“He Regulated Medical Devices. His Wife Represented Their Makers” —

• “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.”
• “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 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.”
• “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.'”
• “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.”
• “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.”

“Egregious conflict of interest surfaces in Jannik Sinner escaping drugs ban despite failed tests as Italian’s lawyer has ITIA on client list” —

• “Jannik Sinner has landed in the eye of a major storm in the tennis world, as the World No. 1 escaped facing a suspension from the sport despite two failed drug tests in March during the Indian Wells Masters. The ITIA (International Tennis Integrity Agency) ruled that the Italian bore no fault for the positive tests and that he was simply the victim of an unintentional use of healing spray by his physio.”
• “As proved by Sinner’s lawyers, the spray used by the physio contained trace amounts of Clostebol, an anabolic steroid that has been banned by the WADA (World Anti-Doping Agency) for stimulating muscle growth. The findings were accepted by the expert team assembled by the ITIA, who let the 23-year-old off with a £250,000 prize money penalty.”
• “After the decision, the reigning Australian Open champion’s lawyer Jamie Singer addressed the press, stating his happiness at winning the verdict.”
• “Singer, it turns out, is the founding member of Onside Law, a UK-based law firm that specializes in sports law. The clients for the firm include, in addition to Sinner, the ECB (England Cricket Board), Real Madrid football star Jude Bellingham, Serie A side AC Milan, PL side West Ham, Football Australia, and Formula 1’s governing body FIA. Interestingly, the law firm also has the ATP (Association of Tennis Professionals) as one of its major clients.”
• “More concerning, Singer himself has the ITIA on his client list… leading to a rather questionable conflict of interest in the situation, wherein he is representing both the investigative agency and the very athlete the agency is investigating in the first place.”