Exposé Hits Ethics Conflicts in Shuren’s Job and Wife’s Industry Roles

An 8/20 New York Times investigative article exposes alleged conflicts of interest in retiring CDRH director Jeff Shuren’s regulatory role and the legal work done by his wife Allison for the same industry at the iconic industry law firm of Arnold & Porter, sometimes apparently overlapping into the same companies, if not the same products.

“Dr. Shuren signed ethics agreements obtained by the Times that were meant to wall him off from matters involving Arnold & Porter’s business,” the article said. “But it’s not clear how rigorously the ethics agreements were actually enforced… In a review of thousands of pages of court documents and FDA records and dozens of interviews with current and former agency staff members and advocates, the Times identified some clients and several instances in which the Shurens’ roles intersected.”

The Times found that Arnold & Porter represented Theranos, the discredited blood testing company, back in 2015. “While Dr. Shuren said he was recused from the matter, court records suggested he remained involved,” it said. “In another case, Ms. Shuren’s firm was working on a $63 billion acquisition of the company Allergan in 2019 when Dr. Shuren initially declined to urge a recall of the company’s breast implants tied to a rare cancer. The couple’s work overlapped again in 2022 when Dr. Shuren announced a proposal to strengthen warnings given to patients preparing for LASIK vision correction surgery. Two of Ms. Shuren’s clients opposed the plan; the recommendations have yet to be put in place.”

In a statement provided to the Times, FDA said “it appears there were certain instances from about 10 years ago for which Dr. Shuren should have either recused himself or sought ethics authorization to participate to avoid any potential appearance of bias.” These lapses were confirmed by the agency to involve the Theranos case as well as Alcon, which was a client of Shuren’s wife. FDA further said that there is “no indication that any FDA regulatory decisions were impacted by Dr. Shuren’s wife’s employment nor that Dr. Shuren made any decisions in the interest of parties other than the public served by the FDA.”

Shuren and possible conflicts of interest involving his wife were first raised in 2015 by cardiothoracic surgeon Hooman Noorchashm, who had earlier demanded Shuren’s resignation on other grounds. In a widely circulated email complaint, Noorchashm questioned how Allison Shuren’s “professional role as a visible defender of device companies could possibly not pose a conflict of interest.

“And if director Shuren claims that his spouse’s professional connections to the device industry do not pose a terrific COI [conflict of interest], this assertion will require a public query on the part of congressional investigators and the GAO,” he said at the time. Noorchashm asked the agency to demand Shuren’s voluntary resignation or transfer him out of CDRH to clean up the Center and refocus it on patient safety and ethical conduct.”

Asked to comment about the Times article, Noorchashm told us that FDA “never addressed my concerns about Dr. Shuren's conflicts of interest with his wife's professional activities as a defense attorney for the medical device industry. It’s about time the mainstream media and the public take note of Dr. Shuren’s conflict of interest. For years, he has pushed the CDRH closer and closer into bed with the medical device industry.”

He said that Shuren has been abusing the 510(k) clearance process to “liberally pump medical devices into the U.S. healthcare market at an astronomical rate outside of a reasonable evidence space framework… Effectively, Jeff Shuren has compromised the public health mission of the FDA in the medical device space… My bet is that CDRH will need a top-down restructuring.”

More recently, Shuren’s close ties to industry and another FDA-focused private attorney are illustrated in a 2023 FDA Webview investigative piece about Shuren and his welcomed coziness with industry and a dispute with an infusion pump manufacturer. This case involved the original designer of the modern spring-powered mechanical infusion pump, Andy Sealfon, of Chester, NY, who first got into Shuren’s gunsights in 2015 with an earlier version of his 510(k)-cleared device, the Freedom60 pump. Back then, as we exclusively reported, Minneapolis attorney Mark DuVal and Shuren allegedly pulled levers inside FDA to inject a false trade complaint into a routine agency inspection then in process at Sealfon’s RMS Medical Products in Chester. The complaint had been generated by a DuVal client, EMED Technologies, that was then and still is a competitor of Sealfon.

DuVal’s high-speed intrusion warped the inspection, ruined Sealfon’s relationship with CDRH and had “devastating” effects for his company in the infusion pump marketplace, eventually leading an activist investor in RMS to force him out of the company he founded. The RMS name was later changed to Koru Medical Systems and moved to Mahwah, NJ. Koru continued his product line through the Freedom60. Sealfon later formed a new partnership with Innovative Health Sciences (IHS). There, he revamped his pump design in a new 510(k) citing the Freedom60 as predicate, thus projecting three companies into imminent competition, two of them (Koru and IHS) with different versions of the same original Sealfon design.

That’s when the latest war between them broke out. Already on the market, Koru’s and EMED’s competing pumps slid through Shuren’s 510(k) review machine with their latest upgrades and label changes in 261 and 90 days respectively, while Sealfon’s new Insignis version was kept out the market under the obstructions of four CDRH reviewers; it had won Europe’s counterpart CE Mark (license to market) within 60 days but is still not cleared for sale in the U.S.

Another example of Shuren’s dereliction of managerial duty was incubating in the still-unresolved safety controversy over mercury-laced dental amalgam when he came aboard as director in 2010. Although a neurologist, he turned a blind eye to amalgam’s neural damage hazard when it was pointed out to him.