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

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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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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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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