Scalpel Weekly News

Week of: September 07, 2015

IN THE NEWS


FDA Warns Cigarette Makers on Claims of Additive-Free, Natural

The FDA has issued warning letters to three tobacco manufacturers — ITG Brands LLC, Santa Fe, Natural Tobacco Company Inc., and Sherman’s 1400 Broadway N.Y.C. Ltd. — who describe their cigarettes on product labeling as “additive-free” and/or “natural.” The warning letters are for violations of section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Click title to continue reading...


 
MEDICAL ALERTS


Allergan Eye Lubricants Recalled Due to Particles in Product

Allergan, PLC, of Dublin, Ireland, recalled to consumer level specific lots of four of its eye products. Click title to continue reading...



Improper Application of Skin Medicine Causes Severe Effects

The FDA warned that it had received reports of severe allergic reactions and herpes zoster (shingles) associated with the use of Picato gel (ingenol mebutate). Picato is used to treat actinic keratosis, a scaly, crusty lesion on the skin that may be red or yellow in color. The lesions are typically located on areas exposed to the sun such as the face, scalp, back of the hands, and chest. The majority of these lesions are not harmful. However, actinic keratosis may occasionally develop into skin cancer. The active ingredient in Picato gel comes from a plant and works by killing the cells that make up the scaly skin patch of actinic keratosis. Click title to continue reading...



U.S. Children Still at Risk for Vaccine-Preventable Diseases

The reduction in morbidity and mortality associated with vaccine-preventable diseases in the United States has been described as one of the ten greatest public health achievements of the first decade of the 21st century. A recent analysis concluded that routine childhood vaccination will prevent 322 million cases of disease and about 732,000 early deaths among children born during 1994–2013, for a net societal cost savings of $1.38 trillion. Click title to continue reading...


  CASE ALERTS


Three-Year Delay in Diagnosing Cystic Fibrosis Did Not Increase Risk of Harm

A girl was born with cystic fibrosis (CF), a genetic disorder. When the girl was four, she switched pediatricians. When the new pediatrician first examined the girl, she had generalized symptoms consistent with a diagnosis of CF: a persistent cough, coughing up sputum, and digestive problems. The pediatrician referred the girl to a gastroenterologist because she presented symptoms of abnormal stools. A year after her first appointment with the gastroenterologist, the girl’s younger sister went to the gastroenterologist for a follow-up consultation. About three months after this appointment, the gastroenterologist wrote the pediatrician describing gastric symptoms generally associated with CF. The pediatrician did not order a CF test. Click title to continue reading...



Physician’s Assistant Info Sufficient for Informed Consent

A woman was diagnosed with a craniopharyngioma, a noncancerous brain tumor that develops at the base of the brain near the pituitary gland. She had it surgically removed. Four years later the cancer recurred. Click title to continue reading...



ERISA Administrators Must Inform Claimants of Judicial Review Deadlines

A woman consulted with a doctor about severe back pain she was experiencing. The doctor diagnosed the woman with a herniated disc and recommended she undergo an endoscopic discectomy. The woman agreed to the proposed treatment plan and executed an assignment of benefits form that assigned to the doctor any and all rights that the woman had for any payment of outstanding medical bills incurred with the doctor. The doctor performed the procedure on the woman’s back. Click title to continue reading...


FEATURE


Complaint: Malpractice-Rheumatoid Arthritis

As a special feature to our Premium subscribers we have included this Feature containing an illustrative Complaint for physician medical malpractice; medical group respondeat superior liability; willful misconduct; intentional concealment; and intentional misrepresentation involving the long-term high-dose use of the drug prednisone to treat a patient’s rheumatoid arthritis. Click title to continue reading...