Current Events in December 2009

Lots of older adults who purchase the herbal supplement Ginkgo biloba, in hopes it will keep them mentally sharp, may be wasting their money. That's the finding of researchers reporting their results in the latest issue of the Journal of American Medicine.

"Ginkgo biloba is marketed widely and used with the hope of improving, preventing, or delaying cognitive impairment associated with aging and neurodegenerative disorders such as Alzheimer disease," the authors write. "Indeed, in the United States and particularly in Europe, Gingko biloba is perhaps the most widely used herbal treatment consumed specifically to prevent age-related cognitive decline."

However, evidence from large clinical trials regarding its effect on long-term cognitive functioning is lacking.

Beth E. Snitz, Ph.D., of the University of Pittsburgh, and colleagues analyzed outcomes from the Ginkgo Evaluation of Memory (GEM) study to determine if Gingko biloba slowed the rate of cognitive decline in older adults who had normal cognition or mild cognitive impairment at the beginning of the study.

The GEM study previously found that Gingko biloba was not effective in reducing the incidence of Alzheimer dementia or dementia overall. The randomized, double-blind, placebo-controlled clinical trial included 3,069 community-dwelling participants, ages 72 to 96 years, who received a twice-daily dose of 120-mg extract of Gingko biloba or identical-appearing placebo.

The study was conducted at six academic medical centers in the United States between 2000 and 2008, with a median (midpoint) follow-up of 6.1 years. Change in cognition was assessed by various tests and measures.

In this study, the largest randomized controlled trial of Gingko biloba to report on outcomes to date, the researchers said they found no evidence for an effect of Gingko biloba on global cognitive change and no evidence of effect on specific cognitive domains of memory, language, attention, visuospatial abilities and executive functions.

They also found no evidence for differences in treatment effects by age, sex, race, education or baseline cognitive status.

"In sum, we find no evidence that Gingko biloba slows the rate of cognitive decline in older adults. These findings are consistent with previous smaller studies examining prevention of decline and facilitation of cognitive performance and with the 2009 Cochrane review of Gingko biloba for dementia and cognitive impairment."

As Americans fight through the most stressful time of the year, Ford Motor Company and the Massachusetts Institute of Technology (MIT) are teaming up to study driver workload and identify new opportunities to use in-vehicle technologies to improve driver safety by lowering stress.

The idea is to see how the car can potentially enhance overall human wellness, become an oasis from stressful situations, and increase driver attention and safety.

Partnering with MIT's AgeLab, the project will identify specific stress-inducing driving situations, monitor a driver's reaction to the situations using biometrics, and evaluate methods to incorporate new stress-reducing features into the next generation of Ford products.

A six-month effort beginning this January will focus on human interaction with a specially equipped 2010 Lincoln MKS, a vehicle already recognized for its advanced safety features.

"We strongly believe that driving can be made safer by reducing the stress load placed on a driver," said Jeff Rupp, Ford manager, Active Safety Research. "Through the use of our existing technologies such as Adaptive Cruise Control with Collision Warning or SYNC, our voice-activated communications system, we are proactively guiding drivers away from difficult situations."

"The goal of this program is to take this one step further by creating the most comfortable driving environment possible so that our driver is always relaxed, calm and able to perform at peak performance," added Rupp.

The current undertaking is the next step in the effort to study and, eventually, significantly improve driver wellness. Ford and MIT's AgeLab, in conjunction with the U.S. Department of Transportation's New England University Transportation Center, have been working since 2004 to develop vehicle systems that detect the state of a driver at key points in time. The project expects to use this information to adjust systems in the car in ways that reduce driver stress. One of the goals is to make driving as enjoyable as it used to be.

"Today's driver is feeling a greater level of anxiety than in the past, both from situations inside and outside the vehicle," said Joseph Coughlin, founder and director of AgeLab and the leader of the initiative. "This arises in part from the chronic stress in individuals' daily lives combined with longer commute times, increased driving demands due to traffic congestion and deteriorating infrastructure."

By monitoring biometrics such as heart rate, skin conductivity and eye movement, researchers at MIT have been working to develop a specific set of parameters for an embedded detection system that could be engineered into future Ford vehicles.

"Increasing human-vehicle connectivity through biometrics may provide the next major breakthrough in vehicle safety and lead the development of aware vehicle systems," said Bryan Reimer, an AgeLab research scientist working on the project.

Ford and MIT expect to conclude this phase of the study in July 2010. Findings of the study will be made public shortly after its conclusion.

December 30, 2009
LG Electronics is recalling about 98,000 portable dehumidifiers. The power connector for the dehumidifiers compressor can short circuit, posing fire and burn hazards to consumers.

LG has received 11 reports of property damage incidents involving arcing, heat, smoke, including four fires that spread to the building structure and involved significant smoke/water damage. No injuries have been reported.

This recall involves 30-pint portable dehumidifiers sold under the brand names in the chart below. The dehumidifiers are white with a red shut-off button, controls for fan speed and humidity control and a front-loading water bucket. Goldstar or Comfort-Aire is printed on the front. The model and serial numbers are printed on the interior of the dehumidifiers and can be viewed after the water bucket is removed.

The dehumidifiers were sold at The Home Depot, Walmart and Heat Controller Inc. nationwide from January 2007 through June 2008 for between $140 and $150. They were made in China.

Consumers should immediately stop using the recalled dehumidifier, contact LG to determine if it is included in the recall and return it to an authorized LG service center for a free repair.

For additional information, contact LG toll-free at (877) 220-0479 between 8 a.m. and 7 p.m. CT Monday through Friday and between 8 a.m. and 2 p.m. CT on Saturday for the location of an authorized LG service center for the repair, or visit the firms Web site at www.30pintdehumidifierrecall.com

The recall is being conducted in cooperation with the U.S. Consumer Product Safety Commission (CPSC).

A class action filed in California yesterday says that software unilaterally installed by BMW on several turbocharged models led to dangerous turbo lag and other engine problems.

The suit, brought in the U.S. District Court for the Central District of California, implicates the BMW 1-, 3-, and 5-Series lines, as well as the Z4 convertible, X5 sport utility, and X6 crossover. All subject vehicles were manufactured between 2007 and 2010 and are equipped with the "N54" engine, a three-liter six-cylinder motor equipped with a twin turbo.

According to the suit, BMW tried to remedy an "undisclosed defect" with the cars by installing an updated version of its so-called "Engine Control Unit" (ECU) software. The defect allegedly originated in the cars' turbochargers, fuel pumps, gas waste mechanisms, and/or turbo software.

The plaintiffs contend that BMW installed the updated ECU software without customers' permission and, in some cases, without their knowledge. The complaint says that BMW installed the software "whenever one of the vehicles in question appeared in the service department of a BMW dealership, regardless of the reason for the service visit." Thus, consumers who experienced "problems with loud rattling...under the hood," for example, were unwittingly outfitted with updated ECU software and sent on their way.

Shortly after the software update, consumers began to complain of engine problems, specifically "loss of power in the lower RPM [revelations per minute] range, decreased fuel efficiency, and most notably, turbo acceleration lag."

Turbo lag, a little-known but potentially dangerous phenomenon, describes a delay between the time a turbocharged car's accelerator is depressed and the time its engine develops enough power to properly accelerate. Turbo lag presents an especially serious risk if it occurs on a highway on-ramp or other area where traffic is moving quickly.

According to the suit, BMW at first dismissed consumers' complaints, assuring them that their respective experiences were "normal." As the complaints continued to grow in number, BMW allegedly installed more ECU updates in a futile attempt to make the problems go away. The plaintiffs also contend that BMW quietly did away with ads bragging that the automaker "eliminated turbo lag altogether."

The class is being represented by Wayne Barney of Orange County. Barney began experiencing turbo lag after his 2007 BMW 335i was serviced for a faulty fuel pump. Barney communicated his concerns to BMW several times, but was "repeatedly assured that he was mistaken about the existence of any problems."

The suit alleges breach of implied and express warranties; breach of the covenant of good faith and fair dealing; deceptive trade practices; and breach of the Magnuson-Moss Act, a federal statute that governs consumer product warranties. The plaintiffs accuse BMW of "us[ing] ECU software to deceive its customers and avoid the cost and labor of properly resolving the hardware problems, which required actual engine work and/or part replacement that was covered under BMW's warranty." The class is seeking compensatory damages and an injunction.

In many cases by the time Parkinson's disease is diagnosed, irreparable damage is already done.

But now, new research by a team of neurologists finds that the manner in which people walk -- including irregular arm swings -- may be a very early marker for the disease.

"This type of early detection research will be critical to advancing the science of therapeutic interventions hoping to slow disease progression," National Parkinson Foundation spokesman Peter N. Schmidt told ConsumerAffairs.com. "Further, the National Parkinson Foundation is supporting the introduction of such quantitative measures and has launched a major initiative around tracking the progression of such measures throughout the course of the disease."

Parkinson's is an age-related disorder involving loss of certain types of brain cells and marked by impaired movement and slow speech.

Xuemei Huang, associate professor of neurology at the Penn State Hershey College of Medicine, believes this kind of early detection may help physicians apply treatments to rein in further brain cell damage until strategies to slow disease progression are available.

"The disease is currently diagnosed by tremors at rest and stiffness in the body and limbs," Huang says. "But by the time we diagnose the disease, about 50 to 80 percent of the critical cells called dopamine neurons are already dead."

The new research, findings of which appear in the current issue of Gait and Posture, confirms Huang's clinical impression that in people with Parkinson's, one arm swings much less than the other as a person walks.

"We know that Parkinson's patients lose their arm swing even very early in the disease but nobody had looked using a scientifically measured approach to see if the loss was asymmetrical or when this asymmetry first showed up," says Huang.

"Our hypothesis is that because Parkinson's is an asymmetrical disease, the arm swing on one arm will be lost first compared to the other," Huang adds.

The researchers compared the arm swing of 12 people diagnosed three years earlier with Parkinson's, with eight people in a control group.

The Parkinson's patients were asked to stop all medication the night before to avoid influencing the test results.

The team used special equipment to measure movement accurately, including reflective markers on the study participants and eight digital cameras that captured the exact position of each segment of the body during a walk.

"Images from the cameras were sent to a computer where special software analyzed the data" explains Huang. "When a person walks, the computer was able to calculate the degree of swing of each arm with millimeter accuracy."

Analysis of the magnitude of arm swing, asymmetry, and walking speed revealed that the arm swing of people with Parkinson's has remarkably greater asymmetry than people in the control group; one arm swung significantly less than the other in the Parkinson's patients.

When the participants walked at a faster speed, the arm swing increased but the corresponding asymmetry between them remained the same.

"We believe this is the first demonstration that asymmetrical arm swings may be a very early sign of the disease," says Huang.

While slightly irregular arm swing occurs in people without Parkinson's, the asymmetry is significantly larger in those suffering from the disease.

"Our data suggests that this could be a very useful tool for the early detection of Parkinson's," notes Huang.

"There are wide scale efforts to find drugs that slow cell death. When they are found, they could be used in conjunction with this technique to arrest or perhaps cure the disease because they could be given before great damage has occurred."

The voluntary recall of Tylenol Arthritis Pain Caplets is being expanded.

McNeil Consumer Healthcare and the Food and Drug Administration (FDA) FDA say the recall now includes all available product lots of the medication's 100-count bottles, with the distinctive red EZ-OPEN CAP.

The recall was launched back in November because of consumer reports of an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea.

The odor is caused by the presence of a chemical -- 2,4,6-tribromoanisole -- believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this compound have not been well studied, and to date all of the observed events reported to McNeil were temporary and non-serious.

Lot numbers in the expanded recall include:

• 07CMC011, 07DMC022, 07DMC024, 07FMC032, 07FMC033, 07GMC038,

• 07GMC039, 07HMC045, 07HMC051, 07HMC053, 07JMC064, 07JMC069,

• 07JMC070, 07JMC071, 07XMC055, 07XMC058, 07XMC062, 08AMC002,

• 08AMC005, 08CMC026, 08DMC029, 08EMC037, 08EMC039, 08FMC044,

• 08FMC045, 08GMC050, 08GMC053, 08GMC063, 08GMC065, 08JMC103,

• 08JMC109, 08JMC110, 08JMC111, 08KMC124, 08KMC127, 08KMC131,

• 08KMC132, 08XMC093, 08XMC094, 08XMC095, 09AMC010, 09CMC041,

• 09EMC075, 09EMC079, 09EMC076, 09GMC096, 09GMC097, 09GMC099,

• 09JMC118, 09JMC126, 09KMC133, 09KMC134, 09XMC114, 09XMC116

The Tylenol Arthritis Pain Caplet 100-count product lot numbers can be found on the side of the bottle label.

Consumers who purchased the medication from the lots included in this recall should stop using the product and contact McNeil for instructions on a refund or replacement.

For these instructions or information regarding how to return or dispose of the product, consumers should call 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) or visit the company Web site at www.tylenol.com.

Consumers who have medical concerns or questions should contact their healthcare provider. Any adverse reactions may also be reported to the FDA's MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Spectranetics Corporation, a Colorado-based medical device manufacturer, has agreed to pay the federal government $4.9 million in civil damages plus a $100,000 forfeiture to resolve claims against the company.

The U.S. Justice Department says the claims arise from allegations that the company illegally imported unapproved medical devices and provided them to physicians for use in patients, conducted a clinical study in a manner that failed to comply with federal regulations and promoted certain products for procedures for which the company had not received Food and Drug Administration approval or clearance.

The company manufactures, distributes and sells certain medical lasers and peripheral devices for those lasers. The government's probe centered specifically on the CVX-300 Medical Laser and the CliRpath Turbo Laser Catheter, the TURBO Elite Laser Ablation Catheter, and the TURBO-Booster Laser Guide Catheter.

In resolving this matter, Spectranetics has entered into a civil settlement agreement and a non-prosecution agreement with the Justice Department and a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services.

According to the non-prosecution agreement, officers and employees who acted on behalf of the company engaged in multiple areas of wrongdoing. Specifically, Spectranetics illegally imported unapproved medical devices from overseas manufacturers and distributed those devices for use in human patients, and failed to meet its reporting obligations to FDA regarding a study named "CORAL" (COronary graft Results after Atherectomy with Lasers) and another associated study in connection with some of its devices.

Under the terms of the non-prosecution agreement, Spectranetics has accepted responsibility for its conduct, has instituted remedial measures to prevent this conduct in the future, and will continue to cooperate in the ongoing criminal investigation. Under the agreement, Spectranetics escapes criminal prosecution. Under the civil settlement agreement, the government asserts that Spectranetics caused false claims to be submitted to the Medicare Program during portions of the time period from 2003 to 2008.

"It is important to hold those who submit false claims to Medicare responsible for their actions," said U.S. Attorney David Gaouette. "Settlements such as this help to protect the integrity of the Medicare system."

Marketers hawking extended auto warranties of dubious value are increasingly coming under scrutiny by law enforcement. Since many of these campaigns are aimed at senior citizens, many state attorneys general have stepped up their efforts to prevent fraud.

In Missouri, Attorney General Chris Koster has sued four more companies he says were selling bogus auto warranty products.

Koster said the businesses he has filed suit against today used misleading telemarketing, letters, and postcards to market what appeared to be "extended auto warranties" to consumers, but actually were "service contracts" or "automotive additives."

He said the businesses would lead consumers to mistakenly believe their current vehicle warranties were about to expire and that they would not have another opportunity to purchase an extended warranty unless they acted immediately. Many potential customers were not informed that the businesses were not affiliated with the dealership or manufacturer from whom the customers bought their vehicles.

Many consumers were unaware they were not actually purchasing auto warranties until they received an auto additive in the mail. The companies sold the products as auto additives to avoid Missouri's service contract laws, which provide some minimal protection for consumers. Consumers did not realize the limited value of the products they were purchasing.

"This extended warranty scam is nothing but a 'bait and switch' scheme that preys on consumers' fears having inadequate vehicle warranty coverage," Koster said. "The 'bait' is to lure vulnerable consumers into extending or purchasing 'auto warranties.' Then the 'switch' is to sell them service contracts, or worse, auto additive warranties with inferior or negligible repair coverage, then making it almost impossible for the consumers to cancel the contract or get refunds.

"I believe this warranty business is rampant with fraud, and Missouri continues to be at the center of this deception," Koster said. "This office will continue to pursue and prosecute businesses such as these that target unsuspecting, innocent consumers."

Koster filed lawsuits against six companies using these scams in November.

The four businesses Koster sued are:

• Carhill Enterprises, Inc., d/b/a Consumer Protection Services, St. Louis

• CarSafe, LLC, d/b/a Dealer Preferred Warranties, LLC, St. Charles

• Dealership Services, St. Louis

• Dealership Warranties, Inc., St. Louis County

Koster is asking the court to issue preliminary and permanent injunctions requiring the companies to comply with Missouri's Merchandising Practices Act; provide full restitution to victims and to the state; and pay civil penalties and court costs.

December 29, 2009
Six persons connected to a Jackson, Miss., nursing home have been arrested and charged with exploiting vulnerable adults.

Mississippi Attorney General Jim Hood, who announced the arrests, said the six were either employees of the Belhaven Senior Care facility or owned the company.

Those arrested are:

• Ponchie McCollough, age 36, of 308 William McKinley, Jackson, MS, a social worker with the facility, was indicted on one count of conspiracy and 19 counts of Felony Exploitation of a Vulnerable Adult. McCollough remains in jail and bond has not been set, but arraignment is set for January 8, 2010.

• Brad Burt, age 35, of 688 Watts Lane, Brookhaven, MS, an administrator with the facility, was indicted on one count of felony exploitation of a vulnerable adult and 14 counts of accessory after the fact in felony exploitation of a vulnerable adult. He is currently out on $75,000 bond.

• Justin Johnson, age 30, of 23 Meadowbrooke Rd, Natchez, MS, Director of Operations for Trend Consultants (owner of Belhaven Senior Care), was indicted on 14 counts of accessory after the fact in felony exploitation of a vulnerable adult. He is currently out on $25,000 bond.

• Tina Brewer, age 43 of 2017 Eleanor4 St, Vidalia, LA, AR Billing Specialist for Trend Consultants, was indicted on 14 counts of accessory after the fact in felony exploitation of a vulnerable adult. She is currently out on $25,000 bond.

• Jessica McKinney, age 21, of 1921 Chandler Drive, Jackson, MS, a friend of McCollough, was indicted on one count of conspiracy and two counts felony exploitation of a vulnerable adult. Bond has been set at $5,000.

• Madeline Floyd, age 23 of 1256 Woodvillage Apartments, Jackson, MS, a friend of McCollough, was indicted on one count of conspiracy and one count of felony exploitation of a vulnerable adult. Floyd's bond was set at $5,000, but she remains in jail.

In each case, McCollough is alleged to have misappropriated resident's funds under the guise of spending down accumulated funds so that residents would not lose Medicaid benefits. The funds, however, were not used for the residents needs, but were allegedly retained by McCollough and other defendants.

Once the matter was discovered by officials of Trend Consultants, some of the defendants are accused of trying to cover up the alleged wrongdoing in an effort to avoid returning the funds to the residents.

"Within the indictments, there are 21 separate incidents of exploitation involving eight residents of Belhaven Senior Care," said Hood, "A total of $25, 785 was taken from the victims."

On December 3, 2009, owners of Trend Consultants agreed to return $25,785.00 to the eight residents and paid a penalty to the State in the amount of $77,355.00. The agreement absolved the corporation, but not the individual employees who are accused of committing crimes individually. Their court dates are pending.

A federal appeals court has upheld the dismissal of a defamation lawsuit filed against ConsumerAffairs.com by Nemet Chevrolet Ltd., a New York City auto dealer.

Nemet, which operates Nemet Chevrolet in Jamaica, Queens, and other dealerships in the New York area, argued that statements published on the ConsumerAffairs.com Website were defamatory and claimed that at least some of the 49 complaints were created by the consumer site rather than by disgruntled customers.

In its notice of appeal, Nemet contended that U.S. District Court Judge Gerald Bruce Lee of the Eastern District of Virginia erred by dismissing Nemet's lawsuit and a subsequent amended complaint.

But in its opinion, the U.S. Court of Appeals for the Fourth Circuit said Nemet's pleading "does not show, or even intimate" that ConsumerAffairs.com contributed to the allegedly fraudulent nature of the complaints.

As to Nemet's claims regarding the alleged "drafting or revision" of complaints by ConsumerAffairs.com, the appeals court said it found the claims "threadbare."

ConsumerAffairs.com argued that it has immunity from defamation and tortious interference under section 230 of the Communications Decency Act, which was enacted by Congress to preserve the "vibrant and competitive free market" of ideas on the Internet.

'Victory for consumers'

"We are grateful to the Court for protecting our readers' right to free expression," said ConsumerAffairs.com President and Editor In Chief James R. Hood. "This is a victory for consumers who every year become more adept at sharing and seeking out mutually beneficial information through the Internet."

"We believe that our site, and the many other review, complaint and opinion sites on the Internet, serve as an invaluable asset not only to consumers but to businesses who seek to provide the highest possible levels of service and quality to their customers," Hood said.

Nemet had sought injunctive relief and $500,000 in damages and $1,500,000 in punitive damages.

The long-running case was not the first time Nemet has sued the consumer site. In July 2006, the company filed suit in New York Eastern District Court in Brooklyn. That case was dismissed Oct. 11, 2006 by Judge Brian M. Cogan.

Tamiflu, the anti-flu drug being snapped up in record amounts, does not prevent serious complications from the flu and should not be used for routine control of the flu in healthy adults, according to Public Citizen.

The group is calling for an independent review of raw data from clinical trials funded by Tamiflu's maker, Roche. The company has claimed that the drug dramatically reduced hospital admissions as well as bronchitis and pneumonia. But a recent investigation by the British Medical Journal and British TV Channel 4 concluded that such claims were meritless.

In the wake of widespread media coverage of the H1N1, or swine flu, virus, Tamiflu sales have skyrocketed. In October, 2.5 million prescriptions were filled in the U.S. compared with just 35,000 prescriptions in October 2008. For the past 12 months, 6.8 million prescriptions were written, compared with 4.3 million the previous 12 months.

"Tamiflu is being erroneously peddled as a panacea to flu," said Sidney Wolfe, M.D., director of Public Citizen's Health Research Group. "In fact, no research exists to support this in healthy adults. At best, it can modestly reduce some minor flu systems in such people for a day."

FDA spokeswoman Patricia El-Hinnawy tells ConsumerAffairs.com that "controlled clinical trials conducted among outpatients with acute uncomplicated seasonal influenza reported a reduction of approximately 1 day in the duration of illness when antiviral treatment with oseltamivir (Tamiflu) was initiated within 48 hours of illness compared with placebo."

All of the clinical research conducted to determine the effectiveness of Tamiflu on healthy adults has been funded by the drug's manufacturer, Roche, Public Citizen said. The British investigation involved a review of all published studies examining the effects of Tamiflu in preventing serious complications of the flu in otherwise healthy adults.

The authors concluded that we "have no confidence in claims that [Tamiflu] reduces the risk of complications and hospital admission in people with influenza," and they wrote that it should not be used in routine control of seasonal influenza. There was also concern about underreporting of side effects of the drug.

El-Hinnawy responds that "a manufacturer conducts clinical trials according to FDA requirements, as part of the application for approval of a drug. The data from the trials are reviewed as part of the application 'package'." She adds that "if claims are being made by the company that are not substantiated by the data we reviewed, then the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) would become involved, but, nothing at this point in time would lead us to require an independent review of the data./p>

Although the data available were gathered before the H1N1 virus made its appearance, the results can probably be extrapolated to H1N1 because it is another variety of flu, Wolfe said.

El-Hinnawy notes that there are some observational studies in the published literature assessing potential benefits of Tamiflu in reducing complications, including deaths, among hospitalized patients with 2009 H1N1. But, she says, "There are limitations to these studies and therefore they are not generally included in product labeling."

December 26, 2009
The U.S. Food and Drug Administration has sent a warning letter to Nestle HealthCare Nutrition, admonishing it against promoting its BOOST Kid Essentials Nutritionally Complete Drink as a medical food.

The letter said the company has improperly labeled the dirnks on its Web site as treatment for the medical condition failure to thrive. The FDA said under regulations, the product is mis-branded because the label is false or misleading in that the product is labeled and marketed as a medical food but does not meet the statutory definition of a medical food under the Orphan Drug Act.

The therapeutic claims on your website establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease, the letter states. The marketing of this product with these claims violates the Act.

Misbranded Food

The Orphan Drug Act defines "medical food" as "a food which is formulated to be consumed or administered internally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation."

FDA said it considers the statutory definition of "medical food" to narrowly constrain the types of products that fit within this category. In addition to other criteria, medical foods must be for the dietary management of a specific disorder, disease, or condition for which there are distinctive nutritional requirements and must be intended to be used under medical supervision.

There is no evidence that patients with the medical condition of "failure to thrive" have distinctive nutritional requirements or unique nutrient needs, as required by the statute, the FDA said. No established distinctive nutritional requirement exists for the conditions for which your product is promoted as a medical food, and your BOOST Kid Essentials Nutritionally Complete Drink product therefore does not meet the statutory or regulatory definition of a medical food. Accordingly, your product is misbranded.

In a separate letter, the FDA warned Nestle that it had made unauthorized nutrient content claims about Juicy Juice Brain Development Fruit Juice Beverage, Juicy Juice All-Natural 100% Juice Orange Tangerine and Juicy Juice All-Natural 100% Juice Grape. The agency said Nestle used the statement "no sugar added" on the brain development drink. That type of claim is not permitted for foods intended for children under age 2, the letter said.

When word got out that Verizon was increasing its contract early termination fees (ETFs) to as high as $350 for its high-end phones, the Federal Communications Commission (FCC) wanted answers. And now that it's finally gotten a response, at least one Commissioner isn't happy with what they received.

Verizon's senior vice-president for regulatory affairs, Kathleen Grillo, said that the increased termination fees were necessary due to the higher costs of marketing and advertising smartphones, in addition to the actual costs of subsidizing the handsets themselves.

"Verizon Wireless incurs additional costs to sign up customers, such as advertising costs, commissions for sales personnel, and store costs," she wrote. "These costs are higher for Advanced Devices: for example, it takes more time (and hence increases the cost to Verizon Wireless) for sales and customer care representatives to handle customer inquiries regarding the complex advanced features and functionalities of Advanced Devices."

That answer didn't make new Commissioner Mignon Clyburn very happy. In her response, she said that Verizon had a "shifting and tenuous rationale" for its actions.

"Consumers already pay high monthly fees for voice and data designed to cover the costs of doing business," she said. "So when they are assessed excessive penalties, especially when they are near the end of their contract term, it is hard for me to believe that the public interest is being well served."

Clyburn also had questions about Verizon's Mobile Web service. Consumers and tech reporters had noted that the service's usage plan kicked in the moment you accessed the service, even if done accidentally or only for a moment, and the resultant $1.99 charge was a hidden fee for Verizon.

In the telecom's response, Grillo said that "In order to protect customers from minimal, accidental usage charges, Verizon Wireless does not charge users when the browser is launched, and opens to the Verizon Wireless Mobile Web homepage. If the browsing session ends there without the customer navigating to another webpage, the customer will not incur charges for Mobile Web browsing."

Clyburn was unconvinced, saying that "recent press reports and consumer complaints strongly suggest otherwise."

Verizon's ETF hike has put the issue back in the hot seat in recent weeks. For many years, wireless companies have claimed that ETFs were necessary to subsidize the costs of handsets, while critics claimed they were a tactic designed to lock consumers into long-term contracts while companies reaped profits.

A recent report by the Government Accountability Office (GAO) found that 42 percent of wireless customers surveyed would not switch from their current carrier to another for fear of incurring a termination fee. The GAO also criticized the FCC for not doing enough to investigate complaints about wireless service by customers.

Advocacy groups such as Consumer Action have been pushing consumers to pay attention to contract changes and new additions to their terms of service, which can often be used to escape a cell phone contract without penalty -- but only with savvy negotiation.

Those computer pop-ups that drive us all nuts are more than just annoying: they can be dangerous.

The FBI is warning consumers that pop-up security messages that appear while you are online may contain a virus that could harm your computer, cause costly repairs or -- even worse -- lead to identity theft. The messages contain scareware -- fake or rogue anti-virus software that looks authentic.

The message may display what appears to be a real-time, anti-virus scan of your hard drive. The scareware will show a list of reputable software icons; however, you can't click a link to go to the real site to review or see recommendations.

Cyber criminals use botnets -- collections of compromised computers -- to push the software, and advertisements on websites deliver it. This is known as malicious advertising or "malvertising."

Once the pop-up warning appears, it can't be easily closed by clicking the "close" or "X" buttons. If you click the pop-up to purchase the software, a form to collect payment information for the bogus product launches. In some instances, the scareware can install malicious code onto your computer, whether you click the warning or not. This is more likely to happen if your computer has an account that has rights to install software.

Downloading the software could result in viruses, malicious software called Trojans, and/or keyloggers -- hardware that records passwords and sensitive data -- being installed on your computer. Malicious software can cause costly damages for individual users and financial institutions. The FBI estimates scareware has cost victims more than $150 million.

Sandra from Alvarado, TX, knows exactly what the FBI is talking about. "This pop-up starts scanning your computer and tells you you have a virus, and asks if you want to get rid of it," she writes ConsumerAffairs.com. "It looks like your own security such as Norton, McAfee, and AVG. If you tell it yes it attaches to your computer, when you realize it is not your security product, and you try to uninstall it, it is almost impossible.

This version "blocked every program I tried to go into, Sandra says. "It would not let me put in passwords, told me they were unsafe programs. If you go to the home page for 'personal anti-virus,' they want you to pay $59.95 for the program. To get rid of it I had to go into program files, because the uninstall icon it put on the screen would not work."

Because cyber criminals use easy-to-remember names and associate them with known applications, the FBI advises consumers to research the exact name of the software being offered. In addition, precautions should be taken to ensure operating systems are updated and security software is current.

Consumers receiving these anti-virus pop-ups should close the browser or shut down the computer system and run a full anti-virus scan whenever the computer is turned back on.

Anyone experiencing the anti-virus pop-ups or a similar scam is urged to notify the Internet Crime Complaint Center (IC3) by filing a complaint at www.ic3.gov.

It's a big problem that comes in a small package -- the "Chihuahua" problem.

California animal shelters are overflowing with the tiny dogs popularized by such movies as "Beverly Hills Chihuahua" and "Legally Blonde." But animal control officials hope pet lovers in that state and others will give these Chihuahuas a home for the holidays.

"We probably have more than 20 Chihuahuas in our shelter," said Deb Campbell with San Francisco's Animal Care and Control. "There're just so many of them. And people are bringing them in pretty much daily."

Campbell's shelter isn't the only one in the Golden State with a burgeoning population of abandoned Chihuahuas. "This seems to be consistent with just about all California shelters," Campbell told ConsumerAffairs.com. "Southern California is experiencing the same thing and many shelters in the bay area are overflowing with Chihuahuas."

Earlier this month, San Francisco's Grateful Dogs Rescue group said 31 of the 66 dogs in its foster care program were Chihuahuas or Chihuahua-mixes. The "featured dog" on its Web site today was a Chihuahua-mix named Cecil.

"Must-have dogs"

Campbell and other animal control officials attribute part of the "Chihuahua problem" to movies and advertisements that prominently feature the "Taco Bell" dogs. All that exposure, coupled with pictures of celebrities sporting their Chihuahuas, transformed the breed into trendy must-have dogs.

"A lot of breeders feed into whatever dog is in the media and crank them out to meet demand," Campbell said. "But they went overboard. Backyard breeders also jumped on board and pretty soon, the number of dogs out there had gone past the demand."

The ailing economy has also played a major role in this Chihuahua problem, Campbell said. "The downturn in the economy has affected a lot of people with pets," she said. "Many pets are now being left at shelters, and all shelters are being flooded with animals."

"It's horrible that so many people are being forced to give up their animals," she added. "These are animals that have been loved members of the family. These people are devastated. It's so sad that they can't care for the pets anymore."

Campbell encouraged anyone looking for a Chihuahua or other dog this holiday season to consider getting one from a shelter.

"We've recently had people come in with purebreds that have AKC (American Kennel Club) papers," she said. "Most people think they can only find big, bruising dogs, like Chows and Pit Bulls, at a shelter. They don't think you can find small, lap dogs or purebreds at the shelter. But consumers can go to just about any shelter and find a Chihuahua or a great small dog to adopt."

Twelve of the Chihuahuas in Campbell's shelter were scheduled to be airlifted on Tuesday to New York. But the snow storm that blanketed the East Coast over the weekend delayed those plans.

"We're now looking at flights in early January," Campbell said, adding Virgin America airlines agreed to transport the dogs free of charge. But why fly the dogs across the country to New York?

"While we are overflowing with Chihuahuas in California, there seems to be a lack of them on the East Coast," Campbell said.

Earlier this month, she and other humane workers in California asked the public to help them with the unprecedented number of Chihuahuas in their shelters. They had one simple wish: Find these dogs a home for the holidays.

"We adopted six right after our press conference and then five more about a week later," Campbell said. "We then heard from shelters on the East Coast that wanted the dogs."

Campbell's shelter is now working with the American Society for the Prevention of Cruelty to Animals (ASPCA) in New York to place many of the Chihuahuas.

"After our appeal, [the New York ASPCA was] overwhelmed with calls from people wanting our dogs," Campbell said. "So there's definitely a need there."

Puppy mill problems

Getting a dog at a shelter, instead of a pet store or Web site, is also a message the Humane Society of the United States (HSUS) is spreading this holiday season.

Consumers who buy a dog from a pet store or online vendor, the animal rights organization warned, could unknowingly fuel the billion-dollar puppy-mill industry.

Puppy mills are mass commercial breeding operations that churn out two to four million puppies each year, the HSUS said. Those puppies, they said, are raised in deplorable conditions and often have health problems, genetic defects, and behavioral issues.

"The Humane Society of the United States braces itself every year for the upsetting calls that come in right after the holidays," says Stephanie Shain, senior director of the puppy mills campaign for HSUS. People call about sick or dying puppies who were purchased for the holidays.

"We encourage people who want a new pet to first consider adoption from local shelters and rescue groups, which are filled with healthy, loving dogs who need a family of their own this holiday."

During a November 2008 interview with ConsumerAffairs.com, Shain predicted that puppy mills would soon start churning out Chihuahuas. Her comments came shortly after the release of "Beverly Hills Chihuahua."

"The breed all depends on what public wants," she told us. "It's driven by consumers' demands. And we have concerns about Chihuahua right now. When any breed gets that much media attention, there is a huge surge in demand and people wanting to capitalize on that demand."

Campbell and other California shelters are now dealing with the consequences of unscrupulous breeders who exploited the demand for Chihuahuas and cranked out too many of the little dogs for their financial gain.

But the shelters are commitmented to finding good homes for all the Chihuahuas and the other dogs and cats in their facilities.

"These Chihuahuas are still available for adoption and consumers can come to our shelter and get one or any of our other great dogs," Campbell said. "And we definitely have more cats than dogs, some of which are purebred."

"My message to pet owners looking for a dog this holiday season is to never be afraid to go to a shelter," she added. "It will make an amazing difference in your life and in the life of an animal."

"They're losing money left and right"

Companies such as the Hartz Mountain Corporation are stepping forward to help animal shelters weather the economic climate.

In July, Hartz pledged to donate more than three million dollars in pet supplies and treats to animal shelters and food banks across the U.S. and Canada. The company is also soliciting help from pet lovers to nominate local animal shelters and food banks for donations of pet supplies.

"The economic downturn has had a profound effect on the financial welfare of families, many of whom have been forced to surrender their beloved pets to shelters," said Bob Shipley, Hartz Senior Vice President of Customer Relations Development. "Yet shelters report that donations are down by as much as 30 percent."

"We hope that our Hartz Shelter Program will help shelters feed and care for abandoned animals and enable at-risk families to keep their pets," Shipley added.

Campbell applauds Hartz' commitment to help shelters nationwide. "Shelters are struggling right now," she said. "Contributions are down. They're losing money left and right."

December 22, 2009
Polaris Industries is recalling about 8,500 ATVs from the 2009-2010 model years. The front suspension ball joint stem can separate from the steering knuckle and cause the rider to lose steering control, posing a risk of injury or death to riders.

Polaris has received 19 reports of incidents involving the recalled ATVs. No injuries have been reported.

This recall involves model year 2009 and 2010 Polaris Sportsman ATVs (models listed below) with certain VIN numbers. The ATVs were manufactured between January and August 2009. The VIN number and manufacture date are located on the right front of the ATV on the frame rail next to the front shock.

Polaris dealers nationwide sold the ATVs from February 2009 through November 2009 for between $7,500 and $10,800. They were made in the United States.

Consumers should immediately stop using the recalled ATVs and contact their local Polaris dealer to determine if your model and VIN number are included in this recall and to schedule a free repair. Polaris is directly contacting registered owners about the recall.

For additional information, contact Polaris toll-free at (888) 704-5290 between 8 a.m. to 5 p.m. CT Monday through Friday, or visit the companys Web site at www.polarisindustries.com.

The recall is being conducted in cooperation with the U.S. Consumer Product Safety Commission (CPSC).

December 22, 2009
Attorney General Mike Cox today announced the arrest of three individuals accused of cheating 125 Michigan seniors out of their life savings by selling them time-shares in foreign resort properties that exceeded what were truly available.

Jeffrey Ron Mitchell, 39, of Walled Lake, Robert Valeri, Sr., 59, of South Lyon, and Robert Antonio Valeri, Jr., 32, of Canton allegedly participated with Indiana resident and scam mastermind Michael Kelly in a massive Ponzi scheme, selling time shares in the form of an unregistered security called a "Universal Lease" through a company called Resort Holdings International.

The Attorney General's office accused them of targeting senior citizens and retirees with marketing efforts that illegally promoted the lease as a safe investment opportunity with the promise of large monetary returns.

While seniors purchasing the lease were allegedly given the option to use the vacation property during specified times over a 25 year term, they were also given the option of having a purported third-party management company arrange for the rental of the unit during the same time period for a guaranteed 9 percent return--whether the unit was rented or not. They were encouraged to elect the latter option and everyone who purchased the lease did.

In reality, Kelly also controlled the third-party management company. The investment scheme took in an estimated $350,000,000 nationwide and as much as $9 million in Michigan. It imploded due to deliberate overselling of shares in the Universal Lease program, leaving investors with empty pockets and broken promises.

"Our parents and grandparents spent their lives working hard to provide for their families and to build the Michigan we enjoy today," said Cox. "They deserve to know that their investments are being made safely and that those who would steal from them are being held accountable."

Mitchell, Valeri, Sr. and Valeri were arrested today and are charged with Conducting Criminal Enterprise (Racketeering), a felony punishable by up to 20 years in prison and/or a fine of up to $100,000 and Conspiracy to Sell an Unregistered Security, a felony punishable by up to 10 years in prison and/or a $10,000 fine. Mitchell and Valeri, Sr. are also charged with Selling an Unregistered Security and Omitting to Disclose Material Information during the Sale of a Security, both felonies punishable by up to 10 years in prison and/or a $25,000 fine.

Each were arraigned in 19th District Court before Judge Richard Wygonik and assigned a $25,000 personal bond. Preliminary exams are scheduled for March 19.

Kelly is in federal custody and is facing federal fraud and securities charges.

The federal court has created a restitution fund, and Kelly's assets have been seized and are being controlled by court order. The value of the seized property is estimated at between $160,000,000 and $175,000,000. Michigan residents who were taken in by the Resort Holdings scheme have the opportunity to recover at least a portion of their investment.

Pennsylvania Attorney General Tom Corbett has filed suit against a company he alleges sold thousands of fraudulent warranties to unsuspecting consumers.

Eagle Warranty, based in Eynon, Pa., sold warranties for used cars, working in tandem with dealers in a number of states.

Eagle offered four-year warranties, ranging from $400 to $2,500. According to Corbett's suit, the company authorized a number of repairs but then failed to pay for them, leaving consumers to fend for themselves when confronted with payment demands from repair shops. A number of consumers received checks from Eagle, only to have them bounce when they tried to cash them.

In a statement, Corbett said that consumers "believ[ed] that they were protecting their vehicles and guarding against future repair expenses," but instead have encountered "unanswered calls, unpaid claims, bounced checks, unrepaired vehicles and worthless warranties."

On December 11, Eagle promptly closed its doors, dashing any hope that the company was in the process of getting its act together.

Nils Frederiksen, a Corbett spokesman, told the Scranton Times-Tribune that Eagle boasted on its website of having 65,000 customers. Frederiksen said that Corbett's office is treating all of those customers as "potential victims."

Corbett is seeking compensatory damages and a penalty of up to $3,000 per consumer for violations of the Consumer Protection Law, which renders illegal unfair methods of competition and unfair or deceptive practices used in commerce. The statute gives the attorney general the power to bring a suit whenever he "has reason to believe that any person is using or is about to use any method, act or practice" prohibited by the law.

The suit also requests an injunction barring Eagle from selling any used car warranties until it has fully compensated all of its alleged victims. Corbett has already achieved a preliminary injunction freezing Eagle's bank accounts and other assets; a court will decide on Tuesday whether to extend the injunction.

Corbett's office has received at least 160 complaints about Eagle. ConsumerAffairs.com has received several complaints as well. Bill of Farragut, TN provides a representative account:

"I purchased the extended warranty 18 mos. ago when I purchased a 03 saab 93 from a dealer. There have been alot of mechanical problems ... Chad at Eagle Warranty claims told me they would be responsible for 767.38 ... I have talked to him and left messages at least 20 times since and he refers me to Holley in accounting. The last time she actually answered the phone she said a check would be mailed out on Aug. 17th. It did not happen and she has avoided answering all calls since. I cannot get in touch with her after trying 40 times ... I am out 2200.00 plus a week of car rental that was authorized and not payed for at 150.00, plus 120.00 of cell phone bill over and above our normal plan because of all the calls to Eagle."

Katheryne of Los Angeles, CA, found herself shafted after Eagle shut its doors:

"I purchased a used 2002 Honda Accord on 12/11/08 from Emmons Motor Company of Pasadena, Texas and with this purchased a $1400.00 warranty (4 yrs unlimited mileage and unlimited repairs Liberty plan). Emmons informed me that Eagle Warranty Corp. closed down and that I must file a complaint with Attorney General of Pennsylvania (which I am currently doing). Emmons informed me that there are other consumers in my situation also."

In addition to Eagle, the suit names as defendants Charles Yaskulski, the company's president, and Charles Yaskulski Jr., a vice president and the elder Yaskulski's son.

Eagle provided warranties for dealerships in Pennsylvania, New York, New Jersey, Michigan, Texas, Delaware, Ohio, Rhode Island, South Carolina, Tennessee, Kentucky, and West Virginia.

Consumers who have experienced a problem with an Eagle warranty should call the Consumer Protection Hotline at 1-800-441-2555 or file a complaint at www.attorneygeneral.gov.

New York Attorney General Andrew Cuomo has announced a settlement with three home health agencies that are alleged to have defrauded Medicaid by billing the system for hundreds of unqualified health aides.

The settlement was reached with Brooklyn-based B&H Health Care Services Inc., doing business as Nursing Personnel Home Care; Excellent Home Care Services LLC, also of Brooklyn; and Manhattan-based Extended Nursing Personnel CHHA LLC of Manhattan. Cuomo's suit accused all three of sending hundreds of health aides with little or no training to provide health care for elderly and indigent New Yorkers.

Under the terms of the settlement, the three providers will return $23,963,100 to Medicaid, with $14,377,860 of that going to New York State. It is the largest settlement reached between New York's Medicaid Fraud Control Unit (MFCU) and the state's home health care industry. The MFCU is the largest unit in the Attorney General's criminal division and has the sole responsibility to prosecute wrondoing related to patient care in hospitals and nursing homes, as well as by home health agencies.

In order to become certified, home health aides in New York must complete a program licensed by either the Department of Health or the Department of Education. Any training program requires at least 75 hours of training, 16 of which must be supervised by a registered nurse. Cuomo's investigation revealed that health aides for the three agencies were operating with false credentials, many of which were sold by "schools" purporting to train home health aides. In addition to the civil suit, Cuomo's investigation resulted in convictions for improperly certified aides, the schools that provided their credentials, and the companies that employed them. More prosecutions are pending.

The suit, filed in May 2008, was part of Cuomo's "Operation Home Alone," a three-year-old investigation of home health care agencies in New York. The investigation was aided by allegations from two whistleblowers, who filed claims under both the federal False Claims Act and state laws. The False Claims Act, also known as the "Lincoln Law," encourages individuals to come forward with evidence of fraud against the government by promising them a substantial portion of any eventual recovered damages. The law has netted about $22 billion for the government since 1986, when significant changes to the satute expanded liability against alleged wrongdoers.

In a statement, Cuomo said, "The size of this settlement underscores the seriousness of the allegations and the importance of vigorous oversight of the Medicaid program and the medical care of our loved ones." He went on to assert that home health providers, which are funded by taxpayer dollars, "have an obligation to ensure that the health care workers they employ are qualified for the job."

This week, California Attorney General Jerry Brown announced that he has settled a suit accusing Schering-Plough of its own brand of Medicaid fraud. Brown's suit accused the pharmaceutical giant of inflating the price of drugs, including Albuterol, used to treat ashtma and other breathing problems. Brown's settlement, which netted $21.3 million, is one of three settlements that netted a grand total of $69 million.