The Food and Drug Administration (FDA) recently inspected the Mounds View, Minn., location of Medtronic’s heart implant division and found problems with the company’s procedures for “preventing and identifying problems with its devices, documenting those problems, and the speed with which it informs the FDA of any issues,” says a report by the Associated Press. Medtronic says they are already planning corrections to the facility. They have 15 days to respond to the FDA warning and company spokespersons say they have already taken measures to address and correct the problems. The FDA announced that they feel the corrections are sufficient to fix the problems.

Medtronic is no stranger to FDA safety alerts and recalls about multiple products manufactured by the company.

In 2008, Medtronic’s AneuRX abdominal stent graft system was linked to more deaths than open surgery for the same purpose; preventing rupturing of swollen vessels that supply blood to the abdomen. However, Medtronic’s company spokesperson, Daniel Beach, said that “based on the highest-quality data available, AneuRX performs better compared to open surgery in late abdominal aortic aneurysms related deaths. He also said that the FDA’s analysis relies on “average mortality risk from surgery rather than a controlled clinical study.”

In another case, Medtronic informed the FDA and clinics worldwide that it had received reports of infusion system difficulties that were attributed to an improper alignment between the catheter’s connector and the pump’s port in heart surgeries. Another problem cited with the same product was a disconnection of the catheter from the pump. The recall was referred to as a Class 1 recall, means the problems or defect could serious injure or kill patients. Medtronic’s investigation claimed the events were caused by misalignments or incomplete connections of the catheter during the implant procedure.

Just last May, the company faced a recall of thousands of its pacemakers due to a wiring defect that made them unresponsive or caused them to run out of battery power. The recall was also deemed a Class 1 recall. Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. The affected pacemakers are the Kappa Series 600/700/900 and the Sigma Series 100/200/300. There are more than 1.7 million Kappa or Sigma pacemakers implanted in patients throughout the world. About 21,000 of those are affected by the recall.

Wyeth chose to hide, obscure and contain the dangers of PremPro and other HRT (hormone replacement therapy drugs).

A Florida lawsuit will result in requiring that Wyeth (a division of Pfizer) must “litigate in the sunshine”. Florida has a statute, which requires products in the nature of a public hazard be litigated in the public forum and citizens of Florida must have access to the documents involved in the case. The driving force of the statute is to allow citizens to be aware of hazardous substances and to prevent corporations from continuing to hide behind carefully crafted court orders.

Searcy Denney partner, Brenda Fulmer, made such an argument and Wyethe agreed to release of the documents rather than go through a public hearing, which may have resulted in a judge’s labeling of their products as public hazards.

Litigation against Wyeth (now a division of Pfizer) continues even after 10 juries have delivered significant verdicts against Wyeth.  So far, in excess of 150 million dollars in verdicts have been levied against Wyeth for conduct, which one juror labeled as “despicable”.

The laws labelling dogs “dangerous” have been tightened in Palm Beach County and across the nation. When a dog is declared dangerous it must be kept away from public places, on a walk it must be muzzled and on a leash and such canines cannot be left to roam freely in their yards.

No one really knows when they get a puppy or adopt a dog that it might have traits that could cause it to be labelled dangerous. This can happen to any breed of dog and is not limited to just the breeds classified as the “main offenders.”

Owning a dog is a responsibility that should not be taken lightly. All dogs should be socialized when young with both other animals and with humans. Take your dog to a basic obedience class to minimize the chances of it becoming a problem to other pets or humans. Any dog, under the right circumstances, can be a destructive and dangerous force.

If you are the victim of a dog bite, report the incident to your local authorities. Although the attack may have been an isolated occurrence that will not happen again, it may also be an alert to a dangerous problem. If by chance you are the victim of a dangerous dog attack there are also civil remedies that can be sought to compensate for your injuries.

You have to love Big Tobacco.  Nothing gets them down – no sir! They can cry foul with the best of ‘em; even when they get caught with their hands in the cookie jar.

First, a jury sees through their smoke and mirrors in a trial down in Fort Lauderdale, Fl. The jury finds in favor of a plaintiff who has and continues to suffer from COPD; awarding over $300 million dollars. We know the jury saw through their smoke and mirrors because they hammered Big Tobacco with over $260 million in punitive damages.

If anyone sees the evidence setting forth the conduct of Big Tobacco over the last several centuries, you can not help but be surprised and outraged that an industry has been allowed to get away with the type of conduct they have displayed.

The response to the verdict by Philip Morris? It was interesting:

“From the beginning, this case was marked by a fundamentally unfair and unconstitutional trial plan that allowed the jury to rely on findings by a prior jury that have no connection to the plaintiff.”

Was the prior jury’s findings wrong? They do not say so.

How was the trial plan “fundamentally unfair and unconstitutional”? Simply because the jury was permitted to hear the findings of a prior jury?

So what has gotten Big Tobacco’s “goat”? They do not like that a higher court has made findings they are, well, “uncomfortable” with. A higher court that has quite clearly set forth things like:

• Smoking cigarettes causes disease, including cancers, COPD, and heart disease
• Nicotine in cigarettes is addictive
• Big Tobacco placed cigarettes on the market that were defective
• Big Tobacco placed cigarettes on the market that were unreasonably dangerous
• Big Tobacco concealed or omitted material information about cigarette dangers (think lie here)
• Big Tobacco issued false or misleading information about the dangers of cigarette smoking
• Big Tobacco concealed or omitted information about the addictive nature of cigarettes
• Big Tobacco was negligent in its mnanufacture of cigarettes

Now, Big Tobacco is in a lather that jurors understand they lied to the American public. Big Tobacco can not believe that jurors actually listened to the large amount of evidence that illustrates their campaign to hopelessly addict people to cigarettes and the continued campaign to keep smokers addicted.

After all, when the “seven dwarves” testified in front of congress, they swore under oath that nicotine was not addictive. Big Tobacco simply can not believe we did not believe them. After all, they swore!

[youtube]http://www.youtube.com/watch?v=jQUNk5meJHs[/youtube]

A message to Big Tobacco: get over yourselves; the public understands you lied and schemed to addict Americans to a drug more addictive and destructive than most “illegal drugs” we spend billions fighting to keep out of our society. And, Big Tobacco, the public understands you paid good money to be allowed to market your drug. Oh yeah, Big Tobacco, after making billions and billions on the scheme….it is in fact time to pay the price for decades of deception!

Today, a Broward county jury delivered a verdict against Big Tobacco that should have sent a message. When jurors in good faith hear the evidence of misconduct, fraud, and deception practiced by the tobacco industry for decades, jurors are willing to render a verdict that relates to the egregious nature of that misconduct.

Jurors today found against Big Tobacco in a verdict including over $240 million in punitive damages. These are damages intended to punish the defendant for conduct the jury must have considered to be significantly bad.

Thanks to jurors who take time from their own lives, listen to evidence and render a verdict in good faith.

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.

“More than 76,000 Americans have been killed walking or crossing the street in the past 15 years, and pedestrian deaths account for about 11.8% of all traffic fatalities;” that published in a joint report by groups Transportation for America and the Surface Transportation Policy Partnership entitled ‘Dangerous by Design: Solving the Epidemic of Preventable Pedestrian Deaths (and Making Great Neighborhoods). And according the recent USA Today article ‘Communities try to prevent pedestrian traffic deaths,’ (USA Today, November 10, 2009, 5A) those groups are lobbying Congress in an effort to require states to spend their share of federal funds on road projects to address the needs of pedestrians. This comprehensive report includes the most dangerous cities for pedestrians and provides safety rankings for each of the 50 states.

However, regardless of Congressional action or future state cooperation in making pedestrian safety a priority, the fact that pedestrians account for approximately 1 in 10 traffic deaths nationwide is staggering.

Every time a pedestrian takes to the street, whether it be walking, jogging or biking, you should recall this statistic and:

• Be defensive;
• Assume that drivers do not see you;
• Assume drivers do not understand pedestrian traffic laws;
• Assume drivers are preoccupied with whatever drama unfolded in their lives that day;
• Assume drivers are late to wherever they are headed;
• Assume drivers are distracted, using a cell phone, reading a newspaper or magazine as they drive;
• Assume drivers are driving a vehicle with defective brakes;
• Assume there will be drivers who have been drinking,

For Floridians, pay particular attention in these “top rated” cities:

1) Orlando.

2) Tampa-St. Petersburg.

3) Miami-Ft. Lauderdale.

4) Jacksonville.

Being outside nearly year round is a perk enjoyed by few, Floridians luckily included. When doing so on bike paths and sidewalks near roads, always be on guard.

Many of you reading this blog may have never heard the song ‘Walking in Memphis,’by singer-songwriter Marc Cohn. This was an early ‘90’s homage to the land of the Delta Blues, influential Beale Street, Elvis, and countless other subtle rock music references by singer-songwriter Marc Cohn. This was an early ‘90’s homage to the land of the Delta Blues, influential Beale Street, Elvis, and countless other subtle rock music references. Evidently additional lyrics are suitable, something to the effect of: “well I was walking in Memphis, but I was hit by a car and was killed.”

Gruesome, but realistic, since Memphis is tabbed as the 5th most dangerous city for pedestrians by the aforementioned report.

One of the leading manufacturers of baby strollers, Maclaren, has recalled one million strollers which pose an amputation danger for children’s fingers.  The Consumer Product Safety Commission reports that 12 children had suffered fingertip amputations after getting them stuck in the closing hinge mechanism of the strollers.

[youtube]http://www.youtube.com/watch?v=UGDjAt0yfyM[/youtube]

In response to the recall, Maclaren has developed a free kit which covers the side hinges of the stroller for any consumers who have purchased one of their strollers during the past decade.  Placement of the kit over the hinge protects children from the hazard of amputation.

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Much has been written recently concerning the sentencing of three youths to life without parole in what has become known as the Dunbar debate. The crime was a particularly heinous one: in a South Florida housing project, a battery of nearly a dozen youths invaded the home of a woman, held her and her son against their will, raped her repeatedly, then sadistically forced her to engage in deviant sexual acts.

Sentencing Judge Krista Marx denounced the trio as “without moral compass”. Seeing no hope of rehabilitation through incarceration, she sentenced them to life without parole; she could not allow society to become victimized again by such vicious acts of inhumanity.

The other side of the argument is that a system that would imprison youths, not yet of majority age, forever, allowing for no hope of rehabilitation, is a system that fails to serve the better interests of society and the felon alike.

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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.