Posts Tagged ‘Errors’

Ethex Recall: Over-Dose Tablets Pose Risks

Thursday, May 21st, 2009

By Lesley Ranft

Ethex Corporation announced multiple recalls of numerous drugs, including morphine, iron and prenatal vitamins. The string of recalls began to commence last year due to double dose tablets of morphine and other potential concerns. There have been recent reports that the FDA is questioning adequate quality control at the manufacturing facility where the morphine tablets were made. As Richard Schulte, Attorney at Law of Dayton, Ohio explains, “This is a clear case of manufacturer defect. The problem we are faced with now is we do not yet know the extent of defective pills on the market and how great of harm they caused to consumers.”

Signs of Overdose
The long term effects of the prenatal vitamins are unknown. Iron supplement overdose side effects usually occur shortly after intake. Iron poisoning side effects may include, vomiting diarrhea, liver dysfunction, jaundice, internal bleeding, and seizures.-1- The initial signs of overdose in morphine are clear and can be life threatening, but may not be fully apparent to the person using the drug. Opioid overdose includes:
• Rapid Heart Beat
• Hypertension
• Tremors
• Bluish Lips
• Headache
• Insomnia
• Dizziness and Fainting
• Blurred vision
• Upset stomach
• Fainting
• Low Blood Pressure

The List of Ethex Recalls

Isosorbide mononitrate: 30mg and 60mg
Propafenone HCI: 150mg, 225mg, and 300 mg
Dextroamphetamine sulfate tablets: 5mg and 10mg
Morphine sulfate ER: 15mg, 30mg, 60mg, 100mg 200mg
Morphine IR: 15mg and 30mg

Prenatal Vitamin Recalls
Advanced NatalCare® Tablets and Advanced-RF NatalCare® Tablets
Cal-Nate™ Tablets
CareNatal™ DHA Tablets
ComBgen Tablets
ComBiRx™Tablets
NataCaps Capsules
NatalCare Gloss, PIC, PIC Forte, Plus, Rx, Three Tablets
NataTab FA Tablets
NataTab RX Tablets
NutriNate® Chewable Tablets
NutriSpire™ Tablets
Prenatal MR 90 FE and MTR w/Selinium Tablets
Prenatal Rx 1 Tablets
Prenatal Z, Advanced Formula Tablets
Ultra NatalCare Tablets

Iron Supplement Recalls
Anemagen Caplets
Anemagen Forte Caplets
Conison™ Capsules
Fe-Tinic™ 150 Forte Capsules

-1- http://www.merck.com/mmhe/sec24/ch297/ch297h.html

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Kugel Mesh Patch Lawsuits

Friday, May 8th, 2009

By Lesley Ranft

The Kugel Mesh Patch was meant to provide a solution for people suffering from hernias. There are 700,000 hernia surgeries performed each year. Yet, no one knew of the problems associated with the Kugel Mesh patch which is meant to be permanently inserted into the treatment area of the body. Unfortunately, there are many potential victims that have been exposed to faulty Kugel Mesh Patches. As early as 2001, reports of complications accumulated, but the Kugel Mesh maker did not conduct a product recall until 2007. As Joe Saunders, Attorney at Law, of Pinnellas Park, Florida explains, “It appears that there has been a failure to design out and guard against the risk of injury from the Kugel Mesh. The abdominal Kugel Mesh is subject to breakage which can puncture an organ. The mesh itself is prone to lose rigidity and may roll up inside the body which creates the risk of the tissue adhesions and other complications.” Complications resulting from the use of the Kugel Mesh Patch include:

• Bowel Obstruction
• Bowel Adhesions
• Constipation
• Abdominal pain
• Fever
• Bowel Perforation
• Tissue Adhesions
• Liver damage
• Liver failure

Several lots of the Kugel Mesh Patch for hernia repair had been recalled in the beginning of 2008. The final recall involving numerous lots of the drug did not come until after an initial 2007 recall of a select type of the Kugel Mesh Patch. Davol, the Kugel Patch manufacturer, had received an unusual number of complication reports from Kugel Mesh Patch users. Soon, the company uncovered defects in the memory recoil ring, including breakage of the ring, which may produce serious complications for patients using the ring. The lots with possible problems are those from December of 2005, March of 2006 and January of 2007. As Ed Jazlowiecki, Attorney at Law of Bristol, Connecticut explains, “The Kugel Mesh Patch has caused a significant number of serious injuries, including bowl perforation which requires surgery and is associated with risks for complications and death. This is particularly disturbing when there are better products on the market.”

Kugel Mesh Patch Recovery
Patients that received a Kugel Mesh Patch from one of the defective lots may be subject to surgery for the removal of the Kugel Mesh Patch. In addition, people receiving the Kugel Mesh may be subject to long term complications that inhibit daily life. As Kate Gillespie, Attorney at Law of Baum, Hedlund, Aristei & Goldman, P.C.explains, “People whose doctors do not know about the Kugel Mesh defects often tell patients to be patient and wait it out. So, people think their problems will resolve themselves shortly. They soon learn that their problems are just the beginning and recovery may be a life long commitment.”

Reports of long term medical issues from the Kugel Mesh Patch include: muscle and tissue adhesions whereby the sticky surface of the mesh adheres to the intestines, stomach or surrounding tissue. Bowel infection, perforation and seaping wounds have also been documented. As Kate Gillespie explains, “The hernia operation is a simple procedure that does not usually involve unmanageable complications. Unlike the Kugel Mesh Patch, a hernia operation often involving permanent uncomfortable injuries.”

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Moisture Plus Consequences: Corneal Infection Increases Risks

Tuesday, April 28th, 2009

The number of contact lens users with corneal infections has grown due to risks of injury from select contact lens solutions such as Moisture Plus, manufactured by Advanced Medical Optics. Diagnosis of corneal infection may be particularly problematic because the type of Keratitis associated with contact lens solution is often mistaken for a different type of eye infection or Keratisis. The type of Keratisis that many people using contact lens solution have is Acanthamoeba Keratitis. Eye doctors may not be familiar with this eye condition because it is rare. There have been reports that people suffering from Acanthamoeba Keratitis have been misdiagnosed. This delay in treatment adds to the risk for blindness from Acanthamoeba Keratitis.

Ophthalmologists that are corneal specialists are more likely to be familiar with Acanthamoeba Keratitis than optometrists and general eye doctors. Different classes of Keratitis are caused by bacteria, virus or fungus. Acanthamoeba Keratitis may be contracted though tap water or the use of contact lenses in the shower, bathtub or pool. The risk of Acanthamoeba Keratitis from using contact lens solution is two to one million, according to All about Vision. The risk from MoisturePlus has been seven times that number.

If you are experiencing symptoms from your contact solution, seek out the advice of an ophthalmologist and tell them about your concern over Acanthamoeba Keratitis There are a select number of product liability attorneys that are familiar with Acanthamoeba Keratitis injuries. They can provide information about the legal rights of victims from MoisturePlus injuries.

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Zencore Plus: Diet Supplement, Sex Life Enhancer Plus Personal Injury

Thursday, April 23rd, 2009

Zencore Plus was recalled because of personal injury risks identified after an FDA analysis of the ingredients. The first analysis showing potential harmful effects from Zencore dated back to two years ago. Presented as a natural herbal supplement, the message sent through marketing by Bodee,LLC, the maker, was ultimately deemed deceptive in March 2009. Furthermore, the label did not reflect chemicals that have known risks associated with them, particularly when combined with one another.
Masked Zencore Ingredients
Sildenafil and aminotadalafil were not identified on the label of Zencore bottles, but were found in FDA analysis. Aminotadalafil is the active ingredient for drugs such as Viagra. Another ingredient found in Zencore was benzamidenafil which is not FDA approved for use in humans. The use of Zencore in people taking medications that contain organic nitrates are particularly at risk. This includes people with cardiovascular conditions and high blood pressure. The known side effects of the above mentioned chemicals include:

* Sudden cardiac death
* Heart attack
* Stroke
* Low blood pressure
* Chest pain
* Irregular heart beat
* Vision loss
* Seizures
* Hearing loss
* Dizziness
* Prolonged erections
* Headaches
* Nasal congestion
* Indigestion
* Abdominal pain
* Sudden blood pressure drop

It is unlawful for prescription medication such as Aminotadalafil to be sold to the public as an over-the-counter drug. The reason why there are prescription medications is so that physicians may screen patients to identify high risk candidates such as cardiac and high blood pressure Zencore users. In addition, manufacturers participate controlled in clinical trials for prescription drugs to help identify drug safety and efficacy before the drug reaches the general public. As an over-the-counter drug, the makers of Zencore have clearly stood clear of two authorities designated to protect consumer health. Personal injury attorneys that focus on product liability can answer legal questions that you may have about Zencore injuries. People that have suffered serious illness or death from Zencore may be entitled to financial compensation for their injuries.

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ZOL AED Plus Defibrillators

Wednesday, April 15th, 2009

People using the ZOL AED Plus Defibrillator who have suffered or died because of a heart attack may be poised for a lawsuit involving the maker, ZOL Medical Corporation. On March 31, 2009 ZOL Medical Corporation sent a warning letter to recipients of the defibrillator following four reports of death from failure of the technology to perform.

New Technology Requires Scrutiny
In 2000, the New England Journal of Medicine reported that defibrillators prevent death in close to half of all users, 10 times the survival rate of those that suffer cardiac arrest without hospital assistance. There were approximately 20,000 users at this time. By 2005, it was estimated that 200,000 people in the U.S. use defibrillators to analyze heart rhythm, detect irregularity and restore natural heart rhymes. While the use of this new technology has saved many lives, people using defibrillators must be cautious about defibrillators. Defibrillators fit the category of new technology and have not passed a test of time. Unfortunately, defects may not be uncovered before the implications hit the general population.
The ZOL defibrillator is used by US based hospital personnel and the public at large in emergency situations. ZOL’s defibrillator was designed to repair irregular heart rhythms and prevent heart attack or death. There has been a flaw detected in the battery of the ZOL defibrillator which prevents the technology from working in time of need.
The faulty defibrillator was sold nationwide beginning May 2004. People may not be aware that the defibrillator they are using may fail at any time they require emergency resuscitation. This can contribute to heart attack and death. People using the defibrillator may contact ZOL through their website for replacement of the defective defibrillator parts. People using the defibrillator should also contact their doctor about the defibrillator.

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