Though the Essure contraceptive device was hailed as a breakthrough for women when it came on the market, a citizens group is calling on the FDA to take the device off the market and newly published data may bolster their claims.
Essure, a permanent birth control method, is a non-surgical sterilization procedure that can be performed in a doctor’s office in about ten minutes with minimal anesthesia. But thousands of women have reported serious injuries from the implant, the New York Times reports. A number of patients have sued Bayer HealthCare Pharmaceuticals, the device’s manufacturer, and patient groups will meet with Bayer officials this week to discuss their concerns. Continue reading
The Food and Drug Administration (FDA) has yet to finalize proposed regulations on e-cigarettes that it issued a year ago, prompting concern among health experts about the delay.
A coalition of 31 health and medical groups including the American Academy of Family Physicians, the American Academy of Pediatrics, and the American Heart Association recently wrote to President Obama urging the federal government to finalize the “long-overdue” regulation, Time magazine reports. The letter warns that cigar and e-cigarette brands are using marketing tactics that seem intended to appeal directly to young people. Many of the products come in a variety of fruit and candy flavors. According to the letter writers, “This process has already taken far too long. We cannot afford more delays that allow tobacco companies to target our kids with a new generation of tobacco products.” Continue reading
On Friday, a New Orleans judge ruled that the federal government is liable for flooding damage caused by Hurricane Katrina. The New York Times reports that Judge Susan G. Braden of the Untied States Court of Federal Claims in Washington honed in on a canal known as the Mississippi River-Gulf Outlet (MR-GO) in her decision. The 76-mile canal was a navigation project built by the Army Corps of Engineers and associated with major flood damage after Hurricane Katrina struck on Aug. 29, 2005. Flooding greatly affected the Lower Ninth Ward neighborhood New Orleans and also damaged St. Bernard Parish nearby. Since the devastating hurricane passed, the canal has been closed.
According to NYT, Judge Braden called the canal a “ticking time bomb” because it has “substantially expanded and eroded” over time. She was highly critical of the Department of Justice, stating that the department had “pursued a litigation strategy of contesting each and every issue.” On the other hand, she commended the Corps of Engineers for their transparency in the matter. Continue reading
The Food and Drug Administration (FDA) is collecting information about the safety and effectiveness of hand sanitizers used by hospital workers dozens of times each day.
Under a proposed rule published last week, companies must submit new studies of key safety issues, including possible hormonal effects and the sanitizers’ contribution to the development of antibiotic-resistant bacteria. Products that are not shown to be safe and effective by 2018 would have to be reformulated or removed from the market, according to The Associated Press (AP). Continue reading
A passenger was killed in a two-car accident on State Route 22 in Patterson, New York, on Wednesday, April 29 just before 4 p.m.
New York State Police from the Brewster barracks responded to the accident, which occurred on State Route 22, just north of State Route 311, Hudson Valley News Network reports. Continue reading
People in a town in Entre Rios province in Argentina are demanding action on the high cancer death rates in the town. Nearly half of all deaths there in recent years have been caused by cancer, a rate far higher than the national average of 18 percent.
Statistics compiled by local residents show that 43.3 percent of deaths in San Salvador between 2010 and 2013 were due to some form of cancer. Many residents blame the cancers on the heavy use of pesticides in the rice and soybean plots close to the town, the Buenos Aires Herald reports. “There’s something going on here,” said local resident Andrea Kloster, who is involved in the community group “Todos por Todos,” which was formed by residents after the sudden death of a friend from a brain tumor. Kloster is among those who are convinced the high cancer rate has an environmental cause in the agricultural chemicals so widely used in the area. Continue reading
A former employee of hedge-fund advisory company Paradigm has been awarded over $600,000 in a retaliation case. Wall Street Journal reports that for the first time, the Securities and Exchange Commission (SEC) gave the whistleblower a maximum 30 percent cut from from the penalty the company had to pay. It is the first time the agency has distributed part of a penalty to a tipster.
SEC says the whistleblower submitted a tip of Paradigm’s alleged wrongdoing in March 2012, WSJ reports. He alleged that while the company was trading on behalf of hedge-fund client PCM Partners L.P. II, it engaged in prohibited principal transactions with affiliated broker-dealer C.L. King & Associates. According to the agency, the whistleblower faced retaliatory actions after informing owner Candace King Weir that he reported the issue in 2012. The company changed his job function, took away his supervisory responsibilities and tasked him to investigating the conduct he reported. Later on, he resigned. Continue reading
On Tuesday, Takeda Pharmaceuticals announced a settlement that could go as high as $2.7 billion to resolve thousands of lawsuits from patients and their families who claim the diabetes drug Actos (pioglitazone) caused their bladder cancer.
The New York Times reports that about 9,000 bladder cancer cases are pending. Takeda said the settlement would resolve most of the lawsuits. Takeda said it will take a $2.7 billion charge against earnings to cover the settlement and litigation costs for the remaining cases. The settlement will become effective if 95 percent of the plaintiffs agree to it, and Takeda would pay $2.37 billion. If 97 percent of plaintiffs participate, Takeda would pay $2.4 billion. Payment amounts to individual plaintiffs will depend on a number of factors, including cumulative dosage of the drug, the extent of the injury and their smoking history. Continue reading
Artificial sweeteners, such as aspartame, sucralose and saccharin, are a popular option for those looking to add sweetness without the calories. They are used to flavor a wide variety of common products, from Diet Coke to toothpaste, but there are concerns about their long-term health effects. According to Scientific American, the case against artificial sweeteners was strengthened last year, when a team of Israeli researchers found that artificial sweeteners could, ironically, lead to obesity and related conditions such as diabetes by changing the gut bacteria in mice. While other studies have found a link between obesity and artificial sweeteners, this was the first to propose a causal mechanism. Continue reading
Despite years of warnings from the Food and Drug Administration (FDA), Medtronic Corp. failed to correct problems with its SynchroMed infusion drug pumps, and now the Justice Department has taken legal action to halt the sale of the pumps.
At the request of the FDA, the Justice Department has filed a legal complaint and a proposed consent decree in the U.S. District Court for the District of Minnesota. The consent decree will resolve allegations that the company and two of its executives violated provisions of the federal Food, Drug and Cosmetic Act (FDCA). According to the Justice Department, the pumps were not manufactured in accordance with current good manufacturing processes and some SynchroMed pumps deliver either too much or too little medication. Continue reading