Category: Firm News

Rhode Island Hospital has been fined $300,000 for a surgical error that left a piece of broken drill bit in a patient’s skull. The Rhode Island Department of Health has twice previously fined the hospital, but this is the largest fine it has received thus far.

The hospital acknowledged that a small piece of a drill bit broke off during neurosurgery and was left in a patient’s scalp on August 4, 2010. The piece was one quarter of an inch long, and it was discovered the day after the patient’s surgery during a routine diagnostic imaging exam. The piece was removed on August 6, and the patient was discharged that day, reported The Providence Journal.

Rhode Island Hospital policy states that a patient must undergo an X-ray before leaving the operating room if any surgical tool is unaccounted for after a procedure. After investigating the incident, the Rhode Island Department of Health and the U.S. Centers for Medicare & Medicaid Services (CMS) found that the patient was not X-rayed as required and that the hospital is not actively ensuring that operating-room staff follows established procedures, according to a Department of Health news release.

Further, the Department of Health discovered that the hospital has not responded to multiple reports from staff that equipment was not correctly counted after surgery. The director of the Department of Health, David R. Gifford, said there is a “troubling pattern of disregard for established policies that are designed to protect patient safety and prevent medical errors.”

The Providence Journal reported that, in addition to the fine, the CMS has asked the Department of Health to inspect all areas of the hospital and ensure that it is in compliance with CMS’s Conditions for Participation for Medicare. Licensing boards are also investigating a nurse and two doctors involved in the incident for possible disciplinary action.

Source: Rhode Island Hospital fined for drill-bit piece left in head, Neurosurgery error prompts state investigation of Rhode Island Hospital

With recent pushes to remove the once popular prescription drug Avandia from the market comes a greater awareness of the risks of prescription medication.

In July, a medical advisory panel for the U.S. Food and Drug Administration (FDA) reviewed claims about the serious, even fatal side effects caused by taking the diabetes medication Avandia, which used to be the world’s leading drug for combating high blood-sugar levels. Among the risks of Avandia is an increased risk of heart attacks.

At the conclusion of the Avandia hearings, the majority of the 33-member advisory panel voted to withdraw the prescription drug from the market, narrowly outvoting 10 members of the panel who suggested restricting rather than banning Avandia sales. With such a split vote on the advisory panel, it is unclear how the FDA will respond to the panel’s recommendations.

A similar diabetes medication, Rezulin, was withdrawn from the market in 2000 after the drug was linked to fatal liver damage.

Withdrawing a Drug From the Market

In considering whether a drug should be removed from the market, the FDA considers numerous factors, including:

• The prevalence of a safer alternative
• The severity of the possible harm
• The seriousness of the illness treated by the drug compared to the harm
• The magnitude of evidence against the use of the drug

In the cases of both Avandia and Rezulin, critics have argued that the initial trials lacked trustworthiness and were insufficient to demonstrate drug safety. The FDA is currently reviewing pre-market clinical trial standards to determine whether more rigorous standards exist that could improve trial quality.

Products Liability and Risky Prescription Drugs

Prescription-drug makers may be held responsible for serious side effects of harmful drugs. For more information on prescription drug reactions and product liability, contact an experienced personal injury attorney in your state if you or someone you know has been harmed by dangerous medication.