The U.S. Food and Drug Administration (FDA) just issued a warning letter to Smith & Nephew PLC, the Associated Press (AP) reported. The orthopedic replacement hip maker was cited over issues with manufacturing at its German plant this year, the AP explained.
It seems that government inspectors reviewed the plant, located in Tuttlingen, Germany, this summer, citing the firm for a number of quality control issues, said the December 21st warning letter, according to the AP.
The warning letter also said that Smith & Nephew did not document some critical production steps such as quality tests and resolution to device parts produced at the plant, said the AP. While the firm, which is based in London, did respond to the FDAâ€™s letter in August, this recent FDA warning letter indicates that the response was not â€œadequate,â€ wrote the FDA.
The letter requests that Smith & Nephew answer the letter within 15 business days and include a corrective plan of action, the AP reported, adding that the agency issues such warning letters when firms fail to follow established mandates for the manufacture and marketing of medications, medical devices, and other products. The FDA can sue firms if the letters are ignored, added the AP. Calls placed to Smith & Nephew by the AP have not been returned.
The financial relationships between the drug and medical device industries and doctors have caused controversy in recent years. Critics have long held that such relationships create conflicts of interest and could unduly influence everything from research findings to prescribing practices. Over the past several years, states, medical schools, medical societies, and other entities have passed regulations requiring doctors to disclose their financial relationships with drug and device makers, and some have even tried to curb the gifts and other perks doctors can receive.
In 2007, we wrote that the Justice Department filed criminal complaints against five major medical device companiesâ€”<"https://www.yourlawyer.com/topics/overview/Johnson-and-Johnson-DePuy-Hip-Implant">DePuy Orthopedics, Biomet Orthopedics, Smith & Nephew, Zimmer Holdings, and Stryker Corporationâ€”alleging they paid kickbacks to doctors for using their products. The charges were dropped last year after the companies paid fines and agreed to pay physicians only for legitimate consulting services.
Late this year we wrote that an emerging study revealed that about half of those U.S. surgeons compensated for at least $1 million in payments from <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">orthopedic device companies did not disclose their financial ties when they published articles about the devices in medical journals. The researchers at the Institute on Medicine as a Profession (IMAP) from Columbia University College of Physicians and Surgeons in New York point out that when others, such as medical professionals, read these articles, they do not know that conflicts of interest exist, said Business Week, which could impact how patients are treated.
The Team learned that the five manufacturers, which included Smith & Nephew, issued 1,654 payments totaling $248 million for â€œconsulting, honoraria, and other â€¦ services,â€ said Business Week. Mostâ€”about 62-percentâ€”of those funds were paid to 41 orthopedic surgeon researchers, meaning that amounts received ranged from over $1 million to $8.8 million. Of the journal articles publishedâ€”95 by the 41 consultantsâ€”most were about a medical device and none indicated a financial tie existed between author and device maker. Consumers should be concerned, said the team. The report was published in the journal Archives of Internal Medicine.