medical devices

FDA hasn’t eliminated secret reports

The U.S. Food and Drug Administration said it wants to improve transparency around medical device safety, yet the agency is still allowing device companies to file secretive reports of deaths involving novel, permanent implants in the heart.

Earlier this year, the FDA ended a little-noticed but long-running system known as “alternative summary reporting” (ASR), which previously had let device companies avoid publicly filing full narrative reports about specific devices that the agency felt were well-understood.

The ASR program was ended after then-FDA Commissioner Dr. Scott Gottlieb tweeted in March that it was “imperative that all safety information be available to the public.” (Gottlieb left the agency in April.)

Yet last week, the FDA declined to release any information about four deaths summarized in a report about Boston Scientific’s Watchman left-atrial appendage closure device — a novel, permanent heart implant used to cut stroke risk in patients with atrial fibrillation.

And in October, a research letter published in JAMA Internal Medicine said the FDA was still accepting secretive “summary” reports of problems involving Edwards Lifesciences’ Sapien 3 aortic heart valve and Abbott Laboratories’ MitraClip system for mitral valve repair.

Though the FDA ended alternative summary reporting, it still allowed Boston Scientific to file an adverse event report that summarized four deaths in a few lines of text, and even kept secret the name of the underlying study that uncovered the deaths. The FDA declined to release any further detail about the four deaths.

An FDA official said in an e-mail that the secret Watchman reports were part of a different summary reporting system that the FDA continues to operate.

Last year, the FDA said it was making changes in its device-surveillance division to “free up resources to better focus on addressing the highest risks, such as deaths and serious injuries, associated with medical devices.”

Boston Scientific said the Watchman carries a low complication rate, but the FDA considers it a Class III device, the highest-risk category. There was no device like the Watchman on the U.S. market until it was approved in 2015. Even today, the plug-like system has no direct competitor in the domestic market.

Like other devices, the Watchman is being studied as part of a large-scale “postmarket” research effort called a device registry.

FDA officials said adverse-event reports captured in device registries can be exempted from federal laws requiring public disclosure, though it’s not clear that the agency has ever published rules on how the system works.

Madris Tomes, a former FDA device-report reviewer who now runs a device-transparency business called Device Events, said the problem with device registries is that they offer no transparency to most doctors or the public.

“Providing these registry exemptions makes it so that deaths can be summarized and very difficult to quantify even to the manufacturers,” Tomes said in an e-mail. “When a summary report is submitted to the FDA there is no narrative, which is the section that explains the patient outcome. To make matters worse, the patient problem codes [outcomes] are redacted by the FDA. This renders the summary reports almost useless.”

An FDA spokeswoman said it is not true that the agency knowingly allows medical device companies to keep secret the details of fatalities involving novel, high-risk devices. She said the granting of an exemption for a registry study does not relieve a manufacturer of the requirement to investigate and report problems involving medical devices.

Joe Carlson

legal services

Rosenbaum saluted for LegalCorps service

Marty Rosenbaum, a veteran Minneapolis business lawyer, found a perfect fit when he signed up to volunteer with LegalCorps.

“I got involved as a LegalCorps when I was looking for opportunities to get Maslon’s transactional attorneys more involved in pro bono work,” Rosenbaum said. “LegalCorps … allows business lawyers to use our special skills and expertise. As I have served LegalCorps clients and interacted with our partner agencies, I have seen the value of providing access to business law advice that can strengthen our underserved communities in Minnesota.”

Last month, the nonprofit adviser to fledgling small businesses and nonprofits, recognized him for 15 years of continuing service.

In addition to a decade on the board, Rosenbaum continues to staff “advice” clinics since 2006, and helps numerous shoestring entrepreneurs, including a St. Paul woman’s business that helps seniors live independently at a fraction of nursing home costs.

Rosenbaum also serves as co-chair of the Pro Bono Committee of the Business Law Section of the Minnesota State Bar Association, and is past chair of the Maslon Pro Bono Committee.

Neal St. Anthony