Thursday, December 16, 2010

12/16/2010 Darvocet Legal News for Savannah, Richmond Hill and Brunswick, GA

Judge wll not ban Brunswick's Disorderly Ordinance

A federal judge has ruled Brunswick police may continue to enforce the city's disorderly conduct ordinance and have the legal authority to ask small groups of protestors whether they have a permit to demonstrate.

Under the city's ordinance, any group 100 or larger must obtain a city permit.

Read more here: http://jacksonville.com/news/crime/2010-12-07/story/federal-judge-declines-ban-brunswick-disorderly-conduct-ordinance

Elbert County News

Official seal of Elberton, GeorgiaImage via WikipediaElbert County residents fought hard against a plan to build a waste-to-energy incinerator and 39-acre landfill west of Elberton by funding lawsuits, signing petitions and talking to their neighbors.

GreenFirst announced its decision a week after winning a ruling in one of the four lawsuits spawned by the proposal. Northern Circuit Superior Court Judge Jeffery Malcom rejected residents' efforts to hold a referendum on Elbert County government policies that cleared the way for the incinerator.
Plant Granite, which the company planned to build off Georgia Highway 72 between Elberton and Carlton, would have burned garbage and wood to generate electricity, and would have disposed of the ash in an on-site landfill.

But GreenFirst decided to abandon the incinerator plan when Covanta, the company that would have operated the plant, backed out of the project.

Read more at the source: http://www.onlineathens.com/stories/121210/new_755348800.shtml 
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Friday, December 10, 2010

More Good News about Amazing Aspirin


"Baby" AspirinFrom NPR:


I'm one of those guys who takes an aspirin daily. So, I read this news with interest:

A British study claims evidence that aspirin can prevent death from a variety of cancers, if you take the medicine long enough in middle age. Even a baby aspirin might be enough.

 Published in The Lancet, the study suggests aspirin could provide protection against a wide variety of tumors. They range from pancreatic cancer to the type of lung cancer that strikes nonsmokers.

For some of these cancers, the reduction in death was noteworthy. Twenty years after people had started taking aspirin regularly (and kept it up for at least five years), their deaths from esophageal cancer were reduced by 60 percent compared to study subjects who got a placebo.

http://www.npr.org/blogs/health/2010/12/07/131873139/study-aspirin-cuts-deaths-from-wide-variety-of-cancers
Read more: 

Sunday, December 5, 2010

Is Social Media Crucial to Law Firm Marketing?

I know that when it comes to the law practice (and consumer law/personal injury), it's much different than selling shoes. Alas, some so called 'social media experts' do not understand that. Imagine if Zappos.com the shoe sales site had to actually have its employees sit and take a licensing test in order for shoes to be sold in Florida?

That takes me to the subject of social media for lawyers. I will tell you that I have spoken more than a dozen time at lawyer CLE courses about law and technology, and marketing in the 21st century using the web. First and foremost I find that at least in terms of lawyers in the injury field, many lawyers get an "F" grade just for their websites. Lawyers with blogs? Right. I would say 10-15% blog, and of those less than half blog regularly.

So, why dive into social media marketing headlong, like Rene Perras suggests in this article, "Social Media is Crucial to Law Firm Marketing Efforts?"

It's easy. You don't. I will accept at face value for the sake of this post that the statement that "Currently, there are over 500 million active users on Facebook, who spend over $700 billion a month" is correct. There is a Twitter reference as well. Law services -- sticking again to the injury law practice - is not like buying books on Amazon.

Parras then goes on to write what I think is just plain bullsh*t: "Cepac uses specialized approaches to find online conversations people are having that are relevant to law firms to capture potential clients." 

Remember myspace.com? Three to four years ago, the buzz was you and your firm had better get on myspace or you'd be roadkill. Folks who were 'experts' insisted to me that I had better get with it. Now, a new .com, but the same old verse. What happens in 3 years if FB goes away?

For lawyers, you make mistake number one if you or your firm go to Social Media first without taking an honest assessment of your website and the message the site conveys. Oh, I also have news for you. Now law firms (like mine) have multiple websites, niche sites, and blogs. Combined with a sensible google adwords approach, those are the touchstones to the tech/internet approach to marketing on the web.

Where does Social Media fall? Let's compare: I have almost 2700 tweets since jumping into Twitter in December of 2008. I have almost 1900 followers. Zero cases. In fact, since I have started, only one lead.

Now, look at my firm's blog network, including this one and the others. In a typical week, my firm will post 2-10 times on any given subject or set of subjects. By the end of each month, we average more than 50 calls or emails a month, and usually meet with and are retained by no less than 15 new clients. A month.While there is a cost in terms of posting time, there is zero cost for google adwords.

Google adwords has --separate and apart from the blogs - helped the firm prosper. Huge successes. Right now, though -- today -- there are firms wasting thousands on google with crooked and incompetent vendors. Start there if not with blogs. In Georgia, at the top of the results is a sponsored link for a firm - seeking a very niche client - that not only is based in California, but the firm (who I called) will not even accept a case in GA. Does that sound wise to you?  Lawyers, however, will pore over a grocery bill and argue about being overcharged for milk, but won't ask why thousand of $$ are being spent on the web in areas other than your practice zone, or will spend money on adwords that don't generate leads, and don't question their vendor. Start there. I will tell you that I actually make fun of certain firms that simply don't get it when it comes to google adwords. Learn it!    

Now what about Social Media? Twitter to me is good for information gathering. I'm able to direct folks to our firm blogs for news.

Facebook? I've tried it a bit with a business page at the beginning of the year. Advertise on FB? We do. Just like we have ad buys on linkedin.com. For a biz page or other page, however, you and your firm are foolhardy if you hire some person out of the blue to handle SM. Beware the 'experts' in the area.

Social media is like that new client who walks in the door. Do the research on your own. Biz lawyers call it due diligence. Don't allow yourself to get your eyes glazed over and let someone else do it for some price  Roll up your sleeves and spend no less than 50 hours on sites like I have (and I may be your competition) first.

Never mind that what Parras suggests would possibly be unethical in some states. In Florida, you're not even permitted to have on your own website a page about verdicts without first posting a "warning" page ahead of it that the user acknowledges that the page is deemed an ad before viewing. Never mind that lawyers who are not licensed in Mississippi who wind up with info that may reach citizens there could risk a criminal charge.

My advice: Look very closely at the substance before rushing headlong into SM. Perhaps toutmeisters who seek SM clients might look up the definition of "crucial" - "Extremely significant or important. " Better yet:    "Vital."  None of those words in my view would marry up with lawyers, their practices and 'social media.'

I will tell you this: Look at Social Media closely. It's crucial that you don't make a costly mistake.     

 

Saturday, November 27, 2010

Advanced Bionic Recall of HiRes 90K Implant

Image representing Advanced Bionics as depicte...Image via CrunchBaseAdvanced Bionic has advanced a recall of its  cochlear implant systems, announced today that it has notified the US Food & Drug Administration (FDA) that it will voluntarily recall its HiRes 90K cochlear implant device and is retrieving all unimplanted devices in distribution. This action is being taken in response to two confirmed instances where the product experienced a malfunction requiring explantation.

These recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device.

There are three companies in the world that manufacture cochlear implants: Med-El, Cochlear Corporation, and Advanced Bionics.  Advanced Bionics is based in the Los Angeles, California area, and Advanced Bionics was recently acquired by Sonova, a Swiss corporation.  Advanced Bionics was previously controlled and owned by Boston Scientific Corporation. Over the course of its history, Advanced Bionics has manufactured three types of cochlear implants: (1) The Clarion / Clarion 1.2 / C1.2, (2) The Clarion II / CII, and (3) The HiResolution 90k / HiRes90k.

In 2004, Advanced Bionics issued a worldwide recall of all unimplanted Clarion and HiRes90k devices. The company was issued a Warning Letter by the United States Food and Drug Administration (FDA) in February 2005. Later, in March 2006, the company issued a second recall of all unimplanted HiRes90k devices containing a feedthrough manufactured by AstroSeal, Inc. / vendor B. Almost 4,500 persons around the world were implanted with HiRes90k with vendor B feedthrough components.

Talk with us if you believe that you have a defective or recall implant. Call
404-451-7781.
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Friday, November 19, 2010

Darvon and Darvocet/Propoxyphene Recall News November 19, 2010

The FDA  has asked that propoxyphene, (brand names Darvon and Darvocet, Xanodyne Pharmaceuticals) be removed from the US market. The decision will also affect generic manufacturers and the makers of propoxyphene-containing products.


The FDA has told medical professionals to stop prescribing propoxyphene. Patients who are taking the stated medications should not sinply stop taking it, ut should contact their doctor soon as possible to discuss switching to another pain-management therapy.
 
Propoxyphene is an opioid typically used to treat mild to moderate pain. It was first approved by the FDA in 1957. It is sold by prescription under various names alone or in combination with acetaminophen. Since 1978, the FDA has received two requests to remove propoxyphene from the market.
 
In January 2009, an FDA advisory committee voted 14 to 12 against the continued marketing of propoxyphene products. At that time, the committee called for additional information about the drug's cardiac effects.
 
From Public Citizen:

Dr. Sidney Wolfe of the Public Citizen's Health Research Group said it was too little, too late, noting that Britain banned the drug six years ago.
"Due to FDA negligence, at least 1,000 to 2,000 or more people in the United States have died from using propoxyphene since the time the U.K. ban was announced," Wolfe said in a statement.
"Our February 2006 petition to the FDA to ban the drug, following the U.K. ban announcement, did not even result in an FDA advisory committee hearing until we had sued the agency in 2008 to force them to respond to our petition."

An FDA advisory committee split on whether to ban the drug in 2009. The European Medicines Agency pulled it from the market in June 2009.
 
 

Thursday, November 18, 2010

Tech, The Web, and Being Told what Lawyers Should Do

The way lawyers do business is changing rapidly, which is obvious to just about every attorney in the business. That may not be news. It is also not news to have non lawyers who do not run an office, seek clients, counsel clients, pay bills, or handle 'bet the company' litigation trying to tell lawyers how to do all of some of those.
Today was no different. A webinar was hosted today by a company that from its site provides services like software to lawyers. The webinar dispense free information to attorneys. Some of it was helpful, some - not so much.
First a little about our office - we have a very diverse clientele. It is not uncommon for us to send emails with updates. For some of the younger, mobile generation, many of those clients only have a cellphone. More than a handful will move at least once during the course of a case that lasts two years or more.
With that being said, here is the first bad advice this company (through a speak) gave in its webinar:
1. Bad advice #1: Don't text with clients. Then later, "Never text message your clients."
In my offices, texts are common but limited in subject matter. When we call on the phone and leave a client a message, it is short. "Please call us when you have time." Same for texts - it is to ask the client to call. We never give advice, or simply remark on a pending case. 
We have a policy in place for texts. No one in the office but a law partner may text, and that person may only leave a msg to call us back, or to give an address for a meeting or deposition, or to confirm that the attorney is at a meeting place. 
It's overly simplistic that "never" is the rule. It once again shows how non lawyers, without clients - especially injury clients - lack an understanding of how an office operates now. 
2.  Minimize mobile emailing as well. It's very reactionary..
I'm in court or on the road - a lot. It does take discipline to limit emails. If like me you are in a courthouse, or another office, or on the way to/from either, it's just a way of life to address and prioritize what you may respond to while 'mobile.' 
3.Don't answer the phone simply because it's ringing.
I saw this one from the vendor on twitter. It's a head scratcher. May need better context. For a call into my office, I may let it ring to VM. For the office as a whole, they get answered. After 5PM lawyers may answer. 


A story - it was after 8 PM one night. A new call came to my cell. I answered. It was one of the most significant cases for us that year, a fellow lawyer who needed help on a legal case (his own) and he was impressed that I took the time not only to answer but to talk for an hour. 


My advice - we are all busy. Answer. 

Finally, not bad advice, just not sure how real this one is: "Work with a clean desk" 

I worked with a clean desk. My first day in the practice of law. Never again since.  


 

Wednesday, October 20, 2010

Avandia News for Southeast Georgia: Avandia Legal

AvandiaImage by neofedex via Flickr
A good report from American Counsel on Science and Health:

As drugs continue to be taken for longer periods of time, unexpected complications may arise that were absent from short-term clinical trials. New York Times science journalist Gina Kolata reported on what happens when drugs cause problems they were originally developed to prevent, focusing on the risks associated with the now highly restricted diabetes drug Avandia, and bisphosphonates, a class of medicine used to treat osteoporosis. 

After post-market analysis revealed that Avandia is alleged to be associated with an increased risk of heart failure, the drug was temporarily removed from the market in Europe and then restricted by the FDA last month. 

Diabetic treatment is supposed to reduce the rate of diabetic complications including vascular disease, kidney disease and neuropathy — not merely control blood sugar. Studies that show Avandia may increase the risk of heart failure illustrate a case of when a drug does the opposite of what it’s supposed to.” 

Here is the link: http://www.acsh.org/factsfears/newsID.1961/news_detail.asp

In the Middle East, this news:
The UAE Ministry of Health has ordered all doctors and hospitals to suspend prescribing the diabetes drug Avandia.

According to a circular issued Sunday, health officials have decided to suspend all products containing Rosiglitazone over fears in the United States and Europe over its safety. Bahraini health officials have also banned drugs containing Rosiglitazone, like Avandaryl, Avandamet and Avandia, the Gulf Daily News reports.

Dr Ameen Al Amiri, CEO for medical practice and licensing at the ministry, was reported by the official news agency WAM as saying the drug control directorate had held extensive talks with Avandia’s manufacturers and local distributors.

http://www.arabianbusiness.com/avandia-diabetes-drug-be-banned-over-health-fears-351519.html


http://www.markzamora.com/AvandiaGA/index.html
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Tuesday, October 12, 2010

SE georgia LAwyer: Recalls, Meridia and others

FdaImage via WikipediaThe folks at the FDA have been busy the past several weeks. Here's a short list of recalls:

Amgen Initiates Voluntary Nationwide Recall of Certain Lots Of Epogen® And Procrit® (Epoetin Alfa):The product that is being recalled may contain extremely thin glass flakes (lamellae) that are barely visible in most cases. The lamellae result from the interaction of the formulation with glass vials over the shelf life of the product. The products are indicated for the treatment of anemia related to HIV therapy, chronic renal failure, and chemotherapy. Link.

 

Pfizer Consumer Healthcare Issues Voluntary Recall of One Lot of ThermaCare HeatWraps Menstrual Product  The company said it is taking this precautionary step after finding a potential for a leak of the components contained in the wrap, which could cause skin injury such as irritation or burn. Link

 

Recall of AROM-X Capsules, AROM-X UTT Liquid, AROM-XL Liquid, 4-AD Capsules and Decavol Capsules Marketed as a Dietary Supplements Containing ATD: FDA's states that the ingresidnets 1,4,6 etioallocholan-dione do not meet the definition of a dietary ingredient and therefore the product is in violation of provisions of the Food, Drug and Cosmetic Act.

 

Recall of Reversitol a Product Marketed as a Dietary Supplement Containing ATD: FDA has requested that iForce Nutrition inform consumers that adverse events associated with the use of aromatase inhibitors could include the following: decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure, and liver dysfunction. Consumers with liver, kidney, adrenal, or prostate abnormalities are at higher risk for developing adverse events. iForce Nutrition has not received any adverse event reports nor are they aware of any adverse events associated with the use of these products. Link.

 

 


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Monday, October 11, 2010

Georgia: Meridia Recalled

From the FDA:

AUDIENCE: Primary Care, Consumers

ISSUE: Abbott Laboratories and FDA notified healthcare professionals and patients about the voluntary withdrawal of Meridia (sibutramine), an obesity drug, from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke.

BACKGROUND: Meridia was approved November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving sibutramine lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone. FDA has now requested market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT is part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of the drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared with another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.

RECOMMENDATION: Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.

Talk to us at 404-451-7781

Wednesday, September 29, 2010

18 Wheeler Truck Wrecks in Georgia

A rear dump trailer with a daycab tractorImage via Wikipedia18 Wheeler Dangers:

The size of a tractor-trailer means that they handle much differently than a passenger vehicle. One of the biggest differences is stopping distance. At 65 mph, a car requires approximately 160 feet to stop. A semi-truck, on the other hand, needs approximately 420 feet to stop.

A big rig also has huge blind spots, commonly referred to as "no zone" areas. We are all used to the blind spot in our own car, but trucks have multiple blind spots, including in the front and the back. This makes it difficult for the driver to spot surrounding vehicles, which could lead to a collision.


In addition, semi-trucks make wide turns. A driver often has to swing in the opposite direction before negotiating a turn. For example, before making a right turn, a tractor-trailer driver may first swing the truck left to accommodate the wide turning radius. This can endanger vehicles on either side of the truck.

The height and weight distribution of an 18-wheeler makes it particularly susceptible to rollovers. Although often caused by speeding, truck rollovers can occur even at very low speeds, especially when going around corners and up or down a steep pitch. Rollovers may also occur when a tire goes off the pavement and a driver tries to return the semi-truck to the road.

Driver Error

Aside from the physical limitations of 18-wheelers, other factors can lead to truck accidents. Although truck drivers by and large are skilled, attentive, courteous drivers, even minor lapses in judgment on their part can lead to a catastrophic situation. Actions such as speeding, tailgating, swerving, failing to signal, and driving under the influence of drugs or alcohol can all lead to a truck accident.

There are also a number of factors inherent to the trucking business that can lead to a big rig accident. Truck drivers often operate within a system of compensation that encourages driving faster and for more consecutive hours than is safe. They may also drive through hazardous conditions in order to meet deadlines. Additionally, drivers may receive inadequate training that does not prepare them for the danger of driving a tractor-trailer.
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GA: LNH Trucks on Roads are too Risky

Source: http://savannahnow.com/column/2010-09-29/watson-lng-truck-route-too-risky

The recent debate on these pages over the proposed trucking of liquified natural gas through Savannah is unfortunately typical of what passes for policy discussions these days, with competing interests making technically true but misleading statements.

The letter from Bruce Hughes of Southeast LNG on Sunday is an excellent example. As a scientist involved in energy and natural hazard research I feel compelled to dissect his letter in the hope of shedding a little light on this debate.

The claims by industry that LNG cannot burn or explode, and that when it evaporates it rises, are true. Yet they are also misleading.

Natural gas at ambient temperatures will rise, but LNG is extremely cold. Even as the liquid evaporates, the vapor is too cold to rise for some time and can travel for a significant distance over the ground before dissipating below dangerous levels. The radius of risk varies depending on weather and terrain, but can be several hundred feet for a truck accident.

While LNG may not explode in the conventional sense, it can undergo a process known as a rapid phase transition (RPT), which while physically a different process, has the destructive potential of an explosion. This process is triggered by contact with water - something we have in abundance along the route.

Of special concern is a truck running off the Truman Parkway and landing in the Casey Canal near Memorial Hospital. This could create a situation where a small leak results in an RPT event, catastrophically rupturing the container, and creating a cloud of cold gas.

Even a simple traffic accident could result in a pool fire, which would be a dangerous situation if it occurred near the hospitals. An LNG pool fire, while short lived, burns extremely hot - so hot it can cause burns and trigger secondary fires at a considerable distance from the fire itself. A pool fire in traffic would surely ignite adjacent vehicles and cause multiple severe burn injuries and fatalities.

The standard (and essentially only) practice for dealing with a pool fire is to let it burn itself out. Given that risk, I would not want these trucks passing closer than 1,000 feet to a hospital or other critical facility on a regular basis, certainly not in the volumes proposed by Southeast LNG, which would exceed two trucks an hour.

As to the repeated claim that LNG is "clean," while it may be true relative to coal, it is false overall. The LNG production and transport process is energy intensive, and the net impact on the environment per unit of energy produced by LNG is far greater than other energy sources, especially when compared to nuclear or renewables.

Mr. Hughes statement that LNG will "reduce our dependence on oil" is absolutely ridiculous, as we are simply exchanging dependence on foreign oil for dependence on foreign LNG, obtained from the same limited, unfriendly and politically unstable sources.

To be fair, the opponents of LNG often use fear-mongering and exaggeration in their efforts to stop LNG related facilities. The fact is, the risks of LNG are manageable, the environmental impacts no worse, and in some ways better, than comparable sources.

The industry has a fairly good safety record. But LNG does have risks, and natural gas in general is extremely problematic as a fuel, especially if one includes environmental and geopolitical considerations. My own view is that natural gas/LNG is not an appropriate fuel choice and its use should not be expanded, but we should make that decision based on facts, not on either the fears of opponents or the platitudes of industry.

As for the current debate, in my opinion the truck route as proposed is inappropriate, given the risks it presents to our critical lifeline infrastructure in the form of Memorial and Candler Hospitals. The Federal Energy Regulatory Commission should not approve it, and our elected officials should bring all of the pressure they can on Southeast LNG to change the route to avoid critical assets.

If it is approved, all the parties involved, especially the hospitals, must create realistic plans based on realistic scenarios to deal with a potential accident.
Chuck Watson lives in Savannah and runs Watson Technical Consulting, which performs risk assessments.
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Thursday, September 9, 2010

Keppra News

A generic version of the anti-convulsant medication Keppra, commonly used to treat patients that suffer from seizures, such as epileptics, was approved by the U.S. Food and Drug Administration (FDA) for marketing in 2009. However, it seems that patients who switch from Keppra to the generic, Levetiracetam, are experiencing increased re-occurance of seizures after having been seizure-free on the brand name Keppra.

Patients who were switched from Keppra to generic Levetiracetam may suffer economic losses resulting from having their driving privileges revoked because of seizure danger, inability to work, unable to attend school, and other problems. Additionally, there have been reports of injuries and at least one death resulting from a patient who suffered a seizure and died after being switched from Keppra to the generic drug.

In addition to treating patients with epilepsy or other seizure disorders, Keppra or Levetiracetam may be administered to patients who have had a traumatic brain injury (TBI) and had seizures from their brain injury.

Generic Keppra is made by a number of different manufacturers:

Aurobindo Pharma
Cobalt Pharmaceuticals
Dr. Reddy's Laboratories
Mylan Pharmaceuticals
Roxane Laboratories, Inc.
Sandoz
Teva Pharmaceuticals
Generic Keppra tablets are available in the following strengths:

Levetiracetam 250 mg
Levetiracetam 500 mg
Levetiracetam 750 mg
Keppra oral solution (liquid) is also available in generic form.

All generic medications must undergo certain tests to compare them to brand-name medications. The FDA then looks at these tests to decide if the generics are equivalent to the brand-name medications and assigns each generic a rating.

An "AB" rating means that the FDA has determined that a generic medication is equivalent to a brand-name medication. All of the generic Keppra versions currently available have an "AB" rating, meaning they should be equivalent to Keppra.

However, generic medications are allowed to have different inactive ingredients than the brand-name medication. This might include fillers or dyes or other ingredients that may cause problems for people with allergies or sensitivities.

It should also be noted that many health care providers believe that special care should be taken when switching a patient from a brand-name seizure medication to a generic one, or even switching between different generic versions of a medication.

Wednesday, September 8, 2010

ROP and ETROP: The Seminal Study about ROP

My office has worked on cases involving ROP in young children. I get asked about what might be the best source for information and to me it's the ETROP study.


At age 5 1/2 years, the oldest age for which follow-up data are available, children with threshold ROP who were enrolled in the Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) -- Outcome Study showed fewer treated eyes (31.5 percent) than control eyes (48 percent) that were blind (P<0.001). of those eyes that had a favorable structural outcome, with or without retinal ablation (cryotherapy to destroy the fringe of the retina through freezing), only a small percentage had best corrected visual acuity better than or equal to 20/40 at age 5 1/2 years (13 percent in the treated group; 17 percent in the untreated control group (p=0.19)). among the 1398 followed from the 5 large natural history centers of the cryo-rop follow-up study, children with retinal residua of rop (structural changes) had measurable visual acuity that was severly affected and tended to worsen with age. the cryo-rop study proved conclusively that peripheral retinal ablation improves the chances of avoiding blindness, but at least 80 percent of eyes are left with acuity less than 20/40.

Two concerns emerged from the CRYO-ROP extensive study on the natural history of ROP and treatment of threshold ROP. The first of these is failure of peripheral retinal ablation to eliminate all, or nearly all cases, of retinal detachment due to ROP. In the CRYO-ROP Study, 26 percent of eyes with threshold disease in zone II and 78 percent of eyes with zone I threshold disease had an unfavorable structural outcome despite treatment. The second concern is that most children who developed threshold ROP disease had visual acuity worse than 20/40 even if the eye had a favorable structural outcome.

Since no other treatment has yet been shown to be effective in preventing blindness from ROP, retinal ablation remains the treatment of choice. The ETROP Study will test whether earlier treatment is more effective than treatment at threshold in improving functional (visual acuity) outcome following ROP, as well as determining whether earlier treatment decreases the probability of an unfavorable structural outcome.

Description

Earlier treatment is defined as retinal ablation administered to the avascular retina when an eye reaches high risk prethreshold retinopathy of prematurity (ROP). Prethreshold indicates any Zone I ROP; or Zone II stage 2 with plus disease, or stage 3; or Zone II with less than 5 contiguous or 8 cumulative clock hours of stage 3 ROP with plus disease. Recognizing that a substantial number of eyes undergo spontaneous resolution of ROP, eyes will be randomized to early treatment only when high risk for an unfavorable visual acuity outcome is identified. High risk will be determined using a risk model analysis program based on longitudinal natural history data obtained from the CRYO-ROP study. This model integrates risk factors to assign a risk of progression to blindness without treatment. These factors include birth weight, gestational age, ethnicity, singleton/multiple status, outborn status, Zone on first exam, severity of ROP and rate of progression of ROP. When an infant develops prethreshold ROP and greater than or equal to 15 percent risk of unfavorable outcome, randomization to early treatment of one eye will occur. Visual acuity outcome will be measured by masked observers after wearing best corretion using the Teller Acuity Card Procedure at 9 months corrected age.

Patient Eligibility

Infants <1251 grams birthweight born at participating centers and/or examined by 42 days of life are eligible. the early treatment trial requires that an infant have prethreshold retinopathy of prematurity (rop).

Patient Recruitment Status

Completed. A total of 317 infants with birth weights less than 1251 g and birth dates between October 1, 2000, and September 30, 2002, were enrolled at 26 participating centers.
Grating acuity results showed a reduction in unfavorable visual acuity outcomes with earlier treat-ment, from 19.5% to 14.5% (P = .01). Unfavorable structural outcomes were reduced from 15.6% to 9.1% (P<.001) at 9 months. further analysis supported retinal ablative therapy for eyes with type 1 rop, defined as zone i, any stage rop with plus disease (a degree of dilation and tortuosity of the posterior retinal blood vessels meeting or exceeding that of a standard photograph); zone i, stage 3 rop without plus disease; or zone ii, stage 2 or 3 rop with plus disease. the analysis supported a wait-and-watch approach to type 2 rop, defined as zone i, stage 1 or 2 rop without plus disease or zone ii, stage 3 rop without plus disease. these eyes should be considered for treatment only if they progress to type 1 or threshold rop.

Early treatment of high-risk prethreshold ROP significantly reduced unfavorable outcomes to a clinically important degree. Additional analyses led to modified recommendations for the use of peripheral retinal ablation in eyes with ROP. Long-term follow-up is being conducted to learn whether the benefits noted in the first year after birth will persist into childhood.

OTHER OCULAR AND CLINICAL FINDINGS
The distribution of refractive errors at the 9-month examination was similar between the high-risk prethreshold eyes that received early treatment and those that were conventionally managed.
Cataract or aphakia that was not associated with total retinal detachment or vitrectomy was found in 4 eyes (1.2%) in the group treated at high-risk prethreshold and 4 eyes (1.2%) in the conventionally managed group. Nystagmus occurred in 22% of randomized infants with bilateral high-risk ROP.

  A table ompares other ocular and systemic complications of treatment among infants treated at high-risk prethreshold vs conventionally managed infants in whom high-risk prethreshold ROP progressed and who later underwent treatment at threshold. Ocular complication rates were similar in the 2 groups. Systemic complications were higher following treatment at high-risk prethreshold. Infants with high-risk prethreshold ROP who were randomized to early treatment received peripheral retinal ablation at a mean postmenstrual age of 35.2 weeks compared with 37 weeks in conventionally treated infants who underwent peripheral retinal ablation at threshold.

http://www.nei.nih.gov/neitrials/static/study83.asp

Tuesday, August 31, 2010

Georgia: FDA Recalls DePuy Hip Implants

After receiving  complaints  about the product, orthopedic manufacturer DePuy has issued a recall of  its ASR  hip implants.  This hip system has a shockingly high rate of failure, and many of the victims of these failures have had to undergo a second, painful surgery to remove and replace the defective hip.

Due to a fairly high percentage (12-13%) of five year revision or secondary hip surgeries DePuy Orthopaedics, Inc. reported based on this year's data from the National Joint Registry (NJR) of England and Wales, the manufacturer announced this week it is voluntarily pulling the ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System from the marketplace. DePuy has notified the U.S. Food and Drug Administration (FDA) and other regulatory agencies globally of the voluntary recall.

The ASR device is part of a class of large diameter, monoblock hip resurfacing and replacement devices preferred by surgeons for young patients who may benefit from the stability of the device, thus limiting the chance of repeated dislocation. The DePuy ASR™ Hip Resurfacing System was introduced in 2003 and is only approved for use outside the U.S. The ASR™ XL Acetabular System was first launched in 2004 and has been available worldwide.

The risk for revision was highest with women utilizing ASR head sizes below 50 mm in diameter.

As the numbers suggest, most ASR hip replacement surgeries are successful. However, Depuy is strongly suggesting patients utilizing an ASR device immediately see their implant surgeons for a full evaluation of performance.
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Tuesday, August 24, 2010

Savannah - LNG Tankers are a bad idea

Kenworth-LNG truckImage by TruckPR via FlickrRecently a Liquid Natural Gas producer suggested it should be allowed to deliver LNG from Savannah, GA throughout the south, to include Atlanta.

From Savannahnow.com:

A new proposal from the operator of Elba Island, one of the largest importers of liquefied natural gas or LNG in the country, would have some of that natural gas stay in its liquid state and make the journey out of Elba by tanker truck. The proposed route takes 13,000- gallon double-walled tanker trucks south on the Truman Parkway and then across DeRenne Avenue to I-516. Southeast LNG wants to start its trucking operation in late 2012 with 8-10 trucks a day and ramp up to 58 trucks a day over the ensuing decade.

Both the idea of additional traffic and the transport of hazardous material on DeRenne worry some who live along the already beleaguered corridor.


The Danger?

What is the danger? Outside of normal wrecks, tankers are prone to rollovers.

LNG tankers make perfect terrorist bombs. In Savannah these trucks will pass right by Hunter Army Airfield. It is a military airfield and subordinate installation to Fort Stewart.

Hunter features a runway that is 11,375 feet (3,468 m) long and an aircraft parking area that is more than 350 acres (1.4 km²). The runway and apron, combined with the 72,000 sq ft (6,689 m²) Arrival/Departure Airfield Control Group (A/DACG) Facility and nearby railhead, allow the 3rd Infantry Division from nearby Fort Stewart to efficiently deploy soldiers and cargo worldwide. NASA identified Hunter as an alternate landing site for the Space Shuttle orbiters.

In 1944 a LNG explosion leveled one square mile of Cleveland, known as the Cleveland Disaster. The very first commercial LNG facility built in the United States in 1941, caused a major industrial accident known as the "The Cleveland Disaster." According to the U.S. Bureau of Mines report, LNG holding tanks failed and released their contents into the streets and sewers and their vaporous cloud ignited and fire engulfed the nearby residents and commercial establishments.
The Fiery Inferno Devastated One Square Mile Of Cleveland, Ohio. Liquefied Natural Gas Destroyed 79 Homes, 2 Factories, 217 Cars,7 Trailers, Left 680 Homeless,Injured 225 and Killed 131.

In 2004, a blast at Algerian liquefied natural gas plant killed 27 people.

In Savannah, they propose 58 trucks a day passing local retail stores, businesses with thousands of jobs and homes and families.

Each truck tanker will have 13,000 gallons of Liquid Natural Gas which in a wreck, if released, may convert from liquid to vapor and expand to 600 times to about 8 million gallons of gas....

This would will produce about a 5,000 degree fire.

Simply stated, this is a bad idea. Time to kill the proposal now
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Thursday, June 24, 2010

Paxil Claims Settle

GlaxoSmithKline has agreed to settle almost 200 cases in which plaintiffs allege the use of the antidepressant Paxil caused birth defects.There has been just one trial so far. In Philadelphia a a jury awarded $2.5 million.

The jury awarded only compensatory damages and no punitive damages. But GSK then decided to settle Kilker v. SmithKline Beecham Corp. d/b/a GlaxoSmithKline along with another 190 cases, according to an order signed by Philadelphia Common Pleas Judge Sandra Mazer Moss last week.The cases have settled for confidential amounts, according to the lawyer who litigates the cases.


Up to another 100 cases, including cases that have not yet been filed, have settled.

Source

Tuesday, June 22, 2010

Truck Safety Coalition News

Logo of the United States Federal Motor Carrie...Image via Wikipedia
The Truck Safety Coalition (TSC) today announced that that two of its senior officials, John Lannen and Jane Mathis, were recently appointed to the Motor Carrier Safety Advisory Committee (MCSAC) by Anne Ferro, Administrator of the Federal Motor Carrier Safety Administration (FMCSA).

“Making the nation’s highways safer for all drivers by making truck safety a top national priority is what the Truck Safety Coalition is all about,” said John Lannen, TSC Executive Director. “I am pleased that this Committee is now more balanced with representatives from the safety advocacy community, and we look forward to helping to make some real improvements in motor carrier safety policy.”


Established by Congress in 2006, the MCSAC is charged with providing information, advice and recommendations to the FMCSA on motor carrier safety programs and regulations. The eight new MCSAC members will begin their two-year terms on June 8, 2010. For more details on the other members and upcoming MCSAC public meetings, visit http://mcsac.fmcsa.dot.gov.

“From ideas and concepts concerning truck drivers’ hours-of-service to raising the safety bar for new carriers entering the industry, the members of the MCSAC make an invaluable contribution to the safety mission of our agency,” said FMCSA Administrator Anne S. Ferro. “We welcome our new MCSAC members and look forward to working with the committee to explore new ways to strengthen commercial vehicle safety.”

Jane Mathis, Board Member of Parents Against Tired Truckers, from St. Augustine, Florida, whose son and daughter-in-law were killed in a truck crash returning home from their honeymoon in 2004 said, “I know all too well the tragedy that can happen when truck safety is not the main concern on our roads. I look forward to offering the perspective of a mother whose child’s death could have been prevented had stronger regulations and enforcement been in place to this Committee.

It is a testament to the leadership of the U.S. Department of Transportation and FMCSA that a victim/volunteer has a seat at the table with the industry.”

The Truck Safety Coalition is a partnership between Citizens for Reliable and Safe Highways (CRASH) and Parents Against Tired Truckers (P.A.T.T) dedicated to reducing death and injury caused by truck-related crashes, providing compassionate support to truck crash survivors and families of truck crash victims, and educating the public, policy-makers and media about truck safety issues.

http://www.patt.org/images/stories/tsc%20fmcsa%20mcsac%206%202%2010%20release.pdf

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Monday, June 21, 2010

Jones County Truck Wreck

Electricity has been restored to 350 Georgia customers in Jones County after a tractor-trailer carrying frozen chickens bound for Savannah hit a power pole off Gray Highway near Creekside Drive.
The power came back on at about 9:45 a.m., said Georgia Power spokesman Jeff Wilson.

Marco Carswell, the owner of the rig, said driver Brent Gooden was parking on the side of the road when the rig rolled on the muddy shoulder, slid on its side down an embankment, and came to rest on the pole at about 6:15 a.m. about four miles into Jones County.
Gooden was not hurt in the incident but northbound traffic detoured in the southbound lanes on Ga. 11 so crews could lift the rig. The road reopened at about noon.

Trucks and Safety Data

The FMCSA recently stated that only 8,851 trucking companies, out of the 650,000 active trucking companies in the US, have bothered to see the company safety data that is compiled on each company by the FMCSA. These figures were as as of May 21, 2010, according to FMCSA spokesman Duane DeBruyne. This is ironic considering 1 in 5 trucks are unsafe based on Roadcheck percentages and the industry's stated desire to be  "safe."

Safe Boating

Water skiingImage via Wikipedia
Rangers with the Georgia Department of Natural Resources are reminding boaters, fishermen and swimmers to use common sense and follow precautions while enjoying state waters in the summer boating season.

"For many people, the holiday weekend signals the perfect time to be out on the water with family and friends," said Col. Terry West, chief of DNR's Law Enforcement Division. "We want to remind everyone that public waters will be very crowded. ... We encourage boat operators to stay sober and alert and know Georgia's boating laws before heading out on the water."

Last year, 13 people died and 113 were injured statewide in 158 boating accidents. Forty people drowned last year. Alcohol was a contributing factor in 20 cases. Meanwhile, DNR rangers arrested 177 people for boating under the influence of alcohol or drugs last year, according to state records.
DNR recommends people follow these safety rules year-round on Georgia waters:

- Never swim alone.
- Never dive into unknown waters.
- Wear a life jacket while boating, using a personal watercraft or water skiing.
- Don't drink alcohol and swim, operate a boat or personal watercraft.
- Don't swim or operate a boat or personal watercraft while under the influence of drugs.
- Designate a driver for boats or personal watercraft.
- Use navigation lights at night regardless of whether the boat is anchored or moving.
- Know the boating "rules of the road" and boating safety procedures.
- Don't overload the boat with people or equipment.
- Personal watercraft operators should maintain a safe and legal speed. Don't jump wakes.
- Boaters and personal watercraft operators should stay clear of other vessels and watercraft.
- Georgia law requires the reporting of any boating accident resulting in death, serious injury or at least $2,000 in property damage.
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Beware of phony Tamiflu sold online warns FDA

:Original raster version: :Image:Food and Drug...Image via Wikipedia
In an attempt to protect consumers from internet medication fraud, the Food and Drug Administration (FDA) issued a warning on June 17 alerting consumers about fake Tamiflu being sold through illegal internet pharmacies which could prove to be perilous to the health of the user.
According to the health regulators, the fraudulent drug is being sold as “generic” Tamiflu online.

Dr. Margaret Hamburg, the U.S. commissioner of food and drugs, stated, "A rogue internet website marketing drug products may look like a professional and legitimate website but may actually be an illegal operation.
"Medicines purchased from websites operating outside the law put consumers at increased risk due to a higher potential that the products will be counterfeit, impure, contaminated, or have too little or too much of the active ingredient.”

Source.
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Saturday, June 19, 2010

FL Court Ruling: Fisherman can make Pollution claims

A recent Florida Supreme Court decision is especially timely given the man made catastrophe in the Gulf. The Court answered two certified questions:



    DOES FLORIDA RECOGNIZE A COMMON LAW THEORY UNDER WHICH COMMERCIAL FISHERMEN CAN RECOVER FOR ECONOMIC LOSSES PROXIMATELY CAUSED BY THE NEGLIGENT RELEASE OF POLLUTANTS DESPITE THE FACT THAT THE FISHERMEN DO NOT OWN ANY PROPERTY DAMAGED BY THE POLLUTION?

    DOES THE PRIVATE CAUSE OF ACTION RECOGNIZED IN SECTION 376.313, FLORIDA STATUTES (2004), PERMIT COMMERCIAL FISHERMEN TO RECOVER DAMAGES FOR THEIR LOSS OF INCOME DESPITE THE FACT THAT THE FISHERMEN DO NOT OWN ANY PROPERTY DAMAGED BY THE POLLUTION?    

As to the first question, here's what the Court held:

"The Legislature has enacted a far-reaching statutory scheme aimed at remedying, preventing, and removing the discharge of pollutants from Florida‟s waters and lands. To effectuate these purposes, the Legislature has provided for private causes of action to any person who can demonstrate damages as defined under the statute. There is nothing in these statutory provisions that would prevent commercial fishermen from bringing an action pursuant to chapter 376."

The Court wrote as to the second question:

'We have plaintiffs who have brought traditional negligence and strict liability claims against a defendant who has polluted Tampa Bay and allegedly caused them injury. Thus, the economic loss rule does not prevent the plaintiffs from bringing this cause.'

The Court went on:

We conclude, as did many of the courts in the cases discussed above, that the defendant owed a duty of care to the commercial fishermen, and that the commercial fishermen have a cause of action sounding in negligence.

In the present case, the duty owed by Mosaic arose out of the nature of Mosaic‟s business and the special interest of the commercial fisherman in the use of the public waters. First, Mosaic‟s activities created an appreciable zone of risk within which Mosaic was obligated to protect those who were exposed to harm.

Mosaic's business involved the storage of pollutants and hazardous contaminants. It was forseeable that, were these materials released into the public waters, they would cause damage to marine and plant life as well as to human activity.

Here, the discharge of the pollutants constituted a tortious invasion that interfered with the special interest of the commercial fishermen to use those public waters to earn their livelihood. We find this breach of duty has given rise to a cause of action sounding in negligence. We note, however, that in order to be entitled to compensation for any loss of profits, the commercial fishermen must prove all of the elements of their causes of action, including damages.

Find the opinion here. http://www.floridasupremecourt.org/decisions/2010/sc08-1920.pdf 
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Tuesday, April 13, 2010

FL Accident in the News

A multiple-vehicle collision involving a van, pickup truck and car resulted in the tragic death of six family members on Friday, April 2, 2010. The fatal motor vehicle collision (MVC) occurred in Nassau County, according to information provided by News4Jax.com.

Authorities from the Florida Highway Patrol (FHP) reported the family’s van en route from Georgia to Jacksonville, Florida to visit a family member, who was being released from prison, when a car struck it. The impact sent the van careening into the median of the roadway, causing it to become involved in a collision with a pickup truck. The pickup truck had allegedly attempted to “avoid a cloud of dust kicked up by the wreck”, when it violently hit the van. The car involved in the horrifying three-vehicle wreck was reportedly traveling at an excessively high rate of speed when it crashed into the van.

The automobile accident resulted in six fatalities, sadly eliminating members from three different generations within the family. The victims, who were occupants of the van during the accident, were identified as 57-year-old Brenda Mitchell Edwards; her 39-year-old daughter Melissa L. Mitchell; Mitchell’s children, 11-year-old Miya Mitchell, and 4-year-old twins Christian and Keyshawn Perry; as well as Edward’s 16-year-old granddaughter Dhanja Mitchell. It was not stated whether emergency medical services (EMS) personnel responded to the scene to transport any severely injured victims to area hospitals or if they were all pronounced dead at the scene.

A public viewing and funeral is scheduled for 2 p.m. Saturday at Charlton County High School, 500 Indian Trail, in Folkston, Ga.

An account in the Mitchell-Family name has been established to help pay for funeral expenses at VyStar Credit Union. The account’s number is 702814864.

Trucker Honored for saving an Accident Victim

The Truckload Carriers Association has honored Peter Pearce, a truck driver for Flying J, Inc., as a Highway Angel for helping an accident victim get out of her overturned car.

On Feb. 9, 2010, Pearce was heading north on Highway 42 between Debolt and Grand Prairie in Alberta when a pickup truck passed him going close to the speed limit. As the driver switched back into her original lane, the vehicle slipped on a patch of black ice, careened backward into a ditch, flipped over three times, crashed through a fence and landed upside down in a field.

Both Pearce and another motorist stopped to help. While the other driver called emergency personnel, Pearce ran down the embankment and leapt over a crash barrier to reach the pickup. The vehicle's engine was still running, and the rear wheels were turning. The driver was in a state of panic, screaming for help.

Since both doors were too damaged to open, Pearce asked the woman to cover her face while he broke a window. He then reached in, turned off the ignition and extracted the driver. He moved her a few feet away and covered her with a travel blanket that the other motorist provided. The woman had a large gash on the back of her head, so Pearce retrieved a cushion from her car to help absorb the flow of blood. All three waited together for the next 20 minutes until paramedics arrived at the scene.

For his efforts, Pearce will receive a Highway Angel lapel pin, certificate, and patch. Flying J will also receive a certificate acknowledging that one of its drivers is a Highway Angel.

Saturday, March 20, 2010

Zocor News

Based on new data, the FDA warned that higher doses of the cholesterol-lowering drug Zocor, sold generically as simvastatin, carry an increased risk of muscle injury.

The FDA also warns that mixing Zocor with certain other drugs also increases patients' risk of muscle injury, including the rare but serious complication known as rhabdomyolysis. Rhabdomyolysis can sometimes result in fatal kidney damage.

From the FDA site:

Based on review of data from a large clinical trial and data from other sources, the U.S. Food and Drug Administration (FDA) is informing the public about an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, Zocor (simvastatin) 80 mg, compared to patients taking lower doses of simvastatin and possibly other drugs in the "statin" class.

The clinical trial data being reviewed is from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial. The agency is also reviewing data from other clinical trials, observational studies, adverse event reports, and data on prescription use of simvastatin to better understand the relationship between high-dose simvastatin use and muscle injury


Patients should:

* Not stop taking simvastatin unless told to by their healthcare professional.
* Talk to their healthcare professional about any questions they have about the use of simvastatin.
* Call their healthcare professional if they experience any of the following: muscle pain, tenderness or weakness, urine that is dark or red-colored, or unexplained tiredness.



Rhabdomyolysis (often shortened to simply "rhabdo") is the rapid breakdown (lysis) of skeletal muscle (rhabdomyo) due to injury to muscle tissue. The muscle damage may be caused by physical (e.g., crush injury), chemical, or biological factors. The destruction of the muscle leads to the release of the breakdown products of damaged muscle cells into the bloodstream; some of these, such as myoglobin (a protein), are harmful to the kidney and may lead to acute kidney failure.

The damage is more common at the highest approved dose of Zocor, 80 mg. A large clinical trial comparing 6,031 patients taking 80 mg. daily with 6,033 patients taking 20 mg. found 52 cases of myopathy in the 80-mg. group and only one in the 20-mg. group. Eleven patients in the 80-mg. group developed rhabdomyolysis, but none in the low-dose group.

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Monday, March 8, 2010

Betty Nestlehutt Video - Georgia Medical Malpractice Caps are Wrong




This is a video that discussed Atlanta Oculoplastic Surgery v. Nestlehutt, which challenges the provisions of Senate Bill 3, passed in 2005 by the Georgia General Assembly, that caps noneconomic damages that a jury may award to a victim of medical malpractice at $350,000.00.

The case arose from a medical malpractice claim filed by Adam Malone and Frank Ilardi on behalf of their clients Betty Nestlehutt and her husband Bruce Nestlehutt in the Fulton County State Court in October of 2008. Married for over 50 years, the Nestlehutts raised two children and they shared a real estate business. Bruce handled the behind-the-scenes work, and Betty, a people-person by nature, focused on client and public interaction. Competition was tough and as Betty aged she found that more and more clients seemed to prefer younger agents. So, at seventy-one years of age, Betty Nestlehutt, after much thought and consideration, sought consultation with Dr. Harvey P. Cole of Atlanta Oculoplastic Surgery, P.C. concerning bags under her eyes and lines around her mouth. Dr. Cole recommended she undergo several surgical procedures including a simultaneous CO2 laser resurfacing and full facelift.

Having both the CO2 laser resurfacing and full facelift done together is well-known by practicing cosmetic surgeons to be risky, as the chance of damaging the facial blood supply is greatly increased on a patient of Betty’s age and complexion. However, based on her doctor’s recommendation, Betty went through the combination of procedures and the blood supply to her face was, in fact, severely damaged.

After the surgery, the skin on Betty’s face struggled to live without its usual blood supply and after a 3-week period, died completely, leaving the once fair-skinned wife and mother with huge, gaping wounds from her temple to her jaw line, covering both sides of her face and over both of her cheeks to her chin. Betty Nestlehutt’s face, quite literally, fell off.

In the Nestlehutt case, a Fulton County, Georgia jury awarded Mrs. Nestlehutt well over $350,000.00 for permament injuries she received to her body due to medical malpractice by her physicians. After a trial, the Fulton County jury found Mrs. Nestlehutt's case to be meritorious and awarded her substantially more than the $350,000.00 cap. When judgment was about to be entered, however, the Fulton County trial court judge ruled that the cap of $350,000.00 found in SB3 was unconstitutional.

Expect a decision on this case soon.

Friday, March 5, 2010

Insulin Pump Dangers

Insulin Pump Dangers

The U.S. Food & Drug Administration (FDA) is working to reduce risks from dangerous problems that affect what it described as tens of thousands of diabetics. While the has not provided specific insulin pump manufacturers names in its report, there are known insulin pump makers, including Medtronic Inc, Roche Holding AG, and Johnson & Johnson, said Reuters.

Insulin pumps are primarily used by people with Type I diabetes, a condition in which the pancreas produces little or no insulin, a hormone needed to help the body properly use sugars from foods. People with Type 1 diabetes need to administer insulin daily whether through a pump or other methods like shots.

The more common form of diabetes, Type 2, which is often associated with obesity and typically develops later in life, is managed with oral medications designed to help the body properly use insulin, although some cases do require insulin.

The FDA said the number of Type I diabetics using insulin pumps has increased, with about 375,000 U.S. users in 2007, up from about 130,000 in 2002.

Recalls:

MiniMed Insulin Pumps
The thin plastic tubes are used with the MiniMed Paradigm Medtronic insulin pump to deliver insulin to diabetes patients. The infusion set is typically replaced every three days. However, thousands of patients may have been sold infusion sets that may not allow the insulin pump to vent air pressure properly, potentially resulting in the device delivering too much or too little insulin.

Over or under delivery of insulin from an insulin pump could have serious and catastrophic consequences for diabetes patients.

Medtronic announced that approximately 60,000 Quick-set infusion sets used with the Medtronic MiniMed Paradigm insulin pumps could be defective and not work properly. Therefore, they recalled an estimated 3 million of the infusion sets with reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with an “8”.

Accu-Check:

Accu-Check Spirit insulin pumps were previously recalled by Disetronic Medical Systems Inc., a unit of the Roche Group, because of a potential defect in the “up” and/or “down” buttons of some devices. Malfunctioning buttons could prohibit users from changing any programmed setting on the Accu-Check Spirit insulin pumps. Another earlier recall was issued for battery caps included with some varieties of Aimas insulin pumps. According to Animas Corp, the defective battery caps could cause the pumps to stop administering insulin, putting patients at risk of hyperglycemia or hypoglycemia.

Insulin Overdose Symptoms
Diabetes patients who begin to develop any of the following signs or symptoms should seek medical attention immediately as they may be experiencing an insulin overdose:

* Severe headache
* Increased/rapid heartbeat
* Nausea
* Tremors, anxiety
* Uncontrolled sweating
* Hypoglycemia

Hypoglycemia
One of the most dangerous risks associated with insulin overdose is hypoglycemia, a condition in which a person’s blood sugar (glucose) is too low. Symptoms include: cold sweats, confusion, double vision, convulsions, fatigue and general discomfort. Severe hypoglycemia can result in seizures, coma and death.

Call us today if you believe that an improperly functioning insulin pump has harmed you. You may use the Contact Us form, or call Rob Bunch today.

Thursday, March 4, 2010

Florida/Georgia: Denture Adhesives May Cause Zinc Poisoning and Neuropathy

Several Poligrip lawsuits have been prompted by cases of peripheral neuropathy in the United States among users of Poligrip and other denture adhesive creams. A serious neurological condition, peripheral neuropathy is most commonly seen among diabetics, and the Poligrip lawsuits contend that neuropathy is an unwarranted risk of a denture cream use that is not described by GlaxoSmithKline, the pharmaceutical giant that makes Poligrip.



Denture Adhesive Cream and Neuropathy

Millions of people in America have dentures and use Poligrip or another adhesive on a daily basis to keep their dentures in place. A link between neuropathy from denture cream was claimed to be revealed in the Poligrip lawsuits that have arisen in the past years. These lawsuits note the often debilitating symptoms of neuropathy:

* pain and/or tingling in the extremities (i.e., the "peripheral" part of "peripheral neuropathy")
* sensation disorders, such as a sensation of gloves or stockings being worn although the hands or legs are bare
* a loss of balance, difficulty walking
* cognitive decline

In some cases, neuropathy symptoms improve on their own after a period of time. Unfortunately, however, in other cases, treatment programs do not help and the neuropathy never goes away.
Poligrip and Zinc Poisoning

Neuropathy can be caused by:

* an injury
* a metabolic problem
* an infection
* exposure to toxins
* diabetes (about half of all diabetics develop some degree of neuropathy)
* alcoholism (because of poor dietary habits)

However, the link between denture creams such as Poligrip and neuropathy is based on the zinc content of the creams. Zinc — a mineral that is normally vital to one's health — is toxic at high doses. The USDA recommended daily allowance (RDA) for zinc is 15 milligrams of zinc from food and/or supplements every day. On the other hand, too much zinc can be quite harmful to one's health, because a high-enough level of zinc decreases the body's ability to absorb the essential minerals copper and iron.
In Japan on March 4, 2010, the Japanese subsidiary of GlaxoSmithKline (GSK), announced that it would begin a voluntary recall of Poligrip products that contain zinc in that country. The company's decision followed just three reports of adverse health effects in consumers of the product, sold in Japan as Poligrip EX.

Despite hundreds of American consumers reporting similar disabling effects stemming from the company's many zinc-containing products in the U.S., Glaxo's American subsidiary has yet to order a recall here.

In a letter in 2009, the company had “received an increased number of adverse event reports” that together with recent medical literature suggest that there were serious dangers associated with denture adhesives spiked with zinc.

Even as Glaxo warned doctors of the dangers posed by its denture cream, the company continued to blame users of its products, writing, “some patients apply more adhesive than directed and use it more than once per day.”

Talk with Mark Zamora, who may be reached at mark@markzamora.com or call 404-451-7781.

Thursday, February 25, 2010

Georgia Avandia: Heart Attack and Stroke Risks?

AvandiaImage by neofedex via Flickr


Rosiglitazone (AVANDIA). More than 1000 reports of patient deaths were received for
rosiglitazone in the first three quarters of 2009, more than any other drug we monitor. Rosiglitazone is an oral medication for treating Type 2 or adult onset diabetes. Most deaths were attributed to cardiovascular causes, a problem for which the FDA has required warnings. While these cases do not appear to signal previously undetected risks of rosiglitazone, the large number of reports alleging serious and fatal injuries associated with rosiglitazone further reinforces concerns about its cardiovascular safety. The company, GlaxoSmithKline, told us it believed most reports were generated by lawsuits.

In February 2010 the FDA announced it was conducting an overall safety review of
rosiglitazone and would present its findings to a special advisory committee meeting in July.


"Rosiglitazone should be removed from the market," concluded Dr. David Graham and Dr. Kate Gelperin, both epidemiologists with the FDA. Linkavandia


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