Scalpel Weekly News

Week of: January 28, 2013

IN THE NEWS


FDA Proposes Requiring Metal-on-Metal Total Hip Replacement Manufacturers Submit Premarket Approval Applications, Updates Safety Recommendations

The FDA issued a proposed order requiring manufacturers of metal-on-metal total hip replacement systems to submit premarket approval (PMA) applications. Metal-on-metal total hip replacement systems were marketed in the U.S. prior to 1976 legislation that gave the agency premarket authority over medical devices. Click title to continue reading...


 
MEDICAL ALERTS


Second-Line Anti-Tuberculosis and Other Drug Shortages Cause Deadly Adverse Outcomes, Promote Resistance, and Increase Drug-Resistant Disease

A nationwide survey of TB programs found that the majority of programs reporting multidrug resistant (MDR) TB also have difficulty in obtaining the drugs needed to treat it. In comparison to drug-susceptible TB, treatment of drug-resistant TB requires a lengthy regimen with additional drugs that are less effective, more toxic, and more expensive. Click title to continue reading...



FDA Approves New Seasonal Influenza Vaccine Made Using Novel Technology; Potential Faster Start-Up of Vaccine Manufacturing Process in Pandemic

The FDA approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age. Click title to continue reading...



FDA Approves Plasma Product to Treat Patients with Blood Clotting Disorders

The FDA approved Octaplas, a pooled plasma (human) blood product for the replacement of clotting proteins (coagulation factors) in certain medical conditions where patients have insufficient levels. Clotting protein deficiencies can cause excessive bleeding or excessive clotting. Click title to continue reading...


  CASE ALERTS


Jury Instructions on General Physician Standard of Care and Specialist Standard of Care Not Error When All Testimony Pointed to Specialist Standard

A child suffered from multiple hereditary exostosis, a condition causing osteochondromas or bone tumors to grow around the ends of the long bones. The tumors can cause permanent conditions such as pain, loss of motion, deformity, or joint alignment problems. Click title to continue reading...



Federal Circuit Outlines Elements of Proof Required to Establish Prima Facie Case of Significant Aggravation for Off-Table Vaccine Act Claim

A man received the influenza vaccine. Prior to his vaccination he had no clinical symptoms of multiple sclerosis (MS) or other neurological disorder. Eleven days after his vaccination, the man experienced numbness in his left hand, arm, and the left side of his head and face. Click title to continue reading...



First Circuit Holds Significant Risk of Relapse into Substance Dependence Can Constitute Current Disability Under Long-Term Disability Insurance

An anesthesiologist became addicted to the opioid drugs she administered in her practice. She entered an in-patient substance abuse treatment program. After she was discharged from the in-patient program, she remained under regular medical supervision on an outpatient basis. Click title to continue reading...