Medical Risk Law Weekly News

Week of: April 02, 2012


New FDA Guidance on Considerations Used in Device Approval and De Novo Decisions

The FDA announced first-of-a-kind guidance for medical device manufacturers describing how the benefits and risks of certain medical devices are considered during pre-market review.


Product to Treat Gastroesophageal Reflux Disease as Alternative to Surgery Is Approved

The FDA approved the LINX Reflux Management System for people diagnosed with gastroesophageal reflux disease (GERD) who continue to have chronic symptoms, despite the use of maximum medical therapy for the treatment of reflux.

Correction Notification Issued to Avoid Malfunction for Instructions on Use of Heart Pump

Thoratec Corporation initiated a worldwide medical device correction notification of all serial numbers of the HeartMate II® Left Ventricular Assist Systems (HM II LVAS) having Catalog No. 104692, 103393, 104911, or 104912.


Health Providers Have Immunity for Failure to Resuscitate Accident Victim Appearing Deceased

An action was brought against volunteer emergency medical providers alleging that the victim suffered severe permanent injuries due to the providers’ willful and wanton negligence in failing to timely discover that the accident did not kill the victim.

Expert Testimony Required To Establish Negligence in Removing Pain Pump Catheter

An action seeking damages for negligent removal of a pain pump catheter required expert medical testimony to establish liability and could not rely on a theory of Res Ipsa Loquitur.

Paramedic’s Intubation of Patient Was Ministerial Act Not Entitled to Official Immunity

Upon responding to a 911 call, a paramedic found a man unconscious and intubated him. However, upon arrival at the hospital it was determined that the endotracheal tube was in the patient’s esophagus rather than his trachea, causing the decedent to suffer an anoxic brain injury resulting in his death. The patient’s wife sued the paramedic for wrongful death.