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.

New York Consumers Can Reap Millions As Medicaid Or Medicare Whistleblowers

When a medical provider in New York State -- a hospital, doctor, clinic, pharmacy or medical supply company -- commits fraud against New York State, everyone pays.  You, as a taxpayer, end up picking up the state's losses through an increase in your state and local taxes.  But individuals who know of fraud being committed against New York State and/or New York City can put a stop to it by becoming whistleblowers.

 

Under New York State’s (and New York City’s) whistleblower law known as the False Claims Act (“FCA”), a whistleblower can bring a "Qui Tam" lawsuit against companies and individuals that are cheating New York State and/or New York City.   A Qui Tam lawsuit is an action filed by an individual on behalf of the state and/or city under the FCA.

 

In the face of widespread fraud and in an effort to strengthen New York State’s efforts to fight Medicaid fraud, which is driving up spending and taxes at the state and local levels, Senate Republican Leader Dean Skelos announced the creation of the Senate Republican Task Force on Medicaid Fraud.  “There is no excuse for tolerating any fraud in a program that is the fastest-growing and largest single component of state and county budgets,” said Senator Skelos.  “Medicaid fraud drives up state spending and taxes as well as local property taxes.  We must fight fraud aggressively, restore accountability and integrity to the Medicaid program, and ensure that tax dollars are spent wisely to help the people who really need help, not enrich criminals who prey on the system.”

 

“Medicaid fraud is possibly costing New York State taxpayers billions of dollars.  It’s crucial that we act immediately to prevent this type of fraud at the state and local levels,” said Senator Kemp Hannon.  “During a time when every single cent counts, we cannot afford to let the possibility of this amount of money fall through the cracks of the system through fraud and abuse.”

 

Indeed, whistleblowers are rewarded a significant portion of the proceeds collected on behalf of New York State or New York City.  In fact, whistleblowers are entitled to collect at a minimum 15% to 30% of the total amount of the fraudulent money recovered, and many whistleblowers have collected millions of dollars.

 

The widespread problem of Medicaid fraud has been highlighted by several reports issued by the state Comptroller’s office that documented millions of dollars in Medicaid overpayments and billing errors. Chemung County Executive Thomas J. Santulli, President of the New York Association of Counties, said, “Recently, New York City and forty-two New York Counties obtained a victory in federal court against 13 pharmaceutical manufacturers for fraudulent pricing through the Medicaid Program. These types of actions continue to demonstrate the relevance and importance of county governments insuring the integrity of the Medicaid Program in New York.” Moreover, in December, the state Comptroller released the results of an audit that identified as much as $92 million in Medicaid overpayments, billing errors and other problems.

 

If you are aware of Medicaid and/or Medicare fraud being committed against New York State and/or New York city by a doctor, hospital, clinic, pharmacy and/or medical supply company, you may be entitled to a multi-million dollar award.  You can help hardworking New York taxpayers from being cheated -- and earn millions of dollars in the process -- by blowing the whistle on Medicaid and Medicare fraud.

 

If you know or suspect that Medicaid and/or Medicare fraud is being committed in New York, 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.

Is Your Employer Violating The Law By Not Paying Gratuities Earned By You?

A few months ago we published a blog post about employees who are paid by the hour -- particularly low wage workers -- and who are often cheated by their employers.  We pointed out that hourly workers are routinely denied proper overtime pay and are often paid less than minimum wage according to a newly released study based on a survey of workers in New York, Los Angeles and Chicago.

 

But what about workers who are not being paid their tips, even though their employers are charging customers a mandatory gratuity for various services?  Unfortunately, many employees do not realize that they are entitled to receive all, or a significant portion, of gratuities charged by employers to their customers.

 

Indeed, there are millions of workers in the USA that rely on tips for most of their income, and there are well over two million businesses that rely on tipped employees.  According to recent statistics from the U.S. Department of Labor, food and beverage service-related workers held 6.5 million jobs in 2000 alone.  The U.S. Department of Labor estimates in a 2001 study that tips and gratuities may account for well over $5 billion per year being left on plates and tip trays and financed on credit cards.

 

But let's face facts.  Relying on customers' tips for your income is tough.  The average customer doesn't realize how difficult and hard the average waiter, waitress, hair dresser, concierge, cab driver, maitre de or bartender works for their money.  Dealing with and satisfying the general public is one of the most demanding jobs around.  Many, if not most, tipped employees have a tough time making ends meet.

 

So if your employer is withholding gratuities that you’ve earned, you may have a case under The Fair Labor Standards Act ("FLSA").  The Act mandates that gratuities earned by an employee but collected by an employer must be turned over to the hard working employee whom earned it.  If your employer is not doing so, you may have a basis to file a class action suit to recoup the tips earned by you and all other workers at your work site.  Employers who do not manage and properly account for the gratuities earned by their employees and who do not properly pay their employees tips that they have collected on behalf of their workers may in fact be violating the law.

 

If you believe that your employer is withholding gratuities that you’ve earned, 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.