Posts Tagged ‘medical malpractice’

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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Drug Induced Steven’s Johnson Syndrome

Wednesday, May 6th, 2009

By Lesley Ranft

“The seriousness of the injuries and the fact that the types of drugs that can cause Stevens Johnson Syndrome are in frequent use signify the need for all consumers to take a closer look at the labels for side effect warnings in both over-the-counter and prescription drugs that they are taking. ” as Frank Woodson, Shareholder in the law firm of Beasley, Allen, Crow, Methvin, Portis & Miles of Montgomery, AL explains. Once thought to be an allergic reaction by some, has evolved into a lifelong nightmare for people suffering from severe drug induced Steven’s Johnson Syndrome (SJS).

SJS Symptoms

SJS is toxic, life threatening and may damage the immune system, organs, and neurological function. The underlying skin disorder is so dramatic for people with severe SJS that they may appear to have fourth degree burns, resulting from epidermal rash blisters which may encompass the body. According to legal case reports, the side effects of SJS are, as follows:

• Nausea, vomiting, diarrhea, fever, sore throat, cough, and chills
• Blisters or lesions on the body
• Inability to eat, drink or void
• Burns to the skin and organs such as the esophagus and corneas of the eyes
• Eye conditions such as anterior uveitis, keratitis and panophthalmitis
• Blindness
• Hypotension
• Tachycardia
• Respiratory failure
• Urinary tract impairment or failure
• Gastrointestinal dysfunction or failure
• Kidney impairment or failure
• Vaginal stenosis and penile scarring
• Skin sloughing and necrosis (death) from 10% to 80% of the body
• Seizures
• Coma
• Death

Candidates for SJS

SJS predominantly affects Caucasians, with ratios of two men to one female. Most people contract SJS between their 20’s and 40’s, but children as young as 3 months old have contracted SJS. SJS is commonly misdiagnosed at the onset. SJS is considered idiopathic in 25-50% of all cases. The condition affects people in varying degrees of severity. The risk of death is associated with the extent of skin necrosis (skin death). The mortality rate is 1-5% when necrosis is less than 10%, up to 35% when necrosis is 30% and so on.-1-

SJS Causes: Virus, Disease, Infection and Malignancy

The root associations of SJS may be viral diseases, infections and malignancies including: carcinomas, lymphomas, herpes simplex virus (HSV), AIDS, coxsackie viral infections, influenza, hepatitis, mumps, mycoplasmal infection, lymphogranuloma venereum (LGV), rickettsial infections, and variola. Bacterial associations include: group A beta streptococci, diphtheria, Brucellosis, mycobacteria, Mycoplasma pneumoniae, tularemia, and typhoid. Fungal viruses include: Coccidioidomycosis, dermatophytosis, and histoplasmosis. Malaria and trichomoniasis are also reported causes. Epstein-Barr virus and enteroviruses have been identified as well.

SJS Drug Induced Causes

The medication list of causes that is identified include: Sulfa drugs, Phenytoin, Ciprofloxacin, and Penicillin may trigger SJS. Anticonvulsant drugs such as oxcarbazepine (Trileptal), phenytoin, carbamazepine, valproic acid, and lamotrigine are in the linked category. Non-nucleoside reverse transcriptase inhibitor drugs, Nevirapine, Indinavir, and Modafinil (Provigil) have been identified too. Attorneys have reported an association between SJS and Allopropenol, EFFEXORA, Lemectal, Ibuprofen, Motrin and barbiturates.MRI diagnostic testing equipment using Gado Dye caused an unexpected outbreak of SJS recently.

Check Your Drug Labels

Not all drug labels provide current up-to-date warnings about medical condition risks. For example, Motrin bottles provided a warning label about the risk of Steven’s Johnson Syndrome when it was a prescription drug. However, today’s over-the-counter version of Motrin does not provide a warning for the risk of Steven Johnson’s Syndrome. In addition, it may require a significant amount of time between a reported link between SJS and a drug and the time that the information appears on a drug label. Furthermore, there may be additional time before a drug is recalled for risks of SJS because the foundation of a recall may be based on a high number of reports and the average individual may not know to report the drug or realize the correlation between the drug and the disease.

By the same token, checking your prescription and over-the-counter medications for warnings is important. High incidence ratings may be bumped up on the scale of the label. Severe adverse events and high rates of incidence should appear in the warning or precaution section of label.

Check with Your Doctor

Some people with SJS may only experience fever, sore throat, vomiting and/or diarrhea. In fact, rashes and lesions may never appear. Some doctors may not be familiar with SJS. If you experience any SJS related symptom, contact your doctor and request to stop taking the drugs you are taking. If you suspect SJS, maintain hydration. The diagnosis of Steven’s Johnson Syndrome is conducted through a skin biopsy. The treatment for SJS may consist of medications and treatment for the impairment(s) that you are suffering from.

Check with a Lawyer

A select number of product liability lawyers are accepting SJS legal cases to submit lawsuits against the makers of the drugs who have failed to adequately warn the public about the risk of SJS. It is the culmination of patient reports acquired by lawyers, victims themselves and other interested parties that substantiates the need for public policy makers to take greater action to prevent the public from further harm. Your experience with SJS is important. Check in with a lawyer today.

-1- http://emedicine.medscape.com/article/756523-overview

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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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Zimmer Hip Implant Recipients Be On Alert

Thursday, March 26th, 2009

Since 2006, 12,000 plus people received the Durom Cup hip implant by Zimmer. At the onset, the Durom Cup appeared to provide relief for those struggling with damage to the hip bone and cartilage. In fact, hip replacement surgery is the final treatment plan when all other methods fail. Yet, the treatment plan with the Durom Cup hasn’t ended for many due to the disabilities that have resulted from its use. The Durom Cup was recalled after multiple violations cited by the FDA. In addition, there are several other makers that have faced with recalls due to excessive pain and suffering for people that have underwent hip replacement surgery. In fact the lack of consumer awareness is another cause for concern. As Jackie Quinton, Attorney at Law of The Garrett Law Office in Oklahoma City and surrounding areas explains, “People with the recalled Zimmer Hip Implant often initially believe that the persistent pain and/or dislocation they are experiencing is a natural component of surgery and not attributed to a defective product. In fact, they may go to the emergency room and have subsequent surgeries without knowing the root cause of their disability. Some doctors may not be aware of the defect as well.” The affected hip implants date back to 1998. Over 150,000 hip replacement surgeries are performed each year, according to FDA Talk.

Hip replacement surgery may be performed through a variety of techniques. The techniques for total hip replacement involves the use of artificial implant designed to help mimic the function of the hip joint.

Zimmer Hip Implant Issues
Though initial patient reports of the Durom Cup held promise, the failure rate appeared high in the years following surgery. Patient complaints have included: 1) loose implant 2) inability of the cup to bond with the bone 3) implant migration from initial positioning 4) immobility 5) severe pain. The contentions surrounding the hip implants are, as follows:

• Some personal injury attorneys contend that Durom Cup implants should never have been on the market because the company never proved that their product was superior to others. Also, it is suspected that there is a failure in the design of the implant cup.
• Others contend that the doctors were not adequately trained in Durom Cup placement by the maker.
• The process of bonding implants to bone is highly skill dependent. For example, dentists have been using the process of osteointegration (bonding bone to artificial material) for over ten years. Osteointegration is critical for the success of a dental implant. Yet, the skills used in the bonding technique have required many years of time. Osteointegration techniques are used in other medical applications such as head and neck.
• The FDA cited multiple reasons why the Durom Cup implant was a cause for concern, including: 1) failure to deliver adequate quality control information about the product 2) failure to implement preventative and corrective procedures, 3) failure to deliver complaint handling and trend reporting for side effect cases in a timely fashion.

Though the company did suspend sales and ultimately reported the high failure rate, the problems associated with the implant may produce debilitating pain and the need for revision surgery. In fact, surgeons performing revision surgery may require additional expertise to remove and replace the implant. Revision surgeries also have their own set of risks.
Lawsuits involving hip implants have been filed in behalf of victims suffering from hip replacement. There are a select number of personal injury attorneys that handle hip implant lawsuits.

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