Mark Zamora
Mark Zamora is an attorney in Atlanta, Georgia. He is licensed in Florida and Georgia. A graduate of Cumberland School of Law in Birmingham, Alabama and the University of Florida, he served as a judicial law clerk to the late Edwin L. Nelson, United State District Magistrate/Judge in Birmingham, Alabama in the Northern District of Alabama. Mark is hispanic; he was a founding member of and served on the the Board of Directors of The Southwest Florida Hispanic Chamber of Commerce as well as the Hispanic American Business Association. He is past president of the EZH Alumni Association in Gainesville, Florida. He is a board member of the Southern Trial Lawyers Association.Mark's business emphasis is personal injury litigation and litigation involving unsafe drugs. His practice is nationwide in scope.
Articles By This Author
Alabama/Georgia/Florida: Insulin Pump Recall-Insulin Pump Dangers?
From Rob Bunch, 256.764.0095
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 FDA 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.
According to the FDA panel papers, here are"Device Problems:"
The most frequently reported device problem in MDR’s related to insulin infusion pumps was ‘unknown,’ and the top five reporters identified “unknown” in 5421 of 16640 reports (19.7% of reports). The second most frequent device problem reported was “replace,” which accounted for 2385 entries (9% of reports).
Patient Problems included:
Patient ProblemsThe most frequently reported patient problems were 1) hospitalization, and 2) blood glucose high. Of the 16640 MDRs from the top five manufacturers, hospitalization was identified in 7967 reports (21% of reports) while blood glucose was identified in 6236 reports (16.6% of reports). The other most frequently reported patient problems reported were:
Diabetic Ketoacidosis (8% of reports)
Hyperglycemia (8% of reports)
Treatment with medication (6% of reports)
Blood glucose low (4.7% of reports)
Therapy/non‐surgical treatment (4% of reports)
<Source here>
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. 256-764-0095
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.
Continue Reading...GA, FL, AL: Dilantin and SJS and Purple Glove Syndrome
According to a quarterly report issued in late 2008, the FDA investigated occurrences where Dilantin (phenytoin) injections led to a disorder known Purple Glove Syndrome. This condition -named after the discoloration that often accompanies it, can lead to the need for emergency surgery, and even limb amputation, if it becomes serious.
Phenytoin is an antiepileptic drug. Aside from seizures, it is an option in the treatment of trigeminal neuralgia as well as certain cardiac arrhythmias. In the US, phenytoin is marketed as Phenytek and Dilantin (including Dilantin Kapseals, Dilantin-125 and Dilantin Infatabs).
Phenytoin has been administered intravenously since 1956. But occasionally, this treatment can lead to a complication called Purple Glove Syndrome. Purple Glove Syndrome starts as a pale blue or dark purple discoloration which appears around the intravenous insertion site 2 to 12 hours after the administration of the drug. Progression occurs during the next 12 to 16 hours as developing edema and continued discoloration spread around all sides of the affected limb.
If a patient is fortunate, the discoloration and edema will gradually fade, and the affected limb will heal within 2 to 4 weeks. However, Purple Glove Syndrome can sometimes turn quite serious, resulting in the death of affected tissue. When such necrosis occurs, a patient may require surgery to restore blood flow to the affected tissue. The most severe cases of Purple Glove Syndrome can lead to amputation of the injured limb.
In its report, the FDA did not say how many cases of phenytoin-related Purple Glove Syndrome it was investigating. But a 1998 study conducted by researchers at the Mayo Clinic found that of 152 patients receiving intravenous Dilantin (phenytoin), 9 (about 5.9%) developed Purple Glove Syndrome. The study also found that the disorder was more likely to affect the elderly, and people who received more than one dose of phenytoin.
No one yet understands why intravenous Dilantin can cause Purple Glove Syndrome. The disorder does occur when Dilantin - which has highly alkaline PH - leaks into the interstitial tissue. But Purple Glove Syndrome is also seen in patients were such phenytoin leakage has not occurred. Some health practitioners believe this could have something to do with the exact formulation of the phenytoin injection.
Continue Reading...
Georgia, Florida and USA: Dilantin and Stevens Johnson Syndrome
Dilantin (generic name: phenytoin) is a widely-prescribed antiepileptic drug issued for treatment of partial and generalized tonic clonic seizures associated with epilepsy. The drug, developed in 1938 and currently marketed by Pfizer, has been linked to Stevens Johnson Syndrome (SJS).
Stevens Johnson Syndrome is a severe, life-threatening condition which affects the skin and the mucous membranes. SJS typically begins with a flu-like period of fever, sore throat and headache. Victims then develop circular lesions that cover a majority of the skin. The lesions can develop into blisters and occasionally complete skin detachment.
Many experts agree that a reaction to Dilantin can cause the onset of this horrible disease. While Dilantin has been recalled numerous times since its introduction, it is still prescribed today.
Most common side-effects:
• Nausea, vomiting, constipation, or diarrhea
• Mild dizziness or drowsiness
• Tender or swollen glands
• Swollen or painful gums
• Headache
• Muscle twitches
• Increased facial hair
• Swelling of breasts
• Insomnia
More severe side-effects are:
• An allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives)
• Hallucinations
• Slurred speech or staggering walk
• A rash
• Changes in vision
• Agitation
• Low blood pressure
• Slow or irregular heartbeats
• Abdominal pain, dark urine, light colored stools, or jaundice (yellow skin or eyes)
• Easy bruising or bleeding
• Swollen or tender gums
If you believe your Dilantin use has put you or a loved one in danger call or email us right away
Mark Zamora, 404-451-7781, or mark@mzlawyer.com
Avandia Dangers: Florida, Georgia, North Carolina
One of the most common medical problems that exists in the United States today is diabetes. Given the market’s needs, billions of dollars have been spent on research in an attempt to prevent, cure or otherwise control this condition. One medication to hit the market in recent years was Avandia, which has been offered by GlaxoSmithKline.
Avandia patients who develop one (or more) of the these conditions wmay have the right to make a claim, depending on a number of factors:
- congestive heart failure
- heart attack
- liver toxicity
- severe allergic reaction
- stroke
Even given the early promise that Avandia showed, recent events have brought to light the potential for serious health problems occurring as a result of using Avandia, some claim.
A report released in February by the Senate Finance Committee said Glaxo knew of an increased risk of heart attack linked to Avandia for several years, but played down potential problems to the public and the FDA. The committee was critical of the FDA’s support of Avandia, and the report included studies by two FDA doctors who said in 2008 the drug should be removed from the market.Lawyers Mark Zamora and Joey James are investigating this medication. Email joey@bunchandjames.com, or call 256.764.0095.
Hydroxycut and Georgia Lawyers:Hydroxycut linked to other cases of liver damage
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In a new study, reported in the American Journal of Gastroenterology, researchers analyzed 17 cases of liver damage among Hydroxycut users that had not yet appeared in the medical literature. Nine of the cases had been reported to the FDA, while eight were seen by the authors of the study.
Looking at factors like patients' risk factors for liver disease and the timing of their Hydroxycut use, the researchers found that for eight of the liver-damage cases, there was a greater than 95 percent likelihood that the weight-loss aid was to blame.
In five cases, the researchers concluded that Hydroxycut was "highly likely" the cause (a 75 to 95 percent chance), while it was probably to blame in two cases (a 50 to 74 percent chance). The last two cases were considered to be possibly linked to Hydroxycut use.
From Reuters.com, and the article is from nature. com:Hydroxycut has been clearly implicated as a cause for severe liver injury that may lead to acute liver failure and death. Weight-loss supplements represent a class of dietary supplements that should be regarded as capable of causing severe hepatic toxicity when the usual causes of identified liver injury cannot be otherwise elucidated.
Source here: http://www.nature.com/ajg/journal/vaop/ncurrent/full/ajg20105a.html
Lawyer Mark Zamora is investigating links to claims of liver injuries and this product, mark@mzlawyer.com
Will Georgia Victims of Medical Wrongdoing Have to Jump Through More Hoops?
Yaz and Gallbladder Problems? (Georgia, Florida)
In order to understand the connection with Yaz gall bladder problems and gallstones, it is important to review why stones form in the first place.
Your gallbladder is a small, pear-shaped organ on the right side of your abdomen, just beneath your liver. The gallbladder holds a digestive fluid called bile that's released into your small intestine.
Gallstones (choleliths) are bodies formed within the body, by accretion or concretion.Gallstones can occur anywhere within what is known as the biliary tree, and the gallbladder as well as the the bile duct. Source.
If there are gallstones in the bile duct, the condition is known as Choledocholithiasis.
Bile contains water, cholesterol, fats, bile salts, proteins, and bilirubin—a waste product. Bile salts break up fat, and bilirubin gives bile and stool a yellowish-brown color. If the liquid bile contains too much cholesterol, bile salts, or bilirubin, it can harden into gallstones.
There is a contention that Yaz birth control elevates the level of cholesterol contained within the bile salts produced by the liver.
How does one treat gallstones?
Oral Dissolution Therapy. Oral dissolution therapy uses bile acids in pill form to dissolve gallstones and may be used in conjunction with lithotripsy, although both techniques are rarely used at present. Ursodiol (ursodeoxycholic acid, Actigall) and chenodiol (Chenix) are the standard oral bile acid drugs used for dissolution. Most physicians prefer ursodeoxycholic acid, which is considered to be among the safest of common drugs and does not seem to have significant side effects. Long-term treatment appears to notably reduce the risk of biliary pain and acute cholecystitis. The treatment is only moderately effective, however, since gallstones recur in the majority of patients. Source.
Patients may elect contact dissolution: In contact dissolution of gallstones, a solvent is usually introduced through a percutaneous trans-hepatic catheter into the gallbladder. A catheter is inserted through a small needle puncture into the gallbladder under fluoroscopic or ultrasonographic guidance. The catheter is then connected to a computerized peristaltic pump that delivers small amounts of solvent continuously to slowly dissolve the stones and removes any remaining stone fragments. Gallstones can usually be cleared in hours to days. Care must be taken to limit the time of contact between instillation and drainage to avoid discharge of this potentially toxic agent into the bile duct or the duodenum. Failure to do so may result in transient abdominal pain and duodenitis. Source.
For some, surgery is the way to address gallbladder problems.
Laparoscopic gallbladder surgery 
(cholecystectomy) removes the gallbladder and gallstones through several small incisions in the abdomen. The surgeon inflates your abdomen with air or carbon dioxide in order to see clearly.
The surgeon inserts a lighted scope attached to a video camera (laparoscope) into one incision near the belly button. The surgeon then uses a video monitor as a guide while inserting surgical instruments into the other incisions to remove your gallbladder.
Before the surgeon removes the gallbladder, you may have a special X-ray procedure called intraoperative cholangiography, which shows the anatomy of the bile ducts.
You will need general anesthesia for this surgery, which usually lasts 2 hours or less.
After surgery, bile flows from the liver (where it is made) through the common bile duct and into the small intestine. Because the gallbladder has been removed, the body can no longer store bile between meals. In most people, this has little or no effect on digestion. Source.
Symptomatic gallstones can result in extreme pain and serious medical issues. If you or someone you know has developed gallstones after taking Yaz birth control pills, you may have a legal right to file a claim, call Mark Zamora at 888-574-6454.
Blair Expands Recall of Robes, Jackets and Tops
More news on an expanded recall of Blair products:
A Pennsylvania clothing company has expanded a recall of highly flammable bathrobes, as a Connecticut woman says the company's negligence led directly to her mother's fiery death. Blair LLC, based in Warren, Pa., initially recalled 162,000 of its chenille robes in April, as it announced that it had received reports of three deaths blamed on the robes' extreme flammability.
