The latest buzz in the legal industry focuses on the drug Byetta. The diabetes drug exenatide, trade name Byetta, has been linked to an increased risk of a serious and often deadly form of pancreatitis. The Food and Drug Administration (FDA) recently issued a warning that Byetta might increase risk of acute pancreatitis, a painful inflammation of the pancreas. The FDA is also calling for a stronger warning label on the drug. Despite numerous claims of patients diagnosed with pancreatitis who have taken Byetta, including several deaths, neither the FDA or the drug manufacturer, Amylin Pharmaceuticals, have announced plans to issue a Byetta recall.

Diabetes Health Magazine recently published a study conducted by researchers from Medco Health Solutions, Inc., that says, “Type 2 diabetes patients who take Byetta run no greater risk of developing pancreatitis than patients with type 2 diabetes who do not take the drug.” The study results were presented at the 69th Scientific Sessions of the American Diabetes Association, showing only 0.44 percent of exenatide users experienced an episode of acute pancreatitis. However, Amylin and the drug company Eli Lilly and Company who collaborate on Byetta, said that pancreatitis is rare in the general public but more common among type 2 diabetes patients, who consequently, are the ones taking medications for the treatment of their diabetes.

So is there a link between type 2 diabetics who take Byetta and pancreatitis, or are their chances of developing the illness greater regardless of what medication they are on? Studies are still being conducted to answer these questions. Industry observers like David Kliff, the publisher of Diabetic Investor, says “There are more than 700,000 patients using Byetta and 30 reports of pancreatitis. That’s 0.00428 percent of one case in 23,364 patients. That’s rare.”

It is very likely this isn’t the last we will hear about Byetta. As consumers, we are bombarded by drug company ads telling us to ask our doctor for their medication. Before you take any medications, do your research. Ask your doctor about the side effects, search the web for studies on the drug, and make an informed choice about what medications to take. Don’t let the drug companies make the choices for you regarding the health of yourself and your loved ones.

Nearly a ton and a half of steel hurling its way down the road at 50 miles an hour suddenly lurches and begins to increase its speed; 60 mph, 70 mph, 75, mph, 80 mph. The driver applies the brakes in a frantic effort to slow the vehicle; it does not slow the vehicle. The vehicle continues to accelerate as the driver continues to try and control the tons of steel and the brakes continue to fail to slow the vehicle.

That is a reasonable picture of the descriptions given by drivers of various Toyota vehicles. Toyota recalled vehicles and blamed floor mats for sudden acceleration of the vehicles, which resulted in crashes. Although floor mats may be an easy…and cheap…fix, that does not seem to be the problem. There are reports coming in of vehicles suddenly accelerating with floor mats different from the mats Toyota claims is the culprit.

For its part, Toyota apparently continues to maintain that no problem exists with any Toyota vehicle in which the proper floor mats are installed. They say the wrong floor mats may be in as many as 3.8 million vehicles.

Toyota owners and drivers should beware of this defect. In the case of any sudden acceleration, drivers should:

• Check your owner’s manual now to determine if you must lightly depress the brake  in order to shift the car to neutral
• Shift the car to neutral
• Apply the brakes evenly
• Bring the vehicle to a stop
• Shut off the ignition
• Do not shut off the ignition until after you have come to a complete stop because you will lose power steering control and other functions allowing you to control the vehicle.

In his June 11, 1963 civil rights address, President John F. Kennedy confronted head-on the unfair treatment of African Americans in our society under our then-existing system of laws. President Kennedy, in imploring Congress to pass fundamental civil rights legislation, stated:

“…the old code of equity law under which we live commands for every wrong a remedy, but in too many communities, in too many parts of the country, wrongs are inflicted on Negro citizens and there are no remedies at law.”

Unfortunately, President Kennedy’s reference to our system of justice having the ability to remedy every wrong states only an ideal, but, sadly, not reality. Sometimes the difference between principle and truth is the result of legislative inaction or by legislative activism. Perhaps the most glaring example of legislative activism stripping away the “guaranteed” rights of citizens to have both their day in court and a remedy for every wrong can be seen in the medical negligence arena.

Let us examine the following two hypothetical scenarios.

First, a fifty six year old unmarried man is killed while traveling home one night. He is stopped at a red light when his car is smashed into by a dump truck, driven by an inattentive driver who was hurrying to get through his assigned route on-time. The deceased man leaves behind three surviving children who are each over the age of twenty five. Each of his three children are emotionally devastated by the sudden, unexpected, and totally avoidable death of their father.

Second, take the same man, but instead of being killed by an inattentive truck driver, he is the victim of medical malpractice. He is hospitalized and a doctor fails to read the clearly documented chart showing that her patient suffers from a severe allergy to penicillin. The physician administers the antibiotic anyway. Her patient dies on the operating room table from severe anaphylactic shock in what is a clearly avoidable death caused by medical negligence.

The surviving children of the victim in our first hypothetical would each have a claim as a legal survivor of their deceased father for their lost parental companionship, instruction, and guidance and for their mental pain and suffering caused by the loss of their father.

In the first scenario, they would have an opportunity to explain to a jury of their peers the tremendous sorrow, pain, and loss they feel as a result of their father’s tragic and untimely death. The jury would then be able to award each surviving adult child an amount of money that was fair and just in light of the evidence. In essence and at least to the extent that our system of justice is able to do, there would be a remedy for this horrible wrong.

The surviving adult children in our second hypothetical, however, are going to be victimized first, by the medical malpractice which claimed their father’s life, and second, by the fact that Florida’s tort system has created special protections for healthcare providers when their negligence results in the preventable deaths of their patients. Specifically, Florida Statute 768.21(8) prevents the adult children of a parent who dies as a result of medical malpractice from bringing a claim for their pain and suffering. In essence, the courthouse doors are closed to them. There is a wrong, but not a remedy. Is the pain felt by the surviving adult children somehow less profound, less real, less debilitating in the second example than in the first? Of course not.

Legislative activism in the medical malpractice arena has left a gaping black hole where medical errors resulting in death can leave grieving survivors without any remedy whatsoever to address the tremendous pain and suffering they experience as a consequence of a parent’s untimely and avoidable death. In essence, Florida Statute 768.21(8) provides healthcare professionals with a virtual “get-out-of-jail-free-card” when their malpractice kills unmarried adults with no children under the age of 25.

There is a wrong, but justice has been taken away.

There has been a lot of talk about the H1N1 virus and now the H1N1 vaccine. Some say get the vaccine, some say it may be a health hazard. Who should you believe?

Vaccinations began in Florida recently and continue to be available for certain at risk populations. However, doctors precaution those seeking the H1N1 vaccine to make sure they understand the side effects. Dr. Brian Thornburg, pediatrician in Naples, Fla., recently submitted an article cautioning those receiving the H1N1 vaccine. He cites the National Institute of Health’s website which says the H1N1 vaccine is still undergoing safety trials and the vaccine is only in the phase two stage out of four phases. So what do we really know about the safety of this vaccine and why is the government continuing to distribute it while they are still studying its effectiveness?

Dr. Thornburg also states that the Center for Disease Control (CDC) and the Food and Drug Administration (FDA) claim the H1N1 vaccine and its side effects are “just like the regular seasonal flu shot.”  They claim the “safety and efficacy of the H1N1 vaccine is being researched and results will be available in the near future.” So what exactly is the “near future,” and does that mean the vaccine is presumably safe?

Regardless of the lack of scientific evidence about the H1N1’s safety, the CDC recommends that the vaccine should be initially administered to persons in the following five target groups:

• pregnant women
• persons who live with or provide care for infants aged 6 months or younger
• health-care and emergency medical services personnel
• persons aged 6 months to 24 years
• persons aged 25-64 years who have medical conditions that put them at higher risk for influenza-related complications

The CDC also warns that, just like the regular flu strain, neurological complications can occur after a respiratory-tract infection with H1N1, including seizures and mental changes.  A concern was first raised in May 2009 when the Dallas County Department of Health and Human Services reported four children with neurological complications associated with H1N1 flu.

For the most part, the majority of reported cases have been mild or relativity the same severity as the common flu. The Center for Disease Control (CDC) also says that those exposed to the flu epidemic in 1957 may have some immunity to the H1N1 virus, explaining why older persons seem to have no symptoms or mild symptoms when exposed to the H1N1 virus.

The government is encouraging many children and adults to receive this vaccine without adequate safety studies as a result to the media hype. Please make sure you are fully informed before putting yourself or your family in potential jeopardy.

It is old hat in the medical device and drug industry; do not ask for permission—simply deal with the fall out of asking for forgiveness.

The US Attorney’s Office announced indictments against a number of Stryker executives for lying to the Food & Drug Administration. Apparently, Stryker was given permission for “limited humanitarian” use of its bone growth products, OP-1 implant and OP-1 Putty, used in spinal and long bone surgeries.

The Stryker products were only supposed to be sold in limited quantities and were only approved for use in treatment of certain rare diseases. It may be hard to believe that Stryker reportedly invented a number of other uses for these products and promoted them to physicians.

Stryker is one of the companies, together with Breg and IFlow, who are being sued over doing this same thing with pain pumps. It has become clear in the pain pump litigation that manufacturers knew that the FDA would require clinical trials (and resulting cost overhead for the manufacturer) in order to promote the use of pain pumps directly into joint spaces. Although manufacturers knew that use of the pumps in the joint spaces was prohibited without prior clinical trials, they promoted that use to physicians anyway. In fact, some of the manufacturers went so far as to promote the use and also promote methods that would allow for higher charges if the pain pump was used the way manufacturers were promoting it.

Now, these same manufacturers are trying to argue in the pain pump litigation that no good scientific studies exist that supports the causal relationship between pain pump use in joint spaces and a devastating condition called chondromalacia. Effectively, manufacturers are trying to convince judges to dismiss lawsuits based on their violation of the FDA requirements and their failure to conduct the scientific studies which the FDA would have required had the manufacturers complied with the law.

So, when selling potentially dangerous drugs and medical devices, apparently the theory is do not ask for permission; reap the profits; and pay for forgiveness later.

There is certainly no shortage of tort reform crusaders who have, in their private lives, sought the assistance of trial lawyers to bring exactly the type of lawsuits that they decry in public: then-Gov. George W. Bush filing suit over a minor fender-bender involving one of his daughters in which no one was hurt; Sen. Rick Santorum and his wife recovering $350,000 in “pain and suffering” damages in a medical malpractice lawsuit;Sen. Trent Lott enlisting a well-known trial lawyer to sue his insurance company over Hurricane Katrina damages; Judge Robert Bork asking for punitive damages (!) after tripping on some steps at the Yale Club. But no group has more forcefully championed tort reform over the years than the U.S. Chamber of Commerce. One of their mottos is “Jobs, Not Lawsuits.” But, in recent months, filing lawsuits seems to have become one of its jobs.

When, in August of this year, the Chamber threatened to sue the Environmental Protection Agency over regulation of greenhouse gas emissions, I just added that to the list of tort reform hypocrisies. But the Chamber jumped straight from the ridiculous to the sublime with its lawsuit, filed this week in federal district court, against the Yes Men. The Yes Men have made quite a name for themselves pretending to be spokespersons for prominent organizations, making false announcements that generate publicity and, they hope, pressure the organizations to make real changes. On October 19, they held a fake press conference announcing that the Chamber of Commerce had reversed its position on climate change policy, and promised to immediately cease lobbying against the Kerry-Boxer pollution reduction bill. They even had cable news organizations fooled for about an hour. The only “damage” that the Chamber of Commerce suffered was having public attention focused on its views about climate change. Yet the Chamber responded by filing a multi-count federal lawsuit. Or maybe the lawsuit itself is another hoax??? If not, this may rank as the Greatest Moment in Tort Reform Hypocrisy … for now.

Insurance companies are always out there wringing their hands, crying poor, and accusing everyone else for high insurance rates and, oh yeah, those “frivolous lawsuits”. The truth is the insurance industry was designated as a special class of corporation over 50 years ago. This special class was caused by exempting them from the McCarran-Ferguson act that prohibits monopolies, among other things.

This special exemption has permitted insurance companies to legally collude over pricing, effectively giving them an invitation to participate in price fixing and limiting market availability.

I have wanted to write an entire article about this whole issue a number of times, but I frankly never had the time to do all the research necessary.

Joanne Doroshow has done the work and written an excellent article for the Huffington Post. Her article is titled:
Medical Malpractice Insurers: Time to End Their License to Gouge.

I highly recommend reading this article that sets forth some of the best reasons why crying about frivolous lawsuits, tort reform and insurance company breaks is so much, well, lies.

Thank you, Ms. Doroshow.

A Single vehicle automobile accident is not always what it appears to be on the surface. Typically, when an automobile crash happens involving a single car, even the police attribute it to driver error, environmental causes, or similar combination of contributing factors.

Not always as simple as it seems on the surface. In-depth investigation of single vehicle, including tractor trailer, accidents can often disclose more interesting information.

The actual cause of single vehicle crashes (auto, truck, ATV, etc) may be the result of product defects or product failure. If any of the following factors are involved in a single vehicle crash, they may warrant additional investigation by competent attorneys skilled in this area of law:

• Roof crush.
• Low speed rollover
• Faulty seat belts.
• Ejection through the back or side windows.
• Fifteen passenger vans.
• Tire blow outs or similar tire failure
• Reclining seat backs.
• Front seat occupants wearing seatbelts, but found in the rear seats after the crash.
• Defective door latch.
• Evidence of sudden or unexplained acceleration.
• Sudden loss of steering.
• Difficulty controlling the vehicle at high speeds.

It is essential that the evidence be carefully preserved. The vehicle involved must be protected from spoliation and an in-depth evaluation for the suspected defects should be made timely. Time can be an enemy in these cases.

Bangor, Maine’s most famous resident (no disrespect directed towards other Bangorians) is horror-writer extraordinaire Stephen King. It seems appropriate then that Bangor’s federal courthouse is the latest venue in which cigarette manufacturers’ horrific decades of long fraudulent practices will be put under the forensic microscope.

In 2005, Maine residents filed suit against cigarette manufacturing giant Philip Morris (i.e., Marlboro) and its parent company Altria Group, Inc., alleging that the cigarette makers advertised that their “light” cigarettes (i.e., Marlboro Light) deliver less nicotine and tar than regular brands, knowing that the message was, in fact, false.

The consumers relied on their state’s ‘Unfair Trade Practices Act.’ However, because of procedural rules, the lawsuit eventually ended up in federal court (as opposed to Maine state court), thus opening the door for Big Tobacco to rely on one of its hallmark excuses for its ghastly depravities: that the existence of a particular federal law – in this case the Federal Cigarette Labeling and Advertising Act – prohibits this particular type of lawsuit brought under state law (aka federal preemption).

By relying on the Labeling Act – the landmark federal law requiring ‘warning labels’ on cigarette packs, the cigarette manufacturers make the excuse that because there are warning labels on cigarette packs, the fact that a consumer has been warned means that what we say in advertising about the virtues of our cigarettes is of no consequence and should have no effect on the consumer. Or, put another way, we feel that this law and the warning labels it produced, gives us the liberty to create the “facts” as we see fit.

However, a majority of the United States Supreme Court did not buy it, and in late 2008, issued its opinion in Altria Group, Inc. v. Good. We now find ourselves just one week before Halloween, the lawsuit brought by Maine residents against a charter member of the Big Tobacco fraternity is alive and well in Stephen King’s hometown … heres hoping that the Bangor Federal Courthouse will be a house of horrors for the defendants. Perhaps in this lawsuit the truth might yet bear out on “The Stand“.

Learning to drive is one of life’s milestones. Parents can serve an important role by encouraging teen driver safety throughout the year.

Despite all of the recent and focused media attention devoted to making us all aware of the potential risks to younger people contracting the H1N1 virus, or Swine Flu, the Center for Disease Control also reminds us that this is not the greatest threat facing today’s teenagers.

Statistics are a good place to start, since they give us a picture of what’s happening. I have included a few sobering facts below from NHTSA, the National Highway Traffic and Safety Administration.

Motor vehicle crashes are the leading cause of death for American teenagers.

• In 2001, 5,341 teens were killed in passenger vehicles involved in motor vehicle crashes. Two thirds of those killed were not buckled up.
• When driver fatality rates are calculated on the basis of estimated annual travel, teen drivers (16 to 19 years old) have a fatality rate that is about four times higher than the fatality rate among drivers 25 through 69 years old.
• In 2001, 3,608 drivers 15 to 20 years old were killed in motor vehicle crashes, and an additional 337,000 were injured.
• Young drivers (16-20) were involved in 7,598 fatal crashes in 2001.
• In the last decade, over 68,000 teens have died in car crashes.
  
• Sixty-five percent of teen passenger deaths occur when another teenager is driving.
• In 2001, 26% of fatally injured teen drivers (16-20 years old) had high blood alcohol concentrations (0.08 percent or more), even though all were under the minimum legal drinking age and are not legally permitted to purchase alcohol.
• Two out of three teenagers killed in motor vehicle crashes are males.

The media coverage of the expected flu outbreak continually reminds us of the precautionary measures that can be taken to minimize exposure to the risk of contracting the disease.  Being aware the risks that we also encounter everyday on our highways and city streets, and being reminded that there are specific steps to be taken can also help to prevent or minimize the exposure to the terrible tragedies that the above statistics illustrate.

Greater risk exposure: Teens often drive at night with other teens in the vehicle, factors that increase crash risk.

Teen drivers are different from other drivers, and their crash experience is different. Compared to other drivers, a higher proportion of teenagers are responsible for their fatal crashes because of their own driving errors:

• A larger percentage of fatal crashes involving teenage drivers are single-vehicle crashes compared to those involving other drivers. In this type of fatal crash, the vehicle usually leaves the road and overturns or hits a roadside object such as a tree or a pole.
• In general, a smaller percentage of teens wear their seat belts compared to other drivers.
• A larger proportion of teen fatal crashes involve speeding, or going too fast for road conditions, compared to other drivers.
• More teen fatal crashes occur when passengers, usually other teenagers ­are in the car than do crashes involving other drivers. Two out of three teens who suffer fatal injuries, are passengers in vehicles driven by other teenagers.

To assist parents and younger drivers be aware of  the greater risk of injuries AAA has come out with a brochure to help parents choose a qualified driving school. The brochure, called, “Choosing a Driving School…A Guide for Beginning Drivers,” can be ordered for free by contacting your local AAA club or clicking on the link above.