Scalpel Weekly News

Week of: January 26, 2015

IN THE NEWS


Diet Supplement Maker under Consent Decree; Poor Sanitation, Unidentified Ingredients

A California dietary supplement manufacturer was ordered by a federal court to stop selling its products until the company comes into compliance with the FDA’s dietary supplement manufacturing regulations and other requirements listed in the consent decree. U.S. District Judge Beverly Reid O’Connell of the Central District of California signed a consent decree of permanent injunction against Health One Pharmaceuticals, Inc., of City of Industry, California, and the firm’s president and owner on January 15, 2015. Click title to continue reading...


 
MEDICAL ALERTS


Infection Control in U.S. Hospitals Requires More Improvement

Progress has been made in the effort to eliminate infections that commonly threaten hospital patients, including a 46 percent decrease in central line-associated bloodstream infections (CLABSI) between 2008 and 2013, according to a report released recently by the CDC.  However, additional work is needed to continue to improve patient safety. The CDC’s Healthcare-Associated Infections (HAI) progress report is a snapshot of how each state and the country are doing in eliminating six infection types that hospitals are required to report to the CDC. For the first time, this year’s HAI progress report includes state-specific data about hospital lab-identified methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections and Clostridium difficile (C. difficile) infections (deadly diarrhea). Click title to continue reading...



FDA Approves First Minimally Invasive Device to Treat Obesity

The FDA recently approved the Maestro Rechargeable System for certain obese adults, the first weight loss treatment device that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness. The Maestro Rechargeable System is manufactured by EnteroMedics of St. Paul, Minnesota. Click title to continue reading...



Patients Injected with Unsterile Training IV Solution Injured; FDA Investigates

The FDA and the CDC are continuing to investigate multiple instances of Wallcur’s practice  intravenous saline products being administered to patients. These products are not sterile and should not be injected in humans or animals. They are for training purposes only. Click title to continue reading...


  CASE ALERTS


Photofacial Laser Injury Claim Failed; Insufficient Expert Testimony on Causation

A man underwent a medical procedure using a photofacial laser device to remove pimples from his face. After the procedure, his face was severely burned, leaving scars on his cheek and nose. The man sued the aesthetician who performed the procedure, the facility where the procedure was performed, and the doctor who supervised the aesthetician. The complaint alleged claims of medical negligence, negligent training and supervision, and negligent infliction of emotional distress. The aesthetician, facility, and doctor filed a motion for summary judgment. The man responded to the motion for summary judgment but did not provide a sworn affidavit from a doctor. Click title to continue reading...



Plaintiffs’ Expert Testimony on Colon Resection Surgery Speculative, Conclusory

A man suffering from diverticulitis underwent colon resection surgery. After the procedure, the man developed an incisional hernia. The surgeon who performed the original colon resection performed a surgical repair by affixing a Kugel mesh patch to the abdominal wall, in a procedure known as an open repair of an incisional ventral hernia. The man developed a recurrent hernia at the incision site. He required further surgery to remove the patch and repair the recurring hernia. Click title to continue reading...



LTD Plan’s Mental Health Exclusion Applied Only If Physical Disability Not Total

A United States Army helicopter pilot was injured in a crash. His doctors were forced to amputate one of his legs at the knee. After retiring from military service, the man began flying helicopters for a private company. The private company purchased a long-term disability insurance policy for the man. After flying for the company for more than 20 years, the man began experiencing severe pain at the site of the amputation, which prevented him from safely wearing his prosthetic limb. As a result, he was no longer able to operate the foot controls of the helicopters, and he was forced to retire from flying. At that time he was earning over $75,000 per year. The man filed a claim for long-term disability benefits with the insurer. Click title to continue reading...