Scalpel Weekly News

Week of: June 03, 2013

IN THE NEWS


Adverse Reactions to Compounded Steroid Injections from Tennessee Pharmacy

The FDA is working closely with the Centers for Disease Control and Prevention and the Tennessee Board of Pharmacy to investigate reports of seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy, LLC (Main Street) of Newbern, Tenn. The reports of adverse events are all from patients who received preservative free methylprednisolone acetate (80 mg/mL) by injection. At least one of these appears to involve fungus. Click title to continue reading...


 
MEDICAL ALERTS


Deadly Potential for Delivery System Catheter Separation Prompts Global Recall

Based on its investigation into complaints that the delivery system of the device had separated at the tip of the inner catheter, Cook Medical has initiated a global recall of its Zilver PTX Drug Eluting Peripheral Stent. The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death. Click title to continue reading...



Methotrexate Sodium Injectable Vials Recalled Due to Particulate Matter Contamination

Sandoz is conducting a voluntary nationwide recall to the hospital/user level of two lots of its Methotrexate Sodium, USP, 25 mg/mL, 40 mL vial injectable product in the U.S., due to the discovery of particulate matter in vials during routine quality examination of retention samples at the manufacturer. The particulates are not associated with microbial contamination. Click title to continue reading... 



Severe Shortage of First-Line Antituberculosis Medication; TB Control Affected

Tuberculosis (TB) continues to be a leading infectious cause of death globally, but most patients can be cured by drug treatment. Isoniazid (INH) was introduced in 1951 as an anti-TB medicine and continues to be one of the leading drugs of choice. Only three suppliers provided this drug in 2012 and now one has stopped. Click title to continue reading... 


  CASE ALERTS


Untimely Vaccine Act Claim Brought in Good Faith Eligible for Attorney Fees

A woman received a series of injections of a Hepatitis-B vaccine. Shortly after her final injection, she began to experience symptoms that, after six years, led to a diagnosis of multiple sclerosis (MS). A year after her diagnosis she learned of a connection between Hepatitis-B vaccine and MS. Click title to continue reading... 



Juror Challenge in Wrongful Death Suit re Ruptured Appendix Required Reversal

A woman in her thirty-seventh week of pregnancy presented to the emergency room suffering from abdominal pain. She was assessed and sent home twice before being admitted on her third visit. Her doctor induced labor and she gave birth to a healthy daughter. The woman continued to suffer from severe abdominal pain. Exploratory surgery revealed a ruptured appendix and abscess. Click title to continue reading...



ISTA Pharmaceuticals Pays $33.5 Million for Drug Misbranding and Illegal Remuneration

Pharmaceutical company ISTA Pharmaceuticals, Inc., pled guilty to conspiracy to introduce a misbranded drug into interstate commerce and conspiracy to pay illegal remuneration in violation of the Federal Anti-Kickback Statute. The guilty pleas are part of a global settlement with the United States in which ISTA agreed to pay $33.5 million to resolve criminal and civil liability arising from its marketing, distribution and sale of its drug Xibrom. Click title to continue reading...