For 15 years, Dr. Jeffrey E. Shuren was the federal official charged with ensuring the safety of a vast array of medical devices including artificial knees, breast implants and Covid tests.
When he announced in July that he would be retiring from the Food and Drug Administration later this year, Dr. Robert Califf, the agency’s commissioner, praised him for overseeing the approval of more novel devices last year than ever before in the nearly half-century history of the device division.
But the admiration for Dr. Shuren is far from universal. Consumer advocates see his tenure as marred by the approval of too many devices that harmed patients and by his own close ties to the $500 billion global device industry.
One connection stood out: While Dr. Shuren regulated the booming medical device industry, his wife, Allison W. Shuren, represented the interests of device makers as the co-leader of a team of lawyers at Arnold & Porter, one of Washington’s most powerful law firms.
Dr. Shuren signed ethics agreements obtained by The Times that were meant to wall him off from matters involving Arnold & Porter’s business. But it’s not clear how rigorously the ethics agreements were actually enforced. His wife’s law firm refused to provide a list of clients — and the agency had no legal authority to require it, said Michael Felberbaum, a spokesman for the F.D.A.
In a review of thousands of pages of court documents and F.D.A. 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.
Her partner at the helm of the firm’s life sciences team began representing Theranos, the discredited blood testing company, in 2015, demanding that the F.D.A. halt an inspection at its sites in California. While Dr. Shuren said he was recused from the matter, court records suggested he remained involved.
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 response to inquiries over several weeks about these cases, the F.D.A. initially said it had no indication that Dr. Shuren had violated ethics rules and needed time to “substantively evaluate” follow-up questions from The Times. In a statement Friday, Shannon P. Hatch, an F.D.A. spokeswoman, said the agency had found that “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.”
Ms. Hatch confirmed that the lapses occurred in the Theranos case as well as another one identified by The Times involving Alcon, an eye care drug and device company that was a client of Ms. Shuren’s.
In 2014, Alcon went before an agency committee convened to advise on whether to approve a lens implanted in the eye. According to a meeting transcript, Dr. Shuren signed off on the appointment of eight new voting members and a new chairman for the hearing, which recommended approval.
Ms. Hatch said the agency “has no indication that any F.D.A. 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 F.D.A.”
While the agency conducts a nationwide search for Dr. Shuren’s replacement, he will work in the commissioner’s office to help ensure a smooth transition, according to the July statement by Dr. Califf announcing his retirement.
The F.D.A. said Friday, “Dr. Shuren has been advised of the need to exercise greater caution in matters concerning his recusal obligations and will be provided additional administrative support to better ensure future compliance.”
Neither Dr. Shuren nor Ms. Shuren responded to requests for interviews.
When The Times initially requested Dr. Shuren’s ethics records from the division he led, an official in the information disclosure unit wrote that the request was “complex” and would take up to two years to fill. Four months later, the F.D.A. provided an agreement that turned out to be two pages long after a lawyer for The Times had requested that a branch of the F.D.A. other than Dr. Shuren’s address the matter.
During the decade and a half of overlapping career trajectories, “Dr. Shuren has not requested, nor has he received any waiver or agency authorization to participate in any particular matter relating to his wife’s employment or any of her clients,” Mr. Felberbaum said.
Ms. Shuren earned from $1 million to $5 million, according to her husband’s financial disclosure form in 2018, the only one that estimated her income. Dr. Shuren’s F.D.A. salary is $400,000 a year.
Dr. Shuren led an office with about 2,500 staff members and a budget of about $790 million. He oversaw thousands of devices, ranging from tests to detect blood-lead levels to IV infusion pumps to ventilators.
Dr. Peter Lurie, a former F.D.A. associate commissioner, said he hoped the next division chief would shape a legacy that is more impartial toward device companies.
“At least from my point of view, it was too friendly to industry,” said Dr. Lurie, who is now president of the Center for Science in the Public Interest. “So somebody who would better protect consumer interests would be welcome.”
A surge in injuries
Trained as a neurologist, Dr. Shuren once told a group of cardiologists that he and Ms. Shuren had decided in the mid-1990s to go to law school together. Her career had been in critical care as a pediatric nurse practitioner. After their first year at the University of Michigan, he briefly worked for the F.D.A. and “fell in love with the mission,” he said in the speech.
He joined the agency full time in 1998, holding policy roles until he began leading the medical device division in 2009, during the Obama administration.Several former colleagues said they were thrilled to work with a brilliant, credentialed leader who came in as a reformer intent on raising standards in the division.
Early in his tenure, Dr. Shuren dismissed criticism from the business community over what it viewed as the slow pace of device approvals compared with Europe. Citing Europe’s lower standards and safety problems, he told The Times in 2011 that the F.D.A. would stand firm.
“We don’t use our people as guinea pigs in the U.S.,” he said at the time.
But congressional leaders on both sides of the aisle pressured the agency for faster medical device approvals. By 2014, Dr. Shuren pledged to make the United States the first place for device makers to sell their products.
In a recent presentation, he boasted that the number of first-in-the-world approvals had soared to 125 in 2023, from 25 in 2009.
“Do things now come here first?” he asked at a conference in May, referring to the new devices. “The answer is yes.”
Over time, Dr. Shuren drew closer to the medical device industry. In 2012, he co-founded a nonprofit called the Medical Device Innovation Consortium with a former executive from Medtronic, a leading device company.
To do so, Dr. Shuren secured a waiver from agency ethics rules, which prohibit federal officials from serving on boards of nonprofits to avoid divided loyalties or interests.
Most of the consortium’s board members were device industry executives, and many of its staff members had previously worked for the industry’s lobbying organizations.
As a board member, Dr. Shuren expanded the nonprofit while facing disturbing episodes at the agency over harm done by medical devices. Thousands of women reported injuries and side effects from Essure devices — small metal birth-control implants that dislodged from the fallopian tubes, tore delicate anatomy or caused allergic reactions. Other women were outraged to discover that an F.D.A.-cleared device called a power morcellator used to pulverize uterine growths might have actually spread their cancer.
Dr. Shuren promised in 2019 that a consortium project called NEST, or the National Evaluation System for Health Technology, would “empower the F.D.A. to more quickly identify, communicate and act on new or increased medical device safety concerns.”
The group has “obviously failed to do that,” said Diana Zuckerman, the president of the National Center for Health Research, a consumer watchdog group.
Agency critics have compared the NEST effort to a fox guarding a henhouse, citing the industry’s leadership at the consortium and a lack of specific safety accomplishments.
Last year, the American Medical Association, the nation’s largest physician group, raised “serious safety concerns” about medical devices, highlighting secrecy around reports of device-related injuries and a system that allowed many devices onto the market with little to no testing in humans.
The F.D.A. defended its approval process, saying it had increasingly sought more evidence before clearing products for sale. Regarding NEST, the agency noted a report by the U.S. Government Accountability Office, a watchdog agency, that said the program would begin monitoring the safety of two types of medical devices in December.
Medical specialists have also raised concerns about the safety and effectiveness of some devices approved during Dr. Shuren’s tenure. They include the CoolSculpting device, which was meant to zap fat but disfigured some people, and the Q-Collar sports safety device, which some experts say may offer little protection from injuries to the brain.
Other specialists and patients have hailed some devices approved on Dr. Shuren’s watch. They include replacement heart valves implanted in a minimally invasive procedure instead of during open-heart surgery. People with diabetes benefited from major advances in systems that monitor blood sugar and automatically adjust insulin levels.
The F.D.A. said it “is proud of Dr. Shuren’s commitment and integrity in serving the American public throughout the course of his extensive government career and stands by his science-based public health decisions.”
In a letter to staff members announcing his retirement, Dr. Shuren noted their mission to be sure that “patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world.”
But safety issues multiplied on his watch. The most urgent F.D.A. recalls of devices that can cause serious injury or death have ticked up, to nearly 100 so far this year, from 29 in 2012, the first year such measures were tracked in an agency database. In March, a heart device was recalled after 49 deaths were linked to a specific concern.
Reports of device-related injuries soared to 900,000 in 2023, up from about 190,000 in 2012, according to Device Events, a company that makes F.D.A. data user-friendly for subscribers.
Ms. Hatch, the F.D.A. spokeswoman, confirmed the company’s recent data. She said the F.D.A. had noted an increase in device-injury reports in 2018, which it attributed to companies’ doing “a better job reporting problems and fixing them due to a continued, concerted effort by the F.D.A. to drive greater device safety.”
Dr. Hooman Noorchashm, a Harvard-trained cardiothoracic surgeon, said he believes the problems are a result of low standards and deference to industry. He emerged as a critic of Dr. Shuren’s after his wife died of a cancer that he said was spread by a power morcellator.
“Essentially,” he said, “he’s pumping medical products into the U.S. marketplace, outside of an evidence-based paradigm.”
Theranos hires Ms. Shuren’s team
When Dr. Shuren was named acting director of the medical device division in 2009, agency lawyers drafted an ethics agreement to prevent conflicts of interest involving his wife and her law firm. Top officials were to screen potential issues of concern, and other agency officials were to take the lead in such cases, according to the document.
Such agreements reflect criminal laws enacted to keep public employees from using their authority to enrich their families, and regulations meant to uphold trust in government.
Issara Baumann, a spokeswoman for Arnold & Porter, said in a statement that the firm “has long had strict protocols in place to assure full compliance with respect to our professional obligations and the F.D.A.’s requirements governing financial conflicts of interest and impartiality.”
A major test occurred in 2015. Daniel A. Kracov, Ms. Shuren’s partner in running the firm’s drug and device team, began representing Theranos.
At the time, he was challenging the F.D.A.’s authority to conduct an inspection at two Theranos offices in California. F.D.A. officials were concerned that the company was shipping its “nanotainer” blood-storage device without agency clearance. Theranos records for 2015 and 2016 show a $1.6 million payment to Arnold & Porter for legal services.
Dr. Shuren said around that time that he was recused from dealing with Theranos, recalled Alberto Gutierrez, then the F.D.A.’s senior scientist on diagnostic tests. But Dr. Gutierrez said he had not been informed that the agency expected another official to step in for Dr. Shuren, and Dr. Gutierrez continued to send him periodic emails about Theranos. (Dr. Gutierrez said he had left the F.D.A. over an unrelated dispute with Dr. Shuren.)
In 2019, lawyers for the Theranos executive Ramesh Balwani, known as Sunny, still sought Dr. Shuren’s testimony in the federal fraud case against him and the company’s founder, Elizabeth Holmes, contending that the division chief was “personally and substantially involved in key issues at the heart of the case,” according to a transcript. Walter Brown, a lawyer for Mr. Balwani, gave the judge 91 documents that he said proved Dr. Shuren was dealing with Theranos matters.
Alison Daw, a lawyer representing the F.D.A., argued that Dr. Shuren had not had substantial involvement.
The judge ordered Dr. Shuren to undergo deposition but placed the transcript and documents under a protective order, preventing public disclosure of the details.
The Times asked the F.D.A. about a court exhibit describing an email from Dr. Shuren to a colleague in 2015, saying he was “happy to take a look” at a key Theranos document. Mr. Felberbaum of the F.D.A. said Dr. Shuren had indicated that he “did not ultimately review or provide feedback on” the message.
Asked about additional emails to Dr. Shuren, including one about responding to an inquiry from Congress, the agency initially said it needed time to review the matter. Then, it said Dr. Shuren should have sought authorization to participate to avoid the appearance of bias.
The courtroom drama is exactly what federal ethics laws are meant to prevent, according to Anthony V. Alfieri, a University of Miami law professor.
“Where were the F.D.A. managers, and where’s the oversight?” Mr. Alfieri asked. “And what was Dr. Shuren thinking?”
Breast implants tied to cancer
In the spring of 2019, the drug and device maker Allergan was under scrutiny at the F.D.A.: Women were developing a rare form of lymphoma linked to the company’s textured breast implants, which had been recalled by more than 30 countries.
At the same time, Arnold & Porter was involved in legal issues involving Allergan. In April, a member of Ms. Shuren’s team began to defend Allergan in a California lawsuit over Botox pricing. The firm was also ushering AbbVie through a $63 billion acquisition of Allergan — a success Ms. Shuren’s team highlights on the firm’s website.
Mr. Felberbaum said Dr. Shuren was not aware of either the Botox case or the acquisition.
At an F.D.A. hearing in 2019, Roxane Vermeland testified that she had undergone a mastectomy for breast cancer and received the Allergan implants as part of her reconstructive surgery in 2012. She subsequently developed the rare cancer and was in the midst of treatment at the time of the hearing.
Ms. Vermeland, now a plaintiff in a lawsuit against Allergan, recalled her heart thundering as she approached the podium to describe her painful ordeal. “Please, please make the right moral decision to ban these implants like the other 30-plus countries and hold Allergan accountable,” she said to a wave of applause during the March hearing.
In May, Dr. Shuren and another F.D.A. official announced that the implants would not be recalled. In June, AbbVie announced its decision to purchase Allergan for $63 billion.
In July, Dr. Shuren and the other official reversed course and said that they would urge a recall, citing additional reports of injuries and deaths related to the lymphoma. Ms. Baumann of Arnold & Porter said that the firm represented AbbVie over antitrust questions and that Ms. Shuren had not worked on the matter.
Mr. Felberbaum of the F.D.A. said that Dr. Shuren’s ethics agreement had not precluded him from working on the breast implant recall because the law firm’s representation of the companies was unrelated.
Three ethics experts said Ms. Shuren’s leadership role at the law firm should have led Dr. Shuren to step aside to avoid the appearance of bias. By 2015, she was a co-chair of the life sciences team, earning a bonus based on her performance, according to Dr. Shuren’s ethics agreement of 2017.
Ms. Vermeland agreed, recalling how angry she and others had been over the initial refusal to recall the implants. “How do you think that looks to us?”
Debates over warnings for LASIK
Paula Cofer has waited 15 years for the F.D.A. to strengthen the warnings given to LASIK vision correction surgery patients. About 700,000 people get the procedure each year; the agency regulates the lasers used in the surgery.
Ms. Cofer had suffered vision problems after undergoing LASIK herself. She served as the patient representative on an F.D.A. panel that held a hearing in 2008 about the procedure’s risks, which include dry eye, distorted vision and, in some cases, pain. Dr. Shuren announced in 2009 that the F.D.A. would study the side effects.
For years, Ms. Cofer said, she agonized as Ms. Shuren, a prominent lawyer in the ophthalmology field, appeared at eye surgery conferences in Hawaii and the Caribbean.
At times, the couple’s work overlapped. Dr. and Ms. Shuren were listed as speakers at an eye surgeon conference in 2015 in the resort town of Deer Valley, Utah.
One of Ms. Shuren’s clients, Alcon, is an eye care company that makes devices, including lenses implanted in the eye and lasers used in LASIK procedures. The company has had a number of products before the agency for approval.
“Dr. Shuren has not participated in matters specific to Alcon,” Mr. Felberbaum said in the F.D.A.’s initial response to The Times’s questions.
But by signing off on the appointment of eight of 12 voting members to a committee that advised the agency to approve an Alcon implantable eye lens, Dr. Shuren was involved in that matter. The F.D.A. confirmed that on Friday, saying that the committee appointments were one of the ethical lapses it had found.
In 2016, the F.D.A.-sponsored study of LASIK found that 45 percent of people who had no visual symptoms before the procedure reported new issues afterward, particularly seeing halos or star bursts. Nearly 4 percent of people reported “very” or “extremely” bothersome symptoms after six months, including double vision.
Years passed until the summer of 2022, when Dr. Shuren announced that the F.D.A. was proposing to require eye surgeons to warn patients about the risks of LASIK surgery.
It felt like a victory to Ms. Cofer at the time, she said. But ophthalmology groups mounted intense opposition. The Times found that those calling on the F.D.A. to rescind the proposal included clients of Dr. Shuren’s wife.
Ms. Shuren has represented one group, the Society for Excellence in Eyecare, as a lobbyist and a lawyer, according to public records from 2002 through 2023. Group leaders include prolific laser surgeons.
Steven Smith, an Alcon spokesman, said the company had “engaged Arnold & Porter to provide legal advice from time to time.”
The Society for Excellence in Eyecare wrote to the F.D.A. about the proposed warnings, arguing that only doctors should inform patients of risks. AdvaMed, the medical device trade association, also urged the F.D.A. to withdraw the guidance, saying that the warnings could scare patients. Mr. Smith said Alcon supported AdvaMed’s letter.
The agency said Dr. Shuren had not been involved in finalizing the policy. Mr. Felberbaum said that ethics rules also allowed Dr. Shuren to participate in matters affecting an “entire industry, including Alcon.”
The proposal itself has not been put in place; the F.D.A. said it was still reviewing comments.
Ms. Cofer said she had felt devastated watching the agency stand by as LASIK patients were harmed. She called for Dr. Shuren to resign years ago.
“Their job is to protect the public health,” she said. “They’re doing the opposite. Anybody who doesn’t see that is not looking.”
The post He Regulated Medical Devices. His Wife Represented Their Makers. appeared first on New York Times.
