Trial Lawyer Resource Center

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.

 

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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.

 

 

This is news in addition to previous claimed links to SJS.

Dilantin is also commonly used to treat and prevent the onset of seizures after a major brain or spinal surgery. Other names for Dilantin include: Dilantin Infatabs, Dilantin Kapseals, Dilantin-125, Phenytek, and Phenytoin Sodium.

In many instances, the consumer sees visible manifestations of a Stevens Johnson Syndrome reaction within a few days of starting the anti-seizure medication. Others may not see or realize the manifestations of the reaction due to Dilantin until weeks later. Typically the reaction starts out with symptoms such as headaches, sore throat, trouble breathing, itchy or irritated eyes, blistered lips, and/or the onset of a skin rash. In time the condition only gets worse, especially if the ingestion of the inducing drug is not stopped immediately.

Call Mark Zamora at 404 451 7781 , or email him at mark@mzlawyer.com

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Does Chelation Therapy Cause Heart Injuries? Chelation therapy is a recognized treatment for heavy metal (such as lead) poisoning. EDTA (Ethylenediamine tetraacetic acid) is injected into the blood and binds the metals, allowing them to be removed from the body in the urine.A potent chelator of cations, especially calcium, it is FDA-approved only for rapid, emergency treatments of hypercalcemia or digitalis toxicity,and for those indications it has long been obsolete. Source.

Na2EDTA is specifically contraindicated for “generalized arteriosclerosis.” Its labeling includes a “black box” warning: “The use of this drug in any particular patient is recommended only when the severity of the clinical condition justifies the aggressive measures associated with this type of therapy." You can find the warning here: http://www.circare.org/foia2/endrate_ppi19740716.pdf



Chelation therapy is not approved by the FDA to treat coronary artery disease, but some physicians and alternative medicine practitioners use it for this purpose.

In August 2002, the National Center for Complementary and Alternative Medicine (NCCAM) and the National Heart, Lung, and Blood Institute (NHLBI), which are both components of the National Institutes of Health (NIH), announced the launch of the Trial to Assess Chelation Therapy (TACT). This placebo-controlled, double-blind study involves participants age 50 years and older who’ve had a heart attack, and is expected to reach a total enrollment of 1,950. Participants are representative of the U.S. population.

Last August, the federal Office of Human Research Protections began a probe into whether the people in the study were being fully informed of risks and adequately protected. Researchers then suspended enrollment.

The most common immediate side effects of oral chelation therapy include: skin rashes, redness and swelling, headaches, diarrhea, nausea, fainting, fatigue, joint pain, body aches, cramps and convulsions.

Kidney damage from chelation therapy has resulted in permanent damage requiring ongoing dialysis. Deaths have also occurred during chelation therapy from kidney failure and cardiac arrhythmia.

Death and permanent injury have resulted from chelation therapy, even in doctor-supervised clinical trials. The American Heart Association warns of severe and life-threatening side effects and does not endorse chelation as a treatment for heart disease.

Other observers have reported cases of hypocalcemia leading to cardiac arrhythmias and tetany;  decreased blood clotting ability with abnormal bleeding; thrombophlebitis and embolism; hypoglycemia and insulin shock; severe vasculitis and autoimmune related hemolytic anemia, dermatitis with pruritus and generalized eczema; and extensive clumping of platelets in the blood of some patients with atherosclerosis and other chronic diseases.

 

This post was written by Mark Zamora, and you can reach him at ageorgialawyer.com

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Sometimes in life, we can make the diving catches but we miss the soft ground balls hit right at us. 

If you are reading this, chances want tools to make yourself a better lawyer.  And you are doing creative things to make yourself better.  But if you are not on your local listserv, you are missing one of those easy ground balls. Because I cannot think of a single personal injury lawyer who would not benefit by joining their state trial lawyer listserv.

Listserves are essentially e-mail groups catering to a specific topic or community. A host will maintain the registry of participants by determining what members to accept and decline, and will sometimes assist in regulating content to keep the discussions to fundamental purpose of the list. 

Many listserves useful to plaintiffs’ lawyers are those maintained by the American Association for Justice (AAJ, formerly the Association of Trial Lawyers of America, ATLA) and various state trial lawyers associations. AAJ has over 30 listserves based on practice area and member type (for example, auto accident,  products liability, medical malpractice, new lawyers, paralegal members), and more listserves based on “litigation groups” featuring current litigation topics (for example gadolinium, pain pumps, Yaz, jury bias). State trial lawyers associations have their own topics that cater to the needs of their members. In order to access these listserves, you must be a member of the parent organization and, in some cases, a member of a particular section or group within the organization.  Our listerv in Maryland is absolutely fantastic.  There is no a single lawyer who participates that does not learn something. 

 

There are typically policies or “rules of conduct” governing a user’s right to participate in the listserve discussions. Frequently they include rules that topics must be relevant to the listserve’s purpose, political discussions are forbidden, and listserve discussions are private and cannot be shared with non-members. 

 

Messages can typically be received in varying formats, including individual messages, a daily digest (one message each day including all messages sent that day) or a daily index (one message each day indicating the subjects of the day’s postings). Listserve archives are typically searchable.  

 

Some people get turned off by lawyers on their listserv because (1) lawyers who are writing to hear themselves talk and (2) subject matter that is nonsensical/irrelevant or otherwise just plain silly.  This is a pandemic listserv problem.  My advice?  Just deal with it.  Because it is worth it.

 

These listserves allow members to provide information and ask questions to a group of like-minded attorneys in a particular area. It is an invaluable tool for advice and guidance. There is not a single lawyer in the country handling personal injury cases who would not be served by being on its state's trial lawyer association listserv.

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At my offices, we are investigating claims of injury allegedly linked to this birth control pill, call  us at 877-573-4526, or email us at markzamora.com, or mark@mzlawyer.com

 

Yasmin and Yaz are two types of birth control pills manufactured by Bayer Healthcare, and the generic, Ocella, is marketed and distributed by Barr Laboratories, Inc. Yasmin and Yaz contain the same estrogenic compound, ethinyl estradiol, that has been used in “The Pill” since the 1970s, but the progestin in Yasmin and Yaz is new. Yasmin and Yaz both contain drospirenone, a “fourth generation” progestin – no other birth control pills contain drospirenone, except for a recently approved generic version, Ocella.

 

 

Side Effects of Yaz/Yasmin Birth Control Pills

Yaz/Yasmin was approved by the Food and Drug Administration (FDA) in 2006 as an oral contraceptive, and was marketed by its manufacturer, Bayer. Once the drug hit the market, however, the FDA started to receive reports of side effects when taking Yaz/Yasmin, including:

• Deep Vein Thrombosis (DVT)
• Pulmonary Embolism (PE)
• Heart Arrhythmia
• Heart Attack/Myocardial Infarctions and
• Stroke and Transient Ischemic Attacks

What is in the pill:

Yaz/Yasmin contains a synthetic progestin called drospirenone, which some claim will raise blood potassium levels. Doing so may result in a dangerous condition known as hyperkalemia. Hyperkalemia can lead to life-threatening heart problems.

From the first quarter of 2004 through the third quarter of 2008, more than 40 reports of death among users of Yasmin and Yaz have been filed with FDA. These include numerous deaths with reported cardiac arrhythmia, cardiac arrest, intracardiac thrombus (blood clots in the heart), pulmonary embolism (blood clot in the lungs), and stroke in women under 50 years of age.

After ads were run on this pill, there were complaints. In an agreement with the FDA and attorneys general from 27 states, Bayer agreed to drop the misleading ads and run a new campaign to educate the public about Yaz/Yasmin’s health risks. Unfortunately, innocent women across the country have already been hurt by taking Yaz/Yasmin. To date, a number of lawsuits have been filed against Bayer, claiming that the drug company misled women and their doctors about the dangers of their birth control pill.

 

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From the AAJ:

 

EMERGENCY MEDICARE SET ASIDE INFORMATION

Dear Colleague:

       In cases involving Medicare beneficiaries, attorneys for both the plaintiff and defendant are required to report certain information to the Centers for Medicare and Medicaid Services (CMS).  In addition, any case settlement or judgment must reimburse Medicare where the Trust Fund has made conditional payments for medical costs.  Under the Medicare Secondary Payer Act, attorneys have been settling cases involving liability claims without completing a Medicare Set Aside (MSAs) to account for future medical costs.  However, attorneys representing claimants in workers' compensation cases have been preparing MSAs on a case-by-case basis.

       It has come to our attention that some defense firms and insurance providers are now claiming that CMS requires MSAs in liability cases pursuant to Section 111 reporting requirements included in the Medicare, Medicaid & SCHIP Act of 2007 (MMSEA), Public Law No. 110-173.  This is false.  Section 111 contains reporting requirements for responsible reporting entities(1)  (RREs) only.  Section 111 does not impact or change the requirements for plaintiffs' attorneys.

       Moreover, statements from CMS, and other federal entities, make clear that the agency does not require set-asides for liability claims.  Since the MMSEA's passage, CMS has held several Town Hall teleconferences to discuss the Section 111 requirements.  During the March 24, 2009 call, Barbara Wright, CMS' Acting Director of the Division of Medicare Debt Management, made several statements reiterating that Section 111 has no impact on liability MSAs.(2)   For example:

• In response to a question as to whether liability set-asides will be required under Section 111, she said "the point is the set-aside process is totally separate from the Section 111 reporting process.  As we've said in more than one call we don't anticipate changing our routine recovery process."  (Transcript, pg. 24)
   
• When explaining that worker's compensation agreements use a formal review process which makes set-asides recommended, she said that was in contrast to liability agreements.  Liability "does not have the same formal review process although our regional offices will consider review of proposed liability set-aside amounts depending on their particular work load and whether or not they believe significant dollars are at issue." 
  (Transcript, pg. 24).

       In addition, CMS also has released several Alerts explaining Section 111, which do not indicate any intent to require MSAs for liability claims.  For example:

• "Unless you are a business entity which qualifies as [a required reporting entity (RRE)] for purposes of Section 111, you do not need to initiate any specific actions in connection with Section 111."  (CMS Alert, 2/23/09).(3)
   
• "The new Section 111 requirements do not change or eliminate any existing obligations under the MSP statutory provisions or regulations."  (CMS Alert, 2/23/09).

       Moreover, the Congressional Research Service (CRS) provided Congress with an "objective and non-partisan analysis" analysis of the MMSEA.  As there was no legislative history regarding the bill, the CRS research report is the most reliable analysis of the MMSEA, including the Section 111 reporting requirements.

       CRS' analysis of the Section 111 reiterates that it is a reporting requirement, and makes no mention of the need for set-asides in liability cases.  The Section 111 analysis states, in part:

This provision requires an insurer or third-party administrator for a group health plan (and in the case of a group health plan that is self-insured and self-administered, a plan administrator or fiduciary) to (1) secure from the plan sponsor and participants information required by the Secretary for the purpose of identifying situations where the group health plan is or has been a primary plan to Medicare, and (2) submit information specified by the Secretary.  If an insurer or third-party administrator for a group health plan fails to comply, then a $1,000 per day civil monetary penalty will be imposed for each individual for which information should have been submitted.(4)

If CRS believed that the legislative language implies any Congressional endorsement of liability set-asides, it would have been included in this analysis.

       We hope this information will be useful in your settlement negotiations. 

 

 

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Segeorgialaw.com I noted earlier had its debut this week.

From that site:

 

The lawyers will work for folks who live in Southeast Georgia – Brunswick,  Nahunta, Waycross, Homerville, Kingsland,  St. Mary’s, and our counties – Camden, Glynn, Charlton, Brantley. People in those areas don’t have to pick up the phone and talk with a North Florida-based lawyer to get justice.

 

The Docket: I've filed three cases in Glynn County involving auto accidents this month. Our office is located at 1728 Newcastle Street in Brunswick, and we're there this Friday.

 

 

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My firm has opened an office in Brunswick, Georgia handling automobile accidents, pharmacy litigation, and other injury cases.

I've been litigating in Southeast Georgia for some time now, and given how much time I spend there, it was an easy decision. 

My office helps those in Glynn County, Brantley, Camden, and others. Cities like Brunswick, Woodbine, St. Mary's, Waycross, Nahunta are within our lawyer assistance area. 

Here are a few tips on how to handle a claim yourself:

 

Here are some tips that could help maximize your auto insurance claim without litigation.  If you disagree with your insurance company you can use these tips on disputed insurance claims to maximize them.

 

You can reach Mark Zamora:  segeorgialaw@yahoo.com

1. Most of the time your agent may not be able to solve your problem if there is a dispute.  It is best to deal directly with the insuring company.  Get the name and phone number of your insurance companies Claims Department. It's usually an 800 number. Ask for their Consumer Complaint Department or Customer Services.  Most insurance companies have consumer cell who would be more forthcoming in helping you as it is a matter of goodwill and brand building for all good companies.  Talk to them and explain the problem in detail.  Get the specific name of the person with whom you spoke. Make a note of the person you talked with and hold onto that until you've finished with your dispute.  

2. You may follow up your talk with your case by sending a letter or email to the individual whom you spoke with which contains all the documents you have to back up your position.

3. All insurance companies have either an "Appraisal Service" or "Arbitration Service" to help settle differences and/or disputes. Your policy should explain these options.  If you can't find either of these ask your agent to find them for you!

4. If you've followed their rules for resolving your dispute, and you're still not satisfied, your own state's insurance department should be able to help you.  Most countries have an Insurance ombudsman to monitor such grievances.

 

Or, call us at 877-474-6454

 

 

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Four generic drug makers named as defendants Federal Court in Vermont were not permitted to seek an interlocutory appeal on a Motion for Summary Judgment which was filed by them. Each claimed that because the warning label was not designed or written by any of them, there was no liability.  

Reglan (metoclopramide) is prescribed for short-term treatment of gastrointestinal disorders, and is only supposed to be used for under 12 weeks.

 

Specifically, the makers of generic Reglan argued that they should be dismissed from the litigation because the plaintiff’s failure to warn claims are preempted by FDA regulations that require the generic version of medications to contain the same warning label as the branded version.

Back at the end of 2008, the Court denied the motion to dismiss, and the drug makers filed a request for an interlocutory appeal to immediately challenge the Court’s decision and stay the proceedings.

In an order issued April 10, 2009, Judge Sessions denied the request, which will require the generic drug makers to participate in discovery and further litigation of the case.

Attorneys Mark Zamora and Joey James are investigating these claims.

http://www.markzamora.com/reg/index.html

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FDA Requires Boxed Warning and Risk Mitigation Strategy for Reglan and Metoclopramide-Containing Drugs

Alabama Attorney Joey James and Georgia and Florida licensed attorney Mark Zamora are investigating - Tel #888-422-2882, or email mark@mzlawyer.com.

 

 

From the FDA site:

The U.S. Food and Drug Administration announced that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken.

Manufacturers will be required to implement a risk evaluation and mitigation strategy, or REMS, to ensure patients are provided with a medication guide that discusses this risk.

Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment. The development of this condition is directly related to the length of time a patient is taking metoclopramide and the number of doses taken. Those at greatest risk include the elderly, especially older women, and people who have been on the drug for a long time.

Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, or lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. These symptoms are rarely reversible and there is no known treatment. However, in some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.

Metoclopramide works by speeding up the movement of the stomach muscles, thus increasing the rate at which the stomach empties into the intestines. It is used as a short-term treatment of gastroesophageal reflux disease in patients who have not responded to other therapies, and to treat diabetic gastroparesis (slowed emptying of the stomach’s contents into the intestines). It is recommended that treatment not exceed three months.

Metoclopramide is available in a variety of formulations including tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection. More than two million Americans use these products.

What is Tardive Dyskinesia?

Tardive dyskinesias (TDs) are involuntary movements of the tongue, lips, face, trunk, and extremities that occur in patients treated with long-term dopaminergic antagonist medications. Although they are associated with the use of neuroleptics, TDs apparently existed before the development of neuroleptics. People with schizophrenia appear especially vulnerable to developing TDs after exposure to conventional neuroleptics, anticholinergics, toxins, substances of abuse, and other agents. TDs are most common in patients with schizophrenia, schizoaffective disorder, or bipolar disorder who have been treated with antipsychotic medication for long periods, but TDs occasionally occur in other patients as well. For example, people with fetal alcohol syndrome, other developmental disabilities, and other brain disorders are vulnerable to the development of tardive dyskinesias, even after receiving a single dose of the causative agent.

TDs may be differentiated from acute movement disorders that commonly occur in the same patient groups. The acute movement disorders that occur as manifestations of effects of neuroleptics and other dopamine antagonists include akathisia, acute dystonia, and other hyperkinetic dyskinesias. Acute effects of dopamine antagonists also include Parkinsonian syndromes manifested by bradykinesia, rigidity, and pill rolling tremor. The acute movement disorders resulting from exposure to dopamine antagonists are commonly termed extrapyramidal syndromes (EPS).

Reglan- associated with Dystonia?

Symptoms vary according to the kind of dystonia involved. In most cases, dystonia tends to lead to abnormal posturing, particularly on movement. Many sufferers have continuous pain, cramping and relentless muscle spasms due to involuntary muscle movements.

Early symptoms may include loss of precision muscle coordination (sometimes first manifested in declining penmanship, frequent small injuries to the hands, dropped items and a noticeable increase in dropped or chipped dishes), cramping pain with sustained use and trembling. Significant muscle pain and cramping may result from very minor exertions like holding a book and turning pages. It may become difficult to find a comfortable position for arms and legs with even the minor exertions associated with holding arms crossed causing significant pain similar to restless leg syndrome. 

Affected persons may notice trembling in the diaphragm while breathing, or the need to place hands in pockets, under legs while sitting or under pillows while sleeping to keep them still and to reduce pain. Trembling in the jaw may be felt and heard while lying down, and the constant movement to avoid pain may result in the grinding and wearing down of teeth, or symptoms similar to TMD. The voice may crack frequently or become harsh, triggering frequent throat clearing. Swallowing can become difficult and accompanied by painful cramping.

 

 

 

 

 

 

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