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Medicis Pharmaceutical Corporation of Scottsdale, Ariz., will pay the United States $9.8 million to settle allegations that the company violated the False Claims Act with respect to claims submitted to Medicaid, the Justice Department announced today. The settlement resolves allegations that Medicis promoted the use of a topical skin preparation, Loprox, for use on children under the age of 10, without approval by the Food & Drug Administration (FDA).

The United States and the whistleblowers – former Medicis employees – alleged that from approximately November 2001 through April 2004, Medicis sales personnel targeted pediatricians, urging the doctors to use Loprox as a treatment for diaper rash. The use of Loprox, which is approved by FDA as a fungicide for patients over 10 years of age, is not a “medically accepted indication” for the treatment of diaper dermatitis and other skin disorders in children under 10.

“This settlement demonstrates our ongoing commitment to protecting funds for federal health care programs,” said Assistant Attorney General Peter D. Keisler. “Pharmaceutical companies need to know that they will be held accountable for off-label marketing schemes and other illegal activities that affect those programs.”

The Food, Drug & Cosmetic Act prohibits pharmaceutical companies from marketing or promoting a drug for uses that the FDA has not approved, a practice known as “off-label marketing.” In the case against Medicis, the United States alleged that the Medicaid program paid millions of dollars for Loprox prescriptions that would not have been reimbursed if government authorities had known that the prescriptions resulted from the company’s off-label marketing campaign.

Medicis sold its pediatric sales unit in 2004.

The civil settlement resolves claims brought by four former Medicis sales representatives. As a result of the settlement, the whistleblowers will collectively receive in excess of $1,078,000 as their statutory award. Under the qui tam provisions of the False Claims Act, private parties can file an action on behalf of the United States and receive a portion of the settlement if the government reaches a monetary agreement with the defendants.

Posted under Health, Safety

The nation’s largest airlines recorded a rate of on-time flights this past March that was higher than in February but down from the rate posted in March 2006, according to the Air Travel Consumer Report released by the U.S. Department of Transportation (DOT).

The 20 carriers reporting on-time performance recorded an overall on-time arrival rate of 73.3 percent in March, down from March 2006’s 76.1 but an improvement over February 2007’s 67.3 percent.

Special jeers for U.S. Airways. According to the government agency, the airline had by far the lowest on-time rate at 55.5% (JetBlue was next with 63% — that’s a huge difference). Even more astonishing was the performance of several US Airways flight. The survey found that one flight between Washington, D.C.’s Reagan National Airport to New York — a flight with direct competition from Delta’s “shuttle” was late 100% of the time. That’s right, every single flight. Here are the worst five flights and the top 3 overall performing airlines:

Most Frequently Delayed Flights

1. US Airways flight 2188 from Washington Reagan to New York LaGuardia – late 100%  of the time
2. ExpressJet Airlines flight 2575 from Newark, NJ to Pittsburgh – late 96.15 percent of the time
3. Comair flight 5274 from Boston to New York JFK – late 96.00 percent of the time
4. US Airways flight 836 from Boston to Philadelphia – late 95.00 percent of the time
5. US Airways flight 834 Charlotte, NC to Buffalo, NY – late 92.86 percent of the time

Highest On-Time Arrival Rates

1. Hawaiian Airlines – 93.9 percent
2. Aloha Airlines – 93.2 percent
3. Frontier Airlines – 84.8 percent

Posted under Travel

Industry experts estimate that as many as one out of 25 previously damaged vehicles may have non-functional air bags. Con men purposely replace deployed air bags with anything from packing peanuts to stolen units. This growing scam is threatening the lives of used car buyers everywhere. To help consumers protect themselves, Carfax now makes the air bag deployment information in its database available for free.

“No question, air bags are a lifesaver,” said Larry Gamache, Carfax’s Communications Director. “To best protect yourself, follow these two important steps: Use the free Carfax air bag check and always have your mechanic test the air bag system to ensure it’s functioning properly before you buy. Do not assume your car’s air bags will deploy when you need them, because most victims of this scam may never know until it’s too late.”

According to the National Highway Transportation Safety Administration, nearly 20,000 lives have been saved by air bags deploying in an accident. As the height of used car buying season quickly approaches, consumers need to be on the lookout for scams like air bag fraud that can threaten their safety.

“While we don’t know about every air bag deployment, we want consumers to have access to what we do know,” added Gamache. “We also encourage all of our customers who have information about a previous air bag deployment not currently in our database to tell us so we can further help consumers steer clear of this scam.”

Consumers can log on to www.carfax.com/airbag to access the free Carfax air bag check and can report air bag deployment information using the “Tell Us What You Know” link on all consumer-purchased Carfax Vehicle History Reports.

Posted under Automotive, Safety

Florida Agriculture and Consumer Services Commissioner Charles H. Bronson is urging consumers to check their refrigerators for Ole Mexican Foods Verole Queso Fresco Authentic Mexican Crumbling Cheese and Ole Fresco Authentic Mexican Crumbling Cheese. The two products may be contaminated with E. coli bacteria.

The potential for this contamination was determined after random testing performed by the Florida Department of Agriculture and Consumer Services revealed the presence of E.coli bacteria in samples of both of the cheeses.

“The discovery of this problem demonstrates the importance of an integrated pro-active food safety program, where products from stores and food processors are not only inspected but tested in our labs, as well,” Bronson said.

Department inspectors are working with Florida grocery chains to remove any of the potentially tainted cheese from those stores and are checking warehouses in Florida from which the products were distributed. Bronson said his agency has also notified the U.S. Food Drug Administration, which is responsible for the products in other states.

The affected code for Verole Queso Fresco Authentic Mexican Crumbling Cheese Net Wt. 15 oz. is V7&8 052 47193 SELL BY: 05/31/07; the affected code for Ole Fresco Authentic Mexican Crumbling Cheese Net Wt. 12 oz. is V5&6 051 47193 SELL BY: 05/30/07. Consumers who have purchased these products are urged to return them to the place of purchase.

No illnesses have been reported to date in connection with this problem.

Posted under Recalls

Menu Foods has previously recalled wet cat and dog food produced with adulterated wheat gluten supplied by ChemNutra Inc. Menu Foods is now expanding the recall to include cuts and gravy and select other products which do not include ChemNutra wheat gluten but which were manufactured at any of Menu Foods’ plants during the period that ChemNutra wheat gluten was used at that plant, to the extent they have not already been subject to a recall, due to the possibility of cross-contamination. Menu Foods has received a report from a customer and has received study results, both of which indicate cross-contamination.

As a result, Menu advises the public:

* Additional items in the United States and Canada have been added to the recall list as shown below. A further two varieties for Europe have been added to the recall list.
* The recall dates of those products previously recalled have been modified to include all dates during the period that ChemNutra wheat gluten was used in the applicable Menu plant. All of these products, including the expanded dates, have previously been withdrawn from the market and should already be off the retailer shelves.

Menu estimates that this additional recall represents less than 5% of the products that have already been recalled or withdrawn.

Posted under Health, Recalls