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

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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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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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 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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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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