Study: one in five newly admitted nursing home patients to suffer fall within one month.

 HealthDay (6/26) reports, "A new study finds that one in five newly admitted nursing home patients has a fall within one month, and that higher levels of staffing with certified nursing assistants reduces the risk of patient falls." The researchers said, "Identifying and managing fall risks among these residents is a challenge because these people are in a new place and are unfamiliar to staff." 

Dole recalls salads amid listeria fears.

MSNBC (6/26, Aleccia) reported in its "Vitals" blog that "Dole Fresh Vegetables has recalled 1,077 cases of bagged salads sold at Kroger and Wal-Mart stores in six states because of concerns about potential listeria contamination." According to MSNBC, "The products carry a best-use date of June 19, 2012, and should have already been removed from retailers' shelves, but consumers should make sure they don't have the products at home." MSNBC reports that "no illnesses have been reported in association with the recall." Reuters (6/26), Food Safety News (6/26), the Huffington Post (6/26), and The Packer (6/26) also cover the story. 

J&J marketed vaginal mesh implant for nine months after FDA ordered halt.

Bloomberg News (6/26, Voreacos, Nussbaum) reports, "Johnson & Johnson... continued to sell a vaginal mesh implant for nine months after US regulators told the company to stop marketing the device, according to court records." As revealed in court documents, in a letter dated Aug. 24 2007, "the US Food and Drug Administration told J&J...to halt Gynecare Prolift sales until the agency decided whether the device was 'substantially equivalent' to other products on the market. The FDA cited the 'potential high risk for organ perforation' when surgeons insert the mesh vaginally to support weakened pelvic tissue." The agency told J&J that it would be violating the Federal Food, Drug and Cosmetic Act if it marketed the device without conforming to certain requirements and if it did not have FDA approval. 

Watchdog group warns of heart valve risk related to diet pill.

Reuters (6/26, Kelly) reports that as regulators prepare to rule on whether to approve Arena Pharmaceuticals' diet pill lorcaserin on Wednesday, watchdog group Public Citizen has asked the US Food and Drug Administration to reject the experimental drug, citing concerns that it could pose a risk to heart valves. The group noted that doctors at an FDA advisory meeting last month said evidence from clinical trials showed an increased heart valve disease risk in patients who used lorcaserin. The panel still voted to recommend the drug for approval by a vote of 18 to 4.

        U-T San Diego (6/27) reports the FDA "could delay its decision and require Arena to file more information about Lorcaserin, which could become the first new weight loss drug of its kind approved in the US in more than a decade. The agency is expected to review a possible competing drug -- Vivus' Anexa, on July 17." 

FDA: metal hip implants need more frequent testing.

Bloomberg News (6/26, Edney) reports the Food and Drug Administration has ruled that metal-on-hip implants produced by Johnson & Johnson and Simmer Holding "need more consistent testing to help lower high failure rates that lead to risky replacement surgeries, a report by regulators said." FDA staff "said agency advisers meeting on the devices this week should consider when and how patients should undergo imaging and ion testing to measure the metal's effect on surrounding tissue, according to documents posted on the agency's website today." According to Bloomberg, the FDA "will convene an advisory panel meeting June 27 and 28 to discuss the implants, which have been the subject of thousands of patient lawsuits."

        The AP (6/26, Perrone) reports some surgeons have turned to metal implants in recent years, believing them to be more durable than traditional plastic and ceramic implants. But "in March, British experts at the world's largest artificial joint registry told doctors to stop using metal-on-metal hip replacements, citing an analysis showing they have to be replaced more often than other implants. Hip replacements are supposed to last between 10 to 15 years, but more than 6 percent of patients with metal hips needed them replaced after less than five years. That compared with just 2 percent of people who had ceramic or plastic joints." 

Spurs' Tony Parker sues NYC club over eye injury

The Associated Press – Fri, Jun 22, 2012 11:20 AM EDT

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  FILE - In this June 6, 2012 file photo, San Antonio Spurs point guard Tony Parker (9), of France, takes the ball downcourt past Oklahoma City Thunder small …

NEW YORK (AP) San Antonio Spurs guard Tony Parker is suing a New York City club and its operators for $20 million over a scratched cornea he says he suffered during a fight involving singerChris Brown and members of hip-hop star Drake's entourage.

The suit was filed in State Supreme Court in Manhattan on Thursday. It says the W.i.P club in SoHo and its operators were negligent in security and supervision, which allowed the fight to take place.

Chris Brown, his girlfriend and his bodyguard were among eight injured during the fight inside the club last week. Police say members of Drake's entourage stopped Brown as he was leaving. The fight escalated and bottles were thrown.

There was no answer at phone numbers listed as affiliated with those named in the lawsuit.

Feds open safety probe of Ford Explorers, Chrysler 200s

       . USA Today (6/23) reported, "Federal safety investigators are looking into complaints that the power steering can fail on 83,000 Ford Explorer SUVs from the 2011 model year." The National Highway Traffic Safety Administration "says it has received 15 complaints in which drivers reported that it forced them to use more effort to steer the SUVs." The Chrysler probe "involves complaints about engine stalling in Chrysler 200 midsize sedans from the 2011 model year that have 3.6-liter V-6 engines." 

Engine fire risk spurs GM to recall Cruze.

The Detroit News (6/23, Shepardson, Burden) reported GM "is recalling all 475,000 Chevrolet Cruze compacts, from the first off the line in 2009 through May 31, after reports of engine fires. It's a setback for the Detroit automaker looking to boost sales of fuel-efficient compact cars." GM "will modify the engine shield, which will help prevent liquids from being trapped in the engine compartment, where a fire could start and spread."

        The Detroit Free Press (6/23, Bomey) explained the fires "can break out when fluids drip onto a hot plastic shield below the engine. The recall is not by any means the largest ever, but it represents a potential setback for the company that demonstrated with the strong-selling vehicle that it and Detroit could compete effectively in the high-m.p.g. compact car market."

        The New York Times (6/23, Vlasic, Subscription Publication) added, "The safety recall was one of two announced by G.M. on the Cruze." The purpose of the second, separate recall "is to inspect for faulty welds on fuel-tank brackets. G.M. said it believed that 249 cars of the 61,000 in the recall could have weld problems."

Jeep investigation is "growing."

ABC World News (6/17, story 9, 2:05, Muir) reported, "troubling news, safety questions this evening, about some of the most popular SUVs on American roads," the Jeep Grand Cherokee. "The investigation is now growing into whether some Jeeps run a greater risk of catching on fire if the gas tank is hit." ABC (Schriffen) added that the government is investigating Grand Cherokee models made between 1993 and 2004, Cherokees made between 1993 to 2001, and Liberty models made between 2002 to 2007. "Clarence Ditlow, Center for Auto Safety" said, "We have 3.5 million Jeep Grand Cherokees, Cherokees and Liberties, driving around with defective fuel systems that, if hit in the rear, can result in a fuel leak and a catastrophic fire." Schriffen reported that government statistics claim that up to 15 people have been fatally burned to death because of the manufacturing flaw.

Investigation into Toyota Camry fires expands.

The CBS Evening News (6/18, story 7, 0:25, Pelley) reported, "Some later model Toyota Camrys were added today to a government investigation of fires inside car doors. It now includes 1.4 million Toyota cars and SUVs model years 2007 through 2009. A malfunction with the power windows may have caused 161 fires, and nine people were injured." 

Biker groups lobbying against stricter helmet enforcement.

The Philadelphia Inquirer (6/11, Schmitt) reports, "In a highly touted safety achievement, deaths on the nation's roads and highways have fallen sharply in recent years, to the lowest total in more than half a century." However, "motorcyclists have missed out on that dramatic improvement, and the news for them has been increasingly grim." Despite this development, biker groups want federal regulators and lawmakers to "back away from promoting or enforcing requirements for safe helmets, the most effective way known to save bikers' lives." Lobbyists for biker groups are attempting to block more National Highway Traffic Safety Administration grants "to conduct highway stops of motorcyclists to check for safety violations such as wearing helmets that don't meet federal standards." Moreover, biker groups want a 1998 rule that prevents NHTSA from advancing motorcycle safety measures at the state and local level to be continued.

New lawsuit filed against 1-800-GET-THIN.

The Los Angeles Times (6/13, Pfeifer) reports, "Surgery centers affiliated with the 1-800-GET-THIN ad campaign used improperly sterilized surgical equipment during Lap-Band weight-loss surgeries and failed to notify several patients that they might have been exposed to the hepatitis C virus, two former workers alleged in a new lawsuit" filed last Thursday in Los Angeles County Superior Court. Dietician Jessica Meyle and surgical assistant Amy Demonbreun are seeking "monetary damages from 1-800-GET-THIN, an affiliated surgery center in San Diego, and Michael and Julian Omidi, the brothers who the lawsuit says own and operate the weight-loss business." 

Spray tan substance may be harmful when inhaled.

ABC World News (6/12, story 9, 2:45, Stephanopoulos) reported, "We all know the risks of sun bathing and tanning beds, and that has led many to try chemical spray tans as a safer alternative. With the help of a hidden camera, ABC's consumer watchdog, Mark Greenblatt, has discovered that those spray tans may have come with new risks we didn't know about." ABC (Greenblatt) pointed out that "the chemicals inside that spray, which actually turns your skin brown, [are] only approved for external use, like in lotions, not for spray tanning. The concern, you might inhale it."

        The UK's Daily Mail (6/13, Bates, Borland) reports, "Spray tans, used by many as a safer alternative to sunbeds, may create serious health problems including cancer, scientists warned last night" in an ABC News investigation. "Those seeking a bronzed skin tone without exposing themselves to harmful radiation could instead be at risk from the main ingredient in sprays, which is potentially harmful if inhaled. The substance – known as dihydroxyacetone, or DHA – enters the lungs and is then absorbed into the bloodstream where it could damage DNA and cause tumours," according to Lynn Goldman, MD, dean of the School of Public Health and Health Services at George Washington University.

        The UK's Telegraph (6/13) quotes University of Pennsylvania lung specialist Reynold A. Panettieri, MD, who explained "there was unlikely to be a risk to casual users, but said the safety of the products had not been tested." He stated, "The lungs have a huge surface area, so this compound gets into cells and gets absorbed into the bloodstream." Panettieri "raised the possibility that DHA could make problems like chronic obstructive pulmonary disorder (COPD) worse." 

Evenflo recalls high chairs.

The Boston Globe (6/7, Lipka) reports in its "Consumer Alert" column, "A line of Evenflo high chairs that convert to a toddler table and chair were recalled today after reports of the trays unexpectedly coming off, the US Consumer Product Safety Commission said." The models affected are "29111259, 29111271 and 29111234." Evenflo is offering replacement trays.

        WebMD (6/7, McMillen) reports, "The reason for the recall is that the chairs' activity tray could unexpectedly detach, allowing unrestrained children to fall. Evenflo has received 18 reports of cases in which the trays detached. In nearly half of those cases, the toddler fell from the chair, suffering bumps and bruises."

Fragile brake pedal mounts cause Kia to issue another recall. USA Today (6/7) reports that Kia has issued "another recall, this one for Borrego SUVs." USA Today reports that the "National Highway Traffic Safety Administration says the latest call-back is because a brake pedal mount in 21,912 of the 2009 Borregos, built May 2, 2008, through Jan. 20, 2009, isn't sturdy enough and could break in a crash." USA Today adds that "yesterday, Kia announced a recall of 2006 through 2008 Rio subcompacts because front passenger air bags might deploy when they shouldn't." 

Orthofix pays $42 million to settle fraudulent claims cases.

The AP (6/8, Lozano) reports that Orthofix Inc., "a Dallas-area medical manufacturer has agreed to pay $42 million in penalties to settle civil and criminal cases related to fraudulent claims it made to Medicare and other federal health care programs when selling bone growth stimulator devices, the Justice Department announced Thursday." The total includes "$34.2 million to settle a whistle-blower civil lawsuit under the False Claims Act that alleged the company improperly waived patient co-payments," and "a related criminal case" in which it "has been ordered to pay a nearly $7.8 million criminal fine." The company "said the 'settlement is neither an admission of liability by the company or its subsidiaries ...' and that the settlement will not affect the company's participation in federal health care programs."

        Modern Healthcare (6/8, McKinney, Subscription Publication) reports, "According to a news release from the Justice Department, Lewisville, Texas-based Orthofix 'paid kickbacks to physicians and their staffs in the form of 'fitter fees,' referral fees and other comparable fees to induce the use' of the company's bone growth stimulator devices." And "Stuart Delery, head of the Justice Department's civil division" said in a statement, "The resolution of this matter yielded a substantial recovery for taxpayers, and should deter other companies from engaging in such conduct in the future." 

Judge rules Allergan shareholders may proceed with Botox suit.

Bloomberg News (6/12, Feeley, Milford) reports, "Allergan Inc. investors can seek to hold directors responsible for criminal sanctions and a $600 million penalty that the maker of the wrinkle smoother Botox was ordered to pay for marketing the drug for unapproved uses, a judge ruled." Bloomberg continues, "Two pension funds who contend that Allergan's board failed to properly oversee executives who marketed Botox for ailments that hadn't been approved by regulators have amassed enough evidence about the illegal sales effort to proceed with their claims, Delaware Chancery Court Judge Travis Laster concluded" on Monday. "The funds' allegations 'support a reasonable inference that the board consciously approved a business plan predicated on violating the federal statutory prohibition against off-label marketing,' Laster said in his 82-page ruling." 

DOT maps campaign against distracted driving.

On its front-page, the Detroit News (6/9, Shepardson) continues coverage about Secretary of Transportation Ray LaHood's distracted driving speech Thursday, when he unveiling a blueprint to "pass more laws, address technology and crack down on texting," a move praised by the Alliance of Automobile Manufacturers. Nevertheless, LaHood stopped short of calling for a ban on hands-fee calling unless research emerges that supports the move. LaHood reiterated his description of distracted driving as an "epidemic" and called on the remaining 11 states to pass legislation to ban texting while driving. He said, "While we've made progress in the past three years by raising awareness about this risky behavior, the simple fact is people are continuing to be killed and injured -- and we can put an end to it." To assist state efforts to curb the practice, USDOT unveiled $2.4 million for pilot projects in California and Delaware that "will examine whether increased police enforcement coupled with news media coverage can significantly reduce distracted driving."

        California, Delaware receive $2.4 million for pilot projects. The Los Angeles Times (6/9, Goldberg) noted California will receive about $1.5 million from USDOT to highlight the dangers of distracted driving through advertisements and increased police enforcement, building on the success of smaller-scale programs in Hartford, CT and Syracuse, NY -- programs that resulted in a 72% drop in texting in Hartford and a 32% drop in Syracuse. "As part of the 'Phone in One Hand, Ticket in the Other' campaign," Secretary LaHood announced that USDOT "would provide $2.4 million to California and Delaware to initiate pilot programs aimed at examining whether increased police enforcement and paid media advertisements can seriously reduce distracted driving." California "will use its federal money to saturate the Sacramento Valley media market with advertisements and pay for extra officers to patrol solely for distracted driving over two-week periods in December, February or March, and June, said Chris Cochran, spokesman for the Office of Traffic Safety."

        CDC survey shows teens' widespread calling, texting while driving. The AP (6/11, Svensson) reports on a new survey by the Centers for Disease Control and Prevention on distracted driving which found that "about 58 percent of high school seniors said they had texted or emailed while driving during the previous month," while approximately 43 percent of high school juniors also said they drive while using their phone. The AP discusses the industry's attempts to find a solution to prevent drivers from using their phones while driving and points to the companies that have "slightly more sophisticated solutions: apps that make sure you're in your car before putting the phone in 'driver mode.'"

FTC plans to depose Google's 

Smith & Nephew pulling metal liner used in hip replacements.

The AP (6/2) reported, "Smith & Nephew PLC said Friday that it is pulling from the market a metal liner used in hip replacements." Smith & Nephew "said the device is the optional metal liner for its R3 Acetabular System hip devices."

        Reuters (6/2) reported that the company had found that some patients had experienced problems such as infections and dislocations related to the device.

        MedPage Today (6/4, Gever) reports that "the company said 7,700 of the liners had been implanted since it was introduced in 2009." 

DOT clarifies hours-of-service for truck drivers at drilling sites.

NPR (6/6, Detrow) reported on its website that the US "Department of Transportation is clarifying a new rule regulating how much time truck drivers hauling materials to and from" oil and gas "drilling sites can spend on the road." According to the report, "drivers are limited to 14 hours a day, and the DOT says time spent loading and unloading material needs to count toward that limit." NPR reports that this "clarification comes two weeks after a New York Times report about how many drivers were working more than 14 hours by not counting on-site time." 

Iowa researcher finds sick hens "almost certainly" laid salmonella-tainted eggs.

The AP (6/5, Subscription Publication) reports, "An Iowa State University scientist found evidence that sick hens at farms owned by an Iowa egg producer were 'almost certainly' laying eggs contaminated with salmonella months before one of the nation's largest outbreaks of food-borne illness came to light, newly released records show." The piece notes, "Lawyers for several executives have denied their clients did anything criminal in connection to the outbreak, which the Food and Drug Administration has estimated sickened up to 62,000 Americans." 

J&J unit requests FDA approval to stop selling vaginal mesh implants.

Bloomberg News (6/5, Nussbaum, Feeley) reports, "Johnson & Johnson's Ethicon unit told a federal judge in West Virginia it intends to stop selling four vaginal mesh implants after being sued by more than 600 women who say the products caused internal injuries. Johnson & Johnson said it has requested approval from the Food and Drug Administration to stop 'commercializing' the devices." The company "has asked the FDA for 120 days to end sales so it can 'notify its customers and provide those hospitals and surgeons with sufficient time to select alternative treatment options for their patients.'"

Coalition urges lawmakers to address medical device 

Actos may be linked to increased risk of bladder cancer.

Reuters (6/1) reported that, according to a study published online in BMJ, the diabetes medication Actos (pioglitazone) may be linked to an increased risk of bladder cancer.

        HealthDay (6/1, Reinberg) reported that investigators "collected data on nearly 116,000 people treated for diabetes from 1988 to 2009 and listed in the General Practice Research Database, which contains records from more than 600 medical offices in the United Kingdom."

        MedPage Today (6/1, Walsh) added that "patients with type 2 diabetes who were ever treated with pioglitazone had an 83% higher risk for bladder cancer (adjusted rate ratio 1.83, 95% CI 1.10 to 3.05) than those who had never used the thiazolidinedione." The investigators reported that "this was a drug-specific effect, because patients taking rosiglitazone (Avandia) did not have an elevated risk (RR 1.14, 95% CI 0.78 to 1.68)." The findings from "this analysis differed from those of a study being presented this week at the annual meeting of the American Society of Clinical Oncology, which suggested that the bladder cancer risk was a class effect for glitazones." Also covering the story was the UK's Telegraph

Tide to add lid latch to keep children out of detergent packets.

The AP (5/25, Ball, Merchant) reported, "The maker of Tide Pods will create a new double-latch lid to deter children from accessing and eating the brightly colored detergent packets, a company spokesman said Friday. Procter & Gamble spokesman Paul Fox said the Cincinnati-based company plans to create a new lid on tubs of Tide Pods 'in the next couple of weeks.'" The reason is the number of poisoning incidents, attributed to the attractive colors of the small packets.