Florida appellate court upholds Florida law against generic drug switching - even if the generic has been FDA approved

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

Debate about Generic Drug Substitution & US Marshals seize Generic Drugs from Caraco Parmaceutical Detroit-Based Plant Today

The headline about US Marshals seizing drugs and raw materials from a generic drug manufacturer grabbed my attention today and reminded me about what I heard earlier this week about 'generic drug substitution' or 'therapeutic switching.'


Generic Drug Substitution:

A debate seems to be brewing about pharmacists dispensing generic versus the brand name drug written on the prescription. A few days ago, it was reported that people suffering from epilepsy that are given generic, instead of the suggested brand named drug, are having increased seizures. This 'therapeutic switching' or generic substitution

Read the Detroit Free Press article. "To her surprise, Pauley found a generic drug, not Lamictal, a brand-name drug that had effectively controlled most of Cheyenne's seizures. In the next week, Cheyenne, age 11, had 21 seizures -- many more than usual."

A fierce legislative campaign is playing out in Michigan and other states over generic substitution and therapeutic switching, a practice that allows health insurers to fill a prescription with drugs similar to brand-name drugs.

Usually, a doctor can stop a switch by writing "DAW" on a prescription. But problems still can occur, and appeals are time-consuming. The Michigan Osteopathic Association (7,000 members) and the 3,000-member Michigan Association of Family Physicians have some worries. They're concerned that the preference by many health plans toward generics and nearly equivalent drugs called therapeutic substitutes leave too many patients and their doctors out of the decision-making about which drug they can prescribe or use.

Today, generic drugs made by Caraco Pharmaceutical Laboratories Ltd. were seized by U.S. authorities for violating manufacturing standards.

This is rather troubling since Caraco manufactures and markets 67 different products, according to the company’s Web site. The FDA said the seizure could affect 33 drugs in different dosages. Sun Pharmaceutical Industries Ltd., a Mumbai, India-based drugmaker, owns 76 percent of Caraco’s stock, according to Sun’s Web site.

Drugs and raw ingredients for pain, heart ailment and psychiatric medications were confiscated today at three Detroit, Michigan facilities to prevent Caraco from distributing its products until the manufacturing deficiencies are corrected, the U.S. Food and Drug Administration said in their statement.

The FDA said drug seizure could lead to shortages of one pill, choline magnesium trisalicylate, a generic pain-relief medication. If you are taking this, the FDA suggested consumers to contact their doctors about other alternative pain-relief medications.

Inspectors who visited the Caraco facilities in May 2009 found “serious violations” of manufacturing standards and “serious deficiencies” in quality control, Deborah Autor, director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research, said in a briefing with reporters.

In October 2008, the FDA issued a warning letter to Caraco after inspections in May and June found manufacturing deficiencies, including the cross contamination of two drugs.

In April 2009, Caraco announced a voluntary recall of some undisclosed products, according to an April 17 federal regulatory filing.

During a May 2009 inspection of Caraco plants, the FDA found “unresolved violations” of manufacturing standards.

“Given the firm’s history, we thought this was the next appropriate step to protect the public’s health,” Autor said.

Corrective actions had been taken and “continual improvements” are being made while Caraco works with the FDA to resolve the agency’s concerns, the company said in a statement.

The drug seizure “may have a material adverse effect” on near-term operations, though the company hasn’t determined the financial impact, Caraco said in its statement.

Mesothelioma

Yesterday, I met with a client of mine. He is in his 80's and was diagnosed two months ago, with mesothelioma. He starts chemotherapy next week.

He reminded me much of my grandfather, whom I was very close. He was a child of the depression and World War II. He smiled and laughed as he described, in perfect detail, many aspects of his life that even his children had not known. His wife of 63 years nodded and smiled as he spoke of their life together her "country cooking". It made me yearn for the conversations that I had with my grandfather, who was of the same generation, grew up working in the mines, and believed in working hard, playing by the rules, reading his bible, and giving something back, especially to those in need or without.

I worry about his condition in 6 months and whether he will be alive a year from now.

We have all heard of Mesothelioma. We see ads on television day and night. We know the stories about the industry having knowledge of the dangers of asbestos going back to the turn of the century, but some basic information bears repeating.

Background

Mesothelioma is a rare form of cancer in which malignant (cancerous) cells are found in the mesothelium, a protective sac that covers most of the body's internal organs. Most people who develop malignant mesothelioma have worked on jobs where they were exposed to and inhaled asbestos particles.

Mesothlium cells are found in the sac lining of the chest (pleura), the abdomen (peritoneum), or the heart (pericardium). The specific type of mesothelioma is named for the tissue where the cancer originates.

Approximately 70% of mesothlioma cases starts in the chest (pleural mesothelioma), which surrounds the outer lining of the lungs and internal chest wall.

Symptoms of the illness typically take 20 to 50 years to appear. While there is no cure, treatments involve a combination of surgery, chemotherapy and radiation.

Although reported incidence rates have increased in the past 20 years, mesothelioma is still a relatively rare cancer. About 2,000 new cases of mesothelioma are diagnosed in the United States each year.

Mesothelioma occurs more often in men than in women and risk increases with age, but this disease can appear in either men or women at any age.

The Center for Disease Control noted from a 2003 study that “because mesothelioma manifests 20--40 years after first exposure, the number of mesothelioma deaths will likely peak by 2010.”

If you or a loved one has been diagnosed with mesothelioma, please give me a call to discuss your case. 205-322-8880 or email me @ Chrish@PDKHLaw.com .

FDA urges consumers to stop using Zicam due to loss of sense of smell

The U.S. Food and Drug Administration advised consumer to stop using three Zicam products marketed over-the-counter as cold remedies because they are associated wtih the loss of sense of smell (anosmia) on June 16th.

The products are:
--Zicam Cold Remedy Nasal Gel
--Zicam Cold Remedy Nasal Swabs
--Zicam Cold Remedy Swabs, Kids Size (a discontinued product)

More than 130 reports of loss of sense of smell associated with the use of these three Zicam products were reported to the FDA. Many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products.

“Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason.”

People who have experienced a loss of sense of smell or other problems after use of the affected Zicam products should contact their health care professional. The loss of sense of smell can adversely affect a person’s quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment.

The FDA has issued Matrixx Initiatives, maker of these Zicam products, a warning letter telling it that these products cannot be marketed without FDA approval.

See the FDA website links below for more information on Zicam :
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm166931.htm

NIH provides information about homeopathy: http://nccam.nih.gov/health/homeopathy/

Green Lawsuits Starting to Sprout

Litigation over green buildings that don't get LEED certification (Leadership in Energy and Environmental Design), resulting in the failure of building owners to receive tax credits is on the rise.

Contractors have allegedly represented to developers and building owners that their building will be environmentally friendly and qualify for tax credits.

In a recent case, the developer claimed that a builder failed to meet environmental standards set by the U.S. Green Building Counsel, a Washington D.C. based non-profit that creates standards and certifies buildings as environmentally friendly.

Many municipalities have been offering tax credits or zoning variances for construction that meets the USGBC standards. It is expected that in the future, municipalities will require all buildings to meet such standards. What happens when buildings don't meet the standards?

The builders will claim that the certification entities have wrongfully withheld certification. They may even attempt to add the certification companies as defendants, which may be difficult since they are private companies who claim they have no legal obligation to approve projects.

Other issues in this area include what happens when buildings are built to green standards, but don't deliver green results and result in other unforeseen problems.

You can be sure there will be much litigation in this area in the days, weeks, and years to come.

Read this New York Times Article for more reveling information: http://greeninc.blogs.nytimes.com/2009/05/29/the-legal-risks-of-building-green/

Report by Harvard Law School Points to Potential Legal Problems in Building Green: view the PDF here: http://www.mgkflaw.com/Green%20Building%20Revolution.pdf

For more information about building green, view the NRDC site: http://www.nrdc.org/buildinggreen/leed.asp

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

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.

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