Scalpel Weekly News

Week of: July 04, 2016

IN THE NEWS


FDA Uses Whole Genome Sequencing to Investigate Foodborne Illness

A person commits a crime, and the detective uses DNA evidence collected from the crime scene to track the criminal down. An outbreak of foodborne illness makes people sick, and the FDA uses DNA evidence to track down the bacteria that caused it. Click title to continue reading...


 
MEDICAL ALERTS


FDA Streamlining Access to Some Investigational Drugs

On June 21, 2016, Richard A. Moscicki, M.D., the FDA’s Deputy Center Director for Science Operations, Center for Drug Evaluation and Research, wrote about gaining access to investigational drugs on the FDA Voice blog. The blog is stated below. Click title to continue reading...



Modification for Anticonvulsant Used for Seizures; Weighing Risks

On June 21, 2016, the FDA announced the approval of a supplemental New Drug Application (sNDA) modifying the risk evaluation and mitigation strategy (REMS) for Sabril. The FDA determined that, although the risk of vision loss with Sabril still exists, requiring submission of OAFs as an element of the REMS is no longer necessary to ensure the benefits of Sabril outweigh its risks. Prescribers should continue to follow the vision monitoring recommendations described in the prescribing information for Sabril. Click title to continue reading...



Child Blood Lead Levels High With Flint River Water; Levels Better after Switch to Detroit System

On June 24, 2016, the CDC released the results of its investigation into the potential health impact that lead contamination in the Flint, Michigan water supply had on the blood lead levels of local children. The findings indicate that when the source of the water supply was switched to the Flint River, without appropriate corrosion control measures, young children who drank the water had blood lead levels (BLLs) that were significantly higher than when the source of water was the Detroit water system. Click title to continue reading...


  CASE ALERTS


California Agreement of Woman Who Died after Liposuction Subject to Federal Arbitration Act

A woman consulted with a plastic surgeon and his practice group for various plastic surgery procedures. She signed a physician-patient arbitration agreement. The arbitration agreement stated, “I agree that any lawsuit or arbitration that is brought against [the plastic surgeon], his corporation, associates, or organization, will be tried in Pasadena, California (the ‘venue’ is Los Angeles Superior Court in Pasadena, the ‘jurisdiction’ is the State Court of California…Note, you have signed a binding arbitration contract and this above applies to any court involvement that might be necessary for arbitration, or any legal action that enters the courts.” Click title to continue reading...



Positioning Patients on Operating Table Not Subject to Res Ipsa Loquitor

A man underwent an eight-hour surgery to remove a facial tumor on the left side of his face. After the surgery, his right hand swelled, and he was diagnosed with right hand compartment syndrome which required an additional surgery. Click title to continue reading...



Florida Insurer Recovers When Clinics Director Failed to Review Billings

Three medical clinics operated in and were licensed by the State of Florida. As a result, they were required to and did appoint a medical director to ensure their compliance with Florida’s statutory licensing requirements. All three clinics appointed the same medical director. The medical director was responsible for systematically reviewing clinic billings to ensure that they were not fraudulent or unlawful. Click title to continue reading...


FEATURE


Genetic Disorder Disclaimer

As a special feature for our Premium subscribers we have included this feature, an agreement containing a Disclaimer of genetic diseases or defects in a surrogacy parenting agreement. Click title to continue reading...