Public Health Advisory: Drug Interaction, Prilosec/Plavix

A new Public Health Advisory from the FDA was published on November 17th. The FDA has new data showing a drug interaction between the drug omeprazole (Prilosec and Prilosec OTC) and clopidogrel (Plavix) which reduces the effects of the clopidogrel (Plavix) by almost half when both are taken by the same patient. The drug interaction in this case is caused by the omeprazole (Prilosec) blocking the "conversion of the Plavix into its active form."

Clopidogrel (Plavix) is a medication taken by heart attack or stroke patients to aid anticoagulation and prevent further clotting of the blood. Omeprazole (Prilosec) is commonly taken by prescription and over the counter to treat frequent heart burn. The FDA wants patients taking clopidogrel (Plavix) to know the following:

• Patients using clopidogrel should consult with their healthcare provider if they are currently taking or considering taking omeprazole, including Prilosec OTC.
• Both clopidogrel and omeprazole can provide significant benefits to patients, and patients should always consult with their healthcare professional before starting or stopping any medication.
• It is very important that patients talk with their healthcare professional about any over-the-counter (OTC) drugs they are taking before starting or while using clopidogrel

The FDA recommends patients taking clopidogrel (Plavix) that need a medication for stomach acid can use the following medications without serious interference with anti-coagulation medications such as Plavix: antacids such as Maalox or Mylanta, Zantac, Pepcid, or Axid.

The label for clopidogrel will be updated with the new warnings. If you are concerned about these drugs or their interactions with any medication you are taking, you should speak with your doctor.

Related resources:

• FDA Public Heath Advisory on Prilosec and Plavix (fda.gov)
• Things You Should Know: Taking Prescription Medications (FindLaw)
• Pharmacy and Prescription Errors (provided by Burnside Wall LLP)
• How to Avoid the Risks of Medical Negligence (provided by The Watson Law Group, Steven M. Watson)

Never Mind, Rapunzel: Illinois AG Sues Hair Growth Institute

Hair today, gone... no, that's just too easy. What is more difficult than promised, apparently, is for follically challenged Illinois consumers to get their money back from the Natural Hair Growth Institute. The Institute is a company supposedly promoting hair growth remedies. In a suit announced November 17, Illinois Attorney General, Lisa Madigan, is seeking $50,000 in penalties for each violation of the Consumer Fraud Act, full restitution for customers, and to ban the defendants Natural Hair Growth Institute (NHGI) and owner, Steve Bennis, from operating in Illinois.

According to the Attorney General's News Release, the claims made by the NHGI are completely unsupported by science. The company, for a token $8,000-$12,000, guarantees (or your money back) that its laser therapy, scalp massage and topical hair products will help re-grow hair within six months. The NHGI also claims that it uses an FDA approved "Orbit Laser Light" treatment like one commonly used in that great oasis of cutting edge health treatments, Europe. In fact, Madigan says, the laser used is not the same as the approved Orbit Laser Light device. 

The Illinois AG's Office has received nine complaints by consumers that, even after the promised "scalp detoxification... massage" and additional treatments failed to work, they did not receive their money back, as promised. Even after repeated requests.

ChicagoBreakingNews.com reports that the defendant remains unbowed.  A spokeswoman for Bennis said Tuesday night that he stands behind his businesses and called the suit a waste of taxpayer money. The suit "is 100 percent one-sided and has no basis whatsoever," spokeswoman Angela Kolton said.  Maybe hats will just come back into fashion in Illinois.

Related Resources:

• What is Fraud? (FindLaw)
• Madigan Files Suit against Natural Hair Growth Institute (Ill. AG's Office)
• Lawsuit alleges hair growth firm's claims are bald (Chicago Sun Times)
• State sues 2 local hair growth businesses (ChicagoBreakingNews.com)

Feds Crack Down on Gift Cards in Time for Holidays

With the holidays approaching, it seems like the best way to handle those pesky shopping lists is just to buy a bunch of gift cards right? Wrong! Sometimes you end up giving a nightmare instead of a dream gift.

Why is that? Sometimes retailers pretend that gift cards are like cash, but there are things in the fine print. For example, gift cards can expire before they can be used. Or the gift card has a monthly "maintenance" fee. Gift card fees and gift card expiration aren't exactly what most gift givers have in mind.

The government has heard many complaints and it has finally decided to crackdown on these unfair gift card practices. Complaints have been steady since 2007 about gift card practices. For example, Kmart had to settle charges brought against it by the Federal Trade Commission which charged that the retailer engaged in deceptive practices in selling and advertising its gift card. It promoted its card as the equivalent of cash but there were fees placed on the cards after two years of non-use. The retailer also advertised that the card never expired when it really did expire after a certain period of time.

Well this holiday season promises to be a bit brighter with help from the Federal Reserve Board. It announced that proposed rules to restrict fees and expiration dates would apply to gift cards. This would prevent all of those problems that consumers have had in the past with gift cards as outlined above.

According to the press release from the Federal Reserve Board: "The proposed rules would prohibit dormancy, inactivity, and service fees on gift cards unless: (1) there has been at least one year of inactivity on the certificate or card; (2) no more than one such fee is charged per month; and (3) the consumer is given clear and conspicuous disclosures about the fees. Expiration dates for funds underlying gift cards must be at least five years after the date of issuance, or five years after the date when funds were last loaded."

This is in order to help implement the provisions outlined in the Credit Card Accountability Responsibility and Disclosure Act of 2009 which are specifically for gift cards.

So make sure you read the fine print this holiday season. That way you can prevent retailers from scrooging your gift card recipients.

Related Resources:

• Banking - Gift Cards (Findlaw)
• CARD Act Move-Up: Credit Card Reform May Come Early (Findlaw's Common Law)
• Kmart Settles Charges Over Gift Cards (Findlaw's Common Law)

Update: Utah Settles with Eli Lilly in Zyprexa Case

As we previously discussed regarding Eli Lilly's $1.42 Billion Zyprexa settlement, major pharmaceutical company Eli Lilly has faced a host of suits over its marketing tactics for the drug Zyprexa. Last week Utah Attorney General, Mark Shurtleff, announced that state's settlement of the drug lawsuit with Lily, for $24 million.

Shurtleff feels this was a big win for the state, not only in terms of the money, but because the he wanted Lilly's "bad conduct to stop." According to Utah's four year investigation, 1,769 patients over the age of 65 received the drug with out the appropriate diagnosis. 

Utah, like 13 other states, choose to go it alone in its suit against the drug company instead of joining the 32 state group who's suit against Lilly ended in a $62 million dollar settlement last year. The group suit, like the Utah case, centered around Lilly's aggressive marketing of the drug for off-label uses for dementia, Alzheimer's, agitation, aggression, hostility, depression and generalized sleep disorder. The FDA has not approved the drug for treating these conditions.  

The settlement money will be useful for Utah which, like so many other states, is struggling with a huge budget shortfall. "There are plenty of opportunities and critical needs for this money," House Speaker David Clark, R-Santa Clara, said as he accepted a faux $24 million check from Shurtleff.

In the Utah Attorney General's News Release, Robert Steed, Assistant Attorney General and Director of the Utah Medicaid Fraud Control Unit said, "Today's announcement should send a clear message that those who would put corporate profits ahead of patient safety will be held accountable."

Related Resources:

• Utah Snags $24m in drug case (Salt Lake Tribune)
• Utah Attorney General News Release
• Eli Lilly Zyprexa Settlement: Drug Maker to Pay Record $1.42 Billion> (FindLaw's Common Law)
• FDA Overview (provided by Goldenberg & Johnson, PLLC)

Heads Up: BPA in High Levels Linked to Sexual Dysfunction

After numerous reports on the potential harmful effects of the chemical bisphenol A, known as BPA, one more issue rears its ugly head: potential problems with sexual function in men. In a new report from Kaiser Permanente and published in the journal Human Reproduction, researchers spent five years studying workers in factories in China with relatively high levels of exposure to BPA. Numerous effects on sexual function were reported.

Earlier research has linked BPA exposure to reproduction problems in animals, but the new study is the first to do so in humans, reports webmd.com. Critics who were quicker to reject reports based on animal subjects may have a more difficult time dismissing this one. Additionally, there is the subject matter. Based on self-reporting techniques, the study found the BPA exposed workers had nearly a fourfold increased risk of reduced sexual desire, an even greater risk of erectile dysfunction and a more than sevenfold risk of ejaculation difficulty than non-exposed men. 

American Chemical Council spokesman Steve Hentges, PhD, tells WebMD.com he still has doubts. He finds the study sample small, "with just 230 occupationally exposed and 404 unexposed workers," and is concerned by the "self-reported observations of sexual dysfunction." However, doubts about the self reporting should be considered carefully since workers might well be likely to under-report, rather than over-report, such problems.

Consumers should be aware of these new findings, as BPA is found not only in plastic goods such as bottles, but in the lining of cans used for food products. However, it should be noted that the men in the study were exposed to about 50 times higher levels of BPA than the average American male. 

SanFranciscoGate.com also reports that while the FDA found in 2008 that trace amounts of BPA are not harmful, some manufacturers have stopped using it and several regional and state governments have banned it in baby products such as bottles and sippy cups.

Researches who published the report for Kaiser Permanente would like to do further research investigating the effects of lower levels of exposure, like those to consumers of products containing BPA.

Related Resources:

• Study: High BPA Linked to Sex Problems in Men (WedMD)
• Article: Study: Bisphenol A Linked to Sexual Dysfunction (SFGate.com)
• Study: Occupational exposure to bisphenol-A (BPA) and the risk of Self-Reported Male Sexual Dysfunction (Journal of Human Reproduction)
• BPA in Canned foods (FindLaw's Common Law)
• Personal Injuried from Dangerous Products (provided by Stulce & Yantis)
• Personal Injury - An Overview (provided by Carter & Fulton, P.S.) 

FDA Considering New Food Tracing Guidelines

In a November 13, 2009 press release, the Food and Drug Administration (FDA) released a food safety report from the Institute of Food Technologists (IFT) recommending objectives be set to improve tracking on global food supply chains. The IFT is a nonprofit scientific society focusing on the science of food. This report was commissioned by the FDA's Center for Food Safety and Applied Nutrition in 2008.

Since food can become contaminated at any point in the supply chain, the improved ability to trace the movement of food products will allow the FDA and other agencies to more quickly identify the source of contaminated foods and thus hopefully reduce the instances of illnesses in consumers.

According to WorldPoultry.net, the recommendations from the IFT and their expert panel include basic plans to integrate and update food tracing systems. Suggestions include: use of electronic data systems for data transfer, comprehensive record keeping to allow linking of information with partners, standardization of formats of information. As elementary as some of these tasks sound, partners in food production and supply include a diverse, global group including farm workers, shippers, importers, wholesalers, retailers, government agencies and consumers. It will be a large task to develop a system to allow information from each of these groups to be available to all the others.

The improved ability to track and pinpoint the origin of food borne diseases will of course enable the FDA to "get risky products off the market faster," notes the FDA press release. This report is only part of the record the FDA will consider when, as meat international.com reports, the FDA and the U.S. Department of Agriculture's Food Safety and Inspection Service will hold a public meeting on food product tracing in Washington, D.C., on December 9 and 10, 2009. The agencies will be seeking written input from stakeholders on improving the food tracing system.   

Related Resources:

• New Report Recommends Enhanced Food Tracing Guidelines (FDA)
• Study: Establishing comprehensive tracing system (WorlPoultry.net)
• New report recommends enhanced food tracing guidelines (MeatInternational.com)
• Beef Recall: 500,00 Pounds Due to E. coli; 2 Deaths Linked (FindLaw's Common Law)
• Personal Injuries from Dangerous or Defective Products (provided by Warner Law Offices PLLC)
• PI Overview (provided by Hagner & Zohlman, LLC) 

Will the FDA Ban Alcoholic Energy Drinks?

The FDA announced Friday that sent a letter to about 30 companies regarding their production of energy drinks with alcohol. Why would the FDA target manufacturers of legal products with an additive that is as seemingly safe as caffeine? Don't we all take in more caffeine with a morning latte?

Attorneys General from 18 different states and one City Attorney sent a letter to the FDA expressing concerns about the health risks of alcoholic energy drinks. A 2007 study at Wake Forest University found that the mixture of alcohol, a depressant, and caffeine, a stimulant, actually masked the drinker's intoxication level and lead to an increase in injury, willingness to ride with an intoxicated driver and even increased instances of sexual assault.

The FDA will give companies 30 days to show that under their regulations, the addition of caffeine has either been previously sanctioned by the agency, or is what the agency calls GRAS (Generally Recognized As Safe, unfortunately, no pun intended). At this time, the FDA has only approved caffeine as an additive in drinks at levels of no more than 200 parts per million and has not approved caffeine for use at any level in alcoholic beverages.

However, even your Red Bull may not be safe from increased regulation. Last October, a number of scientists and doctors petitioned the FDA for more regulation over the amount of caffeine found in non-alcoholic energy drinks such as Red Bull, Rock Star and Monster. The group is hoping for better notification of the disparity in caffeine levels in the various drinks and a warning about potential risks when mixed with alcohol.

According to CNN, some manufacturers of alcoholic drinks have already taken their caffeinated variants off the market, including Anheuser-Busch and Miller who have reformulated their drinks Tilt, Sparks and Bud Extra to leave out the caffeine. 

Related Resources:

• FDA: Caffeinated Alcoholic Drinks May Be Illegal (CNN Health)
• FDA Press Release on Caffeinated Alcoholic Drinks
• FDA Manufacturers List
• Food Ingredients & Packaging Guidance (FDA)
• Personal Injuries from Dangerous Products (provided by Duffield, Lovejoy & Stemple, Attorneys at Law)
• Drunk Driving Accidents - An Overview (provided by Rawls, Dickinson & Scheer, P.A.) 

Bank on This: New Rules on Overdraft Fees Issued

One change in overdraft fees and bank regulation in favor of consumers down, and about 100 still to go. The Federal Reserve announced last Thursday that new rules concerning overdraft protection charges plaguing consumers' bank balances are set to go into mandatory effect for new cards on July, 1, 2010.

As discussed in previous Common Law posts, consumers have numerous concerns with overdraft. Some of those we've previously addressed include:

• processing order (banks often do the largest transaction first, rather than in chronological order),
• getting signed up for overdraft "protection" perhaps without even knowing it,
• not having an opportunity to back out of a transaction if it puts the balance, in negative territory,
• having no, or high daily or yearly limits on overdraft fees levied, and
• having fees that are disproportionate to the amount overdrawn.

The Fed has chosen this time around to address one of the above issues frustrating bank customers. As of July next year (August 15 for existing accounts), consumers will have the right to receive clear information about and the opportunity to opt out of OD services and related charges pertaining to check card transactions at retailers and ATM's only.

As reported by the New York Times, it seems that consumers are simply not as upset about the overdraft fees on paper checks or on re-occurring scheduled withdrawals (such as monthly phone bills), so they are exempt from this rule.

Under the new rules, consumers will have an opportunity decline overdraft protection for ATM and check card transactions. Banks will be then prohibited from "discriminating" (that is trying to make up the loss with added fees elsewhere) against customers who do choose to opt out. Customers will also have the option of revoking their consent to the service. 

The banks, of course, are predicting doom and gloom and a loss to the customer-beloved institution of overdraft protection due to all the losses that they argue mostly smaller banks will incur under the new rules (though big banks will surely miss some of the billions they've been reaping off overdraft fees).

Still up for future consideration is legislation introduced by Senators Christopher Dodd and Charles Schumer to limit the number of overdraft fees to one a month and to require a bank to seek permission from consumers to cover debit card and check purchases that would push their bank balance below zero.

Unfortunately, the Fed did not yet address other troubling bank practices such as processing a larger transaction ahead of smaller ones which could push a customer into the red, thus triggering overdraft protection and those pesky fees.  Maybe next time.

Related Resources:

• Overdraft Fee Reform: 5 Terms to Watch (FindLaw's Common Law)
• Overdraft Fee Bonanza (FindLaw's Common Law)
• New Rules Restrict Overdraft Fees on Cards (NY Times)

Illinois AG Sues over Credit Cards Interest Rate Telemarketing Scams

In this time of economic woe, most of us are putting less on our credit cards. If you haven't been so wise and are facing large bills and increasing interest rates, be careful whom you choose to help you out of your hole. On November 10, 2009, Illinois Attorney General Lisa Madigan filled suit against two companies for telemarketing scams promising to lower consumer's credit card interest rates.

According to ConsumerAffairs.com, the Illinois AG's suit alleges two Texas and Washington based companies guaranteed customers a minimum savings of $2,500 in reduced credit card rates, or their money back. Once a customer enrolled in the program, they were charged fees from $391 up to $1590 which were promised to be refunded, but never were. In addition, when the promised interest rate reduction did not materialize, refunds were refused or sent minus an undisclosed $199 fee.

Unfortunately, this type of scam is nothing new. A strikingly similar operation was run out of Canada and halted by the FTC in February of 2007. In that scheme, telemarketers also promised to save consumers $2,500 (were they reading from the same handbook?) and then charged $695 for materials that of course failed, as did the company, to save consumers a dime.

What can you do to protect yourself from like scammers? A few simple guidelines may help: 

• never reveal your credit card number to unsolicited callers
• ask for and read contracts, literature or any company prospectus before buying or investing
• ask for information from the seller: name, company name, address, website 
• if you think you have been the victim of fraud, contact your Better Business Bureau, the FTC, state Attorney General's office or other appropriate agency

Illinois AG Lisa Madigan recommends consumers contact credit counseling companies to assist them with their credit problems.

Finally, use common sense. Just like your mother told you, if it sounds too good to be true, it probably is.

Related Resources:

• Beware Of Credit Card Debt Reduction Offers (WCBV, Boston)
• How to Avoid Debt Reduction Scams (BillEater.com)
• CARD Act Move-Up: Credit Card Reform May Come Early (FindLaw's Common Law)
• Collections and Consumer Rights FAQ (provided by Boyle, Neblett & Wenger)
 

FDA Warning on Selling Illegally Flavored Cigarettes

The U.S. Food and Drug Administration issued warning letters on Monday to companies continuing to sell illegal flavored cigarettes to consumers through their Web sites.

According to the FDA, it is enforcing the ban on flavored cigarette under the Family Smoking Prevention and Tobacco Control Act. These efforts are part of a multi-level initiative to steer children and youth away from cigarettes.

The FDA requested a written response from each of the companies within 15 days outlining the corrective actions to cease the marketing and sale of these products.

The FDA's warning letters are posted on the agency's site and detail the offending websites and flavored cigarette products.

Nearly 500,000 Americans die from tobacco-related causes each year, according to the American Cancer Society. Smoking is responsible for 87% of all lung cancer deaths.

FDA Commissioner Dr. Margaret Hamburg also points out that 90% of adult smokers started as teenagers.

Prevously, we discussed the list of tobacco products covered under the ban.

In addition, here are some already passed rules which will be going into effect over the next few years:

• By January 2010, tobacco manufacturers and importers will submit information to the FDA about ingredients and additives in tobacco products.
• By July 2010, tobacco manufacturers may no longer use the terms "light," "low," and "mild" on tobacco products without an FDA order in effect.
• By July 2010, warning labels for smokeless tobacco products will be revised and strengthened.
• By October 2012, warning labels for cigarettes will be revised and strengthened.

Related Resources:

• General Questions and Answers on the Ban of Cigarettes that Contain Certain Characterizing Flavors (FDA)
• Feds ban candy- and fruit-flavored cigarettes (Los Angeles Times)
• FDA: Flavors for Candy, Not Cigarettes (FindLaw's Law & Daily Life)
• Injuries from dangerous products (provided by Kessler DiGiovanni & Jesuele, LLP)
• Consumer Safety Links (provided by Caravona & Czack, P.L.L.)