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
The U.S. Food and Drug Administration (FDA) is facing mounting pressure to regulate e-cigarettes after the federal government recently announced that use of the devices has tripled among young people within one year. Even though the agency has had the authority to regulate all tobacco products since 2009, there are still no rules in place to restrict e-cigarettes. In a New York Times op-ed article, former FDA Commissioner David A. Kessler and Campaign for Tobacco-Free Kids president Matthew L. Myers assert that it is high time for the agency to act.
Kessler and Myers say that the sharp increase in e-cigarettes use among youth is not surprising, given that the devices have been able to dodge federal regulation and are using the same strategies as cigarette companies to get teens hooked. The devices are endorsed by celebrities, and portrayed as glamorous or masculine in TV and magazine ads. E-cigarette makers have also sponsored race cars and music festivals. The devices also come in sweet flavors such as gummy bear and cotton candy. Continue reading
Boston Scientific failed in its bid to remove punitive damages claims in a pelvic mesh lawsuit this month, Mass Device reports. This case is one out of 15,000 product liability lawsuits filed over the devices, which are used to treat stress urinary incontinence. According to Mass Device, the plaintiff in the case alleged that she suffered multiple complications after being implanted with Boston Scientific’s Advantage Fit device in 2010. In April 2013, she sued for negligence, strict liability for design defect, manufacturing defect and failure to warn, breaches of express and implied warranties and punitive damages. Continue reading
The use of microscopic hair analysis as evidence against defendants was flawed for over two decades before 2000, the Justice Department and FBI admit. According to the Washington Post, the agencies admit that almost every examiner an elite FBI forensic unit, the FBI Laboratory’s microscopic hair comparison unit, gave flawed testimony in nearly every trial where they provided evidence against criminal defendants.
The National Association of Criminal Defense Lawyers (NACDL) and the Innocence Project, which are helping the government with the nation’s biggest post-conviction review of questioned forensic evidence, has reviewed 268 trials. The groups found that in over 95 percent of these cases, 26 of 28 examiners in the FBI unit overstated forensic hair matches in ways that favored prosecutors. The trials include 32 defendants who received the death sentence; 14 have either been executed or died in prison. The groups issued these findings under an agreement to release results after reviewing the first 200 convictions, Washington Post reports. Continue reading