, 2008, the Food and Drug Administration (“FDA”) placed a “black box” warning – the most severe warning possible – on OsmoPrep and on another Salix bowel cleanser, Visicol.  The FDA stated that OsmoPrep and Visicol carry the risk of kidney damage and directed Salix to develop a risk evaluation and mitigation strategy (REMS), distribute a Medication Guide to alert patients to the risk of acute kidney injury associated with the use of these products, and to conduct a post-marketing clinical trial to further assess the risk of acute kidney injury.  The lawsuit alleges, however, that Salix was aware of the two drugs’ dangers before the FDA ordered the “black box” warning.

If you or someone you know were given OsmoPrep and/or Visicol and have suffered kidney damage, please contact us to discuss your legal options.

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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.

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The ever present desire for athletes to train to the extreme to obtain an edge on the competition exists at every level of athletics from high school to the professional athlete.  In the past this desire has led to the imprudent use of anabolic steroids by athletes in all levels of competition.

The dangers of using anabolic steroids have been well-documented and the subject of extensive media coverage.  The BALCO investigation is just one example. The serious and often fatal risks associated with using steroids to increase body strength and performance, clearly should prohibit the use of such substances.  There is, however, the ongoing desire to obtain that edge on the competition.   Thus, to avoid the stigma associated with steroids, certain products have been developed by some manufacturers that have been marketed as dietary supplements, but which actually contain synthetic steroids.

The Food and Drug Administration (“FDA”) issued a Public Health Advisory on July 28, 2009, warning consumers to stop using body building products marketed as dietary supplements, but are instead unapproved and misbranded drugs.  These products are sold online and in retail stores and are promoted as hormone products and/or alternatives to anabolic steroids.  The FDA warned that these products are potentially harmful and that it has not approved them or reviewed their safety before marketing.

The FDA also sent a warning letter to American Cellular Labs, the manufacturer of TREN-Xtreme and MASS Xtreme.  Other products identified by the FDA include ESTRO Xtreme, AH-89-Xtreme, HMG Xtreme, MMA-3 Xtreme, VNS-9 Xtreme, and TT‑40‑Xtreme.

The FDA has received adverse event reports for these products which include cases of serious liver injury, stroke, kidney failure, and pulmonary embolism.  Other conditions that can be associated with these products include shrinkage of the testes, male infertility, masculinization of women, breast enlargement in males, short stature in children, adverse affects on blood lipid levels and increased risk of heart attack and stroke.  As such, the FDA recommends that consumers immediately stop using these products and has also cautioned that athletes taking these products may test positive for performance-enhancing drugs.

If you have been injured as a result of using any of these products, please contact us to discuss your legal options.

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On August 24, 2009, the Food and Drug Administration ("FDA") issued an “Early Communication” to inform the public about concerns related to the weight loss medication, Orlistat, and potential injury to the liver.

The FDA announced there were 32 reports of liver injury suspected to be associated with the use of Orlistat between 1999 and 2008.  The medication is available by prescription, and is marketed as Xenical (120 milligrams).  The medication is also marketed and available over the counter under the brand name Alli (60 milligrams).

Potential side effects from Orlistat may manifest themselves as jaundice, abdominal pain, nausea, vomiting, brown urine, weakness, fatigue, fever, loss of appetite and itching.  If you have experienced these symptoms and have ingested the weight loss medication, you should consult your health care professional and report the symptoms to the FDA’s MedWatch Adverse Event Reporting program.

If you have been injured as a result of using Orlistat either as Xenical and/or Alli, please contact us to discuss your legal options.

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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.

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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

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Health and consumer advocates are calling for the Food and Drug Administration ("FDA") to ban Yasmin, Yaz and Ocella -- brand names under which the birth control drug combination drospirenone and ethinyl estradiol are sold -- because of the pill’s potential to cause blood clots, heart attack and stroke.  Yasmin, for example, was introduced in the U.S. in 2001 and is now also available as a generic.  Revenues from Yasmin sales are reported to have reached $500 million in 2007, and its popularity can be attributed to the fact that some unpleasant side effects of other birth control pills, such as acne and unwanted hair, are diminished.  But some Yasmin users have allegedly reported serious health impacts, including inability to conceive after stopping use as well as heart and other health problems.  Indeed, Public Citizen petitioned the FDA in 2007 to ban the Yaz birth control pill for similar reasons.

If you have taken Yasmin, Yaz and/or Ocella and experienced adverse health impacts, contact us to discuss your legal options.

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The Food and Drug Administration (“FDA”) and the Institute for Safe Medication Practices (“ISMP”) recently reported that consumers were swallowing Benadryl Itch Stopping Gel, an over-the-counter (“OTC”) product that must be used topically.  Orally ingesting the product can cause serious adverse reactions, including death, burning of the mouth and throat, nausea and vomiting, irritability, confusion, seizures, coma and respiratory failure.

The FDA and ISMP have suggested that the way Benadryl has packaged this particular product is the reason consumers are ingesting the product rather than applying it topically to the skin.  Instead of being packaged in a tube – like many other OTC topical products – Benadryl Itch Stopping Gel is sold in a 4 ounce bottle.  Thus, the FDA points out, consumers believe they are purchasing an oral liquid which should be ingested instead of applied topically.  Moreover, adding to consumer confusion, Benadryl Itch Stopping Gel has the same shape and size as other oral liquid products.  And although the words “external use” appear on the back of the bottle, the front of the bottle states “Topical Analgesic” in small letters, which “consumers could miss or not understand."  The ISMP claims that, "The packaging and labeling of Benadryl Gel is one of the key contributing factors associated with these errors."

If you or someone you know has ingested Benadryl Itch Stopping Gel and has been injured as a result, please contact us to discuss your legal options.

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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.

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As the dangers of cigarette smoking have become well known, many smokers have resorted to various substitutes to their daily pack of smokes.  We all have friends or relatives who have tried to “kick the habit” by means of nicotine patches, nicotine chewing gums, herbal remedies, and prescription medicines.  Recently, electronic cigarettes – battery-operated devices that have the look, feel, and even taste of a normal cigarette – have been touted as an allegedly “safe” alternative to traditional cigarettes.  Hundreds of thousands of Americans looking for their nicotine fix have now taken up smoking these “e-cigarettes” based upon the belief that these devices pose no threat to their health.  Unfortunately, there are serious questions regarding the dangers of electronic cigarettes that remain unanswered.

The appeal of electronic cigarettes stems in large part from the fact that smokers inhale liquid nicotine, and exhale a mist of vapor, thus replicating the experience of smoking traditional cigarettes but without also ingesting the tar or tobacco that are present in traditional cigarettes.  According to a recent New York Times article, what many e-cigarette users don’t know is that along with liquid nicotine they are also inhaling propylene glycol, a liquid that is used in anti-freeze solutions and in brake and hydraulic fluids.  The material data safety sheet for propylene glycol states that chronic exposure of that substance may cause “reproductive and fetal effects,” “central nervous system depression,” damage to cell membranes, and possible seizures.  Moreover, there appears to be no evidence that inhalation of propylene glycol over a prolonged period of time is safe, and there are no independent scientific studies demonstrating that electronic cigarettes can help people to stop smoking. 

Electronic cigarettes are already banned in Australia and Hong Kong due to safety concerns.  And the Food and Drug Administration (“FDA”) has refused entry of shipments of electronic cigarettes coming into the U.S.  “These appear to be unapproved drug device products,” said Karen Riley, a spokeswoman for the FDA, “and as unapproved products they can’t enter the United States."

If you have purchased electronic cigarettes, or have been injured by using “e-cigarettes,” please contact us to discuss your legal options.

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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.

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On May 12, 2009, the Food and Drug Administration ("FDA") issued a consumer alert advising consumers to stop using certain cosmetic “Face Paint” items labeled as distributed by Oriental Trading Co., due to adverse event reports of skin reactions in children. Adverse reactions included rashes, itchiness, burning sensation, and swelling where the face paints were applied.  Significant microbial contamination was indicated in most of the products in testing by an FDA laboratory. Blue, purple, red, orange, black and green “Face Paints” manufactured by Shanghai Color Art Stationery Company Limited, Shanghai, China, are being voluntarily recalled by Fun Express Inc., a wholly-owned subsidiary of Oriental Trading Co.  For a full list "Face Paint" items and lot numbers recalled, please click here.

If you suffered injuries related to cosmetic items, including "Face Paint," please contact us to discuss your legal options.

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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 month 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.

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In a post published back in January 14, 2009, this blog discussed the fact that the Food and Drug Administration (“FDA”) had identified a number of weight loss products as containing potentially dangerous ingredients. Recent events have shown the warnings to be justified.

The FDA has warned consumers to immediately stop using the Hydroxycut line of weight loss products, citing reports of death due to liver failure and other serious health problems. The Hydroxycut brand includes pills, drinks and powders marketed to increase energy, burn calories and fat, and control appetite. Hydroxycut products have been widely sold at national chain stores, including GNC and Vitamin Shoppe. The FDA has received 23 reports of significant health problems in persons using Hydroxycut products ranging from jaundice and elevated liver enzymes (an indication of potential liver injury) to liver damage requiring a liver transplant. According to the FDA, symptoms of liver injury include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching and loss of appetite. Other health problems associated with the use of Hydroxycut products reported to the FDA include seizures, cardiovascular disorders and a type of muscle damage known as rhabdomyolysis that can lead to other serious health problems, including kidney failure.

If you have purchased and used a Hydroxycut product, please contact us to discuss your legal options.  

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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.

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The Food and Drug Administration (“FDA”) has issued a warning to consumers to avoid more than two dozen weight loss products because they contain undeclared ingredients that could pose serious health risks. The products claim to contain only “natural” or “herbal” ingredients, but in fact contain undeclared ingredients such as anti-seizure medication to suspected carcinogens.

For example, the FDA analysis of these weight loss products found unlisted ingredients such as sibutramine (a controlled substance), rimonabant (a drug not approved for sale in the U.S.), phenytoin (an anti-seizure medication), and phenolphthalein (a suspected cancer-causing agent). In addition, some of the amounts of active listed ingredients greatly exceed FDA recommended levels, putting consumers’ health at risk.

Some of the dangerous weight loss products identified by the FDA are: Fatloss Slimming, Japan Lingzhi 24 Hours Diet, 7 Day Herbal Slim, 999 Fitness Essence, Imelda Perfect Slim, Perfect Slim, ProSlim Plus, Slim Express 360, Superslim, Venom Hyperdrive 3.0, Slim Waist Formula, Sana Plus, Slim Burn, Slim 3 in 1 Extra Slim Waist Formula, 2 Day Diet Slim Advance, Meili, Cosmo Slim, Body Creator and 21 Double Slim.

The FDA advises consumers who have used any of these products to stop taking them immediately and consult their doctors. The FDA is also seeking to have the products recalled.

To read the FDA news alert and for a complete list of these dangerous weight loss products, click here.

If you have a purchased any of these weight loss products, please contact us to discuss your legal options.

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