Pampers Dry Max Diapers Under Investigation for Chemical Burns

Are Pampers diapers causing chemical burns on babies?  Thousands of parents think so, and now government officials are investigating their claims.  The Consumer Product Safety Commission (“CPSC”) has announced that it is reviewing complaints received about diaper rashes that appear to be associated with the use of Pampers diapers with Dry Max, manufactured by Proctor and Gamble (“P&C”).  Parents have reported the appearance of what look like chemical burns on their children when using Pampers Swaddlers diapers with Dry Max and Pampers Cruisers diapers with Dry Max.  Indeed, in March, 2010, P&C changed its "Pampers Swaddlers" and "Pampers Cruisers" to include "Dry Max."  Dry Max is a thinner and more absorbent material that replaced the paper pulp previously used.  P&C calls the change "new and improved" but some parents are calling it a nightmare.

 

For example, Jenny Cooper of Eugene, Oregon is one of those parents.  Cooper told KVAL News that within about two days of using Dry Max diapers her son Paul developed a rash.  "And then it started to get worse," she said. "It actually started to blister on him.  And the blisters started to bleed on him.”  Paul was in so much pain, he would fight his mom when she tried to change him.  "There was a lot of screaming and crying and tears," said Cooper. "And he didn't want to sit down because his bum was really sore."

 

Cooper thought it might be a reaction to the diaper so she went online to find out more information. At one point, she went onto the Pampers Facebook page and found a link to another Facebook group with more than 6,500 members called "Pampers bring back the OLD CRUISERS/SWADDLERS."  The site includes numerous horror stories, tips from parents of how to cure the rash, and some very graphic pictures of irritated skin.

 

As for Jenny, she changed Paul into Huggies and said the problem has gone away.  She told KVAL News she strongly believes her son's rash was directly connected to the diapers.  "There's something wrong with the diapers," she said. "I'd like to see a mass recall of all the Pampers Cruisers and any of the other affected products.”  Cooper told KVAL News she called P&C to complain but says it didn't do anything.  She called P&C again a few days later and told the P&C customer representative she was taking her story to the news.  It was at that point that P&G quickly agreed to refund her money.

 

If you purchased and used "Pampers Swaddlers" and/or "Pampers Cruisers" and your child has been injured as a result, please contact us to discuss your legal options.

FDA Warns Consumers To Stay Away From Ear Candles

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.

Accutane Users Have Won Verdicts Worth More Than $56 million Alleging That Roche Failed To Warn Of The Drug's Risk

A Birmingham-area man won a $25.16 million verdict this month against Switzerland-based Roche Holding AG ("Roche") after claiming its acne medicine led to inflammatory bowel disease.  Andrew McCarrell, 38, won the verdict against Roche after a retrial in state court in New Jersey, where a company unit that produced the drug Accutane is based.

 

McCarrell is a computer technician who has lived in the Birmingham area 13 to 15 years.  He testified he got sick after taking Accutane in 1995.  He needed five surgeries, including one to remove his colon.

 

"I never thought it would be like this," McCarrell said. "Never in my wildest dreams."

 

Six former Accutane users have now won verdicts worth $56 million.  All claimed Roche failed to warn of the drug's risks.  Roche stopped selling Accutane last year, citing competition from generic formulations and legal costs from defending personal injury suits.  Roche faces almost 1,000 other cases.

 

McCarrell had played small-college football in the Midwest and "was a vibrant healthy guy until he started taking this drug," said his lawyer. "A year after he started taking it, he had his colon removed."  McCarrell goes to the bathroom 10 to 20 times a day and "suffers from massive gastrointestinal upset," his lawyer said. "Imagine going though that every day.  He and his wife are living day by day."

 

The lawsuit alleged that Roche had internal documents that said Accutane caused inflammatory bowel disease and did not tell anyone.  Indeed, some patients who were prescribed Accutane have allegedly suffered such severe injuries as a result.  While Accutane is still on the market, it is the focus of lawsuits nationwide.

 

If you or someone you know were prescribed Accutane and have suffered serious injuries as a result, please contact us to discuss your legal options.

Beware Of Dangerous Cribs And Strollers

The continuing dangers posed to infants by certain products has been highlighted by the recall announced this month by the U.S. Consumer Product Safety Commission (“CPSC”) of approximately 635,000 cribs manufactured by Dorel Asia SRL of Barbados.  The recall was announced after the reported death of a 6 month old child who became entrapped and strangled in a Dorel crib after the drop side hardware broke.  The drop side hardware on the cribs can fail causing the drop side to detach from the crib creating a space in which an infant can become entrapped and suffocate or strangle.  This, as well as bruising and lacerations, may also occur if one of the slats is damaged.

 

Moreover, thirty six incidents of slat breakage have been reported. The drop side hardware failure or slat damage may occur while the crib is in use, in storage, being assembled, taken apart or reassembled or during shipping and handling.  The Dorel cribs were sold at Kmart, Sears and Wal-Mart stores nationwide from January 2005 through December 2009.

 

The CPSC also recently announced the recall of about 1.5 million strollers manufactured by Graco Children’s Products, Inc. of Atlanta, Georgia, between October 2004 and February 2008, due to fingertip amputation and laceration hazards.  There have been seven reports of children placing their fingers in the stroller's plastic, jointed canopy hinge mechanism while the canopy was being opened or closed, resulting in five fingertip amputations and two fingertip lacerations.  The recalled strollers were sold at AAFES, Burlington Coat Factory, Babies “R” Us, Toys “R” Us, Kmart, Fred Meyer, Meijers, Navy Exchange, Sears, Target, Wal-Mart and other retailers nationwide from October 2004 to December 2009.

 

If any infants or children you know have been injured by these products please contact us to discuss your legal options.

Public Citizen Warns Of The Dangers Of Savella

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.

Parkers Farm Recalls Products Contaminated With Listeria

Parkers Farm of Coon Rapids, Minnesota is recalling products because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infection in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals may suffer short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, but Listeria infection can also cause severe injuries like miscarriages and stillbirths among pregnant women.



The recalled products were distributed nationwide in the following retail stores: Hy-Vee, CUB, Rainbow, Byerlys Lunds, Target, Whole Foods, Jewel, Dominicks, Marsh, Price Chopper, Shop Rite, Nash Finch, Sam’s Club, Costco, Safeway.



The following recalled products were sold under the Parkers Farm or Parkers label: (a) 16 ounce peanut butter in square plastic containers (tub with snap on lid), varieties are creamy, crunchy, honey creamy and honey crunchy with sell by dates between 11/14/2010 and 12/31/2010; (b) 34 ounce peanut butter in round plastic containers (tub with snap on lid), varieties are creamy and crunchy with sell by dates between 8/11/2010 and 9/30/2010; (c) 7 ounce bagel spreads in white plastic containers (tub with snap on lid), varieties are garden veggie, wild berry, strawberry, apple cinnamon and honey walnut) with sell by dates between 5/13/2010 and 6/30/2010; (d) 14 ounce dips & spreads in square plastic containers (tub with snap on lid), varieties are jalapeño nacho, pimento and salsa con queso with sell by dates between 8/11/2010 and 9/30/2010; (e) 8 ounce, 12 ounce and 16 ounce cold pack cheese in round or square plastic containers (tub with snap on lid), varieties are sharp cheddar, bacon, onion, smoked cheddar, swiss almond, horseradish, garlic, port wine, and swiss & cheddar with sell by dates between 11/14/2010 and 12/31/2010; and (f) 16 ounce salsa in square plastic containers (tub with snap on lid), varieties are hot, mild, garlic, black bean and fire roasted with sell by dates between 3/14/2010 and 4/30/2010.




Other labels affected by this recall: (a) 16 ounce Happy Farms Cold Pack Cheese in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port wine and swiss almond with sell by dates between 11/24/2010 and 12/10/2010; (b) 8 ounce Kroger Cold Pack Cheese in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port wine and swiss almond with sell by dates between 11/18/2010 thru 12/15/2010; (c) 8 ounce Central Markets Cold Pack Cheese in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port win and swiss almond, horseradish with sell by dates of 12/9/2010; (d) 14 oz. Central Markets Salsa Con Queso in round plastic containers (tub with snap on lid) with sell by dates of 8/16/2010; (e) 16 oz. Central Markets Salsa in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port wine, swiss almond, horseradish with sell by dates of 3/17/2010 thru 3/24/2010; and (f) 8 oz. Dutch Farms Cold Pack Cheese in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port wine, swiss almond, horseradish, and swiss & cheddar with sell by dates of 11/16/2010 thru 11/18/2010.

 

If you purchased any of the above Parkers Farm products and have suffered injuries, please contact us to discuss your legal options.

Are You Driving On "New" Tires That Can Kill You?

Would it surprise you that purchasing “new” tires for your car or truck from major retailers, like Sears and Wal-Mart, may place you and your family in danger?  It shouldn’t, because even if a tire looks new and has good tread depth it may in fact have been manufactured many years prior to your purchase.  And tires that are more than 6 years old, even if never driven one mile, are much more susceptible to suddenly coming apart on the road.  There are thousands of consumer complaints online, and hundreds of lawsuits filed across the country, regarding “new” tires which were, in fact, manufactured many years ago resulting in the tires literally falling apart and causing catastrophic damage both to the vehicle and its passengers.

 

A tire’s biggest foes are heat and oxygen.  Over time, heat and oxygen break down a tire’s internal adhesive bond between the various layers of the tire’s internal laminate structure.  This phenomenon is known as thermo-oxidative degradation.  Thus, tires older than 6 years have been exposed to prolonged heat and oxygen, causing the tire to become a safety risk.  Indeed, the safety research firm, Safety Research & Strategies, Inc. ("SRS"), has linked 50 serious accidents and 37 fatalities to older tires.  Sean Kane, who runs SRS, asserts that, "The factor that linked them all together is the tires were all six years old or older and, in most cases, were unused or barely used, and had more than ample tread depth on them, and no visible appearance of any problem."  From the outside, tires may look perfectly fine, but Kane says as tires age, they start to break down on the inside, and that can cause them to suddenly come apart on the road.  "The tread will peel off like a banana, and that's what can cause a crash," he observes.  Kane wants tire companies to stamp an expiration date on their tires so consumers know to get rid of them after six years.

 

In any event, there is a way to determine the age of many tires.  A code printed on the side of all tires, called the DOT number, has three or four numbers.  If those numbers are, for example, 0, 3 and 6, it would mean the tire was made in the third week of either 1986 or 1996.  For tires made in 2000 and beyond, consumers should look at the last four numbers.  If they are 0, 3, 0, 1 it would mean the tire was made in the third week of 2001.

 

If you, one of your family members, or friends have been injured by a tread separation on a tire, please contact us to discuss your legal options.

Johnson & Johnson Recalls Six Million Bottles Of Tylenol Arthritis Pain Caplets

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 28th -- 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.

Prempro Alleged To Cause Breast Cancer

46 Indiana women are planning to sue the pharmaceutical company Wyeth (“Wyeth”) alleging that it sold its Prempro menopause medication without first warning the public that the medication can cause breast cancer.  The Indiana women who plan to sue the drugmaker said they have a document that shows Wyeth officials were aware of the risks of Prempro and chose not to disclose it.   They also claim Wyeth oversold the benefits of the drug, promoting it as helping bones and the heart as well as menopause symptoms.

 

In 2003, Wyeth disclosed that Prempro could cause breast cancer, but the admission came too late for many women who had been taking the drug between 1999 and 2003.  Indeed, some women who were prescribed Prempro have allegedly developed breast cancer as a result.  While Prempro is still on the market, it is the focus of lawsuits nationwide resulting in jury verdicts totaling more than $103 million.  In fact, Pfizer -- the pharmaceutical company that now owns Wyeth -- has lost six of nine jury verdicts over its menopause drugs since the cases began going to trial in 2006.  Jurors have ruled against the company in the last four verdicts in a row.

 

If you or someone you know were prescribed Prempro and have developed breast cancer, please contact us to discuss your legal options.

Drugs Used In Preparation For A Colonoscopy Alleged To Cause Kidney Damage

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.

Does Fosamax Cause Jaw Damage?

At least 900 lawsuits have been filed against pharmaceutical giant Merck & Co. (“Merck”) alleging that its Fosamax medication used to treat osteoporosis causes jaw damage.  Fosamax belongs to the bisphosphonate family of osteoporosis drugs that also include the branded drugs Actonel and Boniva.  Merck claims that Fosamax prevents bone fractures, particularly in post-menopausal women, by helping to increase bone density.

 

Consumers, however, allege that the drug can cause jaw damage after less than three years of use.  Indeed, plaintiffs in the hundreds of lawsuits filed against Merck allege that Fosamax users have suffered osteonecrosis of the jaw, or “dead jaw,” a disease resulting from the temporary or permanent loss of blood supply to the bones.   Without blood, the bone tissue dies, and ultimately the jaw bone may collapse.  Fosamax users allegedly run the risk of developing a serious case of osteonecrosis of the jaw and suffering through the extreme pain associated with the death of jawbone tissue.

 

In a court decision released last week, United States District Court Judge John Keenan refused to dismiss 24 cases alleging that Fosamax caused jaw damage.  The court ruled that the plaintiffs could introduce expert medical testimony to show that Fosamax can cause jaw damage, and that the evidence submitted by plaintiffs is sufficiently reliable to allow a jury to establish such a connection.   As such, these cases were allowed to proceed and the plaintiffs now have an opportunity to convince a jury that Fosamax allegedly causes jaw damage.

 

If you have been prescribed Fosamax and have experienced osteonecrosis of the jaw (“dead jaw”), please contact us to discuss your legal options.

Accuracy Of Home Glucose Monitors In Doubt

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.

Should Consumers Beware Of Pyrex Bakeware?

You may have received an email recently, or heard stories from friends, that the venerable Pyrex brand cookware is susceptible to “exploding” and/or shattering when used in the oven or microwave.  Pyrex, of course, has always prided itself on the fact that its dishes can be used safely in baking food in the oven or microwave, used to freeze foods and is dishwasher safe.  So should consumers be concerned that Pyrex dishes are not as safe as they once were, or as safe as the company that now manufactures Pyrex dishes claims?

 

For example, rumors are circulating over the Internet that Pyrex dishes, originally manufactured and sold by Corning, were indestructible because they were made of borosilicate glass.  Purportedly, once Corning sold the Pyrex brand to World Kitchen (a Chinese based company), the dishes were no longer made in the U.S. and were no longer manufactured by using borosilicate glass.  Instead, World Kitchen was manufacturing Pyrex dishes in China by using soda lime glass which is allegedly not as indestructible as borosilicate glass and a lot cheaper.  Today, Wal-Mart is the largest distributor of Pyrex products, and the Pyrex dishes consumers grew to love and trust is not the product they think it is.  That is, it is not as safe or indestructible as the Pyrex dishes originally manufactured by Corning.

 

The truth, however, is a bit more complicated than the narrative described above.  First, all brands of glass bakeware may be susceptible to breakage under certain conditions, particularly when subjected to extreme changes in temperature.  Glass bakeware is not, in every case, “indestructible.”  However, although glass bakeware is not “indestructible,” there are hundreds of consumer complaints on the Internet of sudden breakage involving Pyrex branded glass bakeware.  Moreover, as of 2008, the Consumer Product Safety Commission (“CPSC”) had received 66 complaints about Pyrex incidents over the last ten years.  Second, the claim that when the Pyrex brand was sold by Corning to World Kitchen, World Kitchen immediately changed the material used to make the dishes from borosilicate glass to lime-glass is not completely true.  In fact, Corning itself began manufacturing Pyrex dishes out of soda-lime glass -- instead of borosilicate glass -- back in the 1940’s.  Finally, the rumors quoted above claim that World Kitchen is a Chinese based company that manufactures its Pyrex branded bakeware in China.  Not true.  World Kitchen is a subsidiary of WKI Holding Co., which is based in Rosemont, IL and manufactures its products in the U.S.

 

Nonetheless, some critics have maintained that Pyrex dishes are involved in a number of dangerous shattering incidents, allegedly caused by negligent manufacturing of Pyrex dishes.  For example, U.S. Senator Dick Durbin has called for an investigation of Pyrex, some critics maintain that the Pyrex dishes sold today are inadequately tempered and other critics maintain that World Kitchen’s product instructions are allegedly insufficient, misleading and/or deceptive.  And, as noted above, there are hundreds of consumer complaints that can be found online describing Pyrex dishes shattering after normal use, sometimes ending with someone being severely injured.

 

If you have purchased Pyrex brand glass bakeware, and have been injured as a result of the bakeware shattering, please contact us to discuss your legal options.

Recent Clinical Studies Warn Of The Dangers Of Yaz And Yasmin

A couple of months ago, we published a blog post on the dangers of Yaz and Yasmin birth control.  Since then, the results of clinical studies regarding this new class of birth control pills have been published in peer reviewed medical journals, and their conclusions are not encouraging for the millions of women who are currently taking Yaz or Yasmin.

 

For example, two studies published in August in the British Medical Journal found a higher risk for blood clots in women taking the newer progestins like the drospirenone found in Yaz and Yasmin.  Birth control pills work by altering a woman’s hormone levels, and researchers have long known that taking a combination hormone birth control pill which contains estrogen and a progestin hormone can increase the risk of stroke and blood clots in the legs and lungs.  Yaz, which contains drospirenone and a lower dose of estrogen, was approved by the FDA in 2006 and has been aggressively marketed by Bayer since then.  But because drospirenone can increase potassium levels in the body, it may put women who have liver or kidney problems at risk for serious heart problems, including possible liver or kidney failure.

 

The combination of estrogen and drospirenone found in Yaz also affects a woman’s hormonal level in a way that previous classes of birth control pills did not, and may also cause bouts of severe anxiety, depression and other mental health issues.  Indeed, Dr. Frits Rosendaal, the author of one of the studies published in the British Medical Journal, said the adverse reports regarding Yaz and Yasmin were worth acting on – by switching to the older class of birth control pills containing levonorgestrel.  “Even if the risk of thrombosis is low, why not choose the lowest risk, just in case?” he said.

 

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

The FDA Warns Illegal Marketers Of Topical Ibuprofen

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.

Call for Ban of Yaz, Yasmin and Ocella Birth Control

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.

FDA Issues Warning Regarding Benadryl Itch Stopping Gel

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.

Chinese Drywall Causing Problems For Homeowners

If you live in a home that was built or remodeled in the last few years and smells like rotten eggs, you may have a Chinese Drywall problem.

 

Since around 2004, more than 500 million pounds of drywall has been imported from China, and much of it is defective.  According to the Wall Street Journal, the Chinese Drywall that is now causing problems in many American homes contains high levels of sulfur dioxide and other sulfides, and emits sulfur dioxide that produces the odor of rotten eggs.  The sulfur dioxide also causes metals (such as air conditioning coils and computer cables) to corrode.  Exposure to sulfur dioxide fumes can also be associated with illnesses, such as respiratory and sinus problems.

 

Much of the Chinese Drywall that was imported into the United States was placed into homes in the Southeast after several years of devastating hurricanes required intense rebuilding.  Most of the complaints about the Chinese Drywall come from states such as Louisiana, Florida or Mississippi, where the warm, humid environment encourages the emission of the sulfur dioxide fumes.  However, Chinese Drywall was likely used in all parts of the country, but the effects may be less noticeable where the climate is cooler and dryer.

 

If you have Chinese Drywall in your home, you may not only experience exposure to unhealthy sulfur dioxide fumes, but you also may be unable to sell your home.  Most States require that a home seller disclose adverse conditions that affect a home for sale, and if you know that your home is contaminated with sulfur dioxide fumes as a result of defective drywall, you probably have to disclose that to a buyer.  This will impact the value of your home.

 

In addition, if the drywall in your home needs to be replaced because it emits sulfur dioxide, your homeowners’ insurance may not cover the replacement costs.  Many insurance companies will consider a situation like this to be pollution or contamination that most insurance policies do not cover.

 

If you have suffered property damage and/or personal injuries as a result of Chinese Drywall installed in your home or business, please contact us to discuss your legal options.

FDA Mandates New Warnings For Prescription Smoking Cessation Drugs

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.

FDA Warns Consumers To Stop Using Intranasal Zicam Products

In past posts, this blog warned consumers of potentially dangerous ingredients that may be harmful to you or your child’s health.  Recent events have shown the warnings to be justified.

The Food and Drug Administration (“FDA”) has warned consumers to stop using zinc-based intranasal Zicam cold products and discard them or return them to stores because they have been associated with anosmia -- long lasting or permanent loss of smell.  The loss of smell can be "life-threatening," said Deborah M. Autor, director of the office of compliance for the FDA's Center for Drug Evaluation and Research, because people with impaired smell cannot detect leaking gas or smoke and cannot tell if food has spoiled before they eat it.  Indeed, the FDA has received more than 130 reports of anosmia associated with use of Zicam products from doctors and consumers.  The loss of sense of smell may be long-lasting or even permanent in some people.

The affected Zicam branded products, manufactured by Matrixx Initiatives, are Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs, Kids Size (a discontinued product that consumers may still have in their homes).

Moreover, Zicam products are marketed as cold remedies used purportedly to reduce the duration and severity of cold symptoms.  According to the FDA, however, these products have not seen to be effective in the reduction of the duration and severity of cold symptoms.  As such, consumers may have been deceived into purchasing a useless product.

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

FDA Issues Recall Regarding Children's Face Paint

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.

FDA To Require New Boxed Warning For Topical Testosterone Gel Products

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.

Defective Energy Saving Compact Fluorescent Bulbs Not Saving The Planet Or Consumers Any Money

When Congress mandated last year that all consumers (and businesses) begin replacing their traditional light bulbs with new energy saving bulbs, primarily manufactured by Feit Electric and General Electric, most jumped at the chance. After all -- albeit for more money -- you could purchase bulbs that lasted purportedly ten times longer than traditional bulbs and save as much as $5.40 a bulb each year in electricity. What consumers weren’t told was that most of these new energy saving bulbs do not work and are defective.

 

For example, as the New York Times reported, one of sixteen bulbs purchased at Costco did not work at all and three others died within hours. And these are bulbs which are supposed to last a minimum of 10,000 hours. Consumers are posting complaints on the internet by the thousands, all discussing how newly purchased bulbs don’t work out of the box, die within hours (or a day or two), or die within a month. And the bulbs aren’t cheap; they cost, on average, twice as much as a traditional bulb. With 330 million bulbs sold in the past year, consumers are out tens of millions of dollars.

 

Experts interviewed by the Times assert that the quality of the bulbs is poor and that the manufacturers’ poor packaging instructions are compounding the problem. Moreover, disposal of the defective bulbs is fast becoming a problem for consumers: The new bulbs contain high levels of mercury, a toxic metal harmful to adults and children alike, and can not be easily handled or disposed of.

 

Even Alan Feit, vice-president of Feit Electric, acknowledged quality control problems with his bulbs. Indeed, Victor Roberts -- an independent expert who conducted failure analysis testing compact fluorescent bulbs -- suspects that the manufacturers are using substandard components, many of them from China. “Somebody decides to save a little money somewhere,” he said, “and suddenly we have hundreds of thousands of failures.”  Or as Michael Siminovitch, director of a lighting center at the University of California, Davis has put it: “In pursuit of the holy grail, we stepped on the consumer.”

 

If you have purchased defective energy saving compact fluorescent bulbs manufactured by Feit Electric and/or General Electric, please contact us to discuss your legal options.

Class Action Against Apple For Defective iMac Computer Displays

Meisleman, Denlea, Packman, Carton & Eberz, P.C. is investigating a potential class action complaint on behalf of consumers and all others similarly situated (the “Class”) alleging that Apple’s iMac computers, specifically iMacs with 20” and 24” displays, have a widespread and commonplace characteristic screen defect and design flaw. The problem manifests as a change of colors from the top to the bottom of the iMac screen. A solid colored background appears normal at the top of the screen and gradually changes color as your eye approaches the bottom of the screen. At the bottom of the display, the color appears faded or washed out. Medium blue becomes light blue and light colors become white. Apple has refused to acknowledge the problem, and refuses to fix the defect if the computer is out of warranty, which expires one year after purchase.  Unfortunately, consumers who choose to repair the defect can incur costs of more than $600 in parts and labor. Moreover, the defect oftentimes manifests itself months or even years after purchase of a new iMac with a 20” or 24” display.

 

Consumers have posted complaints on various Apple related internet sites, stating that they have had to repair the defective displays at their own expense, that Apple has refused to reimburse them for the expense incurred, and that Apple has refused to exchange defective iMac displays for iMacs with properly functioning displays.

 

If you have an iMac computer with a defective 20” or 24” display which Apple has refused to warrant or fix free of charge, please contact us immediately to discuss your legal options.

Class Action Filed Against Apple For Defective PowerBook Computers

In October, 2008, Meisleman, Denlea, Packman, Carton & Eberz, P.C. filed a class action complaint in federal court in California on behalf of Giorgio Gomelsky and all others similarly situated (the “Class”) alleging that Apple’s PowerBook G4 computers have a widespread and commonplace characteristic defect and design flaw which renders one or more of the PowerBook G4's memory slots inoperative. The defect manifests itself when a PowerBook owner adds additional memory (RAM) to the first or second (upper or lower) memory slot available in the PowerBook G4. Typically, when the additional memory is added, the Powerbook does not recognize the memory, resulting in slower processing speeds, decreased computer function and other computing problems. Unfortunately for consumers, because both memory slots are hardwired to the PowerBook’s motherboard, consumers who choose to repair the defect can incur costs of more than $500 in parts and labor. Moreover, the defect oftentimes manifests itself months or even years after purchase of a new PowerBook and/or installation of memory (RAM) in a memory slot.

 

In response to thousands of complaints from its PowerBook customers, Apple has admitted that its PowerBooks, specifically certain PowerBook G4 models, have defective memory slots. Aside from a limited number of PowerBooks manufactured between January, 2005 and April, 2005, however, Apple has refused to repair the defect which has manifested itself in PowerBooks manufactured before and after this time period. As a result of Apple’s actions, thousands of its customers have purchased PowerBook computers with defective memory slots. Apple has refused to repair the defect free of charge, and has refused its customers’ requests for refunds or exchanges of their defective PowerBooks.   As such, thousands of Apple PowerBook owners have been compelled to either repair the defective memory slot at their own expense or lose permanently the ability to add additional memory to their computers.

 

Consumers have posted complaints on various Apple related internet sites, stating that they have had to repair the defective memory slot at their own expense, that Apple has refused to reimburse them for the expense incurred, and that Apple has refused to exchange defective PowerBooks for PowerBooks with properly functioning memory slots. Moreover, an online petition has been initiated by Apple customers who have purchased PowerBooks with defective memory slots, and which Apple has refused to repair. As of November, 2008, almost 5,000 PowerBook owners have signed the petition, demanding that Apple repair the defective memory slots or reimburse the petitioners for expenses incurred in repairing the memory slots.

 

This class action lawsuit is brought on behalf of a nationwide class of all persons who have purchased Apple PowerBook G4 computers manufactured with defective memory slots. The lawsuit seeks compensatory damages, reimbursement of expenses incurred by consumers to repair defective memory slots or the repair of defective memory slots by Apple free of charge.

 

If you have a PowerBook G4 computer with one or more defective memory slots which Apple has refused to warrant or fix free of charge, please contact us to discuss your legal options.