Medical Risk Law Weekly News

Week of: July 30, 2012


Ventilator Recalled Due To Potential Adverse Health Consequences Including Death

The EnVe Ventilator, intended for continuous breathing support for the care of newborns through adult patients who require mechanical ventilation, was voluntarily recalled. This ventilator is used in hospitals and other health care facilities. The manufacturer sent an "Urgent Product Recall" letter to its customers.


CDC Provides 50-State Survey of Prescription Drug Overdose Laws

The CDC's National Center for Injury Prevention and Control and CDC's Public Health Law Program have collaborated and released a legal guide dealing with state prescription drug overdose laws.

Kyprolis Approved For Multiple Myeloma

The FDA approved Kyprolis (carfilzomib) to treat patients with multiple myeloma who have received at least two prior therapies, including treatment with Velcade (bortezomib) and an immunomodulatory therapy.

Afinitor Approved For Advanced Breast Cancer

The FDA approved Afinitor (everolimus) for use in combination with Aromasin (exemestane) to treat certain postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer. The drug combination is intended for use in women with recurrence or progression of their cancer after treatment with Femara (letrozole) or Arimidex (anastrozole).


Medical Expert’s Affidavit and CV Together Meet Expert Qualification and Injury Causation Requirements

A woman with a combination of immune diseases that left her susceptible to infection consulted a plastic surgeon about surgical breast reduction. The plastic surgeon performed the surgery without giving the woman pre- or post-operative antibiotics. The woman called the surgeon eight days later complaining of a blister on her breast. The surgeon examined her that day and noted some necrotic tissue, which he removed. Four days later the woman saw the plastic surgeon in the emergency room where he noted black tissue cast off from the surface of the skin. The woman was admitted for surgery to remove the necrotic tissue, which was tested for signs of infection.  The test results came back three days later positive for staphylococcus epidermis and enterococcus faecjum. The woman was prescribed antibiotics and sent home. Two days later she returned to the plastic surgeon’s office complaining of pain. She was admitted to the hospital where she was given IV antibiotics and underwent an MRI, which revealed fluid collecting in both breasts. The plastic surgeon drained the fluid from both breasts. The fluid was not tested for signs of infection. The wound where the plastic surgeon had removed necrotic tissue enlarged over the next twenty days. Ultimately the woman was referred to another doctor for breast reconstruction and skin grafts. The woman sued the plastic surgeon for negligently performing surgery without first prescribing prophylactic antibiotics and failing to promptly diagnose and treat her infection.

Healthcare Provider Assigned Personal Injury Protection Benefits Not Obligated To Provide Business, Billing, or Referral Information

Individuals had personal injury protection (PIP) policies from the plaintiff insurance company, and when they were injured, they received medical care from the defendant healthcare provider.  To pay for their medical care, the individuals assigned their PIP benefits to the healthcare provider. The healthcare provider submitted claims for reimbursement under the PIP policies to the insurer.


Suspecting the healthcare provider of fraud, the insurer asked the healthcare provider for information regarding its ownership structure, billing practices, and regulatory compliance. The healthcare provider refused to provide this information. The insurer sought a declaratory judgment that the healthcare provider as the assignee of the PIP benefits was required to provide the information. The insurer argued that the terms of the PIP policies required the insureds to cooperate with the investigation of any claim under the policy and the defendant’s failure to supply the information violated the state’s PIP discovery statute. As relief, the insurer requested that either the healthcare provider provide the information or they would be ineligible to receive PIP reimbursement. The trial court granted declaratory judgment in favor of the insurer. The appellate court reversed.

Rescue Squad Not Immune From Wrongful Death Suit

A few miles from a hospital a man was shot. The city rescue squad arrived on the scene shortly after. The two emergency medical technicians (EMTs) staffing the ambulance performed CPR and requested helicopter evacuation of the patient to another hospital. Their request was denied.  They loaded the man into the ambulance and arrived at the nearby hospital thirty minutes after they arrived on the scene. The estate of the man sued the rescue squad for negligently delaying his transportation to the nearby hospital, thereby causing his death.