Scalpel Weekly News

Week of: June 04, 2018

IN THE NEWS


AI Detects Wrist Fractures

On May 24, 2018, the FDA authorized Imagen to market the OsteoDetect device, a type of computer-aided detection and diagnosis software designed to detect wrist fractures in adult patients. Click title to continue reading...


 
MEDICAL ALERTS


New Treatment for Phenylketonuria (PKU); Genetic Disease

On May 24, 2018, the FDA granted BioMarin Pharmaceutical Inc. approval to market Palynziq (pegvaliase-pqpz) for adults with a rare and serious genetic disease known as phenylketonuria (PKU). Patients with PKU are born with an inability to break down phenylalanine (Phe), an amino acid present in protein-containing foods and high-intensity sweeteners used in a variety of foods and beverages. Palynziq is a novel enzyme therapy for adult PKU patients who have uncontrolled blood Phe concentrations on current treatment. Click title to continue reading...



Risk of Fatal Blood Disorder; Oral Benzocaine Products

On May 23, 2018, the FDA warned that over-the-counter (OTC) oral drug products containing benzocaine should not be used to treat infants and children younger than two years of age. The FDA also warned that benzocaine oral drug products should only be used in adults and children two years and older if they contain certain warnings on the drug label. These products carry serious risks and provide little to no benefits for treating oral pain, including sore gums in infants due to teething. Benzocaine, a local anesthetic, can cause a condition in which the amount of oxygen carried through the blood is greatly reduced. This condition, called methemoglobinemia, can be life-threatening and result in death. Click title to continue reading...



Few Adult Stroke Survivors Use Outpatient Rehabilitation

On May 25, 2018, the CDC published a report that found that, although outpatient stroke rehabilitation use among survivors helps improve outcomes and might reduce stroke recurrences, in 2013, only 31.2 percent of stroke survivors reported participation in outpatient stroke rehabilitation in 20 states and the District of Columbia (DC). Use increased significantly between 2013 and 2015, but remained suboptimal. Click title to continue reading...


  CASE ALERTS


Failure to Disclose Medical Resident’s Inexperience

A 39-year-old woman required a laparoscopic-assisted vaginal hysterectomy (LAVH) to remove the uterus, ovaries, and fallopian tubes. The woman discussed the procedure with the surgeon. In explaining the consent forms, the surgeon told the woman that the surgeon would perform the surgery with an assistant. The surgeon did not tell the woman that a resident would perform part of the surgery. Click title to continue reading...



Patient’s Diary Entry and Sticky Note on Medical Record Admissible; Informed Consent

An MRI revealed the presence of abnormal tissue at the top of a woman’s lung. A surgeon told the woman that a biopsy would be necessary to rule out cancer. The surgeon asked an interventional radiologist if a fine needle aspiration (FNA) biopsy would be possible. An FNA biopsy is an outpatient procedure in which a radiologist inserts a long, hollow needle through the skin and into the mass to extract cells, which are then microscopically analyzed. If an FNA biopsy was not possible, the surgeon explained to the woman that an open surgical biopsy, a more invasive procedure, would be the only option to rule out cancer. The woman proceeded to schedule an appointment for an FNA biopsy. Click title to continue reading...



No Personal Jurisdiction; Out-Of-State Insurer; Out-Of-Network Payment

A health insurance company based in Maryland sold health insurance policies to Maryland residents and Maryland companies which may have employees outside of Maryland. The insurance company was a licensee of Blue Cross and participated in a program which allowed insureds to receive treatment nationwide while allowing the health insurance company to charge the in-state discounted rate that Blue Cross used in the state where the member received treatment. Click title to continue reading...


FEATURE


Complaint: Compounded Drug Injury

As a special feature for our Premium subscribers we have included this feature containing an illustrative complaint for an action alleging injuries caused by an improperly compounded drug. In this illustrative situation, a man was prescribed a compounded drug by a primary care physician because there was no commercially available medication that could adequately treat the man’s condition. The written prescription specified each component to be used in compounding the drug, the percentage of each component for the compounded drug, and the dosage. The man presented the prescription to the compounding pharmacy recommended by his physician. The pharmacist compounded the drug using different percentages than specified in the prescription. The man suffered a severe adverse reaction to the improperly compounded drug. The man sued both the compounding pharmacy and the pharmacist who compounded the drug. Party identifying information has been redacted to protect privacy. Click title to continue reading...