Fentanyl patch blamed in autistic teen's death

Oct 1, 2009

2008 08 29 15 39 44 564 Justice Scale 70

The mother of a 15-year-old boy who died from wearing a fentanyl patch prescribed after dental surgery is suing Seattle Children's Hospital and the two dentists who prescribed the drug.

“I cannot even begin to describe the pain and sorrow that I feel for the death of my dear son.”
— Tammy Jarbo-Blankenship

The hospital has accepted responsibility for the boy's death, calling it a "fatal medication error." But a thorough investigation concluded the tragedy was not the fault of any one individual, according to hospital officials.

Michael P. Blankenship of King County, WA, was admitted to the dental clinic at Seattle Children's Hospital for a routine teeth extraction and cleaning procedure on March 9 of this year, according to a complaint filed in King County Superior Court.

The attending physician and surgeon, Barbara Sheller, D.D.S., and her assistant, dental resident Soultana Chatzopoulos D.D.S., are also named in the lawsuit.

After the surgery, Blankenship was prescribed a fentanyl patch for pain relief because he was autistic and could not tolerate pills or liquid medicines. He was given a 100-microgram patch, the highest dosage of fentanyl sold in patch form.

Drs. Sheller and Chatzopoulos had never written or issued a prescription for a fentanyl patch and were unfamiliar with the proper dosage that should be prescribed to any patient, according to the complaint. They also were unaware of the potential contraindications -- notably, that the patch should only be given to opioid-tolerant patients, the complaint alleges.

Blankenship was not opioid-tolerant, according to the complaint.

The complaint faults Drs. Sheller and Chatzopoulos for ignoring or failing to inquire whether any of the contraindications for prescribing fentanyl existed when they prescribed the medication for Blankenship. The discharge nurse, hospital staff members, and the staff pharmacists also assured Blankenship's mother, Tammy Jarbo-Blankenship, that the patch and dosage were safe.

She went ahead and applied it that evening, but found him unresponsive the next morning. Paramedics were called to resuscitate him, but their efforts failed.

Blankenship's younger brother was present when his brother was declared dead, then carried out of the home in a body bag, according to the complaint.

The King County medical examiner determined that the cause of death was from fetanyl and ketamine intoxication. The concomitant use of fentanyl and ketamine increases the risk of respiratory depression, hypotension, and profound sedation that could lead to death, according to the complaint. The dentists were either unaware of or ignored these risks when they prescribed fentanyl while ketamine was still in Blankenship's system from the surgery.

Fentanyl patch warnings

Incorrect prescription of the fentanyl patch has become a persistent problem in recent years, leading to numerous reports of overdoses and life-threatening injuries, according to the U.S. FDA.

The agency first issued an advisory on the safe use of the fentanyl patch in 2005. In 2007, the FDA issued a second and more strongly worded advisory, warning that the patch should only be used by patients who are opioid-tolerant and have chronic pain that is not well-controlled with other pain medicines:

Despite issuing an advisory in July 2005 that emphasized the safe use of the fentanyl patch, FDA continues to receive reports of death and life-threatening side effects in patients who use the fentanyl patch. The reports indicate that doctors have inappropriately prescribed the fentanyl patch to patients for acute pain following surgery, for headaches, occasional or mild pain, and other indications for which a fentanyl patch should not be prescribed. ... For patients who are not opioid-tolerant, the amount of fentanyl in one fentanyl patch of the lowest strength is large enough to cause dangerous side effects, such as respiratory depression (severe trouble breathing or very slow or shallow breathing) and death.

Also, the amount of fentanyl in Blankenship's system at or near the time of death was 19.1 nanograms per milliliter (ng/mL), a level considered toxic for a patient who is not opioid-tolerant.

The complaint alleges that Seattle Children's Hospital and its doctors were negligent and reckless by failing to maintain and/or follow appropriate safeguards for the proper and accurate prescription of the powerful pain medication.

"I cannot even begin to describe the pain and sorrow that I feel for the death of my dear son," Jarbo-Blankenship said in a prepared statement. "Michael's needless death has devastated my entire family, and has especially impacted my youngest boy who still refuses to live in our home where Michael was found dead. And knowing how egregious and preventable the mistake was just makes our grief and suffering that much more unbearable."

David Fisher, M.D., medical director at Seattle Children's Hospital, said in a prepared statement that the hospital staff is "deeply sorry" for the family.

"While this medication was prescribed and dispensed with the intention of providing the best care for the patient, in this case, both the delivery system and the dose were inappropriate," the hospital said in the statement. "Our detailed root cause analysis identified that this occurred because our processes failed at multiple points."

As a result, the hospital has changed its policy on fentanyl patches. Hospital clinicians now need to get approval from pain medicine specialists before prescribing and administering fentanyl. Also, the hospital has added information to its medication database that highlights the indications and contraindications for using a fentanyl patch.

Jarbo-Blankenship is seeking unspecified damages for wrongful death, severe grief, and emotional distress.