Posts Tagged ‘Medical’

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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Ortho Evra Recall Sets the Stage for Lawsuits

Wednesday, February 25th, 2009

As Ed Jazlowiecki, Attorney at Law of Bristol Connecticut explains, “All oral contraceptives may cause injury, but Ortho Evra injuries are on the rise.” The FDA cited that Ortho Evra patch had placed thousands of potential women at risk for questionable levels of estrogen. Ortho Evra was the first oral contraceptive to deliver estrogen through a patch. Ortho Evra is manufactured by Ortho-McNeil.

At the Core of Concern

The stem of Ortho Erva’s increased risk for blood clots, stroke, heart attack and death lies in the disposition of the product. As Doug Monsour, Attorney at Law of Longview, Texas explains, “The dangers associated with Ortho Erva are under-reported. For example, smokers are particularly at risk. The overdose of estrogen and increased risk of blood clots coupled with cigarette smoking further increases the risk for deep vein thrombosis, pulmonary embolism, stroke heart attack and mortality.” The patch is designed to deliver hormones when applied to the skin. However, every woman has unique limitations when it comes to hormone exposure. Some contend that the healthcare system is ill equipped to monitor intake levels particularly in light of the fact that women taking Ortho Erva may be exposed to 60% more estrogen when compared to other oral contraceptives. Since 2002, the FDA had gathered numerous reports of women dying due to the product.

Ortho Erva Warning Signs
• Chest pain and tightness
• Difficulty breathing
• Calf pain
• Excessive headache
• Vomiting
• Dizziness and fainting
• Weakened speech capacity
• Vision impairment
• Breast lumps
• Stomach pain
• Insomnia
• Lack of energy
• Mood swings
• Jaundice
• Fever
• Appetite loss
• Darkened urine
• Bowel discoloration

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Medical Mal Practice, Common in the U.S. Market Space?

Friday, February 20th, 2009
Medical MalpracticeAreas

By Lesley Ranft

Medical Error Death Toll

Medical errors accounted for 225,000 deaths in the U.S. in 2005, according to a published report in The Journal of the American Medical Association (JAMA), authored by Dr. Barbara Starfield of Johns Hopkins School of Hygiene and Public Health. This statistic signifies the third leading cause of death, with heart disease at 652,091 and cancer at 559,312. Stroke victims accounted for slightly less than half of the number of deaths attributed to medical errors. Barry D. Lang, M.D., J.D. of Boston, Massachusetts explains, “Many people do not understand the disease process or medical treatment that is available to prevent and deter early stage disease. In many cases, people could have been saved had they been made aware of screenings for disease. For example, colon cancer is curable with early DIAGNOSIS. Stroke damage may be PREVENTED with early diagnosis.”

The Patient Point of View

“The number of deaths caused by physician and/or hospital negligence is equal to a 747 plane going down every other day. It is vitally important that patients proceed with great caution before undergoing any surgical procedure or taking any over-the-counter or pharmaceutical drug. Unfortunately, patients are often misinformed with lack knowledge about their own health care.” as NY patient activist Patricia Donnelly explains. Mrs. Donnelly was instrumental in developing the Patient Health Information and Quality Improvement ACT of 2000, helping to provide 19 million New Yorkers access to www.nyprofile.com or call 888-338-6999. Harisson Donnelly, Pat’s grandson, died due to medical malpractice at 5 years of age.

A Root For the Doctors

In truth, the majority of physicians in America today often perform  exceptionally well in delivering a diagnosis, treatment options and alternatives for people in need- all requirements in informed consent. Yet, when we consider the high number of diseases and procedures today, it may be all but impossible for physicians to keep up. Add to this, the great number of people in need of care,  managed care issues, health insurance caps, and lack of accessibility to advanced technology, physicians can only do their best to provide exceptional patient care today.

Medical Malpractice Related Deaths-1-:

  • Unnecessary Surgery: 12,000
  • Medication Errors, Hospitals: 7,000
  • Misc. Errors, Hospitals: 20,000
  • Infections, Hospitals: 80,000
  • Drugs Side Effects: 106,000

Medical Error Incidents

  • Medication Errors: 1.5 million, of which 400,000 occurred in hospitals, 800,000 long term care, 530,000 outpatient Medicare clinics, according to Institute of Medicine, July 2006.
  • Missing Test Results: 13.6% of physician visits; resulting in 44% adverse effects and 59.5% delayed care or duplicate services, according to JAMA, February 2005.

Drug Errors

As Tony Nemo, Attorney at Law, Minneapolis, MN states, “Though doctors may do a good job identifying risks and benefits associated with medications, the information relating to side effects may be buried by the manufacturer. This creates the risk for both doctors and consumers to miss valuable data that may be relevant to their medical condition.” Drug errors may contribute to unhealthy side effects, illnesses, medical conditions and death. In fact, even though drug errors may seem highly unlikely, drug errors may easily occur, as described below:

  • Drug Interaction: The interaction of one drug with another that has a negative effect
  • Improper Drug Dosage: Confusion in reading the physician’s writing resulting in improper dosage.
  • Wrong Drug: Mix up of drugs at hospitals sometimes due to closely related names
  • Lack of Discovery in Drug Side Effects
  • Unsuitable Drug Labeling: Packaging that does not adequately warn consumers and physicians about drug side effects
  • Lack of Patient Information Disclosure: Patients that do not disclose full information about medical history, over the counter drugs, medications, vitamins, natural healing remedies are at risk of a negative interaction between the drug and any new treatment that a doctor prescribes.

Patient Tips
As Kevin O’Brien, Attorney at Law, Chicago, Illinois warns, “It is important for consumers to understand that they must participate in the decisions regarding their health care. Though insurance companies may not approve of treatment that your doctor has prescribed, seek out those treatments and submit expenses to insurance companies accordingly. Should treatment costs be rejected by your third party administrator, you can resubmit claims through an appeal process which can result in payment for the associated expenses.” There are several other proactive actions that patients can take, including:

  • When you undergo laboratory tests, follow up with the doctor about test results and inquire about the next step.
  • Don’t be afraid to ask questions.
  • Consider a second opinion or second hospital when you are not comfortable with the diagnosis or treatment provided by the first opinion or hospital.
  • Research information about medications that are prescribed to you. Verify information through several resources such as the Internet, pharmacy, and manufacturer.
  • Thoroughly read the detail information about the medications you are taking that is provided in the manufacturers package insert.
  • Check on the medication dosage that has been prescribed for you.
  • Always have another person with you to support you when visiting doctors and hospitals. The additional person can take in and inquire about information provided by the attending doctors.
  • Do not allow insurance companies to decide if you require treatment. Insurance companies may not approve of tests or treatment that you may need. It is important to seek out such tests and treatment. Plan to submit expenses thereafter.

As Matthew Curtis, Attorney at Law of Southfield, Michigan adds, “Consumers today should research information about the doctors that they are planning to see. Unfortunately, information about doctors is not often readily accessible. However, information may be found on the Internet, courthouse records and the attorney general’s office. Consumers need to ask doctors about their training. Inquire about the number of times that the procedure has been performed by the doctor.”

Medical Malpractice and the Law
While it’s true that to err is human, the end result of medical malpractice can be life changing in many ways. There’s little chance of  financial recovery as well. Ironically enough, an auto accident victim’s family may recover damages from insurance companies should the accident result in death, but a medical error victim may not.  The laws regarding medical malpractice have been rewritten over recent years, making it difficult for people suffering from harm to recover. As Bob Karney, Attorney at Law, of Charlotte North Carolina explains, “The laws today restrict the rights of individuals. Lawmakers have narrowed the criteria for the submission of expert witness testimony, making it difficult to present varying opinions from medical experts that would help demonstrate the validity of med mal cases. These laws have seemingly obstructed the nations’ check and balance system that would otherwise help to reduce medical errors. Today, it is important for consumers to carefully select their doctors and seek out second opinions.”  Only a select number of attorneys take on medical malpractice cases. Such cases usually involve severe, permanent damage that is life changing for the injured party and family members.

Connected Topics: Product Liability, Pharmaceutical Drugs, Personal
Injury Attorneys and You
, Personal Injury Compensation.

-1- http://www.cdc.gov/nchs/FASTATS/lcod.htm


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Chantix: Pending Recall? Lawsuits Spark

Friday, February 13th, 2009

Chantix: Pending Recall? Lawsuits Spark

Cigarettes contain over 4000 substances. Cigarette smoking decreases cutaneous blood flow by 38% in habitual smokers and 28% in casual smokers who may only have one cigarette.  Smoking also increases the heart rate and systolic blood pressure. But, no one knew the devastating side effects of the smoking cessation drug, Chantix, until recently. Kristian Rasmussen, veteran pharmaceutical in Alabama has received more than 2,400 calls from various Chantix victims.  As Mr. Rasmussen said, “We take this litigation very seriously.  I have devoted a team of lawyers and assembled experts from across the country to investigate claims on behalf of innocent Chantix victims.  We have been investigating claims on behalf of Chantix victims and their family members for more than a year now and my opinion is similar to that of many leading independent experts; Chantix is dangerous and Pfizer either knew or should have known the risks for a long time.” It is not known how many other victims exist in the U.S. Though, 3 million use Chantix for smoking cessation, according to Pfizer.

The Action of Chantix
According to the Institute for Safe Medicine Practices, Chantix was associated with more serious adverse events than any other drug in the fourth quarter of 2007 and by first quarter of 2008 Chantix was associated with more serious adverse events than all of the top ten pharmaceutical drugs combined.

Chantix, also known as Varenicline Tartrate, is manufactured and distributed by Pfizer to assist smokers with quitting by limiting cravings and the gratifying effects of smoking. Initially, Chantix users may experience nausea, headache, indigestion, difficulty sleeping and deviant dreaming. However, adverse events may surface at any time after use of the drug.  As Tiffany J. Marko, Esq. of Carey and Danis, L.L.C. in Saint Louis, Missouri explains, “Chantix has been associated with diabetes, abusive behavior, hallucinations, seizures, black outs, suicidal ideation, and suicide.  It definitely isn’t an anti-smoking drug I would recommend to my family members or friends.”

The FDA’s Action

By November of 2007, the FDA received 37 suicide reports, 400 suicidal behavior reports and numerous reports of depression, agitation, and suicidal behavior. To date, the drug remains on the market. People taking Chantix may check with their doctor about Chantix and should monitor their behavior while on the drug.FDA Linking Chantix to Suicide

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