A "Senate investigation of deadly infections spread by contaminated scopes found that not one of the 16 or more American hospitals where patients were sickened appeared to have properly filed" a "report required when a medical device kills or seriously injures a patient." The "mandatory federal reports are meant to alert regulators to dangerous defects in devices so that lives can be saved." A Food and Drug Administration spokesperson said hospitals can face fines and other penalties for not filing mandatory reports. The FDA has "investigated cases and taken compliance actions but we are not aware of criminal prosecutions that have resulted from a failure to report adverse events."
2015 saw an all-time high in the number of automotive recalls, surpassing a record set the previous year. Recalls last year totaled 51.2 million, with those involving Takata airbags a major contributor to that figure. However, National Highway Traffic Safety Administration head Mark Rosekind, speaking at a Washington, D.C, auto show, also described "a vigilance in looking for defects" as a reason recalls continue to mount. "Automakers and automotive suppliers are being driven to be more proactive in addressing problems," with "federal regulators showing far less tolerance and levying far larger fines than ever before for safety lapses." Official data on last year's record recalls were released as NHTSA and its parent agency, the Department of Transportation, are trying to collaborate on safety initiatives with the industry, rather than relying solely on enforcement measures.
Lawyers involved in the multi-district litigation against Johnson & Johnson and Bayer's Xarelto argue that the "two major pharmaceutical companies, in an effort to protect their blockbuster drug, mislead editors at" the New England Journal of Medicine by leaving out laboratory data that could have showed the effect of a faulty blood testing device on the trial results. Bayer frequently declined to comment when asked about Xarelto trial results. Last "fall, Bayer submitted an analysis to the Europeanen Medicines Agency that was nearly identical to the approach used by the Duke researchers, comparing the outcomes of patients who had specific medical conditions with outcomes of those who did not."