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FDA Meets the Challenge of Regulating Reporting of Adverse Events

Feb 9, 2017
FDA Meets the Challenge of Reporting of Adverse Events

The U.S. Food and Drug Administration (FDA) recently conducted a broad survey regarding reporting standards of medical facilities across the United States. Of the 17 institutions inspected, the vast majority did not file timely reports of injuries and deaths allegedly caused by medical devices.

FDA Examines Adverse Effect Reporting Policies

The inspections in 2016 were sparked by public scrutiny of power morcellation, a surgical procedure that has become controversial due to the potential of spreading of undetected uterine cancer via the device's spinning blades. In addition, there were reports of infections linked to contaminated duodenoscopes. These are flexible, lighted tubes that are inserted into the mouth, throat, and stomach into the top of the small intestine as a diagnostic tool.

"While these events appeared to be the kind that would have fallen under our current medical device reporting requirements, we did not see corresponding adverse event reports in our adverse event (MAUDE) database," acknowledged Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health. Despite these findings, the FDA imposed no penalties against hospitals that neglected to comply with the reporting requirements.

These findings triggered a conversation with FDA officials. In a three-year investigative series, "How Medical Devices Do Harm," a paper known as "The Cancer Letter" focused on failure on the part of hospitals and device manufacturers to report patient injury and death resulting from power morcellators. Personal injury attorneys at Parker Waichman LLP are actively reviewing potential lawsuits on behalf of individuals who have suffered injury from alleged defective medical devices, including power morcellators.

Power Morcellation and Insufficient Information

Power Morcellation and Insufficient Information

A case is cited where a woman underwent power morcellation at Harvard-affiliated Brigham & Women's Hospital on October 17, 2013. After the woman and her husband realized that the power morcellator contributed to the upstaging of her unsuspected leiomyosarcoma, the couple learned they were not the first to be affected. Leiomyosarcoma is a malignant (cancerous) tumor.

Another patient who underwent the same procedure at the same hospital over a year earlier, died on December 7, 2014 from metastatic disease. As this patient was dying, the first patient mentioned, was recovering from her first round of treatments. She subsequently learned she could have avoided power morcellation. The gynecologists at Brigham, allegedly knew of the risks, but did not inform her or report the second woman's case to the FDA.

In the case of the power morcellator, "there was clearly corporate negligence - at best professional lethargy - at work," said "The Cancer Letter." In the years following, over 300 patients and families have come forward claiming injury. The FDA said it did not receive any reports of adverse events relating to power morcellators before December 2013.

During the 2016 inspection, the FDA found that Brigham & Women's Hospital did not, upon becoming aware of patient injury or death, submit adverse outcome reports to the FDA or to device manufacturers within the 10 working days, as required by federal law.

A Brigham spokeswoman told The Wall Street Journal and The Boston Globe that the hospital contacted the FDA by phone in March 2014 about the aforementioned events. However, hospital officials did not believe the events were reportable as the cases did not meet the criteria for mandatory reporting.

The spokeswoman said, "The device functioned as expected and was used in the way it was intended, although with unintended and tragic consequences." Other hospitals linked to patient harm resulting from power morcellators included Rochester General Hospital and the University of Rochester Medical Center. They were found to lack written medical device reporting procedures and did not meet documentation and recordkeeping requirements, according to the FDA report.

The FDA issued a safety advisory in April 2014, against power morcellators, finding that one in 350 women with symptomatic fibroids are at risk of having an undetected cancer spread by morcellation.

Progress Ongoing for Timely Reporting of Adverse Events

Lapses were also found through inspection at hospitals including Massachusetts General, UMass Memorial, New York Presbyterian Hospital, and UCLA Ronald Reagan Medical Center. The facilities "failed to provide all information concerning individual adverse event reports that is reasonably known to them, including information found in documents in possession of the user facility," according to the agency report.

The agency has since set up a network of 300 hospitals, called MedSun, or the Medical Product Safety Network. Even with MedSun, all hospitals were required to continue reporting until FDA implements, by regulation, a program limiting user facility reporting to a subset of facilities. "Based on the number of user facilities in the United States and the number of reports we receive, we believe that these hospitals are not unique in that there is limited to no reporting to FDA or to the manufacturers at some hospitals," Jeffrey Shuren wrote. "We want to work with all hospitals to address these issues."

Legal Information and Advice Regarding Medical Devices

Parker Waichman LLP has had years of experience representing clients in numerous allegedly defective medical device lawsuits. The firm offers free, no-obligation case evaluations to anyone with questions about filing a lawsuit over adverse effects from medical devices. We urge you to contact us at 1-800-YOURLAWYER (1-800-1968-7529).


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