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FDA to push drugmakers to provide latest drug safety information electronically


Pharmaceutical companies must provide health care providers with the latest available drug safety information via real-time electronic updates, according to a new rule proposed by the Food and Drug Administration (FDA). “This would ensure that the most up-to-date version of the prescribing information is available to health care professionals and the public,” the rule states. The new guidelines require drug makers to include a link on their drugs’ safety labels and outside packaging of the products that connects directly to a publicly accessible online repository with the drug’s most current instructions, including dosage recommendations, adverse events, and contraindications or drug interactions. The new ... Read More

Whistleblower lawsuit says the Art Institutes corporation is duping veterans


Education Management Corporation (EDMC), a for-profit chain of colleges, manipulated student job placement data to attract as many students as possible and to maximize the amount of taxpayer-subsidized federal student loan money, a whistleblower lawsuit unsealed in federal court last week alleges. The lawsuit is the third whistleblower case to be filed against the EDMC, which owns the giant Art Institutes chain comprised of more than 50 campuses throughout North America. The U.S. Justice Department and four states intervened in another whistleblower complaint brought against EDMC in 2007 alleging the college corporation defrauded the government by paying recruiters based on ... Read More

Mercedes-Benz faces lawsuit over fuel leaks in E-Class vehicles


Mercedes-Benz USA, parent company Daimler AG, and 15 Meredes-Benz dealerships in New Jersey have been hit with a federal lawsuit claiming gasoline leaks in certain E-Class model vehicles exposed occupants to serious health risks. Defects in the fuel delivery system of 2003 to 2009 E-Class model vehicles cause gasoline and vapor to seep into the cars, the lawsuit alleges. Gasoline vapor is a suspected carcinogen that can cause liver damage, harm to developing fetuses and problems with female fertility. The fumes are also a fire hazard because the vehicles are sold with ashtrays and cigarette lighters. Since Mercedes-Benz reasonably expects ... Read More

Compounding pharmacy owners, employees face criminal charges in fungal meningitis outbreak


Two officials with the Massachusetts compounding pharmacy that caused a multistate outbreak of deadly fungal infections in 2012 have been charged with criminal activity including second-degree murder. The 131-count indictment lays out charges against the company’s co-founders and 12 other employees of the New England Compounding Center (NECC), which produced about 18,000 contaminated steroid shots and shipped them to medical facilities in 23 states. The shots, used to treat back, neck and joint pain, sickened more than 750 people with fungal infections including fungal meningitis, and killed 64. Co-founder Barr Cadden and senior pharmacist Glenn Chin were charged with the ... Read More

Statin therapy linked to serious cataracts


People who use cholesterol-lowering statin medication are at greater risk of developing cataracts severe enough to require surgery, according to two studies. Researchers say the findings suggest more research is warranted “especially in light of increased statin use for primary prevention of cardiovascular disease and the importance of acceptable vision in old age, when cardiovascular disease is common,” researchers wrote. The study is published in the December 2014 issue of the Canadian Journal of Cardiology. One of the cohorts involved 162,501 men and women who during follow-up visits with ophthalmologists from 2000 to 2007 became candidates for surgery to correct ... Read More

Lawsuit questions exorbitant price tag of Hepatitis C drug Sovaldi

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Even before the Food and Drug Administration (FDA) approved the marketing of drug to treat the most common form of Hepatitis C, questions were raised about the seemingly exorbitant price tag. Now the Southeastern Pennsylvania Transportation Authority (SEPTA) has filed a lawsuit against Gilead Sciences, makers of the drug Sovaldi. The class action lawsuit claims that Gilead’s patent protection is not enough to justify the tens of thousands it costs per treatment course. Since the drug was approved late last year, SEPTA has spent $2.4 million on Sovaldi for its employees. A single 12-week regime of Sovaldi costs $84,000. In ... Read More

Virginia sues Trinity over potentially deadly guardrails

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Virginia has become the first state to take legal action against Trinity industries over its ET-Plus guardrail systems, claiming the manufacturer sold it guardrails that were unapproved, untested, and potentially dangerous to motorists. The state’s complaint was prompted by a lawsuit filed against Trinity by whistleblower Joshua Harman under the federal False Claims Act. Mr. Harman accused Trinity of secretly altering its widely used ET-Plus guardrails in 2005 without the consent or approval of U.S. highway safety regulators. The redesign, Mr. Harman asserted, made the guardrails dangerous, turning them into giant spears that could impale vehicles and their occupants. A federal ... Read More

Retaliation against corporate whistleblowers surges in the U.S.


A surge of retaliation against corporate whistleblowers is taking place in the U.S., pushing the number of reports of wrongful termination, verbal and physical abuse and harassment, threats, and intimidation experienced by employees to an all-time high. Nearly half of U.S. workers have observed instances of serious fraud and other forms of misconduct at their place of work, the Ethics Resource Center (ERC) says in its latest National Business Ethics Survey (NBES). Of the 45 percent of workers who experienced or observed wrongdoing on the job, 65 percent voiced their concerns or objections to their supervisors, the ERC said. Twenty-two ... Read More

Xarelto side effects lawsuits consolidated in multidistrict litigation

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The U.S. Judiciary Panel on Multidistrict Litigation has consolidated nearly two dozen lawsuits in Louisiana federal court filed against Johnson & Johnson subsidiary Janssen Pharmaceuticals and Bayer Corp., alleging the drug companies failed to warn that the blood thinner Xarelto could cause serious bleeding events. Defendants fought centralizing the lawsuits, claiming discrepancies in dosage and patients’ medical history made the cases too dissimilar. But the panel found the Xarelto side effects lawsuits struck a similar chord in their claims that the drug companies withheld information from clinical trials that showed the drug could increase the risk for life-threatening bleeding events. ... Read More

Stryker subsidiary ordered to pay millions in penalties involving illegal marketing practices


It’s been a difficult year for medical device maker Stryker. The company agreed last month to pay $1.43 billion to settle thousands of lawsuits claiming its metal-on-metal hip replacement was defective, causing injuries and poisoning patients who had them. This week, following a federal criminal investigation, Stryker subsidiary OtisMed Corp. and its former CEO pleaded guilty to selling unapproved surgical products and agreed to paying penalties that, along with a settlement of a related action, add up to more than $80 million. The latest development involves OtisMed’s OtisKnee guides used in knee replacement procedures to help surgeons make more accurate ... Read More