Trial Lawyer Resource Center

Georgia High Schools Fail to Protect Players from Oppressive Heat

Mark Zamora — Thu, 04 Aug 2011 17:04:42 -0500

By: Buddy Morrison

Butler, Wooten & Fryhofer, LLP

Columbus, GA

Football is the South's favorite fall tradition. While the games are usually played on cool autumn nights, high schools begin their preparation in August, during the most brutal heat of the year. Unfortunately, practicing this fall sport in the dog days of summer is a dangerous and often deadly mix. Already this year two

Georgia

high school students have died from heat exposure during football practice - two deaths that were entirely avoidable and treatable.

Georgia

high schools were allowed to begin "mandatory" outdoor football practice on Monday, August 1, in the middle of an oppressive heat wave. On Tuesday, two

Georgia

teenagers died after practicing in that heat. On Tuesday morning, Fitzgerald High School defensive lineman DJ Searcy, 16, died after practice with his team's football camp in Lake City, Florida. Later in the evening, Locust Grove High School offensive lineman Forest Jones, 16, died after passing out and spending a week in a coma after a voluntary workout with his team.

These two deaths come on the heels of a report by the CDC that nearly one-fourth of all emergency room visits for heat illness are attributable to football, and that August is the most common month for heat illness to occur. Over the past fifty years, hundreds of football players have died from heat-related illnesses - with most of those deaths coming in the first couple of days of practice.

Unfortunately,

Georgia

schools are not doing nearly enough to protect students. The Georgia High School Association (GHSA) and its member schools have failed to properly regulate practice in the heat in order to prevent the onset of heat-related illness. Even after these two recent deaths,

Georgia

high school coaches are still subjecting children to overexertion in dangerous heat conditions. Even worse, schools are not taking adequate steps to diagnose heat illness. Finally, even when heat illness is diagnosed, schools are not taking simple steps that would make death from heat illness entirely preventable. August football practices at

Georgia

high schools are unreasonably dangerous.

In response to Tuesday's deaths, the GHSA shifted responsibility by noting that it requires individual schools to submit their own written policies for practicing football in the heat. The GHSA has also been conducting a study with Michael Ferrara, Ph.D. at the University of Georgia, to study the relationship between heat levels and heat illness, but that study has not yet been completed. The GHSA stated that it may implement a uniform heat policy in the future.

The GHSA began requiring heat policies from its member schools five years ago, when a RockdaleCounty football player suffered a heat-related death. The policies must specify the time of day practices may be held and the amount of time allotted to rest at various heat/humidity levels, as well as set a maximum heat/humidity level where outdoor practices must be terminated. Essentially, the school must implement a sliding scale related to the heat index - when the heat index is X, practice must start before Y. When the heat index reaches Z, practice must be canceled altogether or moved indoors.

The "sliding scales" drawn up by the individual schools vary widely from district to district. Dr. Frerrara noted that "we have seen some policies that have been conservative while others have allowed practice to continue in extreme conditions." More importantly, the policies do not apply to "voluntary workouts" during the summer - only to "mandatory" workouts. So long as the players are not required to be at the workout, the coach can hold the workout in any manner he chooses regardless of the heat index. According to the GHSA, both of the players who died this week were participating in "voluntary workouts" not subject to the GHSA or school regulations.

Even for the "mandatory" practices, including the critical first week of practice beginning August 1, GSHA schools are not required to submit written guidelines for the total amount of time spent practicing, the type of equipment worn, or procedures for diagnosing and treating heat illness. Instead, the GHSA practice rules simply provide that "mandatory" practice may begin on August 1, and that in the first five days of practice, at least two days must have "players dressed in shorts, helmets, shoulder pads, mouthpieces and shoes only." For the other three days, players may wear full pads. Further, schools can have "voluntary workouts" at any time, where the players may only wear helmets and mouthpieces.

The GHSA and its member schools need not apply such a haphazard set of rules - uniform, comprehensive guidelines for practicing football in the summer are not hard to find. In 2009, the National Athletic Trainers' Association (NATA) issued comprehensive guidelines for beginning football practice that are stricter than even the GHSA practice-time rules. The NATA recommends that the first two days of practice be helmets-only and that the next three days be limited to helmets and shoulder pads. The NATA further recommends that an athletic trainer be present at every practice, only one practice per day during the first five days of practice, a maximum of three hours of practice during the first five days, and no consecutive "two-a-days" (two practices in one day) during the second week of football practice.

It is clear that, even in the wake of these two deaths, some

Georgia

coaches are not taking the risk of heat illness and death seriously. This week, Temple High School and West Hall High Schoolkicked off their football camps with three-a-day workouts, and continued doing so even after Tuesday's tragic news. Schools throughout the state are still conducting two practices a day. Although many schools, including Atlanta public schools, have canceled outdoor afternoon practices during the heat wave, other schools around the state have not altered their practice plans in response to the oppressive heat.

Other coaches mistakenly place the responsibility for proper heat acclimatization on the players themselves. The coach of Mt. Zion High School attributed heat issues to players "laying on their couch all summer." The coach of Carrolton High School suggested that players participating in the "voluntary workouts" handled the heat better than other players. (The NATA guidelines call for proper heat acclimatization for all players - even those who do not participate in the "voluntary workouts" throughout the summer.) Marion County High School actually depended on the voluntary workouts to get players acclimated to the heat. Coach Mike Swaney observed: "If you let the kids stay home in the air conditioning and let them play video games and watch TV -- if they don't do anything all summer -- they will be in a situation where they'd be in a state of shock to come out in this kind of heat."

Not only are

Georgia

high schools failing to take adequate measures to prevent heat illness, they are also failing to adequately diagnose and treat symptoms. Although most coaches now allow players to take a break and rehydrate whenever necessary, "sometimes coaches confuse heat stroke with goofing off, so they push the players harder," said William Roberts, M.D., former president of the American College of Sports Medicine.

The most effective way to determine if a particular athlete is suffering from heat illness is with a rectal thermometer. A body temperature of over 104 degrees Fahrenheit is considered to be heat stroke. High schools are not using the best objective method to diagnose heat stroke. Depending on the athlete to volunteer that he is experiencing symptoms is not enough - first, athletes often fail to report symptoms to exhibit their "toughness," and second, an elevated core temperature decreases the athlete's cognitive ability and judgment.

Even when a player does show symptoms of heat illness, teams often fail to take adequate steps to protect their players from further damage. Water, rest, and shade are not enough. Death from heat stroke is 100% preventable, but it requires immediate and correct medical attention. "You have to diagnose [heat stroke] quickly and treat it quickly or a cascade of bad events starts to happen," Dr. Roberts said. Players who show signs of heat illness should be placed in a tub of ice water, which can reduce body temperature from above 108ºF to below 102ºF in 20 to 40 minutes. Rehydration alone cannot stop heat stroke quickly enough. According to Douglas Casa, Ph.D., director of athletic training education at the University of Connecticut, if teams kept a "kiddie pool" of ice water available at practices, they could prevent heat-related deaths. Even in August's sweltering heat, most football teams fail to take this simple precaution.

While heat illness is more prevalent in high school football than other sports, no student-athlete is immune from its effects. Baseball, soccer, and cheerleading all have their share of heat-related illnesses, as confirmed by the CDC report. Also during this time of year, the marching band practices alongside the football team in the blazing heat. Notably, these sports and activities lack even the superficial safeguards that have been implemented for football.

This week has reminded us that mixing fall football with August heat is a deadly combination. Unfortunately for

Georgia

's student-athletes, schools are making football unreasonably dangerous by requiring too much practice in the heat and failing to properly care for players who suffer from heat illness brought on by that over-exertion. Two sixteen-year-old boys died on Tuesday from a condition that was both 100% avoidable and 100% treatable.

July 28, 2011 Transvaginal Mesh Failure Information

Mark Zamora — Thu, 28 Jul 2011 09:33:46 -0500

Transvaginal Mesh Patch Failure

A July 2011 FDA alert warns of serious complications associated with transvaginal mesh patches when implanted to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI). The FDA has received more than 3,800 reports of adverse effects caused by the surgical mesh or during implantation of the patch.

According to the FDA, significant complications resulting from transvaginal mesh patches are not rare and commonly include serious issues such as:

Erosion of the vaginal tissue
Infection
Bleeding
Pain
Urinary problems such as incontinence
Pain during sexual intercourse (dyspareunia)
Organ perforation (puncturing) from surgical tools during mesh implantation

Less frequent problems included

Return of POP
Neuro-muscular problems
Vaginal scarring/shrinkage
Emotional problems

FDA Alerts and Research Find Transvaginal Patches Unsafe

2011 FDA Alert – Serious and painful complications are associated with the transvaginal placement of surgical mesh, and their occurrence is not rare. FDA also finds the risky surgical mesh treatment of POP to be no more effective than traditional treatment.

2011 Study Published – The New England Journal of Medicine published research showing an increased risk of complications associated with transvaginal mesh implants. Compared to colporrhaphy, a traditional treatment of POP, surgical mesh had a higher risk of defect including:

7 times the risk of bladder perforation
Nearly twice the risk of urinary incontinence (loss of bladder control)
3.2 percent of women required follow-up surgery to correct problems

2008 to 2010 – FDA received 2,874 more reports of adverse complications linked to transvaginal mesh repair of POP and stress urinary incontinence (SUI). This brings the total adverse reports to over 3,800.

2010 Study Published – A study featured in the Obstetrics & Gynecology journal had to be terminated due to the extent of injuries to participants who received the transvaginal mesh patch. Of the women who were treated with the surgical mesh, 15 percent experienced erosions, and other complications included two cystotomies (bladder incision) and one blood transfusion.

2005 to 2008 – FDA received more than 1,000 reports from nine surgical mesh manufacturers about complications related to the device and its treatment of POP and SUI.

Over 200 Lawsuits Filed Already

More than 200 women across the United States have filed lawsuits against three of the makers of transvaginal mesh patches:

C.R. Bard
Johnson & Johnson’s Ethicon
American Medical Systems

Complications have been reported for several other manufacturers of surgical mesh as well including:

Boston Scientific Scimmed
Sofradim
Caldera
Mentor Corporation

Post by Mark Zamora, email mark(at)markzamora.com, 404-451-7781

GA Law: Recent Order Regarding Service of Process

Mark Zamora — Thu, 28 Jul 2011 09:13:42 -0500

Georgia requires service in a short window after a Complaint has been filed. At the link is a recent Order that may help Georgia licensed lawyer:

www.slideshare.net/mzamoralaw/lee-serviceorder

Avastin "Cure for Retinopathy of Prematurity?"

Mark Zamora — Wed, 20 Jul 2011 13:01:52 -0500

This is a guest post from Richard Shapiro:

Bevacizumab, the generic name for the brand drug Avastin, has slowly, over the last few years, gained in popularity as the drug to not simply augment, but completely replace the well-established and conservative treatment of peripheral retinal ablation (laser surgery). Bevacizumab is the brainchild of Genentech/Roche. It was manufactured as a treatment for certain cancers, together with a host of other chemotherapeutic agents.

At first, Avastin was used “off label” together with surgical therapies. Its efficacy became apparent as some ophthalmologists at academic centers throughout the United States recognized the drugs capacity to prevent the neovascularization of new tortuous blood vessels responsible for the proliferation of ROP to the extent of retinal detachment.

In February of 2011, Helen Mintz-Hittner of the University of Texas published an article in the New England Journal of Medicine, singing the praises of Avastin. She and her colleagues penned a new acronym (BEATROP) which followed several long-term well accepted groups whose goal was the elimination of blindness due to ROP such as CRYOROP and ETROP. In essence, she told the medical world through this study that Bevacizumab was the cure for ROP. The destructive, inefficient laser surgery (photocoagulation) and its predecessors (cryotherapy) would no longer be required to salvage vision for premature infants at risk for the disease. Her study utilized only 150 children and failed to consider the long-term effect of Avastin upon the visual systems as other organs.

The concern expressed by experts extensively involved in the treatment and study of ROP over the course of the last three decades was that too many medical practitioners involved in the diagnosis and treatment of ROP would opt for the drug in lieu of the well-established cure rates demonstrated in repeated long-term studies following surgical options where “cure” rates were in the 90+ percentile for good vision following laser in high risk children.

In recent months, several of the nationally accredited clinicians and researchers involved in the ETROP and CRYOROP studies have expressed concern for the Avastin only therapy. Again, no long-term high patient population studies had been published. Experts such as Earl Palmer M.D., at the Casey Eye Institute at the Oregon Health & Science University remain fearful that given the relative cost differential between surgery and Avastin (the drug in much less expensive), the ease of use and relative need for serial screening examination, treaters would indiscriminately choose Bevacizumab. Palmer is authoring with others, an article warning treaters to avoid the leap to Avastin by utilizing existing therapies until the long-term effects of Avastin are studied and understood.

The week after Dr. Helen Mintz-Hittner’s study was published, Michael Shapiro (no relation to this author), at the University of Illinois in Chicago published in Pediatric Retina, “A Discussion about the Practice of Pediatric Retina with Photographs.” In essence, Dr. Shapiro, while congratulating Dr. Mintz-Hittner and her group for their undertaking, expressed concern for “later recurrences (of ROP) that would be missed by examination at 55 weeks post menstrual age.” Dr. Shapiro was fearful that Avastin may indeed “cure” some children with ROP, but may only delay the disease’s progression in other children to a time long after they have been discharged from the hospital and long after repeated serial retinal screening have ceased. It is a known caveat among those who treat the disease, that careful repeated examinations are crucial in discovering the property time window for progression of ROP to an extent where laser intervention would arrest the growth of neovascularization (new vessels). Should a child treated only with Avastin who appeared to respond to the drug be discharged home after care had ceased, progression of the disease could recur many months later. Without continual screening, once ROP recurred, it would progress to Stage 5, or total detachment, where no current therapies have shown meaningful promise for preservation of long-term vision in a large percentage of the ROP population.

Thus, the message is clear that while Avastin holds great promise in the treatment of ROP in the years ahead and now in conjunction with therapies such as photocoagulation and cryotherapy, it should not be the exclusive basis for treatment of the disease.

Sample Motion to Consolidate (GA)

Mark Zamora — Tue, 19 Jul 2011 09:51:55 -0500

MOTION TO CONSOLIDATE ACTIONS

(with incorporated Memorandum of Law)

Plaintiffs, through counsel, file this Motion to Consolidate related matters, for purposes of holding a consolidated hearing on Plaintiff’s Motion for Fees and Expenses from both actions and shows the Court as follows:

I. BRIEF INTRODUCTION

As the Court is aware, Civil Action xxxx was filed on March 5, 2008 seeking injunctive relief to prevent the continuation of construction on the South Peachtree Creek Trail project during the pendency of the appeal to the DeKalb County Zoning Board of Appeals. After the Court granted a TRO and refused to lift the TRO, the County voided the permits to “moot” the first appeal. Plaintiffs sought to supplement the complaint with events which transpired after March 5, 2008 but the County refused to consent to the supplementation and the Court denied a motion related to same. On April 1, 2008, Plaintiffs filed a second complaint, Civil Action No. xxxx wherein the original facts of Three Forks I were restated and the new facts were added. That action resulted in an Order, on August 6, on Plaintiffs’ Mandamus and Declaratory Judgment Claim that effectively resolves the issues raised in Three Forks I as well as those two claims in Three Forks II.

Plaintiffs are concurrently filing their Motion for Fees and Expenses in both actions. The questions of law and facts necessary for the Court to decide Plaintiffs’ Motion for Fees and Expenses will be the same in both actions; therefore, Plaintiffs request the Court consolidate the two actions under xxx and that the Court hold a consolidated hearing on the Motion for Fees and Expenses from both actions.

II. ARGUMENTS AND CITATIONS OF LAW

Georgia Code Section 9-11-42 provides: “When actions involving a common question of law or fact are pending before the court, if the parties consent, the court may . . . order all the actions consolidated.” Here, but for the juxtaposition of different requirements of the Civil Practice Act these actions would have been filed as one suit. The parties are virtually identical; the facts and occurrences about which the actions are concerned are virtually identical. The claims for expenses and fees are virtually identical. No prejudice will accrue to any party and a tremendous waste of judicial resources would occur should the matters be heard separately. It is hoped that counsel for the County will not oppose this motion. The other defendants have never answered either lawsuit and both are in default. For the convenience of the Court, a propose Order has been included with this filing.

Respectfully submitted this _______ day of September, 2008.

OT: OLA Bobcats Sports Website in Atlanta

Mark Zamora — Tue, 19 Jul 2011 09:44:47 -0500

Not law related, just a school that I assist in athletics. We lawyers are human too, you know.

http://www.olabobcats.org/

CSPC issues recall on gel used to light ceramic fire pots (Napa Home & Garden/Bed Bath and Beyond)

Mark Zamora — Thu, 23 Jun 2011 16:48:27 -0500

he CPSC has announced the recall of nearly a half-million bottles and jugs of the gel fuel used in the patio decorations.

"The pourable gel fuel can ignite unexpectedly and splatter onto people and objects nearby when it is poured into a firepot that is still burning," the Consumer Product Safety Commission said.

About 460,000 bottles and jugs of gel fuel are being recalled. They were distributed by Napa Home & Garden of Duluth, Ga., and sold atBed Bath & Beyond, Restoration Hardware, and other home and garden stores between December 2009 and June 2011.

The problem is that consumers apparently cannot always tell whether the flame in the firepots, which can burn blue or clear with little smoke, is completely extinguished. Pouring more gel on a still-burning pot can lead to dangerous flares or burns, the CPSC said.

The commission said Napa is aware of 37 reports of incidents, including 23 burn injuries to consumers.

Napa owner Jerry Cunningham said the company first started selling the product in late 2009, but only recently learned of a rash of incidents that resulted in injury.

"All of the actions, to our knowledge, were where people are refilling the cups" that hold the fuel in the firepots, he said.

While Napa won't be selling the bottles and big jugs of gel fuel anymore, Cunningham said the company is looking at the possibility of selling single-use cans of gel fuel.

Consumers are being asked to stop using the recalled pourable gel fuel immediately and return the bottles or jugs to the retailer where the products were purchased for a full refund.

The agency said a retrofit for the Napa-brand firepots is being evaluated and may be available in the near future.

On June 14, the CPSC issued a warning about firepots following two burn accidents inNew York. Both victims, a teenager and a man in his 20s, suffered serious injuries.

http://www.myfox8.com/news/wghp-story-gel-pot-recall-110622,0,1853391.story

John Stossel: Hypocrisy about Tort Reform

Mark Zamora — Thu, 16 Jun 2011 13:14:32 -0500

I'm a conservative living in the south who happens to represent consumers. I'm probably more conservative than many defense attorneys in other parts of the country. I'm also one of many lawyers who help folks when they are injured. I'm one of many thousands of lawyers who say "no" to a potential client because of many factors - bad law, bad facts, no one at fault for some perceived wrong.

So we now have John Stossel again "reporting" on attorneys and lawsuits.

Many folks have yet to see this video of Stossel and a wrestler:

http://youtu.be/zrX9Ca7LSyQ
The problem is that Stossel but had no problem bringing a lawsuit. He goaded one of the pros into bitch-slapping him (Stossel) during the interview and then sued the wrestler. It settled for a princely sum, according to internet reports.

What is also worthy of note? Accuracy isn’t one of Stossel’s strong suits. He has confirmed that he had made mistakes in his reporting, and he also has been sued in connection with his reporting.

From one website: "In 2000, for example, Stossel declared that organic produce was worse for you than conventional fruits and vegetables; it turned out his report had been based on faulty research and he was forced to issue a public apology. " Link.

Are there too many lawsuits? Absolutely. Stossel does more harm to the justice system however with his clearly biased tone in his reports. Any "news" outlet that gives him a voice is likewise GUILTY.

No to Avastin for Retinopathy Of Prematurity?

Mark Zamora — Fri, 10 Jun 2011 14:23:34 -0500

There is news this week on a recent article titled: On the use of antiangiogenetic medications for retinopathy of prematurity.

From the article:

In contrast to the adult, the third trimester fetus experiences one of the most intense periods of growth and maturation of its lifetime. Early development is characterized by the existence of critical periods when environmental factors effectively produce long lasting changes.

Proliferative Retinopathy of Prematurity (ROP) is a potentially blinding disease characterized by uncontrolled retinal angiogenesis. This pathologic angiogenesis is the target for two new treatment modalities for retinopathy of prematurity (ROP) i.e. intravitreal anti VEGF (bevacizumab) and systemic propranolol, which are being evaluated in ongoing or planned studies. VEGF is essential for normal angiogenesis in a growing infant and the adrenergic system is important for many organ systems and, in addition, for plasticity of the visual and olfactory systems.

Conclusion: This viewpoint raises concerns regarding the currently studied antiangiogenetic treatments for ROP and their possible general effects on the developing preterm infant.

There may be some question that Avastin is a source of treatment instead of laser therapy to cure retinopathy of prematurity. It's important to discuss this medication to treat r.o.p.

This article was written by Pennsylvania and Florida licensed attorney Richard Shapiro, 800-258-HELP.

www.babyblindness.com

Florida: Zoloft

Mark Zamora — Tue, 07 Jun 2011 15:34:57 -0500

Several studies from 2005 onward suggest that antidepressant drugs like Zoloft, Paxil, Celexa, Effexor, Lexapro, Pristiq and Prozac may increase the risk of cardiac birth defects. Mothers who have taken antidepressant drugs during pregnancy have reported these devastating medical problems:

Cardiac (heart) defects
PPHN (Persistent Pulmonary Hypertension of the Newborn)
Neural tube defects (brain and spinal cord)
Craniosynostosis (skull defect)
Infant omphalocele (abdominal wall defects)
Clubfoot (one or both feet turn downward and inward)
Anal atresia
Cleft lip and cleft palate
Limb Defects

Taking antidepressants such as Zoloft, in the early stages of pregnancy may alter development of the fetus, a new study indicates.

Many woman take antidepressants during pregnancy with no effect, but Zoloft, among others, may double the risk of a heart defect if taken early in the pregnancy, finds this study out of Aarhus University, Denmark, which looked at nearly half a million children born there between 1996 and 2003.

For the purposes of this study, early pregnancy was defined as 28 days before conception to 112 days after conception. The heart defect was very specific. It is in a piece of tissue that separates areas of the heart.

Zoloft increased the risk, as did Prozac and Celexa. So did using more than one antidepressant at a time reports Reuters. Zoloft more than tripled the risk, while Celexa more than doubled the risk.

Translating that into births – for every 250 women who do not take antidepressants during pregnancy, expect one infant to be born with the defect. That number increases to two infants for every SSRI taken, and four infants for mothers taking more than one.

SSRIs or selective serotonin reuptake inhibitors taken during pregnancy have also been connected with birth defects and heart defects in other studies.

From the FDA site in 2006:

FDA ALERT [7/2006]: Increased Risk of Neonatal Persistent Pulmonary Hypertension

A recently published case-control study has shown that infants born to mothers who took selective serotonin reuptake inhibitors (SSRIs) after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy (see SSRI drug names at the bottom of this sheet). The background risk of a woman giving birth to an infant affected by PPHN in the general population is estimated to be about 1 to 2 infants per 1000 live births. Neonatal PPHN is associated with significant morbidity and mortality. The FDA is updating the prescribing information for all SSRIs with this new information. The FDA is also accruing data from additional sources pertaining to the potential association between SSRIs and neonatal PPHN. The FDA will provide additional information when it becomes available. In the interim, the FDA recommends that physicians carefully consider and discuss with patients the potential risks and benefits of SSRI treatment throughout pregnancy, including late pregnancy

From a 2007 study:

One study of nearly 10,000 infants born with birth defects and nearly 6,000 healthy infants found that women who took sertraline (Zoloft) in the first few months of pregnancy had twice the risk of having a baby born with a heart defect, while those on paroxetine (Paxil) had more than three times the risk. Paxil also increased the risk of a rare hernia called an omphalocele. But this doesn’t mean antidepressants are unsafe: The heart defects seen in the study normally occur in 5 out of 10,000 babies, so a doubling of the risk means they occur in 10 in 10,000 and a tripling in 15 in 10,000—thus, a baby’s risk is still far less than 1 percent.

Source.

Mark Zamora 404-451-7781

More signs that a diabetes drug is linked to bladder cancer?

Mark Zamora — Wed, 18 May 2011 13:27:14 -0500

Between 2004 and 2009, more than half a million adverse reactions among people taking anti-diabetic drugs were added to an official U.S. Food and Drug Administration database. Among those reports were 138 instances of bladder cancer in patients taking at least one of more than 15 different anti-diabetic drugs.
However, more than a fifth of those bladder cancers were in patients taking Actos (pioglitazone), suggesting a "disproportionate risk" in comparison with other anti-diabetics, said study author Dr. Elisabetta Poluzzi of the University of Bologna in Italy.

The article is: "Assessing the Association of Pioglitazone Use and Bladder Cancer Through Drug Adverse Event Reporting" and may be found here.

Here is the abstract:

OBJECTIVE To analyze the association between pioglitazone use and bladder cancer through a spontaneous adverse event reporting system for medications.

RESEARCH DESIGN AND METHODS Case/noncase bladder cancer reports associated with antidiabetic drug use were retrieved from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) between 2004 and 2009 and analyzed by the reporting odds ratio (ROR).

RESULTS Ninety-three reports of bladder cancer were retrieved, corresponding to 138 drug-reaction pairs (pioglitazone, 31; insulin, 29; metformin, 25; glimepiride, 13; exenatide, 8; others, 22). ROR was indicative of a definite risk for pioglitazone (4.30 [95% CI 2.82–6.52]), and a much weaker risk for gliclazide and acarbose, with very few cases being treated with these two drugs (6 and 4, respectively).

CONCLUSIONS In agreement with preclinical and clinical studies, AERS analysis is consistent with an association between pioglitazone and bladder cancer. This issue needs constant epidemiologic surveillance and urgent definition by more specific studies.

http://care.diabetesjournals.org/content/early/2011/04/20/dc10-2412.abstract

mark@markzamora.com

Multi Mex Recall of Amoxilina for May, 2011

Mark Zamora — Tue, 17 May 2011 15:17:21 -0500

Multi-Mex Distributor Inc., of Tucker, Ga., is recalling dietary supplements whose packaging appears to be an intentional marketing ploy to mimic antibiotics and may be directed at Hispanic buyers, according to the Food and Drug Administration.

The products were distributed to retail stores and distributors in Texas, Georgia, Tennessee, California, Illinois, North Carolina, South Carolina, Colorado and Indiana.

The FDA inspected the full range of products from Multi-Mex and recalled all of them, including Amoxilina.

Multi-Mex products are in U.S. stores with names that sounded very similar to names in México, including Bisolbom (Bosilvon), Vermex (Vermox), Neolubrina (Neomelubrina), Pentreximil (Pentrexil), Sinalar (Synalar), Terramocina (Terramicina) and Vitaderogil (Aderogil15).

http://www.brownsvilleherald.com/news/dietary-126527-supplements-company.html

Mark(at)markzamora.com 404 451 7781

Soladek Vitamin Solution Recall News

Mark Zamora — Mon, 04 Apr 2011 15:55:30 -0500

The U.S. Food and Drug Administration is warning consumers to stop using Soladek, a vitamin-solution product marketed by Indo Pharma, S.A., of the Dominican Republic, because the product may contain dangerously high levels of vitamins A and D.

Soladek is marketed with claims that the product treats “hypo and avitaminosis, rickets, growth, dentition, lactation, fractures, infection, convalescence, protection and regeneration of certain epithelium (bronchial, glandular, ocular, cutaneous), corticotherapy, aging and pregnancy.” The product is sold in a box labeled in Spanish and containing a vial of the solution.

FDA recently received information that tested samples of Soladek contained levels of vitamin A and vitamin D that were many times the recommended daily allowances for these vitamins. Intake of excessively high levels of these vitamins poses a risk to human health.

The FDA also received seven reports of serious health problems occurring in consumers using the product. The problems include decreased renal function, elevated levels of calcium in the blood, fatigue, heart arrhythmia, vomiting, and diarrhea. Symptoms of vitamin D toxicity include weakness, fatigue, headache, nausea, vomiting, diarrhea, changes in mental status, increased blood pressure, abnormal heart rate or rhythm, kidney damage, and coma.

Symptoms of vitamin A toxicity include anemia, anorexia, alopecia, joint pain, bone weakness, bulging eyes, liver abnormalities, and birth defects.

Consumers who are in possession of Soladek should stop using the product immediately. Any consumers who have been using Soladek and are experiencing any of the above symptoms should see a doctor immediately.

Soladek cannot currently be marketed legally in the United States because U.S. law prohibits the sale of products claiming to treat disease conditions without review and approval by the FDA. However, the reports of adverse events and other information leads the FDA to conclude that Soladek may be available illegally in the country; therefore, the agency is issuing this warning.

Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm248588.htm

Multaq and Liver Damage? Update for April 2011

Mark Zamora — Wed, 30 Mar 2011 16:27:57 -0500

The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with the heart medication dronedarone (Multaq).

Dronedarone is a drug used to treat abnormal heart rhythm in patients who have had an abnormal heart rhythm (atrial fibrillation or atrial flutter) during the past 6 months. Dronedarone can reduce the risk of being hospitalized for these heart problems. Since dronedarone's approval in July 2009 through October 2010, around 492,000 dronedarone prescriptions were dispensed and around 147,000 patients filled dronedarone prescriptions at outpatient retail pharmacies in the United States.¹ Additional usage can occur in the hospital setting.

Dronedarone was approved with a Risk Evaluation and Mitigation Strategy (REMS) with a goal of preventing its use in patients with severe heart failure or who have recently been in the hospital for heart failure. In a study of patients with these conditions, patients given dronedarone had a greater than two-fold increase in risk of death.

Information about the potential risk of liver injury from dronedarone is being added to the WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections of the dronedarone labels.

Today's communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs. FDA is continuing to review reports of possible adverse events and drug interactions with dronaderone submitted to our Adverse Event Reporting System.

Additional Information for Patients

Contact your healthcare professional if you develop itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools. These may be signs of liver injury.
Talk to your healthcare professional about any concerns you have with this medication.
Do not stop taking dronedarone unless told to do so by your healthcare professional.
Report any side effects you experience to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of the page.
Read the Medication Guide when picking up a prescription for dronedarone. It will help you understand the potential risks and benefits of this medication.

Additional Information for HCPs

Advise patients to contact a healthcare professional immediately if they experience signs and symptoms of hepatic injury or toxicity (anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching) while taking dronedarone.
Consider obtaining periodic hepatic serum enzymes, especially during the first 6 months of treatment. However, it is not known whether routine periodic monitoring of serum liver enzymes (ALT, AST, and alkaline phosphatase) and bilirubin in patients taking dronedarone will prevent the development of severe liver injury.
If hepatic injury is suspected, dronedarone should be promptly discontinued and testing of serum liver enzymes and bilirubin should be performed. If hepatic injury is found, appropriate treatment should be initiated.
Dronedarone should not be restarted in patients who experience hepatic injury without another explanation for the observed liver injury.
Report adverse events involving dronedarone to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.

Data Summary

FDA has received several case reports of hepatocellular liver injury and hepatic failure in patients treated with dronedarone, including two post-marketing reports of acute hepatic failure requiring transplantation. Because these reactions are reported voluntarily from a treatment population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The two cases of acute hepatic failure requiring transplantation occurred at 4.5 and 6 months after initiation of dronedarone in patients with previously normal hepatic serum enzymes. Both patients were female and approximately 70 years of age. In the first case, the patient had underlying intermittent atrial fibrillation, arterial hypertension and stable coronary artery disease. She was treated with dronedarone for 4.5 months. Two weeks prior to hospitalization she reported increased exhaustion and tiredness. One week prior to admission she discontinued dronedarone, and at the time of admission she was noted to have jaundice, coagulopathy, transaminitis and hyperbilirubinemia, which progressed to hepatic encephalopathy over the next nine days. A pre-transplant workup did not reveal another etiology of liver failure. In the second case, the patient had a medical history of paroxysmal atrial fibrillation and Sjogren's syndrome. Following 6 months of treatment with dronedarone she developed weakness, abdominal pain, coagulopathy, transaminitis and hyperbilirubinemia. She was transplanted 1 month later; no alternative etiology for liver failure was identified in the transplant work-up. In both cases, the explanted liver showed evidence of extensive hepatocellular necrosis.

Multaq (dronedarone) is approved to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent history of AF/AFL and associated cardiovascular risk factors (age >70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter ≥ 50 mm or left ventricular ejection fraction <40%) who are in sinus rhythm or who will be cardioverted.

Dronedarone is contraindicated in patients with NYHA Class IV heart failure or NYHA Class II - III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic. In a placebo-controlled study in patients with severe heart failure requiring recent hospitalization or referral to a specialized heart failure clinic for worsening symptoms (the ANDROMEDA Study), patients given dronedarone had a greater than two-fold increase in mortality. Such patients should not be given dronedarone.

Mark Zamora, 4 0 4-451-7781 mark (at) markzamora.com

Retinopathy of Prematurity: Is Treatment with Avastin an Option?

Mark Zamora — Thu, 17 Feb 2011 10:10:26 -0500

Image via WikipediaAn interesting read from the web this morning from the NEJM.

Premature, low birth weight babies face a minefield of issues when brought into the world. One of most serious issues is the propensity for retinal blood vessels to grow amuck in response to erratic biochemical signals; these vessels can bleed and scar, leading to retinopathy of prematurity (ROP) — a major cause of childhood blindness in the developed and developing worlds.

The NEJM asks this question, and answers it in part:

So why not directly inhibit VEGF? Bevacizumab is a humanized monoclonal antibody that does just that. Soon after it was approved to arrest new blood supplies to colon cancer metastases in 2004, doctors began using the inexpensive, easily administered drug off-label to treat a neovascular condition similar to ROP: age-related macular degeneration. Case series have suggested that it works for ROP, but now we have more definitive proof.

In a prospective multi-center trial reported in NEJM this week, researchers from the University of Texas Health Science Center at Houston randomized 150 infants with posterior, stage 3+ ROP in zones 1 and 2 to receive either the standard confluent laser therapy (CLT) or an intravitreal injection of bevacizumab (IVB) in each eye. Stage 3+, defined by prominent new blood vessels growing between the vascular and avascular regions of the eye (the + indicates the vessels are twisted), may be the optimal time for treatment—after VEGF has promoted normal vascularization and before the vessels have formed fibrous bands that would permanently disrupt the retina. The zone refers to the concentric region of retina affected (zone 1 disease includes the optic nerve and is the hardest to treat). The researchers’ primary goal in this federally sponsored study was to prevent recurrence of ROP in one or both eyes before 54 weeks postmenstrual age.

It's a compelling read for those parents, family members, and folks touched by a child with ROP.

Here is the NEJM article: http://blogs.nejm.org/now/index.php/a-cheap-targeted-treatment-for-retinopathy-of-prematurity/2011/02/16/

GA Bar Pres. - Slow Justice Takes an Economic Toll on GA Businesses

Mark Zamora — Tue, 15 Feb 2011 11:24:00 -0500

Court slowdowns cost Georgians jobs. That fact is part of a compelling read from current Georgia Bar President Lester Tate. He wrote to the Atlanta Journal Constitution the letter below. He confirms with real facts that cutting funding to the justice system, while flooding the courts in some states with foreclosure actions and collection lawsuits grinds the system to a halt.

His letter:

What do “jobs” and “justice” have in common? According to an economic study released last week by the State Bar of Georgia, a lot. Increased caseloads in recent years, combined with reduced budgets for the court system, have cost Georgians thousands of jobs and our economy hundreds of millions of dollars.

As a trial lawyer who has spent 23 years of my life trying all types of cases in courtrooms across this state, I know the importance of “justice.”

But to folks like my father, who lost his job while I was in college when the mill where he worked shut down and who had never set foot in a courtroom except as a juror, “justice” probably seemed pretty far removed from daily economic life.

The state bar’s study, however, found the judicial system to be one of the state’s leading economic development foundations. Specifically, the study found that the efficient handling of “cases impacts both the business and social climate of Georgia.”

This is particularly true in the past decade, when a massive increase in the number of cases filed in our state’s courts was accompanied by an 8 percent overall decline in judicial funding.

When courts become less efficient because of more cases and fewer dollars, Georgia businesses and individuals bear the cost of delays. The slowdowns lead to higher costs, more business uncertainty and reduced productivity. Time and money that should be put to use making goods, providing services and creating jobs instead get spent waiting for justice.

Using a widely accepted statistical methodology, the Washington Economics Group estimated court slowdowns cost Georgia between 3,457 and 7,098 jobs throughout the state. That’s between $176 million and $375 million in annual wages for white-collar and blue-collar workers alike. Considering all factors, the total negative impact is between $337 million and $802 million on Georgia’s economy each year.

Such an economic loss has a profound effect on the lives of all citizens, from the single mother needing to collect child support to the corporate board of directors trying to decide whether Georgia or some other state is the best place to do business.

Business, community and political leaders cannot afford to ignore the courts as an important component of our economic recovery.

Certainly, elected officials at the state and local levels have struggled recently in trying to balance their budgets, particularly after three years of plummeting revenues.

But judicial budget cuts have in fact unwittingly contributed to the economic decline responsible for these budget deficits. Between 2008 and 2009 revenue from fines and fees in Georgia courts declined by $52 million because of slower courts, and the new study estimates annual lost income tax revenue caused by court delays at between $51 million and $115 million annually.

In other words, the cuts cost as much or more money than they saved, and that’s only the direct result.

The state bar’s study shows that there are even deeper, more far-ranging consequences. Somewhere a corporation is contemplating locating to Georgia, but it may not want to do business in a state where it can’t get a speedy resolution to disputes. Somewhere in Georgia a small-business owner may want to hire a new employee, but he can’t afford to until a court rules that the money he’s owed has to be paid.

This means that judicial funding and the speedy, efficient operation of the courts is no longer a cause for just lawyers and judges.It’s also the cause of folks like my father, who started working in the mill at age 15 and lost his job at that same mill at age 54. A functional court system is a rising tide that lifts all boats.

Source: http://www.ajc.com/opinion/the-economic-toll-of-835807.html

First Darvocet Case Filed in Georgia State Court 1/7/11

Mark Zamora — Fri, 07 Jan 2011 17:43:53 -0500

Today attorneys Joe Fried and Mark Zamora filed a Darvocet personal injury case in State Court in Georgia. It alleges a heart injury, among other things.

The allegations include negligence, strict liability, and breach of warranties, among others. In the negligence action, among several claims, Plaintiff alleges:

Each Defendant was also Negligent per se in that they violated the following federal safety regulations and laws, each of which was intended for the benefit of individual consumers such as the Plaintiff:

Federal Food, Drug and Cosmetic Act, 21 U.S.C. §301, et seq.

21 U.S.C. § 351

21 U.S.C. §352

21 CFR §201.5

21 CFR §201.56

21 CFR §201.57

21 CFR §210.1

21 CFR §210.122

21 CFR §211.165

21 CFR §211.198

21 CFR §310.303

21 CFR §§310.305 and 314.80

21 CFR §312.32

For more information, mark@markzamora.com

Lupron Legal

Mark Zamora — Sat, 04 Dec 2010 19:56:48 -0500

Lupron As Hormone Therapy

Abbott Labs is the marker of Lupron, more commonly referred to as leuprolide. Lupron is supposed to help both men and women's sexual health, ailing in the treatment of prostate cancer for men and helping to combat endometriosis in women. The medication may also be used for early puberty.

There are five types of Lupron that can be injected under a patients skin to help with his or her hormone therapy. The kinds of Lupron are:

Lupron Depot 30
Lupron Depot 22.5
Lupron Depot 7.5
Lupron Depot 11.25
Lupron Depot 3.75

There are side effects of this drug, including:

There is a long list of potential side effects linked to Lupron. Some apply only to men and others affect just women, but others, such as chronic muscle pain, have been reported in both sexes.
Lupron side effects that have been documented are:

Chronic muscle pain and weakness
Back pain
Joint pain
Limb pain
Urine with blood in it
Diarrhea
Severe headaches
Vomiting
Muscle atrophy
Depression
Decreasing of hemoglobin
Decreasing of hematocrit
Bone density changes
Loss of the sense of smell
Loss of the sense of taste
Enlargement and sensitivity to breasts (women)
Decrease in size of testicles (men)
Erectile dysfunction (men)
Decreased sexual desire (both men and women)
Thyroid problems

In October, the FDA issued an update about Lupron:

The U.S. Food and Drug Administration (FDA) has notified the manufacturers of the Gonadotropin-Releasing Hormone (GnRH) agonists of the need to add new safety information to the Warnings and Precautions section of the drug labels. This new information warns about increased risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke) in men receiving these medications for the treatment of prostate cancer. FDA’s notification to manufacturers of GnRH agonists to add this safety information is based on the Agency’s review of several published studies^1-7, described in the Agency’s Ongoing Safety Review of GnRH Agonists and possible increased risk of diabetes and certain cardiovascular diseases, issued in May 2010.
GnRH agonists are approved to treat the symptoms (palliative treatment) of advanced prostate cancer. The benefits of GnRH agonist use for earlier stages of prostate cancer that have not spread (non-metastatic prostate cancer) have not been established.
Although the risk for diabetes and cardiovascular diseases appears to be low in men receiving GnRH agonists for prostate cancer, it is important for healthcare professionals to evaluate patients for risk factors for these diseases. Healthcare professionals should always carefully weigh the benefits and risks of using GnRH agonists before determining appropriate treatment for prostate cancer.
Patients who are receiving treatment with GnRH agonists should undergo periodic monitoring of blood glucose and/or glycosylated hemoglobin (HbA1c). Increased blood glucose levels may represent development of diabetes or worsening of blood glucose control in patients with diabetes. Healthcare professionals should also monitor patients for signs and symptoms suggestive of development of cardiovascular disease and manage according to current clinical practice.
Additional Information for Patients

GnRH agonists are sold as the brand names – Lupron, Zoladex, Trelstar, Viadur, and Eligard.
Before receiving GnRH agonists, tell your healthcare professional if you have diabetes, heart disease, a previous heart attack or stroke, or any cardiovascular risk factors like high blood pressure, high cholesterol, or cigarette smoking.
If you have any concerns about receiving these medicines, talk to your healthcare professional.
Report any side effects from the use of GnRH agonists to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.

Source:http://www.fda.gov/Drugs/DrugSafety/ucm229986.htm

http://www.markzamora.com/lupron/index.html,

Advanced Bionics Announces Voluntary Recall of the HiRes 90K Cochlear Implant

Mark Zamora — Sat, 27 Nov 2010 08:28:50 -0500

Advanced Bionics has 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.

A cochlear implant (CI) is a surgically implanted electronic device that provides a sense of sound to a person who is profoundly hard of hearing.

As of April 2009, approximately 188,000 people worldwide had received cochlear implants; in the United States, about 30,000 adults and over 30,000 children are recipients. The vast majority are in developed countries due to the high cost of the device, surgery and post-implantation therapy. (Source is Wiki)

Well written Remand Order (USDCT)

Mark Zamora — Sat, 20 Nov 2010 21:14:27 -0500

Find it here:

http://www.slideshare.net/mzamoralaw/steele-remand-order-11th-circuit

From the Order:

The question is whether a specific settlement demand, given all the evidence presented, established by a preponderance of that evidence that the amount in controversy exceeds $75,000. At bottom, the defendants insist that the plaintiffs’ demand of $155,000 must meet this standard simply because the demand was made. The proper assessment of settlement offers is not so facile. “While [a] settlement offer, by itself, may not be determinative, it counts for something.” Burns v. Windsor Insurance Co., 31 F.3d 1092, 1097 (11th Cir. 1994). What it counts for, however, depends on the circumstances. Settlement offers commonly reflect