Johnson & Johnson's Synthes unit sued over death linked to bone-cement trial.

Bloomberg News (7/31, Pearson) reports, "Johnson & Johnson's Synthes unit, a maker of tools and implants to treat damaged bones, along with its former Norian Corp. subsidiary, was sued by the family of a woman who died during an unapproved trial of a bone cement." As Bloomberg describes, "Lois L. Eskind lost her life on Jan. 13, 2003, after a surgeon injected Synthes's Norian SRS drug into her spine mixed with barium sulfate." The plaintiffs claimed that the Synthes The story mentions that "four Synthes executives were sentenced last year to prison terms ranging from five months to eight months for their roles in the unapproved trials."

        The Philadelphia Inquirer (7/31, Sell) "Philly Pharma" blog reports that Synthes faces a lawsuit over a death allegedly caused by a "bone cement made by Synthes and its then-subsidiary Norian." The 

California appeals court reinstates product liability suit against Glock.

The AP (7/26) reports, "A California appeals court has reinstated a now-retired paralyzed Los Angeles police officer's product liability lawsuit against gun manufacturer Glock." The retired officer, Enrique Chavez, "was paralyzed from the waist down when his 3-year-old son accidentally shot him with his service pistol," and the lawsuit claims that the .45-caliber Glock 21 pistol does not have adequate safeguards to prevent accidental discharge. According to the AP, "a Los Angeles judge dismissed the suit two years ago, saying a Police Department review of the gun's design found the Glock's advantages outweighed any inherent risks." 

Peg Perego recalls 223,000 strollers amid safety concerns.

ABC World News (7/24, story 9, 0:30, Sawyer) reported, "A consumer alert now about a huge recall of baby strollers. Tonight more than 200,000 strollers manufactured by Peg Perego are being recalled. There's a risk the child's head will become trapped between the seat and the tray, which could strangle the child. One death has already been reported. Two models, both older, manufactured between 2004 and 2007, are being recalled."

        The Wall Street Journal (7/25, Jones, Subscription Publication) reports that Peg Perego USA Inc. is now recalling about 223,000 strollers because of concerns over safety risks. The safety concerns are especially related to the death of a six-month-old baby from strangulation eight years ago in Tarzana, California. The Journal notes that the US Consumer Product Safety Commission found that the baby was strangled when his head became trapped between the seat and the tray of his Peg Perego stroller.

        CNN (7/25, Sperry) reports on its website that in a separate incident in 2006, "a 7-month-old New York girl nearly died from similar circumstances." The story quotes the CPSC as saying of the Peg Perego stroller, "Entrapment and strangulation can occur, especially to infants younger than 12 months of age, when a child is not harnessed. An infant can pass through the opening between the stroller tray and seat bottom, but his/her head and neck can become entrapped by the tray. Infants who become entrapped at the neck are at risk of strangulation." The Digital Journal (7/25, Goessl) and the Minneapolis Star Tribune (7/25, Stoxen) "Health Check" blog offer similar coverage.

FDA warns of seizure risk in normal dosage of Dalfampridine.

MedPage Today (7/24, Phend) reports that the FDA issued a warning that "multiple sclerosis drug dalfampridine (Ampyra) can cause seizures in patients who are starting the medicine at normal doses," and "most seizures happened in patients with no history of seizures and occurred within days or weeks of starting the drug at its recommended dosage." The medication "was approved in 2010 to improve walking ability in MS." The FDA "pointed out that the drug is excreted renally, so kidney impairment may lead to higher blood levels that raise seizure risk."

        Reuters (7/24, Clarke) the medication, marketed as Fampyra in Europe, was known to have a seizure risk for dosages higher than that recommended. Now the FDA is recommending that kidney function be checked before prescribing the medication and checked at least annually thereafter. Also patients should not make up any missed doses as the extra dosage could increase the risk. 

Cargill recalls 30,000 pounds of ground beef over salmonella concerns.

Food Safety News (7/23) reports, "Cargill Beef late Sunday recalled almost 30,000 pounds of 85 percent lean, fresh, ground beef, produced by the company at Wyalusing, PA on May 25, 2012. The meat may be contaminated with Salmonella Enteritidis (SE) associated with an ongoing multiple state outbreak of SE." The meat was "sold at wholesale in 14 pound chub packages, packed 3 chubs to approximately 42 pound cases, it is thought the beef was repackaged for sale to the public by Cargill's customers."

        The AP (7/23) reports, "Hannaford Supermarkets is alerting consumers that Cargill Beef is voluntarily recalling 29,339 pounds of ground beef that may contain salmonella. ... Hannaford's says consumers should check their ground beef for 'use or sell by' dates between May 29 and June 16." 

Experts claim current noise rules are insufficient to protect workers' hearing

.

The New York Times (7/20, Buckley, Subscription Publication) reports, "Noise levels recorded at nearly a dozen restaurants, gyms and bars in New York City reached heights that, if sustained over as little as two hours, would violate standards set by the Occupational Safety and Health Administration to protect workers' hearing." However, even if the workplace regulations were abided by, many audiologists claim that the existing rules "would not protect hearing enough: federal noise protection standards lag behind much of the industrialized world's." The Times notes that OSHA "requires that workers exposed to an average of 90 decibels - about as loud as truck traffic - for eight hours wear hearing protection." 

CPSC issues new recall of children's high chairs.

Examiner.com (7/19, Evett) reports, "The Consumer Product Safety Commission has issued another recall of children's high chairs, just a little over one month since its' last." According to the story, "the latest recall affects 455,000 Chicco high chairs that were sold at various popular retailers across the US between January 2005 and July 2012." 

Report: Medical malpractice payments have hit a record low.

Fierce Healthcare (7/18, Cheung) reports, "Malpractice payments hit a record low in 2011, according to a report from consumer advocacy group Public Citizen." The article notes that "the number of malpractice payments on behalf of doctors (9,758 payments) was the lowest since 1991, the first full year of data after the NPDB started collecting information. The average size of medical malpractice payments (about $327,000) amounted to $3.2 billion, adjusted for inflation." 

Hospira recalls several lots of four cancer drugs due to defect in glass vials.

The Wall Street Journal (7/17, Dooren, Subscription Publication) reports that Hospira Inc. has recalled several lots of four cancer drugs due to an issue with the vials that contain the medications, according to the drugmaker and the Food and Drug Administration.

        Reuters (7/16, Sherman) reported that the medications involved in the recall are carboplatin, cytarabine, paclitaxel, and methotrexate.

        MedPage Today (7/17, Petrochko) reports that apparently there is a "defect in the glass vials resulting in visible particulate matter." According to MedPage Today, "The affected glass vials have particles embedded in the neck of the vial that may become dislodged, the FDA said in a statement. If injected, the debris can cause bleeding, bruising, inflammation, itching, rash, chest pain, and respiratory symptoms."

        The Boston Business Journal (7/16, Donnelly, Subscription Publication) reported, "Hospira says it has not yet had reports of any adverse events resulting from the foreign particles."

Grassley writes NHTSA over Toyota investigation.

In an article carried by 91 outlets, the AP (7/13) reported that Sen. Charles Grassley sent a letter Thursday to the National Highway Traffic Safety Administration which questioned "whether the government thoroughly investigated electronic gremlins that could have caused Toyota vehicles to accelerate unexpectedly." According to Grassley, "key questions remain unanswered about what caused Toyota's unintended acceleration problems, despite investigations by NHTSA and NASA that found electronic defects weren't to blame." Specifically, "Grassley questions whether a phenomenon called 'tin whiskers' inside the gas pedal assembly or other electronics could be a cause, citing information sent to his office by whistleblowers." In his letter, Grassley requested that NHTSA explain its stance on tin whiskers and whether they could have caused unintended acceleration in Toyota. NHTSA said it would respond to Grassley's letter. Lynda Tran, a NHTSA spokeswoman, said in a statement that the known reasons for unintended acceleration in Toyotas were sticking accelerator pedals and gas pedals that became trapped by floor matting.

        The Los Angeles Times (7/13, Puzzanghera) reported, "Grassley said whistle-blowers recently have provided his office with information suggesting that the investigation by the National Highway Traffic Safety Administration, with the help of NASA engineers, 'may have been too narrow." Grassley also wrote "that NASA engineers said just because they did not find proof that Toyota Motor Corp.'s electronic throttle control system caused the reports of unintended acceleration 'does not mean it could not occur.'" 

485,000 high chairs recalled after injury reports

Posted Thursday, Jul. 12, 20120 Comments PrintReprints

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Topics: Toys "R" Us

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The Associated Press

WASHINGTON — More than 485,000 Chico Polly high chairs are being recalled after a design flaw led to children getting cuts and bruises.

Importer Artsana USA Inc. knows of 21 children getting injured from falling against pegs on the back legs of the chairs, which are meant to store the tray. Four children got cuts serious enough to require stiches, and one had a scratched cornea.

There are 26 chair models involved. They were sold from January 2005 through this month online and at major chains including Babies R Us, Buy Buy Baby and Toys R Us.

Model details are on the U.S. Consumer Product Safety Commission website at http://www.cpsc.gov, or at http://www.chiccousa.com/pollykit.

The company will provide free kits to cover the pegs. Requests may be made online or by calling 800-807-8817.

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Read more here: http://www.star-telegram.com/2012/07/12/4094980/485000-high-chairs-recalled-after.html#storylink=cpy

Stryker recalls modular neck-stem devices attaching to artificial hips.

Stryker recalls modular neck-stem devices attaching to artificial hips.

The Boston Business Journal (7/10, Donnelly, Subscription Publication) reported, "Stryker Orthopaedics has voluntarily recalled two brands of devices used in conjunction with artificial hips in hip replacement surgeries, according to the US Food and Drug Administration website." To date, "there have been at least 45 adverse event reports from patients who say the devices caused pain and/or tissue swelling." This week, Stryker said that "it would remove Rejuvenate and ABG II modular-neck stems, which attach to artificial hips, from the market and cease global distribution."

        The modular neck-stem devices were recalled "because of postmarketing data showing fretting and corrosion at the modular neck junction, according to an alert from the US Food and Drug Administration (FDA)," Medscape (7/11, Hitt) reports. "The FDA posted the company's press release, dated July 6." Stryker "states that patients who already have the implanted modular-neck stems should contact their surgeon only if they experience pain and/or swelling of the hip and should undergo revision surgery only if symptoms of pain and swelling at the local joint site are not attributable to other conditions such as aseptic loosening and periprosthetic sepsis." 

Georgia Supreme Court upholds key tort reform provision.

The Atlanta Journal-Constitution (7/10, Rankin) reports, "The Georgia Supreme Court on Monday declined to strike down a key provision of the state's tort reform law that divvies up damage awards to plaintiffs in liability cases. The ruling was welcomed by property owners who have complained they have had to pay more than their fair share in cases involving attacks of people on their premises. Plaintiffs' lawyers have argued the law will stymie victims from being fully compensated for their injuries." By a 5-2 vote, the Georgia high court responded to a request from the federal judge presiding in federal premises liability lawsuit against an Atlanta Red Roof Inn hotel where a visitor was attacked and robbed by ruling that the jury can apportion any damages between the hotel and his unknown assailants. 

NHTSA fines Volvo for failing to report safety defects.

Bloomberg News (7/3, Keane) reported that the National Highway Traffic Safety Administration has fined Volvo $1.5 million for not disclosing "six defects that led to recalls in 2010 and one this year within five business days of determining that a safety flaw exists." Bloomberg News reported the "recalls included tires that weren't properly labeled, gearshift levers that can become loose and air bags that may not deploy in a crash." A statement from NHTSA Administrator David Strickland said it is "critical to the safety of everyone on our roadways that automakers promptly report safety defects -- and take immediate action to resolve the issue." Strickland added that the "NHTSA expects all manufacturers to obey the law and address automotive safety concerns without delay."

        Also reporting this were the New York Times (7/3, Jensen), the Detroit Free Press (7/3, Spangler), and the Detroit News (7/4,

Childhood poisonings from new detergent packets on the rise.

The New York Times (6/28, O'Connor) "Well" blog reports, "Childhood poisonings from a new type of detergent packet have soared in recent weeks, experts say, with the total climbing to more than 1,200 this week from about 200 in late May." The most recent figures indicate that "poison centers across the country have been seeing an average of 10 cases a day, and as many as 28 a day, said Bruce Ruck, assistant director of the New Jersey Poison Information and Education System." The blog adds, "This week, the California Poison Control System announced that at least nine small children in that state were taken to emergency rooms between Saturday and Tuesday after exposure to the packets, bringing the state's total number of cases to at least 91."