Scalpel Weekly News

Week of: August 05, 2013

IN THE NEWS


FDA Warns 15 Companies - Stop Illegal Sale of Diabetes Products

The FDA is taking action to remove from the market illegal products, including some labeled as dietary supplements that claim to mitigate, treat, cure or prevent diabetes and related complications. The agency recently issued letters warning 15 companies that the sale of their illegally marketed diabetes products violates federal law. Click title to continue reading... 


 
MEDICAL ALERTS


Antifungal Drug Causing Liver and Adrenal Injury; FDA Limits Use

The FDA is taking several actions related to Nizoral (ketoconazole) oral tablets, including limiting the drug’s use, warning that it can cause severe liver injuries and adrenal gland problems, and advising that it can lead to harmful drug interactions with other medications. Click title to continue reading... 



Vascular Graft Recall Due to Blood Leaking After Implantation

The Albograft Vascular Graft was recalled due to blood leaking from the surface of the graft after implantation. This device was manufactured in April 2011, and distributed from April 2011, through June 2013. Within the U.S., this device was distributed only in Pennsylvania. Click to continue reading...



Flow Restrictors Prevent Child Medication Poisonings

Each year, half a million calls are made to poison centers for medication overdoses in young children. The number of emergency department (ED) visits due to children getting into medicines is rising, with more than 60,000 young children brought to an ED every year because they took medicines while an adult wasn’t watching. Click title to continue reading... 


  CASE ALERTS


Dermatologist Qualified as Expert on Chemical Peel Standard of Care

A woman received a chemical peel that left her with painful burns and scars. She filed a medical malpractice lawsuit against the doctors who performed the procedure and their medical practices. Click title to continue reading...



State-Law Pain Reliever Warning-Based Design Defect Action Preempted

The Federal Food, Drug, and Cosmetic Act (FDCA) requires manufacturers to obtain FDA approval before marketing any brand-name or generic drug in interstate commerce. Once a drug is approved, a manufacturer is prohibited from making any major changes to the formulation of the drug product, including active ingredients, or in the specifications provided in the approved application. Click title to continue reading... 



Clinic Director Given Prison for $63 Million Health Care Fraud

 A former health care clinic director and licensed clinical psychologist at defunct health provider Health Care Solutions Network Inc. (HCSN) was sentenced to serve 135 months in prison for her central role in a fraud scheme that resulted in more than $63 million in fraudulent claims to Medicare and Florida Medicaid. In addition to her prison term, she was sentenced to three years of supervised release and ordered to pay $24.1 million in restitution. Click title to continue reading...