Scalpel Weekly News

Week of: November 13, 2017

IN THE NEWS


Illegal and Unproven Marijuana Products Claim to Treat Cancer

On November 1, 2017, the FDA issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support the claimed outcomes. Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food, Drug, and Cosmetic Act, but also can put patients at risk as these products have not been proven to be safe or effective. Click title to continue reading...


 
MEDICAL ALERTS


Quality Control Consent Decree; Defibrillator Manufacturer

On October 31, 2017, the United States District Court for the District of Massachusetts entered a consent decree of permanent injunction between the United States and Philips North America LLC (doing business as Philips Medical Systems and Philips Healthcare) of Andover, Massachusetts, and two of the company’s officers, Carla Kriwet, business group leader for the Patient Care and Monitoring Solutions (PCMS) business group, and Ojas Buch, vice president, head of quality and regulatory for PCMS. Click title to continue reading...



New Treatment for Adults with Mantle Cell Lymphoma

On October 31, 2017, the FDA granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. Click title to continue reading...



Diabetics With End-Stage Renal Disease

On November 3, 2017, the CDC published a report that found that, during 2014, 120,000 persons in the United States and Puerto Rico began treatment for end-stage renal disease (ESRD) (kidney failure requiring dialysis or transplantation). Among these persons, 44 percent (approximately 53,000 persons) had diabetes listed as the primary cause of ESRD (ESRD-D). Click title to continue reading...


  CASE ALERTS


Nursing Negligence Experts; Guidewire Left in Patient

A woman underwent a procedure in a hospital’s emergency department. During the procedure, nurses attempted to establish a central venous line, also known as a central line or a central venous catheter. For a central line, a long, thin, flexible tube (the catheter) is threaded through a large vein into the chest and is used to administer medicines, fluids, nutrients, or blood products, that are unable to be taken by mouth or would harm a smaller peripheral vein. Click title to continue reading...



Neurostimulator Manufacturer’s Website; Breach of Warranty; No Preemption

A man suffered from chronic back pain and leg pain. To manage that pain, a neurostimulator was surgically implanted into the man’s back. The neurostimulator delivered mild electrical signals to the epidural space near the spine through one or more thin wires that provided electrical impulses to thin plastic leads. Click title to continue reading...



Systemic Sclerosis Not Covered by World Trade Center Workers’ Disability Benefits

A police officer worked at the World Trade Center site performing rescue and recovery after the terrorist attack on September 11, 2001. The officer suffered from systemic sclerosis. The police officer applied for accidental disability retirement. In support of the officer’s application, the officer provided the reports of the officer’s treating physicians. Click title to continue reading...


FEATURE


Complaint: Colonoscopy Malpractice Action

As a special feature for our Premium subscribers we have included this feature containing an illustrative complaint for malpractice in the administration of a colonoscopy. In this illustrative situation, a man underwent a colonoscopy. The procedure involved a contaminated colonoscope, which caused the man to become infected with the human papillomavirus (HPV). Click title to continue reading...