A Minneapolis woman says Hennepin Healthcare paramedics violated her civil rights when they forcibly injected her with ketamine last year and enrolled her in a clinical trial without her consent.
Brittany Buckley filed a federal lawsuit this week against the hospital, alleging medical malpractice, negligence and excessive force resulting in breathing and heart complications as EMS workers drove her to the downtown Minneapolis hospital.
After the Star Tribune in June reported on the experience of Buckley and other patients, Hennepin Healthcare halted the drug trial.
"We are aware of the pending litigation," Hennepin Healthcare spokesman Thomas Hayes said in a statement Thursday. "As it moves through the legal process, we cannot comment further publicly other than to say that we always seek to provide the best care and treatment to our patients."
Last December, struggling on the two-year anniversary of her father's death, Buckley relapsed on wine in her northeast Minneapolis apartment. She fell asleep on her couch, and a concerned friend who knew she was trying to quit drinking called 911 asking for a welfare check. Police and paramedics arrived at her apartment, and after a brief conversation, told her she must come to the hospital.
Buckley said she didn't want to go, but the emergency responders strapped her to a gurney, according to the lawsuit. She said she cried and complained but did not physically resist or push against the restraints, according to the lawsuit. The paramedics' accounts indicated she was "kicking, biting and head butting" them.
At that point, the paramedics said they elected to "enroll her into the ketamine trials," referring to a Hennepin Healthcare study comparing the powerful sedative to a similar drug called Versed. Buckley asked not to be drugged when she saw the paramedics preparing the syringe. They gave her the shot anyway.
Almost immediately after the injection, she struggled to breathe on her own, and paramedics put her on a ventilating device in the ambulance. She began showing signs of tachycardia, or abnormally high heart rate, according to the complaint.
Buckley woke up the next day in a bed at HCMC with a breathing tube down her throat and a document in her room saying she'd been enrolled in ketamine research.
"This is all I got," she said in a June interview. "Just this form saying that I'm part of their little test."
Buckley does not remember the entire encounter, but later retrieved footage captured on officer body cameras.
Following a series of Star Tribune reports on incidents of police urging paramedics to use ketamine during 911 calls, Hennepin Healthcare announced it would pause the ketamine study and other research with a similar consent policy.
The lawsuit states paramedics put Buckley at unnecessarily high risk by using such a powerful drug, which came with serious safety concerns, according to previous Hennepin Healthcare studies. The hospital had taken all other sedatives out of the ambulance and instructed paramedics to use only ketamine for the purposes of a drug trial, taking away paramedics' "risk-benefit analysis to choose an appropriate sedative given the circumstances," according to the complaint.
The lawsuit argues Buckley wasn't so agitated that she needed ketamine. To measure agitation, the hospital uses a scale on which "plus-four" means "severely agitated." Buckley was a "plus-two," according to her medical records, which she shared with the Star Tribune.
The study used a "waiver of consent" protocol, meaning patients could opt out, but did not need to consent to be enrolled in the research. Inspectors from the Food and Drug Administration visited the hospital eight times in August and found the board that approved the research had fast-tracked the studies and failed to follow proper guidelines for consent, according to the inspection reports.
Hennepin Healthcare has responded formally to the inspection reports, and the FDA has not completed its report, said hospital CEO Dr. Jon Pryor in an interview last week.
"I do stand by the fact that we followed our processes to the best of our knowledge or the best of our ability," Pryor said. "We didn't flout patient safety rules. We tried to protect our patients who are our community. We care about them."