Florida appellate court upholds Florida Law regulating "generic drug swapping"

Today, a Florida state appellate court ruled that a Florida law banning the substitution of certain drugs must be followed, even if a generic version gets federal approval from the Food and Drug Administration.

A three-judge panel of the 1st District Court of Appeal unanimously said it would be unconstitutional for the Florida Legislature to give up its authority over generic swaps to the federal Food and Drug Administration.

The Florida law lists the drugs for which generics cannot be substituted. The appellate court ruled that the Legislature has to make any changes in that list.

The court sided with Abbott Laboratories, which appealed Administrative Law Judge Susan B. Harrell's decision to remove a thyroid drug, including its name-brand Synthroid, from the list.

"It upholds a fundamental right of patients to receive the medications that are prescribed and intended by their doctors," said Abbott spokesman Scott Stoffel in Chicago.

Abbott's drug is prescribed for patients whose thyroid glands don't make enough of a hormone that regulates energy and metabolism. Synthroid also is used to treat or prevent goiters - an enlargement of the thyroid gland - that can result from hormone imbalances, radiation treatment, cancer or surgery.

Harrell had ruled that a generic version made by Mylan Pharmaceuticals Inc. could be substituted because the FDA in 2007 had given it an A rating, which meant it was the therapeutic equivalent of Synthroid.

Harrell based her ruling on another provision of the law that removes a generic from the list if it gets an A rating in the FDA's "Orange Book."

District Judge William A. Van Nortwick wrote that Harrell should not have applied that provision to editions issued after the law was passed in 2001.

It's up to the Legislature to update the list each year based on revised versions of the Orange Book, though it isn't required to follow the FDA's guidance, Van Nortwick wrote.

Source: http://www.miamiherald.com/news/florida/AP/story/1108552.html

FDA: previous failures and potential powers

Although the Food and Drug Administration touts on its website its task is "protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics and products that emit radiation," the past few years have exposed an underfunded and understaffed organization that has been slow to react, or taken no protective action at all, in response to potential dangers.

Recent examples of contaminated food products, destructive dietary supplements and harmful homeopathic remedies and drugs have highlighted the need for a more proactive, tougher FDA regulatory agency.

The new FDA commissioner, Dr. Margaret A. Hamburg, is taking the lead in trying to facilitate a strengthened regulatory agency for American consumers. Until now, the FDA has been a more reactive agency with limited powers as shown in the past few years with normal household products on the market hurting Americans who purchase and use them.

Fortunately, Dr. Hamburg said that to oversee the increasing flood of imported foods, medical devices and drugs, the F.D.A. would have to create far more partnerships with foreign regulators. “Under my leadership, we’ll see a somewhat more aggressive posture with respect to enforcement,” she said. Unanimously confirmed by the Senate in May, praised by conservative Republicans and liberal Democrats alike, Dr. Hamburg maintains wide support among a diverse and often fractious set of industry, consumer and patient advocacy groups.

The FDA has already made strides, but I expect to see tougher regulations and restrictions on companies producing dietary supplements, homeopathic remedies, medical devices, pharmaceuticals, food, tobacco, and plastics. Currently, the FDA does not regulate dietary supplements or homeopathic remedies (highly diluted drugs made from natural ingredients), which are taken by more than half of Americans and have grown into an estimated $25 billion industry, causing consumers to be guinea pigs to companies’ recipes for healthier life. The sector remains one of the least regulated under current laws: the Dietary Supplement Health and Education Act of 1994 requires that the manufacturer of a dietary supplement, not the FDA, ensure its safety before it is marketed. The FDA is responsible only for taking action against any unsafe product after it's on the market.

U.S. District Court Judge Jack Weinstein in ruling on one Zyprexa case in 2008 said

"Compared to its peer agencies in other parts of the world, the FDA has arguably failed consumers and physicians by over-relying on pharmaceutical companies to provide supporting research for new drug application. The result of such claimed governmental failures arguably causes overuse and overpricing of pharmaceuticals, resulting in mass litigations such as this one for Zyprexa."

Let’s hope the new FDA Commissioner stands by her word and allows Americans to consume safer products, food, and medical devices.

Be Weary of Dietary Supplments; Report Adverse Events directly to the FDA

2 days after the FDA warned consumers about potential loss of smell and Matrixx defended its products calling the FDA warning a "surprise," its CEO revealed the company didn't turn over 800 complaints received from consumers about loss of sense of smell to the FDA.

No only was the company hiding critical information for the FDA to notify consumers, it was still reaping profits while it knew of the 800 complaints, compared to the 130 complaints that the FDA received that forced the product recall/withdrawal.

If you have experience an adverse event with a dietary supplements, homeopathic remedy or pharmaceutical, immediately let the FDA know in addition to the company.

Report adverse events to the FDA at this site: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm


Read full article here: http://www.sltrib.com/business/ci_12624089?source=sphere_article

IRS provides words of caution

I read an interesting article that an IRS special agent wrote about prominent tax schemes and scams to avoid.

He explains tax evasion, money laundering, mortgage fraud, and investment fraud.

I have clients that have been scammed through illegal tax shelters under IRS code 412(i) and other clients who have had their identity stolen. My clients feel betrayed in addition to losing money and privacy. Be cautious and careful with who you do business with and don't ultimately rely on every word they tell you.

Words of wisdom:

• If someone says that they can help you earn extraordinary rates of return on your investment, make sure to get a second opinion from a legal, tax, or investment professional. It could be real fishy.

• If it sounds too good to be true, it is too good to be true.

These statements should be red flags to warn you of trickery and deceit.

In today's economy it is important to protect your self-interest and be vigilant in protecting the integrity of your personal financial affairs.


If you or a loved one has had your identify stolen or have been sold an illegal tax shelter, email me at ChrisH@pdkhlaw.com

Read the whole article here:
http://www.tidewaternews.com/news/2009/jun/17/words-caution-irs/

Calrcon Skin Product: Partial Recall and Warning

The Food and Drug Administration warned consumers Monday, June 8, 2009, not to use skin products made by Clarcon because of high levels of disease-causing bacteria found during a recent inspection. View the FDA press release here.

Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, issued a voluntary recall of some skin sanitizers and skin protectants marketed under several different brand names, the FDA said in a statement.


Consumers should not use any Clarcon products and should throw them away, the FDA said.

FDA said analysis of several samples of over-the-counter topical antimicrobial skin sanitizer and skin protectant products revealed high levels of various bacteria, including some associated with unsanitary conditions. Some of these bacteria can cause opportunistic infections of the skin and underlying tissues and could result in medical or surgical attention as well as permanent damage.

Examples of products that should be discarded include:

• Citrushield Lotion
  
• Dermasentials DermaBarrier
  
• Dermassentials by Clarcon
  
• Antimicrobial Hand Sanitizer
  
• Iron Fist Barrier Hand Treatment
  
• Skin Shield Restaurant
  
• Skin Shield Industrial
  
• Skin Shield Beauty Salon Lotion
  
• Total Skin Care Beauty
  
• Total Skin Care Work

Florida Department of Insurance Issues Show Cause Order Against Liberty National Life Insurance Company

On June 3rd, the Florida Department of Insurance issued an order for Liberty National Life Insurance Company to show cause why a final order suspending or revoking the Certificate of Authority currently held by Liberty National in the state of Florida should not be issued.


The Order arose out of a Market Conduct Examination which took place from June to November of 2008 at Liberty National offices in Birmingham, Alabama.

According to the Order, Liberty National was accused of unfair and deceptive conduct. Specifically, Liberty National is accused of discriminating against people solely because of the individuals national origin.

The order primarily involves individuals from Haiti who applied for insurance, but also addressed applications from individuals from Columbia, India, and Pakistan. The applications reviewed by investigators requested to know if the individual had lived in the United States for the last year. However, Liberty National had an underwriting policy that applicants born in certain countries would be rejected if they had resided in the United States for less than 10 years. This heightened underwriting standard applied to individuals from less developed countries. "This was in direct contrast to the written information provided to applicants as part of the application process that they must have resided in the U.S. for the past year to be eligible for life insurance coverage."


As a result, applicants were denied coverage based solely on their national origin.

Additionally, regulators determined that Liberty National represented a basis for denial as "information not received" which was a completely false and fabricated reason to cancel a policy when no actual reason existed. One underwriting file even contained a handwritten stating "Find a reason to cancel/decline. Info not received?"

For a complete copy of the report, contact Chris Hellums at Chrish@PDKHLaw.com

What is Zombie debt and how does it relate to Debt Collectors and their tactics

One of the things people who have been victims of identity theft report to me frequently is that they have done everything humanly possible to educate debt collectors that the debt is not theirs, yet they continue to harass them repeatedly. They also report that just when they think they have convinced them that the debt is not theirs, they change debt collection companies and it starts over again.

Why does this occur? This occurs because the debt continues to get sold. After some period of time, the original creditor (i.e. credit card company) sells the debt to an entity who purchases that debt for some percentage on the dollar. The age of the debt determines how much it sells for on the secondary market. Often the debt of any number of people is consolidated and sold in blocks.

Depending on the age of the debt, it is possible that it could be sold for pennies on the dollar. Extremely old debt is often referred to in the industry as Zombie debt. Like the name implies, it is debt that, despite the age, refuses to die. Much of this debt is debt that has been written off, discharged in bankruptcy, or resulted from identity theft.

Claims by consumers of illegal tactics by debt collectors have skyrocked. In 2008, consumers complained about debt collectors more than any other industry. The FTC recently issued a report saying that the debt collection system needs reform to insure that collectors are going after the right people for the right amounts of money.

To date, collectors are fighting state officials investigations into their actions.

Are Debt Collectors out of Control?

It all started with a call from a potential client. When the call started, I could tell it was going to be a long conversation. The call was from an elderly woman who sounded as if she was at her wits end. As she told her story, I realized that I had to see if I could help.

Her daughter had gotten into drugs and stolen her identity. She had taken out credit cards and incurred debt in her mother’s name. When her mother found out, she talked with her daughter and told her that there must be consequences for her actions. She contacted the police and filed a complaint against her daughter. This was a difficult decision as she loved her daughter and realized that her actions would effect her daughter’s life. However, she was even more concerned if she did not do something. Her daughter plead guilty and entered into a restitution agreement.

Image via Wikipedia

Shortly thereafter, the mother and true victim began getting calls and letters from debt collectors. She explained the situation to them. She provided them a copy of the complaint she filed. She provided them with a copy of the guilty plea. She even obtained a letter from the District Attorney who prosecuted her daughter describing what happened and stating that she was not now, or had she ever been, a participant in the fraud and in fact, was a victim.

These collectors did not care. Day and night they called. They called at home. They called at work. They even called at her husband’s work. They threatened to garnish her wages. They threatened to take her house. They threatened just about everything you could threaten.

She then went to an attorney. She paid him thousands of dollars to write letters to these people in hopes that would stop the harassment. Nothing seemed to work.

Somehow she found me late one afternoon. Up until this point in time, I had never handled a case like this one. I researched the issues and began looking at consumer sites such as budhibbs.com.

I filed suit against the various creditors and debt collectors.

After filing suit, I received the first of what has become common in these types of cases. The attorneys for the various entities call and say they cannot find my client’s account, their client has no record of any calls to my client. They would never call at work. My client must be mistaken. Fortunately, my client had kept recordings from her answering machine and had co-workers listen in on conversations. Ultimately, we settled with the debt companies and collectors. My client received economic compensation and on some level, felt vindicated.

Since that time, I have represented a number of client’s in these types of transactions.

I advise them all to do the following:

1. Document every conversation
2. Document any phone number which calls them
3. Retain all letters received from any bill collectors
4. Dispute all accounts with the various Credit Reporting Agencies
5. Obtain a police report
6. Send a letter, certified mail, to each creditor and debt collection company

I also tell my clients to be prepared to receive more harassing calls and letters stating that the creditor or debt collectors have completed their investigation and determined that they owe the debt.

To understand why this occurs, consumers need to know more about how the industry works. Stay tuned to future postings about how the industry operates, the tactics they use, and where to go for help.

Chris Hellums is the managing shareholder of Pittman Dutton Kirby & Hellums. He can be reached at CHRISH@PDKHLaw.com or toll free at 866-515-8880

Congress Must Act on Nutritional and Dietary Supplements

We must tighten laws on nutritional and dietary supplements. It is that simple. All day and all night we are barraged with commercials touting (and showing) the benefits of these products. And yes, from time to time, there are articles or exposés which reveal that the women in the ads have lost the weight not from taking the product, but either by gaining the weight on purpose, or comparing against pictures taken shortly after having a baby.

However, this is not enough to deter Americans quest for a bottle cure, and while spending some money on a product that simply does not work is acceptable to many, what most don’t realize are the real dangers of these types of products.

Many assume that manufactures cannot make the exaggerated claims on television unless they are true, or because the Food and Drug Administration regulates prescription drugs so heavily, that they regulate these as well. These assumptions are simply incorrect. The truth of the matter is that the exaggerated claims are made because there is so little regulation and because there is so much money to be made---$22 Billion-a-year. Yes, that is correct, Billion, not Million.

Image via Wikipedia

A 1994 law leaves this industry lightly regulated. Supplement manufacturers don't have to provide scientific proof of a product's purity, safety or effectiveness before they put it on the market. Instead, the FDA generally does not step in until after problems are reported.

The industry argues that the current regulation works well and that one bad apple is not representative of an industry whose manufactures, for the most part, go to great lengths to ensure they sell a safe, quality product.

The problem is that the Hydroxycut has become just another addition to a long list of dietary and nutritional supplements that were heavily hyped and then discovered after perhaps millions were sold, to pose significant and harmful risks.

Last year, Total Body Formula, was recalled after it was determined that it contained toxic amounts of Selenium---the same substance that killed polo horses in Florida. If selenium will kill horses, imagine what it would do to humans. StarCaps, a product used by overweight Minnesota Vikings Kevin and Pat Williams, was found late last year to contain an unlisted prescription diuretic that could increase users' risk of heat stroke and dehydration. In 2004, the FDA banned ephedrine diet aids after a major study linked the products' use to more than 16,000 adverse events, including cardiovascular problems.

Incredibly, Hydroxycut was marketed as a better alternative after the ephedrine ban. It’s name comes from hydroxycitric acid, which comes from a tropical fruit. Reportedly, Hydroxycut sold 9 million units last year. After 23 reported cases of serious health problems in people taking the product, including liver abnormalities, heart problems and possible kidney failure -- Hydroxycut's manufacturer agreed to recall at least 14 products late last week.

The time has long come for Congress to more strongly regulate dietary and nutritional supplements. Of course, once this occurs, we will only have to worry about altered data being sent to the F.D.A. and a revolving door of regulators moving on to work for the industry.








Chris Hellums is the managing partner of Pittman Dutton Kirby & Hellums and is currently co-lead counsel of the Executive Committee to the Personal Injury Plaintiff's Steering Committee for the Total Body Multi-District Litigation. He can be reached at ChrisH@PDKHLaw.com