Archive for the ‘Heparin’ Category

Important Changes for Heparin (December 2009)

Tuesday, January 19th, 2010

Video originally created by FDA -- posted by Lawsuit.com on December 14, 2009

FDA is notifying healthcare professionals and patients about a new USP monograph for heparin. Under the new monograph, the reference standard used to determine the potency of the drug will be changed in order to make it compatible with the WHO International Standard. Despite these changes in the reference standard, heparin dosages will continue to be expressed in USP units. Partly in response to the recent heparin contamination problem, the new monograph also includes additional test methods that can detect potential impurities and contaminants.

As a result of the change in the reference standard, the potency of heparin marketed in the U.S. will now be reduced by about 10 percent, so, there could be up to a 10 percent decrease in heparin activity for each USP unit administered. This means that some patients may require more heparin to achieve and maintain the desired level of anticoagulation. Patients may also require more frequent or intensive monitoring of aPTT or ACT.

This could be especially significant in some situations -- for example, when heparin is administered as a bolus IV dose and it is important to achieve an immediate anticoagulant effect. The changes in heparin potency may not be clinically significant when it is given subcutaneously, because the drug’s bioavailability is lower and more variable when it’s administered this way.

Manufacturers began shipping the new heparin product in early October. For a while, both products will be available at the same time, to assure that there is an adequate supply for all patients. FDA has asked the manufacturers to label their heparin to differentiate between the old and new formulations.

FDA is working with heparin manufacturers to study the possible impact of reduced heparin potency on clinical care, and will share the results of these studies when they are available.

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Confusing Heparin Labels Can Lead to Errors (April 2009)

Tuesday, April 28th, 2009

Video originally created by FDA -- posted by Lawsuit.com on April 9th, 2009

The Institute for Safe Medication Practices (ISMP) points out that some multiple dose heparin vials have potentially confusing labels that could lead to dangerous overdoses. These vials, which contain 4 mL of heparin solution, are labeled “10,000 USP units/ 1 mL,” with the “10,000″ in larger print than the rest of the designation. Because of this, someone quickly reading the label could assume that the entire vial contains 10,000 units. Calculating the patient’s dose based on that mis-reading of the label could result in a fourfold overdose.

To help avoid this potential hazard, ISMP suggests that hospitals consider whether they need heparin in vials that contain more than 10,000 units per vial.

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Higher Mortality for Certain Elderly Patients w/ Innohep (March 2009)

Thursday, March 12th, 2009

Video originally created by FDA -- posted by Lawsuit.com on March 10, 2009

Celgene is alerting healthcare professionals of an increased mortality risk among certain elderly patients treated with Innohep (tinzaparin sodium injection). Innohep is a low-molecular weight heparin that is used along with warfarin to treat acute symptomatic deep vein thrombosis with or without pulmonary embolism.

Results of a controlled clinical study conducted in Europe suggest that elderly patients with kidney dysfunction may have a greater risk of death when treated with Innohep than comparable patients treated with unfractionated heparin. In a July 2008 letter, Celgene had highlighted this risk for patients who are 90 years and older, but the company has now changed the labeling to indicate that these risks apply to patients with kidney dysfunction who are 70 and older. The company says to consider alternatives to Innohep when treating these patients.

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Personal Injury: Med Mal & Nursing Home (3 out 3)

Friday, February 13th, 2009

Medical Malpractice Legal Responsibility:

Medical malpractice
state laws have been rewritten over the years which have led to restricted rights for injured consumers due to medical negligence. Severity in harm and supporting documentation are crucial elements to establish validity in claims. As Manuel L. Dobrinsky,Attorney at Law, of Miami Florida, adds, “Doctors today have many more patients to manage than they had in the past. Thus, the risk of a medical error is more likely than years ago. For this reason, it is important for consumers to take a vested interest in their healthcare by being inquisitive about their diagnosis, medications, treatment, and follow up. In doing so, patients can reduce the risk of potential life threatening illness that may otherwise result in a failure to diagnose or misdiagnose an illness. “
Connected Topics:Medical Malpractice

Nursing Home Abuse Accountability:

Nursing home liability refers to emotional, physical or neglectful acts against an elder by a nursing home employee(s). This may include: malnutrition, dehydration, bed sores, wandering off premises, falls, sexual assault, battery, and wrongful death. Skilled nursing and intermediate care facilities must meet criteria set by Medicare and Medicaid should they serve Medicare or Medicaid recipients. Other facilities that wish to accept Medicare patients must meet standards set by the Federal Medicare Health Insurance Program for the Aged. There are also nursing homes that do not accept Medicare patients which allow them to not fall under federal guidelines. State requirements vary among the states. In fact, certain attorneys are creating movements through state
legislature to improve nursing home abuse accountability. As John J. Perconti, Attorney at Law, Chicago, Illinois, explains, “Nursing home abuse has become more common in recent years. Yet, the laws do not reflect upon the needs of today. For example, nursing homes are not required to carry liability insurance. All nursing home residents and their families need to be informed that the nursing home facility does not have insurance. If there is no financial accountability for negligence, these residents will continue to be neglected and abused.  The rights of abused victims are restricted under the current system.” Currently, Illinois is in the process of passing a bill that would require liability insurance in nursing homes.
Connected Topics: Nursing Home Abuse

Premise Liability:

Property damage or bodily harm that occurs on a homeowner’s property maybe the responsibility of the homeowner where the
damage took place. Homeowner’s insurance policies are designed to provide compensation for damages associated with accidents, negligence, and other forms of harm. A government agency may be liable in some instances whereby the accident occurs on the property of the government. An example of this would be slip and fall that occur because of cracks in sidewalks, faulty curbs, potholes, defective crosswalks, flawed stairs on buses and the like.

Some of the more common injuries that result in premise liability include:dog bites, slip and falls, or any type of property that is termed an attractive nuisance liability which is an item that can harm children regardless of reasonable precautions taken to prevent injury. As Arnold Hernandez, Attorney at Law, of San Diego County, CA explains, “Premise liability is founded on the idea that we all owe a duty of care to our fellow human beings to insure that there are no hidden risks of personal injury on our property and that we have exercised reasonable care in insuring we have removed foreseeable risks. The duty of care is much higher when it comes to children that may come onto our property and we must anticipate how children will behave, including: children’s conduct that to an adult would seem irrational.”
Connected Topics: Dog Bites, Slip and Falls.

Terms for Liability:

Timeliness is important when it comes to liability. Every state has specific rules relating to the number of days that you are permitted to file a claim. It is important to seek the advice of an attorney as soon as you can after injury to provide substantial time necessary to uncover the circumstances surrounding the injury and determine validity for a claim. Once a claim is filed, there will be a select number of days to file a lawsuit. It is important to note that the date of harm may be considered the date of discovery which can sometime occur years after the actual injury. In some cases, both the injured party and the party being held liable are found negligent. This is called comparative negligence. In other cases, negligence may be strictly due to the injured party. Depending
upon the circumstances, personal injury attorneys may refuse to take such cases.

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Personal Injury: Product Liability (2 of 3)

Friday, February 13th, 2009

Personal injury resulting from a product falls under the category of strict liability. Strict liability refers to injury resulting from products whereby the manufacturer may be held responsible because of one or more reasons, including: 1) safeguards in the design of the product failed to protect the injured party from harm despite cautious use 2) failure to design the product through an alternative that would offer better safety mechanisms, 3) the omission of warnings that would otherwise allow for reasonable use of the product.

Product liability may result from food poisoning (such as ecoli and liceria), pharmaceutical drugs, defective toys, playground equipment, recreational apparatus, dysfunctional components in machinery, motorcycles, ATV’s, cars, trucks, strollers or any other product in the marketplace. This may also refer to products that release harmful chemicals such as PBC’s, mercury, lead, asbestos,benzene, and mold.

Personal injury attorneys can assist individuals and serve the public in several ways, including:

1. Aware of technical bulletins and recalls associated with defective products
2. Report defective products to help create awareness about hazards associated with certain products. Understand how to preserve evidence from tampering or destruction.
3. Advocate for large groups and contribute to keeping the public safe from harm.

As Rich Ruohonen, Attorney at Law, Minneapolis, Minnesota, of Pritzker, Ruohonen & Associates, PA. warns, “Manufacturing companies may not be aware of the hazards associated with their product. Consumers can actually help prevent defective products
from causing injury to others by reporting questionable products to the Public Health Department, the Consumer Product Safety Commission and/or other proper authorities.”

Pharmaceutical Drug Damages:

Liability on pharmaceuticalcompanies occurs when t heir drugs cause harm to individuals taking the drug.In fact, the number of pharmaceutical drugs causing health problems and the types of health issues resulting from certain drugs has risen over recent years. As Steve Fields, Attorney at Law, Minneapolis, MN, explains, “It is wise for consumers to be proactive about their healthcare. This equates to doing your own research about medications which can provide stronger outcomes through better informed decisions. The lesson of Trasydol, which resulted in many preventable deaths, should send a message to all that pharmaceutical drugs require ongoing evaluation.”

Construction Accidents:

Construction accident liability may involve the company hired to perform the construction contract such as a construction firm or general contractor. Accidents can occur to many types of workers and the types of injuries can be life changing in many ways. According to the National Institute of Occupational Safety and Health, 17,000 construction workers were killed because of injuries they received while on the job. Falls are the most common type of injury in construction work. As Michael Gunzberg, Attorney at Law, of New York, New York warns, “Construction workers should verify that appropriate safety equipment is being provided and utilized by the general contractor or construction firm for whom they are employed by. For example, construction workers operating on buildings should be equipped with safety harnesses, safety lines and safety nets. Too often I see less than all three types of equipment being utilized during construction work. This can be extremely detrimental to a worker should a fall occur.”

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