Devastating Medication Error; FDA’s Recall Weakness; Insurers Break State Laws

Derick Alison
Derick Alison
6 Min Read

Welcome to the latest edition of Investigative Roundup, highlighting some of the best investigative reporting on healthcare each week.

Hospital Patient Nearly Died After Medication Error

In 2021, a 54-year-old COVID patient was set to receive a final dose of the antiviral drug remdesivir before being discharged. However, he nearly died after he was instead given cisatracurium, a muscle-paralyzing agent that has been used in lethal injections, by mistake, the Philadelphia Inquirer reported.

After more than a month at Mercy Fitzgerald Hospital in Darby, Pennsylvania, Didier Epopa spent several more months in a rehabilitation center, re-learning how to walk and talk, the Inquirer reported. Once a jogger who had been pursuing a new career in information technology, Epopa now suffers from severe brain injuries and may never run or work again.

Medication errors like the one that nearly killed Epopa are among the nation’s top 10 causes of patient deaths and permanent harm, the Inquirer reported.

In Epopa’s case, “Following proper procedures would have prevented the error,” the Inquirer reported, citing a review of his 4,421-page medical record, state pharmacy regulations, and licensing records, as well as the hospital’s policies on medication management. “Yet no one involved has faced public scrutiny or consequences.”

The hospital has singled out a part-time pharmacy intern as having mislabeled the IV bag given to Epopa, the Inquirer reported, citing court records. (Epopa and his wife have filed a medical malpractice suit against Trinity Health Mid-Atlantic, which owns Mercy Fitzgerald Hospital.)

A spokesperson for Trinity Health declined the Inquirer’s request for comment, citing pending litigation.

FDA’s Recall Weakness

Nearly 3 weeks after the FDA requested a recall of potentially contaminated eye drops, the manufacturer finally initiated one, raising concerns about the agency’s effectiveness, STAT reported.

“There have been no reports of injuries, but some key lawmakers are arguing the time it took the FDA to coax a voluntary recall shows the agency should be given the power to force them,” STAT wrote.

The situation stems from unsanitary conditions FDA inspectors found at a facility in India that makes over-the-counter eye drops sold at multiple U.S. retailers and distributors, STAT reported. The FDA initially asked Kilitch Healthcare India Limited to voluntarily recall its product on October 25, but the company didn’t do so until November 13. (Kilitch did not respond to STAT’s request for comment on the matter.)

“When the manufacturer and distributor failed to act quickly to recall the products, the FDA immediately contacted retailers and the brands that sell these products under their name,” a spokesperson for the agency told STAT.

However, some want more power for the FDA, and for drug labels to specify their manufacturers, STAT reported.

“It’s unacceptable that millions of consumers were put at risk for weeks while the manufacturer refused to voluntarily recall their products following an alarming FDA inspection at their manufacturing facility,” a spokesperson for Rep. Frank Pallone (D-N.J.), the ranking Democrat on the House Energy & Commerce Committee, told STAT.

Health Insurers Break State Laws Meant to Protect Patients

In the last 5 years, health plans have violated state laws outlining what insurers must cover no less than dozens of times, ProPublica reported.

“In the most egregious cases, patients have been denied coverage for lifesaving care,” ProPublica wrote. And though hundreds of state laws enacted in recent decades “don’t apply to every type of health plan,” they’re “supposed to provide protections for tens of millions of people.”

State insurance departments are responsible for enforcing such laws, but researchers, consumer advocates, and even some regulators told ProPublica that many departments are simply ill-equipped to do so.

“They just honestly don’t have the resources to do the type of auditing that we would need,” Sara McMenamin, PhD, MPH, associate professor of public health at the University of California San Diego, told ProPublica.

Furthermore, about 65% of employees who get health insurance through their jobs work for employers paying directly for healthcare, ProPublicaa reported. Self-funded plans are regulated by the federal government and exempt from state coverage requirements.

Increasingly, employers are turning to these plans, in part because they don’t have to cover care that states require, ProPublica reported. And though the federal government also has coverage mandates, “state laws can be more robust.”

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    Jennifer Henderson joined MedPage Today as an enterprise and investigative writer in Jan. 2021. She has covered the healthcare industry in NYC, life sciences and the business of law, among other areas.

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