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Author Archives: Jane Akre

J&J’ Deceptive Practices Brings $33 Mil Fine

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, May 25, 2017 ~ For years, the healthcare giant has faced scrutiny over the cleanliness of its plants that produce its over-the-counter products.   Now J&J must pay $33 million over its “deceptive practices.” Fierce Pharma breaks the story this afternoon (here) of the $33 million fine Johnson & [continue reading…]

Morcellator Activist, Victim Amy Reed Dies at 44

By Mesh Medical Device Newsdesk |

Mesh  Medical Device News Desk, May 25, 2017 ~ Drs. Amy Reed and Hooman Noorchashm put a public face on the failures of the U.S. Food and Drug Administration and how it regulates medical devices.  Amy Reed, the Philadelphia physician who put a public, tragic face on the outcome of unregulated medical devices has [continue reading…]

Senate Bill Restricts Gifts From Big Pharma

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, May 24, 2017 ~ A bill just passed the California state Senate that restricts Big Pharma gifts to medical professionals, with the goal of reducing conflicts of interest. SB 790 severely restricts pharmaceutical companies from providing consulting fees, entertainment, flights, speaking fees, all of which can make the recipient [continue reading…]

Scottish Mesh Inquiry Blows-Up

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, May 23, 2017 ~ An official mesh inquiry has blown up in Scotland, falling short of  protecting the public, claim campaigners. A story in the Sunday Post from reporter Marion Scott (here) says an independent inquiry will be conducted into conflicts of interest among authors of an official report that [continue reading…]

Kavaler Expert Witness for J&J on Stand in Beltz Mesh Trial

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, May 17, 2017~ Dr. Elizabeth Kavaler, a urogynecologist, appeared as an expert witness for Ethicon, a division of Johnson & Johnson, in a Philadelphia product liability trial over transvaginal mesh Wednesday. The defense presented her as a medical expert in the case of Beltz v. Ethicon. [*UPDATE-  The Beltz [continue reading…]

Does the FDA’s MAUDE Work?

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, May 17, 2017 ~ Does MAUDE work? MAUDE is the FDA’s central database that’s supposed to identify problems with medical devices that are on the market. Washington University did a review and found it was inadequate.  Printed on the website of Society of American Gastrointestsinal and Endoscopic Surgeons (SAGES),is [continue reading…]

Angel Flight May Help You

By Mesh Medical Device Newsdesk |

Please be aware if you need transportation to a doctor who specializes in treating injuries resulting from your medical device, Angel Flight may be there to help. Angel Flight West  is a nonprofit organization that arranges air travel for those with serious medical conditions.  There are 1,400 pilots located in 13 western states who donate [continue reading…]

Can You Change Your Law Firm?

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, May 15, 2017 ~ Can you change law firms if you are unhappy with your representation? Get your retainer agreement and look at the fine print is a first place to start.  When you research whether you can leave your law firm, most references are for attorneys. At least once [continue reading…]

Breast Implants and a Rare Cancer Possible Link to Biofilms

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, May 15, 2017 ~ Breast Implants, particularly textured variety, have been linked to biofilm and a small cell lymphoma. The FDA has been taking in accounts since 2011.    The New York Times on May 14th tells the story of a woman who had breast reconstructive surgery after a [continue reading…]

Beltz Pelvic Mesh Trial in Philadelphia- Will it be Fourth PA Court Loss for J&J?

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, May 11, 2017 ~ The case of Sharon Beltz began with jury selection Monday in the Philadelphia Court of Common Pleas, the same venue where there have been three straight losses for J&J over its transvaginal mesh, which includes $34.5 million in punitive damages Does this comport with the [continue reading…]

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