{"corpus_id":206624869,"paper_sha":"b56b97364a371ef062748b2e6ae3d15d8147b4e5","doi":"10.5034/inquiryjrnl_50.01.07","arxiv_id":null,"pmid":null,"pmcid":null,"mag_id":null,"dblp_id":"journals/ns/Gordon19","acl_id":null,"title":"A matter of trust","year":2013,"publication_date":"2013-02-01","venue":"Nature","journal":{"name":"Nature","pages":"637-638","volume":"449"},"journal_issn":null,"journal_title":null,"publication_types":["JournalArticle"],"pubmed_pub_types":null,"s2_fields_of_study":["Medicine","Business","Computer Science"],"reference_count":6,"citation_count":9,"influential_citation_count":0,"is_open_access":true,"arxiv_categories":null,"arxiv_license":null,"arxiv_journal_ref":null,"mesh_headings":null,"chemicals":null,"comments_corrections":null,"source_flags":1,"s2_open_access_pdf_url":"https://journals.sagepub.com/doi/pdf/10.5034/inquiryjrnl_50.01.07","s2_open_access_landing_url":"https://www.semanticscholar.org/paper/b56b97364a371ef062748b2e6ae3d15d8147b4e5","s2_open_access_license":"other-oa","s2_open_access_status":"HYBRID","pmc_open_access_pdf_url":null,"pmc_open_access_landing_url":null,"pmc_open_access_license":null,"pmc_open_access_status":null,"unpaywall_open_access_pdf_url":null,"unpaywall_open_access_landing_url":null,"unpaywall_open_access_license":null,"unpaywall_open_access_status":null,"abstract":"In September 2010, health care giant Johnson & Johnson (J&J) announced that it was recalling hip replacement implants produced by its orthopedics unit. In doing so, J&J was responding to two years of consumer complaints that had led to additional hip replacement surgeries in a number of cases. The recall followed a series of other product withdrawals by J&J as well as concerns raised by the Food and Drug Administration regarding the company’s marketing of unapproved medical devices. In an era when product recalls seem to be the rule rather than the exception, one might simply consider J&J’s transgressions as just another instance of poor quality control and lax management and oversight. Consumers might have taken some solace had this been the case and J&J’s mea culpa merely a reflection of an unintentional and random mishap. However, in early 2013, it was revealed that the hip replacement recall was hardly an unfortunate and innocent occurrence, but instead a more pernicious mishap: the release of a product that executives knew was very likely to fail. Press reports (Meier 2013) revealed that internal analyses by the company projected a 40% failure rate over a five-year period and, to make matters worse, company officials dismissed similar findings from analyses by a British implant registry. This disturbing incident has led to the filing of more than 100,000 lawsuits; as of this March writing, the first plaintiff was awarded $8.3 million, with subsequent judgments expected to cost the company billions of dollars. Unfortunately, J&J’s transgression involving harm from a medical product was not an isolated case that could have been averted. For example, in the very recent past, we also have witnessed the recall of implanted heart defibrillators due to flaws leading to short circuit failure and, in the case of devices produced by St. Jude Medical, to electrical wires emerging through coated cables. As Meier and Thomas (2012) note, this is the third highly visible safety concern for defibrillators in the last seven years, with instances of their harmful effects also attributed to products made by Guidant and Medtronic. What is particularly disturbing with regard to the St. Jude case is that the exposed wires are dangerous to remove, yet remain potentially harmful if left in place. Additionally, several observers believe that St. Jude was slow to publicly acknowledge the problem and underplayed its seriousness. Apart from these failures by medical manufacturers to act in a responsible way and to inform the public of these problems, we have had other troublesome instances. These include last year’s meningitis outbreak due to the substandard manufacturing practices of a New England drug compounding company; questions about the efficacy and overuse of chemically coated stents; and the well-publicized recalls of pharmaceutical products such as the arthritis and painkiller medication Vioxx. The latter incidents have led to an announcement by the British Medical Journal (BMJ) that in the future it will not publish the results of clinical trials unless drug companies and researchers provide study data on request (Thomas 2012). The BMJ’s decision was prompted by a long-standing concern that published clinical trial findings often present a drug in a favorable light without scrutiny of data by independent researchers. Consistent with this concern, Goldacre (2013) observed that half of all completed clinical trials for products being used today have never been","claims":[{"public_id":"cl_83d70ae55d8a9d95a1094d03c42e00c5","status":"active","text":"Defibrillator recalls involved short-circuit failures and, in St. Jude Medical devices, electrical wires emerging through coated cables, creating a hazardous condition that is difficult to address because removal is dangerous while leaving the device in place remains harmful.","confidence":0.94,"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_83d70ae55d8a9d95a1094d03c42e00c5"},{"public_id":"cl_de913d86c3de8fc2baf575d0337dd6d6","status":"active","text":"J&J's hip replacement recall was later revealed to involve a product executives knew was very likely to fail, with internal analyses projecting a 40% five-year 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