CMS: Over 17% of nursing-home patients had antipsychotics doses exceeding recommendations.

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The Baton Rouge (LA) Advocate (8/29, Couvillion) reports, "A national initiative launched at the end of May has set an ambitious goal of reducing the use of antipsychotic drugs for nursing home residents by 15 percent by the end of this year. It's called the 'Partnership to Improve Dementia Care in Nursing Homes' and is being led by the Centers for Medicare and Medicaid Services (CMS)." In 2010, according to CMS data, "more than 17 percent of nursing-home patients had daily doses of antipsychotic drugs exceeding recommended levels, according to a CMS news release." 

New York investigates energy drink makers.

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On the front page of its "Business" section, the New York Times (8/29, Schwartz, Subscription Publication) reports that "the New York attorney general has subpoenaed three large makers of so-called energy drinks as part of an investigation into whether the companies are misleading consumers about how much caffeine the drinks contain and the health risks they could pose." Eric T. Schneiderman, the attorney general, is also "looking at whether the companies - Monster Beverage, PepsiCo and Living Essentials - violated federal law in promoting the drinks as dietary supplements rather than as foods, which are regulated more strictly." Citing an anonymous source who has been briefed on the investigation, the Times says that "state authorities are also concerned about whether all of the ingredients that go into the beverages are properly disclosed."

        In a related story, the AP (8/29) reports that "the probe is examining how the drinks are made, often loaded with caffeine and sugar, along with what critics say is a mostly useless amount of Vitamin B, and how they are marketed at sports events and sometimes in bars." Michael Jacobson, executive director of the Center for Science in the Public Interest, remarked, "This has been a slimy sector of the beverage industry almost since the beginning," adding that "it's just kind of playing off peoples' presumptions that they provide a benefit."

        The Wall Street Journal (8/28, Albergotti, Esterl, Subscription Publication) notes that the energy drink makers could face civil fines and penalties if they are found to have violated state laws regulating food and drugs. Additionally, they could be forced to alter their marketing and labeling.

        ABC (8/29, Davies) reports in its "Business" blog that energy drinks have recently been the subject of much criticism. It notes, for instance, that "last year the American Academy of Pediatrics said some products were harmful to children and young adults because they contain large amounts of caffeine and other stimulants." Also covering the story are: Reuters (8/28, Ax, Geller), and NBC News (8/29, Jones) "Market Day" blog. 

Heart device recall at St. Jude may generate higher bills for some.

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The Wall Street Journal (8/27, Weaver, Subscription Publication) reports that patients who are dealing with the recent recall of heart devices from St. Jude Medical Inc. are also facing the potential problem of rising bills as a result of the recall. According to the Journal, physicians are increasingly removing the Riata defibrillation leads from patients due to safety concerns, but the procedure to have them taken out of a patient can be risky and expensive. 

Hospital must pay family $8.5 million, jury rules

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Published: Sun, August 26, 2012 @ 12:00 a.m.

The Plain Dealer
CLEVELAND
In a verdict announced at 3:30 a.m. Saturday after 15 hours of deliberation, a Cuyahoga County Common Pleas jury ordered MetroHealth Medical center to pay $8.5 million to the mother of a child who suffered permanent brain injury at birth three years ago.
Nala Myers, who turned 3 on Saturday, suffered lack of oxygen to the brain because she was not promptly and properly resuscitated after delivery, according to the lawsuit for her mother, Tierra Myers.
She is tube-fed, unable to speak or walk and will never be able to care for herself, said Myers’ attorney, Bill Jacobson of the Cleveland law firm Nurenberg, Paris, Heller & McCarthy.
The hospital contended that a placental infection caused the baby’s distress, he said.
“Our sympathy goes out to the family,” spokeswoman Shannon Mortland said in a statement for MetroHealth. “However, there were complex issues associated with this case, and we feel we acted appropriately.
“We anticipate examining our options for appeal.”
Lawyers for the hospital could not be reached for comment.
The size of the judgment reflects the lifelong care Nala will require. A search of the Lexis.com jury verdict database indicates it is not unusual for cases in Ohio in which significant brain damage occurs during childbirth.
The eight-member civil jury heard almost three weeks of testimony by experts from around the country before starting their deliberations around noon on Friday. They reached their decision at 2:45 a.m. Saturday.

FDA warns supplements contain dangerous drugs.

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In continuing coverage, ABC News (8/24, Neporent) reports on its website that the FDA has issued another Safety Warning about "Reumofan and Reumofan Plus," which are marketed as "natural dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions." The agency said the supplements contain "several potentially dangerous ingredients that are not listed on the label," including dexamethasone, a corticosteroid; diclofenac sodium, an NSAID; and methocarbamol, a muscle relaxant. FDA spokesperson Sarah Clark-Lynn said that since its first Safety Warning in June, the agency "has received dozens of additional adverse event reports, including death and stroke," associated with supplements, which are manufactured in Mexico by Riger Naturals. 

Report: Medical device recalls reach an almost two-year high.

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DOT Med News (8/23, Nafziger) reports, "Nearly 123 million medical devices, such as ultrasound gels and hip implants, were hit with recalls in the last quarter, making for a nearly two-year high, according to a company that tracks food, drug, device, and children's product recalls." The story notes that "while the number of device recalls dropped since the previous quarter, the number of actual units affected passed the 100 million mark for the first time since the third quarter of 2010, according to a quarterly index on recalls published by ExpertRecall, a subsidiary of medical waste management giant Stericycle." The index notes that the US Food and Drug Administration "enforcement reports from Q2 2012 found 242 device recalls, down 13 percent from the 277 in the first quarter, but up 4 percent from the same period last year." 

FDA warns of drug risk in Reumofan dietary supplements.

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The AP (8/22) reports that the Food and Drug Administration is "warning consumers not to use Reumofan dietary supplements, after receiving reports of bleeding, stroke and death among people" who took the supplements. Although Reumofan Plus and Reumofan Plus Premium are "marketed as natural remedies for arthritis and muscle pain," the FDA said a chemical analysis "found that Reumofan Plus contains three drugs, including the muscle relaxant methocarbomal and the anti-inflammatory drug dexamethasone," which can "interact with other medications, causing life-threatening side effects in some patients." The FDA initially "warned consumers about the products" in June, but said it continues to receive reports of complications related to the supplements, which are "manufactured in Mexico by Riger Naturals and sold in the US at retail shops and over the Internet." 

FDA recalls contaminated romaine lettuce

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ABC World News (8/20, story 7, 0:25, Sawyer) reported, "And now we have a new warning tonight about contaminated fruits and vegetables. Last week, we told you about cantaloupe from Indiana carrying salmonella and today a major recall of romaine lettuce grown in California and shipped to 19 states. The fear is E. coli."

        The Santa Fe New Mexican (8/21, Haywood) reports that Food and Drug Administration has "issued a nationwide recall of a specific lot of romaine lettuce, some of which was shipped to New Mexico, that has tested positive for E. coli bacteria." The agency said that some of the "individually wrapped heads of Tanimura & Antle brand romaine could have been sold at Walmart stores in the state between Aug. 2 and Aug. 19." Thus far, no related illnesses have been reported. The New Mexico Environment Department said the recall is a "precaution based on the testing of a single, random sample by the Canadian Food Inspection Agency."

        WUSA-TV Washington (8/21, Wilson) on its website adds that the Tanimaura and Antle Field Fresh Wrapped lettuce wrappings were stamped with an Aug. 19 "use by date." 

General Motors, Isuzu announce recall

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In continuing coverage, ABC World News (8/19, story 5, 0:30, Muir) reported, "We move on to a consumer alert, General Motor and Isuzu recalling 250,000 SUVs because of a possible short circuit that can cause fires." According to the segment, "the recall includes five models including the Chevrolet Trailblazer from 2006 and 2007." The recall was prompted by concerns that "chemicals that clear roads of snow and ice can get inside the driver's door and short circuit the switches controlling power windows and door locks." To date, 28 fires have been reported, though, no injuries have been linked to the defect. 

Covidien issues recall for surgery ventilation device.

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Reuters (8/16) reports Covidien Plc announced a recall Wednesday for some lots of its re-usable, cuffed Shiley tracheostomy tubes, a ventilation device that provides an opening for removing tracheal and lung fluids during surgery. Based on leakage complaints it received, the FDA designated it a Class I recall, which means that problems with device could lead to serious health complications or death. According to Coviden spokesperson Rhonda Luniak, the recall includes roughly 330,000 Shiley tubes from the size 8 adult lots that the company manufactured from October 2009 through June 2012.

        Fierce Medical Devices (8/16, Hollmer) also covers the story and notes that is Covidien's second recall "in the past few months, as the company discovered a packaging issue in some of its Roticulator staplers back in May, recalling 5 models over sterility worries"; and in July, Covidien "warned UK regulators that the batteries in some of its at-home ventilators could fail, but the company did not issue a recall of the devices." 

J&J to remove potential carcinogens from product ingredients.

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ABC World News (8/15, story 9, 0:25,, Sawyer) reported, "There is a big announcement tonight from Johnson & Johnson. The company says it will change the ingredients in all its cosmetics, creams and baby items to guarantee they no longer contain even trace amounts of chemicals that could be linked to cancer. The company's been under pressure to make its products safer."

        According to the AP (8/16, Johnson), J&J released a statement saying it is planning to "remove potentially cancer-causing and other dangerous chemicals from nearly all its adult toiletries and cosmetic products worldwide." Late last year, the company "pledged to remove 'chemicals of concern' from its baby products around the world after being pressed to do so for more than three years by a large coalition of health and environmental groups." And on Tuesday, J&J reiterated that vow, saying it "remains on track to have baby products...reformulated with safer ingredients by the end of 2013"; and it expects to have its adult products "reformulated by the end of 2015." Additionally, J&J on Wednesday, "launched a website, safetyandcarecommitment.com" to keep consumers informed on "what it does to ensure its ingredients are safe and of high quality."

        On the front page of its Business Day section, the New York Times (8/16, B1, Thomas, Subscription Publication) reports that among the ingredients J&J plans to remove is formaldehyde, which "last year was identified by government scientists as a carcinogen," and is released by common preservatives such as "quaternium-15 and DMDM hydantoin," and "1,4 dioxane," which is "created during a process commonly used to make other ingredients gentler on the skin." The company also plans to get rid of "phthalates, which have a variety of uses, like lessening the stiffening effects of hair spray; several fragrance ingredients"; triclosan, an antibacterial; and parabens, a preservative. 

Bumbo recalls 4 million baby seats.

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The CBS Evening News (8/15, story 7, 0:25, Schieffer) reported, "There is a major recall of baby seats tonight. The company Bumbo is recalling four million of the seats. There is a danger that children can wiggle out and fall; 130 falls have actually been reported since 2003. Thirty-five resulted in skull fractures. The recalled seats will be fitted with new restraining belts."

        The AP (8/16) reports, "About 4 million Bumbo Baby Seats are being recalled after nearly two dozen reports of infant skull fractures." According to the Consumer Product Safety Commission, babies "can wiggle out of the floor seats." Since one-million of the company's molded foam seats were recalled in 2007, CPSC and "Bumbo International of South Africa have learned of at least 50 incidents in which babies fell from Bumbo seats while they were being used on raised surfaces." In addition, CPSC says "another 34 babies fell from the seats while they were being used on the floor or at an unknown elevation. In all, there were 21 reports of skull fractures to infants." Meanwhile, the company says it is "adding a restraint belt to enhance the safety of children using the Bumbo seat." 

Listeria victims' attorney says US probing Colorado cantaloupe case.

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The AP (8/15) reports from Denver, "An attorney for people who say they were sickened by cantaloupe contaminated with listeria says US Attorney's officials are investigating the outbreak." Bill Marler "represents the families of about 40 people who were sickened or died following the outbreak linked to a Colorado farm. He said Tuesday that investigators asked for his case files, and he turned them over several weeks ago. A spokesman for the US Department of Justice's civil division, Charles Miller, refused to confirm any investigation or say whether it was civil or criminal."

        Food Safety News (8/15, Flynn) adds that John Walsh, the "US Attorney for Colorado is close to finishing a Federal criminal investigation into the deadly 2011 Listeria outbreak associated with cantaloupes from Jensen Farms, the nonprofit Denver-based I-News Network reports." However, James Pena, who "heads the US District Attorney's healthcare fraud task force, called the Listeria outbreak 'an important public health issue,'" but neither he nor "anyone else" speaking for Walsh would "confirm or deny the existence of the investigation."

        FDA: Cantaloupes, melons from North Carolina recalled amid Listeria concerns. CNN (8/15) reports that the FDA announced Tuesday that Burch Farms has "recalled all cantaloupes and honeydew melons it grew this year because of possible listeria contamination." The agency said it "found Listeria monocytogenes or L. mono on a honeydew melon and at the packing facility in Faison, North Carolina." Consumers can identify the contaminated cantaloupes and melons, which were "sold to distributors in 18 states along the East Coast and in the Midwest but may have been resold in other states," by their stickers which either say "Burch Farms or Cottle Strawberry." Thus far, the FDA said it has received no reports of illness from the products but noted that Listeriosis can occur "several weeks" after eating a contaminated product. 

Dishwashers recalled over concerns about fire hazards.

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The AP (8/10) reports, "More than a million GE dishwashers are being recalled due to fire hazard. The Consumer Product Safety Commission said Thursday the voluntary recall includes about 1.3 million GE, GE Adora, GE Eterna, GE Profile and Hotpoint dishwashers." The story notes that the dishwashers are being recalled over reports that the machines' heating elements may be vulnerable to failure and may cause fires.

        Bloomberg News (8/10, Catts) adds that "owners should contact GE for free repairs or vouchers toward the purchase of a new unit," according to the CPSC. Inez Moore Tenenbaum, chairman of the US Consumer Product Safety Commission, is quoted as saying, "Consumers should stop using these dishwashers immediately and disconnect the power."

        The Boston Globe (8/10, Lipka) "Consumer Alert" blog, KTUL-TV Tulsa, OK (8/10) and WTVM-TV Columbus, GA (8/10) also cover this story. 

Study: Many patients not aware their medications were prescribed off-label.

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HealthDay (8/9) reports, "Many patients who are being treated with 'off-label' drugs are unaware that the medications they have been prescribed by their doctor aren't being used in ways" not approved by the FDA, according to a study "published online Aug. 6 in the Mayo Clinic Proceedings."  Lead author Dr. Christopher Wittich, a Mayo Clinic internal medicine physician called the practice "very common," and the study suggested that the "costs and lengthy process of obtaining FDA approval may deter drug companies from seeking approval for a new drug indication." 

CPSC moves to take magnet toys off the market over child-safety concerns.

The AP (8/8, Lederman) reports, "A standoff between the government and sellers of desktop magnet toys for adults escalated Tuesday, with federal consumer safety officials filing their second complaint to force a company to take the potentially dangerous product off the market." As the story describes, the Consumer Product Safety Commission recently filed "an administrative complaint against Zen Magnets, a Colorado-based company that imports and markets tiny but powerful magnets that can be molded into different shapes." The CPSC maintains that the magnets present a danger to children, even though they are meant for adult use. 

Garden Fresh Foods recalls possible listeria-contaminated products.

The Milwaukee Business Journal (8/3, Smith, Subscription Publication) reported, "Garden Fresh Foods Inc. of Milwaukee, a maker of packaged pasta salads and chicken salads, is recalling 13,600 pounds of products that contain onions possibly contaminated by the bacterium Listeria." The piece noted, "Last week, the FDA released a statement on the release urging consumers who have bought the products to return them to the place of purchase for a full refund. The FDA also provides a complete list of brands that may contain the onions in the release."