20% Of Cars Have An Unfixed Recall

The Arizona Republic (2/11, Merrill, 1.14M) reported that according to the Neighborhood Auto Repair Professionals in Arizona, “one in five cars nationwide has an unfixed recall,” and “one in three minivans and one in five SUVs” have unfixed recalls. The repair group used research from Carfax to estimate that 46 million cars have unfixed recalls in the US.

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GM To Temporarily Stop Selling Some SUVs Due To Pending Goodyear Tire Recall

The Detroit Free Press (1/22, Priddle, 987K) reported that General Motors told dealers to stop selling 2015 Chevrolet Traverse, GMC Acadia and Buick Enclave utility vehicles due to a pending recall of the 18-inch tires on the 6,300. The article states that Goodyear is working with the NHTSA and expects recall 48,500 tires, “of which about 32,100 were made for GM’s family of full-size crossovers.”

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Medtronic Will Pay $2.8 Million To Settle Allegations Of Encouraging Off-Label Use Of Device To Doctors

Law 360 (2/6, Macagnone, 9K) is reporting that Medtronic will settle with the US Justice Department for $2.8 million regarding a False Claims Act Suit contending the company “paid doctors to push an unapproved use” of the company’s neuro-stimulation device, “SubQ stimulation treatment.” The Justice Department has accused Medtronic of paying out “tens of thousands of dollars” to urge physicians to make an off-label use of the device, and to seek Medicare payments for treatments “not approved by the U.S. Food and Drug Administration.”

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FDA Releases Draft Guidance For Risks Included On Medicine Advertisements

The Wall Street Journal (2/6, Silverman, 5.67M) blog “Pharmalot” is reporting that the FDA has issued new draft guidance requesting that drugmakers refrain from including long lists of risks and concerns associated with drugs in favor of a mild summary in print ads and promotional materials. The summary would not have to include information about all side-effect or contraindication. In the draft guidance, the agency explained that not many consumers have the technical background needed to understand some of the information described in the warnings as they exist now. The intention of the summary is to focus on the broader risks and important information instead of an exhaustive list of every possible issue.

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Lawsuit May Improve Protection For Senior Citizens

The Palm Springs (CA) Desert Sun (2/6, Atagi, 85K) reported that “a Rancho Mirage woman’s civil lawsuit citing fraud and elder abuse could be a ‘huge’ step toward protecting senior citizens from potential financial scams, a consumer advocacy group says.” According to a complaint filed “in Riverside County Superior Court last year, Lois Brown claims a Palm Desert insurance agent convinced her to buy annuities under the guise of a program benefiting low-income war veterans and their spouses, even though she wasn’t qualified.” The Palm Springs Desert Sun adds, “Rarely do victims of elder abuse pursue litigation against suspected scammers, said Prescott Cole, senior staff attorney for the California Advocates for Nursing Home Reform in San Francisco.”

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NPR Reports On Workplace Injuries Suffered By Nurses

NPR’s “All Things Considered”(2/4, 1.58M) examined the dangers nurses face at work, noting that the Department of Labor’s Bureau of Labor Statistics (BLS) found that more than 35,000 nursing employees suffer back and other injuries at work each year. According to the BLS, “nursing assistants are injured more than any other occupation, followed by warehouse workers, truckers, stock clerks and registered nurses.” The piece notes how some hospitals are trying to reduce the risk. However, “David Michaels, the assistant secretary of Labor who heads the U.S. Occupational Safety and Health Administration,” said Congress and the courts have severely restricted OSHA’s ability “to require hospitals to protect nursing employees.”

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Senators Request FDA Investigate Dietary Supplements

According to The Hill (2/5, Wheeler, 224K) Senators are encouraging the FDA to launch a “nationwide investigation after four major retailers were accused of selling mislabeled and tainted dietary supplements in their New York stores” by the state’s Attorney General Eric Schneiderman. Sen. Dick Durbin (D-IL) said in a statement, “Today, Sen. [Richard] Blumenthal [D-CT] and I are calling on the FDA to…take steps to protect all American consumers from an industry shown to be selling products they know are at best, ineffective, and at worst, truly harmful.” Sen. Blumenthal said in a statement, “The apparent widespread sale of fraudulently-labeled dietary supplements by four major national retailers should be a major wake-up call that the industry is in desperate need of additional oversight.”
The need for increased oversight over dietary substances is substantiated by the fact that US consumers “are nuts” for products they believe help them “boost their health and lose weight,” despite a “series of studies and investigations that have cast serious doubt on the safety and reliability of” dietary supplements, the Washington Post (2/5, Millman, 5.17M) “Wonkblog” reported. The popularity of dietary supplements is maintained by the “common public misperception that these products face the same rigorous oversight that pharmaceuticals receive from the FDA.” A report from the HHS Inspector General in 2012 “found that 20 percent of the weight loss and immune system support supplements they purchased made illegal claims about their ability to treat and cure disease,” and just a year later, researchers from Harvard “found that between 2004 and 2012, there were 237 recalls of dietary supplements — accounting for more than half of FDA recalls of Class 1 drugs,” which signifies that “the products contain substances that can cause death or serious health problems.”

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OSHA To Fine Ashley Furniture $1.7 Million For Safety Violations

According to The New York Times (2/3, Abrams, Subscription Publication, 9.97M) Ashley Furniture, a major global furniture maker, is facing $1.7 million in OSHA penalties “to settle charges that unsafe conditions at its manufacturing plant in Arcadia, Wis., led to more than 1,000 injuries.” OSHA “cited the company for dozens of violations, including disregard for safety standards that led to a number of gruesome injuries.”

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The Deadline For Filing Claims Regarding GM Faulty Ignition Switches Passed On March 31, 2015

The AP (2/3, Krisher) is reporting that “the families of 51 people who died in crashes caused by faulty” GM ignition switches will receive money from the GM compensation fund, with another 77 to receive money for injuries, according to compensation expert Kenneth Feinberg. The deadline for filing claims was Saturday, March 31, 2015. As of Sunday there were “455 death claims and 3,447 for injuries.” Many are calling for GM to extend the deadline, “because victims do not know yet whether they can sue General Motors Co., the new company that emerged from bankruptcy protection in July 2009.”
According to The CBS Evening News (2/2, story 5, 2:30, Glor, 5.08M) Sens. Ed Markey (D-MA) and Richard Blumenthal (D-CT) are asking GM to reconsider the deadline, “as over a third of the vehicles are still not fixed.”
USA Today (2/2, Healey, 10.32M) reported that GM’s count of victims “only included people in the front seats who would have been protected, presumably,” if not for the defective switches, and only those driving or riding in models that were specifically recalled.

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The FDA’s Adverse Reporting System Includes Numerous Incomplete Reports

The New York Times (2/3, B3, Thomas, Subscription Publication, 9.97M) is reporting that “the main system for keeping track of the dangerous side effects of prescription drugs is deeply flawed, primarily because drug makers are submitting incomplete information about the problems to the” FDA, “according to a new study by” the Institute for Safe Medicine Practices (ISMP), “a nonprofit group that tracks drug safety issues.” An FDA spokesman “acknowledged that adverse-event reports were often incomplete, and said improving the system was ‘of great interest’ to the agency.” But, “doing so ‘is challenging because of the voluntary nature of the reporting.’”
Similarly, The Wall Street Journal (2/2, Silverman, 5.67M) “Pharmalot” blog reports that although the ISMP says reports can only be considered reasonably complete when they include patient age, gender and event date, only 49% of reports contained that information. Additionally, the analysis found that 67% of death reports were of limited value due to incomplete information about the cause of death and the possible role of a medicine. Thomas Moore, an ISMP senior scientist, attributes the lack of completeness in reporting in part to the fact that the FDA’s adverse-alert system has not been updated since 2001 despite the fact that the pharmaceutical market has evolved immensely, yielding new interactions between drugmakers, patient, and consumers.

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