Scalpel Weekly News

Week of: September 23, 2013

IN THE NEWS


FDA Issues Import Alert on India Drug Manufacturer - Unsafe Products

The FDA issued an import alert under which U.S. officials may detain at the U.S. border drug products manufactured at Ranbaxy Laboratories, Ltd.’s facility in Mohali, India. The firm will remain on the import alert until the company complies with U.S. drug manufacturing requirements, known as current good manufacturing practices (CGMP). Click title to continue reading...


 
MEDICAL ALERTS


FDA Approves Botox for Crow’s Feet

The FDA approved a new use for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe lateral canthal lines, known as crow’s feet, in adults. Botox Cosmetic, manufactured by Allergan Inc. based in Irvine, California, is the only FDA approved drug treatment option for lateral canthal lines. Click title to continue reading...



Urine Bacteria Panels Recalled; Infection Treatment Concerns

Siemens Healthcare Diagnostics, Inc., of West Sacremento, California, recalled two of their panels used for determining antimicrobial susceptibility and/or identification for gram-negative bacteria in urine. MicroScan Synergies plus and MicroScan rapID/S plus Negative Panels report false susceptible and false intermediate results for imipenem and meropenem antimicrobial susceptibility testing when using the MicroScan WalkAway System. Click title to continue reading... 



Antibiotic-Resistant Infections: CDC Actions for Halting Health Threat

Every year, more than two million people in the United States get infections that are resistant to antibiotics and at least 23,000 people die as a result, according to a new report issued by the CDC. The report, Antibiotic Resistance Threats in the United States, 2013, presents the first snapshot of the burden and threats posed by antibiotic-resistant germs having the most impact on human health. Click title to continue reading...


  CASE ALERTS


Connecticut Question Certified: "Good Tobacco" Defense to Strict Liability

A former smoker sued a cigarette manufacturer in diversity, asserting claims under Connecticut’s Products Liability Act (CPLA) for strict liability and negligent design. She claimed that the cigarettes she smoked for 25 years were defective and caused her laryngeal cancer. A jury found that the cigarettes were defective. Click title to continue reading... 



Gaps Severed Continuity; Limitations Not Tolled by Continuous Treatment Doctrine

A man suffered from bladder tumors. Over the course of 17 years between his diagnosis and his death, the man was treated by a doctor. When the man experienced hematuria, he would return for treatment. He did not seek treatment for one 28-month period and one 22-month period during the 17 years when he did not experience hematuria. Click title to continue reading...



$3.5 Million to Settle Allegations of Uniformed Service Member Overbilling

Radiation oncology providers in Pensacola, Florida, will pay $3.5 million to the U.S. government and the state of Florida to resolve allegations that they billed Medicare, Medicaid, and TRICARE – the health care program for uniformed service members, retirees and their families worldwide – for radiation oncology services that were not eligible for payment. Click title to continue reading...