Nursing Home Pressure Mounts After Hurricane Devastates Elderly Community
Following the devastation caused by Hurricane Irma, where 11 Florida nursing home residents died after power was lost, nursing homes across the U.S. are being pressured to invest in backup generators, and test any already on site.
NPR reports “a third of U.S. nursing homes have been cited for failing to inspect their generators each week or to test them monthly.”
Brian Lee is the executive director of Texas-based Families for Better Care, a national advocacy group for residents of nursing homes. He said “ could have done this a long time ago. There's an expectation by people who put their loved ones in nursing homes that they are going to be safe. They shouldn't have to be worried about generators.''
Food and Drug Administration
Extension Granted To FDA Medical Device Reporting Time
Until recently, medical device malfunction reports were required to be submitted to the Food and Drug Administration (FDA) only 30 days after the malfunction. But the recently enacted FDA Reauthorization Act of 2017 now allows 90 days to report issues that “may cause harm in the future but have not yet resulted in patient complications, injuries, or deaths,” according to The National Law Review.
The 30-day deadline for reporting events that have already resulted in serious medical consequences to users, known as adverse events, has not changed.
Companies may also submit summary malfunction reports under the Act when the incident reported is already known and understood by the FDA.
J & J’s Legal Troubles Continue As 4,800 Women Sue Over Baby Powder
The New York Times reported that 4,800 women across the U.S. are suing Johnson & Johnson for failing to report developments in links between Baby Powder use and ovarian cancer. Interestingly, instead of a class action suit, the women are suing individually.
All plaintiffs, many of them seriously ill with ovarian cancer, are seeking restitution as well as the addition of a warning to the product’s labeling. If the label isn't updated, women are calling for an outright replacement of Baby Powder’s talcum component with cornstarch. Johnson & Johnson has lost six of the seven cases decided so far, with punitive damages paid to plaintiffs in the hundreds of millions.
Johnson & Johnson has lost six of the seven cases decided so far, with punitive damages paid to plaintiffs in the hundreds of millions.
Developments In Study Of Metal-On-Metal Hip Replacements
The Journal of Bone & Joint Surgery confirms in a recent study that blood metal ion levels specific to the type of hip implant used can help predict patients who are at low risk of adverse reactions to metal debris (ARMD).
Science Daily reports that “researchers performed an external validation study including 710 patients (803 hips) who underwent metal-on-metal hip replacement with one of the two aforementioned MoM hip prostheses at three European hospitals.”
Early detection of ARMD can reduce complications and give the hip replacement patient a more positive outcome.
Phase 1B Trial of New Drug in EU Bodes Well For Ovarian Cancer
The European Society for Medical Oncology 2017 Congress featured a data presentation reflecting very good news for ovarian cancer patients. A new ovarian cancer treatment may be on the horizon.
The abstract titled “PRO-002, a phase 1b dose-escalation study of NUC-1031 with carboplatin for recurrent ovarian cancer” specified 25 patients with a median age of 64 years participated, having received a median of 3 prior lines of therapy. Results conclude “The combination regimen was well tolerated.”
The phase 1b trial, administered by biopharmaceutical company NuCana, found that 96% of patients achieved stable disease following treatment, while 39% had a reduction in tumor volume. NuCana CEO Hugh Griffith said, “The high disease control rate and durable responses achieved with the combination of Acelarin and carboplatin are exciting.”