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  • Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

    A shareholder lawsuit alleging Medtronic Inc. illegally promoted the off-label use of its Infuse bone growth product has been granted class action status by U.S. District Judge Paul Magnuson of Minnesota. According to a report from Law360.com, the Medtronic Infuse off-label promotion lawsuit was filed by several institutional investors ...

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  • Three Firms Recall Dog Foods Over Unacceptble Aflatoxin Levels

    Three firms have recalled dog foods over aflatoxin levels found to be above the acceptable limit. Aflatoxins are produced by toxigenic strains of Aspergillus flavus and A. parasiticus, explained Pet Product News. The aflatoxins are found on peanuts, soybeans, corn, and other cereals and produce in the field or when the ...

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  • Raw Cookie Dough Poses E. Coli Danger

    Raw cookie dough poses dangers because of the sometimes-deadly E. coli food borne illness. As a matter-of-fact, researchers tracing illnesses found that a significant number originated with E. coli and uncooked, pre-packaged cookie dough. It seems that the raw, ready-to-bake cookie dough can be riddled with pathogens such as E. coli, ...

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  • Federal Judge Refuses to Dismiss Light Cigarette Lawsuit Against Philip Morris USA, Altria Group

    A federal judge has refused to dismiss a New York class action lawsuit alleging Philip Morris USA and Altria Group, Inc. deceptively marketed Marlboro Lights cigarettes as a less dangerous alternative to regular cigarettes. John A. Woodcock, Jr., Chief District Judge for the U.S. District Court, District of Maine, ...

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  • Medtronic Settles Charges Over Kickbacks To Doctors

    Medical device giant, Medtronic Inc., is settling charges over kickbacks to doctors. The firms just agreed to pay $23.5 million to settle claims it paid physicians kickbacks in exchange for their use of its pacemakers and defibrillators, according to a U.S. Justice Department announcement yesterday. The company was accused of seeking ...

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  • Gilenya Safety Questioned Following Patient Death

    Gilenya has raised safety concerns after a patient taking the multiple sclerosis medication died last month. Gilenya is manufactured by Novartis AG. The patient died on November 23 after starting Gilenya treatment. Gilenya is the first pill approved by the U.S. Food & Drug Administration (FDA) for the treatment of multiple ...

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Choking Hazard Prompts Infant Bodysuit Recall

Choking hazards prompt an infant bodysuit recall, the U.S Consumer Product Safety Commission (CPSC) has announced.

About 128,000 Carter’s Watch the Wear Bodysuits and Sleep ‘n Play Garments are being recalled. The defective Carter’s Watch the Wear Bodysuits and Sleep ‘n Play Garments were imported and manufactured by Weeplay Kids LLC, of New York, New York; manufactured in Bangladesh; and sold by Big Lots, Century 21, Conway, Cookies, Cost Mart, DD’s Discount, Edison Childrenswear, Gabriel Bros., Kiddy Time, Kids Place, Kidstown, National Stores, Pamida Stores, Real Value, Regine’s, R.H. Reny, Ross, Shoppers World, Valley Wholesale, Variety Wholesalers, and Youngland stores nationwide. The recalled garments sold from November 2010 through August 2011 for about $4 to $9. Continue reading

Posted in Product Recalls |

Aromasin May Cause Bone Loss, Study Finds

A new study linking the breast cancer prevention drug Aromasin (exemestane) to decreased bone density and bone loss has stunted optimism surrounding the drug.

According to The New York Times, a study conducted last summer from University Health Network, Toronto, notes women most at risk of breast cancer taking Aromasin greatly reduce their chances of contracting cancer. A new analysis of that study noted that those same women faced a greater chance of suffering significant bone loss and overall loss of bone density. Continue reading

Posted in Pharmaceuticals |

Bumbleride Strollers Recalled For Fall Hazard

Bumbleride Strollers are being recalled for fall hazard, the U.S. Consumer Product Safety Commission (CPSC) and Health Canada (HC) just announced.

The defective, recalled Bumbleride Indie & Indie Twin Strollers were manufactured in Taiwan; imported by Bumbleride Inc., of San Diego, California; and sold at Buy Buy Baby and other baby product stores nationwide, online at Bumbleride.com, and other online retailers, between January 2009 and January 2012 for $500 and $700.

About 28,000 were sold in the United States; an additional 2,700 were sold in Canada.

The front wheel of the Bumbleride Indie & Indie Twin Strollers can break at the axle hub, causing the stroller to tip and posing a fall hazard. To date, there have been 36 incidents of the front wheel cracking, including two reports of the stroller tipping, which resulted in minor injuries.

The recalled Bumbleride Indie Strollers are model numbers I-107, I-110 and I-205 with a Date of Manufacture (DOM) from January 2009 through August 2011, and which sold in multiple colors. The DOM is located on a white rectangular sticker affixed to the side of the seat frame.

The recalled Bumbleride Indie Twin strollers are model numbers IT-108, IT-111, and IT-305 with a DOM from January 2009 through August 2011 and were sold in multiple colors. The DOM is located on a white rectangular sticker affixed to the underside of the handle.

The firm is advising consumers to immediately stop using the recalled Bumbleride Indie & Indie Twin Strollers and contact Bumbleride to receive a free front wheel retrofit kit. Bumbleride can be reached at its website at www.support.bumbleride.com; by email at support@bumbleride.com; or by telephone, toll-free, at 1.800.530.3930 between 8:00 a.m. and 4:00 p.m., Pacific Time (PT), Monday through Friday.

Bumbleride also alerts consumers that to avoid the risk of strangulation to children, owners of Indie models (I-110, I-205) and Indie Twin models (IT-111, IT-305) with an adjustable bumper bar should never set the bar in the intermediate (car seat) position when a child is seated in the stroller. For more information, visit www.bumbleride.com/updates or call 1.800.530.3930.

Posted in Product Recalls |

Study Sees Big Jump in Use of BMP Bone Growth Products for Spine Surgery

A newly-published study will likely raise more questions about the growing use of bone morphogenetic protein (BMP) in spinal fusion surgeries, The study, published in the February 1 issue of the journal Spine, examined the use of BMP for spinal fusion surgery in older patients with lumbar stenosis, and found that while the bone growth protein increased costs, its use was not associated with better outcomes for patients.

The U.S. Food & Drug Administration (FDA) approved BMP for use in 2002 in one type of spinal fusion procedure, anterior lumbar interbody fusion. One of the more well-known BMP products on the market is Medtronic Inc.’s Infuse bone growth product, also known as recombinant human Bone Morphogenetic Protein-2 or BMP2. Continue reading

Posted in Defective Medical Devices, Medtonic Infuse |

Crickit® Surgical Kits Recalled, May Contain Tainted Triad Povidien Prep Pads

Crickit®, Surgical Kits—which may contain tainted Triad Povidien Prep Pads—are being recalled under the direction of the U.S. Food and Drug Administration (FDA) and involves North American Rescue, LLC Surgical Crichothyroidotomy Kit or Crickit®, due to potential contamination of the Povidien Iodine Prep Pads, manufactured by Triad Group. This recall is a follow up to the May 5, 2011 recall.

North American Rescue, LLC stated that it has successfully contacted 97% of its customers and requested its customers contact its customer service department for return instructions. North American Rescue, LLC also requests that all recipients who have further distributed these recalled devices to advise their customers to facilitate the removal of all affected product. North American Rescue also noted that this is its final attempt to reach out to customers who may still be in possession of these recalled and defective devices. Continue reading

Posted in Defective Medical Devices |

Study Flags Problem with Specific Zimmer NexGen Knee Tibial Component

A new study is reportedly raising more questions about Zimmer Holdings Corp.’s NexGen Knee replacement products. According to a report from Dow Jones Newswires, the single-center study, conducted by researchers at the Mayo Clinic, found that using a Zimmer NexGen knee with a specific type of tibial component can lead to destruction of the implant in a small number of recipients.

The new study is expected to be presented Thursday at a meeting of the American Academy of Orthopaedic Surgeons. The Dow Jones Newswires report did not specify the tibial component cited in the study, but a spokesperson for the company said that the component represents 1.2% of Zimmer’s tibial sales. Continue reading

Posted in Zimmer NexGen Knee Problems |

Raw Milk From Pennsylvania Sickens 35

Raw milk produced in Pennsylvania has sickened 35 people. All 35 consumed raw milk from the same dairy—The Family Cow Farm—located in Chambersburg, Pennsylvania, according to health officials there.

Of those confirmed ill with campylobacter bacterial infection, 28 people reside in Pennsylvania, four in Maryland, two in West Virginia, and one in New Jersey, wrote CBS News/The Associated Press (AP). Continue reading

Posted in Food Poisoning |

Louisiana Family Blames Zoloft for Child’s Birth Defects

A family in Louisiana has filed suit against Pfizer Inc. claiming the company’s antidepressant, Zoloft, was responsible for their child’s birth defects. In their Zoloft lawsuit, Terry and Nelda Rolling accuse Pfizer of failing to adequately warn of the drug’s risks, and of concealing, suppressing, and failing to disclose dangers.

According to the Rollings, Nelda took Zoloft during her pregnancy, and her child was later born with a congenital birth defect. Their complaint alleges that as early as 1996, Pfizer had information suggesting Zoloft could increase the risk of problems for children when taken during pregnancy, yet the drug maker failed to provide adequate warnings to consumers or the medical community. Evidence that Zoloft could harm a developing fetus continued to mount between 2002 and 2006. By 2007, due to the publication of a study in the New England Journal of Medicine, Pfizer knew or should have known that Zoloft and other SSRIs doubled the risk of septal heart defects when taken during pregnancy, the lawsuit claims. Continue reading

Posted in Pharmaceuticals, SSRI Antidepressants |

Furnace Recall Reissued Following Additional Fire Reports

A recall is being reissued on a previously recalled furnace over additional fire reports, the U.S. Consumer Product Safety Commission (CPSC) and Health Canada (HC) just announced.

The recalled Coleman, Coleman Evcon, and Red T Gas Furnaces for Manufactured Homes, which are involved in this reissued recall were manufactured in the United States from 1995 to 2000 and were sold, nationwide, between 1995 and 2000 as original equipment in manufactured homes and as replacement furnaces in manufactured homes. Continue reading

Posted in Legal News |

Recall Issued After Dietary Supplements Found to Contain Drug Ingredients

A recall of dietary supplements has been issued over potential contamination with drug ingredients, the U.S. Food and Drug Administration (FDA) just announced.

Healthy People Co. said it is recalling its dietary supplements sold under the brand Healthy People Co. and that the recall involves the following items: Continue reading

Posted in Pharmaceuticals, Product Recalls, Recalled Drugs |