FDA should require Formula Recall

Even though the Food and Drug Administration said last month it was unable to identify any melamine exposure level as safe for infants, this week a top official said it would be a "dangerous overreaction" for parents to stop feeding infant formula to babies who depend on it.

"The levels that we are detecting are extremely low," said Dr. Stephen Sundlof, director of the FDA's Center for Food Safety and Applied Nutrition. "They should not be changing the diet. If they've been feeding a particular product, they should continue to feed that product. That's in the best interest of the baby."

Melamine is the chemical found in Chinese infant formula — in far larger concentrations — that has been blamed for killing at least three babies and making at least 50,000 others ill.

The Associated Press discovered previously secret FDA tests under the Freedom of Information Act. Those tests show that the FDA has detected melamine in a sample of one popular formula and the presence of cyanuric acid, a chemical relative of melamine, in the formula of a second manufacturer.

A third major formula maker told AP that in-house tests had detected trace levels of melamine in its infant formula.

The three firms — Abbott Laboratories, Nestle and Mead Johnson — manufacture more than 90 percent of all infant formula produced in the United States.

In October the FDA stated there was no acceptable, safe level for melamine in infant formula. But now it apparently believes there are safe levels.

The most common side effect is kidney stones. Kidney stones were found in Chinese babies who were given formula tainted by melamine. While the levels of melamine in Chinese formula were much higher than the levels detected in the United States, melamine is not an acceptable substance for human consumption.

According to the AP:

The concentrations of melamine [in China] were extraordinarily high, as much as 2,500 parts per million. The concentrations detected in the FDA samples were 10,000 times smaller — the equivalent of a drop in a 64-gallon trash bin.

There would be no economic advantage to spiking U.S.-made formula at the extremely low levels found in the FDA testing. It neither raises the protein count nor saves valuable protein, said University of California, Davis chemist Michael Filigenzi, a melamine detection expert.

According to FDA data for tests of 77 infant formula samples, a trace concentration of melamine was detected in one product — Mead Johnson's Infant Formula Powder, Enfamil LIPIL with Iron. An FDA spreadsheet shows two tests were conducted on the Enfamil, with readings of 0.137 and 0.14 parts per million.

Three tests of Nestle's Good Start Supreme Infant Formula with Iron detected an average of 0.247 parts per million of cyanuric acid, a melamine byproduct.

The FDA said last month that the toxicity of cyanuric acid is under study, but that meanwhile it is "prudent" to assume that its potency is equal to that of melamine.

And while the FDA said tests of 18 samples of formula made by Abbott Laboratories, including its Similac brand, did not detect melamine, spokesman Colin McBean said some company tests did find the chemical. He did not identify the specific product or the number of positive tests.

McBean did say the detections were at levels far below the health limits set by all countries in the world, including Taiwan, where the limit is 0.05 parts per million.

A recent report found melamine in Nestle formula sold in Taiwan. A lawsuit has been filed by the parents of a Taiwanese infant who developed kidney stones.

I am very interested in talking to any parents whose babies develop kidney stones and who have been fed forumula that has now been identified as tainted with melamine. Email me at david@toledolaw.com or call 1-888-841-9623. The journalists of this country are doing a good job shining the light on the failures of industry and the FDA. It is up to us as attorneys to bring these corporations to justice.

It is absolutely unconscionable and totally unacceptable for our children and grandchildren to be fed these chemicals. These multinational corporations that go to China for the cheap labor and cheap ingredients must be held accountable.

David W. Zoll

Zoll, Kranz & Borgess

Trouble In Toyland: The 23rd Annual Survey of Toy Safety

Group's annual toy safety advisory warns about chemicals, choking hazards.

Some plastic toys, like the Ernie by Mattel Inc. at left, contain phthalates, a hormone-like chemical. The Ernie doll made of cloth, right, by Fisher Price is phthalate free.

The AP (11/26, Metzler), in an article published in over 100 papers and websites, including the Los Angeles Times, the Chicago Tribune, and the Miami Herald, reports,

If the toy fits inside the tube from a toilet roll, it's too small for the tiny tots

consumer advocates warned Tuesday. US Public Interest Research Group (PRIG) said parents shopping for holiday toys should look out for hazards such as small parts, soft plastics and lead contamination. Although increased consumer protections were approved this summer, US PIRG warned parents that those rules have not yet gone into effect." The group's latest annual "Trouble in Toyland" report focused on the choking hazard of small parts, lead, and phthalates.

The Chicago Tribune (11/26, Schmadeke) adds that the study says that a "Pony Land pony and a googly eyed green fish" on the market both contain phthalates, which are "suspected of causing reproductive and developmental problems, especially in boys. ... Six types of phthalates were banned from use in children's toys under legislation adopted by Congress this year. The law takes effect Feb. 10, but Rep. Bobby Rush (D-Ill.) said at the news conference that he planned to call a subcommittee hearing in December to examine how the law would be enforced by the Consumer Product Safety Commission (CPSC)."
The South Florida Sun-Sentinel (11/26, Lade) adds that the group's investigators found six products on store shelves that would be banned when the provision takes effect, noting that five of those products originate in China, "where about 90 percent of the toys sold in this country are made. The only well-known manufacturer was Hasbro, named because the required label on its Littlest Pet Shop set, warning about small parts that could detach and choke young children, was not clearly visible. ... One toy, a Silly Fish Squirters squirt gun by Toysmith, contained 64 to 400 times more phthalates than allowed under the new law."
The Columbus Dispatch (11/26, Bush) notes that phthalates are "used to make plastics soft and squishy. The problem: it's almost impossible for a parent to know if it's in a toy. But if it's soft plastic, chances are it contains phthalates, according to the Public Interest Research Group, which creates a hazardous toy list every year." The Dispatch adds that the chemicals could impact "genital development in young children." The San Diego Union-Tribune (11/26, Manolatos) adds that this year's report "warns consumers that the list is not comprehensive. 'Simply because a toy does not appear on this list does not mean that it is safe,' the disclaimer says. 'Under current law, toys must meet standards, but no testing is required.'" This piece lists the toys that the report found to be hazardous.
Recalls not yet in effect. The New York Daily News (11/26, Pesce) explains that the CPSC "warned Tuesday that dangerous playthings are still on the market -- despite an industry overhaul after last year's toy recalls. 'We took a great step forward with the Consumer Product Safety Improvement Act that we passed this summer,' Liz Hitchcock, public health advocate for US PIRG, said in releasing the group's annual toy survey. 'Unfortunately, the safety provisions in the law aren't fully in effect yet, so these hazards are still on toy store shelves.'"
ABC News (11/26, Barrett) reports on its website that despite the "huge changes" in safety laws, many impacted toys are still available, quoting Hitchcock discussion of the law's time lag. "The measure signed into law in August includes new requirements for the amount of lead and plastic-softening chemicals known as phthalates in products meant for kids younger than 12. It also calls for mandatory safety tests and sets forth more ways to keep kids safe in the event of a recall. But it will be February before several of its provisions that address toxic chemicals take effect."
Congress calling on CPSC to enforce ban on phthalate in toys. USA Today (11/26, Szabo) reports that California Sen. Diane Feinstein (D) is leading a congressional push to compel the Consumer Product Safety Commission to immediately implement a ban on "several hormone-like chemicals called phthalates in products for children under 12." Feinstein says that she and others in Congress "wanted toys with the controversial chemicals to be off the market when the law takes effect Feb. 10." However, a CPSC attorney last week "released a legal opinion stating that stores may continue to sell toys with phthalates, as long as those items were made before Feb. 10. That could allow toys with phthalates to remain on the shelves for years, with no way for parents to know which toys contain the chemicals, Feinstein says." The piece continues to describe the health risks associated with the compounds, and to analyze the impasse between Congress and the CPSC.
As the grandfather of 3 and another on the way, I am very concerned about toy safety. I can't understand how we, as a society, can permit corporate greed to override the health of our children.
David W. Zoll
Zoll, Kranz & Borgess

AARP Deceptive Marketing Under Fire

Earlier this month, Senator Grassley initiated an inquiry into deceptive marketing practices of certain health insurance products sold by AARP. The insurance plans at issue all limit the maximum amount the insurance company will pay. These limited benefit insurance policies are backed by UnitedHealth Group, and include AARP Medical Advantage, Essential Plus and Hospital Indemnity Plan. As a result of Senator Grassley’s investigation, AARP and UnitedHealth Group have suspended sales of these policies while a formal investigation occurs. Elizabeth Rowe Costle has been asked to conduct the investigation into AARP’s deceptive marketing of these fixed benefit policies. The investigation does not involve any prescription drug plan or Medicare Advantage plans that are only endorsed by AARP.

AARP, an organization that claims to act for its members, has in fact been selling the trusting public policies through UnitedHealth that promise much more than they deliver.

The policies are sold to those over the age of 50, but not yet eligible for Medicare, under the names of AARP Medical Advantage, Essential Plus, and Hospital Indemnity Plan.

As Senator Charles E. Grassley, Republican from Iowa, has said, the marketing is often misleading because it suggests to policy holders that they have comprehensive coverage:

In fact, there's no basic protection against high medical costs. The products may leave consumers seriously in debt if they need intensive medical care.

We are presently representing about 200 retirees who have been cheated out of their long term medical care by their former Employer, Philips Electronics. We have learned, first hand, how devastating the loss of health insurance can be, and how difficult it can be to find coverage, especially for those between the ages of 50 and 65.

We are currently investigating cases for AARP members who have purchased UnitedHealth Insurance products through AARP and are between the ages of 50 and 65. There is no cost to call our toll free number. We believe that this type of deceptive practice can best be addressed by a class action, where many people unite to take on the big business that preys on those most vulnerable.

Call us toll-free at 1-888-841-9623 to talk about your experience with one of these limited benefit insurance policies sold by AARP.

Honda Recalls 13,000 off-road competition motorcycles

Honda has just announced that it has recalled 13,000 off-road bikes. The recall involves 2007-2008 Honda CRF150R/RB motocross competition motorcycles.

The cycles, made in Japan, were sold by Honda motorcycle dealers nationwide from September 2006 through October 2008 for between $4,300 and $4,400.

Consumers should immediately stop using these recalled off-road motorcycles and contact any Honda dealer to schedule a free repair. Registered owners of the recalled motorcycles are being sent a direct notice.

The recall is supported by the United States Consumer Protection Agency.

The recall states:

Hazard: The weld on the right side of the swing arm can fail, causing the rider to lose control and crash. This could pose a risk of injury or death to riders.

Incidents/Injuries: Honda has received two reports of swing arms cracking. No injuries have been reported.

Description: This recall involves model year 2007-2008 Honda CRF150R/RB motocross competition motorcycles.

Sold by: Honda motorcycle dealers nationwide from September 2006 through October 2008 for between $4,300 and $4,400.

Manufactured in: Japan

Remedy: Consumers should immediately stop using these recalled off-road motorcycles and contact any Honda dealer to schedule a free repair *** [see comment below]. Registered owners of the recalled motorcycles are being sent a direct notice.

If you own this bike, you should stop riding it and inspect the swing arm. Even if the swing arm is not yet damaged, it could develop damage and fail. We strongly recommend you get legal advice on this matter by calling us toll free at 1-888-841-9623.

*** I am very interested in seeing one of these bikes. As a dedicated motorcycle rider (I ride and continue to restore my 1975 Honda CB550, a CLASSIC!), I want to look at the swing arm and read the manual to see what limitations are placed on this dirt bike. You would certainly expect that the location of the swing arm would result in the most stress on these dirt bikes, and therefore should have been overengineered. I am also very interested in seeing what type of fix they could possibly come up with on these new bikes that would make them as good as new.
David Zoll, Zoll, Kranz & Borgess

Bayer Healthcare Taken to Task for Marketing Unapproved Over-The-Counter Medications

The U.S. FDA issued two warning letters to Bayer Healthcare on October 28, 2008, giving the company 15 days to investigate and respond. Bayer has been marketing its Bayer Women’s Low Dose Aspirin Plus Calcium (Bayer Womens) as not only assisting in the prevention of heart disease, but also provides a source of dietary calcium to reduce the risk for osteoporosis. Bayer has also been heavily advertising its newest aspirin product, Bayer Aspirin with Heart Advantage (Bayer Heart Advantage), claiming that the supplemental physosterols also help lower bad cholesterol.

Under the US FDA regulations, although Bayer Aspirin itself has been approved for use as an over-the-counter medication for years, Bayer cannot randomly add supplements to the drug for sale without first seeking FDA approval and fully complying with the labeling and advertising requirements. (See 10/27/2008 Bayer Heart Advantage Warning Letter and 10/27/2008 Bayer Womens Warning Letter.) The US FDA made it clear that the supplements added in both products could be marketed individually as dietary supplements, but that by inclusion with the aspirin, both products constitute a drug under federal regulations and thus fail to satisfy federal regulation for approval and labeling. Thus, Bayer has been informed that both products are misbranded and not properly approved for over-the-counter sale as packaged. It should be noted that the US FDA action here is not the result of any adverse reactions reported as a result of the use of either drug.

This is one more example of the drug companies’ use of direct consumer marketing gone bad. Bayers' representations on the health benefits for these products have not been established at the dosages listed on the packages and may not provide the benefits consumers expect. Consumers must hold drug companies accountable for truth in advertisements and full compliance with the US FDA regulations, which are intended to ensure consumer safety.

If you or a family member has taken Bayer Aspirin with Heart Advantage or Bayer Women’s Low Dose Aspirin Plus Calcium, please contact our office at our toll free number. We are particularly interested in talking to consumers who are regular users of either of the following products, even if you have not suffered any physical harm.