The Florida Supreme Court declined to hear an appeal yesterday made by RJ Reynolds Tobacco Co. following a $28.3 million jury verdict in 2009.   The court upheld the verdict in a one-page order, denied jurisdiction, and noted, “no motion for rehearing will be entertained by the Court.”  RJ Reynolds had claimed that the lower court improperly applied the famous Engle decision.

That decision involved Howard A. Engle, M.D. who was a Florida Pediatrician and died in 2009 as a result of lung cancer.  Dr. Engle was the lead plaintiff in the Florida tobacco class action.  A jury awarded the class $145 billion in punitive damages; however, the Florida Supreme Court rejected and ruled that the case could not continue as a class.  Nevertheless, the decision upheld the factual findings in the case and said the findings would apply in all of the subsequent cases filed by smokers who were part of the class. Those smokers are now proceeding with individual lawsuits called “Engle progeny cases”.

The decision that was denied appeal yesterday was made by a Pensacola jury who awarded widow, Mathilde Martin $3.3 million in compensatory and $25 million in punitive damages.  Her husband, Benny Martin, died in 1995 of lung cancer following his long-time smoking addiction to “Lucky Strike” cigarettes.  The jury found RJ Reynolds 66 percent responsible and Benny 34 percent responsible.

The jury determined in the Martin case:

1. smoking cigarettes caused a variety of health problems,
2. cigarettes containing nicotine were addictive,
3. the defendants manufactured unreasonably dangerous cigarettes, and
4. the defendants concealed important information from the public.

Mathilde Martin’s attorney, Matt Schultz, stated, “today the Florida Supreme Court sent a message to Big Tobacco that the era of endless appeals is over. The industry must now answer for its decades-long conspiracy to defraud the public in pursuit of the almighty dollar.”

The Engle progeny cases are unique from most tobacco related lawsuits in the past. The plaintiffs in these cases were people who began smoking and became addicted to cigarettes before the 1960’s Report of the Surgeon General relating to the dangers of cigarettes.

Many of these people began their addiction as a result of cigarettes given away free on street corners by tobacco companies; many were in the military during WWII and started smoking the free cigarettes given to servicemen and women by tobacco companies; and many simply started smoking because everyone seemed to be doing it. Tobacco companies ran advertisements with the rich and famous promoting the positive health and social effects of smoking cigarettes.  Actors, actresses, sports heroes and doctors were used in advertisements telling people that smoking cigarettes was good for them.

It seems as if it has been several decades ago that people learned of the addictiveness and harmful effects of smoking cigarettes. It is true that the Surgeon General issued his warning in the early 1960’s, but as late as 1994, tobacco companies still maintained that cigarettes and nicotine were not addictive. In this video, the seven CEO’s of tobacco companies testified under oath that nicotine was not addictive. These CEO’s became known as “the seven dwarves”:

In fact, tobacco lawyers still, today, come into courtrooms across Florida and the nation claiming that cigarettes are not addictive.

With only a month or so until summer is up, now might be an excellent time to consider childproofing your home.   Many parents can become quite busy around the fall season with the start of school, homework, soccer practices, PTA meetings, etc. (not to stress you out).   Furthermore, for many, fall begins a time when more people enter your home because of football season and the holidays.   This can lead to extra little ones running around your home and it is important that both you and your house are prepared.  Consequently, even though you may have less time for projects, this one should be at the top of your “To Do” list.

In fact, did you know that every year, there are more than 3,000,000 unintentional injuries to children 14 and under that happen in the home and require care in an emergency room? That works out to 8,219 injuries per day.   And sadly, each day approximately six children die from injuries resulting from fires, burns, drowning, poisoning, choking, suffocation, strangulation, and falls in the home.

Kids can be curious and do not always understand the difference between toys and dangerous objects.  Take a thorough look at your home and ask yourself – what looks interesting for my child to play with that could lead to an unsafe situation?

Babies who can sit and crawl are at risk for choking, poisoning, burns, falls, and furniture tip-overs. Once your little one becomes mobile and begins to cruise around, childproofing becomes even more important.

So what can you do as a parent? While constant supervision is the most important safety precaution you can take, it is impractical and sometimes not enough. To create a safer home for your child, look for potential hazards and take steps to remove them before it is too late.  You should also review a home safety checklist that will help remind you of some of the spots in your home you might have forgot.

Topamax, is the antiepileptic drug that has been shown to cause oral clefts in infants whose mothers took the drug while pregnant and may actually increase a woman’s chance of becoming pregnant.

According to Topamax’s label, the drug may reduce the effectiveness of oral contraceptives.  Topamax use can lead to the development of a cleft lip or cleft palate during the first trimester of pregnancy, often before many women are aware that they are pregnant.  Cleft lip and cleft palate are craniofacial birth defects that are the result of the improper formation of a child’s upper lip or palate during fetal development.  Oral clefts continue to cause complications throughout life including feeding difficulties, ear infections, hearing loss, dental problems, and speech and language delays.

Studies have also shown that Topamax reduces the effectiveness of birth control pills when it is used in combination with valproic acid, an anticonvulsant drug also used for the treatment of epilepsy.  When taken with valproic acid, Topamax decreases the body’s expose to ethinyl estradiol, a form of estrogen used in oral contraceptives.

Data collected from the North American Antiepileptic Drug (NAAED) Pregnancy Registry shows a 1.4% incidence of oral clefts in infants whose mothers were treated with Topamax during the first trimester, compared to 0.07% in infants of mothers who were not treated with antiepileptic drugs.

Because of the risk of birth defects associated with Topamax use, the FDA urges doctors to discuss birth control with their female patients.  If a woman discovers she has become pregnant while taking Topamax, she should contact her doctor immediately.

Next summer, sunscreen bottles will be seeing many changes as a result of new federal regulations announced on June 14.  The regulations were created to ensure that sunscreens meet modern standards for safety and effectiveness.

For the first time ever, sunscreen labels that pass FDA approved testing will be able to claim they can reduce the risk of skin cancer and early skin aging, in addition to preventing sunburn.  In order to pass this requirement, sunscreens must be proven to be “broad spectrum” — meaning they protect against both ultraviolet A and ultraviolet B radiation and have a sunburn protection factor of 15 or higher.  Those that do not meet both criteria will carry a warning label indicating that they have not been shown to help prevent skin cancer or early skin aging.

Effect on terms “waterproof,” “sweatproof,” & “sunblock”

The FDA will forbid these terms from being included on labels because they are considered inaccurate.  Sunscreens will be able to claim water resistance based on testing, but they must note whether they are effective for 40 minutes or 80 minutes while swimming or sweating.  Sunscreens will now also carry drug fact labels like those that you see on an over-the-counter medication box.

What about those SPF 100 sunscreens?

The FDA has proposed to limit the maximum SPF to “50+” since there is insufficient, reliable  evidence that higher values, such as 70 or 100, provide greater protection.  Some experts hope this will stop the “escalating war of SPF factors.”

Dr. Warwick L. Morison, a professor of dermatology at Johns Hopkins University and chairman of the photobiology committee for the Skin Cancer Foundation, was disappointed the FDA did not ban the products that contained SPF numbers higher than 50 because such products expose people to more irritating sunscreen ingredients without meaningful added protection.

Some thoughts from the experts:

• There is really no difference between 50 or 70 or 80 SPF designations.
• If you apply the proper amount of sunscreen, with frequent reapplication, you really do not need an SPF that is above 30.
• The amount that should be applied is equivalent to a shot glass full, but on average, people apply only about half that amount.
• Make sure you are re-applying often enough; particularly after swimming.

Concern over sunscreen ingredients

Kelly McMasters, director of the James Graham Brown Cancer Center’s melanoma clinic, is concerned that the agency did not go far enough in addressing safety concerns about some sunscreen ingredients.  For example, some sunscreens may include endocrine disruptors, such as oxybenzone, which may interfere with certain hormones and pregnant women may want to avoid retinyl palmitate because of possible negative effects.  Moreover, zinc oxide and titanium dioxide nanoparticles might have potential reproductive and developmental effects.  The FDA is awaiting the results of new studies to determine whether retinyl palmitate is harmful.

Bottom Line

Excessive sun exposure is the most important preventable cause of all skin cancers, including potentially deadly melanoma. If you would like to view a list of the best beach and sport sunscreens, the environmental working group has an excellent list –available here.

What else can you do to avoid the potentially harmful effects of the sun:

• Wear broad-brimmed hats.
• Cover up with clothing to protect skin—the tighter the weave and the darker the color, the better the SPF protection.
• Avoid sun exposure especially during the hours of 10 a.m. and 4 p.m.
• Be aware that reflective surfaces like water, sand and cars increase chances of sunburns.
• You can still burn on cloudy days. Since UV rays are still strong enough to burn your skin.
• Rinse off when coming indoors or at the end of the day.
• Children’s skin is delicate and can be damaged in as little as 15 minutes of unprotected sun exposure. It takes 15 minutes to see initial effects of exposure, but 12 hours before the whole burn effect to be realized.
• Wear sunglasses that protect against UVA and UVB rays. The rays of the sun can damage eyes; causing cataracts and acceleration of age related vision loss.

As a citizen of the sunshine state, make sure you and your loved ones are lathering up before playing or working in the sun!

Is Casey Anthony guilty of killing her child? I simply do not know. I was not privy to the evidence presented to the jury during the several weeks of trial or to the evidence not presented and held back by the prosecution and defense.

What I do know is the system worked in the Casey Anthony case.

How can I say that you ask?

Our justice system does not promise that justice will be had in every case. The system is designed in a way that a chance for justice exists only if:

• The lawyers do their jobs to the best of their ability
• The judge does his or her job to the best of their ability
• The jury listens carefully to the evidence and follows the law as the judge instructs them it is; whether the jury agrees with the law or not.

Our criminal justice system is in place to protect the innocent, first, not to punish the guilty. The framers of our system of justice believed that the European approach, that you were considered guilty of a crime until YOU proved yourself innocent, was a dangerous system. They believed that system resulted in more innocent people in prison and just as many guilty people set free, than it provided for justice.

Let me suggest a scenario for your consideration of this recent verdict.

You look out your window into the house across the street. You see the man who lives there holding a gun and pointing it, presumably at someone you cannot see through the window. You hear the gun discharge. The next day, you learn that the man’s wife was shot in her house.

What can we say without any reasonable doubt about this scenario?

• We can say the man was seen pointing a gun in the house.
• We can say the man lives in the house.
• We can say the man lives in the house with his wife.
• We can say that the man’s wife was shot (having learned that from other sources).

Can we say the man shot his wife? No.

We want to conclude the man shot his wife. I mean who else could have? The man had a gun pointing at his wife and he shot her, right?

What more facts do we need?

Here are the facts. The man’s gun accidentally discharged at a wall while he was using poor judgment. The man’s wife was in another room and was unharmed by the discharge. You did not see the man leave his house to go to the store. You did not see the intruder break into the house, wrestle the gun from the man’s wife and shoot her.

So, if you examined only “your facts”, the man is guilty. The problem with “your facts” is they leave room for reasonable doubt. Under our form of justice, if I have reasonable doubt you committed a crime I must find you not guilty.

Why? Because we have a system of justice that values justice above punishment.

Our criminal justice system would rather protect an innocent person from being unfairly punished and allow a guilty person to walk free. Our system of justice strives to preserve a person’s liberty above all else.

I would rather see a guilty person released than to see YOU behind bars for the remainder of your life or put to death; accused and convicted of a crime you did not commit, but for which you “seem guilty”.

When a jury sits for weeks hearing evidence which you and I did not hear in its context. When all we receive is “reporting” from “news” agencies. When cutting edge journalism seems to come from the likes of the Nancy Grace’s of the world.

Frankly, it is more than a bit arrogant for me to second guess the judgment of reasonable doubt found by people on a jury who gave up a substantial amount of their life to carefully listen to evidence and render a verdict they knew would probably not be popular.

Did Casey Anthony commit murder? I still do not know. The jury did not find her innocent; the jury found her not guilty.

We do know that the system worked. Even if you do not like the outcome.

Jessie was a healthy 17-year-old who loved cheerleading and playing softball.  Two days after receiving her third Gardasil vaccination, Jessie unexpectedly passed away.

HPV vaccines, such as Gardasil, which are manufactured by Merck Sharp & Dohme Co., have been aggressively marketed to young girls in their early teens as well as their parents.  Gardasil has been marketed as protecting against four types of HPV, two of which may lead to cervical cancer.  However, these two types of HPV are only present in 3.2% of cases.  In fact, Gardasil has been associated with at least as many serious adverse events as there are deaths from cervical cancer annually.  Some doctors are also concerned that women will discontinue annual pap smears because they think they are protected from HPV.

As of February 14, 2011, approximately 33 million Gardasil vaccinations were administered in the United States.  The Vaccine Adverse Event Reporting System (VAERS) has received a total of 18,354 reports of adverse events following the administration of Gardasil vaccines.  Still, the Center for Disease Control recommends HPB vaccinations for the prevention of cervical cancer.

Serious side effects associated with the vaccine include multiple sclerosis, blindness, Guillain-Barre Syndrome, which is a rare neurologic disorder that causes muscle weakness, lupus, rheumatoid arthritis, paralysis, blood clots, and death.

Dr. Diane Harper, a researcher who served as a consultant for Merck and helped carry out safety and effectiveness studies in order to get Gardasil approved, stated that girls and their parents need to receive more information and better warnings before opting for the vaccine.

Scientific data has shown that the vaccine may only last up to five years.  However, the vaccine is offered to girls as young as 11.  These girls are put at risk for serious side effects of the vaccine, but may only be protected by the vaccine until age 16.

Websites, such as Truth about Gardasil, are dedicated to warning about the adverse side effects associated with Gardasil and detailing the stories of victims like Jessie.

Gladys Mensing took metoclopramide, the generic form of Reglan, a nausea medication that was marketed and prescribed off-label for the treatment of reflux disease and other chronic conditions.  Unfortunately, use of metoclopramide or Reglan for more than a few months can cause patients, like Gladys Mensing, to develop severe and debilitating neurological disorders known as tardive dyskinesia.  This movement disorder includes involuntary movements of a patient’s limbs, facial tics, weakness, inability to walk, and other disabling symptoms.  In reference to her grandmother’s disease, Roxanne Mensing stated, “it’s really taken a hit on all of us, and her especially.”  Mensing hoped that justice would be served and the manufacturer, Pliva, would be held liable for failing to adequately warn of the risk of tardive dyskinesia, especially when the drug is taken for more than a few months.

But Mensing did not receive justice.

The Supreme Court of the United States ruled on June 23, 2011, that federal law makes generic drug manufacturers immune from liability for failure-to-warn claims under state law because the generic manufacturers alone do not have the power to change their labels.

State tort law requires that a drug manufacturer that is aware or should be aware of a product’s dangers must label their product accordingly.  However, the FDA requires that generic drugs must have the same warning labels as their brand-name counterparts.  The manufacturer alleged that they were unable to change the warning label because it would then differ from the brand-name version of the drug.  The court sided with the manufacturer and held that the FDA requirement preempts state law.

So what does this mean for those who have been injured by the generic form of a drug? If their pharmacist filled their prescription with a generic form instead of the brand-name, they are out of luck.  According to Justice Sotomayor’s dissenting opinion, this decision will affect 75 percent of all the prescription drugs in the country.  As a patient, do you want to take drugs manufactured by a company who has legal immunity or one that will be held responsible for providing adequate warnings for their products?  The final chapter in this area has not yet been written, and one can only hope that Congress and the FDA will find a way to close this legal loophole and ensure that personal responsibility applies not only to patients but also to generic drug manufacturers who should not enjoy this legal immunity, especially when their products have the potential to cause great harm to patients.

I just heard about a really cool idea.  If you join in, you can help the world without really trying and without spending a dime.  Interested?  Keep reading.

How many times have you spent the night at a hotel, taken one shower and had your soap thrown away with 90% of it left remaining in the soap dish as you check out or had the soap replaced each day of your stay?  The answer is:  almost every time you have spent the night at a hotel.

I travel a lot for business and I cannot tell you the number of times this thought has crossed my mind, “What is going to happen to this soap?  It’s perfectly good and I’ve only used a little and now it’s just going to be thrown away?  Hmmm, maybe someone could take this soap and sterilize it and give it someone in need.”

If you’ve ever had a similar thought, luckily for all of us, the practice of throwing that soap in the garbage is slowly changing, thanks to Derreck Kayongo and his Atlanta-based Global Soap Project.  Kayongo, a native of Uganda who is now a U.S. citizen, thought of the idea in the early 1990’s, after he emigrated from Uganda to escape the dictatorship of Idi Amin.  He was staying at a hotel in Philadelphia and noticed that each day he received a new bar of soap and his old one was thrown away.  Flabbergasted by the waste, the idea for his charity was born.

Kayongo knew that many of the diseases which have been largely wiped out in the United States are still causing deaths in other parts of the world.  He also knew that collecting soap could be the “first line of defense” to eliminate unnecessary deaths around the world.  Each year, more than 2 million children die from diarrheal illness (predominantly among children younger than four living in low-income countries); deaths which can be largely eliminated through the simple act of washing of hands.

“The issue is not the availability of soap. The issue is cost,” Kayongo said. “Make $1 a day, and soap costs 25 cents. I’m not a good mathematician, but I’m telling you I’m not going to spend that 25 cents on a bar of soap. I’m going to buy sugar. I’m going to buy medicine. I’m going to do all the things I think are keeping me alive.

Right now, 300 hotels in the United States have joined Kayongo’s effort and their donated barely used soap bars have amounted to nearly a quarter million pounds soap. Volunteers across the country collect the hotel soaps and ship them to the group’s headquarters in Atlanta. Once each week, on Saturdays, volunteers clean, reprocess and package the bars.

So, the next time you plan a business trip or a family vacation, print out a copy of this form and turn it in to the manager at the front desk.  That simple act, at no cost to you, could very well save a child’s life.  Does it get any better than that?

Prescription drugs are not the solution to all of our health problems.  In fact, they can be the cause of many of them.

Many patients who are being prescribed bisphosphonates for the treatment and prevention of osteoporosis, such as Fosamax, Aredia, and Zometa, are unaware of the risk of long bone or atypical femur fractures associated with the use of these drugs.  Although the risk is small, some patients are at a higher risk for these fractures than others.

Studies have shown that the use of bisphosphonates for 5 years or longer is associated with a higher risk of femoral shaft fractures than transient use of bisphosphonates.  The risk decreases substantially once the use of bisphosphonates is discontinued.  However, bisphosphonates remain in a patient’s system for up to 10 years and have the potential to cause harm long after they have been discontinued.  Additionally, women who ingested these osteoporosis drugs at the same time as corticosteroids or hormone replacement therapy may face greater risks of atypical fractures.

Patients should assess their individual risk of long bone fractures.  In order to determine if they are at risk, patients should read the drug warning label and ask their physician whether their risk of developing long bone fractures outweighs the benefits that the drug can provide.

Osteoporosis affects one in three women and one in five men over the age of 50.  Each year, 22 million prescriptions for bisphosphonates are written for the treatment of osteoporosis.  Bisphosphonates have been demonstrated to impair the body’s ability to regenerate bones, leaving bones weak and brittle.  Patients taking bisphosphonates may actually be increasing their risk of osteoporosis by taking these drugs.

Drugs are not the only way to maintain healthy bones.  Bone health can be maintained without the use of drugs by eating a diet high in amino acids, vitamin D, consuming a healthy balance of omega 6 and 3 fats, and avoiding processed foods, gluten, soda, and sugar.  Exercise is also important for the maintenance of bone health.

Suppose I am a physician and as a part of my practice I want to know whether my patients own guns and whether they properly secure their guns. Suppose I, too, own guns and suppose that as a result of poor gun security someone in my family was tragically shot and killed by a poorly secured gun in the hands of a child. In fact, suppose that I am unwilling to accept as patients anyone who owns guns, has children and refuses to take reasonable measures to secure the guns in their home.

Anything wrong with this? Don’t I have the right to accept or not accept patients as I see fit? Can I put a sign up in my waiting room that says something like:” We reserve the right to refuse treatment to careless gun owners? Be aware that I will ask you about your gun ownership.”

According to the Florida legislature, apparently an enormous problem exists over physicians asking patients about gun ownership. Ask about sexual practices, drinking or drug taking practices; ask about the financial ability to pay fees; but “don’t tread on my guns”.

A group of physicians recently filed a lawsuit over the recently enacted HB 155 which places financial and other penalties on physicians who have the temerity to ask patients about guns in their home. Not surprisingly, the physicians who filed suit are largely pediatricians. This is where the conversation most always arises. New parents and the physician’s general conversation about child safety are old practices of good physicians.

Apparently, though, the bill seems to prohibit every doctor from asking patients about gun ownership. The doctor can ask about knives, poison, explosives, and other potentially lethal accouterments, but is forbidden from asking about guns.

Supporters of the law, like Florida NRA lobbyist Marion Hammer, have a unique view on their normal cry of “less government”:

“We pay doctors to be doctors and give us medical care,” Hammer said in an interview with the Capital News Service last week. “Instead, they are trying to be social workers and bring their gun-ban politics into the examining room.”

Last I checked, confidentiality exists between physician and patient. In addition, patients are free to “fire” their doctor and seek another professional if they do not like what the doctor does or says. Believe me; I have fired my share of opinionated doctors.

The Florida Medical Association withdrew its opposition to the law after assurances were included in the bill “allowing physicians, nurses and other practitioners to ask questions about gun ownership if they feel the patient or a family member might be in danger.”

I suppose that suggests the question: what about the rest of us? Can a physician ask if someone says they just read something written by say, me, and they feel strongly about wanting to me harm?

The NRA is very protective of the Second amendment, but they apparently do not care about the whole free speech thing in the First amendment to the constitution.