Medical Risk Law Weekly News

Week of: July 23, 2012


Anesthesia System Recalled For Failing To Switch On and Off Possibly Causing Severe Injury

The FLOW-i Anesthesia System, which administers anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as supporting patients with a limited ability to breathe, was voluntarily recalled. This is a Class 1 recall, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.


Anesthesia Ventilator Recalled Due To Potential Adverse Health Consequences Including Death from Overdose

The Aestiva/5 7900 Ventilator, intended for continuous breathing support for the care of patients who require mechanical ventilation during surgical procedures, was voluntarily recalled. This ventilator is used in hospitals and other health care facilities. The manufacturer sent an "Urgent Medical Device Correction" letter to its customers.

Heart Test Recalled for Unpredictable False Results

Components of the Alere Triage test system, specifically, the Triage CardioProfiler Panel, Triage Cardiac Panel, Triage Profiler SOB Panel, Triage BNP, and Triage D-dimer, were voluntarily recalled on May 22, 2012.  Alere Triage is a rapid diagnostic test system comprised of a meter and various test devices that aid in the diagnosis of diseases and health conditions including heart failure and myocardial infarction and aid in assessing patients for pulmonary embolism. Customers were instructed to discontinue use of the affected product.

Invasive Staphylococcus Aureus Infections Associated with Pain Injections and Reuse of Single-Dose Vials

Patients in the U.S. healthcare system continue to contract life-threatening, yet completely preventable, infections as a result of healthcare providers’ failure to follow CDC’s safe injection recommendations. Breaches in safe injection practices resulted in outbreaks at two outpatient clinics performing pain remediation procedures. At least ten patients were hospitalized with invasive Staphylococcus aureus or methicillin-resistant Staphylococcus aureus (MRSA) infections.  Additional patients were treated with antibiotics on an outpatient basis, and one patient was found deceased. The cause of death was listed as multiple drug overdoses. However, invasive MRSA could not be ruled out.


Next-of-Kin Has No Property Right in Human Remains Including Brain Disposed of After Lawful Investigation

The defendant county medical examiner performed an autopsy to determine a woman’s cause of death pursuant to a lawful criminal investigation. The woman’s body, except for her brain, was returned to the woman’s next of kin, her daughter. The medical examiner retained the woman’s brain for further study without informing the daughter. The brain was later incinerated as medical waste. The daughter sued the defendant for various state law claims and violating the Due Process Clause of the Fourteenth Amendment by denying her the right to dispose of her mother's brain as she saw fit.

Statute of Repose Applies To Dermatologist’s Failure To Diagnose Melanoma

A woman consulted the defendant dermatologist regarding a number of moles. Over eleven years the dermatologist took biopsies. Initially he sent these biopsies to a pathology laboratory, which determined they were noncancerous. Subsequently he examined the biopsies himself and determined they were noncancerous. Twelve years after initially consulting the dermatologist, the woman discovered a lump on her chin and consulted another physician. The lump was ultimately removed and determined to be melanoma. The biopsies examined by the dermatologist and the original pathology lab were reexamined by another pathologist. Biopsies from as much as twelve years earlier were found to exhibit signs of melanoma. Fifteen months after she was diagnosed with melanoma, the woman died. The woman’s estate sued the dermatologist, his clinic, and the original pathology laboratory for negligence.

Hospital May File Lien on Medicaid-Eligible Patient and Third-Party’s Insurer Settlement

A driver negligently ran a stop sign and crashed into a car containing the plaintiffs, a woman and her three sons. The negligent driver’s car was insured by the defendant insurance company for up to $250,000 for each injured individual, with a total cap of $500,000 for each accident. The plaintiffs received medical care at the defendant hospital valued at $182,799.61. The plaintiffs were eligible for Medicaid at the time of the accident. The defendant hospital did not bill Medicaid for the plaintiffs’ medical care. It filed liens against the proceeds of any future settlement reached between each of the individual plaintiffs and the defendant insurance company.