Common Law - The FindLaw Consumer Protection Law Blog

September 2010 Archives

Fisher-Price Recall: 10 Million Toys Recalled

The CPSC and Fisher-Price have announced today, September 30, that they will recall more than 10 million toys. The Fisher-Price recall will include various models of the company's well known toys. The CPSC recommends that parents have children stop using the recalled toys or other products immediately, unless otherwise instructed.

According to the ABCNews report, the list of toys recalled in the United States includes the following:

  • About 7 million Fisher Price Trikes and Tough Trikes toddler tricycles
  • About 950,000 Healthy Care, Easy Clean and Close to Me High Chairs
  • About 100,000 Fisher-Price Little People Wheelies Stand 'n Play Rampway
  • About 2.8 million Baby Playzone Crawl & Cruise Playground, Baby Playzone Crawl & Slide Arcade, Baby Gymnastics Play Wall, Ocean Wonders Kick & Crawl Aquarium (C3068 and H8094), 1-2-3 Tetherball, Bat & Score Goal.

The recalled toys and products have various hazards to children. In the case of the trikes, the CPSC reports on its website the pretend ignition key can cause serious injury, including genital bleeding when a child sits, strikes, or falls on it. The company has received reports of 10 injuries including six who required medical attention.

The highchairs have pegs on the back legs of the chairs that can cause injury if children fall against them. The CPSC has learned of seven children who fell on or against the pegs and needed stitches and one who had a tooth injury.

In the case of the activity centers, the valve attached to the inflatable balls has can become detached and has been found in the mouths of young children which is a choking hazard. The agency has received 46 reports of valves coming off.

The CPSC praises Fischer-Price for doing the "right thing" in recalling the products and offering free replacements. However, CPSC Inez Tanenbaum told Good Morning America today that, "Manufacturers need to build safety into the product from the very beginning so we don't have to recall on the back end."

For more information about the Fisher Price recall, consumers may contact the company at (800) 432-5437 between 9 a.m. and 6 p.m. ET Monday through Friday or visit the firm's website at www.service.mattel.com.

Related Resources:

'SIDS Preventing' Infant Sleep Positioners Dangerous: FDA

Perhaps this is a case where the cure is as bad as the disease. The infant sleep positioners sometimes used by parents to keep babies sleeping on their backs can cause suffocation, according to the FDA. It has been reported that at least 12 children have suffocated in the past 13 years, leading the agency to say the sleep positioners are not safe.

The New York Times reports that in addition to the reports of actual infant deaths, other dangerous situations have occurred where babies have been found in hazardous positions within or next to the sleep positioners. The positioners are made of flat or slanted mats surrounded by bolsters. It is well known that babies who sleep on their backs are at less risk for Sudden Infant Death Syndrome (SIDS). The producers of the sleep positioners claim they can help keep babies on their backs during sleep.

However, The Times reports there has never been a statement from the FDA approving the products as safe for this use. In addition, the agency has said it was not aware of studies that have shown the sleep positioners were proven to prevent suffocation, SIDS or other life-threatening incidents.

“To date, there is no scientifically sound evidence that infant sleep positioners prevent SIDS,” said Dr. Joshua Sharfstein, the F.D.A.’s principal deputy commissioner.

The recommended ways to prevent SIDS or suffocation in infants is to put babies to sleep on their backs on a firm surface and away from loose blankets, pillows, or stuffed animals.

Related Resources:

FDA Warning to Mouthwash Makers: Stop Making Unproven Claims

The FDA is taking a noticeably harder line under the Obama Administration and letters are going out to companies the agency says are making false or unsubstantiated claims about their products. Now, one more letter has hit a three companies, right in the mouth. Johnson & Johnson, along with Walgreen Co. and CVS have all received FDA warning letters telling them to stop claiming their mouthwash products remove plaque and fight gum disease.

These claims have been a centerpiece of advertising for the companies selling mouthwashes like Listerine Total Care Anticavity Mouthwash (J&J), CVS Complete Care Anticavity Mouthwash and Walgreens Mouth Rinse Full Action. The Los Angeles Times reports that no such proof exists that use of these products will prevent gum disease. Any action by a product that claims to fight a disease makes it a drug for purposes of regulation by the FDA. Unless the claims have been approved by the FDA, or the ingredient has been generally recognized as safe and effective for the claim, the company will be prohibited from making these kinds of statements in their advertising.

Many similar letters have been utilized by the agency recently, including one FDA warning just sent to POM Wonderful regarding that company's claims about the health benefits of pomegranate juice. According to The Times, the FDA is changing the way it approaches this type of advertising. “We’ve got a much more aggressive FDA and FTC, there’s no question about it,” said John Villafranco, a Washington attorney who specializes in advertising and consumer protection issues.

In the case of mouthwash, the active ingredient is sodium fluoride, which has been found to prevent cavities. However, the FDA has not found it to be effective in removing plaque or preventing gum disease. Walgreens has claimed its mouthwash helps remove plaque above the gumline. This is true, but not because of the mouthwash. It is the simple act of rinsing that helps remove plaque, according to Jonathan Shenkin, a pediatric dentist and assistant professor of health policy at Boston University’s School of Dental Medicine. Water will do just as well.

As The Times notes, this is just one more hit for the beleaguered J&J which is dealing with fallout from recalls on everything from Tylenol to hip replacements.

All companies released statements saying they will cooperate with FDA requirements.

Related Resources:

FTC Files Complaint Against Makers of POM Wonderful Juice

Pomegranate juice can do a lot of good things for your health, just possibly not quite as much as one company claims, according to the FTC. On September 27, the Federal Trade Commission filed suit against POM Wonderful, saying that claims its pomegranate products will prevent or treat heart disease, prostate cancer, and erectile dysfunction are false and unsubstantiated by the scientific evidence.

In its suit, reports CNN, the FTC hopes to ensure any further claims about the health benefits of pomegranate juice will become subject to review and verification by the Food and Drug Administration. The FTC is concerned that consumers will believe the company's products will provide a "silver bullet" against a myriad of health problems. "Contrary to POM Wonderful's advertising, the available scientific information does not prove that POM Juice or POMx effectively treats or prevents these illnesses," David Vladeck, director of the FTC's Bureau of Consumer Protection, told CNN.

In a statement made in response to the FTC's suit, POM Wonderful says it wants the government off its back. The suit is "unwarranted" the company says, and the FTC "is wasting taxpayer resources to persecute the pomegranate." POM Wonderful believes that oversight by the FDA would not be appropriate, because they do not claim their products work like drugs. Taking it a step further (or possibly too far), the company claimes the suit violated POM's "constitutional rights" to share information with the public. The company has also filed a lawsuit against the government to "preserve these rights."

The FTC cites ads by POM Wonderful stating that that their POM Juice is "proven to fight for cardiovascular, prostate and erectile health," are misleading when they claim the findings were "backed by $25 million in medical research." According to CNN, the FTC claims many of the scientific studies POM Wonderful conducted were either false, or did not show any of the health benefits that the company claims in its ads.

This was not the first time POM Wonderful has come under the scrutiny of federal agencies. CNN writes the FDA sent a warning letter to POM Wonderful this past February, admonishing the company for promoting claims more suited to a drug than food products.

Related Resources:




Class Action Suit Filed Over Similac Recall

One day after Abbott Laboratories announced the Similac recall for its powdered infant formula, a class action suit was filed. The named plaintiff in the suit is a Kathleen A. Brandner, individually and on behalf of her minor child, against defendants Abbott Labs and Sam's Club. The plaintiffs are being represented by Michael Brandner Jr. of The Brandner Law Firm and Stephen S. Kreller of The Kreller Law Firm in New Orleans, where the suit was filed in federal court.

As discussed in a prior post, Abbott recalled the Similac formula that was manufactured in a plant in Michigan after beetle pieces and beetle larvae were found in a small percentage of the products made at that facility. At the time of the recall, the FDA said there were no immediate health risks, but the company stated the contaminated formula could cause some babies stomach aches that might result in a refusal to eat.

The Louisiana Record reports that the suit contains various causes of action, but one main issue is that of misrepresentation. The plaintiffs claim the company intentionally and negligent misrepresented the product as safe, when it in fact contained beetle parts. The plaintiffs are seeking an award of refunds, general, punitive, and special damages as well as attorneys' fees and court costs.

Class action suits are a key tool in consumer suits, such as the BP suits, the Toyota suits and the Chinese drywall suits. A court will often certify a lawsuit as a class action if it meets certain criteria. The court will look to see if it would be most efficient to try the many claims together, because they contain involve the same or very similar events and are seeking similar remedies. In some cases, the individuals' injuries could be fairly minor, so that it would not be cost effective for them seek legal redress on their own. Together, however, the value of the claims of the class add up, and suing as a class can help organize and pay for attorneys, evidence gathering and expert witnesses, therefore controlling those costs.

The class action suit is also common in employment related cases against major retailers or other companies who have thousands of employees across the country. The class action recently settled with Walmart is just one example.

In the suit stemming from the Similac recall, all the plaintiffs making up the class would have used the same product in the same way with the same expectations of safety that they claim were not met. According to the Record, the suit was filed September 23, and U.S. District Judge Sarah S. Vance has been assigned to the case.

Related Resources:

Hyundai Sonata Recall: Steering Problems Possible

It has been a busy year when it comes to vehicle recalls. As we have reported previously, Toyota has recalled millions of vehicles after discovering vehicles with the possibility to unintentionally accelerate.

Now Hyundai is getting in on the recall action, after consumers began reporting problems with the steering systems in their Hyundai Sonatas. The Hyundai Sonata recall has reached 139,500 Sonatas built between December 11, 2009, and September 10, 2010. The problem is related to a manufacturing defect. The Hyundai recall involves connections in the steering column that are either assembled incorrectly or not full tightened and could potentially cause drivers to lose control of the steering of the vehicle.

According to the The National Highway Traffic Safety Administration, Hyundai dealerships will fully inspect the vehicles and update the steering software in the vehicles free of charge.

The U.S. government first opened an investigation into problems with Hyundai Sonotas in August, The Los Angeles Times reports. The steering problem is potentially serious as it could cause the steering wheel to separate from the steering column, which could ultimately cause the driver to lose control of the vehicle. However, Hyundai said there have been only 10 instances of drivers reporting issues with steering the vehicle and no injuries or accidents related to the recall have been reported.

Hyundai will begin by notifying owners to alert them that they should make an appointment to perform the Hyundai Sonata recall repairs. Owners can make appointments with local dealerships for repairs at their convenience. Owners of recalled Sonatas should make sure they monitor the recall and get their vehicles in as soon as possible.

Related Resources:

FDA to Restrict Access to Avandia Diabetes Drug

The FDA has announced a major tightening on the availability of the diabetes drug Avandia due to the evidence of increased risks of heart issues from the drug. In an unusual move, European officials and the U.S. have acted in concert to limit access to the drug. Europe will suspend sales of the diabetes drug entirely. In the U.S., patients may only be prescribed Avandia when they and their doctor can show that no other drugs are affective and that they are cognizant of the increased risks.

According to the New York Times, the FDA is taking a harder line on drug safety. This is the first time the agency will post memos from senior staff noting strong and sometimes opposing positions on what to do about the diabetes drug.

Critics of the drug such as Dr. Steven Nissen, who has authored studies showing the risks of Avandia, are behind the decision to restrict sales. However, Dr. Nissen has concerns about the process that brought the FDA to its current decision, telling the Times it is, “essential to fully investigate what went wrong with the regulatory process to prevent this type of tragedy from endangering patients in the future.” According to the Times, one study showed more than 47,000 people taking Avandia needlessly suffered a heart attack, stroke, heart failure or died.

Avandia was once the most popular diabetes drug in the world, but sales had already deteriorated after the studies regarding the risks were made public. Sales will drop further as authorities set out the restrictions on the drug.

The Times reports that standards for treatment of this disease, on the rise across the western world, are now going to change. In the past, the FDA had looked only at whether the drug helped control blood sugar levels in diabetic patients. However, due to the heart risks from Avandia, the new standard will likely test whether a new drug improves the quality or length of patients' lives. This is will be a harder standard to reach.

GlaxoSmithKline, the maker of the diabetes drug, stated that “the company continues to believe that Avandia is an important treatment for patients with Type 2 diabetes” and is working with the F.D.A. and European regulators “to implement the required actions.”

Patients currently taking the drug may continue their course of medication.

Related Resources:

Several major health insurance companies have announced they will stop selling individual child only health insurance policies, possibly as soon as Thursday, September 23. Companies such as Anthem Blue Cross, Aetna Inc. and others will stop selling the individual policies in states such as California, Illinois, Florida, Connecticut and others due to the requirement in the healthcare reform law that they not reject children with pre-existing conditions from coverage.

The companies say, according to the Los Angeles Times, that the new healthcare law requirements will just cost them too much. The companies fear the new law will encourage parents to buy coverage only after their children become ill, producing a large amount of ill children to insure. "Unfortunately, this has created an un-level competitive environment," Anthem Blue Cross said in a company statement.

In February of this year, Anthem Blue Cross and its parent company WellPoint threatened to raise policy premiums in California by as much as 39%. They were prevented by the outcry from the public, state and federal officials. The company raised rates recently, at between 14% and 20%

The decision of the insurance companies will not affect current individual child only health insurance policies, family policies or insurance provided to children through their parents' employers. The Times reports experts believe about 500,000 children without insurance nationwide could be affected.

The White House was not pleased with the decision of the insurance companies. "It's obviously very unfortunate that insurance companies continue to make decisions on the backs of children and families that need their help," White House Press Secretary Robert Gibbs said at a news briefing.

Related Resources:

Abbott Labs is recalling some of its baby formula due to a possible beetle contamination. The pharmaceutical company announced that it had initiated the voluntary recall following reports from two consumers that they had found contamination in bottles of the company's No. 1 Similac powdered infant formula. Inspections of one part of a plant in the town of Sturgis, Michigan, showed evidence of beetles or their larvae.

Reuters reports that according to the company, the Similac recall will affect less than 5 million units in the U.S. and other countries. All of the powdered versions of the product that were manufactured in the Michigan plant are under recall. Liquid versions are unaffected by the recall. Company spokeswoman Melissa Brotz claims that after testing, Abbott found that 98.9 percent of the product was free from beetle contamination. Brotz described the beetle in question as one commonly found in houses, office buildings and grocery stores.

Since all the Similac produced in Michigan is being pulled, Reuters reports the company will increase productivity in its other plants to meet demand. The specific Similac products under recall are produced in plastic containers and various can sizes, including 8-ounce, 12.4 ounce and 12.9 ounce.

“The U.S. Food and Drug Administration has determined that while the formula containing these beetles poses no immediate health risk, there is a possibility that infants who consume formula containing the beetles or their larvae could experience symptoms of gastrointestinal discomfort and refusal to eat,” the company said.

The Associated Press reports the company has setup a Web site and consumer hot line. Consumers with questions about the Similac recall may call (800) 986-8850.

The products may be returned to the company at no cost.

Related Resources:

FDA Approves Gilenya, First MS Treatment Pill

Encouraging news for those among the 2.5 million people suffering from relapsing-remitting multiple sclerosis (MS): The Food and Drug Administration just approved an oral drug designed to treat the disease. The new drug is called Gildnya (fingolimod), and differs from other MS drugs, which come in the form of injections or infusion. Gilenya will allow MS sufferers to take a pill once a day, making medication management far easier than it has been in the past.

The case of MS is unknown, though treatment options are slowly improving. MS effects the central nervous system in a strange and complex way. Basically, the body's own immune system attacks part of the brain that protects brain, spine and eye nerves. As the protective layer is removed and destroyed, the resulting scar tissue causes nerve signals to be blocked leading the serious medical complications.

"Gilenya is the first oral drug that can slow the progression of disability and reduce the frequency and severity of symptoms in MS," said FDA director Dr. Russell Katz in a statement, CNN reports.

The drug itself is not a vaccine, nor is it by any means a cure for the disease. Instead, like the other multiple sclerosis drugs developed so far, it slows down and helps patients to manage the disease as best they can. According to Dr. Nicholas LaRocca, Vice President of Health Care Delivery and Policy Research for the National Multiple Sclerosis Society, Gilenya "manipulates the immune system in a way that's beneficial for patients with MS." That said, the drug cut the rate of relapse by as much as 62% in newly diagnosed patients and 44% in patients that had been treated in the past.

It's certainly encouraging news for a disease that continues to wreck the lives of millions of its sufferers.

Related Resources:

Video Game Censorship: Just the Beginning?

An upcoming California case called Schwarzenegger v. Entertainment Merchants Association (EMA) has video game makers, as well as the comic book industry concerned about First Amendment rights.

Legal analysts are keeping a close eye on the case, as this week the Comic Book Legal Defense Fund filed a "friend-of-the-court” brief arguing that the law in question “would undermine more First Amendment principles...than any decision in living memory.” Many other prominent trade organizations and guilds in the industry signed on as well. Comic book companies argue that if the law is allowed to stand, the media could end up being censored, as well as movies, music and any other ind of content.

The executive director for the CBLDF presented a compelling analogy illustrating why they saw the video game censorship law as a threat to the First Amendment that would only grow if upheld. "The case California makes against video games,” said Charles Brownstein, G4TV.com reports “is one familiar to the comic book industry, which was nearly destroyed by government attempts at regulation in the 1950s.  Then, as now, moral crusaders claimed that popular new media containing depictions of violence were detrimental to our youth. Then, as now, pseudo-science was used to back such claims.  Those claims weren't true in the 1950s, and they aren't true now."

Schwarzenegger v. EMA came about after the attempted enactment of a 2005 law which prohibited the sale or rental of violent video games to minors. The law was appealed and U.S. District Court Judge Ronald Whyte granted first a temporary and later a permanent injunction in 2007.

California could have left it at that, but the state chose to challenged the injunction in the Ninth Circuit Court of Appeals, arguing that violent video games deserve a different level of protection than other forms of expression. The 9th Circuit did not agree and ruled the video game censorship law unconstitutional. Schwarzenegger and Attorney General Jerry Brown then appealed the decision to the U.S. Supreme Court.

So as a consumer, what does this mean to you?

Up to this point, it hasn’t mattered much to the average consumer, as the 2005 law was never enacted. However, if the U.S. Supreme Court reverses the lower Court’s decision, you would see a difference in the way that violent video games are regulated, labeled and sold. Then there would be the question as to whether the media industry would see a “chilling effect” and a diminishment of First Amendment rights.

Related Resources:

Don't count your chickens before they hatch. A penny saved is a penny earned. If it looks too good to be true, it probably is. All things that Mom used to say are usually right, especially that last one. Further evidence of this truism can be found in the report on September 16, that one Atlanta photographer promoting a deal on Groupon was using stolen photos to promote herself and could not deliver on the terms of the Groupon deal.

According to TechCrunch, what alerted Groupon users to the fact that the deal offered by the photographer was not all it promised, were the sheer numbers. Commenters noted that it seemed unlikely that the photographer could actually perform the number of packages she was offering (amounting to something like 1,000 in a year). Other allegations then surfaced that the Groupon photographer was not actually the owner of the pictures presented on her website.

While these are currently only allegations, it brings to the forefront the issues surrounding services like those provided by Groupon. Groupon is an online coupon type of service that offers discounted deals on goods and services through "collective buying power." As their website explains, Groupon features bargains on things to "do, see, eat, and buy" in cities across the country. By promising businesses a minimum number of customers, Groupon arranges for unusual discounts for their purchasers.

Despite the power of numbers, there are still some deals that are just too good to be true, as in the case of the Atlanta photographer. Regardless of the backing of a recognized site like Groupon, if something appears not quite right or the numbers just don't add up, it pays to do further research. Since most Groupon users are looking for deals in their own area, ask others for recommendations and do some digging around before you pay up.

At this time, TechCrunch reports that the company is currently re-evaluating the photographer's Groupon deal structure after reviewing the comments on the discussion board. The comments have been removed from the site.

Related Resources:

Google Engineer Accused of Using Access to Stalk Minors Online

Here is a story that is one more reason you should learn as much as you can about online privacy -- and then just cross your fingers. On September 14, it was reported that a Google engineer working in a trusted position as a Site Reliability Engineer allegedly violated the privacy of several minors by improperly accessing many of their Google accounts that were available to him via his position at the company. It has been confirmed by Google that David Barksdale, who worked at the Kirkland, Washington office, has been fired for violating the company's privacy policies.

According to Gawker.com, Barksdale was fired from his position at Google in July of 2010. In his position with the company, Barksdale had access to such accounts as Gmail, chat transcripts, and had the ability to unblock himself from a Gtalk buddy after the minor involved blocked him. There are many egregious allegations of improper access to private accounts of minors and the complaints to the company that followed about their employee's actions.

As an SRE, David Barksdale was one of the engineers responsible for addressing any technical problems that might arise with any of the Google products, according to Gawker. For that reason, SREs have access to a great deal of sensitive and private data in user accounts so they can troubleshoot problems that arise. The lesson here might be this: absolute access corrupts absolutely.

The Electronic Frontier Foundation is a non-profit legal group working on privacy, free speech and consumer issues relating to new and existing technology. They have prepared a detailed list of the 12 best ways to protect your online privacy. Here are just three of the best:

  • Examine privacy policies and seals.
  • Don't reveal personal details to strangers or just-met "friends".
  • Remember that YOU decide what information about yourself to reveal, when, why, and to whom.

Despite this story of possible online privacy violations by a former Google engineer, it should also be remembered that as of now, despite headlines, pictures and the severity of allegations made, no criminal charges have been filed and no civil lawsuits served.

In the comments following the report by Gawker, readers were realistic about the access engineers have to online accounts and the necessity for that access, not to mention the consequences. Here is the best way of looking at it. "Smartastic" commented: "Actually, I trust Google with my most private communications because Google makes stuff I want to use, and I'm too lazy to think about the consequences. I'm pretty sure I'm not alone here." He or she is not alone. If you are going to use the product, make sure you take some time to understand the potential consequences, both good and bad.

Related Resources:

Lobbyists Ask FDA to Rename High Fructose Corn Syrup

Will this syrup, by any other name, taste as sweet? And have as many calories? While interesting, these will not be the most pressing of the questions facing the FDA, now that the agency has been asked by lobbyists to change the name of high fructose corn syrup. Producers of the beleaguered product would like to change its name to "corn sugar." High fructose corn syrup is used in sodas, bread, cereal and many other foods.

The Associated Press reports that the Corn Refiners Association has asked the FDA to approve the name change for use on food labels. Approval of a name change can take as long as two years, but that is not preventing the producers from using the name in new online and TV advertising campaigns. The new ads claim "whether it's corn sugar or cane sugar, your body can't tell the difference. Sugar is sugar."

Under the Federal Food Drug and Cosmetic Act, the FDA is responsible for overseeing labels on most prepared food. Labeling on fresh foods is voluntary.

The Corn Refiners Association hopes the name change will help consumers better 'understand' an ingredient producers feel has been maligned. "It has been highly disparaged and highly misunderstood," Audrae Erickson, president of the Association told the AP. In some ways, those on the other side of the argument seem to agree. "Sugar and high fructose corn syrup are nutritionally the same, and there's no evidence that the sweetener is any worse for the body than sugar," said Michael Jacobson, executive director of the Center for Science in the Public Interest.

It all comes down to how much we take in, but where it is found can be anybody's guess. Even if the "corn sugar" is the same as regular sugar, consumers can find it in food products they would usually not think includes a sweetener. One parent told the AP she found high fructose corn syrup listed as an ingredient in pickles, English muffins and sliced bread.

The AP reports that no matter what the name, Americans are slowly moving in the right direction. The average American ate 35.7 pounds of high fructose corn syrup last year, according to the U.S. Department of Agriculture. That's down 21 percent from 45.4 pounds, a decade before.

Related Resources:

FDA Advisory Panel to Consider Ban on Diet Drug Meridia

The voices urging stronger restrictions or even an outright ban on the diet drug Meridia will have their hearing this week before an FDA advisory panel. The FDA panel will review a study that found an increased risk of heart problems for those patients taking the diet drug. The study also showed an average weight loss of 8.8 lbs (4 kilograms). The FDA has the final decision-making authority, but often follows the panel's advice.

The diet drug Meridia (chemical name sibutramine) is made by Abbott Laboratories and was was first approved in 1997, according to a report by Reuters. The panel will review a study on the drug called the "Scout Study." The Scout study considered results with Meridia from patients with pre-existing heart conditions and/or diabetes. The study seemed to indicate more heart attacks and strokes in subjects taking Meridia than those taking a placebo.

According to Reuters, one FDA staffer, on reviewing the information and evidence regarding the drug said in a memo, "even a small increase in cardiovascular risk seems unwarranted" since the weight loss on Meridia was fairly small and can be re-gained after the drug has been discontinued by the patient.

Abbott Labs, in a memo to the FDA, merely said the Scout trial backs Meridia's current warning against use in patients with heart issues. Safety questions remain if a patient using the drug has an undiagnosed heart condition.

In company documents, Abbott maintained the current data regarding the use of the diet drug Meridia "continues to support its effectiveness as a weight loss agent in an appropriate patient population."

The FDA advisory panel is scheduled to meet Wednesday, September 15.

Related Resources:

Publishers Clearing House to Pay in Deceptive Marketing Case

Publishers Clearing House did not learn its lesson the first time around, so they will have to learn it all over again, to the tune of $3.5 million. This payment will settle a suit brought by 32 states charging the company violated a 2001 agreement regarding deceptive marketing practices. The several million dollar settlement will cover the cost of the investigation by the states into the company's alleged unethical marketing practices. This includes the claim that the Port Washington, New York-based company led customers to believe that making purchases might increase their chance of winning the famed Clearing House sweepstakes.

According to a report by ABC News 15 in Arizona (one of the states party to the settlement) Publishers Clearing House will work with a compliance counsel and an ombudsperson to change any deceptive marketing practices in the future to make them more understandable to the consumer. In addition, PCH will send a letter to each customer who spends $1,000 or more yearly on company products, to notify them that purchases are not necessary to enter or win the sweepstakes.

The Federal Trade Commission says an ad is deceptive if its statements or omissions are likely to mislead reasonable consumers. The misstatement must also be "material," that is it must be important to a consumer's decision to buy or use the product. In this case, the states were concerned that decisions to purchase products were driven by the consumer's belief they would have a better chance of winning the PCH sweepstakes prizes.

BusinessWeek further reports the settlement will require the company to "screen" more of its customers to ensure they are not "disoriented" and not making excessive purchase under the impression that the purchases might help them win. Various states who are party to the agreement will receive varying amounts under the settlement. For instance, BusinessWeek reports Colorado will receive $320,000. According to the Baltimore Sun, the state of Maryland will receive $40,000, which it will use for consumer education.

Related Resources:

FDA Warns Makers of E-Cigarettes: 'You Need Approval'

On September 9, the Food and Drug Administration issued letters to five companies and the trade organization involved in the manufacture and sale of electronic cigarettes or e-cigarettes. The warning letters from the FDA to the companies noted violations of the Federal Food, Drug, and Cosmetic Act including what the FDA says are "unsubstantiated claims and poor manufacturing practices." The letter to the Electronic Cigarette Association warned that FDA intends to regulate electronic cigarettes.

The FDA announced in a press release that it has determined that the e-cigarettes should be considered a drug product and will be regulated by the agency like any other product it oversees. Under the FDA approval process, a drug product must show that it is safe and effective for its intended use. A company must also prove that the manufacturing methods it uses can ensure the strength, quality and purity of the product.

Bloomberg reports e-cigarettes are metallic tubes containing a vaporized liquid version of a nicotine mixture. The e-cigarettes are made to look and feel similar to real cigarettes. The FDA's reason for exerting control over the industry stems from the claims made in the U.S. that the e-cigarettes can help smokers quit the real thing. The FDA goes on to state the companies should not claim they can help treat a "disease" such as nicotine addiction, unless the drug has been proven effective for this use. The FDA believes all five companies receiving letters have claimed the use of e-cigarettes can help smokers quit.

The agency cites additional concerns regarding the inclusion of unapproved drugs in some of the e-cigarettes, such as tadalafil (an erectile dysfunction drug) and rimonabant (a weight loss drug) in the refill cartridges of the E-Cig Technology products. The FDA also noted "deficiencies" in the manufacturing of the products from Johnson Creek Enterprises which markets Smoke Juice, the solution used to refill the e-cigarette cartridges.

The companies receiving warning letters today are: E-CigaretteDirect LLC, Ruyan America Inc., Gamucci America (Smokey Bayou Inc.), E-Cig Technology Inc. and Johnson’s Creek Enterprises LLC.

Related Resources:

Dental Sealants Contain BPA, Safety Still a Question

The effects of the controversial chemical BPA are once again in the news, this time as a result of dental sealants. The sealants and resins are used by dentists in dental repair work and can contain substances that degrade into BPA. Pregnant women and children can be most affected by the chemical, but kids can be protected by rinsing away the residue right after the work is completed, according to a new study.

The study in the journal Pediatrics found that despite the health risks associated with bisphenol A, better known as BPA, the benefits of sealants in preventing kids’ cavities outweighed the risks, according to a report by MSNBC. BPA has been linked to health problems and has been taken out of use in the manufacture of many plastic bottles, especially those used by children. The FDA recently called for more study on the effects of the chemical, especially on the "brain, behavior and prostate glands of fetuses, infants and children.”

According to MSNBC, pregnant women may want to wait if at all possible, until after their babies are born to have dental work involving BPA-associated resins. However, experts caution pregnant women should not take the wrong message away from these words of caution and avoid necessary dental work all together. Gum disease in an expectant mother can have the potential to impact the health of the fetus, say experts.

In the end, the jury is still out on the dangers of exposure to BPA. “This chemical is one that you should not be exposed to at any level,” says Fred von Saal, Curators’ professor of biology at the University of Missouri at Columbia. Others don't agree. Parents should not be overly concerned about their kids, Dr. Burton Edelstein, chairman of social and behavioral sciences at the Columbia University College of Dental Medicine and a co-author on the study, told MSNBC. "The amount of exposure is extremely low. And the layer that contains BPA can be wiped off with cotton or rinsed off with a stream of water that can then be suctioned away by the dental assistant.”

Related Resources:

Osteoporosis Drugs Linked to Esophageal Cancer

A new study in the British Medical Journal  has found a link to higher rates of esophageal cancer and the use of drugs to prevent bone density loss, when taken for more than five years. The study covers a class of osteoporosis drugs called bisphosphonates, which are used to offset bone weakness. The drugs include Merck & Co's Fosamax, Roche's Boniva, Novartis's Reclast and Warner Chilcott's Actonel.

Reuters reports that the study looked at data from the UK General Practice Research database on men and women over 40 who had either esophageal cancer, stomach cancer or colorectal cancer diagnosed between 1995 and 2005. The results showed patients with 10 or more prescriptions for bisphosphonates, or with prescriptions over about five years, had nearly double the risk of esophageal cancer compared with people who did not take bisphosphonates.

However, the study results are not necessarily a cause for alarm, just a consideration of both the risks and benefits. "We have to be concerned, but this is the first large study with long-term follow up that has found this effect, and it is just one observational study," Jane Green of Oxford University's Cancer Epidemiology Unit, whose research was published in the British Medical Journal, told Reuters. Since cancer of the esophagus is fairly rare, even a doubled rate does not increase the risk factors greatly, she added.

To illustrate, the study found that in people aged 60-79, the rate of this kind of cancer is about 1 per 1,000 over five years, in North American and Europe. This increases to about "2 per 1,000 with five years' use of oral bisphosphonates," according to the report.

Dr. Green did note that earlier studies had found no link between osteoporosis drugs and esophageal cancer, but the new study tracked the patients for twice as long as the previous ones.

In a commentary on the study, Diane Wysowski of the U.S. Food and Drug Administration said, "the possibility of adverse effects on the esophagus should prompt doctors who prescribe these drugs to consider risks versus benefits." Wysowski also suggested that patients taking bisphosphonates should tell their doctor if they have any discomfort in their throat or chest or trouble swallowing.

Related Resources:

First Legal Gambling Mobile App Debuts in Nevada

Have you ever wanted to place a sports bet but found the process inconvenient? Sure, you could always place your bet online with an offshore operator, but not everyone wants to do that. For one, some aren't comfortable trusting their money with an overseas gambling operation. Also, the legality of such operations remain murky at best.

Now residents of Nevada will be the first to have an easy and legal option beyond the sportsbooks: a gambling mobile app. The application is designed to only work when a person is in Nevada. When visitors from out of state are in Nevada, the phone application will allow them to place sports bets, whether they are in a casino or not, until they cross back outside of Nevada state lines.

The gambling mobile app is being launched by American Wagering Inc., for BlackBerry mobile phone devices. American Wagering operates almost 60 Leroy's Horse and Sports Place sports books in Nevada. They hope to launch applications for the iPhone, Droid and Windows phones in the near future. The timing of the BlackBerry application launch is designed to allow bets to be placed for the first college and NFL football games of the season, The Associated Press reports.

Vic Salerno, CEO of American Wagering is clearly excited about the possibilities of the new application. So excited that he couldn't avoid using a cheesy poker reference to express himself. "I'm all-in on this," said Vic Salerno, American Wagering's chief executive. "We've reinvented the company entirely."

Nevada gambling regulators have approved the application for the BlackBerry. Separate approval will be required by the Nevada Gaming Control Board for each operating system. The application requires uses to appear one time at one of the Leroy's locations when they open their account, in order to verify age and set the account to a certain phone. Once the account is created, GPS combined with cellular tower technology is used to make sure the better is within the state of Nevada.

State gambling laws prohibit sports wagering in most states, though of course not Nevada (nor Oregon, Delaware and Montana). Most states allow casino gaming, horse racing, and dog racing and the lottery. The new application is likely to create quite a bit of buzz. Although it is limited to Nevada, it will serve as an interesting test case for legalized online sports gambling in the United States. Related Resources:

FDA to Consider if Genetically Altered Fish are Safe to Eat

If you genetically alter fish, are they safe to eat?

The FDA is ready to issue an opinion as to whether fish genetically modified to grow faster pose health rinks. Aqua Bounty Technologies, Inc. boasts a genetically altered salmon that grows twice as fast as Atlantic salmon. Aqua says that the manipulated fish can reduce pressure on the environment and boost the US fish market. If the fish are approved, it could mean the first genetically altered animal food that consumers' see for sale. Consumers would later likely see genetically altered trout and tilapia. Scientists are also working on altering pigs and cows.

Of course not everyone thinks that genetically altered fish are a good idea. Consumer advocates and food safety experts are concerned about potential side effects, which they say are unknown. They point to the fact that there is little data to prove that the fish are safe, Reuters reports.

"This is an Atlantic salmon in every measurable way ... When you look at the fish, it's impossible to see the difference," said Aqua Bounty Chief Executive Ronald Stotish.

Jaydee Hanson, policy analyst for the Center for Food Safety, countered Stotish by saying, "They're basically putting the fish on permanent growth hormone so it grows faster ... so they can sell bigger fish faster."

So the big question for consumers is, what does the data say regarding the safety? Unfortunately, the FDA has not released any data and does not have to release any until two days prior to the meeting, Reuters reports. Aqua has not done any animal or human clinical trials, thought it has conducted several taste tests, with positive results.

So in the end, it is hard for consumers to determine whether this is something they want. Some fear that tinkering with genes could usher in the Apocalypse, although fortunately that did not happen when scientists genetically altered plants. The decision whether to bring the food to store now rests with the FDA. If approved, consumers will be left to vote with their wallets.

Related Resources:

EPA Warns of Unsafe, Scam Bed Bug Exterminators

It is an all too common theme, mentioned here and many other places. An event, tragedy or even a trend occurs and the scams or fakes follow like ants after a picnic. In this case, the bug analogy is apropos, because the issue at hand is bed bugs. As noted in posts on FindLaw's Injured blog, the recent resurgence in bed bug infestations has occurred all over the country, but has made news especially in New York and other large cities. Now, the EPA warns the public of problems relating to the removal and extermination of the pests.

The EPA concerns are two-fold, according to a report by the Associated Press from Ohio. First are the extermination companies making unrealistic or false promises of extermination, or using the wrong or dangerous chemicals in an attempt to exterminate the bugs. As an example, the AP cites one case of an unlicensed exterminator who sprayed an apartment complex in Cincinnati with a pesticide typically used on golf courses. Seven tenants became ill and required hospitalization. The property had to be quarantined, and the tenants forced to move. Criminal charges may result.

One reason for the largest resurgence of bed bug infestations in nearly 50 years, reports the AP, is the lack of DDT. That chemical was responsible for keeping the bugs under control in the 40s and 50s, but was banned in the 1970's after its toxic effects were made clear in the 60's by such information like that found in Rachel Carson's book, Silent Spring.

One pesticide in limited use is propoxur. This chemical can be found in such items as flea collars, but is banned for home use due to effects on children such as dizziness, nausea and blurred vision. The AP reports that some pest control experts believe it is a superior pesticide for use on bed bug infestations and can be used in a way that could protect children. However, the EPA warns would-be users about its safety. Other experts worry whether it will be effective in the long run. "Propoxur is not a silver bullet, and given time, bedbugs would likely become resistant to it, too," Lyn Garling, an entomologist at Penn State University told the AP.

In the meantime, it will take a major public health campaign to address the problem nation-wide. To help prevent a bed bug infestation some suggestions include: hang clothing in the closet farthest from the bed, place luggage on the folding rack found in most hotels, place luggage in the dry cleaning bag found in the hotel, most important, don't bring home a mattress that has been used by unknown sources.

Related Resources:

The Apollo Group Inc, the parent company of for-profit educators The University of Phoenix, acknowledged in a filing on August 31, that it is the subject of a shareholder suit. The suit, filed in Arizona federal court, alleges that the company made materially misleading statements about its business operations between December 7, 2009, and August 3, 2010. The plaintiffs to the suit are seeking class action status.

The complaint includes the company and several of its top executives including the executive chairman, co-chief executive officers, chief financial officer and others, according to a report by Reuters. The complaint alleges that the misrepresentations made by the company artificially inflated the trading price of Apollo common stock, according to the report by the company in its 8-K filing with the SEC. The plaintiffs are seeking compensatory damages.

Apollo is considered a "bellwether" of the for-profit educational industry, reports Reuters. As the industry has come under increasing scrutiny, so has Apollo group. For example, in December 2009, The University of Phoenix and Apollo Group settled with the Department of Education for $78.5 million over whistleblower claims they violated regulations against illegal recruiting when the company paid recruiters based on the number of students they enrolled. Prior to that case, the Apollo Group settled yet another suit for $9.8 million in 2004, over claims of violating federal incentive compensation rules.

Last year, according to Reuters, the SEC investigated Apollo for its revenue recognition practices.

Apollo Group says it will vigorously defend against the current shareholder suit.

Related Resources: