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New York City Medical Malpractice Law Blog

FDA Warns of Symptomatic Bradycardia (slowing heart rate) While Taking Combination of Hepatitis C Drugs

The FDA released a new warning that symptomatic bradycardia (serious slowing of the heart rate) can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) taken in combination with another direct acting antiviral for the treatment of hepatitis C infection. Information about symptomatic bradycardia is being added to the Harvoni and Sovaldi drug labels. Health care professionals should refrain from prescribing this combination of drugs, but patients should speak to their health care professionals before stopping their medications.

FDA Did Not Approve Superbug Scopes

Olympus Corp., manufacturer of endoscopes related to the dangerous superbug outbreak, did not receive approval to sell the medical device. According to the Food and Drug Administration, Olympus began selling these devices in 2010. However, the FDA did not take notice that Olympus was not granted the required permissions until late 2013. The FDA did not give a statement on why this clearance process had not been regulated more thoroughly.

Elder abuse in nursing homes and assisted living facilities

Many New York residents find the prospect of admitting an elderly relative to a nursing home or assisted living facility troubling. While they appreciate that their loved one requires specialized care, they are troubled by frequent media stories about elder abuse or nursing home neglect. It is sometimes difficult for families to find up-to-date information, and the small amount of accurate data available often paints an unpleasant picture.

The federal National Center on Elder Abuse does its best to provide families with reliable information about elder abuse and neglect, but it concedes that its task is a difficult one. The elderly may not report incidents because of fear or a belief that nothing will be done, and nursing home staff often lack the training necessary to identify signs of emotional or physical abuse.

Hormone Replacement Therapy (HRT) Associated with Blood Clots & Stroke

Hormone Replacement Therapy has been found to be associated with risks of blood clots and stroke. The treatment for women with menopause symptoms like hot flashes and fatigue, has come under inspection as a new study by Cochrane Group shows over 40,000 women have reported such risks.

Johnson & Johnson's McNeil Agrees To Pay $25 Million In Settlement For Recall Probe

On March 10, 2015, Johnson & Johnson's subsidiary McNeil, agreed to pay $25 million and forfeit $5 million, for selling recalled infants' Tylenol, Zyrtec, Benadryl, and other children and infants' over-the-counter medicines. McNeil plead guilty to a misdemeanor violation and failure to file necessary documents during the manufacturing process of the medications.

Birth injuries reduced by implementation of safety procedures

As some New York residents may know, the risks associated with giving birth differ from one hospital to another. Although obstetrical organizations have adopted guidelines that might decrease the risks, the guidelines may not be enforced.

Since 2000, four hospital groups have implemented safety programs and guidelines that have resulted in fewer maternal and fetal deaths and birth trauma. The programs include models for dealing with emergencies during the birthing process, more effective communication skills, monitoring compliance with procedures aimed at high-risk pregnancy and the use of cesarean section.

FDA Warns of Deadly Superbug Outbreak

A new bacteria called CRE (carbapenem-resistant enterobacteriacae) is becoming a growing concern in the medical community due to its high resistance to the strongest antibiotic drugs. CRE infected endoscopes, which are used to diagnose and treat liver diseases, allow for the transmission of CRE between patients, leading to an outbreak of the "superbug."

Study reveals biopsy errors common for precancerous cells

Biopsy specialists in New York and elsewhere face remarkable challenges when attempting to differentiate between the different types of cells presented for their review. Studies show that misdiagnoses of samples of breast tissue are unfortunately more common than anyone would prefer. This leads to undesired results such as cancers that are not detected and surgeries on healthy tissue.

There are approximately 1.6 million breast biopsies carried out every year in America. A recent study focused on a sample size of 240 specimens that were examined by 115 different pathologists. The results showed that pathologists have difficulty diagnosing precancerous conditions. Pathologists correctly identify abnormal cells about 50 percent of the time. The lead author of the study characterized this result as "no better than a coin toss." False positive results came back 17 percent of the time, and a full third of all samples analyzed had precancerous cells that were not detected.

FDA Issues Notices for Intuitive Surgical da Vinci Vessel Sealer

The advances in surgical technique over the past few decades have been remarkable. Besides for new types of procedures old procedures are being done in less invasive ways to minimize the risk of complications. More recently, robotic surgery has made strides in becoming more used and well accepted in the surgical field. Using robotic surgery has the potential to improve accuracy and reduce the invasive quality for a host of surgical procedures. Yet, to be successful, the robotic systems must be designed flawlessly for surgeries to have the desired effect. As of yet, this has not been the case. Intuitive Surgical, one of the leading players in the robotic surgery industry has repeatedly faced regulatory issues and recalls because of flawed design and system malfunction.

Cruise Ship Medical Malpractice

The quality of medical care and the liability for medical malpractice on cruise ships has been problematic. The question of whether the medical staff or the cruise ship owners are held liable for malpractice often arises in situations where an ill passenger has no choice but to be treated by the medical staff provided by the cruise.

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