The Department of Justice Is Investigating LifePoint Hospitals

Modern Healthcare (2/13, Schencker, Subscription Publication, 246K) is reporting that in a Feb. 12 filing with the Securities and Exchange Commission, Tennessee-based LifePoint Hospitals “revealed” that it is “the target of federal investigations, more than twelve individual lawsuits and two class action suits alleging the performance of improper interventional heart procedures.” After conducting “an internal review,” LifePoint “identified two cardiologists who ‘independently elected to place cardiac stents that may not have been clinically appropriate,’ according to a LifePoint statement released” yesterday. LifePoint “then self-reported the matter to the Department of Justice.” The two physicians no longer practice at any facilities affiliated with LifePoint, according to a company statement. Currently, the only LifePoint Hospital in Georgia is Rockdale Medical Center.

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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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Kia Motors Recalls Forte Sedans Due To Fire Risk

According to Reuters (1/25, Beech) Kia Motors announced the recall of 86,880 Forte sedans across the US because of problems with the cooling fan resistor, which can overheat and possibly melt, raising the chances of a fire, according to NHTSA. Owners of affected vehicles can go to their dealers for replacement parts.
The AP (1/25) reported that the recall “affects Kia Fortes made from Dec. 5, 2012, through April 17, 2014.”

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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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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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FDA Warns Apotex Regarding Indian Drug Manufacturing Facility

According to The Wall Street Journal (2/4, Silverman, 5.67M) the US Food and Drug Administration sent a warning letter to Apotex, for violations in its manufacturing of generic medications at a facility in Bangalore, India. The FDA has sent several similar letters to Apotex in the past.

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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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