Trial Lawyer Resource Center

Attorney Rob Bunch is investigating these potential claims, and his number is 888-422-2882:

 

Hydroxycut Recall

 

The Recall:

The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.

The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.

“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products,” said Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.

Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.  The list of products being recalled by Iovate currently includes:

Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural

Although the FDA has not received reports of serious liver-related adverse reactions for all Hydroxycut products, Iovate has agreed to recall all the products listed above. Hydroxycut Cleanse and Hoodia products are not affected by the recall. Consumers who have any of the products involved in the recall are advised to stop using them and to return them to the place of purchase. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts.

Health care professionals and consumers are encouraged to report serious adverse events (side effects) or product quality problems with the use of these products to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.
The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.

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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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A good friend of mine and fellow attorney Joey James has been addressing wrongs caused by Central United. That company  issued  cancer policies, and  as has been argued successfully in court, failed  to do what it promised to do in those policies.

Now,  and without  any fanfare, there is a pending State Court class action involving Central United in Alabama which Joey James is NOT a part of, and to him may make little or no sense to policyholders (depending on the facts, and for some it may make sense). There is  a fast approaching deadline.

Mr. James writes this on his blog, http://centralunitedlawsuit.blogspot.com/:

You may also reach him at: 1-877-882-0095 by phone, joey@bunchandjames.com by email.

The Central United Class Action:

The Class Representatives have agreed with Central United to settle for everyone any dispute over claims for chemotherapy/radiation benefits and any claim for wrongful premium increases. It is this author’s opinion that such a settlement may be very inappropriate and not in the best interest of some insureds.

Why?

First, if you have a policy and you have had a cancer claim for chemotherapy and/or radiation benefits and Central United only paid you based upon what your doctor was paid by your medical insurance or Medicare, then you may not have been paid all that you were owed. I have represented clients where their claims were not paid in full and were “short changed” by thousands and thousands of dollars. If you have previously made a claim and they did not pay you what the doctor billed but paid you what your insurance company paid the doctor then you may not have been paid but 30 to 40% of what you were owed. If you do not opt-out, then you will not be able to have a jury determine what they should have paid you. Nor will you get the correct amount in the future if you or a loved one have a reoccurrence of cancer.

If you have never used your policy and you have a claim for radiation and/or chemotherapy in the future, if you do not opt out, you will have to take the amount that Central United wants to pay you and there is nothing you can do about it.

If you have paid Central United premiums, you know that they are going sky high. Many of these increases, I believe, are wrong. If you do not opt out, then you will never be able to do anything about Central United charging you these high premiums. Also, many people have been forced to drop their coverage because of their high premiums. Some of these people may be entitled to bring a lawsuit for this. If you don’t opt out, then you can do nothing about this now or in the future.

I am unable to tell anyone individually whether they should opt out or stay in unless I talk to them. I will say generally that every person should seek legal advice immediately.

Call 1-877-882-0095 by phone, joey@bunchandjames.com by email.

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