Newt Gingrich has, over the years, allowed his mouth to engage before he placed his brain in gear.

“Hypocrisy can afford to be magnificent in its promises, for never intending to go beyond promise, it costs nothing.” Edmund Burke.

His recent comments about hauling judges into congress, arresting judges who refused to respond to the “invite” to appear before congress and refusing to follow Supreme Court rulings with which he disagreed, are all simply a thoughtless extension of his and his supporters’ ideology.

There are rulings by courts and judges everyday that allow for plenty of room for disagreement. In not one of those rulings with which sound people may disagree would it be appropriate to jail the judge or haul her into a tribunal like congress for tongue lashings. That, however, is an ideology born from a group who believes they know best and, as a result, should be above the law and the constitution of this country.

Mr. Gingrich is an historical expert. He is fully schooled about the “separation of powers” included in the constitution. He should be sensitive to the need for the branches of government (executive, legislative and judicial) to maintain a balance of power through checks and balances. He should know that any judge may be removed for misfeasance or malfeasance through the impeachment process. He also knows that he President of the United States does not have the power to jail judges or to haul judges in before congress.

So, how can a man, a leader of his party, an historical expert, a former member of congress, make statements about simply ignoring the constitution?

Mr. Gingrich can make statements like he has because we live in a free country in which that freedom is guarded by the Constitution. The very document allowing Mr. Gingrich to set forth statements he knows to be simply untrue or inaccurate is the document he says he will simply ignore if elected to the office of President.

In a Democracy you can not have it both ways. We can not on one hand hold high a constitution that protects freedoms like free speech and on the other hand ignore those portions of the constitution that may be, well, inconvenient to a particular group.

What does this say about Mr. Gingrich? What does this say about the ideals of those behind Mr. Gingrich?

I have written recently about the “Santa Claus of Bikes”: Jack Hairston.

Our firm and many of our employees were a part of the Jack the Bikeman experience on Sunday. Jack was successful in putting bikes in the hands of nearly 800 kids. By the time we had finished, few bikes were left from the warehouse packed full when we arrived Sunday morning.

To watch the kids file into the warehouse housing the bikes and see their faces light up to be given a bike of their very own was like reliving Christmas morning when I was a kid each time. The joy each child clearly experienced made it all worth the hard work that went into moving bikes from warehouse to child.

The Searcy Denney staff collected bikes, both new and used, for three months before this event. We sent employees out to pick up bikes from people who wanted to donate, but could not get the bikes to Jack. Our employees also contributed new bikes and funds to assist Jack the Bikeman in his quest to make as many kids happy at Christmas time as he could by giving them the responsibility and the freedom a bike provides to a child.

Although we were not able to begin distributing bikes until around 9:00 am, some families were lined up as early as 4:00 am to stake their place in line for a bike.

At the end of a very long day, around 800 kids were just a little happier that they had a bike for Christmas and few bikes went without owners.

Many Searcy Denney employees were involved in the preparations to make sure that Sunday’s bike give away went forward and we are proud to have been involved.

Thank you, Jack the Bikeman!

Big Tobacco has recently agreed to pay over $6 million to settle claims with the US Department of Justice.

A summary of the conduct causing the $6 million payment?

US district Court Judge Gladys Kessler, after hearing mountains of evidence, says this about the tobacco corporations:

• They lied.
• They misrepresented the truth.
• They deceived.
• They concealed.
• They destroyed documents.
• They distorted the truth.
• They abused the legal system.

They conspired to keep away from the public scrutiny documents that demonstrate “smoking’s negative health effects, nicotine addiction, and altered cigarette design to increase addiction, light- and low-tar cigarettes and marketing to young consumers”.

Judge Kessler went on to say:

“In short, defendants have marketed and sold their lethal product with zeal, with deception, with a single-minded focus on their financial success, and without regard for the human tragedy or social costs that success exacted”.

But, Big Tobacco did not act alone. Judge Kessler also had comments about Tobacco’s lawyers: they “played an absolutely central role in the creation and perpetuation of the enterprise and the implementation of its fraudulent schemes”.

These findings and Big Tobacco’s willingness to pay millions in order to avoid an airing of the evidence in a court of law come as no surprise to attorneys who have had to litigate against them. Simply reviewing the tobacco documents that have not been destroyed or hidden by Big Tobacco leads to only one conclusion. The tobacco industry has spent a hundred years perfecting a talent for hiding the truth and spinning facts to a point that fact becomes fiction.

Big Tobacco wrote the playbook for all other corporations who have held “shredding parties” and data dumping get-togethers in order to hide their wrongdoing.

It is a part of the Florida Constitution.

It seemed fair to patients. With hospitals and doctors claiming the medical negligence problem was over blown, Florida Section 25, “Patients’ right to know about adverse medical incidents”, seemed like a common sense and fair law.

Read it. It is not very complicated.

But, since 2004, hospitals have been spending a great deal of time and money trying to circumvent, dodge and slip under the law. Sadly, hospitals have had reasonable success in throwing up legal roadblocks to the constitutional “requirement”.

What does Section 25 set forth? It seems pretty straightforward:

1. Patients have the right to have access to any records made or received in the course of business by a health care facility or a health care provider that relate to any adverse medical incident.
2. The health care provider is required to redact the personal information of any patient records released in complying with the law.
3. A patient is intended to mean: an individual who has sought, is seeking, is undergoing, or has undergone care or treatment in a health care facility or by a health care provider.
4. The law was intended to encompass: “adverse medical incident” means medical negligence, intentional misconduct, and any other act, neglect, or default of a health care facility or health care provider that caused or could have caused injury to or death of a patient.

A Coral Springs man, Harlan Ginsberg, has run headlong into a huge roadblock constructed by Northwest Medical Center, owned by HCA (Hospital Corporation of America), in Margate, Florida.

Mr. Ginsburg suffered a kidney stone attack. In the scheme of medical problems – not exactly a four alarm emergency. Certainly a medical condition that should allow health care providers to be deliberate and careful about their treatment, right?

Before leaving Northwest Medical, however, health care providers had been successful in cutting Mr. Ginsburg’s ureter (a tube that delivers urine to the bladder) and removing a completely healthy kidney, according to testimony of a physician.

Mr. Ginsburg was, understandably, upset. I would be if you removed a perfectly good, properly working organ from my body without even, well, asking me first.

He wanted to know how many other similar incidents occurred at the hospital and what the details were of those other incidents. He asked for the records under Section 25 of the constitution. Northwest Medical refused to provide him with the records. Later, probably after getting some good legal advice, the hospital relented and agreed to search its records for Mr. Ginsburg’s requested data. First, though, the hospital wanted $77,550 up front. I think we can look at $77,550 as a pretty big roadblock.

Section 25 of the Florida Constitution does not set forth anywhere that the hospital is permitted to charge to do a search that will produce the information. In fact, one might argue that if a law requires the provision of certain information, a corporation is intentionally violating the law by not maintaining record keeping in a way that allows compliance. But, that is one of the favored excuses from hospitals – “we do not maintain our records in a way that allows us to easily locate that information”.

Let’s think about that a minute. You run a hospital. I mean let’s pretend you are the CEO of a major hospital corporation. You are sitting in your office trying to determine the types of reports you want to regularly look at to accomplish your job responsibly. Wouldn’t a report that tells you how many medical incidents of negligence or mistake occurred in your hospital be one of the top five reports you would want to see? So, how can that data not be readily available to anyone?

How long will health care facilities and malpractice insurance companies be permitted to simply ignore or to dodge a part of the Florida Constitution? When will our lawmakers start requiring corporate compliance? When will someone stand up for individual citizens rights?

So far, citizens are not seeing any standing up from the executive branch or the legislature.

Florida medical malpractice statutes are a great deal about procedure and less about substance.

As in many states, Florida citizens have suffered the removal of legal rights under Florida’s medical malpractice laws by legislators with specific agendas other than the improvement of citizens’ lives. More often, business and insurance lobbies push for legislation to improve their own financial bottom lines.

In Florida, we have “pre-suit screening procedures” for any medical negligence case before a lawsuit may be filed. These procedures require things like an expert affidavit attesting to the negligence and a 90 day investigation period by all parties. The notion of these things appears to be of value on paper, but in practice – not so much.

The expert affidavit is actually a good idea. Why not require the plaintiff to prove, at least initially, that a good faith basis for a lawsuit exists?

The 90 day pre-suit investigation period would also be a good idea, except for a couple of factors.

Whether it makes any sense or not, medical malpractice insurance companies almost never have any interest in settling a case in the early stages. They want to do a couple of things before they even consider a settlement. First, they want to hold onto their money as long as possible so they can continue to earn investments. Second, they want to see if they can wear down the plaintiff or the plaintiff’s lawyer by spending the plaintiff attorney’s money to litigate the case.

For these and other reasons, for the plaintiff and his lawyer, the 90 day period is filled with a great deal of accumulating documents and responses to questions directed from the insurance company for the physician or hospital. There is almost never any real inquiry of significant substance or discussion of settlement, but mostly an “exercise in exercising” the plaintiff.

I provide this backdrop simply to emphasize the disappointment of a recent case dismissal that was affirmed by the Court of Appeals. The case was filed by another law firm and involved egregious medical malpractice. The basic facts are:

• A man is taken to the emergency room of a local hospital with symptoms of abdominal pain, nausea and vomiting blood.
• The man is found to have elevated blood sugar levels and is in the process of diabetic ketoacidosis.

This is an emergency situation. In fact, from a medical perspective, it should be a four alarm fire. Once the diagnosis of diabetic ketoacidosis was made, the hospital emergency physician knew this man would die without timely treatment by a gastroenterologist.

The decision from the appellate court sets forth that: “Every off-site doctor that [the hospital] contacted refused to come to the hospital to treat” this man. The involved hospital eventually transferred the patient to a hospital in Broward County for treatment, but he died soon after arrival.

The estate for the deceased filed its complaint and apparently alleged that the hospital had violated its duty to provide care and treatment of patients such as the deceased and that care necessarily required providing physicians competent to treat various conditions. So, according to the appellate decision, the plaintiff sued, at least in part, for failures in corporate planning – the failure to provide a framework for properly treating patients. The plaintiff was, in other words, saying that the hospital’s failure, which caused the man’s death, was not medical malpractice, but was corporate negligence. As a result, the plaintiff did not undertake to comply with the pre-suit requirements discussed above.

The appellate court dismissed the lawsuit and set forth that the hospital’s failure did, in fact, constitute medical negligence and the plaintiff’s failure to comply with the pre-suit procedures under the Florida Medical Malpractice statute was fatal to their lawsuit.

So, for largely procedural, administrative, reasons, the death of this young man will go unpunished. No one will be held to account for the gross, reckless conduct of the hospital and its physicians. The family of this poor gentleman will never receive any justice for the callous refusal of the physicians and outrageous failure of the hospital.

Corporate America needs protection from trial lawyers!?

So goes the tort reform mantra. Trial lawyers are victimizing corporations; which is causing job loss; which is ruining the economy; which is leading to higher prices; which is causing Wall Street uncertainty; which is leading to all around chaos.

I have worked for Corporate America and I have worked for lawyers. All the lawyer jokes aside, I am happy to no longer be working in the moral ambiguity of Corporate America.

Let’s take today’s Corporate citizenship example. Pfizer, Inc.

Recently, Pfizer agreed to pay fines of a record amount, $2.3 billion, for hiding off-label drug marketing practices. That would be the practice of selling drugs for uses that the FDA has not approved them for or, in some cases, uses that the FDA has specifically prohibited. Now, Pfizer investors are suing Pfizer saying that the Corporate Pharma “promised” it would stop its off-label marketing practices, but $2.3 billion later proves otherwise.

Also, just unsealed yesterday, is a complaint filed against Pfizer for the marketing of its drug, “Vfend” (voriconazole); an antifungal medication approved for the treatment of invasive aspergillosis and candidemia. Pfizer requested FDA approval to market the drug as “empiric therapy” as well. Empiric therapy is the medical practice of initiating treatment before an actual diagnosis can be made based upon laboratory or other objective studies. Antibiotics and some antifungals are often prescribed, quite correctly, by physicians based only upon their judgment of a patient’s symptoms. Pfizer wanted the ability to market Vfend on this broad basis so that physicians would prescribe it more often and, thus, increase Pfizer’s profits proportionally.

The FDA refused to allow Pfizer to market Vfend as an empiric therapy. So, what did Pfizer do? You guessed it, they marketed Vfend for broad use anyway. Why would a corporation specifically violate FDA regulation?

Vfend was approved for the limited use of treating diagnosed fungal infections in 2002. Certainly, the fact that Pfizer made $825 million in 2010; $798 million in 2009; and $743 million in 2008 off the drug may have played into their decision. Also, Vfend was designed to replace an antifungal, Diflucan, for which Pfizer was losing its US patent. Diflucan had been generating annual sales for Pfizer averaging $1.1 billion per year – an amount they stood to lose if they could not replace Diflucan with a substitute.

The current lawsuit brought by the US government was the result of company “whistleblowers”; former employees of Pfizer who have provided information to the US government suggesting that Pfizer’s off-label marketing resulted in much higher sales and this resulted in a fraud upon Medicare and Medicaid.

Sour grapes from some disgruntled employees? Let’s take a look at those employees; both of whom reportedly resigned from Pfizer:

Catherine Brown was Senior Marketing Manager at Pfizer and had been employed by them from 1996 to 2005. She holds multiple degrees in science and business and she was, in fact, “Representative of the Year” in 1998. She resigned from Pfizer in 2005

Bernard Vezeau was a Senior Product Manager on the “Vfend Marketing Team”. Mr. Vezeau went to West Point, was a Captain in the US Army and held a Master’s degree in Business Administration. He worked for Pfizer between 1989 and 1992; and was rehired by them in 2003.

The complaint brought by the US government gives insight into what allegedly occurred. Apparently, Pfizer was using a study, “the 608 Study” to substantiate its claims that Vfend was effective in treating broad categories of fungal infections. Notably, Pfizer claimed that Vfend was effective in treating a very aggressive and potentially lethal fungal pathogen, C. glabrata. The problem explained in the complaint in detail is that the 608 study results were, first, of a small patient population and, second, the results were substantially manipulated by Pfizer in an effort to cause the study to demonstrate an effectiveness in treating broad categories of fungal infection when it, in fact, was not effective.

While Pfizer marketed Vfend as having an “extended spectrum” and recommending physicians use Vfend “at the earliest clinical suspicion of a fungal infection”, respected medical journals condemned these assertions. The New England Journal reviewers stated that the 608 study “significantly obfuscate the presentation of results” and found the study “a bit deceptive”. The Lancet published comments by a noted and respected expert in fungal infections as finding the results of the 608 study to be “most perplexing” and seeming “seriously flawed”. In English, they did not believe Pfizer’s study and, if the allegations prove to be true, these experts had good reason.

What did Brown and Vezeau do wrong? Well, from Pfizer’s perspective, they insisted on clarification of the study results and asked for substantiation for claims that Vfend was effective in treating broad categories of fungal infections, most notable a life threatening fungal like, C. glabrata. Pfizer’s medical director, Dr. Dr. Schlamm, allegedly complained that Mr. Vezeau, was asking too many questions about the 608 study.

Now, Pfizer stands accused, yet again, of marketing drugs for uses NOT approved by the FDA. In addition, they are accused of manipulating scientific studies and opinion – for what? To maximize profits.

So, ask yourself: who needs protection from whom?

There are so many things for which I am thankful.

I am thankful to have a wonderful wife who is the very best part of me. I am thankful for my “children” – a combination of 2 lovable mutts and 4 cats (who I have grown to like). I am able to live in the Florida country and I employed by some of the most wonderful men and women with whom I have ever been permitted to work. I am truly fortunate.

Each morning during the work week, I try to create my own or find a wise person’s words of wisdom to share with my co-workers. Given that it is Thanksgiving, I thought I would do the same with all of you. Let me thank you for your kind indulgence in allowing me:

• Be thankful for your family; for they will always be there for you.
• Be thankful for each and every moment.
• Be thankful for your friends; for they like you even when you do not like yourself.
• Be thankful for those who have lighted the flame of inspiration within you.
• Be thankful for injuries done to you; for they cause you to cherish the kindness of people that much more.
• Be thankful for the 86,400 seconds given to you each day; do not waste them, but spend them wisely in nurturing others.
• Be thankful you can give without remembering and receive without forgetting.
• Be thankful you live in a country in which freedom still exists and individuality is still valued.
• Be thankful if you have a roof above your family’s head and food upon the table. Sadly, so many do not.
• Be thankful for the opportunities given to you to help others.
• Be thankful that you can be thankful.

Our best wishes go to each and everyone for a safe and joyous holiday.

Increase your possibility for blood clots – take Yaz birth control.

That would be bare truth in advertising were Bayer AG willing to be honest about its block buster contraceptive medication that generated over $1.5 billion in sales last year.

Another truth in advertising for the Yaz drug maker? We were just kidding when we claimed that Yaz was good for clearing up acne and treating all forms of PMS symptoms. We said it, but we did not mean it and, oh yeah, Yaz was never approved for those uses.

In an email discovered during the litigation that has been filed against Bayer, a company official encouraged sales representatives to propose that doctors prescribe Yaz for unapproved, off-label use:

“…what percentage of your patient population suffers from” symptoms common to PMS, versus the more severe form of the disorder, and to seek information on “what they think the impact of Yaz will be.”

Yasmin and Yaz were never approved for treatment of common PMS symptoms.

In another email, a sales representative suggests that a noted gynecologist: “…definitely will mention the off-label benefits of our products.”

We have been writing since early 2009 about Bayer’s less than responsible commercials that used attractive, successful appearing women to promote its drugs Yaz, Yasmin and Ocella while using glitzy advertising to obfuscate the lack of FDA approval for some of its uses and to hide its sometimes lethal side effects.

An upcoming meeting at the FDA, on December 8, 2011, is designed to discuss the fate of oral contraceptives and the studies that have been conducted about them. At least one of the leading studies, conducted by Juergen Dinger then director of the Center for Epidemiology and Health Research, has come under scrutiny. Dr. Dinger is a former employee of the company initially marketing the Yasmin line of oral contraceptives and there have been emails discovered that cast some questionable light on the independence of the study. For example an executive at the company sent a 2005 email talking about the risk of “VTE” and “ATE” (referring to clots in users):

“One major reason for providing only tables and a synopsis is that we do not want to imply that we have a VTE problem but emphasize the fact that the study results indicate that Yasmin’s VTE/ATE is comparable to other” contraceptives.

Like buying “ghost writers”, some companies have sponsored “studies” of their products with the sole goal of supporting the safety of the product, rather than discovering independent, objective findings about their products.

Sadly, $1.5 billion buys a great deal of favorable opinions and provides more than enough motivation for companies to discover supportive findings in any study they conduct.

As I have written many times before, I believe in the jury system, but it requires a well-informed jury, given all the facts and evidence, to arrive at a just decision. Based upon my own research and the below discussion, I must conclude that, more likely than not, the jurors in the case of Hunter v Phillip Morris resulted in a less than full disclosure of the evidence relating to the outrageous conduct of the tobacco industry.

I have read many, many of the documents that comprise those involving Big Tobacco’s evolution in the development and production of cigarettes; evolution and production because what most people think of as tobacco was abandoned by cigarette manufacturers decades ago. What they sold and continue to sell to Americans and the rest of the world is a chemically engineered plant that they have called “the best drug delivery system” ever created.

A federal judge, Judge Gladys Kessler, has also read the documents, heard the testimony and saw fit to condemn Big Tobacco for sins against the American public:

• These cases are about an industry that profits from selling a highly addictive product that causes a staggering number of deaths each year and Big Tobacco has known about the dangers for more than 50 years.
• “Defendants have marketed and sold their lethal products with zeal, with deception, with a single-minded focus on their financial success, and without regard for the human tragedy or social costs that success exacted.”
• “Over the course of more than 50 years, Defendants lied, misrepresented and deceived the American public, including smokers and the young people they avidly sought as ‘replacement’ smokers about the devastating health effects of smoking and environmental tobacco smoke.”
• “The evidence in this case clearly establishes that Defendants have not ceased engaging in unlawful activity…. For example, most Defendants continue to fraudulently deny the adverse health effects of secondhand smoke which they recognized internally; all Defendants continue to market “low tar” cigarettes to consumers seeking to reduce their health risks or quit; all Defendants continue to fraudulently deny that they manipulate the nicotine delivery of their cigarettes in order to create and sustain addiction; some Defendants continue to deny that they market to youth in publications with significant youth readership and with imagery that targets youth; and some Defendants continue to  suppress and conceal information which might undermine their public or litigation position…. Their continuing conduct misleads consumers in order to maximize Defendants’ revenues by recruiting new smokers (the majority of whom are under the age of 18), preventing current smokers from quitting, and thereby sustaining the industry.”
• “Despite Their Internal Knowledge, Defendants Continued, From 1964 Onward, to Falsely Deny and Distort the Serious Health Effects of Smoking”
• “As of 2005, Defendants Still Do Not Admit the Serious Health Effects of Smoking Which They Recognized Internally Decades Ago”

Even a powerful industry like the tobacco companies does not hide, deceive or scheme on their own, though. Judge Kessler also has interesting things to say about lawyers that have counseled and defended the tobacco companies for all these decades:

• “At every stage, (Big Tobacco’s) lawyers played an absolutely central role in the creation and perpetuation of the Enterprise and the implementation of its fraudulent schemes. They devised and coordinated both national and international strategy; they directed scientists as to what research they should and should not undertake; they vetted scientific research papers and reports as well as public relations materials to ensure that the interests of the Enterprise would be protected; they identified “friendly” scientific witnesses, subsidized them with grants from the Center for Tobacco Research and the Center for Indoor Air Research, paid them enormous fees, and often hid the relationship between those witnesses and the industry; and they devised and carried out document destruction policies and took shelter behind baseless assertions of the attorney client privilege.”
• Through their recruiting and training of consultants around the world, Defendants created a cadre of seemingly independent consultants to support the industry’s position on secondhand smoke and to create the impression that a legitimate controversy existed among independent scientists. The global effort to create and manage this program required intense coordination among the companies and their counsel [outside lawyers].

When an objective eye is turned upon all the evidence relating to the conduct of the tobacco industry the conclusions are inescapable. So, how can jurors reach differing verdicts? The lawyers representing Big Tobacco are some of the best in the nation, possibly the world. They have had decades to refine arguments that may convince even the most experienced jurist  to exclude certain relevant evidence.

For example, in a tobacco case brought since the issuance of the Surgeon General’s report on smoking in the 1960’s and after warning labels were put on cigarettes, it might be argued that any evidence of conspiracy or fraud on the part of the tobacco companies that occurred prior to the 1960’s should be kept from the jury. Tobacco lawyers regularly challenge the experts employed by plaintiffs by arguing that those experts are simply reinterpreting prior studies from the past and have done no “independent” testing of their own. The fact is the tobacco industry spent millions of dollars “creating” research results and conducting studies that would bring forth the evidence they wanted revealed; so, actually conducting a study has questionable value.

Once all evidence of Big Tobacco’s conspiracies, fraudulent tactics and deceptive practices hits the “light of day” it Tobacco’s arguments go up in smoke.

Just how much are consumers of eye care products supposed to take before they have had enough? On the heels of two major disasters in the eye care industry yet another has emerged. Cooper Vision a major manufacturer of eye care products including soft contact lenses has announced the recall of five million contact lenses due to sight threatening defects.

Initially Cooper announced in August it was recalling six hundred thousand Avaira Toric lenses after wearers reported severe pain, red eyes and hazy vision. More serious injuries including torn corneas were reported as well. Now the company has recently expanded that recall to five million lenses.

As is usual, the company blamed the problem on something simple and innocuous. This time it was a silicone oil residue on the lenses that they blame for the issues customers have experienced. Also par for the course, the original “recall” included only notice to eye care professionals and not consumers. Since many contact lens wearers buy several months’ worth of lenses at a time, this type of “soft” recall leaves thousands of defective devices in consumers’ medicine cabinets. Only after pressure from the FDA did Cooper take the extra step to alert consumers directly.

The expanded recall includes not only the Avaira Toric lenses but the Avaira Sphere as well. These lenses are sold at Wal-Mart, Costco and LensCrafters.

This recall comes on the heels of two major recalls of contact lens solutions manufactured by Bausch and Lomb and Advanced Medical Optics. In 2006 and 2007 these companies were forced to recall their newest flagship lens solutions when it was determined that they were causing sight threatening infections. Users of these solutions suffered unnecessary Fusarium and Acanthamoeba infections many of which led to the need for corneal transplant surgery and permanent loss of vision. Major litigation followed. To the best of my knowledge, neither Bausch and Lomb nor AMO has tried a single case. All have been resolved through settlement.

To find out if your Cooper Vision lenses are part of the recall, click on this link and see if the lot number on your lenses matches any listed on Cooper Vision’s recall list. http://www.coopervision.com/recall