In a Press Conference on February 3, 2010 Sen. John McCain announced his intention to introduce a new bill that would amend DSHEA (Dietary Supplement Health Reform Act 1994) requiring manufacturers of Dietary Supplements to register and disclose all ingredients.

In the Press conference McCain was quoted “All we’re saying is, list the ingredients, OK?” “And register so people will know what they’re taking into their bodies. It’s not really outrageous when you think about it.”

Council for Nutrition CEO, Steve Mister, responded “The responsible dietary supplement industry represents the health and wellness interests of more than 150 million Americans who use dietary supplements each year. We have consumers’ health and best interests at heart because we recognize that without our consumers, we would not exist as an industry. ”

According to the Bill the definition of “new dietary ingredients.” Would be replaced by “‘Accepted Dietary Ingredients’, to be prepared, published, and maintained by the Secretary.

If the Bill gets passed the  FDA will have authority for mandatory recall as it has now only with medical devices and prescription drugs. The FDA could then determine and act  if there was reasonable that a product marketed and/or sold as a dietary supplement would cause serious, adverse health consequences or death, or is adulterated or misbranded.

Presently the FDA, even with the new CGMP (Good Manufacturing Process) rule to fully roll out in 2010, has no power to enforce or recall a suspected dangerous product or conduct testing on any product for safety and efficacy. Interestingly as more reports of dangerous tainted dietary products hit the news even some manufacturers of Dietary Supplements have an voiced support legislation to ensure the health of the billion dollar supplement Industry by slowing the erosion of trust in the safety of their products.

The bill outlines proposed new changes that include:

• New facility registration requirements to identify all brands, products, and ingredients
• A revised definition of new dietary ingredients (NDIs) that would rely on an FDA-generated positive list of allowed ingredients
• Extension of existing adverse event report (AER) requirements, such that even minor AERs would need to be submitted to FDA annually
• Policing and record maintenance obligations for downstream manufactures and retailers, who will be obliged to obtain written confirmation, from ingredient suppliers or from supplement brand marketers, respectively, of compliance with facility registration and product notification and rules.
• Obligations and authority for FDA with regard to removing products that present the risk of serious adverse health consequences or death, or are adulterated or misbranded

Our firm is proud to announce eight of our attorneys have been awarded Best Lawyers in America designations for 2010. Of the eight attorneys, two were named Lawyers of the Year for 2010.

Christian (Chris) D Searcy was honored by being recognized as Lawyer of the Year in the area of medical malpractice litigation and F. Gregory (Greg) Barnhart was recognized as Lawyer of the Year in the area of personal injury.

Both seasoned and successful litigators, Chris and Greg, are honored to have been recognized amongst their peers in this way.

Six attorneys from Searcy Denney Scarola Barnhart & Shipley, PA were recognized by their peers for inclusion in Best Lawyers in America for 2010:

• John (Jack) Scarola
• John A Shipley III
• David J Sales
• Christopher K Speed
• Darryl L Lewis
• Karen E Terry

These six experienced and successful trial attorneys are also proud to have been honored in this way.

Our firm is extremely pleased and proud that The Best Lawyers in America designation has again been assigned to some of our many successful attorneys. It is our firm’s continued objective to provide our clients with only the very finest legal representation possible.

This case is a tragedy about (4) young lives extinguished long before they should have been. This is also a story about a corporation that lost, destroyed and fabricated evidence in an effort to avoid liability for the death of these four young people.

BNSF Railroad’s story: the four youths tried to drive around the gate to beat the train.

ABC News reports that the Judge, Ellen Maas, felt it happened a little differently, but that the railroad engaged in improper conduct including:

The misconduct included the loss, destruction and fabrication of electronic and physical records, the failure for BNSF to follow its own policies for accident investigation and coordination with law enforcement, interference with the plaintiff’s access to witnesses and the accident site, according to Maas, who also said that BNSF employees provided misleading facts in depositions, sworn affidavits and trial testimony.

The jury returned a $24 million verdict; representing $6 million for each of the deceased.

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More than 8,000 smokers and their loved ones have been waiting for nearly two decades for their opportunity for justice. These smokers were part of the Engle class action that was decertified several years ago.  The Florida Supreme Court upheld a number of findings made by the Engle jury after they heard evidence for nearly a year; which will now apply in individual trials being held across the state for smokers and their surviving family members.  Most of the upcoming trials involve the surviving spouses and children of smokers who died long ago due to lung cancer or chronic obstructive pulmonary disease (COPD).

Below is a summary of upcoming tobacco trials:

In addition to the above trial settings, additional trials should be scheduled during the same time period in Broward, Hillsborough, Lee, Escambia, Duval, Volusia, Alachua, and Levy Counties.  Several judges have indicated a willingness to consider conducting multi-plaintiff or consolidated trials, over the strenuous objection of the tobacco defense lawyers, in hopes of giving every former member of the Engle class action the right to a jury trial during their lifetime.

Down Syndrome strikes 1 in every 800 babies. Although commonly thought to predominantly afflict children of “older” mothers, the fact is that actually 80% of mothers giving birth to children with Down Syndrome are under the age of 35. At one time, Down Syndrome children had little hope and research was not being intensively done. Now, thanks to a number of groups, these children have people “opening doors to create a brighter future.

One such group is The Gold Coast Down Syndrome Organization, which was started in 1980 by three mothers who had a common need to make a better life for their children with Down Syndrome.  The group first met in the home of one of the founders.  At that time, Palm Beach County had no other group dedicated to advocating specifically for persons with Down Syndrome.
On October 18th, Gold Coast Down Syndrome Organization will be holding a Buddy Walk. The funds earned through this charitable donation are used as outlined in the group’s brochure, for:

… raising awareness and generating acceptance of individuals with Down syndrome. We accomplish this through our many programs: Newborn, family outreach, therapeutic playgroups, the Learning Program, school aged social and recreational activities, teen and adult dances and social activities, educational advocacy and training, parent and teacher education, conferences, healthcare conferences, informational resources to our families, and community service liaison.

Register on Line
www.goldcoastdownsyndrome.org

Walk Brochure
http://www.goldcoastdownsyndrome.org/buddywalk/2009%20brochure.pdf

Gold Coast Down Syndrome Organization
15th Annual BUDDY WALK
Sunday, October 18, 2009
8:00 am – 1:00 pm
Walk begins at 9:15 am

The harvesting of bodily tissues without consent is considered battery; however, using tissue previously removed during medical procedures to facilitate research experiments is not prohibited.  Without tissue donations, the production of certain biomedical products would be impossible to produce. Recent law, however, has sided with pharmaceutical companies by stating that tissues removed through a medical procedure can, in fact, be used for “medical research” or commercial purposes without the consent of their donor (Moore v. the Regents of the University of California). Is it immoral for biomedical corporations to profit from products derived from tissues of patients who are not compensated for their use?

There are very few regulations governing the distribution and development of products created using “donated” human tissue. According to the Food and Drug Administration (FDA), tissue banks are largely unregulated. Although they are required to submit to regular inspections, most of these inspections do not take place due to budget constraints.

Even though tissue and organ banks are required to screen organs for diseases, “[i]n 2001, federal investigators reported some human tissue banks repeatedly retest tissue until it complies with safety regulations, a process that is scientifically unsound and unsafe.” This questionable practice may promote the transmission of harmful diseases. Federal Statutes impose penalties of up to $50,000 and up to five years in prison for anyone violating the standard of care by facilitating the implantation of contaminated body parts. Furthermore, due to donor confidentiality issues, there is no way of tracking where particular organs originated. It is therefore nearly impossible to trace that contaminated organs until after their transplantation .

The potential negative implications of the lack of regulation in an industry basing its livelihood on improving human life are frightening. We are faced with an interesting and novel dilemma. The existing situation creates a necessity for change, but the implementation of these improvements will undoubtedly prove difficult. Hopefully, this problem can be resolved through successful litigation and legislation designed to protect the public-both from the transmission of disease and the exploitation of their bodily tissues.

The “Good Old Days” are gone when crops were organically grown, we lived off the land and grew our own produce and raised our own farm animals.

Our environment has become crowded; we have factories that mass produce our food items; and our water, in some instances, has become contaminated along with the air we breathe.

Over the past few years there have been several investigations of birth defects and various types of cancer caused by pesticides and other pollutants introduced into our environment; some knowingly and some unknowingly. 

Just this past week in an area of Palm Beach County, Florida known as the Acreage, it has come to light that there is an ongoing investigation of a possible cancer cluster.  The Acreage, before it became densely populated like it is today, was a large agricultural part of Palm Beach County.  It also was the site of dumping just about anything someone wanted to get rid of.  It is possible that some cancer causing agent has made its way into the soil or water system.  When cancer starts affecting people in a clustered area you can’t help but wonder what is causing it.  Hopefully, in the generations to come, we will find a way to limit the gases, pesticides, fuel emissions and other environmentally unfriendly pollutants that find their way into our environment thus making our planet a safer haven for the human race.

To read more on cancer clusters see www.cancer.gov and search for cancer clusters and agricultural health study.  You can also go to the Palm Beach Post website and search for “Parents in the Acreage fear possible cancer cluster; state looks at incidence rate.”

In most states, insurance departments regulate “big dogs”, but in Florida, our insurance commissioner is forced by law to regulate only “pups”. It is a scam of monumental proportions permitted by Florida law and it is the citizens of our great state that pay for it.

What are “big dogs” and what are “pups”? For example, State Farm Mutual is a “big dog” and State Farm Florida is its “pup”; Allstate is a “big dog” and Allstate Floridian is its “pup”; you get the idea.

When I first moved to Florida 25 years ago, I heard the saying about folks down here not caring how “you do it up north” and, frankly, I mostly agree with that notion. In the case of insurance companies maintaining “pretend” insurance companies just for Florida business, we might take a lesson from our northern brethren. “Pup” carriers are simply a way for insurance companies to enhance profits and create basis for regularly asking for rate increases from Floridians.

But we have big, bad hurricanes here, right? So, State Farm’s exposure in Florida is probably more, right? Well, let’s look at it. The whole gulf coast, the whole southeastern coast and California are all exposed to hurricanes on a regular basis. I mean poor South Carolinians have largely been taking the brunt of most of our hurricanes of late. The Midwest records tornadoes like we record rainfall. The north has freezing roads that sometimes results in hundreds of vehicles in a single accident. Nearly every portion of the country is exposed to one exceptional disaster or another.

If the whole country has its share of disaster, how does each insurance company handle it? It is called the law of large numbers. If 100,000 cars are insured, the probability that more than 10,200 (or less than 9,800) will be stolen is only about 1%. This is an example of the operation of the ‘law of large numbers’. In other words, the more cars insured, the more accurately can be predicted the percentage of cars likely to be stolen. It is this aspect of probability theory that enables the insurer to cope with variations in the pattern of actual losses. Underwriters and actuaries may also consider various measures of dispersion; that is the difference between the actual losses and average losses, when setting premiums or assessing liabilities.

Now, magnify those numbers by millions of risks; both commercial and residential risks. Add to that the various other lines of insurance written by the “big dogs” and that, in a nutshell, is the law of large numbers. So, the more risks an insurance company insures, the better, right? Well, yes, that is the basis for the law of large numbers. That is not, however, the basis for the “pups”.

Pups are there so that the “big dogs” (think State Farm Mutual, Allstate, etc) can cook the books. The “big dogs” create a very limited microcosm to which they apply the law of large numbers (think Florida) and they base their rate increases on the experience in the microcosm rather than applying the math against the experience for the “big dog” in the whole country. So, even though the “big dog” may be rolling in profits nationally, the pup can be made to look underfed and a rate increase is requested based solely on the experience in the microcosm (again, think Florida).

What to do? Read—educate yourself! Read Randy Schultz’s editorial in Sunday’s Palm Beach Post. Read the St. Petersburg Times article about Judge Manby denying State Farm’s puppies’ request for a rate increase.

Write! Write to Governor Chiles (currently busy running for senator); write to Secretary of Finance, Alex Sink; write to your legislators.

Shout! Complain at the top of your lungs. If you are a Floridian you have every right to be mad. Some of the most powerful, wealthy companies in the country have been and continue to be permitted to victimize you.

To the level we see them today; perhaps not. What the Founding Fathers did recognize is to have a civilized society, there must exist some avenue for the redress by citizens of wrongs; whether perceived or real. Judicial economy dictates that some control must be given over to the Courts to regulate the elimination of obviously meritless cases, but that regulation must be carefully applied.

I often have discussion with friends about the criminal justice system and their complaint that “too many crooks and thugs seem to go free”. I explain to them a philosophy that many of them have trouble buying into. That philosophy is: the courts were not designed to punish the guilty, the courts and the justice system must, at all costs, protect the innocent. It is sometimes a tough philosophy. To watch a guilty person go free because of a legal technicality is simply not something that anyone accepts easily. Those legal safeguards, though, are not there to assure the punishment of the guilty person who may be able to take advantage of them, rather they are in place to protect the innocent person from being wrongfully punished.

Similarly, in the civil arena, lawsuits are not primarily intended to punish the defendant for wrongful or negligent conduct; with the exception, of course, of punitive damages. The civil justice system is in place to protect the rights of the injured victim; to allow an injured victim the right to be heard and to explain why the defendant’s conduct was at fault for his injuries. So, permitting lawsuits must be favored over extinguishing the rights of truly injured people.

Will there be abuse of the civil justice system at times by allowing a more liberal view toward favoring the rights of the victim? Absolutely; it is simply unavoidable. Much like allowing the guilty to go free in favor of a system that protects the innocent; the civil system must allow some abuse in order to carefully preserve the rights of the truly injured.

It is a trade off that is both worthy and just.

The Justice Department and 16 states joined two whistleblower lawsuits alleging that Wyeth defrauded the government by offering discounts to hospitals on two of its drugs that it did not offer to Medicaid.

 Once again, one of the big Drug Manufacturers, WYETH, has failed to play by the Rules.  The lawsuits that have been filed in Federal District Court in Massachusetts claim that Wyeth avoided paying hundreds of millions of dollars in rebates to state Medicaid programs for its Protonix Oral and Protonix IV acid-reflux drugs.  Medicaid, the health insurance program for the poor, is entitled to the lowest price on prescription drugs and drug makers are required to pay states rebates based on any discounts offered to other parties.  Wyeth sold $394 million of the drugs in 2008 but they brought in close to $2 billion a year in revenue before generic competition threatened them.  Medicaid is financed half by the Federal Government and half by the States which administer the program.

 The LAWSUITS ALLEGE THAT Wyeth failed to pay Medicaid hundreds of millions of dollars because it didn’t pass along these discounts to the government.  By offering massive discounts to hospitals but then hiding that information from the Medicaid program, it’s believed Wyeth caused Medicaid programs throughout the country to pay much more for these drugs than they should have. 

 Not only to the big drug companies/manufacturers need to be monitored and regulated by the Food and Drug Administration as to their products’ safety they also need to be monitored and held accountable for offering discounts on some of its drugs to hospitals and not being up-front with Medicaid and the Federal Government and States that administer the Medicaid Program.

You can also search online for Wyeth Lawsuits and read additional information on this issue.