Was Uloric Approval the Safe Decision? Attempts in 2005 and 2006 to obtain government-approval to sell Uloric were denied by the FDA due to concerns about research data that showed a slight elevation in the risks of death and heart problems (including acute coronary syndrome, myocardial infarction or heart attacks, […]
Author: Brenda Fulmer
Painkillers Prescribed Haphazardly While Online Sales Soar One of the reasons the nation’s opioid crisis has spun out of control could be the fact that doctors are not trained universally in the field of pain management. So said Dr. Scott Gottlieb, commissioner of the U.S. Food and Drug Administration, in […]
Jerome Adams Calls on Communities To ‘Be Prepared’ and ‘Save A Life’ The opioid epidemic in America is so out of hand that the U.S. surgeon general’s office has issued an advisory: “Be prepared. Get naloxone. Save a life.” Naloxone, a nasal spray marketed as Narcan, immediately reverses the effects […]
CDC Issues Report That Says Overdoses Are Rising in US The Centers for Disease Control and Prevention’s March 2018 issue of Vital Signs addresses the opioid epidemic in America and cites statistics that show the problem is worsening. According to the agency, overdoses caused by opioids spiked 30 percent between […]
U.S. Attorney General Creates Task force To Address Epidemic The opioid crisis in America exists because both the illegal and prescription forms of the drug are highly addictive and commonly abused. In 2016, the latest year for which figures are available, over 100 deaths daily were attributed to overdoses, amounting to […]
Epidemic Costs Country Billions Each Year, Leading Government Entities To Sue Big Pharma Beloved singer Tom Petty became part of America’s opioid crisis when it was revealed that the 66-year-old’s cause of death in Oct. 2, 2017, was an overdose of painkillers for a broken hip. An autopsy conducted by […]
Opioids put nearly 1.3 million people in the hospital in one year. Read this article with horror. Yet another example of the devastating effects of Fentanyl and other opiate abuse in our country. We have had a front row seat to this epidemic in Palm Beach County where our hospitals, […]
Someone asked what was one of the most challenging cases I have worked on as a drug and medical device litigator for the past 23 years. It was the Vioxx litigation. When the drug was first introduced to the market by Merck in 1999, I had concerns it could easily […]
On September 27, 2016, the Department of Health Therapeutic Goods Administration (the Australian equivalent of the Food & Drug Administration) issued a hazard alert relating to LFIT Anatomic CoCr V40 femoral heads manufactured and marketed by Stryker. The LFIT V40 femoral heads are made of a cobalt and chromium alloy and […]
There have been some very recent developments in the national litigation regarding the erectile dysfunction (ED) drug Viagra and the allegation that its use increases a patient’s risk of developing melanoma. Judge Seeborg, the federal judge appointed to oversee all of the Viagra cases filed in federal court from across […]